U.S. SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 10-Q
(Mark One)
|
x
|
QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
|
FOR THE QUARTERLY PERIOD ENDED June 30, 2009
|
¨
|
TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
|
FOR THE TRANSITION PERIOD FROM
TO
Commission file number 1-16467
Cortex Pharmaceuticals, Inc.
(Exact name of registrant as specified in its charter)
|
|
|
|
|
Delaware
|
|
33-0303583
|
|
(State or other jurisdiction of
incorporation or organization)
|
|
(I.R.S. Employer
Identification No.)
|
15241 Barranca Parkway, Irvine, California 92618
(Address of principal executive offices, including zip code)
(949) 727-3157
(Registrant’s telephone number, including area code)
NOT APPLICABLE
(Former name, former
address and former fiscal year, if changed since last report)
Indicate by mark whether the registrant (1) has filed all reports required to be
filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports) and (2) has been subject to such filing requirements for
the past 90 days. YES
x
NO
¨
Indicate by check mark whether the registrant has submitted electronically and posted on its corporate Web site, if any, every Interactive Data File required to be submitted and posted pursuant to Rule 405 of
Regulation S-T (§ 232.405 of this chapter) during the preceding 12 months (or for such shorter period that the registrant was required to submit and post such files). YES
¨
NO
¨
Indicate by check mark whether the registrant is
a large accelerated filer, an accelerated filer, a non-accelerated filer, or a smaller reporting company. See definitions of “large accelerated filer,” “accelerated filer” and “smaller reporting company” in Rule 12b-2
of the Exchange Act.
Large accelerated filer
¨
Accelerated filer
¨
Non-accelerated filer
¨
Smaller reporting company
x
Indicate by check mark whether the registrant is a shell company (as defined in Exchange Act Rule 12b-2). YES
¨
NO
x
Indicate the number of shares outstanding of each
of the issuer’s classes of common stock, as of the latest practicable date.
56,291,680 shares of Common Stock as of August 10,
2009
CORTEX PHARMACEUTICALS, INC.
INDEX
Item 1A of Part II has been omitted based on the Company’s status as a “smaller reporting
company.” Items 1, 3 and 5 of Part II have been omitted because they are not applicable with respect to the current reporting period.
Page 2 of 28
PART I. FINANCIAL INFORMATION
|
Item 1.
|
Financial Statements
|
Cortex Pharmaceuticals, Inc.
Condensed Balance Sheets
|
|
|
|
|
|
|
|
|
|
|
|
|
(Unaudited)
|
|
|
(Note)
|
|
|
|
|
June 30, 2009
|
|
|
December 31, 2008
|
|
|
Assets
|
|
|
|
|
|
|
|
|
|
Current assets:
|
|
|
|
|
|
|
|
|
|
Cash and cash equivalents
|
|
$
|
887,857
|
|
|
$
|
1,430,886
|
|
|
Marketable securities
|
|
|
143,076
|
|
|
|
2,710,434
|
|
|
Other current assets
|
|
|
143,037
|
|
|
|
154,884
|
|
|
|
|
|
|
|
|
|
|
|
|
Total current assets
|
|
|
1,173,970
|
|
|
|
4,296,204
|
|
|
Furniture, equipment and leasehold improvements, net
|
|
|
709,299
|
|
|
|
809,458
|
|
|
Other
|
|
|
46,667
|
|
|
|
46,667
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
$
|
1,929,936
|
|
|
$
|
5,152,329
|
|
|
|
|
|
|
|
|
|
|
|
|
Liabilities and Stockholders’ Equity (Deficit)
|
|
|
|
|
|
|
|
|
|
Current liabilities:
|
|
|
|
|
|
|
|
|
|
Accounts payable
|
|
$
|
1,521,606
|
|
|
$
|
1,123,015
|
|
|
Accrued wages, salaries and related expenses
|
|
|
305,792
|
|
|
|
293,746
|
|
|
Advance for MCI project
|
|
|
313,733
|
|
|
|
311,723
|
|
|
Deferred rent
|
|
|
—
|
|
|
|
27,123
|
|
|
|
|
|
|
|
|
|
|
|
|
Total current liabilities
|
|
|
2,141,131
|
|
|
|
1,755,607
|
|
|
Deferred rent
|
|
|
1,613
|
|
|
|
—
|
|
|
|
|
|
|
|
|
|
|
|
|
Total liabilities
|
|
|
2,142,744
|
|
|
|
1,755,607
|
|
|
Stockholders’ equity (deficit):
|
|
|
|
|
|
|
|
|
|
Series B convertible preferred stock, $0.001 par value; $0.6667 per share liquidation preference; shares authorized: 3,200,000; shares issued
and outstanding: 37,500
|
|
|
21,703
|
|
|
|
21,703
|
|
|
Common stock, $0.001 par value; shares authorized: 105,000,000; shares issued and outstanding: 56,291,680 (June 30, 2009) and 47,615,209
(December 31, 2008)
|
|
|
56,291
|
|
|
|
47,615
|
|
|
Additional paid-in capital
|
|
|
115,009,984
|
|
|
|
112,686,078
|
|
|
Unrealized gain (loss), available for sale marketable securities
|
|
|
390
|
|
|
|
(3,884
|
)
|
|
Accumulated deficit
|
|
|
(115,301,176
|
)
|
|
|
(109,354,790
|
)
|
|
|
|
|
|
|
|
|
|
|
|
Total stockholders’ equity (deficit)
|
|
|
(212,808
|
)
|
|
|
3,396,722
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
$
|
1,929,936
|
|
|
$
|
5,152,329
|
|
|
|
|
|
|
|
|
|
|
|
See accompanying notes.
Note: The balance sheet as of December 31, 2008 has been derived from the audited financial statements at that date, but does not include all of the information and footnotes required by accounting principles
generally accepted in the United States for complete financial statements.
Page 3 of 28
Cortex Pharmaceuticals, Inc.
Condensed Statements of Operations
(Unaudited)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three months ended June 30,
|
|
|
Six months ended June 30,
|
|
|
|
|
2009
|
|
|
2008
|
|
|
2009
|
|
|
2008
|
|
|
Revenues:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Research and license revenue
|
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
—
|
|
|
Grant revenue
|
|
|
—
|
|
|
|
—
|
|
|
|
—
|
|
|
|
—
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total revenues
|
|
|
—
|
|
|
|
—
|
|
|
|
—
|
|
|
|
—
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Operating expenses (A):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Research and development
|
|
|
1,048,500
|
|
|
|
3,132,521
|
|
|
|
3,163,271
|
|
|
|
6,554,009
|
|
|
General and administrative
|
|
|
900,089
|
|
|
|
943,772
|
|
|
|
1,968,586
|
|
|
|
2,081,811
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total operating expenses
|
|
|
1,948,589
|
|
|
|
4,076,293
|
|
|
|
5,131,857
|
|
|
|
8,635,820
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Loss from operations
|
|
|
(1,948,589
|
)
|
|
|
(4,076,293
|
)
|
|
|
(5,131,857
|
)
|
|
|
(8,635,820
|
)
|
|
Interest income, net
|
|
|
2,362
|
|
|
|
129,303
|
|
|
|
17,175
|
|
|
|
317,431
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss
|
|
$
|
(1,946,227
|
)
|
|
$
|
(3,946,990
|
)
|
|
$
|
(5,114,682
|
)
|
|
$
|
(8,318,389
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Accretion of beneficial conversion feature on 0% Series E Convertible Preferred Stock
|
|
|
(831,704
|
)
|
|
|
—
|
|
|
|
(831,704
|
)
|
|
|
—
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss applicable to common stock
|
|
$
|
(2,777,931
|
)
|
|
$
|
(3,946,990
|
)
|
|
$
|
(5,946,386
|
)
|
|
$
|
(8,318,389
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss per share:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Basic and diluted
|
|
$
|
(0.06
|
)
|
|
$
|
(0.08
|
)
|
|
$
|
(0.12
|
)
|
|
$
|
(0.17
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Shares used in calculating per share amounts:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Basic and diluted
|
|
|
49,604,220
|
|
|
|
47,558,920
|
|
|
|
48,615,209
|
|
|
|
47,550,673
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(A) Operating expenses include the following non-cash stock compensation charges:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Research and development
|
|
$
|
54,378
|
|
|
$
|
213,333
|
|
|
$
|
138,428
|
|
|
$
|
483,698
|
|
|
General and administrative
|
|
|
49,050
|
|
|
|
125,283
|
|
|
|
117,762
|
|
|
|
262,435
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
$
|
103,428
|
|
|
$
|
338,616
|
|
|
$
|
256,190
|
|
|
$
|
746,133
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
See accompanying notes.
Page 4 of 28
Cortex Pharmaceuticals, Inc.
