Rebus Holdings, Inc. - Quarter Report: 2009 September (Form 10-Q)
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 September 30, 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.)
|
|
2511
N Loop 1604 W, Suite 204
San
Antonio, TX
|
78258
|
|
(Address
of principal executive offices)
|
(Zip
Code)
|
Registrant’s
telephone number, including area code (210) 479-8112
9901
IH 10 West, Suite 800, San Antonio, TX 78230
(Former
address)
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. x Yes ¨
No
Indicate
by check mark whether the registrant has submitted electronically and posted on
its corporate Web site, if any, every Interactive Data File required to be
submitted and posted pursuant to Rule 405 of Regulation S-T (§232.405 of this
chapter) during the preceding 12 months (or for such shorter period that the
registrant was required to submit and post such files). ¨
Yes ¨
No
Indicate
by check mark whether the registrant is a large accelerated filer, an
accelerated filer, a non-accelerated filer, or a smaller reporting company. See
the definitions of “large accelerated filer,” “accelerated filer” and “smaller
reporting company” in Rule 12b-2 of the Exchange Act.
Large
accelerated filer ¨
|
Accelerated
filer ¨
|
Non-accelerated
filer ¨ (Do
not check if a 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
x No
The number of shares outstanding of
Registrant’s common stock, $0.0001 par value at November 13, 2009 was
15,292,281.
GenSpera,
Inc.
Table of
Contents
Page
|
|||
PART
I -
|
FINANCIAL
INFORMATION
|
||
Item
1.
|
Financial
Statements
|
4 | |
Condensed
Balance Sheets as of September 30, 2009 (Unaudited) and December 31,
2008
|
4
|
||
Condensed
Statements of Operations (Unaudited)
|
5 | ||
Three
and Nine months ended September 30, 2009 and 2008 and for the period from
November 21, 2003 (inception) to September 30, 2009
|
|||
Condensed
Statements of Changes in Stockholders' Equity (Unaudited)
|
6 | ||
For
the period from November 21, 2003 (inception) through September 30,
2009
|
|||
|
|||
Condensed
Statements of Cash Flows (Unaudited)
|
7 | ||
Nine
months ended September 30, 2009 and 2008 and for the period from November
21, 2003 (inception) to September 30, 2009
|
|||
Notes
to Financial Statements (Unaudited)
|
8
|
||
Item
2.
|
Management's
Discussion and Analysis of Financial Condition and Results
of Operations
|
16
|
|
Item
3.
|
Quantitative
and Qualitative Disclosures about Market Risk
|
24
|
|
Item
4.
|
Controls
and Procedures
|
24
|
|
PART
II -
|
OTHER
INFORMATION
|
||
Item
1.
|
Legal
Proceedings
|
25
|
|
Item
1A.
|
Risk
Factors
|
25
|
|
Item
2.
|
Unregistered
Sales of Equity Securities and Use of Proceeds
|
31
|
|
Item
3.
|
Defaults
Upon Senior Securities
|
33
|
|
Item
4.
|
Submission
of Matters to a Vote of Security Holders
|
33
|
|
Item
5.
|
Other
Information
|
33
|
|
Item
6.
|
Exhibits
|
33
|
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,” and
“GenSpera” refer to GenSpera, Inc. Also, any reference to
“common shares” or “common stock” refers to our $.0001 par value common
stock. The information contained herein is current as of the
date of this Quarterly Report (September 30, 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 and nine month periods ended September 30, 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 herein should be read in
conjunction 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 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;
|
·
|
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 Quarterly 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 Quarterly Report or any
other filing to reflect new events or circumstances unless and to the extent
required by applicable law.
3
PART
I
FINANCIAL
INFORMATION
ITEM
1. FINANCIAL
STATEMENTS
GENSPERA
INC.
(A
Development Stage Company)
CONDENSED
BALANCE SHEETS
September
30,
|
December
31,
|
|||||||
2009
|
2008
|
|||||||
|
(Unaudited)
|
|||||||
Assets
|
||||||||
Current
assets:
|
||||||||
Cash
|
$ | 2,742,219 | $ | 534,290 | ||||
Total
current assets
|
2,742,219 | 534,290 | ||||||
Fixed
assets, net of accumulated depreciation of $156 and $0
|
6,090 | - | ||||||
Intangible
assets, net of accumulated amortization of $23,021 and
$11,511
|
161,146 | 172,657 | ||||||
Total
assets
|
$ | 2,909,455 | $ | 706,947 | ||||
Liabilities
and stockholders' equity
|
||||||||
Current
liabilities:
|
||||||||
Accounts
payable and accrued expenses
|
$ | 183,915 | $ | 238,817 | ||||
Accrued
interest - stockholder
|
9,216 | 5,399 | ||||||
Convertible
note payable - stockholder, current portion
|
35,000 | 50,000 | ||||||
Total
current liabilities
|
228,131 | 294,216 | ||||||
Convertible
note payable, net of discount of $0 and $11,046
|
163,600 | 152,554 | ||||||
Convertible
notes payable - stockholder, long term portion
|
105,000 | 105,000 | ||||||
Derivative
liabilities
|
1,920,218 | - | ||||||
Total
liabilities
|
2,416,949 | 551,770 | ||||||
Commitments
and contingencies
|
||||||||
Stockholders'
equity:
|
||||||||
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,
15,292,281 and 12,486,718 shares issued and outstanding
|
1,529 | 1,249 | ||||||
Additional
paid-in capital
|
9,705,941 | 4,922,174 | ||||||
Deficit
accumulated during the development stage
|
(9,214,964 | ) | (4,768,246 | ) | ||||
Total
stockholders' equity
|
492,506 | 155,177 | ||||||
Total
liabilities and stockholders' equity
|
$ | 2,909,455 | $ | 706,947 |
See
accompanying notes to unaudited condensed financial statements.
4
GENSPERA,
INC.
(A
Development Stage Company)
CONDENSED
STATEMENTS OF LOSSES
FOR THE
THREE AND NINE MONTHS ENDED SEPTEMBER 30, 2009 AND 2008
AND FOR
THE PERIOD FROM INCEPTION (NOVEMBER 21, 2003) TO SEPTEMBER 30, 2009
(Unaudited)
Cumulative Period
|
||||||||||||||||||||
from November 21, 2003
|
||||||||||||||||||||
(date of inception) to
|
||||||||||||||||||||
Three Months ended September 30,
|
Nine Months ended September 30,
|
September 30,
|
||||||||||||||||||
2009
|
2008
|
2009
|
2008
|
2009
|
||||||||||||||||
Operating
expenses:
|
||||||||||||||||||||
General
and administrative expenses
|
$ | 659,699 | $ | 90,337 | $ | 1,090,671 | $ | 603,873 | $ | 2,380,213 | ||||||||||
Research
and development
|
878,371 | 829,374 | 1,812,862 | 1,348,369 | 5,237,269 | |||||||||||||||
Total
operating expenses
|
1,538,070 | 919,711 | 2,903,533 | 1,952,242 | 7,617,482 | |||||||||||||||
Loss
from operations
|
(1,538,070 | ) | (919,711 | ) | (2,903,533 | ) | (1,952,242 | ) | (7,617,482 | ) | ||||||||||
Finance
cost
|
(793 | ) | (39,218 | ) | (478,886 | ) | (39,218 | ) | (518,675 | ) | ||||||||||
Change
in fair value of derivative liability
|
(86,514 | ) | - | (769,625 | ) | - | (1,060,081 | ) | ||||||||||||
Interest
income (expense), net
|
1,257 | 3,742 | (4,218 | ) | 531 | (18,726 | ) | |||||||||||||
Loss
before provision for income taxes
|
(1,624,120 | ) | (955,187 | ) | (4,156,262 | ) | (1,990,929 | ) | (9,214,964 | ) | ||||||||||
Provision
for income taxes
|
- | - | - | - | - | |||||||||||||||
Net
loss
|
$ | (1,624,120 | ) | $ | (955,187 | ) | $ | (4,156,262 | ) | $ | (1,990,929 | ) | $ | (9,214,964 | ) | |||||
Net
loss per common share, basic and diluted
|
$ | (0.11 | ) | $ | (0.08 | ) | $ | (0.31 | ) | $ | (0.19 | ) | ||||||||
Weighted
average shares outstanding
|
14,971,487 | 12,030,359 | 13,574,247 | 10,541,760 |
See
accompanying notes to unaudited condensed financial statements.
