Rebus Holdings, Inc. - Quarter Report: 2010 September (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 September 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)
|
(210) 479-8112
Registrant’s telephone number, including area code
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 November 1, 2010, Registrant had 17,604,465 common shares, $0.0001
par value, issued and outstanding.
GenSpera,
Inc.
Page
|
|||||
PART
I -
|
FINANCIAL
INFORMATION
|
4
|
|||
Item
1.
|
Financial
Statements
|
4
|
|||
Condensed
Balance Sheets as of September 30, 2010 (Unaudited) and December 31,
2009
|
4
|
||||
Condensed
Statements of Losses (Unaudited)
|
|||||
Three
and nine months ended September 30, 2010 and 2009 and for the period from
November 21, 2003 (inception) to September 30, 2010
|
5
|
||||
Condensed
Statements of Changes in Stockholders' Equity
(Deficit) (Unaudited)
|
|||||
For
the period from November 21, 2003 (inception) to September 30,
2010
|
6
|
||||
Condensed
Statements of Cash Flows (Unaudited)
|
|||||
Nine
months ended September 30, 2010 and 2009 and for the period from November
21, 2003 (inception) to September 30, 2010
|
7
|
||||
Notes
to Financial Statements (Unaudited)
|
8
|
||||
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
|
29
|
|||
Item
3.
|
Defaults
Upon Senior Securities
|
31
|
|||
Item
4.
|
(Removed
and Reserved)
|
31
|
|||
Item
5.
|
Other
Information
|
31
|
|||
Item
6.
|
Exhibits
|
31
|
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 (September 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 nine month periods ended September 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 history of operating
losses;
|
|
•
|
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
Form 10-Q, 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 document. 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
September 30,
|
December 31,
|
|||||||
2010
|
2009
|
|||||||
(Unaudited)
|
||||||||
Assets
|
||||||||
Current
assets:
|
||||||||
Cash
|
$ | 3,900,949 | $ | 2,255,311 | ||||
Total
current assets
|
3,900,949 | 2,255,311 | ||||||
Fixed
assets, net of accumulated depreciation of $3,083 and $708
|
12,750 | 15,125 | ||||||
Intangible
assets, net of accumulated amortization of $38,368 and
$26,858
|
173,799 | 157,310 | ||||||
Total
assets
|
$ | 4,087,498 | $ | 2,427,746 | ||||
Liabilities
and stockholders' equity (deficit)
|
||||||||
Current
liabilities:
|
||||||||
Accounts
payable and accrued expenses
|
$ | 46,286 | $ | 78,198 | ||||
Accrued
interest - stockholder
|
11,406 | 8,107 | ||||||
Convertible
notes payable - stockholder, current portion
|
75,000 | 35,000 | ||||||
Total
current liabilities
|
132,692 | 121,305 | ||||||
Convertible
notes payable - stockholder, long term portion
|
30,000 | 70,000 | ||||||
Derivative
liabilities
|
1,955,596 | 2,290,686 | ||||||
Total
liabilities
|
2,118,288 | 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,
17,604,465 and 15,466,446 shares issued and outstanding
|
1,760 | 1,547 | ||||||
Additional
paid-in capital
|
14,734,178 | 10,135,737 | ||||||
Deficit
accumulated during the development stage
|
(12,766,728 | ) | (10,191,529 | ) | ||||
Total
stockholders' equity (deficit)
|
1,969,210 | (54,245 | ) | |||||
Total
liabilities and stockholders' equity (deficit)
|
$ | 4,087,498 | $ | 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 NINE MONTHS ENDED SEPTEMBER 30, 2010 AND 2009
AND FOR
THE PERIOD FROM INCEPTION (NOVEMBER 21, 2003) TO SEPTEMBER 30, 2010
(Unaudited)
Cumulative Period
|
||||||||||||||||||||
from November 21, 2003
|
||||||||||||||||||||
(date of inception) to
|
||||||||||||||||||||
Three Months ended September 30,
|
Nine Months ended September 30,
|
September 30,
|
||||||||||||||||||
2010
|
2009
|
2010
|
2009
|
2010
|
||||||||||||||||
Operating
expenses:
|
||||||||||||||||||||
General
and administrative expenses
|
$ | 340,979 | $ | 659,699 | $ | 1,514,603 | $ | 1,090,671 | $ | 4,228,992 | ||||||||||
Research
and development
|
238,225 | 878,371 | 1,329,396 | 1,812,862 | 6,840,937 | |||||||||||||||
Total
operating expenses
|
579,204 | 1,538,070 | 2,843,999 | 2,903,533 | 11,069,929 | |||||||||||||||
Loss
from operations
|
(579,204 | ) | (1,538,070 | ) | (2,843,999 | ) | (2,903,533 | ) | (11,069,929 | ) | ||||||||||
Finance
cost
|
- | (793 | ) | - | (478,886 | ) | (518,675 | ) | ||||||||||||
Change
in fair value of derivative liability
|
862,395 | (86,514 | ) | 248,783 | (769,625 | ) | (1,181,767 | ) | ||||||||||||
Interest
income (expense), net
|
7,758 | 1,257 | 20,017 | (4,218 | ) | 3,643 | ||||||||||||||
Income
(loss) before provision for income taxes
|
290,949 | (1,624,120 | ) | (2,575,199 | ) | (4,156,262 | ) | (12,766,728 | ) | |||||||||||
Provision
for income taxes
|
- | - | - | - | - | |||||||||||||||
Net
income (loss)
|
$ | 290,949 | $ | (1,624,120 | ) | $ | (2,575,199 | ) | $ | (4,156,262 | ) | $ | (12,766,728 | ) | ||||||
Net
income (loss) per common share, basic
|
$ | 0.02 | $ | (0.11 | ) | $ | (0.15 | ) | $ | (0.31 | ) | |||||||||
Net
loss per common share, diluted - see Note 1
|
$ | (0.03 | ) | $ | (0.11 | ) | $ | (0.15 | ) | $ | (0.31 | ) | ||||||||
Weighted
average shares outstanding, basic and diluted
|
17,602,726 | 14,971,487 | 16,675,447 | 13,574,247 |
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 SEPTEMBER 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 | |||||||||||||||
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
|
- | - | 778,836 | - | 778,836 | |||||||||||||||
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 | ) | - | - | ||||||||||||||
Common
stock issued as payment for patents and license
|
20,000 | 2 | 46,798 | - | 46,800 | |||||||||||||||
Salaries
paid with common stock
|
43,479 | 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
|
- | - | - | (2,575,199 | ) | (2,575,199 | ) | |||||||||||||
Balance,
September 30, 2010 (Unaudited)
|
17,604,465 | $ | 1,760 | $ | 14,734,178 | $ | (12,766,728 | ) | $ | 1,969,210 |
See
accompanying notes to unaudited condensed financial statements.
