Rebus Holdings, Inc. - Quarter Report: 2009 March (Form 10-Q)
U.S. SECURITIES AND EXCHANGE COMMISSION
Washington,
D.C. 20549
FORM
10-Q
(Mark
one)
x
|
Quarterly
Report Under Section 13 or 15(d) of the Securities Exchange Act of
1934
|
For
the Quarterly Period Ended March 31, 2009
Or
¨
|
Transition
Report Under Section 13 or 15(d) of the Securities Exchange Act of
1934
|
Commission
File Number 333-153829
GENSPERA,
INC.
(Exact
name of registrant as specified in its charter)
Delaware
|
20-0438951
|
|
State
or other jurisdiction of
incorporation
or organization
|
(I.R.S.
Employer
Identification
No.)
|
|
9901
IH 10 West, Suite 800
San
Antonio, TX
|
78230
|
|
(Address
of principal executive offices)
|
(Zip
Code)
|
Registrant’s
telephone number, including area code (210)
477-8537
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 x
No ¨
Indicate by check mark whether the
registrant has submitted electronically and posted on its corporate Website, if
any, every Interactive Data File required to be submitted and posted pursuant to
Rule 405 of Regulation S-T during the preceding 12 months (or for such shorter
period that the registrant was required to submit and post such files).
Yes o No o
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 o
|
Accelerated
filer o
|
Non-accelerated
filer o (Do
not check if a small reporting company)
|
Smaller
reporting company x
|
Indicate
by check mark whether the registrant is a shell company (as defined in Rule
12b-2 of the Exchange Act) Yes ¨ No
x
The number of shares outstanding of
Registrant’s common stock, $0.0001 par value at May 1, 2009 was
12,953,392.
GenSpera,
Inc.
Table of
Contents
Page
|
|||
PART
I -
|
FINANCIAL
INFORMATION
|
||
Item
1.
|
Financial
Statements
|
5 | |
Condensed
Balance Sheets as of March 31, 2009 (Unaudited) and December 31,
2008
|
5
|
||
Condensed
Statements of Operations (Unaudited)
|
|||
Three
months ended March 31, 2009 and 2008 and for the period from November 21,
2003 (inception) to March 31, 2009
|
6
|
||
Condensed
Statement of Changes in Stockholders' Equity (Unaudited)
|
|||
For the period from
November 21, 2003 (inception) through March 31,
2009
|
7
|
||
|
|
||
Condensed
Statements of Cash Flows (Unaudited)
|
|||
Three
months ended March 31, 2009 and 2008 and for the period from November 21,
2003 (inception) to March 31, 2009
|
8
|
||
Notes
to Condensed Financial Statements (Unaudited)
|
9
|
||
Item
2.
|
Management's
Discussion and Analysis of Financial Condition and Results
of Operations
|
14
|
|
Item
3.
|
Quantitative
and Qualitative Disclosures about Market Risk
|
20
|
|
Item
4.
|
Controls
and Procedures
|
20
|
|
PART
II -
|
OTHER
INFORMATION
|
||
Item
1.
|
Legal
Proceedings
|
21
|
|
Item
1A.
|
Risk
Factors
|
21
|
|
Item
2.
|
Unregistered
Sales of Equity Securities and Use of Proceeds
|
27
|
|
Item
3.
|
Defaults
Upon Senior Securities
|
27
|
|
Item
4.
|
Submission
of Matters to a Vote of Security Holders.
|
28
|
|
Item
5.
|
Other
Information
|
28
|
|
|
|||
Item
6.
|
Exhibits
|
28
|
2
ADVISEMENT
We
urge you to read this entire Quarterly Report on Form 10-Q, including the” Risk
Factors” section, the financial statements, and related notes included
herein. As used in this Quarterly Report, unless the context
otherwise requires, the words “we,” “us,”“our,” “the Company,” “GenSpera” and
“Registrant” refer to GenSpera, Inc. Also, any reference to “common
shares,” “Common Stock,” “common stock” or “Common Shares” refers to our $.0001
par value common stock. The information contained herein is
current as of the date of this Quarterly Report (March 31, 2009), unless another
date is specified.
We
prepare our interim financial statements in accordance with United States
generally accepted accounting principles. Our financials and results of
operation for the three month period ended March 31, 2009 are not necessarily
indicative of our prospective financial condition and results of operations for
the pending full fiscal year ending December 31, 2009. The interim financial
statements presented in this Quarterly Report as well as other information
relating to our company contained in this Quarterly Report should be read in
conjunction and together with the reports, statements and information filed by
us with the United States Securities and Exchange Commission
(“SEC”).
SPECIAL
NOTE REGARDING FORWARD-LOOKING STATEMENTS
Certain
statements contained in this Quarterly Report on Form 10-Q constitute
“forward-looking statements” within the meaning of Section 27A of the
Securities Act of 1933 and Section 21E of the Securities Exchange Act of
1934. All statements included in this Report, including those related to our
cash, liquidity, resources and our anticipated cash expenditures, as well as any
statements other than statements of historical fact, regarding our strategy,
future operations, financial position, projected costs, prospects, plans and
objectives are forward-looking statements. These forward-looking
statements are derived, in part, from various assumptions and analyses we have
made in the context of our current business plan and information currently
available to us and in light of our experience and perceptions of historical
trends, current conditions and expected future developments and other factors we
believe are appropriate in the circumstances. You can generally identify forward
looking statements through words and phrases such as “believe”, “expect”,
“seek”, “estimate”, “anticipate”, “intend”, “plan”, “budget”, “project”, “may
likely result”, “may be”, “may continue” and other similar
expressions, although not all forward-looking statements contain these
identifying words. We cannot guarantee future results, levels of activity,
performance or achievements, and you should not place undue reliance on our
forward-looking statements.
Our
actual results could differ materially from those anticipated in these
forward-looking statements as a result of various factors, including the risks
described in Part II, Item 1A, “Risk Factors” and elsewhere in this
Report. Our forward-looking statements do not reflect the potential impact of
any future acquisitions, mergers, dispositions, joint ventures or strategic
investments. In addition, any forward-looking statements represent our
expectation only as of the day this Report was first filed with the Securities
and Exchange Commission (“SEC”) and should not be relied on as representing our
expectations as of any subsequent date. While we may elect to update
forward-looking statements at some point in the future, we specifically disclaim
any obligation to do so, even if our expectations change.
When
reading any forward-looking statement you should remain mindful that actual
results or developments may vary substantially from those expected as expressed
in or implied by such statement for a number of reasons or factors, including
but not limited to:
·
|
the
success of our research and development activities, the development of a
viable commercial product, and the speed with which regulatory
authorizations and product launches may be achieved;
|
·
|
whether
or not a market for our product develops and, if a market develops, the
rate at which it develops;
|
·
|
our
ability to successfully sell our products if a market
develops;
|
·
|
our
ability to attract and retain qualified personnel to implement our growth
strategies;
|
·
|
our
ability to develop sales, marketing, and distribution
capabilities;
|
·
|
the
accuracy of our estimates and projections;
|
·
|
our
ability to fund our short-term and long-term financing
needs;
|
3
·
|
changes
in our business plan and corporate growth strategies;
and
|
·
|
other
risks and uncertainties discussed in greater detail in the section
captioned “Risk Factors”
|
Each
forward-looking statement should be read in context with and in understanding of
the various other disclosures concerning our company and our business made
elsewhere in this Annual Report as well as our public filings with the SEC. You
should not place undue reliance on any forward-looking statement as a prediction
of actual results or developments. We are not obligated to update or revise any
forward-looking statements contained in this Annual Report or any other filing
to reflect new events or circumstances unless and to the extent required by
applicable law.
4
PART
I
FINANCIAL
INFORMATION
ITEM
1.
|
FINANCIAL
STATEMENTS
|
GENSPERA
INC.
(A
Development Stage Company)
CONDENSED
BALANCE SHEETS
March 31,
|
December 31,
|
|||||||
2009
|
2008
|
|||||||
|
(Unaudited)
|
|||||||
Assets
|
||||||||
Current
assets:
|
||||||||
Cash
|
$ | 661,360 | $ | 534,290 | ||||
Total
current assets
|
661,360 | 534,290 | ||||||
Intangible
assets, net of accumulated amortization of $15,348 and
$11,511
|
168,820 | 172,657 | ||||||
Total
assets
|
$ | 830,180 | $ | 706,947 | ||||
Liabilities
and stockholders' equity (deficit)
|
||||||||
Current
liabilities:
|
||||||||
Accounts
payable and accrued expenses
|
$ | 142,750 | $ | 238,817 | ||||
Accrued
interest - stockholder
|
6,987 | 5,399 | ||||||
Convertible
note payable - stockholder, current portion
|
50,000 | 50,000 | ||||||
Total
current liabilities
|
199,737 | 294,216 | ||||||
Convertible
note payable, net of discount of $5,948 and $11,046
|
157,652 | 152,554 | ||||||
Convertible
notes payable - stockholder, long term portion
|
105,000 | 105,000 | ||||||
Derivative
liabilities
|
1,723,378 | - | ||||||
Total
liabilities
|
2,185,767 | 551,770 | ||||||
Commitments
and contingencies
|
||||||||
Stockholders'
equity (deficit):
|
||||||||
Preferred
stock, par value $.0001 per share; 10,000,000 shares authorized, none
issued and outstanding
|
- | - | ||||||
Common
stock, par value $.0001 per share; 80,000,000 shares authorized,
12,953,392 and 12,486,718 shares issued and outstanding
|
1,295 | 1,249 | ||||||
Additional
paid-in capital
|
5,259,370 | 4,922,174 | ||||||
Deficit
accumulated during the development stage
|
(6,616,252 | ) | (4,768,246 | ) | ||||
Total
stockholders' equity (deficit)
|
(1,355,587 | ) | 155,177 | |||||
Total
liabilities and stockholders' equity (deficit)
|
$ | 830,180 | $ | 706,947 |
See
accompanying notes to unaudited condensed financial
statements.
5
GENSPERA,
INC.
(A
Development Stage Company)
CONDENSED
STATEMENTS OF LOSSES
FOR THE
THREE MONTHS ENDED MARCH 31, 2009 AND 2008
AND FOR
THE PERIOD FROM INCEPTION (NOVEMBER 21, 2003) TO MARCH 31, 2009
(Unaudited)
Cumulative
Period
|
||||||||||||
from
November 21, 2003
|
||||||||||||
(date
of inception) to
|
||||||||||||
Three
Months ended March 31,
|
March
31,
|
|||||||||||
2009
|
2008
|
2009
|
||||||||||
Operating
expenses:
|
||||||||||||
General
and administrative expenses
|
$ | 199,717 | $ | 374,791 | $ | 1,489,259 | ||||||
Research
and development
|
309,502 | 150,801 | 3,733,909 | |||||||||
Total
operating expenses
|
509,219 | 525,592 | 5,223,168 | |||||||||
Loss
from operations
|
(509,219 | ) | (525,592 | ) | (5,223,168 | ) | ||||||
Finance
cost
|
(472,938 | ) | - | (512,727 | ) | |||||||
Change
in fair value of derivative liability
|
(572,785 | ) | (863,241 | ) | ||||||||
Interest
expense, net
|
(2,608 | ) | (1,606 | ) | (17,116 | ) | ||||||
Loss
before provision for income taxes
|
(1,557,550 | ) | (527,198 | ) | (6,616,252 | ) | ||||||
Provision
for income taxes
|
- | - | - | |||||||||
Net
loss
|
$ | (1,557,550 | ) | $ | (527,198 | ) | $ | (6,616,252 | ) | |||
Net
loss per common share, basic and diluted
|
$ | (0.12 | ) | $ | (0.06 | ) | ||||||
Weighted
average shares outstanding
|
12,699,314 | 9,411,846 |
See
accompanying notes to unaudited condensed financial statements.
6
GENSPERA,
INC.
