Delaware
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2834
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36-3898269
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(State or other jurisdiction of incorporation
or organization)
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(Primary Standard Industrial
Classification Code Number)
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(I.R.S. Employer Identification
Number)
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Large
accelerated filer ¨
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Accelerated
filer ¨
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Non-accelerated
filer ¨
(Do not check if a smaller reporting
company)
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Smaller
reporting company x
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Title of Each Class of
Securities to be Registered
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Amount to
be Registered (1)(2)
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Proposed
Maximum
Offering Price
Per Share(3)
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Proposed
Maximum
Aggregate
Offering
Price(3)
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Amount of
Registration
Fee
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||||||||||||
Common
Stock, par value $0.001 per share
|
57,500,115 | $ | 0.09 | $ | 5,175,011 | $ | 204 |
(1)
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Pursuant to Rule 416 under the
Securities Act of 1933, as amended, this registration statement also
covers such indeterminate number of shares of common stock as may be
required to prevent dilution resulting from stock splits, stock dividends
or similar events.
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(2)
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Includes
57,500,115 shares of common stock issuable upon exercise of outstanding
warrants.
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(3)
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Based
on estimates and calculations in accordance with Rule 457(c) and Rule
457(g) of the Securities Act, as amended. The proposed maximum
offering price per share and the proposed maximum aggregate offering price
have been calculated based on the exercise price of the warrants of $0.09
per share. The average of the high and low sales prices of the
registrant’s common stock on February 17, 2009, as reported on the Over
the Counter Bulletin Board, was $0.048 per
share.
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(4)
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The
registration fee has been paid
previously.
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Preliminary
Prospectus
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Subject to completion, dated
February 23, 2009
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Page
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||
Prospectus
Summary
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1
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Risk
Factors
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5
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Special
Note Regarding Forward-Looking Statements
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15
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Use
of Proceeds
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15
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Price
Range for our Common Stock
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16
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Dividend
Policy
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16
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Selected
Financial Information
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17
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Management’s
Discussion and Analysis of Financial Condition and Results of
Operations
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18
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Business
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37
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Management
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54
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Security
Ownership of Certain Beneficial Owners and Management
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63
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Certain
Relationships and Related Transactions
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65
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Description
of Securities to be Registered
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68
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Shares
Eligible for Future Sale
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73
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Selling
Securityholders
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74
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Plan
of Distribution
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79
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Legal
Matters
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81
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Experts
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81
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Disclosure
of Commission Position on Indemnification for Securities Act
Liabilities
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81
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Where
You Can Find Additional Information
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81
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Financial
Statements
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F-1
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Common
Stock Offered by Selling Securityholders (1):
|
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57,500,115
shares
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Common
Stock Issued and Outstanding as of February 13, 2009(2):
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70,624,232
shares
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Common
Stock Issued and Outstanding after this Offering (3):
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128,124,347
shares
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Use
of Proceeds:
|
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We
will not receive cash proceeds from the sale of shares of common stock by
the selling securityholders. We will receive the proceeds of
any cash exercise of the warrants.
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Over
the Counter Bulletin Board Symbol:
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MHAN
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(1)
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Includes
57,500,115 shares of our common stock issuable upon exercise of
outstanding warrants held by the selling
securityholders.
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(2)
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Excludes
approximately 96,826,432 shares of our common stock issuable upon exercise
of outstanding warrants and options to purchase shares of our common stock
(including the warrants held by the selling securityholders) and
55,555,555 shares of our common stock issuable upon exercise of a
securityholder's right to put, and our right to call, all or a portion of
such securityholder's equity interest in H Pharmaceuticals K/S (formerly
Hedrin Pharmaceuticals K/S).
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(3)
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Based
on the number of shares of our common stock outstanding as of February 13,
2009. Excludes approximately 39,326,317 shares of our common
stock issuable upon exercise of outstanding warrants and options to
purchase shares of our common stock and 55,555,555 shares of our common
stock issuable upon exercise of a securityholder's right to put, and our
right to call, all or a portion of such securityholder's equity interest
in H Pharmaceuticals K/S.
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Year Ended December 31,
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Nine Months Ended
September 30,
|
Cumulative
period from
August 6, 2001
(inception) to
September 30,
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||||||||||||||||||
2007
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2006
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2008
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2007
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2008
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||||||||||||||||
(unaudited)
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(unaudited)
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|||||||||||||||||||
Statements
of Operations Data:
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||||||||||||||||||||
Revenue
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$ | 0 | $ | 0 | $ | 0 | $ | 0 | $ | 0 | ||||||||||
Research
and development expense
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$ | 8,535,687 | $ | 6,172,845 | $ | 1,864,652 | $ | 7,360,040 | $ | 28,353,695 | ||||||||||
General
and administrative expense
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$ | 3,608,270 | $ | 3,827,482 | $ | 2,600,303 | $ | 2,865,161 | $ | 16,452,666 | ||||||||||
Stock-based
compensation
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$ | 1,440,956 | $ | 1,675,499 | $ | 379,060 | $ | 1,078,185 | $ | 3,774,043 | ||||||||||
Net
loss attributable to common shares
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$ | (12,032,252 | ) | $ | (9,695,123 | ) | $ | (4,395,877 | ) | $ | (10,128,078 | ) | $ | (59,394,947 | ) | |||||
Net
loss per common share
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$ | (0.18 | ) | $ | (0.16 | ) | $ | (0.06 | ) | $ | (0.15 | ) | N/A | |||||||
Statements
of Cash Flows Data:
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||||||||||||||||||||
Net
cash used in operating activities
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$ | (10,229,711 | ) | $ | (7,750,738 | ) | $ | (3,524,226 | ) | $ | (8,846,741 | ) | $ | (37,684,782 | ) | |||||
Net
cash provided by (used in) financing activities
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$ | 7,859,413 | $ | (15,257 | ) | $ | 2,919,176 | $ | 7,859,413 | $ | 37,350,145 | |||||||||
Cash
dividends declared
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$ | 0 | $ | 0 | $ | 0 | $ | 0 | $ | 0 |
At
December 31,
2007
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At
September 30,
2008
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|||||||
(unaudited)
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||||||||
Balance
Sheets Data:
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||||||||
Total
assets
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$ | 980,577 | $ | 204,900 | ||||
Total
liabilities
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$ | 1,871,662 | $ | 4,962,802 | ||||
Total
stockholders’ deficiency
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$ | (891,085 | ) | $ | (4,757,902 | ) |
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·
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the
results of any clinical trials;
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·
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the
scope and results of our research and development
programs;
|
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·
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the
time required to obtain regulatory
approvals;
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·
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our
ability to establish and maintain marketing alliances and collaborative
agreements; and
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·
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the
cost of our internal marketing
activities.
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·
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continue
to undertake nonclinical development and clinical trials for our product
candidates;
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·
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seek
regulatory approvals for our product
candidates;
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·
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implement
additional internal systems and
infrastructure;
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·
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lease
additional or alternative office facilities;
and
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·
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hire
additional personnel.
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·
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continuing
to undertake nonclinical development and clinical
trials;
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·
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participating
in regulatory approval processes;
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·
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formulating
and manufacturing products; and
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·
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conducting
sales and marketing activities.
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·
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delay
commercialization of, and our ability to derive product revenues from, our
product candidates;
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·
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impose
costly procedures on us; and
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·
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diminish
any competitive advantages that we may otherwise
enjoy.
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·
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unforeseen
safety issues;
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·
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determination
of dosing issues;
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·
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lack
of effectiveness during clinical
trials;
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·
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slower
than expected rates of patient
recruitment;
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·
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inability
to monitor patients adequately during or after treatment;
and
|
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·
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inability
or unwillingness of medical investigators to follow our clinical
protocols.
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·
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perceptions
by members of the health care community, including physicians, about the
safety and effectiveness of our
products;
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|
·
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cost-effectiveness
of our product relative to competing
products;
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|
·
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availability
of reimbursement for our products from government or other healthcare
payers; and
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·
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effectiveness
of marketing and distribution efforts by us and our licensees and
distributors, if any.
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·
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We
may be unable to identify manufacturers on acceptable terms or at all
because the number of potential manufacturers is limited and the FDA must
approve any replacement contractor. This approval would require
new testing and compliance inspections. In addition, a new manufacturer
would have to be educated in, or develop substantially equivalent
processes for, production of our products after receipt of FDA approval,
if any.
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|
·
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Our
third-party manufacturers might be unable to formulate and manufacture our
products in the volume and of the quality required to meet our clinical
needs and commercial needs, if any.
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·
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Our
future contract manufacturers may not perform as agreed or may not remain
in the contract manufacturing business for the time required to supply our
clinical trials or to successfully produce, store and distribute our
products.
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·
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Manufacturers
of drug and medical devices are subject to ongoing periodic unannounced
inspection by the FDA, the Drug Enforcement Agency, and corresponding
state agencies to ensure strict compliance with good manufacturing
practice and other government regulations and corresponding foreign
standards. We do not have control over third-party
manufacturers’ compliance with these regulations and
standards.
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·
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If
any third-party manufacturer makes improvements in the manufacturing
process for our products, we may not own, or may have to share, the
intellectual property rights to the
innovation.
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·
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developing
drugs;
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·
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undertaking
nonclinical testing and human clinical
trials;
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·
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obtaining
FDA and other regulatory approvals of
drugs;
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·
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formulating
and manufacturing drugs; and
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·
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launching,
marketing and selling drugs.
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·
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the
degree and range of protection any patents will afford us against
competitors including whether third parties will find ways to invalidate
or otherwise circumvent our
patents;
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·
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if
and when patents will issue;
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·
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whether
or not others will obtain patents claiming aspects similar to those
covered by our patents and patent applications;
or
|
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·
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whether
we will need to initiate litigation or administrative proceedings which
may be costly whether we win or
lose.
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|
·
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obtain
licenses, which may not be available on commercially reasonable terms, if
at all;
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·
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redesign
our products or processes to avoid
infringement;
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·
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stop
using the subject matter claimed in the patents held by
others;
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·
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pay
damages; or
|
|
·
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defend
litigation or administrative proceedings which may be costly whether we
win or lose, and which could result in a substantial diversion of our
valuable management resources.
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·
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government
and health administration
authorities;
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·
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private
health maintenance organizations and health insurers;
and
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·
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other
healthcare payers.
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·
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publicity
regarding actual or potential clinical results relating to products under
development by our competitors or
us;
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·
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delay
or failure in initiating, completing or analyzing nonclinical or clinical
trials or the unsatisfactory design or results of these
trials;
|
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·
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achievement
or rejection of regulatory approvals by our competitors or
us;
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·
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announcements
of technological innovations or new commercial products by our competitors
or us;
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·
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developments
concerning proprietary rights, including
patents;
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·
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developments
concerning our collaborations;
|
|
·
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regulatory
developments in the United States and foreign
countries;
|
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·
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economic
or other crises and other external
factors;
|
|
·
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period-to-period
fluctuations in our revenues and other results of
operations;
|
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·
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changes
in financial estimates by securities analysts;
and
|
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·
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sales
of our common stock.
|
|
·
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that
a broker or dealer approve a person’s account for transactions in penny
stocks; and
|
|
·
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the
broker or dealer receive from the investor a written agreement to the
transaction, setting forth the identity and quantity of the penny stock to
be purchased.
|
|
·
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obtain
financial information and investment experience objectives of the person;
and
|
|
·
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make
a reasonable determination that the transactions in penny stocks are
suitable for that person and the person has sufficient knowledge and
experience in financial matters to be capable of evaluating the risks of
transactions in penny stocks.
|
|
·
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sets
forth the basis on which the broker or dealer made the suitability
determination; and
|
|
·
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that
the broker or dealer received a signed, written agreement from the
investor prior to the transaction.
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High
|
Low
|
|||||||
2007
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||||||||
First
Quarter
|
$ | 0.960 | $ | 0.700 | ||||
Second
Quarter
|
$ | 1.100 | $ | 0.690 | ||||
Third
Quarter
|
$ | 0.780 | $ | 0.220 | ||||
Fourth
Quarter
|
$ | 0.230 | $ | 0.090 | ||||
2008
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||||||||
First
Quarter
|
$ | 0.230 | $ | 0.110 | ||||
Second
Quarter
|
$ | 0.180 | $ | 0.100 | ||||
Third
Quarter
|
$ | 0.200 | $ | 0.100 | ||||
Fourth
Quarter
|
$ | 0.090 | $ | 0.007 | ||||
2009
|
||||||||
First
Quarter (through February 13, 2009)
|
$ | 0.060 | $ | 0.009 |
Year Ended December 31,
|
Nine Months Ended
September 30,
|
Cumulative
period from
August 6, 2001
(inception) to
September 30,
|
||||||||||||||||||
2007
|
2006
|
2008
|
2007
|
2008
|
||||||||||||||||
(unaudited)
|
(unaudited)
|
|||||||||||||||||||
Statements
of Operations Data:
|
||||||||||||||||||||
Revenue
|
$ | 0 | $ | 0 | $ | 0 | $ | 0 | $ | 0 | ||||||||||
Research
and development expense
|
$ | 8,535,687 | $ | 6,172,845 | $ | 1,864,652 | $ | 7,360,040 | $ | 28,353,695 | ||||||||||
General
and administrative expense
|
$ | 3,608,270 | $ | 3,827,482 | $ | 2,600,303 | $ | 2,865,161 | $ | 16,452,666 | ||||||||||
Stock-based
compensation
|
$ | 1,440,956 | $ | 1,675,499 | $ | 379,060 | $ | 1,078,185 | $ | 3,774,043 | ||||||||||
Net
loss attributable to common shares
|
$ | (12,032,252 | ) | $ | (9,695,123 | ) | $ | (4,395,877 | ) | $ | (10,128,078 | ) | $ | (59,394,947 | ) | |||||
Net
loss per common share
|
$ | (0.18 | ) | $ | (0.16 | ) | $ | (0.06 | ) | $ | (0.15 | ) | N/A | |||||||
Statements
of Cash Flows Data:
|
||||||||||||||||||||
Net
cash used in operating activities
|
$ | (10,229,711 | ) | $ | (7,750,738 | ) | $ | (3,524,226 | ) | $ | (8,846,741 | ) | $ | (37,684,782 | ) | |||||
Net
cash provided by (used in) financing activities
|
$ | 7,859,413 | $ | (15,257 | ) | $ | 2,919,176 | $ | 7,859,413 | $ | 37,350,145 | |||||||||
Cash
dividends declared
|
$ | 0 | $ | 0 | $ | 0 | $ | 0 | $ | 0 |
At
December 31,
2007
|
At
September 30,
2008
|
|||||||
(unaudited)
|
||||||||
Balance
Sheets Data:
|
||||||||
Total
assets
|
$ | 980,577 | $ | 204,900 | ||||
Total
liabilities
|
$ | 1,871,662 | $ | 4,962,802 | ||||
Total
stockholders’ deficiency
|
$ | (891,085 | ) | $ | (4,757,902 | ) |
|
·
|
Topical
PTH (1-34) for the treatment of
psoriasis;
|
|
·
|
Altoderm,
a proprietary formulation of topical cromolyn sodium for the treatment of
atopic dermatitis;
|
|
·
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Hedrin,
a novel, non-insecticide treatment for head lice, through H
Pharmaceuticals (formerly Hedrin Pharmaceuticals K/S), a joint venture
between the Company Nordic Biotech Fund II K/S;
and
|
|
·
|
Altolyn,
a proprietary site specific tablet formulation of oral cromolyn sodium for
the treatment of mastocytosis.
