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 March 31, 2008
|
¨
|
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 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
x
Non-accelerated filer
¨
Smaller reporting
company
¨
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.
47,542,426 shares of Common Stock as of May 5, 2008
CORTEX PHARMACEUTICALS, INC.
INDEX
Page 2 of 24
PART I. FINANCIAL INFORMATION
|
Item 1.
|
Financial Statements
|
Cortex Pharmaceuticals, Inc.
Condensed Balance Sheets
|
|
|
|
|
|
|
|
|
|
|
|
|
(Unaudited)
|
|
|
(Note)
|
|
|
|
|
March 31, 2008
|
|
|
December 31, 2007
|
|
|
Assets
|
|
|
|
|
|
|
|
|
|
Current assets:
|
|
|
|
|
|
|
|
|
|
Cash and cash equivalents
|
|
$
|
3,608,759
|
|
|
$
|
4,020,881
|
|
|
Marketable securities
|
|
|
10,360,050
|
|
|
|
13,263,560
|
|
|
Accounts receivable
|
|
|
6,251
|
|
|
|
—
|
|
|
Other current assets
|
|
|
290,170
|
|
|
|
246,960
|
|
|
|
|
|
|
|
|
|
|
|
|
Total current assets
|
|
|
14,265,230
|
|
|
|
17,531,401
|
|
|
Furniture, equipment and leasehold improvements, net
|
|
|
921,402
|
|
|
|
850,647
|
|
|
Other
|
|
|
46,667
|
|
|
|
46,667
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
$
|
15,233,299
|
|
|
$
|
18,428,715
|
|
|
|
|
|
|
|
|
|
|
|
|
Liabilities and Stockholders’ Equity
|
|
|
|
|
|
|
|
|
|
Current liabilities:
|
|
|
|
|
|
|
|
|
|
Accounts payable
|
|
$
|
1,702,649
|
|
|
$
|
970,702
|
|
|
Accrued wages, salaries and related expenses
|
|
|
426,353
|
|
|
|
398,344
|
|
|
Advance for MCI project
|
|
|
307,348
|
|
|
|
305,422
|
|
|
Deferred rent
|
|
|
61,872
|
|
|
|
52,226
|
|
|
|
|
|
|
|
|
|
|
|
|
Total current liabilities
|
|
|
2,498,222
|
|
|
|
1,726,694
|
|
|
|
|
|
|
Deferred rent
|
|
|
10,849
|
|
|
|
25,119
|
|
|
|
|
|
|
|
|
|
|
|
|
Total liabilities
|
|
|
2,509,071
|
|
|
|
1,751,813
|
|
|
|
|
|
|
Stockholders’ equity:
|
|
|
|
|
|
|
|
|
|
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; common shares issuable upon conversion: 3,679
|
|
|
21,703
|
|
|
|
21,703
|
|
|
Common stock, $0.001 par value; shares authorized: 75,000,000; shares issued and outstanding: 47,542,426 (March 31, 2008 and December 31,
2007)
|
|
|
47,542
|
|
|
|
47,542
|
|
|
Additional paid-in capital
|
|
|
111,747,025
|
|
|
|
111,339,508
|
|
|
Unrealized gain, available for sale marketable securities
|
|
|
38,281
|
|
|
|
27,073
|
|
|
Accumulated deficit
|
|
|
(99,130,323
|
)
|
|
|
(94,758,924
|
)
|
|
|
|
|
|
|
|
|
|
|
|
Total stockholders’ equity
|
|
|
12,724,228
|
|
|
|
16,676,902
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
$
|
15,233,299
|
|
|
$
|
18,428,715
|
|
|
|
|
|
|
|
|
|
|
|
See accompanying notes.
Note: The balance sheet as of December 31, 2007 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 24
Cortex Pharmaceuticals, Inc.