(A
Development Stage Company)
CONDENSED
STATEMENT OF STOCKHOLDERS' EQUITY
FROM DATE
OF INCEPTION (NOVEMBER 21, 2003) TO MARCH 31, 2009
(Unaudited)
Deficit
|
||||||||||||||||||||
Accumulated
|
||||||||||||||||||||
Additional
|
During
the
|
|||||||||||||||||||
Common
Stock
|
Paid-in
|
Development
|
Stockholders'
|
|||||||||||||||||
Shares
|
Amount
|
Capital
|
Stage
|
Equity
|
||||||||||||||||
Balance,
November 21, 2003
|
- | $ | - | $ | - | $ | - | $ | - | |||||||||||
Sale
of common stock to founders at $0.0001 per share in November,
2003
|
6,100,000 | 610 | (510 | ) | - | 100 | ||||||||||||||
Contributed
services
|
- | - | 120,000 | - | 120,000 | |||||||||||||||
Net
loss
|
- | - | - | (125,127 | ) | (125,127 | ) | |||||||||||||
Balance,
December 31, 2003
|
6,100,000 | 610 | 119,490 | (125,127 | ) | (5,027 | ) | |||||||||||||
Contributed
services
|
- | - | 192,000 | - | 192,000 | |||||||||||||||
Stock
based compensation
|
- | - | 24,102 | - | 24,102 | |||||||||||||||
Net
loss
|
- | - | - | (253,621 | ) | (253,621 | ) | |||||||||||||
Balance,
December 31, 2004
|
6,100,000 | 610 | 335,592 | (378,748 | ) | (42,546 | ) | |||||||||||||
Contributed
services
|
- | - | 48,000 | - | 48,000 | |||||||||||||||
Stock
based compensation
|
- | - | 24,100 | - | 24,100 | |||||||||||||||
Net
loss
|
- | - | - | (126,968 | ) | (126,968 | ) | |||||||||||||
Balance,
December 31, 2005
|
6,100,000 | 610 | 407,692 | (505,716 | ) | (97,414 | ) | |||||||||||||
Contributed
services
|
- | - | 144,000 | - | 144,000 | |||||||||||||||
Stock
based compensation
|
- | - | 42,162 | - | 42,162 | |||||||||||||||
Net
loss
|
- | - | - | (245,070 | ) | (245,070 | ) | |||||||||||||
Balance,
December 31, 2006
|
6,100,000 | 610 | 593,854 | (750,786 | ) | (156,322 | ) | |||||||||||||
Shares
sold for cash at $0.50 per share in November,
2007
|
1,300,000 | 130 | 649,870 | - | 650,000 | |||||||||||||||
Shares
issued for services
|
735,000 | 74 | 367,426 | - | 367,500 | |||||||||||||||
Contributed
services
|
- | - | 220,000 | - | 220,000 | |||||||||||||||
Stock
based compensation
|
- | - | 24,082 | - | 24,082 | |||||||||||||||
Exercise
of options for cash at $0.003 per share in March and June,
2007
|
900,000 | 90 | 2,610 | - | 2,700 | |||||||||||||||
Net
loss
|
- | - | - | (691,199 | ) | (691,199 | ) | |||||||||||||
Balance,
December 31, 2007
|
9,035,000 | 904 | 1,857,842 | (1,441,985 | ) | 416,761 | ||||||||||||||
Exercise
of options for cash at $0.50 per share on March 7,2008
|
1,000,000 | 100 | 499,900 | - | 500,000 | |||||||||||||||
Sale
of common stock and warrants at $1.00 per share - July and August
2008
|
2,320,000 | 232 | 2,319,768 | - | 2,320,000 | |||||||||||||||
Cost
of sale of common stock and warrants
|
- | - | (205,600 | ) | - | (205,600 | ) | |||||||||||||
Shares
issued for accrued interest
|
31,718 | 3 | 15,856 | - | 15,859 | |||||||||||||||
Shares
issued for services
|
100,000 | 10 | 49,990 | - | 50,000 | |||||||||||||||
Stock
based compensation
|
- | - | 313,743 | - | 313,743 | |||||||||||||||
Contributed
services
|
- | - | 50,000 | - | 50,000 | |||||||||||||||
Beneficial
conversion feature of convertible debt
|
- | - | 20,675 | - | 20,675 | |||||||||||||||
Net
loss
|
- | - | - | (3,326,261 | ) | (3,326,261 | ) | |||||||||||||
Balance,
December 31, 2008
|
12,486,718 | 1,249 | 4,922,174 | (4,768,246 | ) | 155,177 | ||||||||||||||
Cumulative
effect of change in accounting principle
|
- | - | (444,161 | ) | (290,456 | ) | (734,617 | ) | ||||||||||||
Warrants
issued for extension of debt maturities
|
- | - | 51,864 | - | 51,864 | |||||||||||||||
Stock
based compensation
|
- | - | 29,554 | - | 29,554 | |||||||||||||||
Sale
of common stock and warrants at $1.50 per share - February
2009
|
466,674 | 46 | 699,939 | - | 699,985 | |||||||||||||||
Net
loss
|
- | - | - | (1,557,550 | ) | (1,557,550 | ) | |||||||||||||
Balance,
March 31, 2009 (Unaudited)
|
12,953,392 | $ | 1,295 | $ | 5,259,370 | $ | (6,616,252 | ) | $ | (1,355,587 | ) |
See
accompanying notes to unaudited condensed financial statements.
7
GENSPERA,
INC.
(A
Development Stage Company)
CONDENSED
STATEMENTS OF CASH FLOWS
FOR THE
THREE MONTHS ENDED MARCH 31, 2009 AND 2008
AND FOR
THE PERIOD FROM INCEPTION (NOVEMBER 21, 2003) TO MARCH 31, 2009
(Unaudited)
Cumulative Period
|
||||||||||||
from November 21, 2003
|
||||||||||||
(date of inception) to
|
||||||||||||
Three months ended March 31,
|
March 31,
|
|||||||||||
2009
|
2008
|
2009
|
||||||||||
Cash
flows from operating activities:
|
||||||||||||
Net
loss
|
$ | (1,557,550 | ) | $ | (527,198 | ) | $ | (6,616,252 | ) | |||
Adjustments
to reconcile net loss to net cash used in operating
activities:
|
||||||||||||
Amortization
|
3,837 | - | 15,348 | |||||||||
Stock
based compensation
|
29,554 | 267,465 | 875,243 | |||||||||
Warrants
issued for financing costs
|
467,840 | - | 467,840 | |||||||||
Change
in fair value of derivative liability
|
572,785 | - | 863,241 | |||||||||
Contributed
services
|
- | - | 774,000 | |||||||||
Amortization
of debt discount
|
5,098 | - | 14,727 | |||||||||
Increase
in accounts payable and accrued expenses
|
(94,479 | ) | 17,732 | 165,596 | ||||||||
Cash
used in operating activities
|
(572,915 | ) | (242,001 | ) | (3,440,257 | ) | ||||||
Cash
flows from investing activities:
|
||||||||||||
Acquisition
of intangibles
|
- | (184,168 | ) | (184,168 | ) | |||||||
Cash
used in investing activities
|
- | (184,168 | ) | (184,168 | ) | |||||||
Cash
flows from financing activities:
|
||||||||||||
Proceeds
from sale of common stock and warrants
|
699,985 | 500,000 | 4,130,785 | |||||||||
Proceeds
from convertible notes - stockholder
|
- | - | 155,000 | |||||||||
Cash
provided by financing activities
|
699,985 | 500,000 | 4,285,785 | |||||||||
Net
increase in cash
|
127,070 | 73,831 | 661,360 | |||||||||
Cash,
beginning of period
|
534,290 | 590,435 | - | |||||||||
Cash,
end of period
|
$ | 661,360 | $ | 664,266 | $ | 661,360 | ||||||
Supplemental
cash flow information:
|
||||||||||||
Cash
paid for interest
|
$ | 79 | $ | - | ||||||||
Cash
paid for income taxes
|
$ | - | $ | - | ||||||||
Non-cash
financial activities:
|
||||||||||||
Accrued
interest paid with common stock
|
$ | - | $ | 15,859 |
See
accompanying notes to unaudited condensed financial statements.
8
GENSPERA, INC.
(A
Development Stage Company)
NOTES
TO FINANCIAL STATEMENTS
FOR
THE THREE MONTH PERIODS ENDED MARCH 31, 2009 AND 2008
(Unaudited)
NOTE
1 - SUMMARY OF ACCOUNTING POLICIES
A summary
of the significant accounting policies applied in the preparation of the
accompanying financial statements follows.
Business
and Basis of Presentation
GenSpera
Inc. (“we”, “us”,
“our company “, “our”, “GenSpera” or the “Company” )
was formed under the laws of the State of Delaware in 2003. We are a development
stage company, as defined by Statement of Financial Accounting Standards
(“SFAS”) No. 7. GenSpera, Inc. is a pharmaceutical company focused on the
development of targeted cancer therapeutics for the treatment of cancerous
tumors, including breast, prostate, bladder and kidney cancer. Our operations
are based in San Antonio, Texas.
To date,
we have generated no sales revenues, have incurred significant expenses and have
sustained losses. Consequently, our operations are subject to all the risks
inherent in the establishment of a new business enterprise. For the period from
inception on November 21, 2003 through March 31, 2009, we have accumulated
losses of $6,616,252.
The
accompanying unaudited condensed financial statements as of March 31, 2009 and
for the three month periods ended March 31, 2009 and 2008 and from date of
inception as a development stage enterprise (November 21, 2003) to March 31,
2009 have been prepared by GenSpera pursuant to the rules and regulations of the
Securities and Exchange Commission, including Form 10-Q and Regulation S-X. The
information furnished herein reflects all adjustments (consisting of normal
recurring accruals and adjustments) which are, in the opinion of management,
necessary to fairly present the operating results for the respective periods.
Certain information and footnote disclosures normally present in annual
financial statements prepared in accordance with accounting principles generally
accepted in the United States of America have been omitted pursuant to such
rules and regulations. The company believes that the disclosures provided are
adequate to make the information presented not misleading. These financial
statements should be read in conjunction with the audited financial statements
and explanatory notes for the year ended December 31, 2008 as disclosed in the
company's 10-K for that year as filed with the SEC, as it may be
amended.
The
results of the three months ended March 31, 2009 are not necessarily indicative
of the results to be expected for the pending full year ending December 31,
2009.
Going
Concern
The
accompanying financial statements have been prepared on a going concern basis,
which contemplates the realization of assets and the satisfaction of liabilities
in the normal course of business. As shown in the accompanying financial
statements during three month period ended March 31, 2009 and from inception to
March 31, 2009 the Company has incurred losses of $1,557,550 and $6,616,252
respectively. Additionally the Company has generated no sales revenues. These
factors among others may indicate that the Company will be unable to continue as
a going concern for a reasonable period of time.
In order
to address our capital requirements, we intend to seek to raise additional cash
for working capital purposes through the public or private sales of debt or
equity securities, the procurement of advances on contracts or licenses, funding
from joint-venture or strategic partners, debt financing or short-term loans, or
a combination of the foregoing. We may also seek to satisfy indebtedness without
any cash outlay through
9
NOTE
1 - SUMMARY OF ACCOUNTING POLICIES (cont’d)
the
private issuance of debt or equity securities. There can be no assurance the
Company will be successful in its effort to secure additional equity
financing.
If
operations and cash flows continue to improve through these efforts, management
believes that the Company can continue to operate. However, no assurance can be
given that management's actions will result in profitable operations or the
resolution of its liquidity issues.
The
accompanying financial statements do not include any adjustments that might
result should the Company be unable to continue as a going concern.
Use
of Estimates
The
preparation of financial statements in conformity with generally accepted
accounting principles requires management to make estimates and assumptions that
affect the amounts reported in the financial statements and accompanying
disclosures. Although these estimates are based on management's best knowledge
of current events and actions the Company may undertake in the future, actual
results may differ from those estimates.
Research
and Development
Research
and development costs include expenses incurred by the Company for research and
development of therapeutic agents for the treatment of cancer and are charged to
operations as incurred. Our research and development expenses consist primarily
of expenditures for toxicology and other studies, manufacturing, and
compensation and consulting costs.
GenSpera
incurred research and development expenses of $309,502, $150,801 and $3,733,909
for the three months ended March 31, 2009 and 2008, and from November 21, 2003
(inception) through March 31, 2009, respectively.
Loss
Per Share
We use
SFAS No. 128, “Earnings Per Share” for calculating the basic and diluted
loss per share. We compute basic loss per share by dividing net loss and net
loss attributable to common shareholders by the weighted average number of
common shares outstanding. Basic and diluted loss per share are the same, in
that any potential common stock equivalents would have the effect of being
anti-dilutive in the computation of net loss per share. There were 4,517,867
common share equivalents at March 31, 2009 and 1,971,094 at March 31,
2008. For the three month periods ended March 31, 2009 and 2008, these
potential shares were excluded from the shares used to calculate diluted
earnings per share as their inclusion would reduce net loss per
share.
