tenq-0609.htm
UNITED
STATES
SECURITIES
AND EXCHANGE COMMISSION
Washington,
D.C. 20549
FORM
10-Q
(Mark
One)
ý QUARTERLY
REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF
1934
For the
quarterly period ended June 30, 2009
Or
¨ TRANSITION REPORT
PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF
1934
For the
transition period from ________________________
Commission
file number: 000-53404
________Bio-Path
Holdings, Inc.________
(Exact
name of registrant as specified in its charter)
|
Utah
|
|
87-0652870
|
|
|
(State
or other jurisdiction of
|
|
(I.R.S.
employer
|
|
|
incorporation
or organization
|
|
identification
No.)
|
|
3293 Harrison Boulevard,
Suite 230, Ogden, UT 84403
(Address
of principal executive offices)
Registrant's telephone no.,
including area code: (801) 399-5500
Indicate
by check mark whether the registrant (1) has filed all reports required to be
filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the
preceding 12 months (or for such shorter period that the registrant was required
to file such reports), and (2) has been subject to such filing requirements for
the past 90 days. Yes ý No ¨
Indicate
by check mark whether the registrant is a large accelerated filer, an
accelerated filer, a non-accelerated filer, or a smaller reporting
company. See the definitions of “large accelerated filer,”
“accelerated filer” and “smaller reporting company” in Rule 12b-2 of the
Exchange Act.
Large
accelerated filer ¨
|
Accelerated
filer ¨
|
Non-accelerated
filer ¨ (Do not check if
a smaller reporting company)
|
Smaller
reporting company ý
|
Indicate
by check mark whether the registrant is a shell company (as defined in Rule
12b-2 of the Exchange Act). Yes ¨ ý No
At August
14, 2009, the Company had 42,649,602 outstanding shares of common stock, $0.001
par value.
DOCUMENTS
INCORPORATED BY REFERENCE: NONE
Forward-Looking
Statements
Statements
in this quarterly report on Form 10-Q that are not strictly historical in nature
are forward-looking statements. These statements may include, but are not
limited to, statements about: the timing of the commencement, enrollment, and
completion of our anticipated clinical trials for our product candidates; the
progress or success of our product development programs; the status of
regulatory approvals for our product candidates; the timing of product launches;
our ability to protect our intellectual property and operate our business
without infringing upon the intellectual property rights of others; and our
estimates for future performance, anticipated operating losses, future revenues,
capital requirements, and our needs for additional financing. In some cases, you
can identify forward-looking statements by terms such as “anticipates,”
“believes,” “could,” “estimates,” “expects,” “intends,” “may,” “plans,”
“potential,” “predicts,” “projects,” “should,” “will,” “would,” “goal,” and
similar expressions intended to identify forward-looking statements. These
statements are only predictions based on current information and expectations
and involve a number of risks and uncertainties. The underlying information and
expectations are likely to change over time. Actual events or results may differ
materially from those projected in the forward-looking statements due to various
factors, including, but not limited to, those set forth under the caption “Risk
Factors” in “ITEM 1. BUSINESS” of our Form 10-K for the fiscal year ended
December 31, 2008, and those set forth in our other filings with the Securities
and Exchange Commission. Except as required by law, we undertake no obligation
to publicly update or revise any forward-looking statements, whether as a result
of new information, future events or otherwise.
TABLE OF
CONTENTS
PART I - FINANCIAL
INFORMATION
Item
1.
|
Financial Statements
|
Page
|
|
Consolidated
Balance Sheets
|
|
|
Consolidated
Statement of Operations
|
|
|
Consolidated
Statement of Cash Flows
|
|
|
Notes
to Interim Consolidated Financial Statements Ending June 30,
2009
|
|
Item
2.
|
Management's
Discussion and Analysis of Financial Condition and Results
of Operations
|
|
Item
3.
|
Quantitative
and Qualitative Disclosure about Market Risk
|
|
Item
4(T).
|
Controls
and Procedures
|
|
PART II - OTHER
INFORMATION
Item
1.
|
Legal
Proceedings
|
|
Item
1A.
|
Risk
Factors
|
|
Item
2.
|
Unregistered
Sales of Equity Securities and Use of Proceeds
|
|
Item
3.
|
Defaults
by the Company on its Senior Securities
|
|
Item
4.
|
Submission
of Matters to a Vote of Security Holders
|
|
Item
5.
|
Other
Information
|
|
Item
6.
|
Exhibits
|
|
PART
I - FINANCIAL INFORMATION
ITEM
1. FINANCIAL STATEMENTS
The accompanying unaudited financial
statements have been prepared in accordance with the instructions to Form 10-Q
pursuant to the rules and regulations of the Securities and Exchange Commission
and, therefore, do not include all information and footnotes necessary for a
complete presentation of our financial position, results of operations, cash
flows, and stockholders' equity in conformity with generally accepted accounting
principles. In the opinion of management, all adjustments considered
necessary for a fair presentation of the results of operations and financial
position have been included and all such adjustments are of a normal recurring
nature.
Our unaudited balance sheet at June 30,
2009; the related unaudited consolidated statements of operations for the three
month periods ended June 30, 2009 and 2008, and from inception (May 10, 2007) to
June 30, 2009; and the related unaudited statement of cash flows for the six
month periods ended June 30, 2009 and 2008, and from inception (May 10, 2007)
through June 30, 2009, are attached hereto.
BIO-PATH
HOLDINGS, INC.
(A
Development Stage Company)
|
|
June
30
|
|
|
December
31
|
|
|
|
2009
|
|
|
2008
|
|
|
|
(Unaudited)
|
|
|
|
|
ASSETS
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Current
assets
|
|
|
|
|
|
|
Cash
|
|
$ |
515,748 |
|
|
$ |
1,507,071 |
|
Drug
product for testing
|
|
|
591,600 |
|
|
|
292,800 |
|
Other
current assets
|
|
|
55,823 |
|
|
|
82,772 |
|
|
|
|
|
|
|
|
|
|
Total
current assets
|
|
|
1,163,171 |
|
|
|
1,882,643 |
|
|
|
|
|
|
|
|
|
|
Other
assets
|
|
|
|
|
|
|
|
|
Technology
licenses
|
|
|
2,729,167 |
|
|
|
2,704,167 |
|
Less
Accumulated Amortization
|
|
|
(290,501 |
) |
|
|
(199,505 |
) |
|
|
|
2,438,666 |
|
|
|
2,504,662 |
|
|
|
|
|
|
|
|
|
|
TOTAL
ASSETS
|
|
$ |
3,601,837 |
|
|
$ |
4,387,305 |
|
|
|
|
|
|
|
|
|
|
LIABILITIES
& SHAREHOLDERS' EQUITY
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Current
liabilities
|
|
|
|
|
|
|
|
|
Accounts
payable
|
|
|
2,059 |
|
|
|
185,843 |
|
Accrued
expense & other accruals
|
|
|
153,028 |
|
|
|
16,442 |
|
Accrued
license payments
|
|
|
75,000 |
|
|
|
125,000 |
|
|
|
|
|
|
|
|
|
|
Total
current liabilities
|
|
|
230,087 |
|
|
|
327,285 |
|
|
|
|
|
|
|
|
|
|
Long
term debt
|
|
|
- |
|
|
|
- |
|
|
|
|
|
|
|
|
|
|
TOTAL
LIABILITIES
|
|
|
230,087 |
|
|
|
327,285 |
|
|
|
|
|
|
|
|
|
|
Shareholders'
Equity
|
|
|
|
|
|
|
|
|
Preferred
Stock, $.001 par value
|
|
|
- |
|
|
|
- |
|
10,000,000
shares authorized, no shares issued and outstanding
|
|
|
|
|
|
|
|
|
Common
Stock, $.001 par value, 200,000,000 shares authorized
|
|
|
42,649 |
|
|
|
41,923 |
|
42,649,602
and 41,923,602 shares issued and outstanding as of 6/30/09 and 12/31/08,
respectively
|
|
|
|
|
|
|
|
|
Additional
paid in capital
|
|
|
7,593,009 |
|
|
|
7,152,261 |
|
Accumulated
deficit during development stage
|
|
|
(4,263,908 |
) |
|
|
(3,134,164 |
) |
|
|
|
|
|
|
|
|
|
Total
shareholders' equity
|
|
|
3,371,750 |
|
|
|
4,060,020 |
|
|
|
|
|
|
|
|
|
|
TOTAL
LIABILITIES & SHAREHOLDERS' EQUITY
|
|
$ |
3,601,837 |
|
|
$ |
4,387,305 |
|
See Accompanying Notes to Financial
Statements
BIO-PATH
HOLDINGS, INC.
