AS FILED WITH THE SECURITIES AND
EXCHANGE COMMISSION ON APRIL 7, 2006 REGISTRATION NO. 333-120784
================================================================================
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
----------------------
FORM SB-2/A
REGISTRATION STATEMENT UNDER THE SECURITIES ACT OF 1933
(AMENDMENT NO. 4)
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IR BIOSCIENCES HOLDINGS, INC.
(NAME OF SMALL BUSINESS ISSUER IN ITS CHARTER)
DELAWARE 2834 13-3301899
-------- ---- ----------
(STATE OR OTHER (PRIMARY STANDARD (I.R.S. EMPLOYER
JURISDICTION OF INDUSTRIAL CLASSIFICATION IDENTIFICATION NO.)
INCORPORATION OR CODE NUMBER)
ORGANIZATION)
4021 NORTH 75TH STREET, SUITE 201
SCOTTSDALE, ARIZONA 85251
(480) 922-3926
(ADDRESS AND TELEPHONE NUMBER OF PRINCIPAL EXECUTIVE OFFICES)
--------------------------------------
MICHAEL K. WILHELM, CHIEF EXECUTIVE OFFICER
4021 NORTH 75TH STREET, SUITE 201
SCOTTSDALE, ARIZONA 85251
(480) 922-3926
(NAME, ADDRESS AND TELEPHONE NUMBER OF AGENT FOR SERVICE)
--------------------------------------
COPIES TO
THOMAS J. POLETTI, ESQ.
ANH Q. TRAN, ESQ.
KIRKPATRICK & LOCKHART NICHOLSON GRAHAM LLP
10100 SANTA MONICA BLVD., 7TH FLOOR
LOS ANGELES, CA 90067
TELEPHONE (310) 552-5000 FACSIMILE (310) 552-5001
--------------------------------------
APPROXIMATE DATE OF PROPOSED SALE TO THE PUBLIC: From time to time after the
effective date of this Registration Statement
If any of the securities being registered on this form are to be offered on
a delayed or continuous basis pursuant to Rule 415 under the Securities Act of
1933, check the following box. |X|
If this form is filed to register additional securities for an offering
pursuant to Rule 462(b) under the Securities Act, check the following box and
list the Securities Act registration statement number of the earlier effective
registration statement for the same offering. |_|
If this form is a post-effective amendment filed pursuant to Rule 462(c)
under the Securities Act, check the following box and list the Securities Act
registration statement number of the earlier effective registration statement
for the same offering. |_|
If this form is a post-effective amendment filed pursuant to Rule 462(d)
under the Securities Act, check the following box and list the Securities Act
registration statement number of the earlier effective registration statement
the same offering. |_|
If delivery of the prospectus is expected to be made pursuant to Rule 434,
please check the following box. |_|
CALCULATION OF REGISTRATION FEE
==================================================================================================================================
PROPOSED MAXIMUM PROPOSED MAXIMUM
AMOUNT TO BE OFFERING PRICE AGGREGATE OFFERING AMOUNT OF
TITLE OF EACH CLASS OF SECURITIES TO BE REGISTERED REGISTERED (1) PER SHARE PRICE REGISTRATION FEE
----------------------------------------------------------------------------------------------------------------------------------
Common stock, $.001 par value (7) 33,075,843 $ 0.18(2) $ 5,953,652(2) $ 702
Common stock, $.001 par value (8) 10,019,600 0.18(2) 1,803,528(2) 241
Common stock, $.001 par value (7) 5,192,135 0.31(3) 1,609,562(3) 189
Common stock, $.001 par value (8) 5,432,891 0.31(3) 1,684,196(3) 198
Common stock, $.001 par value (7) 2,545,140 0.50(4) 1,272,570(4) 150
Common stock, $.001 par value (7) 1,928,400 0.23(5) 443,532(5) 52
Common stock, $.001 par value (7) 5,708,938 0.32(6) 1,826,860(6) 195
Common stock, $.001 par value (8) 642,800 0.32(6) 205,696(6) 22
========= =========
Total Registration Fee $ 1,749(9)
=========
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(Footnotes to table on next page)
(1) In accordance with Rule 416(a), the Registrant is also registering
hereunder an indeterminate number of additional shares of common stock
that shall be issuable pursuant to Rule 416 to prevent dilution resulting
from stock splits, stock dividends or similar transactions.
(2) Estimated pursuant to Rule 457(c) of the Securities Act of 1933 solely for
the purpose of computing the amount of the registration fee based on the
average of the bid and ask prices reported on the OTC Bulletin Board on
November 22, 2004.
(3) Estimated pursuant to Rule 457(c) of the Securities Act of 1933 solely for
the purpose of computing the amount of the registration fee based on the
average of the bid and ask prices reported on the OTC Bulletin Board on
July 19, 2005.
(4) Estimated pursuant to Rule 457(c) of the Securities Act of 1933 solely for
the purpose of computing the amount of the registration fee based on the
average of the bid and ask prices reported on the OTC Bulletin Board on
November 11, 2005.
(5) Estimated pursuant to Rule 457(c) of the Securities Act of 1933 solely for
the purpose of computing the amount of the registration fee based on the
average of the bid and ask prices reported on the OTC Bulletin Board on
February 16, 2006.
(6) Estimated pursuant to Rule 457(c) of the Securities Act of 1933 solely for
the purpose of computing the amount of the registration fee based on the
average of the bid and ask prices reported on the OTC Bulletin Board on
April 4, 2006.
(7) Represents shares of the Registrant's common stock being registered for
resale that have been issued to the selling stockholders named in the
prospectus or a prospectus supplement.
(8) Represents shares of the Registrant's common stock being registered for
resale that have been or may be acquired upon the exercise of warrants
issued to the selling stockholders named in the prospectus or a prospectus
supplement.
(9) Previously paid.
THE REGISTRANT HEREBY AMENDS THIS REGISTRATION STATEMENT ON SUCH DATE OR
DATES AS MAY BE NECESSARY TO DELAY ITS EFFECTIVE DATE UNTIL THE REGISTRANT
SHALL FILE A FURTHER AMENDMENT WHICH SPECIFICALLY STATES THAT THIS
REGISTRATION STATEMENT SHALL HEREAFTER BECOME EFFECTIVE IN ACCORDANCE WITH
SECTION 8(A) OF THE SECURITIES ACT OF 1933 OR UNTIL THE REGISTRATION
STATEMENT SHALL BECOME EFFECTIVE ON SUCH DATE AS THE COMMISSION, ACTING
PURSUANT TO SUCH SECTION 8(A), MAY DETERMINE.
PROSPECTUS
Subject to Completion, Dated April 7, 2006
--------------------------------------------------------------------------------
================================================================================
The information in this prospectus is not complete and may be changed. We may
not sell these securities until the registration statement filed with the
Securities and Exchange Commission is effective. This prospectus is not an offer
to sell these securities and we are not soliciting offers to buy these
securities in any state where the offer or sale is not permitted.
================================================================================
64,545,747 SHARES
IR BIOSCIENCES HOLDINGS, INC.
COMMON STOCK
This prospectus relates to 64,545,747 shares of common stock of IR
BioSciences Holdings, Inc. that may be sold from time to time by the selling
stockholders named in this prospectus. We will not receive any proceeds from the
sales by the selling stockholders, but we will receive funds from the exercise
of warrants held by selling stockholders, if exercised.
--------------------------------------
Our common stock is traded on the OTC Bulletin Board maintained by the
National Association of Securities Dealers, Inc. under the symbol "IRBO." On
April 4, 2006, the closing sales price for our common stock on the OTC Bulletin
Board was $0.30 per share.
--------------------------------------
THE SECURITIES OFFERED BY THIS PROSPECTUS INVOLVE A HIGH DEGREE OF
RISK. SEE "RISK FACTORS" BEGINNING ON PAGE 6.
--------------------------------------
Neither the Securities and Exchange Commission nor any state securities
commission has approved or disapproved of these securities or determined if this
prospectus is truthful or complete. Any representation to the contrary is a
criminal offense.
--------------------------------------
The date of this prospectus is ________________ ___, 2006
TABLE OF CONTENTS
Prospectus Summary.............................................................1
Risk Factors...................................................................6
Special Note Regarding Forward-looking Statements.............................17
Use of Proceeds...............................................................18
Dividend Policy...............................................................19
Management's Discussion and Analysis of Financial Condition
and Results of Operations...................................................19
Business......................................................................31
Management....................................................................55
Certain Relationships and Related Transactions................................62
Principal and Selling Stockholders............................................64
Description of Capital Stock..................................................92
Shares Eligible for Future Sale...............................................97
Plan of Distribution..........................................................98
Legal Matters................................................................100
Experts......................................................................101
Additional Information.......................................................101
Index to Financial Statements................................................F-1
--------------------
PROSPECTUS SUMMARY
This summary highlights some information from this prospectus, and it
may not contain all of the information that is important to you. You should read
the following summary together with the more detailed information regarding our
company and the common stock being sold in this offering, including "Risk
Factors" and our consolidated financial statements and related notes, included
elsewhere in this prospectus. All share and per share information included in
this prospectus has been adjusted for a 1-for-20 reverse split of our common
stock that we effected in July 2003 and a 2-for-1 forward stock split of our
common stock that we effected in April 2004.
OUR COMPANY
GENERAL
IR BioSciences Holdings, Inc. is a development-stage biopharmaceutical
company. Through our wholly owned subsidiary, ImmuneRegen BioSciences, Inc., we
are engaged in the research and development of potential therapeutics for a
number of applications. All therapeutics in development are based on Sar9, Met
(O2)11-Substance P, an analog of the naturally occurring human neuropeptide
Substance P. This neuropeptide can be found throughout the body, including in
the airways of humans and many other species. We use the generic name Homspera
to refer to the synthetic Sar9, Met (O2)11-Substance P peptide. All of our
research and development efforts are early, pre-clinical stage and Homspera has
only undergone exploratory studies to evaluate its biological activity in small
animals.
Currently, the majority of our development efforts are centered on two
potential therapeutic applications for the active ingredient in Homspera.
Radilex is being formulated specifically for the potential treatment of acute
exposure to radiation. Viprovex is being formulated specifically for potential
applications relating to the treatment of maladies caused by exposure to various
chemical and biological agents. We are currently sponsoring ongoing pre-clinical
studies in these areas, specifically two mouse radiation studies on the efficacy
of Radilex in treating acute radiation exposure and a mouse study on the
efficacy of Viprovex in treating exposure to anthrax. We are designing the
protocols for additional radiation studies in mice using Radilex. Additionally,
we are designing the protocols for an avian flu study in mice using Viprovex.
To date we have submitted preliminary study data to the U.S. Food and
Drug Administration (FDA) and have been issued two Pre-Investigational New Drug
(PIND) numbers, one for the potential use of Radilex in the treatment of acute
radiation syndrome and the other for the potential use of Viprovex in the
treatment of avian influenza. In addition, we have recently submitted a PIND
data package for the use of Viprovex in the potential treatment of chemical
exposure. We intend to file final radiation study data from mice with the FDA
within six months, and at this time we expect to request a meeting with the FDA
regarding the authorization of a large animal study protocol to test the
efficacy of Radilex as a potential treatment for acute radiation syndrome. Also
within the next six to twelve months, we plan to submit an Investigational New
Drug (IND) application for the potential use of Viprovex in treating Acute
Respiratory Distress Syndrome (ARDS).
We have filed patent applications and provisional patent applications,
where applicable, in many jurisdictions, inside and outside of the United
States, for the use of the active ingredient Sar9, Met (O2)11-Substance P in
applications that we are researching. We own two issued U.S. and two issued
foreign patents and two pending Patent Cooperation Treaty (PCT) applications,
seven pending U.S. provisional patent applications and 16 pending foreign
provisional patent applications.
Our current potential drug candidates, Radilex and Viprovex and other
technologies utilizing Homspera, are at early stages of development and may not
be shown to be safe or effective and may never receive regulatory approval.
Neither Radilex nor Viprovex nor our technologies utilizing Homspera have yet
been tested in large animals or humans. There is no guarantee that regulatory
authorities will ever permit large animal or human testing of Radilex, Viprovex
or any other potential products derived from Homspera. Even if such testing is
permitted, none of Radilex, Viprovex or any other potential drug candidates, if
any, derived from Homspera may be successfully developed or shown to be safe or
effective.
1
The results of our pre-clinical studies and clinical trials may not be
indicative of future clinical trial results. A commitment of substantial
resources to conduct time-consuming research, pre-clinical studies and clinical
trials will be required if we are to develop any commercial applications using
Homspera or any derivatives thereof. Delays in planned patient enrollment in our
future clinical trials may result in increased costs, program delays or both.
None of our potential applications or technologies may prove to be safe or
effective in clinical trials. Approval of the FDA, or other regulatory
approvals, including export license permissions, may not be obtained and even if
successfully developed and approved, our potential applications may not achieve
market acceptance. Any potential applications resulting from our programs may
not be successfully developed or commercially available for a number of years,
if at all.
To date, we have not obtained regulatory approval for or commercialized
any applications using Homspera or any of its derivatives. We have incurred
significant losses since our inception and we expect to incur annual losses for
at least the next three years as we continue with our drug research and
development efforts.
COMPANY HISTORY
We were originally incorporated in the State of Delaware in June 1985
under the name Vocaltech, Inc. to develop, design, manufacture and market
products utilizing proprietary speech-generated tactile feedback devices. We
completed our initial public offering of our securities in October 1987. In
January 1992, we effected a 1-for-6.3 reverse stock split of our common stock.
We changed our name to InnoTek, Inc. in November 1992. In December 1994, we
acquired all of the outstanding stock of InnoVisions, Inc., a developer and
marketer of skin protective products, discontinued our prior operations in their
entirety and changed our name to DermaRx Corporation. In April 2000, we effected
a reverse merger with a subsidiary of Go Public Network, Inc., which was engaged
in assisting early-stage development and emerging growth companies with
financial and business development services. We changed our name to
GoPublicNow.com, Inc., effected a 1-for-5 reverse stock split and discontinued
our prior operations in their entirety. In November 2000, we changed our name to
GPN Network, Inc. In July 2001, we discontinued the operations of GPN Network,
Inc. in their entirety and began looking for appropriate merger partners. Our
objective became the acquisition of an operating company with the potential for
growth in exchange for our securities. In July 2003, we effected a reverse
merger with ImmuneRegen BioSciences, Inc., adopted our current business model
and thereafter changed our name to IR BioSciences Holdings, Inc. In July 2003,
we effected a 1-for-20 reverse stock split, and in April 2004, we effected a
2-for-1 stock split. ImmuneRegen BioSciences, Inc. was incorporated in October
2002; all information contained herein refers to the operations of ImmuneRegen
BioSciences, Inc., our wholly-owned operational subsidiary.
RECENT DEVELOPMENTS
On March 10, 2006 we issued to our Chief Financial Officer, John N.
Fermanis, 100,000 registered common stock per the terms of his employment
agreement.
On August 10, 2005, we entered into a new employment agreement with our
President and Chief Executive Officer, Michael K. Wilhelm. The employment
agreement calls for a salary at the rate of $275,000 per annum and provides for
bonus incentives. Our Board of Directors granted 103,030 discretionary incentive
stock options to our Chief Executive Officer, Michael K. Wilhelm, per this new
employment agreement. The options have an exercise price of $0.33 and a term of
five years.
On May 20, 2005, our Board of Directors granted 150,000 discretionary
incentive stock options to our Chief Executive Officer, Michael K. Wilhelm, per
his employment agreement. The options have an exercise price of $0.44 and a term
of five years.
In January 2005, we made a tender offer to temporarily reduce the
exercise price of certain warrants issued in October 2004 from $0.50 to $0.20
per share. The tender offer expired on March 4, 2005. We accepted for exercise a
2
total of 6,600,778 warrants validly tendered and not withdrawn pursuant to the
terms of the tender offer, which represents approximately 48% of the aggregate
13,780,449 warrants that were subject to the offer.
On December 9, 2004 we filed for trademarks with US Patent and
Trademark Office (USPTO) for Homspera, Radilex and Viprovex. Federal trademark
applications are pending.
In October 2004, we completed a private placement, whereby we sold an
aggregate of $2,450,000 worth of units to accredited investors. Each unit was
sold for $10,000 and consisted of (a) a number of shares of our common stock
determined by dividing the unit price by $0.125, and (b) a warrant to purchase,
at any time prior to the fifth anniversary following the date of issuance of the
warrant, a number of shares of our common stock equal to fifty percent (50%) of
the number of shares included within the unit, at a price equal to $0.50 per
share of common stock. We issued in the private placement an aggregate of
19,600,000 shares of our common stock and warrants to purchase 9,800,000 shares
of our common stock. In consideration of the investment, we granted to each
investor certain registration rights and anti-dilution rights. We agreed to
register these shares along with the shares underlying these warrants within
ninety days from the closing date of the transaction, or we would incur a
penalty equivalent to an additional 2% of the shares and warrants to be
registered for every 30 days that we fail to complete this registration. This
penalty amounts to an aggregate of 461,200 shares and 181,600 warrants per 30
day period until such a time as a registration statement that includes these
shares and warrants is made effective. At March 31, 2006, we have accrued
liabilities to issue 6,625,907 shares of common stock and warrants to purchase
an additional 2,608,987 shares for total shares of 9,234,895. The original
values of these liabilities were $2,448,511 for the shares, and $744,177 for the
warrants for a total of $3,188,691. Additions for the quarter ended March 31,
2006 were 1,383,600 shares of common stock with a market value of approximately
$456,588 and warrants to purchase 544,800 shares of common stock with a value of
approximately $105,339.
Pursuant to the terms of a placement agency agreement, dated September
3, 2004, by and between us and Joseph Stevens & Co., Inc., we issued 4,900,000
shares of our common stock to Joseph Stevens & Co., Inc. or its designees, upon
the closing of the private placement. The shares were issued as consideration
for the services of Joseph Stevens & Co., Inc. as our placement agent in the
private placement.
Further to the private placement, we entered into a settlement
agreement with certain creditors whereby for full and complete satisfaction of
claims totaling an aggregate of $157,218, we issued to the creditors the
following: (a) a number of shares of our common stock determined by dividing the
$157,218 by $0.125, and (b) warrants to purchase, at any time prior to the fifth
anniversary following the date of issuance of the warrant, a number of shares of
our common stock equal to fifty percent (50%) of the number of shares described
above, at a price equal to $0.50 per share of common stock. The warrants are
identical to the warrants issued in the private placement. Pursuant to the
settlement we issued an aggregate of 1,257,746 shares of common stock and
warrants to purchase 628,873 shares of common stock. Under the terms of the
settlement agreement, the creditors released us from all claims, known or
unknown, relating to the $157,218 claim amount.
Between June 2003 and August 2004 eleven investors entered into fifteen
convertible promissory notes totaling $558,500 with interest rates ranging
between 8% and 12% and having various maturities. In October 2004, these notes
were converted into equity in the aggregate amount of $558,500 plus accrued
interest of $56,757. For full and complete satisfaction of debt, we issued to
the note holders the following: (a) a number of shares of our common stock
determined by dividing the debt amount by an amount between $0.075 and $0.125,
and (b) warrants to purchase, at any time prior to the fifth anniversary
following the date of issuance of the warrant, a number of shares of our common
stock equal to fifty percent (50%) of the number of shares described above, at a
price equal to $0.50 per share of common stock. The warrants are identical to
the warrants issued in the October 2004 private placement. Pursuant to the debt
conversion we issued an aggregate of 6,694,149 shares of common stock and
3
warrants to purchase 3,347,076 shares of common stock. Under the terms of the
conversion agreement, the note holders released us from all claims, known or
unknown, relating to the debt amount.
We also previously issued convertible promissory notes in the aggregate
principal amount of $35,000. On December 24, 2004 all outstanding principal and
accrued interest was forgiven by the noteholder. Consideration of $100.00 was
paid by us to the noteholder. Under the terms of the agreement, the noteholder
released us from all claims, known or unknown, relating to the amount owed.
Effective December 17, 2004, Eric Hopkins resigned from his position as
our Chief Financial Officer. Effective December 22, 2004, our Board of Directors
appointed John N. Fermanis to serve as our Chief Financial Officer. Our Board
resolved to issue 100,000 shares of registered common stock to Mr. Fermanis for
his acceptance of this position. These shares were issued to Mr. Fermanis in May
2005.
Effective December 22, 2004, Dr. Harris resigned from his position as a
member of our Board of Directors and a member of the Board of Directors of
ImmuneRegen BioSciences, Inc., our subsidiary
Effective December 22, 2004, Steven J. Scronic resigned from his
position as our Corporate Secretary. Effective December 22, 2004, our board of
directors appointed Michelle R. Laroche to serve as our Corporate Secretary.
THE OFFERING
Common stock offered by
selling stockholders................64,545,747 shares(1)
Common stock outstanding............69,536,322 shares(2)
Use of proceeds.....................We will not receive any proceeds from the
sale of the common stock, but we will
receive funds from the exercise of warrants
by selling stockholders, if exercised.
OTC Bulletin Board................. IRBO
----------
(1) Represents 54,351,234 shares of our common stock that were issued to
selling stockholders and 10,194,513 shares of our common stock
underlying warrants that were issued to selling stockholders.
(2) The number of shares of common stock outstanding as of April 4, 2006
listed above excludes:
o 63,212 shares of our common stock issuable upon exercise of
options at a weighted average exercise price of $25.00 per
share that were granted outside of our 2003 Stock Option,
Deferred Stock and Restricted Stock Plan;
o 150,000 shares of common stock issuable upon the exercise of
five-year purchase options at an exercise price of $0.44
granted under our 2003 Stock Option, Deferred Stock and
Restricted Stock Plan;
o 103,030 shares of common stock issuable upon the exercise of
five-year purchase options at an exercise price of $0.33
granted under our 2003 Stock Option, Deferred Stock and
Restricted Stock Plan;
o 1,000 shares of common stock issuable upon the exercise of
five-year purchase options at an exercise price of $0.31
granted under our 2003 Stock Option, Deferred Stock and
Restricted Stock Plan;
o 11,616,869 shares of our common stock issuable upon exercise
of warrants with exercise prices ranging from $0.01 to $2.00
per share; and
o 183,530 shares of common stock that have been approved for
issuance by our Board of Directors that are not yet issued.
The total number of shares of common stock offered for resale by the
selling stockholders listed in this prospectus includes 6,456,800 shares of
issued and outstanding common stock and 2,542,400 shares of common stock
issuable upon the exercise of five-year warrants with an exercise price of $0.50
4
issued in connection with a penalty clause regarding the registration of shares
sold in our private placement in October 2004. For each 30-day period beyond
90-days following the second closing date (October 26, 2004), we have agreed to
issue to the holders of units sold in the private placement an additional 2% a
month, or in aggregate 461,200 shares and 181,600 warrants until such a time as
this Registration Statement is declared effective by the Securities and Exchange
Commission. We have committed these shares although they remain unissued.
SUMMARY FINANCIAL INFORMATION
The following summary financial information has been derived from the
financial statements that are included elsewhere in this prospectus. You should
read this information in conjunction with "Management's Discussion and Analysis
of Financial Condition and Results of Operations" and the financial statements
and the related notes thereto included elsewhere in this prospectus.
For the Period
For the For the October 30,
Year Ended Year Ended 2002 (Inception)
December 31, December 31, to December 31,
2005 2004 2005
------------ ------------ ------------
Operating expenses:
Selling, general and administrative expenses $ 2,534,417 $ 4,498,390 $ 8,124,301
Merger fees and costs -- -- 350,000
Financing cost -- -- 90,000
Impairment of intangible asset 6,393 -- 6,393
------------ ------------ ------------
Total operating expenses 2,540,810 4,498,390 8,570,694
------------ ------------ ------------
Operating loss (2,540,810) (4,498,390) (8,570,694)
Other expense:
Cost of penalty for late registration of shares 2,630,761 -- 2,630,761
Gain from marking to market - warrant portion
of penalty for late registration of shares (254,693) -- (254,693)
Gain from marking to market - stock portion
of penalty for late registration of shares (314,385) -- (314,385)
Interest (income) expense, net (11,386) 807,017 1,166,757
------------ ------------ ------------
Total other (income) expense (2,050,297) 807,017 3,228,440
------------ ------------ ------------
Loss before income taxes (4,591,107) (5,305,407) (11,799,134)
Provision for income taxes -- -- --
------------ ------------ ------------
Net loss $ (4,591,107) $ (5,305,407) $(11,799,134)
============ ============ ============
Net loss per share - basic and diluted $ (0.07) $ (0.16) $ (0.30)
============ ============ ============
Weighted average shares outstanding -
basic and diluted 67,691,598 33,510,168 38,934,503
ADDITIONAL INFORMATION
We are incorporated in State of Delaware. Our executive offices are
located at 4021 N. 75th Street, Suite 201, Scottsdale, Arizona 85251. Our
telephone number is (480) 922-3926. We maintain a website at
www.immuneregen.com. The reference to our worldwide web address does not
constitute incorporation by reference of the information contained on our
website.
In this prospectus, the terms "we," "us," the "Company," and "our"
refer to IR BioSciences Holdings, Inc., a Delaware corporation, and its
consolidated subsidiary, as appropriate in the context, and, unless the context
otherwise requires, "common stock" refers to the common stock, par value $0.001
per share, of IR BioSciences Holdings, Inc.
5
RISK FACTORS
Any investment in our common stock involves a high degree of risk. You
should carefully consider the risks described below and all of the information
contained in this prospectus before deciding whether to purchase our common
stock. The risks described below are all of the material risks that are facing
our company. If any of the following risks actually occur, our business,
financial condition and results of operations could be harmed. The trading price
of our common stock could decline, and you may lose all or part of your
investment in our common stock.
RISKS RELATED TO OUR FINANCIAL RESULTS
WE HAVE LIMITED CASH RESOURCES, AN ACCUMULATED DEFICIT, ARE NOT CURRENTLY
PROFITABLE AND EXPECT TO INCUR SIGNIFICANT EXPENSES IN THE NEAR FUTURE.
As of December 31, 2005, we had a working capital deficit of
$2,273,444. This amount consists of cash of $265,860 and current assets of
$24,507, accounts payable of $243,703, accrued current liabilities of $258,426
and an accrued current liability of $2,061,683 related to a penalty for the late
registration of the securities sold in our October 2004 private placement. We
anticipate settling this late registration penalty in additional shares of
common stock and warrants to purchase additional shares of common stock. If this
non-cash liability were to be removed from our working capital position as of
December 31, 2005, we would have a working capital deficit of $211,761. We have
incurred a substantial net loss for the period from our inception in October
2002 to December 31, 2005, and are currently experiencing negative cash flow. We
expect to continue to experience negative cash flow and operating losses through
at least 2009 and possibly thereafter. As a result, we will need to generate
significant revenues to achieve profitability.
WE MAY FAIL TO BECOME AND REMAIN PROFITABLE OR WE MAY BE UNABLE TO FUND OUR
CONTINUING LOSSES, IN WHICH CASE OUR BUSINESS MAY FAIL.
We are focused on product development and have not generated any
revenue to date. We do not believe we will begin earning revenues from
operations until the calendar year 2009 as we transition from a development
stage company. We have incurred operating losses since our inception. Our net
loss for the fiscal year ended December 31, 2005 was $4,591,107. As of December
31, 2005, we had an accumulated deficit of $11,799,134.
OUR INDEPENDENT OUTSIDE AUDITORS HAVE RAISED SUBSTANTIAL DOUBT ABOUT OUR ABILITY
TO CONTINUE AS A GOING CONCERN.
Our independent certified public accountants have stated in their report
included in this Form 10-KSB/A that the Company has incurred a net loss and
negative cash flows from operations of $4,591,107 and $1,884,113, respectively,
for the year ended December 31, 2005, and a lack of operational history, among
other matters, that raise substantial doubt about its ability to continue as a
going concern, which contemplates, among other things, the realization of assets
and satisfaction of liabilities in the normal course of business. The effect of
this going concern would materially and adversely affect our ability to raise
capital, our relationship with potential suppliers and customers, and have other
unforeseen effects.
WE WILL BE REQUIRED TO RAISE ADDITIONAL CAPITAL TO FUND OUR OPERATIONS. IF WE
CANNOT RAISE NEEDED ADDITIONAL CAPITAL IN THE FUTURE, WE WILL BE REQUIRED TO
CEASE OPERATIONS.
Based on our current plans, we believe our existing financial
resources, and interest earned thereon, will be sufficient to meet our operating
expenses and capital requirements through April 2006. However, changes in our
research and development plans or other events affecting our operating expenses
may result in the expenditure of such cash before that time. We estimate that we
will require approximately $5 million over the next 12 months in order to
finance our research and development efforts, fund operating expenses, pursue
regulatory clearances and prosecute and defend our intellectual property rights.
We may seek such additional funding through public or private financing or
through collaborative arrangements with strategic partners.
You should be aware that in the future:
o we may not obtain additional financial resources when necessary or
on terms favorable to us, if at all; and
o any available additional financing may not be adequate.
6
If we cannot raise additional funds when needed, or on acceptable
terms, we will not be able to continue to develop our drug candidates. We
require substantial working capital to fund our operations. Since we do not
expect to generate significant revenues in the foreseeable future, in order to
fund operations, we will be completely dependent on additional debt and equity
financing arrangements. There is no assurance that any financing will be
sufficient to fund our capital expenditures, working capital and other cash
requirements beyond April 2006. Our working capital deficit as of December 31,
2005 was $211,761 net of the accrual of securities pursuant to the penalty
provision of our October 2004 private placement. No assurance can be given that
any such additional funding will be available or that, if available, can be
obtained on terms favorable to us. If we are unable to raise needed funds on
acceptable terms, we will not be able to develop or enhance our products, take
advantage of any future opportunities or respond to competitive pressures or
unanticipated requirements. A material shortage of capital will require us to
take drastic steps such as reducing our level of operations, disposing of
selected assets or seeking an acquisition partner. If cash is insufficient, we
will not be able to continue operations.
WE HAVE DEFERRED, AND MAY CONTINUE TO DEFER, PAYMENT OF SOME OF OUR OBLIGATIONS,
WHICH MAY ADVERSELY AFFECT OUR ABILITY TO OBTAIN GOODS AND SERVICES IN THE
FUTURE.
We estimate that we will require approximately $5 million to meet our
expenses for the next 12 months. Until such time, if at all, as we receive
adequate funding, we intend to defer payment of all of our obligations that are
capable of being deferred. Such deferment has resulted in the past, and may
result in the future, in some vendors demanding cash payment for their goods and
services in advance, and other vendors refusing to continue to do business with
us, which may adversely affect our ability to obtain goods and services in the
future, or to do so on favorable terms.
WE WILL NEED TO CONDUCT SIGNIFICANT ADDITIONAL RESEARCH, PRECLINICAL TESTING AND
CLINICAL TESTING AND EXPECT TO INCUR LOSSES AS WE RESEARCH, DEVELOP AND SEEK
REGULATORY APPROVALS FOR OUR POTENTIAL PRODUCTS.
All of our research and development efforts are early, pre-clinical
stage and Homspera has only undergone exploratory studies to evaluate its
biological activity in small animals. We will need to conduct significant
additional research, pre-clinical testing and clinical testing before we can
file applications with the FDA for approval of our product candidates. To date
we have not yet made applications with the FDA or any other governmental
regulatory agency for approval for our drug candidates, nor have we been in a
position to seek such approval. Until such time as we are able to file a New
Drug Application (NDA),and it is subsequently approved, we will not be able to
market or manufacture any products.
If our potential products fail in clinical trials or do not gain
regulatory approval, or if our products do not achieve market acceptance, we
will not be profitable. If we fail to become and remain profitable, or if we are
unable to fund our continuing losses, our business may fail. In addition, to
compete effectively, any future products must be easy to use, cost-effective and
economical to manufacture on a commercial scale. We may not achieve any of these
objectives.
OUR OPERATING EXPENSES ARE UNPREDICTABLE, WHICH MAY ADVERSELY AFFECT OUR
BUSINESS, OPERATIONS AND FINANCIAL CONDITION.
As a result of our limited operating history and because of the
emerging nature of the markets in which we will compete, our financial data is
of limited value in planning future operating expenses. To the extent our
operating expenses precede or are not rapidly followed by increased revenue, our
business, results of operations and financial condition may be materially
adversely affected. Our expense levels will be based in part on our expectations
concerning future revenues. We currently anticipate that a significant portion
of any revenue would be derived from Radilex and Viprovex; however, the size and
extent of such revenues, if any, are wholly dependent upon the choices and
demand of individuals, which are difficult to forecast accurately. We may be
unable to adjust our operations in a timely manner to compensate for any
unexpected shortfall in revenues. Further, business development and marketing
expenses may increase significantly as we expand our operations.
RISKS RELATED TO OUR BUSINESS
IF OUR PLAN IS NOT SUCCESSFUL OR MANAGEMENT IS NOT EFFECTIVE, THE VALUE OF OUR
COMMON STOCK MAY DECLINE.
7
Our operating subsidiary, ImmuneRegen BioSciences, Inc., was founded in
October 2002. As a result, we are a development stage company with a limited
operating history that makes it impossible to reliably predict future growth and
operating results. Our business and prospects must be considered in light of the
risks and uncertainties frequently encountered by companies in their early
stages of development. In particular, we have not demonstrated that we can:
o ensure that any potential drug candidate would function as intended
in large animal studies or human clinical applications;
o obtain the regulatory approvals necessary to commercialize products
that we may develop in the future;
o manufacture, or arrange for third-parties to manufacture, future
products in a manner that will enable us to be profitable;
o establish many of the business functions necessary to operate,
including sales, marketing, administrative and financial functions,
and establish appropriate financial controls;
o make, use, and sell future products without infringing upon third
party intellectual property rights; or
o respond effectively to competitive pressures.
We cannot be sure that we will be successful in meeting these
challenges and addressing these risks and uncertainties. If we are unable to do
so, our business will not be successful.
IF WE DO NOT OBTAIN GOVERNMENT REGULATORY APPROVAL FOR OUR PRODUCTS, WE CANNOT
SELL OUR PRODUCTS AND WE WILL NOT GENERATE REVENUES.
Our principal development efforts are currently centered on Radilex and
Viprovex, which are potential drug candidates derived from Homspera. All drug
candidates require U.S. Food and Drug Administration ("FDA") and foreign
government approvals before they can be commercialized. These regulations change
from time to time and new regulations may be adopted. Our research and
development efforts for our drug candidates are at a very early stage; they have
not been, and may not be, approved for commercial sale by the FDA or any other
governmental regulatory agency. We may incur significant additional operating
losses over the next several years as we fund development, clinical testing and
other expenses while seeking regulatory approval. To date we have conducted
limited pre-clinical studies of our potential drug candidates using various
small animal models; significant additional trials are required, and we may not
be able to demonstrate that these drug candidates are safe or effective. If we
are unable to demonstrate the safety and effectiveness of a particular drug
candidate to the satisfaction of regulatory authorities, the drug candidate will
not obtain required government approval. If we do not receive FDA or foreign
approvals for our products, we will not be able to sell our potential products
and will not generate revenues. Even if we receive regulatory approval of a
potential product, such approval may impose limitations on the indicated uses
for which we may market the product, which may limit our ability to generate
significant revenues.
ALL OUR APPLICATIONS ARE DERIVED FROM THE USE OF HOMSPERA. IF HOMSPERA IS FOUND
TO BE UNSAFE OR INEFFECTIVE, OUR BUSINESS WOULD BE MATERIALLY HARMED.
Our current potential drug candidates, Radilex and Viprovex, are
derived from Homspera. In addition, we plan to utilize Homspera in the
development of any future products we market. If these current or future product
candidates are found to be unsafe or ineffective due to the use of Homspera, we
may have to modify or cease production of the products. As all of our
applications utilize or will utilize Homspera, any findings that Homspera is
unsafe or ineffective would severely harm our business operations, since all of
our primary revenue sources would be negatively affected by such findings.
IF WE FAIL TO SUCCESSFULLY DEVELOP AND COMMERCIALIZE PRODUCTS, WE WILL HAVE TO
CEASE OPERATIONS.
Our failure to develop and commercialize products successfully will
cause us to cease operations. Our current potential drug candidates, Radilex and
Viprovex, will require significant additional research and development efforts
and regulatory approvals prior to potential commercialization in the future. We
cannot guarantee that we will ever obtain any regulatory approvals of Homspera,
Radilex or Viprovex. We currently are focusing our core competencies on the
development of Radilex and Viprovex although there may be no assurance that we
8
will be successful in so doing.
Our current potential drug candidates, Radilex, Viprovex and our
technologies utilizing Homspera are at early stages of development and may not
be shown to be safe or effective and may never receive regulatory approval.
Neither Radilex nor Viprovex nor our technologies utilizing Homspera have yet
been tested in large animals or humans. Regulatory authorities may not permit
large animal or human testing of Radilex, Viprovex or any other potential
products derived from Homspera. Even if large animal or human testing is
permitted, none of Radilex, Viprovex or any other potential drug candidate, if
any, derived from Homspera may be successfully developed or shown to be safe or
effective.
The results of our pre-clinical studies may not be indicative of future
pre-clinical or clinical trial results. A commitment of substantial resources to
conduct time-consuming research, pre-clinical studies and clinical trials will
be required if we are to develop any products. Delays in planned patient
enrollment in our clinical trials may result in increased costs, program delays
or both. None of our potential products or technologies may prove to be safe or
effective in clinical trials. Approval of the FDA, or other regulatory
approvals, including export license permissions, may not be obtained and even if
successfully developed and approved, our potential products may not achieve
market acceptance. Any potential products resulting from our programs may not be
successfully developed or commercially available for a number of years, if at
all.
Moreover, unacceptable toxicity or side effects could occur at any time
in the course of human clinical trials or, if any products are successfully
developed and approved for marketing, during commercial use of any of our
proposed products. The appearance of any unacceptable toxicity or side effects
could interrupt, limit, delay or abort the development of any of our proposed
products or, if previously approved, necessitate their withdrawal from the
market.
THE MARKET FOR TREATING ASPECTS OF ACUTE RADIATION SYNDROME AND EXPOSURE TO
VARIOUS CHEMICAL AND BIOLOGICAL AGENTS IS UNCERTAIN AND IF WE ARE UNABLE TO
SUCCESSFULLY COMMERCIALIZE RADILEX OR VIPROVEX, WE WILL NOT RECOGNIZE A
SIGNIFICANT PORTION OF OUR FUTURE REVENUES, IF ANY.
We do not believe any drug has ever been approved and commercialized
for the treatment of severe acute radiation injury. In addition, the incidence
of large-scale exposure to nuclear, radiological or biological agents has been
low. Accordingly, even if Radilex, our current drug candidate to treat aspects
of acute radiation syndrome (ARS) and Viprovex, our drug candidate to treat
exposure to various biological agents, are approved by the FDA, we cannot
predict with any certainty the size of the markets for them, if any. The
potential market for Radilex and Viprovex is largely dependent on the size of
stockpiling orders, if any, procured by the U.S. and foreign governments. While
a number of governments have historically stockpiled drugs to treat indications
such as smallpox, anthrax exposure, plague, tularemia and certain long-term
effects of radiation exposure, we are unaware of any significant stockpiling
orders for drugs to treat ARS.
To date, although we have filed formal responses to governmental
grants, Request for Information (RFI) and Request for Proposal (RFP) for
therapeutics to treat ARS and exposure to various chemical and biological
agents, none have resulted in funding, stockpiling orders or a commitment to
purchase our potential products, if any. Additionally, we cannot guarantee that
our response to any future RFI, RFP or other grant application will result in
funding, stockpiling orders or a commitment to purchase our potential products,
if any.
Any decision by the U.S. Government to enter into a commitment to
purchase Radilex or Viprovex prior to FDA approval is largely out of our
control. Our development plans and timelines may vary substantially depending on
whether we receive such a commitment and the size of such commitment, if any. In
addition, even if Radilex or Viprovex is approved by regulatory authorities, we
cannot guarantee that we will receive any stockpiling orders for Radilex or
Viprovex, that any such order would be profitable to us or that Radilex or
Viprovex will achieve market acceptance by the general public.
THE LENGTHY PRODUCT APPROVAL PROCESS AND UNCERTAINTY OF GOVERNMENT REGULATORY
REQUIREMENTS MAY DELAY OR PREVENT US FROM COMMERCIALIZING PROPOSED PRODUCTS, AND
THEREFORE ADVERSELY AFFECT THE TIMING AND LEVEL OF FUTURE REVENUES, IF ANY.
The process of obtaining FDA and other regulatory approvals is time
9
consuming, expensive and difficult to design and implement. Our current drug
candidates, Radilex and Viprovex, will have to undergo clinical trials and the
marketing and manufacturing of these drug candidates, if any, will be subject to
rigorous testing procedures. Our research and development efforts are at a very
early stage and Radilex and Viprovex have only undergone pre-clinical testing in
mice. We may not be able to obtain the necessary approvals for clinical trials,
manufacturing or marketing of Radilex and Viprovex or any other potential
products, if any, derived from Homspera. Moreover, any significant delays in
clinical trials will impede our ability to commercialize our applications and
generate revenue and could significantly increase our development costs. The
commencement and completion of clinical trials for Radilex, Viprovex or any
other potential products, if any, derived from Homspera, could be delayed or
prevented by a variety of factors, including:
o delays in obtaining regulatory approvals to commence a study;
o delays in identifying and reaching agreement on acceptable terms
with prospective clinical trial sites;
o delays in the enrollment of patients;
o lack of efficacy during clinical trials; or,
o unforeseen safety issues.
Even if marketing approval from the FDA is received, the FDA may impose
post-marketing requirements, such as:
o labeling and advertising requirements, restrictions or limitations,
including the inclusion of warnings, precautions, contra-indications
or use limitations that could have a material impact on the future
profitability of our applications;
o testing and surveillance to monitor our future products and their
continued compliance with regulatory requirements;
o submitting products for inspection and, if any inspection reveals
that the product is not in compliance, prohibiting the sale of all
products;
o suspending manufacturing; or,
o withdrawing marketing clearance.
Additionally, the FDA's policies may change and additional government
regulations may be enacted which could prevent or delay regulatory approval of
our applications. We cannot predict the likelihood, nature or extent of adverse
government regulation that may arise from future legislation or administrative
action, either in the United States or abroad. If we are not able to maintain
regulatory compliance, we might not be permitted to market our potential future
products and our business could suffer.
Even if human clinical trials of Radilex, Viprovex or any other
potential products, if any, derived from Homspera are initiated and successfully
completed, the FDA may not approve any of them for commercial sale. We may
encounter significant delays or excessive costs in our efforts to secure
necessary approvals. Regulatory requirements are evolving and uncertain. Future
United States or foreign legislative or administrative acts could also prevent
or delay regulatory approval of our products. We may not be able to obtain the
necessary approvals for clinical trials, manufacturing or marketing of any of
our potential products under development. Even if commercial regulatory
approvals are obtained, they may include significant limitations on the
indicated uses for which a product may be marketed.
The FDA has not designated expanded access protocols for Radilex or
Viprovex as "treatment" protocols. The FDA may not determine that Radilex or
Viprovex meet all of the FDA's criteria for use of an investigational drug for
treatment use. Even if Radilex or Viprovex are allowed for treatment use, third
party payers may not provide reimbursement for the costs of treatment with any
of them. The FDA also may not consider Radilex or Viprovex to be an appropriate
candidate for acceptance as Emergency Use Authorization for Promising Medical
Countermeasures Under Development, accelerated approval, expedited review or
fast track designation.
IF WE FAIL TO OBTAIN APPROVAL FROM FOREIGN REGULATORY AUTHORITIES, WE WILL NOT
BE ALLOWED TO MARKET OR SELL OUR POTENTIAL PRODUCTS IN OTHER COUNTRIES, WHICH
10
WOULD ADVERSELY AFFECT OUR LEVELS OF FUTURE REVENUES, IF ANY.
Marketing any drug products outside of the United States will subject
us to numerous and varying foreign regulatory requirements governing the design
and conduct of human clinical trials and marketing approval. Additionally, our
ability to export our potential drug candidates outside the United States on a
commercial basis will be subject to the receipt from the FDA of export
permission, which may not be available on a timely basis, if at all.
Approval procedures vary among countries and can involve additional
testing, and the time required to obtain approval may differ from that required
to obtain FDA approval. Foreign regulatory approval processes include all of the
risks associated with obtaining FDA approval set forth above, and approval by
the FDA does not ensure approval by the health authorities of any other country.
CLINICAL TRIALS MAY FAIL TO DEMONSTRATE THE SAFETY AND EFFICACY OF OUR POTENTIAL
DRUG CANDIDATES, THE EFFECT OF WHICH COULD PREVENT OR SIGNIFICANTLY DELAY
REGULATORY APPROVAL AND THEREFORE ADVERSELY AFFECT THE TIMING AND LEVEL OF
FUTURE REVENUES, IF ANY.
Prior to receiving approval to commercialize Radilex, Viprovex or any
other potential products, if any, derived from Homspera, we must demonstrate
with substantial evidence from well-controlled clinical trials, and to the
satisfaction of the FDA and other regulatory authorities in the United States
and abroad, that they are both safe and effective. We will need to demonstrate
such potential products' efficacy and monitor their safety throughout the
process. If any future clinical trials are unsuccessful, our business and
reputation would be harmed and our stock price would be adversely affected.
All of our applications are prone to the risks of failure inherent in
biologic development. The results of early-stage clinical trials of our
applications do not necessarily predict the results of later-stage clinical
trials. Applications in later-stage clinical trials may fail to show desired
safety and efficacy traits despite having progressed through initial clinical
testing. Even if we believe the data collected from clinical trials of our
applications is promising, this data may not be sufficient to support approval
by the FDA or any other U.S. or foreign regulatory approval. Pre-clinical and
clinical data can be interpreted in different ways. Accordingly, FDA officials
could interpret such data in different ways than we do, which could delay, limit
or prevent regulatory approval. The FDA, other regulatory authorities, or we may
suspend or terminate clinical trials at any time. Any failure or significant
delay in completing clinical trials for our applications, or in receiving
regulatory approval for the sale of any products resulting from our
applications, may severely harm our business and reputation.
DELAYS IN THE CONDUCT OR COMPLETION OF OUR PRE-CLINICAL OR CLINICAL STUDIES OR
THE ANALYSIS OF THE DATA FROM OUR PRE-CLINICAL OR CLINICAL STUDIES MAY RESULT IN
DELAYS IN OUR PLANNED FILINGS FOR REGULATORY APPROVALS OR ADVERSELY AFFECT OUR
ABILITY TO ENTER INTO COLLABORATIVE ARRANGEMENTS.
We may encounter problems with some or all of our completed or ongoing
studies that may cause us or regulatory authorities to delay or suspend our
ongoing studies or delay the analysis of data from our completed or ongoing
studies. If the results of our ongoing and planned studies for our drug
candidates are not available when we expect or if we encounter any delay in the
analysis of the results of our studies for our drug candidates:
o we may not have the financial resources to continue research and
development of any of our drug candidates; and,
o we may not be able to enter into collaborative arrangements relating
to any drug candidate subject to delay in regulatory filing.
Any of the following reasons, among others, could delay or suspend the
completion of our ongoing and future studies:
o delays in enrolling volunteers;
o interruptions in the manufacturing of our drug candidates or other
delays in the delivery of materials required for the conduct of our
studies;
o lower than anticipated retention rate of volunteers in a trial;
o unfavorable efficacy results;
11
o serious side effects experienced by study participants relating to
the drug candidate;
o new communications from regulatory agencies about how to conduct
these studies; or,
o failure to raise additional funds.
IF THE MANUFACTURERS OF OUR PRODUCTS DO NOT COMPLY WITH CURRENT GOOD
MANUFACTURING PRACTICES REGULATIONS, OR CANNOT PRODUCE THE AMOUNT OF PRODUCTS WE
NEED TO CONTINUE OUR DEVELOPMENT, WE WILL FALL BEHIND ON OUR BUSINESS
OBJECTIVES.
The manufacture of our product candidates or any future products,
whether done by outside contractors as planned or internally, must comply with
current Good Manufacturing Practices, or cGMP, regulations enforced by the FDA
and foreign equivalents. If a manufacturer of our drug candidates does not
conform to the cGMP regulations and cannot be brought up to such a standard, we
will be required to find alternative manufacturers that do conform. This may be
a long and difficult process, and may delay our ability to receive FDA or
foreign regulatory approval of our products.
We also rely on our manufacturers to supply us with a sufficient
quantity of our drug candidates to conduct clinical trials. If we have
difficulty in the future obtaining our required quantity and quality of such
supply, we could experience significant delays in our development programs and
regulatory process.
OUR LACK OF COMMERCIAL MANUFACTURING, SALES, DISTRIBUTION AND MARKETING
EXPERIENCE MAY PREVENT US FROM SUCCESSFULLY COMMERCIALIZING PRODUCTS, WHICH
WOULD ADVERSELY AFFECT OUR LEVEL OF FUTURE REVENUES, IF ANY.
The manufacturing process of Radilex, Viprovex or any other potential
products, if any, derived from Homspera is expected to involve a number of steps
and requires compliance with stringent quality control specifications imposed by
us and by the FDA. We have no experience in the sales, marketing and
distribution of pharmaceutical or biotechnology products and we have not
manufactured any of the limited quantities of Radilex and Viprovex used in our
studies to date. We may not successfully arrange for contract manufacturing of
Radilex, Viprovex or any other potential products, if any, derived from Homspera
in production quantities and this could prevent us from commercializing products
or limit our profitability from any such proposed products.
WE RELY ON THIRD PARTY MANUFACTURERS FOR THE MANUFACTURE OF RADILEX, VIPROVEX
AND HOMSPERA. OUR INABILITY TO MANUFACTURE RADILEX, VIPROVEX AND HOMSPERA, AND
OUR DEPENDENCE ON SUCH MANUFACTURERS, MAY DELAY OR IMPAIR OUR ABILITY TO
GENERATE REVENUES, OR ADVERSELY AFFECT OUR PROFITABILITY.
We may enter into arrangements with contract manufacturing companies in
order to meet requirements for Radilex, Viprovex and Homspera or to attempt to
improve manufacturing efficiency. If we choose to contract for manufacturing
services, we may encounter costs, delays and/or other difficulties in producing,
packaging and distributing our clinical trials and finished product, if any.
Further, contract manufacturers must also operate in compliance with the cGMP
requirements; failure to do so could result in, among other things, the
disruption of our proposed product supplies. Our planned dependence upon third
parties for the manufacture of our proposed products may adversely affect our
potential profit margins, if any, and our ability to develop and deliver
proposed products on a timely and competitive basis.
For the manufacture of Radilex, Viprovex and Homspera, we obtain
synthetic peptides from third party manufacturers. If any of these proposed
manufacturing operations prove inadequate, there may be no assurance that any
other arrangements may be established on a timely basis or that we could
establish other manufacturing capacity on a timely basis. Although, we believe
that the synthetic substance P and other materials necessary to produce Radilex,
Viprovex and Homspera are readily available from various sources, and several
suppliers are capable of supplying Homspera in both clinical and commercial
quantities, our dependence on such manufacturers, may delay or impair our
ability to generate revenues, or adversely affect our profitability.
ADVERSE DETERMINATIONS CONCERNING PRODUCT PRICING, REIMBURSEMENT AND RELATED
MATTERS COULD PREVENT US FROM SUCCESSFULLY COMMERCIALIZING RADILEX, VIPROVEX AND
HOMSPERA WHICH WOULD ADVERSELY AFFECT OUR LEVEL OF FUTURE REVENUES, IF ANY.
Our ability to earn any revenue on Radilex, Viprovex or any other
12
potential products, if any, derived from Homspera will depend in part on the
extent to which reimbursement for the costs of such products and related
treatments will be available from government health administration authorities,
private health coverage insurers, managed care organizations and other
organizations. Failure to obtain appropriate reimbursement may prevent us from
successfully commercializing Radilex, Viprovex or any other potential products,
if any, derived from Homspera. Third-party payers are increasingly challenging
the prices of medical products and services. If purchasers or users of Radilex,
Viprovex or any such other potential products, if any, derived from Homspera are
not able to obtain adequate reimbursement for the cost of using such products,
they may forego or reduce their use. Significant uncertainty exists as to the
reimbursement status of newly approved health care products and whether adequate
third party coverage will be available.
THE MEDICAL COMMUNITY MAY NOT ACCEPT AND UTILIZE RADILEX, VIPROVEX OR ANY OTHER
POTENTIAL PRODUCT, IF ANY, DERIVED FROM HOMSPERA, THE EFFECT OF WHICH WOULD
PREVENT US FROM SUCCESSFULLY COMMERCIALIZING ANY PROPOSED PRODUCT AND ADVERSELY
AFFECT OUR LEVEL OF FUTURE REVENUE, IF ANY.
Our ability to market and commercialize Radilex, Viprovex or any other
potential product, if any, derived from Homspera depends on the acceptance of
potential drug candidates based on Homspera by the medical community. We will
need to develop commercialization initiatives designed to increase awareness
about us and Homspera among targeted audiences, including public health
activists and community-based outreach groups in addition to the investment
community. Currently, we have not developed any such initiatives. Without such
acceptance of potential drug candidates based on Homspera, we may not be able to
successfully commercialize any proposed products or generate revenue.
PRODUCT LIABILITY EXPOSURE MAY EXPOSE US TO SIGNIFICANT LIABILITY OR COSTS WHICH
WOULD ADVERSELY IMPART OUR FUTURE OPERATING RESULTS AND DIVERT FUNDS FROM THE
OPERATION OF OUR BUSINESS.
We face an inherent business risk of exposure to product liability and
other claims and lawsuits in the event that the development or use of our
technology or prospective products is alleged to have resulted in adverse
effects. We may not be able to avoid significant liability exposure. We may not
have sufficient insurance coverage, and we may not be able to obtain sufficient
coverage at a reasonable cost. An inability to obtain product liability
insurance at acceptable cost or to otherwise protect against potential product
liability claims could prevent or inhibit the commercialization of our products.
A product liability claim could hurt our financial performance. Even if we avoid
liability exposure, significant costs could be incurred that could hurt our
financial performance.
WE MAY FAIL TO PROTECT ADEQUATELY OUR PROPRIETARY TECHNOLOGY, WHICH WOULD ALLOW
COMPETITORS TO TAKE ADVANTAGE OF OUR RESEARCH AND DEVELOPMENT EFFORTS, THE
EFFECT OF WHICH COULD ADVERSELY AFFECT ANY COMPETITIVE ADVANTAGE WE MAY HAVE.
We own two issued U.S. and two issued foreign patents and two pending
Patent Cooperation Treaty (PCT) applications, seven pending U.S. provisional
patent applications and 16 pending foreign provisional patent applications. Our
success will depend in part on our ability to obtain additional United States
and foreign patent protection for our drug candidates and processes, preserve
our trade secrets and operate without infringing the proprietary rights of third
parties. We place considerable importance on obtaining patent protection for
significant new technologies, products and processes.
Our long-term success largely depends on our ability to market
technologically competitive processes and products. If we fail to obtain or
maintain these protections, we may not be able to prevent third parties from
using our proprietary rights. Our currently pending or future patent
applications may not result in issued patents. In the United States, patent
applications are confidential until patent applications are published or the
patent is issued, and because third parties may have filed patent applications
for technology covered by our pending patent applications without us being aware
of those applications, our patent applications may not have priority over any
patent applications of others. In addition, our issued patents may not contain
claims sufficiently broad to protect us against third parties with similar
technologies or products or provide us with any competitive advantage. If a
third party initiates litigation regarding our patents, and is successful, a
court could revoke our patents or limit the scope of coverage for those patents.
Legal standards relating to the validity of patents covering
pharmaceutical and biotechnology inventions and the scope of claims made under
such patents are still developing. In some of the countries in which we intend
13
to market our products, pharmaceuticals are either not patentable or have only
recently become patentable. Past enforcement of intellectual property rights in
many of these countries has been limited or non-existent. Future enforcement of
patents and proprietary rights in many other countries may be problematic or
unpredictable. Moreover, the issuance of a patent in one country does not assure
the issuance of a similar patent in another country. Claim interpretation and
infringement laws vary by nation, so the extent of any patent protection is
uncertain and may vary in different jurisdictions. The U.S. Patent and Trademark
Office, commonly referred to as the USPTO, and the courts have not consistently
treated the breadth of claims allowed in biotechnology patents. If the USPTO or
the courts begin to allow broader claims, the incidence and cost of patent
interference proceedings and the risk of infringement litigation will likely
increase. On the other hand, if the USPTO or the courts begin to allow narrower
claims, the value of our proprietary rights may be limited. Any changes in, or
unexpected interpretations of the patent laws may adversely affect our ability
to enforce our patent position.
We also rely upon trade secrets, proprietary know-how and continuing
technological innovation to remain competitive. We protect this information with
reasonable security measures, including the use of confidentiality agreements
with our employees, consultants and corporate collaborators. It is possible that
these individuals will breach these agreements and that any remedies for a
breach will be insufficient to allow us to recover our costs. Furthermore, our
trade secrets, know-how and other technology may otherwise become known or be
independently discovered by our competitors.
OUR PATENTS AND PROPRIETARY TECHNOLOGY MAY NOT BE ENFORCEABLE AND THE PATENTS
AND PROPRIETARY TECHNOLOGY OF OTHERS MAY PREVENT US FROM COMMERCIALIZING
PRODUCTS, WHICH WOULD ADVERSELY AFFECT OUR LEVEL OF FUTURE REVENUES, IF ANY.