5
GENSPERA,
INC.
(A
Development Stage Company)
CONDENSED
STATEMENT OF STOCKHOLDERS' EQUITY
FROM DATE
OF INCEPTION (NOVEMBER 21, 2003) TO SEPTEMBER 30, 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
|
- | - | 1,242,388 | - | 1,242,388 | |||||||||||||||
Common
stock issued for services
|
86,875 | 10 | 104,109 | - | 104,119 | |||||||||||||||
Sale
of common stock and warrants at $1.50 per share - February
2009
|
466,674 | 46 | 699,939 | - | 699,985 | |||||||||||||||
Sale
of common stock and warrants at $1.50 per share - April
2009
|
33,334 | 3 | 49,997 | - | 50,000 | |||||||||||||||
Sale
of common stock and warrants at $1.50 per share - June
2009
|
1,420,895 | 142 | 2,038,726 | - | 2,038,868 | |||||||||||||||
Sale
of common stock and warrants at $1.50 per share - July
2009
|
604,449 | 60 | 838,024 | - | 838,084 | |||||||||||||||
Sale
of common stock and warrants at $1.50 per share - September
2009
|
140,002 | 14 | 202,886 | - | 202,900 | |||||||||||||||
Common
stock and warrants issued as payment of placement fees
|
53,334 | 5 | (5 | ) | - | - | ||||||||||||||
Net
loss
|
- | - | - | (4,156,262 | ) | (4,156,262 | ) | |||||||||||||
Balance,
September 30, 2009
|
15,292,281 | $ | 1,529 | $ | 9,705,941 | $ | (9,214,964 | ) | $ | 492,506 |
See
accompanying notes to unaudited condensed financial statements.
6
GENSPERA,
INC.
(A
Development Stage Company)
CONDENSED
STATEMENTS OF CASH FLOWS
FOR
THE NINE MONTHS ENDED SEPTEMBER 30, 2009 AND 2008
AND FOR
THE PERIOD FROM INCEPTION (NOVEMBER 21, 2003) TO SEPTEMBER 30,
2009
(Unaudited)
Cumulative
Period
|
||||||||||||
from
November 21, 2003
|
||||||||||||
(date
of inception) to
|
||||||||||||
Nine
months ended September 30,
|
September
30,
|
|||||||||||
2009
|
2008
|
2009
|
||||||||||
Cash
flows from operating activities:
|
||||||||||||
Net
loss
|
$ | (4,156,262 | ) | $ | (1,990,929 | ) | $ | (9,214,964 | ) | |||
Adjustments
to reconcile net loss to net cash used in operating
activities:
|
||||||||||||
Depreciation
and amortization
|
11,667 | 7,674 | 23,178 | |||||||||
Stock
based compensation
|
1,346,507 | 315,310 | 2,192,196 | |||||||||
Warrants
issued for financing costs
|
467,840 | - | 467,840 | |||||||||
Change
in fair value of derivative liability
|
769,625 | - | 1,060,081 | |||||||||
Contributed
services
|
- | 50,000 | 774,000 | |||||||||
Amortization
of debt discount
|
11,046 | 4,418 | 20,675 | |||||||||
(Decrease)
increase in accounts payable and accrued expenses
|
(51,085 | ) | 126,909 | 208,990 | ||||||||
Cash
used in operating activities
|
(1,600,662 | ) | (1,486,618 | ) | (4,468,004 | ) | ||||||
Cash
flows from investing activities:
|
||||||||||||
Acquisition
of property and equipment
|
(6,246 | ) | - | (6,246 | ) | |||||||
Acquisition
of intangibles
|
- | (184,168 | ) | (184,168 | ) | |||||||
Cash
used in investing activities
|
(6,246 | ) | (184,168 | ) | (190,414 | ) | ||||||
Cash
flows from financing activities:
|
||||||||||||
Proceeds
from sale of common stock and warrants
|
3,829,837 | 2,778,000 | 7,260,637 | |||||||||
Proceeds
from convertible notes - stockholder
|
- | 155,000 | ||||||||||
Repayments
of convertible notes - stockholder
|
(15,000 | ) | - | (15,000 | ) | |||||||
Cash
provided by financing activities
|
3,814,837 | 2,778,000 | 7,400,637 | |||||||||
Net
increase (decrease) in cash
|
2,207,929 | 1,107,214 | 2,742,219 | |||||||||
Cash,
beginning of period
|
534,290 | 590,435 | - | |||||||||
Cash,
end of period
|
$ | 2,742,219 | $ | 1,697,649 | $ | 2,742,219 | ||||||
Supplemental
cash flow information:
|
||||||||||||
Cash
paid for interest
|
$ | 1,075 | $ | - | ||||||||
Cash
paid for income taxes
|
$ | - | $ | - | ||||||||
Non-cash
financial activities:
|
||||||||||||
Common
stock units issued as payment of placement fees
|
$ | 80,000 | $ | - | ||||||||
Warrants
issued as payment for due diligence expenses
|
120,266 | - | ||||||||||
Warrants
issued as payment of placement fees
|
78,503 | - | ||||||||||
Accrued
interest paid with common stock
|
- | 15,859 | ||||||||||
Convertible
note issued as payment of placement fees
|
- | 163,600 | ||||||||||
Fair
value of warrants issued with convertible debt recorded as debt
discount
|
- | 20,675 |
See
accompanying notes to unaudited condensed financial statements.
7
GENSPERA, INC.
(A
Development Stage Company)
NOTES
TO CONDENSED FINANCIAL STATEMENTS
FOR
THE NINE MONTH PERIODS ENDED SEPTEMBER 30, 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 entity, as defined by the Financial Accounting Standards Board (“FASB”)
Accounting Standards Codification (“ASC”) Topic 915. 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 September 30, 2009, we have accumulated
losses of $9,214,964.
The
accompanying unaudited condensed financial statements as of September 30, 2009
and for the three and nine month periods ended September 30, 2009 and 2008 and
from date of inception as a development stage enterprise (November 21, 2003) to
September 30, 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 nine months ended September 30, 2009 are not necessarily
indicative of the results to be expected for the pending full year ending
December 31, 2009.
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.
8
NOTE
1 - SUMMARY OF ACCOUNTING POLICIES (cont’d)
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 $878,371 and $829,374 for the
three months ended September 30, 2009 and 2008, respectively, and $1,812,862 and
$1,348,369 for the nine months ended September 30, 2009 and 2008, respectively,
and $5,237,269 from November 21, 2003 (inception) through September 30,
2009.
Loss
Per Share
We use
ASC 260, “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 7,884,502 common share
equivalents at September 30, 2009 and 3,481,752 at September 30, 2008. For
the three and nine month periods ended September 30, 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.
Fair
value of financial instruments
In April
2009, we adopted new accounting guidance for our interim period ended
June 30, 2009 which requires disclosures about fair value of financial
instruments for interim reporting periods of publicly traded companies as well
as in annual financial statements.
Our
short-term financial instruments, including cash, accounts payable and other
liabilities, consist primarily of instruments without extended maturities, the
fair value of which, based on management’s estimates, reasonably approximate
their book value. The fair value of long term convertible notes is based on
management estimates and reasonably approximates their book value after
comparison to obligations with similar interest rates and maturities. The fair
value of the Company’s derivative instruments is determined using option pricing
models.
Fair
value measurements
Effective
January 1, 2008, we adopted new accounting guidance pursuant to ASC 820
which established a framework for measuring fair value and expands disclosure
about fair value measurements. The Company did not elect fair value accounting
for any assets and liabilities allowed by previous guidance. Effective
January 1, 2009, the Company adopted the provisions accounting guidance
that relate to non-financial assets and liabilities that are not required or
permitted to be recognized or disclosed at fair value on a recurring basis.