(A
Development Stage Company)
Unaudited
|
|
Second
Quarter
|
|
|
Year
to Date
|
|
|
From
inception
|
|
|
|
April
1 to June 30
|
|
|
January
1 to June 30
|
|
|
05/10/07
to
|
|
|
|
2009
|
|
|
2008
|
|
|
2009
|
|
|
2008
|
|
|
6/30/09
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Revenue
|
|
$ |
- |
|
|
$ |
- |
|
|
$ |
- |
|
|
$ |
- |
|
|
$ |
- |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Operating
expense
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Research
and development
|
|
|
112,936 |
|
|
|
27,518 |
|
|
|
325,545 |
|
|
|
45,168 |
|
|
|
667,192 |
|
General
& administrative
|
|
|
224,706 |
|
|
|
180,362 |
|
|
|
418,031 |
|
|
|
284,022 |
|
|
|
1,276,475 |
|
Stock
issued for services
|
|
|
|
|
|
|
180,000 |
|
|
|
|
|
|
|
260,000 |
|
|
|
300,000 |
|
Stock
options & warrants
|
|
|
150,156 |
|
|
|
78,267 |
|
|
|
298,883 |
|
|
|
78,267 |
|
|
|
1,800,122 |
|
Amortization
|
|
|
45,731 |
|
|
|
42,583 |
|
|
|
90,996 |
|
|
|
85,167 |
|
|
|
290,501 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total
operating expense
|
|
|
533,529 |
|
|
|
508,730 |
|
|
|
1,133,455 |
|
|
|
752,624 |
|
|
|
4,334,290 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net
operating loss
|
|
$ |
(533,529 |
) |
|
$ |
(508,730 |
) |
|
$ |
(1,133,455 |
) |
|
$ |
(752,624 |
) |
|
$ |
(4,334,290 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Other
income
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Interest
income
|
|
|
480 |
|
|
|
12,474 |
|
|
|
3,712 |
|
|
|
30,162 |
|
|
|
70,382 |
|
Total
Other Income
|
|
|
480 |
|
|
|
12,474 |
|
|
|
3,712 |
|
|
|
30,162 |
|
|
|
70,382 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net
Loss
|
|
$ |
(533,049 |
) |
|
$ |
(496,256 |
) |
|
$ |
(1,129,743 |
) |
|
$ |
(722,462 |
) |
|
$ |
(4,263,908 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Loss
per share
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net
loss per share, basic and diluted
|
|
$ |
(0.01 |
) |
|
$ |
(0.01 |
) |
|
$ |
(0.03 |
) |
|
$ |
(0.02 |
) |
|
$ |
(0.12 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Basic
and diluted weighted average number of common shares
outstanding
|
|
|
42,165,602 |
|
|
|
41,823,602 |
|
|
|
42,044,602 |
|
|
|
40,483,929 |
|
|
|
36,130,281 |
|
See
Accompanying Notes to Financial Statements
BIO-PATH
HOLDINGS, INC.
(A
Development Stage Company)
Unaudited
|
|
Year
to Date
|
|
|
From
inception
|
|
|
|
January
1 to June 30
|
|
|
05/10/2007
to
|
|
|
|
2009
|
|
|
2008
|
|
|
6/30/2009
|
|
CASH
FLOW FROM OPERATING ACTIVITIES
|
|
|
|
|
|
|
|
|
|
Net
loss
|
|
$ |
(1,129,743 |
) |
|
$ |
(722,462 |
) |
|
$ |
(4,263,908 |
) |
Adjustments
to reconcile net loss to net cash used in operating
activities
|
|
|
|
|
|
|
|
|
|
|
|
|
Amortization
|
|
|
90,996 |
|
|
|
85,167 |
|
|
|
290,501 |
|
Common
stock issued for services
|
|
|
- |
|
|
|
260,000 |
|
|
|
300,000 |
|
Stock
options and warrants
|
|
|
298,883 |
|
|
|
78,267 |
|
|
|
1,800,122 |
|
(Increase)
decrease in assets
|
|
|
|
|
|
|
|
|
|
|
|
|
Restricted
escrow cash
|
|
|
- |
|
|
|
208,144 |
|
|
|
- |
|
Drug
product for testing
|
|
|
(298,800 |
) |
|
|
- |
|
|
|
(591,600 |
) |
Other
current assets
|
|
|
26,949 |
|
|
|
(44,600 |
) |
|
|
(55,823 |
) |
Increase
(decrease) in liabilities
|
|
|
|
|
|
|
|
|
|
|
|
|
Accounts
payable and accrued expenses
|
|
|
(97,198 |
) |
|
|
(22,868 |
) |
|
|
230,087 |
|
Escrow
cash payable
|
|
|
- |
|
|
|
(208,144 |
) |
|
|
- |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net
cash used in operating activities
|
|
|
(1,108,913 |
) |
|
|
(366,496 |
) |
|
|
(2,290,621 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
CASH
FLOW FROM INVESTING ACTIVITIES
|
|
|
|
|
|
|
|
|
|
|
|
|
Purchase
of exclusive license
|
|
|
(25,000 |
) |
|
|
- |
|
|
|
(375,000 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
Net
cash used in investing activities
|
|
|
(25,000 |
) |
|
|
- |
|
|
|
(375,000 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
CASH
FLOW FROM FINANCING ACTIVITIES
|
|
|
|
|
|
|
|
|
|
|
|
|
Proceeds
from convertible notes
|
|
|
|
|
|
|
|
|
|
|
435,000 |
|
Cash
repayment of convertible notes
|
|
|
. |
|
|
|
|
|
|
|
(15,000 |
) |
Net
proceeds from sale of common stock
|
|
|
142,590 |
|
|
|
1,400,225 |
|
|
|
2,761,369 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net
cash from financing activities
|
|
|
142,590 |
|
|
|
1,400,225 |
|
|
|
3,181,369 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
NET
INCREASE/(DECREASE) IN CASH
|
|
|
(991,323 |
) |
|
|
1,033,729 |
|
|
|
515,748 |
|
Cash, beginning
of period
|
|
|
1,507,071 |
|
|
|
1,219,357 |
|
|
|
- |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cash, end
of period
|
|
$ |
515,748 |
|
|
$ |
2,253,086 |
|
|
$ |
515,748 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
SUPPLEMENTAL
DISCLOSURE OF CASH FLOW INFORMATION
|
|
|
|
|
|
|
|
|
|
|
|
|
Cash
paid for
|
|
|
|
|
|
|
|
|
|
|
|
|
Interest
|
|
$ |
- |
|
|
$ |
- |
|
|
$ |
- |
|
Income
taxes
|
|
$ |
- |
|
|
$ |
- |
|
|
$ |
- |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Non-cash
financing activities
|
|
|
|
|
|
|
|
|
|
|
|
|
Common
stock issued upon conversion of convertible notes
|
|
|
|
|
|
|
|
|
|
$ |
420,000 |
|
Common
stock issued to Placement Agent
|
|
$ |
16,500 |
|
|
$ |
78,970 |
|
|
$ |
294,845 |
|
Common
stock issued to M.D. Anderson for technology license
|
|
|
|
|
|
|
|
|
|
$ |
2,354,167 |
|
See
Accompanying Notes to Financial Statements
Notes to the Interim Consolidated Financial Statements Ending June
30, 2009
The
accompanying interim financial statements have been prepared without audit,
pursuant to the rules and regulations of the Securities and Exchange Commission.