|
Nine Months ended September 30,
|
||||||||||||||||
2008
|
2007
|
Increase
(decrease)
|
% Increase
(decrease)
|
|||||||||||||
COSTS
AND EXPENSES
|
||||||||||||||||
Research
and development
|
||||||||||||||||
Share-based
compensation
|
$ | 100,000 | $ | 341,000 | $ | (241,000 | ) | (71 | )% | |||||||
Other
research and development expense
|
$ | 1,765,000 | $ | 7,019,000 | $ | (5,254,000 | ) | (75 | )% | |||||||
Total
research and development expense
|
$ | 1,865,000 | $ | 7,360,000 | $ | (5,495,000 | ) | (75 | )% | |||||||
General
and administrative
|
||||||||||||||||
Share-based
compensation
|
$ | 279,000 | $ | 737,000 | $ | (458,000 | ) | (62 | )% | |||||||
Other
general and administrative expense
|
$ | 2,321,000 | $ | 2,128,000 | $ | 193,000 | 9 | % | ||||||||
Total
general and administrative expense
|
$ | 2,600,000 | $ | 2,865,000 | $ | (265,000 | ) | (9 | )% | |||||||
Other
(income) expense
|
$ | (69,000 | ) | $ | (97,000 | ) | $ | (28,000 | ) | (29 | )% | |||||
NET
LOSS
|
$ | 4,396,000 | $ | 10,128,000 | $ | (5,732,000 | ) | (57 | )% |
Quarter ended September 30,
|
||||||||||||||||
2008
|
2007
|
Increase
(decrease)
|
% Increase
(decrease)
|
|||||||||||||
COSTS
AND EXPENSES
|
||||||||||||||||
Research
and development
|
||||||||||||||||
Share-based
compensation
|
$ | 19,000 | $ | 117,000 | $ | (98,000 | ) | (84 | )% | |||||||
Other
research and development expense
|
$ | 480,000 | $ | 1,692,000 | $ | (1,212,000 | ) | (72 | )% | |||||||
Total
research and development expense
|
$ | 499,000 | $ | 1,809,000 | $ | (1,310,000 | ) | (72 | )% | |||||||
General
and administrative
|
||||||||||||||||
Share-based
compensation
|
$ | 64,000 | $ | 255,000 | $ | (191,000 | ) | (75 | )% | |||||||
Other
general and administrative expense
|
$ | 821,000 | $ | 643,000 | $ | 178,000 | 28 | % | ||||||||
Total
general and administrative expense
|
$ | 885,000 | $ | 898,000 | $ | (13,000 | ) | (1 | )% | |||||||
Other
(income) expense
|
$ | 11,000 | $ | (38,000 | ) | $ | 49,000 | N/A | ||||||||
NET
LOSS
|
$ | 1,395,000 | $ | 2,669,000 | $ | (1,274,000 | ) | (48 | )% |
|
Years ended December 31,
|
Increase
|
% Increase
|
|||||||||||||
2007
|
2006
|
(decrease)
|
(decrease)
|
|||||||||||||
Costs
and expenses
|
||||||||||||||||
Research
and development
|
||||||||||||||||
Share-based
compensation
|
$ | 539,000 | $ | 529,000 | $ | 10,000 | 1.89 | % | ||||||||
In-license,
milestone and related fees
|
2,245,000 | 250,000 | 1,995,000 | 798.00 | % | |||||||||||
Other
research and development expenses
|
5,752,000 | 5,394,000 | 358,000 | 6.64 | % | |||||||||||
Total
research and development expenses
|
8,536,000 | 6,173,000 | 2,363,000 | 38.28 | % | |||||||||||
General
and administrative
|
||||||||||||||||
Share-based
compensation
|
902,000 | 1,147,000 | (245,000 | ) | (21.36 | ) % | ||||||||||
Other
general and administrative expenses
|
2,706,000 | 2,680,000 | 26,000 | 0.97 | % | |||||||||||
Total
general and administrative expenses
|
3,608,000 | 3,827,000 | (219,000 | ) | (5.72 | ) % | ||||||||||
Other
income
|
112,000 | 305,000 | (193,000 | ) | (63.28 | ) % | ||||||||||
Net
loss
|
$ | 12,032,000 | $ | 9,695,000 | $ | 2,337,000 | 24.11 | % |
|
U.S.
Patent Application No. 2007/0142330, entitled, “Method and composition for
the control of arthropods.” Jayne Ansell, Inventor. Application filed
February 12, 2007. This application is a divisional of U.S. application
Ser. No. 10/097,615, filed Mar. 15, 2002, which is a continuation of
International Application No. PCT/GB00/03540, which designated the United
States and was filed on Sep. 14, 2000. This application has not yet issued
as a patent. Any patent that issues will expire on September14,
2020.
|
1.
|
U.S. Patent No. 5,527,772,
entitled “Regulation of cell proliferation and differentiation using
peptides.” M.F. Holick, Inventor. Application filed July, 28, 1994. Patent
issued June 18, 1996. This patent expires June 18,
2013.
|
2.
|
U.S. Patent No. 5,840,690,
entitled “Regulation of cell proliferation and differentation using
peptides.” M.F. Holick, Inventor. Application filed June 6, 1995. Patent
issued November 24, 1998. This patent expires June 18,
2013.
|
3.
|
U.S. Provisional application No.
US60/940,509, entitled “Topical Compositions comprising a macromolecule
and methods of using same.” Application was filed on May 29,
2007.
|
1.
|
U.S. Patent No. 7,109,246,
entitled “Pharmaceutical compositions comprising an amphoteric surfactant
an alkoxylated cetyl alcohol and a polar drug.” Brian Hawtin, Inventor.
Application filed May 20, 1999. Patent issued September 19, 2006. This
patent expires on May 20,
2019.
|
2.
|
U.S. Application Publication No.
2007/0036860, entitled “Treatment of allergic conditions.” Alexander James
Wigmore, Inventor. Any patent that issues will expire on November 9, 2019.
This patent covers both Altoderm and
Altolyn.
|
1.
|
U.S. Patent No. 7,258,872,
entitled “Chromone enteric release formulation.” Alexander James Wigmore,
Inventor. Application filed November 9, 1999, claiming the benefit of a GB
application filed November 11, 1998. Patent issued August 21, 2007. The
expected date of expiration, which was November 9, 2019, has been extended
by 793 days (expiration date Jan 10,
2022).
|
2.
|
U.S. Application Publication No.
2007/0036860, entitled “Treatment of allergic conditions.” Alexander James
Wigmore, Inventor. Application filed October 13, 2006, claiming the
benefit of a prior U.S. application, which claimed the benefit of a PCT
application filed November 9, 1999. This application has not yet issued as
a patent. Any patent that issues is expected to expire on November 9,
2019. This patent covers both Altoderm and
Altolyn.
|
·
|
nonclinical laboratory tests,
animal studies, and formulation
studies,
|
·
|
submission to the FDA of an IND
for human clinical testing, 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 drug for
each indication,
|
·
|
submission to the FDA of an
NDA,
|
·
|
satisfactory completion of an FDA
inspection of the manufacturing facility or facilities at which the drug
is produced to assess compliance with current good manufacturing
practices, or cGMPs, and
|
·
|
FDA review and approval of the
NDA.
|
Name
|
Age
|
Position(s)
Held
|
Director
Since
|
|||||||
Douglas
Abel
|
47
|
President,
Chief Executive Officer and Director
|
2005
|
|||||||
Neil
Herskowitz
|
52
|
Director
|
2004
|
|||||||
Malcolm
Hoenlein
|
65
|
Director
|
2004
|
|||||||
Timothy
McInerney
|
48
|
Director
|
2004
|
|||||||
Richard
I. Steinhart
|
51
|
Director
|
2004
|
|||||||
Michael
Weiser, M.D.
|
46
|
Director
|
2003
|
Name
of Committee
|
Membership
|
|
Audit
|
Messrs.
Herskowitz, Hoenlein and Steinhart (Chair)
|
|
Compensation
|
Messrs.
Herskowitz, Hoenlein, Steinhart and Weiser (Chair)
|
|
Nominating
and Governance
|
Messrs.
Herskowitz, Hoenlein and Steinhart
(Chair)
|
Name
|
Age
|
Position
|
||
Douglas
Abel
|
47
|
President
& Chief Executive Officer and Director
|
||
Michael
G. McGuinness
|
55
|
Chief
Operating and Financial Officer &
Secretary
|
Name and
Principal
Position
|
Year
|
Salary
|
Bonus
|
Option
Awards
|
Non-Equity
Incentive Plan
Compensation
|
Nonqualified
Deferred
Compensation
Earnings
|
All Other
Compensation
|
Total
|
||||||||||||||||||||||
Douglas Abel
|
2007
|
$ | 345,000 | $ | 180,000 |
(3)
|
$ | 910,224 |
(5)
|
$ | 0 | $ | 0 | $ | 42,333 |
(4)
|
$ | 1,477,557 | ||||||||||||
Chief
Executive Officer and President
|
2006
|
$ | 325,000 | $ | 150,000 | $ | 1,156,065 |
(5)
|
$ | 0 | $ | 0 | $ | 116,776 |
(4)
|
$ | 1,748,841 | |||||||||||||
Alan G. Harris (1)
|
2007
|
$ | 288,333 | $ | 0 | $ | 292,530 |
(5)
|
$ | 0 | $ | 0 | $ | 9,000 |
(6)
|
$ | 589,863 | |||||||||||||
Chief
Medical Officer
|
2006
|
$ | 252,083 | $ | 107,500 | $ | 98,837 |
(5)
|
$ | 0 | $ | 0 | $ | 8,800 |
(6)
|
$ | 467,220 | |||||||||||||
Michael McGuinness(2)
|
2007
|
$ | 238,333 | $ | 100,000 |
(3)
|
$ | 95,528 |
(5)
|
$ | 0 | $ | 0 | $ | 9,000 |
(6)
|
$ | 442,861 | ||||||||||||
Chief
Operating and Financial Officer, Secretary
|
2006
|
$ | 98,229 | $ | 60,000 | $ | 23,622 |
(5)
|
$ | 0 | $ | 0 | $ | 0 | $ | 181,851 |
|
(1)
|
Dr.
Harris was appointed our Chief Medical Officer on February 1,
2006. Dr. Harris’ employment with us ended effective December
31, 2007.
|
|
(2)
|
Mr.
McGuinness was appointed our Chief Financial Officer on July 10, 2006 and
Chief Operating Officer on April 1,
2008.
|
|
(3)
|
The
Company has accrued for such bonuses but has not paid such
bonuses. Payment of such bonuses are contingent upon our
raising additional financing and shall be paid as follows: (i)
50% will be paid when we have consummated a financing transaction with
gross proceeds (net of commissions) to the Company of at least $1,000,000
and (ii) the remaining 50% will be paid when we have consummated a
financing transaction with gross proceeds (net of commissions) to us of at
least $2.5 million (cumulative, including the $1 million
financing transaction referred to
above).
|
|
(4)
|
For
2007 represents a payment in the amount of $33,333, which represents the
approximate amount of additional expense incurred by Mr. Abel relating to
his commuting between Boston and New York and a tax “gross up” to cover
the additional tax liability to Mr. Abel from such payment, and a matching
contributions by us pursuant to our company’s 401(k) retirement plan of
$9,000. For 2006 represents a payment in the amount of $83,333,
which represents the approximate amount of additional expense incurred by
Mr. Abel relating to his commuting between Boston and New York and a tax
“gross up” to cover the additional tax liability to Mr. Abel from such
payment, reimbursement of certain commuting expenses of $24,643 and a
matching contributions by us pursuant to our company’s 401(k) retirement
plan of $8,800.
|
|
(5)
|
Represents
the amount of share-based costs recognized by us during 2007 under SFAS
No. 123(R). See Note 3 to our Consolidated Financial
Statements included in our annual report for 2007 on Form 10-K and for
2006 on Form 10-KSB for the assumptions made in the
valuation.
|
|
(6)
|
Represents
matching contributions by us pursuant to our company’s 401(k) retirement
plan.
|
Option Awards
|
||||||||||||||
Name
|
Number of
Securities
Underlying
Unexercised
Options (#)
Exercisable
|
Number of
Securities
Underlying
Unexercised
Options (#)
Unexercisable
|
Option Exercise
Price ($)
|
Option
Expiration Date
|
||||||||||
Douglas
Abel
|
2,923,900 | 0 | $ | 1.50 |
04/01/2015
|
|||||||||
0 | 250,000 | $ | 0.95 |
04/25/2017
|
||||||||||
Alan
Harris
|
300,000 | 0 | $ | 1.35 |
12/31/2009
|
|||||||||
100,000 | 0 | $ | 0.95 |
12/31/2009
|
||||||||||
Michael
McGuinness
|
73,333 | 146,667 | $ | 0.70 |
07/10/2016
|
|||||||||
20,000 | 40,000 | $ | 1.35 |
07/10/2016
|
||||||||||
0 | 320,000 | $ | 0.95 |
04/25/2017
|
Name
|
Fees Earned or
Paid in
Cash
|
Option
Awards (1)
|
All Other
Compensation
|
Total
|
||||||||||||
Neil
Herskowitz
|
$ | 27,500 | $ | 7,948 |
(3)
|
$ | 0 | $ | 35,448 | |||||||
Malcolm
Hoenlein
|
$ | 25,000 | $ | 7,948 |
(4)
|
$ | 0 | $ | 32,948 | |||||||
Timothy
McInerney
|
$ | 24,000 | $ | 7,948 |
(5)
|
$ | 0 | $ | 31,948 | |||||||
Joan
Pons Gimbert(2)
|
$ | 12,000 | $ | 7,948 |
(6)
|
$ | 0 | $ | 19,948 | |||||||
Richard
I. Steinhart
|
$ | 27,000 | $ | 7,948 |
(7)
|
$ | 0 | $ | 34,948 | |||||||
Michael
Weiser
|
$ | 24,500 | $ | 7,948 |
(8)
|
$ | 0 | $ | 32,448 |
(1)
|
Represents
the amount of share-based costs recognized by us during 2006 under SFAS
No. 123(R). See Note 3 to our Consolidated Financial
Statements included in our annual report for 2006 on Form 10-KSB for the
assumptions made in the valuation.
|
(2)
|
Joan
Pons Gimbert resigned from the Board in July
2007.
|
(3)
|
As
of February 13, 2009, Mr. Herskowitz had options to purchase an aggregate
of 216,010 shares of our common
stock.
|
(4)
|
As
of February 13, 2009, Mr. Hoenlein had options to purchase an aggregate of
216,010 shares of our common stock.
|
(5)
|
As
of February 13, 2009, Mr. McInerney had options to purchase an aggregate
of 236,010 shares of our common
stock.
|
(6)
|
As
of February 13, 2009, Mr. Pons Gimbert had options to purchase an
aggregate of 133,334 shares of our common
stock.
|
(7)
|
As
of February 13, 2009, Mr. Steinhart had options to purchase an aggregate
of 216,010 shares of our common
stock.
|
(8)
|
As
of February 13, 2009, Mr. Weiser had options to purchase an aggregate of
230,000 shares of our common stock.
|
|
o
|
by
each person known by us to be the beneficial owner of 5% or more of our
common stock;
|
|
o
|
by
each of our directors and executive officers;
and
|
|
o
|
by
all of our directors and executive officers as a
group.
|
Name of Beneficial Owners, Officers and Directors
|
Number of
Shares
Beneficially
Owned (#)
|
Percentage
Beneficially
Owned (%)
|
||||||
Douglas
Abel (1)
|
3,052,899 | 5.3 | ||||||
Michael
McGuinness (2)
|
1,060,667 | 1.5 | ||||||
Michael
Weiser (3)
|
2,595,985 | 3.7 | ||||||
Timothy
McInerney (4)
|
1,024,191 | 1.4 | ||||||
Neil
Herskowitz (5)
|
390,462 | * | ||||||
Richard
I. Steinhart (6)
|
188,311 | * | ||||||
Malcolm
Hoenlien (7)
|
183,869 | * | ||||||
All
directors and officers as a group (8)(7
persons)
|
9,386,384 | 12.2 | ||||||
Lester
Lipschutz (9)
1650
Arch Street, Philadelphia, PA 19103
|
8,941,873 | 12.7 | ||||||
Lindsay
Rosenwald (10)
787
Seventh Avenue
New
York, NY 10019
|
4,224,268 | 5.9 | ||||||
Nordic
Biotech Venture Fund II K/S(11)
Ostergrade
5, 3rd floor, DK-1100
Copenhagen
K, Denmark
|
66,666,666 | 48.6 |
(1)
|
Includes
3,873,899 shares issuable upon exercise of vested portions of options and
24,000 shares issuable upon exercise of warrants.
|
|
(2)
|
Includes
1,026,667 shares issuable upon exercise of vested portions of options and
24,000 shares issuable upon exercise of warrants.
|
|
|
(3)
|
Includes
196,668 shares issuable upon the exercise of vested portions of options,
and 151,754 shares issuable upon exercise of
warrants.
|
|
(4)
|
Includes
216,668 shares issuable upon exercise of vested portions of options; and
139,863 shares issuable upon exercise of
warrants.
|
|
(5)
|
Includes
182,678 shares issuable upon exercise of vested portions of options, and
43,444 shares issuance upon exercise of warrants; 77,288 shares held by
Riverside Contracting, LLC, a limited liability company of which Mr.