6
GENSPERA,
INC.
(A
Development Stage Company)
CONDENSED
STATEMENTS OF CASH FLOWS
FOR THE
NINE MONTHS ENDED SEPTEMBER 30, 2010 AND 2009
AND FOR
THE PERIOD FROM INCEPTION (NOVEMBER 21, 2003) TO SEPTEMBER 30, 2010
(Unaudited)
Cumulative Period
|
||||||||||||
from November 21, 2003
|
||||||||||||
(date of inception) to
|
||||||||||||
Nine months ended September 30,
|
September 30,
|
|||||||||||
2010
|
2009
|
2010
|
||||||||||
Cash
flows from operating activities:
|
||||||||||||
Net
loss
|
$ | (2,575,199 | ) | $ | (4,156,262 | ) | $ | (12,766,728 | ) | |||
Adjustments
to reconcile net loss to net cash used in operating
activities:
|
||||||||||||
Depreciation
and amortization
|
13,886 | 11,667 | 41,452 | |||||||||
Stock
based compensation
|
878,836 | 1,346,507 | 3,359,180 | |||||||||
Common
stock issued for acquisition of license
|
28,800 | - | 28,800 | |||||||||
Warrants
issued for financing costs
|
- | 467,840 | 467,840 | |||||||||
Change
in fair value of derivative liability
|
(248,783 | ) | 769,625 | 1,181,767 | ||||||||
Contributed
services
|
- | - | 774,000 | |||||||||
Amortization
of debt discount
|
- | 11,046 | 20,675 | |||||||||
Changes
in assets and liabilities:
|
||||||||||||
Increase
(decrease) in accounts payable and accrued expenses
|
(28,613 | ) | (51,085 | ) | 84,116 | |||||||
Cash
used in operating activities
|
(1,931,073 | ) | (1,600,662 | ) | (6,808,898 | ) | ||||||
Cash
flows from investing activities:
|
||||||||||||
Acquisition
of property and equipment
|
- | (6,246 | ) | (15,833 | ) | |||||||
Acquisition
of intangibles
|
(10,000 | ) | - | (194,168 | ) | |||||||
Cash
used in investing activities
|
(10,000 | ) | (6,246 | ) | (210,001 | ) | ||||||
Cash
flows from financing activities:
|
||||||||||||
Proceeds
from sale of common stock and warrants
|
3,461,710 | 3,829,837 | 10,689,847 | |||||||||
Proceeds
from exercise of warrants
|
125,001 | - | 125,001 | |||||||||
Proceeds
from convertible notes - stockholder
|
- | - | 155,000 | |||||||||
Repayments
of convertible notes - stockholder
|
- | (15,000 | ) | (50,000 | ) | |||||||
Cash
provided by financing activities
|
3,586,711 | 3,814,837 | 10,919,848 | |||||||||
Net
increase in cash
|
1,645,638 | 2,207,929 | 3,900,949 | |||||||||
Cash,
beginning of period
|
2,255,311 | 534,290 | - | |||||||||
Cash,
end of period
|
$ | 3,900,949 | $ | 2,742,219 | $ | 3,900,949 | ||||||
Supplemental
cash flow information:
|
||||||||||||
Cash
paid for interest
|
$ | - | $ | 1,075 | ||||||||
Cash
paid for income taxes
|
$ | - | $ | - | ||||||||
Non-cash
financial activities:
|
||||||||||||
Derivative
liability reclassified to equity upon exercise of warrants
|
$ | 86,307 | $ | - | ||||||||
Common
stock issued for acquisition of patent
|
18,000 | - | ||||||||||
Common
stock units issued as payment of placement fees
|
- | 80,000 | ||||||||||
Warrants
issued as payment for due diligence expenses
|
- | 120,266 | ||||||||||
Warrants
issued as payment of placement fees
|
- | 78,503 |
See
accompanying notes to unaudited condensed financial statements.
7
GENSPERA,
INC.
(A
Development Stage Company)
NOTES
TO CONDENSED FINANCIAL STATEMENTS
FOR
THE NINE MONTH PERIODS ENDED SEPTEMBER 30, 2010 AND 2009
AND
FOR THE PERIOD FROM NOVEMBER 21, 2003
(INCEPTION)
TO SEPTEMBER 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 September 30, 2010, we have accumulated
losses of $12,766,728.
The
accompanying unaudited condensed financial statements as of September 30, 2010
and for the three and nine month periods ended September 30, 2010 and 2009 and
from date of inception as a development stage enterprise (November 21, 2003) to
September 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 nine months ended September 30, 2010 are not necessarily
indicative of the results to be expected for the pending full year ending
December 31, 2010.
Liquidity
As of
September 30, 2010, we had working capital of $3,768,257. Our cash
flow used in operations was $1,931,073 and $1,600,662 for the nine months ended
September 30, 2010 and 2009, respectively. At September 30, 2010, we
had cash on hand of approximately $3,901,000 of which we 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.
8
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 $238,225 and $878,371 for the
three months ended September 30, 2010 and 2009, respectively, and $1,329,396 and
$1,812,862 for the nine months ended September 30, 2010 and 2009, respectively,
and $6,840,937 from November 21, 2003 (inception) through September 30,
2010.
Loss
Per Share
We use
ASC 260, “Earnings Per Share” for calculating the basic and diluted income
(loss) per share. We compute basic income (loss) per share by dividing net
income (loss) and net income (loss) attributable to common shareholders by
the weighted average number of common shares outstanding.
