Rebus Holdings, Inc. - Quarter Report: 2010 June (Form 10-Q)
U.S.
SECURITIES AND EXCHANGE COMMISSION
Washington,
D.C. 20549
FORM
10-Q
(Mark
one)
x
|
Quarterly
Report Under Section 13 or 15(d) of the Securities Exchange Act of
1934
|
For
the Quarterly Period Ended June 30, 2010
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
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
As
of August 14, 2010, Registrant had 17,604,465 common shares, $0.0001
par value, issued and outstanding.
GenSpera,
Inc.
Table of
Contents
Page
|
||||
PART I - |
FINANCIAL
INFORMATION
|
4
|
||
Item
1.
|
Financial
Statements
|
4
|
||
Balance
Sheets as of June 30, 2010 (Unaudited) and December 31,
2009
|
4
|
|||
Statements
of Operations (Unaudited)
|
||||
Three
and six months ended June 30, 2010 and 2009 and for the period from
November 21, 2003 (inception) to June 30, 2010
|
5
|
|||
Statements
of Changes in Stockholders' Equity (Unaudited)
|
||||
For
the period from November 21, 2003 (inception) to June 30,
2010
|
6
|
|||
Statements
of Cash Flows (Unaudited)
|
||||
Three and
six months ended June 30, 2010 and 2009 and for the period from November
21, 2003 (inception) to June 30, 2010
|
8
|
|||
Notes
to Financial Statements (Unaudited)
|
9
|
|||
Item
2.
|
Management's
Discussion and Analysis of Financial Condition and Results
of Operations
|
14
|
||
Item
3.
|
Quantitative
and Qualitative Disclosures about Market Risk
|
21
|
||
Item
4.
|
Controls
and Procedures
|
21
|
||
PART II - |
OTHER
INFORMATION
|
22
|
||
Item
1.
|
Legal
Proceedings
|
22
|
||
Item
1A.
|
Risk
Factors
|
22
|
||
Item
2.
|
Unregistered
Sales of Equity Securities and Use of Proceeds
|
27
|
||
Item
3.
|
Defaults
Upon Senior Securities
|
28
|
||
Item
4.
|
(Removed
and Reserved)
|
28
|
||
Item
5.
|
Other
Information
|
28
|
||
Item
6.
|
Exhibits
|
29
|
2
ADVISEMENT
We
urge you to read this entire Quarterly Report, including the “Risk Factors”
section, the financial statements, and related notes included herein. As
used in this Quarterly Report, unless the context otherwise requires, the words
“we,” “us,”“our,” “the Company,” “GenSpera” and “Registrant” refer to GenSpera,
Inc. Also, any reference to “common shares,” 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 (June 30, 2010), 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 six month periods ended June 30, 2010 are not
necessarily indicative of our prospective financial condition and results of
operations for the pending full fiscal year ending December 31, 2010. The
interim financial statements presented in this Quarterly Report as well as other
information relating to our company contained in this Quarterly Report should be
read in conjunction and together with the reports, statements and information
filed by us with the United States Securities and Exchange Commission
(“SEC”).
NOTE
REGARDING FORWARD-LOOKING STATEMENTS
This
Quarterly Report contains forward-looking statements within the meaning of
Section 27A of the Securities Act of 1933, as amended, or the Securities
Act, and Section 21E of the Securities Exchange Act of 1934, as amended, or
the Exchange Act. Any statements about our expectations, beliefs, plans,
objectives, assumptions or future events or performance are not historical facts
and may be forward-looking. These forward-looking statements include, but are
not limited to, statements about:
|
•
|
the
development of our drug candidates, including when we expect to undertake,
initiate and complete clinical trials of our product
candidates;
|
|
•
|
the
regulatory approval of our drug candidates;
|
|
•
|
our
use of clinical research centers and other contractors;
|
|
•
|
our
ability to sell, license or market any of our
products;
|
|
•
|
our
ability to compete against other companies;
|
|
•
|
our
ability to secure adequate protection for our intellectual
property;
|
|
•
|
our
ability to attract and retain key personnel;
|
|
•
|
our
ability to obtain adequate financing;
and
|
|
•
|
the
volatility of our stock price.
|
These
statements are often, but not always, made through the use of words or phrases
such as “anticipate,” “estimate,” “plan,” “project,” “continuing,” “ongoing,”
“expect,” “believe,” “intend” and similar words or phrases. Accordingly, these
statements involve estimates, assumptions and uncertainties that could cause
actual results to differ materially from those expressed in them. Discussions
containing these forward-looking statements may be found throughout this
quarterly report, including Part I, the section entitled “Item 2: Management’s
Discussion and Analysis of Financial Condition and Results of Operations.” These
forward-looking statements involve risks and uncertainties, including the risks
discussed in Part II, Item 1A of this Report, under the caption “Risk Factors”,
that could cause our actual results to differ materially from those in the
forward-looking statements. We undertake no obligation to publicly release any
revisions to the forward-looking statements or reflect events or circumstances
after the date of this report. The risks discussed in this report should be
considered in evaluating our prospects and future financial
performance.
3
PART
I
FINANCIAL
INFORMATION
ITEM
1.
|
FINANCIAL
STATEMENTS
|
GENSPERA
INC.
(A
Development Stage Company)
CONDENSED
BALANCE SHEETS
June 30,
|
December 31,
|
|||||||
2010
|
2009
|
|||||||
(Unaudited)
|
||||||||
Assets
|
||||||||
Current
assets:
|
||||||||
Cash
|
$ | 4,498,942 | $ | 2,255,311 | ||||
Total
current assets
|
4,498,942 | 2,255,311 | ||||||
Fixed
assets, net of accumulated depreciation of $2,292 and $708
|
13,541 | 15,125 | ||||||
Intangible
assets, net of accumulated amortization of $34,532 and
$26,858
|
149,636 | 157,310 | ||||||
Total
assets
|
$ | 4,662,119 | $ | 2,427,746 | ||||
Liabilities
and stockholders' equity (deficit)
|
||||||||
Current
liabilities:
|
||||||||
Accounts
payable and accrued expenses
|
$ | 149,807 | $ | 78,198 | ||||
Accrued
interest - stockholder
|
10,294 | 8,107 | ||||||
Convertible
note payable - stockholder, current portion
|
75,000 | 35,000 | ||||||
Total
current liabilities
|
235,101 | 121,305 | ||||||
Convertible
note payable, net of discount of $0 and $11,046
|
- | - | ||||||
Convertible
notes payable - stockholder, long term portion
|
30,000 | 70,000 | ||||||
Derivative
liabilities
|
2,817,991 | 2,290,686 | ||||||
Total
liabilities
|
3,083,092 | 2,481,991 | ||||||
Commitments
and contingencies
|
||||||||
Stockholders'
equity (deficit):
|
||||||||
Preferred
stock, par value $.0001 per share; 10,000,000 shares authorized, none
issued and outstanding
|
- | - | ||||||
Common
stock, par value $.0001 per share; 80,000,000 shares authorized,
17,584,465 and 15,466,446 shares issued and outstanding
|
1,758 | 1,547 | ||||||
Additional
paid-in capital
|
14,634,946 | 10,135,737 | ||||||
Deficit
accumulated during the development stage
|
(13,057,677 | ) | (10,191,529 | ) | ||||
Total
stockholders' equity (deficit)
|
1,579,027 | (54,245 | ) | |||||
Total
liabilities and stockholders' equity (deficit)
|
$ | 4,662,119 | $ | 2,427,746 |
See
accompanying notes to unaudited condensed financial statements.
4
GENSPERA,
INC.