Although we believe our proprietary technology to be protected and our
patents enforceable, the failure to obtain meaningful patent protection for our
potential products and processes would greatly diminish the value of our
potential products and processes.
In addition, whether or not our applications are issued, or issued with
limited coverage, others may receive patents that contain claims applicable to
our potential products. Patents we are not aware of may adversely affect our
ability to develop and commercialize any potential products.
The patent positions of biotechnology and pharmaceutical companies are
often highly uncertain and involve complex legal and factual questions.
Therefore, the breadth of claims allowed in biotechnology and pharmaceutical
patents cannot be predicted. We also rely upon non-patented trade secrets and
know how, and others may independently develop substantially equivalent trade
secrets or know how. We also rely on protecting our proprietary technology in
part through confidentiality agreements with our current and former corporate
collaborators, employees, consultants and certain contractors. These agreements
may be breached, and we may not have adequate remedies for any such breaches.
Litigation may be necessary to defend against claims of infringement, to enforce
our patents or to protect trade secrets. Litigation could result in substantial
costs and diversion of management efforts regardless of the results of the
litigation. An adverse result in litigation could subject us to significant
liabilities to third parties, require disputed rights to be licensed or require
us to cease using certain technologies.
Our potential products could infringe on the intellectual property
rights of others, which may cause us to engage in costly litigation and, if not
successful, could cause us to pay substantial damages and prohibit us from
selling our products. Because patent applications in the United States are not
publicly disclosed until the patent application is published or the patent is
issued, applications may have been filed which relate to services similar to
those offered by us. We may be subject to legal proceedings and claims from time
to time in the ordinary course of our business, including claims of alleged
infringement of the trademarks and other intellectual property rights of third
parties.
If our potential products violate third-party proprietary rights, we
cannot assure you that we would be able to arrange licensing agreements or other
satisfactory resolutions on commercially reasonable terms, if at all. Any claims
made against us relating to the infringement of third-party proprietary rights
could result in the expenditure of significant financial and managerial
resources and injunctions preventing us from providing services. Such claims
could severely harm our financial condition and ability to compete.
In addition, if another party claims the same subject matter or subject
14
matter overlapping with the subject matter that we have claimed in a United
States patent application or patent, we may decide or be required to participate
in interference proceedings in the USPTO in order to determine the priority of
invention. Loss of such an interference proceeding would deprive us of patent
protection sought or previously obtained and could prevent us from
commercializing our potential products. Participation in such proceedings could
result in substantial costs, whether or not the eventual outcome is favorable.
These additional costs could adversely affect our financial results.
FAILURE TO COMPLY WITH ENVIRONMENTAL LAWS OR REGULATIONS COULD EXPOSE US TO
SIGNIFICANT LIABILITY OR COSTS WHICH WOULD ADVERSELY IMPACT OUR OPERATING
RESULTS AND DIVERT FUNDS FROM THE OPERATION OF OUR BUSINESS HAVE A MATERIAL
ADVERSE EFFECT ON OUR BUSINESS.
We may be required to incur significant costs to comply with current or
future environmental laws and regulations. Our research and development
processes involve the controlled storage, use and disposal of hazardous
materials, biological hazardous materials and radioactive compounds. We are
subject to federal, state and local laws and regulations governing the use,
manufacture, storage, handling and disposal of these materials and some waste
products. Although we believe that our safety procedures for handling and
disposing of these materials comply with the standards prescribed by these laws
and regulations, the risk of contamination or injury from these materials cannot
be completely eliminated. In the event of an incident, IR BioSciences Holdings,
Inc. or ImmuneRegen BioSciences, Inc. could be held liable for any damages that
result, and any liability could exceed our resources. Current or future
environmental laws or regulations may have a material adverse effect on our
operations, business and assets.
WE DEPEND ON THE CONTINUED SERVICES OF OUR EXECUTIVE OFFICERS AND THE LOSS OF A
KEY EXECUTIVE COULD SEVERELY IMPACT OUR OPERATIONS.
The execution of our present business plan depends on the continued
services of Michael K. Wilhelm, our Chief Executive Officer and President. We
currently maintain a key-man insurance policy for $1,000,000, payable to the
company, on his life. While we have entered into employment agreements with Mr.
Wilhelm, the loss of any of his services would be detrimental to us and could
have a material adverse effect on our business, financial condition and results
of operations.
OUR EXECUTIVE OFFICERS, DIRECTORS AND PRINCIPAL STOCKHOLDERS CONTROL OUR
BUSINESS AND MAY MAKE DECISIONS THAT ARE NOT IN OUR BEST INTERESTS.
Our officers, directors and principal stockholders, and their
affiliates, in the aggregate, own over a majority of the outstanding shares of
our common stock. As a result, such persons, acting together, have the ability
to substantially influence all matters submitted to our stockholders for
approval, including the election and removal of directors and any merger,
consolidation or sale of all or substantially all of our assets, and to control
our management and affairs. Accordingly, such concentration of ownership may
have the effect of delaying, deferring or preventing a change in ownership,
discouraging a potential acquirer from making a tender offer or otherwise
attempting to obtain control of our business, even if such a transaction would
be beneficial to other stockholders.
RISKS RELATED TO THIS OFFERING
A LIMITED PRIOR PUBLIC MARKET AND TRADING MARKET MAY CAUSE VOLATILITY IN THE
PRICE OF OUR COMMON STOCK AND THUS ADVERSELY AFFECT THE VALUE OF YOUR
INVESTMENT.
Our common stock is currently traded on a limited basis on the OTC
Bulletin Board (the "OTCBB") under the symbol "IRBO". The OTCBB is an
inter-dealer, Over-The-Counter market that provides significantly less liquidity
than the NASDAQ Stock Market. Quotes for stocks included on the OTCBB are not
listed in the financial sections of newspapers as are those for the NASDAQ Stock
Market. Therefore, prices for securities traded solely on the OTCBB may be
difficult to obtain and holders of common stock may be unable to resell their
securities at or near their original offering price or at any price.
The NASD has enacted recent changes that limit quotations on the OTCBB
to securities of issuers that are current in their reports filed with the
Securities and Exchange Commission. The effect on the OTCBB of these rule
changes and other proposed changes cannot be determined at this time.
The quotation of our common stock on the OTCBB does not assure that a
meaningful, consistent and liquid trading market currently exists, and in recent
15
years such market has experienced extreme price and volume fluctuations that
have particularly affected the market prices of many smaller companies like us.
Our common stock is thus subject to this volatility.
SALES OR ISSUANCES OF ADDITIONAL EQUITY SECURITIES MAY ADVERSELY AFFECT THE
MARKET PRICE OF OUR COMMON STOCK AND YOUR RIGHTS IN US MAY BE REDUCED.
Certain of our stockholders have the right to register securities for
resale that they hold pursuant to registration rights agreements. We expect to
continue to incur product development and selling, general and administrative
costs, and in order to satisfy our funding requirements, we will need to sell
additional equity securities, which may be subject to similar registration
rights. The sale or the proposed sale of substantial amounts of our common stock
in the public markets may adversely affect the market price of our common stock.
An aggregate of 64,545,747 shares of our common stock are being registered with
the SEC in the registration statement. The registration and subsequent sales of
such shares of common stock will likely have an adverse effect on the market
price of our common stock.
The registration and subsequent sales of shares of our common stock
will likely have an adverse effect on the market price of our common stock. From
time to time, certain stockholders of our company may be eligible to sell all or
some of their shares of common stock by means of ordinary brokerage transactions
in the open market pursuant to Rule 144, promulgated under the Act ("Rule 144"),
subject to certain limitations. In general, pursuant to Rule 144, a stockholder
(or stockholders whose shares are aggregated) who has satisfied a one-year
holding periods may, under certain circumstances, sell within any three-month
period a number of securities which does not exceed the greater of 1% of the
then outstanding shares of our common stock or the average weekly trading volume
of the class during the four calendar weeks prior to such sale. Rule 144 also
permits, under certain circumstances, the sale of securities, without any
limitations, by a non-affiliate of our company who has satisfied a two-year
holding period. Any substantial sale of our common stock pursuant to Rule 144 or
pursuant to any resale prospectus may have an adverse effect on the market price
of our securities.
Our stockholders may experience substantial dilution and a reduction in
the price that they are able to obtain upon sale of their shares. Also, any new
equity securities issued, including any new series of preferred stock authorized
by our Board of Directors, may have greater rights, preferences or privileges
than our existing common stock. To the extent stock is issued or options and
warrants are exercised, holders of our common stock will experience further
dilution. In addition, as in the case of the warrants, in the event that any
future financing should be in the form of, be convertible into or exchangeable
for, equity securities and upon the exercise of options and warrants, security
holders may experience additional dilution.
The 366,420 shares of our common stock, and 450,000 shares of our
common stock issuable upon warrants presently issued and outstanding as of the
date hereof are held by promoters of our prior company, GPN Networks, Inc., or
such promoters' affiliates and assignees, or their transferees. It should be
noted that because GPN Network, Inc. was a "blank check" company as that term is
defined under the Securities Act, these shares may not be sold by these
promoters or their affiliates and assignees, or their transferees, pursuant to
Rule 144 of the Securities Act. The position of the staff of the Division of
Corporation Finance of the Securities and Exchanges Commission is that any such
resale transaction under Rule 144 would appear to be designed to distribute or
redistribute such shares to the public without coming within the registration
requirements of the Securities Act. Therefore, these promoters or their
affiliates and assignees, or their transferees, can only resell the shares they
hold as of the date hereof through a registration statement filed under the
Securities Act. All of these shares are being registered hereunder.
THERE IS NO CAP ON THE SHARES AND WARRANTS WE MAY ISSUE PURSUANT TO THE DELAYED
REGISTRATION PENALTY PROVISION UNDER THE OCTOBER 2004 PRIVATE PLACEMENT, WHICH
MAY ADVERSELY AFFECT THE MARKET PRICE OF OUR STOCK.
Under the October 2004 private placement, we agreed to register the
shares sold in the transaction, along with the shares underlying the warrants
sold within ninety days from the closing date of the private placement. If these
securities were not so registered, we would incur a penalty equivalent to an
additional 2% of the shares and warrants to be registered for every 30 days that
we failed to complete the registration. Through March 31, 2006, we have accrued
6,625,987 shares and 2,608,987 warrants pursuant to this penalty provision. No
cap exists to limit the penalty for failure to register the shares and warrants
in the October 2004 private placement. Accordingly, the amount of additional
16
equity securities we issue pursuant to the delayed registration penalty may
adversely affect the market price of our common stock and the rights of our
stockholders may be substantially reduced. Moreover, our authorized capital
consists of 100,000,000 shares of common stock. As of March 31, 2006, we have
fully diluted 90,633,160 shares of common stock outstanding. Therefore, because
no cap exists to limit the issuance of penalty shares, we may not have a
sufficient number of authorized shares available for the settlement of the
registration penalty. As a result, the investors entitled to these shares may
take legal or other action against us, which may cause us to pay substantial
damages and adversely affect our business.
OUR COMMON STOCK IS CONSIDERED A "PENNY STOCK," AND IS SUBJECT TO ADDITIONAL
SALE AND TRADING REGULATIONS THAT MAY MAKE IT MOVE DIFFICULT TO SELL.
Our common stock is considered to be a "penny stock" since it does not
qualify for one of the exemptions from the definition of "penny stock" under
Section 3a51-1 of the Securities Exchange Act for 1934 as amended (the "Exchange
Act"). Our common stock is a "penny stock" because it meets one or more of the
following conditions (i) the stock trades at a price less than $5.00 per share;
(ii) it is NOT traded on a "recognized" national exchange; (iii) it is NOT
quoted on the Nasdaq Stock Market, or even if so, has a price less than $5.00
per share; or (iv) is issued by a company that has been in business less than
three years with net tangible assets less than $5 million.
The principal result or effect of being designated a "penny stock" is
that securities broker-dealers participating in sales of our common stock will
be subject to the "penny stock" regulations set forth in Rules 15-2 through
15g-9 promulgated under the Exchange Act. For example, Rule 15g-2 requires
broker-dealers dealing in penny stocks to provide potential investors with a
document disclosing the risks of penny stocks and to obtain a manually signed
and dated written receipt of the document at least two business days before
effecting any transaction in a penny stock for the investor's account. Moreover,
Rule 15g-9 requires broker-dealers in penny stocks to approve the account of any
investor for transactions in such stocks before selling any penny stock to that
investor. This procedure requires the broker-dealer to (i) obtain from the
investor information concerning his or her financial situation, investment
experience and investment objectives; (ii) reasonably determine, based on that
information, that transactions in penny stocks are suitable for the investor and
that the investor has sufficient knowledge and experience as to be reasonably
capable of evaluating the risks of penny stock transactions; (iii) provide the
investor with a written statement setting forth the basis on which the
broker-dealer made the determination in (ii) above; and (iv) receive a signed
and dated copy of such statement from the investor, confirming that it
accurately reflects the investor's financial situation, investment experience
and investment objectives. Compliance with these requirements may make it more
difficult and time consuming for holders of our common stock to resell their
shares to third parties or to otherwise dispose of them in the market or
otherwise.
NOTE REGARDING THIS PROSPECTUS
------------------------------
Please read this prospectus carefully. It describes our business, our
financial condition and results of operations. We have prepared this prospectus
so that you will have the information necessary to make an informed investment
decision.
You should rely on the information contained in this prospectus. We
have not authorized anyone to provide you with information different from that
contained in this prospectus. The selling stockholders are offering to sell
shares of our common stock and seeking offers to buy shares of our common stock
only in jurisdictions where offers and sales are permitted. The information
contained in this prospectus is accurate only as of the date of the prospectus,
regardless of the time the prospectus is delivered or the common stock is sold.
SPECIAL NOTE REGARDING FORWARD-LOOKING STATEMENTS
In addition to historical information, this prospectus contains
statements relating to our future business and/or results, including, without
limitation, the statements under the captions "Summary," "Risk Factors,"
"Management's Discussion and Analysis of Financial Condition and Results of
Operations" and "Business." These statements include certain projections and
business trends that are "forward-looking" within the meaning of the United
States Private Securities Litigation Reform Act of 1995 (the "PSLRA"). The safe
harbor for forward-looking statements under the PSLRA does not apply to our
company. You can identify these statements by the use of words like "may,"
17
"could," "should," "project," "believe," "anticipate," "expect," "plan,"
"estimate," "forecast," "potential," "intend," "continue" and variations of
these words or comparable words. Forward-looking statements do not guarantee
future performance and involve risks and uncertainties. Actual results will
differ, and may differ materially, from projected results as a result of certain
risks and uncertainties. These risks and uncertainties include, without
limitation, those described under "Risk Factors" and those detailed from time to
time in our filings with the SEC, and include, among others, the following:
o Our ability to raise additional funding and the amounts raised, if
any;
o Our ability to successfully develop and commercialize any other
proposed products, if any, derived from Homspera;
o A lengthy approval process and the uncertainty of FDA and other
government regulatory requirements may have a material adverse
effect on our ability to commercialize Radilex, Viprovex or any
other proposed product, if any, derived from Homspera;
o Clinical trials may fail to demonstrate the safety and effectiveness
of Radilex, Viprovex or any other proposed product, if any, derived
from Homspera, which could have a material adverse effect on our
ability to obtain government regulatory approval;
o The degree and nature of our competition;
o The shares and warrants that we accrue due to the delayed
registration penalty provision under the October 2004 private
placement;
o Our ability to employ and retain qualified employees; and
o The other factors referenced in this prospectus, including, without
limitation, under the sections entitled "Risk Factors,"
"Management's Discussion and Analysis of Financial Condition and
Results of Operations," and "Business."
Other sections of this prospectus may include additional factors which
could adversely impact our business and financial performance. Moreover, we
operate in a very competitive and rapidly changing environment. New risk factors
emerge from time to time and it is not possible for our management to predict
all risk factors, nor can we assess the impact of all factors on our business or
to the extent to which any factor, or combination of factors, may cause actual
results to differ materially from those contained in any forward-looking
statements. Given these risks and uncertainties, investors should not place
undue reliance on forward-looking statements as a prediction of actual results.
These forward-looking statements are made only as of the date of this
prospectus. Except for our ongoing obligation to disclose material information
as required by federal securities laws, we do not intend to update you
concerning any future revisions to any forward-looking statements to reflect
events or circumstances occurring after the date of this prospectus.
USE OF PROCEEDS
We will not receive any proceeds from the sale of the shares of common
stock by the selling stockholders, but we will receive funds from the exercise
of warrants held by selling stockholders, if exercised.
MARKET FOR COMMON STOCK AND RELATED STOCKHOLDER MATTERS
Our common stock is approved for quotation on the NASD OTC Bulletin
Board under the symbol "IRBO". The following table sets forth the high and low
bid prices for our common stock for the periods noted, as reported by the
National Daily Quotation Service and the Over-The-Counter Bulletin Board.
Quotations reflect inter-dealer prices, without retail mark-up, markdown or
commission and may not represent actual transactions.
2006
----------------------------------
High Low
-------------- --------------
1st Quarter (through April 4, 2006) $ 0.35 $ 0.20
18
2005
----------------------------------
High Low
-------------- --------------
1st Quarter $ 1.00 $ 0.33
2nd Quarter 0.52 0.26
3rd Quarter 0.48 0.28
4th Quarter 0.52 0.19
2004
---------------------------------
High Low
-------------- --------------
1st Quarter $ 1.00 $ 0.32
2nd Quarter* 0.51 0.11
3rd Quarter 0.19 0.09
4th Quarter 0.40 0.15
-------
* Effected 2-for-1 forward stock split in April 2004.
On April 4, 2006, the closing price of our common stock as reported by
the OTC Bulletin Board was $0.30 per share. There were approximately 520
shareholders of record and beneficial stockholders of our common stock as of
March 10, 2006. We have not paid any dividends on our common stock since
inception and do not intend to do so in the foreseeable future.
DIVIDEND POLICY
We have not declared or paid any cash dividends on our common stock,
and we currently intend to retain future earnings, if any, to finance the
expansion of our business, and we do not expect to pay any cash dividends in the
foreseeable future. The decision whether to pay cash dividends on our common
stock will be made by our Board of Directors, in their discretion, and will
depend on our financial condition, operating results, capital requirements and
other factors that the Board of Directors considers significant. We have never
declared or paid any dividends on our securities. We currently intend to retain
our earnings for funding growth and, therefore, do not expect to pay any
dividends in the foreseeable future.
MANAGEMENT'S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION
AND RESULTS OF OPERATIONS
This prospectus contains forward-looking statements within the meaning
of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the
Securities Exchange Act of 1934, as amended. Please note that the safe harbor
for forward-looking statements under the Securities Act of 1933 and the
Securities Exchange Act do not apply to our company. Our actual results could
differ materially from those set forth as a result of general economic
conditions and changes in the assumptions used in making such forward-looking
statements. The following discussion and analysis of our financial condition and
results of operations should be read together with the audited consolidated
financial statements and accompanying notes and the other financial information
appearing elsewhere in this prospectus. The analysis set forth below is provided
pursuant to applicable Securities and Exchange Commission regulations and is not
intended to serve as a basis for projections of future events.
Except for historical information contained herein, the matters
discussed in this prospectus are forward-looking statements that are subject to
certain risks and uncertainties that could cause actual results to differ
materially from those set forth in such forward-looking statements. Such
forward-looking statements may be identified by the use of certain
forward-looking terminology, such as "may," "expect," "anticipate," "intend,"
"estimate," "believe," or comparable terminology that involves risks or
uncertainties. Actual future results and trends may differ materially from
historical and anticipated results, which may occur as a result of a variety of
factors. Such risks and uncertainties include, without limitation, factors
discussed in management's discussion and analysis of financial condition and
results of operations set forth below, as well as in "risk factors" set forth
herein. Except for our ongoing obligation to disclose material information as
required by federal securities laws, we do not intend to update you concerning
any future revisions to any forward-looking statements to reflect events or
circumstances occurring after the date of this prospectus.
OVERVIEW
We were originally incorporated in the State of Delaware in June 1985
under the name Vocaltech, Inc. to develop, design, manufacture and market
19
products utilizing proprietary speech-generated tactile feedback devices. We
completed our initial public offering of our securities in October 1987. In
January 1992, we effected a 1-for-6.3 reverse stock split of our common stock.
We changed our name to InnoTek, Inc. in November 1992. In December 1994, we
acquired all of the outstanding stock of InnoVisions, Inc., a developer and
marketer of skin protective products, discontinued our prior operations in their
entirety and changed our name to DermaRx Corporation. In April 2000, we effected
a reverse merger with a subsidiary of Go Public Network, Inc., which was engaged
in assisting early-stage development and emerging growth companies with
financial and business development services. We changed our name to
GoPublicNow.com, Inc., effected a 1-for-5 reverse stock split and discontinued
our prior operations in their entirety. In November 2000, we changed our name to
GPN Network, Inc. In July 2001, we discontinued the operations of GPN Network,
Inc. in their entirety and began looking for appropriate merger partners. Our
objective became the acquisition of an operating company with the potential for
growth in exchange for our securities. In July 2003, we effected a reverse
merger with ImmuneRegen BioSciences, Inc., adopted our current business model
and thereafter changed our name to IR BioSciences Holdings, Inc. In July 2003,
we effected a 1-for-20 reverse stock split, and in April 2004, we effected a
2-for-1 stock split. ImmuneRegen BioSciences, Inc. was incorporated in October
2002; all information contained herein refers to the operations of ImmuneRegen
BioSciences, Inc., our wholly-owned operational subsidiary.
GENERAL
IR BioSciences Holdings, Inc. is a development-stage biopharmaceutical
company. Through our wholly owned subsidiary, ImmuneRegen BioSciences, Inc., we
are engaged in the research and development of potential therapeutics for a
number of applications. All potential therapeutics in development are based on
Sar9, Met (O2)11-Substance P, an analog of the naturally occurring human
neuropeptide Substance P. This neuropeptide can be found throughout the body,
including in the airways of humans and many other species. We use the generic
name Homspera to refer to the synthetic Sar9, Met (O2)11-Substance P peptide.
All of our research and development efforts are early, pre-clinical stage and
Homspera has only undergone exploratory studies to evaluate its biological
activity in small animals.
Currently, the majority of our development efforts are centered on two
potential therapeutic applications for the active ingredient in Homspera.
Radilex is being formulated specifically for the potential treatment of acute
exposure to radiation. Viprovex is being formulated specifically for potential
applications relating to the treatment of maladies caused by exposure to various
chemical and biological agents. We are currently sponsoring ongoing pre-clinical
studies in these areas, specifically two mouse radiation studies on the efficacy
of Radilex in treating acute radiation exposure and a mouse study on the
efficacy of Viprovex in treating exposure to anthrax. In addition, we have
designed the protocols for additional radiation studies in mice using Radilex
and an avian flu study in mice using Viprovex.
To date we have submitted preliminary study data to the U.S. Food and
Drug Administration (FDA) and have been issued two Pre-Investigational New Drug
(PIND) numbers, one for use of Homspera (now Radilex) in the treatment of acute
radiation syndrome and the other for use of Viprovex in the treatment of avian
influenza. In addition, we have recently submitted a PIND data package for the
use of Viprovex in the treatment of chemical exposure. We intend to file final
radiation study data from mice with the FDA within six months, and at that time
we plan to request a meeting with the FDA regarding the authorization of a large
animal study protocol to test the efficacy of Radilex as a treatment for acute
radiation syndrome. Also within the next six months, we plan to submit an
Investigational New Drug (IND) application for the use of Viprovex in treating
Acute Respiratory Distress Syndrome (ARDS)
We have filed patent applications and provisional patent applications,
where applicable, in many jurisdictions, inside and outside of the United
States, for the use of the active ingredient Sar9, Met (O2)11-Substance P in
applications that we are researching. We own two issued U.S. and two issued
foreign patents and two pending Patent Cooperation Treaty (PCT) applications,
seven pending U.S. provisional patent applications and 16 pending foreign
provisional patent applications.
Our current potential drug candidates, Radilex and Viprovex and other
technologies utilizing Homspera, are at early stages of development and may not
be shown to be safe or effective and may never receive regulatory approval.
Neither Radilex nor Viprovex nor our technologies utilizing Homspera have yet
been tested in large animals or humans. There is no guarantee that regulatory
20
authorities will ever permit large animal or human testing of Radilex, Viprovex
or any other potential products derived from Homspera. Even if such testing is
permitted, none of Radilex, Viprovex or any other potential drug candidates, if
any, derived from Homspera may be successfully developed or shown to be safe or
effective.
The results of our preclinical studies and clinical trials may not be
indicative of future clinical trial results. A commitment of substantial
resources to conduct time-consuming research, preclinical studies and clinical
trials will be required if we are to develop any commercial applications using
Homspera or any derivates thereof. Delays in planned patient enrollment in our
clinical trials may result in increased costs, program delays or both. None of
our potential applications may prove to be safe or effective in clinical trials.
Approval of the FDA or other regulatory approvals, including export license
permissions, may not be obtained and even if successfully developed and
approved, our potential applications may not achieve market acceptance. Any
applications resulting from our programs may not be successfully developed or
commercially available for a number of years, if at all.
As traditional efficacy studies would require healthy human volunteers
to be exposed to the potentially lethal agents or pathogens, this cannot be
done. Therefore, we may apply for approval based upon a new rule adopted by the
FDA in 2002, titled "Approval of New Drugs When Human Efficacy Studies Are Not
Ethical or Feasible" (Code of Federal Regulations, Title 21, Part 314, Subpart
I), which is also referred to as the "animal efficacy rule." Pursuant to this
new rule, in situations where it would be unethical to conduct traditional Phase
II and Phase III efficacy studies in humans, as is the case with our
applications relating to the treatment of maladies caused by exposure to high
level gamma radiation and various chemical and biological agents, the FDA will
review new drugs for approval on the basis of safety in humans and efficacy in
relevant animal models. Through development under this paradigm, management
believes near-term development opportunities may exist and development costs are
lessened compared to the more traditional drug development model, as Phase II
and Phase III of the FDA required drug approval process are not required. Under
either scenario, we will not have marketable applications unless and until our
drug candidates complete all required safety studies and clinical trials and
receive FDA approval in the United States or approval by regulatory agencies
outside of the United States.
Prior to FDA approval, Radilex and Viprovex may become eligible for
purchase by the U.S. government. Project BioShield legislation contains
provisions enabling the U.S. Department of Health and Human Services, or HHS, to
begin purchasing new medical countermeasures for the Strategic National
Stockpile in advance of formal FDA approval. This provision, known as an
Emergency Use Authorization, has already been implemented for other development
stage medical countermeasures to weapons of mass destruction. In that our
studies, in the opinion of management, indicate that Radilex may have efficacy
in the treatment of the life-threatening effects of radiation exposure and
Viprovex to exposure to various biological and chemical agents, we believe there
may be interest by government agencies to stockpile Radilex and/or Viprovex if
it is successfully developed. However, there is no assurance that any of such
orders will be forthcoming and we have received no indication from Project
BioShield or any other agency that it intends to purchase any quantities of
Radilex or Viprovex.
To date, we have not obtained regulatory approval for or commercialized
any applications using Homspera or any of its derivatives. We have incurred
significant losses since our inception and we expect to incur annual losses for
at least the next 3 years as we continue with our drug discovery and development
efforts.
PLAN OF OPERATIONS
We expect to continue to incur increasing operating losses for the
foreseeable future, primarily due to our continued research and development
activities attributable to Radilex, Viprovex or any other proposed product, if
any, derived from Homspera and general and administrative activities.
Due to our liquidity and limited cash available our spending on
research and development activities in the years ended December 31, 2004 and
2005 was limited. We spent approximately $113,731 and $150,091 in 2005 and 2004,
respectively, in research and development activities related to the development
of Radilex and Viprovex as potential protectants against the effects of
chemical, biological, radiological and nuclear threats. From our inception in
October 2002, we have spent $306,794 in research and development activities.
These costs only include the manufacture and delivery of our drug by third party
manufacturers and payments to Contract Research Organizations for consulting
21
related to our studies and costs of performing such studies. Significant costs
relating to research and development, such as consulting fees for Drs. Witten
and Siegel, among others, have been classified in consulting fees for
consistency of financial reporting.
We anticipate that during the next 12 months we will increase our
research and development spending to a total of approximately $3,500,000 in an
effort to further develop Radilex and Viprovex. The drug development, clinical
trial and regulatory process is lengthy, expensive and uncertain and subject to
numerous risks including, without limitation, the following risks discussed
under "Risk Factors" - "All Our Applications Are All Derived From The Use Of
Homspera. If Homspera Is Found To Be Unsafe Or Ineffective, Our Business Would
Be Materially Harmed.," "If We Fail To Successfully Develop And Commercialize
Products, We Will Have To Cease Operations.;" and, "The Lengthy Product Approval
Process And Uncertainty Of Government Regulatory requirements may delay or
prevent us from commercializing proposed products, and therefore adversely
affect the timing and level of future revenues, if any."
PRODUCT RESEARCH AND DEVELOPMENT
We incurred an expense of $113,731 for the year ended December 31, 2005
in research and development activities related to the development of Radilex and
Viprovex versus an expense of $150,091 for the year ended December 31, 2004. Due
to our liquidity and limited cash available, our spending on research and
development activities was limited. From our inception in October 2002, we have
spent $306,794 in research and development activities. These costs only include
the manufacture and delivery of our drug by third party manufacturers and
payments to Contract Research Organizations for consulting related to our
studies and costs of performing such studies. Significant costs relating to
research and development, such as consulting fees for Drs. Witten and Siegel,
among others, have been classified in consulting fees for consistency of
financial reporting.
If we are successful in obtaining additional funding through grants or
investment capital, we anticipate that during the next 12 months we will
increase our research and development spending to a total of approximately
$3,500,000 in an effort to further develop Radilex, as a medical countermeasure
against radiological threats, and Viprovex, as a protectant against threats from
various biological agents. The research and development cost includes a
radiation study on large animals, which we estimate will cost up to $2,500,000
depending on the choice of contractor, additional animal pharmacology studies,
formulation and animal safety/toxicity studies, as well as, small pilot
pharmacological studies exploring possible additional indications. If we are
unable to raise additional capital, our research and development activities may
be lessened. The drug development, clinical trial and regulatory process is
lengthy, expensive and uncertain and subject to numerous risks.
We intend to apply to the FDA for approval for the use of Radilex for
the treatment of acute radiation syndrome and for approval for the use of
Viprovex for the treatment of maladies caused by chemical and biological
exposure based upon the "animal efficacy rule." We believe near-term development
opportunities may exist and development costs could potentially be lessened
compared to the more traditional drug development model, as Phase II and Phase
III of the FDA required drug approval process are not required. Even if we are
able to develop this potential application under the animal efficacy rule, we
will not have marketable applications unless and until our drug candidates
complete all required safety studies and clinical trials and receive FDA
approval in the United States or approval by regulatory agencies outside of the
United States. If we are successful in completing the study and achieve the
desired results, we intend to submit the necessary documentation to the FDA and
other regulatory agencies for approval. If approval for Radilex and/or Viprovex
is granted, we expect to begin efforts to commercialize our product, if any,
immediately thereafter. If approved, we are anticipating revenues from the sale
of Radilex and Viprovex, if any, beginning in calendar year 2009.
We will need to generate significant revenues from product sales and or
related royalties and license agreements to achieve and maintain profitability.
Through December 31, 2005, we had no revenues from any product sales, royalties
or licensing fees, and have not achieved profitability on a quarterly or annual
basis. Our ability to achieve profitability depends upon, among other things,
our ability to develop products, obtain regulatory approval for products under
development and enter into agreements for product development, manufacturing and
commercialization. Moreover, we may never achieve significant revenues or
profitable operations from the sale of any of our potential products or
technologies.
22
Our major research and development projects include:
Research and Development of Radilex in Radiological Exposure
Applications.
------------------------------------------------------------
We have commenced initial testing of Radilex to record its potential
therapeutic effects on the treatment of toxic radiation exposure. Our current
and past studies are based on initial studies conducted by our co-founders, Drs.
Mark Witten and David Harris. Subsequently, we have sponsored and/or
co-sponsored six radiation studies on rodents. In addition, we are currently
sponsoring two ongoing radiation studies, one at the University of Arizona and
one at Oak Ridge National Laboratory.
We prepared the protocols for what we believe will be our final phase
of rodent studies for a radiation sensitivity study on rodents to be conducted
at the Oak Ridge National Laboratory in which we will attempt to validate our
prior studies. This study commenced on February 28, 2006. We estimate that the
study will be completed within 3 months at an estimated cost of $90,000. Upon
completion of the aforementioned study we will prepare the protocols necessary
for a non-human primate study to test the efficacy of Radilex as a potential
treatment to acute radiation sickness. We expect this study to begin within the
next 12 to 18 months. We believe that preliminary results will be available
within 90 days from beginning of study, with analysis within an additional 60 to
90 days. We expect up to an additional $2,500,000 will be required to complete
this study. We estimate the completion of this study will be in 18 to 24 months.
If product development or approval does not occur as scheduled our time
to reach market will be lengthened and our costs will substantially increase.
Additionally, we may be requested to expand our findings to gather additional
data or we may not achieve the desired results. If so, we may have to design new
protocols and conduct additional studies. This will increase our costs and delay
the time to market for Radilex as a possible therapeutic for radiation exposure.
Any of these occurrences would have a material negative impact on our business
and our liquidity as it may cause us to seek additional capital sooner than
expected and allow our competitors to successfully enter the market ahead of us.
Research and Development of Viprovex in Chemical and Biological
Exposure Applications.
-----------------------------------------------------------------------
We are sponsoring a series of studies with Hyperion Biotechnology Inc.
at their laboratory facilities located at Brooks City-Base in San Antonio, Texas
with the cooperation of the U.S. Air Force School of Aerospace Medicine
(USAFSAM). The first of these studies was initiated in October 2005. Logistical
considerations related to number of animals requiring exposure and performance
of a full Viprovex dose-response curve within specified time limits following
anthrax exposure required the experiment be performed in two sections, and it is
incomplete at this time. The second half of the full dose-ranging experiment
began in February, 2006. We estimate that the study will be completed within 3
months at an estimated cost of $51,450. If we are successful in achieving
desirable results against anthrax, we intend to design the protocols and begin
further studies for this and other indications, when capital is available. As we
have only collected preliminary data and additional studies are required, we
cannot predict when, if ever, a viable anthrax treatment can be commercialized.
If we do not observe significant results or we lack the capital to further the
development, we may abandon such research and development efforts; thereby
limiting our future potential revenues.
OFF-BALANCE SHEET ARRANGEMENTS
There were no off-balance sheet arrangements made in 2005.
REVENUES
We have not generated any revenues from operations from our inception.
We believe we will begin earning revenues from operations during calendar year
2009 as we transition from a development stage company.
COSTS AND EXPENSES
From our inception (October 30, 2002) through December 31, 2005, we
have incurred losses of $11,799,134. These expenses were associated principally
with equity-based compensation to employees and consultants, product development
costs and professional services.
23
NET LOSS
--------
For the reasons stated above, our net loss for the twelve months ending
December 31, 2005 was $4,591,107, or $0.07 per shares. For the period of
inception (October 30, 2002) through December 31, 2005, our net loss was
$11,799,134, or $0.30 per share. We expect that losses will continue through the
period ending December 31, 2009.
Our independent certified public accountants have stated in our Form
10-KSB/A as filed on March 30, 2006 that we have incurred a net loss and
negative cash flows from operations of $4,591,107 and $1,884,113, respectively,
for the year ended December 31, 2005. This loss, in addition to a lack of
operational history, raises substantial doubt about our ability to continue as a
going concern. In the absence of significant revenue and profits, and since we
do not expect to generate significant revenues in the foreseeable future, we, in
order to fund operations, will be completely dependent on additional debt and
equity financing arrangements. There is no assurance that any financing will be
sufficient to fund our capital expenditures, working capital and other cash
requirements for the fiscal year ending December 31, 2006. No assurance can be
given that any such additional funding will be available or that, if available,
can be obtained on terms favorable to us. If we are unable to raise needed funds
on acceptable terms, we will not be able to develop or enhance our products,
take advantage of future opportunities or respond to competitive pressures or
unanticipated requirements. A material shortage of capital will require us to
take drastic steps such as reducing our level of operations, disposing of
selected assets or seeking an acquisition partner. If cash is insufficient, we
will not be able to continue operations.
Penalties for Late Registration
-------------------------------
In October 2004, we completed a private placement, whereby we sold an
aggregate of $2,450,000 worth of units to accredited investors. Each unit was
sold for $10,000 and consisted of (a) a number of shares of our common stock
determined by dividing the unit price by $0.125, and (b) a warrant to purchase,
at any time prior to the fifth anniversary following the date of issuance of the
warrant, a number of shares of our common stock equal to fifty percent (50%) of
the number of shares included within the unit, at a price equal to $0.50 per
share of common stock. We issued in the private placement an aggregate of
19,600,000 shares of our common stock and warrants to purchase 9,800,000 shares
of our common stock. In consideration of the investment, we granted to each
investor certain registration rights and anti-dilution rights. We agreed to
register these shares along with the shares underlying these warrants within
ninety days from the closing date of the transaction, or we would incur a
penalty equivalent to an additional 2% of the shares and warrants to be
registered for every 30 days that we fail to complete this registration. This
penalty amounts to an aggregate of 461,200 shares and 181,600 warrants per 30
day period until such a time as a registration statement that includes these
shares and warrants is made effective.
At March 31, 2006, we have accrued liabilities to issue 6,625,907
shares of common stock and warrants to purchase an additional 2,608,987 shares
for total shares of 9,234,895. The original values of these liabilities were
$2,448,511 for the shares, and $744,177 for the warrants for a total of
$3,188,691. Additions for the quarter ended March 31, 2006 were 1,383,600 shares
of common stock with a market value of approximately $456,588 and warrants to
purchase 544,800 shares of common stock with a value of approximately $105,339.
The shares were initially valued at the market price of the Company's common
stock at the time the liabilities were incurred. The warrants are valued
utilizing the Black-Scholes valuation model.
The accumulated adjustment for change in market price (mark to market)
were credits to expense of approximately $261,962 for the shares and
approximately $267,515 for the warrants, for a total adjustment of approximately
$525,480. Adjustments for the three months ended March 31, 2006 were increased
expense of approximately $52,423 for the shares, and decreased expense for the
warrants of approximately $12,822 for a net expense of approximately $43,598.
We hope to complete the registration of these shares during the quarter
ended June 30, 2006. If we are able to complete the registration in this time
frame, we expect that an obligation to issue approximately 2,136,893 additional
shares and 841,413 additional warrants at an aggregate cost of approximately
$840,000 will be incurred due to the penalty for late registration for the
period from April 1, 2006 to June 30, 2006. There is no guarantee that we will
be able to complete the registration within the anticipated timeframe.
LIQUIDITY AND CAPITAL RESOURCES
At December 31, 2005, we had current assets of $290,367 consisting of
cash of $265,860 and prepaid services of $24,507. Also, at December 31, 2005, we
24
had current liabilities of $2,563,811, consisting of accounts payable and
accrued liabilities of $2,563,811. This resulted in a working capital deficit of
$2,273,444. During the twelve months ended December 31, 2005, we used cash in
operating activities of $1,884,113. From the date of inception (October 30,
2002) to December 31, 2005, we had a net loss of $11,799,134 and used cash of
$3,958,458 in operating activities. We met our cash requirements from our
inception through December 31, 2005 via the private placement of $3,263,902 of
our common stock and $968,503 from the issuance of notes payable, net of
repayments. In October 2004, we completed a private placement whereby we sold an
aggregate of $2,450,000 worth of units to accredited investors. Each unit was
sold for $10,000 and consisted of (a) a number of shares of our common stock
determined by dividing the unit price of $10,000 by $0.125, and (b) a warrant to
purchase, at any time prior to the fifth anniversary following the date of
issuance of the warrant, a number of shares of our common stock equal to fifty
percent (50%) of the number of shares included within the unit, at a price equal
to $0.50 per share of common stock. We issued an aggregate of 19,600,000 shares
of our common stock and warrants to purchase 9,800,000 shares of our common
stock in this private placement. In consideration of the investment, we granted
to each investor certain registration rights and anti-dilution rights.
We have never generated revenue. There is no guarantee that our
business model will be successful, or that we will be able to generate
sufficient revenue to fund future operations. As a result, we expect our
operations to continue to use net cash, and that we will be required to seek
additional debt or equity financings during the coming quarters. Since
inception, we have financed our operations through debt and equity financing.
While we have raised capital to meet our working capital and financing needs in
the past, additional financing is required in order to meet our current and
projected cash flow deficits from operations and development of our product
line. We met our cash requirements from our inception through December 31, 2005
via the private placement of $3,263,902 net of costs of our common stock,
$1,194,856 of this was from the exercise of common stock purchase warrants net
of costs. An additional $968,503 was received from the issuance of notes
payable, net of repayments.
In January 2005, we made a tender offer to temporarily reduce the
exercise price of certain warrants issued in October 2004 from $0.50 to $0.20
per share. The tender offer expired on March 4, 2005. We accepted for exercise a
total of 6,600,778 warrants validly tendered and not withdrawn pursuant to the
terms of the tender offer, which represents approximately 48% of the aggregate
13,780,449 warrants that were subject to the offer. We raised an aggregate of
$1,190,856 from the tender offer, net of costs.
During the year ended December 31, 2005, we settled in full three (3)
notes payable aggregating $80,000. Payment was made by converting one (1) note
in the amount of $65,003 into 232,153 shares of the Company's common stock
pursuant to the terms of a promissory note dated September 26, 2001, and by
paying cash in the amount of $14,997 in satisfaction of the remaining two (2)
notes. One note which accrued interest at 8% was repaid in full for $4,998
($3,900 principal & $1,097 accrued interest) on April 11, 2005, releasing us
from further obligations under the note. On June 7, 2005, the remaining note in
the principal amount of $50,000 and all accrued interest of $15,003 were
converted into 232,153 shares of our common stock in accordance with the terms
of the note.
On June 13, 2005, we issued 80,000 shares of common stock for cash of
$4,000 pursuant to the exercise of a warrant at $0.05 per share.
We also previously issued convertible promissory notes in the aggregate
principal amount of $35,000. On December 24, 2004 all outstanding principal and
accrued interest was forgiven by the note holder. Consideration of $100.00 was
paid by us to the note holder. Under the terms of the agreement, the note holder
released us from all claims, known or unknown, relating to the amount owed.
Between June 2003 and August 2004 eleven investors entered into fifteen
convertible promissory notes totaling $558,500 with interest rates ranging
between 8% and 12% and having various maturities. In October 2004, these notes
were converted into equity in the aggregate amount of $558,500 plus accrued
interest of $56,757. For full and complete satisfaction of debt, we issued to
the note holders the following: (a) a number of shares of our common stock
determined by dividing the debt amount by an amount between $0.075 and $0.125
and (b) warrants to purchase, at any time prior to the fifth anniversary
following the date of issuance of the warrant, a number of shares of our common
stock equal to fifty percent (50%) of the number of shares described above, at a
price equal to $0.50 per share of common stock. The warrants are identical to
the warrants issued in the Private Placement. Pursuant to the debt conversion we
25
issued an aggregate of 6,694,149 shares of common stock and warrants to purchase
3,347,076 shares of common stock. Under the terms of the conversion agreement,
the note holders released us from all claims, known or unknown, relating to the
debt amount.
Pursuant to our employment agreement with Michael Wilhelm, our
President and Chief Executive Officer, dated December 16, 2002, we paid an
annual salary of $125,000 and $175,000 to Mr. Wilhelm during the first and
second years of his employment, respectively. Thereafter we paid through August
10, 2005, an annual salary of $250,000. On August 10, 2005, we entered into a
new employment agreement with Mr. Wilhelm. The new employment agreement calls
for a salary at the rate of $275,000 per annum and provides for bonus
incentives. Mr. Wilhelm's salary is payable in regular installments in
accordance with the customary payroll practices of our company.
Pursuant to our employment agreement with John Fermanis, our Chief
Financial Officer, dated February 15, 2005, we paid an annual salary of $60,000
until the company completed a financing of $500,000 or more. This occurred on
March 4, 2005 when the company completed a Tender Offer for warrants totaling
$1,211,000 net of fees. From March 4, 2005, until December 31, 2005, we paid an
annual salary of $85,000. Thereafter, we will pay an annual salary of $98,000
for the second year ending December 31, 2006 and an annual salary of $112,000
for the third year ending December 31, 2007. Mr. Fermanis' salary is payable in
regular installments in accordance with the customary payroll practices of our
company.
On December 16, 2002 we entered into a consulting agreement on a
month-to-month basis with Dr. Mark Witten, our Director. Under the terms of this
agreement, Dr. Witten agrees to place at the disposal of us his judgment and
expertise in the area of acute lung injury. In consideration for these services,
we agreed to pay Dr. Witten a non-refundable fee of $5,000 per month. In January
2006, the company received correspondence from Dr. Witten stating that he would
terminate his consulting contract if his specific requirements were not met. We
subsequently accepted his termination effective February 1, 2006.
Since our inception, we have been seeking additional third-party
funding. During such time, we have retained a number of different investment
banking firms to assist us in locating available funding; however, we have not
yet been successful in obtaining any of the long-term funding needed to make us
into a commercially viable entity. During the period from October 2004 to
December 2005, we were able to obtain financing of $3,590,136 from a series of
private placements of our securities (which resulted in net proceeds to us of
$3,162,702). Based on our current plan of operations all of our current funding
is expected to be depleted by the end of April 2006. If we are not successful in
generating sufficient liquidity from operations or in raising sufficient capital
resources, it would have a material adverse effect on our business, results of
operations, liquidity and financial condition.
While we have successfully raised capital to meet our working capital
and financing needs in the past through debt and equity financings, additional
financing will be required in order to implement our business plan and to meet
our current and projected cash flow deficits from operations and development.
There can be no assurance that we will be able to consummate future debt or
equity financings in a timely manner on a basis favorable to us, or at all. If
we are unable to raise needed funds, we will not be able to develop or enhance
our potential products, take advantage of future opportunities or respond to
competitive pressures or unanticipated requirements. A material shortage of
capital will require us to take drastic steps such as reducing our level of
operations, disposing of selected assets or seeking an acquisition partner.
Until such time, if at all, as we receive adequate funding, we intend
to continue to defer payment of all of our obligations which are capable of
being deferred, which actions have resulted in some vendors demanding cash
payment for their goods and services in advance, and other vendors refusing to
continue to do business with us. In the event that we are successful in
obtaining third-party funding, we do not expect to generate a positive cash flow
from our operations for at least several years, if at all, due to anticipated
expenditures for research and development activities, administrative and
marketing activities, and working capital requirements and expect to continue to
attempt to raise further capital through one or more further private placements.
Based on our operating expenses and anticipated research and development
activities, we believe that we will require an additional $5 million to meet our
expenses over the next 12 months.
Acquisition or Disposition of Plant and Equipment
-------------------------------------------------
We did not dispose or acquire any significant property, plant or
26
equipment for the year ended December 31, 2005. We do not anticipate the
acquisition of any significant property, plant or equipment during the next 12
months.
Number of Employees
-------------------
From our inception through the period ended December 31, 2005, we have
relied on the services of outside consultants for services and currently have
five total employees, two contract employees and three full-time employees. Our
full-time employees are Michael K. Wilhelm, our Chief Executive Officer; John
Fermanis, our Chief Financial Officer; and, the third serves in an
administrative role. In order for us to attract and retain quality personnel, we
anticipate we will have to offer competitive salaries to future employees. We do
not anticipate our employment base will significantly change during the next
twelve months, other than the addition of one senior level appointment to the
position of Senior Vice President of Scientific Development. As we continue to
expand, we will incur additional cost for personnel. This projected increase in
personnel is dependent upon our generating revenues and obtaining sources of
financing. There is no guarantee that we will be successful in raising the funds
required or generating revenues sufficient to fund the projected increase in the
number of employees.
CRITICAL ACCOUNTING POLICY
The preparation of our consolidated financial statements in conformity
with accounting principles generally accepted in the United States requires us
to make estimates and judgments that affect our reported assets, liabilities,
revenues, and expenses, and the disclosure of contingent assets and liabilities.
We base our estimates and judgments on historical experience and on
various other assumptions we believe to be reasonable under the circumstances.
Future events, however, may differ markedly from our current expectations and
assumptions. While there are a number of significant accounting policies
affecting our consolidated financial statements; we believe the following
critical accounting policy involves the most complex, difficult and subjective
estimates and judgments:
Stock-based Compensation
------------------------
In December 2002, the FASB issued SFAS No. 148 - Accounting for
Stock-Based Compensation - Transition and Disclosure. This statement amends SFAS
No. 123 - Accounting for Stock-Based Compensation, providing alternative methods
of voluntarily transitioning to the fair market value based method of accounting
for stock based employee compensation. FAS 148 also requires disclosure of the
method used to account for stock-based employee compensation and the effect of
the method in both the annual and interim financial statements. The provisions
of this statement related to transition methods are effective for fiscal years
ending after December 15, 2002, while provisions related to disclosure
requirements are effective in financial reports for interim periods beginning
after December 31, 2003.
We elected to continue to account for stock-based compensation plans
using the intrinsic value-based method of accounting prescribed by APB No. 25,
"Accounting for Stock Issued to Employees," and related interpretations. Under
the provisions of APB No. 25, compensation expense is measured at the grant date
for the difference between the fair value of the stock and the exercise price.
From its inception, the Company has incurred significant costs in connection
with the issuance of equity- based compensation, which is comprised primarily of
our common stock and warrants to acquire our common stock, to non-employees. The
Company anticipates continuing to incur such costs in order to conserve its
limited financial resources. The determination of the volatility, expected term
and other assumptions used to determine the fair value of equity based
compensation issued to non-employees under SFAS 123 involves subjective judgment
and the consideration of a variety of factors, including our historical stock
price, option exercise activity to date and the review of assumptions used by
comparable enterprises.
We account for equity based compensation, issued to non-employees in
exchange for goods or services, in accordance with the provisions of SFAS No.
123 and EITF No. 96-18, "Accounting for Equity Instruments That are Issued to
Other Than Employees for Acquiring, or in Conjunction with Selling, Goods or
Services".
27
Recent Accounting Pronouncements
--------------------------------
In November 2004, the Financial Accounting Standards Board (FASB)
issued SFAS 151, Inventory Costs--an amendment of ARB No. 43, Chapter 4. This
Statement amends the guidance in ARB No. 43, Chapter 4, "Inventory Pricing," to
clarify the accounting for abnormal amounts of idle facility expense, freight,
handling costs, and wasted material (spoilage). Paragraph 5 of ARB 43, Chapter
4, previously stated that ". . . under some circumstances, items such as idle
facility expense, excessive spoilage, double freight, and rehandling costs may
be so abnormal as to require treatment as current period charges. . . ." This
Statement requires that those items be recognized as current-period charges
regardless of whether they meet the criterion of "so abnormal." In addition,
this Statement requires that allocation of fixed production overheads to the
costs of conversion be based on the normal capacity of the production
facilities. This Statement is effective for inventory costs incurred during
fiscal years beginning after June 15, 2005. Management does not believe the
adoption of this Statement will have any immediate material impact on the
Company.
In December 2004, the FASB issued SFAS No.152, "Accounting for Real
Estate Time-Sharing Transactions--an amendment of FASB Statements No. 66 and 67"
("SFAS 152) The amendments made by Statement 152 This Statement amends FASB
Statement No. 66, Accounting for Sales of Real Estate, to reference the
financial accounting and reporting guidance for real estate time-sharing
transactions that is provided in AICPA Statement of Position (SOP) 04-2,
Accounting for Real Estate Time-Sharing Transactions. This Statement also amends
FASB Statement No. 67, Accounting for Costs and Initial Rental Operations of
Real Estate Projects, to state that the guidance for (a) incidental operations
and (b) costs incurred to sell real estate projects does not apply to real
estate time-sharing transactions. The accounting for those operations and costs
is subject to the guidance in SOP 04-2. This Statement is effective for
financial statements for fiscal years beginning after June 15, 2005 with earlier
application encouraged. The Company does not anticipate that the implementation
of this standard will have a material impact on its financial position, results
of operations or cash flows.
On December 16, 2004, the Financial Accounting Standards Board ("FASB")
published Statement of Financial Accounting Standards No. 123 (Revised 2004),
Share-Based Payment ("SFAS 123R"). SFAS 123R requires that compensation cost
related to share-based payment transactions be recognized in the financial
statements. Share-based payment transactions within the scope of SFAS 123R
include stock options, restricted stock plans, performance-based awards, stock
appreciation rights, and employee share purchase plans. The provisions of SFAS
123R are effective as of the first interim period that begins after June 15,
2005. Accordingly, the Company will implement the revised standard in the third
quarter of fiscal year 2005. Currently, the Company accounts for its share-based
payment transactions under the provisions of APB 25, which does not necessarily
require the recognition of compensation cost in the financial statements.
Management is assessing the implications of this revised standard, which may
materially impact the Company's results of operations in the first quarter of
fiscal year 2006 and thereafter.
On December 16, 2004, FASB issued Statement of Financial Accounting
Standards No. 153, Exchanges of Nonmonetary Assets, an amendment of APB Opinion
No. 29, Accounting for Nonmonetary Transactions ("SFAS 153"). This statement
amends APB Opinion 29 to eliminate the exception for nonmonetary exchanges of
similar productive assets and replaces it with a general exception for exchanges
of nonmonetary assets that do not have commercial substance. Under SFAS 153, if
a nonmonetary exchange of similar productive assets meets a commercial-substance
criterion and fair value is determinable, the transaction must be accounted for
at fair value resulting in recognition of any gain or loss. SFAS 153 is
effective for nonmonetary transactions in fiscal periods that begin after June
15, 2005. The Company does not anticipate that the implementation of this
standard will have a material impact on its financial position, results of
operations or cash flows.
RESULTS OF OPERATIONS FOR THE TWELVE MONTH PERIODS ENDED DECEMBER 31, 2005 AND
2004.
Revenue
-------
We are currently in the development stage and have not yet generated
any revenue.
28
Selling, General and Administrative Expenses
--------------------------------------------
Selling, general and administrative expenses were $2,534,417 for the
twelve months ended December 31, 2005 which is a decrease of $1,963,973 or
approximately 44% compared to SG&A of $4,498,390 for the twelve months ended
December 31, 2004. The decrease is primarily due to lower costs of non-cash
compensation. This expense is primarily comprised of non-cash compensation of
$520,853, legal and accounting fees of $556,482, consulting fees of $408,331,
officer compensation of $300,044, payroll and related costs of $100,013,
research and development of $113,731, public relations and marketing of
$113,847, travel and entertainment of $108,509 and rent of $27,785.
Merger Fees and Costs
---------------------
Merger fees and costs were $0 for the twelve months ended December 31,
2005 and 2004.
During the twelve months ending December 31, 2006 we may investigate
potential acquisition candidates, and the potential cash costs of such an
acquisition or acquisitions is not possible to forecast.
Penalties for Late Registration
-------------------------------
During the fiscal year December 31, 2005, we accrued the issuance of
5,242,307 shares of common stock and warrants to purchase an additional
2,064,187 shares of common stock pursuant to a penalty calculation with regard
to the late registration of shares sold in a private placement in October 2004.
In October 2004, we completed a private placement sale of shares of our
common stock and warrants to purchase additional shares of common stock. We
issued in the private placement an aggregate of 19,600,000 shares of our common
stock and warrants to purchase 9,800,000 shares of our common stock. We agreed
to register these shares along with the shares underlying these warrants within
ninety days from the closing date of the transaction, or we would incur a
penalty equivalent to an additional 2% of the shares and warrants to be
registered for every 30 days that we fail to complete this registration. This
penalty amounts to an aggregate of 461,200 shares and 181,600 warrants per 30
day period until such a time as this registration statement is made effective.
As of December 31, 2005, we are required to issue an additional 5,242,307 shares
of common stock and warrants to purchase an additional 2,064,187 shares of
common stock. At the time these liabilities were incurred, the shares were
valued at $1,991,923 and the warrants were valued at $638,838. The shares were
valued at the market price of the Company's common stock at the time the
liabilities were incurred. The warrants were valued utilizing the Black-Scholes
valuation model. The aggregate amount of $2,630,761 was charged to operations as
cost of penalty for late registration of shares during the year ended December
31, 2005.
The shares and warrants were re-valued at December 31, 2005, and the
result of this re-valuation was to decrease the value of the shares by $314,385
and to decrease the value of the warrants by $254,693. These decreases were
credited to other (income) expense during the year ended December 31, 2005. At
December 31, 2005, the fair value of the common stock issuable under the penalty
for late registration of shares is $1,677,538, and the fair value of the
warrants issuable under the penalty for late registration of shares is $384,145.
These amounts appear as current liabilities on the Company's condensed
consolidated balance sheet at December 31, 2005.
As the liability for these penalty shares and warrants must be settled
by the delivery of registered shares and the delivery of the registered shares
is not controlled by the Company, pursuant to EITF 00-19, "Accounting for
Derivative Financial Instruments Indexed to, and Potentially Settled in, a
Company's Own Stock", the net value of the shares and warrants at the date of
issuance was recorded as a liability on the balance sheet and the change in fair
value from the date of issuance to December 31, 2005 has been included in other
income (expense). Upon the registration statement being declared effective, the
fair value of the warrant on that date will be reclassified to equity.
29
Financing Cost
--------------
Financing costs were $0 for the twelve months ending December 31, 2005
and 2004.
