Nevada
|
|
98-0373793
|
(State
or Other Jurisdiction of Incorporation or
Organization)
|
(I.R.S.
Employer identification
number)
|
Large
Accelerated Filer o
|
Accelerated
Filer o
|
Non-accelerated Filer o (do not check if a smaller reporting company) | Smaller reporting company þ |
Page
|
|||||
PART
I
|
|||||
Item
1. Business
|
3
|
||||
Item
1A. Risk Factors.
|
23
|
||||
Item
2. Properties
|
31
|
||||
Item
3. Legal Proceedings
|
32
|
||||
Item
4. Submission of Matters to a Vote of Security Holders
|
32
|
||||
PART
II
|
32
|
||||
Item
5. Market for Registrant’s Common Equity, Related Stockholder Matters and
Issuer Purchases of Equity Securities
|
32
|
||||
Item
6. Selected Financial Data
|
33
|
||||
Item
7. Management’s Discussion and Analysis of Financial Condition and Results
of Operations
|
33
|
||||
Item
7A. Quantitative and Qualitative Disclosures About Market
Risk
|
36
|
||||
Item
8. Financial Statements and Supplementary Data
|
36
|
||||
Item
9. Changes in and Disagreements With Accountants on Accounting and
Financial Disclosure
|
36
|
||||
Item
9A(T). Controls and Procedures
|
36
|
||||
Item
9B. Other Information
|
37
|
||||
PART
III
|
37
|
||||
Item
10. Directors, Executive Officers and Corporate Governance
|
37
|
||||
Item
11. Executive Compensation
|
39
|
||||
Item
12. Security Ownership of Certain Beneficial Owners and Management and
Related Stockholder Matters
|
45
|
||||
Item
13. Certain Relationships and Related Transactions and Director
Independence
|
46
|
||||
Item
14. Principal Accountant Fees and Services
|
47
|
||||
Part
IV
|
|||||
Item
15. Exhibits, Financial Statement Schedules
|
47
|
·
|
525,000
shares of Series A Preferred Stock (representing 10% of the Series A
Preferred Stock purchased by those investors),
and
|
·
|
warrants
to purchase 210,000 shares of Common Stock at an exercise price of $2.00
per share (representing 10% of the Series A Preferred Stock purchased by
those investors),
|
¨
|
the
occurrence of “Non-Registration
Events”;
|
¨
|
an
uncured breach by us of any material covenant, term or condition in the
Certificate of Designation or any of the related transaction documents;
and
|
¨
|
any
money judgment or similar final process being filed against us for more
than $100,000.
|
06/30/06 Purchasers of
Series A Preferred Stock
|
Initial Closing (06/25/08)
|
Qualified Closing (08/25/08)
|
||||||||||||||
|
Preferred Stock
Conversion Price
|
Warrant
Exercise Price
|
Preferred Stock
Conversion Price
|
Warrant
Exercise Price
|
||||||||||||
Alpha
Capital Aktiengesellschaft
|
$
|
0.26
|
$
|
0.52
|
$
|
0.20
|
$
|
0.40
|
||||||||
Longview
Fund, LP
|
$
|
1.25
|
$
|
2.00
|
$
|
0.45
|
$
|
0.90
|
||||||||
Platinum
Partners Long Term Growth III LLC
|
$
|
1.25
|
$
|
2.00
|
$
|
0.10
|
$
|
0.40
|
||||||||
Ellis
International Ltd.
|
$
|
0.26
|
$
|
0.52
|
$
|
0.20
|
$
|
0.40
|
||||||||
Margie
Chassman
|
$
|
1.25
|
$
|
2.00
|
$
|
0.10
|
$
|
0.40
|
1)
|
An
aging population
|
2)
|
Increased
incidence of antibiotic resistance
|
3)
|
Increase
in co-morbid conditions like cancer and
diabetes
|
4)
|
Increased
use of indwelling medical devices that are susceptible to
infection
|
·
|
improving
the viability of organs which can be harvested from brain-dead organ
donors, and
|
·
|
increasing
the likelihood of organ survival following
transplant.
|
·
|
reduce ventilator and oxygen
therapy requirements;
|
·
|
reduce length of stay in hospital
intensive care units; and
|
·
|
reduce the total cost of patient
care.
|
·
|
improve and maintain the general
health of dialysis patients;
|
·
|
improve the quality of life of
these patients
|
·
|
reduce the total cost of patient
care; and
|
·
|
increase life
expectancy.
|
·
|
continued
progress and cost of our research and development
programs;
|
·
|
progress
with pre-clinical studies and clinical
studies;
|
·
|
the
time and costs involved in obtaining regulatory
clearance;
|
·
|
costs
involved in preparing, filing, prosecuting, maintaining, defending and
enforcing patent claims;
|
·
|
costs
of developing sales, marketing and distribution
channels;
|
·
|
market
acceptance of our products; and
|
·
|
cost
for training physicians and other health care
personnel.
|
·
|
the receipt of regulatory
clearance of marketing claims for the uses that we are
developing;
|
·
|
the establishment and
demonstration of the advantages, safety and efficacy of the our polymer
technology;
|
·
|
pricing and reimbursement
policies of government and third-party payers such as insurance companies,
health maintenance organizations and other health plan
administrators;
|
·
|
our ability to attract corporate
partners, including medical device companies, to assist in commercializing
our products; and
|
·
|
our ability to market our
products.
|
·
|
satisfy their financial or
contractual obligations to
us;
|
·
|
adequately market our products;
or
|
·
|
not offer, design, manufacture or
promote competing products.
|
·
|
the occurrence of
“Non-Registration Events”;
|
·
|
an uncured breach by us of any
material covenant, term or condition in the Certificate of Designation or
any of the related transaction documents;
and
|
·
|
any money judgment or similar
final process being filed against us for more than
$100,000.
|
·
|
required us to file a
registration statement with the SEC on or before 120 days from the closing
to register the shares of Common Stock issuable upon conversion of the
Series A Preferred Stock and exercise of the Warrants, and cause such
registration statement to be effective by February 25, 2007 (240 days
following the closing); and
|
·
|
entitles each of these investors
to liquidated damages in an amount equal to two percent (2%) of the
purchase price of the Series A Preferred Stock if we fail to timely file
that registration statement with, or have it declared effective by, the
SEC.
|
·
|
the occurrence of
“Non-Registration Events”;
|
·
|
an uncured breach by us of any
material covenant, term or condition in the Certificate of Designation or
any of the related transaction documents;
and
|
·
|
any money judgment or similar
final process being filed against us for more than
$100,000.
|
·
|
required us to file a
registration statement with the SEC on or before 180 days from the Initial
Closing to register the shares of Common Stock issuable upon conversion of
the Series B Preferred Stock, and cause such registration statement to be
effective by February 21, 2009 (240 days following the Initial Closing) or
March 23, 2009 if the reasons for delay are solely due to SEC delay;
and
|
·
|
entitles each of these investors
to liquidated damages in an amount equal to two percent (2%) of the
purchase price of the Series A Preferred Stock if we fail to timely file
that registration statement with, or have it declared effective by, the
SEC.
|
Item 1B.
|
Unresolved Staff
Comments.
|
Item 2.
|
Properties.
|
Item 3.
|
Legal
Proceedings.
|
Item 4.
|
Submission of Matters to a Vote
of Security Holders.
|
Item 5.
|
Market for Registrant’s Common
Equity, Related Stockholder Matters and Issuer Purchases of Equity
Securities.
|
Price
|
||||||||
High
|
Low
|
|||||||
2006
|
||||||||
Third
quarter (from August 9)
|
$
|
3.95
|
$
|
1.25
|
||||
Fourth
quarter
|
$
|
1.73
|
$
|
0.57
|
||||
2007
|
||||||||
First
quarter
|
$
|
2.85
|
$
|
1.04
|
||||
Second
quarter
|
$
|
1.45
|
$
|
0.40
|
||||
Third
quarter
|
$
|
0.63
|
$
|
0.16
|
||||
Fourth
quarter
|
$
|
0.44
|
$
|
0.14
|
||||
2008
|
||||||||
First
quarter
|
$
|
0.32
|
$
|
0.15
|
||||
Second
quarter
|
$
|
0.23
|
$
|
0.10
|
||||
Third
quarter
|
$
|
0.20
|
$
|
0.07
|
||||
Fourth
quarter
|
$
|
0.17
|
$
|
0.03
|
2009
|
||||||||
First
quarter
|
$
|
0.21
|
$
|
0.08
|
||||
Second
quarter
|
$
|
0.16
|
$
|
0.05
|
||||
Third
quarter
|
$
|
0.20
|
$
|
0.04
|
||||
Fourth
quarter
|
$
|
0.44
|
$
|
0.13
|
|
Number of securities to be
issued upon exercise of
outstanding options
|
Weighted-average
exercise price of
outstanding options
|
Number of securities remaining
available for future issuance under
equity compensation plans
(excluding securities reflected in
first column)
|
|||||||||
Equity
compensation
plans
approved
by stockholders
|
0 | n/a | 400,000 | (1) | ||||||||
Equity
compensation plans not approved by stockholders
|
23,577,704 | $ | 0.84 | 16,422,296 | (2) | |||||||
Total
|
23,577,704 | (3) | $ | 0.84 | (3) | 16,822,296 |
(1)
|
Represents options that may be
issued under our 2003 Stock Option
Plan.