(A
Development Stage Company)
CONDENSED
STATEMENTS OF LOSSES
FOR THE
THREE AND SIX MONTHS ENDED JUNE 30, 2010 AND 2009
AND FOR
THE PERIOD FROM INCEPTION (NOVEMBER 21, 2003) TO JUNE 30, 2010
(Unaudited)
Cumulative Period
|
||||||||||||||||||||
from November 21, 2003
|
||||||||||||||||||||
(date of inception) to
|
||||||||||||||||||||
Three Months ended June 30,
|
Six Months ended June 30,
|
June 30,
|
||||||||||||||||||
2010
|
2009
|
2010
|
2009
|
2010
|
||||||||||||||||
Operating
expenses:
|
||||||||||||||||||||
General
and administrative expenses
|
$ | 777,744 | $ | 231,255 | $ | 1,173,624 | $ | 430,972 | $ | 3,888,013 | ||||||||||
Research
and development
|
737,106 | 624,989 | 1,091,171 | 934,491 | 6,602,712 | |||||||||||||||
Total
operating expenses
|
1,514,850 | 856,244 | 2,264,795 | 1,365,463 | 10,490,725 | |||||||||||||||
Loss
from operations
|
(1,514,850 | ) | (856,244 | ) | (2,264,795 | ) | (1,365,463 | ) | (10,490,725 | ) | ||||||||||
Finance
cost
|
- | (5,155 | ) | - | (478,093 | ) | (518,675 | ) | ||||||||||||
Change
in fair value of derivative liability
|
809,880 | (110,326 | ) | (613,612 | ) | (683,111 | ) | (2,044,162 | ) | |||||||||||
Interest
income (expense), net
|
8,886 | (2,867 | ) | 12,259 | (5,475 | ) | (4,115 | ) | ||||||||||||
Loss
before provision for income taxes
|
(696,084 | ) | (974,592 | ) | (2,866,148 | ) | (2,532,142 | ) | (13,057,677 | ) | ||||||||||
Provision
for income taxes
|
- | - | - | - | - | |||||||||||||||
Net
loss
|
$ | (696,084 | ) | $ | (974,592 | ) | $ | (2,866,148 | ) | $ | (2,532,142 | ) | $ | (13,057,677 | ) | |||||
Net
loss per common share, basic and diluted
|
$ | (0.04 | ) | $ | (0.07 | ) | $ | (0.18 | ) | $ | (0.20 | ) | ||||||||
Weighted
average shares outstanding
|
16,752,200 | 13,026,971 | 16,203,123 | 12,864,048 |
See
accompanying notes to unaudited condensed financial statements.
5
GENSPERA,
INC.
(A
Development Stage Company)
CONDENSED
STATEMENT OF STOCKHOLDERS' (DEFICIT) EQUITY
FROM DATE
OF INCEPTION (NOVEMBER 21, 2003) TO JUNE 30, 2010
(Unaudited)
Deficit
|
||||||||||||||||||||
Accumulated
|
||||||||||||||||||||
Additional
|
During the
|
Stockholders'
|
||||||||||||||||||
Common Stock
|
Paid-in
|
Development
|
Equity
|
|||||||||||||||||
Shares
|
Amount
|
Capital
|
Stage
|
(Deficit)
|
||||||||||||||||
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 |
See
accompanying notes to unaudited condensed financial statements.
6
GENSPERA,
INC.
(A
Development Stage Company)
CONDENSED
STATEMENT OF STOCKHOLDERS' (DEFICIT) EQUITY
FROM DATE
OF INCEPTION (NOVEMBER 21, 2003) TO JUNE 30, 2010
(Unaudited)
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
|
- | - | 51,865 | - | 51,865 | |||||||||||||||
Stock
based compensation
|
- | - | 1,530,536 | - | 1,530,536 | |||||||||||||||
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 | 667,439 | - | 667,485 | |||||||||||||||
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 | ) | - | - | ||||||||||||||
Common
stock and warrants issued upon conversion of note and accrued
interest
|
174,165 | 18 | 174,147 | - | 174,165 | |||||||||||||||
Net
loss
|
- | - | - | (5,132,827 | ) | (5,132,827 | ) | |||||||||||||
Balance,
December 31, 2009
|
15,466,446 | 1,547 | 10,135,737 | (10,191,529 | ) | (54,245 | ) | |||||||||||||
Stock
based compensation
|
- | - | 726,402 | - | 726,402 | |||||||||||||||
Sale
of common stock and warrants at $1.65 per share - February and March
2010
|
533,407 | 53 | 806,157 | - | 806,210 | |||||||||||||||
Sale
of common stock and warrants at $2.00 per share - May 2010
|
1,347,500 | 135 | 2,655,365 | - | 2,655,500 | |||||||||||||||
Common
stock and warrants issued as payment of placement fees
|
43,632 | 4 | (4 | ) | - | - | ||||||||||||||
Salaries
paid with common stock
|
43,749 | 4 | 99,996 | - | 100,000 | |||||||||||||||
Exercise
of options and warrants
|
150,001 | 15 | 124,986 | - | 125,001 | |||||||||||||||
Reclassification
of derivative liability upon exercise of warrants
|
- | - | 86,307 | - | 86,307 | |||||||||||||||
Net
loss
|
- | - | - | (2,866,148 | ) | (2,866,148 | ) | |||||||||||||
Balance,
June 30, 2010 (Unaudited)
|
17,584,735 | $ | 1,758 | $ | 14,634,946 | $ | (13,057,677 | ) | $ | 1,579,027 |
See
accompanying notes to unaudited condensed financial statements.
7
GENSPERA,
INC.
(A
Development Stage Company)
CONDENSED
STATEMENTS OF CASH FLOWS
FOR THE
SIX MONTHS ENDED JUNE 30, 2010 AND 2009
AND FOR
THE PERIOD FROM INCEPTION (NOVEMBER 21, 2003) TO JUNE 30, 2010
(Unaudited)
Cumulative Period
|
||||||||||||
from November 21, 2003
|
||||||||||||
(date of inception) to
|
||||||||||||
Six months ended June 30,
|
June 30,
|
|||||||||||
2010
|
2009
|
2010
|
||||||||||
Cash
flows from operating activities:
|
||||||||||||
Net
loss
|
$ | (2,866,148 | ) | $ | (2,532,142 | ) | $ | (13,057,677 | ) | |||
Adjustments
to reconcile net loss to net cash used in operating
activities:
|
||||||||||||
Depreciation
and amortization
|
9,257 | 7,674 | 36,823 | |||||||||
Stock
based compensation
|
826,402 | 134,501 | 3,306,746 | |||||||||
Warrants
issued for financing costs
|
- | 467,840 | 467,840 | |||||||||
Change
in fair value of derivative liability
|
613,612 | 683,111 | 2,044,162 | |||||||||
Contributed
services
|
- | - | 774,000 | |||||||||
Amortization
of debt discount
|
- | 10,253 | 20,675 | |||||||||
Changes
in assets and liabilities:
|
||||||||||||
Increase
(decrease) in accounts payable and accrued expenses
|
73,797 | 55,833 | 186,526 | |||||||||
Cash
used in operating activities
|
(1,343,080 | ) | (1,172,930 | ) | (6,220,905 | ) | ||||||
Cash
flows from investing activities:
|
||||||||||||
Acquisition
of property and equipment
|
- | - | (15,833 | ) | ||||||||
Acquisition
of intangibles
|
- | - | (184,168 | ) | ||||||||
Cash
used in investing activities
|
- | - | (200,001 | ) | ||||||||
Cash
flows from financing activities:
|
||||||||||||
Proceeds
from sale of common stock and warrants
|
3,461,710 | 2,738,852 | 10,689,847 | |||||||||
Proceeds
from exercise of warrants
|
125,001 | - | 125,001 | |||||||||
Proceeds
from convertible notes - stockholder
|
- | - | 155,000 | |||||||||
Repayments
of convertible notes - stockholder
|
- | - | (50,000 | ) | ||||||||
Cash
provided by financing activities
|
3,586,711 | 2,738,852 | 10,919,848 | |||||||||
Net
increase in cash
|
2,243,631 | 1,565,922 | 4,498,942 | |||||||||
Cash,
beginning of period
|
2,255,311 | 534,290 | - | |||||||||
Cash,
end of period
|
$ | 4,498,942 | $ | 2,100,212 | $ | 4,498,942 | ||||||
Supplemental
cash flow information:
|
||||||||||||
Cash
paid for interest
|
$ | - | $ | 79 | ||||||||
Cash
paid for income taxes
|
$ | - | $ | - | ||||||||
Non-cash
financial activities:
|
||||||||||||
Derivative
liability reclassified to equity upon exercise of warrants
|
$ | 86,307 | $ | - |
See
accompanying notes to unaudited condensed financial statements.
