x
|
ANNUAL REPORT PURSUANT TO
SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF
1934
|
¨
|
TRANSITION REPORT PURSUANT TO
SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF
1934
|
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)
|
Large accelerated filer
o
|
Accelerated filer
o
|
Non-accelerated filer
o
(Do not check if a smaller reporting company)
|
Smaller reporting company
x
|
Page
|
||||
PART I
|
||||
Item
1.
|
Business
|
3
|
||
Item
1A.
|
Risk
Factors
|
11
|
||
Item
2.
|
Properties
|
17
|
||
Item
3.
|
Legal
Proceedings
|
17
|
||
Item
4.
|
(Removed
and
Reserved)
|
17
|
||
PART II
|
||||
Item
5.
|
Market
for Registrant’s Common Equity, Related Stockholder Matters and Issuer
Purchases of Equity Securities
|
17
|
||
Item
6.
|
Selected
Financial Data
|
20
|
||
Item
7.
|
Management’s
Discussion and Analysis of Financial Condition and Results of
Operations
|
20
|
||
Item
7A.
|
Quantitative
and Qualitative Disclosures About Market Risk
|
25
|
||
Item
8.
|
Financial
Statements and Supplementary Data
|
25
|
||
Item
9.
|
Changes
in and Disagreements With Accountants on Accounting and Financial
Disclosure
|
26
|
||
Item
9A.
|
Controls
and Procedures
|
27
|
||
Item
9B.
|
Other
Items
|
28
|
||
PART III
|
||||
Item
10.
|
Directors,
Executive Officers and Corporate Governance
|
28
|
||
Item
11.
|
Executive
Compensation
|
33
|
||
Item
12.
|
Security
Ownership of Certain Beneficial Owners and Management and Related
Stockholder Matters
|
37
|
||
Item
13.
|
Certain
Relationships and Related Transactions, and Director
Independence
|
38
|
||
Item
14.
|
Principal
Accounting Fees and Services
|
39
|
||
PART IV
|
||||
Item
15.
|
Exhibits,
Financial Statement Schedules
|
40
|
·
|
the
success of our research and development activities, the development of a
viable commercial product, and the speed with which regulatory
authorizations may be achieved;
|
·
|
whether
or not a market for our products develops and, if a market develops, the
rate at which it develops;
|
·
|
our
ability to successfully sell or license our products if a market
develops;
|
·
|
our
ability to attract and retain qualified
personnel;
|
·
|
the
accuracy of our estimates and
projections;
|
·
|
our
ability to fund our short-term and long-term financing
needs;
|
·
|
changes
in our business plan and corporate growth strategies;
and
|
·
|
other
risks and uncertainties discussed in greater detail in the section
captioned “Risk Factors”
|
ITEM
1.
|
BUSINESS
|
Side
effects
|
Non-cancer
cells in the body are also affected, often leading to serious side
effects.
|
Incomplete tumor
kill
|
Many
of the leading chemotherapeutic agents act during the process
of cell division - they might be effective with tumors comprised of
rapidly-dividing cells, but are much less effective for tumors that
contain cells that are slowly
dividing.
|
Resistance
|
Cancers
will often develop resistance to current drugs after repeated exposure,
limiting the number of times that a treatment can be effectively
applied.
|
Pro-Drug Candidate
|
Activating enzyme
|
Target location of activation
enzyme
|
Status
|
||||
G-202
|
Prostate
Specific Membrane Antigen (PSMA)
|
The
blood vessels of all solid tumors
|
·
|
Phase
I Clinical Trial is underway
|
|||
G-114
|
Prostate
Specific Antigen (PSA)
|
Prostate
cancers
|
·
|
Validated
efficacy in pre-clinical animal models (Johns Hopkins
University)
|
|||
G-115
|
Prostate
Specific Antigen (PSA)
|
Prostate
cancers
|
·
|
Validated
efficacy in pre-clinical animal models (Johns Hopkins
University)
|
|||
Ac-GKAFRR-L12ADT
|
Human
glandular kallikrein 2 (hK2)
|
Prostate
cancers
|
·
|
Validated
efficacy in pre-clinical animal models (Johns Hopkins
University)
|
Estimated Number of
|
Probability of
Developing
(birth to death)
|
|||||||
Cancer
|
New Cases (2006)
|
Male
|
Female
|
|||||
Prostate
|
192,280
|
1
in 6
|
-
|
|||||
Breast
|
194,280
|
n/a
|
1
in 8
|
|||||
Urinary
Bladder
|
70,980
|
1
in 27
|
1
in 84
|
|||||
Kidney
Cancer
|
57,760
|
n/a
|
n/a
|
Number
|
Country
|
Filing
Date
|
Issue Date
|
Expiration
Date
|
Title
|
||||||
Patents
Issued
|
|||||||||||
6,504,014
|
US
|
6/7/00
|
1/7/2003
|
6/6/2020
|
Tissue
specific pro-drug (TG)
|
||||||
6,545,131
|
US
|
7/28/00
|
4/8/2003
|
7/27/2020
|
Tissue
specific pro-drug (TG)
|
||||||
6,265,540
|
US
|
5/19/98
|
7/24/2001
|
5/18/2018
|
Tissue
specific pro-drug (PSA)
|
||||||
6,410,514
|
US
|
6/7/00
|
6/25/2002
|
6/6/2020
|
Tissue
specific pro-drug (PSA)
|
||||||
7,053,042
|
US
|
7/28/00
|
5/30/2006
|
7/27/2020
|
Activation
of peptide pro-drugs by HK2
|
||||||
7,468,354
|
US
|
11/30/01
|
12/23/08
|
11/29/2021
|
Tissue
specific pro-drug
(G-202,
PSMA)
|
||||||
7,635,682
|
US
|
1/6/06
|
12/22/09
|
1/5/2026
|
Tumor
activated pro-drugs
(G-115)
|
||||||
Patents
Pending
|
|||||||||||
US
2008/0247950
|
US
|
3/15/07
|
Pending
|
N/A
|
Activation
of peptide pro-drugs by HK2
|
||||||
US
2007/0160536
|
US
|
1/6/2006
|
Pending
|
N/A
|
Tumor
Activated Pro-drugs (PSA,G-115)
|
||||||
US
2009/0163426
|
US
|
11/25/08
|
Pending
|
N/A
|
Tumor
specific pro-drugs (PSMA)
|
Term
|
The
term of the agreement is for 5
years.
|
Exclusivity
|
Thapsibiza
shall exclusively provide
Thapsia garganica
seeds to the Company. The Company has the ability to seek addition
suppliers to supplement the supply from Thapsibiza,
SL.
|
Pricing
|
The
price shall be 300 Euro/kg. Thapsibiza may, from time to time, without
notice, increase the price to compensate for any increased governmental
taxes.
|
Minimum
Order
|
Upon
successfully securing $5,000,000 of equity financing, and for so long as
the Company continues to develop drugs derived from thapsigargin, the
minimum purchase shall be 50kg per harvest period
year.
|
Indemnification
|
Once
the product is delivered to an acceptable carrier, the Company shall be
responsible for an injury or damage result from the handling of the
product. Prior to delivery, Thapsibiza shall be solely
responsible.
|
|
·
|
Preclinical
laboratory and animal tests;
|
|
·
|
Submission
of an Investigational New Drug Application (“IND”), which must become
effective before human clinical trials may
begin;
|
|
·
|
Adequate
and well-controlled human clinical trials to establish the safety and
efficacy of the product candidate for its intended
use;
|
|
·
|
Submission
to the FDA of an New Drug Application (“NDA”);
and
|
|
·
|
FDA
review and approval of an NDA.
|
|
·
|
Phase
I: The drug candidate is initially introduced into cancer patients and
tested for safety and tolerability at escalating
dosages,
|
|
·
|
Phase
II: The drug candidate is studied in a limited cancer patient population
to further identify possible adverse effects and safety risks, to evaluate
the efficacy of the drug candidate for specific targeted diseases and to
determine dosage tolerance and optimal
dosage.