Effective April 1, 2009, the Company adopted new accounting guidance which
provides additional guidance for estimating fair value in accordance with ASC
820, when the volume and level of activity for the asset or liability have
significantly decreased. The adoptions of the provisions of ASC 820 did not have
a material impact on our financial position or results of
operations.
ASC 820
defines fair value as the amount that would be received for an asset or paid to
transfer a liability (i.e., an exit price) in the principal or most advantageous
market for the asset or liability in an orderly transaction between market
participants on the measurement date. ASC 820 also establishes a fair value
hierarchy that requires an entity to maximize the use of observable inputs and
minimize the use of unobservable inputs when measuring fair value. ASC 820
describes the following three levels of inputs that may be used:
9
NOTE
1 - SUMMARY OF ACCOUNTING POLICIES (cont’d)
Level 1:
Quoted prices (unadjusted) in active markets that are accessible at the
measurement date for identical assets and liabilities. The fair value hierarchy
gives the highest priority to Level 1 inputs.
Level 2:
Observable prices that are based on inputs not quoted on active markets but
corroborated by market data.
Level 3:
Unobservable inputs when there is little or no market data available, thereby
requiring an entity to develop its own assumptions. The fair value hierarchy
gives the lowest priority to Level 3 inputs.
The table
below summarizes the fair values of our financial liabilities as of
September 30, 2009:
Fair
Value at
|
Fair Value Measurement
Using
|
|||||||||||||||
September 30,
2009
|
Level 1
|
Level 2
|
Level 3
|
|||||||||||||
Convertible notes payable | $ | 303,600 | $ |
—
|
$ |
—
|
$ | 303,600 | ||||||||
Warrant
derivative liability
|
|
1,920,218
|
|
—
|
|
—
|
|
1,920,218
|
||||||||
$
|
2,223,818
|
$
|
—
|
$
|
—
|
$
|
2,223,818
|
The
following is a description of the valuation methodologies used for these
items:
Warrant derivative liability
— these instruments consist of certain of our warrants with anti-dilution
provisions. These instruments were valued using pricing models which incorporate
the Company’s stock price, volatility, U.S. risk free rate, dividend rate
and estimated life.
Change
in Accounting Principle
In June
2008, the FASB issued new accounting guidance which 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 ASC 815 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 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 new accounting guidance which 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. This guidance also
changes the manner in which the net income of the subsidiary is reported and
disclosed in the controlling company’s income statement. The guidance also
establishes guidelines for accounting or changes in ownership percentages and
for deconsolidation. The guidance is effective for financial statements for
fiscal years beginning on or after December 15, 2008 and interim periods within
those years. The adoption of this guidance did not have a material impact on our
financial position, results of operations or cash flows.
10
NOTE
1 - SUMMARY OF ACCOUNTING POLICIES (cont’d)
In March
2008, the FASB issued new accounting guidance which requires enhanced
disclosures about an entity’s derivative and hedging activities and thereby
improves the transparency of financial reporting. This guidance is effective for
financial statements issued for fiscal years and interim periods beginning after
November 15, 2008, with early application encouraged. The adoption of this
guidance did not have a material impact on our financial position, results of
operations or cash flows.
Effective
January 1, 2009, the Company adopted new accounting guidance which requires that
all unvested share-based payment awards that contain non-forfeitable rights to
dividends should be included in the basic earnings per share
calculation. The adoption of this guidance did not affect the
financial position or results of operations.
In April
2009, the FASB issued new accounting guidance to be utilized in determining
whether impairments in debt securities are other than temporary, and modifies
the presentation and disclosures surrounding such instruments. The guidance is
effective for interim periods ending after June 15, 2009, but early adoption is
permitted for interim periods ending after March 15, 2009. The adoption of this
guidance during the second quarter of 2009 had no impact on the Company’s
financial position or results of operations.
In April
2009, the FASB issued new accounting guidance to be utilized in determining
whether the market for a financial asset is not active and a transaction is not
distressed for fair value measurement purposes. The guidance is effective for
interim periods ending after June 15, 2009, but early adoption is permitted for
interim periods ending after March 15, 2009. The adoption of this guidance
during the second quarter of 2009 had no impact on the Company’s financial
position or results of operations.
In April
2009, the FASB issued new accounting guidance which requires disclosures about
fair value of financial instruments in interim financial statements as well as
in annual financial statements. This guidance is effective for interim periods
ending after June 15, 2009, but early adoption is permitted for interim periods
ending after March 15, 2009. The adoption of this guidance during the second
quarter of 2009 had no impact on the Company’s financial position or results of
operations.
In May
2009, the FASB issued new accounting guidance which establishes general
standards of accounting for and disclosures of events that occur after the
balance sheet date but before financial statements are issued or are available
to be issued. The guidance is effective for interim and annual financial periods
ending after June 15, 2009. The Company adopted the guidance during the
three months ended June 30, 2009 and has evaluated subsequent events
through the issuance date of these financial statements. The adoption of this
guidance had no impact on the Company’s financial position or results of
operations.
In June
2009, the FASB issued new accounting guidance which will require more
information about the transfer of financial assets where companies have
continuing exposure to the risks related to transferred financial assets. This
guidance is effective at the start of a company’s first fiscal year beginning
after November 15, 2009, or January 1, 2010 for companies reporting earnings on
a calendar-year basis.
In June
2009, the FASB issued new accounting guidance which will change how a company
determines when an entity that is insufficiently capitalized or is not
controlled through voting (or similar rights) should be consolidated. Under this
guidance, determining whether a company is required to consolidate an entity
will be based on, among other things, an entity's purpose and design and a
company's ability to direct the activities of the entity that most significantly
impact the entity's economic performance. This guidance is effective at the
start of a company’s first fiscal year beginning after November 15, 2009, or
January 1, 2010 for companies reporting earnings on a calendar-year
basis.
11
NOTE
1 - SUMMARY OF ACCOUNTING POLICIES (cont’d)
In June
2009, the FASB issued SFAS No. 168, “The FASB Accounting Standards
Codification and the Hierarchy of Generally Accepted Accounting Principals – a
replacement of FAS No.162” (“SFAS No. 168”). This statement establishes
the Codification as the source of authoritative U.S. accounting and reporting
standards recognized by the FASB for use in the preparation of financial
statements of nongovernmental entities that are presented in conformity with
GAAP. Rules and interpretive releases of the SEC under authority of federal
securities laws are also sources of authoritative GAAP for SEC registrants. The
Codification was the result of a project of FASB to organize and simplify all
authoritative GAAP literature into one source. This statement is effective for
interim reporting and annual periods ending after September 15, 2009.
Accordingly, the Company has adopted SFAS No. 168 during the quarter ended
September 30, 2009. The adoption of this standard during the third quarter of
2009 had no impact on the Company’s financial position or results of
operations.
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.
12
NOTE
2 - CAPITAL STOCK AND STOCKHOLDER’S EQUITY (cont’d)
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, during February and April we sold the investors units
aggregating approximately $750,000 (“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 this 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.
On June
29, 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
$2,131,000. 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. We
incurred a total of $142,467 in fees and expenses incurred in connection with
the transaction. Of this amount, $50,000 has been paid through the
issuance of 33,334 units. We also issued a total of 43,894 additional common
stock purchase warrants as compensation to certain finders. The
warrants have the same terms as the investor warrants.
On July
10, 2009, we issued a common stock purchase warrant to purchase 150,000 common
shares as reimbursement of due diligence expenses related to the June
transaction. The warrants have a term of five years and entitle the holder to
purchase our common shares at a price per share of $3.00.
On July
29, 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
$907,000. 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. We
incurred a total of $79,583 in fees and expenses incurred in connection with the
transaction. Of this amount, $14,000 has been paid through the issuance of
9,333 units. We also issued a total of 40,001 additional common stock purchase
warrants as compensation to certain finders. The warrants have the
same terms as the investor warrants.
On
September 2, 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
$210,000. 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. We
incurred a total of $23,100 in fees and expenses incurred in connection with the
transaction. Of this amount, $16,000 has been paid through the issuance of
10,667 units. We also issued a total of 12,267 additional common stock purchase
warrants as compensation to certain finders. The warrants have the
same terms as the investor warrants.