Dilutive
common stock equivalents consist of shares issuable upon conversion of debt and
the exercise of our stock options and warrants. In accordance with ASC
260-45-20, common stock equivalents derived from shares issuable through
the exercise of our warrants subject to derivative accounting are not considered
in the calculation of the weighted average number of common shares outstanding
because the adjustments in computing income available to common stockholders
would result in a loss. Accordingly, the diluted EPS would be computed in
the same manner as basic earnings per share.
The
following is a reconciliation of net income and share amounts used in the
computation of loss per share for the three months ended September 30,
2010:
Three
Months
|
||||
Ended
|
||||
September
30, 2010
|
||||
Net
income used in computing basic net income per share
|
$ | 290,949 | ||
Impact
of assumed assumptions:
|
||||
Gain on warrant liability marked
to fair value
|
862,395 | |||
Net
loss used in computing diluted net loss per share
|
$ | (571,446 | ) |
There
were 8,959,649 common share equivalents at September 30, 2010 and 7,884,502 at
September 30, 2009. For the three and nine months ended September
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.
9
Level 2:
Observable prices that are based on inputs not quoted on active markets but
corroborated by market data.
Level 3:
Unobservable inputs when there is little or no market data available, thereby
requiring an entity to develop its own assumptions. The fair value hierarchy
gives the lowest priority to Level 3 inputs.
The table
below summarizes the fair values of our financial liabilities as of September
30, 2010:
Fair Value at
|
Fair Value Measurement Using
|
|||||||||||||||
September 30,
2010
|
Level 1
|
Level 2
|
Level 3
|
|||||||||||||
Warrant
derivative liability
|
$
|
1,955,596
|
—
|
—
|
$
|
1,955,596
|
||||||||||
$
|
1,955,596
|
$
|
—
|
$
|
—
|
$
|
1,955,596
|
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 nine months ended
September 30, 2010.
2010
|
|
|||
Balance
at beginning of year
|
$
|
2,290,686
|
||
Additions
to derivative instruments
|
-
|
|||
Change
in fair value of warrant liability
|
(248,783
|
)
|
||
Reclassification
to equity upon exercise of warrants
|
(86,307
|
)
|
||
Balance
at end of period
|
$
|
1,955,596
|
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.
10
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.
11
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.
During
the third quarter of 2010 we issued 8,000 shares of common stock, valued at
$18,000, for the acquisition of two patents and we issued 12,000 shares of
common stock, valued at $28,800, as payment for a license.
During
the nine months ended September 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 nine months ended September 30, 2010 we have recorded an expense of $24,125
and $42,152, respectively, related to the fair value of the options that vested
or are expected to vest.
On August
14, 2010, we granted a total of 63,000 common stock options to a director. The
options have an exercise price of $2.00 per share. Of these options, 25,000
vested upon grant and the balance will vest quarterly over one year. The options
lapse if unexercised after five years. The options have an aggregate
grant date fair value of $26,974, determined using the Black-Scholes method
based on the following weighted average assumptions: (1) risk
free interest rate of 0.193%; (2) dividend yield of 0%;
(3) volatility factor of the expected market price of our common stock
of 88%; and (4) an expected life of the options of 0.45 years.
During the three and nine months ended September 30, 2010 we have recorded an
expense of $12,739 related to the fair value of the options that vested or are
expected to vest.
During
the three and nine months ended September 30, 2010 we have recorded a credit of
$12,546 and an expense of $221,503, 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 nine months ended September 30, 2010, we have recorded an expense
of $28,116 and $113,167, 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.
12
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
September 30, 2010, we recalculated the fair value of our remaining warrants
subject to derivative accounting and have determined that their fair value at
September 30, 2010 is $1,955,596. The value of the warrants was determined using
the Black-Scholes method based on the following
assumptions: (1) risk free interest rate of 0.375%;
(2) dividend yield of 0%; (3) volatility factor of the expected market
price of our common stock of 96%; and (4) an expected life of the
warrants of 2 years. We have recorded credits of $862,395 and $266,858
during the three and nine months ended September30, 2010, respectively, 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 third
quarter of 2010 to the comparable period in 2009, and (ii) the nine month
period ended September 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 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 (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.
Additionally,
we will continue to protect our intellectual property position particularly with
regard to the outstanding claims contained within the core PSMA-prodrug patent
application in the United States. We will also continue to prosecute the
claims contained in our other patent applications in the United
States.
14
We
anticipate that during the remainder of 2010 and the first half of 2011 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).
It is likely that we will expand the Phase I study to another site(s) in the
United States early in 2011 so as to facilitate rapid expansion of enrollment
into a Phase IB program when we reach the maximum tolerated dose of the drug.
This is not expected to have a significant effect on the current projected
expenditures in the first half of 2011.
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 GMP grade G-202 over the coming six
months. The costs for manufacture of this clinical batch of drug are
included in the current projected expenditures.
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
$1,200,000 and will be completed in the second quarter of 2011.
We
estimate that Phase II clinical studies will cost an additional $7,000,000 and
are expected to 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 will need to
complete a significant financing before we can embark upon a Phase II clinical
program with G-202.
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 or decide not 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 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 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. The extra costs
for preclinical development of G-115 to an IND submission may total up to
$2,500,000. We do not plan to expend significant monies into this project until
we are assured of monies being available without negatively affecting the G-202
clinical program.
We have
identified 4 prodrug candidates: G-202, G-114, G-115 and Ac-GKAFRR-L12ADT. At
this time, we are engaged solely in the development of G-202 with development of
G-115 expected to begin in the fourth quarter 2010. 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 September 30, 2010 the vast majority of costs incurred have
been devoted to G-202. We estimate that we have incurred costs of approximately
$295,000 related to G-114, G-115 and Ac-GKAFRR-L12ADT. Substantially all of
these costs were incurred prior to December 2007, at which time we began
focusing solely on G-202. We have spent approximately $60,000 during the third
quarter of 2010 as we plan to begin development of G-115 in the fourth
quarter of 2010. The balance of our costs, aggregating approximately $6,546,000,
were 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, were incurred
in the development of G-202. For the nine months ended September 30, 2010
and 2009, we incurred costs of approximately $1,269,000 and $1,813,000,
respectively, in the development of G-202.