|
|
·
|
Phase
III: When Phase II evaluations demonstrate that a dosage range of the drug
candidate may be effective and has an acceptable safety profile, Phase III
trials are undertaken to further evaluate dose response, clinical efficacy
and safety profile in an expanded patient population, often at
geographically dispersed clinical study
sites.
|
ITEM
1A.
|
RISK
FACTORS
|
|
·
|
our
development programs;
|
|
·
|
the
progress and costs of pre-clinical studies and clinical
trials;
|
|
·
|
the
time and costs involved in obtaining regulatory
clearance;
|
|
·
|
the
costs involved in preparing, filing, prosecuting, maintaining and
enforcing patent claims;
|
|
·
|
the
costs and our ability to license our
products;
|
|
·
|
competing
technological and market
developments;
|
|
·
|
market
acceptance of our proposed products, if developed;
and
|
|
·
|
the
costs for recruiting and retaining employees, consultants and
professionals.
|
|
·
|
our
demonstration to the medical community of the clinical efficacy and safety
of our proposed products;
|
|
·
|
our
ability to create products that are superior to alternatives currently on
the market;
|
|
·
|
our
ability to establish in the medical community the potential advantage of
our treatments over alternative treatment methods;
and
|
|
·
|
the
reimbursement policies of government and third-party
payors.
|
|
·
|
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.
|
ITEM
2.
|
PROPERTIES
|
ITEM
3.
|
LEGAL
PROCEEDINGS
|
ITEM
4.
|
(REMOVED
AND RESERVED)
|
ITEM
5.
|
MARKET
FOR REGISTRANT’S COMMON EQUITY, RELATED STOCKHOLDER MATTERS AND ISSUER
PURCHASES OF EQUITY SECURITIES
|
(a)
|
(b)
|
(c)
|
||||||
Number of Securities
to be Issued
upon Exercise of
Outstanding
Options, Warrants
and Rights
|
Weighted-Average
Exercise Price of
Outstanding
Options,
Warrants and
Rights
|
Number of Securities
Remaining Available for
Future Issuance under
Equity Compensation Plans
(Excluding Securities
Reflected in Column (a))
|
||||||
Equity
compensation plans approved by security holders
|
||||||||
2007 Stock Plan, as
amended
(1)
|
784,000
|
$
|
0.67
|
5,216,000
|
||||
Equity
compensation plans not approved by security holders
|
||||||||
2009
Executive Compensation Plan
|
1,775,000
|
1.58
|
0
|
|||||
Total
|
2,559,000
|
$
|
1.30
|
5,216,000
|
(1)
|
Our
2007 Stock Plan, as amended, provides for the issuance of up to 1,500,000
common shares during any calendar year. The plan provides for
authorizes the issuance of up to 6,000,000 common shares in the
aggregate.
|
|
·
|
On
February 17, 2009, we entered into a modification with TRW with regard to
our 5% Convertible Debenture issued to TRW in the amount of
$163,600. Pursuant to the modification, TRW agreed to extend
the maturity date of the debenture from July 14, 2009 to July 14,
2010. As consideration for the modification, we issued TRW a
common stock purchase warrant entitling TRW to purchase 50,000 shares of
our common stock at a per share purchase price of $1.50. The
warrant has a five year term and contains certain anti-dilution provisions
requiring us to adjust the exercise price and number of shares upon the
occurrence of a stock split, stock dividends or stock
consolidation.
|
|
·
|
On
February 17, 2009, we entered into a modification with Craig Dionne, our
Chief Executive Officer and Chairman with regard to our 4% Convertible
Promissory Note issued to Mr. Dionne in the amount of
$35,000. Pursuant to the modification, Mr. Dionne agreed to
extend the maturity date of the Note from December 2, 2008 to December 2,
2009. Mr. Dionne had previously deferred repayment of the
note. As consideration for the modification, we issued Mr.
Dionne a common stock purchase warrant entitling Mr. Dionne to purchase
11,000 shares of our common stock at a per share purchase price of
$1.50. The warrant has a five year term and contains certain
anti-dilution provisions requiring us to adjust the exercise price and
number of shares upon the occurrence of a stock split, stock dividends or
stock consolidation.
|
|
·
|
On
February 19, 2009, we entered into a securities purchase agreement with a
number of accredited investors. Pursuant to the terms of the
securities purchase agreement, we sold the investors 500,000 units in the
aggregate amount of approximately $750,000. The price per unit
was $1.50. Each unit consists of: (i) one share of common
stock; and (ii) one-half common stock purchase warrant. The
warrants have a term of five years and allow the holder to purchase our
common shares at a price per share of $3.00. The warrants also
contain anti-dilution protection in the event of stock splits, stock
dividends and other similar transactions. The provisions
do not provide for any adjustment in the event of subsequent equity sales
or transactions. The warrants are also callable by the Company
in the event the Company’s shares are publically traded in the future and
certain price and volume conditions are
met.
|
|
·
|
On
May 8, 2009, we issued 61,875 common shares to Lyophilization Services of
New England, Inc. as payment for services valued at $74,869 provided in
connection with manufacturing of our first drug
compound. The shares were valued at $1.50 per
share.
|
|
·
|
In
June and July of 2009 we entered into a series of securities purchase
agreements with a number of accredited and institutional
investors. Pursuant to the terms of the agreements, we offered
and sold an aggregate of 2,025,344 units resulting in gross proceeds to us
of approximately $3,038,000. The price per unit was
$1.50. Each unit consists of: (i) one share of common stock;
and (ii) one half common stock purchase warrant. The warrants
have a term of five years and entitle the investors to purchase our common
shares at a price per share of $3.00. The warrants also contain
provisions providing for an adjustment in the underlying number of shares
and exercise price in the event of stock splits or stock dividends and
fundamental transactions. The provisions do not provide for any
adjustment in the event of subsequent equity sales or
transactions. The warrants are also callable in the event our
common stock becomes publically traded and certain other conditions, as
described in the warrants, are met. The Company incurred a
total of $222,050 in fees and expenses incurred in connection with the
transactions. Of this amount, $64,000 was paid through the
issuance of 42,667 units. We also issued a total of 83,895 additional
common stock purchase warrants as compensation to certain
finders. The warrants have the same terms as the investor
warrants. The securities purchase agreements are substantially
similar other than the agreement entered into on June 29, 2009 extended
the expiration of most favored nation treatment from 90 days until
December 31, 2009.
|
|
·
|
On
July 10, 2009, we issued Kemmerer Resources Corp. a common stock purchase
warrant to purchase 150,000 common shares as reimbursement of due
diligence expenses. The warrants have a term of five years and entitle the
investors to purchase our common shares at a price per share of
$3.00. The warrants also contain provisions providing for an
adjustment in the underlying number of shares and exercise price in the
event of stock splits or stock dividends and fundamental
transactions. The provisions do not provide for any adjustment
in the event of subsequent equity sales or
transactions.
|
|
·
|
On
September 2, 2009 we entered a securities purchase agreement with a number
of accredited investors. Pursuant to the terms of the
agreement, the Company sold units in the aggregate of 140,000 units
resulting in gross proceeds of $210,000. The price per unit was
$1.50. Each unit consists of: (i) one share of the Company’s
common stock; and (ii) one half common stock purchase
warrant. The warrants have a term of five years and entitle the
Investors to purchase the Company’s common shares at a price per share of
$3.00. The warrants also contain provisions providing for an
adjustment in the underlying number of shares and exercise price in the
event of stock splits or stock dividends and fundamental
transactions. The provisions do not provide for any adjustment
in the event of subsequent equity sales or transactions. The
warrants are also callable in the event the our common stock becomes
publically traded and certain other conditions, as described in the
warrants, are met. In connection with the offering, we incurred
a total of $23,100 in fees and expenses incurred in connection with the
transaction. Of this amount, $16,000 has been paid through the
issuance of 10,667 units. We also issued warrants to purchase 12,267,
common shares, with identical terms to the warrant, as a partial finder’s
fee in connection with the
offering.