Interest(Income)/Expense (Net)
----------------------
Interest(income)/expense (net)was ($11,386) for the twelve months ended
December 31, 2005. This amount consists of interest earned on cash balances net
of interest on notes payable and is a decrease of $818,403 compared to interest
expense of $807,017 for the twelve months ended December 31, 2004. The decrease
is due to a decrease in debt along with an increase in cash balances.
Net Loss
--------
For the reasons above, primarily lower SG&A expenses and lower interest
expenses offset by the late registration penalty expenses, the net loss for the
twelve months ended December 31, 2005 was $4,591,107, or $0.07 per share, a
decrease of $714,300 or approximately 13% compared to a net loss of $5,305,407
for the twelve months ended December 31, 2004. We expect that losses will
continue through the period ending December 31, 2009.
RESULTS OF OPERATIONS FOR THE TWELVE MONTH PERIODS ENDED DECEMBER 31, 2005 AND
FOR THE PERIOD OF INCEPTION (OCTOBER 30, 2002) TO DECEMBER 31, 2005.
Revenue
-------
We are currently in the development stage and have not yet generated
any revenue.
Selling, General and Administrative Expenses
--------------------------------------------
Total SG&A expenses for the period of inception (October 30, 2002)
through December 31, 2005, were $8,124,301. This increase of $5,589,884 from the
twelve months ended December 31, 2005 consists primarily of an additional
$3,371,188 in non-cash compensation, an additional $300,000 in officer wages, an
additional $535,707 in legal and accounting fees, and an additional $373,665 in
consulting fees.
Merger Fees and Costs
---------------------
Merger fees and costs were $0 for the twelve months ended December 31,
2005 and $350,000 for the period of inception (October 30, 2002) to December 31,
2005. This amount is related to the reverse merger between GPN Network, Inc. and
ImmuneRegen Biosciences, Inc., which was consummated in July 2003. $185,000 of
this amount were monies paid to the former controlling shareholder of GPN
Network, Inc., and the remaining $165,000 of these funds were used to satisfy
certain outstanding liabilities of GPN Network, Inc.
Penalties for Late Registration
-------------------------------
During the period of inception (October 22, 2002) to December 31, 2005,
we accrued the issuance of 5,242,307 shares of common stock and warrants to
purchase an additional 2,064,187 shares of common stock pursuant to a penalty
calculation with regard to the late registration of shares sold in a private
placement in October 2004.
In October 2004, we completed a private placement sale of shares of our
common stock and warrants to purchase additional shares of common stock. We
issued in the private placement an aggregate of 19,600,000 shares of our common
stock and warrants to purchase 9,800,000 shares of our common stock. We agreed
to register these shares along with the shares underlying these warrants within
ninety days from the closing date of the transaction, or we would incur a
penalty equivalent to an additional 2% of the shares and warrants to be
registered for every 30 days that we fail to complete this registration. This
penalty amounts to an aggregate of 461,200 shares and 181,600 warrants per 30
day period until such a time as this registration statement is made effective.
As of December 31, 2005, we are required to issue an additional 5,242,307 shares
of common stock and warrants to purchase an additional 2,064,187 shares of
common stock. At the time these liabilities were incurred, the shares were
30
valued at $1,991,923 and the warrants were valued at $638,838. The shares were
valued at the market price of the Company's common stock at the time the
liabilities were incurred. The warrants were valued utilizing the Black-Scholes
valuation model. The aggregate amount of $2,630,761 was charged to operations as
cost of penalty for late registration of shares during the year ended December
31, 2005.
The shares and warrants were re-valued at December 31,2005, and the
result of this re-valuation was to decrease the value of the shares by $314,385
and to decrease the value of the warrants by $254,693. These decreases were
credited to other (income) expense during the year ended December 31, 2005. At
December 31, 2005, the fair value of the common stock issuable under the penalty
for late registration of shares is $1,677,538, and the fair value of the
warrants issuable under the penalty for late registration of shares is $384,145.
These amounts appear as current liabilities on the Company's condensed
consolidated balance sheet at December 31, 2005.
As the liability for these penalty shares and warrants must be settled
by the delivery of registered shares and the delivery of the registered shares
is not controlled by the Company, pursuant to EITF 00-19, "Accounting for
Derivative Financial Instruments Indexed to, and Potentially Settled in, a
Company's Own Stock", the net value of the shares and warrants at the date of
issuance was recorded as a liability on the balance sheet and the change in fair
value from the date of issuance to December 31, 2005 has been included in other
income (expense). Upon the registration statement being declared effective, the
fair value of the warrant on that date will be reclassified to equity.
Financing Cost
--------------
Financing costs were $0 for the twelve months ending December 31, 2005
and $90,000 for the period of inception (October 30, 2002) to December 31, 2005.
This amount consists of non-refundable prepaid travel and road show costs
relating to the reverse merger and an aborted private offering.
Interest(Income)/Expense (Net)
----------------------
Interest(income)/expense (net)was ($11,386) for the twelve months ended
December 31, 2005. This amount consists of interest earned on cash balances net
of interest on notes payable. Interest(income)/expense (net) was $1,166,757 from
the period of inception (October 30, 2002) to December 31, 2005 due to an
additional $1,241,143 of interest that was accrued during the period of
inception(October 30, 2002) through December 31, 2004.
Net Loss
--------
For the reasons above, primarily lower SG&A expenses and lower interest
expenses offset by the late registration penalty expenses, the net loss for the
twelve months ended December 31, 2005 was $4,591,107, or $0.07 per share. For
the period of inception (October 30, 2002) through December 31, 2005, our net
loss was $11,799,134 or $0.30 per share. We expect that losses will continue
through the period ending December 31, 2009.
BUSINESS
OVERVIEW
IR BioSciences Holdings, Inc. is a development-stage biopharmaceutical
company. Through our wholly owned subsidiary, ImmuneRegen BioSciences, Inc., we
are engaged in the research and development of potential therapeutics for a
number of applications. All therapeutics in development are based on Sar9, Met
(O2)11-Substance P, an analog of the naturally occurring human neuropeptide
Substance P. This neuropeptide can be found throughout the body, including in
the airways of humans and many other species. We use the generic name Homspera
to refer to the synthetic Sar9, Met (O2)11-Substance P peptide. All of our
research and development efforts are early, pre-clinical stage and Homspera has
only undergone exploratory studies to evaluate its biological activity in small
animals.
31
Currently, the majority of our development efforts are centered on two
potential therapeutic applications for the active ingredient in Homspera.
Radilex is being formulated specifically for the potential treatment of acute
exposure to radiation. Viprovex is being formulated specifically for potential
applications relating to the treatment of maladies caused by exposure to various
chemical and biological agents. We are currently sponsoring ongoing pre-clinical
studies in these areas, specifically two mouse radiation studies on the efficacy
of Radilex in treating acute radiation exposure and a mouse study on the
efficacy of Viprovex in treating exposure to anthrax. We are designing the
protocols for additional radiation studies in mice using Radilex. Additionally,
we are designing the protocols for an avian flu study in mice using Viprovex.
To date we have submitted preliminary study data to the U.S. Food and
Drug Administration (FDA) and have been issued two Pre-Investigational New Drug
(PIND) numbers, one for the potential use of Radilex in the treatment of acute
radiation syndrome and the other for the potential use of Viprovex in the
treatment of avian influenza. In addition, we have recently submitted a PIND
data package for the use of Viprovex in the potential treatment of chemical
exposure. We intend to file final radiation study data from mice with the FDA
within six months, and at this time we will request a meeting with the FDA
regarding the authorization of a large animal study protocol to test the
efficacy of Radilex as a potential treatment for acute radiation syndrome. Also
within the next six to twelve months, we plan to submit an Investigational New
Drug (IND) application for the potential use of Viprovex in treating Acute
Respiratory Distress Syndrome (ARDS).
We have filed patent applications and provisional patent applications,
where applicable, in many jurisdictions, inside and outside of the United
States, for the use of the active ingredient Sar9, Met (O2)11-Substance P in
applications that we are researching. We own two issued U.S. and two issued
foreign patents and two pending Patent Cooperation Treaty (PCT) applications,
seven pending U.S. provisional patent applications and 16 pending foreign
provisional patent applications.
Our current potential drug candidates, Radilex and Viprovex and other
technologies utilizing Homspera, are at early stages of development and may not
be shown to be safe or effective and may never receive regulatory approval.
Neither Radilex nor Viprovex nor our technologies utilizing Homspera have yet
been tested in large animals or humans. There is no guarantee that regulatory
authorities will ever permit large animal or human testing of Radilex, Viprovex
or any other potential products derived from Homspera. Even if such testing is
permitted, none of Radilex, Viprovex or any other potential drug candidates, if
any, derived from Homspera may be successfully developed or shown to be safe or
effective.
The results of our pre-clinical studies and clinical trials may not be
indicative of future clinical trial results. A commitment of substantial
resources to conduct time-consuming research, pre-clinical studies and clinical
trials will be required if we are to develop any commercial applications using
Homspera or any derivatives thereof. Delays in planned patient enrollment in our
future clinical trials may result in increased costs, program delays or both.
None of our potential applications or technologies may prove to be safe or
effective in clinical trials. Approval of the FDA, or other regulatory
approvals, including export license permissions, may not be obtained and even if
successfully developed and approved, our potential applications may not achieve
market acceptance. Any potential applications resulting from our programs may
not be successfully developed or commercially available for a number of years,
if at all.
To date, we have not obtained regulatory approval for or commercialized
any applications using Homspera or any of its derivatives. We have incurred
significant losses since our inception and we expect to incur annual losses for
at least the next three years as we continue with our drug research and
development efforts.
APPLICATIONS IN DEVELOPMENT
SUBSTANCE P AND HOMSPERA (Sar9, Met (O2)11-Substance P)
-------------------------------------------------------
Substance P, discovered in 1931, is a naturally occurring small (1348 D
molecular weight) peptide of 11 amino acids that is found throughout the body.
Relevant to our current studies, Substance P is localized to the nerves in the
airways of many species, including humans. It is believed to be the most potent
member of the tachykinin family of neuropeptides, which are widely distributed
in the peripheral and central nervous systems and have direct, receptor-mediated
actions on most tissues and organs.
32
In an attempt to find a commercially viable Substance P analog with
similar or expanded capabilities, scientists, including our co-founders, Drs.
Mark Witten and David Harris, working in the area of Substance P and pulmonary
function developed a Substance P analog (Sar9, Met (O2)11-Substance P). In the
opinion of management, this compound has been shown to have Neurokinin-1 (NK1)
receptor specificity, which has become the basis for our research and
development efforts. Homspera is the name by which we refer to the chemical
Sar9, Met (O2)11-Substance P in the context of our research and development.
Radilex and Viprovex
--------------------
The majority of our development efforts are centered on two potential
drug candidates formulated from Homspera, Radilex and Viprovex. The active
ingredient, Homspera, is chemically equivalent in both Radilex and Viprovex. As
they are used in differing indications and the formulations and dosing regimens
may ultimately also differ, we have created trade names to more easily
differentiate the two potential applications with respect to their development
and potential future market opportunities. Radilex is the name of the
preparation being tested to potentially protect against radiation exposure.
Viprovex is the name of the anti-viral preparation for indications to
potentially protect against exposure to various chemical and biological agents.
-----------------------------------------------------------------------------------------------------------
Trade names for different
Chemical Name and Amino Acid Sequence Generic Name formulations / indications
-----------------------------------------------------------------------------------------------------------
Sar9, Met (O2)11-Substance P Arg-Pro-Lys-Pro-Gln-Gln-Phe- Homspera Radilex Viprovex
Phe-Sar-Leu-Met(O2)-NH2
-----------------------------------------------------------------------------------------------------------
Applications
Our potential applications are based on various formulations of
Homspera. We currently have potential applications at various stages of
pre-clinical development. Our initial pre-clinical applications are in acute
radiation syndrome (Radilex) and infectious disease and chemical exposure
(Viprovex.)
The basis for our development of potential uses of Homspera is derived
from observations made during research funded by the Air Force Office of
Scientific Research in early 1994 by our co-founders Dr. Mark Witten and Dr.
David Harris. During this research it was observed that the exposure of animals
to jet fuel (JP-8) resulted in pathological changes in the lungs and immune
systems of those exposed. In the opinion of management, these studies further
showed that the administration of Sar9, Met(O2)11-Substance P prevented and
reversed the effects of JP-8 jet fuel exposure in the lungs, as well as
protected and regenerated the immune system. It is our opinion that, based on
the results of these studies, Homspera directly treats the effects of toxic
exposure on living cells by inhibiting cell apoptosis (cell-initiated death
process). We continue to explore the multiple potential capabilities of Sar9,
Met (O2)11-Substance P and to better understand the mechanisms by which this
compound can potentially provide protection against gamma radiation, respiratory
viruses and various chemical and biological agents.
As traditional efficacy studies would require healthy human volunteers
to be exposed to the potentially lethal agents or pathogens, which cannot be
done, we intend to apply for approval based upon a new rule adopted by the FDA
in 2002, titled "Approval of New Drugs When Human Efficacy Studies Are Not
Ethical or Feasible" (Code of Federal Regulations, Title 21, Part 314, Subpart
I), which is also referred to as the "animal efficacy rule." Pursuant to this
new rule, in situations where it would be unethical to conduct traditional Phase
II and Phase III efficacy studies in humans, as is the case with our
applications relating to the treatment of maladies caused by exposure to high
level gamma radiation and various chemical and biological agents, the FDA will
review new drugs for approval on the basis of safety in humans and efficacy in
relevant animal models. Through development under this paradigm, management
believes near-term development opportunities may exist and development costs are
lessened compared to the more traditional drug development model, as Phase II
and Phase III of the FDA required drug approval process are not required. Under
either scenario, we will not have marketable applications unless and until our
drug candidates complete all required safety studies and clinical trials and
receive FDA approval in the United States or approval by regulatory agencies
outside of the United States.
33
The table below illustrates our current product candidates and their
stage of development within the FDA approval process.
----------------------------------------------------------------------------------------------------------
Product Candidate Pharmacological Animal Pre-Clinical
Identification Safety Mechanistic Phase I Phase II* Phase III*
----------------------------------------------------------------------------------------------------------
Acute Radiation
Syndrome
Radilex In-progress Planned In-progress
Infectious disease
Viprovex In-progress Planned In-progress
Chemical exposure
Viprovex In-progress
----------
* In development under the animal efficacy rule Phase II and Phase III are
potentially not required.
To date we have been issued two Pre-Investigational New Drug (PIND)
numbers by the U.S. Food & Drug Administration (FDA) - one for the potential use
of Radilex in the treatment of acute radiation syndrome and one for the use of
Viprovex in the potential treatment of avian influenza. In addition, we have
recently submitted a PIND for the use of Viprovex in the potential treatment of
chemical exposure. We expect to file a final radiation study using data
collected from our mice studies with the FDA within six months. At this time we
expect to request a meeting regarding the establishment of the protocols
necessary for a large animal study to test the efficacy of Radilex as a
potential treatment for acute radiation syndrome. Also within the next six to
twelve months, we expect to submit an Investigational New Drug (IND) application
for the use of Viprovex in potentially treating Acute Respiratory Distress
Syndrome (ARDS).
RADILEX
To date we have sponsored five studies and co-sponsored three radiation
studies all of which were conducted utilizing rodents to determine dose response
to radiation, the maximum efficacious dose of Radilex, the impact on survival
and to distinguish survival response between aerosol delivery versus intra
muscular delivery. In each of these studies mice were exposed to varying levels
of radiation. In the opinion of management, these studies have demonstrated in
C57BL/6 mouse model studies that Radilex-treated mice exhibited survival rates
of up to 50% at 90 days post-radiation exposure to an otherwise lethal dose of
whole body ionizing radiation. Additionally, it was observed that these mice had
normal immune system function at the 90-day post-radiation time point compared
to longitudinal control mice. Thus far, in our opinion, the results from our
sponsored and co-sponsored rodent studies using Radilex demonstrate efficacy in
treating acute radiation syndrome when administered via an inhaler device
without requiring any prophylactic treatment. If these results can be reproduced
in further studies, including large animal studies, we believe that our
treatment could potentially increase an individual's chance of survival in the
event of exposure to radiation.
Currently, we are sponsoring additional pre-clinical studies on mice to
confirm the potential efficacy of Radilex in treating acute radiation syndrome.
In parallel with these studies we are also determining the protocols that we
believe will allow us to initiate large animal clinical trials that will be
necessary for establishing efficacy per the animal efficacy rule. Assuming
adequate funding is available to us, we expect these large animal studies to
begin within the next 12 to 18 months. In conjunction with this, we are
establishing protocols for toxicology and human safety studies that will also be
needed to support a New Drug Application (NDA).
Prior to our formation, initial studies were conducted using Homspera
(now Radilex) under the direction of our co-founders, Dr. Mark Witten and Dr.
David Harris. These studies are summarized below.
o Mouse radiation study number one was an initial pilot study
using C57BL/6 male mice sponsored by the Air Force Office of
Scientific Research (AFOSR). This study was initiated at the
University of Arizona College of Medicine, Tucson, Arizona on
September 24, 2002. This study attempted to identify an LD50
value, that is, the dose of radiation after which 50% of the
mice will die, for subsequent standardization of exposure. The
study found that, in the opinion of the lead scientists, the
dose rate being delivered in the model system was so great
that an LD50 value could not be determined, therefore lower
doses were to be explored in subsequent studies.
34
o Mouse radiation study number two was a pilot study sponsored
by the AFOSR. This study was initiated at the University of
Arizona College of Medicine, Tucson, Arizona on January 24,
2003. This study lowered the radiation dosage (from 10 Gy to 9
Gy) and administered now Radilex via aerosol administration to
determine if the drug had efficacy by increasing survival time
from the potentially lethal dose of radiation. The lead
scientists believe that this study demonstrated that Radilex
treatment after 9 Gy radiation may have efficacy against acute
radiation syndrome and that the radiation exposed, Radilex
treated mice lived an average of two days longer than
untreated, radiation exposed mice.
Our sponsored and co-sponsored studies completed to date, as well as
current and planned studies with regard to the development of Radilex are
summarized below.
o Pilot mouse radiation study number 3, co-sponsored by us, was
performed at the University of Arizona College of Medicine,
Tucson, Arizona, starting on April 10, 2003. The study was
intended to determine if Radilex treatment would prolong life
in C57BL/6 male mice exposed to a single total body
irradiation 7.75 Gy dose of Gamma radiation. In the opinion of
management, this study demonstrated that a treatment of a 50
micromolar dose of Radilex kept 25% of the mice alive until 37
days after radiation until the experiment was terminated. The
U.S. Food & Drug Administration and the National Cancer
Institute utilize a 30-day survival time limit to determine
recovery from acute radiation syndrome.
o Pilot mouse radiation study number 4, co-sponsored by us was
initiated at the University of Arizona College of Medicine,
Tucson, Arizona on June 16, 2003. This study was conducted to
analyze whether higher concentrations of Radilex treatment
would prolong life in C57BL/6 male mice exposed to a single
total body dose of lethal radiation. In the opinion of
management, this study demonstrated that the treatment at the
higher concentration level was not efficacious in increasing
mouse survival time from a potentially lethal dose of gamma
radiation.
o Pilot mouse radiation study number 5, sponsored by the AFOSR
and co-sponsored by us was initiated at the University of
Arizona College of Medicine, Tucson, Arizona on July 11, 2003.
This study was designed to confirm radiation lethality and
Radilex efficacy of Radilex in preventing lethality in mice.
In the opinion of management, this study, replicating pilot
radiation mouse study number 3, demonstrated efficacy in
increasing mouse survival from a potentially lethal dose of
radiation. 50% of radiation-exposed, Radilex-treated mice
survived to 90 days post exposure when they were euthanized.
Further, in the opinion of management, results of the study
showed that when compared with non-irradiated mice, the
Radilex-treated, radiation-exposed mice showed no significant
differences in their immune system.
o Pilot mouse radiation study number 6, sponsored by us, was
initiated at the University of Arizona College of Medicine,
Tucson, Arizona on June 28, 2004. This study was initiated at
the request of the US FDA to determine efficacy in treating
radiation exposure with Radilex by intramuscular injection,
rather than inhalation.
The test subjects consisted of 300 mice separated into three
groups of 100. Each group was exposed to different levels of
radiation - 7 Gy, 8 Gy (lethal dose) and 9 Gy (lethal dose) -
and consisted of 25 male subjects treated with Radilex, 25
female subjects treated with Radilex, and the corresponding
control subjects. Each mouse was given a single dose of
radiation, and then all non-control mice received a dose of
Radilex by direct muscle injection on a daily basis for 60
consecutive days.
35
In the opinion of management, based on the findings of the
study, direct muscle injection was observed to be less
effective at similar dosing parameters. We believe this
finding may be due to a difference of neurokinin receptors in
the lungs of the mice to those in the skeletal muscle, as
Radilex is believed to be a neurokinin-1 receptor agonist.
Past research has shown the predominant neurokinin receptor in
the lungs is the neurokinin-1 receptor, whereas, the
predominant neurokinin receptor in rodent skeletal muscle was
demonstrated to be the neurokinin-2 receptor.
Furthermore, while conducting this study, scientists believe
that they witnessed potential wound healing properties of
Radilex. During the testing, some of the subjects developed
open wounds from natural causes. At the end of the 60-day
study, the injuries of the control group remained, while the
wounds of the Radilex treated mice had healed. We have filed a
provisional patent for the use of Radilex in the promotion of
wound healing. If additional funding becomes available in the
future, we may look to further study this potential use of
Radilex.
o Pilot mouse radiation study number 7, sponsored by
ImmuneRegen, was initiated at the University of Arizona
College of Medicine, Tucson, Arizona on November 20, 2004.
This study was intended to find a maximum efficacious dose of
Homspera in mice exposed to total body 7.75 Gy dose of Gamma
radiation. All mice remained alive until 17 days post
exposure, when they were exposed to a second dose of
radiation, at 9 Gy. All of the mice died at roughly the same
time. In the opinion of management, this study may have been
confounded by the fact that the mice spent their first 7 days
post-exposure in Biolevel 2 conditions which maintains a lower
bacterial load, masking the immunocompromised subjects'
vulnerability to elements that would impact study results.
o A blood profile study sponsored by us was conducted at the
University of Arizona College of Medicine, Tucson, Arizona
beginning on August 25, 2005. This was an exploratory pilot
study to demonstrate protection of C57BL/6 mice from
neutropenia and thrombocytopenia (decreases in systemic
neutrophils and platelets, respectively) and lethality
following a single dosage of gamma radiation of 8.25 Gy. In
the opinion of management, efficacy was demonstrated, as the
treated mice trended toward restored blood and platelet cell
numbers with normalized pathology of bone marrow compared to
the control group. Although the study demonstrated efficacy,
we were unable to demonstrate mechanistic effects due to an
inability to collect enough blood for adequate study.
o On January 9, 2006, based on these studies and other
pre-clinical observations, we sponsored a radiation
sensitivity animal model study using C57BL/6 mice at the
University of Arizona College of Medicine, Tucson. We designed
this radiation study to further the proof of concept for the
formulation of Sar9, Met (O2)11-Substance P with either a TFA
salt or HCl salt. We expect this study to be completed by
April 2006.
o We have finalized the protocols for what we believe will be
our final phase of rodent studies. Based on these protocols we
are currently sponsoring a radiation study on mice. This study
commenced on February 28, 2006 and is being conducted at Oak
Ridge National Laboratory. This study was designed to follow
the AFRRI model for radiation sickness. The purpose of this
study is to provide confirmation evidence supporting the
efficacy of Radilex as a treatment to a lethal dose of
radiation exposure. Several factors are being evaluated in
this study, including dosage, route of administration, and the
need for, and extent of, required pretreatment. In our
opinion, if these studies are deemed successfully completed,
under the current animal efficacy rule, we will qualify to
move to studies in large animals. We estimate the initial
study of this phase of rodent studies will be concluded within
90 days of initiation at a cost of approximately $90,000.
36
On January 14, 2004, we received a Pre-Investigational New Drug
Application (PIND) number for the use of Radilex (PIND No. 63,255) in the
treatment of acute radiation syndrome. We are currently inserting new data and
summarizing recent study results. We expect to file an updated PIND submission
for the use of Radilex in the treatment of acute radiation syndrome with this
new data to the FDA's Department of Counterterrorism within the next 120 days.
If desirable results are achieved, we anticipate filing the results of the Oak
Ridge National Laboratory study with the FDA's Department of Counterterrorism
within the next 6 to 9 months. At such time, we would request a meeting with the
FDA to establish a protocol for a Radilex study on primates.
VIPROVEX
We are also researching the efficacy of Viprovex as a potential
treatment for exposure to various chemical agents, including formalin, and
biological agents, including influenza and anthrax, as well as a potential
treatment for acute respiratory distress syndrome (ARDS). Based on past
research, the active ingredient in Viprovex (Sar9, Met (O2)11-Substance P), in
the opinion of management, plays an important role during early responses of the
lungs to various substances, including, what we believe to be a blocking of the
inflammatory cascade that potentially leads to the destruction of lung tissue.
To date, we have only conducted limited preclinical studies with regard
to the development of Viprovex. In the opinion of management, preliminary
results from pilot studies reveal the potential effects of Viprovex on the
immune system, including protection and replenishment, increased cytokines
(TNF(alpha), interferon-gamma) that reflect system activation, enhanced
phagocytotic activity, potential dendritic cell/T cell activation, inhibition of
apoptosis and increased T cell mitogenesis. It is the opinion of management that
these results may underlie the potential ability of Viprovex to enhance flu
therapies, minimize the respiratory impact of influenza infection and augment
the capability of vaccination to induce a protective immune response.
Prior to our formation, initial studies were conducted using Homspera
(now Viprovex) under the direction of our co-founder and Director, Dr. Mark
Witten. These studies were the basis for our research and development efforts. A
series of initial studies were conducted on the efficacy of Homspera (now
Viprovex) in treating JP-8 jet fuel induced immunotoxicity in mice. Mice were
administered a dose of JP-8 jet fuel to develop a chemically-induced AIDS with
the near total destruction of all immune system cells. In the opinion of
management, aerosol treatment with Viprovex directly stimulated the production
of immune system cells which remained viable after Viprovex treatment.
Pilot studies to date and current studies with regard to the
development of Viprovex are summarized below.
o In September 2003, a third party pilot study was conducted at
the University of Arizona, Arizona Health Sciences Center,
Lung Injury Laboratory using Homspera (now Viprovex) as a
potential treatment for mice infected with the LP-BM5 murine
leukemia retrovirus. In the mice infected with the LP-BM5
murine leukemia retrovirus, it is the opinion of management
that Viprovex treatment caused a seven-fold increase in spleen
interferon-gamma production and a significant increase in
spleen T-cell mitogenesis. Based on these findings, it is the
opinion of management that the administration of exogenous
interferon-gamma has potential efficacy, suggesting that
increased endogenous production may enhance protection against
some respiratory viruses.
o In October 2003 the AFOSR sponsored preliminary studies with
the Hong Kong influenza virus (A/Hong Kong/8/68) at the
University of Arizona, Arizona Health Sciences Center, Lung
Injury Laboratory. These studies demonstrated, in the opinion
of management, that in mice exposed to the irritant JP-8 jet
fuel and then inoculated with the Hong Kong respiratory virus
(HKV), the elevated levels of inflammatory cells in their
lungs were reduced in animals also treated with Viprovex. In
contrast to hydrocarbon-weakened control animals exposed to
the virus, animals also treated with Viprovex did not develop
the clinical symptoms of viral infection, the increases in
alveolar macrophages and neutrophils in broncho-alveolar
lavage fluid, and the loss of ciliated epithelium (the latter
as determined by electron microscopy). Treated animals also
had lower levels of leukotriene B4 than animals not treated
with Viprovex. Elevated LTB4 would attract the inflammatory
37
cells, particularly neutrophils, which would follow infection
with virus. Electron micrographs showed no virus particles in
the Viprovex-treated animals, in contrast to the HKV/JP-8
controls, suggesting, in our opinion, that Viprovex actually
prevented viral replication and pathology, perhaps by
stimulating the pulmonary alveolar macrophages to actively
phagocytose the virus more effectively. Without virons in the
lungs, there would be no need to mount an immune response.
Based on the results of this study, it is the opinion of
management that Viprovex may be used to enable the body's own
immune system to naturally fight off flu strains. Thereby,
opening up the possibility that Viprovex could be used either
as a stand alone treatment or as an adjunct to a vaccine or
other therapy. Further, based on the results from this study
we are pursuing government and military collaborations to test
Viprovex on treating avian influenza (H5N1).
o We co-sponsored an asthma pilot study in February, 2005
initiated at the University of Arizona by Dr. Mark Witten. The
pilot study was to determine if Viprovex is effaceable in
blocking the development of airway hyperactivity. Twenty-three
male C57BL/6 mice, seven of which were controls, were exposed
to cigarette/cigar smoke to induce an "asthma-like"
bronchoconstrictive condition. The mice were divided into
cigar or cigarette smoking groups and half of each received a
daily aerosol treatment of Viprovex. Dr. Witten then
administered one hour smoke exposure for five days a week for
three consecutive weeks. In the opinion of management, the
results indicated that Viprovex treatments could be utilized
to attenuate the development of airway hyperactivity after
toxic exposure to either cigarette or cigar smoke.
o A third party formalin pilot study in rats was initiated at
the University of Arizona College of Medicine, Tucson, Arizona
sponsored by Dr. Witten on August 22, 2005. This study was
designed to determine if aerosolized Viprovex would be
efficacious in attenuating lung injury after chemical
(formalin) exposure. The data collected from the study was
given to us by Dr. Witten and, in the opinion of management,
indicates that Viprovex treatment before formalin exposure to
the lungs greatly attenuated the lung injury normally induced
by formalin as evidenced by electron micrographs and
lethality. Based on these results, as additional research and
development funding is made available to us we plan to conduct
additional studies on the use of Viprovex as a treatment for
chemical exposure, to include chemicals such as formalin and
ricin.
o We are sponsoring a series of studies with Hyperion
Biotechnology Inc. at their laboratory facilities located at
Brooks City-Base in San Antonio, Texas with the cooperation of
the U.S. Air Force School of Aerospace Medicine (USAFSAM). We
designed these studies based on our opinion that Viprovex may
block the inflammatory cascade that can lead to the
destruction of lung tissue and our conjecture that Viprovex
may have a similar effect on combating exposure to anthrax
spores.
These studies are being conducted in hope of determining the
efficacy of Viprovex in treating exposure to anthrax bacilli.
The purpose of these studies is to determine if Viprovex will
reduce the mortality rate of an active infection of pulmonary
anthrax. These tests will also look for efficacy of Viprovex
as a preventive to pulmonary anthrax sickness.
The first of these studies was initiated in October 2005.
Logistical considerations related to number of animals
requiring exposure and performance of a full Viprovex
dose-response curve within specified time limits following
anthrax exposure required the experiment be performed in two
sections, and it is incomplete at this time. The second half
of the full dose-ranging experiment began in February, 2006.
On November 29, 2005 we applied for a PIND from the Department of
Health and Human Services (HHS) for the use of Viprovex in the treatment of
38
avian influenza. The PIND number for the use of Viprovex in treating avian flu
was issued on December 19, 2005 (PIND No. 73,709). We expect to continue to
investigate the efficacy of Viprovex in the treatment of avian influenza, with
the goal of submitting an application for an IND under the animal efficacy rule
within the next 12 to 18 months.
Based on the results of this formalin pilot study in rats, we applied
for a PIND from the HHS for the use of Viprovex in treating chemical exposure on
November 28, 2005. As we await PIND status, we intend to plan additional studies
to further our research and development activities as it relates to this
indication.
Based on data from early initial and subsequent studies indicating the
potential use of Viprovex in treating chemically induced ARDS, we plan to submit
an IND application to the FDA for the treatment of the effects of ARDS using
Viprovex within the next 12 to 18 months.
Due to our liquidity and limited cash available our spending on
research and development activities in the years ended December 31, 2004 and
2005 was limited. We spent approximately $113,731 and $150,091 in 2005 and 2004,
respectively, in research and development activities related to the development
of Radilex and Viprovex as protectants against the effects of chemical,
biological, radiological and nuclear threats. From our inception in October
2002, we have spent $306,794 in research and development activities. These costs
only include the manufacture and delivery of our drug by third party
manufacturers and payments to Contract Research Organizations for consulting
related to our studies and costs of performing such studies. Significant costs
relating to research and development, such as consulting fees for Drs. Witten
and Siegel among others, have been classified in consulting fees for consistency
of financial reporting.
If we are successful in obtaining additional funding through grants or
investment capital, we anticipate that during the next 12 months we will
increase our research and development spending to a total of approximately
$3,500,000 in an effort to further develop Radilex and Viprovex. This research
and development cost estimate includes a radiation study on large animals, which
we estimate will cost up to $2,500,000 depending on the choice of contractor,
additional animal pharmacology studies, formulation and animal safety/toxicity
studies, as well as, small pilot pharmacological studies exploring possible
additional indications. If we are unable to raise additional capital, our
research and development activities may be lessened.
The preliminary results of our pre-clinical studies using Radilex or
Viprovex may not be indicative of results that will be obtained from subsequent
studies or from more extensive trials. Further, our pre-clinical or clinical
trials may not be successful, and we may not be able to obtain the required
regulatory approvals in a timely fashion, or at all. See "Risk Factors."
POTENTIAL FUTURE PIPELINE APPLICATIONS
During our research and development efforts, we may, from time to time,
observe results that may lead to other potential applications using Homspera. At
the time of such an observation, we may design studies to further evaluate the
use for the indication. If these further studies support our initial
observations, we may file provisional patent applications for the use of
Homspera with the hope of protecting future development rights until we have the
ability to design additional studies and protocols and perform research with
regard to such applications.
To date, we have filed use patent applications in multiple
jurisdictions, inside and outside of the U.S., for use of the active ingredient
in Homspera for: ameliorating or preventing damage caused by cigarette smoke,
for treating patients with SARS (Severe Acute Respiratory Syndrome) or ARDS
(Acute Respiratory Distress Syndrome) or to prevent those exposed to their
causative agents, for inducing new hair growth or retarding hair loss, for
reducing certain ageing effects, such as interrupted sleep patterns, residual
muscle pain, short term memory loss, diminished visual accommodation, decreased
muscle strength, and arthritic pain, for stimulating wound healing in a
radiation-exposed mammal, for treating asthma, for treating skin diseases, in
particular, eczema, psoriasis, acne, and basal cell carcinoma, for
prophylactically treating domestic fowl to prevent respiratory infections, and
for maintaining or inducing hair color. To date, our development activities in
these areas have been limited to only small pilot exploratory studies in order
to observe and collect data that would justify filing use patent applications.
In the future, we may choose to conduct additional research and development to
further our observations in these areas.
39
DEVELOPMENT PROGRAM
Use of Contract Research Organizations (CRO)
--------------------------------------------
It is understood that extensive time and money is spent developing new
drug applications by the time they are approved by required regulatory agencies
for use on the market. In order to efficiently and expeditiously navigate the
research, development and regulatory approval process in hopes of bringing our
applications to market, our development program relies on the use of Contract
Research Organizations (CRO's).
CRO's are independent laboratories, registered with the FDA, that
provide contract services to the pharmaceutical industry. These CRO's offer
broad therapeutic expertise, advanced technologies and extensive resources for
drug discovery and drug and device development, and in some instances partnering
opportunities. In the opinion of management, using these outside organizations
helps to maximize our flexibility and minimize our one-time costs in outsourcing
very expensive programs to those companies that maintain the necessary
infrastructure to perform these cost-effectively according to internationally
recognized standards. Further, as product demands change, we believe that this
structure will allow us to move our resources to more appropriate contract
research or development or formulation or manufacturing facilities without
incurring loss of time or money on outdated projects and programs. As we move
our candidate products into FDA-compliant animal safety testing, we expect to
contract with specialty groups, organizations or companies that meet regulatory
requirements and have adequate and appropriate technical capabilities, rather
than develop and maintain an animal use and care facility ourselves that is
compliant with current Good Laboratory Practices.
In September, 2003, we contracted with Synergos, Inc. of The Woodlands,
Texas, a CRO, to represent us in all FDA communications and to contact and
interact with the FDA on our behalf. Likewise, in October, 2003 we contracted
with Huntingdon Life Sciences of East Millstone, New Jersey to conduct a two
week inhalation toxicity study of Homspera in rats. Further studies on
analytical techniques, toxicology and formulation of Homspera were conducted by
AppTec Laboratory Services of San Jose, California starting in November, 2003
through August, 2005.
GRANTS
From time to time, we may apply for governmental grants and respond to
formal requests from the government for additional information, thereby possibly
allowing us to be included as a candidate for potential future grants. The
submission of grants by us is summarized below.
In May, 2003 we applied for a grant with the Department of Health and
Human Services (DHHS), solicitation Number 266-01-SARS, Treatment from the
National Institute of Allergy and Infectious Diseases. The agency was seeking
potential treatments for the SARS virus infection. Our proposal called for
$771,000 to research Viprovex (then Homspera) as a potential treatment for SARS.
Our application for grant funding was not accepted.
On September 20, 2004 we submitted a grant application to the DHHS in
response to its Request for Application (RFA) entitled Biodefense Countermeasure
Development: Project Bioshield. Our proposal called for $1,500,000 to study
Radilex (then Homspera) as a countermeasure for radiation exposure. Our
application for grant funding was not accepted.
In October 2004, the DHHS released a Request for Information (RFI)
regarding potential therapeutics for the treatment for acute radiation syndrome,
entitled Therapeutics to Treat Neutropenia and Thrombocytopenia associated with
Acute radiation Syndrome. We notified the DHHS of our intent to submit in
December 2004. In June 2005, the terms of the RFI were changed by the DHHS and a
Request for Proposal (RFP) was issued. Although we intended to apply for the
RFP, no proposal was submitted as we believed that our technology did not meet
the specific criteria under the new terms of the RFP.
On March 11, 2005, we submitted a final response to an invitation to
participate in the Canadian Defense Ministry's "Universal Protectants Proposal"
respective to the use of Radilex for potentially treating the negative effects
of acute radiation syndrome and/or other health threats, such as anthrax, that
may result from chemical, biological, radiological and nuclear (CBRN) terrorist
threats. The goal of this program was to find a "universal" treatment for these
CBRN threats. The proposal is under the auspices of the Ottawa and Suffield
40
provincial branches of the Canadian Defense Ministry's research and development
program, the CBRN Research and Technology Initiative. We responded to this
initiative as we believe Radilex may have the potential to be a candidate as a
universal protectant against maladies caused by chemical, biological,
radiological and nuclear (CBRN) attacks. We are led to this conclusion because
in management's opinion the methods of action of Radilex do not simply
neutralize the attacking agent, but actually increase immune system activity,
thereby allowing the body's own immune system to attack and overcome the CBRN
agent. This program was abandoned by the Canadian government for budgetary
reasons prior to the acceptance of any companies into the study.
On October 11, 2005 we submitted a grant proposal for the US Army
Research Office's Broad Agency Announcement (BAA) W911NF-05-R-0011. The purpose
of the BAA was to develop new technologies for the Department of Defense's
Chemical and Biological Defense Transformational Medical Technologies Initiative
Fund. We signed a letter of intent with Battelle Laboratories Medical Research
and Evaluation Facility in West Jefferson, Ohio to conduct the Bio-level III
containment studies with Viprovex and avian influenza if our proposal is
accepted. The amount of funding sought in the grant proposal was approximately
$1,000,000. Our application for grant funding was not accepted.
On January 6, 2006, we applied for a grant offered by the Defense
Threat Reduction Agency (DTRA), solicitation number DTRA01-06-BAA-01. The
objective of our grant proposal, entitled "Advanced Proteomic Analysis of
Putative Universal Protectant Mechanisms of a Biologically Active Synthetic
Peptide," is: (i) to identify biomarkers for further defining our previous
observations relating to Radilex/Viprovex-modulated resistance to chemical,
biological and radiological stress and (ii) developing a model of mechanistic
pathways for potential chemical, biological and radiological injury protection.
We have entered into an agreement with Pacific Northwest National Laboratory
(PNNL) for this research if our application is accepted. The research involved
would be performed through the National Institute of Health (NIH)-funded
Proteomics Research Resource of Integrative Biology at PNNL. The funding sought
for this grant application is $2,325,000. As of the date of this prospectus, the
status of the grant is still pending.
On January 31, 2006 we submitted a response to sources sought notice
W9113M-06-S-0002 issued by the Department of Defense (DoD). The purpose of this
announcement was to identify companies that believe they have a viable candidate
for drugs that can be expeditiously developed and will provide a safe and
effective countermeasure against radiation injury. We are anticipating a formal
RFP to be issued by the DoD. As of the date of this prospectus, an RFP is still
pending.
On February 7, 2006 we submitted a grant proposal to the Defense
Advanced Research Projects Agency's (DARPA) Broad Agency Announcement (BAA)
BAA-05-19. The purpose of the BAA was to develop new technologies for DARPA's
Defense Science Office (DSO) program. The specific aim for us in this grant was
the development of defense against weapons of mass destruction: technologies to
render biological, chemical, nuclear, or radiation attacks against the U.S.
military harmless. More specifically, we focused on medical countermeasures
against both known and unknown pathogens and infectious disease, accelerated
manufacture of biologics, including vaccines and immune modifiers, and medical
countermeasures against radiation exposure. We proposed collaboration with
Pacific Northwest National Laboratory (PNNL) in Richland, Washington in which
studies would be conducted to explore the mechanism of Sar(9), Met
(O2)(11)-Substance P to mitigate or prevent mortality/morbidity resulting from
exposure to inhaled viruses, chemical toxicants and whole body radiation.
Through multiplexed cytokine analysis and evaluation of the proteomic
modifications induced by Sar(9), Met (O2)(11)-Substance P, we hoped to identify
common pathogenesis pathways for use of our compound as a universal protectant.
Our application for grant funding was not accepted.
CORRESPONDENCE WITH THE FOOD AND DRUG ADMINISTRATION(FDA), NATIONAL INSTITUTE OF
HEALTH(NIH) AND OTHER GOVERNMENT AGENCIES
The following is a chronological summary of our correspondence with the
U.S. Food and Drug Administration (FDA), the National Institutes of Health (NIH)
and other government agencies.
On October 16, 2003, Jennifer L. Wike of Synergos, Inc., our Contract
Research Organization (CRO), spoke with Sandy Barnes, FDA Project Manager. Ms.
Barnes inquired as to whether our ARDS Pre-IND meeting package was ready to be
sent to the FDA. Further, she informed us that she had put ImmuneRegen on their
meeting agenda for two possible dates in November 2003. Twelve copies of the
meeting information package were subsequently sent to the FDA by the Company.
41
On October 30, 2003, Jennifer L. Wike returned a call to Dr. Ray
Anthracite, FDA Medical Reviewer. Dr. Anthracite had called to further inquire
about the amino acid comprising the structure of Sar9,Met(O2)11-SubstanceP. Dr.
Anthracite confirmed that he is the medical reviewer for our potential product;
however, he could not confirm a date for the Pre-IND teleconference. He did
state that the agency had an internal meeting for our potential product set for
November 5, 2003.
On November 4, 2003, Jaye Thompson, Ph.D. of Synergos, Inc. received a
call from Cheryl Turner of the FDA Division of Counterterrorism (DCT). Ms.
Turner stated that the division wanted to have an introductory call with the
Company. A date of November 17, 2003 at 2:00PM EST was selected. We were
informed that Mary Purucker, MD, Division Director, DCT would be present for the
meeting and that despite the delays in contacting us, her division was
interested in the potential of Sar9, Met (O2)11-Substance P for treating acute
radiation syndrome (ARS).
On November 17, 2003 we and regulatory consultants from Synergos, Inc.
engaged in a teleconference with representatives from the FDA's Division of
Counterterrorism (DCT) to discuss the development of Homspera for use in the
event of a radiological terrorist event. Although the counterterrorism group
could not comment upon the specifics of the planned studies, they indicated that
development of this product would be regulated according to the provisions of
the animal efficacy rule. They also indicated that, with submission of
appropriate toxicity data, the selected animal model would be acceptable.
On January 14, 2004, we received a communication from Ryan Barraco, FDA
Consumer Safety Officer via facsimile confirming a meeting date of March 12,
2004 at 1:30PM EST in Rockville, MD in relation to a Pre-IND meeting to discuss
Homspera and the potential of a derivative to have potential efficacy in the
treatment of acute radiation syndrome. The confirmation also stated that the
agency required receipt of 33 hard copies and one disk of the company's
background package no later than February 13, 2004.
Also on January 14, 2004 we received a fax from Cheryl Turner, FDA
Division of Counter-Terrorism with a summary of the Pre-IND meeting that was
held on November 17, 2003 to determine the appropriate division for submitting
"Homspera for Treatment of Acute Radiation Syndrome (ARS)."
On February 18, 2004 our Pre-IND 63,255 (Treatment of ARS) Meeting
Package was sent to Ryan Barraco of the FDA for use in the corresponding meeting
set for March 12, 2004.
On March 12, 2004, we met with representatives of the FDA regarding
Radilex to discuss pre-clinical studies that will need to be completed prior to
submission of a marketing application, other requirements for product approval
and the study design of the proposed post-marketing study. The representatives
from the FDA suggested that we perform additional studies using specific
guidelines, i.e. number of mice, gender of mice, range of radiation dosage and
additional potential methods of administration. The representatives also
suggested that the company develop a "response team" that can be rapidly
deployed to an incident site to help in implementation, conduct and data
acquisition of the proposed study.
On October 21, 2004 Dr. Helen Quill of the National Institute of Health
(NIH) contacted us to request that Homspera's mechanisms of action were needed
in conjunction with a Request for Information (RFI) submission. These were
subsequently electronically sent to Dr. Quill on November 1, 2004.
On January 11, 2005, we received a meeting confirmation from Ryan
Barraco, FDA Consumer Safety Officer via fax. A meeting date of February 17,
2005 at 11:30AM EST in Rockville, MD was set in relation to Pre-IND 63,255 for
Radilex (Homspera). The confirmation letter also stated that the agency required
receipt of 18 hard copies and one electronic copy of our background package no
later than January 20, 2005.
On February 15, 2005 we received a fax from Ryan Barraco, FDA Consumer
Safety Officer, regarding responses from the FDA to our questions in the
background package.
On February 22, 2005 our representatives met with members of the NIH to
discuss: the potential use of Viprovex in an anthrax model; conducting further
studies under an AFRRI model using Radilex for a treatment for acute radiation
syndrome; as well as, additional pharmacokinetic and dose-timing research.
42
On July 1, 2005 Mui Erkun, Director of Procurement, Department of
Homeland Security (DHS), contacted us to request a meeting regarding our
potential therapeutics with interest in assisting the company with communication
to government officials and or agencies.
On September 6, 2005 Michael Wilhelm, our CEO, and Dr. Hal Siegel, our
Director of Product Development and Regulatory Affairs met with the Department
of Homeland Security in Washington, DC. They met with Drs. Vitko and Pilai in
order to discuss our potential therapeutics and efficacy. Also discussed was our
request for support. Both doctors indicated interest, but mentioned that until
the Chief Medical Officer, Jeff Runge, took office with DHS the office would
only be focused on consequence management involving logistical preparation and
detection, not therapeutics.
On September 21, 2005 Michael Wilhelm, Dr. Hal Siegel and Dr. Mark
Witten presented to Armed Forces Radiobiology Research Institute (AFRRI) at
their offices in Bethesda, Maryland. They presented their findings of possible
efficacy in treating acute radiation syndrome with Radilex. We mentioned that we
have used survival as an end point to the lethal exposure in our studies.
Further, we reported our observations that we believe that the best form of
administration of our potential therapeutic is via inhalation. AFRRI researchers
confirmed that a study using the preexisting AFRRI rodent radiation model as a
guide needs to be completed.
On December 19, 2005 we received a letter via US Mail from the
Department of Health and Human Services (DHHS) thanking us for our Avian Flu
Pre-IND Submission. A Pre-IND number was assigned (73,709).
COLLABORATORS AND CONTRACTORS
We have fostered and managed relationships with other laboratories
working in related areas of research and government agencies who are interested
in learning more of our applications, and perhaps helping to bring them to
commercialization. Collaborators and Contractors who we have already worked with
or are implementing a program are described below.
o We have sponsored or co-sponsored six mouse radiation studies
and co-sponsored one inhalation study at the University of
Arizona College of Medicine, Tucson, Arizona since January,
2005. Additionally, we are currently sponsoring a radiation
study which began on January 9, 2006. In addition, the Air
Force Office of Scientific Research, AFOSR, has sponsored
additional studies at the University of Arizona College of
Medicine utilizing Homspera, Radilex and Viprovex.
o Hyperion Biotechnology Inc. performs research programs in the
areas of probiotics, biomarker discovery, infectious disease
and human performance enhancement. We have contracted a series
of anthrax studies with Hyperion testing Viprovex as a
treatment to anthrax infection. These studies are conducted by
Hyperion at its research facility located on the U.S. Air
Force School of Aerospace Medicine (USAFSAM) campus in Brooks
City-Base in San Antonio, Texas.
o St. Joseph's Hospital and Medical Center (Phoenix, Arizona)
has performed assays on Homspera for us on a sub-contracting
basis.
o Battelle Memorial Institute's Medical Research and Evaluation
Facility (MREF) (Columbus, Ohio) has issued a letter of intent
to support us in our testing of Homspera as an Avian Influenza
therapeutic in mice. The letter of intent was included in a
grant application we submitted to the Army Research Office in
October, 2005 in response to their Broad Agency Announcement
Grant # W911NF-05-R-0010 for therapeutics against
bio-terrorism.
o Pacific Northwest National Laboratory (Redmond, Washington)
has issued a letter of intent to support us in our testing of
Homspera as a Universal Protectant therapeutic. The letter of
intent was included in a grant application we submitted to the
Defense Threat Reduction Agency (DTRA) in January, 2006 in
response to their Broad Agency Announcement, Grant #
DTRA01-06-BAA-01 for therapeutics against bio-terrorism.
o We have contracted with Oak Ridge National Laboratory (Oak
Ridge, Tennessee) to conduct Proof of Concept mouse radiation
43
studies that began in February, 2006 and to help facilitate
additional pre-clinical and future clinical trials with regard
to determining the potential efficacy of Radilex as a
treatment for acute radiation syndrome.
ADVISORY BOARDS AND CONSULTANTS
To assist us in the research and development of our various applications
we make use of outside consultants and advisory boards.
Consultants
We currently contract three outside consultants related to the research and
development, including regulatory affairs, of our potential products.
HAL SIEGEL, PH.D., through his consulting company, Siegel Consultancy,
provides strategic and tactical expertise to life science companies, helping
them meet FDA requirements from pre-clinical studies through the regulatory
submission process and into the post-approval marketplace. He has over a decade
of experience delivering scientific, clinical and regulatory compliance
assistance as well as submission preparation and management services to life
sciences client companies developing drugs, therapeutic biologics, combination
products, traditional devices and in vitro diagnostic products. His degrees are
from Rensselaer Polytechnic Institute and SUNY Buffalo (Ph.D., Biochemical
Pharmacology). Our contract with Siegel Consultancy, signed on March 16, 2005,
calls for the consultant to provide initial and ongoing product development,
quality control compliance, regulatory consulting and submission preparation as
needed. Compensation is at an hourly rate and includes reimbursement for travel
and documented expenses. There is no set termination date with this contract.
KELLY MCQUEEN, MD, MPH, PLLC was engaged on July 29, 2005 for a term of
three months to provide comprehensive public health consulting and act as
liaison with United States military services to pursue collaborative research in
the area of infectious diseases and upper respiratory illnesses. Kelly McQueen
is a practicing anesthesiologist and public health consultant in Phoenix,
Arizona. She currently works with the United States (U.S.) Army and the US
Northern Combatant Command on Infectious Disease, Disaster Planning and other
public health projects. She also teaches infectious disease threat management
and treatment for the International Committee for the Red Cross (ICRS) course on
Health Emergencies in Large Populations (HELP). Ms. McQueen's contract with us
provides for cash compensation on an hourly basis and reimbursement for travel
and expenses. We have mutually agreed to extend the contract at the same terms
on a month by month basis.
DR. JACK CARAVELLI, PH.D. was contracted on November 5, 2005 to provide
advisory services in support of ImmuneRegen's initiative to commercialize
radiation sickness treatments, bio-defense applications and countermeasures. He
is presently a senior Advisor for the Threat Reduction Cooperation with the
Office of Policy at the U.S. Department of Energy (D.O.E.). Dr. Caravelli's
contract calls for cash compensation at an hourly rate and reimbursement for any
related travel and expenses. The initial contract had a term of two months and
we have mutually agreed to extend the contract at the same terms on a month by
month basis.
Advisory Board
--------------
We currently have three advisory boards: Drug Development, Oncology &
Dermatology and Bioterrorism Preparedness. Advisory board members are appointed
for one-year terms by our management. For services rendered, members of our
advisory boards are compensated on a quarterly basis in common stock purchase
warrants.
The Drug Development and Oncology & Dermatology Boards were formed to
educate and provide direction with regard to the development of applications
using Homspera in the areas of expertise of the various advisory board members.
The following individuals comprise our Drug Development Advisory Board:
MOSHE ARDITI, M.D., Senior Advisor: Director, Division of Pediatric
Infectious Diseases, Cedars-Sinai Medical Center, Los Angeles, CA,
MR. RALPH DI LIBERO, Associate Advisor: Vice President, European Sales
and Marketing, PolyPeptide Laboratories A/S in Denmark
44
K.A. KELLY MCQUEEN, M.D., MPH, Associate Advisor: Anesthesiologist and
Public Health Consultant; Infectious Disease and Disaster Planning for
U.S. Army and US Northern Combatant Command
HAL SIEGEL, PH.D., Associate Advisor: Principal and Founder,
Scientific, Clinical, and Regulatory Compliance, Siegel Consulting
SIMON WONG, M.D., MPH, Associate Advisor: Research Assistant Professor,
University of Arizona Health Science Center, Department of Pediatrics.
The following individuals comprise our Oncology & Dermatology Advisory Board:
DR. JOHN DANN, M.D., D.D.S., Senior Advisor
DR. JEFFERY FRIEDMAN, M.D., Senior Advisor: Diplomat, American Board of
Cosmetic Surgery, American Board of Otolaryngology Head and Neck
Surgery, Fellow of the American Academy of Cosmetic Surgery
ELIZABETH CEILLEY HYSLOP, M.D., Associate Advisor: Clinical
Practitioner, Durango Cancer Center.
The Bioterrorism Preparedness Advisory Board, was formed at the
suggestion of the U.S. Food and Drug Administration's (FDA) Division of
Counterrorism (DCT) to develop a "response team" that can be rapidly deployed to
an incident site in the event of a biological or radiological attack to help in
implementation, conduct and data acquisition. As there are several first
responder teams already in place, we opted to concentrate on forming a group to
discuss logistics and coordination between agencies and these first responder
groups in the event of an attack. We have attempted to appoint knowledgeable
military and private citizens that possess first hand experience in combat
casualty and mass trauma scenarios, including preparation for a bioterrorist
attack and/or medical or scientific expertise. The following individuals
comprise our Bioterrorism Preparedness Advisory Board:
JAMES R. CAMPBELL, PhD, M.P.H, Senior Advisor: Commanding Officer of
the Office of Naval Research Global, United States NAVY, Medical Corps,
(Ret.), Manager for Biosecurity and Biodefense, in the National
Security Directorate at the Pacific Northwest National Laboratory.
THE HONORABLE ASA HUTCHINSON, J.D. Senior Advisor: former Under
Secretary for Border and Transportation Security at the Department of
Homeland Security, Partner and chair of Venable LLP's Homeland Security
Group.
DENNIS E. AMUNDSON, D.O., Senior Advisor: Captain, United States Navy,
Medical Corps, Naval Medical Center, San Diego, Pulmonary Medicine
MOSHE ARDITI, M.D., Senior Advisor: Director, Division of Pediatric
Infectious Diseases, Cedars-Sinai Medical Center, Los Angeles, CA
MR. MICHAEL CARIDI, Senior Advisor: Chairman, MAJIC Development Group,
SRC Industries Inc. and Protection Plus Security Consultants, Inc.
PAUL CARLTON, M.D., Senior Advisor: Lt. General, USAF, Medical Corps,
(Ret.), Director, Homeland Security for The Health Science Center The
Texas A&M University System, Former USAF Surgeon General
MR. RALPH DI LIBERO, Associate Advisor: Former-Vice President, European
Sales and Marketing, PolyPeptide Laboratories A/S in Denmark
WILLIAM HOEHN, PH.D., Associate Advisor: Visiting Professor, Georgia
Tech, Sam Nunn School of International Affairs, Center for
International Strategy, Technology, and Policy
COL. KERRIE LINDBERG (RET.), Associate Advisor: Colonel, USAF, Nurse
Corps, (Ret.), Former Director, Defense Institute for Medical
Operations (DIMO), Brooks City-Base, Texas
MR. MICHAEL DEUTSCH, Associate Advisor: Homeland Security Liaison,
Principal, Immediate Solutions, LLC
Additionally, as part of the process of researching a deployment plan
and keeping the Bioterrorism Preparedness Advisory Board current with recent
events, our management has met with several congressional leaders responsible
for legislation relating to Homeland Security, including the office of Senator
Joseph Lieberman and the office of House Representative J.D. Hayworth to have
45
the opportunity to ascertain their viewpoints on emerging preparedness.