Change
in Accounting Principle
In June
2008, the FASB issued Emerging Issues Task Force No. 07-5 (EITF 07-5),
Determining Whether an
Instrument (or Embedded Feature) is Indexed to an Entity’s Own Stock.
EITF 07-5 requires entities to evaluate whether an equity-linked financial
instrument (or embedded feature) is indexed to its own stock by assessing the
instrument’s contingent exercise provisions and settlement provisions.
Instruments not indexed to their own stock fail to meet the scope exception of
Statement of Financial Accounting Standards No. 133, Accounting for Derivative
Instruments and Hedging Activities , paragraph 11(a), and should be
classified as a liability and marked-to-market. The statement is effective for
fiscal years beginning after December 15, 2008 and is to be applied to
outstanding instruments upon adoption with the cumulative effect of the change
in accounting principle recognized as an adjustment to the opening balance of
retained earnings. The Company has assessed its outstanding equity-linked
financial instruments and has concluded
10
NOTE
1 - SUMMARY OF ACCOUNTING POLICIES (cont’d)
that
effective January 1, 2009, warrants issued during 2008 with a fair value of
$734,617 on January 1, 2009 will need to be reclassified from equity to a
liability. The cumulative effect of the change in accounting principle on
January 1, 2009 is an increase in our derivative liability related to the
fair value of the warrants of $734,617, a decrease in additional paid-in capital
of $444,161, based on the fair value of the warrants at date of issue, and a
$290,456 increase to the deficit accumulated during development stage to reflect
the change in fair value of the derivative liability from date of issue to
January 1, 2009.
Recent
Accounting Pronouncements
In
December 2007, the FASB issued SFAS No. 160, “Non-controlling Interests in
Consolidated Financial Statements-an amendment of ARB No. 51” (SFAS 160). SFAS
160 requires that non-controlling (or minority) interests in subsidiaries be
reported in the equity section of the company’s balance sheet, rather than in a
mezzanine section of the balance sheet between liabilities and equity. SFAS 160
also changes the manner in which the net income of the subsidiary is reported
and disclosed in the controlling company’s income statement. SFAS 160 also
establishes guidelines for accounting or changes in ownership percentages and
for deconsolidation. SFAS 160 is effective for financial statements for fiscal
years beginning on or after December 15, 2008 and interim periods within those
years. The adoption of SFAS 160 did not have a material impact on our financial
position, results of operations or cash flows.
In March
2008, the FASB issued SFAS No. 161, “Disclosures about Derivative Instruments
and Hedging Activities-an amendment of FASB Statement No. 133” (SFAS 161). SFAS
161 requires enhanced disclosures about an entity’s derivative and hedging
activities and thereby improves the transparency of financial reporting. SFAS
161 is effective for financial statements issued for fiscal years and interim
periods beginning after November 15, 2008, with early application encouraged.
The adoption of SFAS 161 did not have a material impact on our financial
position, results of operations or cash flows.
Effective
January 1, 2009, the Company adopted the Financial Accounting Standards Board's
Staff Position (FSP) on the Emerging Issues Task Force (EITF) Issue No. 03-6-1,
“Determining Whether Instruments Granted in Share-Based Payment Transactions are
Participating Securities.” The FSP required that all unvested
share-based payment awards that contain nonforfeitable rights to dividends
should be included in the basic Earnings Per Share (EPS)
calculation. This standard did not affect the financial position or
results of operations.
In April
2009, the FASB issued FSP FAS No. 115-2 and FAS No. 124-2, “Recognition and
Presentation of Other-Than-Temporary Impairments” (“FSP FAS No. 115-2”). FSP FAS
No. 115-2 provides guidance in determining whether impairments in debt
securities are other than temporary, and modifies the presentation and
disclosures surrounding such instruments. This FSP is effective for interim
periods ending after June 15, 2009, but early adoption is permitted for interim
periods ending after March 15, 2009. The Company plans to adopt the provisions
of this Staff Position during the second quarter of 2009, but does not believe
this guidance will have a significant impact on its financial
statements.
In April
2009, the FASB issued FSP FAS No. 157-4, “Determining Fair Value When the Volume
and Level of Activity for the Asset or Liability Have Significantly Decreased
and Identifying Transactions That Are Not Orderly” (“FSP FAS No. 157-4”). FSP
FAS No. 157-4 provides additional guidance in determining whether the market for
a financial asset is not active and a transaction is not distressed for fair
value measurement purposes as defined in SFAS No. 157, “Fair Value
Measurements.” FSP FAS No. 157-4 is effective for interim periods ending after
June 15, 2009, but early adoption is permitted for interim periods ending after
March 15, 2009. The Company will apply the provisions of this statement
prospectively beginning with the second quarter 2009, and does not expect its
adoption to have a material effect on its financial statements.
11
In April
2009, the FASB issued FSP FAS No. 107-1 and APB 28-1, “Interim Disclosures about
Fair Value of Financial Instruments” (“FSP FAS No. 107-1 and APB 28-1”). This
FSP amends FASB Statement No. 107, “Disclosures about Fair Values of Financial
Instruments,” to require disclosures about fair value of financial instruments
in interim financial statements as well as in annual financial statements. APB
28-1 also amends APB Opinion No. 28, “Interim Financial Reporting,” to require
those disclosures in all interim financial statements. This standard is
effective for interim periods ending after June 15, 2009, but early adoption is
permitted for interim periods ending after March 15, 2009. The Company plans to
adopt FSP FAS No. 107-1 and APB 28-1 and provide the additional disclosure
requirements beginning in second quarter 2009.
Other
recent accounting pronouncements issued by the FASB (including its Emerging
Issues Task Force), the AICPA, and the SEC did not, or are not believed by
management to, have a material impact on the Company's present or future
financial statements.
NOTE
2 - CAPITAL STOCK AND STOCKHOLDER’S EQUITY
We are
authorized to issue 80,000,000 shares of common stock with a par value of $.0001
per share and 10,000,000 shares of preferred stock with a par value of $.0001
per share.
On
February 17, 2009, we entered into a modification with Dr. Dionne with regard to
our 4% Convertible Promissory Note issued to Dionne in the amount of $35,000
(“Note”). Pursuant to the modification, Dr. Dionne agreed to extend
the maturity date of the Note from December 2, 2008 to December 2, 2009. As
consideration for the modification, the Company issued Dr. Dionne a common stock
purchase warrant entitling him to purchase 11,000 shares of our common stock at
a per share purchase price of $1.50. The warrant has a five year
term. The warrants also contain anti-dilution protection in the event of stock
splits, stock dividends and other similar transactions. We have recorded a
financing expense of $9,353 during the three months ended March 31, 2009 related
to the fair value of the warrants, using the Black-Scholes method based on the
following assumptions: (1) risk free interest rate
of 0.875%; (2) dividend yield of 0%; (3) volatility factor of the
expected market price of our common stock of 156%; and (4) an expected
life of the warrants of 2 years.
On
February 17, 2009, we entered into a modification with TR Winston & Company,
LLC (“TRW”) with regard to the Company’s 5% Convertible Debenture issued to TRW
in the amount of $163,600. Pursuant to the modification, TRW agreed
to extend the maturity date of the debenture from July 14, 2009 to July 14,
2010. As consideration for the modification, the we issued TRW a
common stock purchase warrant entitling TRW to purchase 50,000 shares of our
common stock at a per share purchase price of $1.50. The warrant has
a five year term. The warrants also contain anti-dilution protection in the
event of stock splits, stock dividends and other similar transactions. We have
recorded a financing expense of $42,511 during the three months ended March 31,
2009 related to the fair value of the warrants, using the Black-Scholes method
based on the following assumptions: (1) risk free interest rate
of 0.875%; (2) dividend yield of 0%; (3) volatility factor of the
expected market price of our common stock of 156%; and (4) an expected
life of the warrants of 2 years.
On
February 19, 2009, we entered into a Securities Purchase Agreement with a number
of accredited investors. Pursuant to the terms of the Securities
Purchase Agreement, we sold the investors units aggregating approximately
$700,000 “Offering”. The price per unit was $1.50. Each
unit consists of: (i) one share of the Company’s common stock; and (ii) one half
Common Stock Purchase Warrant. The Warrants have a term of five years
and allow the investors to purchase our common shares at a price per share of
$3.00. The warrants also contain anti-dilution protection in the
event of stock splits, stock dividends and other similar
transactions.
As a
result of offering, the anti-dilution provisions in our warrants issued during
the July and August 2008 financing were triggered. These
anti-dilution provisions resulted in the exercise price of these warrants being
reduced from $2.00 from $1.50. Additionally, we are obligated to
issue holders of these warrants an additional 506,754 warrants, and we are
obligated to file a registration statement for the common stock underlying such
warrants pursuant to the registration rights agreement entered into in
connection with the July and August 2008 financing. We have recorded a financing
expense of $415,976 during the three months ended March 31, 2009 related to the
fair value of the additional warrants, using the Black-Scholes method based on
the following assumptions: (1) risk free interest rate
of 0.875%; (2) dividend yield of 0%; (3) volatility factor of the
expected market price of our common stock of 149%; and (4) an expected
life of the warrants of 2 years. Because these additional warrants are
subject to the same anti-dilution provisions as the original 2008 warrants we
have recorded the fair value of the warrants as a derivative
liability.
12
NOTE
3 – DERIVATIVE LIABILITY
In June
2008, the FASB issued Emerging Issues Task Force No. 07-5 (EITF 07-5),
Determining Whether an
Instrument (or Embedded Feature) is Indexed to an Entity’s Own Stock.
EITF 07-5 requires entities to evaluate whether an equity-linked financial
instrument (or embedded feature) is indexed to its own stock by assessing the
instrument’s contingent exercise provisions and settlement provisions.
Instruments not indexed to their own stock fail to meet the scope exception of
Statement of Financial Accounting Standards No. 133, Accounting for Derivative
Instruments and Hedging Activities, paragraph 11(a), and should be
classified as a liability and marked-to-market. The Company has assessed its
outstanding equity-linked financial instruments and has concluded that warrants
issued during 2008 with a fair value of $734,617 on January 1, 2009 are
required to be reclassified from equity to a liability. Fair value at January 1,
2009 was determined using the Black-Scholes method based on the following
assumptions: (1) risk free interest rate of 0.875%;
(2) dividend yield of 0%; (3) volatility factor of the expected market
price of our common stock of 144%; and (4) an expected life of the
warrants of 2 years.
As a
result of our February offering described in Note 2, the anti-dilution
provisions in our warrants issued during the July and August 2008 financing were
triggered. These anti-dilution provisions resulted in the exercise
price of these warrants being reduced from $2.00 from
$1.50. Additionally, we are obligated to issue holders of these
warrants an additional 506,754 warrants, and we are obligated to file a
registration statement for the common stock underlying such warrants pursuant to
the registration rights agreement entered into in connection with the July and
August 2008 financing. We have recorded the fair value of the additional
warrants as a derivative liability upon issue. The fair value of the warrants of
$415,976 was determined using the Black-Scholes method based on the following
assumptions: (1) risk free interest rate of 0.875%;
(2) dividend yield of 0%; (3) volatility factor of the expected market
price of our common stock of 149%; and (4) an expected life of the
warrants of 2 years.
At March
31, 2009 we recalculated the fair value of our warrants subject to derivative
accounting and have determined that their fair value at March 31, 2009 is
$1,723,377. The value of the warrants was determined using the Black-Scholes
method based on the following assumptions: (1) risk free
interest rate of 0.875%; (2) dividend yield of 0%; (3) volatility
factor of the expected market price of our common stock of 156%; and
(4) an expected life of the warrants of 2 years. We have recorded an
expense of $572,785 during the three months ended March 31, 2009 related to the
change in fair value during that period.