Herskowitz is a member holding 50% ownership and 44,168 shares held by
ReGen Capital II, LLC, a limited liability company of which Mr. Herskowitz
is a member holding 50% ownership.
|
|
(6)
|
Includes
182,678 shares issuable upon exercise of vested portions of
options.
|
|
(7)
|
Includes
182,678 shares issuable upon exercise of vested portions of
options.
|
(8)
|
Includes
5,861,936 shares issuable upon exercise of vested portions of options;
383,061 shares issuable upon the exercise of warrants; 77,288 shares held
by Riverside Contracting, LLC, a limited liability company of which Mr.
Herskowitz is a member holding 50% ownership and 44,168 shares held by
ReGen Capital II, LLC, a limited liability company of which Mr. Herskowitz
is a member holding 50% ownership.
|
|
(9)
|
Includes
8,941,873 shares of Common Stock held by separate trusts for the benefit
of Dr. Rosenwald or his family with respect to which Mr. Lipschutz is
either trustee or investment manager and in either case has investment and
voting power. Mr. Lipschutz disclaims beneficial ownership of these
shares, except to the extent of his pecuniary interest therein, if
any. The foregoing information is derived from a Schedule
13G filed on behalf of the reporting person on August 1,
2007
|
|
(10)
|
Includes
3,183,497 shares held directly by Dr. Rosenwald, 1,040,658 shares issuable
upon the exercise of warrants, 80 shares held by the Dr. Rosenwald's wife,
over which Dr. Rosenwald may be deemed to have sole voting and dispositive
power, although he disclaims beneficial ownership of such shares except
with regard to his pecuniary interest therein, if any, and 33 shares held
by Dr. Rosenwald’s children, over which Dr. Rosenwald may be deemed to
have sole voting and dispositive power, although he disclaims beneficial
ownership of such shares except with regard to his pecuniary interest
therein, if any. The foregoing information is derived from a
Schedule 13G/A filed on behalf of the reporting person on February 13,
2008.
|
|
(11)
|
Includes
55,555,555 shares issuable upon exercise of Nordic's right to put all or a
portion of Nordic Biotech Venture Fund II K/S' equity interest in H
Pharmaceuticals K/S (formerly Hedrin Pharmaceuticals K/S), a Danish
limited partnership, of which we and Nordic are partners
and 11,111,111 shares issuable upon exercise of an outstanding
warrant held by Nordic. Florian Schonharting and Christian
Hansen have voting and investment control over such
securities.
|
|
·
|
any breach of his or her duty of
loyalty to us or our
stockholders;
|
|
·
|
acts or omissions not in good
faith which involve intentional misconduct or a knowing violation of
law;
|
|
·
|
the payment of dividends or the
redemption or purchase of stock in violation of Delaware law;
or
|
|
·
|
any transaction from which the
director derived an improper personal
benefit.
|
|
•
|
1.0%
of the number of ordinary shares then outstanding, which will equal
706,242 shares immediately after this offering;
or
|
|
•
|
the
average weekly trading volume of the ordinary shares during the four
calendar weeks preceding the filing of a notice on Form 144 with respect
to the sale.
|
Number of
|
||||||||||||||||
Shares
|
||||||||||||||||
of Common
|
Common Stock Beneficially
|
|||||||||||||||
Stock
|
Owned After this Offering
|
|||||||||||||||
Beneficially
|
Shares
|
Number of
|
Percent
|
|||||||||||||
Owned Prior
|
Being
|
Shares
|
of Shares
|
|||||||||||||
Selling Securityholder
|
to
the Offering
|
Offered(1)
|
Outstanding
|
Outstanding
|
||||||||||||
Neel
B. Ackerman and Martha N. Ackerman
|
7,498,609 | (2) | 6,666,680 | 831,929 | (3) | 1.18 | % | |||||||||
Stephen
M. Burnich Revocable Trust u/a 10/08/04 (4)
|
983,335 | (5) | 833,335 | 150,000 | * | |||||||||||
Ennio
De Pianto
|
1,720,670 | (6) | 1,666,670 | 54,000 | (7) | * | ||||||||||
Matthew
Ernst
|
843,335 | (5) | 833,335 | 10,000 | * | |||||||||||
John
M. Goodman Living Trust (8)
|
870,361 | (9) | 833,335 | 37,026 | (10) | * | ||||||||||
Leon
Kanner & Rosemary E. Kanner
|
863,335 | (5) | 833,335 | 30,000 | * | |||||||||||
Richard
Kindt
|
447,334 | (11) | 333,334 | 114,000 | * | |||||||||||
Douglas
E. Pritchett
|
1,756,670 | (12) | 1,666,670 | 90,000 | * | |||||||||||
Jerome
A. Shinkay
|
333,334 | (11) | 333,334 | 0 | * | |||||||||||
Michael
J. Spezia
|
918,335 | (5) | 833,335 | 85,000 | * | |||||||||||
George
D. Wilson & Diane J. Wilson
|
358,334 | (11) | 333,334 | 25,000 | * | |||||||||||
Joseph
L. Jerger
|
333,334 | (11) | 333,334 | 0 | * | |||||||||||
David
& Nancy Pudelsky
|
967,745 | (13) | 833,335 | 134,410 | (14) | * | ||||||||||
James
R. Buck
|
413,334 | (11) | 333,334 | 80,000 | * | |||||||||||
John
O. Dunkin
|
881,391 | (15) | 500,001 | 381,390 | (14) | * | ||||||||||
NFS/FMTC
SEP IRA FBO Jay Jennings (16)
|
640,001 | (17) | 500,001 | 140,000 | * | |||||||||||
Landmark
Community Bank Collateral Account FBO
Estate
of Catherine Nasser (18)
|
2,166,671 | (1) | 2,166,671 | 0 | 0.00 | % | ||||||||||
Nasser
Family Trust (19)
|
833,335 | (5) | 833,335 | 0 | 0.00 | % | ||||||||||
James
R. Kahn & Debra A. Kahn, JTWROS
|
166,667 | (20) | 166,667 | 0 | 0.00 | % | ||||||||||
Carolyn
N. Taylor & A. Starke Taylor, Jr.
|
2,012,437 | (21) | 1,666,670 | 345,767 | (22) | * | ||||||||||
Mark
Vollmer
|
166,667 | (20) | 166,667 | 0 | 0.00 | % | ||||||||||
Robert
J. Guercio
|
1,067,745 | (13) | 833,335 | 234,410 | (14) | * | ||||||||||
Ralph
Hanby
|
166,667 | (20) | 166,667 | 0 | 0.00 | % |
Number of
|
||||||||||||||||
Shares
|
||||||||||||||||
of Common
|
Common Stock Beneficially
|
|||||||||||||||
Stock
|
Owned After this Offering
|
|||||||||||||||
Beneficially
|
Shares
|
Number of
|
Percent
|
|||||||||||||
Owned Prior
|
Being
|
Shares
|
of Shares
|
|||||||||||||
Selling Securityholder
|
to the Offering
|
Offered(1)
|
Outstanding
|
Outstanding
|
||||||||||||
Robert
E. Jacobson & Saralee Jacobson, JTWROS
|
333,334 | (11) | 333,334 | 0 | 0.00 | % | ||||||||||
Michael
Cushing
|
1,000,002 | (1) | 1,000,002 | 0 | 0.00 | % | ||||||||||
Raymond
Yarusi, Jr.
|
166,667 | (20) | 166,667 | 0 | 0.00 | % | ||||||||||
James
Orr
|
833,335 | (5) | 833,335 | 0 | 0.00 | % | ||||||||||
Vernon
L. Simpson
|
943,751 | (23) | 833,335 | 110,416 | (24) | * | ||||||||||
Michael
H. Yokoyama & Jaye S. Venuti
Family
Trust (25)
|
893,096 | (5) | 833,335 | 59,761 | * | |||||||||||
Frederick
Peet
|
666,668 | (1) | 666,668 | 0 | 0.00 | % | ||||||||||
Ronald
Rasmussen
|
333,334 | (11) | 333,334 | 0 | 0.00 | % | ||||||||||
Lewis
R. Jacobson
|
273,667 | (20) | 166,667 | 107,000 | * | |||||||||||
Mark
B. Ginsburg
|
833,335 | (5) | 833,335 | 0 | 0.00 | % | ||||||||||
Gregory
J. Dovolis
|
705,519 | (1) | 666,668 | 38,851 | (1) | * | ||||||||||
William
Silver
|
1,243,751 | (23) | 833,335 | 410,416 | (24) | * | ||||||||||
Praful
Desai
|
1,237,745 | (13) | 833,335 | 404,410 | (14) | * | ||||||||||
Thomas
Gemellaro
|
166,667 | (20) | 166,667 | 0 | 0.00 | % | ||||||||||
Howard
M. Tanning Rollover IRA
|
2,629,185 | (26) | 2,333,338 | 295,847 | (27) | * | ||||||||||
Steve
Vogt
|
166,667 | (20) | 166,667 | 0 | 0.00 | % | ||||||||||
Joseph
Carrubba
|
575,001 | (17) | 500,001 | 75,000 | * | |||||||||||
Daniel
R. Lapin
|
166,667 | (20) | 166,667 | 0 | 0.00 | % | ||||||||||
David
Partain
|
166,667 | (20) | 166,667 | 0 | 0.00 | % | ||||||||||
Harvey
Lustig & Ronnie Lustig
|
575,001 | (17) | 500,001 | 75,000 | * | |||||||||||
Roger
Levy
|
333,334 | (11) | 333,334 | 0 | 0.00 | % | ||||||||||
Elliot
H. Philipson
|
166,667 | (20) | 166,667 | 0 | 0.00 | % | ||||||||||
Garry
A. Hansen Rollover IRA
|
833,335 | (5) | 833,335 | 0 | 0.00 | % | ||||||||||
Terry
Van Hilsen
|
833,335 | (5) | 833,335 | 0 | 0.00 | % | ||||||||||
PESI
FBO Alan M. Woolf IRA
|
671,001 | (17) | 500,001 | 171,000 | * | |||||||||||
Kevin
B. Allodi
|
333,334 | (11) | 333,334 | 0 | 0.00 | % | ||||||||||
Jesus
A. Anaya
|
166,667 | (20) | 166,667 | 0 | 0.00 | % | ||||||||||
Stephen
J. Blaser
|
833,335 | (5) | 833,335 | 0 | 0.00 | % | ||||||||||
Michael
Bily
|
166,667 | (20) | 166,667 | 0 | 0.00 | % | ||||||||||
Harvey
W. Berman
|
166,667 | (20) | 166,667 | 0 | 0.00 | % | ||||||||||
Virgil
Boatright
|
166,667 | (20) | 166,667 | 0 | 0.00 | % | ||||||||||
John
Gasidlo
|
333,334 | (11) | 333,334 | 0 | 0.00 | % | ||||||||||
Raymond
J. Dracker
|
166,667 | (20) | 166,667 | 0 | 0.00 | % | ||||||||||
James
Regan
|
933,335 | (5) | 833,335 | 100,000 | * | |||||||||||
Mike
Lyons
|
873,335 | (5) | 833,335 | 40,000 | * | |||||||||||
Breining
Living Trust w/a 12/14/98 Ronald and Sally
Breining
TTEE (28)
|
166,667 | (20) | 166,667 | 0 | 0.00 | % | ||||||||||
Richard
Kindt
|
614,001 | (17) | 166,667 | 447,334 | (11) | * | ||||||||||
Terry
Barr & Martha Barr
|
500,001 | (17) | 500,001 | 0 | 0.00 | % | ||||||||||
Michael
Levy
|
333,334 | (11) | 333,334 | 0 | 0.00 | % | ||||||||||
PFSI
FBO David Deloury R/O IRA
|
666,668 | (1) | 666,668 | 0 | 0.00 | % | ||||||||||
PFSI
FBO Edward Bolus IRA
|
1,666,670 | (1) | 1,666,670 | 0 | 0.00 | % | ||||||||||
Morris
A. Arnston, Jr.
|
760,001 | (17) | 500,001 | 260,000 | * | |||||||||||
James
Lucey
|
433,334 | (11) | 333,334 | 100,000 | * | |||||||||||
Thomas
E. Simmons
|
231,667 | (20) | 166,667 | 65,000 | * | |||||||||||
PFSI
FBO John R. Durant SEP IRA
|
1,078,002 | (29) | 1,000,002 | 78,000 | * | |||||||||||
James
E. Harris
|
1,000,002 | (29) | 1,000,002 | 0 | 0.00 | % |
Number of
|
||||||||||||||||
Shares
|
||||||||||||||||
of Common
|
Common Stock Beneficially
|
|||||||||||||||
Stock
|
Owned After this Offering
|
|||||||||||||||
Beneficially
|
Shares
|
Number of
|
Percent
|
|||||||||||||
Owned Prior
|
Being
|
Shares
|
of Shares
|
|||||||||||||
Selling Securityholder
|
to the Offering
|
Offered(1)
|
Outstanding
|
Outstanding
|
||||||||||||
The
Marianne Higgins Revocable Trust (30)
|
191,067 | (20) | 166,667 | 24,400 | * | |||||||||||
Ricky
Ravens
|
173,667 | (20) | 166,667 | 7,000 | * | |||||||||||
James
C. Arnold and Susan M. Arnold
|
500,001 | (17) | 500,001 | 0 | 0.00 | % | ||||||||||
Michael
J. Piatt
|
504,624 | (11) | 333,334 | 171,290 | * | |||||||||||
Kevin
Mack
|
1,666,667 | (1) | 1,666,667 | 0 | 0.00 | % | ||||||||||
David
Ernst
|
1,000,002 | (1) | 1,000,002 | 0 | 0.00 | % | ||||||||||
Paul
Sallwasser
|
343,334 | (11) | 333,334 | 10,000 | * | |||||||||||
Michael
Schneider and Valerie Schneider
|
333,334 | (11) | 333,334 | 0 | 0.00 | % | ||||||||||
John
Mohl and Carmen Mohl JTTEN
|
181,667 | (20) | 166,667 | 15,000 | * | |||||||||||
Richard
Hornstrater
|
166,667 | (20) | 166,667 | 0 | 0.00 | % | ||||||||||
Ralph
Grunwald
|
166,667 | (20) | 166,667 | 0 | 0.00 | % | ||||||||||
PFSI
FBO Edward A. Kubycheck R/O IRA
|
190,667 | (20) | 166,667 | 24,000 | * | |||||||||||
William
R. Weir
|
333,334 | (11) | 333,334 | 0 | 0.00 | % | ||||||||||
Joseph
Beachboard
|
345,334 | (11) | 333,334 | 12,000 | * | |||||||||||
Randy
Burns
|
343,334 | (11) | 333,334 | 10,000 | * | |||||||||||
Robert
M. Burzinski
|
166,667 | (20) | 166,667 | 0 | 0.00 | % | ||||||||||
PFSI
FBO Jerry D. Stevenson IRA
|
500,001 | (17) | 500,001 | 0 | 0.00 | % | ||||||||||
The
Silverman 1984 Trust 5/20/84 (31)
|
575,001 | (17) | 500,001 | 75,000 | * | |||||||||||
David
W. Maehling
|
333,334 | (11) | 333,334 | 0 | 0.00 | % | ||||||||||
Barry
A. Fitelson
|
166,667 | (20) | 166,667 | 0 | 0.00 | % | ||||||||||
Paul
V. Washburn
|
333,334 | (11) | 333,334 | 0 | 0.00 | % | ||||||||||
Allan
D. Johnson
|
181,667 | (20) | 166,667 | 15,000 |
|
* |
(1)
|
Represents
shares of our common stock underlying warrants held by the selling
securityholder.