8
GENSPERA, INC.
NOTES
TO CONDENSED FINANCIAL STATEMENTS
FOR
THE SIX MONTH PERIODS ENDED JUNE 30, 2010 AND 2009
AND
FOR THE PERIOD FROM NOVEMBER 21, 2003
(INCEPTION)
TO JUNE 30, 2010
(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 June 30, 2010, we have accumulated losses
of $13,057,677.
The
accompanying unaudited condensed financial statements as of June 30, 2010 and
for the three and six month periods ended June 30, 2010 and 2009 and from date
of inception as a development stage enterprise (November 21, 2003) to June 30,
2010 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, 2009 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 six months ended June 30, 2010 are not necessarily indicative of
the results to be expected for the pending full year ending December 31,
2010.
Liquidity
As of
June 30, 2010, we had working capital of $4,263,841. Our cash flow
used in operations was $1,343,080 and $1,172,930 for the six months ended June
30, 2010 and 2009, respectively. At June 30, 2010, we had cash on
hand of approximately $4,499,000 and raised approximately $3,587,000 in the
first two quarters of 2010. Based upon current cash flow projections,
management believes the Company will have sufficient capital resources to meet
projected cash flow requirements through 2010.
9
Use
of Estimates
The
preparation of financial statements in conformity with generally accepted
accounting principles requires management to make estimates and assumptions that
affect the amounts reported in the financial statements and accompanying
disclosures. Although these estimates are based on management's best knowledge
of current events and actions the Company may undertake in the future, actual
results may differ from those estimates.
Research
and Development
Research
and development costs include expenses incurred by the Company for research and
development of therapeutic agents for the treatment of cancer and are charged to
operations as incurred. Our research and development expenses consist primarily
of expenditures for toxicology and other studies, manufacturing, clinical trials
and compensation and consulting costs.
GenSpera
incurred research and development expenses of $737,106 and $624,989 for the
three months ended June 30, 2010 and 2009, respectively, and $1,091,171 and
$934,491 for the six months ended June 30, 2010 and 2009, respectively, and
$6,602,712 from November 21, 2003 (inception) through June 30,
2010.
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 8,894,425 common share
equivalents at June 30, 2010 and 5,248,197 at June 30, 2009. For the three
and six months ended June 30, 2010 and 2009, 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
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
We follow
the guidance established pursuant to ASC 820 which established a framework for
measuring fair value and expands disclosure about fair value measurements. 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:
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.
10
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 June 30,
2010:
Fair Value at
|
Fair Value Measurement Using
|
|||||||||||||||
June 30,
2010
|
Level 1
|
Level 2
|
Level 3
|
|||||||||||||
Warrant
derivative liability
|
$
|
2,817,991
|
—
|
—
|
$ |
2,817,991
|
||||||||||
$
|
2,817,991
|
$
|
—
|
$
|
—
|
$
|
2,817,991
|
The table below sets forth
a summary of changes in the fair value of the Company’s Level 3 financial
liabilities (warrant derivative liability) for the six months ended June 30,
2010 and 2009.
2010
|
|
2009
|
||||||
Balance
at beginning of year
|
$
|
2,290,686
|
$
|
-
|
||||
Additions
to derivative instruments
|
-
|
1,150,593
|
||||||
Change
in fair value of warrant liability
|
613,612
|
683,111
|
||||||
Reclassification
to equity upon exercise of warrants
|
(86,307
|
)
|
-
|
|||||
Balance
at end of period
|
$
|
2,817,991
|
$
|
1,833,704
|
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.
Income
Taxes
We
utilize ASC 740 “Income Taxes” which requires the recognition of deferred tax
assets and liabilities for the expected future tax consequences of events that
have been included in the financial statements or tax returns. Under this
method, deferred income taxes are recognized for the tax consequences in future
years of differences between the tax bases of assets and liabilities and their
financial reporting amounts at each year-end based on enacted tax laws and
statutory tax rates applicable to the periods in which the differences are
expected to affect taxable income.
Stock-Based
Compensation
We
account for our stock based compensation under ASC 718 “Compensation – Stock
Compensation” using the fair value based method. Under this method, compensation
cost is measured at the grant date based on the value of the award and is
recognized over the service period, which is usually the vesting
period. This guidance establishes standards for the accounting for
transactions in which an entity exchanges it equity instruments for goods or
services. It also addresses transactions in which an entity incurs liabilities
in exchange for goods or services that are based on the fair value of the
entity’s equity instruments or that may be settled by the issuance of those
equity instruments.
11
We use
the fair value method for equity instruments granted to non-employees and use
the Black-Scholes model for measuring the fair value of options. The stock based
fair value compensation is determined as of the date of the grant or the date at
which the performance of the services is completed (measurement date) and is
recognized over the vesting periods.
Recent
Accounting Pronouncements
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. The adoption of this guidance did not have a material
impact on the Company’s financial position or results of
operations.
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. The
adoption of this guidance did not have a material impact on the Company’s
financial position or results of operations.
In
February 2010, the FASB issued FASB ASU 2010-09, “Subsequent Events, Amendments
to Certain Recognition and Disclosure Requirements,” which clarifies certain
existing evaluation and disclosure requirements in ASC 855 “Subsequent Events”
related to subsequent events. FASB ASU 2010-09 requires SEC filers to evaluate
subsequent events through the date in which the financial statements are issued
and is effectively immediately. The new guidance does not have an effect on it’s
the Company’s results of operations and financial condition.
In
January 2010, the FASB issued Accounting Standards Update (“ASU”) 2010-06,
“Improving Disclosures about Fair Value Measurements,” which clarifies certain
existing disclosure requirements in ASC 820 “Fair Value Measurements and
Disclosures,” and requires disclosures related to significant transfers between
each level and additional information about Level 3 activity. FASB ASU 2010-06
begins phasing in the first fiscal period after December 15, 2009. The Company
is currently assessing the impact on its consolidated results of operations
and financial condition.
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.
During
January and March 2010, we entered into securities purchase agreements with a
number of accredited investors. Pursuant to the terms of the
agreements, we sold 533,407 units resulting in gross proceeds of approximately
$880,000. The price per unit was $1.65. 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
investors to purchase our common shares at a price per share of
$3.10. The warrants also contain anti-dilution protection in the
event of stock splits, stock dividends and other similar transactions. We
incurred placement agent fees of $73,910 in connection with the
transaction. We also issued a total of 42,673 additional common stock
purchase warrants as compensation. The warrants have the same terms
as the investor warrants except that 12,160 warrants have an exercise price of
$2.20 and 30,513 warrants have an exercise price of $2.94.
During
May 2010, we entered into securities purchase agreements with a number
of accredited investors. Pursuant to the terms of the
agreements, we sold 1,347,500 units resulting in gross proceeds
of $2,695,000. The price per unit was
$2.00. 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 investors to purchase our common shares at a price per
share of $3.50. The warrants also contain anti-dilution protection in
the event of stock splits, stock dividends and other similar transactions. We
incurred placement agent and escrow fees of $39,500 in connection with the
transaction. We issued an additional 43,632 units as payment of $87,264 of
consulting fees. We also issued a total of 18,000 additional common stock
purchase warrants as compensation. The warrants have the same terms
as the investor warrants.
12
During
the six months ended June 30, 2010, we issued 150,001 shares of common stock
upon exercise of an equivalent number of options and warrants and received cash
proceeds of $125,001.