13
NOTE
2 - CAPITAL STOCK AND STOCKHOLDER’S EQUITY (cont’d)
On
September 2, 2009, we granted a total of 125,000 common stock options for
professional, legal and consulting services. The options have an exercise price
of $1.50 per share. The options vested upon grant and lapse if unexercised
on September 2, 2014. We have recorded an expense of $116,196 related to
the fair value of the options, using the Black-Scholes method based on the
following weighted average assumptions: (1) risk free interest
rate of 1%; (2) dividend yield of 0%; (3) volatility factor of
the expected market price of our common stock of 188%; and (4) an
expected life of the options of 2 years.
On
September 2, 2009, we granted a total of 120,000 common stock warrants for
consulting services. The warrants have an exercise price of $1.50 per
share. The warrants vested upon grant and lapse if unexercised on September
2, 2014. We have recorded an expense of $111,548 related to the fair value
of the warrants, using the Black-Scholes method based on the following weighted
average assumptions: (1) risk free interest rate of 1%;
(2) dividend yield of 0%; (3) volatility factor of the expected market
price of our common stock of 188%; and (4) an expected life of the
options of 2 years.
On
September 2, 2009, we granted a total of 1,000,000 common stock options to our
chief executive officer. The options have an exercise price of $1.65 per
share. Of these options, 500,000 options vested upon grant and 500,000 options
will vest upon the attainment of various milestones. The options lapse if
unexercised on September 2, 2016. The options have an aggregate grant date
fair value of $918,413, determined using the Black-Scholes method based on the
following weighted average assumptions: (1) risk free interest
rate of 1%; (2) dividend yield of 0%; (3) volatility factor of
the expected market price of our common stock of 188%; and (4) an
expected life of the options of 2 years. During the three months ended
September 30, 2009 we have recorded an expense of $512,378 related to the fair
value of the options that vested or are expected to vest.
On
September 2, 2009, we granted a total of 775,000 common stock options to our
chief operating officer. The options have an exercise price of $1.50 per
share. Of these options, 400,000 options vested upon grant and 375,000 options
will vest upon the attainment of various milestones. The options lapse if
unexercised on September 2, 2016. The options have an aggregate
grant date fair value of $720,415, determined using the Black-Scholes method
based on the following weighted average assumptions: (1) risk
free interest rate of 1%; (2) dividend yield of 0%;
(3) volatility factor of the expected market price of our common stock
of 188%; and (4) an expected life of the options of 2 years.
During the three months ended September 30, 2009 we have recorded an expense of
$412,190 related to the fair value of the options that vested or are expected to
vest.
During
May 2009 we issued 61,875 shares of common stock, valued at $74,869, for
services.
During
September 2009 we issued 25,000 shares of common stock, valued at $29,250, for
services.
NOTE
3 – DERIVATIVE LIABILITY
In June
2008, the FASB issued new accounting guidance which 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 ASC 815 “Derivative and
Hedging”
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 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. 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.
14
NOTE
3 – DERIVATIVE LIABILITY (cont’d)
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
September 30, 2009 we recalculated the fair value of our warrants subject to
derivative accounting and have determined that their fair value at September 30,
2009 is $1,920,218. The value of the warrants was determined using the
Black-Scholes method based on the following
assumptions: (1) risk free interest rate of 1%;
(2) dividend yield of 0%; (3) volatility factor of the expected market
price of our common stock of 194%; and (4) an expected life of the
warrants of 2 years. We have recorded an expense of $86,514 and $769,625
during the three and nine months ended September 30, 2009, respectively, related
to the change in fair value during those periods.
NOTE
4 – SUBSEQUENT EVENTS
In
accordance with FASB ASC 855 “Subsequent Events”, the Company has evaluated
subsequent events through the date of filing (November 13,
2009).
15
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 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 our business 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: (i) the third
quarter of 2009 to the comparable period in 2008; and (ii) the nine month
period ended September 30, 2009 to the comparable period in
2008.
|
•
|
Liquidity and Capital
Resources — A discussion of our financial condition and
potential sources of liquidity.
|
The
various sections of this MD&A contain a number of 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 Risk Factors section of this Prospectus. 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 are
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. We are considered to be in the
development stage as defined by Financial Accounting Standards Board (“FASB”)
Accounting Standards Codification (“ASC”) Topic 915 “Development Stage
Entities”.
Business
Strategy
Our
business strategy is to develop a series of therapeutics based on our
target-activated pro-drug technology platform and bring 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 resources and expertise to finalize drug development and market the
drugs.
16
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 have manufactured sufficient G-202 to supply
our Phase I clinical needs.
On June
23, 2009, we submitted our first Investigational New Drug application (“IND”)
for G-202 to the United States Food and Drug Administration
(“FDA”). On September 4, 2009, we received approval from the FDA for
our IND in order to commence clinical trials. Although we have
received approval 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. Over the next twelve months we plan to focus on clinical
trials of G-202 in cancer patients.
Additionally,
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 during the fourth quarter of 2009, and much of 2010, we will be
engaged in conducting the 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: (i) Sidney Kimmel Comprehensive Cancer Center at Johns
Hopkins (Michael Carducci, MD as Principal Investigator); and (ii) University of
Wisconsin Carbone Cancer Center (George Wilding, MD as Principal Investigator).
We are currently negotiating contracts for conduct of the Phase I
studies. The final terms of the contracts have not yet been
determined.
Assuming
successful completion of the Phase I clinical trial, 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.
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.
From
inception through September 30, 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 $5,002,000, was
incurred in the development of G-202. For the nine months ended September 30,
2009 and 2008, approximately $1,813,000 and $1,348,000, respectively, was
incurred in the development of G-202.
It is
estimated that the development of G-202 will occur as follows:
It is
estimated that the Phase I clinical trial will cost approximately $2,000,000 and
will be completed in the fourth quarter of 2010.
Phase II
clinical studies will cost an additional $4,200,000 and will be completed in the
fourth quarter of 2011.
We
anticipate that we will license G-202 to a third party during Phase
I/II. In the event we are not able to license G-202, we will proceed
with Phase III Clinical trials. We estimate that 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.
17
We
currently have budgeted $2,395,000 in cash expenditures for the twelve month
period following the date of this report, including (1) $1,095,000 to cover our
projected general and administrative expense during this period; and (2)
$1,300,000 for research and development activities. Our cash on hand as of
September 30, 2009 is sufficient to fund our operations for the next thirteen
months after which time we will need to undertake additional
financings.
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 nine months ended
September 30, 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 Financial Accounting Standards Board
(“FASB”) Accounting Standards Codification (“ASC”) Topic 360, "Property, Plant and Equipment
", 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 ASC Topic 718 “Compensation – Stock
Compensation”.
18
Fair Value of
Financial Instruments — Our
short-term financial instruments, including cash, accounts payable and other
liabilities, consist primarily of instruments without extended maturities, the
fair value of which, based on management’s estimates, reasonably approximate
their book value. The fair value of long term convertible notes is based on
management estimates and reasonably approximates their book value after
comparison to obligations with similar interest rates and maturities. The fair
value of the Company’s derivative instruments is determined using option pricing
models.
Recent
Accounting Pronouncements
In
December 2007, the FASB issued new accounting guidance which 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. This guidance also
changes the manner in which the net income of the subsidiary is reported and
disclosed in the controlling company’s income statement. The guidance also
establishes guidelines for accounting or changes in ownership percentages and
for deconsolidation. The guidance is effective for financial statements for
fiscal years beginning on or after December 15, 2008 and interim periods within
those years. The adoption of this guidance did not have a material impact on our
financial position, results of operations or cash flows.
In March
2008, the FASB issued new accounting guidance which requires enhanced
disclosures about an entity’s derivative and hedging activities and thereby
improves the transparency of financial reporting. This guidance is effective for
financial statements issued for fiscal years and interim periods beginning after
November 15, 2008, with early application encouraged. The adoption of this
guidance did not have a material impact on our financial position, results of
operations or cash flows.