Additionally, in February 2005, management met with the New York State Office of
Public/Homeland Security (NYSOPS), the agency responsible for detection,
identification, response, prevention and recovery for a terrorist act or threat
in New York State.
MANUFACTURING
Management expects that Radilex and Viprovex will ultimately have
distinct formulations and dosing regimens, however, at this early stage of
development, the formulations used are identical. We do not have, and do not
intend to establish, manufacturing facilities to produce Homspera, Radilex or
Viprovex or any potential products, if any, derived from Homspera. We have used
and expect to continue to use third party manufacturers to obtain synthetic
Sar9, Met (O2)11-Substance P. We believe Sar9, Met (O2)11-Substance P is readily
available at low cost from several life science and technology companies that
provide biochemical and organic chemical products used in scientific and genomic
research, biotechnology, pharmaceutical development and the diagnosis of disease
and chemical manufacturing. Further, we believe that the Sar9, Met
(O2)11-Substance P is readily available from various sources, and several
suppliers are capable of supplying such in both clinical and initial commercial
quality and quantities.
To date, we have acquired Sar9, Met (O2)11-Substance P (Homspera),
which is the active ingredient in experimental formulations of Radilex and
Viprovex from three different manufacturers. These are Sigma Aldrich, Inc. of
Dallas Texas, PolyPeptide Laboratories A/S of Hillerod, Denmark and C S Bio
Company Inc. of Menlo Park, California. Since we are only purchasing research
quantities of the drug at this time, we have not entered into any contracts or
agreements with any third party manufacturers, other than standard
non-disclosure agreements.
The manufacture of Radilex, Viprovex or any potential products, if any,
derived from Homspera, whether done by outside contractors, as planned, or
internally, will be subject to rigorous regulations, including the need to
comply with the FDA's current Good Manufacturing Practice (cGMP) standards. As
part of obtaining FDA approval for each product, each of the manufacturing
facilities must be inspected, approved by and registered with the FDA. In
addition to obtaining FDA approval of the prospective manufacturer's quality
control and manufacturing procedures, domestic and foreign manufacturing
facilities are subject to periodic inspection by the FDA and/or foreign
regulatory authorities.
PATENTS AND PROPRIETARY RIGHTS
Patents and other proprietary rights are essential to our business. We
file patent applications to protect our technologies, inventions, and
improvements to our inventions that we consider important to the development of
our business. We also rely upon trade secrets, know-how, continuing
technological innovations and licensing opportunities to develop and maintain
our competitive position.
The active ingredient in Homspera, Radilex and Viprovex is the compound
Sar9, Met (O2)11-Substance P. The intellectual property owned by us, as further
described below, is for the various potential uses of Sar9, Met (O2)11-Substance
P. Additionally, we are in the process of pursuing several other use patent
applications based on the use of Homspera.
We currently hold issued patents in the U.S. for use of Sar9, Met
(O2)11-Substance P, the active ingredient in Homspera, Radilex, and Viprovex for
inhibiting tumor growth and/or metastasis in cancer patients and for stimulating
the immune system of immunocompromised individuals such as Acute Radiation
Syndrome victims. Similar patent rights are held in Europe and Australia. In the
latter two regions, we also have been issued patent rights for use of the active
ingredient in Homspera, Radilex and Viprovex for stimulating the maturation of a
juvenile immune system, for stimulating an immune response to a viral or
bacterial infection, and for reducing the risk of cancer.
We have also filed patent applications in many jurisdictions, inside
and outside of the U.S., for use of the active ingredient in Homspera, Radilex
and Viprovex for ameliorating or preventing damage caused by cigarette smoke;
for treating patients with SARS (Severe Acute Respiratory Syndrome) or ARDS
(Acute Respiratory Distress Syndrome) or to prevent these conditions in those
exposed to putative causative agents; for inducing new hair growth or retarding
hair loss; for reducing certain aging effects, such as interrupted sleep
patterns, residual muscle pain, short term memory loss, diminished visual
46
accommodation, decreased muscle strength, and arthritic pain; for stimulating
wound healing in a radiation-exposed mammal; for treating asthma; for treating
skin diseases, in particular, eczema, psoriasis, acne, and basal cell carcinoma;
for prophylactically treating domestic fowl to prevent respiratory infections,
and for maintaining or inducing hair color. Because these applications have not
yet been granted, the rights in these subject matters remain potential.
The following is a list of the registered patents and provisional
patent applications in our portfolio. All of the inventor rights for all patents
and all patent applications listed have been assigned to us by the inventors,
Dr. Mark Witten and/or Dr. David Harris. Some of our research has been or is
being funded by the Air Force Office of Scientific Research and has been or is
being conducted at the University of Arizona. We have received waivers of rights
to the invention from the United States Air Force and the University of Arizona
in regard to patent and patent applications for Substance P Treatment for
Immunostimulation. We are expecting to receive similar waivers from the United
States Air Force and the University of Arizona for the remaining patent
applications in our intellectual property portfolio. In total, our patent
portfolio consists of two issued U.S. and two issued foreign patents and two
pending Patent Cooperation Treaty (PCT) applications, seven pending U.S.
applications and 16 pending foreign patent applications. The assignment
documents are included as Exhibits.
Registered Patents:
-------------------
Title Serial No.
----- ----------
Substance P Treatment for Immunostimulation US 5,945,508
Substance P Treatment for Immunostimulation US 5,998,376
Substance P Treatment for Immunostimulation Australia 737201
Substance P Treatment for Immunostimulation European 0957930
PATENTS PENDING:
Title Serial No.
----- ----------
Acute Respiratory Syndromes US 10/553232
Acute Respiratory Syndromes Europe (Application number TBA)
Acute Respiratory Syndromes Singapore (Application number TBA)
Acute Respiratory Syndromes Vietnam 1-2005-015
Amelioration of Effects of Cigarette Smoke US 10/645,839
Amelioration of Effects of Cigarette Smoke Singapore 2005 01072-3
Amelioration of Effects of Cigarette Smoke Vietnam 1-2005-00215
Amelioration of Effects of Cigarette Smoke Japan 2004-532943
Amelioration of Effects of Cigarette Smoke European Union 3791722.6
Amelioration of Effects of Cigarette Smoke Canada -2496447
Anti-Aging Effects of Substance P PCT/US05/13113
Inducing and Maintaining Hair Color PCT/US05/13112
Method to Promote Wound Healing US 60/622,015
Prevention of Respiratory Diseases in Fowl US 60/641153
Prevention of Respiratory Diseases in Fowl Singapore 200500467-6
Prevention of Respiratory Infection in Fowl Vietnam 1-2005-00599
Prevention of Respiratory Infection in Fowl Thailand 097659
Stimulation of Hair Growth US 10/539/734
Substance P Treatment for Immunostimulation Canada 2,261,885
Treatment of Asthma US 60/667,062
Treatment of Asthma Singapore 200504104-1
Treatment of Skin Diseases US 60/642,996
Treatment of Skin Diseases Vietnam 1-2005-00598
Treatment of Skin Diseases Thailand 098080
Treatment of Skin Diseases Singapore 200500466-8
Our rights to the US Patent Nos. 5,945,508 and 5,998,376, Substance P
Treatment for Immunostimulation, have certain limitations with respect to the
University of Arizona and the United States Air Force as described below. If
patents are issued for any of our pending patent applications, the same
limitations would most likely apply.
Our agreements with the University of Arizona outline very specific
rights in regard to our sponsored-supported projects. In accordance with our
sponsored-supported project agreements, the University of Arizona retains the
right to use data developed during these projects for non-commercial purposes,
including teaching, research and education. ImmuneRegen BioSciences, Inc.
retains the rights to trade secrets, inventions, developments and discoveries as
limited by the University of Arizona's employment contracts in effect at the
time the intellectual property was created. Further to this point, the principal
47
investigator at the University of Arizona, Dr. Mark Witten, was a consultant to
ImmuneRegen BioSciences, and, under the terms of his consulting agreement,
ImmuneRegen BioSciences, Inc. retains rights to any developments or discoveries
that he made in the course of working for us.
As a result of governmental funding, the U.S. Government has certain
rights in the technology developed with such funds. These rights include a
non-exclusive, paid-up, worldwide license under such inventions for any
governmental purpose. In addition, the government has the right to require us to
grant an exclusive license under any of such inventions to a third party if the
government determines that: (i) adequate steps have not been taken to
commercialize such inventions, (ii) such action is necessary to meet public
health or safety needs, or (iii) such action is necessary to meet requirements
for public use under federal regulations.
In this regard, the United States Air Force has reserved a
non-exclusive license to the patents (US Patent Nos. 5,945,508 and 5,998,376) in
connection with Air Force grant F49620-94-1-0297 and may, under certain
conditions, have commensurate or additional license rights under the Bayh-Dole
Act. Those rights are set forth in 35 USC 202(c)(4) and 37 CFR 401.9 and 14(a).
Under the federal Bayh Dole Act, a party which acquires an exclusive
license for an invention that was partially funded by a federal research grant
is subject to the following government rights: (i) products using the invention
which are sold in the U.S. are to be manufactured substantially in the U.S.
unless a waiver is obtained; (ii) the government may force the granting of a
license to a third party who will make and sell the needed product if the
licensee does not pursue reasonable commercialization of a needed product using
the invention; and (iii) the U.S. Government may use the invention for its own
needs.
Moreover, besides the rights that have been granted to the U.S.
Government, the validity and breadth of claims in medical technology patents
involve complex legal and factual questions and, therefore, may be highly
uncertain. No assurance can be given that any patents based on pending patent
applications or any future patent applications by us will be issued, that the
scope of any patent protection will exclude competitors or provide competitive
advantages to us, that any of the patents that have been or may be issued to us
will be held valid if subsequently challenged or that others will not claim
rights in or ownership of the patents and other proprietary rights held by us.
Furthermore, there can be no assurance that others have not developed or will
not develop similar products, duplicate any of our products or design around any
patents that have been or may be issued to us. Since patent applications in the
U.S. are maintained in secrecy until shortly before a patent's issuance, we also
cannot be certain that others did not first file applications for inventions
covered by our pending patent applications, nor can we be certain that we will
not infringe any patents that may be issued to others on such applications.
We also rely on trade secrets and unpatentable know-how that we seek to
protect, in part, by confidentiality agreements. It is our policy to require our
employees, consultants, contractors, manufacturers, outside scientific
collaborators and sponsored researchers and other advisors to execute
confidentiality agreements upon the commencement of employment or consulting
relationships with us. These agreements provide that all confidential
information developed or made known to the individual during the course of the
individual's relationship with us is to be kept confidential and not disclosed
to third parties except in specific limited circumstances. We also require
signed confidentiality or material transfer agreements from any company that is
to receive our confidential information. In the case of employees, consultants
and contractors, the agreements generally provide that all inventions conceived
by the individual while rendering services to us shall be assigned to us as our
exclusive property. There can be no assurance, however, that these agreements
will not be breached, that we would have adequate remedies for any breach, or
that our trade secrets or unpatentable know-how will not otherwise become known
or be independently developed by competitors.
Our potential success will also depend in part on our ability to
develop commercially viable products without infringing the proprietary rights
of others. We have not conducted freedom of use patent searches and no assurance
can be given that patents do not exist or could not be filed which would have an
adverse affect on our ability to market our products or maintain our competitive
position with respect to our products. If our technology components, devices,
designs, products, processes or other subject matter are claimed under other
existing U.S. or foreign patents, or are otherwise protected by third party
proprietary rights, we may be subject to infringement actions. In such event, we
48
may challenge the validity of such patents or other proprietary rights or we may
be required to obtain licenses from such companies in order to develop,
manufacture or market our products. There can be no assurances that we would be
able to obtain such licenses or that such licenses, if available, could be
obtained on commercially reasonable terms. Furthermore, the failure to either
develop a commercially viable alternative or obtain such licenses could result
in delays in marketing our proposed products or the inability to proceed with
the development, manufacture or sale of products requiring such licenses, which
could have a material adverse affect on our business, financial condition and
results of operations. If we are required to defend ourselves against charges of
patent infringement or to protect our proprietary rights against third parties,
substantial costs will be incurred regardless of whether we are successful. Such
proceedings are typically protracted with no certainty of success. An adverse
outcome could subject us to significant liabilities to third parties and force
us to curtail or cease our development and sale of our products and processes.
We may collaborate in the future with other entities on research,
development and commercialization activities. Disputes may arise about
inventorship and corresponding rights in know-how and inventions resulting from
the joint creation or use of intellectual property by us and our collaborators,
partners, licensors and consultants. As a result, we may not be able to maintain
our proprietary position.
RESEARCH AND LICENSE AGREEMENTS
Our patents and continued research on Sar9, Met (O2)11-Substance P are
derived from discoveries made during research studies funded by the Air Force
Office of Scientific Research in early 1994 by our Director, Dr. Mark Witten. In
December 2002 we entered into consulting agreements on a month-to-month basis
with Dr. Mark Witten and Dr. David Harris, who are our two founders and largest
shareholders. Under the terms of these agreements, Drs. Witten and Harris agree
to place at the disposal of us their judgment and expertise in the area of acute
lung injury. In consideration for these services, we agreed to pay each of Drs.
Witten and Harris a non-refundable fee of $5,000 per month. We and Dr. Harris
agreed to terminate the consulting agreement for Dr. Harris in March 2005. In
January 2006, the company received correspondence from Dr. Witten stating that
he would terminate his consulting contract if his specific requirements were not
met. We subsequently accepted his termination effective February 1, 2006.
In December 2002, we entered into a royalty-free license agreement with
Drs. Witten and Harris. Under the terms of the license agreement, Drs. Harris
and Witten granted to us an exclusive license to use and sublicense certain
patents, medical applications, and other technologies developed by them. Our
obligations under this agreement include (i) reasonable efforts to protect any
licensed patents or other associated property rights; (ii) reasonable efforts to
maintain confidentiality of any proprietary information; (iii) upon the granting
by the U. S. Food and Drug Administration to us the right to market a product,
we will, for so long as we sell any product or medical application which
incorporates or utilizes the patents, medical applications, and other
technologies developed by Drs. Witten and Harris, maintain in full force and
effect policies of general liability insurance (with Broad Form General
Liability and Product Liability endorsements) with limits of not less than
$1,000,000 per occurrence and $1,000,000 annual aggregate. The license agreement
will terminate ten years after the date of the expiration of the last patent
issued or issuing with respect to the licensed patents, medical applications,
and other technologies. The resignation of Dr. Harris as a director of our
company in December 2004 and as a consultant in March 2005 does not have any
impact upon the terms of the license agreement. The resignation of Dr. Witten as
a consultant to our company in February 2006 does not have any impact upon the
terms of the license agreement.
In February 2005, Drs. Witten and Harris executed assignment documents
in which, for good and valuable consideration, patent applications and patents
developed by them were assigned to ImmuneRegen BioSciences, Inc. The assignment
documents included all of the patents and patent applications which were
included in and covered by the Licensing Agreement, as amended. Drs. Witten and
Harris have also assigned all proprietary technology developed at ImmuneRegen
subsequent to the execution of the February 2005 assignment documents.
GOVERNMENTAL REGULATION
Our research and development activities and the manufacturing and
marketing of our applications are subject to the laws and regulations of
governmental authorities in the U.S. and other countries in which our
applications may be potentially marketed. Specifically, in the U.S., the FDA,
among other activities, regulates new product approvals to establish safety and
efficacy of these applications. Governmental authorities in the United States
49
extensively regulate the pre-clinical and clinical testing, safety, efficacy,
research, development, manufacturing, labeling, storage, record-keeping,
advertising, promotion, export, marketing and distribution, among other things,
of pharmaceutical products. Governments in other countries have similar
requirements for testing and marketing. In the U.S., in addition to meeting FDA
regulations, we are also subject to other federal laws as well as certain state
laws.
REGULATORY PROCESS IN THE UNITED STATES
In the United States, the FDA, under the Federal Food, Drug, and
Cosmetic Act (FFDCA), the Public Health Service Act and other federal statutes
and regulations, subject pharmaceutical and biologic products to rigorous
review. If we do not comply with applicable requirements, we may be fined, the
government may refuse to approve our marketing applications or allow us to
manufacture or market our products or product candidates, and we may be
criminally prosecuted. The FDA also has the authority to discontinue or suspend
manufacture or distribution, require a product withdrawal or recall or revoke
previously granted marketing authorizations, if we fail to comply with
regulatory standards or if we encounter problems following initial marketing.
Approval of new pharmaceutical (and biological) products is a lengthy
procedure leading from development of a new product through pre-clinical and
clinical testing. This process takes a number of years and the expenditure of
significant resources. There can be no assurance that our product candidates
will ultimately receive regulatory approval.
Regardless of how our product candidates are regulated, the FFDCA and
other Federal statutes and regulations govern or influence the research,
testing, manufacture, safety, labeling, storage, record-keeping, approval,
distribution, use, product reporting, advertising and promotion of such
products. Noncompliance with applicable requirements can result in civil
penalties, recall, injunction or seizure of products, refusal of the government
to approve or clear product approval applications or to allow us to enter into
government supply contracts, withdrawal of previously approved applications and
criminal prosecution.
PRODUCT APPROVAL IN THE UNITED STATES
To obtain approval of a new product from the FDA, we must, among other
requirements, submit data demonstrating the product's safety and efficacy, as
well as, detailed information and reports on the manufacture and composition of
the product candidate. In most cases, this entails extensive laboratory tests,
pre-clinical and clinical trials. This testing and the preparation of necessary
applications and processing of those applications by the FDA are expensive and
typically take many years to complete. The FDA may deny our applications or may
not act quickly or favorably in reviewing these applications, and we may
encounter significant difficulties or costs in our efforts to obtain FDA
approvals that could delay or preclude us from marketing any products we may
develop. The FDA also may require post-marketing testing and surveillance to
monitor the effects of approved products or place conditions on any approvals
that could restrict the commercial applications of these products. Regulatory
authorities may withdraw product approvals if we fail to comply with regulatory
standards or if we encounter problems following initial marketing. With respect
to patented products or technologies, delays imposed by the governmental
approval process may materially reduce the period during which we will have the
exclusive right to exploit the products or technologies.
The FDA does not apply a single regulatory scheme to human tissues and
the products derived from human tissue. On a case-by-case basis, the FDA may
choose to regulate such products as transplanted human tissue, medical devices
or biologics. A fundamental difference in the treatment of products under these
classifications is that the FDA generally permits human tissue for
transplantation to be commercially distributed without marketing approval. In
contrast, products regulated as medical devices or biologics usually require
such approval.
The process required by the FDA before a new drug or biologic may be
marketed in the United States generally involves the following:
o completion of pre-clinical laboratory tests or trials and
formulation studies;
o submission to the FDA of an IND for a new drug or biologic,
which must become effective before human clinical trials may
begin;
50
o performance of adequate and well-controlled human clinical
trials to establish the safety and efficacy of the proposed
drug or biologic for its intended use; and,
o submission and approval of a New Drug Application, or NDA, for
a drug, or a Biologics License Application, or BLA, for a
biologic.
Pre-clinical tests include laboratory evaluation of product chemistry,
formulation and stability, as well as studies to evaluate toxicity. The results
of pre-clinical testing, together with manufacturing information and analytical
data, are submitted to the FDA as part of an IND application. The FDA requires a
30-day waiting period after the filing of each IND application before clinical
trials may begin, in order to ensure that human research subjects will not be
exposed to unreasonable health risks. At any time during this 30-day period or
at any time thereafter, the FDA may halt proposed or ongoing clinical trials, or
may authorize trials only on specified terms. The IND application process may
become extremely costly and substantially delay development of our products.
Moreover, positive results of pre-clinical tests will not necessarily indicate
positive results in clinical trials.
The sponsor typically conducts human clinical trials in three
sequential phases, which may overlap. These phases generally include the
following:
Phase I: The product is usually first introduced into healthy humans
or, on occasion, into patients, and is tested for safety,
dosage tolerance, absorption, distribution, excretion and
metabolism.
Phase II: The product is introduced into a limited patient population
to:
o assess its efficacy in specific, targeted
indications;
o assess dosage tolerance and optimal dosage; and,
o identify possible adverse effects and safety
risks.
Phase III: These are commonly referred to as pivotal studies. If a
product is found to have an acceptable safety profile and to
be potentially effective in Phase II clinical trials, new
clinical trials will be initiated to further demonstrate
statistically significant clinical efficacy, optimal dosage
and safety within an expanded and diverse patient population
at geographically-dispersed clinical study sites.
As described above, for several of the product opportunities we are
pursuing, we may apply for approval based upon a new rule adopted by the FDA in
2002, titled "Approval of New Drugs When Human Efficacy Studies Are Not Ethical
or Feasible" (Code of Federal Regulations, Title 21, Part 314, Subpart I), which
is also referred to as the "animal efficacy rule." Pursuant to this new rule, in
situations where it would be unethical to conduct traditional Phase II and Phase
III efficacy studies in humans, as is the case with our applications relating to
the treatment of maladies caused by exposure to various chemical and biological
agents, the FDA will review new drugs for approval on the basis of safety in
humans and efficacy in relevant animal models.
If the FDA does ultimately approve the product, it may require
post-marketing testing, including potentially expensive Phase IV studies, to
monitor its safety and effectiveness.
Clinical trials must meet requirements for Institutional Review Board,
or IRB, oversight, informed consent and the FDA's Good Clinical Practices. Prior
to commencement of each clinical trial, the sponsor must submit to the FDA a
clinical plan, or protocol, accompanied by the approval of the committee
responsible for overseeing clinical trials at one of the clinical trial sites.
The FDA and the IRB at each institution at which a clinical trial is being
performed may order the temporary or permanent discontinuation of a clinical
trial at any time if it believes that the clinical trial is not being conducted
in accordance with FDA requirements or presents an unacceptable risk to the
clinical trial patients.
51
The sponsor must submit to the FDA the results of the pre-clinical and
clinical trials, together with, among other things, detailed information on the
manufacturing and composition of the product, in the form of an NDA, or, in the
case of a biologic, a BLA. Once the submission has been accepted for filing, the
FDA has 180 days to review the application and respond to the applicant. The
review process is often significantly extended by FDA requests for additional
information or clarification. The FDA may refer the BLA to an advisory committee
for review, evaluation and recommendation as to whether the application should
be approved, but the FDA is not bound by the recommendation of an advisory
committee.
It is possible that our product candidates will not successfully
proceed through this approval process or that the FDA will not approve them in
any specific period of time, or at all. The FDA may deny or delay approval of
applications that do not meet applicable regulatory criteria, or if the FDA
determines that the clinical data do not adequately establish the safety and
efficacy of the product. Satisfaction of FDA pre-market approval requirements
for a new biologic is a process that may take several years and the actual time
required may vary substantially based upon the type, complexity and novelty of
the product or disease. The FDA reviews these applications and, when and if it
decides that adequate data are available to show that the product is both safe
and effective and that other applicable requirements have been met, approves the
drug or biologic for marketing. Government regulation may delay or prevent
marketing of potential products for a considerable period of time and impose
costly procedures upon our activities. Success in early stage clinical trials
does not assure success in later stage clinical trials. Data obtained from
clinical activities is not always conclusive and may be susceptible to varying
interpretations that could delay, limit or prevent regulatory approval. Upon
approval, a product candidate may be marketed only for those indications
approved in the BLA or NDA and may be subject to labeling and promotional
requirements or limitations, including warnings, precautions, contraindications
and use limitations, which could materially impact profitability. Once approved,
the FDA may withdraw the product approval if compliance with pre- and
post-market regulatory standards is not maintained or if safety, efficacy or
other problems occur after the product reaches the marketplace.
The FDA may, during its review of an NDA or BLA, ask for additional
test data. If the FDA does ultimately approve the product, it may require
post-marketing testing, including potentially expensive Phase IV studies, to
monitor the safety and effectiveness of the product. In addition, the FDA may,
in some circumstances, impose restrictions on the use of the product, which may
be difficult and expensive to administer and may require prior approval of
promotional materials.
ONGOING FDA REQUIREMENTS
Before approving an NDA or BLA, the FDA will inspect the facilities at
which the product is manufactured and will not approve the product unless the
manufacturing facilities are in compliance with the FDA's current Good
Manufacturing Practices, or cGMP, requirements which govern the manufacture,
holding and distribution of a product. Manufacturers of biologics also must
comply with the FDA's general biological product standards. Following approval,
the FDA periodically inspects drug and biologic manufacturing facilities to
ensure continued compliance with the cGMP requirements. Manufacturers must
continue to expend time, money and effort in the areas of production, quality
control, record keeping and reporting to ensure full compliance with those
requirements. Failure to comply with these requirements subjects the
manufacturer to possible legal or regulatory action, such as suspension of
manufacturing, seizure of product, voluntary recall of product, withdrawal of
marketing approval or civil or criminal penalties. Adverse experiences with the
product must be reported to the FDA and could result in the imposition of
marketing restrictions through labeling changes or market removal. Product
approvals may be withdrawn if compliance with regulatory requirements is not
maintained or if problems concerning safety or efficacy of the product occur
following approval.
The labeling, advertising, promotion, marketing and distribution of a
drug or biologic product also must be in compliance with FDA and FTC
requirements which include, among others, standards and regulations for
direct-to-consumer advertising, industry-sponsored scientific and educational
activities, and promotional activities involving the internet. The FDA and FTC
have very broad enforcement authority, and failure to abide by these regulations
can result in penalties, including the issuance of a Warning Letter directing
the company to correct deviations from regulatory standards, a requirement that
future advertising and promotional materials be pre-cleared by the FDA and
52
enforcement actions that can include seizures, injunctions and criminal
prosecution.
Manufacturers are also subject to various state and Federal laws and
regulations governing laboratory practices (specifically, the requirement for
certain studies to comply with current Good Laboratory Practices), the
experimental use of animals and the use and disposal of hazardous or potentially
hazardous substances in connection with their research. In each of the above
areas, the FDA has broad regulatory and enforcement powers, including the
ability to levy fines and civil penalties, suspend or delay issuance of
approvals, seize or recall products and deny or withdraw approvals.
Some of our drug candidates may need to be administered using
specialized drug delivery systems. We may rely on drug delivery systems that are
already approved to deliver drugs like ours to similar physiological sites or,
in some instances, we may need to modify the design or labeling of the legally
available device for delivery of our product candidate. In such an event, the
FDA may regulate the product as a combination product or require additional
approvals or clearances for the modified device. Further, to the extent the
delivery device is owned by another company, we would need that company's
cooperation to implement the necessary changes to the device and to obtain any
additional approvals or clearances. Obtaining such additional approvals or
clearances, and cooperation of other companies, when necessary, could
significantly delay, and increase the cost of obtaining, marketing approval,
which could reduce the commercial viability of a drug candidate.
HIPAA REQUIREMENTS
Other federal legislation may affect our ability to obtain certain
health information in conjunction with our research activities. The Health
Insurance Portability and Accountability Act of 1996, or HIPAA, mandates, among
other things, the adoption of standards designed to safeguard the privacy and
security of individually identifiable health information. In relevant part, the
U.S. Department of Health and Human Services, or HHS, has released two rules to
date mandating the use of new standards with respect to such health information.
The first rule imposes new standards relating to the privacy of individually
identifiable health information. These standards restrict the manner and
circumstances under which covered entities may use and disclose protected health
information so as to protect the privacy of that information. The second rule
released by HHS establishes minimum standards for the security of electronic
health information. While we do not believe we are directly regulated as a
covered entity under HIPAA, the HIPAA standards impose requirements on covered
entities conducting research activities regarding the use and disclosure of
individually identifiable health information collected in the course of
conducting the research. As a result, unless they meet these HIPAA requirements,
covered entities conducting clinical trials for us may not be able to share with
us any results from clinical trials that include such health information.
In addition to the statutes and regulations described above, we are
also subject to regulation under the Occupational Safety and Health Act, the
Environmental Protection Act, the Toxic Substances Control Act, the Resource
Conservation and Recovery Act and other present and potential future federal,
state and local regulations.
SECURITIES LAWS
Because our common stock is publicly traded, we are subject to a
variety of rules and regulations of federal, state and financial market exchange
entities charged with the protection of investors and the oversight of companies
whose securities are publicly traded. These entities, including the Securities
and Exchange Commission, the Public Company Accounting Oversight Board and the
NASD OTC Bulletin Board, have recently issued new requirements and regulations
and are currently developing additional regulations and requirements in response
to recent laws enacted by Congress, most notably the Sarbanes-Oxley Act of 2002.
As certain rules are not yet finalized, we do not know the level of resources we
will have to commit in order to be in compliance. Our compliance with current
and proposed rules is likely to require the commitment of significant financial
and managerial resources. As a result, our management's attention might be
diverted from other business concerns, which could negatively affect our
business.
DISTRIBUTION
If Radilex or Viprovex receives approval from the FDA, we will attempt
to commercialize these applications. Upon such approval, if Radilex we intend to
use our best efforts to market it as a treatment to the damaging effects of
53
radiation injury that result after exposure to total body irradiation. If
Viprovex, we intend to use our best efforts to market it as a medical
countermeasure to the effects of exposure to various biological and chemical
agents. We intend to offer for sale these applications to various governmental
agencies at the local, state and federal levels, both domestically and
potentially outside the United States.
Prior to FDA approval, Radilex and Viprovex may become eligible for
purchase by the U.S. government. Project BioShield legislation contains
provisions enabling the HHS to begin purchasing new medical countermeasures for
the Strategic National Stockpile in advance of formal FDA approval. This
provision, known as an Emergency Use Authorization, has already been implemented
for other development stage medical countermeasures to weapons of mass
destruction. In that our studies, in the opinion of management, indicate that
Radilex may have efficacy in the treatment of the life-threatening effects of
radiation exposure and Viprovex to exposure to various biological and chemical
agents, we believe there may be interest by government agencies to stockpile
Radilex and/or Viprovex if it is successfully developed. However, there is no
assurance that any of such orders will be forthcoming and we have received no
indication from Project BioShield or any other agency that it intends to
purchase any quantities of Radilex or Viprovex.
COMPETITIVE ENVIRONMENT
The biotechnology and pharmaceutical industries are intensely
competitive. We have numerous competitors in the United States and elsewhere.
Because we are pursuing potentially large markets, our competitors include major
multinational pharmaceutical companies, specialized biotechnology firms and
universities and other research institutions. Several of these entities have
already successfully marketed and commercialized products that will compete with
our products, assuming that our products gain regulatory approval. Competitors
such as Amgen Inc., Hollis-Eden Pharmaceuticals, Inc. and Akorn, Inc. have
developed or are developing products for treating aspects of severe acute
radiation injury. Companies such as VaxGen, Inc., Acambis plc and Emergent
BioSolutions have developed or are developing vaccines against infectious
diseases, including anthrax.
Many of our competitors have greater financial and other resources,
larger research and development staffs and more effective marketing and
manufacturing organizations than we do. In addition, academic and government
institutions have become increasingly aware of the commercial value of their
research findings. These institutions are now more likely to enter into
exclusive licensing agreements with commercial enterprises, including our
competitors, to develop and market commercial products.
Our competitors may succeed in developing or licensing technologies and
drugs that are more effective or less costly than the potential products we are
developing. Our competitors may succeed in obtaining FDA or other regulatory
approvals for drug candidates before we do. If competing drug candidates prove
to be more effective or less costly than our drug candidates, our drug
candidates, even if approved for sale, may not be able to compete successfully
with our competitors' existing products or new products under development. If we
are unable to compete successfully, we may never be able to sell enough of our
potential products at a price sufficient to permit us to generate profits.
We believe that due to the global political environment that time to
market is critical in the discovery of an effective countermeasure to radiation
exposure and other biological and chemical threats. New developments in areas in
which we are conducting our research and development are expected to continue at
a rapid pace in both industry and academia. It is due to these reasons that we
believe that competition will be driven by time to market.
If our proposed product candidates are successfully developed and
approved, we will face competition based on the safety and effectiveness of our
proposed products, the timing and scope of regulatory approvals, availability of
manufacturing, sales, marketing and distribution capabilities, reimbursement
coverage, price and patent position. There can be no assurance that our
competitors will not develop more effective or more affordable technology or
products, or achieve earlier patent protection, product development or product
commercialization than us. Accordingly, our competitors may succeed in
commercializing products more rapidly or effectively than us, which could have a
material adverse effect on our business, financial condition and results of
operations.
54
EMPLOYEES
From our inception through the period ended December 31, 2005, we have
relied on the services of outside consultants for services and currently have
five total employees, two contract employees and three full-time employees. Our
full-time employees are Michael K. Wilhelm, our Chief Executive Officer; John
Fermanis, our Chief Financial Officer; and, the third serves in an
administrative role. In order for us to attract and retain quality personnel, we
anticipate we will have to offer competitive salaries to future employees. We do
not anticipate our employment base will significantly change during the next
twelve months, other than the addition of one senior level appointment to the
position of Senior Vice President of Scientific Development.
As we continue to expand, we will incur additional costs for personnel.
This projected increase in personnel is dependent upon our generating revenues
and obtaining sources of financing. There is no guarantee that we will be
successful in raising the funds required or generating revenues sufficient to
fund the projected increase in the number of employees.
Our future success depends in large part upon our ability to attract
and retain highly skilled scientific personnel. The competition in the
scientific industry for such personnel is intense, and we cannot be sure that we
will be successful in attracting and retaining such personnel. Most of our
consultants and employees and several of our executive officers began working
for us recently, and all employees are subject to "at will" employment. We
cannot guarantee that we will be able to replace any of our scientific personnel
in the event their services become unavailable.
FLUCTUATION OF QUARTERLY OPERATING RESULTS
Our quarterly operating results may fluctuate significantly in the
future as a result of a variety of factors, many of which are outside our
control. These factors include: the level of demand for Radilex, Homspera and
any other products; our ability to attract and retain personnel with the
necessary strategic, technical and creative skills required for effective
operations; the amount and timing of expenditures by customers; the amount and
timing of capital expenditures and other costs relating to the expansion of our
operations; government regulation and legal developments regarding the use of
Homspera; and general economic conditions. As a strategic response to changes in
the competitive environment, we may from time to time make certain pricing,
service, technology or marketing decisions that could have a material adverse
effect on our quarterly results. Due to all of these factors, our operating
results may fall below the expectations of securities analysts, stockholders and
investors in any future quarter.
PROPERTY
Our corporate headquarters are currently located at 4021 N. 75th
Street, Suite 201, Scottsdale, Arizona 85251, where we have leased approximately
1,800 square feet of office space through September 30, 2007. Our rent expense
is $2,320 per month in year one and will increase to $2,380 in year two. We
believe that our facilities are adequate for our current needs and suitable
additional or substitute space will be available in the future to replace our
existing facilities, if necessary, or accommodate expansion of our operations.
LEGAL PROCEEDINGS
On December 13, 2001, service of process was effectuated upon GPN
Network, Inc. with regard to a fee agreement between GPN Network, Inc. and
Silver & Deboskey, a Professional Corporation located in Denver, Colorado. The
complaint sought compensation for legal services allegedly rendered to DermaRx
Corp. On November 7, 2002, the District Court in Denver, Colorado rendered
judgment in favor of Silver & Deboskey in the amount of $28,091. At December 31,
2004, we had not paid any of this amount.
The judgment was subsequently settled in full for a cash payment of
$35,107 paid on August 2, 2005 releasing us from all obligations under the
judgment.
MANAGEMENT
Executive officers are elected annually by the Board of Directors.
Board members serve one-year terms until their death, resignation or removal by
the Board of Directors.
Name Age Position
--------------------------------------------------------------------------------
Michael K. Wilhelm 39 President, Chief Executive Officer and Director
John N. Fermanis 52 Chief Financial Officer
Mark L. Witten, Ph.D. 52 Director
Theodore E. Staahl, M.D. 61 Director
55
MICHAEL K. WILHELM, PRESIDENT, CHIEF EXECUTIVE OFFICER AND DIRECTOR.
Mr. Wilhelm has served as our President and Chief Executive Officer and on our
Board of Directors since July 2003 and as President and Chief Executive Officer
of ImmuneRegen BioSciences, Inc. since December 2002 and on its Board of
Directors since November 2002. Mr. Wilhelm has been actively involved in the
financial industry since 1990. After leaving the brokerage industry, Mr. Wilhelm
founded Foresight Capital Partners in July 1996, a company designed to identify
early stage companies with above average growth potential and assist them in
reaching the next stage of development. In working with these companies, Mr.
Wilhelm took an active role, provided advisory services and facilitated
financing for continued growth and development. Mr. Wilhelm was Managing
Director of Foresight Capital Partners until December 2002. Mr. Wilhelm works on
average 70 hours per week.
JOHN N. FERMANIS, CHIEF FINANCIAL OFFICER. Mr. Fermanis was appointed
as our Chief Financial Officer, effective as of December 22, 2004. Mr. Fermanis
is a co-founder of AMPS Wireless Data, Inc., a privately held Arizona
corporation founded in 1998, where he served as Chief Financial Officer from
May, 2001 to October, 2004. Mr. Fermanis had overall financial responsibility at
AMPS and was instrumental in raising over $5 Million in venture capital. From
1997 to 2001, he held the position of Treasury Manager for Peter Piper, Inc., a
national restaurant chain headquartered in Scottsdale, Arizona, where he was
responsible for managing a $25 Million revolving line of credit and cash
concentration and disbursement for a company with over $100 Million annual
sales. Mr. Fermanis has over 18 years of financial management experience with
both the American Express Corporation and Citigroup in New York City. Mr.
Fermanis holds a Bachelor of Arts degree from the S.U.N.Y. at Stony Brook and
attended Pace University's Graduate School of Management in New York City. Mr.
Fermanis works on average 60 hours per week.
THEODORE E. STAAHL, M.D., DIRECTOR. Dr. Staahl has served on our Board
of Directors since April 2003. Dr. Staahl is employed at the Cosmetic, Plastic
and Reconstructive Surgery Center, a company which he founded in 1978. Dr.
Staahl's professional training was received at the University of Illinois and
the University of Wisconsin and is board certified by the American Board of
Facial, Plastic and Reconstruction Surgeons, the Board of Cosmetic Surgeons and
the American Board of Head and Neck Surgeons. Dr. Staahl has presented papers at
national and international meetings on hair transplant, rhinoplasty and cleft
lip deformities. Dr. Staahl devotes on average 3 hours per week to our business.
MARK L. WITTEN, PH.D., DIRECTOR. Dr. Witten has served on our Board of
Directors since July 2003 and has served on the Board of Directors for
ImmuneRegen BioSciences, Inc. since November 2002. Dr. Witten served as a
research scientist for ImmuneRegen BioSciences, Inc. from July 2003 to February
2006. Dr. Witten has served as a Research Professor at the University of Arizona
since July 2000. Since July 1998 Dr. Witten has served as the Director of the
Joan B. and Donald R. Diamond Lung Injury Laboratory in the Department of
Pediatrics at the University of Arizona College of Medicine. Dr. Witten obtained
his Ph.D. from Indiana University in 1983 with a double major in physiology and
exercise physiology. He conducted a post-doctoral fellowship in Respiratory
Sciences at the University of Arizona College of Medicine from 1983 to 1988. He
then spent two years as an Assistant Biologist at Massachusetts General Hospital
and Instructor in Medicine at Harvard Medical School. He returned to The
University of Arizona College of Medicine in 1990. Dr. Witten has authored over
200 published manuscripts, book chapters and abstracts. Dr. Witten devotes on
average 3 hours per week to our business.
There are no family relationships among the directors and executive officers.
COMMITTEES AND ATTENDANCE AT BOARD MEETINGS
Our Board of Directors does not maintain a separate audit, nominating
or compensation committee. Functions customarily performed by such committees
are performed by our Board of Directors as a whole. We are not required to
maintain such committees under the applicable rules of the Over-the-Counter
Bulletin Board. None of our independent directors qualify as an "audit committee
financial expert" as that term is defined in Item 401(e) of Regulation S-B.
EXECUTIVE COMPENSATION
The following table sets forth information concerning the compensation
earned by our Chief Executive Officer and each of the other executive officers
who served during the year ended December 31, 2005, and whose annual salary and
bonus during the fiscal years ended December 31, 2003, 2004 and 2005 exceeded
$100,000 (the "Named Executive Officers").
56
ANNUAL COMPENSATION
-------------------------------
NAME AND PRINCIPAL POSITION YEAR SALARY ($) BONUS ($)
-------------------------------------------------------------------------
Michael K. Wilhelm(1)
Chief Executive Officer
and President 2005 275,000 28,870(2)
2004 175,000 247,301(3)
2003 125,000 0
John N. Fermanis 2005 161,416(5) 4,590(6)
Chief Financial Officer (4) 2004 0 0
2003 0 0
----------
(1) Michael K. Wilhelm has served as Chief Executive Officer and President of
IR BioSciences Holdings, Inc. since July 2003 when the Reorganization was
completed. Prior to the completion of the Reorganization, Mr. Wilhelm
served as Chief Executive Officer and President of ImmuneRegen
BioSciences, Inc. since December 2002. Mr. Wilhelm's compensation is
reported in the table with respect to his positions at both IR BioSciences
Holdings, Inc. and ImmuneRegen BioSciences, Inc. for the years ended
December 31, 2003, 2004 and 2005.
(2) Reflects the value of 80,811 warrants granted to Michael K. Wilhelm as
performance bonuses per his employment agreement. In May 2005, the Company
issued a warrant to Mr. Wilhelm to purchase 80,811 shares (post-split) of
common stock at a price of $0.30 per share (post-split). The Company
valued these warrants using the Black-Scholes model, and charged the
amount of $28,870 to operations during the twelve months ended December
31, 2005.
(3) Reflects the value of 948,980 warrants granted to Michael K. Wilhelm as
performance bonuses. In May 2004, the Company issued a warrant to Mr.
Wilhelm to purchase 500,000 shares (post-split) of common stock at a price
of $0.25 per share (post-split). The warrants were issued as performance
bonuses. The Company valued these warrants using the Black-Scholes model,
and charged the amount of $134,604 to operations during the twelve months
ended December 31, 2004. In October 2004, the Company issued a warrant to
Mr. Wilhelm to purchase 448,980 shares (post-split) at a price of $0.125
per share (post-split) as a performance bonus for achieving certain
objectives. The Company valued this warrant using the Black-Scholes
valuation model, and charged the amount of $112,697 to operations during
the twelve months ended December 31, 2004.
(4) John N. Fermanis served as Chief Financial Officer from December 2004.
(5) Reflects the value of 100,000 shares of common stock issued to John N.
Fermanis in the three months ended March 31, 2005 as part of compensation
per his employment agreement. For the twelve months ended December 31,
2005, the Company charged $35,000 to operations for the issuance of these
100,000 shares to Mr. Fermanis.
Also reflects the value of an additional 100,000 shares of common stock
issued to John N. Fermanis as part of compensation per his employment
agreement. The shares were earned at the rate of 1/12 or 8,333 per month
beginning January 2005. The Company charged to operations the market value
of these shares as of the first day of each month. For the twelve months
ended December 31, 2005, the Company charged $41,416 to operations for the
issuance of 100,000 shares to Mr. Fermanis.
(6) Reflects the value of 12,500 warrants granted to John N. Fermanis as
performance bonuses per his employment agreement. In May 2005, the Company
issued a warrant to Mr. Fermanis to purchase 12,500 shares of common stock
at a price of $0.31 per share. The Company valued these warrants using the
Black-Scholes model, and charged the amount of $4,590 to operations during
the twelve months ended December 31, 2005.
COMPENSATION OF DIRECTORS
STANDARD ARRANGEMENTS. Directors currently receive no cash compensation
from IR BioSciences Holdings, Inc. for their services as members of the Board or
57
for attendance at committee meetings. Members of the Board are reimbursed for
some expenses in connection with attendance at Board and committee meetings.
OTHER ARRANGEMENTS. We may from time to time issue warrants to
executives and directors for fulfilling certain performance goals.
On December 16, 2002 we entered into consulting agreements Mark Witten,
our chief research scientist and director. The consulting agreement is on a
month-to-month basis. Under the terms of this agreement, Dr. Witten agrees to
place at the disposal of us his judgment and expertise in the area of acute lung
injury. In consideration for these services, we agree to pay Dr. Witten a
non-refundable fee of $5,000 per month. This contract was terminated effective
February 1, 2006.
EMPLOYMENT AGREEMENTS
On August 10, 2005, we entered into a new employment agreement with our
President and Chief Executive Officer, Michael K. Wilhelm. The employment
agreement calls for a salary at the rate of $275,000 per annum. The salary will
be subject to adjustment of at least 10% per year at the end of each year. We
also agreed to defend and indemnify, to the fullest extent permitted by our
certificate of incorporation and bylaws and the Delaware General Corporation
Law, Mr. Wilhelm and hold him harmless against any liability that he incurs
within the scope of his employment under the agreement. The agreement also
provides for the following various bonus incentives:
(i) A target incentive bonus in cash and/or stock if we consummate
a transaction with any unaffiliated third party such as an
equity or debt financing, acquisition, merger , strategic
partnership or other similar transaction.
(ii) A one time grant of an incentive option to purchase 103,030
shares of the Company's Common Stock, at an exercise price
equal to the fair market value per share on the date option is
granted and a nonstatutory option to purchase 1,896,970 shares
at such time that the Company's 2003 Stock Plan is amended to
authorize additional shares.
In connection with Mr. Wilhelm's new employment agreement, we also
entered into a change of control agreement and a severance agreement with him on
August 10, 2005. Under the change of control agreement, Mr. Wilhelm shall be
entitled to a continuation of his base salary for a period of 18 months
following an involuntary termination, which means, at any time within that
period which is one-year from the change of control date (including such date),
the termination of the employment of Mr. Wilhelm (i) by us without cause or (ii)
due to constructive termination, as such terms are defined in the change of
control agreement. Further, in the event of an involuntary termination, the
agreement provides that we shall pay Mr. Wilhelm a lump sum amount in cash,
equal to the sum of (i) any unpaid incentive compensation which has been
allocated or awarded to Mr. Wilhelm for a completed fiscal year or other
measuring period preceding the date of involuntary termination under any annual
or long-term incentive plan and which, as of the date of involuntary
termination, is contingent only upon the continued employment of Mr. Wilhelm to
a subsequent date, and (ii) a pro rata portion to the date of involuntary
termination of the aggregate value of all contingent incentive compensation
awards to Mr. Wilhelm for all then uncompleted periods under any such plan.
Further, 100% of the unvested portion of each outstanding stock option granted
to Mr. Wilhelm shall be accelerated so that they become immediately exercisable
upon the date of involuntary termination.
Under the severance agreement, Mr. Wilhelm shall be entitled to a
continuation of his base salary for a period of 18 months following an
involuntary termination, which means the termination of the employment of Mr.
Wilhelm (i) by us without cause or (ii) due to constructive termination, as such
terms are defined in the severance agreement. Further, in the event of an
involuntary termination, the agreement provides that we shall pay Mr. Wilhelm an
amount equal to the amount of executive incentive pay (bonus) that he would have
received for the year in which the involuntary termination occurred had he met
one hundred percent (100%) of the target for such incentive pay. Also, under
this agreement, 100% of the unvested portion of each outstanding stock option
granted to Mr. Wilhelm shall be accelerated so that they become immediately
exercisable upon the date of involuntary termination.
On February 15, 2005, we entered into an employment agreement with John
N. Fermanis, our Chief Financial Officer. The employment agreement expires on
December 31, 2007, unless terminated earlier pursuant to the terms of the
58
agreement. Under the terms of the employment agreement, Mr. Fermanis is entitled
to a base salary of $60,000 until the company completed a funding of $500,000 or
more which occurred on March 4, 2005, at which time the base salary was
increased to $85,000 until December 31, 2005. Thereafter, the second year salary
will be $98,000 per annum and the third year will be $112,000 per annum.
Severance provisions include two months salary for termination for cause and six
months salary for constructive termination. This agreement also provides for the
following various bonus incentives:
(i) A quarterly discretionary bonus based upon our performance in
the previous quarter. This discretionary bonus will be in the
form of stock options.
(ii) A quarterly five-year warrant to purchase up to 12,500 shares
of our common stock at 75% of the fair market value of the
stock on the date the warrant is granted.
STOCK OPTIONS
We issued 253,030 stock options to our Chief Executive Officer, Michael
Wilhelm, during the fiscal year ended December 31, 2005.
OPTIONS GRANTED IN THE YEAR ENDED DECEMBER 31, 2005
The following table sets forth information concerning individual grants
of stock options in 2005 to the Named Executive Officers:
Individual Grants
-------------------------------------------------------- Potential Realizable
Value at Assumed
Number of Annual Rates of Stock
Securities Percent of Price Appreciation
Underlying Total Options Exercise or for Option Term(1)
Options Granted to Base Price Expiration
Name Granted Employees Per Share Date 5% 10%
---------------------- -------------- -------------- ------------- -------------- --------- ----------
Michael K. Wilhelm 103,030 40.6% $ 0.33 8/10/10 $ 9,394 $ 20,757
150,000 59.0 0.44 5/20/10 18,235 40,294
(1) In order to comply with the rules of the SEC, we are including the gains or
"option spreads" that would exist for the respective options we granted to
the Named Executive Officers. We calculated these gains by assuming an
annual compound stock price appreciation of 5% and 10% from the date of the
option grant until the termination date of the option, which is the fifth
anniversary of the grant date. These gains do not represent our estimate or
projection of the future price of the ordinary shares.
OPTIONS EXERCISES AND OPTIONS VALUES FOR YEAR ENDED DECEMBER 31, 2005
The following table sets forth information concerning option exercises in 2005
and option values as of December 31, 2005 to the Named Executive Officers:
Number of Securities Value of Unexercised
Underlying Unexercised In-the-Money Options
Shares Options at Fiscal Year-End at Fiscal Year-End (1)
Acquired --------------------------------------------------------------------
on Value
Name Exercise Realized Exercisable Un-exercisable Exercisable Un-exercisable
-------------- ------------ --------- --------------- ------------------- ------------- -----------------
Michael K. -- $ -- 253,030 -- $ -- $ --
Wilhelm
(1) The value of unexercised "in-the-money" options is based on a price per
share of $0.32, which was the price of a share as quoted on the OTC Bulletin
Board at the close of business on December 31, 2005, minus the exercise
price, multiplied by the number of shares underlying the option.
2003 STOCK OPTION, DEFERRED STOCK AND RESTRICTED STOCK PLAN
We adopted the 2003 Stock Option, Deferred Stock and Restricted Stock
Plan (the "Plan") which authorizes the Board of Directors in accordance with the
terms of the Plan, among other things, to grant incentive stock options, as
defined by Section 422(b) of the Internal Revenue Code, nonstatutory stock
options (collectively, the "Stock Options") and awards of restricted stock and
deferred stock and to sell shares of common stock of the Company ("Common
Stock") pursuant to the exercise of such stock options for up to an aggregate of
59
3,600,000 shares. The options will have a term not to exceed ten years from the
date of the grant.
At December 31, 2005, an aggregate of 254,030 stock options were
outstanding under the Plan at prices ranging from $0.31 to $0.44 per share. At
such date, there were 201,996 stock options available for grant. Further, the
Board approved a one time grant of an incentive option to our Chief Executive
Officer to purchase 1,896,970 shares at the fair market value per share on the
date the option is granted. The options shall be granted at such time that the
Company's 2003 Stock Plan is amended to authorize additional shares.
During the fiscal year ended December 31, 2005, 150,000 discretionary
incentive stock options were granted to our Chief Executive Officer, Michael K.
Wilhelm, per his employment agreement. The options have an exercise price of
$0.44 and a term of five years. Additionally, the Board approved a one time
grant of an incentive option to our Chief Executive Officer to purchase 103,030
shares of the Company's Common Stock. The options have an exercise price of
$0.33 and a term of five years. Further, our Board of Directors approved a one
time grant of a nonstatutory option to purchase 1,896,970 shares at the fair
market value per share on the date the option to our Chief Executive Officer,
Michael K. Wilhelm. These warrants will be granted such time that the Company's
2003 Stock Plan is amended to authorize additional shares.
Through December 31, 2003, we had granted, prior to the merger with
ImmuneRegen BioSciences, Inc., options to purchase 63,212 shares of our common
stock at a weighted average exercise price of $25.00 per share to certain
employees and consultants that are exercisable over various periods through
March 2010. These stock options were granted outside of our 2003 Stock Option,
Deferred Stock and Restricted Stock Plan.
SECURITIES AUTHORIZED FOR ISSUANCE UNDER EQUITY COMPENSATION PLANS
The following table provides information as of December 31, 2005
regarding compensation plans (including individual compensation arrangements)
under which equity securities of our company are authorized for issuance. All
share information included in this table has been adjusted to reflect a 2-for-1
forward stock split of our common stock that was effected in April 2004.
Number of securities
remaining available for
Number of Securities to be Weighted- average future issuance under equity
issued upon exercise of exercise price of compensation plans
outstanding options, outstanding options, (excluding securities
Plan Category warrants and rights warrants and rights reflected in column (a)
(a) (b) (c)
------------------------- ---------------------------- ---------------------- -------------------------------
Equity compensation
plans approved by
security holders........ 254,030(1) $0.39 201,966(3)
Equity compensation
plans not approved by
security holders........ 11,680,077(2) $0.59 --
Total................... 11,934,107 201,966
========== =======
(1) Represents 254,030 stock options at a weighted average price of $0.39
outstanding under our 2003 Stock Option, Deferred Stock and Restricted Stock
Plan.
(2) Represents 11,616,865 stock purchase warrants at a weighted average price of
$0.46 and 63,212, options at a weighted average exercise price of $25.00.
(3) Represents 201,996 shares are available for future issuance under our 2003
Stock Option, Deferred Stock and Restricted Stock as of the date hereof.
Further, the Board approved a one time grant of an incentive option to our
Chief Executive Officer, Michael K. Wilhelm, to purchase 1,896,970 shares
at the fair market value per share on the date the option is granted. The
options shall be granted at such time that the Company's 2003 Stock Plan is
amended to authorize additional shares.
60
Employee Stock Options
----------------------
The Company has adopted the 2003 Stock Option, Deferred Stock and Restricted
Stock Plan (the "Plan") which authorizes the Board of Directors in accordance
with the terms of the Plan, among other things, to grant incentive stock
options, as defined by Section 422(b) of the Internal Revenue Code, nonstatutory
stock options (collectively, the "Stock Options") and awards of restricted stock
and deferred stock and to sell shares of common stock of the Company ("Common
Stock") pursuant to the exercise of such stock options for up to an aggregate of
6,465,316 shares . The options will have a term not to exceed ten years from the
date of the grant. There have been no options granted under this Plan.
Through December 31, 2002, GPN had granted pre-merger stock options to certain
employees and consultants which are exercisable over various periods through
March 2010. These stock options are currently held by the Company outside of the
Plan.
The following table summarizes the changes in options outstanding and the
related prices for the shares of the Company's common stock issued to employees
of the Company under a non-qualified employee stock option plan.
Options Outstanding Options Exercisable
----------------------------------- --------------------------------------
Weighted Weighted
Average Weighted Average
Remaining Average Remaining
Exercise Number Contractual Exercise Number Contractual
Prices Outstanding Life (years) Price Exercisable Life (years)
-------- ----------- ------------ --------- ----------- ------------
$25.00 63,212 4.24 $25.00 63,212 4.24
0.31 1,000 4.95 0.31 1,000 4.95
0.33 103,030 4.61 0.33 103,030 4.61
0.44 150,000 4.34 0.44 150,000 4.34
------- -------
317,242 317,242
======= =======
Transactions involving stock options issued to employees are summarized as
follows:
Weighted Average
Number of Shares Price Per Share
---------------- ----------------
Outstanding at December 31, 2003 63,212 25.00
Granted -- --
Exercised -- --
Canceled or expired -- --
------- ------
Outstanding at December 31, 2004 63,212 $25.00
Granted 254,030 0.39
Exercised -- --
Canceled or expired -- --
------- ------
Outstanding at December 31, 2005 317,242 $ 5.30
======= ======
Warrants
--------
The following table summarizes the changes in warrants outstanding and the
related prices for the shares of the Company's common stock issued to
non-employees of the Company. These warrants were granted in lieu of cash
compensation for services performed or financing expenses and in connection with
placement of convertible debentures.
Warrants Outstanding Warrants Exercisable
----------------------------------- --------------------------------------
Weighted Weighted
Average Weighted Average
Remaining Average Remaining
Exercise Number Contractual Exercise Number Contractual
Prices Outstanding Life (years) Price Exercisable Life (years)
-------- ----------- ------------ --------- ----------- ------------
$ .05-.10 519,780 3.38 $.05-.10 519,780 3.38
.125-.21 911,819 3.46 .125-.21 911,819 3.46
.25-.56 9,271,405 3.57 .25-.56 9,271,405 3.57
1.00 867,311 2.08 1.00 867,311 2.08
2.00 46,550 3.21 2.00 46,550 3.21
----------- ------------ ----------- -----------
11,616,865 3.44 11,616,865 3.44
=========== ============ =========== ===========
61
Transactions involving warrants are summarized as follows:
Number of Shares Weighted Average
(post-split) Price Per Share
(post-split)
--------------- ------------------
Outstanding at January 1, 2004 832,510 $ .82
Granted 16,831,199 .47
Exercised (6,600,778) .50
Canceled or expired -- --
---------- --------
Outstanding at December 31, 2004 11,062,931 .48
Granted 757,464 .44
Exercised (80,000) .05
Canceled or expired (123,530) 2.00
---------- --------
Outstanding at December 31, 2005 11,616,865 $ .46
========== ========
The estimated value of the compensatory warrants granted to non-employees in
exchange for services and financing expenses was determined using the
Black-Scholes pricing model and the following assumptions:
2005 2004
---- ----
Significant assumptions (weighted-average):
Risk-free interest rate at grant date 3.75% 3.75%
Expected stock price volatility 93% to 179% 163% to 262%
Expected dividend payout -- --
Expected option life-years (a) 5 5
(a) The expected option life is based on contractual expiration dates.