|
|
·
|
The
Company also entered into a Registration Rights Agreement with the
investors granting the Investors certain registration rights with regard
to the Shares and the shares underlying the Warrants. The
Company has fulfilled all of its requirements pursuant to the Registration
Rights Agreements.
|
|
·
|
On
September 2, 2009, in connection with their employment agreements, we
issued Messrs Dionne and Richerson common stock purchase options to
purchase an aggregate of 1,775,000 common shares (
Dionne-1,000,000,
Richerson—775,000
) for a further description of the transaction see
the section of this Report entitled “
Employment Agreements and
Change in Control
.”
|
|
·
|
On
September 2, 2009, we issued certain consultants options to purchase an
aggregate of 125,000 common shares. The options were granted
pursuant to our 2007 Equity Compensation Plan, have an exercise price of
$1.50 per share and are fully vested at the grant date. The
options have a term of 5 years and can be exercised at any time during
their term.
|
|
·
|
On
September 2, 2009, we issued a consultant a warrant to purchase 20,000
common shares. The warrant was issued as compensation for
services related to our clinical trials. The warrant has an
exercise price of $1.50 per share and is fully vested at the grant
date. The warrant has a term of 5
years.
|
|
·
|
On
September 2, 2009, we issued a consultant a warrant to purchase 100,000
common shares. The warrant was issued as compensation for
investor relations services. The warrant has an exercise price
of $1.50 per share and is fully vested at the grant date. The
warrant has a term of 5 years.
|
|
·
|
On
September 2, 2009, we issued one of our service providers 25,000 common
shares as compensation for services relating to the coordination of
clinical trial sites and CRO services. The shares were valued
at $1.50 per share or an aggregate consideration of
$37,500.
|
|
·
|
On
November 2, 2009, we issued TR Winston & Company, LLC, 174,165 common
shares as payment in full ($163,500 principal and $10,565 accrued
interest) of its 5% convertible debenture dated July 14,
2009.
|
|
·
|
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 553,407 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 of $70,410 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.
|
ITEM
6.
|
SELECTED
FINANCIAL DATA
|
ITEM
7.
|
MANAGEMENT’S
DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF
OPERATIONS
|
|
·
|
Overview —
Discussion of our business and plan of operations, overall analysis
of financial and other highlights affecting our business in order to
provide context for the remainder of
MD&A.
|
|
·
|
Significant Accounting
Policies —
Accounting policies that we believe are important to
understanding the assumptions and judgments incorporated in our reported
financial results and forecasts.
|
|
·
|
Results of Operations
—
Analysis of our financial results comparing 2009 to
2008.
|
|
·
|
Liquidity and Capital
Resources —
A discussion of our financial condition and
potential sources of liquidity.
|
|
|
|
|
|
Change in
|
|
||||||||||
|
|
|
|
|
|
2009
|
|
|||||||||
Versus 2008
|
||||||||||||||||
2009
|
2008
|
$
|
%
|
|||||||||||||
Operating
Expenses
|
||||||||||||||||
General
and administrative expenses
|
$
|
1,424,847
|
$
|
854,294
|
$
|
570,553
|
66.8
|
% | ||||||||
Research
and development
|
2,087,134
|
2,432,991
|
(345,857
|
) |
(14.2
|
)% | ||||||||||
Total
expense
|
$
|
3,511,981
|
$
|
3,287,285
|
$
|
224,696
|
6.8
|
% |
|
|
|
|
|
Change in
|
|
||||||||||
|
|
|
|
|
|
2009
|
|
|||||||||
|
|
|
|
|
|
Versus 2008
|
|
|||||||||
|
|
2009
|
|
|
2008
|
|
|
$
|
|
|
%
|
|
||||
Other
Expenses
|
||||||||||||||||
Financing
Cost
|
$
|
(478,886
|
) |
$
|
(39,789
|
)
|
$
|
(439,097
|
) |
1104
|
% | |||||
Change
in fair value of derivative liablity
|
(1,140,094
|
) |
-
|
(1,140,094
|
) |
-
|
||||||||||
Interest
income (expense)
|
(1,886
|
) |
813
|
(2,699
|
) |
331
|
% | |||||||||
Total
expense
|
$
|
(1,620,846
|
) |
$
|
(38,976
|
)
|
$
|
(1,581,870
|
) |
4058
|
% |
Change in
|
||||||||||||||||
2009
|
||||||||||||||||
Versus 2008
|
||||||||||||||||
2009
|
2008
|
$
|
%
|
|||||||||||||
Cash
& Cash Equivalents
|
$
|
2,255,311
|
$
|
534,290
|
$
|
1,721,021
|
322.1
|
% | ||||||||
Net
cash used in operating activities
|
$
|
(2,010,483
|
) |
$
|
(2,649,977
|
) |
$
|
639,494
|
24.1
|
% | ||||||
Net
cash used in investing activities
|
$
|
(15,833
|
) |
$
|
(184,168
|
) |
$
|
168,335
|
91.4
|
% | ||||||
Net
cash provided by financing activities
|
$
|
3,747,337
|
$
|
2,778,000
|
$
|
969,337
|
34.9
|
% |
|
·
|
During November of 2007, we sold
an aggregate of 1,300,000 common shares resulting in gross proceeds of
$650,000.
|
|
·
|
During March of 2008, we issued
1,000,000 common shares upon the exercise of outstanding warrants which
resulted in gross proceeds to us of
$500,000.
|
|
·
|
During July and August of 2008,
we sold an aggregate of 2,320,000 units resulting in gross proceeds of
$2,320,000.
|
|
·
|
In February and April of 2009, we
sold 500,000 units resulting in gross proceeds of approximately
$750,000.
|
|
·
|
In June and July of 2009, we sold
2,025,344 units resulting in gross proceeds of approximately
$3,038,000.
|
|
·
|
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.
|
ITEM
7A.
|
QUANTITATIVE
AND QUALITATIVE DISCLOSURE ABOUT MARKET
RISK
|
ITEM
8.