Condensed Statements of Cash Flows
(Unaudited)
|
|
|
|
|
|
|
|
|
|
|
|
|
Six months ended
June 30,
|
|
|
|
|
2009
|
|
|
2008
|
|
|
Cash flows from operating activities:
|
|
|
|
|
|
|
|
|
|
Net loss
|
|
$
|
(5,114,682
|
)
|
|
$
|
(8,318,389
|
)
|
|
Adjustments to reconcile net loss to net cash used in operating activities:
|
|
|
|
|
|
|
|
|
|
Depreciation and amortization
|
|
|
101,650
|
|
|
|
60,418
|
|
|
Stock option compensation expense
|
|
|
256,190
|
|
|
|
746,133
|
|
|
Changes in operating assets/liabilities:
|
|
|
|
|
|
|
|
|
|
Accrued interest on marketable securities
|
|
|
(292
|
)
|
|
|
(29,016
|
)
|
|
Other current assets
|
|
|
11,847
|
|
|
|
39,295
|
|
|
Accounts payable and accrued expenses
|
|
|
383,514
|
|
|
|
845,006
|
|
|
Advance for MCI project and other
|
|
|
4,207
|
|
|
|
(35,000
|
)
|
|
|
|
|
|
|
|
|
|
|
|
Net cash used in operating activities
|
|
|
(4,357,566
|
)
|
|
|
(6,691,553
|
)
|
|
|
|
|
|
|
|
|
|
|
|
Cash flows from investing activities:
|
|
|
|
|
|
|
|
|
|
Purchase of marketable securities
|
|
|
—
|
|
|
|
(1,092,376
|
)
|
|
Proceeds from sales and maturities of marketable securities
|
|
|
2,571,340
|
|
|
|
8,004,884
|
|
|
Purchase of fixed assets
|
|
|
(1,491
|
)
|
|
|
(111,141
|
)
|
|
|
|
|
|
|
|
|
|
|
|
Net cash provided by investing activities
|
|
|
2,569,849
|
|
|
|
6,801,367
|
|
|
|
|
|
|
|
|
|
|
|
|
Cash flows from financing activities:
|
|
|
|
|
|
|
|
|
|
Proceeds from issuance of preferred stock in April 2009 registered direct offering, gross
|
|
|
1,475,000
|
|
|
|
—
|
|
|
Costs related to issuance of preferred stock in April 2009 registered direct offering
|
|
|
(230,312
|
)
|
|
|
—
|
|
|
|
|
|
|
|
|
|
|
|
|
Net cash provided by financing activities
|
|
|
1,244,688
|
|
|
|
—
|
|
|
|
|
|
|
|
|
|
|
|
|
Increase (decrease) in cash and cash equivalents
|
|
|
(543,029
|
)
|
|
|
109,814
|
|
|
Cash and cash equivalents, beginning of period
|
|
|
1,430,886
|
|
|
|
4,020,881
|
|
|
|
|
|
|
|
|
|
|
|
|
Cash and cash equivalents, end of period
|
|
$
|
887,857
|
|
|
$
|
4,130,695
|
|
|
|
|
|
|
|
|
|
|
|
See accompanying notes.
Page 5 of 28
Cortex Pharmaceuticals, Inc.
Notes to Condensed Financial Statements
(Unaudited)
Note 1 — Basis of Presentation and Significant Accounting Principles
The accompanying unaudited interim condensed financial statements have been prepared in accordance with accounting principles generally accepted in the United States for interim financial information and the instructions to Form 10-Q and
Article 10 of Regulation S-X. Accordingly, they do not include all of the information and footnotes required by accounting principles generally accepted in the United States for complete financial statements. In the opinion of management, all
adjustments (consisting only of normal recurring accruals) considered necessary for a fair presentation have been included. Operating results for the six-month period ended June 30, 2009 are not necessarily indicative of the results that may be
expected for the full fiscal year. For further information, refer to the financial statements and notes thereto included in the Company’s Annual Report on Form 10-K for the fiscal year ended December 31, 2008.
In January 1999, Cortex Pharmaceuticals, Inc. (“Cortex” or the “Company”) entered into a research collaboration and exclusive
worldwide license agreement with NV Organon (“Organon”). The agreement will enable Organon to develop and commercialize the Company’s A
MPAKINE
®
technology for the treatment of schizophrenia and depression. Two collaboration compounds, Org24448 and Org26576, are currently in clinical development. In
November 2007, Organon was acquired by Schering-Plough Corporation. Subsequently, in March 2009, Merck & Co. Inc. entered into a definitive merger agreement with Schering-Plough Corporation.
In October 2000, the Company entered into a research collaboration agreement and a license agreement with Les Laboratoires Servier (“Servier”), covering
defined territories. The agreements, as amended to date, will enable Servier to develop and commercialize select A
MPAKINE
compounds developed during the research collaboration period for the treatment of (i) declines in cognitive
performance associated with aging, (ii) neurodegenerative diseases and (iii) anxiety disorders. The indications covered include, but are not limited to, Alzheimer’s disease, mild cognitive impairment, sexual dysfunction, and the
dementia associated with multiple sclerosis and Amyotrophic Lateral Sclerosis. In early December 2006, Cortex terminated the research collaboration with Servier and as a result the worldwide rights for the A
MPAKINE
technology for
treatment of neurodegenerative diseases were returned to Cortex, other than three compounds retained by Servier for commercialization.
The Company has
incurred net losses and cash outflows from operations of $5,115,000 and $4,358,000, respectively, for the six months ended June 30, 2009 and expects to incur additional losses and negative cash flow from operations in fiscal 2009 and for
several more years. With the net proceeds from the closing of a private placement of convertible preferred stock and warrants to purchase shares of common stock completed in July 2009, as described more fully in Note 2, management believes the
Company has adequate financial resources to conduct operations late into the fourth quarter of 2009. This raises substantial doubt about the Company’s ability to continue as a going concern, which will be dependent on its ability to obtain
additional financing and to generate sufficient cash flows to meet its obligations on a timely basis.
Page 6 of 28
In March 2009, as part of its efforts to conserve its existing capital resources, the Company implemented a reduction of
approximately 50% of its workforce and reduced the base salary for each of its executive officers by 20%.
The Company is exploring its strategic and
financial alternatives, including, but not limited to, new collaborations for its A
MPAKINE
program which would provide capital to the Company in exchange for exclusive or non-exclusive license or other rights to certain of the
technologies and products that the Company is developing. Although the Company is presently engaged in discussions with a number of candidate companies, there can be no assurance that an agreement will arise from these discussions in a timely
manner, or at all.
The Company also may need to raise additional capital through the sale of debt or equity. If the Company is unable to obtain additional
financing to fund operations beyond the fourth quarter of 2009, it will need to eliminate some or all of its activities, merge with another company, license or sell some or all of its assets to another company, or cease operations
entirely. There can be no assurance that the Company will be able to obtain additional financing on favorable terms or at all, or that the Company will be able to merge with another Company or license or sell any or all of its assets.
Revenue Recognition
The Company recognizes revenue
when all four of the following criteria are met: (i) pervasive evidence that an arrangement exists; (ii) delivery of the products and/or services has occurred; (iii) the fees earned can be readily determined; and
(iv) collectibility of the fees is reasonably assured.
In November 2002, the Emerging Issues Task Force (“EITF”) of the Financial
Accounting Standards Board (the “FASB”) reached consensus on Issue 00-21. EITF Issue 00-21 addresses the accounting for arrangements that may involve the delivery or performance of multiple products, services and/or rights to use assets.
As required, the Company applies the principles of Issue 00-21 to multiple element research and licensing agreements that it enters into after July 1, 2003.
In accordance with the Securities and Exchange Commission’s Staff Accounting Bulletin No. 104 (“SAB 104”), amounts received for upfront technology license fees under multiple-element arrangements are deferred and
recognized over the period of committed services or performance, if such arrangements require the Company’s on-going services or performance.
Employee Stock Options and Stock-based Compensation
The Company’s 2006 Stock Incentive Plan (the “2006 Plan”) provides for a
variety of equity vehicles to allow flexibility in implementing equity awards, including incentive stock options, nonqualified stock options, restricted stock grants, stock appreciation rights, stock payment awards, restricted stock units and
dividend equivalents to qualified employees, officers, directors, consultants and other service providers. The exercise price of stock options offered under the 2006 Plan must be at least 100% of the fair market value of the common stock on the date
of grant. If the person to whom an incentive stock option is granted is a 10% stockholder of the Company on the date of grant, the exercise price per share shall not be less than 110% of the fair market value on the date of grant. Options granted
generally vest over a three-year period, although options granted to officers may include more accelerated vesting. Options generally expire ten years from the date of grant, but options granted to consultants may expire five years from the date of
grant.
Page 7 of 28
In accordance with Statement of Financial Accounting Standards (“SFAS”) No. 123(R), “Share Based
Payment,” the Company recognizes expense in its financial statements for all share-based payments to employees, including grants of employee stock options, based on their fair values.