Condensed Statements of Operations
(Unaudited)
|
|
|
|
|
|
|
|
|
|
|
|
|
Three months ended
March 31,
|
|
|
|
|
2008
|
|
|
2007
|
|
|
Revenues:
|
|
|
|
|
|
|
|
|
|
Research and license revenue
|
|
$
|
—
|
|
|
$
|
—
|
|
|
Grant revenue
|
|
|
—
|
|
|
|
—
|
|
|
|
|
|
|
|
|
|
|
|
|
Total revenues
|
|
|
—
|
|
|
|
—
|
|
|
|
|
|
|
Operating expenses (A):
|
|
|
|
|
|
|
|
|
|
Research and development expenses
|
|
|
3,421,488
|
|
|
|
2,991,656
|
|
|
General and administrative expenses
|
|
|
1,138,039
|
|
|
|
1,035,262
|
|
|
|
|
|
|
|
|
|
|
|
|
Total operating expenses
|
|
|
4,559,527
|
|
|
|
4,026,918
|
|
|
|
|
|
|
|
|
|
|
|
|
Loss from operations
|
|
|
(4,559,527
|
)
|
|
|
(4,026,918
|
)
|
|
Interest, net
|
|
|
188,128
|
|
|
|
142,852
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss
|
|
$
|
(4,371,399
|
)
|
|
$
|
(3,884,066
|
)
|
|
|
|
|
|
|
|
|
|
|
|
Basic and diluted net loss per share:
|
|
$
|
(0.09
|
)
|
|
$
|
(0.10
|
)
|
|
|
|
|
|
|
|
|
|
|
|
Shares used in calculating per share amounts
|
|
|
|
|
|
|
|
|
|
Basic and diluted
|
|
|
47,542,426
|
|
|
|
38,269,756
|
|
|
|
|
|
|
|
|
|
|
|
|
(A) Operating expenses include the following non-cash stock compensation charges:
|
|
|
|
|
|
|
|
|
|
Research and development
|
|
$
|
270,364
|
|
|
$
|
459,443
|
|
|
General and administrative
|
|
|
137,153
|
|
|
|
193,633
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
$
|
407,517
|
|
|
$
|
653,076
|
|
|
|
|
|
|
|
|
|
|
|
See accompanying notes.
Page 4 of 24
Cortex Pharmaceuticals, Inc.
Condensed Statements of Cash Flows
(Unaudited)
|
|
|
|
|
|
|
|
|
|
|
|
|
Three months ended
March 31,
|
|
|
|
|
2008
|
|
|
2007
|
|
|
Cash flows from operating activities:
|
|
|
|
|
|
|
|
|
|
Net loss
|
|
$
|
(4,371,399
|
)
|
|
$
|
(3,884,066
|
)
|
|
Adjustments to reconcile net loss to net cash used in operating activities:
|
|
|
|
|
|
|
|
|
|
Depreciation and amortization
|
|
|
47,919
|
|
|
|
28,195
|
|
|
Stock option compensation expense
|
|
|
407,517
|
|
|
|
653,076
|
|
|
Changes in operating assets/liabilities:
|
|
|
|
|
|
|
|
|
|
Accrued interest on marketable securities
|
|
|
(17,419
|
)
|
|
|
(3,353
|
)
|
|
Accounts receivable
|
|
|
(6,251
|
)
|
|
|
160,088
|
|
|
Other current assets
|
|
|
(43,210
|
)
|
|
|
24,678
|
|
|
Accounts payable and accrued expenses
|
|
|
769,602
|
|
|
|
(468,611
|
)
|
|
Advance for MCI project and other
|
|
|
(17,843
|
)
|
|
|
2,910
|
|
|
|
|
|
|
|
|
|
|
|
|
Net cash used in operating activities
|
|
|
(3,231,084
|
)
|
|
|
(3,487,083
|
)
|
|
|
|
|
|
|
|
|
|
|
|
Cash flows from investing activities:
|
|
|
|
|
|
|
|
|
|
Purchase of marketable securities
|
|
|
(1,092,376
|
)
|
|
|
(3,696,484
|
)
|
|
Proceeds from sales and maturities of marketable securities
|
|
|
4,030,012
|
|
|
|
3,394,094
|
|
|
Purchase of fixed assets
|
|
|
(118,674
|
)
|
|
|
(20,644
|
)
|
|
|
|
|
|
|
|
|
|
|
|
Net cash provided by (used in) investing activities
|
|
|
2,818,962
|
|
|
|
(323,034
|
)
|
|
|
|
|
|
|
|
|
|
|
|
Cash flows from financing activities:
|
|
|
|
|
|
|
|
|
|
Proceeds from issuance of common stock in January 2007 registered direct offering, net
|
|
|
—
|
|
|
|
5,080,301
|
|
|
Proceeds from issuance of common stock upon exercise of warrants and stock options
|
|
|
—
|
|
|
|
28,710
|
|
|
|
|
|
|
|
|
|
|
|
|
Net cash provided by financing activities
|
|
|
—
|
|
|
|
5,109,011
|
|
|
|
|
|
|
|
|
|
|
|
|
(Decrease) increase in cash and cash equivalents
|
|
|
(412,122
|
)
|
|
|
1,298,894
|
|
|
Cash and cash equivalents, beginning of period
|
|
|
4,020,881
|
|
|
|
1,649,414
|
|
|
|
|
|
|
|
|
|
|
|
|
Cash and cash equivalents, end of period
|
|
$
|
3,608,759
|
|
|
$
|
2,948,308
|
|
|
|
|
|
|
|
|
|
|
|
See accompanying notes.