|
(2)
|
Represents the unadjusted number
of options that may be issued under our 2006 Long-Term Incentive
Plan. The options available under the pool may be increased to
maintain 15% of the fully diluted share count as
needed.
|
(3)
|
Represents options to purchase
(i) 118,667 shares of Common Stock at a price of $41.47 per share, (ii)
232,051 shares of Common Stock at a price of $31.52 per share, (iii)
35,488 shares of Common Stock at a price of $21.57 per share, (iv)
15,944 shares of Common Stock at a price of $19.91 per share, (v) 439,740
shares of Common Stock at a price of $6.64 per share, (vi) 173,000 shares
of Common Stock at a price of $1.90 per share, (vii) 306,000 shares of
Common Stock at a price of $1.65 per share, (viii) 400,000 shares of
Common Stock at a price of $1.26 per share, (ix) 166,756 shares of Common
Stock at a price of $1.25 per share, (x) 3,014,000 shares of Common Stock
at a price of $0.25, (xi) 137,622 shares of Common Stock at a price of
$0.22, (xii) 2,365,000 shares of Common Stock at a price of $0.168, (xiii)
300,000 shares of Common Stock at a price of $0.166, (xiv) 2,753,858
shares of Common Stock at a price of $0.084, (xv) 115,000 shares of Common
Stock at a price of $0.08, and (xvi) 13,004,578 shares of Common Stock at
a price of $0.035.
|
Item 6.
|
Selected Financial
Data.
|
Item 7.
|
Management’s Discussion and
Analysis of Financial Condition and Results of
Operations.
|
Name
|
Age
|
Position
|
||
Phillip
Chan, MD
|
39
|
President
and Chief Executive Officer, Director
|
||
Al
Kraus
|
65
|
Chairman
of the Board
|
||
Joseph
Rubin, Esq.
|
71
|
Director
|
||
Edward
R. Jones, MD, MBA
|
61
|
Director
|
||
James
Gunton
|
43
|
Director
|
||
Vincent
Capponi
|
52
|
Chief
Operating Officer
|
||
David
Lamadrid
|
39
|
Chief
Financial Officer
|
||
Robert
Bartlett, MD
|
70
|
Chief
Medical Officer
|
Name and Principal
Position
|
Year
|
Salary
($)
|
Bonus
($)
|
Option
Awards (1)
($)
|
Total ($)
|
|||||||||||||
Phillip
Chan
|
||||||||||||||||||
Chief
Executive Officer
|
2009
|
216,351 | -0- | 12,971 | (2) | 229,322 | ||||||||||||
Vincent
Capponi,
|
||||||||||||||||||
Chief
Operating Officer
|
2009
|
205,303 | 200 | 510 | (3) | 206,013 | ||||||||||||
2008
|
195,527 | 150 | 155,795 | (4) | 351,472 | |||||||||||||
2007
|
195,527 | -0- | -0- | 195,527 | ||||||||||||||
David
Lamadrid,
|
||||||||||||||||||
Chief
Financial Officer
|
2009
|
189,992 | (9) | 200 | 510 | (5) | 190,702 | |||||||||||
2008
|
157,630 | 150 | 196,555 | (6) | 354,335 | |||||||||||||
2007
|
145,801 | -0- | 137,781 | (7) | 283,582 | |||||||||||||
Dr.
Robert Bartlett
|
||||||||||||||||||
Chief
Medical Officer
|
2009
|
50,000 | -0- | 73 | (8) | 50,073 |
(1)
|
The value of option awards
granted to the Named Executive Officers has been estimated pursuant to
recognition requirements of accounting standards for accounting for
stock-based compensation for the options described in the
footnotes below, except that for purposes of this table, we have assumed
that none of the options will be forfeited. The Named Executive Officers
will not realize the estimated value of these awards in cash until these
awards are vested and exercised or sold. For information regarding our
valuation of option awards, see “Stock-Based Compensation” in Note 2 of
our financial statements for the period ended December 31,
2009.
|
(2)
|
Reflects options to purchase
2,503,858 shares of Common Stock at an exercise price of $0.084 per share,
which were granted on January 8, 2009 and expire on January 8, 2019. This
option vested and became exercisable as to 1,251,929 shares on the date of
grant, and vested and became exercisable as to 1,251,929 shares on January
8, 2010.
|
(3)
|
Reflects options to purchase
400,000 shares of Common Stock at an exercise price of $0.168 per share,
which were granted on January 28, 2009 and expire on January 28, 2019.
This option vested and became exercisable as to 100,000 shares on the date
of grant, vested and became exercisable as to 100,000 shares on January
28, 2010, vests and becomes exercisable as to 100,000 shares on January
28, 2011, and vests and becomes exercisable as to 100,000 shares on
January 28, 2012.
|
(4)
|
Reflects options to purchase
1,100,000 shares of Common Stock at an exercise price of $0.25 per share,
which were granted on January 16, 2008 and expire on January 16, 2018.
This option vested and became exercisable as to 366,666 shares on the date
of grant, vested and became exercisable as to 366,667 shares on January
16, 2009; and vested and became exercisable as to 366,667 shares on
January 16, 2010. Reflects options to purchase 2,250,000 shares
of Common Stock at an exercise price of $0.035 per share, which were
granted on June 25, 2008 and expire on June 25, 2018. This option vested
and became exercisable as to 562,500 shares on the date of grant, vested
and became exercisable as to 562,500 shares on June 25, 2009, vests
and becomes exercisable as to 562,500 shares on June 25, 2010, and vests
and becomes exercisable as to 562,500 shares on June 25,
2011.
|
(5)
|
Reflects options to purchase
400,000 shares of Common Stock at an exercise price of $0.168 per share,
which were granted on January 28, 2009 and expire on January 28, 2019.
This option vested and became exercisable as to 100,000 shares on the date
of grant, vested and became exercisable as to 100,000 shares on January
28, 2010, vests and becomes exercisable as to 100,000 shares on January
28, 2011, and vests and becomes exercisable as to 100,000 shares on
January 28, 2012.
|
(6)
|
Reflects options to purchase
1,400,000 shares of Common Stock at an exercise price of $0.25 per share,
which were granted on January 16, 2008 and expire on January 16, 2018.
This option vested and became exercisable as to 466,667 shares on the date
of grant, vested and became exercisable as to 466,667 shares on January
16, 2009; and vested and became exercisable as to 466,666 shares on
January 16, 2010. Reflects options to purchase 2,750,000 shares
of Common Stock at an exercise price of $0.035 per share, which were
granted on June 25, 2008 and expire on June 25, 2018. This option vested
and became exercisable as to 687,500 shares on the date of grant, vested
and became exercisable as to 687,500 shares on June 25, 2009, vests and
becomes exercisable as to 687,500 shares on June 25, 2010, and vests and
becomes exercisable as to 687,500 shares on June 25,
2011.
|
(7)
|
Reflects options to purchase
150,000 shares of Common Stock at an exercise price of $1.90 per share,
which were granted on January 16, 2007 and expire on January 16, 2017.