The amount of the expense charged to operations for compensatory warrants
granted in exchange for services was $279,711 and $406,571 during the years
ended December 31, 2005 and 2004, respectively.
The Company also capitalized financing costs of $0 and $397,394 for warrants
granted in connection with placement of convertible debentures for the years
ended December 31, 2005 and 2004, respectively.
At December 31, 2002, the Company had outstanding warrants to purchase 26,939
shares (post-split) of common stock at $0.835 per share (post-split).
During the twelve months ended December 31, 2003, the Company issued warrants to
purchase 169,572 shares (post-split) of common stock at prices ranging from
$0.125 to $1.00 per share (post-split) to eight service providers. The Company
valued the warrants using the Black-Scholes calculation model, and the warrants
were deemed to have a combined value of $85,860. This amount was charged to
expense on the Company's financial statements for the twelve months ending
December 31, 2003.
CERTAIN RELATIONSHIPS AND RELATED TRANSACTIONS
IMMUNEREGEN BIOSCIENCES, INC.
ImmuneRegen BioSciences, Inc. is a wholly-owned subsidiary of IR
BioSciences Holdings, Inc. IR BioSciences Holdings, Inc. and ImmuneRegen
BioSciences, Inc. have interlocking executive positions and share common
ownership.
IMMUNEREGEN BIOSCIENCES ASIA PTE. LTD.
ImmuneRegen BioSciences Asia PTE. LTD. ("ImmuneRegen Asia"), a
Singaporean company, is an affiliate of IR BioSciences Holdings, Inc.
Approximately 94% of the company is owned equally between our Chief Executive
Officer and Chairman, Michael K. Wilhelm, and our Director, Mark Witten. IR
BioSciences Holdings, Inc. holds less than 1% ownership in the company. For the
62
three month period ended December 31, 2005, we incurred no expenses. For the
period of inception (October 30, 2002) to December 31, 2005, we incurred
expenses totaling approximately $133,781, $114,660 on a Singapore-based
consultant and $19,121 on travel regarding corporate development and the
attendance of symposiums and conferences.
In November 2003, based on observations made during early preclinical
animal model studies we approached Ever Progressing System PTE LTD ("EPS"), a
Singapore based contract research organization (CRO), in an attempt to increase
our market presence, attract potential funding sources for our research and
development efforts and to identify and receive governmental grants. EPS advised
us that a presence in Singapore would be desirable if we wanted to pursue such
efforts in Singapore and elsewhere in Asia.
Acting on their advice, we incorporated, under the Singapore Companies
Act, ImmuneRegen Asia on June 5, 2004 and retained a Singapore-based consultant
to assist us in (i) the development and set-up of our Singapore corporation;
(ii) increasing our visibility in Asia through attendance of conferences,
meetings, symposiums, etc.; (iii) reaching out to contacts in various
governmental organizations; and, (iv) contact bankers, institutional and private
sources of funds for start-up costs, research and development and working
capital related to ImmuneRegen Asia.
Between November 2003 and January 2005, we held discussions with the
Economic Development Board of Singapore ("EDB") to assist in establishing a
research and development and clinical trials presence in Singapore. In October
2004, our Singapore-based consultant and representatives of ImmuneRegen
BioSciences, Inc. met with several members of Thailand's Department of Disease
Control, Ministry of Public Health in Bangkok. Also in October 2004, our
Singapore-based consultant met with various departments of the Philippines
Department of Health in Manila.
By April 2005, our efforts to further discussions with the EDB and
other governmental agencies and to secure adequate funding had proven
unsuccessful. At that time our Board of Directors opted to terminate the
Singapore-based consultant, dissolve ImmuneRegen Asia and focus solely on our
United States operations. We have since abandoned all discussions with EPS the
EDB and other governments in Asia regarding our research and development
activities.
Dissolution of ImmuneRegen Asia of which we own less than a 1%
interest, has been initiated pursuant to the requirements of Section 344 of the
Singapore Companies Act. ImmuneRegen Asia has not conducted any business since
its creation in May 2004, and is expected to satisfy the requirements for
dissolution with completion of the process anticipated in the near future. Upon
adequate and sufficient showing to the Singapore Registrar of Companies,
ImmuneRegen Asia will be struck off the register of companies and the company
will be dissolved. Shareholder and Board approval have occurred and the required
documents are being filed with the registrar of companies in Singapore.
OFFICE LEASE
During the period from December 1, 2002 through August 31, 2004, the
Company leased office space from an entity controlled by the our Chief Executive
Officer under a sub-let agreement. The rental cost of $2,734 per month was
passed through to the Company at the same rental rate charged by the facility's
primary landlord.
INONE CONTRACT
We have entered into a series of contracts with InOne Advertising &
Design, Inc. ("InOne"). At the time of the initiation of the contracts, InOne
employed the spouse of Michael Wilhelm, the Company's CEO. These contracts
include (i) a three-year agreement dated January 13, 2003 whereby InOne will
design and create certain corporate identity and marketing materials in exchange
for 72,000 shares (post split) of our common stock and $15,000. This Agreement
also provides that InOne will bill us on an hourly basis for additional
services, as well as a $100,000 termination fee if the agreement is terminated
as a result of a merger or acquisition of the Company; (ii) an Agreement dated
March 14, 2003 whereby InOne will design, create, maintain, and host our website
for one year in exchange for 140,000 shares (post split) of our common stock and
$4,200; (iii) an Agreement dated December 30, 2003 whereby InOne will name and
design a logo for respiratory infectious diseases, such as SARS (Viprovex), in
exchange for $5,000 and a warrant to purchase 20,000 shares (post-split) of our
63
common stock at a price of $0.125; (iv) an Agreement dated December 31, 2003
whereby InOne will name and design a logo for Acute Radiation Syndrome (ARS)
medical countermeasure for radiation (Radilex) in exchange for $5,000 and a
warrant to purchase 20,000 shares (post-split) of our common stock at a price of
$0.125.
At December 31, 2005, InOne no longer employs or has any business
relationship with the spouse of Mr. Wilhelm.
The amounts due InOne at December 31, 2005 and 2004 are $0 and $2,700,
respectively.
RELATED PARTY LOANS
As of August 15, 2004, we had accrued payables due to our President and
CEO, Michael Wilhelm, of $109,374. In connection with our completed private
offering in October 2004, $89,500 of such amount was converted into 716,000
shares of common stock and warrants to purchase 358,000 shares of common stock.
Additionally, there were no loans to related parties outstanding at December 31,
2005.
LICENSE AGREEMENT
In December 2002, we entered into a royalty-free license agreement with
David Harris and Mark Witten, who are our two founders and largest shareholders.
Under the terms of the license agreement, Messrs. Harris and Witten granted to
us an exclusive license to use and sublicense certain patents, medical
applications, and other technologies developed by them. Our obligations under
this agreement include (i) reasonable efforts to protect any licensed patents or
other associated property rights; (ii) reasonable efforts to maintain
confidentiality of any proprietary information; (iii) upon the granting by the
U. S. Food and Drug Administration to us the right to market a product, we will
maintain a broad form general liability and product liability insurance.
In February 2005, Drs. Witten and Harris executed assignment documents
in which, for good and valuable consideration, patent applications and patents
developed by them were assigned to ImmuneRegen BioSciences, Inc. The assignment
documents included all of the patents and patent applications which were
included in and covered by the licensing agreement, as amended. Drs. Witten and
Harris have also assigned all proprietary technology developed at ImmuneRegen
subsequent to the execution of the February 2005 assignment documents.
In May 2005, for assignment of patents we issued to Dr. Witten 50,000
common stock purchase warrants with a strike price of $0.125. The warrants
expire five years after date of issuance.
Neither the termination of Dr. Harris' consulting agreement in March
2005 nor the termination of Dr. Witten's consulting agreement in February 2006
have any impact on the license agreement.
CONSULTING AGREEMENTS
On December 16, 2002 we entered into consulting agreements with David
Harris and Mark Witten, who were our two founders and research scientists. The
consulting agreements are on a month-to-month basis. Under the terms of these
agreements, Messrs. Harris and Witten agreed to place at the disposal of us
their judgment and expertise in the area of acute lung injury. In consideration
for these services, we agreed to pay each of them a non-refundable fee of $5,000
per month. In March 2005, Dr. Harris resigned as consultant to us and our
subsidiaries. In January 2006, the company received correspondence from Dr.
Witten stating that he would terminate his consulting contract if his specific
requirements were not met. We subsequently accepted his termination effective
February 1, 2006.
Pursuant to consulting agreements entered into with David Harris and
Mark Witten, who are our two founders and chief research scientists, during the
period from October 30, 2002 (inception) to December 31, 2002, we accrued $5,000
in consulting fees. During the period from January 1, 2003 to December 31, 2003,
we accrued an additional $120,000 in consulting fees. We had accrued payables
collectively due to Drs. Harris and Witten of $125,000 and $5,000 as of December
31, 2003 and 2002, respectively. In connection with our recently completed
private offering in October 2004, $90,500 of such amount owed to Dr. Witten
converted into 724,000 shares of our common stock and warrants to purchase
362,000 shares of common stock. In October 2004, because Dr. Harris had not
taken an active role in the management of the Company, he agreed that he would
forgive the amount accrued to him under the Consulting agreement of $107,500. We
accounted for the transaction as a forgiveness of indebtedness under FAS No. 140
during the period ended December 31, 2004.
64
DUE TO RELATED PARTIES
Pursuant to consulting agreements entered into with David Harris and
Mark Witten, who are our two founders and chief research scientists, during the
period from October 30, 2002 (inception) to December 31, 2002, we accrued $5,000
in consulting fees. During the period from January 1, 2003 to December 31, 2003,
we accrued an additional $120,000 in consulting fees. We had accrued payables
collectively due to Drs. Harris and Witten of $125,000 and $5,000 as of December
31, 2003 and 2002, respectively. In connection with our recently completed
private offering in October 2004, $90,500 of such amount owed to Dr. Witten
converted into 724,000 shares of our common stock and warrants to purchase
362,000 shares of common stock. In October 2004, because Dr. Harris had not
taken an active role in the management of the Company, he agreed that he would
forgive the amount accrued to him under the Consulting agreement of $107,500. We
accounted for the transaction as a forgiveness of indebtedness under FAS No. 140
during the period ended December 31, 2004.
As of August 15, 2004, we had accrued payables due to our President and
CEO, Michael Wilhelm, of $109,374. In connection with our recently completed
private offering in October 2004, $89,500 of such amount was converted into
716,000 shares of common stock and warrants to purchase 358,000 shares of common
stock.
OUTSTANDING LOANS
In January 2003, we were loaned $15,000 by an accredited investor.
Pursuant to the terms of this transaction, we provided this lender with a
warrant to purchase 26,939 shares of our common stock at a price $0.17 per
share. The interest rate was 8% per annum. The principal was repaid in March
2005. Interest owed of $2,410.96 was converted into 19,288 shares of common
stock per the term of the note.
Between August 2001 and April 2003 we were loaned money by our
President and Chief Executive Officer. We repaid the remaining balance in full
for $4,998 ($3,900 principal and $1,097 accrued interest) on April 11, 2005
releasing us from further obligations under the note.
In September 2001 , we were loaned $50,000 by an accredited investor.
On June 7, 2005, the remaining note in the principal amount of $50,000 and all
accrued interest of $15,003 were converted into 232,153 shares of our common
stock in accordance with the original terms of the note.
STRATUM CONSULTING GROUP, LLC
On April 1, 2004, we entered into a consulting agreement with Stratum
Consulting Group, LLC. ("Stratum," "The Stratum Agreement") a company controlled
by Steven J. Scronic, our former Secretary. The Stratum Agreement has a term of
twelve months, and calls for Stratum to provide us with financial consulting
services, including but not limited to working directly with senior management
regarding the business and business development, attendance at meetings,
preparation of internal financial models and business plans and various
presentations in return for the following: 200,000 shares (post-split) of our
common stock upon execution of the agreement, and the number of shares of our
common stock equal to $2,500 per month for the term of the agreement. The
Stratum Agreement also calls for a cash fee of an additional $2,500 per month.
There is nothing outstanding under the Stratum Agreement.
PRINCIPAL AND SELLING STOCKHOLDERS
This prospectus relates to the resale from time to time of up to a
total of 64,545,747 shares of common stock by the selling stockholders,
comprising:
o 54,351,234 shares of our common stock that were issued to
selling stockholders pursuant to transactions exempt from
registration under the Securities Act of 1933; and
o 10,194,513 shares of common stock underlying warrants that
were issued to selling stockholders pursuant to transactions
exempt from registration under the Securities Act of 1933.
o The total number of shares of common stock offered for resale
by the selling stockholders includes 6,456,800 shares and
2,542,400 shares of common stock issuable upon the exercise of
five-year warrants with an exercise price of $0.50 in
connection with a penalty clause regarding the registration of
securities sold in our Private Offering in October 2004. For
65
each 30-day period beyond 90-days following the second closing
date (October 26, 2004), we have agreed to issue to the
holders of units sold in the Private Offering an additional 2%
a month, or in aggregate 461,200 shares and 181,600 warrants
until such a time as this Registration Statement is made
effective. We have committed these shares although they remain
unissued.
The following table sets forth certain information as of March 31, 2006
regarding the selling stockholders and the beneficial ownership of our common
stock as to (1) each person known to us to beneficially own more than five
percent of our common stock, (2) each director, (3) our executive officers, (4)
all directors and executive officers as a group and (5) the shares offered by
them in this prospectus. Beneficial ownership is determined in accordance with
the rules of the Securities and Exchange Commission, or SEC. In computing the
number of shares beneficially owned by a selling stockholder and the percentage
of ownership of that selling stockholder, shares of common stock underlying
shares of convertible preferred stock, options or warrants held by that selling
stockholder that are convertible or exercisable, as the case may be, within 60
days of March 31, 2006 are included. Those shares, however, are not deemed
outstanding for the purpose of computing the percentage ownership of any other
selling stockholder. Each selling stockholder's percentage of ownership in the
following table is based upon 69,536,322 shares of common stock outstanding as
of March 31, 2006.
Except as described below, none of the selling stockholders within the
past three years has had any material relationship with us or any of our
affiliates:
o MICHAEL WILHELM has served as our company's Chief Executive
Officer since December 2002 and on our Board of Directors
since November 2002;
o MARK WITTEN has served as a research scientist for our company
since December 2002 and on our Board of Directors since
November 2002;
o THEODORE STAAHL has served on our Board of Directors since
April 2003;
o DR. HARRIS is a co-founder, one of our largest shareholders
and was a member of the Board of Directors of ImmuneRegen
BioSciences Holdings, Inc. and ImmuneRegen BioSciences, Inc.,
our subsidiary, and resigned from both his positions effective
December 22, 2004.
o CDM GROUP, SYNERGOS, INC., SPELLING COMMUNICATIONS, STRATUM
CONSULTING GROUP, LLC, DEBRA GESSNER, AND MICHAEL CARIDI have
provided services to our company within the past three years,
and we agreed to issue shares of our common stock and warrants
to purchase additional shares of our common stock to each of
them in exchange for the settlement of outstanding
indebtedness; and,
o STEVEN J. SCRONIC, our company's former Secretary, is a
control party of Stratum Consulting Group, LLC.
The term "selling stockholders" also includes any transferees, pledges,
donees, or other successors in interest to the selling stockholders named in the
table below. To our knowledge, subject to applicable community property laws,
each person named in the table has sole voting and investment power with respect
to the shares of common stock set forth opposite such person's name.
66
Percentage of Percentage of
Shares of Number of Shares Shares of
Number of Shares Common Stock of Common Stock Common Stock
of Common stock Beneficially Number of Shares Beneficially Beneficially
Beneficially Owned Prior of Common Stock Owned After Owned After
Owned Prior to to the Registered for Completion of Completion of the
Offering Offering Sale Hereby the Offering (1) Offering (1)
------------------------------------- ------------------- -------------- ------------------- -------------------- -----------------
Named Executive Officers and directors:
Michael K. Wilhelm
11007 N. Ridgeview Ct
Fountain Hills, AZ 85268 8,172,814(2) 11.5% 1,254,000(2) 6,918,814(2) 9.7%
Mark L. Witten
7032 E. Rosewood St
Tucson, AZ 85710-1236 9,501,138(3) 13.6% 1,086,000(3) 8,415,138(3) 12.0%
John N. Fermanis
11375 E. Sahuaro Dr., #2041
Scottsdale, AZ 85259 217,500(4) * 0 217,500(4) *
Theodore Staahl
1329 Spanos Court
Suite A-1
Modesto, CA 95356 3,489,464(5) 5.0% 350,000(5) 3,139,464(5) 4.5%
All directors and executive
officers as a group
(4 persons) 21,380,916(6) 29.6% 2,690,000(6) 18,690,916(6) 27.0%
Owners of 5% or more:
David Harris
1501 N Campbell Ave
Dept B1M Build 90 U of A
Tucson, AZ 85721 5,066,138(7) 7.3% 5,066,138(7) 0 *
67
Percentage of Percentage of
Shares of Number of Shares Shares of
Number of Shares Common Stock of Common Stock Common Stock
of Common stock Beneficially Number of Shares Beneficially Beneficially
Beneficially Owned Prior of Common Stock Owned After Owned After
Owned Prior to to the Registered for Completion of Completion of the
Offering Offering Sale Hereby the Offering (1) Offering (1)
-------------------------------------- ------------------- -------------- ------------------- -------------------- -----------------
Other Selling Stockholders:
Richard Ackner
14643 Drafthorse Ln
Wellington, FL 33414 153,600(8) * 153,600(8) 0 *
Wayne Adams
4845 Campo Ct
Coral Gables, FL 33146 384,000(9) * 384,000(9) 0 *
Jason J. Aiello &
Rachel Aiello JT WROS
714 Willowbrook Rd
Staten Island, NY 10314 153,600(10) * 153,600(10) 0 *
John Alderson
Hunter World Markets, Inc.
9300 Wilshire Blvd
Suite 600
Beverly Hills, CA 90212 200,000(11) * 200,000(11) 0 *
Richard B. Aronson
11 Lawrence Ln
Lexington, MA 02421 153,600(8) * 153,600(8) 0 *
Richard E. Beattie
101 Graystone Farm Rd
White Hall, MD 21161 307,200(12) * 307,200(12) 0 *
David Benadum
13960 Fox Trail Dr.
Holland, MI 49424 153,600(8) * 153,600(8) 0 *
John J. Bender
2803 S. 22nd St
LaCrosse, WI 54601 153,600(8) * 153,600(8) 0 *
68
Percentage of Percentage of
Shares of Number of Shares Shares of
Number of Shares Common Stock of Common Stock Common Stock
of Common stock Beneficially Number of Shares Beneficially Beneficially
Beneficially Owned Prior of Common Stock Owned After Owned After
Owned Prior to to the Registered for Completion of Completion of the
Offering Offering Sale Hereby the Offering (1) Offering (1)
-------------------------------------- ------------------- -------------- ------------------- -------------------- -----------------
Lester B. Boelter
50 Shady Oak Ct
Winona, MN 55987 1,152,000(13) 1.7% 1,152,000(13) 0 *
Delaware Charter Guarantee Trust Co.
F/B/O ML Bond Dental MP-Money Purch
Keogh/FBO
Betty C. Bond**
P.O. Box 558
Gretna, VA 24557 153,600(10) * 153,600(10) 0 *
Delaware Charter Guarantee Trust Co.
F/B/O ML Bond Dental MP-Money Purch
Keogh/FBO
Michael L. Bond**
601 S. Main St
Gretna, VA 24557 153,600(10) * 153,600(10) 0 *
Michael L. Bond
601 S. Main St
Gretna, VA 24557 307,200(14) * 307,200(14) 0 *
Roger Bouchard
32 Walnut Road
Rocky Hill, CT 06067 994,625(49) 1.4% 833,291(49) 161,334(49) *
Elliot Braun
3775 Park Ave
Edison, NJ 08820 384,000(15) * 384,000(15) 0 *
David Briskie
15006 Beltway Dr.
Addison, TX 75001 384,000(15) * 384,000(15) 0 *
69
Percentage of Percentage of
Shares of Number of Shares Shares of
Number of Shares Common Stock of Common Stock Common Stock
of Common stock Beneficially Number of Shares Beneficially Beneficially
Beneficially Owned Prior of Common Stock Owned After Owned After
Owned Prior to to the Registered for Completion of Completion of the
Offering Offering Sale Hereby the Offering (1) Offering (1)
-------------------------------------- ------------------- -------------- ------------------- -------------------- -----------------
Robert Burkhardt
2615 Kingston Point
Fort Wayne, IN 46815 307,200(14) * 307,200(14) 0 *
Michael Caridi
32 Cutler Road
Greenwich, CT 06831 514,778(50) * 120,000(50) 384,778(50) *
CDM Group
Jerry Teich**
3541 East Broadway Rd
Phoenix, AZ 85040 102,564(51) * 102,564(51) 0 *
Edward L. Chant
226 Edward Street
Suite #2
Aurora Ontario L4G 3S8
Canada 768,000(16) 1.1% 768,000(16) 0 *
Jerry Chitwood
3276 Lexington Rd
Richmond, KY 40475 153,600(10) * 153,600(10) 0 *
Salvatore Clark
P.O. Box 317
Deer Park, NY 11729 281,600(17) * 281,600(17) 0 *
Antonio Coladonato
2526 Harway Ave
Brooklyn, NY 11214 6,400(18) * 6,400(18) 0 *
Keith H. Cooper
5840 De Claire Ct
Atlanta, GA 30328 307,200(12) * 307,200(12) 0 *
70
Percentage of Percentage of
Shares of Number of Shares Shares of
Number of Shares Common Stock of Common Stock Common Stock
of Common stock Beneficially Number of Shares Beneficially Beneficially
Beneficially Owned Prior of Common Stock Owned After Owned After
Owned Prior to to the Registered for Completion of Completion of the
Offering Offering Sale Hereby the Offering (1) Offering (1)
-------------------------------------- ------------------- -------------- ------------------- -------------------- -----------------
Raymond B. Cromer
873 Westtown Rd
West Chester, PA 19382 153,600(10) * 153,600(10) 0 *
William Crowell &
Patricia Crowell JT WROS
9045 E. Havasupia Dr.
Scottsdale, AZ 85255 153,600(8) * 153,600(8) 0 *
John Dann
895 Moraga Road, Suite 7
Lafayette, CA 94549 1,338,958(52) 1.9% 1,183,125(52) 153,833(52) *
Kris Destefano
2 Manchester Drive
Bethpage, NY 11714 236,800(19) * 236,800(19) 0 *
Sherida Downer Downer JT WROS
546 Merimont Blvd
Auburn AL 36830 230,400(20) * 230,400(20) 0 *
Edward Duffy
178 Hanson Ln
New Rochelle, NY 10804 153,600(10) * 153,600(10) 0 *
John R. Durant
1867 S. Ashe Ct
Auburn, AL 36830 307,200(12) * 307,200(12) 0 *
Matt Earl
5120 Aihama Dr.
Woodland Hills, CA 91364 153,600(8) * 153,600(8) 0 *
71
Percentage of Percentage of
Shares of Number of Shares Shares of
Number of Shares Common Stock of Common Stock Common Stock
of Common stock Beneficially Number of Shares Beneficially Beneficially
Beneficially Owned Prior of Common Stock Owned After Owned After
Owned Prior to to the Registered for Completion of Completion of the
Offering Offering Sale Hereby the Offering (1) Offering (1)
-------------------------------------- ------------------- -------------- ------------------- -------------------- -----------------
Gary Ecklar
1630 N. Broadway
Lexington, KY 40505 921,600(21) 1.3% 921,600(21) 0 *
Robert Lee England IV
3 Montcrest Dr.
Birmingham, AL 35213 153,600(8) * 153,600(8) 0 *
Roger Erickson
850 S. Boulder Hwy. 222
Henderson, NV 89015 460,800(22) * 460,800(22) 0 *
Delaware Charter Guarantee Co.
F/P/O Roger Erickson**
SEP IRA
850 S. Boulder Hwy. 222
Henderson, NV 89015 307,200(12) * 307,200(12) 0 *
Donn Fassero
600 Coffee Road
Modesto, CA 95355 607,771(53) * 557,771(53) 50,000(53) *
Kristina Fasullo
77 Claradon Lane
Staten Island, NY 10305 6,400(18) * 6,400(18) 0 *
Alan Ferraro
7201 4th Avenue
Apt. #C-14
Brooklyn, NY 11209 211,200(23) * 211,200(23) 0 *
Arturo L. Filippe
1300 N. Portero Grande Dr. A
Rosemead, CA 91770 153,600(8) * 153,600(8) 0 *
72
Percentage of Percentage of
Shares of Number of Shares Shares of
Number of Shares Common Stock of Common Stock Common Stock
of Common stock Beneficially Number of Shares Beneficially Beneficially
Beneficially Owned Prior of Common Stock Owned After Owned After
Owned Prior to to the Registered for Completion of Completion of the
Offering Offering Sale Hereby the Offering (1) Offering (1)
-------------------------------------- ------------------- -------------- ------------------- -------------------- -----------------
Flagship Mortgage Co.
c/o Brian Shannon**
30 East Padonia Rd
Ste 207
Timonium, MD 21093 153,600(71) * 153,600(71) 0 *
William L. Fox &Lynne Fox JT WROS
450 Music Mountain Rd
Falls Village, CT 06031 768,000(16) 1.1% 768,000(16) 0 *
Franz Family Trust
D/T/D 8/16/02
David Franz Franz**
TTEES 5553 Wellesley Dr.
Calabasas, CA 91302 153,600(8) * 153,600(8) 0 *
William Christopher Frasco
532 Nugent Ave
Staten Island, NY 10305 128,000(24) * 128,000(24) 0 *
Jerome French
1600 N. Foliage Dr.
Wichita, KS 67206 1,653,229 2.4% 1,528,229 125,000 *
Jeffrey Friedman
12074 Broadway Terrace
Oakland, CA 94611 2,898,518(55) 4.2% 2,236,468(55) 660,050(55) *
Janine Frisco 70,000(73) * 70,000(73) 0 *
Bernie Gallas
5200 N. Diversey Blvd. #204
Milwaukee, WI 53217 230,400(20) * 230,400(20) 0 *
73
Percentage of Percentage of
Shares of Number of Shares Shares of
Number of Shares Common Stock of Common Stock Common Stock
of Common stock Beneficially Number of Shares Beneficially Beneficially
Beneficially Owned Prior of Common Stock Owned After Owned After
Owned Prior to to the Registered for Completion of Completion of the
Offering Offering Sale Hereby the Offering (1) Offering (1)
-------------------------------------- ------------------- -------------- ------------------- -------------------- -----------------
Delaware Charter GT Co. Trust Co.
F/B/O
Anthony Gentile** IRA
7076 Via Quito
Pleasanton, CA 94566 384,000(9) * 384,000(9) 0 *
Myron Gerber
84 Gifford St. #33
New Bedford, MA 02744 307,200(14) * 307,200(14) 0 *
Debra Gessner
9331 E. Calle de Valle
Scottsdale, AZ 85255 270,000(56) * 270,000(56) 0 *
William M. Goldstein
787 Trethanny Ln
Wayne, PA 19087 192,000(25) * 192,000(25) 0 *
Dian Griesel
11 Stone Street, 4th Floor
New York, NY 10004 300,000 * 300,000 0 *
Gummersbach LTD
Lisa Marshall
22 Victoria St
Hamilton, Bermuda HMF 12 768,000(72) 1.1% 768,000(72) 0 *
Steven Gurewitsch
930 5th Ave
Apt. 3-G
New York, NY 10021 614,400(26) * 614,400(26) 0 *
74
Percentage of Percentage of
Shares of Number of Shares Shares of
Number of Shares Common Stock of Common Stock Common Stock
of Common stock Beneficially Number of Shares Beneficially Beneficially
Beneficially Owned Prior of Common Stock Owned After Owned After
Owned Prior to to the Registered for Completion of Completion of the
Offering Offering Sale Hereby the Offering (1) Offering (1)
-------------------------------------- ------------------- -------------- ------------------- -------------------- -----------------
Jack Ham Revocable Living Trust
Dtd 3/22/00 Jack Ham** Trustee
3143 Marcus Pointe Blvd
Pensicola, FL 32505 307,200(12) * 307,200(12) 0 *
Mark Hellner
900 West Olive
Merced, CA 95348 614,400(27) * 614,400(27) 0 *
Michael Hennessy
686 Bowman Rd
Chamberburg, PA 17201 153,600(8) * 153,600(8) 0 *
Don Jackler
246 E 51st Street, Suite 8
New York, NY 10022 792,500 1.1% 700,000 92,500 *
William J. Kathol
7220 S. 141st
Omaha, NE 68138 768,000(16) 1.1% 768,000(16) 0 *
Joel Katz**
c/o American Business
1205 Northern Blvd
Manahasset, NY 11030 384,000(15) * 384,000(15) 0 *
Robert Koch
1825 Eye St. N.W
Ste 1100
Washington, DC 20006 307,200(14) * 307,200(14) 0 *
Michael Kramm &
Doris Kramm JT WROS
39 Rugen Dr.
Harrington Pk., NJ 07640 153,600(10) * 153,600(10) 0 *
75
Percentage of Percentage of
Shares of Number of Shares Shares of
Number of Shares Common Stock of Common Stock Common Stock
of Common stock Beneficially Number of Shares Beneficially Beneficially
Beneficially Owned Prior of Common Stock Owned After Owned After
Owned Prior to to the Registered for Completion of Completion of the
Offering Offering Sale Hereby the Offering (1) Offering (1)
-------------------------------------- ------------------- -------------- ------------------- -------------------- -----------------
Michael Kulick, MD
Profit Shared Plan
Michael Kulick, MD
450 Sutter, Suite 2620
San Francisco, CA 94118 1,122,020(57) 1.6% 922,020(57) 200,000(57) *
Indy S. Kullar
8631 Armstrong Ave
Burnaby BC 999 999 230,400(20) * 230,400(20) 0 *
David Bruce Laughton
12065 Beaufait Ave
Northridge, CA 91326 153,600(8) * 153,600(8) 0 *
Peter J. Lawrence
5 Landsdowne Crescent
London W11 2NH
United Kingdom 460,800(22) * 460,800(22) 0 *
Myron A. Leon
2806 Saklan Indian Dr.
Walnut Creek, CA 94595 153,600(10) * 153,600(10) 0 *
David Lind
267 Dedham St
Norfolk, MA 02056 384,000(15) * 384,000(15) 0 *
Lind Family
Investments LP Barry Lind**,
General Partner Philip
Lind**, Limited Partner
1000 West Washington St
Suite #502
Chicago, IL 60607 153,600(70) * 153,600(70) 0 *
76
Percentage of Percentage of
Shares of Number of Shares Shares of
Number of Shares Common Stock of Common Stock Common Stock
of Common stock Beneficially Number of Shares Beneficially Beneficially
Beneficially Owned Prior of Common Stock Owned After Owned After
Owned Prior to to the Registered for Completion of Completion of the
Offering Offering Sale Hereby the Offering (1) Offering (1)
-------------------------------------- ------------------- -------------- ------------------- -------------------- -----------------
Barry Lind Revocable Trust
Barry Lind** Trustee U/A/D 12/19/1989
1000 West Washington St.
Suite #502
Chicago, IL 60607 921,600(21) 1.3% 921,600(21) 0 *
Dwight E. Long
406 Belle Glen Ln
Brentwood, TN 37027 460,800(22) * 460,800(22) 0 *
Randall K. Lowry, Jr
14511 Falling Creek Dr.
Houston, TX 77014 768,000(16) 1.1% 768,000(16) 0 *
Steven Markowitz
c/o Joseph Stevens Inc.
285 Benadict Rd
Staten Island, NY 10304 768,800(28) 1.1% 768,800(28) 0 *
Mike Marr
3577 Fruitville Ave
Oakland, CA 94602 307,200(14) * 307,200(14) 0 *
George F. McCabe Jr. Family Trust
DTD 2/11/98
George F. McCabe** TTEE
926 Hawk Landing
Frontland Park, FL 34731 384,000(15) * 384,000(15) 0 *
James L. McCormack
3355 Fruitvale Rd
Lincoln, CA 95648 153,600(8) * 153,600(8) 0 *
77
Percentage of Percentage of
Shares of Number of Shares Shares of
Number of Shares Common Stock of Common Stock Common Stock
of Common stock Beneficially Number of Shares Beneficially Beneficially
Beneficially Owned Prior of Common Stock Owned After Owned After
Owned Prior to to the Registered for Completion of Completion of the
Offering Offering Sale Hereby the Offering (1) Offering (1)
-------------------------------------- ------------------- -------------- ------------------- -------------------- -----------------
John Kevin McCrary
4520 Red Fox Rd.
Fort Collins, CO 80526 153,600(8) * 153,600(8) 0 *
Matthew S. Menies
52 Beach Road
Massapequa, NY 11758 160,000(29) * 160,000(29) 0 *
Fabio Migliaccio
658 Henry Street
Brooklyn, NY 11231 256,000(30) * 256,000(30) 0 *
Sloane M. Miles
10660 E. Mercer Dr.
Scottsdale, AZ 85259 116,000 * 116,000 0 *
E. Scott Millbury
S. Shore Dr.
Millbury Lane
Rangely, ME 04970 153,600(8) * 153,600(8) 0 *
John Richard Miller
29 Bishop Kirk Place
Oxford
England
UK 768,000(16) 1.1% 768,000(16) 0 *
Sanford J. Miller &
Babette D. Miller JT WROS
7606 Forsyth Blvd
St. Louis, MO 63105 384,000(15) * 384,000(15) 0 *
78
Percentage of Percentage of
Shares of Number of Shares Shares of
Number of Shares Common Stock of Common Stock Common Stock
of Common stock Beneficially Number of Shares Beneficially Beneficially
Beneficially Owned Prior of Common Stock Owned After Owned After
Owned Prior to to the Registered for Completion of Completion of the
Offering Offering Sale Hereby the Offering (1) Offering (1)
-------------------------------------- ------------------- -------------- ------------------- -------------------- -----------------
Glen Miskiewicz
48 Par-La-Ville Rd.
Apt. 724 Hamilton, HM11
Bermuda 768,000(16) 1.1% 768,000(16) 0 *
Enrico Monaco
2230 Ocean Ave
Brooklyn, NY 11229 230,400(20) * 230,400(20) 0 *
Dina Mondelli
1-74th Street
Apt. #2S
Brooklyn, NY 11209 6,400(18) * 6,400(18) 0 *
Steven Moore
1026 Rodeo Rd
Pebble Beach, CA 93953 1,365,242(58) 2.0% 1,215,242(58) 150,000(58) *
MSB Family Trust
D/T/D 6/25/93 Michael Blechman**
TTEE 295 Shadowood Ln
Northfield, IL 60093 691,200(31) * 691,200(31) 0 *
James Mulryan &
Maureen Mulryan JT WROS
9925 S. Bell Ave
Chicago, IL 60643 153,600(8) * 153,600(8) 0 *
Daniel Navarro Jr. &
Richard Navarro JT WROS
2036 Highway 35 N
South Amboy, NJ 08879 153,600(32) * 153,600(32) 0 *
79
Percentage of Percentage of
Shares of Number of Shares Shares of
Number of Shares Common Stock of Common Stock Common Stock
of Common stock Beneficially Number of Shares Beneficially Beneficially
Beneficially Owned Prior of Common Stock Owned After Owned After
Owned Prior to to the Registered for Completion of Completion of the
Offering Offering Sale Hereby the Offering (1) Offering (1)
-------------------------------------- ------------------- -------------- ------------------- -------------------- -----------------
Daniel P. Neri
308 Bordeaux Lane
Cary, NC 27511 457,334(59) * 407,334(59) 50,000(59) *
John G. Nesbett
11 Stone Street, 4th Floor
New York, NY 10004 50,000 * 50,000 0 *
David R. Nichols &
Angela S. Nichols
Revocable Trust 1993
David Nichols and Angela
Nichols** TTEES
2250 Applewood Ln
Camarillo, CA 93012 768,000(16) 1.1% 768,000(16) 0 *
Allen Notowitz
2710 Victoria Mnr
San Carlos, CA 94070 153,600(8) * 153,600(8) 0 *
Michael O'Brien
1575 Professional Way
P.O. Box 2737
Auburn, AL 36831 230,400(20) * 230,400(20) 0 *
Peter Orthos
52 Stone Hill Drive S
Manhasset, NY 11030 256,000(33) * 256,000(33) 0 *
Alexander Orthos
Orthos JT WROS
52 Stone Hill Drive S
Manhasset, NY 11030 1,710,400(34) 2.3% 1,710,400(34)) 0 *
80
Percentage of Percentage of
Shares of Number of Shares Shares of
Number of Shares Common Stock of Common Stock Common Stock
of Common stock Beneficially Number of Shares Beneficially Beneficially
Beneficially Owned Prior of Common Stock Owned After Owned After
Owned Prior to to the Registered for Completion of Completion of the
Offering Offering Sale Hereby the Offering (1) Offering (1)
-------------------------------------- ------------------- -------------- ------------------- -------------------- -----------------
Nelson Pan
985 Main St.
Melrose, MA 02176 230,400(20) * 230,400(20) 0 *
George Paxinos
24 Vanderbilt Ave (Apt.1B)
Manhasset, NY 11030 108,800(35) * 108,800(35) 0 *
Robert Petrozzo
20 Woods Lane
East Hampton, NY 11937 435,200(36) * 435,200(36) 0 *
Paul B. Poulsen &
Kathleen J. Poulsen JT WROS
215 Alverado Ave
Los Altos, CA 94022 307,200(12) * 307,200(12) 0 *
Professional Traders Fund LLC
Marc Swickle and Howard Berger**
1400 Old Country Road, Suite 206
Westbury, NY 11590 366,420(60) * 366,420(60) 0 *
Progressive Ins. Services, Inc.
Money Purchase Pension Plan
Russell E. Davis** TTEE
205 E. Reynolds Rd
Lexington, KY 40571 153,600(8) * 153,600(8) 0 *
Palangat Radhakrishnan &
Devika Radhakrishnan JT WROS
115 White Ave
New Hyde PK., NY 11040 384,000(15) * 384,000(15) 0 *
81
Percentage of Percentage of
Shares of Number of Shares Shares of
Number of Shares Common Stock of Common Stock Common Stock
of Common stock Beneficially Number of Shares Beneficially Beneficially
Beneficially Owned Prior of Common Stock Owned After Owned After
Owned Prior to to the Registered for Completion of Completion of the
Offering Offering Sale Hereby the Offering (1) Offering (1)
-------------------------------------- ------------------- -------------- ------------------- -------------------- -----------------
Prahalathan Rajasekaran**
c/o Jupiter Asset Management
27 Cool Gardie Ave
Chigwell
Essex 1G7 5AX 460,800(22) * 460,800(22) 0 *
James Rathgeber
14 Richbourne Lane
Melville, NY 11747 524,800(37) * 524,800(37) 0 *
Reichert, Wenner, Koch,
Profit Sharing Plan
F/B/O John Koch**
501 St. Germain
St. Cloud, MN 56302 230,400(20) * 230,400(20) 0 *
Frank Restivo
1311 S. Hidden Valley Dr.
W. Covina, CA 91791 153,600(8) * 153,600(8) 0 *
The Richardson Family
Trust D/T/D
07/19/90
Dennis L. Richardson &
Evette Richardson** TTEES
537 Ocampo Dr.
Pacific Palisades, CA 90272 614,400(38) * 614,400(38) 0 *
Delaware Charter
Guaranty Co.
FBO Stanley Riggins** IRA
1937 Whatley Dr.
Auburn, AL 36830 153,600(8) * 153,600(8) 0 *
82
Percentage of Percentage of
Shares of Number of Shares Shares of
Number of Shares Common Stock of Common Stock Common Stock
of Common stock Beneficially Number of Shares Beneficially Beneficially
Beneficially Owned Prior of Common Stock Owned After Owned After
Owned Prior to to the Registered for Completion of Completion of the
Offering Offering Sale Hereby the Offering (1) Offering (1)
-------------------------------------- ------------------- -------------- ------------------- -------------------- -----------------
Paul Sallwasser &
Teri Sallwasser JT WROS
301 Windmill Palm Ave.
Plantation, FL 33324 307,200(14) * 307,200(14) 0 *
Barry Saxe
35 McDaniel Rd
Shady, NY 12409 2,406,200(39) 3.5% 2,343,200(39) 63,000(39) *
Jody R. Saxe
Saxe JT WROS
3 West Ledge Rd
Marblehead, MA 01945 153,600(8) * 153,600(8) 0 *
SBM Certificate Company
Eric Westbury
5101 River Road, Suite 101
Bethesda, MD 20816 900,000(61) 1.3% 900,000(61) 0 *
Steve Scronic
7575 E. Indian Bend Rd. #2107
Scottsdale, AZ 85250 307,987(62) * 287,987(62) 20,000(62) *
Ronald S. Sheldon Self Directed
Profit Sharing Plan &Trust
Ronald S. Sheldon** TTEE
1488 Old Barn Lane
Highland Pk., IL 60035 307,200(12) * 307,200(12) 0 *
Delaware Charter
Guarantee &Trust Co.
FBO Stanley Sides** IRA
631 Walker Ferry Rd
Alexander City, AL 35010 307,200(12) * 307,200(12) 0 *
83
Percentage of Percentage of
Shares of Number of Shares Shares of
Number of Shares Common Stock of Common Stock Common Stock
of Common stock Beneficially Number of Shares Beneficially Beneficially
Beneficially Owned Prior of Common Stock Owned After Owned After
Owned Prior to to the Registered for Completion of Completion of the
Offering Offering Sale Hereby the Offering (1) Offering (1)
-------------------------------------- ------------------- -------------- ------------------- -------------------- -----------------
Lawrence M. Silver
225 West Hubbard
Suite #600
Chicago, IL 60610 537,600(40) * 537,600(40) 0 *
Delaware Charter Guarantee Trust Co.
F/B/O
Richard S. Simms** II Keogh Plan
5951 S. Middlefield Rd
Ste. 105
Littleton, CO 80123 153,600(10) * 153,600(10) 0 *
Joseph Sorbara
4 Windham Court
Muttontown, NY 11545 768,800(41) 1.1% 768,800(41) 0 *
Spelling Communications
Daniel Spelling**
2211 Corinth Avenue, Suite 210
Los Angeles, CA 89064 300,532(63) * 286,164(63) 14,368(63) *
John Spiziri
5 Nettie Lane
Lancaster, PA 17603 153,600(8) * 153,600(8) 0 *
Claire Spooner
111 Seaview Ct
Neptune, NJ 07753 153,600(8) * 153,600(8) 0 *
Charles D. Stadterman
5620 Elgin St
Pittsburgh, PA 15206 230,400(20) * 230,400(20) 0 *
84
Percentage of Percentage of
Shares of Number of Shares Shares of
Number of Shares Common Stock of Common Stock Common Stock
of Common stock Beneficially Number of Shares Beneficially Beneficially
Beneficially Owned Prior of Common Stock Owned After Owned After
Owned Prior to to the Registered for Completion of Completion of the
Offering Offering Sale Hereby the Offering (1) Offering (1)
-------------------------------------- ------------------- -------------- ------------------- -------------------- -----------------
Henry Steinberg
934 Southern Drive
Franklin Sq., NY 11010 153,600(8) * 153,600(8) 0 *
Warren Stout
800 E. Colorado Blvd., Suite 450
Pasadena, CA 91101 1,267,838(65)() 1.8% 1,117,838(65) 150,000(65) *
Stratum Consulting Group, LLC
Steve Scronic**
11442 E. Aster Drive
Scottsdale, AZ 85259 268,800(66) * 268,800(66) 0 *
Daniel C. Strum
95 Upper Hampden Rd
Monson, MA 01057 307,200(12) * 307,200(12) 0 *
Frank Sylva
450 Sylva Lane
Lakeport, CA 95453 153,600(42) * 153,600(42) 0 *
Synergos, Inc.
Jaye Thompson and J.T. Thompson**
2202 Timberloch Place, Suite 230
The Woodlands, TX 77380 839,091(67) 1.2% 839,091(67) 0 *
Edward Taylor
6415 Boulevard East
West New York, NJ 07093 60,000(43) * 60,000(43) 0 *
Andrea Todaro
55 92nd Street
Apt. #2F
Brooklyn, NY 11209 25,600(44) * 25,600(44) 0 *
85
Percentage of Percentage of
Shares of Number of Shares Shares of
Number of Shares Common Stock of Common Stock Common Stock
of Common stock Beneficially Number of Shares Beneficially Beneficially
Beneficially Owned Prior of Common Stock Owned After Owned After
Owned Prior to to the Registered for Completion of Completion of the
Offering Offering Sale Hereby the Offering (1) Offering (1)
-------------------------------------- ------------------- -------------- ------------------- -------------------- -----------------
Drew Tranchina
178-15 69th Ave.
Fresh Meadows, NY 11365 70,400(45) * 70,400(45) 0 *
William S. Tyrrell
2711 Edgehill Ave
Bronx, NY 10463 921,600(21) 1.2% 921,600(21) 0 *
Value Management Research AG
Attn: Kevin Devine, CEO
Campus Kronberg 7
D-61476 Kronberg im Taunus
Germany 232,153(68) * 232,153(68) 0 *
Michael Van Petten
100 N Tampa Street
Suite 2200
Tampa, FL 33602 153,600(8) * 153,600(8) 0 *
Louis John Ventre
1339 85th Street
Brooklyn, NY 11228 128,000(24) * 128,000(24) 0 *
Stephen Walker
5829 Niwot Road
Longmont, CO 80503 41,162(69) * 39,912(69) 1,250(69) *
John Wechsler
159 Bedford Rd
Greenwich, CT 06831 192,000(46) * 192,000(46) 0 *
86
Percentage of Percentage of
Shares of Number of Shares Shares of
Number of Shares Common Stock of Common Stock Common Stock
of Common stock Beneficially Number of Shares Beneficially Beneficially
Beneficially Owned Prior of Common Stock Owned After Owned After
Owned Prior to to the Registered for Completion of Completion of the
Offering Offering Sale Hereby the Offering (1) Offering (1)
-------------------------------------- ------------------- -------------- ------------------- -------------------- -----------------
Westrock Advisors
Ed Taylor**
230 Park Ave.
Suite #934
New York, NY 10169 20,000(47) * 20,000(47) 0 *
Peter T. White
122 Wilsondale St
Westwood, MA 02090 384,000(15) * 384,000(15) 0 *
Robert Wilner
787 King St
Rye Brook, NY 10573 614,400(27) * 614,400(27) 0 *
Olen C. Wilson
2404 Teckla Blvd
Amarillo, TX 79106 230,400(20) * 230,400(20) 0 *
Tad Wilson
877 Maple Dr.
Spencer, IN 47460 153,600(8) * 153,600(8) 0 *
Jonathan H. Witherspoon
730 Yorkshire Road
Winston Salem, NC 27106 153,600(8) * 153,600(8) 0 *
Jeffrey Blake Woolf
80 Park Ave
Apt. #7F
New York, NY 10016 102,400(48) * 102,400(48) 0 *
Alan J. Young
1750 Braeside Avenue
Northbrook, IL 60062 537,600(40) * 537,600(40) 0 *
87
----------
* Less than 1 percent.
** Beneficial owner(s) based information provided to us by the selling
stockholder.
1 Represents the amount of shares that will be held by the selling
stockholders after completion of this offering based on the assumption
that all shares registered for sale hereby will be sold. However, the
selling stockholders may offer all, some or none of the shares pursuant to
this prospectus, and to our knowledge there are currently no agreements,
arrangements or understanding with respect to the sale of any of the
shares that may be held by the selling stockholders after completion of
this offering.
2 Includes 1,788,718 shares underlying warrants that are currently
exercisable at prices ranging from $0.05 to $2.00, 4,106,138 of which
represent warrants, exercisable at $0.05, to purchase shares held by David
T. Harris. Includes 253,030 stock purchase options at with strike prices
ranging from $0.30 to $0.40. Also includes 20,000 shares held by Michael K
Wilhelm that underlie currently exercisable warrants held by one
individual.
3 Includes 712,000 shares underlying warrants that are currently exercisable
at prices ranging from $0.125 to $0.50. Includes 163,000 shares held by
Mark L. Witten that underlie currently exercisable warrants held by 7
individuals.
4 Includes 74,997 common shares which have been committed. These shares to
be issued per Mr. Fermanis's employment agreement. Includes 17,500 shares
underlying warrants that are currently exercisable at prices ranging from
$0.25 to $0.41.
5 Includes 93,300 common shares which have been committed These shares are
being issued in conjunction with the conversion of an outstanding
convertible promissory note in September 2003. Includes 203,000 shares
underlying warrants that are currently exercisable at prices ranging from
$0.038 to $1.00, 17,500 of which represent warrants to purchase shares
held by David T. Harris and 17,500 of which represent warrants to purchase
shares held by Mark L. Witten.
6 Includes 168,297 common shares that have been committed. Includes 150,000
common stock purchase warrants issued to Michael K. Wilhelm per his
employment agreement. Includes 6,596,218 shares underlying warrants that
are currently exercisable at prices ranging from $0.005 to $1.00, and
4,106,138 of which are underlying warrants to purchase shares held by
David T. Harris. Includes an aggregate of 386,000 shares held by Michael,
K. Wilhelm, Mark L. Witten and David T. Harris that underlie currently
exercisable warrants held by 9 individuals.
7 Includes 4,066,138 shares held by David T. Harris that underlie currently
exercisable warrants held by Foresight Capital Corporation, a company
owned by Michael K. Wilhelm, and an additional 203,000 shares held by Mr.
Harris that underlie currently exercisable warrants held by 8 individuals.
8 Includes 22,400 common shares and 11,200 common stock purchase warrants
that are currently exercisable at a price of $0.50 that have been
committed due to penalty registration clause.
9 Includes 100,000 shares underlying warrants that are currently exercisable
at $0.50. Includes 56,000 common shares and 28,000 common stock purchase
warrants that are currently exercisable at $0.50 that have been committed
due to penalty registration clause.
10 Includes 40,000 shares underlying warrants that are currently exercisable
at $0.50. Includes 22,400 common shares and 11,200 common stock purchase
88
warrants that are currently exercisable at $0.50 that have been committed
due to penalty registration clause.
11 Includes 200,000 shares underlying warrants that are currently exercisable
at a price of $0.125 per share.
12 Includes 44,800 common shares and 22,400 common stock purchase warrants
that are currently exercisable at a price of $0.50 that have been
committed due to penalty registration clause.
13 Includes 168,000 common shares and 84,000 common stock purchase warrants
that are currently exercisable at a price of $0.50 that have been
committed due to penalty registration clause.
14 Includes 80,000 shares underlying warrants that are currently exercisable
at $0.50. Includes 44,800 common shares and 22,400 common stock purchase
warrants that are currently exercisable at $0.50 that have been committed
due to penalty registration clause.
15 Includes 56,000 common shares and 28,000 common stock purchase warrants
that are currently exercisable at a price of $0.50 that have been
committed due to penalty registration clause.
16 Includes 112,000 common shares and 56,000 common stock purchase warrants
that are currently exercisable at a price of $0.50 that have been
committed due to penalty registration clause.
17 Includes 61,600 common shares that have been committed due to penalty
registration clause.
18 Includes 1,400 common shares that have been committed due to penalty
registration clause.
19 Includes 51,800 common shares that have been committed due to penalty
registration clause.
20 Includes 33,600 common shares and 16,800 common stock purchase warrants
that are currently exercisable at a price of $0.50 that have been
committed due to penalty registration clause.
89
21 Includes 240,000 shares underlying warrants that are currently exercisable
at $0.50. Includes 134,400 common shares and 67,200 common stock purchase
warrants that are currently exercisable at $0.50 that have been committed
due to penalty registration clause.
22 Includes 67,200 common shares and 33,600 common stock purchase warrants
that are currently exercisable at a price of $0.50 that have been
committed due to penalty registration clause.
23 Includes 46,200 common shares that have been committed due to penalty
registration clause.
24 Includes 28,000 common shares that have been committed due to penalty
registration clause.
25 Includes 28,000 common shares and 14,000 common stock purchase warrants
that are currently exercisable at a price of $0.50 that have been
committed due to penalty registration clause.
26 Includes 65,000 shares underlying warrants that are currently exercisable
at $0.50. Includes 89,600 common shares and 44,800 common stock purchase
warrants that are currently exercisable at $0.50 that have been committed
due to penalty registration clause.
27 Includes 89,600 common shares and 44,800 common stock purchase warrants
that are currently exercisable at a price of $0.50 that have been
committed due to penalty registration clause.
28 Includes 168,175 common shares that have been committed due to penalty
registration clause.
29 Includes 35,000 common shares that have been committed due to penalty
registration clause.
30 Includes 56,000 common shares that have been committed due to penalty
registration clause.
31 Includes 180,000 shares underlying warrants that are currently exercisable
at $0.50. Includes 100,800 common shares and 50,400 common stock purchase
warrants that are currently exercisable at $0.50 that have been committed
due to penalty registration clause.
32 Includes 20,000 shares underlying warrants that are currently exercisable
at $0.50. Includes 22,400 common shares and 11,200 common stock purchase
warrants that are currently exercisable at $0.50 that have been committed
due to penalty registration clause.
33 Includes 56,000 common shares that have been committed due to penalty
registration clause.
34 Includes 374,150 common shares that have been committed due to penalty
registration clause.
35 Includes 23,800 common shares that have been committed due to penalty
registration clause.
36 Includes 95,200 common shares that have been committed due to penalty
registration clause.
37 Includes 114,800 common shares that have been committed due to penalty
registration clause.
38 Includes 160,000 shares underlying warrants that are currently exercisable
at $0.50. Includes 89,600 common shares and 44,800 common stock purchase
warrants that are currently exercisable at $0.50 that have been committed
due to penalty registration clause.
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39 Includes 268,800 common shares and 134,400 common stock purchase warrants
that are currently exercisable at a price of $0.50 that have been
committed due to penalty registration clause.
40 Includes 140,000 shares underlying warrants that are currently exercisable
at $0.50. Includes 78,400 common shares and 39,200 common stock purchase
warrants that are currently exercisable at $0.50 that have been committed
due to penalty registration clause.
41 Includes 168,175 common shares that have been committed due to penalty
registration clause.
42 Includes 20,000 shares underlying warrants that are currently exercisable
at $0.50. Includes 22,400 common shares and 11,200 common stock purchase
warrants that are currently exercisable at $0.50 that have been committed
due to penalty registration clause.
43 Includes 13,125 common shares that have been committed due to penalty
registration clause.
44 Includes 5,600 common shares that have been committed due to penalty
registration clause.
45 Includes 15,400 common shares that have been committed due to penalty
registration clause.
46 Includes 50,000 shares underlying warrants that are currently exercisable
at $0.50. Includes 28,000 common shares and 14,000 common stock purchase
warrants that are currently exercisable at $0.50 that have been committed
due to penalty registration clause.
47 Includes 4,375 common shares that have been committed due to penalty
registration clause. Dan Hunter is the Chief Operating Officer and control
person of Westrock Advisors.
48 Includes 22,400 common shares that have been committed due to penalty
registration clause.
49 Includes 367,264 shares underlying warrants that are currently exercisable
at prices ranging from $0.038 to $1.00, 8,000 of which represent warrants
to purchase shares held by Mark L. Witten and 8,000 of which represent
warrants to purchase shares held by David T. Harris.
50 Includes 434,778 shares underlying warrants that are currently exercisable
at prices ranging from $0.125 to $0.50.
51 Includes 34,188 shares underlying warrants that are currently exercisable
at $0.50. Excludes 7,500 shares underlying warrants that are currently
exercisable held by the owner of CDM Group. Jerry Teich is the control
person of CDM Group.
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52 Includes 490,208 shares underlying warrants that are currently exercisable
at prices ranging from $0.25 to $0.50.
53 Includes 235,924 shares underlying warrants that are currently exercisable
at prices ranging from $0.038 to $1.00.
54 Includes 634,410 shares underlying warrants that are currently exercisable
at prices ranging from $0.038 to $1.00.
55 Includes 40,000 shares that have been committed pending issuance. Includes
1,040,540 shares underlying warrants that are currently exercisable at
prices ranging from $0.09 to $2.00, 62,500 of which represent warrants to
purchase shares held by Mark L. Witten and 62,500 of which represent
warrants to purchase shares held by David T. Harris.
56 Includes 90,000 shares underlying warrants that are currently exercisable
at a price of $0.50 per share.
57 Includes 507,340 shares underlying warrants that are currently exercisable
at prices ranging from $0.038 to $1.00.
58 Includes 480,081 shares underlying warrants that are currently exercisable
at prices ranging from $0.50 to $1.00, 37,500 of which represent warrants
to purchase shares held by Mark L. Witten and 37,500 of which represent
warrants to purchase shares held by David T. Harris.
59 Includes 50,000 shares underlying warrants that are currently exercisable,
25,000 at a price of $1.00, 12,500 of which represent warrants to purchase
shares held by Mark L. Witten and 12,500 of which represent warrants to
purchase shares held by David T. Harris.