13
ITEM
2.
|
MANAGEMENT’S
DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF
OPERATIONS
|
Our
Management’s Discussion and Analysis of Financial Condition and Results of
Operations (MD&A) is provided in addition to the accompanying consolidated
financial statements and notes to assist readers in understanding our results of
operations, financial condition, and cash flows. MD&A is organized as
follows:
•
|
Overview — Discussion of
our business and plan of operations, overall analysis of financial and
other highlights affecting the company in order to provide context for the
remainder of MD&A.
|
|
•
|
Significant Accounting
Policies —
Accounting policies that we believe are important to understanding
the assumptions and judgments incorporated in our reported financial
results and forecasts.
|
|
•
|
Results of
Operations
— Analysis of our financial results comparing the first
quarter of 2009 to the comparable period in 2008.
|
|
•
|
Liquidity and Capital
Resources
— An analysis of changes in our balance sheets and cash flows,
and discussion of our financial condition including the credit quality of
our investment portfolio and potential sources of
liquidity.
|
The
various sections of this MD&A contain a number of forward-looking
statements. Words such as “expects,” “goals,” “plans,” “believes,” “continues,”
“may,” and variations of such words and similar expressions are intended to
identify such forward-looking statements. In addition, any statements that refer
to projections of our future financial performance, our anticipated growth and
trends in our businesses, and other characterizations of future events or
circumstances are forward-looking statements. Such statements are based on our
current expectations and could be affected by the uncertainties and risk factors
described throughout this filing and particularly in the “Overview” section (see
also “Risk Factors” in Part II, Item 1A of this Form 10-Q). Our actual results
may differ materially.
Overview
We are a
development stage company focused on the development of targeted cancer
therapeutics for the treatment of cancerous tumors, including breast, prostate,
bladder and kidney cancer. Our operations are based in San Antonio,
TX.
Management's
Plan of Operation
We were
pursuing a business plan related to the development of targeted cancer
therapeutics for the treatment of cancerous tumors, including breast, prostate,
bladder and kidney cancer and were considered to be in the development stage as
defined by SFAS No. 7, “ Accounting and reporting by
Development Stage Enterprises “.
14
Business
Strategy
Our
business strategy is to develop a series of therapeutics based on our
target-activated pro-drug technology platform and bringing them through Phase
I/II clinical trials. At that point, we plan to license the rights to further
development of the drug candidates to major pharmaceutical companies. We believe
that major pharmaceutical companies see significant value in drug candidates
that have passed one or more phases of clinical trials, and these organizations
have the significant resources and expertise already in-house to finalize drug
development and market the drugs.
Plan
of Operation
We have
made significant progress in key areas such as drug manufacture, toxicology, and
pre-clinical activities for our lead compound G-202.
For the
manufacture of G-202, we have secured a stable supply of source material (Thapsia garganica seeds) from
which thapsigargin is isolated, have a sole source agreement with a European
supplier, Thapsibiza, SL, and have obtained the proper import permits from the
USDA for these materials. We have also identified a clinically and commercially
viable formulation for G-202 and are in the process of manufacturing G-202 at a
large scale to supply our Phase I clinical needs. We have also determined that
the stabilities of seeds, manufacturing intermediates and final drug substance
are more than sufficient to allow reliable manufacture and stability of drug
substance.
Definitive
toxicology studies in rats and monkeys were launched in early September. We
received final reports of the studies results in the second quarter of
2009.
In
preparation for our clinical activities, we have formulated a draft Phase I
clinical plan for the development of G-202 together with investigators at the
Johns Hopkins Oncology Center and the University of Wisconsin Comprehensive
Cancer Center, where we intend to conduct the Phase I trial.
As part
of our regulatory activities, we sought and conducted a pre-IND meeting with the
United States Food and Drug Administration (“FDA”) in August of 2008. For this
process we compiled all the information from our manufacturing processes and
preliminary toxicological studies together with our proposed further development
and clinical plans to obtain guidance from, and open a dialog with, the FDA. The
FDA responded to our proposed development plan with some helpful suggestions and
remarks but did not require us to change any aspect of our proposed development
program including our manufacture, toxicology or clinical plans.
Over the
next twelve months we plan to focus on the remaining pre-clinical work for G-202
and initiate clinical trials of G-202 in cancer patients.
Firstly,
we have initiated the manufacture of clinical grade G-202 under Good
Manufacturing Practice (GMP) guidelines. We have contracted manufacture of the
cytotoxin 12ADT to the company InB: Hauser Pharmaceutical Services (Denver, CO),
synthesis of the peptide to Ambiopharm (Augusta, SC), and the final coupling of
the peptide to 12ADT to make G-202 to InB: Hauser. We intend to vial the drug at
Lyophilization Services of New England (Manchester, NH).
We plan
to prepare and submit an Investigational New Drug Application (“IND”) with the
FDA in 2009. The main purpose of an IND application is to provide the data
showing that it is reasonable to begin clinical evaluation of a new drug
candidate in humans. The application contains all of the preclinical data
pertaining to G-202 including the scientific rationale, efficacy data in
animals, toxicological data, manufacturing information, drug formulation and
stability, etc., and the proposed clinical plan. Although it is possible to
assemble this data after completion of all the studies, we make a point of
assembling reports and documents in final submissible format as the data are
collected in order to facilitate the rapid assembly of the final IND
application. Nevertheless, we expect the application to require at least one
month for assembly and up to $100,000 in consultant’s fees to assure that we
have complied with the high level of regulatory requirements inherent in this
process.
Finally,
we will continue to protect our intellectual property position particularly with
regard to the outstanding claims contained within the core PSMA-pro-drug patent
application in the United States. We will also continue to prosecute the claims
contained in our other patent applications in the United States.
We
anticipate that the second year, and much of the third year, of operations we
will be engaged in the conduct of a Phase I clinical trial of G-202, and, if
appropriate, extension into a Phase II clinical trial of G-202. The purpose of a
Phase I study of G-202 is to evaluate safety, understand the pharmacokinetics
(the process by which a compound is absorbed, distributed, metabolized, and
eliminated by the body) of the drug candidate in humans, and to determine an
appropriate dosing regime for the subsequent clinical studies. We currently plan
to conduct the Phase I study in refractory cancer patients (those who have
relapsed after former treatments) with any type of solid tumors. This strategy
is intended to facilitate enrollment and perhaps give us a glimpse of safety
across a wider variety of patients. We expect to enroll up to 30 patients in
this Phase I study at Johns Hopkins Oncology Center (Michael Carducci, MD as
Principal Investigator), and the University of Wisconsin Comprehensive Cancer
Center (George Wilding, MD as Principal Investigator). We are currently
negotiating contracts for conduct of the Phase I studies at these institutions,
and the final terms of the contracts have not yet been determined.
Assuming
successful completion of the Phase I clinical program, we expect to conduct a
Phase II clinical trial to determine the therapeutic efficacy of G-202 in cancer
patients. Although we believe that G-202 will be useful across a wide variety of
cancer types, it is usually most efficient and medically prudent to evaluate a
drug candidate in a single tumor type within a single trial. It is currently too
early in the pre-clinical development process to determine which single tumor
type will be evaluated, but we expect that over 40 patients will be required for
an appropriate evaluation over a total time span of 18 months.
15
The
amounts and timing of our actual expenditures may vary significantly from our
expectations depending upon numerous factors, including our results of
operation, financial condition and capital requirements. Accordingly, we will
retain the discretion to allocate the available funds among the identified uses
described above, and we reserve the right to change the allocation of available
funds among the uses described above.
Significant
Accounting Policies
Our
financial statements have been prepared in accordance with accounting principles
generally accepted in the United States of America. The preparation of these
financial statements requires management to make estimates and assumptions that
affect the reported amounts of assets, liabilities, revenues and expenses.
Note 1 of the Notes to Financial Statements describes the significant
accounting policies used in the preparation of the financial statements. Certain
of these significant accounting policies are considered to be critical
accounting policies, as defined below. We do not believe that there have been
significant changes to our accounting policies during the quarter ended March
31, 2009, as compared to those policies disclosed in the December 31, 2008
financial statements except as disclosed in the notes to financial
statements..
A
critical accounting policy is defined as one that is both material to the
presentation of our financial statements and requires management to make
difficult, subjective or complex judgments that could have a material effect on
our financial condition and results of operations. Specifically, critical
accounting estimates have the following attributes: 1) we are required to
make assumptions about matters that are highly uncertain at the time of the
estimate; and 2) different estimates we could reasonably have used, or
changes in the estimate that are reasonably likely to occur, would have a
material effect on our financial condition or results of
operations.
Estimates
and assumptions about future events and their effects cannot be determined with
certainty. We base our estimates on historical experience and on various other
assumptions believed to be applicable and reasonable under the circumstances.
These estimates may change as new events occur, as additional information is
obtained and as our operating environment changes. These changes have
historically been minor and have been included in the financial statements as
soon as they became known. Based on a critical assessment of our accounting
policies and the underlying judgments and uncertainties affecting the
application of those policies, management believes that our financial statements
are fairly stated in accordance with accounting principles generally accepted in
the United States, and present a meaningful presentation of our financial
condition and results of operations. We believe the following critical
accounting policies reflect our more significant estimates and assumptions used
in the preparation of our financial statements:
Use of
Estimates — These financial statements have been prepared in accordance
with accounting principles generally accepted in the United States and,
accordingly, require management to make estimates and assumptions that affect
the reported amounts of assets and liabilities at the date of the financial
statements and the reported amounts of revenues and expenses during the
reporting period. Specifically, our management has estimated the expected
economic life and value of our licensed technology, our net operating loss for
tax purposes and our stock, option and warrant expenses related to compensation
to employees and directors and consultants. Actual results could differ from
those estimates.
Fair Value of
Financial Instruments — For certain of our financial instruments,
including accounts payable, accrued expenses and notes payable, the carrying
amounts approximate fair value due to their relatively short
maturities.
Cash and
Equivalents — Cash equivalents are comprised of certain highly liquid
investments with maturity of three months or less when purchased. We maintain
our cash in bank deposit accounts, which at times, may exceed federally insured
limits. We have not experienced any losses in such accounts.
Intangible and
Long-Lived Assets — We follow SFAS No. 144, "Accounting for Impairment of
Disposal of Long-Lived Assets", which established a "primary asset"
approach to determine the cash flow estimation period for a group of assets and
liabilities that represents the unit of accounting for a long lived asset to be
held and used. Long-lived assets to be held and used are reviewed for impairment
whenever events or changes in circumstances indicate that the carrying amount of
an asset may not be recoverable. The carrying amount of a long-lived asset is
not recoverable if it exceeds the sum of the undiscounted cash flows expected to
result from the use and eventual disposition of the asset. Long-lived assets to
be disposed of are reported at the lower of carrying amount or fair value less
cost to sell. We have not recognized any impairment losses.
Research and
Development Costs — Research and development costs include expenses
incurred by the Company for research and development of therapeutic agents for
the treatment of cancer and are charged to operations as incurred.
Stock Based
Compensation — We account for our share-based compensation under the
provisions of FASB Statement No. 123(R), “Share-Based Payment”, (“FAS
123R”). We adopted FAS 123R as of January 1, 2006, using the modified
prospective application method. Prior to January 1, 2006 we applied the
provisions of FAS 123, “Accounting for Stock-Based
Compensation”.
16
Result
of Operations – First Quarter
of 2009 Compared to First Quarter of 2008
Our
results of operations have varied significantly from year to year and quarter to
quarter and may vary significantly in the future.
Revenue
The
company did not have revenue for the three months ended March 31, 2009 and 2008,
respectively. We do not anticipate any revenues for 2009.
Operating
Expenses
Operating
expense totaled $509,219 and $525,592 for the three months ended March 31, 2009
and 2008, respectively. The decrease in Operating expenses is the
result of the following factors.
Three
Months Ended March 31,
|
||||||||
2009
|
2008
|
|||||||
Operating
expenses
|
||||||||
General
and administrative expenses
|
$
|
199,717
|
$
|
374,791
|
||||
Research
and development
|
309,502
|
150,801
|
||||||
Total
expense
|
$
|
509,219
|
$
|
525,592
|
General
and Administrative Expenses
G&A
expenses totaled $199,717 for the three months ended March 31, 2009 compared to
$374,791 for the same period of 2008. The decrease of $175,074 or 47%
for the three months ended March 31, 2009 compared to the comparable period in
2008 was primarily attributable to decreases of approximately $241,000 in
compensation and consulting expense and $8,000 in insurance expense, offset by
an increase of approximately $60,000 in professional fees.