This option vested and became exercisable as to 50,000 shares on the date
of grant, vested and became exercisable as to 50,000 shares on January 16,
2008; and vested and became exercisable as to 50,000 shares on January 16,
2009.
|
(8)
|
Reflects options to purchase
50,000 shares of Common Stock at an exercise price of $0.084 per share,
which were granted on January 8, 2009 and expire on January 8, 2014. This
option vested and became exercisable as to 12,500 shares on January 8,
2010, vests and becomes exercisable as to 12,500 shares on January 8,
2011; vests and becomes exercisable as to 12,500 shares on January 8,
2012, and vests and becomes exercisable as to 12,500 shares on January 8,
2013.
|
(9)
|
Amount includes payments in the
approximate amount of $14,992 for certain other expenses pursuant to an
employment agreement.
|
Option Awards
|
|||||||||||||
Name
|
Number of
Securities Underlying
Unexercised Options
(#)
Exercisable
|
Number of Securities
Underlying Unexercised
Options
(#)
Unexercisable
|
Option
Exercise
Price
($)
|
Option
Expiration Date
|
|||||||||
Phillip
Chan
|
15,000 | 0.08 | (1) |
12/31/18
|
|||||||||
1,251,929 | 1,251,929 | 0.084 | (2) |
1/8/19
|
|||||||||
Vincent
Capponi
|
50,000 | 1.65 | (1) |
12/31/16
|
|||||||||
733,333 | 366,667 | 0.25 | (3) |
01/16/18
|
|||||||||
1,125,000 | 1,125,000 | 0.035 | (4) |
06/25/18
|
|||||||||
100,000 | 300,000 | 0.168 | (5) |
01/28/19
|
|||||||||
David
Lamadrid
|
150,000 | 1.90 | (1) |
01/16/17
|
|||||||||
933,333 | 466,667 | 0.25 | (6) |
01/16/18
|
|||||||||
1,375,000 | 1,375,000 | 0.035 | (7) |
06/25/18
|
|||||||||
100,000 | 300,000 | 0.168 | (8) |
01/28/19
|
|||||||||
Robert
Bartlett
|
50,000 | 0.084 | (9) |
01/08/14
|
(1)
|
Fully
vested
|
(2)
|
Vests and becomes exercisable as
to (i) 1,251,929 shares on January 8, 2009; and (ii) 1,251,929 shares on
January 8, 2010.
|
(3)
|
Vests and becomes exercisable as
to (i) 366,666 shares on January 16, 2008; (ii) 366,667 shares on January
16, 2009; and (iii) 366,667 shares on January 16,
2010.
|
(4)
|
Vests and becomes exercisable as
to (i) 562,500 shares on June 25, 2008; (ii) 562,500 shares on June 25,
2009; (iii) 562,500 shares on June 25, 2010; and (iv) 562,500 shares on
June 25, 2011.
|
(5)
|
Vests and becomes exercisable as
to (i) 100,000 shares on January 28, 2009; (ii) 100,000 shares on January
28, 2010; (iii) 100,000 shares on January 28, 2011; and (iv) 100,000
shares on January 28, 2012.
|
(6)
|
Vests and becomes exercisable as
to (i) 466,666 shares on January 16, 2008; (ii) 466,667 shares on January
16, 2009; and (iii) 466,667 shares on January 16,
2010.
|
(7)
|
Vests and becomes exercisable as
to (i) 687,500 shares on June 25, 2008; (ii) 687,500 shares on June 25,
2009; (iii) 687,500 shares on June 25, 2010; and (iv) 687,500 shares on
June 25, 2011.
|
(8)
|
Vests and becomes exercisable as
to (i) 100,000 shares on January 28, 2009; (ii) 100,000 shares on January
28, 2010; (iii) 100,000 shares on January 28, 2011; and (iv) 100,000
shares on January 28, 2012.
|
(9)
|
Vests and becomes exercisable as
to (i) 12,500 shares on January 8, 2010; (ii) 12,500 shares on January 8,
2011; (iii)12,500 shares on January 8, 2012 and (iv) 12,500 shares on
January 8, 2013.
|
Name
|
Fees Earned or
Paid in
Cash
($)
|
Option
Awards
($) (1)
|
Total
($)
|
||||||||||
Joseph
Rubin
|
8,000 | 230 | (2)(3) | 8,230 | |||||||||
Edward
R. Jones
|
8,000 | 230 | (2)(4) | 8,230 | |||||||||
James
Gunton
|
— | — | (5) | — | |||||||||
Al
Kraus
|
20,000 | 1,840 | (6) | 21,840 | |||||||||
Phillip
Chan
|
(7)
|
— | — | — |
(1)
|
The value of option awards
granted to directors has been estimated pursuant to SFAS No. 123(R) for
the options described in the footnotes below, except that for purposes of
this table, we have assumed that none of the options will be forfeited.
The directors will not realize the estimated value of these awards in cash
until these awards are vested and exercised or sold. For information
regarding our valuation of option awards, see “Stock-Based Compensation”
in Note 2 of our financial statements for the period ended December 31,
2009.
|
(2)
|
Fully
vested
|
(3)
|
At December 31, 2009, in
connection with his service as a director we had issued Mr. Rubin the
following: options to purchase 21,098 shares of our Common Stock at an
exercise price of $31.52 per share, which were granted on June 30, 2006
and expire on December 13, 2010; options to purchase 5,274 shares of our
Common Stock at an exercise price of $21.57 per share, which were granted
on June 30, 2006 and expire on January 26, 2012; options to purchase 3,014
shares of our Common Stock at an exercise price of $21.57 per share, which
were granted on June 30, 2006 and expire on December 11, 2012; options to
purchase 753 shares of our Common Stock at an exercise price of $21.57 per
share, which were granted on June 30, 2006 and expire on December 28,
2013; options to purchase 1,507 shares of our Common Stock at an exercise
price of $6.64 per share, which were granted on June 30, 2006 and expire
on December 29, 2014; options to purchase 10,000 shares of our Common
Stock at an exercise price of $1.25 per share, which were granted on June
30, 2006 and expire on January 30, 2016; options to purchase 15,069 shares
of our Common Stock at an exercise price of $1.25 per share, which were
granted on June 30, 2006 and expire on June 12, 2016; options to purchase
5,000 shares of our Common Stock at an exercise price of $1.25 per share,
which were granted on August 1, 2006 and expire on August 1, 2016; options
to purchase 10,000 shares of our Common Stock at an exercise price of
$0.22 per share, which were granted on December 31, 2007 and expire on
December 31, 2017; options to purchase 45,000 shares of our Common Stock
at an exercise price of $0.035 per share, which were granted on June 25,
2008 and expire on June 25, 2018; options to purchase 30,000 shares of our
Common Stock at an exercise price of $0.08 per share, which were granted
on December 31, 2008 and expire on December 31, 2018; and options to
purchase 100,000 shares of our Common Stock at an exercise price of $0.166
per share, which were granted on December 31, 2009 and expire on December
31, 2019.
|
(4)
|
At December 31, 2009, in
connection with his service as a director we had issued Dr. Jones the
following: options to purchase 7,500 shares of our Common Stock at an
exercise price of $0.22 per share, which were granted on December 31, 2007
and expire on December 31, 2017; options to purchase 45,000 shares of our
Common Stock at an exercise price of $0.035 per share, which were granted
on June 25, 2008 and expire on June 25, 2018; and options to purchase
30,000 shares of our Common Stock at an exercise price of $0.08 per share,
which were granted on December 31, 2008 and expire on December 31, 2018;
and options to purchase 100,000 shares of our Common Stock at an exercise
price of $0.166 per share, which were granted on December 31, 2009 and
expire on December 31, 2019.
|
(5)
|
As of December 31, 2009, in
connection with his service as a director we had issued Mr. Gunton the
following: options to purchase 15,000 shares of our Common Stock at an
exercise price of $0.08 per share, which were granted on December 31, 2008
and expire on December 31, 2018. In connection with Mr.
Gunton’s service as a director in 2009, the NJTC Venture Fund was entitled
to receive options to purchase 108,000 shares of our Common
Stock. These options were issued on January 1, 2010 with an
exercise price of $0.166 per share and expire on January 1,
2020.
|
(6)
|
At December 31, 2009, in
connection with his service as a director we had issued Mr. Kraus the
following: options to purchase 200,000 shares of our Common Stock at an
exercise price of $0.084 per share, which were granted on January 8, 2009
and expire on January 8, 2019; and options to purchase 100,000 shares of
our Common Stock at an exercise price of $0.166 per share, which were
granted on December 31, 2009 and expire on December 31,
2019.
|
(7)
|
Effective July 24, 2008, Dr. Chan
was appointed to the Company’s Board of Directors and Compensation
Committee. Effective January 1, 2009, Dr. Chan entered into an
employment agreement becoming interim Chief Executive Officer of the
Company. In January 2009, Dr. Chan resigned his position as a
member on the Compensation Committee. During 2009 Dr. Chan was
an employee Director and was not eligible to receive compensation for
Director services.
|
Item 12.
|
Security Ownership of Certain
Beneficial Owners and Management and Related Stockholder
Matters.
|
SHARES
BENEFICIALLY
OWNED1
|
||||||||
Number
|
Percent (%)
|
|||||||
Beneficial
Owners of more than 5% of Common Stock (other than directors and executive
officers)
|
||||||||
Guillermina
Montiel(2)
|
5,052,456 | 6.1 | % | |||||
Directors
and Executive Officers
|
||||||||
Al
Kraus(3)
|
9,932,001 | 10.9 | % | |||||
Phillip
Chan (4)
|
3,222,422 | 3.8 | % | |||||
David
Lamadrid (5)
|
3,208,734 | 3.7 | % | |||||
Vince
Capponi (6)
|
2,993,086 | 3.5 | % | |||||
Joseph
Rubin (7)
|
1,016,688 | 1.2 | % | |||||
Robert
Bartlett (8)
|
47,500 | * | ||||||
James
Gunton (9)
|
15,000 | * | ||||||
Edward
R. Jones (10)
|
182,500 | * | ||||||
All directors and executive
officers as a group (eight persons)(11)
|
20,626,003 | 20.4 | % |
*
|
Less than
1%.
|
1
|
Gives effect to the shares of
Common Stock issuable upon the exercise of all options exercisable within
60 days of March 18, 2010 and other rights beneficially owned by the
indicated stockholders on that date. Beneficial ownership is determined in
accordance with the rules of the Securities and Exchange Commission and
includes voting and investment power with respect to shares. Unless
otherwise indicated, the persons named in the table have sole voting and
sole investment control with respect to all shares beneficially owned.