|
(2)
|
Includes
6,744,382 shares of common stock underlying warrants held by the selling
securityholder.
|
(3)
|
Includes
77,702 shares of common stock underlying warrants held by the selling
securityholder.
|
(4)
|
Stephen
M. Burnich, trustee of the Stephen M. Burnich Revocable Trust u/a 10/08/04
has voting and investment control over such
securities.
|
(5)
|
Includes
833,335 shares of common stock underlying warrants held by the selling
securityholder.
|
(6)
|
Includes
1,680,670 shares of common stock underlying warrants held by the selling
securityholder.
|
(7)
|
Includes
14,000 shares of common stock underlying warrants held by the selling
securityholder.
|
(8)
|
John
M. Goodman, trustee of the John M. Goodman Living Trust has voting and
investment control over such
securities.
|
(9)
|
Includes
837,839 shares of common stock underlying warrants held by the selling
securityholder.
|
(10)
|
Includes
4,504 shares of common stock underlying warrants held by the selling
securityholder.
|
(11)
|
Includes
333,334 shares of common stock underlying warrants held by the selling
securityholder.
|
(12)
|
Includes
1,666,670 shares of common stock underlying warrants held by the selling
securityholder.
|
(13)
|
Includes
863,177 shares of common stock underlying warrants held by the selling
securityholder.
|
(14)
|
Includes
29,842 shares of common stock underlying warrants held by the selling
securityholder.
|
(15)
|
Includes
529,843 shares of common stock underlying warrants held by the selling
securityholder.
|
(16)
|
Jay
B. Jennings has investment and voting control over the securities held by
the selling securityholder.
|
(17)
|
Includes
500,001 shares of common stock underlying warrants held by the selling
securityholder.
|
(18)
|
William
K. Nasser, Jr. has investment and voting control over the
securities.
|
(19)
|
William
K. Nasser, Jr., trustee of the Nasser Family Trust, has investment and
voting control over the securities.
|
(20)
|
Includes
166,667 shares of common stock underlying warrants held by the selling
securityholder.
|
(21)
|
Includes
1,723,345 shares of common stock underlying warrants held by the selling
securityholder.
|
(22)
|
Includes
56,675 shares of common stock underlying warrants held by the selling
securityholder.
|
(23)
|
Includes
843,751 shares of common stock underlying warrants stock held by the
selling securityholder.
|
(24)
|
Includes
10,416 shares of common stock underlying warrants held by the selling
securityholder.
|
(25)
|
Michael
H. Yokoyama and Jaye S. Venuti, as co-trustees of the Michael H. Yokoyama
and Jaye S. Venuti Family Trust have investment and voting control over
the securities.
|
(26)
|
Includes
2,397,526 shares of common stock underlying warrants and 231,659 shares of
common stock held by the selling
securityholder.
|
(27)
|
Includes
64,188 shares of common stock underlying warrants held by the selling
securityholder.
|
(28)
|
Ronald
Breining and Sally Breining, as co-trustees of the Breining Living Trust
w/a 12/14/98 Ronald and Sally Breining TTEE, have investment and voting
control over the securities.
|
(29)
|
Includes
1,000,002 shares of common stock underlying warrants held by the selling
securityholder.
|
(30)
|
Marianne
Higgins, as trustees of the Marianne Higgins Revocable Trust, has
investment and voting control over the
securities.
|
(31)
|
Robert
J. Silverman and Judith Ann Silverman, as co-trustees of The Silverman
1984 Trust, have investment and voting control over the
securities.
|
|
-
|
ordinary
brokerage transactions and transactions in which the broker-dealer
solicits purchasers;
|
|
-
|
block
trades in which the broker-dealer will attempt to sell the shares as
agent, but may position and resell a portion of the block as principal to
facilitate the transaction;
|
|
-
|
purchases
by a broker-dealer as principal and resale by the broker-dealer for its
account;
|
|
-
|
an
exchange distribution in accordance with the rules of the applicable
exchange;
|
|
-
|
privately
negotiated transactions;
|
|
-
|
short
sales effected after the date the registration statement of which this
prospectus is a part is declared effective by the
Commission;
|
|
-
|
through
the writing or settlement of options or other hedging transactions,
whether through an options exchange or
otherwise;
|
|
-
|
broker-dealers
may agree with the selling securityholders to sell a specified number of
such shares at a stipulated price per share;
and
|
|
-
|
a
combination of any such methods of
sale.
|
Page
|
||
Unaudited
Condensed Consolidated Financial Statements as of September 30, 2008 and
2007
|
||
Unaudited
Condensed Consolidated Balance Sheets as of September 30, 2008 and
December 31, 2007
|
F-2
|
|
Unaudited
Condensed Consolidated Statements of Operations For the Three and Nine
Months Ended September 30, 2008 and 2007 and the cumulative period from
August 6, 2001 (inception) to September 30, 2008
|
F-3
|
|
Unaudited
Condensed Consolidated Statement of Stockholders’ Equity (Deficiency) from
August 6, 2001 (inception) to September 30, 2008
|
F-4
|
|
Unaudited
Condensed Consolidated Statements of Cash Flows For the Nine Months Ended
September 30, 2008 and 2007 and the cumulative period from
August 6, 2001 (inception) to September 30, 2008
|
F-6
|
|
Notes
to Unaudited Condensed Consolidated Financial Statements
|
F-7
|
|
Financial Statements as of December 31, 2007 and
2006
|
||
Report
of Independent Registered Public Accounting Firm
|
F-21
|
|
Consolidated
Balance Sheets as of December 31, 2007 and 2006
|
F-22
|
|
Consolidated
Statements of Operations for the Years Ended December 31, 2007 and 2006
and the cumulative period from August 6, 2001 (inception) to December 31,
2007
|
F-23
|
|
Consolidated
Statement of Stockholders’ Equity (Deficiency) for the Years Ended
December 31, 2007 and 2006 and the cumulative period from August 6, 2001
(inception) to December 31, 2007
|
F-24
|
|
Consolidated
Statements of Cash Flows for the Years Ended December 31, 2007 and 2006
and the cumulative period from August 6, 2001 (inception) to December 31,
2007
|
F-26
|
|
Notes
to Consolidated Financial Statements
|
F-27
|
September
30,
2008
|
December
31,
2007
|
|||||||
|
(Unaudited)
|
(See
Note 1)
|
||||||
Assets
|
||||||||
Current
assets:
|
||||||||
Cash
and cash equivalents
|
$ | 35,664 | $ | 649,686 | ||||
Prepaid
expenses and other current assets
|
75,422 | 215,852 | ||||||
Total
current assets
|
111,086 | 865,538 | ||||||
Investment
in Hedrin JV
|
2,269 | - | ||||||
Property
and equipment, net
|
11,920 | 44,533 | ||||||
Other
assets
|
79,625 | 70,506 | ||||||
Total
assets
|
$ | 204,900 | $ | 980,577 | ||||
Liabilities and Stockholders’
Deficiency
|
||||||||
Current
liabilities:
|
||||||||
Secured
10% notes payable
|
$ | 70,000 | $ | - | ||||
Accounts
payable
|
705,323 | 1,279,485 | ||||||
Accrued
expenses
|
1,238,303 | 592,177 | ||||||
Total
current liabilities
|
2,013,626 | 1,871,662 | ||||||
Exchange
obligation
|
2,949,176 | - | ||||||
Total
liabilities
|
4,962,802 | 1,871,662 | ||||||
Commitments
and contingencies
|
||||||||
Stockholders’
deficiency:
|
||||||||
Preferred
stock, $.001 par value. Authorized 1,500,000 shares; no shares
issued
|
||||||||
and
outstanding at September 30, 2008 and December 31, 2007
|
||||||||
Common
stock, $.001 par value. Authorized 300,000,000 shares;
70,624,232
|
||||||||
shares
issued and outstanding at September 30, 2008 and December 31,
2007
|
70,624 | 70,624 | ||||||
Additional
paid-in capital
|
54,566,421 | 54,037,361 | ||||||
Deficit
accumulated during the development stage
|
(59,394,947 | ) | (54,999,070 | ) | ||||
Total
stockholders’ deficiency
|
(4,757,902 | ) | (891,085 | ) | ||||
Total
liabilities and stockholders' deficiency
|
$ | 204,900 | $ | 980,577 |
Three months ended
September 30,
|
Nine months ended
September 30,
|
Cumulative
period from
August 6,
2001
(inception)
to
September
30
|
||||||||||||||||||
2008
|
2007
|
2008
|
2007
|
2008
|
||||||||||||||||
Costs
and expenses:
|
||||||||||||||||||||
Research
and development
|
$ | 498,853 | $ | 1,808,958 | $ | 1,864,652 | $ | 7,360,040 | $ | 28,353,695 | ||||||||||
General
and administrative
|
884,705 | 898,063 | 2,600,303 | 2,865,161 | 16,452,666 | |||||||||||||||
In-process
research and development charge
|
— | — | — | — | 11,887,807 | |||||||||||||||
Impairment
of intangible assets
|
— | — | — | — | 1,248,230 | |||||||||||||||
Loss
on disposition of intangible assets
|
— | — | — | — | 1,213,878 | |||||||||||||||
Total
operating expenses
|
1,383,558 | 2,707,021 | 4,464,955 | 10,225,201 | 59,156,276 | |||||||||||||||
|
||||||||||||||||||||
Operating
loss
|
(1,383,558 | ) | (2,707,021 | ) | (4,464,955 | ) | (10,225,201 | ) | (59,156,276 | ) | ||||||||||
Other
(income) expense:
|
||||||||||||||||||||
Equity
in loss of Hedrin JV
|
140,138 | — | 247,731 | — | 247,731 | |||||||||||||||
Interest
and other income
|
(148,184 | ) | (37,600 | ) | (335,613 | ) | (97,598 | ) | (1,157,510 | ) | ||||||||||
Interest
expense
|
18,804 | — | 18,804 | 475 | 44,838 | |||||||||||||||
Realized
gain on sale of marketable equity securities
|
— | — | — | — | (76,032 | ) | ||||||||||||||
Total
other (income) expense
|
10,758 | (37,600 | ) | (69,078 | ) | (97,123 | ) | (940,973 | ) | |||||||||||
Net
loss
|
(1,394,316 | ) | (2,669,421 | ) | (4,395,877 | ) | (10,128,078 | ) | (58,215,303 | ) | ||||||||||
Preferred
stock dividends (including imputed amounts)
|
— | — | — | — | (1,179,644 | ) | ||||||||||||||
Net
loss applicable to common shares
|
$ | (1,394,316 | ) | $ | (2,669,421 | ) | $ | (4,395,877 | ) | $ | (10,128,078 | ) | $ | (59,394,947 | ) | |||||
Net
loss per common share:
|
||||||||||||||||||||
Basic
and diluted
|
$ | (0.02 | ) | $ | (0.04 | ) | $ | (0.06 | ) | $ | (0.15 | ) | ||||||||
|
||||||||||||||||||||
Weighted
average shares of common stock outstanding:
|
||||||||||||||||||||
Basic
and diluted
|
70,624,232 | 70,591,623 | 70,624,232 | 67,134,882 |
Series A
convertible
preferred
stock
|
Series A
convertible
preferred
stock
|
Common
stock
|
Common
stock
|
Additional
paid-in
capital
|
Subscription
receivable
|
Deficit
accumulated
during
development
stage
|
Dividends
payable in
Series A
preferred
stock
|
Accumulated
other
comprehensive
income (loss)
|
Unearned
consulting
services
|
Total
stockholders’
equity
(deficiency)
|
||||||||||||||||||||||||||||||||||
Shares
|
Amount
|
Shares
|
Amount
|
Amount
|
Amount
|
Amount
|
Amount
|
Amount
|
Amount
|
Amount
|
||||||||||||||||||||||||||||||||||
Stock
issued at $0.0004 per share for subscription receivable
|
— | $ | — | 10,167,741 | $ | 10,168 | $ | (6,168 | ) | $ | (4,000 | ) | $ | — | $ | — | $ | — | $ | — | $ | — | ||||||||||||||||||||||
Net
loss
|
— | — | — | — | — | — | (56,796 | ) | — | — | — | (56,796 | ) | |||||||||||||||||||||||||||||||
Balance
at December 31, 2001
|
— | — | 10,167,741 | 10,168 | (6,168 | ) | (4,000 | ) | (56,796 | ) | — | — | — | (56,796 | ) | |||||||||||||||||||||||||||||
Proceeds
from subscription receivable
|
— | — | — | — | — | 4,000 | — | — | — | — | 4,000 | |||||||||||||||||||||||||||||||||
Stock
issued at $0.0004 per share for license rights
|
— | — | 2,541,935 | 2,542 | (1,542 | ) | — | — | — | — | — | 1,000 | ||||||||||||||||||||||||||||||||
Stock
options issued for consulting services
|
— | — | — | — | 60,589 | — | — | — | — | (60,589 | ) | — | ||||||||||||||||||||||||||||||||
Amortization
of unearned consulting services
|
— | — | — | — | — | — | — | — | — | 22,721 | 22,721 | |||||||||||||||||||||||||||||||||
Common
stock issued at $0.63 per share, net of expenses
|
— | — | 3,043,332 | 3,043 | 1,701,275 | — | — | — | — | — | 1,704,318 | |||||||||||||||||||||||||||||||||
Net
loss
|
— | — | — | — | — | (1,037,320 | ) | — | — | — | (1,037,320 | ) | ||||||||||||||||||||||||||||||||
Balance
at December 31, 2002
|
— | — | 15,753,008 | 15,753 | 1,754,154 | — | (1,094,116 | ) | — | — | (37,868 | ) | 637,923 | |||||||||||||||||||||||||||||||
Common
stock issued at $0.63 per share, net of expenses
|
— | — | 1,321,806 | 1,322 | 742,369 | — | — | — | — | — | 743,691 | |||||||||||||||||||||||||||||||||