Certain information and disclosures normally included in financial statements
prepared in accordance with generally accepted accounting principles have been
condensed or omitted. In the opinion of management, the accompanying interim
financial statements contain all adjustments, consisting of normal recurring
accruals, necessary for a fair presentation. The results of operations for the
period ended June 30, 2009, are not necessarily indicative of the results for a
full-year period.
1. Organization
and Business
Bio-Path
Holdings, Inc. (“Bio-Path” or the “Company”) is a development stage company
founded with technology from The University of Texas, M. D. Anderson Cancer
Center (“M. D. Anderson”) dedicated to developing novel cancer drugs under an
exclusive license arrangement. The Company has drug delivery platform
technology with composition of matter intellectual property that enables
systemic delivery of antisense, small interfering RNA (“siRNA”) and small
molecules for treatment of cancer. In addition to its existing
technology under license, the Company expects to have a close working
relationship with key members of the M. D. Anderson’s staff, which should
provide Bio-Path with a strong pipeline of promising drug candidates in the
future. Bio-Path expects the program with M. D. Anderson to enable
the Company to broaden its technology to include cancer drugs other than
antisense and siRNA.
Bio-Path
believes that its core technology, if successful, will enable it to be at the
center of emerging genetic and molecular target-based therapeutics that require
systemic delivery of DNA and RNA-like material. The Company’s two
lead drug candidates treat acute myeloid leukemia, chronic myelogenous leukemia,
acute lymphoblastic leukemia and follicular lymphoma, and if successful, could
potentially be used in treating many other indications of
cancer. These two lead drug candidates will be ready for clinical
trials after receiving an investigational new drug (“IND”) status from the
FDA. The Company has filed an IND application for its lead drug
candidate and currently anticipates commencing a Phase I clinical trial of this
drug by the end of the year.
The
Company was founded in May of 2007 as a Utah corporation. In February
of 2008, Bio-Path completed a reverse merger with Ogden Golf Co. Corporation, a
public company traded over the counter that had no current
operations. The name of Ogden Golf was changed to Bio-Path Holdings,
Inc. and the directors and officers of Bio-Path, Inc. became the directors and
officers of Bio-Path Holdings, Inc. Bio-Path has become a publicly
traded company (symbol OTCBB: BPTH) as a result of this merger.
The
Company’s operations to date have been limited to organizing and staffing the
Company, acquiring, developing and securing its technology and undertaking
product development for a limited number of product candidates including
readying its lead drug product candidate BP-100-1.01 for a Phase I clinical
trial. Assuming the FDA grants an IND to the Company for the drug
BP-100-1.01, the Company currently expects to be able to commence a Phase I
clinical trial in BP-100-1.01 in the fourth quarter 2009.
Bio-Path
is currently in the process of raising additional funds for
operations. The Company has received a $500,000 verbal commitment
from certain current investors of Bio-Path to purchase shares of the Company’s
commons stock, of which $165,000 was closed on in the second quarter
2009. Assuming the IND is granted for Bio-Path’s drug candidate
BP-100-1.01, Management believes there is sufficient liquidity to commence the
Phase I clinical trial in BP-100-1.01. However, the Company needs to
raise additional capital to continue beyond the fourth quarter 2009 and complete
this clinical trial.
As the
Company has not begun its planned principal operations of commercializing a
product candidate, the accompanying financial statements have been prepared in
accordance with principles established for development stage
enterprises.
2. Drug
Product for Testing
The
Company has paid installments to its contract drug manufacturing supplier
totaling $591,600 during the third quarter and fourth quarters of 2008 and first
quarter of 2009 pursuant to a Project Plan and Supply Agreement (see Note 6.
below) for the manufacture and delivery of the Company’s lead drug product for
testing in a Phase I clinical trial. This amount is carried on the
Balance Sheet as of June 30, 2009 at cost for Testing the Phase 1 Drug Product,
and will be expensed as the drug product is used during the Phase I clinical
trial.
3. Convertible
Debt
The
Company issued $435,000 in notes convertible into common stock at a rate of $.25
per common share. As of December 31, 2007, $15,000 of the convertible
notes had been repaid in cash and $420,000 of the convertible notes had been
converted into 1,680,000 shares of Bio-Path common stock and were included in
the seed round completed in August of 2007. No interest was recorded
because interest was nominal prior to conversion. No beneficial
conversion feature existed as of the debt issuance date since the conversion
rate was greater than or equal to the fair value of the common stock on the
issuance date.
Issuance of
Common Stock – In May and June of 2007, the Company issued 6,505,994
shares of common stock for $6,506 in cash to founders of the
Company. In August of 2007, the Company issued 3,975,000 shares of
common stock for $993,750 in cash to investors in the Company pursuant to a
private placement memorandum. In August of 2007 the Company issued an
additional 1,333,334 shares of common stock for $1,000,000 in cash to one
investor in the Company pursuant to a second round of financing. The
Company issued 530,833 shares of common stock to the Placement Agent as
commission for the shares of common stock sold to investors. In
November of 2007, the Company issued 3,138,889 shares in common stock to M. D.
Anderson as partial consideration for its two technology licenses from M.
D.Anderson. In February of 2008, the Company issued 1,579,400 shares
of common stock for $1,579,400 in cash to investors in the Company pursuant to a
private placement memorandum. The Company issued 78,970 in common
stock to the Placement Agent as commission for the shares of common stock sold
to investors. In February, the Company completed a reverse merger
with Ogden Golf Co. Corporation and issued 38,023,578 shares of common stock of
the public company Bio-Path Holdings (formerly Ogden Golf Co. Corporation) in
exchange for pre-merger common stock of Bio-Path, Inc. In addition,
shareholders of Ogden Golf Co. Corporation retained 3,600,000 shares of common
stock of Bio-Path Holdings. In February of 2008 Bio-Path issued
80,000 shares of common stock to strategic consultants pursuant to executed
agreements and the fair value was expensed upfront as common stock for
services. In April of 2008, the Company issued 200,000 shares of
common stock to a firm in connection with introducing Bio-Path, Inc. to its
merger partner Ogden Golf Co. Corporation. The fair value of this
stock issuance was expensed upfront as common stock for services. In
April of 2008, the Company recorded an additional 24 shares for rounding in
accordance with FINRA rules. In December of 2008, the Company issued
100,000 shares of common stock to an investor relations firm for
services. The fair value of this stock issuance was expensed upfront
as common stock for services valued at $40,000. There were no
issuances of shares during the first quarter of 2009. In June of
2009, the Company issued 660,000 shares of common stock and warrants to purchase
an additional 660,000 shares of common stock for $165,000 in cash to investors
in the Company pursuant to a private placement memorandum. The
warrants must be exercised within two years from the date of
issuance.