We have
budgeted $3,852,000 in cash expenditures for the twelve month period following
September 30, 2010, including (1) $1,300,000 to cover our projected general and
administrative expense during this period; and (2) $2,552,000 for research and
development activities. Our cash on hand as of September 30, 2010 is sufficient
to fund our operations for the next 12 months through September, 2011 after
which time we will need to undertake additional financings. These assumptions
are based upon operations focused solely on the G-202 Phase I clinical program
including manufacture of G-202 in anticipation of the Phase II clinical
program.
15
The
amounts and timing of our actual expenditures may vary significantly from our
expectations depending upon numerous factors, including our results of
operation, financial condition and capital requirements. Accordingly, we will
retain the discretion to allocate the available funds among the identified uses
described above, and we reserve the right to change the allocation of available
funds among the uses described above.
Significant
Accounting Policies
Our
financial statements have been prepared in accordance with accounting principles
generally accepted in the United States of America. The preparation of these
financial statements requires management to make estimates and assumptions that
affect the reported amounts of assets, liabilities, revenues and expenses.
Note 1 of the Notes to Financial Statements describes the significant
accounting policies used in the preparation of the financial statements. Certain
of these significant accounting policies are considered to be critical
accounting policies, as defined below. We do not believe that there have been
significant changes to our accounting policies during the 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 nine month period ended September 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.
16
Recent
Accounting Pronouncements
For a
discussion of new accounting pronouncements affecting the Company, refer to Note
1 of Notes to Financial Statements.
Result
of Operations for Third Quarter of 2010
Compared to Third Quarter of 2009
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 September, 2010 and 2009,
respectively. We do not anticipate any revenues
during 2010.
Operating
Expenses
Operating
expense totaled $579,204 and $1,538,070 for the three months ended September 30,
2010 and 2009, respectively. The decrease in operating expenses is
the result of decreases in both the general and administrative and research and
development expense categories as described below.
Three
Months Ended September 30,
|
||||||||
2010
|
2009
|
|||||||
Operating
expenses
|
||||||||
General
and administrative expenses
|
$
|
340,979
|
$
|
659,699
|
||||
Research
and development
|
238,225
|
878,371
|
||||||
Total
expense
|
$
|
579,204
|
$
|
1,538,070
|
General
and Administrative Expenses
G&A
expenses totaled $340,979 and $659,699 for the three months ended September 30,
2010 and 2009, respectively. The decrease of $318,720 or 48% for
the three months ended September 30, 2010 compared to the same period in 2009
was primarily attributable to a number of factors, including a decrease
in stock based compensation of approximately $229,000, a decrease
in stock based consulting and professional fees of approximately
$201,000, offset by 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. Professional and other
fees increased by approximately $33,000 and travel and entertainment expense
increased by approximately $21,000.
Research
and Development Expenses
Research
and development expenses totaled $238,225 and $878,371 for the three months
ended September 30, 2010 and 2009, respectively. The decrease of
$640,146 or 73% for the three months ended September 30, 2010 compared to
the same period in 2009 was primarily attributable to decreases in stock based
compensation of approximately $699,000 and 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 $31,000),
partially offset by an increase in other compensation of approximately $5,000
and an increase in third party development costs of approximately $85,000. The
decrease in stock based compensation results primarily from stock options that
vested upon grant in September 0f 2009.
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 CROs and CMOs. Manufacturing will be outsourced to
organizations with approved facilities and manufacturing
practices.
Other
Income (Expenses)
Other
income (expenses) totaled $870,153 of income for the three months ended
September 30, 2010 and $86,050 of expense for the three months ended
September 30, 2009.
17
Three
Months Ended September 30,
|
||||||||
2010
|
2009
|
|||||||
Other
expense:
|
||||||||
Finance
Cost
|
$
|
-
|
$
|
(793
|
)
|
|||
Change
in fair value of derivative liability
|
862,395
|
(86,514
|
)
|
|||||
Interest
income (expense) net
|
7,758
|
1,257
|
||||||
Total
other income (expenses)
|
$
|
870,153
|
$
|
(86,050
|
)
|
Finance
Cost
Expenses
related to Finance Cost totaled $0 and $793 for the three months ended September
30, 2010 and 2009, respectively. This cost consists of amortization of debt
discount during the 2009 period.
Change
in fair value of derivative liability
Change in
fair value of derivative liability totaled resulted in income of
$862,395 for the three months ended September 30, 2010 and an expense of
$86,514 for the same period of 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.
At
September 30, 2010, we recalculated the fair value of our remaining warrants
subject to derivative accounting and have determined that their fair value at
September 30, 2010 is $1,955,596. The value of the warrants was determined using
the Black-Scholes method based on the following
assumptions: (1) risk free interest rate of 0.375%;
(2) dividend yield of 0%; (3) volatility factor of the expected market
price of our common stock of 96%; and (4) an expected life of the
warrants of 2 years. We have recorded income of $862,395 during the three
months ended September 30, 2010 related to the change in fair value during that
period.
At
September 30, 2009 we recalculated the fair value of our warrants subject to
derivative accounting and have determined that their fair value at September 30,
2009 is $1,920,218. The fair value of the warrants was determined using the
Black-Scholes method based on the following
assumptions: (1) risk free interest rate of 1%;
(2) dividend yield of 0%; (3) volatility factor of the expected market
price of our common stock of 194%; and (4) an expected life of the
warrants of 2 years. We have recorded an expense of $86,514 during the
three months ended September 30, 2009 related to the change in fair value during
that period.
Interest
expense
We had
net interest income of $7,758 and $1,257 for the three months ended September
30, 2010 and 2009, respectively. The increase in net interest income
of $6,501 for the three months ended September 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 Nine Months Ended September 30, 2010 Compared to the Same
Period of 2009
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 nine months ended September, 2010 and 2009,
respectively. We do not anticipate any revenues
during 2010.