|
FINANCIAL
STATEMENTS AND SUPPLEMENTARY DATA
|
Page
|
||
Report
of RBSM, LLP, Independent Registered Public Accounting
Firm
|
F-1
|
|
Balance Sheets
|
F-2
|
|
Statements of Losses |
F-3
|
|
Statements of Stockholders’
Equity
|
F-4
|
|
Statements of Cash Flows |
F-5
|
|
Notes to
Financial Statements
|
F-6
|
/s/
RBSM
LLP
|
|
RBSM LLP | |
New
York, New York
|
|
March
30, 2010
|
December 31,
|
December 31,
|
|||||||
2009
|
2008
|
|||||||
Assets
|
||||||||
Current
assets:
|
||||||||
Cash
|
$ | 2,255,311 | $ | 534,290 | ||||
Total
current assets
|
2,255,311 | 534,290 | ||||||
Fixed
assets, net of accumulated depreciation of $708 and $0
|
15,125 | - | ||||||
Intangible
assets, net of accumulated amortization of $26,858 and
$11,511
|
157,310 | 172,657 | ||||||
Total
assets
|
$ | 2,427,746 | $ | 706,947 | ||||
Liabilities
and stockholders' equity (deficit)
|
||||||||
Current
liabilities:
|
||||||||
Accounts
payable and accrued expenses
|
$ | 78,198 | $ | 238,817 | ||||
Accrued
interest - stockholder
|
8,107 | 5,399 | ||||||
Convertible
note payable - stockholder, current portion
|
35,000 | 50,000 | ||||||
Total
current liabilities
|
121,305 | 294,216 | ||||||
Convertible
note payable, net of discount of $0 and $11,046
|
- | 152,554 | ||||||
Convertible
notes payable - stockholder, long term portion
|
70,000 | 105,000 | ||||||
Derivative
liabilities
|
2,290,686 | - | ||||||
Total
liabilities
|
2,481,991 | 551,770 | ||||||
Commitments
and contingencies
|
||||||||
Stockholders'
equity (deficit):
|
||||||||
Preferred
stock, par value $.0001 per share; 10,000,000 shares
authorized,
|
||||||||
none
issued and outstanding
|
- | - | ||||||
Common
stock, par value $.0001 per share; 80,000,000 shares
authorized,
|
||||||||
15,466,446
and 12,486,718 shares issued and outstanding
|
1,547 | 1,249 | ||||||
Additional
paid-in capital
|
10,135,737 | 4,922,174 | ||||||
Deficit
accumulated during the development stage
|
(10,191,529 | ) | (4,768,246 | ) | ||||
Total
stockholders' equity (deficit)
|
(54,245 | ) | 155,177 | |||||
Total
liabilities and stockholders' equity (deficit)
|
$ | 2,427,746 | $ | 706,947 |
Cumulative Period
|
||||||||||||
from November 21, 2003
|
||||||||||||
(date of inception) to
|
||||||||||||
Years ended December 31,
|
December 31,
|
|||||||||||
2009
|
2008
|
2009
|
||||||||||
Operating
expenses:
|
||||||||||||
General
and administrative expenses
|
$ | 1,424,847 | $ | 854,294 | $ | 2,714,389 | ||||||
Research
and development
|
2,087,134 | 2,432,991 | 5,511,541 | |||||||||
Total
operating expenses
|
3,511,981 | 3,287,285 | 8,225,930 | |||||||||
Loss
from operations
|
(3,511,981 | ) | (3,287,285 | ) | (8,225,930 | ) | ||||||
Finance
cost
|
(478,886 | ) | (39,789 | ) | (518,675 | ) | ||||||
Change
in fair value of derivative liability
|
(1,140,094 | ) | - | (1,430,550 | ) | |||||||
Interest
income (expense), net
|
(1,866 | ) | 813 | (16,374 | ) | |||||||
Loss
before provision for income taxes
|
(5,132,827 | ) | (3,326,261 | ) | (10,191,529 | ) | ||||||
Provision
for income taxes
|
- | - | - | |||||||||
Net
loss
|
$ | (5,132,827 | ) | $ | (3,326,261 | ) | $ | (10,191,529 | ) | |||
Net
loss per common share, basic and diluted
|
$ | (0.37 | ) | $ | (0.30 | ) | ||||||
Weighted
average shares outstanding
|
14,035,916 | 11,030,657 |
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 for derivative
liability
|
- | - | (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 | ) |
Cumulative Period
|
||||||||||||
from
November 21, 2003
|
||||||||||||
(date of inception) to
|
||||||||||||
Years ended December 31,
|
December 31,
|
|||||||||||
2009
|
2008
|
2009
|
||||||||||
Cash
flows from operating activities:
|
||||||||||||
Net
loss
|
$ | (5,132,827 | ) | $ | (3,326,261 | ) | $ | (10,191,529 | ) | |||
Adjustments
to reconcile net loss to net
|
||||||||||||
cash
used in operating activities:
|
||||||||||||
Depreciation
and amortization
|
16,055 | 11,511 | 27,566 | |||||||||
Stock
based compensation
|
1,634,655 | 363,743 | 2,480,344 | |||||||||
Warrants
issued for financing costs
|
467,840 | - | 467,840 | |||||||||
Change
in fair value of derivative liability
|
1,140,094 | - | 1,430,550 | |||||||||
Contributed
services
|
- | 50,000 | 774,000 | |||||||||
Amortization
of debt discount
|
11,046 | 9,629 | 20,675 | |||||||||
Changes
in assets and liabilities:
|
||||||||||||
(Decrease)
increase in accounts payable and accrued expenses
|
(147,346 | ) | 241,401 | 112,729 | ||||||||
Cash
used in operating activities
|
(2,010,483 | ) | (2,649,977 | ) | (4,877,825 | ) | ||||||
Cash
flows from investing activities:
|
||||||||||||
Acquisition
of property and equipment
|
(15,833 | ) | - | (15,833 | ) | |||||||
Acquisition
of intangibles
|
- | (184,168 | ) | (184,168 | ) | |||||||
Cash
used in investing activities
|
(15,833 | ) | (184,168 | ) | (200,001 | ) | ||||||
Cash
flows from financing activities:
|
||||||||||||
Proceeds
from sale of common stock and warrants
|
3,797,337 | 2,778,000 | 7,228,137 | |||||||||
Proceeds
from convertible notes - stockholder
|
- | - | 155,000 | |||||||||
Repayments
of convertible notes - stockholder
|
(50,000 | ) | - | (50,000 | ) | |||||||
Cash
provided by financing activities
|
3,747,337 | 2,778,000 | 7,333,137 | |||||||||
Net
increase (decrease) in cash
|
1,721,021 | (56,145 | ) | 2,255,311 | ||||||||
Cash,
beginning of period
|
534,290 | 590,435 | - | |||||||||
Cash,
end of period
|
$ | 2,255,311 | $ | 534,290 | $ | 2,255,311 | ||||||
Supplemental
cash flow information:
|
||||||||||||
Cash
paid for interest
|
$ | 3,537 | $ | - | ||||||||
Cash
paid for income taxes
|
$ | - | $ | - | ||||||||
Non-cash
investing and financing activities:
|
||||||||||||
Common
stock units issued as payment of placement fees
|
$ | 80,000 | $ | - | ||||||||
Warrants
issued as payment of placement fees
|
78,503 | - | ||||||||||
Common
stock issued as payment of convertible note
|
163,600 | - | ||||||||||
Accrued
interest paid with common stock
|
10,565 | 15,859 | ||||||||||
Convertible
note issued as payment of placement fees
|
- | 163,600 | ||||||||||
Fair
value of warrants issued with convertible debt recorded
|
||||||||||||
as
debt discount
|
- | 20,675 |
Fair Value at
|
Fair Value Measurement Using
|
|||||||||||||||
December 31,
2009
|
Level 1
|
Level 2
|
Level 3
|
|||||||||||||
Convertible
notes payable
|
$
|
105,000
|
$
|
—
|
$
|
—
|
$
|
105,000
|
||||||||
Warrant
derivative liability
|
|
2,290,686
|
—
|
—
|
2,290,686
|
|||||||||||
$
|
2,395,686
|
$
|
—
|
$
|
—
|
$
|
2,395,686
|
December 31,
2009
|
December 31,
2008
|
|||||||
Office
equipment
|
$ | 15,833 | $ | - | ||||
Accumulated
depreciation
|
(708 | ) | - | |||||
Carrying
value
|
$ | 15,125 | $ | - |
2009
|
2008
|
|||||||||||||||
Number
|
Weighted
Average
Exercise Price
|
Number
|
Weighted
Average Exercise
Price
|
|||||||||||||
Outstanding
at beginning of the period
|
659,000
|
$
|
0.51
|
—
|
$
|
—
|
||||||||||
Granted
during the period
|
1,900,000
|
1.58
|
675,000
|
0.51
|
||||||||||||
Exercised
during the period
|
—
|
—
|
—
|
—
|
||||||||||||
Terminated
during the period
|
—
|
—
|
(16,000
|
)
|
0.50
|
|||||||||||
Outstanding
at end of the period
|
2,559,000
|
$
|
1.30
|
659,000
|
$
|
0.51
|
||||||||||
Exercisable
at end of the period
|
1,604,000
|
$
|
1.19
|
424,000
|
$
|
0.52
|
2009
|
2008
|
|||||||||||||||
Number
|
Weighted
Average
Exercise Price
|
Number
|
Weighted
Average Exercise
Price
|
|||||||||||||
Outstanding
at beginning of the period
|
2,570,200
|
$
|
1.61
|
—
|
$
|
—
|
||||||||||
Granted
during the period
|
2,293,270
|
2.55
|
3,570,200
|
1.30
|
||||||||||||
Exercised
during the period
|
—
|
—
|
(1,000,000
|
)
|
0.50
|
|||||||||||
Terminated
during the period
|
—
|
—
|
—
|
—
|
||||||||||||
Outstanding
at end of the period
|
4,863,470
|
$
|
1.90
|
2,570,200
|
$
|
1.61
|
||||||||||
Exercisable
at end of the period
|
4,863,470
|
$
|
1.90
|
2,570,200
|
$
|
1.61
|
Range of Exercise Prices
|
Remaining
Number
Outstanding
|
Weighted Average
Contractual Life
(Years)
|
Weighted
Average
Exercise Price
|
|||||||||
$0.50
- $1.00
|
1,659,000
|
3.7
|
$
|
0.81
|
||||||||
$1.50
- $2.00
|
4,157,954
|
5.0
|
$
|
1.54
|
||||||||
$3.00
|
1,605,516
|
4.5
|
$
|
3.00
|
2009
|
2008
|
|||||||
Deferred
tax assets:
|
||||||||
Net
operating loss carryforward
|
1,730,000
|
1,078,000
|
||||||
Tax
credits
|
159,000
|
105,000
|
||||||
Valuation
allowance
|
(1,889,000
|
)
|
(1,183,000
|
)
|
||||
Net
deferred tax assets
|
$
|
-
|
$
|
-
|
||||
Statutory
federal income tax rate
|
-34
|
%
|
-34
|
%
|
||||
State
income taxes, net of federal taxes
|
-0
|
%
|
-0
|
%
|
||||
Non-deductible
items
|
21
|
%
|
4
|
%
|
||||
Tax
credits
|
1
|
%
|
3
|
%
|
||||
Valuation
allowance
|
12
|
%
|
27
|
%
|
||||
Effective
income tax rate
|
0
|
%
|
0
|
%
|
(a)
|
Operating
Leases
|
Fiscal year
ending
December 31,
|
Mini
mum
Lease
Comm
itments
|
|||
2010
|
$ | 17,488 | ||
2011
|
18,764 | |||
2012 | 13,080 | |||
$ | 49,332 |
(b)
|
Employment
Agreements
|
Chief Executive
Officer
|
Chief Operating
Officer
|
|||||||
Terminated
without cause
|
$ | 720,000 | $ | 300,000 | ||||
Terminated,
change of control without good reason
|
1,440,000 | - | ||||||
Disability
|
240,000 | 200,000 |
ITEM
9.