Effect
of reverse acquisition
|
— | — | 6,287,582 | 6,287 | 2,329,954 | — | — | — | — | — | 2,336,241 | |||||||||||||||||||||||||||||||||
Amortization
of unearned consulting costs
|
— | — | — | — | — | — | — | — | — | 37,868 | 37,868 | |||||||||||||||||||||||||||||||||
Unrealized
loss on short-term investments
|
— | — | — | — | — | — | — | — | (7,760 | ) | — | (7,760 | ) | |||||||||||||||||||||||||||||||
Payment
for fractional shares for stock combination
|
— | — | — | — | (300 | ) | — | — | — | — | — | (300 | ) | |||||||||||||||||||||||||||||||
Preferred
stock issued at $10 per share, net of expenses
|
1,000,000 | 1,000 | — | — | 9,045,176 | — | — | — | — | — | 9,046,176 | |||||||||||||||||||||||||||||||||
Imputed
preferred stock dividend
|
418,182 | — | (418,182 | ) | — | — | ||||||||||||||||||||||||||||||||||||||
Net
loss
|
— | — | — | — | — | — | (5,960,907 | ) | — | — | — | (5,960,907 | ) | |||||||||||||||||||||||||||||||
Balance
at December 31, 2003
|
1,000,000 | 1,000 | 23,362,396 | 23,362 | 14,289,535 | — | (7,473,205 | ) | — | (7,760 | ) | — | 6,832,932 | |||||||||||||||||||||||||||||||
Exercise
of stock options
|
— | — | 27,600 | 27 | 30,073 | — | — | — | — | — | 30,100 | |||||||||||||||||||||||||||||||||
Common
stock issued at $1.10, net of expenses
|
— | — | 3,368,952 | 3,369 | 3,358,349 | — | — | — | — | — | 3,361,718 | |||||||||||||||||||||||||||||||||
Preferred
stock dividend accrued
|
— | — | — | — | — | — | (585,799 | ) | 585,799 | — | — | — | ||||||||||||||||||||||||||||||||
Preferred
stock dividends paid by issuance of shares
|
24,901 | 25 | — | — | 281,073 | — | — | (282,388 | ) | — | — | (1,290 | ) | |||||||||||||||||||||||||||||||
Conversion
of preferred stock to common stock at $1.10 per share
|
(170,528 | ) | (171 | ) | 1,550,239 | 1,551 | (1,380 | ) | — | — | — | — | — | — | ||||||||||||||||||||||||||||||
Warrants
issued for consulting services
|
— | — | — | — | 125,558 | — | — | — | — | (120,968 | ) | 4,590 | ||||||||||||||||||||||||||||||||
Amortization
of unearned consulting costs
|
— | — | — | — | — | — | — | — | — | 100,800 | 100,800 | |||||||||||||||||||||||||||||||||
Unrealized
gain on short-term investments and reversal of unrealized loss on
short-term investments
|
— | — | — | — | — | — | — | — | 20,997 | — | 20,997 | |||||||||||||||||||||||||||||||||
Net
loss
|
— | — | — | — | — | — | (5,896,031 | ) | — | — | — | (5,896,031 | ) | |||||||||||||||||||||||||||||||
Balance
at December 31, 2004
|
854,373 | 854 | 28,309,187 | 28,309 | 18,083,208 | — | (13,955,035 | ) | 303,411 | 13,237 | (20,168 | ) | 4,453,816 |
Series A
convertible
preferred
stock
|
Series A
convertible
preferred
stock
|
Common
stock
|
Common
stock
|
Additional
paid-in
capital
|
Subscription
receivable
|
Deficit
accumulated
during
development
stage
|
Dividends
payable
in Series A
preferred
stock
|
Accumulated
other
comprehensive
income
(loss)
|
Unearned
consulting
services
|
Total
stockholders’
equity
(deficiency)
|
||||||||||||||||||||||||||||||||||
Shares
|
Amount
|
Shares
|
Amount
|
Amount
|
Amount
|
Amount
|
Amount
|
Amount
|
Amount
|
Amount
|
||||||||||||||||||||||||||||||||||
Common
stock issued at $1.11 and $1.15, net of expenses
|
— | — | 11,917,680 | 11,918 | 12,238,291 | — | — | — | — | — | 12,250,209 | |||||||||||||||||||||||||||||||||
Common
stock issued to vendor at $1.11 per share in satisfaction of accounts
payable
|
— | — | 675,675 | 676 | 749,324 | — | — | — | — | — | 750,000 | |||||||||||||||||||||||||||||||||
Exercise
of stock options
|
— | — | 32,400 | 33 | 32,367 | — | — | — | — | — | 32,400 | |||||||||||||||||||||||||||||||||
Exercise
of warrants
|
— | — | 279,845 | 279 | 68,212 | — | — | — | — | — | 68,491 | |||||||||||||||||||||||||||||||||
Preferred
stock dividend accrued
|
— | — | — | — | — | — | (175,663 | ) | 175,663 | — | — | — | ||||||||||||||||||||||||||||||||
Preferred
stock dividends paid by issuance of shares
|
41,781 | 42 | — | — | 477,736 | — | — | (479,074 | ) | — | — | (1,296 | ) | |||||||||||||||||||||||||||||||
Conversion
of preferred stock to common stock at $1.10 per share
|
(896,154 | ) | (896 | ) | 8,146,858 | 8,147 | (7,251 | ) | — | — | — | — | — | — | ||||||||||||||||||||||||||||||
Share-based
compensation
|
— | — | — | — | 66,971 | — | — | — | — | 20,168 | 87,139 | |||||||||||||||||||||||||||||||||
Reversal
of unrealized gain on short-term investments
|
— | — | — | — | — | — | — | — | (12,250 | ) | — | (12,250 | ) | |||||||||||||||||||||||||||||||
Stock
issued in connection with acquisition of Tarpan Therapeutics,
Inc.
|
— | — | 10,731,052 | 10,731 | 11,042,253 | — | — | — | — | — | 11,052,984 | |||||||||||||||||||||||||||||||||
Net
loss
|
— | — | — | — | — | — | (19,140,997 | ) | — | — | — | (19,140,997 | ) | |||||||||||||||||||||||||||||||
Balance
at December 31, 2005
|
— | — | 60,092,697 | 60,093 | 42,751,111 | — | (33,271,695 | ) | — | 987 | — | 9,540,496 | ||||||||||||||||||||||||||||||||
Cashless
exercise of warrants
|
— | — | 27,341 | 27 | (27 | ) | — | — | — | — | — | — | ||||||||||||||||||||||||||||||||
Share-based
compensation
|
— | — | — | — | 1,675,499 | — | — | — | — | — | 1,675,499 | |||||||||||||||||||||||||||||||||
Unrealized
loss on short-term investments
|
— | — | — | — | — | — | — | — | (987 | ) | — | (987 | ) | |||||||||||||||||||||||||||||||
Costs
associated with private placement
|
— | — | — | — | (15,257 | ) | — | — | — | — | — | (15,257 | ) | |||||||||||||||||||||||||||||||
Net
loss
|
— | — | — | — | — | — | (9,695,123 | ) | — | — | — | (9,695,123 | ) | |||||||||||||||||||||||||||||||
Balance
at December 31, 2006
|
— | — | 60,120,038 | 60,120 | $ | 44,411,326 | — | (42,966,818 | ) | — | — | — | 1,504,628 | |||||||||||||||||||||||||||||||
Common
stock issued at $0.84 and $0.90 per shares, net of
expenses
|
— | — | 10,185,502 | 10,186 | 7,841,999 | — | — | — | — | — | 7,852,185 | |||||||||||||||||||||||||||||||||
Common
stock issued to directors at $0.72 per share in satisfaction of accounts
payable
|
— | — | 27,776 | 28 | 19,972 | — | — | — | — | — | 20,000 | |||||||||||||||||||||||||||||||||
Common
stock issued to in connection with in-licensing agreement at $0.90 per
share
|
— | — | 125,000 | 125 | 112,375 | — | — | — | — | — | 112,500 | |||||||||||||||||||||||||||||||||
Common
stock issued to in connection with in-licensing agreement at $0.80 per
share
|
— | — | 150,000 | 150 | 119,850 | — | — | — | — | — | 120,000 | |||||||||||||||||||||||||||||||||
Exercise
of warrants
|
— | — | 10,327 | 15 | 7,219 | — | — | — | — | — | 7,234 | |||||||||||||||||||||||||||||||||
Cashless
exercise of warrants
|
— | — | 5,589 | — | (6 | ) | — | — | — | — | — | (6 | ) | |||||||||||||||||||||||||||||||
Share-based
compensation
|
— | — | — | — | 1,440,956 | — | — | — | — | — | 1,440,956 | |||||||||||||||||||||||||||||||||
Warrants
issued for consulting
|
83,670 | 83,670 | ||||||||||||||||||||||||||||||||||||||||||
Net
loss
|
— | — | — | — | — | — | (12,032,252 | ) | — | — | — | (12,032,252 | ) | |||||||||||||||||||||||||||||||
Balance
at December 31, 2007
|
— | — | 70,624,232 | 70,624 | 54,037,361 | — | (54,999,070 | ) | — | — | — | (891,085 | ) | |||||||||||||||||||||||||||||||
Sale
of warrant
|
150,000 | 150,000 | ||||||||||||||||||||||||||||||||||||||||||
Share-based
compensation
|
— | — | — | — | 379,060 | — | — | — | — | — | 379,060 | |||||||||||||||||||||||||||||||||
Net
loss
|
— | — | — | — | - | — | (4,395,877 | )) | — | — | — | (4,395,877 | )) | |||||||||||||||||||||||||||||||
Balance
at September 30, 2008
|
— | $ | — | 70,624,232 | $ | 70,624 | $ | 54,566,421 | $ | — | $ | (59,394,947 | )) | $ | — | $ | — | $ | — | $ | (4,757,902 | )) |
Nine months ended
September 30,
|
Cumulative
period from
August 6, 2001
(inception) to
September 30,
|
|||||||||||
2008
|
2007
|
2008
|
||||||||||
Cash flows from operating activities:
|
||||||||||||
Net
loss
|
$ | (4,395,877 | ) | $ | (10,128,078 | ) | $ | (58,215,303 | ) | |||
Adjustments
to reconcile net loss to net cash used in operating
activities:
|
||||||||||||
Equity
in loss of Hedrin JV
|
247,731 | — | 247,731 | |||||||||
Share-based
compensation
|
379,060 | 1,078,185 | 3,744,043 | |||||||||
Shares
issued in connection with in-licensing agreement
|
— | 232,500 | 232,500 | |||||||||
Warrants
issued to consultant
|
— | — | 83,670 | |||||||||
Amortization
of intangible assets
|
— | — | 145,162 | |||||||||
Gain
on sale of marketable equity securities
|
— | (76,032 | ) | |||||||||
Depreciation
|
23,258 | 40,406 | 219,083 | |||||||||
Non
cash portion of in-process research and development charge
|
— | — | 11,721,623 | |||||||||
Loss
on impairment and disposition of intangible assets
|
— | — | 2,462,108 | |||||||||
Loss
on sale of fixed assets
|
18,327 | — | 23,917 | |||||||||
Changes
in operating assets and liabilities, net of acquisitions:
|
||||||||||||
(Increase)/decrease
in prepaid expenses and other current assets
|
140,430 | 62,425 | (17,177 | ) | ||||||||
Increase
in other assets
|
(9,119 | ) | - | (79,625 | ) | |||||||
Increase
/(decrease) in accounts payable
|
(574,162 | ) | (520,806 | ) | 1,125,536 | |||||||
Increase
in accrued expenses
|
646,126 | 388,627 | 697,982 | |||||||||
Net
cash used in operating activities
|
(3,524,226 | ) | (8,846,741 | ) | (37,684,782 | ) | ||||||
Cash
flows from investing activities:
|
||||||||||||
Purchase
of property and equipment
|
(8,972 | ) | (9,135 | ) | (239,607 | ) | ||||||
Cash
paid in connection with acquisitions
|
— | — | (26,031 | ) | ||||||||
Net
cash provided from the purchase and sale of short-term investments,
net
|
— | — | 435,938 | |||||||||
Proceeds
from the sale of license
|
— | — | 200,001 | |||||||||
Net
cash (used in) provided by investing activities
|
(8,972 | ) | (9,135 | ) | 370,301 | |||||||
Cash
flows from financing activities:
|
||||||||||||
Repayments
of notes payable to stockholders
|
— | — | (884,902 | ) | ||||||||
Proceeds
related to sale of common stock, net
|
— | 7,852,185 | 25,896,262 | |||||||||
Proceeds
from sale of preferred stock, net
|
— | — | 9,046,176 | |||||||||
Proceeds
from exercise of warrants and stock options
|
— | 7,228 | 138,219 | |||||||||
Proceeds
from the Hedrin JV Agreement, net
|
2,699,176 | — | 2,699,176 | |||||||||
Sale
of warrant
|
150,000 | — | 150,000 | |||||||||
Proceeds
from sale of 10% Secured Notes
|
70,000 | — | 70,000 | |||||||||
Other,
net
|
— | — | 235,214 | |||||||||
Net
cash provided by financing activities
|
2,919,176 | 7,859,413 | 37,350,145 | |||||||||
Net
(decrease) increase in cash and cash equivalents
|
(614,022 | ) | (996,463 | ) | 35,664 | |||||||
Cash
and cash equivalents at beginning of period
|
649,686 | 3,029,118 | — | |||||||||
Cash
and cash equivalents at end of period
|
$ | 35,664 | $ | 2,032,655 | $ | 35,664 | ||||||
|
||||||||||||
Supplemental
disclosure of cash flow information:
|
||||||||||||
Interest
paid
|
$ | — | $ | 475 | $ | 26,033 | ||||||
Supplemental
disclosure of noncash investing and financing activities:
|
||||||||||||
Common
stock issued in satisfaction of accounts payable
|
$ | — | $ | 20,000 | $ | 750,000 | ||||||
Imputed
preferred stock dividend
|
— | — | 418,182 | |||||||||
Preferred
stock dividends accrued
|
— | — | 761,462 | |||||||||
Preferred
stock dividends paid by issuance of shares
|
— | — | 9,046,176 | |||||||||
Conversion
of preferred stock to common stock
|
— | — | 759,134 | |||||||||
Issuance
of common stock for acquisitions
|
— | — | 13,389,226 | |||||||||
Issuance
of common stock in connection with in-licensing agreement
|
— | 232,500 | 232,500 | |||||||||
Marketable
equity securities received in connection with sale of
license
|
— | — | 359,907 | |||||||||
Warrants
issued to consultant
|
— | — | 83,670 | |||||||||
Net
liabilities assumed over assets acquired in business
combination
|
— | — | (675,416 | ) | ||||||||
Investment
in Hedrin JV
|
250,000 | — | 250,000 | |||||||||
Cashless
exercise of warrants
|
— | 6 | 33 | |||||||||
Issuance
of warrants to holders of 10% secured notes
|
— | — | — |
1.
|
SUMMARY OF
SIGNIFICANT ACCOUNTING
POLICIES
|
2.
|
LIQUIDITY
|
3.
|
COMPUTATION OF
NET LOSS PER COMMON SHARE
|
4.