The
exercise price of the warrants is $1.50 a share. In connection with
this private placement, the Company issued 66,000 shares of common stock to the
Placement Agent as commission for the shares of common stock sold to
investors. As of June 30, 2009, there were 42,649,602 shares of
common stock issued and outstanding. There are no preferred shares outstanding
as of June 30, 2009.
5. Stock
Options and Warrants
Stock Options - -
In April of 2008 the Company made stock option grants for services over
the next three years to purchase in the aggregate 1,615,000 shares of the
Company’s common stock. Terms of the stock option grants require,
among other things, that the individual continues to provide services over the
vesting period of the option, which is four or five years from the date that
each option granted to the individual becomes effective. The exercise
price of the options is $0.90 a share. None of these stock options
grants were for current management and officers of the Company. The
Company determined the fair value of the stock options granted using the Black
Scholes model and expenses this value monthly based upon the vesting schedule
for each stock option award. For purposes of determining fair value,
the Company used an average annual volatility of seventy two percent (72%),
which was calculated based upon an average of volatility of similar
biotechnology stocks. The risk free rate of interest used in the
model was taken from a table of the market rate of interest for U. S. Government
Securities for the date of the stock option awards and interpolated as necessary
to match the appropriate effective term for the award. The
total value of stock options granted was determined using this methodology to be
$761,590, which will be expensed over the next six years based on the stock
option service period.
In
October of 2008 the Company made stock option grants to management and officers
to purchase in the aggregate 2,500,000 shares of the Company’s common
stock. Terms of the stock option grants require that the individuals
continue employment with the Company over the vesting period of the option,
fifty percent (50%) of which vested upon the date of the grant of the stock
options and fifty percent (50%) of which will vest over 3 years from the date
that the options were granted. The exercise price of the options is
$1.40 a share. The Company determined the fair value of the stock
options granted using the Black Scholes model and expenses this value monthly
based upon the vesting schedule for each stock option award. For
purposes of determining fair value, the Company used an average annual
volatility of eighty four percent (84%), which was calculated based upon taking
a weighted average of the volatility of the Company’s common stock and the
volatility of similar biotechnology stocks. The risk free rate of
interest used in the model was taken from a table of the market rate of interest
for U. S. Government Securities for the date of the stock option awards and
interpolated as necessary to match the appropriate effective term for the
award. The total value of stock options granted to management
and officers was determined using this methodology to be $2,485,000, half of
which was expensed at the date of grant and the balance will be expensed over
the next three years based on the stock option service period.
In
December of 2008 the Company made stock option grants for services over the next
three years to purchase in the aggregate 100,000 shares of the Company’s common
stock. Terms of the stock option grants require, among other things,
that the individual continues to provide services over the vesting period of the
option, which is three or four years from the date that each option granted to
the individual becomes effective. The exercise price of the options
is $0.30 a share. None of these stock options grants were for current
management and officers of the Company. The Company determined the
fair value of the stock options granted using the Black Scholes model and
expenses this value monthly based upon the vesting schedule for each stock
option award. For purposes of determining fair value, the Company
used an average annual volatility of eighty four percent (84%), which was
calculated based upon taking a weighted average of the volatility of the
Company’s common stock and the volatility of similar biotechnology
stocks. The risk free rate of interest used in the model was taken
from a table of the market rate of interest for U. S. Government Securities for
the date of the stock option awards and interpolated as necessary to match the
appropriate effective term for the award.
The total
value of stock options granted was determined using this methodology to be
$21,450, which will be expensed over the next four years based on the stock
option vesting schedule. There were no new stock option awards made
during the first and second quarters of 2009. Total stock option
expense for the current quarter ending June 30, 2009 being reported on totaled
$150,156.
Warrants -
In April of 2008 the Company awarded warrants for services to purchase in
the aggregate 85,620 shares of the Company’s common stock. The
exercise price is $0.90 a share. The warrants were one hundred
percent (100%) vested upon issuance and were expensed upfront as warrants for
services. The fair value of the warrants expensed was determined
using the same methodology as described above for stock options. The
total value of the warrants granted was determined using this methodology to be
$36,050, the total amount of which was expensed in the second quarter
2008.
There
were no new warrants issued for services in the current quarter ending June 30,
2009 being reported on.
6. Drug
Project Plan and Supply Agreement
In June
of 2008, Bio-Path entered into a Project Plan agreement with a contract drug
manufacturing suppler for delivery of drug product to support commencement of
the Company’s Phase I clinical trial of its first cancer drug
product. The Company currently expects to start this trial by the end
of the year 2009. The clinical grade drug batch to be used in the
clinical trial was manufactured at the end of July 2009 and is currently being
tested. In the current quarter ending June 30, 2009, the Company paid
$78,666 to this manufacturer, $12,000 of which was expensed as R&D expense,
$66,000 of which was previously accrued as R&D expense and the balance of
$666 was recorded as a prepaid expense. Previously, $591,600 in
payments were made to this manufacturer under this agreement that is carried at
cost as Drug Product for Testing on the balance sheet (see Note
2.). The Company expects to pay an additional $168,150, of which
$72,000 has been accrued as R&D expense, to this supplier when the project
is completed and the drug manufacturer delivers clinical grade drug product
fully tested to the Company for its clinical trial.
7.
|
Commitments and
Contingencies
|
Technology
License - The Company has negotiated exclusive licenses from M. D.
Anderson to develop drug delivery technology for siRNA and antisense drug
products. These licenses require, among other things, the Company to
reimburse M. D. Anderson for ongoing patent expense. In the current
quarter ending June 30, 2009, the Company paid $25,000 to MD Anderson for
reimbursement of patent expenses invoiced to the Company. In
addition, accrued license payments totaling $75,000 are included in Current
Liabilities as of June 30, 2009. As of June 30, 2009, the Company
estimates these expenses will total approximately $225,000. The
Company will be required to pay the patent expenses at the rate of $25,000 per
quarter per license.
8. Subsequent
Events
In July
2009, the Company paid an additional $47,334 to its drug manufacturing
supplier. This payment was for additional R&D expense for
validation testing and was included in Current Liabilities as of June 30,
2009.
In July,
2009, the Company entered into a Sponsored Research Agreement with M. D.
Anderson for the Phase I clinical trial of the Company’s drug product
BP-100-1.01. The agreement covers payments for hospital costs, the
study principal investigator and support costs. The Company paid
approximately $40,000 upon execution of the agreement representing payment of
the institution’s fee and costs for the first two patients in the clinical
trial.
The
Company has executed a new exclusive license for tumor targeting of liposomes
from M. D. Anderson. Final execution of the license from M. D.
Anderson is expected to be received during the third quarter 2009.