Percentage ownership is calculated based on 82,574,856 shares of Common
Stock outstanding as of April 5,
2010.
|
2
|
Includes 58,472 shares of Common
Stock issuable upon exercise of stock
options.
|
3
|
Includes 8,538,370 shares of
Common Stock issuable upon exercise of stock
options.
|
4
|
Includes 603,564 shares of Common
Stock issuable upon conversion of Series B Preferred Stock, and 2,618,858
shares of Common Stock issuable upon exercise of stock
options.
|
5
|
Includes 3,205,000 shares of
Common Stock issuable upon exercise of stock
options.
|
6
|
Includes 2,575,000 shares of
Common Stock issuable upon exercise of stock
options.
|
7
|
Includes 2,758 shares of Common
Stock issuable upon conversion of Series A Preferred Stock, 418,066 shares
of Common Stock issuable upon conversion of Series B Preferred Stock, and
521,672 shares of Common Stock issuable upon exercise of warrants and
stock options. Does not include shares of Common Stock beneficially owned
by Mr. Rubin’s spouse, as to which he disclaims beneficial
ownership.
|
8
|
Includes 47,500 shares of Common
Stock issuable upon exercise of stock
options.
|
9
|
These shares are issuable upon
exercise of stock options.
|
10
|
These
shares are issuable upon exercise of stock
options.
|
11
|
Includes an aggregate of 2,758
shares of Common Stock issuable upon conversion of Series A Preferred
Stock, 1,021,630 shares of Common Stock issuable upon conversion of Series
B Preferred Stock, and 17,703,900 shares of Common Stock issuable upon
exercise of warrants and stock
options.
|
2009
|
2008
|
|||||||
Audit
fees
(1)
|
$ | 116,930 | $ | 105,010 | ||||
Audit
related fees
|
— | — | ||||||
Tax
fees
|
5,460 | 10,700 | ||||||
All
other fees
|
$ | — | $ | — | ||||
Total
fees
|
$ | 122,390 | $ | 115,710 |
(1)
|
Includes fees paid for
professional services rendered in connection with the audit of annual
financial statements and the review of quarterly financial statements, and
the review of such financial statements in the Company’s Annual Report on
Form 10-K, Quarterly Reports on Form 10-Q, Registration Statement on Form
SB-2, S-1 and S-8, and Current Reports on Form
8-K.
|
Exhibit
No.
|
|
Description
|
31.1
|
Certification
of Philip Chan pursuant to 18 U.S.C. Section 1350 as adopted pursuant to
Section 302 of the Sarbanes-Oxley Act of 2002.
|
|
31.2
|
Certification
of David Lamadrid pursuant to 18 U.S.C. Section 1350 as adopted pursuant
to Section 302 of the Sarbanes-Oxley Act of 2002.
|
|
32.1
|
Certification
of Philip Chan pursuant to 18 U.S.C. Section 1350 as adopted pursuant to
Section 906 of the Sarbanes-Oxley Act of 2002.
|
|
32.2
|
Certification
of David Lamadrid pursuant to 18 U.S.C. Section 1350 as adopted pursuant
to Section 906 of the Sarbanes-Oxley Act of
2002.
|
MEDASORB
TECHNOLOGIES CORPORATION
|
||
By:
|
/s/ Phillip Chan
|
|
Phillip
Chan
|
||
Chief
Executive Officer
|
Signature
|
Title
|
Date
|
||
/s/ Phillip Chan
|
Chief
Executive Officer (Principal
|
April
9, 2010
|
||
Phillip
Chan
|
Executive
Officer) and Director
|
|||
/s/ David Lamadrid
|
Chief
Financial Officer (Principal
|
April
9, 2010
|
||
David
Lamadrid
|
Accounting
and Financial Officer)
|
|||
/s/ Al Kraus
|
Chairman
of the Board
|
April
9, 2010
|
||
Al
Kraus
|
||||
/s/ Joseph Rubin
|
Director
|
April
9, 2010
|
||
Joseph
Rubin, Esq.
|
||||
/s/ Edward R. Jones
|
Director
|
April
9, 2010
|
||
Edward
R. Jones
|
||||
/s/ James Gunton
|
Director
|
April
9, 2010
|
||
James
Gunton
|
||||
Page
|
||
Report
of Independent Registered Public Accounting Firm
|
F-2
|
|
Consolidated
Balance Sheets at December 31, 2009 and December 31, 2008
|
F-4
|
|
Consolidated
Statements of Operations for the years ended December 31, 2009 and 2008,
and from inception to December 31, 2009
|
F-5
|
|
Consolidated
Statements of Changes in Stockholders’ Equity (Deficiency) period from
inception to December 31, 2009
|
F-6
|
|
Consolidated
Statements of Cash Flows for the for the years ended December 31, 2009 and
2008, and from inception to December 31, 2009
|
F-11
|
|
Notes
to Financial Statements
|
F-13
|
December
31,
|
2009
|
2008
|
||||||
ASSETS
|
||||||||
Current
Assets:
|
||||||||
Cash
and cash equivalents
|
$ | 1,595,628 | $ | 2,749,208 | ||||
Short-term
investments
|
— | 199,607 | ||||||
Prepaid
expenses and other current assets
|
369,091 | 117,003 | ||||||
Total
current assets
|
1,964,719 | 3,065,818 | ||||||
Property
and equipment - net
|
18,853 | 52,057 | ||||||
Other
assets
|
254,908 | 269,310 | ||||||
Total
long-term assets
|
273,761 | 321,367 | ||||||
Total
Assets
|
$ | 2,238,480 | $ | 3,387,185 | ||||
LIABILITIES
AND STOCKHOLDERS' EQUITY (DEFICIENCY)
|
||||||||
Current
Liabilities:
|
||||||||
Accounts
payable
|
$ | 852,167 | $ | 885,465 | ||||
Accrued
expenses and other current liabilities
|
118,598 | 92,239 | ||||||
Total
current liabilities
|
970,765 | 977,704 | ||||||
Notes
Payable:
|
||||||||
Notes
payable
|
— | 50,000 | ||||||
Total
Long Term Liabilities
|
— | 50,000 | ||||||
Total
liabilities
|
970,765 | 1,027,704 | ||||||
Stockholders
Equity/(Deficiency):
|
||||||||
10%
Series B Preferred Stock, Par Value $0.001, 200,000 shares authorized at
December 31, 2009 and 2008, respectively; 68,723.88 and 55,558.64 issued
and outstanding , respectively
|
69 | 55 | ||||||
10%
Series A Preferred Stock, Par Value $0.001, 12,000,000 shares authorized
at December 31, 2009 and 2008, 6,255,813 and 8,793,060 shares issued and
outstanding, respectively
|
6,256 | 8,793 | ||||||
Common
Stock, Par Value $0.001, 500,000,000 shares authorized at December 31,
2009 and 2008, 66,374,856 and 25,263,517 shares issued and outstanding,
respectively
|
66,375 | 25,264 | ||||||
Additional
paid-in capital
|
80,097,536 | 77,786,850 | ||||||
Deficit
accumulated during the development stage
|
(78,902,521 | ) | (75,461,481 | ) | ||||
Total
stockholders’ equity/(deficiency)
|
1,267,715 | 2,359,481 | ||||||
Total
Liabilities and Stockholders' Equity (Deficiency)
|
$ | 2,238,480 | $ | 3,387,185 |
Period from
|
||||||||||||
January 22,1997
|
||||||||||||
(date of inception) to
|
Year ended
|
Year ended
|
||||||||||
December 31,
|
December 31,
|
December 31,
|
||||||||||
2009
|
2009
|
2008
|
||||||||||
Revenue
|
$ | — | $ | — | $ | — | ||||||
Expenses:
|
||||||||||||
Research
and development
|
46,253,723 | 1,961,960 | 1,983,483 | |||||||||
Legal,
financial and other consulting
|
7,307,977 | 307,952 | 351,357 | |||||||||
General
and administrative
|
23,066,897 | 757,450 | 909,372 | |||||||||
Change
in fair value of management and incentive units
|
(6,055,483 | ) | — | — | ||||||||