|
CHANGES
IN AND DISAGREEMENTS WITH ACCOUNTANTS ON ACCOUNTING AND FINANCIAL
DISCLOSURE
|
ITEM
9A.
|
CONTROLS
AND PROCEDURES
|
|
·
|
pertain
to the maintenance of records that in reasonable detail accurately and
fairly reflect the transactions and dispositions of the assets of the
Company;
|
|
·
|
provide
reasonable assurance that transactions are recorded as necessary to permit
preparation of financial statements in accordance with generally accepted
accounting principles, and that receipts and expenditures of the Company
are being made only in accordance with authorizations of management and
directors of the Company; and
|
|
·
|
provide
reasonable assurance regarding prevention or timely detection of
unauthorized acquisition, use or disposition of the Company’s assets that
could have a material effect on the financial
statements.
|
ITEM 9B
|
OTHER
INFORMATION
|
ITEM
10.
|
DIRECTORS,
EXECUTIVE OFFICERS AND CORPORATE
GOVERNANCE
|
Name
|
|
Principal Occupation
|
|
Age
|
|
Director
Since
|
Craig
A. Dionne, PhD
|
Chief
Executive Officer, Chief Financial Officer, President and Director of
GenSpera
|
52
|
11/03
|
|||
John
M. Farah, Jr., PhD
|
Vice
President Intercontinental Operations at Cephalon (NASDAQ:
CEPH)
|
57
|
02/08
|
|||
Scott
Ogilvie
|
President
and CEO of Gulf Enterprises International, Ltd.
|
56
|
02/08
|
Name
|
|
Position
|
|
Age
|
|
Position Since
|
Craig
A. Dionne, PhD
|
Chief
Executive Officer, Chief Financial Officer and President
|
52
|
11/03
|
|||
Russell
Richerson, PhD
|
Chief
Operating Officer and Secretary
|
57
|
07/08
|
Director
|
Audit Committee
|
Nominating
and Corporate
Governance
Committee
|
Leadership
Development
and Compensation
Committee
|
|||
Scott
V. Ogilvie
|
Chair
|
Member
|
Member
|
|||
John
M. Farah, Jr., Ph.D
|
Member
|
Chair
|
Chair
|
|
·
|
Selecting
and hiring our independent
auditors.
|
|
·
|
Evaluating
the qualifications, independence and performance of our independent
auditors.
|
|
·
|
Approving
the audit and non-audit services to be performed by our independent
auditors.
|
|
·
|
Reviewing
the design, implementation, adequacy and effectiveness of our internal
controls and our critical accounting
policies.
|
|
·
|
Overseeing
and monitoring the integrity of our financial statements and our
compliance with legal and regulatory requirements as they relate to
financial statements or accounting
matters.
|
|
·
|
Reviewing
with management any earnings announcements and other public announcements
regarding our results of
operations.
|
|
·
|
Reviewing
regulatory filings with management and our
auditors.
|
|
·
|
Preparing
any report the SEC requires for inclusion in our annual proxy
statement.
|
|
·
|
Evaluating
the composition, size, organization and governance of our board of
directors and its committees, determining future requirements, and making
recommendations regarding future planning, the appointment of directors to
our committees and selection of chairs of these
committees.
|
|
·
|
Reviewing
and recommending to our board of directors director independence
determinations made with respect to continuing and prospective
directors.
|
|
·
|
Establishing
a policy for considering stockholder nominees for election to our board of
directors.
|
|
·
|
Recommending
ways to enhance communications and relations with our
stockholders.
|
|
·
|
Evaluating
and recommending candidates for election to our board of
directors.
|
|
·
|
Overseeing
our board of directors’ performance and self-evaluation process and
developing continuing education programs for our
directors.
|
|
·
|
Evaluating
and recommending to the board of directors termination of service of
individual members of the board of directors as appropriate, in accordance
with governance principles, for cause or for other proper
reasons.
|
|
·
|
Making
regular written reports to the board of
directors.
|
|
·
|
Reviewing
and reexamining the committee’s charter and making recommendations to the
board of directors regarding any proposed
changes.
|
|
·
|
Reviewing
annually the committee’s own performance against responsibilities outlined
in its charter and as otherwise established by the board of
directors.
|
|
·
|
Reviewing
and approving our general compensation
strategy.
|
|
·
|
Establishing
annual and long-term performance goals for our CEO and other executive
officers.
|
|
·
|
Conducting
and reviewing with the board of directors an annual evaluation of the
performance of the CEO and other executive
officers.
|
|
·
|
Evaluating
the competitiveness of the compensation of the CEO and the other executive
officers.
|
|
·
|
Reviewing
and making recommendations to the board of directors regarding the salary,
bonuses, equity awards, perquisites and other compensation and benefit
plans for the CEO.
|
|
·
|
Reviewing
and approving all salaries, bonuses, equity awards, perquisites and other
compensation and benefit plans for our other executive
officers.
|
|
·
|
Reviewing
and approving the terms of any offer letters, employment agreements,
termination agreements or arrangements, change-in-control agreements,
indemnification agreements and other material agreements between the
company and our executive officers.
|
|
·
|
Acting
as the administering committee for our stock and bonus plans and for any
equity or cash compensation arrangements that we may adopted from time to
time.
|
|
·
|
Providing
oversight for our overall compensation plans and benefit programs,
monitoring trends in executive and overall compensation and making
recommendations to the board of directors with respect to improvements to
such plans and programs or the adoption of new plans and
programs.
|
|
·
|
Reviewing
and approving compensation programs as well as salaries, fees, bonuses and
equity awards for non-employee members of the board of
directors.
|
|
·
|
Reviewing
plans for the development, retention and succession of our executive
officers.
|
|
·
|
Reviewing
executive education and development
programs.
|
|
·
|
Monitoring
total equity usage for compensation and establishing appropriate equity
dilution levels.
|
|
·
|
Reporting
regularly to the board of directors on the committee’s
activities.
|
|
·
|
Reviewing
and discussing with management the any required annual compensation
discussion and analysis disclosure, if any, regarding named executive
officer compensation and, based on this review and discussions, making a
recommendation to include in our annual public
filings.
|
|
·
|
Preparing
and approving any required committee report to be included in our annual
public filings.