Operating
Expenses
Operating
expense totaled $2,843,999 and $2,903,533 for the nine months ended September
30, 2010 and 2009, respectively. The decrease in operating expenses
is primarily the result of a decrease in Research and Development expense
partially offset by an increase in General and Administrative
Expense.
18
Nine
Months Ended September 30,
|
||||||||
2010
|
2009
|
|||||||
Operating
expenses
|
||||||||
General
and administrative expenses
|
$
|
1,514,603
|
$
|
1,090,671
|
||||
Research
and development
|
1,329,396
|
1,812,862
|
||||||
Total
expense
|
$
|
2,843,999
|
$
|
2,903,533
|
General
and Administrative Expenses
G&A
expenses totaled $1,514,603 and $1,090,671 for the nine months ended September
30, 2010 and 2009, respectively. The increase of $423,932 or 39%
for the nine months ended September 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 $95,000), plus an increase in Dr. Dionne’s compensation of
$83,000 in 2010. Stock based compensation decreased by approximately $84,000,
related primarily to options granted during the third quarter of 2009. Stock
based consultant and professional fee expense increased by approximately
$142,000 during the 2010 period, related to stock warrants granted during the
2010 period. Professional and other fees increased by approximately $73,000,
insurance expense increased by approximately $32,000 and travel and
entertainment expense increased by approximately $30,000.
Research
and Development Expenses
Research
and development expenses totaled $1,329,396 and $1,812,862 for the nine months
ended September 30, 2010 and 2009, respectively. The decrease of
$483,466 or 27% for the nine months ended September 30, 2010 compared to the
same period in 2009 was primarily attributable to a decrease in compensation
expense of approximately $561,000 offset by increases in license fees of
approximately $29,000 and third party development costs of approximately
$49,000. The decrease in compensation was a result of a decrease in stock based
compensation of approximately $521,000 offset by an increase in other
compensation of approximately $55,000, which was 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 $95,000).
Other
Expenses
Other
income (expenses) totaled $268,800 of income for the nine months ended September
30, 2010 and $1,252,729 of expense for the nine months ended September 30,
2009.
Nine
Months Ended September 30,
|
||||||||
2010
|
2009
|
|||||||
Other
expense:
|
||||||||
Finance
Cost
|
$
|
-
|
$
|
(478,886
|
)
|
|||
Change
in fair value of derivative liability
|
248,783
|
(769,625
|
)
|
|||||
Interest
income (expense) net
|
20,017
|
(4,218
|
)
|
|||||
Total
other expenses
|
$
|
268,800
|
$
|
(1,252,729
|
)
|
Finance
Cost
Expenses
related to Finance Cost totaled $0 and $478,886 for the nine months ended
September 30, 2010 and 2009, respectively. During the nine months ended
September 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 resulted in income of
$248,783 for the nine months ended September 30, 2010 and an expense of
$769,625 for the same period of 2009.
19
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 nine months ended September 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.
At
September 30, 2010, we recalculated the fair value of our remaining warrants
subject to derivative accounting and have determined that their fair value at
September 30, 2010 is $1,920,218. The value of the warrants was determined using
the Black-Scholes method based on the following
assumptions: (1) risk free interest rate of 0.375%;
(2) dividend yield of 0%; (3) volatility factor of the expected market
price of our common stock of 96%; and (4) an expected life of the
warrants of 2 years. We have recorded income of $266,858 during
the nine months ended September 30, 2010 related to the change in fair value
during that period.
At
September 30, 2009 we recalculated the fair value of our warrants subject to
derivative accounting and have determined that their fair value at September 30,
2009 is $1,920,218. The fair value of the warrants was determined using the
Black-Scholes method based on the following
assumptions: (1) risk free interest rate of 1%;
(2) dividend yield of 0%; (3) volatility factor of the expected market
price of our common stock of 194%; and (4) an expected life of the
warrants of 2 years. We have recorded an expense of $769,625 during the
nine months ended September 30, 2009 related to the change in fair value during
that period.
Interest
expense
We had
net interest income of $20,017 for the nine months ended September 30, 2010 and
net interest expense of $4,218 for the same period of 2009. The
increase in net interest income of $24,235 for the nine months ended September
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 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 $430,000 in the fourth quarter of 2010 and first quarter of 2011 primarily
due to G-202 manufacturing costs but it will then decrease to $212,000 per month
for the second and third quarters of 2011. We anticipate that our
available cash will be sufficient to finance most of our current activities for
at least the next 12 months from September 30, 2010. Assuming monies are
available from future financings, we anticipate that we will expend an
additional $400,000 per month through the first half of 2011 in the development
of G-115.
Nine
Months Ended September 30,
|
||||||||
2010
|
2009
|
|||||||
Cash
& Cash Equivalents at Beginning of Period
|
$
|
2,255,311
|
$
|
534,290
|
||||
Cash
used in operating activities
|
$
|
(1,931,073
|
)
|
$
|
(1,600.662
|
)
|
||
Cash
used in investing activities
|
$
|
(10,000
|
)
|
$
|
(6,246
|
)
|
||
Cash
provided by financing activities
|
$
|
3,586,711
|
$
|
3,814,837
|
||||
Cash
& Cash Equivalents at End of Period
|
$
|
3,900,949
|
$
|
2,742,219
|
Total
cash was $3,900,949 and $2,742,219 at September 30, 2010 and 2009,
respectively. The increase of $1,158,730 at September 30, 2010,
compared to the same period of 2009, was attributable to capital raised through
equity sales in the first half of 2010.
Cash
Used in Operating Activities
In our
operating activities we used cash of $1,931,073 and $1,600,662 for the nine
months ended September 30, 2010 and 2009, respectively. The increase of
$330,411 in cash used for the nine months ended September 30, 2010 compared to
the same period in 2009 was primarily attributable to an increase in
losses of $352,883 (after adjusting for non cash items) offset by a
decrease in payments for accounts payable of $22,472.
20
Cash
Used in Investing Activities
Cash used
in investing activities was $10,000 and $6,246 for the nine months ended
September 30, 2010 and 2009, respectively. We expended $10,000 for
patent acquisitions in 2010 and $6,246 for the acquisition of furniture and
equipment in 2009.