For options granted during the three months ended June 30, 2009 and the six months ended June 30, 2009 and 2008, the fair value of each option award was
estimated using the Black-Scholes option pricing model and the following assumptions:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three months ended
June 30, 2009
|
|
|
Six months ended
June 30,
|
|
|
|
|
|
2009
|
|
|
2008
|
|
|
Weighted average risk-free interest rate
|
|
3.1
|
%
|
|
3.1
|
%
|
|
3.0
|
%
|
|
Dividend yield
|
|
0
|
%
|
|
0
|
%
|
|
0
|
%
|
|
Volatility factor of the expected market price of the Company’s common stock
|
|
100
|
%
|
|
100
|
%
|
|
97
|
%
|
|
Weighted average life
|
|
7 years
|
|
|
7 years
|
|
|
6.7 years
|
|
There were no options granted during the three months ended June 30, 2008.
Expected volatility is based on the historical volatility of the Company’s stock. The Company also uses historical data to estimate the expected term of options
granted and employee termination rates. The risk-free rate for periods within the contractual life of the options is based on the U.S. Treasury yield curve in effect at the time of grant.
The weighted-average grant-date fair value per share of options granted during the three months ended June 30, 2009 was $0.24. The weighted average grant-date fair
value per share of options granted during the six months ended June 30, 2009 and 2008 was $0.24 and $0.48, respectively.
A summary of option activity
for the six months ended June 30, 2009 is as follows:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Shares
|
|
|
Weighted
Average
Exercise Price
|
|
Weighted Average
Remaining
Contractual Term
|
|
Aggregate
Intrinsic Value
|
|
Balance, December 31, 2008
|
|
11,554,319
|
|
|
$
|
1.73
|
|
|
|
|
|
Granted
|
|
181,000
|
|
|
$
|
0.29
|
|
|
|
|
|
Exercised
|
|
—
|
|
|
|
—
|
|
|
|
|
|
Forfeited
|
|
(285,077
|
)
|
|
$
|
1.09
|
|
|
|
|
|
Expired
|
|
(752,994
|
)
|
|
$
|
1.46
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balance, June 30, 2009
|
|
10,697,248
|
|
|
$
|
1.74
|
|
5.8 years
|
|
—
|
|
Exercisable, June 30, 2009
|
|
8,605,260
|
|
|
$
|
1.97
|
|
5.2 years
|
|
—
|
As of June 30, 2009, there was approximately $423,000 of total unrecognized compensation cost related to
non-vested share-based compensation arrangements. That non-cash cost is expected to be recognized over a weighted-average period of one year.
The Company
continues to follow EITF Issue 96-18, “Accounting for Equity Instruments that are Issued to Other than Employees for Acquiring, or in Conjunction with Selling Goods and Services,” for stock options and warrants issued to consultants and
other non-employees. In accordance with EITF Issue 96-18, these stock options and warrants issued as compensation for services to be provided to the Company are accounted for based upon the fair value of the services provided or the estimated fair
market value of
Page 8 of 28
the option or warrant, whichever can be more clearly determined. The Company recognizes these expenses over the period in which the services are provided.
These expenses are non-cash charges and have no impact on the Company’s available cash or working capital.
There were no stock option exercises
during the six months ended June 30, 2009 or 2008. The Company issues new shares to satisfy stock option exercises.
A summary of warrant activity for
the six months ended June 30, 2009 is as follows:
|
|
|
|
|
|
|
|
|
|
|
Shares
|
|
|
Weighted
Average Per Share
Exercise Price
|
|
Balance, December 31, 2008
|
|
11,920,628
|
|
|
$
|
2.67
|
|
Granted
|
|
7,375,000
|
|
|
$
|
0.34
|
|
Exercised
|
|
—
|
|
|
|
—
|
|
Expired
|
|
(3,979,137
|
)
|
|
$
|
3.25
|
|
|
|
|
|
|
|
|
|
Balance, June 30, 2009
|
|
15,316,491
|
|
|
$
|
1.40
|
|
|
|
|
|
|
|
|
Outstanding warrants as of June 30, 2009 include a five-year warrant issued in July 2005 to purchase 100,000
shares of the Company’s common stock at an exercise price of $2.75 per share. This warrant is subject to certain conditions before becoming exercisable, which conditions remain unmet as of June 30, 2009.
Outstanding warrants as of June 30, 2009 also include three and a half-year warrants to purchase 6,941,176 shares of the Company’s common stock at an exercise
price of $0.3401 per share and warrants to purchase 433,824 shares of the Company’s common stock at an exercise price of $0.26 per share. These warrants were issued in connection with the Company’s registered direct offering completed in
April 2009 and become exercisable on October 17, 2009. All other warrants outstanding as of June 30, 2009 are immediately exercisable.
The
effect of potentially issuable shares of common stock was not included in the calculation of diluted loss per share given that the effect would be anti-dilutive.
Registration Payment Arrangements
In connection with a prior private placement of the Company’s common stock and warrants to purchase
shares of the Company’s common stock completed in December 2004, the Company entered into an agreement that committed it to timely register the shares underlying the issued warrants. The registration agreement specified potential cash penalties
if the Company did not timely register the related shares with the Securities and Exchange Commission (the “SEC”).
The registration rights
agreement for the related transaction further provides that if a registration statement is not filed or does not become effective within the defined time period, or if after its initial effectiveness the registration statement ceases to remain
continuously effective for all securities for which it is required to be effective, then in addition to any other rights the holders may have, the Company would be required to pay each holder an amount in cash, as liquidated damages, equal to
2% per month of the aggregate purchase price paid by such holder in the private placement for the common stock and warrants then held, prorated daily.
The registration statement for the transaction was filed and declared effective by the SEC within the allowed timeframe. As a result, the Company was not required to pay any liquidated damages in connection with the initial registration for
such transaction.
Page 9 of 28
In December 2006, the FASB issued FASB Staff Position (“FSP”) EITF No. 00-19-2, “Accounting for
Registration Payment Arrangements.” This FSP specifies that companies that enter into agreements to register securities will be required to recognize a liability if a payment to investors for failing to fulfill the agreement is probable and can
be reasonably estimated. This accounting differs from the guidance in EITF 00-19, which required a liability to be recognized and measured at fair value, regardless of probability.
FSP EITF No. 00-19-2 is effective immediately for registration payment arrangements and the financial instruments subject to those arrangements that are entered into or modified after the date of issuance of this FSP.
For the Company’s registration payment arrangements and financial instruments subject to those arrangements that were entered into prior to the issuance of this FSP, the guidance was effective beginning January 1, 2007.
In connection with its obligation to maintain effectiveness of the registration statements filed with the December 2004 transaction, as of June 30, 2009 the Company
has estimated the maximum potential amount of undiscounted payments that it could be required to make under the registration arrangements as approximately $857,000.
Given that the Company did not deem the transfer of consideration under its existing registration payment arrangement as probable as of June 30, 2009 or 2008, no related expense or liability has been recorded
during the six-month periods ended June 30, 2009 and 2008.
Marketable Securities
The Company adopted Statement of Financial Accounting Standards (“SFAS”) No. 157, “Fair Value Measurements,” effective January 1, 2008, as required, on a prospective basis. SFAS 157
defines fair value, provides a framework for measuring fair value and expands the disclosures required for fair value measurements. The standard applies to other accounting pronouncements, but does not require any new fair value measurements. The
Company utilizes quoted prices in active markets for identical assets to record the fair value of its marketable securities. SFAS 157 terms quoted prices in active markets for similar assets as Level 1 inputs in its hierarchy of fair value
measurements.
Marketable securities are carried at fair value, with unrealized gains and losses, net of any tax, reported as a separate component of
stockholders’ equity. The amortized cost of debt securities is adjusted for amortization of premiums and accretion of discounts to maturity. Such amortization is included in interest income. Realized gains and losses and declines in value
judged to be other-than-temporary on short-term investments are included in interest income. The cost of securities sold is based on the specific identification method. Interest and dividends on securities classified as available-for-sale are
included in interest income.
Comprehensive Loss
The
Company presents unrealized gains and losses on its marketable securities, classified as “available for sale,” in its statement of stockholders’ equity and comprehensive income or loss on an annual basis and in a footnote in its
quarterly reports. During the three months ended June 30, 2009 and 2008, total comprehensive loss was approximately $1,947,000 and $3,982,000, respectively. During the six months ended June 30, 2009 and 2008, total comprehensive loss was
approximately $5,110,000 and $8,343,000, respectively. Other comprehensive income or loss consists of unrealized gains or losses on the Company’s marketable securities, which are comprised of securities of the U.S. government or its agencies,
corporate
Page 10 of 28
bonds and other asset backed securities. Unrealized losses on the Company’s marketable securities for the three months ended June 30, 2009 and 2008
amounted to a loss of approximately $1,000 and $35,000, respectively. For the six months ended June 30, 2009 and 2008, unrealized gains and losses on the Company’s marketable securities amounted to a gain of approximately $4,000 and a loss
of approximately $24,000, respectively.