Page 5 of 24
Cortex Pharmaceuticals, Inc.
Notes to Condensed Financial Statements
(Unaudited)
Note 1 — Basis of Presentation
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 three-month period ended
March 31, 2008 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, 2007.
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. In November 2007, Organon was acquired by 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 wordwide 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 is
seeking collaborative arrangements with other pharmaceutical companies for other applications of the A
MPAKINE
compounds, under which such companies would provide additional capital to the Company in exchange for exclusive or
non-exclusive license or other rights to the technologies and products that the Company is developing. Competition for corporate partnering with major pharmaceutical companies is intense, with a large number of biopharmaceutical companies attempting
to arrive at such arrangements. Accordingly, although the Company is in discussions with candidate companies, there is no assurance that an agreement will arise from these discussions in a timely manner, or at all, or that an agreement that may
arise from these discussions will successfully reduce the Company’s short or longer-term funding requirements.
To supplement its existing resources,
in addition to seeking licensing arrangements with other pharmaceutical companies, the Company may seek to raise additional capital through the sale of debt or equity. There can be no assurance that such capital will be available on favorable terms,
or at all. If additional funds are raised by issuing equity securities, dilution to existing stockholders is likely to result.
Page 6 of 24
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.
The Company records grant revenues as the expenses related to the
grant projects are incurred. All amounts received under collaborative 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 acknowledgement from the collaborator, provided that (i) the milestone event is substantive and its achievement was not
reasonably assured at the inception of the agreement, and (ii) the Company’s performance obligations after the milestone achievement will continue to be funded by the 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 period of the Company’s performance obligations under the arrangement.
If a collaborator develops and markets a product that utilizes the Company’s technology, the Company will be eligible to receive royalties on net sales of the product, as defined by the relative agreement. The
Company will recognize such royalties, if any, at the time that the royalties become payable to the Company from the collaborator.
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.
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.
Page 7 of 24
For options granted during the three months ended March 31, 2008 and 2007, the fair value of each option award was
estimated using the Black-Scholes option pricing model and the following assumptions:
|
|
|
|
|
|
|
|
|
|
|
Three months ended
March 31,
|
|
|
|
|
2008
|
|
|
2007
|
|
|
Weighted average risk-free interest rate
|
|
3.0
|
%
|
|
4.5
|
%
|
|
Dividend yield
|
|
0
|
%
|
|
0
|
%
|
|
Volatility factor of the expected market price of the Company’s common stock
|
|
97
|
%
|
|
90
|
%
|
|
Weighted average life
|
|
6.7 years
|
|
|
4.7 years
|
|
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 of options granted during the three months ended March 31, 2008 and 2007 was $0.48 and $0.92,
respectively.