Cash
Provided by Financing Activities
Cash
provided by financing activities was $3,586,711 and $3,814,837 for the nine
months ended September 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.
|
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).
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 September 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.
21
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.
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.
We
are not profitable, may never be profitable and as a result of our limited
operating history, you cannot rely upon our historical performance to make an
investment decision.
Since
inception in 2003 and through September 30, 2010, we have raised approximately
$10,815,000 in capital. During this same period, we have recorded
accumulated losses totaling $12,766,728. As of September 30, 2010, we
had working capital of $3,768,257 and stockholders’ equity of $1,969,210. 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. We intend to develop our drug compounds through
Phase I/II then license our drug compounds to third parties after Phase I/II
clinical trials. It is expected that such third parties would then continue to
develop, market, sell, and distribute the resulting products. Even if
we succeed in developing one or more product candidates, we expect to incur
substantial losses for the foreseeable future and may never become
profitable.
We also
expect to experience negative cash flow for the foreseeable future as we fund
our operating losses and capital expenditures. As a result, we will need to
generate significant revenues in order to achieve and maintain profitability. We
may not be able to generate these revenues or achieve profitability in the
future. Our failure to achieve or maintain profitability could negatively impact
the value of our securities.
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
currently have no product revenues and will need to raise additional capital to
operate our business.
To date,
we have generated no product revenues. Until, and unless, we
receive approval from the FDA and other regulatory authorities for our product
candidates, we cannot sell our drugs and will not have product revenues.
Currently, our only product candidates are G-202 and G-115 and none of these
products are approved for sale by the FDA. Therefore, for the foreseeable
future, we will have to fund all of our operations and capital expenditures from
cash on hand and, potentially future offerings. Currently, we believe we have
cash on hand to fund our operations until September 30,
2011. However, changes may occur that would consume our available
capital before that time, including changes in and progress of our development
activities, acquisitions of additional product candidates and changes in
regulation. Accordingly, we will need additional capital to fund our continuing
operations. Since we do not generate any revenue, the most likely sources of
such additional capital include private placements of our equity securities,
including our common stock, debt financing or funds from a potential strategic
licensing or collaboration transaction involving the rights to one or more of
our product candidates. To the extent that we raise additional capital by
issuing equity securities, our stockholders will likely experience dilution,
which may be significant depending on the number of shares we may issue and the
price per share. If we raise additional funds through collaborations and
licensing arrangements, it may be necessary to relinquish some rights to our
technologies, product candidates or products, or grant licenses on terms that
are not favorable to us. If we raise additional funds by incurring
debt, we could incur significant interest expense and become subject to
covenants in the related transaction documentation that could affect the manner
in which we conduct our business.
22
However,
we have no committed sources of additional capital and our access to capital
funding is always uncertain. This uncertainty is exacerbated due to the current
global economic turmoil, which has severely restricted access to the U.S. and
international capital markets, particularly for biopharmaceutical and
biotechnology companies. Accordingly, despite our ability to secure adequate
capital in the past, there is no assurance that additional equity or debt
financing will be available to us when needed, on acceptable terms or even at
all. If we fail to obtain the necessary additional capital when needed, we may
be forced to significantly curtail our planned research and development
activities, which will cause a delay in our drug development
programs.
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 our
securities. 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
September 30, 2010, we had cash on hand of approximately $3,901,000 which we
anticipate will fund our operations through September of
2011. Presently, the Company has an average monthly cash burn rate of
$298,000. This will increase to $430,000 in the fourth quarter of 2010 and first
quarter of 2011 primarily due to G-202 manufacturing costs but it will then
decrease to $212,000 per month for the second and third quarters of 2011.
Assuming monies are available from future financings, we will expend an
additional $400,000 per month through the first half of 2011 in the development
of G-115.
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.
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.
23
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.
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.
24
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.
Our
current manufacturing process requires acetonitrile.
The
current manufacturing process for our compounds requires the common solvent
acetonitrile. Beginning in late 2008, there was a 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 our compounds 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:
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our
demonstration to the medical community of the clinical efficacy and safety
of our proposed products;
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our
ability to create products that are superior to alternatives currently on
the market;
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our
ability to establish in the medical community the potential advantage of
our treatments over alternative treatment methods;
and
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the
reimbursement policies of government and third-party
payors.
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If the
health care community does not accept our products for any of the foregoing
reasons, or for any other reason, our business will be materially
harmed.
We
may be required to secure land for cultivation and harvesting of Thapsia
garganica.
We
believe that we can satisfy our needs for clinical development of G-202 through
completion of Phase III clinical studies from Thapsia garganica that grows
naturally in the wild. In the event G-202 is approved for commercial
marketing, our current supply of Thapsia garganica may not be
sufficient for the anticipated demand. We estimate that in order to
secure sufficient quantities of Thapsia garganica for the
commercialization of a product comprising G-202, we will need to secure
approximately 100 acres of land to cultivate and grow Thapsia garganica. We
anticipate the cost to lease such land would be $40,000 per year but have not
yet fully assessed what other costs would be associated with a full-scale
farming operation. There can be no assurances that we can secure such acreage,
or that even if we are able to do so, that we could adequately grow sufficient
quantities of Thapsia
garganica to satisfy any commercial objectives that involve G-202. Our
inability to secure adequate seeds will result in us not being able to develop
and manufacture our proposed drug and will adversely impact our
business.
Thapsia
garganica and Thapsigargin can cause severe skin irritation.
It has
been known for centuries that the plant Thapsia garganica can cause
severe skin irritation when contact is made between the plant and the
skin. In 1978, thapsigargin was determined to be the skin-irritating
component of the plant Thapsia
garganica. The therapeutic component of our products, including our lead
product G-202, is derived from thapsigargin. We obtain thapsigargin from the
above-ground seeds of Thapsia
garganica. These seeds are harvested by hand and those conducting the
harvesting must wear protective clothing and gloves to avoid skin contact.
Although we obtain the seeds from a third-party contractor located in Spain, and
although the contractor has contractually waived any and all liability
associated with collecting the seeds, it is possible that the contractor or
those employed by the contractor may suffer medical issues related to the
harvesting and subsequently seek compensation from us via, for example,
litigation. No assurances can be given, despite our contractual
relationship with the third party contractor, that we will not be the subject of
litigation related to the harvesting.