New Accounting Standards
In December 2007, the FASB issued SFAS No. 141(R), “Business Combinations” (“SFAS 141(R)”). SFAS 141(R) establishes principles and requirements for how an acquirer’s financial
statements recognize and measure the identifiable assets acquired, the liabilities assumed, any noncontrolling interest in the acquiree and the goodwill acquired. SFAS 141(R) also establishes disclosure requirements to enable the evaluation of the
nature and financial effects of the business combination. SFAS 141(R) became effective for the Company’s fiscal year beginning January 1, 2009. Unless the Company enters into any business combinations, adoption of SFAS 141(R) will not have
a material impact on its financial statements.
In December 2007, the FASB issued SFAS No. 160, “Noncontrolling Interests in Consolidated
Financial Statements – an amendment of Accounting Research Bulletin No. 51” (“SFAS 160”). SFAS 160 changes the accounting and reporting for minority interests, which will be re-characterized as non-controlling interests and
classified as a component of equity. SFAS 160 became effective on a prospective basis for business combinations that occur in fiscal years beginning after January 1, 2009. Given that the Company does not currently have any minority interests,
adoption of SFAS 160 did not have a material impact on its consolidated financial statements.
In March 2008, the FASB issued SFAS No. 161,
“Disclosures about Derivative Instruments and Hedging Activities, an amendment to FASB Statement No. 133” (“SFAS 161”), which changes the disclosure requirements for derivative instruments and hedging activities. SFAS 161
requires entities to provide enhanced disclosures on how and why the entity uses derivative instruments, how derivative instruments and related hedging items are accounted for under SFAS No. 133, and how derivative instruments and related
hedging items affect an entity’s financial position, financial performance and cash flows. The provisions of SFAS 161 became effective for the Company on January 1, 2009 and did not have a material impact on its financial statements.
In May 2009, the FASB issued SFAS No. 165, “Subsequent Event” (“SFAS 165”), to establish the general standards of accounting for
and disclosure of events or transactions that occur after the balance sheet date but before the financial statements are issued. SFAS 165 requires entities to disclose the date through which subsequent events have been evaluated, as well as whether
that date is the date that the financial statements were issued or were available to be issued. SFAS 165 became effective for the Company on June 30, 2009 and did not have a material impact on its financial statements.
In June 2009, the FASB issued SFAS No. 168, “The FASB Accounting Standards Codification and the Hierarchy of Generally Accepted Accounting Principles”
(“SFAS 168”) as the source of authoritative U.S. generally accepted accounting principles recognized by the FASB to be applied by nongovernmental entities. Rules and interpretive releases of the SEC under authority of federal securities
laws are also sources of authoritative generally accepted accounting principles for SEC registrants. On the effective date of this Statement, the Codification included within SFAS 168 will supersede all then-existing non-SEC accounting and reporting
standards. SFAS 168 is effective for the Company’s financial statements
Page 11 of 28
for the three and nine months ending September 30, 2009. The Company does not anticipate that adoption of SFAS 168 will have a material impact on its
financial statements.
Note 2 — Registered Direct Offering of Newly-Designated Series E Convertible Preferred Stock
In April 2009, the Company completed a registered direct offering of 1,475 shares of its newly designated 0% Series E Convertible Preferred Stock and warrants to purchase
an aggregate of 6,941,176 shares of its common stock to a single institutional investor in exchange for gross proceeds of $1,475,000. Net proceeds from the offering were approximately $1,250,000.
The convertible preferred stock and warrants were sold in units, at a per unit purchase price of $1,000, and with each unit consisting of one share of convertible
preferred stock and a warrant to purchase approximately 4,706 shares of common stock. The preferred stock was subsequently converted into 8,676,471 shares of the Company’s common stock at a conversion price of $0.17 per share. The warrants have
an exercise price of $0.3401 per share and are exercisable on or after October 17, 2009 and on or before October 17, 2012.
The Company also
issued warrants to purchase up to an additional aggregate of 433,824 shares of the Company’s common stock to the placement agent for the transaction. These warrants have an exercise price of $0.26 per share and are subject to the same term of
exercisability as the warrants issued to the investor.
In recording the proceeds from this offering, the Company estimated the fair value of the warrants
issued to the investor using the Black-Scholes option pricing model. The Company then used the relative fair value method to allocate the proceeds to the investor warrants and the convertible preferred stock.
After this allocation, the value of the common shares issuable upon conversion of the preferred stock (the amount for which the common shares could have been sold)
exceeded the proceeds from the offering that were allocated to the preferred stock due to beneficial conversion rights. The beneficial conversion rights relate to the difference between the fair value of the Company’s common stock and the
conversion price of the preferred stock on the closing date of the offering.
In accordance with EITF 98-5, “Accounting for Convertible Securities
with Beneficial Conversion Features of Contingently Adjustable Conversion Ratios,” given that the 0% Series E Convertible Preferred Stock was immediately convertible, the value of the beneficial conversion rights was fully amortized at the date
of issuance of the preferred stock through a charge to the Company’s accumulated deficit. That charge is reflected in the accompanying statement of operations as an increase in the net loss for purposes of determining the net loss applicable to
common stock for the three months and six months ended June 30, 2009.
Note 3 — Subsequent Event
The Company has evaluated events or transactions that have occurred subsequent to the balance sheet date of June 30, 2009 through August 14, 2009, which is the
date of issuance of the financial statements.
In July 2009, the Company completed a private placement of 4,029 shares of its newly designated Series F
Convertible Preferred Stock with a stated value of $1,000 per share and warrants to purchase an
Page 12 of 28
aggregate of 6,060,470 shares of its common stock to a single institutional investor in exchange for gross proceeds of $4,029,000, of which $2,029,000 was
placed in an escrow account. If the convertible preferred stock is converted at any time prior to July 29, 2014, Cortex has agreed to pay the holder an amount from the escrow account equal to approximately $504 per $1,000 of stated value of the
preferred stock converted.
Subject to certain ownership limitations, the preferred stock is convertible into 12,120,939 common shares of the Company at a
conversion price of $0.3324 per share. The warrants have an exercise price of $0.2699 per share and are exercisable on or after January 31, 2010 and on or before January 31, 2013.
The Company also issued warrants to purchase up to an additional aggregate of 606,047 shares of the Company’s common stock to the placement agent for the
transaction. These warrants have an exercise price of $0.3656 per share and the same term of exercisability as the warrants issued to the investor.
Page 13 of 28
|
Item 2.
|
Management’s Discussion and Analysis of Financial Condition and Results of Operations
|
The following discussion and analysis should be read in conjunction with the Financial Statements and Notes relating thereto appearing elsewhere in this report and with “Management’s Discussion and
Analysis of Financial Condition and Results of Operations” presented in our Annual Report on Form 10-K for the fiscal year ended December 31, 2008.
Introductory Note
This Quarterly Report on Form 10-Q contains certain forward-looking statements within the meaning of Section 27A of
the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended, or the Exchange Act, and we intend that such forward looking statements be subject to the safe harbors created thereby. These
forward-looking statements, which may be identified by words including “anticipates,” “believes,” “intends,” “estimates,” “expects,” “plans,” and similar expressions include, but are not
limited to, statements regarding (i) future research plans, expenditures and results, (ii) potential collaborative arrangements, (iii) the potential utility of our proposed products and (iv) the need for, and availability of,
additional financing.
The forward-looking statements included herein are based on current expectations, which involve a number of risks and uncertainties
and assumptions regarding our business and technology. These assumptions involve judgments with respect to, among other things, future scientific, economic and competitive conditions, and future business decisions, all of which are difficult or
impossible to predict accurately and many of which are beyond our control. Although we believe that the assumptions underlying the forward-looking statements are reasonable, any of the assumptions could prove inaccurate and, therefore, there can be
no assurance that the results contemplated in forward-looking statements will be realized and actual results may differ materially. In light of the significant uncertainties inherent in the forward-looking information included herein, the inclusion
of such information should not be regarded as a representation by us or any other person that our objectives or plans will be achieved. We undertake no obligation to publicly release the result of any revisions to these forward-looking statements
that may be made to reflect events or circumstances after the date hereof, or to reflect the occurrence of unanticipated events. Readers should carefully review the risk factors described in this and other documents that we file from time to time
with the Securities and Exchange Commission, or the SEC, including, without limitation, Quarterly Reports on Form 10-Q, Annual Reports on Form 10-K and subsequent Current Reports on Form 8-K.
About Cortex Pharmaceuticals
We are engaged in
the discovery and development of innovative pharmaceuticals for the treatment of psychiatric disorders, neurological diseases and brain-mediated breathing disorders. Our primary focus is to develop novel small molecules that positively modulate
AMPA-type glutamate receptors, a complex of proteins involved in communication between nerve cells in the mammalian brain. We are developing a family of proprietary pharmaceuticals known as A
MPAKINE
®
compounds, which enhance the activity of the AMPA receptor. We believe that A
MPAKINE
compounds hold promise for the treatment of neurological
and psychiatric diseases and disorders that are known, or thought, to
Page 14 of 28
involve depressed functioning of pathways in the brain that use glutamate as a neurotransmitter. Our most advanced clinical compounds are CX717 and CX1739,
which currently are in Phase II clinical development.