|
SHARE-BASED
COMPENSATION
|
Three months ended
September 30,
|
Nine months ended
September 30,
|
|||||||||||||||
2008
|
2007
|
2008
|
2007
|
|||||||||||||
General
and administrative expense:
|
||||||||||||||||
Share-based
employee compensation cost
|
$ | 64,071 | $ | 254,870 | $ | 279,476 | $ | 726,414 | ||||||||
Share-based
consultant and non-employee (credit) cost
|
— | — | — | 10,550 | ||||||||||||
$ | 64,071 | $ | 254,870 | $ | 279,476 | $ | 736,964 | |||||||||
Research
and development expense:
|
||||||||||||||||
Share-based
employee compensation cost
|
$ | 18,978 | $ | 125,533 | $ | 98,978 | $ | 356,983 | ||||||||
Share-based
consultant and non-employee (credit) cost
|
347 | (8,767 | ) | 606 | (15,762 | ) | ||||||||||
$ | 19,325 | $ | 116,766 | $ | 99,584 | $ | 341,221 | |||||||||
Total
share-based cost
|
$ | 83,396 | $ | 371,636 | $ | 379,060 | $ | 1,078,185 |
Three months ended
September 30,
|
Nine months ended
September 30,
|
|||||||||||||||
2008
|
2007
|
2008
|
2007
|
|||||||||||||
Expected
Volatility
|
92.3 | % | 79.7 - 93.2 | % | 92.3 | % | 79.7 - 93.2 | % | ||||||||
Dividend
yield
|
- | - | - | - | ||||||||||||
Expected
term (in years)
|
6 | 6 - 8 | 6 | 6 - 8 | ||||||||||||
Risk-free
interest rate
|
2.81 | % | 4.56% - 4.96 | % | 2.81 | % | 4.56% - 4.96 | % |
Shares
|
Weighted
Average
Exercise
Price
|
Weighted
Average
Remaining
Contractual
Term (years)
|
Aggregate
Intrinsic
Value
|
|||||||||||||
Outstanding
at December 31, 2007
|
8,033,808 | $ | 1.25 | |||||||||||||
Granted:
|
||||||||||||||||
Officers
|
2,400,000 | |||||||||||||||
Directors
|
375,000 | |||||||||||||||
Employees
|
192,500 | |||||||||||||||
Total
granted
|
2,967,500 | 0.17 | ||||||||||||||
Exercised
|
- | |||||||||||||||
Cancelled
|
(324,972 | ) | 0.17 | |||||||||||||
Outstanding
at September 30, 2008
|
10,676,336 | $ | 0.94 | 7.19 | $ | - | ||||||||||
Exercisable
at September 30, 2008
|
8,093,025 | $ | 1.12 | 6.56 | ||||||||||||
Weighted
average fair value of options granted during the nine months ended
September 30, 2008
|
$ | 0.13 |
5.
|
COMMITMENTS
AND CONTINGENCIES
|
6.
|
PRIVATE
PLACEMENT OF COMMON SHARES
|
7.
|
IN-LICENSING
TRANSACTIONS
|
8.
|
JOINT
VENTURE
|
9.
|
AMERICAN STOCK
EXCHANGE
|
10.
|
10% PROMISSORY
NOTES
|
11.
|
SUBSEQUENT EVENT - 12% PROMISSORY
NOTES
|
Shares Issuable
upon the exercise
of Nordic’s Put
|
Additional
Shares Issuable
upon the exercise
of Nordic’s Put,
if certain
conditions are
met
|
Shares Issuable
upon the exercise
of Nordic’s
Warrant
|
Total Shares
Issuable upon
the exercise of
Nordic’s Put and
Warrant
|
|||||||||||||
Before
the financing
|
26,785,714 | 8,928,572 | 7,142,857 | 42,857,143 | ||||||||||||
Antidilution
shares
|
14,880,953 | 4,960,317 | 3,968,254 | 23,809,524 | ||||||||||||
After
the financing
|
41,666,667 | 13,888,889 | 11,111,111 | 66,666,667 |
December 31,
2007
|
December 31,
2006
|
|||||||
Assets
|
||||||||
Current
assets:
|
||||||||
Cash
and cash equivalents
|
$ | 649,686 | $ | 3,029,118 | ||||
Prepaid
expenses
|
215,852 | 264,586 | ||||||
Total
current assets
|
865,538 | 3,293,704 | ||||||
Property
and equipment, net
|
44,533 | 83,743 | ||||||
Other
assets
|
70,506 | 70,506 | ||||||
Total
assets
|
$ | 980,577 | $ | 3,447,953 | ||||
Liabilities
and Stockholders’ Equity (Deficiency)
|
||||||||
Current
liabilities:
|
||||||||
Accounts
payable
|
$ | 1,279,485 | $ | 1,393,296 | ||||
Accrued
expenses
|
592,177 | 550,029 | ||||||
Total
liabilities
|
1,871,662 | 1,943,325 | ||||||
Commitments
and contingencies
|
||||||||
Stockholders’
equity (deficiency):
|
||||||||
Preferred
stock, $.001 par value. Authorized 1,500,000 shares; no shares issued and
outstanding at December 31, 2007 and 2006
|
||||||||
Common
stock, $.001 par value. Authorized 150,000,000 shares; 70,624,232 and
60,120,038 shares issued and outstanding at December 31, 2007 and December
31, 2006, respectively
|
70,624 | 60,120 | ||||||
Additional
paid-in capital
|
54,037,361 | 44,411,326 | ||||||
Deficit
accumulated during the development stage
|
(54,999,070 | ) | (42,966,818 | ) | ||||
Total
stockholders’ equity (deficiency)
|
(891,085 | ) | 1,504,628 | |||||
Total
liabilities and stockholders' equity (deficiency)
|
$ | 980,577 | $ | 3,447,953 |
Years ended December 31,
|
Cumulative
period from
August 6, 2001
(inception) to
December 31,
|
|||||||||||
2007
|
2006
|
2007
|
||||||||||
Revenue
|
$ | — | $ | — | $ | — | ||||||
Costs
and expenses:
|
||||||||||||
Research
and development
|
8,535,687 | 6,172,845 | 26,489,043 | |||||||||
General
and administrative
|
3,608,270 | 3,827,482 | 13,852,363 | |||||||||
In-process
research and development charge
|
— | — | 11,887,807 | |||||||||
Impairment
of intangible assets
|
— | — | 1,248,230 | |||||||||
Loss
on disposition of intangible assets
|
— | — | 1,213,878 | |||||||||
Total
operating expenses
|
12,143,957 | 10,000,327 | 54,691,321 | |||||||||
Operating
loss
|
(12,143,957 | ) | (10,000,327 | ) | (54,691,321 | ) | ||||||
Other
(income) expense:
|
||||||||||||
Interest
and other income
|
(112,181 | ) | (307,871 | ) | (821,897 | ) | ||||||
Interest
expense
|
476 | 1,665 | 26,034 | |||||||||
Realized
(gain)/loss on sale of marketable equity securities
|
— | 1,002 | (76,032 | ) | ||||||||
Total
other income
|
(111,705 | ) | (305,204 | ) | (871,895 | ) | ||||||
Net
loss
|
(12,032,252 | ) | (9,695,123 | ) | (53,819,426 | ) | ||||||
Preferred
stock dividends (including imputed amounts)
|
— | — | (1,179,644 | ) | ||||||||
Net
loss applicable to common shares
|
$ | (12,032,252 | ) | $ | (9,695,123 | ) | $ | (54,999,070 | ) | |||
Net
loss per common share:
|
||||||||||||
Basic
and diluted
|
$ | (0.18 | ) | $ | (0.16 | ) | ||||||
Weighted
average shares of common stock outstanding:
|
||||||||||||
Basic
and diluted
|
68,015,075 | 60,112,333 |
Series A
convertible
preferred
stock
|
Series A
convertible
preferred
stock
|
Common
stock
|
Common
stock
|
Additional
paid-in
capital
|
Subscription
receivable
|
Deficit
accumulated
during
development
stage
|
Dividends
payable in
Series A
preferred
stock
|
Accumulated
other
comprehensive
income (loss)
|
Unearned
consulting
services
|
Total
stockholders’
equity
(deficiency)
|
||||||||||||||||||||||||||
Shares
|
Amount
|
Shares
|
Amount
|
Amount
|
Amount
|
Amount
|
Amount
|
Amount
|
Amount
|
Amount
|
||||||||||||||||||||||||||
Stock
issued at $0.0004 per share for subscription receivable
|
— | $ | — | 10,167,741 | $ | 10,168 | $ | (6,168 | ) | $ | (4,000 | ) | $ | — | $ | — | $ | — | $ | — | $ | — | ||||||||||||||
Net
loss
|
— | — | — | — | — | — | (56,796 | ) | — | — | — | (56,796 | ) | |||||||||||||||||||||||
Balance
at December 31, 2001
|
— | — | 10,167,741 | 10,168 | (6,168 | ) | (4,000 | ) | (56,796 | ) | — | — | — | (56,796 | ) | |||||||||||||||||||||
Proceeds
from subscription receivable
|
— | — | — | — | — | 4,000 | — | — | — | — | 4,000 | |||||||||||||||||||||||||
Stock
issued at $0.0004 per share for license rights
|
— | — | 2,541,935 | 2,542 | (1,542 | ) | — | — | — | — | — | 1,000 | ||||||||||||||||||||||||
Stock
options issued for consulting services
|
— | — | — | — | 60,589 | — | — | — | — | (60,589 | ) | — | ||||||||||||||||||||||||
Amortization
of unearned consulting services
|
— | — | — | — | — | — | — | — | — | 22,721 | 22,721 | |||||||||||||||||||||||||
Common
stock issued at $0.63 per share, net of expenses
|
— | — | 3,043,332 | 3,043 | 1,701,275 | — | — | — | — | — | 1,704,318 | |||||||||||||||||||||||||
Net
loss
|
— | — | — | — | — | (1,037,320 | ) | — | — | — | (1,037,320 | ) | ||||||||||||||||||||||||
Balance
at December 31, 2002
|
— | — | 15,753,008 | 15,753 | 1,754,154 | — | (1,094,116 | ) | — | — | (37,868 | ) | 637,923 | |||||||||||||||||||||||
Common
stock issued at $0.63 per share, net of expenses
|
— | — | 1,321,806 | 1,322 | 742,369 | — | — | — | — | — | 743,691 | |||||||||||||||||||||||||
Effect
of reverse acquisition
|
— | — | 6,287,582 | 6,287 | 2,329,954 | — | — | — | — | — | 2,336,241 | |||||||||||||||||||||||||
Amortization
of unearned consulting costs
|
— | — | — | — | — | — | — | — | — | 37,868 | 37,868 | |||||||||||||||||||||||||
Unrealized
loss on short-term investments
|
— | — | — | — | — | — | — | — | (7,760 | ) | — | (7,760 | ) | |||||||||||||||||||||||
Payment
for fractional shares for stock combination
|
— | — | — | — | (300 | ) | — | — | — | — | — | (300 | ) | |||||||||||||||||||||||
Preferred
stock issued at $10 per share, net of expenses
|
1,000,000 | 1,000 | — | — | 9,045,176 | — | — | — | — | — | 9,046,176 | |||||||||||||||||||||||||
Imputed
preferred stock dividend
|
418,182 | — | (418,182 | ) | — | — | ||||||||||||||||||||||||||||||
Net
loss
|
— | — | — | — | — | — | (5,960,907 | ) | — | — | — | (5,960,907 | ) | |||||||||||||||||||||||
Balance
at December 31, 2003
|
1,000,000 | 1,000 | 23,362,396 | 23,362 | 14,289,535 | — | (7,473,205 | ) | — | (7,760 | ) | — | 6,832,932 | |||||||||||||||||||||||
Exercise
of stock options
|
— | — | 27,600 | 27 | 30,073 | — | — | — | — | — | 30,100 | |||||||||||||||||||||||||
Common
stock issued at $1.10, net of expenses
|
— | — | 3,368,952 | 3,369 | 3,358,349 | — | — | — | — | — | 3,361,718 | |||||||||||||||||||||||||
Preferred
stock dividend accrued
|
— | — | — | — | — | — | (585,799 | ) | 585,799 | — | — | — | ||||||||||||||||||||||||
Preferred
stock dividends paid by issuance of shares
|
24,901 | 25 | — | — | 281,073 | — | — | (282,388 | ) | — | — | (1,290 | ) | |||||||||||||||||||||||
Conversion
of preferred stock to common stock at $1.10 per share
|
(170,528 | ) | (171 | ) | 1,550,239 | 1,551 | (1,380 | ) | — | — | — | — | — | — | ||||||||||||||||||||||
Warrants
issued for consulting services
|
— | — | — | — | 125,558 | — | — | — | — | (120,968 | ) | 4,590 | ||||||||||||||||||||||||
Amortization
of unearned consulting costs
|
— | — | — | — | — | — | — | — | — | 100,800 | 100,800 | |||||||||||||||||||||||||
Unrealized
gain on short-term investments and reversal of unrealized loss on
short-term investments
|
— | — | — | — | — | — | — | — | 20,997 | — | 20,997 | |||||||||||||||||||||||||
Net
loss
|
— | — | — | — | — | — | (5,896,031 | ) | — | — | — | (5,896,031 | ) | |||||||||||||||||||||||
Balance
at December 31, 2004
|
854,373 | 854 | 28,309,187 | 28,309 | 18,083,208 | — | (13,955,035 | ) | 303,411 | 13,237 | (20,168 | ) | 4,453,816 |
Series A
convertible
preferred
stock
|
Series A
convertible
preferred
stock
|
Common
stock
|
Common
stock
|
Additional
paid-in
capital
|
Subscription
receivable
|
Deficit
accumulated
during
development
stage
|
Dividends
payable in
Series A
preferred
stock
|
Accumulated
other
comprehensive
income (loss)
|
Unearned
consulting
services
|
Total
stockholders’
equity
(deficiency)
|
||||||||||||||||||||||
Shares
|
Amount
|
Shares
|
Amount
|
Amount
|
Amount
|
Amount
|
Amount
|
Amount
|
Amount
|
Amount
|
||||||||||||||||||||||
Common
stock issued at $1.11 and $1.15, net of expenses
|
—
|
—
|
11,917,680
|
11,918
|
12,238,291
|
—
|
—
|
—
|
—
|
—
|
12,250,209
|
|||||||||||||||||||||
Common
stock issued to vendor at $1.11 per share in satisfaction of accounts
payable
|
—
|
—
|
675,675
|
676
|
749,324
|
—
|
—
|
—
|
—
|
—
|
750,000
|
|||||||||||||||||||||
Exercise
of stock options
|
—
|
—
|
32,400
|
33
|
32,367
|
—
|
—
|
—
|
—
|
—
|
32,400
|
|||||||||||||||||||||
Exercise
of warrants
|
—
|
—
|
279,845
|
279
|
68,212
|
—
|
—
|
—
|
—
|
—
|
68,491
|
|||||||||||||||||||||
Preferred
stock dividend accrued
|
—
|
—
|
—
|
—
|
—
|
—
|
(175,663
|
)
|
175,663
|
—
|
—
|
—
|
||||||||||||||||||||
Preferred
stock dividends paid by issuance of shares
|
41,781
|
42
|
—
|
—
|
477,736
|
—
|
—
|
(479,074
|
)
|
—
|
—
|
(1,296
|
)
|
|||||||||||||||||||
Conversion
of preferred stock to common stock at $1.10 per share
|
(896,154
|
)
|
(896
|
)
|
8,146,858
|
8,147
|
(7,251
|
)
|
—
|
—
|
—
|
—
|
—
|
—
|
||||||||||||||||||
Share-based
compensation
|
—
|
—
|
—
|
—
|
66,971
|
—
|
—
|
—
|
—
|
20,168
|
87,139
|
|||||||||||||||||||||
Reversal
of unrealized gain on short-term investments
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
(12,250
|
)
|
—
|
(12,250
|
)
|
|||||||||||||||||||
Stock
issued in connection with acquisition of Tarpan Therapeutics,
Inc.