Total
expenses
|
70,573,114 | 3,027,362 | 3,244,212 | |||||||||
Other
(income) expenses:
|
||||||||||||
Gain
on disposal of property and equipment
|
(21,663 | ) | — | — | ||||||||
Gain
on extinguishment of debt
|
(216,617 | ) | — | — | ||||||||
Interest
(income) expense, net
|
5,607,395 | 8,142 | 22,207 | |||||||||
Penalties
associated with non-registration of Series A Preferred
Stock
|
361,495 | — | — | |||||||||
Total
other (income) expense, net
|
5,730,610 | 8,142 | 22,207 | |||||||||
Loss
before benefit from income taxes
|
76,303,724 | 3,035,504 | 3,266,419 | |||||||||
Benefit
from income taxes
|
(547,318 | ) | (298,789 | ) | (248,529 | ) | ||||||
Net
loss
|
(75,756,406 | ) | (2,736,715 | ) | (3,017,890 | ) | ||||||
Preferred
stock dividend
|
3,146,115 | 704,325 | 905,382 | |||||||||
Net
loss available to common shareholders
|
$ | (78,902,521 | ) | $ | (3,441,040 | ) | $ | (3,923,272 | ) | |||
Basic
and diluted net loss per common share
|
$ | (0.08 | ) | $ | (0.16 | ) | ||||||
Weighted
average number of common stock outstanding
|
41,593,607 | 25,121,377 |
Members
Equity
|
Deferred
|
Common
Stock
|
Preferred
Stock B
|
Preferred
Stock A
|
Additional
Paid-In
|
Deficit
Accumulated
During
the
Development
|
Total
Stockholders'
|
|||||||||||||||||||||||||||||||||||||
(Deficiency)
|
Compensation
|
Shares
|
Par
value
|
Shares
|
Par
Value
|
Shares
|
Par
Value
|
Cap
ital
|
Stage
|
Equity
(Deficit)
|
||||||||||||||||||||||||||||||||||
Balance
at January 22, 1997 (date of inception)
|
$
|
—
|
$
|
—
|
—
|
$
|
—
|
$
|
—
|
$
|
—
|
$
|
—
|
$
|
—
|
$
|
—
|
$
|
—
|
$
|
—
|
|||||||||||||||||||||||
Equity
contributions
|
1,143,487
|
—
|
—
|
—
|
—
|
—
|
1,143,487
|
|||||||||||||||||||||||||||||||||||||
Subscriptions
receivable
|
440,000
|
—
|
—
|
—
|
—
|
—
|
440,000
|
|||||||||||||||||||||||||||||||||||||
Technology
contribution
|
4,550,000
|
—
|
—
|
—
|
—
|
—
|
4,550,000
|
|||||||||||||||||||||||||||||||||||||
Net
loss
|
—
|
—
|
—
|
—
|
—
|
(5,256,012
|
)
|
(5,256,012
|
)
|
|||||||||||||||||||||||||||||||||||
Balance
at December 31, 1997
|
6,133,487
|
—
|
—
|
—
|
—
|
(5,256,012
|
)
|
877,475
|
||||||||||||||||||||||||||||||||||||
Equity
contributions
|
2,518,236
|
—
|
—
|
—
|
—
|
—
|
2,518,236
|
|||||||||||||||||||||||||||||||||||||
Options
issued to consultants
|
1,671
|
—
|
—
|
—
|
—
|
—
|
1,671
|
|||||||||||||||||||||||||||||||||||||
Subscriptions
receivable
|
50,000
|
—
|
—
|
—
|
—
|
—
|
50,000
|
|||||||||||||||||||||||||||||||||||||
Net
loss
|
—
|
—
|
—
|
—
|
—
|
(1,867,348
|
)
|
(1,867,348
|
)
|
|||||||||||||||||||||||||||||||||||
Balance
at December 31, 1998
|
8,703,394
|
—
|
—
|
—
|
—
|
(7,123,360
|
)
|
1,580,034
|
||||||||||||||||||||||||||||||||||||
Equity
contributions
|
1,382,872
|
—
|
—
|
—
|
—
|
—
|
1,382,872
|
|||||||||||||||||||||||||||||||||||||
Equity
issued to consultants
|
88,363
|
—
|
—
|
—
|
—
|
—
|
88,363
|
|||||||||||||||||||||||||||||||||||||
Recognition
of deferred compensation
|
47,001
|
(47,001
|
)
|
—
|
—
|
—
|
—
|
—
|
||||||||||||||||||||||||||||||||||||
Amortization
of deferred compensation
|
—
|
15,667
|
—
|
—
|
—
|
—
|
15,667
|
|||||||||||||||||||||||||||||||||||||
Subscriptions
receivable
|
100,000
|
—
|
—
|
—
|
—
|
—
|
100,000
|
Net
loss
|
—
|
—
|
—
|
—
|
—
|
(3,066,388
|
)
|
(3,066,388
|
)
|
|||||||||||||||||||||||||||||||||||
Balance
at December 31, 1999
|
10,321,630
|
(31,334
|
)
|
—
|
—
|
—
|
(10,189,748
|
)
|
100,548
|
|||||||||||||||||||||||||||||||||||
Equity
contributions
|
14,407,916
|
—
|
—
|
—
|
—
|
—
|
14,407,916
|
|||||||||||||||||||||||||||||||||||||
Equity
issued to consultants
|
1,070,740
|
—
|
—
|
—
|
—
|
—
|
1,070,740
|
|||||||||||||||||||||||||||||||||||||
Warrants
issued to consultants
|
468,526
|
—
|
—
|
—
|
—
|
—
|
468,526
|
|||||||||||||||||||||||||||||||||||||
Recognition
of deferred compensation
|
27,937
|
(27,937
|
)
|
—
|
—
|
—
|
—
|
—
|
||||||||||||||||||||||||||||||||||||
Amortization
of deferred compensation
|
—
|
46,772
|
—
|
—
|
—
|
—
|
46,772
|
|||||||||||||||||||||||||||||||||||||
Net
loss
|
—
|
—
|
—
|
—
|
—
|
(10,753,871
|
)
|
(10,753,871
|
)
|
|||||||||||||||||||||||||||||||||||
Balance
at December 31, 2000
|
26,296,749
|
(12,499
|
)
|
—
|
—
|
—
|
(20,943,619
|
)
|
5,340,631
|
|||||||||||||||||||||||||||||||||||
Equity
contributions
|
13,411,506
|
—
|
—
|
—
|
—
|
—
|
13,411,506
|
|||||||||||||||||||||||||||||||||||||
Equity
issued to consultants
|
161,073
|
—
|
—
|
—
|
—
|
—
|
161,073
|
|||||||||||||||||||||||||||||||||||||
Stock
options issued to employee
|
2,847
|
—
|
—
|
—
|
—
|
—
|
2,847
|
|||||||||||||||||||||||||||||||||||||
Fees
incurred in raising capital
|
(1,206,730
|
)
|
—
|
—
|
—
|
—
|
—
|
(1,206,730
|
)
|
|||||||||||||||||||||||||||||||||||
Amortization
of deferred compensation
|
—
|
12,499
|
—
|
—
|
—
|
—
|
12,499
|
|||||||||||||||||||||||||||||||||||||
Net
loss
|
—
|
—
|
—
|
—
|
—
|
(15,392,618
|
)
|
(15,392,618
|
)
|
|||||||||||||||||||||||||||||||||||
Balance
at December 31, 2001
|
38,665,445
|
—
|
—
|
—
|
—
|
(36,336,237
|
)
|
2,329,208
|
||||||||||||||||||||||||||||||||||||
Equity
contributions
|
6,739,189
|
—
|
—
|
—
|
—
|
—
|
6,739,189
|
|||||||||||||||||||||||||||||||||||||
Equity
issued to consultants
|
156,073
|
—
|
—
|
—
|
—
|
—
|
156,073
|
|||||||||||||||||||||||||||||||||||||
Options
issued to consultant
|
176,250
|
—
|
—
|
—
|
—
|
—
|
176,250
|
|||||||||||||||||||||||||||||||||||||
Options
issued to employee
|
2,847
|
—
|
—
|
—
|
—
|
—
|
2,847
|
|||||||||||||||||||||||||||||||||||||
Fees
incurred in raising capital
|
(556,047
|
)
|
—
|
—
|
—
|
—
|
—
|
(556,047
|
)
|
|||||||||||||||||||||||||||||||||||
Forgiveness
of loan receivable in exchange for equity
|
(1,350,828
|
)
|
—
|
—
|
—
|
—
|
—
|
(1,350,828
|
)
|
|||||||||||||||||||||||||||||||||||
Net
loss
|
—
|
—
|
—
|
—
|
—
|
(11,871,668
|
)
|
(11,871,668
|
)
|
|||||||||||||||||||||||||||||||||||
Balance
at December 31, 2002
|
43,832,929
|
—
|
—
|
—
|
—
|
(48,207,905
|
)
|
(4,374,976
|
)
|
|||||||||||||||||||||||||||||||||||
Equity
contributions
|
4,067,250
|
—
|
—
|
—
|
—
|
—
|
4,067,250
|
|||||||||||||||||||||||||||||||||||||
Equity
issued to consultants
|
16,624
|
—
|
—
|
—
|
—
|
—
|
16,624
|
|||||||||||||||||||||||||||||||||||||
Change
in fair value of management units
|
2,952,474
|
—
|
—
|
—
|
—
|
—
|
2,952,474
|
|||||||||||||||||||||||||||||||||||||
Options
issued to consultant
|
65,681
|
—
|
—
|
—
|
—
|
—
|
65,681
|
|||||||||||||||||||||||||||||||||||||
Fees
incurred in raising capital
|
(343,737
|
)
|
—
|
—
|
—
|
—
|
—
|
(343,737
|
)
|
|||||||||||||||||||||||||||||||||||
Forgiveness