Research
and Development Expenses
Research
and development expenses totaled $309,502 for the three months ended March 31,
2009 compared to $150,801 for the same period of 2008. The increase
of $158,701 or 105% for the three months ended March 31, 2009 compared to the
comparable period in 2008 was attributable to increases of approximately $68,000
in compensation expense and approximately $81,000 in costs associated with
manufacture and other expenses related to our lead drug.
Our
research and development expenses consist primarily of expenditures for
toxicology and other studies, manufacturing, and compensation and consulting
costs.
Under the
planning and direction of key personnel, we expect to outsource all of our GLP
preclinical development activities (e.g., toxicology) and GMP manufacturing and
clinical development activities to Contract Research Organizations (CROs) and
Contract Manufacturing Organizations (CMOs). Manufacturing will be
outsourced to organizations with approved facilities and manufacturing
practices.
Prior to
the assignment of the patents to GenSpera in 2008, we had an exclusive option to
license 5 issued patents and 3 patent applications pending worldwide. The
previous owner of the intellectual property, John Hopkins University, agreed to
assign the patents underlying the technology to our co-founders (the “Assignee
Co-Founders”) in return for their assumption of future patent fees and costs,
and patent attorney fees and costs, associated with all of the assigned
technology. In exchange for us continuing to pay for these future costs, the
Assignee Co-Founders entered into world-wide, exclusive option agreements with
us. Therefore, we have continued to pay these costs as we have used the
technology prior to the actual assignment.
We have
identified 4 pro-drug candidates: G-202, G-114, G-115 and Ac-GKAFRR-L12ADT. At
this time, we are engaged solely in the development of G-202. It is anticipated
that the development of the remaining candidates will not commence until we have
sufficient resources to devote to their development and in all likelihood this
will not occur until after the development of G-202.
Through
March 31, 2009, the vast majority of costs incurred have been devoted to G-202.
We estimate that we have incurred costs of approximately $235,000 related to
G-114, G-115 and Ac-GKAFRR-L12ADT. All of these costs were incurred prior to
December 2007, at which time we began focusing solely on G-202. The balance of
our costs, aggregating approximately $3,499,000, was incurred in the development
of G-202. For the three months ended March 31, 2009 and 2008, approximately
$310,000 and $151,000, respectively, was incurred in the development of
G-202.
17
It is
estimated that the development of G-202 will occur as follows:
From the
date of this document it is expected that the Company will expend another
$900,000 to complete the preclinical testing and manufacture of G-202 and file
an IND.
It is
estimated that the Phase I clinical trial will cost approximately $2,000,000 and
will be completed in the second quarter of 2010.
Phase II
clinical studies will cost an additional $4,200,000 and will be completed in the
fourth quarter of 2011. Phase III Clinical trials will cost approximately
$25,000,000 and will be completed in the fourth quarter of 2014. If all goes as
planned, we may expect marketing approval in the second half of 2015 with an
additional $3,000,000 spent to get the NDA approved. We do not expect material
net cash inflows before late 2015.
The Phase
III estimated costs are subject to major revision simply because we have not yet
entered clinical testing of our drug in patients. The estimates will become more
refined as we obtain clinical data.
At this
time, we have suspended the development of our other drug candidates, G-114,
G-115 and Ac-GKAFRR-L12ADT. As a result we are unable to reasonably estimate the
nature, timing and estimated costs and completion dates of those projects at
this time.
We have
not yet applied for approval by the FDA to conduct clinical trials. Even if we
successfully file an IND application and receive clearance from the FDA to
commence trials, the outcome of pre-clinical, clinical and product testing of
our products is uncertain, and if we are unable to satisfactorily complete such
testing, or if such testing yields unsatisfactory results, we will be unable to
commercially produce our proposed products. Before obtaining regulatory
approvals for the commercial sale of any potential human products, our products
will be subjected to extensive pre-clinical and clinical testing to demonstrate
their safety and efficacy in humans. No assurances can be given that the
clinical trials of our products, or those of licensees or collaborators, will
demonstrate the safety and efficacy of such products at all, or to the extent
necessary to obtain appropriate regulatory approvals, or that the testing of
such products will be completed in a timely manner, if at all, or without
significant increases in costs, program delays or both, all of which could harm
our ability to generate revenues. In addition, our proposed products may not
prove to be more effective for treating disease or injury than current
therapies. Accordingly, we may have to delay or abandon efforts to research,
develop or obtain regulatory approval to market our proposed products. Many
companies involved in biotechnology research and development have suffered
significant setbacks in advanced clinical trials, even after promising results
in earlier trials. The failure to adequately demonstrate the safety and efficacy
of a therapeutic product under development could delay or prevent regulatory
approval of the product and could harm the Company's ability to generate
revenues, operate profitably or produce any return on an investment in the
Company. This would have a material adverse affect on our operations, financial
position and liquidity.
Other
Expenses
Other
expenses totaled $1,048,331 and $1,606 for the three months ended March 31, 2009
and 2008, respectively.
Three
Months Ended March 31,
|
||||||||
2009
|
2008
|
|||||||
Other
expense:
|
||||||||
Finance
Cost
|
$
|
(472,938
|
)
|
$
|
—
|
|||
Change
in fair value of derivative liability
|
(572,785
|
)
|
—
|
|||||
Interest
income (expense)
|
(2,608
|
)
|
(1,606
|
)
|
||||
Total
other expenses
|
$
|
(1,048,331
|
)
|
$
|
(1,606
|
)
|
Finance
Cost
Finance
Cost totaled $472,938 for the three months ended March 31, 2009 compared to $0
for the same period of 2008. The increase of $472,938 for the three months ended
March 31, 2009 compared to the comparable period in 2008 was primarily
attributable to a $415,976 charge for the fair value of additional warrants
issued when the anti-dilution provisions in our warrants issued during the July
and August 2008 financing were triggered plus a $51,864 charge for the fair
value of additional warrants issued as consideration for the extension of the
maturity dates of notes payable.
18
Change
in fair value of derivative liability
Change in
fair value of derivative liability totaled $572,785 for the three months ended
March 31, 2009 compared to $0 for the same period of 2008. The increase of
$572,785 for the three months ended March 31, 2009 compared to the comparable
period in 2008 was the result of a change to the accounting treatment of our
issued and outstanding warrants which contain certain anti-dilution
provisions.
In June
2008, the FASB issued Emerging Issues Task Force No. 07-5 (EITF 07-5),
Determining Whether an
Instrument (or Embedded Feature) is Indexed to an Entity’s Own Stock.
EITF 07-5 requires entities to evaluate whether an equity-linked financial
instrument (or embedded feature) is indexed to its own stock by assessing the
instrument’s contingent exercise provisions and settlement provisions.
Instruments not indexed to their own stock fail to meet the scope exception of
Statement of Financial Accounting Standards No. 133, Accounting for Derivative
Instruments and Hedging Activities, paragraph 11(a), and should be
classified as a liability and marked-to-market. The Company has assessed its
outstanding equity-linked financial instruments and has concluded that warrants
issued during 2008 with a fair value of $734,617 on January 1, 2009 are
required to be reclassified from equity to a liability. Fair value at January 1,
2009 was determined using the Black-Scholes method based on the following
assumptions: (1) risk free interest rate of 0.875%;
(2) dividend yield of 0%; (3) volatility factor of the expected market
price of our common stock of 144%; and (4) an expected life of the
warrants of 2 years.
As a
result of our February offering described in Note 2 to our financials statements
contained in this Report, the anti-dilution provisions in our warrants issued
during the July and August 2008 financing were triggered. These
anti-dilution provisions resulted in the exercise price of these warrants being
reduced from $2.00 from $1.50. Additionally, we are obligated to
issue holders of these warrants an additional 506,754 warrants, and we are
obligated to file a registration statement for the common stock underlying such
warrants pursuant to the registration rights agreement entered into in
connection with the July and August 2008 financing. We have recorded the fair
value of the additional warrants as a derivative liability upon issue. The fair
value of the warrants of $415,976 was determined using the Black-Scholes method
based on the following assumptions: (1) risk free interest rate
of 0.875%; (2) dividend yield of 0%; (3) volatility factor of the
expected market price of our common stock of 149%; and (4) an expected
life of the warrants of 2 years.
At March
31, 2009 we recalculated the fair value of our warrants subject to derivative
accounting and have determined that their fair value at March 31, 2009 is
$1,723,377. The fair value of the warrants was determined using the
Black-Scholes method based on the following
assumptions: (1) risk free interest rate of 0.875%;
(2) dividend yield of 0%; (3) volatility factor of the expected market
price of our common stock of 156%; and (4) an expected life of the
warrants of 2 years. We have recorded an expense of $572,785 during the
three months ended March 31, 2009 related to the change in fair value during
that period.
Interest
expense
Interest
expense totaled $2,608 for the three months ended March 31, 2009 compared to
$1,606 for the same period of 2008. The increase of $1,002 for the three months
ended March 31, 2009 compared to the comparable period in 2008 was attributable
to an increase in debt outstanding in 2009, partially offset by interest earned
on deposits.
Liquidity
and Capital Resources
Since our
inception, we have financed our operations through the private placement of our
securities and loans from Craig Dionne, our Chief Executive Officer. Our
currently monthly cash burn rate is approximately $220,000. We expect the
monthly burn rate to decrease during the remainder of the year after July, 2009.
We anticipate that our available cash and expected income will be sufficient to
finance most of our current activities for at least the next three months from
March 31, 2009, although certain activities and related personnel may need to be
reduced.
Three
Months Ended March 31,
|
||||||||
2009
|
2008
|
|||||||
Cash
& Cash Equivalents
|
$
|
661,360
|
$
|
664,266
|
||||
Net cash used in operating
activities
|
$
|
(572,915
|
)
|
$
|
(242,001
|
)
|
||
Net cash used in investing
activities
|
—
|
(184,168
|
)
|
|||||
Net cash provided by financing
activities
|
699,985
|
500,000
|
19
Net
Cash Used in Operating Activities
In our
operating activities we used $572,915 for the three months ended March 31, 2009
compared to $242,001 for the same period of 2008. An increase in net loss of
approximately $1,030,000 was partially offset by increases in noncash expenses
of approximately $803,000.
Net
Cash Used in Investing Activities
In our
investment activities we used $0 for the three months ended March 31, 2009
compared to $184,168 for the same period of 2008. The decrease in investment
activities of $184,168 for the three months ended March 31, 2009 compared to the
comparable period in 2008 was attributable to the $184,168 cost associated with
acquisition of key intellectual property in 2008.
Net
Cash Provided by Financing Activities
During
the three months ended March 31, 2009 we raised approximately $700,000 through
the sale of common stock units. During the comparable period of 2008 we received
proceeds of $500,000 upon the exercise of warrants.
Listed
below are key financing transactions we have entered into. Also,
please refer to the section of this Report entitled “Recent Sale of Unregistered
Securities” for a further description of the following
transactions:
•
|
During
November of 2007, we sold an aggregate of 1,300,000 common shares
resulting in gross proceeds of $650,000.
|
|
•
|
During
March of 2008, we issued 1,000,000 common shares upon the exercise of
outstanding warrants which resulted in gross proceeds to us of
$500,000.
|
|
•
|
During
July and August of 2008, we sold an aggregate of 2,320,000 units resulting
in gross proceeds of $2,320,000.
|
|
•
|
In
February of 2009, we sold 466,667 units resulting in gross proceeds of
approximately $700,000.
|
We have
incurred significant operating losses and negative cash flows since inception.
We have not achieved profitability and may not be able to realize sufficient
revenue to achieve or sustain profitability in the future. We do not expect to
be profitable in the next several years, but rather expect to incur additional
operating losses. We have limited liquidity and capital resources and must
obtain significant additional capital resources in order to sustain our product
development efforts, for acquisition of technologies and intellectual property
rights, for preclinical and clinical testing of our anticipated products,
pursuit of regulatory approvals, acquisition of capital equipment, laboratory
and office facilities, establishment of production capabilities, for general and
administrative expenses and other working capital requirements. We rely on cash
balances and the proceeds from the offering of our securities, exercise of
outstanding warrants and grants to fund our operations.
The
source, timing and availability of any future financing will depend principally
upon market conditions, interest rates and, more specifically, on our progress
in our exploratory, preclinical and future clinical development programs.