|
—
|
—
|
10,731,052
|
10,731
|
11,042,253
|
—
|
—
|
—
|
—
|
—
|
11,052,984
|
|||||||||||||||||||||
Net
loss
|
—
|
—
|
—
|
—
|
—
|
—
|
(19,140,997
|
)
|
—
|
—
|
—
|
(19,140,997
|
)
|
|||||||||||||||||||
Balance
at December 31, 2005
|
—
|
—
|
60,092,697
|
60,093
|
42,751,111
|
—
|
(33,271,695
|
)
|
—
|
987
|
—
|
9,540,496
|
||||||||||||||||||||
Cashless
exercise of warrants
|
—
|
—
|
27,341
|
27
|
(27
|
)
|
—
|
—
|
—
|
—
|
—
|
—
|
||||||||||||||||||||
Share-based
compensation
|
—
|
—
|
—
|
—
|
1,675,499
|
—
|
—
|
—
|
—
|
—
|
1,675,499
|
|||||||||||||||||||||
Unrealized
loss on short-term investments
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
(987
|
)
|
—
|
(987
|
)
|
|||||||||||||||||||
Costs
associated with private placement
|
—
|
—
|
—
|
—
|
(15,257
|
)
|
—
|
—
|
—
|
—
|
—
|
(15,257
|
)
|
|||||||||||||||||||
Net
loss
|
—
|
—
|
—
|
—
|
—
|
—
|
(9,695,123
|
)
|
—
|
—
|
—
|
(9,695,123
|
)
|
|||||||||||||||||||
Balance
at December 31, 2006
|
—
|
—
|
60,120,038
|
60,120
|
44,411,326
|
—
|
(42,966,818
|
)
|
—
|
—
|
—
|
1,504,628
|
||||||||||||||||||||
Common
stock issued at $0.84 and $0.90 per shares, net of
expenses
|
—
|
—
|
10,185,502
|
10,186
|
7,841,999
|
—
|
—
|
—
|
—
|
—
|
7,852,185
|
|||||||||||||||||||||
Common
stock issued to directors at $0.72 per share in satisfaction of accounts
payable
|
—
|
—
|
27,776
|
28
|
19,972
|
—
|
—
|
—
|
—
|
—
|
20,000
|
|||||||||||||||||||||
Common
stock issued to in connection with in-licensing agreement at $0.90 per
share
|
—
|
—
|
125,000
|
125
|
112,375
|
—
|
—
|
—
|
—
|
—
|
112,500
|
|||||||||||||||||||||
Common
stock issued to in connection with in-licensing agreement at $0.80 per
share
|
—
|
—
|
150,000
|
150
|
119,850
|
—
|
—
|
—
|
—
|
—
|
120,000
|
|||||||||||||||||||||
Exercise
of warrants
|
—
|
—
|
10,327
|
15
|
7,219
|
—
|
—
|
—
|
—
|
—
|
7,234
|
|||||||||||||||||||||
Cashless
exercise of warrants
|
—
|
—
|
5,589
|
—
|
(6
|
)
|
—
|
—
|
—
|
—
|
—
|
(6
|
)
|
|||||||||||||||||||
Share-based
compensation
|
—
|
—
|
—
|
—
|
1,440,956
|
—
|
—
|
—
|
—
|
—
|
1,440,956
|
|||||||||||||||||||||
Warrants
issued for consulting
|
83,670
|
83,670
|
||||||||||||||||||||||||||||||
Net
loss
|
—
|
—
|
—
|
—
|
—
|
—
|
(12,032,252
|
)
|
—
|
—
|
—
|
(12,032,252
|
)
|
|||||||||||||||||||
Balance
at December 31, 2007
|
—
|
—
|
|
70,624,232
|
70,624
|
$
|
54,037,361
|
$
|
—
|
$
|
(54,999,070
|
)
|
$
|
—
|
$
|
—
|
$
|
—
|
$
|
(891,085
|
)
|
Years
ended December 31,
|
Cumulative
period
from
August
6, 2001
(inception)
to
December
31,
|
|||||||||||
2007
|
2006
|
2007
|
||||||||||
Cash
flows from operating activities:
|
|
|||||||||||
Net
loss
|
$ | (12,032,252 | ) | $ | (9,695,123 | ) | $ | (53,819,426 | ) | |||
Adjustments
to reconcile net loss to net cash used in operating
activities:
|
||||||||||||
Share-based
compensation
|
1,440,956 | 1,675,499 | 3,364,983 | |||||||||
Shares
issued in connection with in-licensing agreement
|
232,500 | — | 232,500 | |||||||||
Warrants
issued to consultant
|
83,670 | — | 83,670 | |||||||||
Amortization
of intangible assets
|
— | — | 145,162 | |||||||||
(Gain)/loss
on sale of marketable equity securities
|
— | 1,002 | (76,032 | ) | ||||||||
Depreciation
|
48,345 | 60,186 | 195,825 | |||||||||
Non
cash portion of in-process research and development charge
|
— | — | 11,721,623 | |||||||||
Loss
on impairment and disposition of intangible assets
|
— | — | 2,462,108 | |||||||||
Other
|
— | — | 5,590 | |||||||||
Changes
in operating assets and liabilities, net of acquisitions:
|
||||||||||||
Decrease
(increase) in prepaid expenses and other current assets
|
48,734 | (69,810 | ) | (157,607 | ) | |||||||
Increase
in other assets
|
— | — | (70,506 | ) | ||||||||
Increase
(decrease) in accounts payable
|
(93,812 | ) | (224,193 | ) | 1,699,698 | |||||||
Increase
in accrued expenses
|
42,148 | 501,701 | 51,856 | |||||||||
Net
cash used in operating activities
|
(10,229,711 | ) | (7,750,738 | ) | (34,160,556 | ) | ||||||
Cash
flows from investing activities:
|
||||||||||||
Purchase
of property and equipment
|
(9,134 | ) | (37,052 | ) | (230,635 | ) | ||||||
Cash
paid in connection with acquisitions
|
— | — | (26,031 | ) | ||||||||
Net
cash provided from the purchase and sale of short-term
investments
|
— | 1,005,829 | 435,938 | |||||||||
Proceeds
from sale of license
|
— | — | 200,001 | |||||||||
Net
cash (used in) provided by investing activities
|
(9,134 | ) | 968,777 | 379,273 | ||||||||
Cash
flows from financing activities:
|
||||||||||||
Repayments
of notes payable to stockholders
|
— | — | (884,902 | ) | ||||||||
Proceeds
(costs) related to sale of common stock, net
|
7,852,185 | (15,257 | ) | 25,896,262 | ||||||||
Proceeds
from sale of preferred stock, net
|
— | — | 9,046,176 | |||||||||
Proceeds
from exercise of warrants and stock options
|
7,228 | — | 138,219 | |||||||||
Other,
net
|
— | — | 235,214 | |||||||||
Net
cash provided by (used in) financing activities
|
7,859,413 | (15,257 | ) | 34,430,969 | ||||||||
Net
(decrease) increase in cash and cash equivalents
|
(2,379,432 | ) | (6,797,218 | ) | 649,686 | |||||||
Cash
and cash equivalents at beginning of period
|
3,029,118 | 9,826,336 | — | |||||||||
Cash
and cash equivalents at end of period
|
$ | 649,686 | $ | 3,029,118 | $ | 649,686 | ||||||
Supplemental
disclosure of cash flow information:
|
||||||||||||
Interest
paid
|
$ | 475 | $ | 1,665 | $ | 26,033 | ||||||
Supplemental
disclosure of noncash investing and financing activities:
|
||||||||||||
Common
stock issued in satisfaction of accounts payable
|
$ | 20,000 | $ | — | $ | 770,000 | ||||||
Imputed
preferred stock dividend
|
— | — | 418,182 | |||||||||
Preferred
stock dividends accrued
|
— | — | 761,462 | |||||||||
Conversion
of preferred stock to common stock
|
— | — | 1,067 | |||||||||
Preferred
stock dividends paid by issuance of shares
|
— | — | 759,134 | |||||||||
Issuance
of common stock for acquisitions
|
— | — | 13,389,226 | |||||||||
Issuance
of common stock in connection with in-licensing agreement
|
232,500 | 232,500 | ||||||||||
Marketable
equity securities received in connection with sale of
license
|
— | — | 359,907 | |||||||||
Warrants
issued to consultant
|
83,670 | — | 83,670 | |||||||||
Net
liabilities assumed over assets acquired in business
combination
|
— | — | (675,416 | ) | ||||||||
Cashless
exercise of warrants
|
6 | 27 | 33 |
2007
|
2006
|
|||||||
General
and administrative expense:
|
||||||||
Share-based
employee compensation cost
|
$ | 891,897 | $ | 1,176,618 | ||||
Share-based
consultant and non-employee cost
|
10,550 | (29,842 | ) | |||||
$ | 902,447 | $ | 1,146,776 | |||||
Research
and development expense
|
||||||||
Share-based
employee compensation cost
|
$ | 555,663 | $ | 494,043 | ||||
Share-based
consultant and non-employee cost
|
(17,154 | ) | 34,680 | |||||
$ | 538,509 | $ | 528,723 | |||||
Total
share-based cost
|
$ | 1,440,956 | $ | 1,675,499 |
2007
|
2006
|
|||||||
Expected
volatility
|
93 | % | 84% - 98 | % | ||||
Dividend
yield
|
— | — | ||||||
Expected
term (in years)
|
5 - 10 | 5 - 10 | ||||||
Risk-free
interest rate
|
3.6% - 4.9 | % | 4.45% - 5.1 | % | ||||
Forfeiture
rate
|
7 | % | 4 | % |
2007
|
2006
|
|||||||
Property
and equipment
|
$ | 226,010 | $ | 244,040 | ||||
Less
accumulated depreciation
|
(181,477 | ) | (160,297 | ) | ||||
Net
property and equipment
|
$ | 44,533 | $ | 83,743 |
2007
|
||||||||||||||||
Shares
|
Weighted
average
exercise
price
|
Weighted
Average
Remaining
Contractual
Term
(years)
|
Aggregate
Intrinsic
Value
|
|||||||||||||
Outstanding
at beginning of year
|
7,000,504 | $ | 1.310 | |||||||||||||
Granted
|
1,342,500 | $ | 0.875 | |||||||||||||
Exercised
|
- | |||||||||||||||
Cancelled
|
(309,166 | ) | $ | 0.336 | ||||||||||||
Outstanding
at end of year
|
8,033,838 | $ | 1.253 | 6.887 | $ | |||||||||||
Options
exercisable at year-end
|
5,601,714 | $ | 1.263 | 6.625 | $ | |||||||||||
Weighted-average
fair value of
|
||||||||||||||||
options
granted during the year
|
$ | 0.63 |
Number
|
Remaining
|
Number
of
|
|||||||||||
Exercise
|
of
Options
|
Contractual
|
Options
|
||||||||||
Price
|
Outstanding
|
Life
(years)
|
Exercisable
|
||||||||||
$
|
0.40 | 876,090 | 5.16 | 876,090 | |||||||||
0.43
|
400 | 5.15 | 400 | ||||||||||
0.70
|
220,000 | 8.53 | 73,333 | ||||||||||
0.72
|
365,000 | 9.09 | 32,500 | ||||||||||
0.82
|
75,000 | 9.08 | - | ||||||||||
0.89
|
16,667 | 8.38 | 16,667 | ||||||||||
0.95
|
670,000 | 9.32 | 100,000 | ||||||||||
0.97
|
440,000 | 6.75 | 440,000 | ||||||||||
1.00
|
65,000 | 4.24 | 65,000 | ||||||||||
1.00
|
290,698 | 7.04 | 290,698 | ||||||||||
1.25
|
12,000 | 4.08 | 12,000 | ||||||||||
1.25
|
163,750 | 4.14 | 163,750 | ||||||||||
1.35
|
108,333 | 8.08 | 64,999 | ||||||||||
1.35
|
300,000 | 8.09 | 300,000 | ||||||||||
1.35
|
60,000 | 8.53 | 20,000 | ||||||||||
1.50
|
2,923,900 | 7.25 | 1,949,277 | ||||||||||
1.50
|
250,000 | 2.58 | 25,000 | ||||||||||
1.60
|
100,000 | 7.46 | 75,000 | ||||||||||
1.65
|
1,077,000 | 6.08 | 1,077,000 | ||||||||||
4.38
|
10,000 | 3.14 | 10,000 | ||||||||||
20.94
|
10,000 | 2.28 | 10,000 | ||||||||||
Total
|
8,033,838 | 5,601,714 |
Number
of
|
Remaining
|
Number
of
|
|||||||||||
Exercise
price
|
Warrants
outstanding
|
contractual life
(years)
|
warrants
exercisable
|
||||||||||
$
|
0.28 | 150,000 | 4.64 | 150,000 | |||||||||
0.78
|
10,000 | 1.98 | 10,000 | ||||||||||
1.00
|
3,564,897 | 4.25 | 3,564,897 | ||||||||||
1.00
|
509,275 | 4.25 | 509,275 | ||||||||||
1.10
|
909,090 | .85 | 909,090 | ||||||||||
1.10
|
326,499 | 1.04 | 326,499 | ||||||||||
1.44
|
2,161,767 | 2.65 | 2,161,767 | ||||||||||
1.44
|
540,449 | 2.65 | 540,449 | ||||||||||
1.44
|
135,135 | 2.65 | 135,135 | ||||||||||
1.49
|
221,741 | 2.67 | 221,741 | ||||||||||
1.49
|
55,000 | 2.67 | 55,000 | ||||||||||
1.90
|
10,000 | 1.21 | 10,000 | ||||||||||
1.90
|
90,000 | 1.21 | 90,000 | ||||||||||
6.69
|
185,601 | .10 | 185,601 | ||||||||||
Total
|
8,869,454 | 8,869,454 |
(9)
|
Income
Taxes
|
2007
|
2006
|
|||||||
Deferred
tax assets:
|
||||||||
Tax
loss carryforwards
|
$ | 22,513,000 | $ | 18,265,000 | ||||
Research
and development credit
|
1,769,000 | 1,374,000 | ||||||
In-process
research and development charge
|
4,850,000 | 4,850,000 | ||||||
Stock
based compensation
|
1,270,000 | 682,000 | ||||||
Other
|
85,000 | 29,000 | ||||||
Gross
deferred tax assets
|
30,487,000 | 25,200,000 | ||||||
Less
valuation allowance
|
(30,487,000 | ) | (25,200,000 | ) | ||||
Net
deferred tax assets
|
$ | — | $ | — |
2007
|
2006
|
|||||||||||||||
% of
|
% of
|
|||||||||||||||
pretax
|
pretax
|
|||||||||||||||
Amount
|
loss
|
Amount
|
loss
|
|||||||||||||
Federal
income tax benefit at statutory rate
|
$ | (4,102,000 | ) | (34.0) | % | $ | (3,296,000 | ) | (34.0) | % | ||||||
State
income taxes, net of federal tax
|
(820,000 | ) | (6.8) | % | (659,000 | ) | (6.8) | % | ||||||||
Research
and development credits
|
(366,000 | ) | (3.0) | % | (200,000 | ) | (1.7) | % | ||||||||
Other
|
1,000 | 0.0 | % | (166,000 | ) | (2.1) | % | |||||||||
Change
in valuation allowance
|
5,287,000 | 43.8 | % | 4,321,000 | 44.6 | % | ||||||||||
— | — | % | — | — | % |
(10)
|
License
and Consulting Agreements
|
(11)
|
Commitments
and Contingencies
|
Years Ending December 31,
|
Commitment
|
|||
2008
|
$ | 100,000 | ||
2009
and subsequent
|
$ | 0 |
12.
|
Subsequent
events
|
SEC
registration fee
|
$ | 205.00 | ||
Legal
fees and expenses
|
10,000.00 | |||
Printing
fees and expenses
|
1,000.00 | |||
Accounting
fees and expenses
|
10,000.00 | |||
Miscellaneous
fees and expenses
|
2,000.00 | |||
Total
|
$ | 23,205.00 |
Exhibit No.
|
Description
|
|
2.1
|
Agreement
and Plan of Merger among the Company, Manhattan Pharmaceuticals
Acquisition Corp. and Manhattan Research Development, Inc. (formerly
Manhattan Pharmaceuticals, Inc.) dated December 17, 2002 (incorporated by
reference to Exhibit 2.1 from Form 8-K filed March 5,
2003).
|
|
2.2
|
Agreement
and Plan of Merger among the Registrant, Tarpan Therapeutics, Inc. and
Tarpan Acquisition Corp., dated April 1, 2005 (incorporated by reference
to Exhibit 2.1 of the Registrant’s Form 8-K/A filed June 15,
2005).
|
|
3.1
|
Certificate
of incorporation, as amended through September 25, 2003 (incorporated by
reference to Exhibit 3.1 to the Registrant’s Form 10-QSB for the quarter
ended September 30, 2003).
|
|
3.2
|
Bylaws,
as amended to date (incorporated by reference from Registrant’s
registration statement on Form SB-2, as amended (File
No.33-98478)).
|
4.1
|
Specimen
common stock certificate (incorporated by reference from Registrant’s
registration statement on Form SB-2, as amended (File
No.33-98478)).
|
|
4.2
|
Form
of warrant issued by Manhattan Research Development, Inc., which
automatically converted into warrants to purchase shares of the
Registrant’s common stock upon the merger transaction with such company
(incorporated by reference to Exhibit 4.1 to the Registrant’s Form 10-QSB
for the quarter ended March 31, 2003).
|
|
4.3
|
Form
of warrant issued to placement agents in connection with the Registrant’s
November 2003 private placement of Series A Convertible Preferred Stock
and the Registrant’s January 2004 private placement (incorporated by
reference to Exhibit 4.18 to the Registrant’s Registration Statement on
Form SB-2 filed January 13, 2004 (File No.