The
Company is continuing fund raising activities. The Placement
Memorandum open at the end of the second quarter ending June 30, 2009 covering
the offering of the Company’s stock has expired and the Company plans to prepare
a new Memorandum to raise additional capital. The Company has verbal
commitments from certain current investors in the Company to invest an
additional $500,000 into the Company and has closed on $165,000 of this funding
by the end of the second quarter ending June 30, 2009. Management
believes that the ability to raise additional capital will significantly improve
once the Company has patient data from its Phase I clinical
trial. This is based upon feedback from large institutional investors
who have expressed a high level of confidence in being able to raise substantial
amounts of capital for the Company after Bio-Path’s technology has been
demonstrated in human patients in the Phase I clinical trial.
9. New
Accounting Pronouncements
Statement
of Financial Accounting Standards No. 165, Subsequent Events (“SFAS
165”) establishes general standards of accounting for and disclosure of events
that occur after the balance sheet date but before financial statements are
issued or are available to be issued. SFAS 165 incorporates into GAAP certain
guidance that previously existed under generally accepted auditing standards,
which require the disclosure of the date through which subsequent events have
been evaluated and whether that date is the date on which the financial
statements were issued or the date on which the financial statements were
available to be issued. We adopted SFAS 165 in the second quarter of 2009. We
evaluated subsequent events through August 19, 2009, which is the date the
financial statements were issued. The adoption of SFAS 165 did not have an
impact on our financial statements.
On
June 12, 2009, the FASB issued Statement No. 167, Amendments to FASB Interpretation
No. 46(R) ("SFAS No. 167"). SFAS No. 167 modifies the
existing quantitative guidance used in determining the primary beneficiary of a
variable interest entity ("VIE") by requiring entities to qualitatively assess
whether an enterprise is a primary beneficiary, based on whether the entity has
(i) power over the significant activities of the VIE, and (ii) an
obligation to absorb losses or the right to receive benefits that could be
potentially significant to the VIE. SFAS No. 167 becomes effective for all
new and existing VIEs on January 1, 2010. The adoption of SFAS No. 167
is not expected to have a material effect on our consolidated financial
statements.
On
June 29, 2009, the FASB issued Statement No. 168, The FASB Accounting Standards
Codification and the Hierarchy of Generally Accepted Accounting Principles—A
Replacement of FASB Statement No. 162
("SFAS No. 168"). SFAS No. 168 establishes the FASB Accounting
Standards Codification (the "Codification") as the primary source of
authoritative GAAP recognized by the FASB to be applied by nongovernmental
entities. Rules and interpretive releases of the SEC are also sources of
authoritative GAAP for SEC registrants. SFAS No. 168 and the Codification
become effective on September 30, 2009. When effective, the Codification
will supersede all existing non-SEC accounting and reporting standards and the
FASB will not issue new standards in the form of Statements, FASB Staff
Positions, or Emerging Issues Task Force Abstracts. Instead, the FASB will issue
Accounting Standards Updates, which will serve only to: (a) update the
Codification; (b) provide background information about the guidance; and
(c) provide the basis for conclusions on the change(s) in the Codification.
The adoption of SFAS No. 168 and the Codification on September 30,
2009 will not have a material effect on our consolidated financial
statements.
ITEM 2. MANAGEMENT'S DISCUSSION AND ANALYSIS OF FINANCIAL
CONDITION AND RESULTS OF OPERATIONS
When
you read this section of this Quarterly Form 10Q, it is important that you also
read the financial statements and related notes included elsewhere in this Form
10Q. This section of this quarterly report contains forward-looking statements
that involve risks and uncertainties, such as statements of our plans,
objectives, expectations, and intentions. We use words such as “anticipate,”
“estimate,” “plan,” “project,” “continuing,” “ongoing,” “expect,” “believe,”
“intend,” “may,” “will,” “should,” “could,” and similar expressions to identify
forward-looking statements. Our actual results could differ materially from
those anticipated in these forward-looking statements for many reasons,
including the matters discussed under the caption “Risk Factors” in “Item 1,
BUSINESS” in our annual report on Form 10-K for the fiscal year ended December
31, 2008 those additional risks, discussed in ITEM 1A. of Part II of
this quarterly report and other risks and uncertainties discussed in filings
made with the Securities and Exchange Commission.
Overview
Bio-Path Holdings, Inc., through our
subsidiary Bio-Path, Inc. (“Bio-Path Subsidiary”) is engaged in the
business of financing and facilitating the development of novel cancer
therapeutics. Our initial plan is and continues to be, the
acquisition of licenses for drug technologies from The University of Texas M. D.
Anderson Cancer Center (“M. D. Anderson”), funding clinical and other trials for
such technologies and to commercialize such technologies. We have acquired two
exclusive licenses (“License Agreements”) from M.D. Anderson for three lead
products and nucleic acid drug delivery technology. These licenses specifically
provide drug delivery platform technology with composition of matter
intellectual property that enables systemic delivery of antisense, small
interfering RNA (“siRNA”) and potentially small molecules for treatment of
cancer.
Our business plan is to act efficiently
as an intermediary in the process of translating newly discovered drug
technologies into authentic therapeutic drugs candidates. Our
strategy is to selectively license potential drug candidates for certain
cancers, and, primarily utilizing the comprehensive drug development
capabilities of M. D. Anderson, to advance these candidates through proof of
concept into a safety study (Phase I), to human efficacy trials (Phase IIA), and
then out-license each successful potential drug to a pharmaceutical
company.
Bio-Path Subsidiary was formed in May
2007. Bio-Path acquired Bio-Path Subsidiary in February 2008 in a reverse merger
transaction (the “Merger”).
Our principal executive offices are
located at, 3293 Harrison Boulevard, Suite 230, Ogden, UT 84403. Our
telephone number at that address is (801) 399-5500. Our Internet website
address is www.biopathholdings.com, and all of our filings with the Securities
and Exchange Commission are available free of charge on our
website.
Plan
of Operation
Our plan of operation over the next 36
months is focused on achievement of milestones with the intent to demonstrate
clinical proof-of concept of our drug delivery technology and lead drug
products. Furthermore, we will attempt to validate our business model by
in-licensing additional products to broaden the drug product
pipeline.
We anticipate that over the next 33
months, we will need to raise approximately $11,500,000 to completely implement
our business plan. Since its inception, Bio-Path Subsidiary completed
several financings raising net proceeds of $3,181,369. Our short term plan is to
achieve three key milestones:
(1) conduct a Phase I
clinical trial of our lead drug BP-100-1.01, which if successful, will validate
our liposomal delivery technology for nucleic acid drug products including
siRNA;
(2) perform necessary
pre-clinical studies in our lead liposomal siRNA drug candidate, BP-100-2.01 to
enable the filing of an Investigational New Drug (“IND”) for a Phase I clinical
trial; and
(3) out-license
(non-exclusively) our delivery technology for either antisense or siRNA to a
pharmaceutical partner to speed development applications of our
technology.
In June 2008, we entered into a Project
Plan Agreement with Althea Technologies, Inc. (“Althea”) relating to supply of
drug product for our first Phase I clinical trials of our BP-100-1.01
drug. In September 2008 we executed a definitive agreement with
Althea.
Results
of Operations
Results
of Operations for the three months and six months ended June 30, 2009 and
2008.
Revenues. We
have no operating revenues since our inception. We had interest
income of $480, for the three months ended June 30, 2009 compared to $12,474 for
the three months ended June 30, 2008. We had interest income of $3,712, for the
six months ended June 30, 2009 compared to $30,162 for the six months ended June
30, 2008. Our interest income was derived from cash and cash equivalents net of
bank fees. The decrease in interest income in the respective periods
results from increased operating expenses related to drug development, as such,
there was less cash held in our savings account earning interest.