A summary of option activity for the three months ended March 31, 2008 is as follows:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Shares
|
|
|
Weighted
Average
Exercise Price
|
|
Weighted Average
Remaining
Contractual Term
|
|
Aggregate
Intrinsic Value
|
|
Balance, December 31, 2007
|
|
10,141,496
|
|
|
$
|
1.92
|
|
|
|
|
|
|
Granted
|
|
1,567,000
|
|
|
$
|
0.59
|
|
|
|
|
|
|
Exercised
|
|
—
|
|
|
|
—
|
|
|
|
|
|
|
Forfeited
|
|
(33,333
|
)
|
|
$
|
1.76
|
|
|
|
|
|
|
Expired
|
|
—
|
|
|
|
—
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balance, March 31, 2008
|
|
11,675,163
|
|
|
$
|
1.74
|
|
6.9 years
|
|
$
|
482,181
|
|
Exercisable, March 31, 2008
|
|
7,790,307
|
|
|
$
|
2.05
|
|
5.8 years
|
|
$
|
125,073
|
As of March 31, 2008, there was approximately $1,602,000 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 1.5 years.
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 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 three months ended March 31, 2008. During the three months ended
March 31, 2007, the Company received cash from stock option exercises totaling approximately $29,000. The Company issues new shares to satisfy stock option exercises.
Page 8 of 24
A summary of warrant activity for the three months ended March 31, 2008 is as follows:
|
|
|
|
|
|
|
|
|
|
|
Shares
|
|
|
Weighted
Average Per Share
Exercise Price
|
|
Balance, December 31, 2007
|
|
13,811,296
|
|
|
$
|
2.65
|
|
Granted
|
|
—
|
|
|
|
—
|
|
Exercised
|
|
—
|
|
|
|
—
|
|
Expired
|
|
(52,000
|
)
|
|
$
|
0.79
|
|
|
|
|
|
|
|
|
|
Balance, March 31, 2008
|
|
13,759,296
|
|
|
$
|
2.65
|
Outstanding warrants as of March 31, 2008 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 March 31, 2008. All other warrants outstanding as
of March 31, 2008 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
On August 21, 2003, the Company issued 3,333,334 shares of common stock to accredited investors in a private placement transaction for $1.50 per share, providing
gross proceeds of $5,000,000. Net proceeds from the transaction, after issuance costs and placement fees, were approximately $4,500,000. In connection with the transaction, the Company also issued five-year warrants to the investors to purchase up
to an additional 3,333,334 shares of the Company’s common stock at an exercise price of $2.55 per share. As of March 31, 2008, related warrants issued to investors to purchase 1,816,668 shares of common stock remained outstanding.
On January 7, 2004, the Company issued 6,909,091 shares of common stock to accredited investors in a private placement transaction for $2.75 per
share, resulting in gross proceeds of $19,000,000. Net proceeds from the transaction, after issuance costs and placement fees, were approximately $17,500,000. In connection with the January 2004 transaction, the Company issued five-year warrants to
the investors to purchase up to 4,490,910 shares of the Company’s common stock at an exercise price of $3.25 per share. As of March 31, 2008, related warrants issued to investors to purchase 3,969,137 shares of common stock remained
outstanding.
On December 14, 2004, the Company issued 4,233,333 shares of common stock to accredited investors in a private placement transaction for
$2.66 per share, resulting in gross proceeds of $11,260,663. Net proceeds from the transaction, after issuance costs and placement fees, were approximately $10,400,000. In connection with the December 2004 transaction, the Company issued five-year
warrants to the investors to purchase up to 2,116,666 shares of the Company’ common stock at an exercise price of $3.00 per share. As of March 31, 2008, related warrants issued to investors to purchase 1,775,689 shares of common stock
remained outstanding.
Pursuant to the terms of the registration rights agreements entered into in connection with each of the above transactions, within
defined timelines the Company was required to file, and did file, with the Securities and Exchange Commission (the “SEC”) a registration statement under the Securities Act of 1933, as amended, covering the resale of all of the common stock
purchased and the common stock underlying the issued warrants.
Page 9 of 24
The registration rights agreement for each 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 placements for the common
stock and warrants then held, prorated daily.
The registration statement for each 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 any of the foregoing transactions.