60 Mark Swickle and Howard Berger are the control persons of Professional
Traders Fund LLC.
61 Eric Westbury is the control person of SBM Certificate Company.
62 Includes 34,464 common shares which have been committed. Includes 26,939
shares underlying warrants that are currently exercisable at $0.278 per
share. Steven J. Scronic is the control person of Stratum Consulting
Group, LLC.
63 Includes 95,388 shares underlying warrants that are currently exercisable
at a price of $0.50. Excludes 40,000 shares and 20,000 shares underlying
warrants that are currently exercisable held by the owner of Spelling
Communications. Daniel Spelling is the control person of Spelling
Communications.
64 Not used.
65 Includes 522,613 shares underlying warrants that are currently exercisable
at prices ranging from $0.038 to $1.00.
66 Includes 89,600 shares underlying warrants that are currently exercisable
at a price of $0.50. Excludes 261,048 shares and 26,939 shares underlying
warrants that are currently exercisable held by the owner of Stratum
Consulting Group, LLC. Steven J. Scronic is the control person of Stratum
Consulting Group, LLC.
67 Includes 279,697 shares underlying warrants that are currently exercisable
at a price of $0.50. Excludes 20,000 shares underlying warrants that are
currently exercisable held by the shareholders of Synergos, Inc, Jaye
Thompson and J.T. Thompson. Jaye Thompson is the control person of
Synergos, Inc.
68 Kevin Devine is the control person of Value Management Research AG.
69 Includes 14,554 shares underlying warrants that are currently exercisable
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at prices ranging from $0.35 to $0.50.
70 Includes 40,000 shares underlying warrants that are currently exercisable
at $0.50. Includes 22,400 common shares and 11,200 common stock purchase
warrants that are currently exercisable at $0.50 that have been committed
due to penalty registration clause. Barry Lind is the General Partner and
control person of Lind Family Investments LP.
71 Includes 40,000 shares underlying warrants that are currently exercisable
at $0.50. Includes 22,400 common shares and 11,200 common stock purchase
warrants that are currently exercisable at $0.50 that have been committed
due to penalty registration clause. Brian Shannon is the control person of
Flagship Mortgage Co..
72 Includes 112,000 common shares and 56,000 common stock purchase warrants
that are currently exercisable at a price of $0.50 that have been
committed due to penalty registration clause. Lisa Marshall is the
President and control person of Gummersback LTD.
73 Includes 70,000 shares underlying warrants that are currently exercisable
at a price of $0.30.
74 Includes 25,000 shares underlying warrants that are currently exercisable
at a price of $0.038.
We will not receive any of the proceeds from the sale of the shares by
the selling stockholders. We have agreed to bear expenses incurred by the
selling stockholders, up to a maximum limit of $15,000, that relate to the
registration of the shares being offered and sold by the selling stockholders,
including the Securities and Exchange Commission registration fee and legal,
accounting, printing and other expenses of this offering.
DESCRIPTION OF CAPITAL STOCK
We are authorized to issue 100,000,000 shares of common stock, $0.001
par value per share, and 10,000,000 shares of preferred stock, $0.001 par value
per share. The following description of our capital stock does not purport to be
complete and is governed by and qualified by our certificate of incorporation
and bylaws, which are included as exhibits to the registration statement of
which this prospectus forms a part, and by the provisions of applicable Delaware
law.
COMMON STOCK
As of March 27, 2006, we had 69,536,319 shares of common stock
outstanding, which were held of record and beneficially by approximately 520
stockholders. As of March 27, 2006, Our Board of Directors has also approved the
issuance of 183,530 common shares that remain unissued. Additionally, in regard
to the penalty for delayed registration, pursuant to the terms of our October
2004 Private Placement, we have committed to the issuance of 6,456,800 common
shares. As of March 27, 2006, there were 11,616,869 shares of common stock
underlying outstanding warrants. Additionally, in regard to the penalty for
delayed registration, pursuant to the terms of our October 2004 Private
Placement, we have committed to the issuance of 2,542,400 warrants to purchase
shares of our common stock. Options to purchase 63,212 shares of common stock
had been granted or were outstanding outside our 2003 Stock Option, Deferred
Stock and Restricted Stock Plan and 254,030 options had been granted or were
outstanding under our 2003 Stock Option, Deferred Stock and Restricted Stock
Plan; 101,966 shares remain available for issuance under this plan.
The holders of our common stock are entitled to one (1) vote per share
on all matters submitted to a vote of our stockholders. In addition, such
holders are entitled to receive ratably such dividends, if any, as may be
declared from time to time by our Board of Directors out of funds legally
available therefore. No dividends may be paid on the common stock until all
accrued but unpaid dividends on the shares of our preferred stock have been
paid. In the event of the dissolution, liquidation or winding up of our company,
the holders of common stock are entitled to share ratably in all assets
remaining after payment of all liabilities of our company and the preference
amount distributable to the holders of the shares of preferred stock. The
holders of common stock do not have any subscription, redemption or conversion
rights, nor do they have any preemptive or other rights to acquire or subscribe
for additional, unissued or treasury shares.
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Pursuant to our bylaws, except for any matters which pursuant to
Delaware law require a greater percentage vote for approval, the holders of a
majority of the outstanding shares of common stock, if present in person or by
proxy, are sufficient to constitute a quorum for the transaction of business at
meetings of our stockholders. Except as to any matters which pursuant to
Delaware law require a greater percentage vote for approval, the affirmative
Vote of the holders of a majority of the shares of common stock present in
person or by proxy at any meeting (provided a quorum is present) is sufficient
to authorize, affirm or ratify any act or action, including the election of our
Board of Directors.
The holders of the common stock do not have cumulative voting rights.
Accordingly, the holders of more than half of the outstanding shares of common
stock can elect all of the directors to be elected in any election, if they
choose to do so. In such event, the holders of the remaining shares of common
stock would not be able to elect any directors. Our Board of Directors is
empowered to fill any vacancies on the Board created by the resignation, death
or removal of directors.
In addition to voting at duly called meetings at which a quorum is
present in person or by proxy, Delaware law and our bylaws provide that
stockholders may take action without the holding of a meeting by written consent
or consents signed by the holders of a majority of the outstanding shares of our
capital stock entitled to vote thereon. Prompt notice of the taking of any
action without a meeting by less than unanimous consent of the stockholders will
be given to those stockholders who do not consent in writing to the action. The
purposes of this provision are to facilitate action by stockholders and to
reduce the corporate expense associated with special meetings of stockholders.
MARKET PRICE OF OUR COMMON STOCK
The price of our common stock has been volatile in the past and will
likely continue to fluctuate in the future. The stock market in general and the
market for shares of life science companies in particular have experienced
extreme stock price fluctuations. In some cases, these fluctuations have been
unrelated to the operating performance of the affected companies. Many companies
in the life science and related industries have experienced dramatic volatility
in the market prices of their common stock. We believe that a number of factors,
both within and outside our control, could cause the price of our common stock
to fluctuate, perhaps substantially. Factors such as the following could have a
significant adverse impact on the market price of our common stock:
o Our ability to obtain additional financing and, if available,
the terms and conditions of the financing;
o Our financial position and results of operations;
o Biological or medical discoveries by competitors;
o The results of preclinical studies and clinical trials by us,
our collaborators or our competitors;
o Concern as to, or other evidence of, the safety or efficacy of
our proposed products or our competitors' products;
o Announcements of technological innovations or new products by
us or our competitors;
o U.S. and foreign governmental regulatory actions;
o Delays in the conduct or analysis of our preclinical or
clinical studies;
o Unfavorable results from preclinical or clinical studies;
o Unfavorable developments concerning patents or other
proprietary rights;
o Unfavorable domestic or foreign regulatory developments;
o Actual or anticipated changes in drug reimbursement policies;
o Developments with our collaborators, if any;
o Developments concerning patent or other proprietary rights of
us or our competitors (including litigation);
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o Status of litigation;
o Period-to-period fluctuations in our operating results;
o Changes in estimates of our company's performance by any
securities analysts;
o New regulatory requirements and changes in the existing
regulatory environment;
o Market conditions for life science stocks in general.
o The issuance of new equity securities pursuant to a future
offering;
o Changes in interest rates;
o Competitive developments, including announcements by
competitors of new products or services or significant
contracts, acquisitions, strategic partnerships, joint
ventures or capital commitments;
o Variations in quarterly operating results;
o Change in financial estimates by securities analysts; o The
depth and liquidity of the market for our common stock;
o Investor perceptions of our company and the technologies
industries generally; and
o General economic and other national conditions.
Trading in our securities could be subject to extreme price
fluctuations that could adversely affect your investment. The market prices for
securities of life sciences companies, particularly those that are not
profitable, have been highly volatile, especially recently. Publicized events
and announcements may have a significant impact on the market price of our
common stock. The factors listed above may have the effect of temporarily or
permanently driving down the price of our common stock. In addition, the stock
market from time to time experiences extreme price and volume fluctuations which
particularly affect the market prices for emerging and life sciences companies,
such as ours, and which are often unrelated to the operating performance of the
affected companies. For example, our per share stock price has ranged from $0.09
to $1.00 between January 1, 2004 and April 4, 2006.
These broad market fluctuations may adversely affect the ability of a
stockholder to dispose of his shares at a price equal to or above the price at
which the shares were purchased. In addition, in the past, following periods of
volatility in the market price of a company's securities, securities
class-action litigation has often been instituted against that company. Any
litigation against our company, including this type of litigation, could result
in substantial costs and a diversion of management's attention and resources,
which could materially adversely affect our business, financial condition and
results of operations.
PREFERRED STOCK
Under our certificate of incorporation, shares of our preferred stock
may, without any action by our stockholders, be issued by our Board of Directors
from time to time in one or more series for such consideration and with such
relative rights, privileges and preferences as the Board may determine.
Accordingly, our Board of Directors has the power, without stockholder approval,
to fix the dividend rate and to establish the provisions, if any, relating to
voting rights, redemption rate, sinking fund, liquidation preferences and
conversion rights for any series of preferred stock (subject to the preferences
of the shares of common stock offered hereby) issued in the future, which could
adversely affect the voting power or other rights of the holders of common
stock.
Our Board of Directors' authority to issue preferred stock provides a
convenient vehicle in connection with possible acquisitions and other corporate
purposes, but could have the effect of making it more difficult for a person or
group to gain control of our company. As of the date of the prospectus, there
are no shares of preferred stock outstanding, and we do not have present plans
to issue any shares of preferred stock or designate any series of preferred
stock.
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STOCK OPTIONS
As of March 31, 2006, there were 317,242 outstanding stock options at a
weighted average exercise price of $5.30, of which 254,030 are at an average
price of $0.37 per share and were granted under our 2003 Stock Option, Deferred
Stock and Restricted Stock Plan and 63,212 shares at a weighted average exercise
price of $25.00 per share that were granted outside of our 2003 Stock Option,
Deferred Stock and Restricted Stock Plan. There are 101,966 shares reserved for
future grant under our 2003 Stock Option, Deferred Stock and Restricted Stock
Plan.
Our Board of Directors has approved the issuance of a nonstatutory
option to purchase 1,896,970 shares at 110% of the fair market value per share
to our Chief Executive Officer under our 2003 Stock Option, Deferred Stock and
Restricted Stock Plan. Due to the fact that there are currently not enough
shares available under our 2003 Stock Option, Deferred Stock and Restricted
Stock Plan to grant these options to our Chief Executive Officer, we have not
yet made a commitment to issue these options. We recognize that if, at such a
time as the Company's 2003 Stock Plan is amended to authorize additional shares,
a commitment will be made and the options granted.
WARRANTS
As of March 31, 2006, there were 11,616,869 shares of common stock
underlying outstanding warrants with exercise prices ranging from $0.04 to $2.00
per share, with a weighted average exercise price of $0.46. Additionally, in
regard to the penalty for delayed registration, pursuant to the terms of our
October 2004 Private Placement, we have committed to the issuance of 2,542,400
warrants to purchase shares of our common stock. Exercise prices of these
warrants are $0.50 per share.
DELAWARE ANTI-TAKEOVER LAW AND CHARTER AND BYLAW PROVISIONS
We are subject to the provisions of Section 203 of the Delaware General
Corporation Law. In general, this statute prohibits a publicly-held Delaware
corporation from engaging in a "business combination" with an "interested
stockholder" for a period of three years after the date that the person became
an interested stockholder unless, with certain exceptions, the business
combination or the transaction in which the person became an interested
stockholder is approved in a prescribed manner. Generally, a "business
combination" includes a merger, asset or stock sale, or other transaction
resulting in a financial benefit to the stockholder.
Generally, an "interested stockholder" is a person who, together with
affiliates and associates, owns or within three years prior, did own 15% or more
of the corporation's voting stock. These provisions may have the effect of
delaying, deferring or preventing a change in control of us without further
action by our stockholders.
Our certificate of incorporation and bylaws contain provisions that
could have the effect of discouraging potential acquisition proposals or making
a tender offer or delaying or preventing a change in control of our company,
including changes a stockholder might consider favorable. In particular, our
certificate of incorporation and bylaws, as applicable, among other things,
will:
o provide our Board of Directors with the ability to alter our bylaws
without stockholder approval;
o provide that special meetings of stockholders can only be called by
our Board of Directors or by a committee of our Board of Directors
that has been duly designated by the Board and whose powers and
authority included the power to call such meetings;
o provide for an advance notice procedure with regard to the
nomination of candidates for election as directors and with regard
to business to be brought before a meeting of stockholders;
o provide that vacancies on our Board of Directors may be filled by a
majority of directors in office, although less than a quorum; and
o allow us to issue up to 10,000,000 shares of preferred stock with
rights senior to those of the common stock and that otherwise could
adversely affect the rights and powers, including voting rights, of
the holders of common stock. In some circumstances, this issuance
could have the effect of decreasing the market price of our common
stock, as well as having the anti-takeover effects discussed above.
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Such provisions may have the effect of discouraging a third-party from
acquiring us, even if doing so would be beneficial to our stockholders. These
provisions are intended to enhance the likelihood of continuity and stability in
the composition of our Board of Directors and in the policies formulated by
them, and to discourage some types of transactions that may involve an actual or
threatened change in control of our company. These provisions are designed to
reduce our vulnerability to an unsolicited acquisition proposal and to
discourage some tactics that may be used in proxy fights. We believe that the
benefits of increased protection of our potential ability to negotiate with the
proponent of an unfriendly or unsolicited proposal to acquire or restructure our
company outweigh the disadvantages of discouraging such proposals because, among
other things, negotiation of such proposals could result in an improvement of
their terms. However, these provisions could have the effect of discouraging
others from making tender offers for our shares that could result from actual or
rumored takeover attempts. These provisions also may have the effect of
preventing changes in our management.
BROKER-DEALER REQUIREMENTS FOR "PENNY STOCK" TRANSACTIONS
Our common stock is considered to be a "penny stock" since it meets one
or more of the definitions in Rules 15g-2 through 15g-6 promulgated under
Section 15(g) of the Securities Exchange Act of 1934, as amended. Section 15(g)
of the Securities Exchange Act of 1934, as amended, and Rule 15g-2 promulgated
thereunder by the SEC require broker-dealers dealing in penny stocks to provide
potential investors with a document disclosing the risks of penny stocks and to
obtain a manually signed and dated written receipt of the document before
effecting any transaction in a penny stock for the investor's account.
Compliance with this and other requirements may make it more difficult for
holders of our common stock to resell their shares to third parties or to
otherwise dispose of them in the market or otherwise.
TRANSFER AGENT AND REGISTRAR
The transfer agent for our common stock is Stalt, Inc., located at 671
Oak Grove Avenue, Suite C, Menlo Park, California 94025.
SHARES ELIGIBLE FOR FUTURE SALE
As of March 31, 2006, we had outstanding 69,536,322 shares of common
stock.
RULE 144
Of our outstanding shares, 18,859,388 shares of common stock are
immediately eligible for sale in the public market without restriction or
further registration under the Securities Act. All other outstanding shares of
our common stock are "restricted securities" as such term is defined under Rule
144, in that such shares were issued in private transactions not involving a
public offering and may not be sold in the absence of registration other than in
accordance with Rules 144 or another exemption from registration under the
Securities Act.. If shares are purchased by our "affiliates" as that term is
defined in Rule 144 under the Securities Act of 1933, their sales of shares
would be governed by the limitations and restrictions that are described below.
In general, under Rule 144 as currently in effect, a person (or persons
whose shares are aggregated) who has beneficially owned shares of our common
stock for at least one year, including any person who may be deemed to be an
"affiliate" (as the term "affiliate" is defined under the Securities Act of
1933), would be entitled to sell, within any three-month period, a number of
shares that does not exceed the greater of 1% of the number of shares of common
stock then outstanding, which as of March 31, 2006 would equal approximately
695,363 shares.
Sales under Rule 144 are also governed by other requirements regarding
the manner of sale, notice filing and the availability of current public
information about us. Under Rule 144, however, a person who is not, and for the
three months prior to the sale of such shares has not been, an affiliate of the
issuer is free to sell shares that are "restricted securities" which have been
held for at least two years without regard to the limitations contained in Rule
144. The selling stockholders will not be governed by the foregoing restrictions
when selling their shares pursuant to this prospectus.
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RULE 144(K)
Under Rule 144(k), a person who is not deemed to have been one of our
affiliates at any time during the three months preceding a sale, and who has
beneficially owned the shares proposed to be sold for at least two years,
including the holding period of any prior owner other than an affiliate, is
entitled to sell such shares without complying with the manner of sale, notice
filing, volume limitation or notice provisions of Rule 144.
SEC POSITION ON RULE 144 SALES
In November 2000, we changed our name to GPN Network, Inc. In July
2001, we discontinued the operations of GPN Network, Inc. in their entirety and
began looking for appropriate merger partners. Our objective became the
acquisition of an operating company with the potential for growth in exchange
for our securities. In July 2003, we effected a reverse merger with ImmuneRegen
BioSciences, Inc. and adopted our current business model.
Prior to the merger with ImmuneRegen Biosciences, Inc., we were a blank
check company and did not have any operations or receive any revenues since
inception. A "blank check" company is a development stage company that has no
specific business plan or purpose or has indicated its business plan is to
engage in a merger or acquisition with an unidentified company or companies, or
other entity or person.
The Securities and Exchange Commission has taken the position that
promoters or affiliates of a blank check company and their transferees, both
before and after a business combination, would act as an "underwriter" under the
Securities Act when reselling the securities of a blank check company because
their resale transactions would appear to be designed to distribute or
redistribute securities to the public without compliance with the registration
requirement of the Securities Act. Accordingly, the Securities and Exchange
Commission believes that those securities can be resold only through a
registered offering and that Rule 144 would not be available for those resale
transactions despite technical compliance with the requirements of Rule 144. As
of October 3, 2005, 366,420 shares of our outstanding common stock, and 450,000
shares of our common stock issuable upon warrants presently issued and
outstanding as of the date hereof are held by promoters or affiliates (or their
transferees) of our prior company, GPN Networks, Inc.. These shares are being
registered hereby.
Additionally, stockholders who obtained securities directly from a
blank check issuer and through promoters and affiliates, cannot use Rule 144 to
resell their securities, since their resale transactions would appear to be
designed to distribute or redistribute securities to the public without
compliance with the registration requirement of the Securities Act. As a result,
this policy applies to stockholders of ImmuneRegen Biosciences, Inc., prior to
the merger with our company.
PLAN OF DISTRIBUTION
The selling stockholders, and any of their pledgees, assignees and
successors-in-interest, may, from time to time, sell any or all of their shares
of our common stock on any stock exchange, market or trading facility on which
the shares are traded or in private transactions. These sales may be at fixed or
negotiated prices. The selling stockholders may use any one or more of the
following methods when selling shares:
o ordinary brokerage transactions and transactions in which the
broker-dealer solicits purchasers;
o block trades in which the broker-dealer will attempt to sell the
shares as agent but may position and resell a portion of the block
as principal to facilitate the transaction;
o purchases by a broker-dealer as principal and resale by the
broker-dealer for its account;
o an exchange distribution in accordance with the rules of the
applicable exchange;
o privately negotiated transactions;
o settlement of short sales entered into after the date of this
prospectus;
o broker-dealers may agree with the selling stockholders to sell a
specified number of such shares at a stipulated price per share;
98
o a combination of any such methods of sale; or
o through the writing or settlement of options or other hedging
transactions, whether through an options exchange or otherwise.
The selling stockholders may also sell shares under Rule 144 under the
Securities Act of 1933, if available, rather than under this prospectus.
Broker-dealers engaged by the selling stockholders may arrange for
other brokers-dealers to participate in sales. Broker-dealers may receive
commissions or discounts from the selling stockholders (or, if any broker-dealer
acts as agent for the purchaser of shares, from the purchaser) in amounts to be
negotiated. Each selling stockholder does not expect these commissions and
discounts relating to its sales of shares to exceed what is customary in the
types of transactions involved.
In connection with the sale of our common stock or interests therein,
the selling stockholders may enter into hedging transactions with broker-dealers
or other financial institutions, which may in turn engage in short sales of the
common stock in the course of hedging the positions they assume. The selling
stockholders may, after the date of this prospectus, also sell shares of our
common stock short and deliver these securities to close out their short
positions, or loan or pledge the common stock to broker-dealers that in turn may
sell these securities. The selling stockholders may also enter into option or
other transactions with broker-dealers or other financial institutions or the
creation of one or more derivative securities which require the delivery to such
broker-dealer or other financial institution of shares offered by this
prospectus, which shares such broker-dealer or other financial institution may
resell pursuant to this prospectus (as supplemented or amended to reflect such
transaction).
The selling stockholders and any broker-dealers or agents that are
involved in selling the shares may be deemed to be "underwriters" within the
meaning of the Securities Act in connection with such sales. In such event, any
commissions received by such broker-dealers or agents and any profit on the
resale of the shares purchased by them may be deemed to be underwriting
commissions or discounts under the Securities Act. Each selling stockholders has
informed us that it does not have any agreement or understanding, directly or
indirectly, with any person to distribute our common stock.
The shares of common stock underlying the warrants issued to those
selling stockholders who, as indicated in the Selling Stockholder table above,
received such warrants as part of compensation pursuant to a placement agency
agreement between us and Joseph Stevens & Co. are restricted in accordance with
Rule 2710(g)(I) of the NASD Conduct Rules. Accordingly, those selling
stockholders shall not directly or indirectly, offer, sell, agree to offer or
sell, transfer, assign, pledge, hypothecate or subject to hedging, short sale,
derivative, put or call transaction such shares for a period of 180 days after
the date this registration statement is declared effective by the SEC
We are required to pay certain fees and expenses incurred by us
incident to the registration of the shares. We have agreed to indemnify the
selling stockholders against certain losses, claims, damages and liabilities,
including liabilities under the Securities Act.
Because selling stockholders may be deemed to be "underwriters" within
the meaning of the Securities Act, they will be subject to the prospectus
delivery requirements of the Securities Act. In addition, any securities covered
by this prospectus which qualify for sale pursuant to Rule 144 under the
Securities Act may be sold under Rule 144 rather than under this prospectus.
Each selling stockholder has advised us that they have not entered into any
agreements, understandings or arrangements with any underwriter or broker-dealer
regarding the sale of the resale shares. There is no underwriter or coordinating
broker acting in connection with the proposed sale of the resale shares by the
selling stockholders.
We agreed to keep this prospectus effective until the earlier of (i)
the date on which the shares may be resold by the selling stockholders without
registration and without regard to any volume limitations by reason of Rule
144(k) under the Securities Act or any other rule of similar effect or (ii) all
of the shares have been sold pursuant to the prospectus or Rule 144 under the
Securities Act or any other rule of similar effect. The resale shares will be
sold only through registered or licensed brokers or dealers if required under
applicable state securities laws. In addition, in certain states, the resale
shares may not be sold unless they have been registered or qualified for sale in
99
the applicable state or an exemption from the registration or qualification
requirement is available and is complied with.
Under applicable rules and regulations under the Securities Exchange
Act of 1934, any person engaged in the distribution of the resale shares may not
simultaneously engage in market making activities with respect to our common
stock for a period of two business days prior to the commencement of the
distribution. In addition, the selling stockholders will be subject to
applicable provisions of the Exchange Act and the rules and regulations
thereunder, including Regulation M, which may limit the timing of purchases and
sales of shares of our common stock by the selling stockholders or any other
person. We will make copies of this prospectus available to the selling
stockholders and have informed them of the need to deliver a copy of this
prospectus to each purchaser at or prior to the time of the sale.
DISCLOSURE OF COMMISSION POSITION OF
INDEMNIFICATION FOR SECURITIES ACT LIABILITIES
Under Section 145 of the General Corporation Law of the State of
Delaware, we can indemnify our directors and officers against liabilities they
may incur in such capacities, including liabilities under the Securities Act of
1933, as amended (the "Securities Act"). Our certificate of incorporation
provides that, pursuant to Delaware law, our directors shall not be liable for
monetary damages for breach of the directors' fiduciary duty of care to us and
our stockholders. This provision in the certificate of incorporation does not
eliminate the duty of care, and in appropriate circumstances equitable remedies
such as injunctive or other forms of nonmonetary relief will remain available
under Delaware law. In addition, each director will continue to be subject to
liability for breach of the director's duty of loyalty to us or our
stockholders, for acts or omissions not in good faith or involving intentional
misconduct or knowing violations of the law, for actions leading to improper
personal benefit to the director, and for payment of dividends or approval of
stock repurchases or redemptions that are unlawful under Delaware law. The
provision also does not affect a director's responsibilities under any other
law, such as the federal securities laws or state or federal environmental laws.
Our bylaws provide for the indemnification of our directors to the
fullest extent permitted by the Delaware General Corporation Law. Our bylaws
further provide that our Board of Directors has sole discretion to indemnify our
officers and other employees. We may limit the extent of such indemnification by
individual contracts with our directors and executive officers, but have not
done so. We are required to advance, prior to the final disposition of any
proceeding, promptly on request, all expenses incurred by any director or
executive officer in connection with that proceeding on receipt of an
undertaking by or on behalf of that director or executive officer to repay those
amounts if it should be determined ultimately that he or she is not entitled to
be indemnified under our bylaws or otherwise. We are not, however, required to
advance any expenses in connection with any proceeding if a determination is
reasonably and promptly made by our Board of Directors by a majority vote of a
quorum of disinterested Board members that (a) the party seeking an advance
acted in bad faith or deliberately breached his or her duty to us or our
stockholders and (b) as a result of such actions by the party seeking an
advance, it is more likely than not that it will ultimately be determined that
such party is not entitled to indemnification pursuant to the applicable
sections of our bylaws.
We have been advised that in the opinion of the Securities and Exchange
Commission, insofar as indemnification for liabilities arising under the
Securities Act of 1933 (the "Securities Act") may be permitted to our directors,
officers and controlling persons pursuant to the foregoing provisions, or
otherwise, such indemnification is against public policy as expressed in the
Securities Act and is therefore unenforceable. In the event a claim for
indemnification against such liabilities (other than our payment of expenses
incurred or paid by our director, officer or controlling person in the
successful defense of any action, suit or proceeding) is asserted by such
director, officer or controlling person in connection with the securities being
registered, we will, unless in the opinion of our counsel the matter has been
settled by controlling precedent, submit to a court of appropriate jurisdiction
the question of whether such indemnification by us is against public policy as
expressed in the Securities Act and will be governed by the final adjudication
of such issue.
LEGAL MATTERS
The validity of the common stock offered by this prospectus will be
passed upon for us by Kirkpatrick & Lockhart Nicholson Graham LLP, Los Angeles,
California.
100
EXPERTS
The financial statements appearing in this Prospectus and Registration
Statement have been audited by Russell Bedford Stefanou Mirchandani LLP,
independent accountants; to the extent and for the periods indicated in their
report appearing elsewhere herein, and are included in reliance upon such report
and upon the authority of such firms as experts in accounting and auditing.
ADDITIONAL INFORMATION
We filed with the Securities and Exchange Commission a registration
statement on Form SB-2 under the Securities Act of 1933 for the shares of common
stock in this offering. This prospectus does not contain all of the information
in the registration statement and the exhibits and schedule that were filed with
the registration statement. For further information with respect to us and our
common stock, we refer you to the registration statement and the exhibits and
schedule that were filed with the registration statement. Statements contained
in this prospectus about the contents of any contract or any other document that
is filed as an exhibit to the registration statement are not necessarily
complete, and we refer you to the full text of the contract or other document
filed as an exhibit to the registration statement. A copy of the registration
statement and the exhibits and schedules that were filed with the registration
statement may be inspected without charge at the Public Reference Room
maintained by the Securities and Exchange Commission at 100 F Street, N.E.,
Washington, D.C. 20549, and copies of all or any part of the registration
statement may be obtained from the Securities and Exchange Commission upon
payment of the prescribed fee. Information regarding the operation of the Public
Reference Room may be obtained by calling the Securities and Exchange Commission
at 1-800-SEC-0330. The Securities and Exchange Commission maintains a web site
that contains reports, proxy and information statements, and other information
regarding registrants that file electronically with the SEC. The address of the
site is www.sec.gov.
We are subject to the information and periodic reporting requirements
of the Securities Exchange Act of 1934, and in accordance with the Securities
Exchange Act of 1934, we file annual, quarterly and special reports, and other
information with the Securities and Exchange Commission. These periodic reports
and other information are available for inspection and copying at the regional
offices, public reference facilities and website of the Securities and Exchange
Commission referred to above.
101
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
FINANCIAL STATEMENTS AND SCHEDULES
DECEMBER 31, 2005 AND 2004
IR BIOSCIENCES HOLDINGS, INC.
F-1
IR BioSciences Holdings, Inc.
Index to Financial Statements
Page No.
--------
Report of Independent Registered Certified Public Accounting Firm............F-3
Consolidated Balance Sheet at December 31, 2005..............................F-4
Consolidated Statements of Losses for the two years
ended December 31, 2005 and 2004 and the period October
30, 2002 (Date of Inception) through December 31, 2005.......................F-5
Consolidated Statements of Stockholders' Equity (Deficit)
for the period October 30, 2002 (Date of Inception)
through December 31, 2005.............................................F-6 to F-9
Consolidated Statements of Cash Flows for the two years
ended December 31, 2005 and 2004 and the period October
30, 2002 (Date of Inception) through December 31, 2005..............F-10 to F-11
Notes to Consolidated Financial Statements..........................F-12 to F-27
F-2
RUSSELL BEDFORD STEFANOU MIRCHANDANI LLP
CERTIFIED PUBLIC ACCOUNTANTS
REPORT OF INDEPENDENT REGISTERED CERTIFIED PUBLIC ACCOUNTING FIRM
Board of Directors
IR BioSciences Holdings, Inc.
Scottsdale, Arizona
We have audited the accompanying consolidated balance sheets of IR BioSciences
Holdings, Inc. a development stage company as of December 31, 2005 and the
related consolidated statements of losses, deficiency in stockholders' equity,
and cash flows for the years ended December 31, 2005 and 2004 and the period
October 22, 2002 (date of inception) through December 31, 2005. These financial
statements are the responsibility of the company's management. Our
responsibility is to express an opinion on the financial statements based upon
our audits.
We have conducted our audits in accordance with auditing standards of the Public
Company Accounting Oversight Board (PCAOB) (United States of America). Those
standards require that we plan and perform the audit to obtain reasonable
assurance about whether the financial statements are free of material
misstatement. An audit includes examining on a test basis, evidence supporting
the amounts and disclosures in the financial statements. An audit also includes
assessing the accounting principles used and significant estimates made by
management, as well as evaluating the overall financial statement presentation.
We believe our audits provide a reasonable basis for our opinion.
In our opinion, the financial statements referred to above present fairly, in
all material respects, the financial position of IR BioSciences Holdings, Inc. a
development stage company at December 31, 2005 and the results of its operations
and its cash flows for the years ended December 31, 2005 and 2004, and the
period October 22, 2002 (date of inception) through December 31, 2005 in
conformity with accounting principles generally accepted in the United States of
America.
The accompanying financial statements have been prepared assuming the Company
will continue as a going concern. As discussed in the Note A to the accompanying
financial statements, the Company is in the development stage and has not
established a source of revenues. This raises substantial doubt about the
company's ability to continue as a going concern. The financial statements do
not include any adjustments that might result from the outcome of this
uncertainty.
/s/ RUSSELL BEDFORD STEFANOU MIRCHANDANI LLP
--------------------------------------------
Russell Bedford Stefanou Mirchandani LLP
New York, New York
March 24, 2006*
*Adjusted for typographical error
F-3
IR BioSciences Holdings, Inc. and Subsidiary
(A Development Stage Company)
Consolidated Balance Sheet
December 31,
2005
-------------
Assets
Current assets
Cash and cash equivalents $ 265,860
Prepaid services and other current assets 24,507
-------------
Total current assets 290,367
Deposits and other assets 2,260
Furniture and equipment, net of accumulated
depreciation of $3,862 4,226
-------------
Total assets $ 296,853
=============
Liabilities and Stockholders' Deficit
Current liabilities
Accounts payable and accrued liabilities 502,128
Warrant portion of penalty for late registration
of shares - with registration rights (See note E) 384,145
Common stock portion of penalty for late
Registration of shares (See note E) 1,677,538
--------------
Total current liabilities 2,563,811
Commitments and Contingencies --
Stockholders' deficit
Preferred stock, 0.001 par value:
10,000,000 shares authorized, no shares
issued and outstanding --
Common stock, $0.001 par value; 100,000,000
shares authorized; 69,436,319 shares issued
and outstanding at December 31, 2005 69,435
Additional paid-in capital 9,465,501
Deferred compensation (2,760)
Deficit Accumulated during the Development Stage (11,799,134)
-------------
Total stockholder's deficit (2,266,958)
-------------
Total liabilities and stockholders' deficit $ 296,853
=============
The accompanying notes are an integral part of these
consolidated financial statements.
F-4
IR BioSciences Holdings, Inc. and Subsidiary
(A Development Stage Company)
Consolidated Statements of Losses
For the Period
For the For the October 30,
Year Ended Year Ended 2002 to
December 31, December 31, December 31,
2005 2004 2005
------------ ------------ ------------
Operating expenses:
Selling, general and administrative expenses $ 2,534,417 $ 4,498,390 $ 8,124,301
Merger fees and costs -- -- 350,000
Financing cost -- -- 90,000
Impairment of intangible asset 6,393 -- 6,393
------------ ------------ ------------
Total operating expenses 2,540,810 4,498,390 8,570,694
------------ ------------ ------------
Operating loss (2,540,810) (4,498,390) (8,570,694)
Other expense:
Cost of penalty for late registration of shares 2,630,761 -- 2,630,761
Gain from marking to market - warrant portion
of penalty for late registration of shares (254,693) -- (254,693)
Gain from marking to market - stock portion
of penalty for late registration of shares (314,385) -- (314,385)
Interest (income) expense, net (11,386) 807,017 1,166,757
------------ ------------ ------------
Total other (income) expense (2,050,297) 807,017 3,228,440
------------ ------------ ------------
Loss before income taxes (4,591,107) (5,305,407) (11,799,134)
Provision for income taxes -- -- --
------------ ------------ ------------
Net loss $ (4,591,107) $ (5,305,407) $(11,799,134)
============ ============ ============
Net loss per share - basic and diluted $ (0.07) $ (0.16) $ (0.30)
============ ============ ============
Weighted average shares outstanding -
basic and diluted 67,691,598 33,510,168 38,934,503
============ ============ ============
The accompanying notes are an integral part of these
consolidated financial statements.
F-5
IR Biosciences Holding, Inc. and Subsidiary
(A Development Stage Company)
Consolidated Statement of Stockholders' Equity (Deficit)
From date of inception (October 30, 2002) to December 31, 2005
Common Stock Additional
------------------------ Paid-In Deferred Accumulated
Shares Amount Capital Compensation Deficit Total
----------- ----------- ----------- ------------ ----------- -----------
Balance at October 30, 2002 (date of inception) -- $ -- $ -- -- $ -- $ --
Shares of common stock issued at $0.0006
per share to founders for license of
proprietary right in December 2002 16,612,276 16,612 (7,362) -- -- 9,250
Shares of common stock issued at $0.0006 per
share to founders for services rendered in
December 2002 1,405,310 1,405 (623) -- -- 782
Shares of common stock issued at $0.1671 per
share to consultants for services rendered
in December 2002 53,878 54 8,946 (9,000) -- --
Sale of common stock for cash at $0.1671 per
share in December 2002 185,578 186 30,815 -- -- 31,001
Net loss for the period from inception
(October 30, 2002) to December 31, 2002 -- -- -- -- (45,918) (45,918)
----------- ----------- ----------- ------------ ----------- -----------
Balance at December 31, 2002 (reflective of
stock splits) 18,257,042 18,257 31,776 (9,000) (45,918) (4,885)
Shares granted to consultants at $0.1392 per
share for services rendered in January 2003 98,776 99 13,651 -- -- 13,750
Sale of shares of common stock for cash at
$0.1517 per share in January 2003 329,552 330 49,670 -- -- 50,000
Shares granted to consultants at $0.1392 per
share for services rendered in March 2003 154,450 154 21,346 -- -- 21,500
Conversion of notes payable to common stock
at $0.1392 per share in April 2003 1,436,736 1,437 198,563 -- -- 200,000
Shares granted to consultants at $0.1413 per
share for services rendered in April 2003 14,368 14 2,016 -- -- 2,030
Sale of shares of common stock for cash at
$0.2784 per share in May 2003 17,960 18 4,982 -- -- 5,000
Sales of shares of common stock for cash at
$0.2784 per share in June 2003 35,918 36 9,964 -- -- 10,000
Conversion of notes payable to common stock
at $0.1392 per share in June 2003 718,368 718 99,282 -- -- 100,000
Beneficial conversion feature associated with
notes issued in June 2003 -- -- 60,560 -- -- 60,560
Amortization of deferred compensation -- -- -- 9,000 -- 9,000
Costs of GPN Merger in July 2003 2,368,130 2,368 (123,168) -- -- (120,799)
Value of warrants issued with extended notes
payable in October 2003 -- -- 189,937 -- -- 189,937
Value of Company warrants issued in
conjunction with fourth quarter notes
payable issued October through
December 2003 -- -- 207,457 -- -- 207,457
Value of warrants contributed by founders
in conjunction with fourth quarter notes
payable issued October through
December 2003 -- -- 183,543 -- -- 183,543
Value of warrants issued for services in
October through December 2003 -- -- 85,861 -- -- 85,861
Net loss for the year ended
December 31, 2003 -- -- -- -- (1,856,702) (1,856,702)
----------- ----------- ----------- ------------ ----------- -----------
Balance at December 31, 2003 23,431,300 23,431 1,035,441 -- (1,902,620) (843,748)
The accompanying notes are an integral part of these
consolidated financial statements.
F-6
IR Biosciences Holding, Inc. and Subsidiary
(A Development Stage Company)
Consolidated Statement of Stockholders' Equity (Deficit)
From Date of Inception (October 30, 2002) to December 31, 2005
Common Stock Additional
------------------------ Paid-In Deferred Accumulated
Shares Amount Capital Compensation Deficit Total
----------- ----------- ----------- ------------ ----------- -----------
Shares granted at $1.00 per share pursuant to
the Senior Note Agreement in January 2004 600,000 600 599,400 (600,000) -- --
Shares issued at $1.00 per share to a
consultant for services rendered in
January 2004 800,000 800 799,200 (800,000) -- --
Shares issued to a consultant at $0.62
per share for services rendered in
February 2004 40,000 40 24,760 (24,800) -- --
Shares issued to a consultant at $0.40 per
share for services rendered in March 2004 1,051,600 1,051 419,589 (420,640) -- --
Shares issued to a consultant at $0.50 per
share for services rendered in March 2004 500,000 500 249,500 (250,000) -- --
Shares sold for cash at $0.15 per share
in March, 2004 8,000 8 1,192 -- -- 1,200
Shares issued at $0.50 per share to
consultants for services rendered in
March 2004 20,000 20 9,980 -- -- 10,000
Shares issued to a consultant at $0.40 per
share for services rendered in March 2004 2,000 2 798 -- -- 800
Shares issued to consultants at $0.32 per
share for services rendered in March 2004 91,600 92 29,220 -- -- 29,312
Shares to be issued to consultant at $0.41 per
share in April 2004 for services to be
rendered through March 2005 -- -- -- (82,000) -- (82,000)
Shares granted pursuant to the New Senior Note
Agreement in April 2004 600,000 600 149,400 (150,000) -- --
Shares issued to officer at $0.32 per share for
services rendered in April 2004 200,000 200 63,800 -- -- 64,000
Conversion of note payable to common stock at
$0.10 per share in May 2004 350,000 350 34,650 -- -- 35,000
Beneficial Conversion Feature associated with
note payable in May 2004 -- -- 35,000 -- -- 35,000
Issuance of warrants to officers and founder
for services rendered in May 2004 -- -- 269,208 -- -- 269,208
Shares to a consultant at $0.20 per share as a
due diligence fee in May 2004 125,000 125 24,875 -- -- 25,000
Shares issued to a consultant at $1.00 per
share for services to be rendered over
twelve months beginning May 2004 500,000 500 499,500 (500,000) -- --
Beneficial Conversion Feature associated with
notes payable issued in June 2004 -- -- 3,000 -- -- 3,000
Issuance of warrants to note holders in April,
May, and June 2004 -- -- 17,915 -- -- 17,915
Issuance of warrants to employees and
consultants for services rendered in
April through June 2004 -- -- 8,318 -- -- 8,318
Shares issued in July to a consultant at
$0.10 for services to be rendered through
July 2005 250,000 250 24,750 (25,000) -- --
Shares issued to a consultant in July and
September at $0.41 per share for services
to be rendered through April 2005 200,000 200 81,800 -- -- 82,000
Shares issued to a consultant in September at
$0.12 to $0.22 for services rendered
through September 2004 127,276 127 16,782 -- -- 16,909
F-7
IR Biosciences Holding, Inc. and Subsidiary
(A Development Stage Company)
Consolidated Statement of Stockholders' Equity (Deficit)
From Date of Inception (October 30, 2002) to December 31, 2005
Common Stock Additional
------------------------ Paid-In Deferred Accumulated
Shares Amount Capital Compensation Deficit Total
----------- ----------- ----------- ------------ ----------- -----------
Shares issued in July to September 2004 as
interest on note payable 300,000 300 35,700 -- -- 36,000
Issuance of warrants with notes payable in
July and August 2004 -- -- 72,252 -- -- 72,252
Accrued deferred compensation in August 2004
to a consultant for 100,000 shares at $0.10
per share, committed but unissued -- -- -- (10,000) -- (10,000)
Shares issued in August 2004 at $0.14 to a
consultant for services to be performed
through October 2004 100,000 100 13,900 (14,000) -- --
Shares issued in August 2004 at $0.125 per
share for conversion of $30,000 demand loan 240,000 240 29,760 -- -- 30,000
Shares issued in August 2004 at $0.16 per
share to a consultant for services provided 125,000 125 19,875 -- -- 20,000
Shares issued in October 2004 to employees at
$0.16 to $0.25 per share 48,804 49 8,335 -- -- 8,384
Commitment to issue 100,000 shares of stock to
a consultant at $0.23 per share for services
to be provided through September 2005 -- -- -- (23,000) -- (23,000)
Sale of stock for cash in October at $0.125 per
share, net of costs of $298,155 18,160,000 18,160 1,345,763 -- -- 1,363,923
Value of warrants issued with sale of common
stock in October, net of costs -- -- 607,922 -- -- 607,922
Issuance of warrant to officer in October, 2004 -- -- 112,697 -- -- 112,697
Issuance of stock to investment bankers in
October 2004 for commissions earned 4,900,000 4,900 (4,900) -- -- --
Conversion of accounts payable to stock in
October at $0.125 per share 1,257,746 1,258 107,382 -- -- 108,640
Value of warrants issued with accounts
payable conversions -- -- 48,579 -- -- 48,579
Conversion of demand loan to stock in October
at $0.11 per share 93,300 93 10,170 -- -- 10,263
Forgiveness of notes payable in October 2004 -- -- 36,785 -- -- 36,785
Issuance of stock to officer and director at
$0.125 per share in October for conversion
of liability 1,440,000 1,440 122,493 -- -- 123,933
Value of warrants issued with officer and
director conversion of liabilities -- -- 56,067 -- -- 56,047
Conversion of debt and accrued interest to
common stock at $0.075 to $0.125 per share 6,703,151 6,703 417,514 -- -- 424,217
Value of warrants issued with conversion
of debt -- -- 191,111 -- -- 191,111
Conversion of note payable in October into
common stock at $0.075 per share 67,613 68 4,932 -- -- 5,000
Issuance of warrants to note holders in
October 2004 -- -- 112,562 -- -- 112,562
Value of shares issued to CFO as compensation 100,000 100 34,900 -- -- 35,000
Value of warrants issued to members of
advisory committees in November
and December -- -- 16,348 -- -- 16,348
Beneficial conversion feature associated with
notes payable -- -- 124,709 -- -- 124,709
Shares issued in error to be cancelled (9,002) (9) 9 -- -- --
Amortization of deferred compensation through
December 31, 2004 -- -- -- 2,729,454 -- 2,729,454
Loss for the year ended
December 31, 2004 -- -- -- -- (5,305,407) (5,305,407)
----------- ----------- ----------- ------------ ----------- -----------
Balance at December 31, 2004 62,423,388 62,423 7,922,943 (169,986) (7,208,027) 607,353
=========== =========== =========== ============ =========== ===========
The accompanying notes are an integral part of these
consolidated financial statements.
F-8
IR Biosciences Holding, Inc. and Subsidiary
(A Development Stage Company)
Consolidated Statement of Stockholders' Equity (Deficit)
From date of inception (October 30, 2002) to December 31, 2005
Common Stock Additional
------------------------ Paid-In Deferred Accumulated
Shares Amount Capital Compensation Deficit Total
----------- ----------- ----------- ------------ ----------- -----------
Sale of shares of common stock for cash at
$0.20 per share in Mar 2005 for warrant
exercise, net of costs 6,600,778 6,600 1,184,256 -- -- 1,190,856
Value of warrants issued to members
of advisory committees in March 2005 -- -- 137,049 -- -- 137,049
Deferred compensation in Feb 2005 to a
consultant for 50,000 shares of stock at
$0.65 per share. -- -- -- (32,500) -- (32,500)
Warrants exercised at $0.05 per share
in June 2003 80,000 80 3,920 -- -- 4,000
Value of warrants issued to members of
advisory committee in June 2005 -- -- 70,781 -- -- 70,781
Value of warrants issued to investors and
service providers in June 2005 -- -- 32,991 -- -- 32,991
Issuance of 232,153 shares of common
stock in July 2005 for conversion of
notes payable 232,153 232 64,771 -- -- 65,003
Issuance of 100,000 shares of common stock
in August 2005 to a consultant for
services provided 100,000 100 9,900 -- -- 10,000
Value of warrants issued to advisory
committee in September 2005 for services -- -- 20,491 -- -- 20,491
Amortization of deferred comp for the
twelve months ended December, 2005 -- -- -- 199,726 -- 199,726
Value of warrants issued in October
and December 2005 to investors and
service providers -- -- 18,399 -- -- 18,399
Loss for the year ended
December 31, 2005 -- -- -- -- (4,591,107) (4,591,107)
------------ ----------- ----------- ------------ ----------- -----------
69,436,319 69,435 9,465,501 (2,760) (11,799,134) (2,266,958)
The accompanying notes are an integral part of these
consolidated financial statements.
F-9
IR BioSciences Holdings, Inc. and Subsidiary
(A Development Stage Company)
Consolidated Statements of Cash Flows
For the Period
For the Year Ended For the Year Ended October 30, 2002 to
December 31, 2005 December 31, 2004 December 31, 2005
----------------- ----------------- ------------------
Cash flows from operating activities:
Net loss $ (4,591,107) $ (5,305,407) $ (11,799,134)
Adjustments to reconcile net loss to net
cash used in operating activities:
Non-cash compensation 520,853 3,284,577 3,920,853
Cost of penalty for late registration of shares -
stock portion 1,991,923 -- 1,991,923
Cost of penalty for late registration of shares -
warrant portion 638,838 -- 638,838
(Gain) loss from marking to market - stock portion
of penalty for late registration of shares (314,385) -- (314,385)
(Gain) loss from marking to market - warrant portion
of penalty for late registration of shares (254,693) -- (254,693)
Impairment of intangible asset 6,393 -- 6,393
Interest expense 4,007 83,776 156,407
Amortization of discount on notes payable -- 704,633 1,006,935
Depreciation and amortization 3,201 13,255 29,218
Changes in operating assets and liabilities:
Prepaid services and other assets 9,946 29,130 3,234
Accounts payable and accrued expenses 100,911 148,854 655,953
----------------- ----------------- ------------------
Net cash used in operating activities (1,884,113) (1,041,182) (3,958,458)
Cash flows from investing activities:
Acquisition of property and equipment -- (4,783) (8,087)
----------------- ----------------- ------------------
Net cash used in investing activities -- (4,783) (8,087)
Cash flows from financing activities:
Proceeds from notes payable -- 32,500 1,233,500
Principal payments on notes payable and demand loans (14,997) -- (264,997)
Shares of stock sold for cash 1,190,856 1,973,045 3,259,902
Proceeds from exercise of warrant 4,000 -- 4,000
Officer repayment of amounts paid on his behalf -- -- 19,880
Cash paid on behalf of officer -- -- (19,880)
----------------- ----------------- ------------------
Net cash provided by financing activities 1,179,859 2,005,545 4,232,405
Net increase (decrease) in cash and cash equivalents (704,254) 959,580 265,860
Cash and cash equivalents at beginning of period 970,114 10,534 --
----------------- ----------------- ------------------
Cash and cash equivalents at end of period $ 265,860 $ 970,114 $ 265,860
================= ================= ==================
The accompanying notes are an integral part of these
consolidated financial statements.
F-10
IR BioSciences Holdings, Inc. and Subsidiary
(A Development Stage Company)
Consolidated Statements of Cash Flows (continued)
For the Period
For the Year Ended For the Year Ended October 30, 2002 to
December 31, 2005 December 31, 2004 December 31, 2005
----------------- ----------------- ------------------
Supplemental disclosures of cash flow information:
Cash paid during the period for:
Interest $ 1,706 $ 54 $ 43,553
Taxes $ - $ - $ -
Acquisition and capital restructure:
Assets acquired - - -
Liabilities assumed - - (120,799)
Common stock retained - - (2,369)
Adjustment to additional paid-in capital - - 123,168
Organization costs - - 350,000
----------------- ----------------- ------------------
Total consideration paid $ - $ - $ 350,000
================= ================= ==================
Common stock issued in exchange for proprietary rights $ - $ - $ 9,250
================= ================= ==================
Common stock issued in exchange for services $ 10,000 $ 2,878,006 $ 2,925,286
================= ================= ==================
Common stock issued in exchange for previously incurred
debt and accrued interest $ 65,003 $ 695,591 $ 1,060,594
================= ================= ==================
Common stock issued as interest $ - $ 36,000 $ 36,000
================= ================= ==================
Amortization of beneficial conversion feature $ - $ 162,709 $ 223,269
================= ================= ==================
Stock options and warrants issued in exchange for services
rendered $ 279,949 $ 406,571 $ 772,381
================= ================= ==================
Debt and accrued interest forgiveness from note holders $ - $ 36,785 $ 36,785
================= ================= ==================
Common stock issued in satisfaction of amounts due to an
Officer and a Director $ - $ 180,000 $ 180,000
================= ================= ==================
Common stock issued in satisfaction of accounts payable $ - $ 157,219 $ 157,219
================= ================= ==================
Amortization of deferred compensation $ 199,726 $ - $ 199,726
================= ================= ==================
Fair value of common stock and warrants in connection
with the late filing of registration statement $ 2,630,761 $ - $ 2,630,761
================= ================= ==================
Gain from marking to market - stock portion of
penalty for late registration of shares $ 314,385 $ - $ 314,385
================= ================= ==================
Gain from marking to market - warrant portion of
penalty for late registration of shares $ 254,693 $ - $ 254,693
================= ================= ==================
Impairment of intangible asset $ 6,393 $ - $ 6,393
================= ================= ==================
The accompanying notes are an integral part of these
consolidated financial statements.
F-11
IR BIOSCIENCES HOLDINGS, INC. AND SUBSIDIARY
(A DEVELOPMENT STAGE COMPANY)
NOTES TO FINANCIAL STATEMENTS
FOR THE YEARS ENDED DECEMBER 31, 2005 AND 2004
AND FOR THE PERIOD FROM OCTOBER 30, 2002
(INCEPTION) TO DECEMBER 31, 2005
NOTE A - SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES
A summary of the significant accounting policies applied in the preparation of
the accompanying consolidated financial statements follows.
Nature of Business
------------------
IR BioSciences Holdings, Inc. (the "Company," "we," or "us") formerly GPN
Network, Inc. ("GPN") is currently a development stage company under the
provisions of Statement of Financial Accounting Standards ("SFAS") No. 7. The
Company, which was incorporated under the laws of the State of Delaware on
October 30, 2002, is a biopharmaceutical company. Through our wholly owned
subsidiary, ImmuneRegen BioSciences, Inc., we are engaged in the research and
development of potential therapeutics for a number of applications. All
therapeutics in development are based on Sar9, Met (O2)11-Substance P, an analog
of the naturally occurring human neuropeptide Substance P. This neuropeptide can
be found throughout the body, including in the airways of humans and many other
species. We use the generic name Homspera to refer to the synthetic Sar9, Met
(O2)11-Substance P peptide. All of our research and development efforts are
early, pre-clinical stage and Homspera has only undergone exploratory studies to
evaluate its biological activity in small animals.
The consolidated financial statements include the accounts of the Company and
its wholly owned subsidiary, ImmuneRegen BioSciences, Inc. Significant
intercompany transactions have been eliminated in consolidation.
Going Concern
-------------
The accompanying consolidated financial statements have been prepared on a going
concern basis, which contemplates the realization of assets and the satisfaction
of liabilities in the normal course of business. As shown in the accompanying
financial statements during the years ended December 31, 2005 and 2004, the
Company incurred losses from operations of $ 4,591,107 and $ 5,305,407,
respectively. In addition, its current liabilities exceed its current assets by
$2,273,444 as of December 31, 2005. These factors among others may indicate that
the Company will be unable to continue as a going concern for a reasonable
period of time.
In order to address our capital requirements, we intend to seek to raise
additional cash for working capital purposes through the public or private sales
of debt or equity securities, the procurement of advances on contracts or
licenses, funding from joint-venture or strategic partners, debt financing or
short-term loans, or a combination of the foregoing. We may also seek to satisfy
indebtedness without any cash outlay through the private issuance of debt or
equity securities. There can be no assurance the Company will be successful in
its effort to secure additional equity financing.
If operations and cash flows continue to improve through these efforts,
management believes that the Company can continue to operate. However, no
assurance can be given that management's actions will result in profitable
operations or the resolution of its liquidity problems.
The accompanying consolidated financial statements do not include any
adjustments that might result should the Company be unable to continue as a
going concern.
Use of Estimates
----------------
The preparation of financial statements in conformity with accounting principles
generally accepted in the United States of America requires management to make
estimates and assumptions that affect the reported amounts of assets and
liabilities and disclosure of contingent assets and liabilities at the date of
the financial statements, and the reported amounts of revenues and expenses
during the reported periods. Actual results could materially differ from those
estimates.
F-12
Cash and Cash Equivalents
--------------------------
For purposes of the statement of cash flows, cash equivalents include all highly
liquid debt instruments with original maturities of three months or less which
are not securing any corporate obligations.
Long-lived Assets
-----------------
The Company has adopted Statement of Financial Accounting Standards No. 144
(SFAS 144). The Statement requires that long-lived assets and certain
identifiable intangibles held and used by the Company be reviewed for impairment
whenever events or changes in circumstances indicate that the carrying amount of
an asset may not be recoverable. Events relating to recoverability may include
significant unfavorable changes in business conditions, recurring losses, or a
forecasted inability to achieve break-even operating results over an extended
period. The Company evaluates the recoverability of long-lived assets based upon
forecasted undercounted cash flows. Should an impairment in value be indicated,
the carrying value of intangible assets will be adjusted, based on estimates of
future discounted cash flows resulting from the use and ultimate disposition of
the asset. SFAS No. 144 also requires assets to be disposed of be reported at
the lower of the carrying amount or the fair value less costs to sell.
Income Taxes
------------
The Company has implemented the provisions on Statement of Financial Accounting
Standards No. 109, "Accounting for Income Taxes" (SFAS 109). SFAS 109 requires
that income tax accounts be computed using the liability method. Deferred taxes
are determined based upon the estimated future tax effects of differences
between the financial reporting and tax reporting bases of assets and
liabilities given the provisions of currently enacted tax laws.
Net Loss Per Common Share
-------------------------
The Company computes earnings per share under Financial Accounting Standard No.
128, "Earnings Per Share" (SFAS 128). Net loss per common share is computed by
dividing net loss by the weighted average number of shares of common stock and
dilutive common stock equivalents outstanding during the year. Dilutive common
stock equivalents consist of shares issuable upon conversion of convertible
notes and the exercise of the Company's stock options and warrants (calculated
using the treasury stock method). During 2005, 2004 and 2003, common stock
equivalents were not considered in the calculation of the weighted average
number of common shares outstanding because they would be anti-dilutive, thereby
decreasing the net loss per common share.