Research and Development
Expenses. Our research and development costs were $112,936 for
the three months ended June 30, 2009; an increase of $85,418 over the three
months ended June 30, 2008. Our research and development costs were
$325,545 for the six months ended June 30, 2009; an increase of $280,377 over
the six months ended June 30, 2008. This increase is the result of
significant drug research and development and manufacturing protocol from year
to year. The majority of the expenses related to the lead drug
candidate, BP-100-1.01, have been paid. The Company does not expect
this increase to continue with this specific drug candidate.
General and
Administrative Expenses. Our general and administrative
expenses were $224,706 for the three months ended June 30, 2009; an increase of
$44,344 over the three months ended June 30, 2008. Our general and
administrative expenses were $418,031 for the six months ended June 30, 2009; an
increase of $134,009 over the six months ended June 30, 2008. The
increase in general and administrative expenses in the respective periods
results from the increased operating expenses relating to drug development
activity.
Net
Loss. Our net loss was $533,049 for the three months ended
June 30, 2009, compared to a loss of $496,256 for the three months ended June
30, 2008. Net loss per share, both basic and diluted was $0.01 and
$0.01 for the respective periods. Our net loss was $1,129,743 for the
six months ended June 30, 2009, compared to a loss of $722,462 for the six
months ended June 30, 2008. Net loss per share, both basic and
diluted was $0.03 and $0.02 for the respective periods. The primary reason for
the difference in the increase in net loss in the comparable period’s results
from increases in research and development expenses related to preparing the
lead drug candidate for the upcoming clinical trial.
Liquidity
and Capital Resources
Since our inception, we have funded our
operations primarily through private placements of our capital
stock. We expect to finance our foreseeable cash requirements through
cash on hand, cash from operations, public or private equity offerings and debt
financings. Additionally, we are seeking collaborations and license arrangements
for our three product candidates. We may seek to access the public or
private equity markets whenever conditions are favorable, even if we do not have
an immediate need for additional capital at that time. We cannot be certain that
additional funding, which will be required in the next term, will be available
on acceptable terms, or at all. Our inability to obtain required funding will
have a material adverse effect on one or more of our research or development
programs or curtail some of our commercialization efforts.
At June 30, 2009, we had cash of
$515,748 compared to $1,507,071 at December 31, 2008. We currently
have no lines of credit or other arranged access to debt financing.
Net cash used in operations during the
six months ended June 30, 2009 was $1,108,913 compared to $366,496 for six
months ended June 30, 2008. The significant increase in net cash used
results from implementing the business model of drug development working towards
the Phase I study of the lead drug – BP-100-1.01. Inasmuch as we have
not yet generated revenues, our entire expenses of operations are funded by our
cash assets.
Currently all of our cash is, and has
been, generated from financing activities. We raised $142,590
of net cash from financing activities for the three months ended June 30,
2009. Since inception we have net cash from financing activities of
$3,181,369. As discussed in our Plan of Operation above, we believe that our
available cash will be sufficient to fund our liquidity and capital expenditure
requirements through the fiscal year ending December 31,
2009. However, we believe that we will need to raise approximately an
additional $11,500,000 in net proceeds to completely implement our business
plan. We do need to raise additional capital during 2009, in order to
fund our operations in 2010. There can be no assurance that we will
be able to raise cash when it is needed to fund our operations.
Projected
Financing Needs
We believe that our available cash will
be sufficient to fund our liquidity and capital expenditure requirements through
the fiscal year ending December 31, 2009. In the second quarter
of 2009, we raised $142,590 in net proceeds from the sale of shares of our
common stock. The proceeds were allocated to general working
capital. However, we believe that we will need to raise approximately
an additional $11,500,000 in net proceeds to completely implement our business
plan. We do need to raise additional capital during 2009, in order to
fund our operations in 2010. There can be no assurance that we will
be able to raise cash when it is needed to fund our operations.
BP-100-1.01
BP-100-1.01 is our lead lipid delivery
RNAi drug, which will be clinically tested for validation in Acute Myeloid
Leukemia (AML), Myelodysplastic Syndrome (MDS) and Chronic Myelogenous Leukemia
(CML). If this outcome is favorable, we expect there will be
opportunities to negotiate non-exclusive license applications involving upfront
cash payments with pharmaceutical companies developing antisense drugs that need
systemic delivery technology.
The IND
for BP-100-1.01 was submitted to the FDA in February of 2008 and included all
in vitro testing,
animal studies and manufacturing and chemistry control studies
completed. The FDA requested some changes be made to the application
submission. The Company is currently finalizing the requested
changes. The final package submission to the FDA must include the
manufacturing and chemistry control test data from an engineering test batches
that incorporated the same manufacturing procedures to be used to manufacture
the drug product to be used on human patients in the Phase I clinical
trial. The clinical batch of drug product has been manufactured and
the Company expects to have the final data submitted to the FDA during the third
quarter of 2009. Based on this timetable, the Company anticipates
having the IND approved and commencement of patient enrollment for the Phase I
clinical trial to start during the end of the third or beginning of the fourth
quarter of 2009. The primary objective of the Phase I clinical trial,
as in any Phase I clinical trial, is the safety of the drug for treatment of
human patients. An additional key objective of the trial is to assess
that the effectiveness of the delivery technology.
The Phase I clinical trial of
BP-100-1.01 is budgeted for $1,675,000. A significant portion of this
budget is for acquisition of the drug material to be tested, a majority of which
has been paid by the Company. Commencement of the Phase I clinical
trial depends on the Federal Drug Administration (“FDA”) approving the IND for
BP-100-1.01.
We have entered into a supply agreement
with Althea Technologies, Inc. for the manufacture of BP-100-1.01 for our
upcoming Phase I Clinical Trial. Althea is a contract manufacturer
who will formulate and lyophilize our BP-100-1.01 product requirements according
to current Good Manufacturing Practices (cGMP). The contract includes estimated
remaining payments by Bio-Path of approximately $300,000 for process development
and manufacture of cGMP product suitable for use in human patients in the
Company’s Phase I clinical trial. Bio-Path has the right to terminate
the agreement at any time, subject to payment of a termination fee to
Althea. The termination fee is not material.
BP-100-2.01
BP-100-2.01 is our lead siRNA drug,
which will be clinically tested for validation as a novel, targeted ovarian
cancer therapeutic agent. The Company prepared a review package of
the testing data for this drug product and reviewed the information with the
FDA. Based on this review and feedback, performing the remaining
pre-clinical development work for BP-100-2.01 expected to be required for an IND
is budgeted for $225,000. The additional pre-clinical work is expected to
include two toxicity studies in mice and primates.
There can be no assurance of the
following: (1) That the actual costs of a particular trial will come within our
budgeted amount; (2) That any trials will be successful or will result in drug
commercialization opportunities, or (3) That we will be able to raise the
sufficient funds to allow us to operate for three years or to complete our
trials.
Other
Events
None.
Off-Balance
Sheet Arrangements
We do not have any off-balance sheet
arrangements that have or are reasonably likely to have a current or future
effect on our financial condition, changes in financial condition, revenues or
expenses, results of operations, liquidity, capital expenditures or capital
resources that is material to investors.