In accordance with EITF 00-19, “Accounting for Derivative Financial Instruments Indexed To, and Potentially Settled In a Company’s Own Stock,” (“EITF 00-19”) and the terms of the warrants and
the transaction documents, for each of the above transactions the Company recorded the estimated fair value of the warrants as a liability, with an offsetting reduction to additional paid-in capital received from the private placement. The fair
value of the warrants was estimated using the Black-Scholes option pricing model.
The estimated fair value of the warrants was re-measured at each
reporting date and on the date of effectiveness of the related registration statement, with the increase in fair value recorded as other expense in the Company’s Statement of Operations. As of date of the effectiveness of the registration
statement, the warrant liability was reclassified to additional paid-in capital, evidencing the non-impact of these adjustments on the Company’s financial position and business operations.
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.
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 each of the August 2003, January 2004 and December 2004 transactions, as of March 31, 2008 the Company
has estimated the maximum potential amount of undiscounted payments that it could be required to make under the registration arrangements as approximately $165,000, $2,091,000 and $3,277,000, respectively.
Given that the Company did not deem the transfer of consideration under its existing registration payment arrangements as probable as of March 31, 2008 or 2007, no
related expense or liability has been recorded during the three-month periods ended March 31, 2008 and 2007.
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
Page 10 of 24
a footnote in its quarterly reports. During the three months ended March 31, 2008 and 2007, total comprehensive loss was approximately $4,360,000 and
$3,877,000, 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 bonds and other
asset backed securities. Unrealized gains on the Company’s marketable securities for the three months ended March 31, 2008 and 2007 amounted to approximately $11,000 and $7,000, respectively.
New Accounting Standards
In September 2006, the FASB issued SFAS
No. 157, “Fair Value Measurements” (“SFAS 157”). 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. SFAS 157 is effective for the Company’s fiscal year beginning January 1, 2009 on a prospective basis. The Company does not anticipate that adopting SFAS157
will have a material impact on its financial position or results of operations.
In February 2007, the FASB issued SFAS No. 159, “The Fair Value
Option for Financial Assets and Financial Liabilities” (“SFAS 159”). The guidance within SFAS 159 allows reporting entities to choose to measure many financial instruments and certain other items at fair value. The provisions of SFAS
159 became effective as of January 1, 2008, but the Company does not anticipate electing the fair value option or that such an election would materially impact its financial position or results of operations.
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) is effective for fiscal years beginning after December 15, 2008. The Company is evaluating SFAS 141(R) and has not yet
determined the impact that adoption will have on the consolidated 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 is effective on a prospective basis for business combinations that occur in fiscal years beginning after December 15, 2008. Given that the Company
does not currently have any minority interests, at this time it does not anticipate that adoption of SFAS 160 will 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 are effective for fiscal years and interim
periods beginning after November 15, 2008. The Company does not expect the adoption of this pronouncement to have a material impact on its financial statements.
Page 11 of 24
|
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, 2007.
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 (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 (“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 neurodegenerative diseases and other neurological and psychiatric disorders. Our primary focus is to develop novel
small molecule compounds that positively modulate AMPA-type glutamate receptors, a complex of proteins involved in communication between nerve cells in the mammalian brain. These compounds, termed A
MPAKINE
®
compounds, enhance the activity of the AMPA receptor. These molecules are designed and developed as proprietary pharmaceuticals because we believe that they hold promise for the treatment of neurological and
psychiatric diseases and disorders that are
Page 12 of 24
known, or thought, to involve depressed functioning of pathways in the brain that use glutamate as a neurotransmitter. Our most advanced clinical compound is
CX717, which currently is in Phase II clinical development.
The A
MPAKINE
program 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
products for those indications that require sizable, expensive Phase III clinical
trials and very large sales forces to achieve significant market penetration.
At the same time, 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.
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 consequently 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” (“SAB 104”). SAB 104 provides guidance in applying accounting
principles generally accepted in the United States to revenue recognition issues, and specifically
Page 13 of 24
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 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 (“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 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” (“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 March 31, 2008, there was approximately $1,602,000 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 1.5 years.
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.