Funding may not be available when needed — at all, or on terms acceptable
to us. Lack of necessary funds may require us, among other things, to delay,
scale back or eliminate some or all of our research and product development
programs, planned clinical trials, and/or our capital expenditures or to license
our potential products or technologies to third parties.
ITEM
3. QUANTITATIVE
AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK.
We are
not required to provide the information required by this items as we are
considered a smaller reporting company, as defined by Rule
229.10(f)(1).
ITEM
4. CONTROLS
AND PROCEDURES.
Evaluation
of Disclosure Controls and Procedures
We
maintain disclosure controls and procedures (as defined in Rules 13a-15(e) and
15d-15(e) of the Securities Exchange Act of 1934, as amended (the “Exchange
Act”) that are designed to be effective in providing reasonable assurance that
information required to be disclosed in our reports under the Exchange Act is
recorded, processed, summarized and reported within the time periods specified
in the rules and forms of the Securities and Exchange Commission (the “ SEC”),
and that such information is accumulated and communicated to our management to
allow timely decisions regarding required disclosure.
20
The
Company’s management, under the supervision and with the participation of the
Company's Chief Executive Officer and Chief Financial (and principal accounting)
Officer, carried out an evaluation of the effectiveness of the design and
operation of the Company's disclosure controls and procedures (as defined in
Rule 13a-15(e) and 15d-15(e) of the Exchange Act) as of December 31, 2008 and
March 31, 2009. Based upon that evaluation and the identification of
the material weakness in the Company’s internal control over financial reporting
as described below the Chief Executive Officer and Chief Financial Officer
concluded that the Company’s disclosure controls and procedures were ineffective
as of the end of the period covered by this quarterly report.
The
Company has limited resources and a limited number of employees. As a result,
management concluded that our internal control over financial reporting is not
effective in providing reasonable assurance regarding the reliability of
financial reporting and the preparation of financial statements for external
purposes in accordance with U.S. generally accepted accounting principles. To
mitigate the current limited resources and limited employees, we rely heavily on
direct management oversight of transactions, along with the use of legal and
accounting professionals. As we grow, we expect to increase our number of
employees, which will enable us to implement adequate segregation of duties
within the internal control framework.
Limitations
on Effectiveness of Controls and Procedures
Our
management, including our Chief Executive Officer and Chief Financial Officer,
does not expect that our disclosure controls and procedures or our internal
controls will prevent all errors and all fraud. A control system, no matter how
well conceived and operated, can provide only reasonable, not absolute,
assurance that the objectives of the control system are met. Further, the design
of a control system must reflect the fact that there are resource constraints
and the benefits of controls must be considered relative to their costs. Because
of the inherent limitations in all control systems, no evaluation of controls
can provide absolute assurance that all control issues and instances of fraud,
if any, within the Company have been detected. These inherent limitations
include, but are not limited to, the realities that judgments in decision-making
can be faulty and that breakdowns can occur because of simple error or mistake.
Additionally, controls can be circumvented by the individual acts of some
persons, by collusion of two or more people, or by management override of the
control. The design of any system of controls also is based in part upon certain
assumptions about the likelihood of future events and there can be no assurance
that any design will succeed in achieving its stated goals under all potential
future conditions. Over time, controls may become inadequate because of changes
in conditions, or the degree of compliance with the policies or procedures may
deteriorate. Because of the inherent limitations in a cost-effective control
system, misstatements due to error or fraud may occur and not be
detected.
Changes
in Internal Control over Financial Reporting
There
were no changes to 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 period covered by this report that have materially affected, or are
reasonably likely to materially affect, our internal control over financial
reporting.
PART
II
OTHER
INFORMATION
ITEM
1. LEGAL
PROCEEDINGS
As of the
date of this Report, there are no material pending legal or governmental
proceedings relating to our company or properties to which we are a party, and
to our knowledge there are no material proceedings to which any of our
directors, executive officers or affiliates are a party adverse to us or which
have a material interest adverse to us.
ITEM
1A. RISK
FACTORS
We
have described below a number of uncertainties and risks which, in addition to
uncertainties and risks presented elsewhere in this Report, may adversely affect
our business, operating results and financial condition. The uncertainties
and risks enumerated below as well as those presented elsewhere in this Report
should be considered carefully in evaluating us and our business and the value
of our securities. The following important factors, among others, could cause
our actual business, financial condition and future results to differ materially
from those contained in forward-looking statements made in this Annual Report or
presented elsewhere by management from time to time.
21
Risks
Relating to Our Stage of Development
As a result of
our limited operating history, you cannot rely upon our historical performance
to make an investment decision.
Since
inception in 2003 and through March 31, 2009 we have raised approximately
$4,131,000 in capital. During this same period, we have recorded
accumulated losses totaling $6,616,252. As of March 31, 2009, we had working
capital of $461,623 and a deficiency in stockholders’ equity of $1,355,587. Our
net losses for the two most recent fiscal years ended December 31, 2007 and 2008
have been $691,199 and $3,326,261, respectively. Since inception, we have
generated no revenue.
Our
limited operating history means that there is a high degree of uncertainty in
our ability to: (i) develop and commercialize our technologies and proposed
products; (ii) obtain approval from the FDA; (iii) achieve market acceptance of
our proposed product; (iv) respond to competition; or (v) operate the business,
as management has not previously undertaken such actions as a company. No
assurances can be given as to exactly when, if at all, we will be able to fully
develop, commercialize, market, sell and derive material revenues from our
proposed products in development.
We will need to
raise additional capital to continue operations.
We
currently generate no cash. We have relied entirely on financing to fund
operations. Such financing has historically come primarily from the sale of
common stock to third parties, loans from our Chief Executive Officer and the
exercise of warrants/options. We have expended and will continue to expend
substantial cash in the development and pre-clinical and clinical testing of our
proposed products. We will require additional cash to conduct drug development,
establish and conduct pre-clinical and clinical trials, support commercial-scale
manufacturing arrangements and provide for the marketing and distribution of our
products if developed. We anticipate that we will require an additional $7
million to take our lead drug through Phase II clinical evaluation, currently
anticipated to occur in the fourth quarter of 2011.
We
anticipate, based on current proposed plans and assumptions relating to our
operations and financing, that our current working capital will be sufficient to
satisfy contemplated cash requirements through July of 2009, assuming we do not
engage in an extraordinary transaction or otherwise face unexpected events or
contingencies, any of which could affect cash requirements. As of March 31,
2009, we had cash on hand of $661,000. Presently, the Company has a monthly cash
burn rate of approximately $220,000. Accordingly, we will need to
raise additional capital to fund anticipated operating expenses after July of
2009. We cannot assure you that financing whether from external sources or
related parties will be available if needed or on favorable terms. If additional
financing is not available when required or is not available on acceptable
terms, we may be unable to fund operations and planned growth, develop or
enhance our technologies, take advantage of business opportunities or respond to
competitive market pressures. Any negative impact on our operations may make the
raising of capital more difficult.
Additional
funds may not be available on acceptable terms, if at all. If adequate funds are
unavailable from any source, we may have to delay, reduce the scope of or
eliminate one or more of our research, development or commercialization programs
or product launches or marketing efforts. Any such change may
materially harm our business, financial condition and operations.
Our long
term capital requirements are expected to depend on many factors,
including:
·
|
the
continued progress and cost of our development
programs;
|
·
|
the
progress of pre-clinical studies and clinical
trials;
|
·
|
the
time and costs involved in obtaining regulatory
clearance;
|
·
|
the
costs involved in preparing, filing, prosecuting, maintaining and
enforcing patent claims;
|
·
|
the
costs of developing sales, marketing and distribution channels and its
ability to sell the Company's
products;
|
·
|
competing
technological and market
developments;
|
·
|
market
acceptance of our proposed products if
developed;
|
·
|
the
costs for recruiting and retaining employees and consultants;
and
|
·
|
the
costs for educating and training physicians about our
products.
|
We may
consume available resources more rapidly than currently anticipated, resulting
in the need for additional funding. If adequate funds are not
available, we may be required to significantly reduce or refocus our development
and commercialization efforts.
We
may have difficulty raising needed capital in the future as a result of our
limited operating history.
When
making investment decisions, investors typically look at a company’s historical
performance in evaluating the risks and operations of the business and the
business’s future prospects. Our limited operating history makes such evaluation
and an estimation of our future performance substantially more difficult. As a
result, investors may be unwilling to invest in us or such investment may be on
terms or conditions which are not acceptable. If we are unable to secure such
additional finance, we may need to cease operations.
22
Our
independent auditors have issued a qualified report as of and for the year ended
December 31, 2008 with respect to our ability to continue as a going
concern.
For the
year ended December 31, 2008, our accountants issued a report relating to our
audited financial statements which contains a qualification with respect to our
ability to continue as a going concern because, among other things, our ability
to continue as a going concern is dependent upon our ability to develop a
product and generate profits from operations in the future or to obtain the
necessary financing to meet our obligations and repay our liabilities when they
come due.
We may not be
able to commercially develop our technologies which will prevent us from
generating revenues, operating profitably or providing investors any return on
their investment.
We have
concentrated our research and development on our drug
technologies. Our ability to generate revenue and operate profitably
will depend on our being able to develop these technologies for human
applications. Our technologies are primarily directed toward the development of
cancer therapeutic agents. We cannot guarantee that the results obtained in
pre-clinical and clinical evaluation of our therapeutic agents will be
sufficient to warrant approval by the FDA. Even if our therapeutic agents are
approved for use by the FDA, there is no guarantee that they will exhibit an
enhanced efficacy relative to competing therapeutic modalities such that they
will be adopted by the medical community. Without significant adoption by the
medical community our agents will have limited commercial potential which will
likely result in the loss of your entire investment.
Inability to
complete pre-clinical and clinical testing and trials will impair our
viability.
We have
not yet submitted an IND to the FDA to conduct clinical trials. Even if we
successfully file an IND application and receive clearance from the FDA to
commence trials, the outcome of the trials is uncertain and, if we are unable to
satisfactorily complete such trials, or if such trials yield unsatisfactory
results, we will be unable to commercialize our proposed products. No assurances
can be given that the clinical trials, if commenced, will successful. The
failure of such trials could delay or prevent regulatory approval and could harm
our ability to generate revenues, operate profitably or produce any return on an
investment.
Our
additional financing requirements will result in dilution to existing
stockholders.
We will
require additional financing in the future. The issuance of our securities in
connection with a future financing will result in a decrease of our current
stockholders’ percentage ownership. We have authority to issue additional shares
of common stock and preferred stock, as well as additional classes or series of
ownership interests or debt obligations which may be convertible into any one or
more classes or series of ownership interests. We are authorized to issue 80
million shares of common stock and 10 million shares of preferred stock. Such
securities may be issued without the approval or consent of our
stockholders.
Risks
Relating to Intellectual Property and Government Regulation
We may not be
able to withstand challenges to our intellectual property
rights.
We rely
on our intellectual property, including our issued and applied for patents, as
the foundation of our business. Our intellectual property rights may come under
challenge, and no assurances can be given that, even though issued, our current
and potential future patents will survive claims commencing in the court system
alleging invalidity or infringement on other patents. The viability of our
business will suffer if such patent protection becomes limited or is eliminated.
Moreover, the costs associated with defending or settling intellectual property
claims will have a materially adverse effect on our business.
We may not be
able to adequately protect our intellectual property.
Considerable
research with regard to our technologies is being performed in countries outside
of the United States. The laws protecting intellectual property in some of those
countries may not provide protection for our trade secrets and intellectual
property. If our trade secrets or intellectual property are
misappropriated in those countries, we may be without adequate remedies to
address the issue. At present, we are not aware of any infringement of our
intellectual property. In addition to our patents, we rely on confidentiality
and assignment of invention agreements to protect our intellectual property.
These agreements provide for contractual remedies in the event of
misappropriation. We do not know to what extent, if any, these
agreements and any remedies for their breach will be enforced by a foreign
court. In the event our intellectual property is misappropriated or infringed
upon and an adequate remedy is not available, our future prospects will greatly
diminish.
23
Our proposed
products may not receive FDA approval.