|
|
·
|
Performing
a review, at least annually, of the performance of the committee and its
members and reporting to the board of directors on the results of this
review.
|
|
·
|
Investigating
any matter brought to its attention, with full access to all our books,
records, facilities and employees and obtaining advice, reports or
opinions from internal or external counsel and expert advisors in order to
help it perform its
responsibilities.
|
|
(a)
|
as
to each person whom the stockholder proposes to nominate for election as a
director (i) the name, age, business address and residence address of the
person, (ii) the principal occupation or employment of the person, (iii)
the class or series and number of shares of capital stock of the
corporation which are owned beneficially or of record by the person, (iv)
a description of all arrangements or understandings between the
stockholder and each nominee and any other person or persons (naming such
person or persons) pursuant to which the nominations are to be made by the
stockholder, and (v) any other information relating to such person that is
required to be disclosed in solicitations of proxies for elections of
directors, or is otherwise required, in each case pursuant to Regulation
14A under the Exchange Act (including without limitation such person’s
written consent to being named in the proxy statement, if any, as a
nominee and to serving as a director if elected);
and
|
|
(b)
|
as
to such stockholder giving notice, the information required to be provided
pursuant to our Bylaws.
|
ITEM
11.
|
EXECUTIVE
COMPENSATION
|
Name and
principal
position
|
Year
|
Salary
($)
|
Bonus
($)
|
Stock
Awards
($)
|
Option
Award
($)
|
Nonequity
Incentive
Plan
compensation
($)
|
Non-qualified
deferred
compensation
earning
($)
|
All other
Compensation
($) (4)
|
Total
($)
|
|||||||||||||||||||||||||
Craig
Dionne, PhD
Chief
Executive
Officer/Chief
Financial Officer
|
2009
|
240,000 | 918,413 | (2) | 23,369 | 1,181,782 | ||||||||||||||||||||||||||||
2008
|
240,000 | 20,000 | ||||||||||||||||||||||||||||||||
Russell
Richerson, PhD
Chief
Operating Officer
Secretary
|
2009
|
200,000 | 720,415 | (3) | 10,796 | 931,211 | ||||||||||||||||||||||||||||
2008
|
100,000 | (1) | 100,000 |
(1)
|
During
2008, Dr. Richerson forwent second quarter compensation in the amount of
$50,000. Dr. Richerson began receiving a salary in July of
2008.
|
(2)
|
Mr.
Dionne was awarded an option grant on September 2, 2009 in the amount of
1,000,000 shares. The grant was valued using the Black-Sholes option
pricing model with the following assumptions: (i) exercise price of $1.65
per share; (ii) fair value of a share of common stock of $1.17; (iii)
volatility of 188%; (iv) dividend rate of 0%; (v) risk free interest rate
of 1%; and (vi) estimated life of 2 years. 500,000 options vested upon
grant and 500,000 options will vest upon the attainment of certain
milestones. The option lapse if unexercised on September 2,
2016.
|
(3)
|
Mr.
Richerson was awarded an option grant on September 2, 2009 in the amount
of 775,000 shares. The grant was valued using the Black-Sholes option
pricing model with the following assumptions: (i) exercise price of $1.50
per share; (ii) fair value of a share of common stock of $1.17; (iii)
volatility of 188%; (iv) dividend rate of 0%; (v) risk free interest rate
of 1%; and (vi) estimated life of 2 years. 400,000 options vested upon
grant and 375,000 options will vest upon the attainment of certain
milestones. The option lapse if unexercised on September 2,
2016.
|
(4)
|
Represents
payments for medical
insurance.
|
Option Awards
|
Stock Awards
|
||||||||||||||||||||||||||||||||
Name
(a)
|
Number of
securities
underlying
unexercised
options
(#)
exercisable
(b)
|
Number of
securities
underlying
unexercised
options
(#)
unexercisable
(c)
|
Equity
incentive
plan
awards:
Number of
securities
underlying
unexercised
unearned
options
(#)
(d)
|
Option
exercise
price
($)
(e)
|
Option
expiration
date
(f)
|
Number
of shares
or units
of stock
that have
not
vested
(#)
(g)
|
Market
value of
shares of
units of
stock that
have not
vested
($)
(h)
|
Equity
incentive
plan
award:
Number
of un-
earned
shares,
units or
other
rights that
have not
vested
(#)
(i)
|
Equity
incentive
plan
awards:
Market or
payout
value of
unearned
shares,
units or
other
rights that
have not
vested
($)
(j)
|
||||||||||||||||||||||||
|
|
||||||||||||||||||||||||||||||||
Craig
Dionne, PhD
Chief
Executive
Officer/Chief
Financial Officer
|
500,000 | 500,000 | $ | 1.65 |
09/02/16
|
||||||||||||||||||||||||||||
Russell
Richerson, PhD
Chief
Operating Officer, Secretary
|
400,000 | 375,000 | $ | 1.50 |
09/02/16
|
|
·
|
Options
to purchase an aggregate of 500,000 shares were vested
immediately. The options represent compensation for prior
services and an inducement
grant.
|
|
·
|
150,000
options vest upon: (i) the Company’s Common Stock becoming listed on a
national exchange or on the Over-the-Counter Bulletin Board; and (ii) the
enrollment of the first patient in a Phase 1 clinical trial for G-202
(
This milestone was
achieved on January 19,
2010
.)
|
|
·
|
200,000
options vest upon: (i) enrollment of first patient in a second Phase 1
clinical trial; (ii) enrollment of first patient in a Phase II clinical
trial or an expanded cohort in a Phase 1B clinical trial; or
(iii) enrollment of tenth patient in a Phase II clinical trial or in an
expanded cohort in a phase 1B clinical
trial.
|
|
·
|
150,000
options vest upon an additional: (i) enrollment of first patient in a
second Phase 1 clinical trial; (ii) enrollment of first patient in a Phase
II clinical trial or an expanded cohort in a Phase 1B clinical
trial; or (iii) enrollment of tenth patient in a Phase II
clinical trial or in an expanded cohort in a phase 1B clinical trial. (for
purposes of clarity, these milestones are in addition to those required
for the vesting of options to purchase 200,000 shares of Common Stock as
contained in the paragraph immediately
above)
|
Officer
|
Salary
|
Bonus
|
Health
|
Accelerated
Vesting of
Options
|
Total
|
|||||||||||||||
Craig
Dionne
|
||||||||||||||||||||
Terminated
without cause (1)
|
$
|
720,000
|
(2)
|
$
|
0
|
(3)
|
$
|
54,000
|
(4)
|
$
|
1,150,000
|
(5)
|
$
|
774,000
|
||||||
Terminated,
change of control (6)
|
$
|
1,440,000
|
$
|
0
|
(3)
|
$
|
54,000
|
(4)
|
$
|
1,150,000
|
(5)
|
$
|
1,494,000
|
|||||||
Disability
|
$
|
240,000
|
—
|
—
|
—
|
$
|
240,000
|
|||||||||||||
Other
|
—
|
—
|
—
|
—
|
—
|
(1)
|
Also
includes termination by Mr. Dionne with Good
Reason
|
(2)
|
Represents
36 months of Mr. Dionne’s base
salary.
|
(3)
|
There
has been no bonus established for the current
year.
|
(4)
|
Represents
36 months of Mr. Dionne’s monthly health care reimbursement of
$1,500.
|
(5)
|
There
does not presently exist a market for the Company’s
securities. In the event of termination, Mr. Dionne’s 1,000,000
common stock options would vest and would remain exercisable for their
term.
|
(6)
|
Assumes
termination without cause or good
reason.
|
|
·
|
Options
to purchase an aggregate of 350,000 shares were vested
immediately. The options represent compensation for prior
services and an inducement grant.
|
|
·
|
112,500
options vest upon: (i) development of a plan acceptable to the Company’s
CEO for the synthesis and/or purification of G-202 bulk from first
synthesis to enough G-202 API to complete Phase I and Phase II clinical
trials for G-202; (ii) develop and implement plan to define site and
studies for G-202 propagation and determination of Thapsigargin
distribution in plan parts; (iii) the Company’s Common Stock
becoming listed on a national exchange or on the Over-the-Counter Bulletin
Board; and (iv) the enrollment of the first patient in a Phase 1 clinical
trial for G-202.