of loan receivable in exchange for equity
|
(281,340
|
)
|
—
|
—
|
—
|
—
|
—
|
(281,340
|
)
|
|||||||||||||||||||||||||||||||||||
Net
loss
|
—
|
—
|
—
|
—
|
—
|
(6,009,283
|
)
|
(6,009,283
|
)
|
|||||||||||||||||||||||||||||||||||
Balance
at December 31, 2003
|
50,309,881
|
—
|
—
|
—
|
—
|
(54,217,188
|
)
|
(3,907,307
|
)
|
|||||||||||||||||||||||||||||||||||
Equity
contributions
|
512,555
|
—
|
—
|
—
|
—
|
—
|
512,555
|
|||||||||||||||||||||||||||||||||||||
Change
in fair value of management units
|
(2,396,291
|
)
|
—
|
—
|
—
|
—
|
—
|
(2,396,291
|
)
|
Fees
incurred in raising capital
|
(80,218
|
)
|
—
|
—
|
—
|
—
|
—
|
(80,218
|
)
|
|||||||||||||||||||||||||||||||||||
Net
Loss
|
—
|
—
|
—
|
—
|
—
|
(1,096,683
|
)
|
(1,096,683
|
)
|
|||||||||||||||||||||||||||||||||||
Balance
at December 31, 2004
|
48,345,927
|
—
|
—
|
—
|
—
|
(55,313,871
|
)
|
(6,967,944
|
)
|
|||||||||||||||||||||||||||||||||||
Equity
contributions
|
92,287
|
—
|
—
|
—
|
—
|
—
|
92,287
|
|||||||||||||||||||||||||||||||||||||
Settlement
of accounts payable in exchange for equity
|
836,319
|
—
|
—
|
—
|
—
|
—
|
836,319
|
|||||||||||||||||||||||||||||||||||||
Conversion
of convertible notes payable and accrued interest for
equity
|
51,565
|
—
|
—
|
—
|
—
|
—
|
51,565
|
|||||||||||||||||||||||||||||||||||||
Change
in fair value of management units
|
(14,551
|
)
|
—
|
—
|
—
|
—
|
—
|
(14,551
|
)
|
|||||||||||||||||||||||||||||||||||
Fees
incurred in raising capital
|
(92,287
|
)
|
—
|
—
|
—
|
—
|
—
|
(92,287
|
)
|
|||||||||||||||||||||||||||||||||||
Reorganization
from LLC to "C" Corporation
|
(49,219,260
|
)
|
—
|
4,829,120
|
4,829
|
49,214,431
|
—
|
—
|
||||||||||||||||||||||||||||||||||||
Net
loss
|
—
|
—
|
—
|
—
|
—
|
(3,665,596
|
)
|
(3,665,596
|
)
|
|||||||||||||||||||||||||||||||||||
Balance
at December 31, 2005
|
—
|
—
|
4,829,120
|
4,829
|
49,214,431
|
(58,979,467
|
)
|
(9,760,207
|
)
|
|||||||||||||||||||||||||||||||||||
Issuance
of common stock for stock subscribed
|
—
|
—
|
240,929
|
241
|
—
|
—
|
799,644
|
—
|
799,885
|
|||||||||||||||||||||||||||||||||||
Issuance
of common stock to investor group for price protection
|
—
|
—
|
100,000
|
100
|
—
|
—
|
(100
|
)
|
—
|
—
|
||||||||||||||||||||||||||||||||||
Issuance
of stock options to employees, consultants and directors
|
—
|
—
|
—
|
—
|
—
|
—
|
143,352
|
—
|
143,352
|
|||||||||||||||||||||||||||||||||||
Issuance
of 10% Series A Preferred Stock for cash
|
—
|
—
|
—
|
—
|
5,300,000
|
5,300
|
5,530,143
|
(235,443
|
)
|
5,300,000
|
||||||||||||||||||||||||||||||||||
Cost
of raising capital associated with issuance of preferred
stock
|
—
|
—
|
—
|
—
|
—
|
—
|
(620,563
|
)
|
—
|
(620,563
|
)
|
|||||||||||||||||||||||||||||||||
Shares
held by original stockholders of Parent immediately prior to
merger
|
—
|
—
|
3,750,000
|
3,750
|
—
|
—
|
(3,750
|
)
|
—
|
—
|
||||||||||||||||||||||||||||||||||
Conversion
of convertible debt, related accrued interest and shares to induce
conversion into common stock
|
—
|
—
|
5,170,880
|
5,171
|
—
|
—
|
11,376,939
|
—
|
11,382,110
|
|||||||||||||||||||||||||||||||||||
Issuance
of common stock in consideration for funding $1,000,000 convertible
note payable per terms of merger transaction
|
—
|
—
|
10,000,000
|
10,000
|
—
|
—
|
990,000
|
—
|
1,000,000
|
|||||||||||||||||||||||||||||||||||
Issuance
of common stock in exchange for accounts payable and services
rendered
|
—
|
—
|
778,274
|
779
|
—
|
—
|
587,035
|
—
|
587,814
|
|||||||||||||||||||||||||||||||||||
Conversion
of common stock issued prior to reverse merger for 10% Series A
Preferred Stock
|
—
|
—
|
(240,929
|
)
|
(241
|
)
|
799,885
|
800
|
30,194
|
(30,753
|
)
|
—
|
||||||||||||||||||||||||||||||||
Non-cash
stock dividends on 10% Series A Preferred Stock
|
—
|
—
|
—
|
—
|
303,700
|
303
|
303,397
|
(303,700
|
)
|
—
|
||||||||||||||||||||||||||||||||||
Issuance
of preferred stock for redemption of convertible note
|
—
|
—
|
—
|
—
|
1,000,000
|
1,000
|
1,204,640
|
(205,640
|
)
|
1,000,000
|
Issuance
of warrants to consultants for services
|
— | — | — | — | — | — |
9,883
|
— |
9,883
|
|||||||||||||||||||||||||||||||||||
Issuance
of warrants in exchange for accounts payable
|
—
|
—
|
—
|
—
|
—
|
—
|
192,311
|
—
|
192,311
|
|||||||||||||||||||||||||||||||||||
Net
loss
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
(7,671,580
|
)
|
(7,671,580
|
)
|
|||||||||||||||||||||||||||||||||
Balance
at December 31, 2006
|
—
|
—
|
24,628,274
|
24,629
|
7,403,585
|
7,403
|
69,757,556
|
(67,426,583
|
)
|
2,363,005
|
||||||||||||||||||||||||||||||||||
Issuance
of stock options to employees, consultants and directors
|
—
|
—
|
—
|
—
|
498,955
|
—
|
498,955
|
|||||||||||||||||||||||||||||||||||||
Issuance
of common stock in settlement of accounts payable
|
—
|
—
|
11,501
|
11
|
—
|
—
|
22,991
|
—
|
23,002
|
|||||||||||||||||||||||||||||||||||
Conversion
of preferred stock into common stock
|
—
|
—
|
405,157
|
405
|
(506,446
|
)
|
(506
|
)
|
101
|
—
|
—
|
|||||||||||||||||||||||||||||||||
Issuance
of Series A Preferred Stock as dividends and settlement of
dividends/penalties payable in connection with non-registration
event
|
—
|
—
|
—
|
—
|
1,122,369
|
1,122
|
1,121,246
|
(760,872
|
)
|
361,496
|
||||||||||||||||||||||||||||||||||
Net
loss
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
(3,350,754
|
)
|
(3,350,754
|
)
|
|||||||||||||||||||||||||||||||||
Balance
at December 31, 2007
|
—
|
—
|
25,044,932
|
25,045
|
8,019,508
|
8,019
|
71,400,849
|
(71,538,209
|
)
|
(104,296
|
)
|
|||||||||||||||||||||||||||||||||
Stock
based compensation - employees, consultants and directors
|
—
|
—
|
—
|
—
|
—
|
—
|
363,563
|
—
|
363,563
|
|||||||||||||||||||||||||||||||||||
Issuance
of Series A Preferred Stock as dividends
|
—
|
—
|
—
|
—
|
830,384
|
831
|
277,087
|
(277,918
|
)
|
—
|
||||||||||||||||||||||||||||||||||
Issuance
of Series B Preferred Stock for
cash
and conversion of $175,000 of
convertible
debt
|
52,931.47
|
53
|
5,657,842
|
(364,747
|
)
|
5,293,148
|
||||||||||||||||||||||||||||||||||||||
Cost
of raising capital associated with issuance of Series B Preferred
Stock
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
(215,398
|
)
|
—
|
(215,398
|
)
|
|||||||||||||||||||||||||||||||
Issuance
of Series B Preferred Stock as dividends
|
—
|
—
|
—
|
—
|
2,627.17
|
2
|
—
|
—
|
262,715
|
(262,717
|
)
|
—
|
||||||||||||||||||||||||||||||||
Issuance
of warrants upon conversion of convertible notes payable into Series B
Preferred Stock
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
40,354
|
40,354
|
||||||||||||||||||||||||||||||||||