We previously reported statistically and clinically positive results with CX717 in the treatment of
adult patients with Attention Deficit Hyperactivity Disorder, or ADHD. The compound has been targeted for acute use as an intravenous agent in the treatment of drug-induced respiratory depression. During 2008, we announced results from two pilot
studies completed with oral CX717, which demonstrated that the compound prevented the onset of opiate-induced respiratory depression in humans, while at the same time, maintaining the pain-relieving properties of the opiate. We have now completed
the development of an intravenous. formulation of CX717 that has shown accelerated stability over a period of more than eight months. With this data, we plan to conduct pharmacokinetic and dose-ranging studies with the new formulation of intravenous
CX717 prior to initiating Phase IIb efficacy trials.
Our A
MPAKINE
compound CX1739 is substantially more potent than CX717, has successfully
completed human Phase I clinical trials and is currently in Phase II trials in the U.K. for the treatment of sleep apnea. We plan to begin Phase II trials with CX1739 for the treatment of adult ADHD at such time as we have sufficient financial
resources.
Additional drug candidates are being readied for further development, including CX1942, CX2007 and CX2076. CX1942 has enhanced water solubility
that may facilitate its formulation as an intravenous agent for a hospital product for the treatment of respiratory depression. It may also be developed as a fixed-dose combination product with a generic opioid as a safer oral analgesic. CX2007 and
CX2076 exhibit a significantly increased metabolic half-life in animals, which may ultimately result in a once a day treatment potential in humans. This further development will be dependent upon obtaining additional financial resources to conduct
such studies.
Over the past three years, we have filed several new patents for our A
MPAKINE
compounds that, if granted, will provide patent
protection for our new compounds up to 2029. Additionally, the method of use patent that we licensed from the University of Alberta may provide patent coverage through 2027 for the use of A
MPAKINE
compounds in the treatment of
respiratory depression.
The A
MPAKINE
platform addresses large potential markets. Our business plan involves partnering with larger
pharmaceutical companies for research, development, clinical testing, manufacturing and global marketing of A
MPAKINE
compounds for those indications that require sizable, expensive Phase III clinical trials and very large sales forces
to achieve significant market penetration.
Page 15 of 28
At the same time, subject to availability of sufficient financial resources, we plan to develop compounds internally for
a selected set of indications, many of which will allow us to apply for orphan drug status. Such designation by the Food and Drug Administration, or the FDA, is usually applied to products where the number of patients in the United States in the
given disease category is typically less than 200,000. These orphan drug indications typically require more modest investment in the development stages, follow a quicker regulatory path to approval, and involve a more concentrated and smaller sales
force targeted at selected medical centers and a limited number of medical specialists in the United States and Europe.
In our licensing discussions, we
seek to reserve rights that may be viewed as a natural expansion beyond some of the orphan drug uses to selected larger areas of therapy to thereby allow us to potentially further develop our compounds for such larger non-orphan drug indications. If
we are successful in the pursuit of this operating strategy, we may be in a position to contain our costs over the next few years, to maintain our focus on the research and early development of novel pharmaceuticals (where we believe that we have
the ability to compete) and eventually to participate more fully in the commercial development of A
MPAKINE
products in the United States.
Critical Accounting Policies and Management Estimates
The SEC defines critical accounting policies as those that are, in management’s
view, most important to the portrayal of our financial condition and results of operations and most demanding of our judgment. Our discussion and analysis of our financial condition and results of operations are based upon our financial statements,
which have been prepared in accordance with accounting principles generally accepted in the United States. The preparation of these financial statements requires us to make estimates and judgments that affect the reported amounts of assets,
liabilities, revenues and expenses and related disclosures of contingent assets and liabilities.
We base our estimates on historical experience and on
various other assumptions that are believed to be reasonable under the circumstances. This process forms the basis for making judgments about the carrying values of assets and liabilities that are not readily apparent from other sources. Actual
results may differ from these estimates under different assumptions or conditions.
Revenue Recognition
Our revenue recognition policies are in accordance with the SEC’s Staff Accounting Bulletin No. 104, “Revenue Recognition”, or SAB 104. SAB 104
provides guidance in applying accounting principles generally accepted in the United States to revenue recognition issues, and specifically addresses revenue recognition for up-front, nonrefundable fees received in connection with research
collaboration arrangements.
In accordance with SAB 104, revenues from up-front fees from our collaborators are deferred and recorded over the term that we
provide ongoing services. Similarly, research support payments are recorded as revenue as we perform the research under the related agreements. We record grant revenues as we incur expenses related to the grant projects. All amounts received under
collaborative
Page 16 of 28
research agreements or research grants are nonrefundable, regardless of the success of the underlying research.
Revenues from milestone payments are recognized when earned, as evidenced by written acknowledgment from our collaborator, provided that (i) the
milestone event is substantive and its achievement was not reasonably assured at the inception of the agreement, and (ii) our performance obligations after the milestone achievement will continue to be funded by its collaborator at a comparable
level to that before the milestone achievement. If both of these criteria are not met, the milestone payment is recognized over the remaining minimum period of our performance obligations under the agreement.
In November 2002, the Emerging Issues Task Force, or EITF, of the Financial Accounting Standards Board reached consensus on Issue 00-21. EITF Issue 00-21 addresses the
accounting for arrangements that may involve the delivery or performance of multiple products, services and/or rights to use assets. As required, we apply the principles of EITF Issue 00-21 to multiple element agreements that we enter into after
July 1, 2003.
Employee Stock Options and Stock-Based Compensation
Under the fair value recognition provisions of Statement of Financial Accounting Standards No. 123(R), “Share Based Payment”, or SFAS 123(R), we measure our share-based compensation cost at the grant
date based on the estimated value of the award and recognize it as expense over the vesting period. Determining the fair value of share-based awards at the grant date requires judgment in estimating the amount of share-based awards that are expected
to be forfeited. If actual results differ significantly from these estimates, stock-based compensation expense and our results of operations could be materially impacted.
As of June 30, 2009, there was approximately $423,000 of total unrecognized compensation cost related to non-vested share-based compensation arrangements. These non-cash costs are expected to be recognized over a
weighted-average period of one year.
In accordance with EITF Issue 96-18, “Accounting for Equity Instruments that are Issued to Other than Employees
for Acquiring, or in Conjunction with Selling Goods and Services,” stock options and warrants issued to our consultants and other non-employees as compensation for services to be provided to us are accounted for based upon the fair value of the
services provided or the estimated fair market value of the option or warrant, whichever can be more clearly determined. We recognize this expense over the period the services are provided.
The above listing is not intended to be a comprehensive list of all of our accounting policies. In many cases, the accounting treatment of a particular transaction is
specifically dictated by accounting principles generally accepted in the United States, with no need for our judgment in their application. There are also areas in which our judgment in selecting any available alternative would not produce a
materially different result.
Page 17 of 28
Going Concern
Our
independent registered public accounting firm has expressed substantial doubt as to our ability to continue as a going concern, in its report for the fiscal year ended December 31, 2008, based on significant operating losses that we incurred
and the fact that we do not have adequate working capital to finance our day-to-day operations. Our continued existence depends upon the success of our efforts to raise additional capital necessary to meet our obligations as they become due and to
obtain sufficient capital to execute our business plan. We intend to obtain capital primarily through issuances of debt or equity or entering into collaborative arrangements with corporate partners. There can be no assurance that we will be
successful in completing additional financing or collaboration transactions. If we cannot obtain adequate funding, we may be required to significantly curtail or even shut down our operations.
Results of Operations
General
In January 1999, we entered into a research collaboration and exclusive worldwide license agreement with NV Organon, or Organon. In November 2007, Organon was acquired by
Schering-Plough Corporation. Subsequently, in March 2009, Merck & Co. Inc. entered into a definitive merger agreement with Schering-Plough Corporation. Our agreement with Organon will allow them to develop and commercialize our proprietary
A
MPAKINE
technology for the treatment of schizophrenia and depression. In connection with the agreement, we received $2,000,000 up-front and research support payments of approximately $3,000,000 per year for two years. The agreement
with Organon also includes milestone payments based upon clinical development, plus royalty payments on worldwide sales. To date, we have received milestone payments from Organon totaling $6,000,000. For each milestone payment, we recorded the
related revenue upon achievement of the milestone.