|
|
·
|
150,000
options vest upon: (i) enrollment of first patient in a second Phase 1
clinical trial; (ii) enrollment of first patient in a Phase II clinical
trial or an expanded cohort in a Phase 1B clinical trial; or
(iii) enrollment of tenth patient in a Phase II clinical trial or in an
expanded cohort in a phase 1B clinical
trial.
|
|
·
|
112,500
options vest upon an additional: (i) enrollment of first patient in a
second Phase 1 clinical trial; (ii) enrollment of first patient in a Phase
II clinical trial or an expanded cohort in a Phase 1B clinical
trial; or (iii) enrollment of tenth patient in a Phase II
clinical trial or in an expanded cohort in a phase 1B clinical trial. (for
purposes of clarity, these milestones are in additional to those required
for the vesting of options to purchase 150,000 shares of Common Stock as
contained in the paragraph immediately
above)
|
Officer
|
Salary
|
Bonus
|
Health
|
Accelerated
Vesting of
Options
|
Total
|
|||||||||||||||
Russell
Richerson
|
||||||||||||||||||||
Terminated
without cause (1)
|
$
|
300,000
|
(2)
|
$
|
0
|
(3)
|
$
|
27,000
|
(4)
|
$
|
1,007,500
|
(5)
|
$
|
327,000
|
||||||
Terminated,
change of control
|
—
|
—
|
—
|
1,007,500
|
(5)
|
—
|
||||||||||||||
Disability
|
$
|
200,000
|
—
|
—
|
—
|
$
|
200,000
|
|||||||||||||
Other
|
—
|
—
|
—
|
—
|
—
|
(1)
|
Also
includes termination by Mr. Richerson with Good
Reason
|
(2)
|
Represents
18 months of Mr. Richerson’s base
salary.
|
(3)
|
There
has been no bonus established for the current
year.
|
(4)
|
Represents
18 months of Mr. Richerson’s monthly health care reimbursement of
$1,500.
|
(5)
|
There
does not presently exist a market for the Company’s
securities. In the event of termination, Mr. Richerson’s
775,000 common stock options would vest and would remain exercisable for
their term.
|
ITEM
12.
|
SECURITY
OWNERSHIP OF CERTAIN BENEFICIAL OWNERS AND MANAGEMENT AND RELATED
STOCKHOLDER MATTERS
|
·
|
each
person, or group of affiliated persons, known by us to be the beneficial
owner of 5% or more of any class of our voting
securities;
|
·
|
each
of our current directors and
nominees;
|
·
|
each
of our current named executive officers;
and
|
·
|
all
current directors and named executive officers as a
group.
|
Common Stock
|
||||||||||
Name and Address of Beneficial Owner(1)
|
Shares
|
Shares
Underlying
Convertible
Securities(2)
|
Total
|
Percent of
Class(2)
|
||||||
Directors
and named executive officers
|
||||||||||
Craig
Dionne, PhD
|
2,438,662
|
889,172
|
3,327,834
|
19.7%
|
||||||
Russell
B. Richerson, PhD
|
925,000
|
512,500
|
1,437,500
|
8.7%
|
||||||
John
M. Farah, PhD
|
-
|
100,000
|
100,000
|
0.6%
|
||||||
Scott
Ogilvie
|
-
|
115,000
|
115,000
|
0.7%
|
||||||
All
directors and executive officers as a group
(4 persons)
|
3,363,662
|
1,616,672
|
4,980,334
|
28.2%
|
||||||
Beneficial
Owners of 5% or more
|
||||||||||
John
T. Isaacs, PhD(4)
|
1,271,528
|
45,000
|
1,316,528
|
8.2%
|
||||||
Samuel
R. Denmeade, M.D (5)
|
1,271,528
|
45,000
|
1,316,528
|
8.2%
|
*
|
Less
than one percent.
|
(1)
|
Except
as otherwise indicated, the persons named in this table have sole voting
and investment power with respect to all shares of common stock shown as
beneficially owned by them, subject to community property laws where
applicable and to the information contained in the footnotes to this
table. Unless otherwise indicated, the address of the beneficial owner is
GenSpera, Inc., 2511 N Loop 1604 W, Suite 204, San Antonio, TX 78258 San
Antonio, TX 78258
|
(2)
|
Pursuant
to Rules 13d-3 and 13d-5 of the Exchange Act, beneficial ownership
includes any shares as to which a shareholder has sole or shared voting
power or investment power, and also any shares which the shareholder has
the right to acquire within 60 days, including upon exercise of common
shares purchase options or warrant. There are 16,033,187 shares of common
stock issued and outstanding as of March 22,
2010.
|
(3)
|
5050
East Gleneagles Drive, Tucson, AZ
85718
|
(4)
|
13638
Poplar Hill Road, Phoenix, MD 21131
|
(5)
|
5112
Little Creek Drive, Ellicott City, MD
21043
|
ITEM
13.
|
CERTAIN
RELATIONSHIPS AND RELATED TRANSACTIONS, AND DIRECTOR
INDEPENDENCE
|
|
·
|
On
January 7, 2008, we granted 100,000 shares of common stock, valued at
$50,000, to a Mr. Burgoon, a former director, as compensation for serving
on the board. The shares vested upon
grant.
|
|
·
|
On
February 1, 2008, we granted each of Messrs Isaacs and Denmeade, our
Scientific Advisors, common stock purchase options to purchased 60,000
shares, as compensation for joining the Company’s scientific advisory
board. The options have an exercise price of $0.50 per share. The
options vest in equal installments quarterly over a period of three years
commencing March 31, 2008, and lapse if unexercised on January
31, 2018.
|
|
·
|
In
March of 2008, we granted options to purchase an aggregate of 300,000
(100,000 each) common shares to our directors Messrs Farah and Ogilvie as
well as our former director Mr. Burgoon. Each director received options to
purchase 100,000 common shares at an exercise price of $0.50 per share.
Each director’s grant vests 50,000 upon grant with the balance vesting
quarterly over a period of two years commencing March 31, 2008, and lapses
if unexercised on April 1,
2018.
|
|
·
|
On March 7, 2008, we issued
31,718 shares of common stock to our Chief Executive Officer and
President, Craig A. Dionne, Ph.D., as payment of accrued interest in the
amount of $15,859.
|
|
·
|
On
March 11, 2008 we exercised our option to license certain intellectual
property from Messrs Isaacs and Denmeade. As consideration for the option
exercise, we paid each of Isaacs and Denmeade: (i) $37,995.90 which they
immediately transferred to John Hopkins University as repayment of past
patent costs; and (ii) $18,997 as a “gross-up” to pay for relevant tax
consequences of the option exercise
payment.
|
|
·
|
In
April of 2008, Messrs Isaacs and Denmeade transferred to the Company their
interest in the intellectual property licensed on March 11,
2008.
|
|
·
|
In
October of 2008, we granted options to purchase an aggregate of 15,000
common shares to our director Scott Ogilvie at an exercise price of $1.00
per share. The options vested on the date of grant and lapse if
unexercised on October 16, 2018.
|
|
·
|
On
February 17, 2009, we entered into a modification with Craig Dionne, our
Chief Executive Officer and Chairman with regard to our 4% Convertible
Promissory Note issued to Mr. Dionne in the amount of
$35,000. Pursuant to the modification, Mr. Dionne agreed to
extend the maturity date of the Note from December 2, 2008 to December 2,
2009. Mr. Dionne had previously deferred repayment of the
note. As consideration for the modification, we issued Mr.