The FDA
and comparable government agencies in foreign countries impose substantial
regulations on the manufacture and marketing of pharmaceutical products through
lengthy and detailed laboratory, pre-clinical and clinical testing procedures,
sampling activities and other costly and time-consuming procedures. Satisfaction
of these regulations typically takes several years or more and varies
substantially based upon the type, complexity and novelty of the proposed
product. We cannot yet accurately predict when we might first submit any IND
application to the FDA, or whether any such IND application will be granted on a
timely basis, if at all. We cannot assure you that we will
successfully complete any clinical trials in connection with any such IND
application. Notwithstanding our inability to predict when such submission will
be made, we anticipate a filing sometime during the second quarter of 2009.
Further, we cannot yet accurately predict when we might first submit any product
license application for FDA approval or whether any such product license
application would be granted on a timely basis, if at all. As a result, we
cannot assure you that FDA approval for any products developed by us will be
granted on a timely basis, if at all. Any delay in obtaining, or failure to
obtain, such approvals could have a materially adverse effect on the
commercialization of our products and its ability to generate product
revenue.
Risks
Relating to Competition
Our competitors
have significantly greater experience and financial
resources.
We
compete against numerous companies, many of which have substantially greater
financial and other resources than us. Several such enterprises have research
programs and/or efforts to treat the same diseases we target. Companies such as
Merck, Ipsen and Diatos, as well as others, have substantially greater resources
and experience than we do and are situated to compete with us
effectively.
Risks
Relating to Reliance on Third Parties
We
intend to rely exclusively upon the third-party FDA-approved manufacturers and
suppliers for our products.
We
currently have no internal manufacturing capability, and will rely exclusively
on FDA-approved licensees, strategic partners or third party contract
manufacturers or suppliers. Should we be forced to manufacture our product, we
cannot give you any assurance that we will be able to develop an internal
manufacturing capability or procure third party suppliers. In the event we seek
third party suppliers, they may require us to purchase a minimum amount of
compound or could require other unfavorable terms. Any such event would
materially impact our prospects and could delay the development and sale of our
products. Moreover, we cannot give you any assurance that any contract
manufacturers or suppliers we procure will be able to supply our products in a
timely or cost effective manner or in accordance with applicable regulatory
requirements or our specifications.
General
Risks Relating to Our Business
We depend on
Craig A. Dionne, PhD, our Chief Executive Officer, and Russell Richerson PhD,
our Chief Operating Officer, for our continued operations and future
success.
The loss
of Craig A. Dionne, PhD, our Chief Executive Officer, or Russell Richerson, PhD,
our Chief Operating Officer, would be detrimental to us. We currently maintain a
one million dollar “key person” life insurance policy on the life of Dr. Dionne
but do not maintain a policy of Dr. Richerson. Nevertheless, our prospects and
operations will be significantly hindered upon the death or incapacity of either
of these key individuals. We currently do not have employment agreements with
Messrs Dionne or Richerson.
We
will require additional personnel to move forward with our business
plan.
Our
anticipated growth and expansion into areas and activities requiring additional
expertise, such as clinical testing, regulatory compliance, manufacturing and
marketing, may require the addition of new management personnel and the
development of additional expertise by existing management personnel. There is
intense competition for qualified personnel in such areas. There can
be no assurance that we will be able to continue to attract and retain the
qualified personnel necessary for the development of our business. Although to
date we have not encountered significant difficulties with respect to
identifying and retaining personal, the failure to attract and retain such
personnel or to develop such expertise in the future would adversely affect the
our business.
Our business
is dependent upon securing sufficient quantities of a natural product that
currently grows in very specific locations outside of the United
States.
The
therapeutic component of our products, including our lead compound G-202, is
referred to as 12ADT. 12ADT functions by dramatically raising the levels of
calcium inside cells, which leads to cell death. 12ADT is derived from a
material called Thapsigargin. Thapsigargin is derived from the seeds of a plant
referred to as Thapsia
garganica. We currently secure seeds from Thapsia garganica
plants that grow along the coastal regions of Spain from our third
party supplier, Thapsibiza, SL. There
can be no assurances that the countries from which we can secure Thapsia garganica will
continue to allow Thapsibiza, SL to collect such seeds and/or to do so and
export the seeds derived from Thapsia
garganica to the United States. In the event we are no longer
able to import these seeds, we will not be able to produce our proposed drug and
our business will be adversely impacted.
24
To
our knowledge, there are no commercially viable means to synthesize the active
ingredient of our therapeutics from laboratory chemicals.
Generally,
attempts are often made to develop a synthetic approach using laboratory
chemicals to make an active ingredient derived from a natural substance.
Although a group has recently published a scientific paper on the full chemical
synthesis of Thapsigargin, we believe that the number of individual chemical
steps required to make synthetic Thapsigargin (42 individual steps) is too large
for economically feasible commercial synthesis of this compound. We cannot
provide any assurances, however, that another group at some time may be able to
significantly reduce the number of individual chemical steps to make synthetic
Thapsigargin. To our current knowledge, there is no commercially viable means to
conduct such synthesis for 12ADT, the active component of our therapeutic
agents. Therefore, we believe that our ability to produce the therapeutic
component 12ADT will always depend upon our ability to secure seeds from the
plant Thapsia
garganica. There can be no assurances that our ability to
secure such seeds can be adequate to satisfy our development and commercial
needs.
The
current manufacturing process of G-202 requires acetonitrile.
The
current manufacturing process for G-202 requires the common solvent
acetonitrile. Beginning in late 2008, there has been a worldwide shortage of
acetonitrile for a variety of reasons, and this shortage is predicted to last at
least until the end of 2009 and possibly into future years. We have also
observed that the available supply of acetonitrile is of variable quality for
our requirements. If we are unable to successfully change our
manufacturing methods to avoid the reliance upon acetonitrile, we may incur
prolonged production timelines and increased production costs. In an extreme
case this situation could adversely affect our ability to manufacture G-202
altogether, thus significantly impacting our future operations.
In order to
secure market share and generate revenues, our proposed products must be
accepted by the health care community.
Our
proposed products, if approved for marketing, may not achieve market acceptance
since hospitals, physicians, patients or the medical community in general may
decide not to accept and utilize them. We are attempting to develop products
that will likely be first approved for marketing in late stage cancer where
there is no truly effective standard of care. If approved for use in late stage,
the drugs will then be evaluated in earlier stage where they would represent
substantial departures from established treatment methods and will compete with
a number of more conventional drugs and therapies manufactured and marketed by
major pharmaceutical companies. It is too early in the development cycle of the
drugs for us to accurately predict our major
competitors. Nonetheless, the degree of market acceptance of any of
our developed products will depend on a number of factors,
including:
·
|
our
demonstration to the medical community of the clinical efficacy and safety
of our proposed products;
|
·
|
our
ability to create products that are superior to alternatives currently on
the market;
|
·
|
our
ability to establish in the medical community the potential advantage of
our treatments over alternative treatment methods;
and
|
·
|
the
reimbursement policies of government and third-party
payors.
|
If the
health care community does not accept our products for any of the foregoing
reasons, or for any other reason, our business will be materially
harmed.
Commercial
requirements, if any, for our therapeutic products may require us to secure land
for cultivation and harvesting of the seeds derived from Thapsia
garganica.
While we
believe that we can satisfy our needs for clinical development of G-202 through
completion of Phase III clinical studies from Thapsia garganica that grows
naturally in the wild, with respect to commercial operations, if any, that
involve development of an approved therapeutic that comprises G-202, we may not
be able to rely upon securing the seeds from Thapsia
garganica that grow naturally. We estimate that in order to
secure sufficient quantities of Thapsia garganica
for the commercialization of a product comprising G-202, we will
need to secure approximately 100 acres of land to cultivate and grow Thapsia
garganica. We anticipate the cost to lease such land would be
$40,000 per year but have not yet fully assessed what other costs would be
associated with a full-scale farming operation. There can be no assurances that
we can secure such acreage, or that even if we are able to do so, that we could
adequately grow sufficient quantities of Thapsia garganica
to satisfy any commercial objectives that involve G-202. Our
inability to secure adequate seeds will result in us not being able to develop
and manufacture our proposed drug and will adversely impact our
business.
Thapsia garganica
and Thapsigargin, when brought into contact with the skin, can cause severe
irritation.
It has
been known for centuries that the plant Thapsia garganica can cause
severe skin irritation when contact is made between the plant and the skin1. Skin
plasters made from the plant have been part of the Medical Pharmacopeia2 in Western
Europe as recently as the 1930s. The therapeutic action of the plaster is that
of a severe counter-irritant. In 1978, Thapsigargin was determined to be the
skin-irritating component of the plant Thapsia garganica. The
therapeutic component of our products, including our lead product G-202, is
derived from Thapsigargin. We obtain Thapsigargin from the above-ground seeds
of Thapsia garganica.
These seeds are currently harvested by hand and those conducting the harvesting
must wear protective clothing and gloves to avoid contact of the skin with the
seeds. Although we obtain the seeds from a third-party contractor located in
Spain, and although the contractor has contractually waived any and all
liability associated with collecting the seeds for our supply needs, it is
possible that the contractor or those employed by the contractor may suffer
medical issues related to the harvesting and subsequently seek compensation from
us via, for example, litigation. No assurances can be given, despite our
contractual relationship with the third party contractor, that the Company may
not be the subject of litigation related to the harvesting of the
seeds.
2
|
Medical
Pharmacopeia is a book containing an official list of medicinal drugs
together with articles on their preparation and
use.
|
25
The
synthesis of 12ADT must be conducted in a facility qualified for
making compounds that have a toxic effect on human cells.
There are
a limited number of facilities that are qualified to handle toxic agents for the
manufacture of therapeutic agents. This limits the potential number of possible
manufacturing sites for our therapeutic compounds that are derived from Thapsia garganica.
No assurances can be provided that these facilities will be
available for the manufacture of our therapeutic compounds under our time
schedules or within the parameters of our manufacturing budget. In the event
facilities are not available for manufacturing our therapeutic compounds, the
Company’s business and future prospects will be adversely affected.
Our
lead therapeutic compound, G-202, has not been subjected to large scale
manufacturing procedures
G-202 has
been manufactured in an academic setting in limited quantities. We
have not yet completed large scale manufacturing of G-202. There can be no
assurances that the current procedure for manufacturing G-202 can be
manufactured under larger scale manufacturing procedures. In the
event G-202 cannot be manufactured in sufficient qualities, our future prospects
could be significantly impacted.
We have no
product liability insurance.
The
testing, manufacturing, marketing and sale of human therapeutic products entail
an inherent risk of product liability claims. We cannot assure you
that substantial product liability claims will not be asserted against us. We
have no product liability insurance. In the event we are forced to expend
significant funds on defending product liability actions, and in the event those
funds come from operating capital, we will be required to reduce our business
activities, which could lead to significant losses.
We cannot assure
you that adequate insurance coverage will be available in the future on
acceptable terms.
We have
secured director and officer insurance in the amount of $5,000,000. Any
significant insurance claims would have a material adverse effect on our
business, financial condition and results of operations. Insurance availability,
coverage terms and pricing continue to vary with market conditions. We will
endeavor to obtain appropriate insurance coverage for insurable risks that we
identify. We may not be able to obtain appropriate insurance
coverage. The occurrence of an uninsured claim may have an adverse
material effect on our business.
Risks
Relating Our Common Stock
There
is no public market for our securities.
Our stock
is not traded on an exchange or on the OTC Bulletin Board. An
investment in our common stock should be considered totally
illiquid. No assurances can be given that a public market for our
securities will ever materialize. Additionally, even if a public market for our
securities develops and our securities become traded, the trading volume may be
limited, making it difficult for an investor to sell shares.
We face risks
related to compliance with corporate governance laws and financial reporting
standards.
The
Sarbanes-Oxley Act of 2002, as well as related new rules and regulations
implemented by the Securities and Exchange Commission and the Public Company
Accounting Oversight Board, require changes in the corporate governance
practices and financial reporting standards for public companies. These new
laws, rules and regulations, including compliance with Section 404 of the
Sarbanes-Oxley Act of 2002 relating to internal control over financial reporting
(“Section 404”), will materially increase the Company's legal and financial
compliance costs and make some activities more time-consuming and more
burdensome. As a result, management will be required to devote more time to
compliance which could result in a reduced focus on the development thereby
adversely affecting the Company’s development activities. Also, the increased
costs will require the Company to seek financing sooner that it may otherwise
have had to.