25
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 therapeutic
compounds have not been subjected to large scale manufacturing
procedures.
To date,
G-202 and G-115 have 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 and G-115 will work at a larger scale adequate for
commercial needs. In the event our therapeutic compounds cannot be
manufactured in sufficient quantities, our future prospects could be
significantly impacted.
We
face product liability risks and may not be able to obtain adequate insurance to
protect us against losses.
We
currently have no products that have been approved for commercial sale. However,
the current and future use of our product candidates by us in clinical trials,
and the sale of any approved products in the future, may expose us to liability
claims. These claims might be made directly by consumers or healthcare providers
or indirectly by pharmaceutical companies, or others selling such products. We
may experience financial losses in the future due to product liability claims.
We have obtained limited general commercial liability insurance coverage for our
clinical trials. However, we may not be able to maintain insurance
coverage at a reasonable cost or in sufficient amounts to protect us against all
losses. If a successful product liability claim or series of claims is brought
against us for uninsured liabilities or in excess of insured liabilities, our
assets may not be sufficient to cover such claims and our business operations
could be impaired.
Risks
Relating to Intellectual Property and Government Regulation
We
may not be able to withstand challenges to our intellectual property
rights.
We rely
on our intellectual property, including our issued and applied for patents, as
the foundation of our business. Our intellectual property rights may come under
challenge. No assurances can be given that, even if issued, our
patents will survive claims alleging invalidity or infringement on other
patents. The viability of our business will suffer if such patent protection
becomes limited or is eliminated.
We
may not be able to adequately protect our intellectual property.
Considerable
research with regard to our technologies has been performed in countries outside
of the United States. The laws protecting intellectual property in some of those
countries may not provide protection for our trade secrets and intellectual
property. If our trade secrets or intellectual property are
misappropriated in those countries, we may be without adequate remedies to
address the issue. At present, we are not aware of any infringement of our
intellectual property. In addition to our patents, we rely on confidentiality
and assignment of invention agreements to protect our intellectual property.
These agreements provide for contractual remedies in the event of
misappropriation. We do not know to what extent, if any, these
agreements and any remedies for their breach will be enforced by a court. In the
event our intellectual property is misappropriated or infringed upon and an
adequate remedy is not available, our future prospects will greatly
diminish.
Our
proposed products may not receive FDA approval.
The FDA
and comparable government agencies in foreign countries impose substantial
regulations on the manufacture and marketing of pharmaceutical products through
lengthy and detailed laboratory, pre-clinical and clinical testing procedures,
sampling activities and other costly and time-consuming procedures. Satisfaction
of these regulations typically takes several years or more and varies
substantially based upon the type, complexity and novelty of the proposed
product. 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.
26
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.
Our
stock price may be particularly volatile because we are a drug development
company.
The
market prices for securities of biotechnology companies in general, and
early-stage drug development companies in particular, have been highly volatile
and may continue to be highly volatile in the future. The following factors, in
addition to other risk factors described in this section, may have a significant
impact on the market price of our common stock:
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the
development status of our drug candidates, particularly the results of our
clinical trials of G-202;
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market
conditions or trends related to the biotechnology and pharmaceutical
industries, or the market in
general;
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announcements
of technological innovations, new commercial products, or other material
events by our competitors or us;
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disputes
or other developments concerning our proprietary
rights;
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changes
in, or failure to meet, securities analysts’ or investors’ expectations of
our financial performance;
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additions
or departures of key personnel;
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discussions
of our business, products, financial performance, prospects, or stock
price by the financial and scientific press and online investor
communities such as chat rooms;
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public
concern as to, and legislative action with respect to, testing or other
research areas of biopharmaceutical companies, the pricing and
availability of prescription drugs, or the safety of
drugs;
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regulatory
developments in the United States or foreign countries;
and
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economic
and political factors.
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In the
past, following periods of volatility in the market price of a particular
company’s securities, securities class action litigation has often been brought
against that company. We may become subject to this type of litigation, which is
often extremely expensive and diverts management’s attention.
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 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.
27
Compliance
with changing regulation of corporate governance and public disclosure will
result in additional expenses and will divert time and attention away from
revenue generating activities.
Changing
laws, regulations and standards relating to corporate governance and public
disclosure, including the Sarbanes-Oxley Act of 2002 and related SEC
regulations, have created uncertainty for public companies and significantly
increased the costs and risks associated with accessing the public markets and
public reporting. For example, on January 30th, 2009, the SEC adopted rules
requiring companies to provide their financial statements in interactive data
format using the eXtensible Business Reporting Language, or XBRL. We will have
to comply with these rules by June 15th, 2011. Our management team will need to
invest significant management time and financial resources to comply with both
existing and evolving standards for public companies, which will lead to
increased general and administrative expenses and a diversion of management time
and attention from revenue generating activities to compliance activities which
could have an adverse effect on our business.
Our
common stock may be considered a “penny stock,” and thereby be subject to
additional sale and trading regulations that may make it more difficult to
sell.
Our
common stock, which currently trades on the OTCQB, may be considered to be a
“penny stock” if it does not qualify for one of the exemptions from the
definition of “penny stock” under Section 3a51-1 of the Securities Exchange Act
for 1934, as amended (the “Exchange Act”). Our common stock may be a
“penny stock” if it meets one or more of the following conditions (i) the stock
trades at a price less than $5.00 per share; (ii) it is NOT traded on a
“recognized” national exchange; (iii) it is NOT quoted on the Nasdaq Capital
Market, or even if so, has a price less than $5.00 per share; or (iv) is issued
by a company that has been in business less than three years with net tangible
assets less than $5 million.