Liquidity
---------
As shown in the accompanying financial statements, the Company has incurred a
net loss of $11,799,134 from its inception through December 31, 2005. The
Company incurred a net loss of $ 4,591,107 and $ 5,305,407 from operations
during the years ended December 31, 2005 and 2004, respectively. The Company's
has a net working capital deficit of $2,273,444 with cash and cash equivalents
of $265,860 at December 31, 2005.
Research and Development
------------------------
The Company accounts for research and development costs in accordance with the
Financial Accounting Standards Board's Statement of Financial Accounting
Standards No. 2 ("SFAS 2"), "Accounting for Research and Development Costs.
Under SFAS 2, all research and development costs must be charged to expense as
incurred. Accordingly, internal research and development costs are expensed as
incurred. Third-party research and developments costs are expensed when the
contracted work has been performed or as milestone results have been achieved.
Company-sponsored research and development costs related to both present and
future products are expensed in the period incurred. Total expenditures on
research and product development for the years 2005, 2004, and the period from
October 30, 2002 (date of inception) to December 31, 2005 were $113,731,
$150,091 and $306,794, respectively.
F-13
Concentrations of Credit Risk
-----------------------------
Financial instruments and related items, which potentially subject the Company
to concentrations of credit risk, consist primarily of cash, cash equivalents
and related party receivables. The Company places its cash and temporary cash
investments with credit quality institutions. At times, such investments may be
in excess of the FDIC insurance limit. The Company periodically reviews its
trade receivables in determining its allowance for doubtful accounts. There is
no allowance for doubtful accounts established as of December 31, 2005.
Comprehensive Income
---------------------
Statement of Financial Accounting Standards No. 130 ("SFAS 130"), "Reporting
Comprehensive Income," establishes standards for reporting and displaying of
comprehensive income, its components and accumulated balances. Comprehensive
income is defined to include all changes in equity except those resulting from
investments by owners and distributions to owners. Among other disclosures, SFAS
130 requires that all items that are required to be recognized under current
accounting standards as components of comprehensive income be reported in a
financial statement that is displayed with the same prominence as other
financial statements. The Company does not have any items of comprehensive
income in any of the periods presented.
Stock Based Compensation
------------------------
In December 2002, the FASB issued SFAS No. 148, "Accounting for Stock-Based
Compensation-Transition and Disclosure-an amendment of SFAS 123." This statement
amends SFAS No. 123, "Accounting for Stock-Based Compensation," to provide
alternative methods of transition for a voluntary charge to the fair value based
method of accounting for stock-based employee compensation. In addition, this
statement amends the disclosure requirements of SFAS No. 123 to require
prominent disclosures in both annual and interim financial statements about the
method of accounting for stock-based employee compensation and the effect of the
method used on reported results. The Company has chosen to continue to account
for stock-based compensation using the intrinsic value method prescribed in APB
Opinion No. 25 and related interpretations. Accordingly, compensation expense
for stock options is measured as the excess, if any, of the fair market value of
the Company's stock at the date of the grant over the exercise price of the
related option. The Company has adopted the annual disclosure provisions of SFAS
No. 148 in its financial reports for the year ended December 31, 2005 and 200
and for subsequent periods.
For purposes of pro forma disclosures, the estimated fair value of the options
is amortized over the options' vesting period. The Company's pro forma
information was as follows:
Twelve months ended
December 31,
2005 2004
----------- -----------
Net loss, as reported $(4,591,107) $(5,305,407)
Compensation recognized under
under APB 25 -- --
Compensation recognized under
SFAS 123 (83,150) --
----------- -----------
Pro forma net loss $(4,674,257) $(5,305,407)
=========== ===========
Pro forma loss per share $ (0.07) $ (0.16)
=========== ===========
Segment Information
-------------------
Statement of Financial Accounting Standards No. 131, "Disclosures about Segments
of an Enterprise and Related Information" ("SFAS 131") establishes standards for
reporting information regarding operating segments in annual financial
statements and requires selected information for those segments to be presented
in interim financial reports issued to stockholders. SFAS 131 also establishes
standards for related disclosures about products and services and geographic
F-14
areas. Operating segments are identified as components of an enterprise about
which separate discrete financial information is available for evaluation by the
chief operating decision maker, or decision-making group, in making decisions
how to allocate resources and assess performance. The information disclosed
herein materially represents all of the financial information related to the
Company's principal operating segment.
Fair Value of Financial Instruments
-----------------------------------
The Company measures its financial assets and liabilities in accordance with
accounting principles generally accepted in the United States of America. The
estimated fair values approximate their carrying value because of the short-term
maturity of these instruments or the stated interest rates are indicative of
market interest rates.
Property and Equipment
-----------------------
Property and equipment are valued at cost. Depreciation and amortization are
provided over the estimated useful lives up to seven years using the
straight-line method. The estimated service lives of property and equipment are
as follows:
Computer equipment 3 years
Furniture 7 years
Website Development Costs
-------------------------
The Company recognizes website development costs in accordance with Emerging
Issue Task Force ("EITF") No. 00-02, "Accounting for Website Development Costs."
As such, the Company expenses all costs incurred that relate to the planning and
post implementation phases of development of its website. Direct costs incurred
in the development phase are capitalized and recognized over the estimated
useful life of two years. The Company follows the policy of charging costs
associated with repair or maintenance for the website to expenses incurred.
Advertising
-----------
The Company follows the policy of charging the costs of advertising to expenses
incurred. The Company has not incurred any advertising costs during the years
ended December 31, 2005 or 2004.
Reclassifications
-----------------
Certain reclassifications have been made in prior year's financial statements to
conform to classifications used in the current year.
New Accounting Pronouncements
-----------------------------
In May 2005, the FASB issued FASB Statement No. 154, ("FAS 154"), "Accounting
Changes and Error Corrections." FAS 154 establishes retrospective application as
the required method for reporting a change in accounting principle in the
absence of explicit transition requirements specific to the newly adopted
accounting principle. FAS 154 also provides guidance for determining whether
retrospective application of a change in accounting principle is impracticable
and for reporting a change when retrospective application is impracticable. FAS
154 becomes effective for accounting changes and corrections of errors made in
fiscal years beginning after December 15, 2005. We do not expect the adoption of
FAS 154 to have a material impact on our financial position, cash flows or
results of operations.
In December 2004, the FASB issued FASB Statement No. 123(R), ("FAS 123(R)"),
"Share-Based Payment," which is a revision of FASB Statement No. 123 ("FAS
123"), "Accounting for Stock-Based Compensation." FAS 123(R) supersedes APB
Opinion No. 25, (APB 25), "Accounting for Stock Issued to Employees," and amends
FASB Statement No. 95, "Statement of Cash Flows." FAS 123(R) requires all
share-based payments to employees, including grants of employee stock options,
to be recognized in the financial statements based on their fair values at the
date of grant and to record that cost as compensation expense over the period
during which the employee is required to perform service in exchange for the
award (generally over the vesting period of the award). Excess tax benefits, as
F-15
defined by FAS 123(R), will be recognized as an addition to common stock. In
April 2005, the SEC adopted a new rule that amends the compliance dates for FAS
123(R). In accordance with the new rule, we are required to implement FAS 123(R)
at the beginning of our fiscal year that begins January 1, 2006. The
Commission's new rule does not change the accounting required by FAS 123(R); it
changes only the dates of compliance.
In November 2005, the FASB issued FASB Staff Position No. FAS 123(R)-3,
"Transition Election Related to Accounting for Tax Effects of Share-Based
Payment Awards." The alternative transition method includes simplified methods
to establish the beginning balance of the additional paid-in capital pool ("APIC
pool") related to the tax effects of employee share-based compensation, and to
determine the subsequent impact on the APIC pool and consolidated statements of
cash flows of the tax effects of employee share-based compensation awards that
are outstanding upon adoption of SFAS 123(R). An entity may make a one-time
election to adopt the transition method described in this guidance and may take
up to one year from the later of its initial adoption of SFAS 123(R) or the
effective date of this guidance, which was November 11, 2005. We are in the
process of determining whether to adopt the alternative transition method
provided in FAS 123(R)-3 for calculating the tax effects of share-based
compensation pursuant to SFAS 123(R).
Effective January 1, 2006, we will adopt FAS 123(R) using the modified
prospective transition method, which provides for certain changes to the method
for valuing share-based compensation. The valuation provisions of FAS 123(R)
apply to new awards and to awards that are outstanding at the effective date and
subsequently modified or cancelled. Estimated compensation expense for awards
outstanding at January 1, 2006 will be recognized over the remaining service
period using the compensation cost calculated for pro forma disclosure purposes
under FAS 123. In accordance with the modified prospective transition method,
our statements of operations for periods prior to January 1, 2006 will not be
restated to reflect the impact of FAS 123(R).
Our calculation of share-based compensation expense in future periods will be
calculated using the Black-Scholes option valuation model and will include the
portion of share-based payment awards that is ultimately expected to vest during
the period and therefore will be adjusted to reflect estimated forfeitures. SFAS
123(R) requires forfeitures to be estimated at the time of grant and revised, if
necessary, in subsequent periods if actual forfeitures differ from those
estimates. In our pro forma information required under SFAS 123 for the periods
prior to 2006, we accounted for forfeitures as they occurred. For share awards
granted after January 1, 2006, expenses will be amortized under the
straight-line attribution method. For share awards granted prior to 2006,
expenses are amortized under the straight-line single option method prescribed
by SFAS 123. We expect that our adoption of FAS 123(R) in 2006 will have a
material impact on our results of operations and net loss per share.
NOTE B - PROPERTY, PLANT AND EQUIPMENT
The Company's property and equipment at December 31, 2005 consists of the
following:
Office Equipment $6,665
Office Fixtures and Furniture 1,423
-------
8,088
Accumulated Depreciation (3,862)
-------
$4,226
=======
Depreciation expense included as a charge to income amounted to $2,274, $1,078,
and $3,862 for the years ended December 31, 2005 and 2004 and from inception to
December 31, 2005, respectively.
NOTE C - INTANGIBLE ASSETS
The Company has adopted SFAS No. 142, Goodwill and Other Intangible Assets,
whereby the Company periodically tests its intangible assets for impairment. On
an annual basis, and when there is reason to suspect that their values have been
diminished or impaired, these assets will be tested for impairment, and
write-downs to be included in results from operations may be necessary.
The Company has licensed from its founders certain proprietary rights which the
Company intends to utilize in the execution of its business plan . Consideration
for this license was the issuance of 16,612,276 shares (post-split) of the
F-16
Company's restricted common, valued at the shares' par value of $0.001 per
share, aggregating $ 9,250. These proprietary rights are being amortized over
the term of the license agreement, or ten years.
The costs and accumulated amortization of intangible assets at December 31 are
summarized as follows:
2005
--------
Technology License $ 9,250
Website 22,500
Less: accumulated amortization (25,357)
Impairment of intangible asset ( 6,393)
--------
Intangible assets, net $ -
========
Amortization expense included as a charge to income amounted to $927, $12,177,
and $25,357 for the years ended December 31, 2005 and 2004, and the period from
inception to December 31, 2005, respectively. In December 2005, the Company
determined it was necessary to record an impairment charge related to our
intangible asset totaling $6,393 , which was charged to operations during the
year ended December 31, 2005.
NOTE D - ACCOUNTS PAYABLE AND ACCRUED LIABILITIES
Accounts payable and accrued liabilities at December 31, 2005 are as follows:
Common stock portion of penalty for late
registration of shares $1,677,538
Warrant portion of penalty for late
registration of shares - with
registration rights 384,145
Accounts payable & accrued liabilities 475,030
Insurance contract payable 18,000
Accrued interest 9,098
----------
Total $2,563,811
==========
NOTE E - PENALTY FOR LATE REGISTRATION OF SHARES
During the fiscal year December 31, 2005, the Company accrued the issuance of
5,242,307 shares of common stock and warrants to purchase an additional
2,064,187 shares of common stock pursuant to a penalty calculation with regard
to the late registration of shares sold in a private placement in October 2004.
In October 2004, we completed a private placement sale of shares of our common
stock and warrants to purchase additional shares of common stock. We issued in
the private placement an aggregate of 19,600,000 shares of our common stock and
warrants to purchase 9,800,000 shares of our common stock. We agreed to register
these shares along with the shares underlying these warrants within ninety days
from the closing date of the transaction, or we would incur a penalty equivalent
to an additional 2% of the shares and warrants to be registered for every 30
days that we fail to complete this registration. This penalty amounts to an
aggregate of 461,200 shares and 181,600 warrants per 30 day period until such a
time as this registration statement is made effective. As of December 31, 2005,
we are required to issue an additional 5,242,307 shares of common stock and
warrants to purchase an additional 2,064,187 shares of common stock. At the time
these liabilities were incurred, the shares were valued at $1,991,923 and the
warrants were valued at $638,838. The shares were valued at the market price of
the Company's common stock at the time the liabilities were incurred. The
warrants were valued utilizing the Black-Scholes valuation model. The aggregate
amount of $2,630,761 was charged to operations as cost of penalty for late
registration of shares during the year ended December 31, 2005.
The shares and warrants were re-valued at December 31,2005, and the result of
this re-valuation was to decrease the value of the shares by $314,385 and to
decrease the value of the warrants by $254,693. These decreases were credited to
other (income) expense during the year ended December 31, 2005. At December 31,
2005, the fair value of the common stock issuable under the penalty for late
registration of shares is $1,677,538, and the fair value of the warrants
issuable under the penalty for late registration of shares is $384,145. These
amounts appear as current liabilities on the Company's condensed consolidated
balance sheet at December 31, 2005.
F-17
As the liability for these penalty shares and warrants must be settled by the
delivery of registered shares and the delivery of the registered shares is not
controlled by the Company, pursuant to EITF 00-19, "Accounting for Derivative
Financial Instruments Indexed to, and Potentially Settled in, a Company's Own
Stock", the net value of the shares and warrants at the date of issuance was
recorded as a liability on the balance sheet and the change in fair value from
the date of issuance to December 31, 2005 has been included in other income
(expense). Upon the registration statement being declared effective, the fair
value of the warrant on that date will be reclassified to equity.
We hope to complete the registration of these shares during the quarter ended
June 30, 2006, but expect that an obligation to issue approximately 2,136,893
additional shares and 841,413 additional warrants at an aggregate cost of
approximately $840,000 will be incurred during the period January 1, 2006 to
June 30, 2006.
NOTE F - RELATED-PARTY TRANSACTIONS
Employment Agreements
---------------------
PRESIDENT AND CHIEF EXECUTIVE OFFICER:
On August 10, 2005, the Company entered into a new employment agreement with its
President and Chief Executive Officer, Michael K. Wilhelm. The employment
agreement calls for a salary at the rate of $275,000 per annum. The salary will
be subject to adjustment of at least 10% per year at the end of each year. The
registrant also agreed to defend and indemnify, to the fullest extent permitted
by the registrant's certificate of incorporation and bylaws and the Delaware
General Corporation Law, Mr. Wilhelm and hold him harmless against any liability
that he incurs within the scope of his employment under the agreement. The
agreement also provides for the following various bonus incentives:
i) A target incentive bonus in cash and/or stock if the Company consummates
a transaction with any unaffiliated third party such as an equity or debt
financing, acquisition, merger , strategic partnership or other similar
transaction.
ii) A one time grant of an option to purchase 2,000,000 shares of the
Company's common stock at an exercise price equal to the fair market value per
share on the date option is granted.
In connection with Mr. Wilhelm's new employment agreement, the Company also
entered into a change of control agreement and a severance agreement with him on
August 10, 2005.
Under the change of control agreement, Mr. Wilhelm shall be entitled to a
continuation of his base salary for a period of 18 months following an
involuntary termination, which means, at any time within that period which is
one-year from the change of control date (including such date), the termination
of the employment of Mr. Wilhelm (i) by the Company without cause or (ii) due to
constructive termination, as such terms are defined in the change of control
agreement. Further, in the event of an involuntary termination, the agreement
provides that the registrant shall pay Mr. Wilhelm a lump sum amount in cash,
equal to the sum of (i) any unpaid incentive compensation which has been
allocated or awarded to Mr. Wilhelm for a completed fiscal year or other
measuring period preceding the date of involuntary termination under any annual
or long-term incentive plan and which, as of the date of involuntary
termination, is contingent only upon the continued employment of Mr. Wilhelm to
a subsequent date, and (ii) a pro rata portion to the date of involuntary
termination of the aggregate value of all contingent incentive compensation
awards to Mr. Wilhelm for all then uncompleted periods under any such plan.
Further, 100% of the unvested portion of each outstanding stock option granted
to Mr. Wilhelm shall be accelerated so that they become immediately exercisable
upon the date of involuntary termination.
Under the severance agreement, Mr. Wilhelm shall be entitled to a continuation
of his base salary for a period of 18 months following an involuntary
termination, which means the termination of the employment of Mr. Wilhelm (i) by
the Company without cause or (ii) due to constructive termination, as such terms
are defined in the severance agreement. Further, in the event of an involuntary
termination, the agreement provides that the registrant shall pay Mr. Wilhelm an
amount equal to the amount of executive incentive pay (bonus) that he would have
received for the year in which the involuntary termination occurred had he met
one hundred percent (100%) of the target for such incentive pay. Also, under
F-18
this agreement, 100% of the unvested portion of each outstanding stock option
granted to Mr. Wilhelm shall be accelerated so that they become immediately
exercisable upon the date of involuntary termination.
CHIEF FINANCIAL OFFICER:
Pursuant to our employment agreement with John Fermanis, our Chief Financial
Officer, dated February 15, 2005, we paid a salary of $60,000 until the Company
completed a financing of $500,000 or more. This occurred on March 4, 2005 when
the Company completed a Tender Offer for warrants totaling $1,190,857 net of
fees. From March 4, 2005, until December 31, 2005, we will pay an annual salary
of $85,000. Thereafter, we will pay an annual salary of $98,000 for the second
year ending December 31, 2006 and an annual salary of $112,000 for the third
year ending December 31, 2007. Mr. Fermanis' salary is payable in regular
installments in accordance with the customary payroll practices of the Company.
Mr. Fermanis also receives 100,000 shares of the Company's common stock, which
are earned at the rate of 1/12 or 8,333 per month beginning January 2005. The
Company charges to operations the market value of these shares as of the first
day of each month. For the twelve months ended December 31, 2005, the Company
charged $41,416 to operations for the issuance of 100,000 shares to Mr.
Fermanis. This amount is carried in accrued liabilities at December 31, 2005.
Proprietary Rights Agreement
----------------------------
In December 2002, the Company entered into a royalty-free license agreement with
its two founders and largest shareholders. Under the terms of the license
agreement, the licensors grant to the Company an exclusive license to use and
sublicense certain patents, medical applications, and other technologies
developed by the licensors. The Company's obligations under the license
agreement include (i) reasonable efforts to protect any licensed patents or
other associated property rights; (ii) reasonable efforts to maintain
confidentiality of any proprietary information; (iii) upon the granting by the
U. S. Food and Drug Administration to the Company the right to market a product,
the Company will maintain a broad form general liability and product liability
insurance.
In February 2005, Drs. Witten and Harris executed assignment documents in which,
for good and valuable consideration, patent applications and patents developed
by them were assigned to ImmuneRegen BioSciences, Inc. The assignment documents
included all of the patents and patent applications which were included in and
covered by the licensing agreement, as amended. Drs. Witten and Harris have also
assigned all proprietary technology developed at ImmuneRegen subsequent to the
execution of the February 2005 assignment documents.
Office Lease
------------
During the period from December 1, 2002 through August 31, 2004, the Company
leased office space from an entity controlled by the Company's Chief Executive
Officer under a sub-let agreement. The rental cost of $2,734 per month was
passed through to the Company at the same rental rate charged by the facility's
primary landlord.
In July 2004, the Company leased a new office facility from a third party (see
Note I).
Notes Payable
-------------
During the twelve months ended December 31, 2005, the Company converted notes
payable and accrued interest to Company shareholders in the aggregate amount of
$65,003 into 232,153 shares of the Company's common stock at a price of $0.28
per share (see Note G).
NOTE G - NOTES PAYABLE
During the year ended December 31, 2005, the Company settled in full three (3)
notes payable aggregating $80,000. Payment was made by converting one (1) note
in the amount of $65,003 into 232,153 shares of the Company's common stock, and
by paying cash in the amount of $14,997 in satisfaction of the remaining two (2)
notes. The Company has no notes payable outstanding at December 31, 2005.
NOTE H - CAPITAL STOCK
The Company is authorized to issue 10,000,000 shares of preferred stock, par
value $0.001 per share. No shares of preferred stock have been issued as of
F-19
December 31, 2004. The company has authorized 100,000,000 shares of common
stock, with a par value of $.001 per share. In July, 2003 a one for twenty
reverse stock split of the Company's common stock was effected . On April 6,
2004, the Company effected a 2 for 1 forward split of its common stock. Total
authorized shares and par value remain the unchanged. Accordingly, the effect of
the reverse and subsequent forward split has been presented in the accompanying
financial statement and footnote disclosures. As of December 31, 2005, the
Company has 69,436,319 shares of common stock issued and outstanding.
During the period ended December 31, 2002, the Company issued an aggregate of
1,459,188 shares of common stock to employees and consultants for services in
the amount of $ 9,782. All valuations of common stock issued for services were
based upon the value of the services rendered, which did not differ materially
from the fair value of the Company's common stock during the period the services
were rendered. In addition, the Company issued 16,612,276 shares of common stock
to its founders in exchange for a proprietary license charged to operations,
valued at $ 9,250 (see Note C) . The Company also issued an aggregate of 185,578
shares of common stock in exchange for $ 31,001, net of costs and fees.
During the year ended December 31, 2003, the Company issued an aggregate of
267,594 shares of common stock to consultants for services in the amount of
$37,280. All valuations of common stock issued for services were based upon the
value of the services rendered, which did not differ materially from the fair
value of the Company's common stock during the period the services were
rendered. In addition, the Company issued 2,155,104 shares of common stock in
exchange for $ 300,000 of previously incurred debt. The Company also issued an
aggregate of 383,430 shares of common stock in exchange for $ 65,000 net of
costs and fees. In July, 2003, the Company issued 2,368,130 in connection with
the Company's acquisition and merger with GPN Network, Inc. (see Note A.)
During the year ended December 31, 2004, the Company issued an aggregate of
5,481,280 shares of common stock to consultants for services in the amount of
$2,877,872. All valuations of common stock issued for services were based upon
the value of the services rendered, which did not differ materially from the
fair value of the Company's common stock during the period the services were
rendered. In addition, the Company issued 300,000 shares of common stock as with
a fair value of $36,000 as interest on a note payable. In addition, in
conjunction with a private placement of stock (see below), the Company issued
6,855,062 shares of common stock in exchange for $ 630,591 of previously
incurred debt and accrued interest. In addition, the Company issued 590,000
shares of common stock in exchange for $65,000 of previously issued debt. Total
debt exchanged for stock during the year ended December 31, 2004 was $695,591 of
debt and interest for 7,745,062 shares of common stock. The Company also sold an
aggregate of 18,160,000 shares of common stock in exchange for $ 1,971,045 cash,
net of costs and fees. The Company also sold 8,000 shares of common stock for
$1,200. The Company also issued an aggregate of 4,900,000 shares of common stock
to its investment bankers as fees. The Company also issued 1,257,746 shares of
common stock in settlement of $157,219 of accounts payable. In addition, the
Company issued an aggregate 1,440,000 shares of common stock to an officer and a
director in satisfaction $180,000 of liabilities.
Private Placement of Common Stock
---------------------------------
In October 2004, the Company completed a private placement of its common stock
(the "Private Placement") whereby the Company sold an aggregate of $2,450,000
worth of units (each a "Unit" and collectively, the "Units") to accredited
investors (as defined by Rule 501 under the Securities Act of 1933, as amended)
(the transaction is referred to herein as the "Private Placement"). The Company
received proceeds of $1,971,845 after costs of the issuance of $298,155.
Included in the $2,450,000 sale was conversion of $180,000 of accrued salary and
consulting fees due to an officer and an director of the Company. The number of
shares of common stock issued pursuant to the Private Placement was 19,600,000,
along with warrants to purchase an additional 9,080,000 shares, plus warrants to
purchase an additional 720,000 shares issued to the officer and director. The
Company also issued an additional 4,900,000 shares of common stock to its
investment banker as commission. The investment bankers did not acquire any
warrants pursuant to this transaction.
Pursuant to the terms of the Private Placement, each Unit was sold for $10,000
(the "Unit Price") and consisted of the following:
(a) a number of shares (the "Shares") of common stock of the
Registrant, par value $0.001 per share (the "Common Stock"), determined by
dividing: (i) the Unit Price by (ii) $0.125; and
F-20
(b) a warrant (each a "Warrant" and collectively, the "Warrants") to
purchase, at any time prior to the fifth (5th) anniversary following the date of
issuance of the Warrant, a number of shares of Common Stock equal to fifty
percent (50%) of the number of Shares included within the Unit, at a price equal
to fifty cents ($0.50) per share of Common Stock.
In consideration of the investment, the Company granted to each investor certain
registration rights and anti-dilution rights. The Company is obligated to file a
registration statement for the shares of common stock issued in the private
placement and shares of common stock underlying the warrants issued in the
private placement within 30 days of the final closing date of October 26, 2004,
or November 25, 2004. The Company is also obligated to effectuate the
registration statement within 90 days of the final closing date of October 26,
2004, or January 24, 2005. Failure to meet either of these deadlines results in
the Company subject to a penalty of a 2% increase in the number of shares to be
registered, or 461,200 shares and warrants to purchase an additional 181,600
shares, for every 30 day period beyond the deadline date. As of the date of the
financial statements, the registration statement has not been deemed effective
and as a result, the Company has incurred penalties in the amount of $2,061,683
representing the obligation to issue an additional 5,242,307 shares of common
stock and warrants to purchase an additional 2,064,187 shares of common stock at
a price of $0.50 per share.
The accrued penalties in connection with the issuance of the shares of common
stock is included in accounts payable and accrued expenses at December 31, 2005.
In conjunction with raising capital through the private placement of our common
stock, the Company issued a warrant that has registration rights for the
underlying shares. As the contract must be settled by the delivery of registered
shares and the delivery of the registered shares is not controlled by the
Company, pursuant to EITF 00-19, "Accounting for Derivative Financial
Instruments Indexed to, and Potentially Settled in, a Company's Own Stock", the
net value of the 9,800,000 warrants and an additional 2,064,187 penalty warrants
at their respective dates of issuance has been recorded as a warrant liability
on the balance sheet ($638,838) and the change in fair value from the date of
issuance to December 31, 2005 has been included in other income (expense). The
assumptions used in the Black Scholes model are as follows: (1) dividend yield
of 0%; (2) expected volatility of 79%, (3) risk-free interest rate of 4.5%, and
(4) expected life of 5 years. Upon the registration statement being declared
effective, the fair value of the warrant on that date will be reclassified to
equity.
For the year ended December 31, 2005 the change in fair value of the warrant
issued with registration rights decreased by approximately $254,693 to $384,145
at December 31, 2005 and is recognized in other income (expense).
October 2004, the Company converted certain notes payable with an aggregate
principal amount of $558,500 plus accrued interest of $56,757 for a total of
$630,328 into Units with terms identical to those provided to investors in the
Private Placement. The number of shares of common stock issued via these note
conversions was 6,694,149 along with warrants to purchase an additional
3,347,076 shares (see Note H).
Also in October 2004, the Company entered into a settlement agreements with
certain creditors whereby for full and complete satisfaction of claims totaling
an aggregate of $157,219 the Company issued Units with terms identical to those
provided to investors in the Private Placement. The number of shares of common
stock issued via these creditor conversions was 1,257,746, along with warrants
to purchase an additional 628,873 shares.
On January 24, 2005, the Company made a tender offer to certain of the Company's
shareholders whereby the exercise price of certain warrants issued in October
2004 (the "Warrants") would be reduced from $0.50 to $0.20 per share. In March
2005, 6,600,778 shares of common stock were sold pursuant to this offer for
aggregate proceeds of $1,320,156 less costs of $129,300.
In June 2005, the Company issued 80,000 shares of common stock pursuant to the
Exercise of a warrant at a price of $0.05 per share.
In July 2005, the Company issued 232,153 shares of common stock at a price of
$0.28 per share pursuant to the conversion of a note payable (see Note F.)
In August 2005, the Company issued 100,000 shares of common stock pursuant to an
agreement with a service provider. The fair value of these shares of $10,000 was
amortized over the life of the contract, from July 2004 to July 2005.
F-21
NOTE I - STOCK OPTIONS AND WARRANTS
Employee Stock Options
----------------------
The Company has adopted the 2003 Stock Option, Deferred Stock and Restricted
Stock Plan (the "Plan") which authorizes the Board of Directors in accordance
with the terms of the Plan, among other things, to grant incentive stock
options, as defined by Section 422(b) of the Internal Revenue Code, nonstatutory
stock options (collectively, the "Stock Options") and awards of restricted stock
and deferred stock and to sell shares of common stock of the Company ("Common
Stock") pursuant to the exercise of such stock options for up to an aggregate of
6,465,316 shares . The options will have a term not to exceed ten years from the
date of the grant. There have been no options granted under this Plan.
Through December 31, 2002, GPN had granted pre-merger stock options to certain
employees and consultants which are exercisable over various periods through
March 2010. These stock options are currently held by the Company outside of the
Plan.
The following table summarizes the changes in options outstanding and the
related prices for the shares of the Company's common stock issued to employees
of the Company under a non-qualified employee stock option plan.
Options Outstanding Options Exercisable
----------------------------------- --------------------------------------
Weighted Weighted
Average Weighted Average
Remaining Average Remaining
Exercise Number Contractual Exercise Number Contractual
Prices Outstanding Life (years) Price Exercisable Life (years)
-------- ----------- ------------ --------- ----------- ------------
$25.00 63,212 4.24 $25.00 63,212 4.24
0.31 1,000 4.95 0.31 1,000 4.95
0.33 103,030 4.61 0.33 103,030 4.61
0.44 150,000 4.34 0.44 150,000 4.34
------- -------
317,242 317,242
======= =======
Transactions involving stock options issued to employees are summarized as
follows:
Weighted Average
Number of Shares Price Per Share
---------------- ----------------
Outstanding at December 31, 2003 63,212 25.00
Granted -- --
Exercised -- --
Canceled or expired -- --
------- ------
Outstanding at December 31, 2004 63,212 $25.00
Granted 254,030 0.39
Exercised -- --
Canceled or expired -- --
------- ------
Outstanding at December 31, 2005 317,242 $ 5.30
======= ======
Warrants
--------
The following table summarizes the changes in warrants outstanding and the
related prices for the shares of the Company's common stock issued to
non-employees of the Company. These warrants were granted in lieu of cash
compensation for services performed or financing expenses and in connection with
placement of convertible debentures.
F-22
Warrants Outstanding Warrants Exercisable
----------------------------------- --------------------------------------
Weighted Weighted
Average Weighted Average
Remaining Average Remaining
Exercise Number Contractual Exercise Number Contractual
Prices Outstanding Life (years) Price Exercisable Life (years)
-------- ----------- ------------ --------- ----------- ------------
$ .05-.10 519,780 3.38 $.05-.10 519,780 3.38
.125-.21 911,819 3.46 .125-.21 911,819 3.46
.25-.56 9,271,405 3.57 .25-.56 9,271,405 3.57
1.00 867,311 2.08 1.00 867,311 2.08
2.00 46,550 3.21 2.00 46,550 3.21
----------- ------------ ----------- -----------
11,616,865 3.44 11,616,865 3.44
=========== ============ =========== ===========
Transactions involving warrants are summarized as follows:
Number of Shares Weighted Average
(post-split) Price Per Share
(post-split)
--------------- ------------------
Outstanding at January 1, 2004 832,510 $ .82
Granted 16,831,199 .47
Exercised (6,600,778) .50
Canceled or expired -- --
---------- --------
Outstanding at December 31, 2004 11,062,931 .48
Granted 757,464 .44
Exercised (80,000) .05
Canceled or expired (123,530) 2.00
---------- --------
Outstanding at December 31, 2005 11,616,865 $ .46
========== ========
The estimated value of the compensatory warrants granted to non-employees in
exchange for services and financing expenses was determined using the
Black-Scholes pricing model and the following assumptions:
2005 2004
---- ----
Significant assumptions (weighted-average):
Risk-free interest rate at grant date 3.75% 3.75%
Expected stock price volatility 93% to 179% 163% to 262%
Expected dividend payout -- --
Expected option life-years (a) 5 5
(a) The expected option life is based on contractual expiration dates.
The amount of the expense charged to operations for compensatory warrants
granted in exchange for services was $279,711 and $406,571 during the years
ended December 31, 2005 and 2004, respectively.
The Company also capitalized financing costs of $0 and $397,394 for warrants
granted in connection with placement of convertible debentures for the years
ended December 31, 2005 and 2004, respectively.
At December 31, 2002, the Company had outstanding warrants to purchase 26,939
shares (post-split) of common stock at $0.835 per share (post-split).
During the twelve months ended December 31, 2003, the Company issued warrants to
purchase 169,572 shares (post-split) of common stock at prices ranging from
$0.125 to $1.00 per share (post-split) to eight service providers. The Company
valued the warrants using the Black-Scholes calculation model, and the warrants
were deemed to have a combined value of $85,860. This amount was charged to
expense on the Company's financial statements for the twelve months ending
December 31, 2003.
In October 2003, pursuant to the Amended Note agreements, the Company issued the
Amended Note Warrants to purchase 245,000 shares (post-split) of its common
stock at a price of $1.00 per share (post-split). The Company valued the Amended
Note Warrants using the Black-Scholes calculation model, and the warrants were
deemed to have a combined value of $189,937. This amount was recorded as a
discount to the Amended Notes and an addition to paid-in capital, and was
charged to expense over the term of the notes, or 180 days. During the twelve
F-23
months ended December 31, 2003, the Company recognized $84,169 of expense in
relation to these warrants. During the twelve months ended December 31, 2004,
the remaining $105,768 was charged to operations.
In October, November, and December 2003, pursuant to the Fourth Quarter Note
agreements, the Company issued the Fourth Quarter Company Warrants to purchase
391,000 shares (post-split) of its common stock at a price of $1.00 per share
(post-split).
As an additional incentive to investors in the Secured Convertible Promissory
Notes, the Company provided five-year warrants (the "Secured Note Warrants") to
purchase that number of shares of common stock equal to one-half the initial
principal amount of the Secured Convertible Promissory Notes. For example, an
investor who purchased a $10,000 Secured Convertible Promissory Note would
receive a warrant to purchase 8,979 shares (post-split) of common stock. The
exercise price of the Secured Note Warrants is equal to 60% of the price per
share paid by investors in a future equity financing (the "Reorganization
Financing"). The Secured Note Warrants are not considered granted until the
completion of the Reorganization Financing. In accordance with EITF 00-27,
because the Reorganization Financing had not occurred at December 31, 2003, the
Company ascribed no value to the Secured Note Warrants at December 31, 2003. At
the time of the first closing of the Private Placement in October 2004, warrants
to purchase a total of 444,490 shares (post-split) of common stock at $0.075 per
share (post-split) were issued under the Secured Note Warrants. The value of
these warrants was computed utilizing the Black-Scholes valuation model, and the
total value of these warrants, or $112,562 was charged to operations during the
twelve months ended December 31, 2004.
The Company has outstanding warrants to purchase 250,000 shares of common stock
at $0.30 per share which were issued in 2002 by its predecessor company GPN
Network.
In April through June 2004, the Company issued warrants to purchase 32,500
shares (post-split) at price ranging from $0.25 to $2.00 to consultants for
services performed. The Company valued these warrants using the Black-Scholes
valuation model, and charged the amount of $8,318 to operations during the
twelve months ended December 31, 2004.
In May 2004, the Company issued a warrant to its President and a warrant to a
Director, each warrant to purchase 500,000 shares (post-split) of common stock
at a price of $0.25 per share (post-split). The warrants were issued as
performance bonuses. The Company valued these warrants using the Black-Scholes
model, and charged the amount of $134,604 for each warrant, or a total of
$269,208, to operations during the twelve months ended December 31, 2004.
In October 2004, the Company issued a warrant to its President to purchase
448,980 shares (post-split) at a price of $0.125 per share (post-split) as a
performance bonus for achieving certain objectives. The Company valued this
warrant using the Black-Scholes valuation model, and charged the amount of
$112,697 to operations during the twelve months ended December 31, 2004.
In November and December 2004, the Company issued a warrant to purchase 50,000
shares (post-split) of its common stock at a price of $0.125 per share
(post-split) and a warrant to purchase 10,000 shares (post-split) of its common
stock at a price of $0.075 per share (post-split) to two members of its advisory
boards. The Company valued these warrants using the Black-Scholes valuation
model, and charged the aggregate amount of $16,348 to operations during the
twelve months ended December 31, 2004.
In October 2004, the Company issued warrants to purchase 9,080,000 shares
(post-split) of its common stock at a price of $0.50 per share (post-split) to
the investors in its private placement of equity securities. The Company
allocated $607,922 of the total proceeds of $1,971,845 to the warrants, and
charged this amount to additional paid-in capital during the twelve months ended
December 31, 2004.
In October 2004, the Company issued warrants to purchase an aggregate of 720,000
shares (post-split) of its common stock at a price of $0.50 per share
(post-split) to the an officer and a director for converting a total of $180,000
of amounts owed to these individuals for accrued salary and accrued consulting
fees. The Company allocated $56,067 of the total proceeds of $180,000 to the
warrants, and charged this amount to additional paid-in capital during the
twelve months ended December 31, 2004.
In October 2004, the Company issued warrants to purchase 3,347,076 shares
(post-split) of its common stock at a price of $0.50 per share (post-split) to
the convertible note holders who invested its private placement of equity
F-24
securities via conversion of their notes. The Company allocated $191,111 of the
total amount converted of $615,328 to the warrants, and charged this amount to
additional paid-in capital during the twelve months ended December 31, 2004.
In October 2004, the Company issued warrants to purchase 628,873 shares
(post-split) of its common stock at a price of $0.50 per share (post-split) to
the vendors who invested in its private placement of equity securities via
conversion of amounts owed to them by the Company. The Company allocated $48,579
of the total amount converted of $157,219 to the warrants, and charged this
amount to additional paid-in capital during the twelve months ended December 31,
2004.
In April through June 2004, the Company issued warrants to purchase 77,500
shares (post-split) of its common stock at prices ranging from $0.25 to $2.00
per share (post-split) to certain investors as additional incentive under notes
payable agreements. The Company valued these warrants using the Black-Scholes
model, and charged the amount of $17,915 to additional paid-in capital during
the twelve months ended December 31, 2004.
In July and August 2004, the Company issued warrants to purchase 744,280 shares
(post-split) of its common stock at prices ranging from $0.05 to $2.00 per share
(post-split) to certain investors as additional incentive under notes payable
agreements. The Company valued these warrants using the Black-Scholes model, and
charged the amount of $72,252 to additional paid-in capital during the twelve
months ended December 31, 2004.
During the three months ended March 31, 2005, the Company issued warrants to
purchase 268,033 shares of common stock at prices ranging from $0.125 to $1.00
to consultants for services performed. The Company valued these warrants using
the Black-Scholes valuation model, and charged the amount of $137,049 to
operations during the twelve months ended December 31, 2005.
During the three months ended June 30, 2005, the Company issued warrants to
purchase 366,814 shares of common stock at prices ranging from $0.038 to $1.00
per share to consultants and advisory board members. The Company also cancelled
warrants to purchase 123,530 shares of common stock at a price of $2.00 per
share. The Company valued these issuance and cancellations using the
Black-Scholes valuation model, and charged the amount of $103,772 to operations
during the twelve months ended December 31, 2005.
Also during the three months ended June 30, 2005, warrants to purchase 80,000
shares of common stock at a price of $0.05 per share were exercised.
During the three months ended September 30, 2005, the Company issued warrants to
purchase 77,250 shares of common stock at prices ranging from $0.125 to $1.00
per share to consultants and advisory board members. The Company valued these
warrants using the Black-Scholes valuation model, and charged the amount of
$20,491 to operations during the twelve months ended December 31, 2005.
In October and December 2005, the Company issued warrants to purchase 62,467
shares of common stock at prices ranging from $0.125 to $1.00 to consultants and
advisory board members for services provided. The Company valued these warrants
using the Black-Scholes valuation model, and charged the amount of $18,399 to
operations during the twelve months ended December 31, 2005.
NOTE J - COMMITMENTS AND CONTINGENCIES
Office Leases
-------------
Our corporate headquarters are currently located at 4021 N. 75th Street, Suite
201, Scottsdale, Arizona 85251, where we have leased approximately 1,800 square
feet of office space through September 30, 2007. Our rent expense is $2,320 per
month in year one and will increase to $2,380 in year two. We believe that our
facilities are adequate for our current needs and suitable additional or
substitute space will be available in the future to replace our existing
facilities, if necessary, or accommodate expansion of our operations.
Rent expense amounted to $27,785 for the years ended December 31, 2005, $41,051
for the year ended December 31, 2004, and $102,939 for the period from October
30, 2002 (inception) through December 31, 2005.
F-25
Employment and Consulting Agreements
------------------------------------
The Company has employment agreements with all of its President and Chief
Executive Officer (See Note F). In addition to salary and benefit provisions,
the agreements include non-disclosure and confidentiality provisions for the
protection of the Company's proprietary information. The Company also has a
severance agreement and a change of control agreement in place with its
President and Chief Executive Officer.
The Company also has an employment agreement with its Chief Financial Officer
which provide salary and benefit provisions.
The Company has consulting agreements with outside contractors to provide
marketing and financial and scientific advisory services. The Agreements are
generally for a term of 12 months from inception and renewable automatically
from year to year unless either the Company or Consultant terminates such
engagement by written notice.
The Company has a three-year contract for the period January 2003 to January
2006 with its advertising and design agency. This contract stipulates that there
will be a minimum guaranteed annual fee for consultation, planning, creative and
account service of $100,000 for each of the three years of the contract if
termination of the contract is the result of a merger or acquisition of the
Company. The contract was not terminated upon the GPN Merger Agreement.
Litigation
----------
On December 13, 2001, service of process was effectuated upon GPN Network, Inc.
with regard to a fee agreement between GPN Network, Inc. and Silver & Deboskey,
a Professional Corporation located in Denver, Colorado. The complaint sought
compensation for legal services allegedly rendered to DermaRx Corp. On November
7, 2002, the District Court in Denver, Colorado rendered judgment in favor of
Silver & Deboskey in the amount of $28,091. At December 31, 2004, we had not
paid any of this amount.
The judgment was subsequently settled in full for a cash payment of $35,107 paid
on August 2, 2005 releasing us from all obligations under the judgment.
The Company is subject to other legal proceedings and claims, which arise in the
ordinary course of its business. Although occasional adverse decisions or
settlements may occur, the Company believes that the final disposition of such
matters should not have a material adverse effect on its financial position,
results of operations or liquidity.
NOTE K - INCOME TAXES
The Company has adopted Financial Accounting Standard No. 109 which requires the
recognition of deferred tax liabilities and assets for the expected future tax
consequences of events that have been included in the financial statement or tax
returns. Under this method, deferred tax liabilities and assets are determined
based on the difference between financial statements and tax bases of assets and
liabilities using enacted tax rates in effect for the year in which the
differences are expected to reverse. Temporary differences between taxable
income reported for financial reporting purposes and income tax purposes are
insignificant.
For income tax reporting purposes, the Company's aggregate unused net operating
losses approximate $4,970,000 which expire through 2026, subject to limitations
of Section 382 of the Internal Revenue Code, as amended. The deferred tax asset
related to the carryforward is approximately $1,740,000. The Company has
provided a valuation reserve against the full amount of the net operating loss
benefit, because in the opinion of management based upon the earning history of
the Company, it is more likely than not that the benefits will not be realized.
Components of deferred tax assets as of December 31, 2005 are as follows:
Non Current:
Net operating loss carryforward $1,740,000
Valuation allowance (1,740,000)
-----------
Net deferred tax asset $ --
===========
NOTE L - LOSSES PER COMMON SHARE
The following table presents the computations of basic and dilutive loss per
share:
F-26
For the Period From
October 30, 2002
(Date of Inception)
Through
2005 2004 December 31, 2005
------------ ------------- ------------------
Net loss available to
common shareholders $ (4,591,107) $ (5,305,407) $ (11,799,134)
============ ============ =============
Basic and fully diluted
loss per share $ (0.07) $ (0.16) $ (0.30)
============ ============ =============
Weighted average common
shares outstanding 67,691,598 33,510,168 38,934,503
============ ============ =============
On April 6, 2004, the Company effected a 2 for 1 forward split of its common
stock. Accordingly, the effect of the forward split has been presented in the
accompanying financial statement and footnote disclosures.
At December 31, 2005 and 2004, there were 11,680,077 and 11,380,173,
respectively, shares of common stock issuable subject to stock options and
warrants. These shares were excluded from the computation of diluted net loss
per share as their effect was antidilutive. If we had reported net income, the
calculation of these per share amounts would have included the dilutive effect
of these common stock equivalents using the treasury stock method.
NOTE M - SUBSEQUENT EVENTS
On March 10, 2006 we issued to our Chief Financial Officer, John N. Fermanis,
100,000 registered common stock per the terms of his employment agreement.
From the period of January 1, 2006 to March 20, 2006, we accrued the issuance of
1,214,493 shares of common stock and warrants to purchase an additional 478,213
shares of common stock pursuant to a penalty calculation with regard to the late
registration of shares sold in a private placement in October 2004. As of March
20, 2006, we are required to issue an additional 6,456,800 shares of common
stock and additional warrants to purchase 2,542,400 shares of common stock
pursuant to the late registration penalty.
F-27
PART II
INFORMATION NOT REQUIRED IN PROSPECTUS
ITEM 24 INDEMNIFICATION OF DIRECTORS AND OFFICERS
Under Section 145 of the General Corporation Law of the State of
Delaware, we can indemnify our directors and officers against liabilities they
may incur in such capacities, including liabilities under the Securities Act of
1933, as amended (the "Securities Act"). Our certificate of incorporation
provides that, pursuant to Delaware law, our directors shall not be liable for
monetary damages for breach of the directors' fiduciary duty of care to us and
our stockholders. This provision in the certificate of incorporation does not
eliminate the duty of care, and in appropriate circumstances equitable remedies
such as injunctive or other forms of nonmonetary relief will remain available
under Delaware law. In addition, each director will continue to be subject to
liability for breach of the director's duty of loyalty to us or our
stockholders, for acts or omissions not in good faith or involving intentional
misconduct or knowing violations of the law, for actions leading to improper
personal benefit to the director, and for payment of dividends or approval of
stock repurchases or redemptions that are unlawful under Delaware law. The
provision also does not affect a director's responsibilities under any other
law, such as the federal securities laws or state or federal environmental laws.
Our bylaws provide for the indemnification of our directors to the
fullest extent permitted by the Delaware General Corporation Law. Our bylaws
further provide that our Board of Directors has sole discretion to indemnify our
officers and other employees. We may limit the extent of such indemnification by
individual contracts with our directors and executive officers, but have not
done so. We are required to advance, prior to the final disposition of any
proceeding, promptly on request, all expenses incurred by any director or
executive officer in connection with that proceeding on receipt of an
undertaking by or on behalf of that director or executive officer to repay those
amounts if it should be determined ultimately that he or she is not entitled to
be indemnified under our bylaws or otherwise. We are not, however, required to
advance any expenses in connection with any proceeding if a determination is
reasonably and promptly made by our Board of Directors by a majority vote of a
quorum of disinterested Board members that (a) the party seeking an advance
acted in bad faith or deliberately breached his or her duty to us or our
stockholders and (b) as a result of such actions by the party seeking an
advance, it is more likely than not that it will ultimately be determined that
such party is not entitled to indemnification pursuant to the applicable
sections of our bylaws.
We also have directors' and officers' liability insurance.
ITEM 25 OTHER EXPENSES OF ISSUANCE AND DISTRIBUTION
The following table sets forth the costs and expenses, other than
underwriting discounts and commissions, if any, payable by the Registrant
relating to the sale of common stock being registered. All amounts are estimates
except the SEC registration fee.
SEC registration fee ...........................................$ 1,532
Printing and engraving expenses ................................ 5,000
Legal fees and expenses ........................................ 95,000
Accounting fees and expenses ................................... 50,000
Transfer agent and registrar's fees and expenses ............... 2,000
Miscellaneous expenses ......................................... 6,468
--------
Total......................................................$ 160,000
========
The Registrant has agreed to bear expenses incurred by the selling
stockholders, up to a maximum limit of $15,000, that relate to the registration
of the shares of common stock being offered and sold by the selling
stockholders. All such expenses in excess of $15,000 will be borne by the
selling stockholders in proportion to the number of shares being registered by
each stockholder.
ITEM 26 RECENT SALES OF UNREGISTERED SECURITIES
During the last three years, we have issued unregistered securities to
the persons, as described below. None of these transactions involved any
underwriters, underwriting discounts or commissions, except as specified below,
or any public offering, and we believe that each transaction was exempt from the
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registration requirements of the Securities Act of 1933 by virtue of Section
4(2) thereof and/or Regulation D promulgated thereunder. All recipients had
adequate access, through their relationships with us, to information about us.
In January 2002, we sold to Todd M. Ficeto, who was the sole director
and officer of GPN Network, Inc., 2,500,000 units at $0.06 per unit for an
aggregate purchase price of $150,000. Each unit sold included two shares of our
common stock and one five-year warrant to purchase one share of our common stock
at $0.03 per share. The sale of the units resulted in the issuance of 5,000,000
shares of our common stock and warrants exercisable for an additional 2,500,000
shares of our common stock. The securities were offered and sold in reliance
upon exemption from registration pursuant to Section 4(2) of the Securities Act
and Rule 506 promulgated thereunder.
On January 20, 2003, the Company entered into a $15,000 Convertible
Promissory Note bearing 8% interest per month with an accredited individual
investor. The principal on the note was subsequently repaid. On March 31, 2005
in accordance with the terms of the Promissory Note, accrued interest of
$2,410.96 was converted into 19,288 shares of our common stock releasing the
Company from any further obligation under the Note. These shares have been
accrued pending issuance. No general solicitation or advertising was undertaken
in connection with the offer and sale of the Note and the shares. The investor
represented to the Company that the investor was purchasing the securities for
the investor's own account and not with a present view towards the distribution
thereof. In addition, each investor acknowledged and agreed that the note and
the shares had not been registered under the Securities Act and may not be
offered or sold unless subsequently registered and/or offered, sold or
transferred pursuant to an exemption from the registration requirements.
Therefore, the Company believes that the securities were offered and sold in
reliance upon exemptions from registration pursuant to Section 4(2) under the
Securities Act of 1933, as amended, and Rule 506 promulgated thereunder.
On June 11, 2003, the Company entered into a $50,000 Convertible
Promissory Note bearing 10% interest for a term of 120 days to an individual
accredited investor. The term was extended to October 16, 2004, the closing date
of the Private Placement (see below). Immediately upon the closing of the
Private Placement, and in accordance with the terms of the Promissory Note, all
outstanding principal and accrued interest converted into 746,108 shares of our
common stock along with five-year warrants to purchase an additional 373,054
shares of common stock at $.50 per share releasing the Company from any further
obligation under the Note. No general solicitation or advertising was undertaken
in connection with the offer and sale of the Note. The investor represented to
the Company that the investor was purchasing the Note for the investor's own
account and not with a present view towards the distribution thereof. In
addition, the investor acknowledged and agreed that the Note and the underlying
securities had not been registered under the Securities Act and may not be
offered or sold unless subsequently registered and/or offered, sold or
transferred pursuant to an exemption from the registration requirements.
Therefore, the Company believes that the securities were offered and sold in
reliance upon exemptions from registration pursuant to Section 4(2) under the
Securities Act of 1933, as amended, and Rule 506 promulgated thereunder.
On June 11, 2003, the Company entered into a $50,000 Convertible
Promissory Note bearing 10% interest for a term of 120 days to an individual
accredited investor. The term was extended to October 16, 2004, the closing date
of the Private Placement. Immediately upon the closing of the Private Placement,
and in accordance with the terms of the Promissory Note, all outstanding
principal and accrued interest converted into 745,225 shares of our common stock
along with five-year warrants to purchase an additional 372,613 shares of common
stock at $.50 per share releasing the Company from any further obligation under
the Note. No general solicitation or advertising was undertaken in connection
with the offer and sale of the Note. The investor represented to the Company
that the investor was purchasing the Note for the investor's own account and not
with a present view towards the distribution thereof. In addition, the investor
acknowledged and agreed that the Note and the underlying securities had not been
registered under the Securities Act and may not be offered or sold unless
subsequently registered and/or offered, sold or transferred pursuant to an
exemption from the registration requirements. Therefore, the Company believes
that the securities were offered and sold in reliance upon exemptions from
registration pursuant to Section 4(2) under the Securities Act of 1933, as
ended, and Rule 506 promulgated thereunder.
On June 13, 2003, the Company entered into a $100,000 Convertible
Promissory Note bearing 10% interest for a term of 180 days to an individual
accredited investor. The term was extended to October 16, 2004, the closing date
of the Private Placement. Immediately upon the closing of the Private Placement,
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and in accordance with the terms of the Promissory Note, 50% of the outstanding
principal was paid back in cash and 50% of the principal and accrued interest
converted into 614,680 shares of our common stock along with five-year warrants
to purchase an additional 307,340 shares of common stock at $.50 per share
releasing the Company from any further obligation under the Note. No general
solicitation or advertising was undertaken in connection with the offer and sale
of the Note. The investor represented to the Company that the investor was
purchasing the Note for the investor's own account and not with a present view
towards the distribution thereof. In addition, the investor acknowledged and
agreed that the Note and the underlying securities had not been registered under
the Securities Act and may not be offered or sold unless subsequently registered
and/or offered, sold or transferred pursuant to an exemption from the
registration requirements. Therefore, the Company believes that the securities
were offered and sold in reliance upon exemptions from registration pursuant to
Section 4(2) under the Securities Act of 1933, as amended, and Rule 506
promulgated thereunder.
On June 16, 2003, the Company entered into a $20,000 Convertible
Promissory Note bearing 10% interest for a term of 120 days to an individual
accredited investor. The term was extended to October 16, 2004, the closing date
of the Private Placement. Immediately upon the closing of the Private Placement,
and in accordance with the terms of the Promissory Note, all outstanding
principal and accrued interest converted into 297,722 shares of our common stock
along with five-year warrants to purchase an additional 148,861 shares of common
stock at $.50 per share releasing the Company from any further obligation under
the Note. No general solicitation or advertising was undertaken in connection
with the offer and sale of the Note. The investor represented to the Company
that the investor was purchasing the Note for the investor's own account and not
with a present view towards the distribution thereof. In addition, the investor
acknowledged and agreed that the Note and the underlying securities had not been
registered under the Securities Act and may not be offered or sold unless
subsequently registered and/or offered, sold or transferred pursuant to an
exemption from the registration requirements. Therefore, the Company believes
that the securities were offered and sold in reliance upon exemptions from
registration pursuant to Section 4(2) under the Securities Act of 1933, as
amended, and Rule 506 promulgated thereunder.
On July 20, 2003, we entered into and consummated an agreement and plan
of merger, pursuant to which we acquired ImmuneRegen BioSciences, Inc
("ImmuneRegen") in a reverse merger, which resulted in the issuance of 2,368,130
shares of our common stock. Pursuant to the terms of the merger, the
stockholders of ImmuneRegen were issued shares of our common stock exchange for
their shares in ImmuneRegen. The securities were issued to less than 35
purchasers and in reliance upon exemption from registration pursuant to Section
4(2) of the Securities Act and Rule 506 promulgated thereunder. No general
solicitation or advertising was undertaken in connection with the offer and sale
of the securities. The stockholders were also provided with access to our SEC
filings, including the Company's annual reports on Form 10-KSB and its quarterly
reports on Form 10-QSB.
In May and June 2003, ImmuneRegen BioSciences, Inc. had sold and issued
eight secured convertible promissory notes in the aggregate principal amount of
$495,000 that were due 120 days from the date of issuance. When the notes were
due, three were paid and five were exchanged for 8% amended secured convertible
notes ("Amended Notes") in the aggregate principal amount of $245,000 in October
2003. The five accredited investors who received the Amended Notes were also
issued five-year warrants to purchase a total of 245,000 shares of our common
stock at an exercise price of $1.00 per share. The securities were offered and
sold in reliance upon exemption from registration pursuant to Section 4(2) of
the Securities Act and Rule 506 promulgated thereunder. No general solicitation
or advertising was undertaken in connection with the offer and sale of the
securities. Each investor represented to the Company that the investor was
purchasing the securities for the investor's own account and not with a present
view towards the distribution thereof. In addition, each investor acknowledged
and agreed that the securities and the underlying securities had not been
registered under the Securities Act and may not be offered or sold unless
subsequently registered and/or offered, sold or transferred pursuant to an
exemption from the registration requirements.