In October 2000, we entered into a research collaboration agreement and a license agreement with Les
Laboratoires Servier, or Servier. The agreements will allow Servier to develop and commercialize select A
MPAKINE
compounds in defined territories of Europe, Asia the Middle East and certain South American countries as a treatment for
(i) declines in cognitive performance associated with aging, (ii) neurodegenerative diseases and (iii) anxiety disorders. The indications covered include, but are not limited to, Alzheimer’s disease, mild cognitive impairment,
sexual dysfunction and the dementia associated with multiple sclerosis and Amyotrophic Lateral Sclerosis. The research collaboration agreement, as amended, included an up-front payment by Servier of $5,000,000 and research support payments of
approximately $2,025,000 per year through early December 2006 (subject to us providing agreed-upon levels of research personnel). In early December 2006, we terminated the research collaboration with Servier and as a result the worldwide rights for
the A
MPAKINE
technology for the treatment of neurodegenerative diseases have been returned to us, other than three compounds selected by Servier for commercialization in its territory. Should any of these compounds be successfully
commercialized by Servier, we would receive payments based upon key clinical development milestones and royalty payments on sales in licensed territories.
Page 18 of 28
From inception (February 10, 1987) through June 30, 2009, we have sustained losses aggregating approximately
$112,438,000. Continuing losses are anticipated over the next several years. During that time, our ongoing operating expenses will only be offset, if at all, by proceeds from Small Business Innovative Research grants and by possible milestone
payments from Organon and Servier. Ongoing operating expenses may also be funded by payments under planned strategic alliances that we are seeking with other pharmaceutical companies for the clinical development, manufacturing and marketing of our
products. The nature and timing of payments to us under the Organon and Servier agreements or other planned strategic alliances, if and when entered into, are likely to significantly affect our operations and financing activities and to produce
substantial period-to-period fluctuations in reported financial results. Over the longer term, we will be dependent upon the successful introduction of a new product into the North American market from our internal development, as well as the
successful commercial development of our products by Organon, Servier or our other prospective partners to attain profitable operations from royalties or other product-based revenues.
Comparison of the Three Months and Six Months ended June 30, 2009 and 2008
For the three months ended
June 30, 2009, our net loss applicable to common stock of approximately $2,778,000 compares with a net loss applicable to common stock of approximately $3,947,000 for the corresponding prior year period, a decrease of 30%. Our net loss
applicable to common stock of approximately $5,946,000 for the six months ended June 30, 2009 compares with a net loss applicable to common stock of approximately $8,318,000 for the corresponding prior year period, a decrease of 29%.
The net losses applicable to common stock for the 2009 periods include charges of approximately $832,000 related to the beneficial conversion feature of
our 0% Series E Convertible Preferred Stock that we issued in April 2009. These non-cash charges relate to the accounting requirements for the difference between the fair value of our common stock and the conversion price of the preferred stock on
the date of issuance of the preferred stock. Excluding these non-cash charges, the decreases in net losses applicable to common stock reflect decreased research and development expenses, as explained more fully below.
Our research and development expenses for the three-month period ended June 30, 2009 decreased from approximately $3,133,000 to approximately $1,049,000, or by 67%,
from the corresponding prior year period. For the six-month period ended June 30, 2009, our research and development expenses decreased from approximately $6,554,000 to approximately $3,163,000, or by 52%, primarily as a result of preclinical
development expenses during the prior year periods for our A
MPAKINE
CX1739, which is now in human clinical testing.
Salary and related
expenses for our research and development personnel decreased relative to the corresponding prior year period due to expenses for our President and Chief Executive Officer, Dr. Mark Varney. Before his appointment to President and Chief
Executive Officer in August 2008, Dr. Varney served as our Chief Scientific Officer and Chief Operating Officer and his salary-related expenses were included in research and development. After his appointment, including the three-month and
six-month periods ended June 30, 2009, Dr. Varney’s salary related expenses have been recorded in general and administrative expenses. Salary and related expenses for our research and
Page 19 of 28
development personnel also decreased as a result of our reduction in force that we implemented in mid-March 2009.
Our non-cash stock compensation charges related to research and development for the three months ended June 30, 2009 decreased from approximately $213,000 to
approximately $54,000, or by 75%, relative to the corresponding prior year period. For the six months ended June 30, 2009, the non-cash stock compensation charges for research and development decreased from approximately $484,000 to
approximately $138,000, or by 71%, compared with the corresponding prior year period, reflecting fluctuations in our stock price and the vesting schedules of granted stock options.
Our general and administrative expenses for the three-month period ended June 30, 2009 decreased from approximately $944,000 to approximately $900,000, or by 5%, compared to the corresponding prior year period.
For the six months ended June 30, 2009, our general and administrative expenses decreased from approximately $2,082,000 to approximately $1,969,000, or by 5%, compared to the corresponding prior year period. Most of these decreases resulted
from decreased non-cash stock compensation charges allocated to general and administrative expenses described below.
For the three months ended
June 30, 2009, our non-cash stock compensation charges within general and administrative expenses decreased from approximately $125,000 to approximately $49,000, or by 61%, relative to the corresponding prior year period. For the six months
ended June 30, 2009, these charges decreased from approximately $262,000 to approximately $118,000, or by 55%, relative to the corresponding prior year period, primarily due to fluctuations in our stock price.
For the six months ended June 30, 2009, decreased general and administrative expenses also reflect prior year consulting fees for market research in the field of
respiratory depression, an indication we are pursuing with our A
MPAKINE
CX717. Increased personnel expenses partially offset the decreased consulting fees, and represented expenses for our President and Chief Executive Officer,
Dr. Mark Varney. As explained more fully above, Dr. Varney served as our Chief Scientific Officer and Chief Operating Officer during the corresponding prior year period, when his salary and related costs were recorded with research and
development expenses.
Net interest income for the three months ended June 30, 2009 decreased from approximately $129,000 to approximately $2,000, or
by 98% compared to the corresponding prior year period. For the six months ended June 30, 2009, our net interest income decreased from approximately $317,000 to approximately $17,000, or by 95% compared to the corresponding prior year period,
with decreases for both periods resulting from a decrease in cash available for investing.
Liquidity and Capital Resources
Sources and Uses of Cash
From inception (February 10, 1987) through
June 30, 2009, we have funded our organizational and research and development activities primarily through the issuance of equity securities, funding related to collaborative agreements, various research grants and net interest income.
Page 20 of 28
Under the agreements signed with Servier in October 2000, as amended to date, Servier has selected three
A
MPAKINE
compounds that it may develop for potential commercialization. We remain eligible to receive payments based upon defined clinical development milestones of the licensed compounds and royalties on sales in licensed
territories. Under the terms of the agreement with Organon, we may receive additional milestone payments based on clinical development of Org24448 and Org26576, and ultimately, royalties on worldwide sales.
In December 2004, we completed a private placement of an aggregate of 4,233,333 shares of our common stock at $2.66 per share and five-year warrants to purchase up to an
additional aggregate of 2,116,666 shares at an exercise price of $3.00 per share. We received approximately $10,400,000 in net proceeds from the private placement. In connection with the December 2004 private placement, we also issued three-year
warrants to purchase 164,289 shares of our common stock at an exercise price of $3.43 per share to the placement agent for the transaction. The warrants issued to the placement agent expired unexercised. All of the warrants issued in the December
2004 transaction provide a call right in our favor to the extent that the closing price of our common stock exceeds $7.50 per share for 13 consecutive trading days, subject to certain circumstances. As of June 30, 2009, warrants issued to the
investors to purchase up to 1,775,689 shares remained outstanding. If the remaining warrants are fully exercised, of which there can be no assurance, these warrants would provide us approximately $5,327,000 of additional capital.
In January 2007, we completed a registered direct offering with several institutional investors for 5,021,427 shares of our common stock and warrants to purchase
3,263,927 shares of our common stock for an aggregate purchase price of approximately $5,624,000. Net proceeds from the offering were approximately $5,100,000. The warrants have an exercise price of $1.66 per share and, subject to the terms therein,
are exercisable at any time on or before January 21, 2012. The warrants are subject to a call right in our favor to the extent that the closing price of our common stock exceeds $3.35 per share for any 13 consecutive trading days. As of
June 30, 2009, warrants to purchase up to 2,996,927 shares remained outstanding. If the remaining warrants are fully exercised, of which there can be no assurance, these warrants would provide us approximately $4,975,000 of additional capital.
In August 2007, we completed a registered direct offering with several institutional investors for 7,075,000 shares of our common stock and warrants to
purchase 2,830,000 shares of our common stock for an aggregate purchase price of $14,150,000. Net proceeds from the offering were approximately $13,135,000. The investors’ warrants have an exercise price of $2.64 per share and, subject to the
terms therein, are exercisable on or before August 28, 2012. In addition, we issued warrants to purchase up to an aggregate of 176,875 shares of our common stock to the placement agents in the offering. The placement agents’ warrants have
an exercise price of $3.96 per share and, subject to the terms therein, are exercisable on or before August 28, 2012. As of June 30, 2009, warrants to purchase 3,006,875 shares remained outstanding. If the related warrants are fully
exercised, of which there can be no assurance, these warrants would provide us approximately $8,172,000 of additional capital.