Page 14 of 24
Registration Payment Arrangements
In connection with prior private placements of our common stock and warrants to purchase shares of our common stock, we entered into agreements with investors that committed us to timely register the shares of common
stock purchased as well as the shares underlying the issued warrants. Those registration agreements specified potential cash penalties if we did not timely register the related shares with the SEC.
In accordance with EITF 00-19, “Accounting for Derivative Financial Instruments Indexed To, and Potentially Settled In a Company’s Own Stock,” when the
potential cash penalties were included in registration payment arrangements, we recorded the estimated fair value of the warrants as a liability, with an offsetting reduction to additional paid-in capital received from the private placement. The
fair value of the warrants was estimated using the Black-Scholes option pricing model.
The estimated fair value of the warrants was re-measured at each
reporting date and on the date of effectiveness of the related registration statement, with the increase in fair value recorded as other expense in our Statement of Operations. As of the date of effectiveness of the registration statement, the
warrant liability was reclassified to additional paid-in capital, evidencing the non-impact of these adjustments on our financial position and business operations.
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.
EITF 00-19-2 is effective immediately for registration payment arrangements and the financial
instruments subject to those arrangements that we enter into or modify after the date of issuance of this FSP. For our registration payment arrangements and financial instruments subject to those arrangements that were entered prior to the issuance
of this FSP, the guidance was effective beginning January 1, 2007.
Given that we did not deem the transfer of consideration under our existing
registration payment arrangements as probable, we have not recorded a related liability or expense for these arrangements subsequent to the issuance of this FSP.
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 15 of 24
Results of Operations
General
In January 1999, we entered into a research collaboration and exclusive worldwide license agreement with NV Organon
(“Organon”). In November 2007, Organon was acquired by 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 (“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, MCI, sexual dysfunction and anxiety disorders. 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 (a) declines in cognitive performance associated with aging,
(b) neurodegenerative diseases, (c) anxiety disorders, and (d) sexual dysfunction 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.
From inception (February 10, 1987) through March 31, 2008, we have sustained losses aggregating approximately $97,098,000. 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.
Page 16 of 24
Comparison of the Three Months ended March 31, 2008 and 2007
For the three months ended March 31, 2008, our net loss of approximately $4,371,000 compares with a net loss of approximately $3,884,000 for the corresponding prior
year period, an increase of 13%, mostly due to increased research and development expenses, as explained more fully below.
Our research and development
expenses for the three-month period ended March 31, 2008 increased from approximately $2,992,000 to approximately $3,421,000, or by 14%, from the corresponding prior year period, primarily as a result of increased clinical development,
including expenses related to our Phase IIa studies of our A
MPAKINE
CX717 in respiratory depression. We expect to report related results from these two human clinical studies in late second quarter and early third quarter of 2008,
respectively. Our non-cash stock compensation charges related to research and development for the three months ended March 31, 2008 decreased from approximately $459,000 to approximately $270,000, or by 41%, relative to 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 March 31, 2008 increased from approximately $1,035,000 to approximately $1,138,000, or by 10%, compared to the corresponding prior year period. Most of this increased expense represented market research for the
field of respiratory depression, an indication currently being tested with our A
MPAKINE
CX717, as indicated above. Our general and administrative non-cash stock compensation charges for the three months ended March 31, 2008
decreased from approximately $194,000 to approximately $137,000, or by 29%, relative to the corresponding prior year period, primarily due to fluctuations in our stock price.
Net interest income for the three months ended March 31, 2008 increased from approximately $143,000 to approximately $188,000, or by 32% compared to the corresponding prior year period due to an increase in cash
available for investing.
Liquidity and Capital Resources
Sources and Uses of Cash
From inception (February 10, 1987) through March 31, 2008, 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.
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 the licensed technology and ultimately, royalties on worldwide sales.