On September 9, 2003, the Company entered into a $25,000 Convertible
Promissory Note bearing 8% interest for a term of 180 days to an individual
accredited investor. The term was extended to October 16, 2004, the closing date
of the Private Placement. Immediately upon the closing of the Private Placement,
and in accordance with the terms of the Promissory Note, all outstanding
principal and accrued interest converted into 272,711 shares of our common stock
along with five-year warrants to purchase an additional 136,356 shares of common
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stock at $.50 per share releasing the Company from any further obligation under
the Note. No general solicitation or advertising was undertaken in connection
with the offer and sale of the Note. The investor represented to the Company
that the investor was purchasing the Note for the investor's own account and not
with a present view towards the distribution thereof. In addition, the investor
acknowledged and agreed that the Note and the underlying securities had not been
registered under the Securities Act and may not be offered or sold unless
subsequently registered and/or offered, sold or transferred pursuant to an
exemption from the registration requirements. Therefore, the Company believes
that the securities were offered and sold in reliance upon exemptions from
registration pursuant to Section 4(2) under the Securities Act of 1933, as
amended, and Rule 506 promulgated thereunder.
On September 9, 2003, the Company entered into a $25,000 Convertible
Promissory Note bearing 8% interest for a term of 180 days to an individual
accredited investor. The term was extended to October 16, 2004, the closing date
of the Private Placement. Immediately upon the closing of the Private Placement,
and in accordance with the terms of the Promissory Note, all outstanding
principal and accrued interest converted into 371,847 shares of our common stock
along with five-year warrants to purchase an additional 185,924 shares of common
stock at $.50 per share releasing the Company from any further obligation under
the Note. No general solicitation or advertising was undertaken in connection
with the offer and sale of the Note. The investor represented to the Company
that the investor was purchasing the Note for the investor's own account and not
with a present view towards the distribution thereof. In addition, the investor
acknowledged and agreed that the Note and the underlying securities had not been
registered under the Securities Act and may not be offered or sold unless
subsequently registered and/or offered, sold or transferred pursuant to an
exemption from the registration requirements. Therefore, the Company believes
that the securities were offered and sold in reliance upon exemptions from
registration pursuant to Section 4(2) under the Securities Act of 1933, as
amended, and Rule 506 promulgated thereunder.
On September 23, 2003, the Company entered into a $125,000 Convertible
Promissory Note bearing 8% interest for a term of 180 days to an individual
accredited investor. The term was extended to October 16, 2004, the closing date
of the Private Placement. Immediately upon the closing of the Private Placement,
and in accordance with the terms of the Promissory Note, all outstanding
principal and accrued interest converted into 1,359,511 shares of our common
stock along with five-year warrants to purchase an additional 679,756 shares of
common stock at $.50 per share releasing the Company from any further obligation
under the Note. No general solicitation or advertising was undertaken in
connection with the offer and sale of the Note. The investor represented to the
Company that the investor was purchasing the Note for the investor's own account
and not with a present view towards the distribution thereof. In addition, the
investor acknowledged and agreed that the Note and the underlying securities had
not been registered under the Securities Act and may not be offered or sold
unless subsequently registered and/or offered, sold or transferred pursuant to
an exemption from the registration requirements. Therefore, the Company believes
that the securities were offered and sold in reliance upon exemptions from
registration pursuant to Section 4(2) under the Securities Act of 1933, as
amended, and Rule 506 promulgated thereunder.
On September 25, 2003, the Company entered into a $25,000 Convertible
Promissory Note bearing 8% interest for a term of 180 days to an individual
accredited investor. The term was extended to October 16, 2004, the closing date
of the Private Placement. Immediately upon the closing of the Private Placement,
and in accordance with the terms of the Promissory Note, all outstanding
principal and accrued interest converted into 271,787 shares of our common stock
along with five-year warrants to purchase an additional 135,894 shares of common
stock at $.50 per share releasing the Company from any further obligation under
the Note. No general solicitation or advertising was undertaken in connection
with the offer and sale of the Note. The investor represented to the Company
that the investor was purchasing the Note for the investor's own account and not
with a present view towards the distribution thereof. In addition, the investor
acknowledged and agreed that the Note and the underlying securities had not been
registered under the Securities Act and may not be offered or sold unless
subsequently registered and/or offered, sold or transferred pursuant to an
exemption from the registration requirements. Therefore, the Company believes
that the securities were offered and sold in reliance upon exemptions from
registration pursuant to Section 4(2) under the Securities Act of 1933, as
amended, and Rule 506 promulgated thereunder.
On September 26, 2003, the Company entered into a $30,000 Convertible
Promissory Note bearing 8% interest per month with the father of one of our
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Directors. The principal on the note was subsequently repaid. On January 28,
2005 in accordance with the terms of the Promissory Note, accrued interest of
$2,040.55 was converted into 27,207 shares of our common stock releasing the
Company from any further obligation under the Note. These shares have been
accrued pending issuance. No general solicitation or advertising was undertaken
in connection with the offer and sale of the Note. The investor represented to
the Company that the investor was purchasing the Note for the investor's own
account and not with a present view towards the distribution thereof. In
addition, the investor acknowledged and agreed that the Note and the underlying
securities had not been registered under the Securities Act and may not be
offered or sold unless subsequently registered and/or offered, sold or
transferred pursuant to an exemption from the registration requirements.
Therefore, the Company believes that the securities were offered and sold in
reliance upon exemptions from registration pursuant to Section 4(2) under the
Securities Act of 1933, as amended, and Rule 506 promulgated thereunder.
On September 29, 2003, the Company entered into a $25,000 Convertible
Promissory Note bearing 8% interest for a term of 180 days to an individual
accredited investor. The term was extended to October 16, 2004, the closing date
of the Private Placement. Immediately upon the closing of the Private Placement,
and in accordance with the terms of the Promissory Note, all outstanding
principal and accrued interest converted into 271,556 shares of our common stock
along with five-year warrants to purchase an additional 135,778 shares of common
stock at $.50 per share releasing the Company from any further obligation under
the Note. No general solicitation or advertising was undertaken in connection
with the offer and sale of the Note. The investor represented to the Company
that the investor was purchasing the Note for the investor's own account and not
with a present view towards the distribution thereof. In addition, the investor
acknowledged and agreed that the Note and the underlying securities had not been
registered under the Securities Act and may not be offered or sold unless
subsequently registered and/or offered, sold or transferred pursuant to an
exemption from the registration requirements. Therefore, the Company believes
that the securities were offered and sold in reliance upon exemptions from
registration pursuant to Section 4(2) under the Securities Act of 1933, as
amended, and Rule 506 promulgated thereunder.
In October through December 2003, we sold and issued ten 8% secured
convertible promissory notes ("Fourth Quarter Notes") in the aggregate principal
amount of $391,000 that were due 180 days from the date of issuance. The ten
accredited investors who received the Fourth Quarter Notes were also issued
five-year warrants to purchase a total of 391,000 shares of our common stock at
an exercise price of $1.00 per share. The securities were offered and sold in
reliance upon exemption from registration pursuant to Section 4(2) of the
Securities Act and Rule 506 promulgated thereunder. No general solicitation or
advertising was undertaken in connection with the offer and sale of the Fourth
Quarter Notes. Each investor represented to the Company that the investor was
purchasing the Fourth Quarter Notes for the investor's own account and not with
a present view towards the distribution thereof. In addition, each investor
acknowledged and agreed that the Fourth Quarter Notes and the underlying
securities had not been registered under the Securities Act and may not be
offered or sold unless subsequently registered and/or offered, sold or
transferred pursuant to an exemption from the registration requirements.
In October 2003 through December 2003, we issued, in exchange for
accounting, marketing, business consulting, investor relations and public
relations services valued at approximately $85,861, five-year warrants to eight
investors for the purchase of an aggregate of 169,572 shares of our common stock
at exercise prices ranging from $0.25 to $2.00 per share. The securities were
offered and sold in reliance upon exemption from registration pursuant to
Section 4(2) of the Securities Act and Rule 506 promulgated thereunder. The
investors were financially able to bear the economic risk of the investment and
capable of evaluating the merits and risks of the acquisition of the securities.
Each investor also had received and reviewed all information necessary or
appropriate for deciding whether to purchase the securities, including the
Company's periodic SEC reports. No general solicitation or advertising was
undertaken in connection with the offer and sale of the securities. Each
investor represented to the Company that the investor was purchasing the
securities for the investor's own account and not with a present view towards
the distribution thereof. In addition, each investor acknowledged and agreed
that the securities had not been registered under the Securities Act and may not
be offered or sold unless subsequently registered and/or offered, sold or
transferred pursuant to an exemption from the registration requirements.
On November 10, 2003, the Company entered into a $50,000 Convertible
Promissory Note bearing 8% interest for a term of 180 days to an individual
accredited investor. The term was extended to October 16, 2004, the closing date
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of the Private Placement. Immediately upon the closing of the Private Placement,
and in accordance with the terms of the Promissory Note, all outstanding
principal and accrued interest converted into 538,374 shares of our common stock
along with five-year warrants to purchase an additional 269,187 shares of common
stock at $.50 per share releasing the Company from any further obligation under
the Note. No general solicitation or advertising was undertaken in connection
with the offer and sale of the Note. The investor represented to the Company
that the investor was purchasing the Note for the investor's own account and not
with a present view towards the distribution thereof. In addition, the investor
acknowledged and agreed that the Note and the underlying securities had not been
registered under the Securities Act and may not be offered or sold unless
subsequently registered and/or offered, sold or transferred pursuant to an
exemption from the registration requirements. Therefore, the Company believes
that the securities were offered and sold in reliance upon exemptions from
registration pursuant to Section 4(2) under the Securities Act of 1933, as
amended, and Rule 506 promulgated thereunder.
On November 18, 2003, the Company entered into a $16,000 Convertible
Promissory Note bearing 8% interest for a term of 220 days to an individual
accredited investor. The term was extended to October 16, 2004, the closing date
of the Private Placement. Immediately upon the closing of the Private Placement,
and in accordance with the terms of the Promissory Note, $5,000 of the
outstanding principal was paid back in cash and the remaining $11,000 of the
principal plus accrued interest converted into 129,886 shares of our common
stock along with five-year warrants to purchase an additional 64,943 shares of
common stock at $.50 per share releasing the Company from any further obligation
under the Note. No general solicitation or advertising was undertaken in
connection with the offer and sale of the Note. The investor represented to the
Company that the investor was purchasing the Note for the investor's own account
and not with a present view towards the distribution thereof. In addition, the
investor acknowledged and agreed that the Note and the underlying securities had
not been registered under the Securities Act and may not be offered or sold
unless subsequently registered and/or offered, sold or transferred pursuant to
an exemption from the registration requirements. Therefore, the Company believes
that the securities were offered and sold in reliance upon exemptions from
registration pursuant to Section 4(2) under the Securities Act of 1933, as
amended, and Rule 506 promulgated thereunder.
On December 12, 2003, the Company entered into a $20,000 Convertible
Promissory Note bearing 8% interest per month with an accredited investor, the
mother-in-law Of our Chief Executive Officer. The principal on the note was
subsequently repaid. On October 15, 2004 in accordance with the terms of the
Promissory Note, accrued interest of $1,354.52 was converted into 13,454 shares
of our common stock releasing the Company from any further obligation under the
Note. These shares have been accrued pending issuance. No general solicitation
or advertising was undertaken in connection with the offer and sale of the
securities. The investor represented to the Company that the investor was
purchasing the securities for the investor's own account and not with a present
view towards the distribution thereof. In addition, the investor acknowledged
and agreed that the securities had not been registered under the Securities Act
and may not be offered or sold unless subsequently registered and/or offered,
sold or transferred pursuant to an exemption from the registration requirements.
Therefore, the Company believes that the securities were offered and sold in
reliance upon exemptions from registration pursuant to Section 4(2) under the
Securities Act of 1933, as amended, and Rule 506 promulgated thereunder.
In January 2004, we entered into a 12% senior secured promissory note
("Senior Note") that had a term of 90 days. As an additional incentive to enter
into the Senior Note, we issued 600,000 shares of our common stock to the note
holder, and such shares were valued at $600,000. In April 2004, the Senior Note
was paid and we entered into a new 12% senior secured promissory note ("New
Senior Note") that had a term of 90 days. As an additional incentive to enter
into the New Senior Note, we issued another 600,000 shares of our common stock
to the note holder, and such shares were also valued at $600,000. The note
holders were financially able to bear the economic risk of the investment and
capable of evaluating the merits and risks of the acquisition of the securities.
Each note holder also had received and reviewed all information necessary or
appropriate for deciding whether to purchase the securities, including the
Company's periodic SEC reports. No general solicitation or advertising was
undertaken in connection with the offer and sale of the shares. The note holder
represented to the Company that the note holder was purchasing the securities
for the note holder's own account and not with a present view towards the
distribution thereof. In addition, the note holder acknowledged and agreed that
the shares had not been registered under the Securities Act and may not be
offered or sold unless subsequently registered and/or offered, sold or
transferred pursuant to an exemption from the registration requirements.
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Therefore, the Company believes that the shares were offered and sold in
reliance upon exemptions from registration pursuant to Section 4(2) under the
Securities Act of 1933, as amended, and Rule 506 promulgated thereunder.
In February 2004, we issued 40,000 shares of our common stock at $0.62
per share to a consultant that is an accredited investor in exchange for public
relations services to be provided through August 2004. The services were valued
at approximately $24,800. No general solicitation or advertising was undertaken
in connection with the offer and sale of the shares. The consultant represented
to the Company that the consultant was purchasing the securities for the
consultant's own account and not with a present view towards the distribution
thereof. In addition, the consultant acknowledged and agreed that the shares had
not been registered under the Securities Act and may not be offered or sold
unless subsequently registered and/or offered, sold or transferred pursuant to
an exemption from the registration requirements. Therefore, the Company believes
that the shares were offered and sold in reliance upon exemptions from
registration pursuant to Section 4(2) under the Securities Act of 1933, as
amended, and Rule 506 promulgated thereunder.
In March 2004, we sold and issued 8,000 shares of our common stock at
$0.15 per share for an aggregate purchase price of $1,200 to an investor. The
investor was financially able to bear the economic risk of the investment and
capable of evaluating the merits and risks of the acquisition of the securities.
The investor also had received and reviewed all information necessary or
appropriate for deciding whether to purchase the securities, including the
Company's periodic SEC reports. No general solicitation or advertising was
undertaken in connection with the offer and sale of the shares. Each investor
represented to the Company that the investor was purchasing the securities for
the investor's own account and not with a present view towards the distribution
thereof. In addition, the investor acknowledged and agreed that the shares had
not been registered under the Securities Act and may not be offered or sold
unless subsequently registered and/or offered, sold or transferred pursuant to
an exemption from the registration requirements. Therefore, the Company believes
that the shares were offered and sold in reliance upon exemptions from
registration pursuant to Section 4(2) under the Securities Act of 1933, as
amended, and Rule 506 promulgated thereunder.
In May 2004 we also issued 350,000 shares of our common stock to a note
holder upon conversion of a note payable in the principal amount of $35,000 plus
accrued interest. No general solicitation or advertising was undertaken in
connection with the offer and sale of the shares. The note holder represented to
the Company that the he was acquiring the shares for the his own account and not
with a present view towards the distribution thereof. In addition, the note
holder acknowledged and agreed that the shares had not been registered under the
Securities Act and may not be offered or sold unless subsequently registered
and/or offered, sold or transferred pursuant to an exemption from the
registration requirements. Therefore, the Company believes that the shares were
offered and sold in reliance upon exemptions from registration pursuant to
Section 4(2) under the Securities Act of 1933, as amended, and Rule 506
promulgated thereunder.
In April 2004 extended a 90 day offer to purchase certain rights to our
patents for Homspera for $30,000 to an accredited investor. On August 17, 2004,
at the conclusion of the 90-day period, if not exercised, the option would
convert into common shares of stock and warrants. In accordance with the terms
of the option, upon expiration the $30,000 was converted into 240,000 shares of
our common stock along with five-year warrants to purchase an additional 120,000
shares of common stock at $.50 per share. No general solicitation or advertising
was undertaken in connection with the offer and sale of the securities. The
investor represented to the Company that the he was acquiring the shares for the
his own account and not with a present view towards the distribution thereof. In
addition, the investor acknowledged and agreed that the securities had not been
registered under the Securities Act and may not be offered or sold unless
subsequently registered and/or offered, sold or transferred pursuant to an
exemption from the registration requirements. Therefore, the Company believes
that the securities were offered and sold in reliance upon exemptions from
registration pursuant to Section 4(2) under the Securities Act of 1933, as
amended, and Rule 506 promulgated thereunder.
On May 6, 2004, the Company entered into a $2,500 Convertible
Promissory Note bearing 12% interest for a term of 160 days to an individual
accredited investor. The term was extended to October 16, 2004, the closing date
of the Private Placement. Immediately upon the closing of the Private Placement,
and in accordance with the terms of the Promissory Note, all outstanding
principal and accrued interest converted into 26,608 shares of our common stock
along with five-year warrants to purchase an additional 13,304 shares of common
ii-7
stock at $.50 per share releasing the Company from any further obligation under
the Note. No general solicitation or advertising was undertaken in connection
with the offer and sale of the Note. The investor represented to the Company
that the investor was purchasing the Note for the investor's own account and not
with a present view towards the distribution thereof. In addition, the investor
acknowledged and agreed that the Note and the underlying securities had not been
registered under the Securities Act and may not be offered or sold unless
subsequently registered and/or offered, sold or transferred pursuant to an
exemption from the registration requirements. Therefore, the Company believes
that the securities were offered and sold in reliance upon exemptions from
registration pursuant to Section 4(2) under the Securities Act of 1933, as
amended, and Rule 506 promulgated thereunder.
On May 14, 2004, the Company entered into a $75,000 Convertible
Promissory Note bearing 12% interest for a term of 160 days to an individual
accredited investor. The term was extended to October 16, 2004, the closing date
of the Private Placement. Immediately upon the closing of the Private Placement,
and in accordance with the terms of the Promissory Note, all outstanding
principal and accrued interest converted into 788,750 shares of our common stock
along with five-year warrants to purchase an additional 394,375 shares of common
stock at $.50 per share releasing the Company from any further obligation under
the Note. No general solicitation or advertising was undertaken in connection
with the offer and sale of the Note. The investor represented to the Company
that the investor was purchasing the Note for the investor's own account and not
with a present view towards the distribution thereof. In addition, the investor
acknowledged and agreed that the Note and the underlying securities had not been
registered under the Securities Act and may not be offered or sold unless
subsequently registered and/or offered, sold or transferred pursuant to an
exemption from the registration requirements. Therefore, the Company believes
that the securities were offered and sold in reliance upon exemptions from
registration pursuant to Section 4(2) under the Securities Act of 1933, as
amended, and Rule 506 promulgated thereunder.
In May 2004, we issued five-year warrants to purchase 500,000 shares of
our common stock at an exercise price of $0.25 per share to each of one of our
founders and our Chief Executive Officer, Michael Wilhelm. The securities were
issued in reliance upon exemptions from registration pursuant to Section 4(2)
under the Securities Act of 1933, as amended, and Rule 506 promulgated
thereunder.
In May 2004 we also issued 125,000 shares of our common stock at $0.20
per share to a consultant as a due diligence fee. The consultant was financially
able to bear the economic risk of the investment and capable of evaluating the
merits and risks of the acquisition of the shares. The consultant also had
received and reviewed all information necessary or appropriate for deciding
whether to purchase the shares, including the Company's periodic SEC reports. No
general solicitation or advertising was undertaken in connection with the offer
and sale of the shares. The consultant represented to the Company that the
consultant was purchasing the securities for the consultant's own account and
not with a present view towards the distribution thereof. In addition, the
consultant acknowledged and agreed that the shares had not been registered under
the Securities Act and may not be offered or sold unless subsequently registered
and/or offered, sold or transferred pursuant to an exemption from the
registration requirements. Therefore, the Company believes that the shares were
offered and sold in reliance upon exemptions from registration pursuant to
Section 4(2) under the Securities Act of 1933, as amended, and Rule 506
promulgated thereunder.
In May 2004 we also issued 500,000 shares of our common stock to a
consultant in exchange for business consulting services to be provided through
December 2004, and the stock price of $1.00 per share was determined as of the
date that we entered into the related consulting agreement in December 2003. The
consultant was financially able to bear the economic risk of the investment and
capable of evaluating the merits and risks of the acquisition of the shares. The
consultant also had received and reviewed all information necessary or
appropriate for deciding whether to purchase the shares, including the Company's
periodic SEC reports. No general solicitation or advertising was undertaken in
connection with the offer and sale of the shares. The consultant represented to
the Company that the consultant was purchasing the securities for the
consultant's own account and not with a present view towards the distribution
thereof. In addition, the consultant acknowledged and agreed that the shares had
not been registered under the Securities Act and may not be offered or sold
unless subsequently registered and/or offered, sold or transferred pursuant to
an exemption from the registration requirements. Therefore, the Company believes
that the shares were offered and sold in reliance upon exemptions from
registration pursuant to Section 4(2) under the Securities Act of 1933, as
amended, and Rule 506 promulgated thereunder.
ii-8
On June 18, 2004, the Company entered into a $10,000 Convertible
Promissory Note bearing 8% interest for a term of 120 days to an individual
accredited investor. The term was extended to October 16, 2004, the closing date
of the Private Placement. Immediately upon the closing of the Private Placement,
and in accordance with the terms of the Promissory Note, all outstanding
principal and accrued interest converted into 136,919 shares of our common stock
along with five-year warrants to purchase an additional 68,460 shares of common
stock at $.50 per share releasing the Company from any further obligation under
the Note. No general solicitation or advertising was undertaken in connection
with the offer and sale of the Note. The investor represented to the Company
that the investor was purchasing the Note for the investor's own account and not
with a present view towards the distribution thereof. In addition, the investor
acknowledged and agreed that the Note and the underlying securities had not been
registered under the Securities Act and may not be offered or sold unless
subsequently registered and/or offered, sold or transferred pursuant to an
exemption from the registration requirements. Therefore, the Company believes
that the securities were offered and sold in reliance upon exemptions from
registration pursuant to Section 4(2) under the Securities Act of 1933, as
amended, and Rule 506 promulgated thereunder.
In July 2004, we issued 250,000 shares of common stock at $0.10 per
share to an accredited entity in exchange for Investor and Public Relations
services to be provided though July, 2005. The services were valued at
approximately $25,000. No general solicitation or advertising was undertaken in
connection with the offer and sale of the shares. The consultant represented to
the Company that the consultant was purchasing the securities for the
consultant's own account and not with a present view towards the distribution
thereof. In addition, the consultant acknowledged and agreed that the shares had
not been registered under the Securities Act and may not be offered or sold
unless subsequently registered and/or offered, sold or transferred pursuant to
an exemption from registration requirements. Therefore, the Company believes
that the shares were offered and sold in reliance upon exemptions from
registration pursuant to Section 4(2) under the Securities act of 1933, as
amended, and Rule 506 promulgated thereunder.
In August 2004, we issued 100,000 shares of common stock at $0.14 per
share to an accredited consultant in exchange for Strategic Planning services to
be provided though October 2004. The services were valued at approximately
$14,000. No general solicitation or advertising was undertaken in connection
with the offer and sale of the shares. The consultant represented to the Company
that the consultant was purchasing the securities for the consultant's own
account and not with a present view towards the distribution thereof. In
addition, the consultant acknowledged and agreed that the shares had not been
registered under the Securities Act and may not be offered or sold unless
subsequently registered and/or offered, sold or transferred pursuant to an
exemption from registration requirements. Therefore, the Company believes that
the shares were offered and sold in reliance upon exemptions from registration
pursuant to Section 4(2) under the Securities act of 1933, as amended, and Rule
506 promulgated thereunder.
In July and September of 2004, we issued a total of 200,000 shares of
common stock at $0.41 per share to an accredited consultant in exchange for
financial consulting services to be provided though April 2005. The services
were valued at approximately $82,000. No general solicitation or advertising was
undertaken in connection with the offer and sale of the shares. The consultant
represented to the Company that the consultant was purchasing the securities for
the consultant's own account and not with a present view towards the
distribution thereof. In addition, the consultant acknowledged and agreed that
the shares had not been registered under the Securities Act and may not be
offered or sold unless subsequently registered and/or offered, sold or
transferred pursuant to an exemption from registration requirements. Therefore,
the Company believes that the shares were offered and sold in reliance upon
exemptions from registration pursuant to Section 4(2) under the Securities act
of 1933, as amended, and Rule 506 promulgated thereunder.
On August 16, 2004, the Company entered into a $15,000 Convertible
Promissory Note bearing $500 interest per month for a term of 30 days to an
individual accredited investor. The term was extended to October 16, 2004, the
closing date of the Private Placement. Immediately upon the closing of the
Private Placement, and in accordance with the terms of the Promissory Note, all
outstanding principal and accrued interest converted into 131,467 shares of our
common stock along with five-year warrants to purchase an additional 65,734
shares of common stock at $.50 per share releasing the Company from any further
obligation under the Note. No general solicitation or advertising was undertaken
ii-9
in connection with the offer and sale of the Note. The investor represented to
the Company that the investor was purchasing the Note for the investor's own
account and not with a present view towards the distribution thereof. In
addition, the investor acknowledged and agreed that the Note and the underlying
securities had not been registered under the Securities Act and may not be
offered or sold unless subsequently registered and/or offered, sold or
transferred pursuant to an exemption from the registration requirements.
Therefore, the Company believes that the securities were offered and sold in
reliance upon exemptions from registration pursuant to Section 4(2) under the
Securities Act of 1933, as amended, and Rule 506 promulgated thereunder.
On August 23, 2004, the Company entered into a $5,000 Convertible
Promissory Note bearing 8% interest per month to an individual accredited
investor. On October 26, 2004 in accordance with the terms of the Promissory
Note, principal of $5,000 and accrued interest of $71 was converted into 67,613
shares of our common stock releasing the Company from any further obligation
under the Note. These shares have been accrued pending issuance. No general
solicitation or advertising was undertaken in connection with the offer and sale
of the Note. The investor represented to the Company that the investor was
purchasing the Note for the investor's own account and not with a present view
towards the distribution thereof. In addition, the investor acknowledged and
agreed that the Note and the underlying securities had not been registered under
the Securities Act and may not be offered or sold unless subsequently registered
and/or offered, sold or transferred pursuant to an exemption from the
registration requirements. Therefore, the Company believes that the securities
were offered and sold in reliance upon exemptions from registration pursuant to
Section 4(2) under the Securities Act of 1933, as amended, and Rule 506
promulgated thereunder.
In September 2004, we issued 127,276 shares of common stock at $0.12 -
$0.22 per share to an accredited consultant in exchange for financial consulting
services provided though September 2004. The services were valued at
approximately $16,909. No general solicitation or advertising was undertaken in
connection with the offer and sale of the shares. The consultant represented to
the Company that the consultant was purchasing the securities for the
consultant's own account and not with a present view towards the distribution
thereof. In addition, the consultant acknowledged and agreed that the shares had
not been registered under the Securities Act and may not be offered or sold
unless subsequently registered and/or offered, sold or transferred pursuant to
an exemption from registration requirements. Therefore, the Company believes
that the shares were offered and sold in reliance upon exemptions from
registration pursuant to Section 4(2) under the Securities act of 1933, as
amended, and Rule 506 promulgated thereunder.
In October 2004, we completed a private placement, whereby we sold an
aggregate of $2,450,000 worth of units to accredited investors (the "Private
Placement"). Each unit was sold for $10,000 (the "Unit Price") and consisted of
(a) a number of shares of our common stock determined by dividing the Unit Price
by $0.125, and (b) a warrant to purchase, at any time prior to the fifth
anniversary following the date of issuance of the warrant, a number of shares of
our common stock equal to fifty percent (50%) of the number of shares included
within the unit, at a price equal to $0.50 per share of common stock. Thus, each
unit consisted of 80,000 shares of our common stock and a five-year warrant to
purchase an additional 40,000 shares of our common stock at an exercise price of
$0.50 per share. We issued an aggregate 27,560,897 shares of our common stock
and warrants to purchase 13,780,449 shares of our common stock in the Private
Placement. In consideration of the investment, we granted to each investor
certain registration rights and anti-dilution rights. The registration rights
provide, if the Registration Statement is not effective as of 90-days following
the second closing date (October 26, 2004), we must issue to the holders of
units sold in the Private Offering an additional 2% of their securities each
month. As of March 31, 2006, we have accrued liabilities to issue 6,625,907
shares of common stock and warrants to purchase an additional 2,608,987 shares
for total shares of 9,234,895. No general solicitation or advertising was
undertaken in connection with the offer and sale of the Units. The investors
each represented to the Company that the investor was purchasing Units for the
his or her own account and not with a present view towards the distribution
thereof. In addition, each investor acknowledged and agreed that the Units and
the underlying securities had not been registered under the Securities Act and
may not be offered or sold unless subsequently registered and/or offered, sold
or transferred pursuant to an exemption from the registration requirements. The
securities were offered and sold in reliance upon exemption from registration
pursuant to Section 4(2) of the Securities Act and Rule 506 promulgated
thereunder.
Further to the Private Placement, on October 26, 2004 we entered into a
settlement agreement with 8 accredited creditors whereby for full and complete
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satisfaction of claims totaling an aggregate of $157,218 (the "Claim Amount"),
we issued to the creditors the following: (a) a number of shares of our common
stock determined by dividing the Claim Amount by $0.125, and (b) warrants to
purchase, at any time prior to the fifth anniversary following the date of
issuance of the warrant, a number of shares of our common stock equal to fifty
percent (50%) of the number of shares described above, at a price equal to $0.50
per share of common stock. The warrants are identical to the warrants issued in
the Private Placement. No general solicitation or advertising was undertaken in
connection with the offer and sale of the securities. The investors each
represented to the Company that the investor was acquiring the securities for
the his or her own account and not with a present view towards the distribution
thereof. In addition, each investor acknowledged and agreed that the securities
had not been registered under the Securities Act and may not be offered or sold
unless subsequently registered and/or offered, sold or transferred pursuant to
an exemption from the registration requirements. The securities were offered and
sold in reliance upon exemption from registration pursuant to Section 4(2) of
the Securities Act and Rule 506 promulgated thereunder.
Pursuant to the terms of a placement agency agreement, dated September
3, 2004, by and between us and Joseph Stevens & Co., Inc., we issued 4,900,000
shares of our common stock to Joseph Stevens & Co., Inc. or its designees, upon
the closing of the Private Placement. The shares were issued as consideration
for the services of Joseph Stevens & Co., Inc. as our placement agent in the
Private Placement. There were 98 accredited investors who purchased units in the
Private Placement. The securities were offered and sold in reliance upon
exemption from registration pursuant to Section 4(2) of the Securities Act and
Rule 506 promulgated thereunder.
In September 2004 we entered into a settlement agreement with one of
our Directors, Theodore Staahl, whereby for full and complete satisfaction of
claims totaling $10,263.01, we issued to our Director 93,300 shares of our
common stock, determined by dividing the amount owed by $0.11. Under the terms
of the settlement agreement, our Director released us from all claims, known or
unknown, relating to the amount owed. The securities were issued in reliance
upon exemptions from registration pursuant to Section 4(2) under the Securities
Act of 1933, as amended, and Rule 506 promulgated thereunder. The Director
qualified as an accredited investor (as defined by Rule 501 under the Securities
Act of 1933, as amended).
On November 18, 2004 we issued warrants to a member of our Bioterrorism
Preparedness Advisory Board to purchase, at any time prior to the third
anniversary following the date of issuance of the warrant, a number of shares of
our common stock equal to 50,000, at a price equal to $0.125 per share of common
stock for advice on logistics, introductions to various organizations and
attendance of meetings. No general solicitation or advertising was undertaken in
connection with the offer and sale of the securities. The investor acknowledged
and agreed that the securities had not been registered under the Securities Act
and may not be offered or sold unless subsequently registered and/or offered,
sold or transferred pursuant to an exemption from the registration requirements.
The securities were issued in reliance upon exemptions from registration
pursuant to Section 4(2) under the Securities Act of 1933, as amended, and Rule
506 promulgated thereunder. The investor qualified as an accredited investor (as
defined by Rule 501 under the Securities Act of 1933, as amended).
On December 16, 2004 we issued warrants to a member of our Oncology and
Dermatology Advisory Board to purchase, at any time prior to the third
anniversary following the date of issuance of the warrant, a number of shares of
our common stock equal to 10,000, at a price equal to $0.50 per share of common
stock for advice on potential oncology applications for Homspera. No general
solicitation or advertising was undertaken in connection with the offer and sale
of the securities. The investor acknowledged and agreed that the securities had
not been registered under the Securities Act and may not be offered or sold
unless subsequently registered and/or offered, sold or transferred pursuant to
an exemption from the registration requirements. The securities were issued in
reliance upon exemptions from registration pursuant to Section 4(2) under the
Securities Act of 1933, as amended, and Rule 506 promulgated thereunder. The
investor qualified as an accredited investor (as defined by Rule 501 under the
Securities Act of 1933, as amended).
In January 2005, we made a tender offer to temporarily reduce the
exercise price of certain warrants issued in October 2004 from $0.50 to $0.20
per share. The tender offer expired on March 4, 2005. We accepted for exercise a
total of 6,600,778 warrants validly tendered and not withdrawn pursuant to the
terms of the tender offer, which represents approximately 48% of the aggregate
13,780,449 warrants that were subject to the offer. The tender offer was made in
reliance upon exemption from registration pursuant to Sections 3(a)(9), which
ii-11
provide an exemption for any security exchanged by the issuer with its existing
security holders where no commission or other remuneration is paid or given
directly or indirectly for soliciting such exchange. We did not pay or give any
commission or other remuneration to any person for soliciting the tender offer.
The tender offer also falls within Section 4(2) of the Securities Act since all
the investors were current holders of the warrants and received their securities
from the October 2004 private placement or from issuances in October 2004
pursuant to the terms of settlement agreements or convertible promissory notes.
These transactions were conducted under Section 4(2) and the rules and
regulations promulgated thereunder, including Regulation D.
In May 2005, per his employment agreement we issued 100,000 shares of
our common stock to our Chief Financial Officer, John Fermanis. No general
solicitation or advertising was undertaken in connection with the offer and sale
of the shares. The Company's Chief Financial Officer qualifies as an "accredited
investor" and acknowledged and agreed that the shares had not been registered
under the Securities Act and may not be offered or sold unless subsequently
registered and/or offered, sold or transferred pursuant to an exemption from the
registration requirements. The securities were issued in reliance upon
exemptions from registration pursuant to Section 4(2) under the Securities Act
of 1933, as amended, and Rule 506 promulgated thereunder.
On June 13, 2005, the Company issued 80,000 shares of common stock for
cash of $4,000 pursuant to the exercise of a warrant at $0.05 per share. On
April 15, 2004, the Company entered into a $5,000 Convertible Promissory Note
bearing 12% interest for a term of 60 days to an individual investor. The term
of the Note was extended to June 30, 2004. As additional incentive to the
extension of the note, the investor was issued 5-year warrants to purchase up to
40,000 shares of common stock at $0.05 per share. The term of the Note was again
extended to October 16, 2004, the closing date of the Private Placement. As
additional incentive to the extension of the note, the investor was issued
5-year warrants to purchase up to 40,000 shares of common stock at$0.05 per
share. Immediately upon the closing of the Private Placement, and in accordance
with the terms of the Promissory Note, the principal of $5,000 and $299.56 of
accrued interest was repaid to the investor releasing the Company from any
further obligation under the warrants. The investor was financially able to bear
ii-12
the economic risk of the investment and capable of evaluating the merits and
risks of the acquisition of the warrants. The investor also had received and
reviewed all information necessary or appropriate for deciding whether to
purchase the shares, including the Company's periodic SEC reports. No general
solicitation or advertising was undertaken in connection with the offer and sale
of the warrants. The investor represented to the Company that the investor was
purchasing the warrants for the investor's own account and not with a present
view towards the distribution thereof. In addition, the investor acknowledged
and agreed that the warrants and the underlying securities had not been
registered under the Securities Act and may not be offered or sold unless
subsequently registered and/or offered, sold or transferred pursuant to an
exemption from the registration requirements. Therefore, the Company believes
that the securities were offered and sold in reliance upon exemptions from
registration pursuant to Section 4(2) under the Securities Act of 1933, as
amended, and Rule 506 promulgated thereunder.
On September 28, 2001, the Company entered into a $50,000 Convertible
Promissory Note bearing 8% interest per month with an accredited investor. On
June 7, 2005 in accordance with the terms of the Promissory Note, the
outstanding principal and accrued interest was converted into 232,153 shares of
our common stock releasing the Company from any further obligation under the
Note. No general solicitation or advertising was undertaken in connection with
the offer and sale of the Note and the shares. The investor represented to the
Company that the investor was purchasing the securities for the investor's own
account and not with a present view towards the distribution thereof. In
addition, each investor acknowledged and agreed that the note and the shares had
not been registered under the Securities Act and may not be offered or sold
unless subsequently registered and/or offered, sold or transferred pursuant to
an exemption from the registration requirements. Therefore, the Company believes
that the securities were offered and sold in reliance upon exemptions from
registration pursuant to Section 4(2) under the Securities Act of 1933, as
amended, and Rule 506 promulgated thereunder.
In May 2005, for assignment of patents we issued to our Director, Dr.
Mark Witten, 50,000 common stock purchase warrants with a strike price of
$0.125. The warrants expire five years after date of issuance. No general
solicitation or advertising was undertaken in connection with the offer and sale
of the shares. Mr. Witten, as a director of the Company, qualifies as an
"accredited investor" and acknowledged and agreed that the securities had not
been registered under the Securities Act and may not be offered or sold unless
subsequently registered and/or offered, sold or transferred pursuant to an
exemption from the registration requirements. The securities were issued in
reliance upon exemptions from registration pursuant to Section 4(2) under the
Securities Act of 1933, as amended, and Rule 506 promulgated thereunder.
In July 2005, we issued to our Chief Executive Officer, Michael
Wilhelm, per his employment agreement, 150,000 stock options at a weighted
average exercise price of $0.44 per share under our 2003 Stock Option, Deferred
Stock and Restricted Stock Plan. No general solicitation or advertising was
undertaken in connection with the offer and sale of the shares. The Company's
Chief Executive Officer qualifies as an "accredited investor" and acknowledged
and agreed that the securities had not been registered under the Securities Act
and may not be offered or sold unless subsequently registered and/or offered,
sold or transferred pursuant to an exemption from the registration requirements.
The securities were issued in reliance upon exemptions from registration
pursuant to Section 4(2) under the Securities Act of 1933, as amended, and Rule
506 promulgated thereunder.
For the year ended December 31, 2005 we accrued the issuance of 91,888
common stock purchase warrants pursuant to the respective terms of the
employment agreements of our Chief Executive Officer and Chief Financial
Officer. Our Chief Executive Officer is to receive 79,388 warrants with an
exercise price of $0.30 and a term of five years. Our Chief Financial Officer is
to receive 12,500 warrants with an exercise price of $0.41 and a term of five
years. No general solicitation or advertising was undertaken in connection with
the offer and sale of the shares. Each of the Company's Chief Executive Officer
and Chief Financial Officer qualifies as an "accredited investor" and
acknowledged and agreed that the securities had not been registered under the
Securities Act and may not be offered or sold unless subsequently registered
and/or offered, sold or transferred pursuant to an exemption from the
registration requirements. The securities were issued in reliance upon
exemptions from registration pursuant to Section 4(2) under the Securities Act
of 1933, as amended, and Rule 506 promulgated thereunder.
In March 2006, per his employment agreement we issued 100,000 shares of
our common stock to our Chief Financial Officer, John Fermanis. No general
solicitation or advertising was undertaken in connection with the offer and sale
of the shares. The Company's Chief Financial Officer qualifies as an "accredited
investor" and acknowledged and agreed that the shares had not been registered
under the Securities Act and may not be offered or sold unless subsequently
registered and/or offered, sold or transferred pursuant to an exemption from the
registration requirements. The securities were issued in reliance upon
exemptions from registration pursuant to Section 4(2) under the Securities Act
of 1933, as amended, and Rule 506 promulgated thereunder.
As of March 31, 2006 we have accrued the issuance of 287,828 shares of
common stock. Pursuant to the terms of their respective agreements with us
154,464 shares of common stock are to be issued to consultants. Also included is
142,366 shares relating to the conversion of convertible notes. We also accrued
the cancellation of 9,002 shares of common stock as of March 31, 2006 pursuant
to an error in the issuance of the shares. The shares will bear a restrictive
legend regarding the sale or transfer of such. The shares were issued in
reliance upon exemptions from registration pursuant to Section 4(2) under the
Securities Act of 1933, as amended, and Rule 506 promulgated thereunder. Our
Chief Financial Officer and the consultants each qualifies as an accredited
investor (as defined by Rule 501 under the Securities Act of 1933, as amended).
No general solicitation or advertising was undertaken in connection with the
offer and sale of these shares.
As of March 31, 2006 we have accrued the issuance of 526,500 common
stock purchase warrants to members of our Bioterrorism Advisory Board, Drug
Development Advisory Board and Oncology and Dermatology Advisory Board for
participation during the year. These warrants were issued pursuant to the terms
of their respective agreements with us. The exercise prices of these warrants
range from $0.125 to $1.00 per share. The warrants expire three years after date
of issuance. The warrants will bear a restrictive legend regarding the sale or
transfer of such or the underlying securities. The warrants were issued in
reliance upon exemptions from registration pursuant to Section 4(2) under the
Securities Act of 1933, as amended, and Rule 506 promulgated thereunder. There
were less than 35 investors and each investor had such knowledge and experience
in financial and business matters that the investor was capable of evaluating
the merits and risks of investing in the warrants. No general solicitation or
advertising was undertaken in connection with the offer and sale of these
shares. Each investor was also provided with access to our Exchange Act reports
including our annual report on Form 10-KSB and our quarterly reports on Form
10-QSB.
ITEM 27 EXHIBITS AND FINANCIAL STATEMENT SCHEDULES
(A) EXHIBITS
EXHIBIT NUMBER DESCRIPTION OF EXHIBIT
-------------- --------------------------------------------------------------
2.1 Agreement and Plan of Merger dated July 2, 2003 among the
Registrant, GPN Acquisition Corporation and ImmuneRegen
BioSciences, Inc. (incorporated by reference to exhibit 2 of
the Registrant's current report on Form 8-k filed with the
Securities and Exchange Commission on July 7, 2003).
3.1 Certificate of Incorporation filed with the Delaware Secretary
of State on June 4, 1985 (incorporated by reference to exhibit
3.1 of the Registrant's annual report on Form 10-KSB for the
year ended December 31, 2001 filed with the Securities and
Exchange Commission on April 16, 2002).
ii-12
3.1(a) Certificate of Amendment filed with the Delaware Secretary of
State on July 16, 1987 (incorporated by reference to exhibit
3.1(a) of the Registrant's annual report on Form 10-KSB for
the year ended December 31, 2001 filed with the Securities and
Exchange Commission on April 16, 2002).
3.1(b) Certificate of Amendment filed with the Delaware Secretary of
State on February 3, 1992 (incorporated by reference to
exhibit 3.1(b) of the Registrant's annual report on Form
10-KSB for the year ended December 31, 2001 filed with the
Securities and Exchange Commission on April 16, 2002).
3.1(c) Certificate of Amendment filed with the Delaware Secretary of
State on November 23, 1992 (incorporated by reference to
exhibit 3.1(c) of the Registrant's annual report on Form
10-KSB for the year ended December 31, 2001 filed with the
Securities and Exchange Commission on April 16, 2002).
3.1(d) Certificate of Amendment filed with the Delaware Secretary of
State on December 15, 1994 (incorporated by reference to
exhibit 3.1(d) of the Registrant's annual report on Form
10-KSB for the year ended December 31, 2001 filed with the
Securities and Exchange Commission on April 16, 2002).
3.1(e) Certificate of Amendment filed with the Delaware Secretary of
State on November 7, 1995 (incorporated by reference to
exhibit 3.1(e) of the Registrant's annual report on Form
10-KSB for the year ended December 31, 2001 filed with the
Securities and Exchange Commission on April 16, 2002).
3.1(f) Certificate of Amendment filed with the Delaware Secretary of
State on December 30, 1996 (incorporated by reference to
exhibit 3.1(f) of the Registrant's annual report on Form
10-KSB for the year ended December 31, 2001 filed with the
Securities and Exchange Commission on April 16, 2002).
3.1(g) Certificate of Amendment filed with the Delaware Secretary of
State on November 8, 2000 (incorporated by reference to
exhibit 3.1(h) of the Registrant's annual report on Form
10-KSB for the year ended December 31, 2001 filed with the
Securities and Exchange Commission on April 16, 2002).
3.2 Amended and Restated Bylaws of the Registrant dated as of
January 1, 2002 (incorporated by reference to exhibit 3(b) of
the Registrant's annual report on Form 10-KSB for the year
ended December 31, 2001 filed with the Securities and Exchange
Commission on April 16, 2002).
4.1* Specimen Common Stock Certificate.
4.2 2003 Stock Option, Deferred Stock and Restricted Stock Plan
(incorporated by reference to exhibit 4.1 of the Registrant's
registration statement on Form S-8 (file no. 333-113511) filed
with the Securities and Exchange Commission on March 11,
2004).
4.3 Form of Warrant by and between the Registrant and each of the
Investors or Creditors, as the case may be, who entered into
an Agreement filed as Exhibit 10.6, 10.7, 10.8 or 10.9
herewith (incorporated by reference to exhibit 4.1 of the
Registrant's current report on Form 8-K filed with the
Securities and Exchange Commission on October 19, 2004).
4.4 Form of Registration Rights (Annex A to Subscription
Agreement) by and between the Registrant and each of the
Investors who entered into the Agreements filed as Exhibits
10.6 and 10.8 herewith (incorporated by reference to exhibit
4.2 of the Registrant's current report on Form 8-K filed with
the Securities and Exchange Commission on October 19, 2004).
4.5+ Form of Anti-Dilution Rights (Annex B to Subscription
Agreement) by and between the Registrant and each of the
Investors who entered into the Agreements filed as Exhibits
10.6 and 10.8 herewith (incorporated by reference to exhibit
4.3 of the Registrant's current report on Form 8-K filed with
the Securities and Exchange Commission on October 19, 2004).
ii-14
4.6+ Promissory Note issued from the Registrant to SBM Certificate
Company as of April 28, 2004.
5.1* Opinion of Kirkpatrick & Lockhart Nicholson Graham LLP
10.1+ Employment Agreement dated December 16, 2002 between
ImmuneRegen BioSciences, Inc., a subsidiary of the Registrant,
and Michael Wilhelm.
10.2+ Consulting Agreement dated December 16, 2002 between
ImmuneRegen BioSciences, Inc., a subsidiary of the Registrant,
and David Harris.
10.2(a)+ First Amendment to Consulting Agreement dated January 2003
between ImmuneRegen BioSciences, Inc., a subsidiary of the
Registrant, and David Harris.
10.3+ Consulting Agreement dated December 16, 2002 between
ImmuneRegen BioSciences, Inc., a subsidiary of the Registrant,
and Mark Witten.
10.3(a)+ First Amendment to Consulting Agreement dated January 2003
between ImmuneRegen BioSciences, Inc., a subsidiary of the
Registrant, and Mark Witten.
10.4+ License Agreement dated December 16, 2002 among ImmuneRegen
BioSciences, Inc., a subsidiary of the Registrant, David
Harris and Mark Witten.
10.4(a)+ First Amendment to License Agreement dated December 20, 2002
among ImmuneRegen BioSciences, Inc., a subsidiary of the
Registrant, David Harris and Mark Witten.
10.4(b)+ Second Amendment to License Agreement dated June 26, 2003
among ImmuneRegen BioSciences, Inc., a subsidiary of the
Registrant, David Harris and Mark Witten.
10.4(c)+ Assignment Agreement dated February 23, 2005 between
ImmuneRegen BioSciences, Inc., a subsidiary of the Registrant
and Mark Witten.
10.4(d)+ Assignment Agreement dated February 23, 2005 among ImmuneRegen
BioSciences, Inc., a subsidiary of the Registrant, David
Harris and Mark Witten.
10.4(e)+ Assignment Agreement dated November 7, 2005 between
ImmuneRegen BioSciences, Inc., a subsidiary of the Registrant
and Mark Witten.
10.4(f)+ Assignment Agreement dated November 7, 2005 between
ImmuneRegen BioSciences, Inc., a subsidiary of the Registrant
and Mark Witten.
10.4(g)+ Assignment Agreement dated November 7, 2005 between
ImmuneRegen BioSciences, Inc., a subsidiary of the Registrant
and Mark Witten.
10.4(h)+ Assignment Agreement dated November 7, 2005 between
ImmuneRegen BioSciences, Inc., a subsidiary of the Registrant
and Mark Witten.
10.5+ Lease Agreement dated July 1, 2004 between ImmuneRegen
BioSciences, Inc., a subsidiary of the Registrant, and The
Clayton Companies.
10.6 Form of Subscription Agreement entered into as of October 13,
2004 between the Registrant and each of the Investors set
forth on the Schedule of Investors thereto (incorporated by
reference to exhibit 10.1 of the Registrant's current report
on Form 8-K filed with the Securities and Exchange Commission
on October 19, 2004).
10.7 Form of Settlement Agreement entered into as of October 13,
2004 between the Registrant and each of the Creditors set
ii-15
forth on the Schedule of Creditors thereto (incorporated by
reference to exhibit 10.2 of the Registrant's current report
on Form 8-K filed with the Securities and Exchange Commission
on October 19, 2004).
10.8 Form of Subscription Agreement entered into as of October 26,
2004 between the Registrant and each of the Investors set
forth on the Schedule of Investors thereto (incorporated by
reference to exhibit 10.1 of the Registrant's current report
on Form 8-K filed with the Securities and Exchange Commission
on October 27, 2004).
10.9 Form of Settlement Agreement entered into as of October 26,
2004 between the Registrant and each of the Creditors set
forth on the Schedule of Creditors thereto (incorporated by
reference to exhibit 10.2 of the Registrant's current report
on Form 8-K filed with the Securities and Exchange Commission
on October 27, 2004).
10.10 Employment Agreement dated February 15, 2005 between the
Registrant and John N. Fermanis (incorporated by reference to
exhibit 10.10 of the Registrant's Amendment No. 1 on Form
10-K/A to its annual report for the year ended December 31,
2004).
10.11 Employment Agreement dated August 10, 2005 by and between the
Registrant and Michael K. Wilhelm (incorporated by reference
to exhibit 10.1 of the Registrant's quarterly report on Form
10-QSB for the three months ended September 30, 2005).
10.12 Change of Control Agreement dated August 10, 2005 by and
between the Registrant and Michael K. Wilhelm (incorporated by
reference to exhibit 10.2 of the Registrant's quarterly report
on Form 10-QSB for the three months ended September 30, 2005).
10.13 Severance Agreement dated November 7, 2005 by and between the
Registrant and Michael K. Wilhelm (incorporated by reference
to exhibit 10.3 of the Registrant's quarterly report on Form
10-QSB for the three months ended September 30, 2005).
10.14+ Authorization for Regulatory Contact dated November 7, 2005
between ImmuneRegen BioSciences, Inc., a subsidiary of the
Registrant, and Synergos, Inc.
10.15+ Proforma invoice/quotation dated November 7, 2005 from
Sigma-Aldrich, Inc. to ImmuneRegen BioSciences, Inc., a
subsidiary of the Registrant.
10.16+ Letter of acceptance dated October 2, 2003, from Huntingdon
Life Sciences to ImmuneRegen BioSciences, Inc., a subsidiary
of the Registrant.
10.17+ Price Quotation dated June 27, 2003 received by ImmuneRegen
BioSciences, Inc., a subsidiary of the Registrant from AppTec
Laboratory Services.
10.18+ Consulting Agreement dated March 15, 2005 between ImmuneRegen
BioSciences, Inc., a subsidiary of the Registrant and Dr. Hal
Siegel, Ph.D. (Siegel Consultancy).
10.19+ Consulting Agreement dated November 3, 2005 between
ImmuneRegen BioSciences, Inc., a subsidiary of the Registrant
and Dr. Jack Caravelli, Ph.D.
10.20+ Consulting Agreement dated July 29, 2005 between ImmuneRegen
BioSciences, Inc., a subsidiary of the Registrant and Dr.
Kelly McQueen, MD, MPH.
21.1+ Subsidiaries of Registrant.
23.1 Consent of Russell Bedford Stefanou Mirchandani LLP.
23.2* Consent of Kirkpatrick & Lockhart Nicholson Graham, LLP
contained in Exhibit 5.1).
24.1+ Power of Attorney (included on signature page).
----------
+ Previously filed.
* To be filed by amendment.
ii-16
(B) FINANCIAL STATEMENT SCHEDULES
All such schedules have been omitted because the information required
to be set forth therein is not applicable or is shown in the financial
statements or notes thereto.
ITEM 28 UNDERTAKINGS
The undersigned small business issuer hereby undertakes to:
(1) For determining any liability under the Securities Act, treat the
information omitted from this form of prospectus filed as part of this
registration statement in reliance upon Rule 430A and contained in a form of
prospectus filed by the small business issuer under Rule 424(b)(1), or (4) or
497(h) under the Securities Act of 1933 as part of this registration statement
as of the time the Securities and Exchange Commission declared it effective.
(2) For determining any liability under the Securities Act of 1933,
treat each post-effective amendment that contains a form of prospectus as a new
registration statement for the securities offered in this registration
statement, and that offering of the securities at that time as the initial BONA
FIDE offering of those securities.
The undersigned small business issuer hereby undertakes with respect to
the securities being offered and sold in this offering:
(1) To file, during any period in which it offers or sells securities,
a post- effective amendment to this Registration Statement to:
(a) Include any prospectus required by Section 10(a)(3) of the
Securities Act;
(b) Reflect in the prospectus any facts or events which, individually
or together, represent a fundamental change in the information in this
registration statement. Notwithstanding the foregoing, any increase or decrease
in volume of securities offered (if the total dollar value of securities offered
would not exceed that which was registered) and any deviation from the low or
high end of the estimated maximum offering range may be reflected in the form of
prospectus filed with the Securities and Exchange Commission pursuant to Rule
424(b) if, in the aggregate, the changes in volume and price represent no more
than a 20 percent change in the maximum aggregate offering price set forth in
the "Calculation of Registration Fee" table in the effective registration
statement; and
(c) Include any additional or changed material information on the
plan of distribution.
(2) For determining liability under the Securities Act of 1933, treat
each post- effective amendment as a new registration statement of the securities
offered, and the offering of the securities at that time to be the initial BONA
FIDE offering.
(3) File a post-effective amendment to remove from registration any of
the securities that remain unsold at the end of the offering.
(4) For determining liability of the undersigned small business issuer
under the Securities Act to any purchaser in the initial distribution of the
securities, the undersigned small business issuer undertakes that in a primary
offering of securities of the undersigned small business issuer pursuant to this
registration statement, regardless of the underwriting method used to sell the
securities to the purchaser, if the securities are offered or sold to such
purchaser by means of any of the following communications, the undersigned small
business issuer will be a seller to the purchaser and will be considered to
offer or sell such securities to such purchaser:
(a) Any preliminary prospectus or prospectus of the undersigned small
business issuer relating to the offering required to be filed pursuant to Rule
424;
(b) Any free writing prospectus relating to the offering prepared by
ii-17
or on behalf of the undersigned small business issuer or used or referred to
by the undersigned small business issuer;
(c) The portion of any other free writing prospectus relating to the
offering containing material information about the undersigned small business
issuer or its securities provided by or on behalf of the undersigned small
business issuer; and
(d) Any other communication that is an offer in the offering made by
the undersigned small business issuer to the purchaser.
Insofar as indemnification by the undersigned small business issuer for
liabilities arising under the Securities Act of 1933 may be permitted to
directors, officers and controlling persons of the small business issuer
pursuant to the foregoing provisions, or otherwise, the small business issuer
has been advised that in the opinion of the Securities and Exchange Commission
such indemnification is against public policy as expressed in the Securities Act
of 1933, and is, therefore, unenforceable.
In the event that a claim for indemnification against such liabilities
(other than the payment by the small business issuer of expenses incurred or
paid by a director, officer or controlling person of the small business issuer
in the successful defense of any action, suit or proceeding) is asserted by such
director, officer or controlling person in connection with the securities being
registered, the undersigned small business issuer will, unless in the opinion of
its counsel the matter has been settled by controlling precedent, submit to a
court of appropriate jurisdiction the question whether such indemnification by
it is against public policy as expressed in the Securities Act of 1933 and will
be governed by the final adjudication of such issue.
ii-18
SIGNATURES
Pursuant to the requirements of the Securities Act, the Registrant has
duly caused this Registration Statement to be signed on its behalf by the
undersigned, thereunto duly authorized, in the City of Scottsdale, State of
Arizona, on the 7th day of April, 2006.
IR BioSciences Holdings, Inc.
By: /s/ Michael K. Wilhelm
-------------------------------------
Michael K. Wilhelm
President and Chief Executive Officer
Pursuant to the requirements of the Securities Act of 1933, as amended,
this Registration Statement has been signed by the following persons in the
capacities and on the dates indicated:
SIGNATURE TITLE DATE
--------------------------------------------------------------------------------------------
/s/ Michael K. Wilhelm Chief Executive Officer, President and April 7, 2006
------------------------ Director (Principal Executive Officer)
Michael K. Wilhelm
/s/ John N. Fermanis Chief Financial Officer (Principal Financial April 7, 2006
------------------------ and Accounting Officer)
John N. Fermanis
------------------------ Director
Mark L. Witten, Ph.D.
*
------------------------ Director April 7, 2006
Theodore E. Staahl, M.D.
*By: /s/ Michael K. Wilhelm
----------------------
Michael K. Wilhelm
Attorney in Fact
ii-19