Page 21 of 28
In April 2009, we completed a registered direct offering with a single institutional investor for 1,475 shares of our
newly designated 0% Series E Convertible Preferred Stock and warrants to purchase 6,941,176 shares of our common stock for an aggregate purchase price of $1,475,000. Net proceeds from the offering were approximately $1,250,000. The investor’s
warrants have an exercise price of $0.3401 per share and, subject to the terms therein, are exercisable on or after October 17, 2009 and on or before October 17, 2012. In addition, we issued warrants to purchase up to an aggregate of
433,824 shares of our common stock to the placement agent in the offering with an exercise price of $0.26 per share and the same term of exercisability as the warrants issued to the investor. If the warrants related to this transaction are fully
exercised, of which there can be no assurance, these warrants would provide us with approximately $2,475,000 of additional capital.
In July 2009, we
completed a private placement with a single institutional investor for 4,029 shares of our newly designated Series F Convertible Preferred Stock with a stated value of $1,000 per share and warrants to purchase 6,060,470 shares of our common stock
for an aggregate purchase price of $4,029,000, of which $2,029,000 was placed in an escrow account. If the convertible preferred stock is converted at any time prior to July 29, 2014, we have agreed to pay the holder an amount from the escrow
account equal to approximately $504 per $1,000 of stated value of the preferred stock converted. Net proceeds from the offering, after deducting related expenses, were approximately $1,700,000. The investor’s warrants have an exercise price of
$0.2699 per share and, subject to the terms therein, are exercisable on or after January 31, 2010 and on or before January 31, 2013. In addition, we issued warrants to purchase up to an aggregate of 606,047 shares of our common stock to
the placement agent in the offering with an exercise price of $0.3656 per share and the same term of exercisability as the warrants issued to the investor. If the warrants related to this transaction are fully exercised, of which there can be no
assurance, these warrants would provide us with approximately $1,857,000 of additional capital.
As of June 30, 2009, we had cash, cash equivalents
and marketable securities totaling approximately $1,031,000 and a working capital deficit of approximately $967,000. In comparison, as of December 31, 2008, we had cash, cash equivalents and marketable securities of approximately $4,141,000 and
working capital of approximately $2,541,000. The decreases in cash and working capital reflect amounts required to fund our operations.
For the six months
ended June 30, 2009, net cash used in operating activities was approximately $4,358,000 and included our net loss for the period of approximately $5,115,000, adjusted for non-cash expenses for depreciation and stock compensation approximating
$358,000, and changes in operating assets and liabilities. Net cash used in operating activities was approximately $6,692,000 during the six months ended June 30, 2008, and included our net loss for the period of approximately $8,318,000,
adjusted for non-cash expenses for depreciation and stock compensation approximating $807,000, and changes in operating assets and liabilities.
For the
six months ended June 30, 2009, net cash provided by investing activities approximated $2,570,000 and represented the proceeds from the sales and maturities of marketable securities, partially offset by minimal fixed asset purchases. Net cash
provided by investing activities approximated $6,801,000 during the six months ended June 30, 2008, and primarily resulted from the sales and maturities of marketable securities of approximately $8,004,000, partially offset by the
Page 22 of 28
purchases of marketable securities of approximately $1,092,000. Fixed asset purchases for the prior year period approximated $111,000.
Net cash provided by financing activities approximated $1,250,000 during the six months ended June 30, 2009, and resulted from our registered direct offering of our
0% Series E Convertible Preferred Stock in April 2009. There was no cash provided by or used in financing activities for the six months ended June 30, 2008.
Commitments
We lease approximately 32,000 square feet of research laboratory, office and expansion space under an operating lease that
expires May 31, 2012. The commitments under the lease agreement for the remaining six months of the year ending December 31, 2009 and the years ending December 31, 2010, 2011 and 2012 are approximately $270,000, $556,000, $581,000 and
$248,000, respectively.
In addition to amounts reflected on the balance sheet as of June 30, 2009, our remaining commitments for preclinical and
clinical studies amount to approximately $1,228,000. Separately, we are committed to approximately $93,000 for sponsored research at academic institutions, all of which is payable over the next twelve months.
In June 2000, we received approximately $247,000 from the Institute for the Study of Aging, or the Institute, a non-profit foundation supported by the Estee Lauder
Trust. The advance partially offset our limited costs for our testing in patients with mild cognitive impairment that we conducted with our partner, Servier. Provided that we comply with the conditions of the funding agreement, including the
restricted use of the amounts received, we will not be required to repay the advance unless we enter an A
MPAKINE
compound into Phase III clinical trials for Alzheimer’s disease. Upon such potential clinical trials, repayment
would include interest computed at a rate equal to one-half of the prime lending rate. In lieu of cash, in the event of repayment the Institute may elect to receive the balance of outstanding principal and accrued interest as shares of our common
stock. The conversion price for such form of repayment shall initially equal $4.50 per share, subject to adjustment under certain circumstances.
Staffing
Following our announced reduction in our workforce in March 2009, we have 13 full-time employees. We do not anticipate significant
increases in the number of our full-time employees within the coming year.
Outlook
With the net proceeds from our private placement of convertible preferred stock and warrants completed in July 2009, as discussed more fully above, we believe that we have adequate financial resources to conduct our
operations late into the fourth quarter of 2009. This raises substantial doubt about our ability to continue as a going concern, which will be dependent on our ability to obtain additional financing and generate sufficient cash flows to meet
our obligations on a timely basis.
Page 23 of 28
We incurred net losses of approximately $5,115,000 during the six months ended June 30, 2009. Our ongoing cash
requirements will depend on numerous factors, particularly the progress of clinical trials of our A
MPAKINE
CX1739 and our ability to negotiate and complete collaborative agreements, out-licensing arrangements or other strategic
transactions. In order to help fund our on-going operating cash requirements, we intend to seek new collaborations for our “low impact” and “high impact” A
MPAKINE
programs that include initial cash payments
and on-going development support. We may also seek to raise additional funds and explore other strategic and financial alternatives, such as a merger or sale of assets transaction.
There are significant uncertainties as to our ability to access potential sources of capital. We may not be able to enter into any collaboration on terms acceptable to us, or at all, due to conditions in the
pharmaceutical industry or in the economy in general. Competition for such arrangements is intense, with a large number of biopharmaceutical companies attempting to secure alliances with more established pharmaceutical companies. Although we
have been engaged in discussions with candidate companies, there is no assurance that an agreement or agreements will arise from these discussions in a timely manner, or at all, or that revenues that may be generated thereby will offset operating
expenses sufficiently to reduce our short-term funding requirements.
Even if we are successful in obtaining a collaboration for our
A
MPAKINE
program, we may have to relinquish rights to technologies, product candidates or markets that we might otherwise seek to develop ourselves. These same risks apply to any attempt to out-license our compounds.
Similarly, due to market conditions, the illiquid nature of our stock and other possible limitations on equity offerings, we may not be able to sell additional
securities or raise other funds on terms acceptable to us, if at all. Any additional equity financing, if available, would likely result in substantial dilution to existing stockholders.
Our forecast of the period of time through which our financial resources will be adequate to support our operations is forward-looking information, and actual results
could vary.
Additional Risks and Uncertainties
Our
proposed products are in the preclinical or early clinical stage of development and will require significant further research, development, clinical testing and regulatory clearances. They are subject to the risks of failure inherent in the
development of products based on innovative technologies. These risks include, but are not limited to, the possibilities that any or all of the proposed products will be found to be ineffective or unsafe, or otherwise fail to receive necessary
regulatory clearances; that the proposed products, although effective, will be uneconomical to market; that third parties may now or in the future hold proprietary rights that preclude us from marketing them; or that third parties will market
superior or equivalent products. Accordingly, we are unable to predict whether our research and development activities will result in any commercially viable products or applications. Further, due to the extended testing and regulatory review
process required before marketing clearance can be obtained, we do not expect to be able to commercialize any therapeutic drug for at least four years, either directly or through our current or prospective partners or licensees. There can be no
assurance that our proposed products will prove to be safe or effective or receive regulatory approvals that are required for commercial sale.
Page 24 of 28
Off-Balance Sheet Arrangements
We have not engaged in any “off-balance sheet arrangements” within the meaning of Item 303(a)(4)(ii) of Regulation S-K.
|
Item 3.
|
Quantitative and Qualitative Disclosures About Market Risk
|
We are
exposed to certain market risks associated with interest rate fluctuations on our marketable securities and borrowing arrangement. All investments in marketable securities are entered into for purposes other than trading. We are not subject to
significant risks from currency rate fluctuations as we typically conduct a limited number of transactions in foreign currencies. In addition, we do not utilize hedging contracts or similar instruments.