Contractual
Obligations and Commitments
Bio-Path has entered into two Patent
and Technology License Agreements (the “Licenses”) with M. D. Anderson relating
to its technology. A summary of certain material terms of each of the Licenses
is as follows:
|
Licensor:
|
The
Board of Regents of the University of Texas System on behalf of The
University of Texas M. D. Anderson Cancer Center
|
|
|
|
|
Licensee:
|
Bio-Path,
Inc.
|
|
|
|
|
License:
|
A
royalty bearing, exclusive license to manufacture, use and sell the
Licensed Products
|
|
Territory:
|
Worldwide
|
|
|
|
|
Retained
Rights
|
Certain
research and academic rights are retained by Licensor
|
|
|
|
|
License
Fees:
|
Documentation
Fee - $40,000 for the first license and $60,000 for the second license;
annual maintenance fee - $25,000 for years 1, 2 & 3 increasing to
$100,000 in the eighth year. After the first sale, increasing
to $125,000
|
|
|
|
|
Royalties:
|
Three
percent of net sales
|
|
|
|
|
Milestone
Payments:
|
One-time
payments range from $150,000 to $2,000,000. Total up to
$8,150,000
|
|
|
|
|
Securities
Issuance:
|
1,883,333
shares of Bio-Path for the first License and 1,255,556 shares for the
second License. These shares were converted into shares of the
Company’s common stock in the Merger.
|
|
|
|
|
Expense:
|
Bio-Path
will reimburse M. D. Anderson for expenses
|
|
|
|
|
Term:
|
Full
term of patents
|
In September 2008, we entered into a
supply agreement with Althea Technologies, Inc. for the manufacture of
BP-100-1.01 for our upcoming Phase I Clinical Trial. Althea is a
contract manufacturer who will formulate and lyophilize our BP-100-1.01 product
requirements according to current Good Manufacturing Practices
(cGMP). The contract includes estimated remaining payments by
Bio-Path of approximately $300,000 for process development and manufacture of
cGMP product suitable for use in human patients in the Company’s Phase I
clinical trial. Bio-Path has the right to terminate the agreement at
any time, subject to payment of a termination fee to Althea. The
termination fee is not material.
In April 2009, we entered into an
agreement with ACORN CRO, a full service, oncology-focused clinical research
organization, to provide Bio-Path with a contract medical officer and
potentially other clinical trial support services. Concurrent with
signing the agreement, Bradley G. Somer, M.D., will serve as Bio-Path’s Medical
Officer and medical liaison for the conduct of the Company’s upcoming Phase I
clinical study of liposomal BP-100-1.01 in refractory or relapsed Acute Myeloid
Leukemia (AML), Chronic Myelogenous Leukemia (CML), Acute Lymphoblastic Leukemia
(ALL) and Myelodysplastic Syndrome (MDS).
Inflation
The Company does not believe that
inflation will negatively impact its business plans.
Critical
Accounting Policies
The preparation of financial statements
in conformity with generally accepted accounting principles (“GAAP”) in the
United States has required the management of the Company to make assumptions,
estimates and judgments that affect the amounts reported in the financial
statements, including the notes thereto, and related disclosures of commitments
and contingencies, if any. The Company considers its critical accounting
policies to be those that require the more significant judgments and estimates
in the preparation of financial statements, including the
following:
Concentration of
Credit Risk -- Financial instruments that potentially subject the Company
to a significant concentration of credit risk consist of cash. The
Company maintains its cash balances with one major commercial bank, JPMorgan
Chase Bank. The balances are insured by the Federal Deposit Insurance
Corporation up to $250,000. As a result, $265,748 of the Company’s
cash balances is not covered by the FDIC.
Intangible
Assets/Impairment of Long-Lived Assets -- As of June 30, 2009, other
Assets totaled $2,438,666 for the Company’s two technology licenses, comprised
of $2,729,167 in value acquiring the Company’s technology licenses and its
intellectual property, less accumulated amortization of $290,501. The
technology value consists of $350,000 in cash paid or accrued to be paid to M.D.
Anderson, plus 3,138,889 shares of common stock granted to M.D. Anderson valued
at $2,354,167. This value is being amortized over a fifteen year (15
year) period from November 7, 2007, the date that the technology licenses became
effective. As of December 31, 2008 accrued payments to be made to M.
D. Anderson totaled $125,000, and such payments are expected to be made in 2009.
The Company accounts for the impairment and disposition of its long-lived assets
in accordance with Statement of Financial Accounting Standards (“SFAS”) No. 144,
Accounting for the Impairment or Disposal of Long-Lived Assets. In
accordance with SFAS No. 144, long-lived assets are reviewed for events of
changes in circumstances which indicate that their carrying value may not be
recoverable. The Company estimates that approximately $175,000 will
be amortized per year for each future year for the current value of the
technology licenses acquired until approximately 2022.
Research and
Development Costs -- Costs and expenses that can be clearly identified as
research and development are charged to expense as incurred in accordance with
SFAS No. 2, “Accounting for Research and Development Costs.” From
inception through the period ending June 30, 2009, the Company had $667,192 of
costs classified as research and development expense. Of this amount,
approximately $225,000 is comprised of raw materials and costs for the Company’s
raw material suppliers and contract drug manufacturer to perform unplanned
additional engineering test runs of the Company’s lead drug product in advance
of manufacturing a current Good Manufacturing Practice (cGMP) clinical batch of
this drug for use in an upcoming Phase I Clinical Trial.
Stock-Based
Compensation -- The Company has accounted for stock-based compensation
under the provisions of Statement of Financial Accounting Standards No. 123(R),
“Share-Based Payment.” This statement requires us to record an
expense associated with the fair value of stock-based
compensation. We currently use the Black-Scholes option valuation
model to calculate stock based compensation at the date of
grant. Option pricing models require the input of highly subjective
assumptions, including the expected price volatility. Changes in
these assumptions can materially affect the fair value estimate.
Stock Option
Grants - In April of 2008 the Company made stock option grants
for services over the next three years to purchase in the aggregate 1,615,000
shares of the Company’s common stock. Terms of the stock option
grants require, among other things, that the individual continues to provide
services over the vesting period of the option, which is four or five years from
the date that each option granted to the individual becomes
effective. The exercise price of the options is $0.90 a
share. None of these stock options grants were for current management
and officers of the Company. The Company determined the fair value of
the stock options granted using the Black Scholes model and expenses this value
monthly based upon the service period schedule for each stock option
award. For purposes of determining fair value, the Company used an
average annual volatility of seventy two percent (72%), which was calculated
based upon an average of volatility of similar biotechnology
stocks. The risk free rate of interest used in the model was taken
from a table of the market rate of interest for U. S. Government Securities for
the date of the stock option awards and interpolated as necessary to match the
appropriate effective term for the award. The total value of
stock options granted was determined using this methodology to be $761,590,
which will be expensed over the next six years based on the service
period.
In
October of 2008 the Company made stock option grants to management and officers
to purchase in the aggregate 2,500,000 shares of the Company’s common
stock. Terms of the stock option grants require that the individuals
continue employment with the Company over the vesting period of the option,
fifty percent (50%) of which vested upon the date of the grant of the stock
options and fifty percent (50%) of which will vest over 3 years from the date
that the options were granted. The exercise price of the options is
$1.40 a share. The Company determined the fair value of the stock
options granted using the Black Scholes model and expenses this value monthly
based upon the service period for each stock option award. For
purposes of determining fair value, the Company used an average annual
volatility of eighty four percent (84%), which was calculated based upon taking
a weighted average of the volatility of the Company’s common stock and the
volatility of similar biotechnology stocks. The risk free rate of
interest used in the model was taken from a table of the market rate of interest
for U. S. Government Securities for the date of the stock option awards and
interpolated as necessary to match the appropriate effective term for the
award.