Effective
January 1, 2009, the Company adopted new accounting guidance which requires that
all unvested share-based payment awards that contain non-forfeitable rights to
dividends should be included in the basic earnings per share
calculation. The adoption of this guidance did not affect the
financial position or results of operations.
In April
2009, the FASB issued new accounting guidance to be utilized in determining
whether impairments in debt securities are other than temporary, and modifies
the presentation and disclosures surrounding such instruments. The guidance is
effective for interim periods ending after June 15, 2009, but early adoption is
permitted for interim periods ending after March 15, 2009. The adoption of this
guidance during the second quarter of 2009 had no impact on the Company’s
financial position or results of operations.
In April
2009, the FASB issued new accounting guidance to be utilized in determining
whether the market for a financial asset is not active and a transaction is not
distressed for fair value measurement purposes. The guidance is effective for
interim periods ending after June 15, 2009, but early adoption is permitted for
interim periods ending after March 15, 2009. The adoption of this guidance
during the second quarter of 2009 had no impact on the Company’s financial
position or results of operations.
In April
2009, the FASB issued new accounting guidance which requires disclosures about
fair value of financial instruments in interim financial statements as well as
in annual financial statements. This guidance is effective for interim periods
ending after June 15, 2009, but early adoption is permitted for interim periods
ending after March 15, 2009. The adoption of this guidance during the second
quarter of 2009 had no impact on the Company’s financial position or results of
operations.
In May
2009, the FASB issued new accounting guidance which establishes general
standards of accounting for and disclosures of events that occur after the
balance sheet date but before financial statements are issued or are available
to be issued. The guidance is effective for interim and annual financial periods
ending after June 15, 2009. The Company adopted the guidance during the
three months ended June 30, 2009 and has evaluated subsequent events
through the issuance date of these financial statements. The adoption of this
guidance had no impact on the Company’s financial position or results of
operations.
In June
2009, the FASB issued new accounting guidance which will require more
information about the transfer of financial assets where companies have
continuing exposure to the risks related to transferred financial assets. This
guidance is effective at the start of a company’s first fiscal year beginning
after November 15, 2009, or January 1, 2010 for companies reporting earnings on
a calendar-year basis.
In June
2009, the FASB issued new accounting guidance which will change how a company
determines when an entity that is insufficiently capitalized or is not
controlled through voting (or similar rights) should be consolidated. Under this
guidance, determining whether a company is required to consolidate an entity
will be based on, among other things, an entity's purpose and design and a
company's ability to direct the activities of the entity that most significantly
impact the entity's economic performance. This guidance is effective at the
start of a company’s first fiscal year beginning after November 15, 2009, or
January 1, 2010 for companies reporting earnings on a calendar-year
basis.
In June
2009, the FASB issued SFAS No. 168, “The FASB Accounting Standards
Codification and the Hierarchy of Generally Accepted Accounting Principals – a
replacement of FAS No.162” (“SFAS No. 168”). This statement establishes
the Codification as the source of authoritative U.S. accounting and reporting
standards recognized by the FASB for use in the preparation of financial
statements of nongovernmental entities that are presented in conformity with
GAAP. Rules and interpretive releases of the SEC under authority of federal
securities laws are also sources of authoritative GAAP for SEC registrants. The
Codification was the result of a project of FASB to organize and simplify all
authoritative GAAP literature into one source. This statement is effective for
interim reporting and annual periods ending after September 15, 2009.
Accordingly, the Company has adopted SFAS No. 168 during the quarter ended
September 30, 2009. The adoption of this standard during the third quarter of
2009 had no impact on the Company’s financial position or results of
operations.
19
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.
Result
of Operations
Our
results of operations have varied significantly from year to year and quarter to
quarter and may vary significantly in the future.
Third
Quarter of 2009 Compared to Third Quarter of 2008
Revenue
The
company did not have revenue for the three months ended September 30, 2009 and
2008, respectively. We do not anticipate any revenues for
2009.
Operating
Expenses
Operating
expense totaled $1,538,070 and $919,711 for the three months ended September 30,
2009 and 2008, respectively. The increase in operating expenses is
the result of the following factors.
Three Months
Ended September
30,
|
||||||||
2009
|
2008
|
|||||||
Operating
expenses
|
||||||||
General
and administrative expenses
|
$
|
659,699
|
$
|
90,337
|
||||
Research
and development
|
878,371
|
829,374
|
||||||
Total
expense
|
$
|
1,538,070
|
$
|
919,711
|
General
and Administrative Expenses
G&A
expenses totaled $659,699 for the three months ended September 30, 2009 compared
to $90,337 for the same period of 2008. The increase of $569,362 or
630% for the three months ended September 30, 2009 compared to the comparable
period in 2008 was primarily attributable to increases of approximately $367,000
in compensation and consulting expense (including stock based compensation of
approximately $365,000), $18,000 in insurance expense and $152,000 in
professional fees (including stock based cost of approximately
$88,000).
Research
and Development Expenses
Research
and development expenses totaled $878,371 for the three months ended September
30, 2009 compared to $829,374 for the same period of 2008. The
increase of $48,997 or 6% for the three months ended September 30, 2009 compared
to the comparable period in 2008 was attributable to an increase of
approximately $710,000 in stock based compensation expense partially offset by a
decrease of approximately $661,000 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 Good
Laboratory Practices (“GLP”) preclinical development activities (e.g.,
toxicology) and Good Manufacturing Practices (“GMP”) manufacturing and clinical
development activities to Contract Research Organizations (“CRO”) and Contract
Manufacturing Organizations (“CMO”). Manufacturing will be outsourced to
organizations with approved facilities and manufacturing
practices.
Other
Expenses
Other
expenses totaled $86,050 and $35,476 for the three months ended September 30,
2009 and 2008, respectively.
Three Months
Ended September 30,
|
||||||||
2009
|
2008
|
|||||||
Other
expense:
|
||||||||
Finance
Cost
|
$
|
(793
|
)
|
$
|
(39,218
|
)
|
||
Change
in fair value of derivative liability
|
(86,514
|
)
|
-
|
|||||
Interest
income (expense)
|
1,257
|
3,742
|
||||||
Total
other expenses
|
$
|
(86,050
|
)
|
$
|
(35,476
|
)
|
20
Finance
Cost
Finance
Cost totaled $793 for the three months ended September 30, 2009 compared to
$39,218 for the same period of 2008. This cost consists of the amortization of
debt discount of $793 and $4,418 during 2009 and 2008, respectively, and
a 2008 charge of $34,800 related to a penalty for the late filing of
our registration statement.
Change
in fair value of derivative liability
Change in
fair value of derivative liability totaled $86,514 for the three months ended
September 30, 2009 compared to $0 for the same period of 2008. The increase of
$86,514 for the three months ended September 30, 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.
At
September 30, 2009 we recalculated the fair value of our warrants subject to
derivative accounting and have determined that their fair value at September 30,
2009 is $1,920,218. The fair value of the warrants was determined using the
Black-Scholes method based on the following
assumptions: (1) risk free interest rate of 1%;
(2) dividend yield of 0%; (3) volatility factor of the expected market
price of our common stock of 194%; and (4) an expected life of the
warrants of 2 years. We have recorded an expense of $86,514 during the
three months ended September 30, 2009 related to the change in fair value during
that period.
Interest
expense
Net
interest income totaled $1,257 for the three months ended September 30, 2009
compared to $3,742 for the same period of 2008. The decrease of $2,485 for the
three months ended September 30, 2009 compared to the comparable period in 2008
was attributable to a decrease in interest earned on deposits.
Nine
months ended September 30, 2009 Compared to Nine months ended September 30,
2008
Revenue
The
company did not have revenue for the nine months ended September 30, 2009 and
2008, respectively. We do not anticipate any revenues for
2009.
Operating
Expenses
Operating
expense totaled $2,903,533 and $1,952,242 for the nine months ended September
30, 2009 and 2008, respectively. The increase in operating expenses
is the result of the following factors.