As a
result of the exercise of 50,001 of the warrants, we have reclassified $86,307
of our warrant derivative liability to paid in capital.
On
February 24, 2010, we granted a total of 77,000 common stock options to two
directors. The options have a weighted average exercise price of $2.30 per
share. The options will vest quarterly over one year. The options lapse if
unexercised after five years. The options have an aggregate grant
date fair value of $54,079, determined using the Black-Scholes method based on
the following weighted average assumptions: (1) risk free
interest rate of 0.245%; (2) dividend yield of 0%; (3) volatility
factor of the expected market price of our common stock of 99%; and
(4) an expected life of the options of 0.625 years. During the three
and six months ended June 30, 2010 we have recorded an expense of $13,520 and
$18,027, respectively, related to the fair value of the options that are
expected to vest.
During
the three and six months ended June 30, 2010 we have recorded an expense of
$98,849 and $234,049, respectively, related to the fair value of the options
granted to our chief executive officer and chief operating officer that vested
or are expected to vest.
During
the three and six months ended June 30, 2010, we have recorded an expense of
$38,016 and $85,051, respectively, related to the fair value of options granted
to members of our Scientific Advisory Board that vested during that
period.
During
May and June 2010, we granted a total of 291,425 common stock warrants to
consultants. The warrants have a weighted average exercise price of $1.99
per share. The warrants vested upon grant. The warrants lapse if unexercised
after five years. We have recorded an expense of $389,275, determined
using the Black-Scholes method based on the following weighted average
assumptions: (1) risk free interest rate of 0.625%;
(2) dividend yield of 0%; (3) volatility factor of the expected market
price of our common stock of 100%; and (4) an expected life of the
warrants of 2 years.
During
May 2010 we issued an aggregate of 43,479 shares of common stock to our chief
executive officer and chief operating officer as payment of discretionary
bonuses aggregating $100,000. For purposes of calculating the number of shares
to be issued as payment of the discretionary bonuses, the grant date is May 14,
2010.
NOTE
3 – DERIVATIVE LIABILITY
During
the three months ended March 31, 2010, 33,334 of our warrants subject to
derivative accounting were exercised into common stock. We have recorded an
expense of $21,119 at the date of exercise related to the change in fair value
from January 1, 2010 to the date of exercise. As a result of the exercise of the
warrants, we have reclassified $58,791 of our warrant derivative liability to
paid in capital.
During the three months ended June 30,
2010, 16,667 of our warrants subject to derivative accounting were exercised
into common stock. We have recorded a credit of $3,044 at the date of exercise
related to the change in fair value from April 1, 2010 to the date of exercise.
As a result of the exercise of the warrants, we have reclassified $27,516 of our
warrant derivative liability to paid in capital.
At June
30, 2010, we recalculated the fair value of our remaining warrants subject to
derivative accounting and have determined that their fair value at June 30, 2010
is $2,817,991. The value of the warrants was determined using the Black-Scholes
method based on the following assumptions: (1) risk free
interest rate of 0.625%; (2) dividend yield of 0%; (3) volatility
factor of the expected market price of our common stock of 98%; and
(4) an expected life of the warrants of 2 years. We have recorded a
credit of $806,836 during the three months ended June 30, 2010 and an expense of
$595,537 during the six months ended June30, 2010 related to the change in fair
value during those periods.
13
ITEM
2.
|
MANAGEMENT’S
DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF
OPERATIONS
|
Our
Management’s Discussion and Analysis of Financial Condition and Results of
Operations (MD&A) is provided in addition to the accompanying consolidated
financial statements and notes to assist readers in understanding our results of
operations, financial condition, and cash flows. MD&A is organized as
follows:
|
•
|
Overview — Discussion of
our business and plan of operations, overall analysis of financial and
other highlights affecting the company in order to provide context for the
remainder of MD&A.
|
|
•
|
Significant Accounting
Policies —
Accounting policies that we believe are important to understanding
the assumptions and judgments incorporated in our reported financial
results and forecasts.
|
|
•
|
Results of
Operations
— Analysis of our financial results comparing: (i) the second
quarter of 2010 to the comparable period in 2009, and (ii) the six month
period ended June 30, 2010 to the comparable period in
2009.
|
|
•
|
Liquidity and Capital
Resources
— An analysis of changes in our balance sheets and cash flows,
and discussion of our financial condition and potential sources of
liquidity.
|
The
various sections of this MD&A contain a number of forward-looking
statements. Words such as “expects,” “goals,” “plans,” “believes,” “continues,”
“may,” and variations of such words and similar expressions are intended to
identify such forward-looking statements. In addition, any statements that refer
to projections of our future financial performance, our anticipated growth and
trends in our businesses, and other characterizations of future events or
circumstances are forward-looking statements. Such statements are based on our
current expectations and could be affected by the uncertainties and risk factors
described throughout this filing and particularly in the “Overview” section (see
also “Risk Factors” in Part II, Item 1A of this Form 10-Q). Our actual results
may differ materially.
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.
Plan
of Operation
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 our clinical trials of G-202 in cancer
patients.
14
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 2010 we will be engaged in conducting the Phase I
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 regimen for the
subsequent clinical studies. We are currently conducting 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).
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 clinical development process to determine which tumor types will be
evaluated, but our current expectation is to conduct up to four separate
concurrent Phase II studies in different tumor types over a time span of 18
months.
In
anticipation of the upcoming G-202 Phase II clinical trials, we will manufacture
one or more batches of Good Manufacturing Practice (“GMP”) grade G-202 over
the coming nine 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. We plan
to begin development of G-115 in the fourth quarter of 2010 with an
anticipated filing of an IND in the third quarter of 2011. It is
anticipated that the development of the remaining candidates will not commence
until we have sufficient resources to devote to their development.
From
inception through June 30, 2010 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 $6,368,000, was
incurred in the development of G-202. For the years ended December 31, 2009 and
2008, approximately $2,087,000 and $2,433,000, respectively, was incurred in the
development of G-202. For the six months ended June 30, 2010 and 2009, we
incurred costs of approximately $1,091,000 and $934,000, respectively, in the
development of G-202.
It is
estimated that the development of G-202 will occur as follows:
It is
estimated that the ongoing Phase I clinical trial will cost an additional
approximately $1,200,000 and will be completed in the second quarter of
2011.
Phase II
clinical studies will cost an additional $7,000,000 and will be completed in the
fourth quarter of 2012. The increase in estimated Phase II costs from
previous disclosures is due to the addition of extra Phase II studies into the
G-202 clinical development plan.
We
anticipate that we will license G-202 to a third party during or after Phase II
clinical studies. 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 2015. If all goes as planned, we may expect marketing approval
in the second half of 2016 with an additional $3,000,000 spent to get the NDA
approved. We do not expect material net cash inflows from our own marketing
efforts before late 2016. The Phase III estimated costs are subject to
major revision simply because we have not yet obtained any efficacy data for our
drug in patients and therefore cannot accurately predict what may be the optimal
Phase III patient population. The estimates will become more refined as we
obtain more clinical data.
We
currently have budgeted $3,531,000 in cash expenditures for the twelve month
period following the date of this report, including (1) $1,348,000 to cover our
projected general and administrative expense during this period; and (2)
$2,183,000 for research and development activities. Our cash on hand as of June
30, 2010 is sufficient to fund our operations for the next 16 months through
October, 2011 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.
15
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 year ended December
31, 2009, as compared to those policies disclosed in the December 31, 2008
financial statements except as disclosed in the notes to financial statements or
through the six month period ended June 30, 2010.
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.
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”.
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
For a
discussion of new accounting pronouncements affecting the Company, refer to Note
1 of Notes to Financial Statements.
16
Result
of Operations for the Second Quarter of 2010
Compared to the Second Quarter of 2010
Our
results of operations have varied significantly from year to year and quarter to
quarter and may vary significantly in the future.
Revenue
We did
not have revenue for the three months ended June, 2010 and 2009,
respectively. We do not anticipate any revenues
during 2010.