333-111897)).
|
|
4.4
|
Form
of warrant issued to investors in the Registrant’s August 2005 private
placement (incorporated by reference to Exhibit 4.1 of the Registrant’s
Current Report on Form 8-K filed September 1, 2005).
|
|
4.5
|
Form
of warrant issued to placement agents in the Registrant’s August 2005
private placement (incorporated by reference to Exhibit 4.2 of the
Registrant’s Form 8-K filed September 1, 2005).
|
|
4.6
|
Warrant,
dated April 30, 2008, issued to Nordic Biotech Venture Fund II K/S
(incorporated by reference to Exhibit 4.6 of the Registrant’s Registration
Statement on Form S-1 filed on May 1, 2008 (File No.
333-150580)).
|
|
4.7
|
Form
of Warrant issued to Noteholders on September 11, 2008 (incorporated by
reference to Exhibit 10.2 to the Current Report on Form 8-K filed on
September 15, 2008)
|
|
4.8
|
Form
of Warrant issued to Noteholders on November 19, 2008 (incorporated by
reference to Exhibit 10.6 to the Registrant’s Current Report on Form 8-K
filed on November 25, 2008)
|
|
5.1
|
Opinion
of Lowenstein Sandler PC*
|
|
10.1
|
1995
Stock Option Plan, as amended (incorporated by reference to Exhibit 10.18
to the Registrant’s Form 10-QSB for the quarter ended September 30,
1996).
|
|
10.2
|
Form
of Notice of Stock Option Grant issued to employees of the Registrant from
April 12, 2000 to February 21, 2003 (incorporated by reference to Exhibit
99.2 of the Registrant’s Registration Statement non Form S-8 filed March
24, 1998 (File 333-48531)).
|
|
10.3
|
Schedule
of Notices of Stock Option Grants, the form of which is attached hereto as
Exhibit 4.2.
|
|
10.4
|
Form
of Stock Option Agreement issued to employees of the Registrant from April
12, 2000 to February 21, 2003 (incorporated by reference to Exhibit 99.3
to the Registrant’s Registration Statement on Form S-8 filed March 24,
1998 (File 333-48531)).
|
|
10.5
|
License
Agreement dated on or about February 28, 2002 between Manhattan Research
Development, Inc. (f/k/a Manhattan Pharmaceuticals, Inc.) and
Oleoyl-Estrone Developments SL (incorporated by reference to Exhibit 10.6
to the Registrant’s Amendment No. 2 to Form 10-QSB/A for the quarter ended
March 31, 2003 filed on March 12, 2004).
|
|
10.6
|
License
Agreement dated April 4, 2003 between the Registrant and NovaDel Pharma,
Inc. (incorporated by reference to Exhibit 10.1 to the Registrant’s
Amendment No. 1 to Form 10-QSB/A for the quarter ended June 30, 2003 filed
on March 12, 2004).++
|
10.7
|
2003
Stock Option Plan (incorporated by reference to Exhibit 4.1 to
Registrant’s Registration Statement on Form S-8 filed February 17,
2004).
|
|
10.8
|
Employment
Agreement dated April 1, 2005, between the Registrant and Douglas Abel
(incorporated by reference to Exhibit 10.1 to the Registrant’s Form 8-K/A
filed June 15, 2005).
|
|
10.9
|
Sublicense
Agreement dated April 14, 2004 between Tarpan Therapeutics, Inc., the
Registrant’s wholly-owned subsidiary, and IGI, Inc. (incorporated by
reference to Exhibit 10.109 to IGI Inc.’s Form 10-Q for the quarter ended
March 31, 2004 (File No. 001-08568).
|
|
10.10
|
Form
of subscription agreement between the Registrant and the investors in the
Registrant’s August 2005 private placement (incorporated by reference as
Exhibit 10.1 to the Registrant’s Form 8-K filed September 1,
2005).
|
|
10.11
|
Separation
Agreement between the Registrant and Alan G. Harris December 21, 2007
(incorporated by reference to Exhibit 10.11 to the Registrant's Form 10-K
filed March 31, 2008.)
|
|
10.12
|
Employment
Agreement dated July 7, 2006 between the Registrant and Michael G.
McGuinness (incorporated by reference to Exhibit 10.1 of the Registrant’s
Form 8-K filed July 12, 2006.)
|
|
10.13
|
Summary
terms of compensation plan for Registrant’s non-employee directors
(incorporated by reference to Exhibit 10.1 of Registrant’s Form 8-K filed
February 5, 2007).
|
|
10.14
|
Form
of Stock Option Agreement issued under the Registrant’s 2003 Stock Option
Plan (Incorporated by reference to Exhibit 10.15 to the Registrant's Form
10-KSB filed April 2, 2078.)
|
|
10.15
|
Exclusive
License Agreement for “Altoderm” between Thornton & Ross Ltd. and
Manhattan Pharmaceuticals, Inc. dates April 3, 2007. (Incorporated by
reference to Exhibit 10.3 of the registrant’s form 10-Q for the quarter
ended June 30, 2007 filed on August 14, 2007.)
|
|
10.16
|
Exclusive
License Agreement for “Altolyn” between Thornton &Ross Ltd. and
Manhattan Pharmaceuticals, Inc. dated April 3,
2007. (Incorporated by reference to Exhibit 10.4 of the
registrant’s form 10-Q for the quarter ended June 30, 2007 filed on August
14, 2007.)
|
|
10.17
|
Exclusive
License Agreement for “Hedrin” between Thornton &Ross Ltd. , Kerris,
S.A. and Manhattan Pharmaceuticals, Inc. dated June 26, 2007.
(Incorporated by reference to Exhibit 10.5 of the registrant’s form 10-Q
for the quarter ended June 30, 2007 filed on August 14,
2007.)
|
|
10.18
|
Supply
Agreement for “Hedrin” between Thornton & Ross Ltd. and Manhattan
Pharmaceuticals, Inc. dated June 26, 2007. (Incorporated by reference to
Exhibit 10.6 of the registrant’s form 10-Q for the quarter ended June 30,
2007 filed on August 14, 2007.)
|
|
10.19
|
Joint
Venture Agreement between Nordic Biotech Fund II K/S and Manhattan
Pharmaceuticals, Inc. to develop and commercialize “Hedrin” dated January
31, 2008.
|
|
10.20
|
Amendment
No. 1, dated February 25, 2008, to the Joint Venture Agreement between
Nordic Biotech Fund II K/S and Manhattan Pharmaceuticals, Inc. to develop
and commercialize “Hedrin” dated January 31, 2008 (Incorporated by
reference to Exhibit 10.20 to the Registrant's Form 10-K filed March 31,
2008).
|
10.21
|
Omnibus
Amendment to Joint Venture Agreement and Additional Agreements, dated June
9, 2008, among Manhattan Pharmaceuticals, Inc., Hedrin Pharmaceuticals
K/S, Hedrin Pharmaceuticals General Partner ApS and Nordic Biotech Venture
Fund II K/S.
|
|
10.22
|
Assignment
and Contribution Agreement between Hedrin Pharmaceuticals K/S and
Manhattan Pharmaceuticals, Inc. dated February 25,
2008. (Incorporated by reference to Exhibit 10.21 to the
Registrant's Form 10-K filed March 31, 2008.)
|
|
10.23
|
Registration
Rights Agreement between Nordic Biotech Venture Fund II K/S and Manhattan
Pharmaceuticals, Inc. dated February 25, 2008. (Incorporated by
reference to Exhibit 10.22 to the Registrant's Form 10-K filed March 31,
2008.)
|
|
10.24
|
Letter
Agreement, dated September 17, 2008, between Nordic Biotech Venture Fund
II K/S and Manhattan Pharmaceuticals, Inc.
|
|
10.25
|
Amendment
to Employment Agreement by and between Manhattan Pharmaceuticals, Inc. and
Douglas Abel (Incorporated by reference to Exhibit 10.23 to the
Registrant's Form 10-K filed March 31, 2008.)
|
|
10.26
|
Form
of Secured Promissory Note, dated September 11, 2008 (Incorporated by
reference to Exhibit 10.1 to the Registrant’s Current Report on Form 8-K
filed on September 15, 2008)
|
|
10.27
|
Securities
Purchase Agreement, dated November 19, 2008, by and among the Registrant
and the investors listed on Exhibit A-1 and A-2
thereto (incorporated by reference to Exhibit 10.1 to the
Registrant’s Current Report on Form 8-K filed on November 25,
2008)
|
|
10.28
|
Registration
Rights Agreement, dated November 19, 2008, by and among the Registrant,
the Placement Agent and the investors listed on Exhibit A thereto
(incorporated by reference to Exhibit 10.2 to the Registrant’s Current
Report on Form 8-K filed on November 25, 2008)
|
|
10.29
|
Security
Agreement, dated November 19, 2008, by and among the Registrant and each
person named on Exhibit A-1 and A-2 of the Securities Purchase
Agreement (incorporated by reference to Exhibit 10.3 to the
Registrant’s Current Report on Form 8-K filed on November 25,
2008)
|
|
10.30
|
Default
Agreement, dated November 19, 2008, by and among the Registrant and the
persons and entities listed on Schedule A thereto (incorporated
by reference to Exhibit 10.4 to the Registrant’s Current Report on Form
8-K filed on November 25, 2008)
|
|
10.31
|
Form
of 12% Senior Secured Promissory Note (incorporated by reference to
Exhibit 10.5 to the Registrant’s Current Report on Form 8-K filed on
November 25, 2008)
|
|
10.32
|
Amendment
No. 2 to the Employment Agreement between the Registrant and Douglas Abel,
dated November 19, 2008 (incorporated by reference to Exhibit
10.7 to the Registrant’s Current Report on Form 8-K filed on November 25,
2008)
|
|
10.33
|
Amendment
No. 1 to the Employment Agreement between the Registrant and Michael
McGuinness, dated November 19, 2008 (incorporated by reference
to Exhibit 10.8 to the Registrant’s Current Report on Form 8-K filed on
November 25, 2008)
|
|
10.34
|
Form
of Placement Agent Warrant (incorporated by reference to Exhibit 10.9 to
the Registrant’s Current Report on Form 8-K filed on November 25,
2008)
|
23.1
|
Consent
of J.H. Cohn LLP.
|
|
23.2
|
Consent
of Lowenstein Sandler PC (incorporated by reference to Exhibit
5.1)
|
|
24.1
|
Powers
of Attorney (Included in Signature Page of this Registration
Statement)
|
(1)
|
To
file, during any period in which offers or sales are being made, a
post-effective amendment to this registration
statement:
|
||
|
(i)
|
To
include any prospectus required by Section 10(a)(3) of the Securities Act
of 1933, as amended;
|
|
|
(ii)
|
To
reflect in the prospectus any facts or events arising after the effective
date of the registration statement (or the most recent post-effective
amendment thereof) which, individually or in the aggregate, represent a
fundamental change in the information set forth in the registration
statement. Notwithstanding the foregoing, any increase or decrease in
volume of securities offered (if the total dollar value of securities
offered would not exceed that which was registered) and any deviation from
the low or high end of the estimated maximum offering range may be
reflected in the form of prospectus filed with the Commission pursuant to
Rule 424(b) if, in the aggregate, the changes in volume and price
represent no more than 20 percent change in the maximum aggregate offering
price set forth in the “Calculation of Registration Fee” table in the
effective registration statement; and
|
|
(iii)
|
To
include any material information with respect to the plan of distribution
not previously disclosed in the registration statement or any material
change to such information in the registration
statement;
|
||
provided, however , that
subparagraphs (i) and (ii) above do not apply if the information required
to be included in a post-effective amendment by these subparagraphs is
contained in periodic reports filed with or furnished to the Commission by
the Registrant pursuant to Section 13 or 15(d) of the Securities
Exchange Act of 1934 that are incorporated by reference in this
registration statement.
|
|||
(2)
|
That,
for the purpose of determining any liability under the Securities Act of
1933, as amended, each such post-effective amendment shall be deemed to be
a new registration statement relating to the securities offered therein,
and the offering of such securities at that time shall be deemed to be the
initial bona fide offering thereof.
|
||
(3)
|
To
remove from registration by means of a post-effective amendment any of the
securities being registered which remain unsold at the termination of the
offering.
|
Manhattan
Pharmaceuticals, Inc.
|
||
|
||
By:
|
/s/ Michael
G. McGuinness
|
|
Mr.
Michael G. McGuinness
Chief
Operating and Financial Officer
|
/s/ Douglas Abel
|
Chief
Executive Officer, President and
|
February
23, 2009
|
||
Douglas
Abel
|
Director
(principal executive officer)
|
|||
/s/ Michael G. McGuinness
|
Chief
Operating and Financial
|
February
23, 2009
|
||
Michael
G. McGuinness
|
Officer
& Secretary (principal financial and accounting and
officer)
|
|||
/s/ Neil Herskowitz
|
Director
|
February
23, 2009
|
||
Neil
Herskowitz
|
||||
/s/ Malcolm Hoenlein
|
Director
|
February
23, 2009
|
||
Malcolm
Hoenlein
|
||||
/s/ Timothy McInerney
|
||||
Timothy
McInerney
|
Director
|
February
23, 2009
|
||
/s/ Richard Steinhart
|
||||
Richard
Steinhart
|
Director
|
February
23, 2009
|
||
/s/ Michael Weiser
|
||||
Michael
Weiser
|
Director
|
February
23, 2009
|