Conversion
of Series A Preferred stock into common
|
—
|
—
|
218,585
|
219
|
—
|
—
|
(56,832
|
)
|
(57
|
)
|
(162
|
)
|
—
|
|||||||||||||||||||||||||||||||
Net
loss
|
(3,017,890
|
)
|
(3,017,890
|
)
|
||||||||||||||||||||||||||||||||||||||||
Balance
at December 31, 2008
|
—
|
—
|
25,263,517
|
25,264
|
55,558.64
|
55
|
8,793,060
|
8,793
|
77,786,850
|
(75,461,481
|
)
|
2,359,481
|
||||||||||||||||||||||||||||||||
Stock
based compensation - employees, consultants and directors
|
236,705
|
236,705
|
||||||||||||||||||||||||||||||||||||||||||
Issuance
of Series A Preferred Stock as dividends
|
789,610
|
789
|
110,809
|
(111,598
|
)
|
—
|
Issuance
of Series B Preferred Stock as
dividends
|
5,860.22
|
6
|
586,017
|
(586,023
|
)
|
—
|
||||||||||||||||||||||||||||||||||||||
Exercise
of warrants
|
13,357.52
|
13
|
1,335,741
|
1,335,754
|
||||||||||||||||||||||||||||||||||||||||
Warrant
modification as inducement to exercise
|
14,885
|
14,885
|
||||||||||||||||||||||||||||||||||||||||||
Conversion
of notes payable and accrued interest to Series B Preferred
Shares
|
576.05
|
1
|
64,308
|
(6,704
|
)
|
57,605
|
||||||||||||||||||||||||||||||||||||||
Conversion
of Series A and B Preferred stock into common
|
41,111,339
|
41,111
|
(6,628.55
|
)
|
(6
|
)
|
(3,326,857
|
)
|
(3,326
|
)
|
(37,779
|
)
|
||||||||||||||||||||||||||||||||
Net
loss
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
(2,736,715
|
)
|
(2,736,715
|
)
|
|||||||||||||||||||||||||||||||||
Balance
at December 31, 2009
|
$
|
-
|
$
|
-
|
66,374,856
|
$
|
66,375
|
68,723.88
|
$
|
69
|
6,255,813
|
$
|
6,256
|
$
|
80,097,536
|
$
|
(78,902,521
|
)
|
$
|
1,267,715
|
For the Period from
|
||||||||||||
January 22, 1997
|
||||||||||||
(date of inception) to
|
Year ended
|
Year ended
|
||||||||||
December 31,
|
December 31,
|
December 31,
|
||||||||||
2009
|
2009
|
2008
|
||||||||||
Cash
flows from operating activities:
|
||||||||||||
Net
loss
|
$
|
(75,756,406
|
)
|
$
|
(2,736,715
|
)
|
$
|
(3,017,890
|
)
|
|||
Adjustments
to reconcile net loss to net cash used by operating
activities:
|
||||||||||||
Common
stock issued as inducement to convert convertible notes payable and
accrued interest
|
3,351,961
|
—
|
—
|
|||||||||
Issuance
of common stock to consultants for services
|
30,000
|
—
|
—
|
|||||||||
Depreciation
and amortization
|
2,392,461
|
51,695
|
103,701
|
|||||||||
Amortization
of debt discount
|
1,000,000
|
—
|
—
|
|||||||||
Gain
on disposal of property and equipment
|
(21,663
|
)
|
—
|
—
|
||||||||
Gain
on extinguishment of debt
|
(216,617
|
)
|
—
|
—
|
||||||||
Interest
expense paid with Series B Preferred Stock in connection with conversion
of notes payable
|
3,147
|
—
|
3,147
|
|||||||||
Abandoned
patents
|
183,556
|
—
|
—
|
|||||||||
Bad
debts - employee advances
|
255,882
|
—
|
—
|
|||||||||
Contributed
technology expense
|
4,550,000
|
—
|
—
|
|||||||||
Consulting
expense
|
237,836
|
—
|
—
|
|||||||||
Management
unit expense
|
1,334,285
|
—
|
—
|
|||||||||
Expense
for issuance of warrants
|
533,648
|
14,885
|
40,354
|
|||||||||
Expense
for issuance of options
|
1,490,200
|
236,705
|
363,563
|
|||||||||
Amortization
of deferred compensation
|
74,938
|
—
|
—
|
|||||||||
Penalties
in connection with non-registration event
|
361,496
|
—
|
—
|
|||||||||
Changes
in operating assets and liabilities:
|
||||||||||||
Prepaid
expenses and other current assets
|
(640,639
|
)
|
(252,088
|
)
|
83,679
|
|||||||
Other
assets
|
(56,394
|
)
|
10,239
|
(12,740
|
)
|
|||||||
Accounts
payable and accrued expenses
|
2,797,582
|
666
|
70,837
|
|||||||||
Accrued
interest
|
1,823,103
|
—
|
—
|
|||||||||
Net
cash used by operating activities
|
(56,271,624
|
)
|
(2,674,613
|
)
|
(2,365,349
|
)
|
||||||
Cash
flows from investing activities:
|
||||||||||||
Proceeds
from sale of property and equipment
|
32,491
|
—
|
—
|
|||||||||
Purchases
of property and equipment
|
(2,226,932
|
)
|
(6,411
|
)
|
—
|
|||||||
Patent
costs
|
(435,647
|
)
|
(7,917
|
)
|
(22,052
|
)
|
||||||
Purchases
of short-term investments
|
(393,607
|
)
|
(393,607
|
)
|
||||||||
Proceeds
from sale of short-term investments
|
393,607
|
199,607
|
194,000
|
|||||||||
Loan
receivable
|
(1,632,168
|
)
|
—
|
—
|
||||||||
Net
cash (used) provided by investing activities
|
(4,262,256
|
)
|
185,279
|
(221,659
|
)
|
|||||||
Cash
flows from financing activities:
|
||||||||||||
Proceeds
from issuance of common stock
|
400,490
|
—
|
—
|
|||||||||
Proceeds
from issuance of preferred stock, net of related issuance
costs
|
9,579,040
|
—
|
4,899,603
|
|||||||||
Equity
contributions - net of fees incurred
|
43,046,952
|
1,335,754
|
—
|
|||||||||
Proceeds
from borrowing
|
8,603,631
|
—
|
225,000
|
|||||||||
Proceeds
from subscription receivables
|
499,395
|
—
|
—
|
|||||||||
Net
cash provided by financing activities
|
62,129,508
|
1,335,754
|
5,124,603
|
For the Period from
|
||||||||||||
January 22, 1997
|
||||||||||||
(date of inception) to
|
Year ended
|
Year ended
|
||||||||||
December 31,
|
December 31,
|
December 31,
|
||||||||||
2009
|
2009
|
2008
|
||||||||||
Net
increase (decrease) in cash and cash equivalents
|
1,595,628
|
(1,153,580
|
)
|
2,537,595
|
||||||||
Cash
and cash equivalents at beginning of period
|
—
|
2,749,208
|
211,613
|
|||||||||
Cash
and cash equivalents at end of period
|
$
|
1,595,628
|
$
|
1,595,628
|
$
|
2,749,208
|
||||||
Supplemental
disclosure of cash flow information:
|
||||||||||||
Cash
paid during the period for interest
|
$
|
590,189
|
$
|
—
|
$
|
—
|
||||||
Supplemental
schedule of noncash financing activities:
|
||||||||||||
Note
payable principal and interest conversion to equity
|
$
|
10,434,319
|
$
|
57,605
|
$
|
175,000
|
||||||
Issuance
of member units for leasehold improvements
|
$
|
141,635
|
$
|
—
|
$
|
—
|
||||||
Issuance
of management units in settlement of cost of raising
capital
|
$
|
437,206
|
$
|
—
|
$
|
—
|
||||||
Change
in fair value of management units for cost of raising
capital
|
$
|
278,087
|
$
|
—
|
$
|
—
|
||||||
Exchange
of loan receivable for member units
|
$
|
1,632,168
|
$
|
—
|
$
|
—
|
||||||
Issuance
of equity in settlement of accounts payable
|
$
|
1,609,446
|
$
|
—
|
$
|
—
|
||||||
Issuance
of common stock in exchange for stock subscribed
|
$
|
399,395
|
$
|
—
|
$
|
—
|
||||||
Costs
paid from proceeds in conjunction with issuance of preferred
stock
|
$
|
768,063
|
$
|
0
|
$
|
147,500
|
||||||
Preferred
stock dividends
|
$
|
3,146,115
|
$
|
704,325
|
$
|
905,382
|
||||||
Net
effect of conversion of common stock to preferred stock prior to
merger
|
$
|
559
|
$
|
—
|
$
|
—
|
1.