Operating
Expenses
Operating
expense totaled $1,514,850 and $856,244 for the three months ended June 30, 2010
and 2009, respectively. The increase in operating expenses is primarily
the result of increased general and administrative expenses.
Three Months Ended June 30,
|
||||||||
2010
|
2009
|
|||||||
Operating
expenses
|
||||||||
General
and administrative expenses
|
$ | 777,744 | $ | 231,255 | ||||
Research
and development
|
737,106 | 624,989 | ||||||
Total
expense
|
$ | 1,514,850 | $ | 856,244 |
General
and Administrative Expenses
G&A
expenses totaled $777,744 and $231,255 for the three months ended June 30, 2010
and 2009, respectively. The increase of $546,489 or 236% for the
three months ended June 30, 2010 compared to the same period in 2009 was
primarily attributable to a number of factors, including the allocation of 100%
of Dr. Dionne’s compensation to G&A in 2010 as opposed to the 50% allocation
to G&A for the first three quarters of 2009 (an increase in G& A
allocation of $30,000), plus an increase in Dr. Dionne’s compensation of $7,500
in 2010. Stock based compensation increased by approximately $67,000, related
primarily to options granted during the third quarter of 2009. Stock based
consultant expense increased by approximately $383,000 during the 2010 period,
related to common stock purchase warrants granted during the 2010
period. Professional and other fees increased by approximately $30,000 and
insurance expense increased by approximately $23,000.
Research
and Development Expenses
Research
and development expenses totaled $737,106 and $624,989 for the three months
ended June 30, 2010 and 2009, respectively. The increase of $112,117
or 18% for the three months ended June 30, 2010 compared to the same period in
2009 was primarily attributable to increases in third party development costs of
approximately $57,000, license fees of approximately $29,000 and compensation of
approximately $35,000. The increase in compensation was a result of an increase
in stock based compensation of approximately $60,000 and an increase in other
compensation of approximately $5,000, partially offset by a decrease
attributable to the allocation of 100% of Dr. Dionne’s compensation to G&A
as opposed to the 50% allocation to R & D in 2009 (a decrease in R & D
allocation of $30,000).
Our
research and development expenses consist primarily of expenditures for
toxicology and other studies, manufacturing, clinical trials and compensation
and consulting costs. Under the planning and direction of key personnel,
we expect to outsource all of our GLP preclinical development activities (e.g.,
toxicology) and GMP manufacturing and clinical development activities to
contract research organizations (“CROs”) and contract
manufacturing organizations (“CMOs”).
Manufacturing will be outsourced to organizations with approved facilities and
manufacturing practices.
Other
Income (Expenses)
Other
income (expenses) totaled $818,766 of income for the three months ended June 30,
2010 and $118,348 of expense for the three months ended June 30,
2009.
Three Months Ended June 30,
|
||||||||
2010
|
2009
|
|||||||
Other
expense:
|
||||||||
Finance
Cost
|
$ | - | $ | (5,155 | ) | |||
Change
in fair value of derivative liability
|
809,880 | (110,326 | ) | |||||
Interest
income (expense) net
|
8,886 | (2,867 | ) | |||||
Total
other income (expenses)
|
$ | 818,766 | $ | (118,348 | ) |
17
Finance
Cost
Finance
Cost totaled $0 and $5,155 for the three months ended June 30, 2010 and 2009,
respectively. This cost consists of the amortization of debt discount of $5,155
during the 2009 period.
Change
in fair value of derivative liability
Change in
fair value of derivative liability totaled $809,880 of income for the three
months ended June 30, 2010 and $110,326 of expense for the three months ended
June 30, 2009.
The
change in the fair value of our warrant derivative liability resulted primarily
from the changes in our stock price and the volatility of our common stock
during the reported periods. Refer to Note 3 to the financial statements
for further discussion on our warrant liabilities.
During
the three months ended June 30, 2010, 16,667 of our warrants subject to
derivative accounting were exercised into common stock. We have recorded income
of $3,044 at the date of exercise related to the change in fair value from April
1, 2010 to the date of exercise. As a result of the exercise of the warrants, we
have reclassified $27,516 of our warrant derivative liability to paid in
capital.
At June
30, 2010, we recalculated the fair value of our remaining warrants subject to
derivative accounting and have determined that their fair value at June 30, 2010
is $2,817,991. The value of the warrants was determined using the Black-Scholes
method based on the following assumptions: (1) risk free interest
rate of 0.625%; (2) dividend yield of 0%; (3) volatility factor
of the expected market price of our common stock of 98%; and (4) an
expected life of the warrants of 2 years. We have recorded income of
$806,836 during the three months ended June 30, 2010 related to the change in
fair value during that period.
At June
30, 2009 we recalculated the fair value of our warrants subject to derivative
accounting and have determined that their fair value at June 30, 2009 is
$1,833,703. The fair value of the warrants was determined using the
Black-Scholes method based on the following assumptions: (1) risk
free interest rate of 0.875%; (2) dividend yield of 0%;
(3) volatility factor of the expected market price of our common stock
of 175%; and (4) an expected life of the warrants of 2 years. We
have recorded an expense of $110,326 during the three months ended June 30, 2009
related to the change in fair value during that period.
Interest
expense
We had
net interest income of $8,886 for the three months ended June 30, 2010 and net
interest expense of $2,867 for the three months ended June 30,
2009. The increase in net interest income of $11,753 for the three months
ended June 30, 2010 compared to the same period in 2009 was attributable to a
decrease in debt outstanding in 2010 and an increase in interest earned on
deposits.
Result
of Operations for the First Half of 2010 Compared to the First Half of
2010
Our
results of operations have varied significantly from year to year and quarter to
quarter and may vary significantly in the future.
Revenue
We did
not have revenue for the six months ended June, 2010 and 2009,
respectively. We do not anticipate any revenues
during 2010.
Operating
Expenses
Operating
expense totaled $2,264,795 and $1,365,463 for the six months ended June 30, 2010
and 2009, respectively. The increase in operating expenses is primarily
the result of increased general and administrative expenses.
Six Months Ended June 30,
|
||||||||
2010
|
2009
|
|||||||
Operating
expenses
|
||||||||
General
and administrative expenses
|
$ | 1,173,624 | $ | 430,972 | ||||
Research
and development
|
1,091,171 | 934,491 | ||||||
Total
expense
|
$ | 2,264,795 | $ | 1,365,463 |
18
General
and Administrative Expenses
G&A
expenses totaled $1,173,624 and $430,972 for the six months ended June 30, 2010
and 2009, respectively. The increase of $742,652 or 172% for the six
months ended June 30, 2010 compared to the same period in 2009 was primarily
attributable to a number of factors, including the allocation of 100% of Dr.
Dionne’s compensation to G&A in 2010 as opposed to the 50% allocation to
G&A for the first three quarters of 2009 (an increase in G& A allocation
of $65,000), plus an increase in Dr. Dionne’s compensation of $75,500 in 2010.
Stock based compensation increased by approximately $145,000, related primarily
to options granted during the third quarter of 2009. Stock based consultant
expense increased by approximately $376,000 during the 2010 period, related to
stock warrants granted during the 2010 period. Professional and other fees
increased by approximately $67,000 and insurance expense increased by
approximately $27,000.
Research
and Development Expenses
Research
and development expenses totaled $1,091,171 and $934,491 for the six months
ended June 30, 2010 and 2009, respectively. The increase of $156,680
or 17% for the six months ended June 30, 2010 compared to the same period in
2009 was primarily attributable to increases in license fees of approximately
$29,000 and compensation of approximately $131,000. The increase in compensation
was a result of an increase in stock based compensation of approximately
$145,000 and an increase in other compensation of approximately $46,000,
partially offset by a decrease attributable to the allocation of 100% of Dr.
Dionne’s compensation to G&A as opposed to the 50% allocation to R & D
in 2009 (a decrease in R & D allocation of $60,000).