Nine Months
Ended September
30,
|
||||||||
2009
|
2008
|
|||||||
Operating
expenses
|
||||||||
General
and administrative expenses
|
$
|
1,090,671
|
$
|
603,873
|
||||
Research
and development
|
1,812,862
|
1,348,369
|
||||||
Total
expense
|
$
|
2,903,533
|
$
|
1,952,242
|
General
and Administrative Expenses
G&A
expenses totaled $1,090,671 for the nine months ended September 30, 2009
compared to $603,873 for the same period of 2008. The increase of
$486,798 or 81% for the nine months ended September 30, 2009 compared to the
comparable period in 2008 was primarily attributable to an increase of
approximately $167,000 in compensation and consulting expense (including stock
based compensation of approximately $98,000), and increases of approximately
$239,000 in professional fees (including stock based cost of approximately
$88,000), $23,000 in insurance expense and $12,000 in travel and entertainment
expense.
21
Research
and Development Expenses
Research
and development expenses totaled $1,812,862 for the nine months ended September
30, 2009 compared to $1,348,369 for the same period of 2008. The
increase of $464,493 or 34% for the nine months ended September 30, 2009
compared to the comparable period in 2008 was attributable an increase of
approximately $798,000 in compensation expense (including stock based
compensation of approximately $740,000) partially offset by a decrease of
approximately $334,000 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 CROs and CMOs. Manufacturing will be
outsourced to organizations with approved facilities and manufacturing
practices.
Other
Expenses
Other
expenses totaled $1,252,729 and $38,687 for the nine months ended September 30,
2009 and 2008, respectively.
Nine Months
Ended September
30,
|
||||||||
2009
|
2008
|
|||||||
Other
expense:
|
||||||||
Finance
Cost
|
$
|
(478,886
|
)
|
$
|
(39,218
|
)
|
||
Change
in fair value of derivative liability
|
(769,625
|
)
|
-
|
|||||
Interest
income (expense)
|
(4,218
|
)
|
531
|
|||||
Total
other expenses
|
$
|
(1,252,729
|
)
|
$
|
(38,687
|
)
|
Finance
Cost
Finance
Cost totaled $478,886 for the nine months ended September 30, 2009 compared to
$39,218 for the same period of 2008. The increase of $439,668 for the nine
months ended September 30, 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. The balance of the cost consists of the
amortization of debt discount of $11,046 and $4,418 during 2009 and 2008,
respectively, and a 2008 charge of $34,800 related to a penalty for the late
filing of our registration statement.
Change
in fair value of derivative liability
Change in
fair value of derivative liability totaled $769,625 for the nine months ended
September 30, 2009 compared to $0 for the same period of 2008. The increase of
$769,625 for the nine months ended September 30, 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 new accounting guidance which 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 ASC 815 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 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. 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.
22
At
September 30, 2009 we recalculated the fair value of our warrants subject to
derivative accounting and have determined that their fair value at September 30,
2009 is $1,920,218. The fair value of the warrants was determined using the
Black-Scholes method based on the following
assumptions: (1) risk free interest rate of 1%;
(2) dividend yield of 0%; (3) volatility factor of the expected market
price of our common stock of 194%; and (4) an expected life of the
warrants of 2 years. We have recorded an expense of $769,625 during the
nine months ended September 30, 2009 related to the change in fair value during
that period.
Interest
expense
Interest
expense totaled $4,218 for the nine months ended September 30, 2009
compared to interest income of $531 for the same period of 2008. The increase of
$4,749 for the nine months ended September 30, 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. At
September 30, 2009 we have cash on hand of approximately $2,742,000. Our
currently average monthly cash burn rate is approximately $195,000. We
anticipate that our available cash will be sufficient to finance most of our
current activities for at least the next thirteen months from September 30,
2009, assuming we do not engage in an extraordinary transaction or otherwise
face unexpected events or contingencies.
Nine Months
Ended September
30,
|
||||||||
2009
|
2008
|
|||||||
Cash
& Cash Equivalents
|
$
|
2,742,219
|
$
|
1,697,649
|
||||
Net
cash used in operating activities
|
$
|
(1,600,662
|
)
|
$
|
(1,486,618
|
)
|
||
Net
cash used in investing activities
|
(6,246
|
)
|
(184,168
|
)
|
||||
Net
cash provided by financing activities
|
3,814,837
|
2,778,000
|
Net
Cash Used in Operating Activities
In our
operating activities we used $1,600,662 for the nine months ended September 30,
2009 compared to $1,486,618 for the same period of 2008. An increase in net loss
of approximately $2,165,000 was offset by increases in noncash expenses of
approximately $2,229,000. We also had a decrease in accounts payable and accrued
expenses of approximately $178,000.
Net
Cash Used in Investing Activities
In our
investment activities we used $6,246 for the nine months ended
September 30, 2009 compared to $184,168 for the same period of 2008. The
decrease in investment activities of $177,922 for the nine months ended
September 30, 2009 compared to the comparable period in 2008 was attributable to
the $184,168 cost associated with acquisition of key intellectual property in
2008, with $6,246 expended on fixed assets in 2009.
Net
Cash Provided by Financing Activities
During
the nine months ended September 30, 2009 we raised approximately $3,830,000
through the sale of common stock units. During the comparable period of 2008 we
received proceeds of $2,778,000 through the sale of common stock units and upon
the exercise of warrants.
Listed
below are key financing transactions we have entered
into.
|
•
|
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 and April of 2009, we
sold 500,000 units resulting in gross proceeds of approximately
$750,000.
|
|
•
|
In June and July of 2009, we sold
2,025,344 units resulting in gross proceeds of approximately
$3,038,000.
|
23
|
•
|
In September of 2009, we sold
160,002 units resulting in gross proceeds of approximately
$240,000.
|
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, if 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.
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 September 30,
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.
24
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 Quarterly Report
or presented elsewhere by management from time to time.
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 September 30, 2009 we have raised approximately
$7,261,000 in capital. During this same period, we have recorded
accumulated losses totaling $9,214,964. As of September 30, 2009, we had working
capital of $2,514,088 and stockholders’ equity of $492,506. 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, if developed; (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 external financing to
fund operations. Such financing has historically come 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
amounts of cash in the development, 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, which is
currently anticipated to occur in the fourth quarter of 2011.
We
anticipate that our cash as of September 30, 2009, and will be sufficient to
satisfy contemplated cash requirements through October of 2010, 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 September
30, 2009, we had cash on hand of approximately $2,742,000. Presently,
the Company has an average monthly cash burn rate of approximately
$195,000. We expect this average monthly cash burn rate to remain
constant over the next thirteen months, assuming we do not engage in an
extraordinary transaction or otherwise face unexpected events or
contingencies. Accordingly, we will need to raise additional capital
to fund anticipated operating expenses after October of 2010. In the event we
are not able to secure financing, 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.
25
Our long
term capital requirements are expected to depend on many factors,
including:
·
|
our
development programs;
|
·
|
the
progress and costs 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 our
ability to sell our products;
|
·
|
competing
technological and market
developments;
|
·
|
market
acceptance of our proposed products, if
developed;
|
·
|
the
costs for recruiting and retaining employees, consultants and
professionals; and
|
·
|
the
costs for educating and training physicians about our
products.
|
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.
Raising
needed capital may be difficult 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.
Our
independent auditors have issued a qualified report 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 independent auditor 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. However, during 2009 we have raised approximately $3,830,000 through
our private placements and we expect that our cash on hand at September 30, 2009
will be sufficient to fund operations through October of 2010.
We
may not be able to commercially develop our technologies.
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.
On
September 4, 2009, we received approval from the FDA for our first IND in order
to commence clinical trials. Although we have received approval 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 will be
successful. The failure of such trials could delay or prevent regulatory
approval and could harm our ability to generate revenues, operate profitably or
remain a viable business.
26
Future
financing will result in dilution to existing stockholders.
We will
require additional financing in the future. 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. The issuance of our equity securities in connection with a
future financing will result in a decrease of our current stockholders’
percentage ownership.
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. No assurances can be given that, even if issued, our
patents will survive claims alleging invalidity or infringement on other
patents. The viability of our business will suffer if such patent protection
becomes limited or is eliminated.