|
BASIS OF
PRESENTATION
|
2.
|
PRINCIPAL BUSINESS ACTIVITY AND
SUMMARY OF SIGNIFICANT ACCOUNTING
POLICIES:
|
3.
|
PROPERTY AND EQUIPMENT,
NET:
|
December 31,
|
2009
|
2008
|
Depreciation/
Amortization
Period
|
|||||||
Furniture
and fixtures
|
$ | 130,015 | $ | 130,015 |
7
years
|
|||||
Equipment
and computers
|
1,737,652 | 1,731,242 |
3
to 7 years
|
|||||||
Leasehold
improvements
|
462,980 | 462,980 |
Term
of
lease
|
|||||||
2,330,647 | 2,324,237 | |||||||||
Less
accumulated depreciation and amortization
|
2,311,794 | 2,272,180 | ||||||||
Property
and Equipment, Net
|
$ | 18,853 | $ | 52,057 |
4.
|
OTHER
ASSETS:
|
December 31,
|
2009
|
2008
|
|||||||
Intangible
assets, net
|
$
|
198,514
|
$
|
202,676
|
|||||
Security
deposits
|
56,394
|
66,634
|
|||||||
Total
|
$
|
254,908
|
$
|
269,310
|
December 31,
|
2009
|
2008
|
||||||||||||||
Gross
|
Accumulated
|
Gross
|
Accumulated
|
|||||||||||||
Amount
|
Amortization
|
Amount
|
Amortization
|
|||||||||||||
Patents
|
$
|
252,090
|
$
|
53,576
|
$
|
244,172
|
$
|
41,496
|
5.
|
ACCOUNTS PAYABLE AND ACCRUED
EXPENSES:
|
December 31,
|
||||||||
2009
|
2008
|
|||||||
Other
payable
|
$
|
195,527
|
$
|
316,556
|
||||
Legal,
financial and consulting
|
184,663
|
367,379
|
||||||
Research
and development
|
590,575
|
293,769
|
||||||
$
|
970,765
|
$
|
977,704
|
6.
|
CONVERTIBLE
NOTES:
|
7.
|
INCOME
TAXES:
|
2009
|
2008
|
|||||||
Federal
statutory rate
|
(34.0 | )% | (34.0 | )% | ||||
Decrease
resulting from:
|
||||||||
Non-deductible
expenses
|
2.5 | 4.6 | ||||||
Operating
losses
|
31.5 | 29.4 | ||||||
Effective
tax rate
|
— | % | — | % |
8.
|
COMMITMENTS AND
CONTINGENCIES:
|
2010
|
$
|
136,000
|
|||
2011
|
22,000
|
||||
Total
|
$
|
158,000
|
9.
|
STOCKHOLDERS'
EQUITY
|
|
·
|
the occurrence of
“Non-Registration Events”;
|
|
·
|
an uncured breach by the Company
of any material covenant, term or condition in the Certificate of
Designation or any of the related transaction documents;
and
|
|
·
|
any money judgment or similar
final process being filed against the Company for more than
$100,000.
|
|
·
|
the occurrence of
“Non-Registration Events”;
|
|
·
|
an uncured breach by the Company
of any material covenant, term or condition in the Certificate of
Designation or any of the related transaction documents;
and
|
|
·
|
any money judgment or similar
final process being filed against the Company for more than
$100,000.
|
Weighted
|
||||||||||||
Weighted
|
Average
|
|||||||||||
Average
|
Remaining
|
|||||||||||
Exercise
|
Contractual
|
|||||||||||
Shares
|
per Share
|
Life (Years)
|
||||||||||
Outstanding
January 1, 2008
|
2,098,502 | 9.41 | 7.7 | |||||||||
Granted
|
16,133,578 | 0.075 | 9.4 | |||||||||
Cancelled
|
(73,234 | ) | 26.42 | 0.0 | ||||||||
Exercised
|
— | — | — | |||||||||
Outstanding,
December 31, 2008
|
18,158,846 | 1.05 | 9.1 | |||||||||
Granted
|
5,418,858 | 0.125 | 9.0 | |||||||||
Cancelled
|
— | — | — | |||||||||
Exercised
|
0 | — | — | |||||||||
Outstanding,
December 31, 2009
|
23,577,704 | $ | 0.84 | 8.3 |
|
Weighted
|
|||||||
|
Average
|
|||||||
|
Grant Date
|
|||||||
Shares
|
Fair Value
|
|||||||
Non-vested,
January 1, 2009
|
6,280,604
|
$
|
0.05
|
|||||
Granted
|
5,418,858
|
$
|
0.003
|
|||||
Cancelled
|
—
|
$
|
—
|
|||||
Vested
|
(4,898,409
|
)
|
$
|
0.039
|
||||
Exercised
|
—
|
—
|
||||||
Non-vested,
December 31, 2009
|
6,801,053
|
$
|
0.024
|
Number of Shares
|
Warrant Exercise
|
Warrant
|
||||||
To be Purchased
|
Price per Share
|
Expiration Date
|
||||||
15,569 | $ | 6.64 |
March
31, 2010
|
|||||
816,691 | $ | 4.98 |
June
30, 2011
|
|||||
1,200,000 | $ | 0.90 |
June
30, 2011
|
|||||
900,000 | $ | 0.40 |
June
30, 2011
|
|||||
339,954 | $ | 2.00 |
September 30, 2011
|
|||||
52,080 | $ | 2.00 |
July
31, 2011
|
|||||
400,000 | $ | 0.40 |
October
31, 2011
|
|||||
240,125 | $ | 1.25 |
October
24, 2016
|
|||||
3,986,429 | $ | 0.035 |
June
25, 2013
|
|||||
397,825 | $ | 0.0362 |
September
30, 2014
|
|||||
12,483,665 | $ | 0.107 |
October
5, 2010
|
|||||
20,832,338 |
Number of
|
Warrant Exercise
|
Warrant
|
||||
Shares to be
|
Price per
|
Expiration
|
||||
Purchased
|
Preferred Share
|
Date
|
||||
525,000
|
$
|
1.00
|
June 30, 2011
|
10.
|
NET LOSS PER
SHARE
|
11.
|
SUBSEQUENT
EVENTS
|