Other
Expenses
Other
expenses totaled $601,353 and $1,166,679 for the six months ended June 30, 2010
and 2009, respectively.
Three Months Ended June 30,
|
||||||||
2010
|
2009
|
|||||||
Other
expense:
|
||||||||
Finance
Cost
|
$ | - | $ | (478,093 | ) | |||
Change
in fair value of derivative liability
|
(613,612 | ) | (683,111 | ) | ||||
Interest
income (expense) net
|
12,259 | (5,475 | ) | |||||
Total
other expenses
|
$ | (601,353 | ) | $ | (1,166,679 | ) |
Finance
Cost
Finance
Cost totaled $0 and $478,093 for the six months ended June 30, 2010 and 2009,
respectively. During the six months ended June 30, 2009 we incurred
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 consisted of the amortization of
debt discount. We had no comparable expense during the 2010 period.
Change
in fair value of derivative liability
Change in
fair value of derivative liability totaled $613,612 and $683,111 for the six
months ended June 30, 2010 and 2009, respectively.
The
change in the fair value of our warrant derivative liability resulted primarily
from the changes in our stock price and the volatility of our common stock
during the reported periods. Refer to Note 3 to the financial statements
for further discussion on our warrant liabilities.
During
the six months ended June 30, 2010, 50,001 of our warrants subject to derivative
accounting were exercised into common stock. We have recorded a net aggregate
expense of $18,075 at the dates of exercise related to the change in fair value
from January 1, 2010 (for those warrants exercised during the first quarter) or
April 1, 2010 (for those warrants exercised during the second quarter) to the
dates of exercise. As a result of the exercise of the warrants, we have
reclassified $86,307of our warrant derivative liability to paid in
capital.
19
At June
30, 2010, we recalculated the fair value of our remaining warrants subject to
derivative accounting and have determined that their fair value at June 30, 2010
is $2,817,991. The value of the warrants was determined using the Black-Scholes
method based on the following assumptions: (1) risk free interest
rate of 0.625%; (2) dividend yield of 0%; (3) volatility factor
of the expected market price of our common stock of 98%; and (4) an
expected life of the warrants of 2 years. We have recorded an expense of
$613,612 during the six months ended June 30, 2010 related to the change in fair
value during that period.
At June
30, 2009 we recalculated the fair value of our warrants subject to derivative
accounting and have determined that their fair value at June 30, 2009 is
$1,833,703. The fair value of the warrants was determined using the
Black-Scholes method based on the following assumptions: (1) risk
free interest rate of 0.875%; (2) dividend yield of 0%;
(3) volatility factor of the expected market price of our common stock
of 175%; and (4) an expected life of the warrants of 2 years. We
have recorded an expense of $683,111 during the six months ended June 30, 2009
related to the change in fair value during that period.
Interest
expense
We had
net interest income of $12,259 for the six months ended June 30, 2010 and net
interest expense of $5,475 for the six months ended June 30,
2009. The increase in net interest income of $17,734 for the six months
ended June 30, 2010 compared to the same period in 2009 was attributable to a
decrease in debt outstanding in 2010 and an increase in interest earned on
deposits.
Liquidity
and Capital Resources
Since our
inception, we have financed our operations primarily through the private
placement of our securities. Our currently monthly cash burn rate is $298,000.
This will increase to $391,000 in the fourth quarter of 2010 primarily due to
G-202 manufacturing costs but it will then decrease to $244,000 per month for
the first half of 2011. We anticipate that our available cash and expected
income will be sufficient to finance most of our current activities for at least
the next 16 months from June 30, 2010.
Six Months Ended June 30,
|
||||||||
2010
|
2009
|
|||||||
Cash
& Cash Equivalents
|
$ | 4,498,942 | $ | 2,100,212 | ||||
Net
cash used in operating activities
|
$ | (1,343,080 | ) | $ | (1,172,930 | ) | ||
Net
cash provided by financing activities
|
3,586,711 | 2,738,852 |
Total
cash was $4,498,942 and $2,100,212 at June 30, 2010 and 2009,
respectively. The increase of $2,398,730 at June 30, 2010 compared to 2009
was attributable to capital raised through equity sales in the first half of
2010.
Net
Cash Used in Operating Activities
In our
operating activities we used cash of $1,343,080 and $1,172,930 for the six
months ended June 30, 2010 and 2009, respectively. The increase of $170,150
in cash used for the six months ended June 30, 2010 compared to the same period
in 2009 was primarily attributable to an increase in loss of $188,114
(after adjusting for non cash items) offset by an increase in accounts payable
of $17,964.
Net
Cash Provided by Financing Activities
Cash
provided by financing activities was $3,586,711 and $2,738,852 for the six
months ended June 30, 2010 and 2009, respectively.
Listed
below are key financing transactions we have entered into during 2009 and year
to date 2010.
|
·
|
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.
|
|
·
|
In September of 2009, we sold
140,002 units resulting in gross proceeds of approximately
$210,000.
|
|
·
|
In January and March of 2010, we
sold 553,407 units resulting in gross proceeds of approximately
$880,000.
|
|
·
|
In
May of 2010, we sold 1,347,500 units resulting in gross proceeds of
approximately $2,695,000.
|
20
We have
incurred significant operating losses and negative cash flows since inception.
We have not achieved profitability and may not be able to realize sufficient
revenue to achieve or sustain profitability in the future. We do not expect to
be profitable in the next several years, but rather expect to incur additional
operating losses. We have limited liquidity and capital resources and must
obtain significant additional capital resources in order to sustain our product
development efforts, for acquisition of technologies and intellectual property
rights, for preclinical and clinical testing of our anticipated products,
pursuit of regulatory approvals, acquisition of capital equipment, laboratory
and office facilities, establishment of production capabilities, for general and
administrative expenses and other working capital requirements. We rely on cash
balances and the proceeds from the offering of our securities, exercise of
outstanding warrants and grants to fund our operations.
The
source, timing and availability of any future financing will depend principally
upon market conditions, interest rates and, more specifically, on our progress
in our exploratory, preclinical and future clinical development programs.
Funding may not be available when needed — at all, or on terms acceptable
to us. Lack of necessary funds may require us, among other things, to delay,
scale back or eliminate some or all of our research and product development
programs, planned clinical trials, and/or our capital expenditures or to license
our potential products or technologies to third parties.
ITEM
3.
|
QUANTITATIVE
AND QUALITATIVE DISCLOSURES ABOUT MARKET
RISK.
|
We are
not required to provide the information required by this items as we are
considered a smaller reporting company, as defined by Rule
229.10(f)(1).
ITEM
4.
|
CONTROLS
AND PROCEDURES.
|
Evaluation
of Disclosure Controls and Procedures
We
maintain disclosure controls and procedures (as defined in Rules 13a-15(e) and
15d-15(e) of the Securities Exchange Act of 1934, as amended (the “Exchange
Act”) that are designed to be effective in providing reasonable assurance that
information required to be disclosed in our reports under the Exchange Act is
recorded, processed, summarized and reported within the time periods specified
in the rules and forms of the Securities and Exchange Commission (the “ SEC”),
and that such information is accumulated and communicated to our management to
allow timely decisions regarding required disclosure.
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 June 30, 2010.
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 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.
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.
21
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 Report or
presented elsewhere by management from time to time.
General
Risks Relating to Our Business and Business Model
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 June 30, 2010, we have raised approximately
$10,815,000 in capital. During this same period, we have recorded
accumulated losses totaling $13,057,677. As of June 30, 2010, we had
working capital of $4,263,841 and stockholders’ equity of $1,579,027. Our net
losses for the two most recent fiscal years ended December 31, 2008 and 2009
have been $3,326,261 and $5,132,827, 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, license, 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 come primarily from the sale of equity
securities to third parties 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 and for general working capital needs. We
anticipate that we will require an additional $7 million in addition to $2.25
million in operating costs to take our lead drug through Phase II clinical
evaluations, which is currently anticipated to occur in the fourth quarter of
2012.