We
may not be able to adequately protect our intellectual property.
Considerable
research with regard to our technologies has been 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 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.
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. On September 4, 2009, we received approval from the FDA for
our first IND in order to commence clinical trials. We cannot
assure you that we will successfully complete any clinical trials in connection
with any such IND application. 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. Any delay in obtaining, or failure to
obtain, such approvals could have a materially adverse effect on the
commercialization of our products and the viability of the company.
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. As a result, our competitors may bring competing
products to market that would result in a decrease in demand for our product, if
developed, which could have a materially adverse effect on the viability of the
company.
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 products, we
cannot give you any assurance that we will be able to develop internal
manufacturing capabilities or procure third party suppliers. In the event we
seek third party suppliers, they may require us to purchase a minimum amount of
materials 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 that we select will be able to supply our products in
a timely or cost effective manner or in accordance with applicable regulatory
requirements or our specifications.
27
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.
The loss
of Craig A. Dionne, PhD, our Chief Executive Officer, or Russell Richerson, PhD,
our Chief Operating Officer, would be detrimental to us. Although we have
entered into employment agreements with Messrs Dionne and Richerson, there can
be no assurance that these individuals will continue to provide services to us.
A voluntary or involuntary termination of employment by Messrs. Dionne or
Richerson could have a material adverse effect on our business operations and
negatively impact the price of our common stock. Further, as part of
their employment agreements, Messrs Dionne and Richerson agreed to not compete
with us for a certain amount of time following the termination of their
employment. Once the applicable time of these provisions expires,
Messrs Dionne and Richerson may be employed by a competitor of ours in the
future.
We
currently maintain a one million dollar “key person” life insurance policy on
the life of Dr. Dionne but do not maintain a policy on Dr. Richerson. Our
prospects and operations will be significantly hindered upon the death or
incapacity of either of these key individuals.
We
may be required to make significant payments to members of our management in the
event their employment with us is terminated or if we experience a change of
control.
We are a
party to employment agreements with each of Craig Dionne, our President and
Chief Executive Officer and Russell Richerson, our Chief Operating
Officer. In the event we terminate the employment of any of these
executives, we experience a change in control, or in certain cases, if such
executives terminate their employment with us, such executives will be entitled
to receive certain severance and related payments. Additionally, in
such instance, certain securities held by Messrs. Dionne and Richerson will
become immediately vested and exercisable. Upon the occurrence of any
such event, our obligation to make such payments could significantly impact our
working capital and accordingly, our ability to execute our business plan which
could have a materially detrimental effect to our business. Also,
these provisions may discourage potential takeover attempts.
We
will require additional personnel to execute our business plan.
Our
anticipated growth and expansion into areas and activities requiring additional
expertise, such as clinical testing, regulatory compliance, manufacturing and
marketing, will require the addition of new management personnel and the
development of additional expertise by existing management. 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.
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 which grows along the coastal regions of the
Mediterranean. We currently secure the seeds from Thapsibiza, SL, a third party
supplier. 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 affected.
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, some
of which is not suitable for our purposes. 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;
|
28
|
·
|
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.
We
may be required to secure land for cultivation and harvesting of Thapsia
garganica.
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. In the event G-202 is approved for commercial
marketing, our current supply of Thapsia garganica may not be
sufficient for the anticipated demand. 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 can cause severe skin 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
skin. 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 harvested by hand and those conducting the
harvesting must wear protective clothing and gloves to avoid skin contact.
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, 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 we will not be the subject of
litigation related to the harvesting.
The
synthesis of 12ADT must be conducted in special facilities.
There are
a limited number of manufacturing facilities qualified to handle and manufacture
using toxic agents for therapeutic compounds. This limits the potential number
of possible manufacturing sites for our therapeutic compounds 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, our business and future prospects will be adversely
affected.
Our
lead therapeutic compound, G-202, has not been subjected to large scale
manufacturing procedures.
To date,
G-202 has only been manufactured at a scale adequate to supply early stage
clinical trials. There can be no assurances that the current procedure for
manufacturing G-202 will work at a larger scale adequate for commercial
needs. In the event G-202 cannot be manufactured in sufficient
quantities, our future prospects could be significantly impacted.
We
do not have 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. In the event we are forced to expend significant funds on
defending product liability actions beyond our current coverage, 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.
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 any claim may have
an adverse material effect on our business.
29
Provisions
in Delaware law and executive employment agreements may prevent or delay a
change of control
We are
subject to the Delaware anti-takeover laws regulating corporate
takeovers. These anti-takeover laws prevent Delaware corporations
from engaging in a merger or sale of more than 10% of its assets with any
stockholder, including all affiliates and associates of the stockholder, who
owns 15% or more of the corporation’s outstanding voting stock, for three years
following the date that the stockholder acquired 15% or more of the
corporation’s assets unless:
|
·
|
the Board of Directors approved
the transaction in which the stockholder acquired 15% or more of the
corporation’s assets;
|
|
·
|
after the transaction in which
the stockholder acquired 15% or more of the corporation’s assets, the
stockholder owned at least 85% of the corporation’s outstanding voting
stock, excluding shares owned by directors, officers and employee stock
plans in which employee participants do not have the right to determine
confidentially whether shares held under the plan will be tendered in a
tender or exchange offer; or
|
|
·
|
on or after this date, the merger
or sale is approved by the Board of Directors and the holders of at least
two-thirds of the outstanding voting stock that is not owned by the
stockholder.
|
A
Delaware corporation may opt out of the Delaware anti-takeover laws if its
certificate of incorporation or bylaws so provide. We have not opted out of the
provisions of the anti-takeover laws. As such, these laws could prohibit or
delay mergers or other takeover or change of control of GenSpera and may
discourage attempts by other companies to acquire us.
In
addition, employment agreements with certain executive officers provide for the
payment of severance and acceleration of the vesting of options and restricted
stock in the event of termination of the executive officer following a change of
control of GenSpera. These provisions could have the effect of
discouraging potential takeover attempts.
Risks
Relating To Our Common Stock
There
is no public market for our securities.
On
September 18, 2009, our common shares began quotation on the
OTCBB. Notwithstanding, there has been little or no trading in our
common shares. Accordingly, there is no public market for our
securities. 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 SEC 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
our management assess the company’s internal control over financial
reporting annually and include a report on such assessment in our annual report
filed with the SEC. Effective December 15, 2010 for a smaller reporting company,
our independent registered public accounting firm is required to audit both the
design and operating effectiveness of our internal controls and management's
assessment of the design and the operating effectiveness of such internal
controls.
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.
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.
30
We
do not intend to pay cash dividends.
We do not
anticipate paying cash dividends in the foreseeable future. Accordingly, any
gains on your investment will need to come through an increase in the price of
our common stock. The lack of a market for our common stock makes
such gains highly unlikely.
Our
board of directors has broad discretion to issue additional
securities.
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 September 30, 2009, we have issued and
outstanding 15,292,281 common shares and we have 7,884,502 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
56,823,217 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. Any preferred shares we may issue will 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. The issuance of additional securities may cause
substantial dilution to our shareholders.
Our
Officers and Scientific Advisors beneficially own approximately 43% of our
outstanding common shares.
Our
Officers and Scientific Advisors own approximately 43% of our issued and
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 and may negatively impact the value of your
investment.