Starting
in 2007, Section 404 of the Sarbanes-Oxley Act of 2002 requires that the
Company's management assess the Company's internal control over financial
reporting annually and include a report on its assessment in its annual report
filed with the SEC. Effective December 15, 2009 for a smaller reporting company,
the Company's independent registered public accounting firm is required to audit
both the design and operating effectiveness of its internal controls and
management's assessment of the design and the operating effectiveness of its
internal controls. We anticipate that costs associated with becoming public will
add $150,000 of annual expenses in connection with professional legal and
accounting fees.
Because
of our limited resources, management has concluded that our internal control
over financial reporting may not be effective in providing reasonable assurance
regarding the reliability of financial reporting and the preparation of
financial statements for external purposes in accordance with U.S. generally
accepted accounting principles.
26
To
mitigate the current limited resources and limited employees, we rely heavily on
direct management oversight of transactions, along with the use of legal and
accounting professionals. As we grow, we expect to increase our number of
employees, which will enable us to implement adequate segregation of duties
within the Committee of Sponsoring Organizations of the Treadway Commission
internal control framework.
We do not intend
to pay cash dividends on our common stock.
We do not
anticipate paying cash dividends in the foreseeable future. Since we do not
anticipate paying dividends, any gains on an investment will need to come
through an increase in the price of our common stock. The lack of a
market or exchange for our common stock makes such gains highly
unlikely.
Our
board of directors has broad discretion to issue additional securities which may
greatly impact the value of our common stock.
We are
entitled under our certificate of incorporation to issue up to 80,000,000
common and 10,000,000 “blank check” preferred shares. Blank check preferred
shares provide the board of directors broad authority to determine voting,
dividend, conversion, and other rights. As of December 31, 2008, we have issued
and outstanding 12,486,718 common shares. As of March 31, 2009, after our
February offering, we have issued and outstanding 12,953,392 common shares and
we have 4,517,867 common shares reserved for issuance upon the exercise of
current outstanding options, warrants and convertible securities. Accordingly,
we will be entitled to issue up to 62,528,741 additional common shares
and 10,000,000 additional preferred shares. Our board may generally issue
those common and preferred shares, or options or warrants to purchase those
shares, without further approval by our shareholders based upon such factors as
our board of directors may deem relevant at that time. Any preferred shares we
may issue shall have such rights, preferences, privileges and restrictions as
may be designated from time-to-time by our board, including preferential
dividend rights, voting rights, conversion rights, redemption rights and
liquidation provisions. It is likely that we will be required to issue a large
amount of additional securities to raise capital to further our development and
marketing plans. It is also likely that we will be required to issue a large
amount of additional securities to directors, officers, employees and
consultants as compensatory grants in connection with their services, both in
the form of stand-alone grants or under our various stock plans. We cannot give
any assurance that we will not issue additional common or preferred shares, or
options or warrants to purchase those shares, under circumstances we may deem
appropriate at the time.
Our
Officers and Scientific Advisors beneficially own approximately 50.4% of our
outstanding common shares. As a result, these individuals have the ability to
significantly control our governance and may have interests different than
yours.
Our
Officers and Scientific Advisors own approximately 50.4% of our outstanding
common shares. As a consequence of their level of stock ownership, the group
will substantially retain the ability to elect or remove members of our board of
directors, and thereby control our management. This group of shareholders has
the ability to significantly control the outcome of corporate actions requiring
shareholder approval, including mergers and other changes of corporate control,
going private transactions, and other extraordinary transactions any of which
may be in opposition to the best interest of the other
shareholders.
ITEM
2. UNREGISTERED
SALES OF EQUITY SECURITIES AND USE OF PROCEEDS
We
incorporate by reference the information pertaining to unregistered sales of
equity securities as disclosed in our annual report file on Form 10-K for the
period ended December 31, 2008. The following information is given with
regard to unregistered securities sold during the period covered by this
report.
·
|
On
February 17, 2009, we entered into a modification with TRW with regard to
our 5% Convertible Debenture issued to TRW in the amount of
$163,600. Pursuant to the modification, TRW agreed to extend
the maturity date of the debenture from July 14, 2009 to July 14,
2010. As consideration for the modification, we issued TRW a
common stock purchase warrant entitling TRW to purchase 50,000 shares of
our common stock at a per share purchase price of $1.50. The
warrant has a five year term and contains certain anti-dilution provisions
requiring us to adjust the exercise price and number of shares upon the
occurrence of a stock split, stock dividends or stock
consolidation.
|
·
|
On
February 17, 2009, we entered into a modification with Craig Dionne, our
Chief Executive Officer and Chairman with regard to our 4% Convertible
Promissory Note issued to Mr. Dionne in the amount of
$35,000. Pursuant to the modification, Mr. Dionne agreed to
extend the maturity date of the Note from December 2, 2008 to December 2,
2009. Mr. Dionne had previously deferred repayment of the
note. As consideration for the modification, we issued Mr.
Dionne a common stock purchase warrant entitling Mr. Dionne to purchase
11,000 shares of our common stock at a per share purchase price of
$1.50. The warrant has a five year term and contains certain
anti-dilution provisions requiring us to adjust the exercise price and
number of shares upon the occurrence of a stock split, stock dividends or
stock consolidation.
|
27
·
|
On
February 19, 2009, we entered into a Securities Purchase Agreement with a
number of accredited investors. Pursuant to the
terms of the Securities Purchase Agreement, we sold the investors units in
the aggregate of approximately $700,000. The price per unit was
$1.50. Each unit consists of: (i) one share of common stock;
and (ii) one-half common stock purchase warrant. The warrants
have a term of five years and allow the holder to purchase our common
shares at a price per share of $3.00. The warrants also contain
anti-dilution protection in the event of stock splits, stock dividends and
other similar transactions.
|
·
|
On
February 19, 2009, as a result of offering of the same date, the
anti-dilution provisions in our warrants issued during the July and August
2008 financing were triggered. These anti-dilution provisions
resulted in the exercise price of these warrants being reduced from $2.00
to $1.50. Additionally, we issued holders of these warrants an
additional 506,754 additional warrants. We are obligated to
file a registration statement for the common stock underlying such
warrants pursuant to the registration rights agreement entered into in
connection with the July and August 2008
financing.
|
ITEM
3. DEFAULT
UPON SENIOR SECURITIES
None
ITEM
4. SUBMISSION
OF MATTERS TO A VOTE OF SECURITY HOLDERS
On April
20, 2009, shareholders representing 7,296,718 common shares or 56% of the number
of shares entitled to vote on the matter, approved the amendment of our Equity
Compensation Plan. For a further description of this action, refer to
our Current Report on Form 8-K filed with the SEC on April 24,
2009.
ITEM
5. OTHER
INFORMATION
None
ITEM
5. OTHER
INFORMATION
None
ITEM
6. EXHIBITS
The
exhibits listed in the accompanying index to exhibits are filed or incorporated
by reference as part of this Form 10-Q.
SIGNATURES
In
accordance with the requirements of the Securities Exchange Act of 1934, the
Registrant has caused this report to be signed by the undersigned hereunto duly
authorized.
GENSPERA,
INC.
|
||
|
|
|
Date: May
[___], 2009
|
|
/s/ Craig
Dionne
|
Chief
Executive Officer
|
||
/s/
Craig Dionne
|
||
Chief
Financial Officer
|
||
(Principal
Accounting Officer)
|
28
EXHIBITS
LIST
INDEX
TO EXHIBITS
|
Incorporated
by Reference
|
|||||||||||
Exhibit
No.
|
Description
|
Filed
Herewith
|
Form
|
Exhibit
No.
|
File No.
|
Filing Date
|
||||||
3.01
|
Amended
and Restated Certificate of Incorporation
|
S-1
|
3.01
|
333-153829
|
10/03/08
|
|||||||
3.02
|
Bylaws
|
S-1
|
3.02
|
333-153829
|
10/03/08
|
|||||||
4.01
|
Specimen
of Common Stock certificate
|
S-1
|
4.01
|
333-153829
|
10/03/08
|
|||||||
4.02**
|
Amended
and Restated 2007 Equity Compensation Plan
|
8-K
|
4.01
|
333-153829
|
4/24/09
|
|||||||
4.03**
|
GenSpera
2007 Equity Compensation Plan form of Incentive Stock Option
Grant
|
S-1
|
4.03
|
333-153829
|
10/03/08
|
|||||||
4.04**
|
GenSpera
2007 Equity Compensation Plan form of Nonqualified Stock Option
Grant
|
S-1
|
4.04
|
333-153829
|
10/03/08
|
|||||||
4.05
|
Form
of 4% convertible note issued to shareholder
|
S-1
|
4.05
|
333-153829
|
10/03/08
|
|||||||
4.06
|
Form
of 4% convertible note modification
|
8-K
|
10.01
|
333-153829
|
2/20/09
|
|||||||
4.07
|
Form
of Subscription Agreement for November 2007 offering
|
S-1
|
4.06
|
333-153829
|
10/03/08
|
|||||||
4.08
|
Form
of Warrant dated March 6, 2008 issued to consultant for financial
consulting services.
|
S-1
|
4.07
|
333-153829
|
10/03/08
|
|||||||
4.09
|
Form
of Securities Purchase Agreement—July and August 2008 private
placement
|
S-1
|
4.08
|
333-153829
|
10/03/08
|
|||||||
4.10
|
Form
of Registration Rights Agreement – July and August 2008 private
placement
|
S-1
|
4.09
|
333-153829
|
10/03/08
|
|||||||
4.11
|
Form
of Warrant – July and August 2008 private placement
|
S-1
|
4.10
|
333-153829
|
10/03/08
|
|||||||
4.12
|
Form
of insider Lock-Up Agreement – July and August 2008 private
placement
|
S-1
|
4.11
|
333-153829
|
10/03/08
|
|||||||
4.13
|
Form
of 5% convertible debenture issued to TR Winston & Company,
LLC
|
S-1
|
4.12
|
333-153829
|
10/03/08
|
|||||||
4.14
|
Form
of 5% convertible debenture modification
|
8-K
|
10.02
|
333-153829
|
2/20/09
|
29
4.15
|
Form
of Securities Purchase Agreement dated February 19, 2009
|
8-K
|
10.01
|
333-153829
|
2/20/09
|
|||||||
4.16
|
Form
of Common Stock Purchase Warrant dated February 19, 2009
|
8-K
|
10.02
|
333-153829
|
2/20/09
|
|||||||
4.17
|
Form
of Registration Rights Agreement dated February 19, 2009
|
8-K
|
10.03
|
333-153829
|
2/20/09
|
|||||||
4.18
|
Form
of Common Stock Purchase Warrant issued February 17, 2009 – T.R. Winston
& Company, LLC
|
8-K
|
10.05
|
333-153829
|
2/20/09
|
|||||||
4.19
|
Form
of Common Stock Purchase Warrant issued February 17, 2009 –
C.Dionne
|
8-K
|
10.06
|
333-153829
|
2/20/09
|
|||||||
10.01
|
Form
of Transactional Fee Agreement between the Company and TR Winston &
Company, LLC dated March 17, 2008
|
S-1
|
10.01
|
333-153829
|
10/03/08
|
10.02
|
Exclusive
Supply Agreement between GenSpera and Thapsibiza dated January 22,
2008
|
S-1
|
10.02
|
333-153829
|
10/03/08
|
|||||||
10.03**
|
Terms
of verbal employment agreement with Craig Dionne dated February 11,
2008
|
S-1
|
10.03
|
333-153829
|
10/03/08
|
|||||||
10.04**
|
Terms
of verbal employment agreement with Russell Richerson dated July 1,
2008
|
S-1
|
10.04
|
333-153829
|
10/03/08
|
|||||||
14.01
|
Code
of Ethics
|
*
|
||||||||||
31.1
|
Certification
of the Principal Executive Officer Pursuant to Section 302 of the
Sarbanes-Oxley Act of 2002.
|
*
|
||||||||||
31.2
|
Certification
of the Principal Financial Officer Pursuant to Section 302 of the
Sarbanes-Oxley Act of 2002.
|
*
|
||||||||||
32.1
|
Certification
of Principal Executive Officer Pursuant to 18 U.S.C §
1350.
|
*
|
||||||||||
32.2
|
Certification
of Principal Financial Officer Pursuant to 18 U.S.C §
1350.
|
*
|
**Management
contracts or compensation plans or arrangements in which directors or executive
officers are eligible to participate.
30