As of June 30, 2010, we
had cash on hand of approximately $4,499,000 which we anticipate will fund our
operations through October of 2011. Presently, the Company has an average
monthly cash burn rate of $298,000. This will increase to $391,000 in the fourth
quarter of 2010 primarily due to G-202 manufacturing costs but it will then
decrease to $244,000 per month for the first half of 2011 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 2011. 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.
We cannot
assure you that financing whether from external sources or related parties, will
be available if needed. 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.
22
We
may not be able to commercially develop our technologies.
We have
concentrated our research and development on our pro-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 the 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 could harm our ability to generate
revenues, operate profitably or remain a viable business.
Inability
to complete pre-clinical and clinical testing and trials will impair our
viability.
In the
first quarter of 2010, we commenced our first clinical trials of G-202 at the
University of Wisconsin, Carbone Cancer Center in Madison Wisconsin and at the
Sydney Kimmel Comprehensive Cancer Center at Johns Hopkins University.
Although we have commenced our clinical 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 our 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.
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.
We
depend on Craig A. Dionne, PhD, our Chief Executive Officer, and Russell
Richerson, PhD, our Chief Operating Officer, for our continued
operations.
We only
have 2 full time employees. The loss of either 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 materially
adverse effect on our business. 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
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 adverse 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, may 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 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.
23
We
are dependent upon third-parties to develop our product candidates, and such
parties are, to some extent, outside of our control.
We depend
upon independent investigators and collaborators, such as universities and
medical institutions, to conduct our pre-clinical and clinical trials under
agreements with us. These collaborators are not our employees and we cannot
control the amount or timing of resources that they devote to our programs.
These investigators may not assign as great a priority to our programs or pursue
them as diligently as we would if we were undertaking such programs ourselves.
If outside collaborators fail to devote sufficient time and resources to our
drug-development programs, or if their performance is substandard, the approval
of our FDA applications, if any, and our introduction of new drugs, if any, will
be delayed. These collaborators may also have relationships with other
commercial entities, some of whom may compete with us. If our collaborators
assist our competitors at our expense, our competitive position would be
harmed.
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.
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 Sea.
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 was a temporary worldwide shortage
of acetonitrile for a variety of reasons. We observed that during that period of
time the available supply of acetonitrile was 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 if an
acetonitrile shortage was to reoccur. In an extreme case this situation could
adversely affect our ability to manufacture G-202 altogether, thus significantly
impacting our future operations.
In
order to secure market share and generate revenues, our proposed products must
be accepted by the health care community.
Our
proposed products, if approved for marketing, may not achieve market acceptance
since hospitals, physicians, patients or the medical community in general may
decide not to accept and utilize them. We are attempting to develop products
that will likely be first approved for marketing in late stage cancer where
there is no truly effective standard of care. If approved for use in late stage,
the drugs will then be evaluated in earlier stage where they would represent
substantial departures from established treatment methods and will compete with
a number of more conventional drugs and therapies manufactured and marketed by
major pharmaceutical companies. It is too early in the development cycle of the
drugs for us to accurately predict our major
competitors. Nonetheless, the degree of market acceptance of any of
our developed products will depend on a number of factors,
including:
|
·
|
our demonstration to the medical
community of the clinical efficacy and safety of our proposed
products;
|
|
·
|
our ability to create products
that are superior to alternatives currently on the
market;
|
|
·
|
our ability to establish in the
medical community the potential advantage of our treatments over
alternative treatment methods;
and
|
|
·
|
the reimbursement policies of
government and third-party
payors.
|
If the
health care community does not accept our products for any of the foregoing
reasons, or for any other reason, our business will be materially
harmed.
24
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
therapeutic toxic agents and 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
may not have adequate insurance coverage.
The
testing, manufacturing, marketing and sale of human therapeutic products entail
an inherent risk of product liability claims. We cannot assure you
that substantial claims will not be asserted against us. In the event
we are forced to expend significant funds on defending such claims 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.
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.
25
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 with our lead drug candidate,
G-202. Although we began the G-202 Phase I clinical trial on
January 19, 2010, we cannot assure you that we will successfully complete the
trial. 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 Our Common Stock
There
is no well established public market for our securities.
On
September 18, 2009, our common shares began quotation on the Over-the-Counter
Bulletin Board (“OTCBB”) and Pinksheets. The shares were initially
sporadic traded and as a result, we did not consider that a public market for
our securities existed. Commencing in the first quarter of 2010, our
common shares began trading regularly but with limited volume.
Accordingly, although technically a limited public market for our
securities now exists, it is still relatively illiquid. Any
prospective investor in our common stock should consider the limited market when
making an investment decision as our securities are still relatively
illiquid. No assurances can be given that the trading volume
of our common shares will increase or that a liquid public market will ever
materialize. Additionally, due to the limited trading volume, it may
be 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 a company’s
management to 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. Section 404(b) is not applicable to smaller reporting
companies. Presently we qualify as a smaller reporting company under
Section 404(b) and, accordingly, our independent registered public accounting
firm is not required to audit the design and operating effectiveness of our
internal controls and management's assessment of the design and the operating
effectiveness of such internal controls. In the event we cease to
qualify as a smaller reporting company, we will be required to expand
substantial capital in connection with compliance.
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.
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 June 30, 2010, we have issued and
outstanding 17,584,465 common shares and we have 8,894,425 common shares
reserved for future grants under our equity compensation plans and issuances
upon the exercise of current outstanding options, warrants and convertible
securities. Accordingly, we will be entitled to issue up to 53,521,110
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.
26
Our
Officers and Scientific Advisors beneficially own approximately 37% of our
outstanding common shares.
Our
Officers and Scientific Advisors own approximately 37% 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.
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.
UNREGISTERED
SALES OF EQUITY SECURITIES AND USE OF
PROCEEDS
|
The
following information is given with regard to unregistered securities sold since
January 1, 2010. The following securities were issued in private
offerings pursuant to the exemption from registration contained in the
Securities Act and the rules promulgated thereunder in reliance on Section 4(2)
thereof, relating to offers of securities by an issuer not involving any public
offering.
|
·
|
During
January and March of 2010, we entered into securities purchase agreements
with a number of accredited investors. Pursuant to the terms of
the agreements, we sold 533,407 units resulting in gross proceeds
of approximately $880,000. The price per unit was
$1.65. Each unit consists of: (i) one common share; and (ii)
one half common stock purchase warrant. The warrants have a
term of five years and allow the investors to purchase our common stock at
a price per share of $3.10. The warrants also contain
anti-dilution protection in the event of stock splits, stock dividends and
other similar transactions. The warrants are callable by us assuming the
following: (i) our common stock trades above $5.00 for twenty (20)
consecutive days; (ii) the daily average minimum volume over such 20 days
is 75,000 or greater; and (iii) there is an effective registration
statement covering the underlying shares. We incurred
placement agent fees of $70,410 in connection with the transaction.
We also issued a total of 42,673 additional common stock purchase warrants
to our placement agent as compensation. The warrants have the
same terms as the investor warrants except that 12,160 warrants have an
exercise price of $2.20 and 30,513 warrants have an exercise price of
$2.94.
|
·
|
In
February of 2010, we granted John M. Farah, Jr., Ph.D, one of our outside
directors, options to purchase 39,000 common shares. The
options were granted pursuant to our director compensation plan as
compensation for Dr. Farah’s service on our Board and related
committees. The options have an exercise price of $2.14 per
share, a term of 5 years and vest quarterly over the grant
year.
|
27
·
|
In
March of 2010, we granted Scott Ogilvie, one of our outside directors,
options to purchase 38,000 common shares. The options were
granted pursuant to our director compensation plan as compensation for Mr.