Dionne a common stock purchase warrant entitling Mr. Dionne to purchase
11,000 shares of our common stock at a per share purchase price of
$1.50. The warrant has a five year term and contains certain
anti-dilution provisions requiring us to adjust the exercise price and
number of shares upon the occurrence of a stock split, stock dividends or
stock consolidation.
|
|
·
|
On
September 2, 2009, we issued Messrs Dionne and Richerson common stock
purchase options to purchase an aggregate of 1,775,000 common
shares. For a further description of the grant, refer to the
section of this registration statement entitled “
Employment Agreements and
Change of Control.”
|
|
·
|
On
September 2, 2009, we entered into indemnification agreements with our
Executive Officers.
|
|
·
|
On
September 28, 2009, we paid off the promissory note payable to Craig
Dionne, our Chief Executive Officer, that was originally entered into on
September 29, 2004. The balance of the note, including
principal and interest was $15,996.
|
|
·
|
On
December 2, 2009, we paid off the promissory note payable to Craig Dionne,
our Chief Executive Officer, that was originally entered into on December
2, 2003. The balance of the note, including principal and
interest was $37,462.
|
|
·
|
As
of December 31, 2009, we have 3 promissory notes payable to Mr. Dionne, or
Chief Executive Officer. Each note accrues interest at 4.2% per
annum. The loans were originally made in order to provide us
with working capital. The aggregate balance of the notes are
$105,000 in principal and $8,107 in accrued interest. The notes
are convertible into common shares at a price per share of
$0.50.
|
ITEM
14.
|
PRINCIPAL
ACCOUNTING FEES AND SERVICES
|
Type of Fees
|
2009
|
2008
|
||||||
Audit
Fees
|
$ | 69,014 | $ | 46,764 | ||||
Audit
Related Fees
|
10,250 | 7,542 | ||||||
Tax
Fees
|
— | — | ||||||
All
Other Fees
|
— | — | ||||||
Total
Fee's
|
$ | 79,264 | $ | 54,306 |
ITEM
15.
|
EXHIBITS,
FINANCIAL STATEMENT SCHEDULES
|
1.
|
Financial
Statements: See “Index to Financial Statements” in Part II,
Item 8 of this Form 10-K.
|
|
2.
|
Exhibits:
The exhibits listed in the accompanying index to exhibits are filed or
incorporated by reference as part of this
Form 10-K.
|
|
·
|
may
have been qualified by disclosures that were made to the other parties in
connection with the negotiation of the agreements, which disclosures are
not necessarily reflected in the
agreements;
|
|
·
|
may
apply standards of materiality that differ from those of a reasonable
investor; and
|
|
·
|
were
made only as of specified dates contained in the agreements and are
subject to later developments.
|
GENSPERA,
INC
|
||
Dated:
March 31, 2010
|
By:
|
/S/ Craig Dionne
|
Craig
Dionne
Chief
Executive Officer
|
Name
|
Title
|
Date
|
||
/s/
Craig Dionne
|
Chief
Executive Officer, Chief Financial Officer and Director
(Principal
|
March
31, 2010
|
||
Craig
Dionne
|
executive
officer and Principal financial and accounting officer)
|
|||
/s/
John Farah
|
Director
|
March
31, 2010
|
||
John
Farah
|
||||
/s/
Scott Ogilvie
|
|
Director
|
|
March
31, 2010
|
Scott
Ogilvie
|
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 Subscription Agreement for November 2007 offering
|
S-1
|
4.06
|
333-153829
|
10/03/08
|
|||||||
4.06
|
Form
of Warrant dated March 6, 2008 issued to consultant for financial
consulting services.
|
S-1
|
4.07
|
333-153829
|
10/03/08
|
|||||||
4.07
|
Form
of Securities Purchase Agreement—July and August 2008 private
placement
|
S-1
|
4.08
|
333-153829
|
10/03/08
|
|||||||
4.08
|
Form
of Registration Rights Agreement – July and August 2008 private
placement
|
S-1
|
4.09
|
333-153829
|
10/03/08
|
|||||||
4.09
|
Form
of Warrant – July and August 2008 private placement
|
S-1
|
4.10
|
333-153829
|
10/03/08
|
|||||||
4.10
|
Form
of 5.0% convertible debenture issued to TR Winston & Company,
LLC
|
S-1
|
4.12
|
333-153829
|
10/03/08
|
|||||||
4.11
|
Form
of 5.0% convertible debenture modification between TR Winston
& Company, LLC and GenSpera, Inc.
|
8-K
|
10.01
|
333-153829
|
2/20/09
|
|||||||
4.12
|
Form
of 4.0% convertible debenture modification between GenSpera,
Inc. and shareholder
|
8-K
|
10.02
|
333-153829
|
2/20/09
|
|||||||
4.13
|
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
|
4.14
|
Form
of Common Stock Purchase Warrant issued on 2/17/09 to Craig
Dionne
|
8-K
|
10.06
|
333-153829
|
2/20/09
|
|||||||
4.15
|
Form
of Securities Purchase Agreement dated 2/19/09
|
8-K
|
10.01
|
333-153829
|
2/20/09
|
|||||||
4.16
|
Form
of Common Stock Purchase Warrant dated 2/19/09
|
8-K
|
10.02
|
333-153829
|
2/20/09
|
|||||||
4.17
|
Form
of Registration Rights Agreement dated 2/19/09
|
8-K
|
10.03
|
333-153829
|
2/20/09
|
|||||||
4.18
|
Form
of Securities Purchase Agreement dated 6/29/09
|
8-K
|
10.01
|
333-153829
|
7/06/09
|
|||||||
4.19
|
Form
of Securities Purchase Agreement dated 6/30/09
|
8-K
|
10.02
|
333-153829
|
7/06/09
|
|||||||
4.20
|
Form
of Common Stock Purchase Warrant dated June of 2009
|
8-K
|
10.03
|
333-153829
|
7/06/09
|
|||||||
4.21
|
Form
of Registration Rights Agreement dated 6/29/09
|
8-K
|
10.04
|
333-153829
|
7/06/09
|
|||||||
4.22
|
Form
of Registration Rights Agreement dated 6/30/09
|
8-K
|
10.05
|
333-153829
|
7/06/09
|
|||||||
4.23**
|
2009
Executive Compensation Plan
|
8-K
|
4.01
|
333-153829
|
9/09/09
|
|||||||
4.24
|
Form
of Securities Purchase Agreement – 9/2/09
|
8-K
|
10.01
|
333-153829
|
9/09/09
|
|||||||
4.25
|
Form
of Common Stock Purchase Warrant – 9/2/09
|
8-K
|
10.02
|
333-153829
|
9/09/09
|
|||||||
4.26
|
Form
of Registration Rights Agreement—9/2/09
|
8-K
|
10.03
|
333-153829
|
9/09/09
|
|||||||
4.27
|
Form
of Securities Purchase Agreement – Jan – Mar 2010
|
*
|
||||||||||
*
|
||||||||||||
4.28
|
Form
of Common Stock Purchase Warrant Jan – Mar 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.
|
*
|
I.
PURCHASE
PRICE
|
||||
Gross
Proceeds to be Received
|
$ | |||
II.
DISBURSEMENTS
|
||||
$ | ||||
$ | ||||
$ | ||||
$ | ||||
Total
Amount Disbursed:
|
Warrant
Shares: _______
|
Initial
Exercise Date: February 26,
2010
|
(A)
=
|
the
VWAP on the Business Day immediately preceding the date of such
election;
|
(B)
=
|
the
Exercise Price of this Warrant, as adjusted;
and
|
(X)
=
|
the
number of Warrant Shares issuable upon exercise of this Warrant in
accordance with the terms of this Warrant by means of a cash exercise
rather than a cashless
exercise.
|
GENSPERA,
INC.
|
||
By:
|
||
Name:
Craig A. Dionne, Ph.D.
|
||
Title: President
and CEO
|
/s/ Craig Dionne
|
|
Craig
Dionne
|
|
Chief
Executive Officer
|
/s/ Craig Dionne
|
|
Craig
Dionne
|
|
Chief
Financial Officer
|
|
(Principal
Accounting Officer)
|
/s/ Craig Dionne
|
|
Craig
Dionne
|
|
Chief
Executive Officer
|
/s/ Craig Dionne
|
|
Craig
Dionne
|
|
Chief
Financial Officer
|
|
(Principal
Accounting Officer)
|