Our exposure to interest rate risk arises from financial instruments entered into in the normal course of business. Certain of our financial instruments are fixed rate,
short-term investments in government and corporate notes and bonds. Changes in interest rates generally affect the fair value of the investments, however, because these financial instruments are considered “available for sale,” all such
changes are reflected in the financial statements in the period affected. We manage interest rate risk on our investment portfolio by matching scheduled investment maturities with our cash requirements. As of June 30, 2009, our investment
portfolio had a fair value and carrying amount of approximately $143,000. If market interest rates were to increase immediately and uniformly by 10% from levels as of June 30, 2009, the resulting decline in the fair value of fixed rate bonds
held within the portfolio would not be material to our financial position, results of operations and cash flows.
Our borrowing consists of our advance
from the Institute for the Study of Aging, which is subject to potential repayment in the event that we enter an A
MPAKINE
compound into Phase III clinical testing as a potential treatment for Alzheimer’s disease. Potential
repayment would include interest accruing at a rate equal to one-half of the prime lending rate. Changes in interest rates generally affect the fair value of such debt, but, based upon historical activity, such changes are not expected to have a
material impact on earnings or cash flows. As of June 30, 2009, the principal and accrued interest of the advance amounted to approximately $314,000.
|
Item 4T.
|
Controls and Procedures
|
We maintain disclosure controls and
procedures (as defined in Rules 13a-15(e) and 15(d)-15(e) under the Exchange Act) that are designed to ensure that information required to be disclosed in our reports under the Exchange Act is recorded, processed, summarized and reported within the
time periods specified in the Securities and Exchange Commission’s rules and forms, and that such information is accumulated and communicated to our management, including our Chief Executive Officer, or the CEO, and Chief Financial Officer, or
the CFO, as appropriate, to allow timely decisions regarding required disclosure.
We performed an evaluation, under the supervision and with the
participation of our management, including the CEO and CFO, of the effectiveness of the design and operation of our disclosure
Page 25 of 28
controls and procedures as of the end of the period covered by this report, pursuant to Rules 13a-15(b) and 15d-15(b) under the Exchange Act. Based upon that
evaluation, the CEO and CFO have concluded that our disclosure controls and procedures, as of the end of the period covered by this report, were effective in timely alerting them to material information required to be included in our periodic
filings under the Exchange Act.
There has been no change in our internal control over financial reporting (as defined in Rules 13(a)-15(f) and 15(d)-15(f)
under the Exchange Act) during the period covered by this report that has materially affected, or is reasonably likely to materially affect, our internal control over financial reporting.
Limitations on the Effectiveness of Controls
Our management,
including our CEO and CFO, does not expect that our disclosure controls and internal controls will prevent all error and all fraud. A control system, no matter how well conceived and operated, can provide only reasonable, not absolute, assurance
that the objectives of the control system are met. Further, the design of a control system must reflect the fact that there are resource constraints, and the benefits of controls must be considered relative to their costs. Because of inherent
limitations in all control systems, no evaluation of controls can provide absolute assurance that all control issues and instances of fraud, if any, have been detected. These inherent limitations include the realities that judgments in
decision-making can be faulty, and that breakdowns can occur because of simple error or mistake. Additionally, controls can be circumvented by the individual acts of some persons, by collusion of two or more people, or by management override of the
control.
The design of any system of controls is also based in part upon certain assumptions about the likelihood of future events, and there can be no
assurance that any design will succeed in achieving its stated goals under all potential future conditions; over time, a control may become inadequate because of changes in conditions, or the degree of compliance with the policies or procedures may
deteriorate. Because of inherent limitations in a cost-effective control system, misstatements due to error or fraud may occur and not be detected.
PART II. OTHER INFORMATION
|
Item 2.
|
Sales of Unregistered Securities
|
In connection with our April 2009
issuance of our newly designated 0% Series E Convertible Preferred Stock and warrants, we also issued unregistered warrants to purchase up to an aggregate of 433,824 shares of our common stock to the placement agent for the transaction. These
warrants have an exercise price of $0.26 per share and are exercisable on or after October 17, 2009 and on or before October 17, 2012.
The
issuance of the foregoing warrants were made in reliance upon the exemption from the registration provisions of the Securities Act of 1933, as amended, set forth in Section 4(2) thereof as a transaction by an issuer not involving any public
offering. The warrants contain representations to support our reasonable belief that the placement agent is familiar with or has access to information
Page 26 of 28
concerning our business affairs and financial condition, and the placement agent is acquiring the securities for investment and not with a view to the
distribution thereof. At the time of their issuance, the warrants were deemed to be restricted securities for purposes of the Securities Act of 1933, as amended, and the warrants (and shares issued upon exercise will) bear legends to that effect.
|
Item 4.
|
Submission of Matters to a Vote of Security Holders
|
On
June 5, 2009, we held our Annual Meeting of Stockholders, with stockholders holding 40,166,125 shares of common stock (representing 82.6% of the total number of shares outstanding and entitled to vote) present in person or by proxy at the
meeting. Proxies for the meeting were solicited pursuant to Regulation 14A of the Exchange Act. Robert F. Allnutt, John F. Benedik, Charles J. Casamento, Carl W. Cotman, Ph.D., Peter F. Drake, Ph.D., M. Ross Johnson, Ph.D., Roger G. Stoll, Ph.D. and
Mark A. Varney, Ph.D. were listed as management’s nominees in the proxy statement and were elected as directors at the meeting. The votes for each nominee were as follows:
|
|
|
|
|
|
|
Name
|
|
Number of Affirmative Votes
|
|
Number of Votes Withheld
|
|
|
|
|
|
Robert F. Allnutt
|
|
35,679,044
|
|
4,487,081
|
|
John F. Benedik
|
|
36,099,238
|
|
4,066,887
|
|
Charles J. Casamento
|
|
35,885,464
|
|
4,280,661
|
|
Carl W. Cotman, Ph.D.
|
|
36,014,781
|
|
4,151,344
|
|
Peter F. Drake, Ph.D.
|
|
36,280,056
|
|
3,886,069
|
|
M. Ross Johnson, Ph.D.
|
|
36,077,893
|
|
4,088,232
|
|
Roger G. Stoll, Ph.D.
|
|
35,281,132
|
|
4,884,993
|
|
Mark A. Varney, Ph.D.
|
|
36,976,512
|
|
3,189,613
|
At the meeting, we also sought approval of an amendment to our 2006 Stock Incentive Plan to increase the number of
shares of our common stock authorized for issuance thereunder by 3,000,000 shares, bringing the total number of authorized shares thereunder to 7,363,799. This proposal was approved with 5,948,319 affirmative votes. There were 3,691,007 negative
votes, 100,813 abstentions and 30,425,986 broker non-votes.
We also sought the ratification of Haskell & White LLP as our independent auditors
for the fiscal year ending December 31, 2009. This proposal was approved by 38,432,446 affirmative votes. There were 1,584,841 negative votes and 148,838 abstentions.
Page 27 of 28
Exhibits
|
|
|
|
|
3.7
|
|
Certificate of Designation of Preferences, Rights and Limitations of 0% Series E Convertible Preferred Stock, incorporated by reference to Exhibit 3.7 to the Company’s Current Report on
Form 8-K filed April 17, 2009.
|
|
|
|
|
4.4
|
|
Placement Agency Agreement, dated April 13, 2009, by and between the Company and Rodman & Renshaw, LLC, Form of Securities Purchase Agreement and Form of Common Stock Purchase Warrant issued
by the Company, incorporated by reference to Exhibits 1.1, 1.2 and 4.1, respectively, to the Company’s Current Report on Form 8-K filed April 17, 2009.
|
|
|
|
|
10.115
|
|
Amendment No. 2 to the Company’s 2006 Stock Incentive Plan, effective as of June 5, 2009.
|
|
|
|
|
31.1
|
|
Certification by Chief Executive Officer Pursuant to Rule 13a-14(a)/15d-14(a), As Adopted Pursuant to Section 302 of the Sarbanes-Oxley Act of 2002.
|
|
|
|
|
31.2
|
|
Certification by Chief Financial Officer Pursuant to Rule 13a-14(a)/15d-14(a), As Adopted Pursuant to Section 302 of the Sarbanes-Oxley Act of 2002.
|
|
|
|
|
32
|
|
Certification Pursuant to 18 U.S.C. Section 1350, As Adopted Pursuant to Section 906 of the Sarbanes-Oxley Act of 2002.
|
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned, thereunto duly authorized.
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
CORTEX PHARMACEUTICALS, INC.
|
|
|
|
|
|
|
August 14, 2009
|
|
|
|
By:
|
|
/s/ Maria S. Messinger
|
|
|
|
|
|
|
|
|
|
Maria S. Messinger
|
|
|
|
|
|
|
|
|
|
Vice President and Chief Financial Officer;
Corporate
Secretary
|
|
|
|
|
|
|
|
|
|
(Chief Accounting Officer)
|
Page 28 of 28
Cortex Pharm (AMEX:COR)
Gráfica de Acción Histórica
De Nov 2024 a Dic 2024
Cortex Pharm (AMEX:COR)
Gráfica de Acción Histórica
De Dic 2023 a Dic 2024