Ogilvie’s service on our Board and related committees. The
options have an exercise price of $2.47 per share, a term of 5 years and
vest quarterly over the grant
year.
|
·
|
In
May of 2010, we issued warrants to purchase 235,000 common shares as
compensation for business advisory services. The warrant has an
exercise price of $1.65 per share, a term of 5 years and provides for
cashless exercise after 6 months in the event the shares underlying the
warrant are not registered at the time of
exercise.
|
·
|
In
May of 2010, we issued 5,800 common stock purchase warrants as
compensation to a consultant. The warrants have an exercise
price of $2.40 and a term of 5 years and provides for cashless exercise
after 6 months in the event the shares underlying the warrant are not
registered at the time of
exercise.
|
·
|
In
May of 2010, we issued Craig Dionne, our CEO, and Russell Richerson, our
COO, an aggregate of 43,479 common shares as payment for their 2009
discretionary bonuses. The shares were valued at $2.30 which
represents their fair market value on the grant date of May 14,
2010.
|
·
|
On
May 18, 2010, we sold 1,347,500 units resulting in gross proceeds of
approximately $2,695,000. The price per unit was
$2.00. Each unit consists of the following: (i) one common
share, and (ii) one half common stock purchase warrant. The
warrants have a term of five years and an exercise price of
$3.50. 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 dividends and fundamental
transactions. The securities purchase agreement, pursuant to
which the offering was completed, also contains a 180 days most favored
nation provision whereby if we enters into a subsequent financing with
another individual or entity on terms that are more favorable to the third
party, then at the discretion of the holder, the agreements between us and
the investors shall be amended to include such better
terms. The warrants are callable by us assuming the following:
(i) our common stock trades above $6.50 for twenty (20) consecutive days;
(ii) the daily average minimum volume over such 20 days is 50,000 or
greater; and (iii) there is an effective registration statement covering
the underlying shares. We also granted the investors
certain piggy-back registration rights.
In
connection with the transaction, we incurred a total of $39,500 in fees
and expenses. We also issued warrants to purchase a total of
18,000 shares to our placement agent. The placement agent
warrant has the same terms and conditions as the investor
warrant.
As
part of the offering, we also agreed to exchange 43,632 units for $87,264
in payables owed to a consultant. The exchange was on the same
terms and conditions as the offering.
As
a result of the offering and the exchange, we issued a total of 1,391,132
shares and issued 713,566
warrants.
|
·
|
In
June of 2010, we issued 100,000 common shares upon the exercise of an
outstanding common stock purchase option. The exercise price of
the option was $0.50 per share and we received gross proceeds of
$50,000.
|
·
|
In
June of 2010, we issued warrants to purchase an aggregate of 50,625 common
shares. The warrants were issued as compensation to
consultants. The warrants have an exercise price of $3.50, a
term of 5 years, are callable in the event certain conditions are met, and
generally have the same terms and conditions as the warrants issued to our
investors in the May 18, 2010
offering.
|
ITEM
3. DEFAULT
UPON SENIOR SECURITIES
None
ITEM
4. (REMOVED
AND RESERVED)
None
ITEM
5. OTHER
INFORMATION
None
ITEM
5. OTHER
INFORMATION
None
28
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.
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: August
13, 2010
|
|
/s/ Craig
Dionne
|
Chief
Executive Officer
|
||
/s/
Craig Dionne
|
||
Chief
Financial Officer
|
||
(Principal
Accounting
Officer)
|
29
INDEX
TO EXHIBITS
Incorporated by
Reference
|
||||||||||||
Exhibit
No.
|
Description
|
Filed
Herewith
|
Form
|
Exhibit
No.
|
File No.
|
Filing Date
|
||||||
3.01
|
Amended
and Restated Certificate of Incorporation
|
S-1
|
3.01
|
333-153829
|
10/03/08
|
|||||||
3.02
|
Amended
and Restated Bylaws
|
8-K
|
3.02
|
333-153829
|
1/11/10
|
|||||||
4.01
|
Specimen
of Common Stock certificate
|
S-1
|
4.01
|
333-153829
|
10/03/08
|
|||||||
4.02**
|
Amended
and Restated GenSpera 2007 Equity Compensation Plan adopted on January ,
2010
|
8-K
|
4.01
|
333-153829
|
1/11/10
|
|||||||
4.03**
|
GenSpera
Form of 2007 Equity Compensation Plan Grant and 2009 Executive
Compensation Plan Grant
|
8-K
|
4.02
|
333-153829
|
9/09/09
|
|||||||
4.04
|
Form
of 4.0% convertible note issued to shareholder
|
S-1
|
4.05
|
333-153829
|
10/03/08
|
|||||||
4.05
|
Form
of Warrant dated March 6, 2008 issued to consultant for financial
consulting services.
|
S-1
|
4.07
|
333-153829
|
10/03/08
|
|||||||
4.06
|
Form
of Warrant – July and August 2008 private placement
|
S-1
|
4.10
|
333-153829
|
10/03/08
|
|||||||
4.07
|
Form
of 4.0% convertible debenture modification between GenSpera,
Inc. and shareholder
|
8-K
|
10.02
|
333-153829
|
2/20/09
|
|||||||
4.08
|
Form
of Common Stock Purchase Warrant issued on 2/17/09 to TR Winston &
Company, LLC
|
8-K
|
10.05
|
333-153829
|
2/20/09
|
|||||||
4.09
|
Form
of Common Stock Purchase Warrant issued on 2/17/09 to Craig
Dionne
|
8-K
|
10.06
|
333-153829
|
2/20/09
|
|||||||
4.10
|
Form
of Common Stock Purchase Warrant dated 2/19/09
|
8-K
|
10.02
|
333-153829
|
2/20/09
|
|||||||
4.11
|
Form
of Common Stock Purchase Warrant dated June of 2009
|
8-K
|
10.03
|
333-153829
|
7/06/09
|
|||||||
4.12**
|
2009
Executive Compensation Plan
|
8-K
|
4.01
|
333-153829
|
9/09/09
|
|||||||
4.13
|
Form
of Common Stock Purchase Warrant – 9/2/09
|
8-K
|
10.02
|
333-153829
|
9/09/09
|
30
4.14
|
Form
of Securities Purchase Agreement – Jan – Mar 2010
|
10-K
|
4.27
|
333-153829
|
3/31/10
|
|||||||
4.15
|
Form
of Common Stock Purchase Warrant Jan – Mar 2010
|
10-K
|
4.28
|
333-153829
|
3/31/10
|
|||||||
4.16
|
Form
of Securities Purchase Agreement – May 18, 2010
|
8-K
|
10.01
|
333-153829
|
5/25/10
|
|||||||
4.17
|
Form
of: (i) Common Stock Purchase Warrant – May 18, 2010
offering, and (ii) June Consultant Warrants
|
8-K
|
10.02
|
333-153829
|
5/25/10
|
|||||||
4.18
|
Form
of Consultant Warrants Issued in May of 2010
|
*
|
||||||||||
10.01
|
Exclusive
Supply Agreement between GenSpera and Thapsibiza dated January 22,
2008
|
S-1
|
10.02
|
333-153829
|
10/03/08
|
|||||||
10.02**
|
Craig
Dionne Employment Agreement
|
8-K
|
10.04
|
333-153829
|
9/09/09
|
|||||||
10.03** |
Amendment
dated May 14, 2010 to the Employment Agreement of Craig
Dionne
|
*
|
||||||||||
10.04**
|
Craig
Dionne Severance Agreement
|
8-K
|
10.05
|
333-153829
|
9/09/09
|
|||||||
10.05**
|
Craig
Dionne Proprietary Information, Inventions And Competition
Agreement
|
8-K
|
10.06
|
333-153829
|
9/09/09
|
|||||||
10.06**
|
Form
of Indemnification Agreement
|
8-K
|
10.07
|
333-153829
|
9/09/09
|
|||||||
10.07**
|
Russell
Richerson Employment Agreement
|
8-K
|
10.08
|
333-153829
|
9/09/09
|
|||||||
10.08** |
Amendment
dated May 14, 2010 to the Employment Agreement of Russell
Richerson
|
*
|
||||||||||
10.09**
|
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.
31