The total
value of stock options granted to management and officers was determined using
this methodology to be $2,485,000, half of which was expensed at the date of
grant and the balance will be expensed over the next three years based on the
stock option vesting
schedule.
In
December of 2008 the Company made stock option grants for services over the next
three years to purchase in the aggregate 100,000 shares of the Company’s common
stock. Terms of the stock option grants require, among other things,
that the individual continues to provide services over the vesting period of the
option, which is three or four years from the date that each option granted to
the individual becomes effective. The exercise price of the options
is $0.30 a share. None of these stock options grants were for current
management and officers of the Company. The Company determined the
fair value of the stock options granted using the Black Scholes model and
expenses this value monthly based upon the vesting schedule for each stock
option award. For purposes of determining fair value, the Company
used an average annual volatility of eighty four percent (84%), which was
calculated based upon taking a weighted average of the volatility of the
Company’s common stock and the volatility of similar biotechnology
stocks.
The risk
free rate of interest used in the model was taken from a table of the market
rate of interest for U. S. Government Securities for the date of the stock
option awards and interpolated as necessary to match the appropriate effective
term for the award. The total value of stock options granted
was determined using this methodology to be $21,450, which will be expensed over
the next four years based on the stock option vesting schedule.
Total
stock option expense being reported for the period ending June 30, 2009 is
$150,156 and from inception May 10, 2007 to June 30, 2009 is
$1,800,122.
Warrant
Grants - In April of 2008 the Company awarded warrants for services to
purchase in the aggregate 85,620 shares of the Company’s common
stock. The exercise price is $0.90 a share. The warrants
were one hundred percent (100%) vested upon issuance and were expensed upfront
as warrants for services. The fair value of the warrants expensed was
determined using the same methodology as described above for stock
options. The total value of the warrants granted was determined using
this methodology to be $36,050, the total amount of which was expensed in the
second quarter 2008. In the second quarter of 2009, the Company
issued 660,000 shares of common stock and warrants to purchase an additional
660,000 shares of common stock for $165,000 in cash to investors in the Company
pursuant to a private placement memorandum. The warrants must be
exercised within two years from the date of issuance. The exercise
price of the warrants is $1.50 a share.
Net Loss Per
Share – In accordance with SFAS No. 128, Earnings Per Share, and SEC
Staff Accounting Bulletin (“SAB”) No. 98, basic net loss per common share is
computed by dividing net loss for the period by the weighted average number of
common shares outstanding during the period. Under SFAS No. 128,
diluted net income (loss) per share is computed by dividing the net income
(loss) for the period by the weighted average number of common and common
equivalent shares, such as stock options and warrants, outstanding during the
period.
Comprehensive
Income -- Comprehensive income (loss) is defined as all changes in a
company’s net assets, except changes resulting from transactions with
shareholders. At June 30, 2009, the Company has
no reportable differences between net loss and comprehensive loss.
Use of Estimates
-- The preparation of consolidated financial statements in conformity
with accounting principles generally accepted in the United States requires
management to make estimates and assumptions that affect the amounts reported in
the Company’s consolidated financial statements and accompanying notes. On an
ongoing basis, the Company evaluates its estimates and judgments, which are
based on historical and anticipated results and trends and on various other
assumptions that the Company believes to be reasonable under the circumstances.
By their nature, estimates are subject to an inherent degree of uncertainty and,
as such, actual results may differ from the Company’s estimates.
ITEM 3. QUANTITATIVE AND QUALITATIVE DISCLOSURE ABOUT MARKET
RISK
Information not required for smaller
reporting companies.
ITEM 4(T). CONTROLS AND PROCEDURES
(a) Evaluation of Disclosure Controls
and Procedures. Our management, with the participation of our principal
executive officer and principal financial officer, have evaluated the
effectiveness of our disclosure controls and procedures (as such term is defined
in Rules 13a-15(e) and 15d-15(e) under the Securities Exchange Act of 1934, as
amended (the “Exchange Act”)) as of the end of the period covered by this
quarterly report (the “Evaluation Date”). Based on such evaluation, our
principal financial officer and principal executive officer have concluded that,
as of the Evaluation Date, our disclosure controls and procedures are effective
and designed to ensure that the information relating to our company (including
our consolidated subsidiaries) required to be disclosed in our reports filed or
submitted under the Exchange Act is recorded, processed, summarized and reported
within the requisite time periods.
(b) Changes in Internal
Controls. There was no change in our internal control over financial
reporting (as defined in Rules 13a–15(f) and 15d-15(f) under the Exchange
Act) that occurred during the quarter covered by this report that has materially
affected, or is reasonably likely to materially affect, such
controls.
PART
II – OTHER INFORMATION
None.
There
have been no material changes to the risk factors described in the Company’s
Form 10-K filed with the Securities and Exchange Commission on April 3,
2009
ITEM 2. UNREGISTERED SALES OF EQUITY SECURITIES AND USE
OF PROCEEDS
During the quarter ended June 30, 2009,
we sold 660,000 shares of our common stock and received net proceeds of
$142,590. For each share of common stock sold, there was one warrant
issued for a total of 660,000 warrants. The warrants are exercisable
at $1.50 per share. The warrants have an exercise period of two years
from the date of the investment. In connection with such offering, we
also issued 66,000 shares of common stock to the placement agent. All
of the shares of common stock and warrants issued were issued in non registered
transactions in reliance on Section 4(2) of the Securities Act of 1933, as
amended (the “Securities Act”).
ITEM 3. DEFAULTS BY THE COMPANY ON ITS SENIOR
SECURITIES
None.
ITEM 4. SUBMISSION OF MATTERS TO A VOTE OF SECURITY
HOLDERS
We held our annual meeting of
stockholders on July 15, 2009. The following is a brief description of each
matter voted upon at the annual meeting and the number of votes cast for,
withheld, or against, the number of abstentions and the number of broker
non-votes with respect to each matter:
1. To
elect four directors to our board of directors to hold office until our 2010
annual meeting of stockholders.
Name
|
|
Number
of Shares
|
|
|
For
|
|
Withheld
|
|
|
|
|
|
Peter
H. Nielsen
|
|
22,000,334
|
|
3,008
|
Douglas
P. Morris
|
|
22,000,334
|
|
3,008
|
Thomas
Garrison
|
|
22,000,334
|
|
3,008
|
Gillian
Ivers-Read
|
|
22,000,334
|
|
3,008
|
2. To
ratify the appointment of Mantyla & Mc Reynolds as our independent
registered public accounting firm for the fiscal year ending December 31,
2009.
|
For
|
|
21,867,500
|
|
|
Against
|
|
3,008
|
|
|
Abstain
|
|
129,826
|
|
|
Broker
Non-Vote
|
|
0
|
|
None
|
Certification
of Chief Executive Officer and Chief Financial Officer Pursuant to Section
302 of the Sarbanes Oxley Act of 2002.
|
|
Certification
of Chief Executive Officer and Chief Financial Officer Pursuant to Section
906 of the Sarbanes Oxley Act of 2002.
|
SIGNATURE
In
accordance with the requirements of the Exchange Act, the Company has caused
this report to be signed on its behalf by the undersigned thereunto duly
authorized.
Dated:
August 19, 2009
|
BIO-PATH
HOLDINGS, INC.
|
|
|
|
By /s/
Peter H. Nielsen,
|
|
Chief
Executive Officer, President/Principal Executive Officer, Chief Financial
Officer, Principal Financial
Officer
|