The
principal result or effect of being designated a “penny stock” is that
securities broker-dealers participating in sales of our common stock will be
subject to the “penny stock” regulations set forth in Rules 15-2 through 15g-9
promulgated under the Exchange Act. For example, Rule 15g-2 requires
broker-dealers dealing in penny stocks to provide potential investors with a
document disclosing the risks of penny stocks and to obtain a manually signed
and dated written receipt of the document at least two business days before
effecting any transaction in a penny stock for the investor’s
account. Moreover, Rule 15g-9 requires broker-dealers in penny stocks
to approve the account of any investor for transactions in such stocks before
selling any penny stock to that investor. This procedure requires the
broker-dealer to (i) obtain from the investor information concerning his or her
financial situation, investment experience and investment objectives; (ii)
reasonably determine, based on that information, that transactions in penny
stocks are suitable for the investor and that the investor has sufficient
knowledge and experience as to be reasonably capable of evaluating the risks of
penny stock transactions; (iii) provide the investor with a written statement
setting forth the basis on which the broker-dealer made the determination in
(ii) above; and (iv) receive a signed and dated copy of such statement from the
investor, confirming that it accurately reflects the investor’s financial
situation, investment experience and investment
objectives. Compliance with these requirements may make it more
difficult and time consuming for holders of our common stock to resell their
shares to third parties or to otherwise dispose of them in the market or
otherwise.
As
an issuer of “penny stock” the protection provided by the federal securities
laws relating to forward looking statements does not apply to us.
Although
the federal securities law provide a safe harbor for forward-looking statements
made by a public company that files reports under the federal securities laws,
this safe harbor is not available to issuers of penny stocks. As a result, if we
are a penny stock we will not have the benefit of this safe harbor protection in
the event of any based upon an claim that the material provided by us contained
a material misstatement of fact or was misleading in any material respect
because of our failure to include any statements necessary to make the
statements not misleading.
If
securities or industry analysts do not publish research or reports or publish
unfavorable research about our business, the price and trading volume of our
common stock could decline.
The
trading market for our common stock will depend in part on the research and
reports that securities or industry analysts publish about us or our business.
We do not currently have and may never obtain research coverage by securities
and industry analysts. If no securities or industry analysts commence coverage
of us the trading price for our common stock and other securities would be
negatively affected. In the event we obtain securities or industry analyst
coverage, if one or more of the analysts who covers us downgrades our
securities, the price of our securities would likely decline. If one
or more of these analysts ceases to cover us or fails to publish regular reports
on us, interest in the purchase of our securities could decrease, which could
cause the price of our common stock and other securities and their trading
volume to decline.
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.
28
Our
board of directors has broad discretion to issue additional
securities.
We are
entitled under our certificate of incorporation to issue up to 80,000,000 common
and 10,000,000 “blank check” preferred shares. Blank check preferred shares
provide the board of directors broad authority to determine voting, dividend,
conversion, and other rights. As of September 30, 2010, we have issued and
outstanding 17,604,465 common shares and we have 14,121,649 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 48,273,886
additional common shares and 10,000,000 additional preferred shares. Our board
may generally issue those common and preferred shares, or options or warrants to
purchase those shares, without further approval by our
shareholders. Any preferred shares we may issue will have such
rights, preferences, privileges and restrictions as may be designated from
time-to-time by our board, including preferential dividend rights, voting
rights, conversion rights, redemption rights and liquidation provisions. It is
likely that we will be required to issue a large amount of additional securities
to raise capital to further our development and marketing plans. It is also
likely that we will be required to issue a large amount of additional securities
to directors, officers, employees and consultants as compensatory grants in
connection with their services, both in the form of stand-alone grants or under
our various stock plans. The issuance of additional securities may cause
substantial dilution to our shareholders.
Our
Officers and Scientific Advisors beneficially own approximately 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
|
|
·
|
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.
|
29
|
·
|
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.
|
|
·
|
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 our
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.
|
30
|
·
|
In
July of 2010, we issued 12,000 common shares to Johns Hopkins University
and 8,000 common shares to Soren Brogger Christensen, PhD, as partial
payment for the license of certain intellectual property. We
valued the issuances at $28,800 and $18,800,
respectively.
|
·
|
On
August 16, 2010, upon joining the board, we granted Bo Jesper Hansen MD
Ph.D, options to purchase 63,000 common shares. The options
were granted pursuant to our director compensation plan as compensation
for Bo Jesper Hansen MD Ph.D’s service on our Board and related
committees. The options have an exercise price of $2.00 per
share and a term of 5 years. Of the Options granted, 25,000 are
vested with the balance vest quarterly over the grant
year. Additionally, we also entered into our standard
indemnification agreement with Bo Jesper Hansen MD
Ph.D.
|
ITEM
3.
|
DEFAULT
UPON SENIOR SECURITIES
|
None
ITEM
4.
|
(REMOVED
AND RESERVED)
|
None
ITEM
5.
|
OTHER
INFORMATION
|
None
ITEM
6.
|
EXHIBITS
|
The
exhibits listed in the accompanying index to exhibits are filed or incorporated
by reference as part of this Form 10-Q.
In
accordance with the requirements of the Securities Exchange Act of 1934, the
Registrant has caused this report to be signed by the undersigned hereunto duly
authorized.
GENSPERA,
INC.
|
||
Date: November
12, 2010
|
/s/ Craig
Dionne
|
|
Chief
Executive Officer
|
||
/s/
Craig Dionne
|
||
Chief
Financial Officer
|
||
(Principal
Accounting
Officer)
|
31
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
|
32
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
|
5/24/10
|
|||||||
4.17
|
Form
of Common Stock Purchase Warrant – May 18, 2010 and June
Consultant Warrants
|
8-K
|
10.02
|
333-153829
|
5/24/10
|
|||||||
4.18
|
Form
of Consultant Warrant 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**
|
Craig
Dionne Severance Agreement
|
8-K
|
10.05
|
333-153829
|
9/09/09
|
|||||||
10.04**
|
Craig
Dionne Proprietary Information, Inventions And Competition
Agreement
|
8-K
|
10.06
|
333-153829
|
9/09/09
|
|||||||
10.05**
|
Form
of Indemnification Agreement
|
8-K
|
10.07
|
333-153829
|
9/09/09
|
|||||||
10.06**
|
Russell
Richerson Employment Agreement
|
8-K
|
10.08
|
333-153829
|
9/09/09
|
|||||||
10.07**
|
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.
33