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.
|
·
|
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.
|
31
|
·
|
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 500,000 units in
the aggregate amount of approximately $750,000. 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. The provisions
do not provide for any adjustment in the event of subsequent equity sales
or transactions. The warrants are also callable by the Company
in the event the Company’s shares are publically traded in the future and
certain price and volume conditions are
met.
|
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 to $1.50. Additionally, we issued holders of these
warrants an additional 506,754 additional warrants. We were 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 also
entered into registration rights agreements with the investors granting certain
registration rights with regard to the shares and the shares underlying the
warrants. The registration rights Agreement provides for penalties to
be paid in restricted shares in the event the Company: (i) fails to file a
registration statement or have such registration statement declared effective
within a certain period of time; or (ii) fails to maintain the registration
statement effective until all the securities registered therein are sold or are
eligible for resale pursuant to Rule 144 without manner of sale or volume
restrictions. Subsequent to the issuance, a majority of the investors
agreed to waive the date by which the registration statement needed to be
filed. As a result of the waiver, a registration statement covering
the shares and shares underlying the warrants was filed.
|
·
|
On
May 8, 2009, we issued 61,875 common shares to Lyophilization Services of
New England, Inc. as payment for services valued at $74,869 provided in
connection with manufacturing of our first drug
compound. The shares were valued at $1.50 per
share.
|
|
·
|
In
June and July of 2009 we entered into a series of securities purchase
agreements with a number of accredited and institutional
investors. Pursuant to the terms of the agreements, we offered
and sold an aggregate of 2,025,344 units resulting in gross proceeds to us
of approximately $3,038,000. 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 entitle the investors to purchase our common
shares at a price per share of $3.00. The warrants also contain
provisions providing for an adjustment in the underlying number of shares
and exercise price in the event of stock splits or stock dividends and
fundamental transactions. The provisions do not provide for any
adjustment in the event of subsequent equity sales or
transactions. The warrants are also callable in the event our
common stock becomes publically traded and certain other conditions, as
described in the warrants, are met. The Company incurred a
total of $222,050 in fees and expenses incurred in connection with the
transactions. Of this amount, $64,000 was paid through the
issuance of 42,667 units. We also issued a total of 83,895 additional
common stock purchase warrants as compensation to certain
finders. The warrants have the same terms as the investor
warrants. The securities purchase agreements are substantially
similar other than the agreement entered into on June 29, 2009 extended
the expiration of most favored nation treatment from 90 days until
December 31, 2009.
|
The
Company also entered into two Registration Rights Agreements with the investors
granting the Investors certain registration rights with regard to the Shares and
the shares underlying the Warrants. The Company has fulfilled all of
its requirements pursuant to the Registration Rights
Agreements.
32
|
·
|
On
July 10, 2009, we issued Kemmerer Resources Corp. a common stock
purchase warrant to purchase 150,000 common shares as reimbursement of due
diligence expenses. The warrants have a term of five years and entitle the
investors to purchase our common shares at a price per share of
$3.00. The warrants also contain provisions providing for an
adjustment in the underlying number of shares and exercise price in the
event of stock splits or stock dividends and fundamental
transactions. The provisions do not provide for any adjustment
in the event of subsequent equity sales or
transactions.
|
|
·
|
On
September 2, 2009 we entered a securities purchase agreement with a number
of accredited investors. Pursuant to the terms of the
agreement, the Company sold units in the aggregate of 160,000 units
resulting in gross proceeds of $240,000. 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 entitle the
Investors to purchase the Company’s common shares at a price per share of
$3.00. The warrants also contain provisions providing for an
adjustment in the underlying number of shares and exercise price in the
event of stock splits or stock dividends and fundamental
transactions. The provisions do not provide for any adjustment
in the event of subsequent equity sales or transactions. The
warrants are also callable in the event the our common stock becomes
publically traded and certain other conditions, as described in the
warrants, are met. In connection with the offering, we incurred
a total of $23,100 in fees and expenses incurred in connection with the
transaction. Of this amount, $16,000 has been paid through the
issuance of 10,667 units. We also issued warrants to purchase 12,267,
common shares, with identical terms to the warrant, as a partial finder’s
fee in connection with the
offering.
|
|
The
Company also entered into a Registration Rights Agreement with the
investors granting the Investors certain registration rights with regard
to the Shares and the shares underlying the Warrants. The
Company has fulfilled all of its requirements pursuant to the Registration
Rights Agreements.
|
|
·
|
On September 2, 2009, we issued
Messrs Dionne and Richerson common stock purchase options to purchase an
aggregate of 1,775,000 common
shares.
|
|
·
|
On September 2, 2009, we issued
certain consultants options to purchase an aggregate of 125,000 common
shares. The options were granted pursuant to our 2007 Equity
Compensation Plan, have an exercise price of $1.50 per share and are fully
vested at the grant date. The options have a term of 5 years
and can be exercisable at any time during their
term.
|
|
·
|
On September 2, 2009, we issued a
consultant a warrant to purchase 20,000 common shares. The
warrant was issued as compensation for services related to our clinical
trials. The warrant has an exercise price of $1.50 per share
and is fully vested at the grant date. The warrant has a term
of 5 years.
|
|
·
|
On September 2, 2009, we issued a
consultant a warrant to purchase 100,000 common shares. The
warrant was issued as compensation for investor relations
services. The warrant has an exercise price of $1.50 per share
and is fully vested at the grant date. The warrant has a term
of 5 years.
|
|
·
|
On September 2, 2009, we issued
one of our service providers 25,000 common shares as compensation for
services relating to the coordination of clinical trial sites and CROs
services. The shares were valued at $1.50 per share or an
aggregate consideration of
$37,500.
|
ITEM
3. DEFAULT
UPON SENIOR SECURITIES
None
ITEM
4. SUBMISSION
OF MATTERS TO A VOTE OF SECURITY HOLDERS
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.
33
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: November
13, 2009
|
|
/s/ Craig
Dionne
|
Chief
Executive Officer
|
||
/s/
Craig Dionne
|
||
Chief
Financial Officer
|
||
(Principal
Accounting Officer)
|
34
EXHIBITS
LIST
INDEX
TO EXHIBITS
|
Incorporated by
Reference
|
|||||||||||
Exhibit
No.
|
Description
|
Filed
Herewith
|
Form
|
Exhibit
No.
|
File No.
|
Filing Date
|
||||||
4.01**
|
GenSpera
Form of 2007 Equity Compensation Plan Grant and 2009 Executive
Compensation Plan
|
8-K
|
4.02
|
333-153829
|
9/09/09
|
|||||||
4.02
|
Form
of Securities Purchase Agreement dated 6/29/09
|
8-K
|
10.01
|
333-153829
|
7/06/09
|
|||||||
4.03
|
Form
of Securities Purchase Agreement dated 6/30/09
|
8-K
|
10.02
|
333-153829
|
7/06/09
|
|||||||
4.04
|
Form
of Common Stock Purchase Warrant dated June of 2009
|
8-K
|
10.03
|
333-153829
|
7/06/09
|
|||||||
4.05
|
Form
of Registration Rights Agreement dated 6/29/09
|
8-K
|
10.04
|
333-153829
|
7/06/09
|
|||||||
4.06
|
Form
of Registration Rights Agreement dated 6/30/09
|
8-K
|
10.05
|
333-153829
|
7/06/09
|
|||||||
4.07**
|
2009
Executive Compensation Plan
|
8-K
|
4.01
|
333-153829
|
9/09/09
|
|||||||
4.08
|
Form
of Securities Purchase Agreement – September 2, 2009
|
8-K
|
10.01
|
333-153829
|
9/09/09
|
|||||||
4.09
|
Form
of Common Stock Purchase Warrant – September 2, 2009
|
8-K
|
10.02
|
333-153829
|
9/09/09
|
|||||||
4.10
|
Form
of Registration Rights Agreement—September 2, 2009
|
8-K
|
10.03
|
333-153829
|
9/09/09
|
|||||||
10.01**
|
Craig
Dionne Employment Agreement
|
8-K
|
10.04
|
333-153829
|
9/09/09
|
|||||||
10.02**
|
Craig
Dionne Severance Agreement
|
8-K
|
10.05
|
333-153829
|
9/09/09
|
|||||||
10.03**
|
Craig
Dionne Proprietary Information, Inventions And Competition
Agreement
|
8-K
|
10.06
|
333-153829
|
9/09/09
|
|||||||
10.04**
|
Form
of Indemnification Agreement
|
8-K
|
10.07
|
333-153829
|
9/09/09
|
35
10.05**
|
Russell
Richerson Employment Agreement
|
8-K
|
10.08
|
333-153829
|
9/09/09
|
|||||||
10.06**
|
Russell
Richerson Proprietary Information, Inventions And Competition
Agreement
|
8-K
|
10.09
|
333-153829
|
9/09/09
|
|||||||
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.
36