Page 17 of 24
In August 2003, we completed a private placement of an aggregate of 3,333,334 shares of our common stock at $1.50 per
share and five-year warrants to purchase up to an additional aggregate of 3,333,334 shares at an exercise price of $2.55 per share. We received approximately $4,500,000 in net proceeds from the private placement. In connection with the August 2003
private placement, we also issued warrants to two placement agents to purchase 30,000 and 83,061 shares of our common stock, respectively. The warrant to purchase 30,000 shares of our common stock has an exercise price of $1.50 per share and a
five-year term. The warrant to purchase 83,061 shares of our common stock has an exercise price of $2.71 per share and a three-year term. All of the warrants issued in the August 2003 transaction provide a call right in our favor to the extent that
the closing price of our common stock exceeds $6.00 per share for 13 consecutive trading days, subject to certain circumstances. During the year ended December 31, 2007, we received approximately $170,000 of proceeds from the exercise of
related warrants. As of March 31, 2008, related warrants issued to investors to purchase up to 1,816,668 shares remained outstanding and warrants issued to placement agents to purchase up to 1,000 shares remained outstanding. If the remaining
warrants are fully exercised, of which there can be no assurance, such exercise would provide us approximately $4,634,000 of additional capital.
In
January 2004, we completed a private placement of an aggregate of 6,909,091 shares of our common stock at $2.75 per share and five-year warrants to purchase up to an additional aggregate of 4,490,910 shares at an exercise price of $3.25 per share.
We received approximately $17,500,000 in net proceeds from the private placement. In connection with the January 2004 private placement, we also issued two additional warrants to purchase 54,750 and 272,959 shares of our common stock, respectively,
to two placement agents. The warrant to purchase 54,750 shares of our common stock has an exercise price of $2.75 per share and a five-year term. The warrant to purchase 272,959 shares of our common stock has an exercise price of $3.48 per share and
a three-year term. All of the warrants issued in the January 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. During the year ended December 31, 2007, we did not receive any proceeds from the exercise of related warrants. As of March 31, 2008, related warrants issued to investors to purchase up to 3,969,137 shares remained
outstanding and warrants issued to placement agents to purchase up to 4,000 shares remained outstanding. If the remaining warrants are fully exercised, of which there can be no assurance, these warrants would provide us approximately $12,911,000 of
additional capital.
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
March 31, 2008, warrants issued to the investors to purchase up to 1,775,689 shares remained outstanding. If
Page 18 of 24
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. During the year ended December 31, 2007, we received approximately $443,000 from the exercise of related warrants. As of March 31, 2008, 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. 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.
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. During the year ended December 31, 2007, we did not receive any proceeds from the exercise of related warrants. As of March 31, 2008, 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.
As of
March 31, 2008, we had cash, cash equivalents and marketable securities totaling approximately $13,969,000 and working capital of approximately $11,767,000. In comparison, as of December 31, 2007, we had cash, cash equivalents and
marketable securities of approximately $17,284,000 and working capital of approximately $15,805,000. The decreases in cash and working capital reflect amounts required to fund our operations.
Net cash used in operating activities was approximately $3,231,000 during the three months ended March 31, 2008, and included our net loss for the period of
approximately $4,371,000, adjusted for non-cash expenses for depreciation and stock compensation approximating $455,000, and changes in operating assets and liabilities. For the three months ended March 31, 2007, net cash used in operating
activities was approximately $3,487,000, and included our net loss for the period of approximately $3,884,000, adjusted for non-cash expenses for depreciation and stock compensation approximating $681,000, and changes in operating assets and
liabilities.
Net cash provided by investing activities approximated $2,819,000 during the three months ended March 31, 2008, and primarily resulted
from the sales and maturities of marketable securities of
Page 19 of 24
approximately $4,030,000, partially offset by the purchases of marketable securities of approximately $1,092,000. Fixed asset purchases for the current year
period approximated $119,000. For the three months ended March 31, 2007, net cash used in investing activities approximated $323,000, and primarily resulted from the purchase of marketable securities of approximately $3,696,000, partially
offset by the sales and maturities of marketable securities of approximately $3,394,000. Fixed asset purchases for the prior year period approximated $21,000.
There was no cash provided by or used in financing activities for the three months ended March 31, 2008. Net cash provided by financing activities amounted to approximately $5,109,000 for the three months ended March 31, 2007 and
resulted primarily from the net proceeds from our offering of our common stock and warrants to purchase shares of our common stock in late January 2007.
Commitments
We lease approximately 32,000 square feet of research laboratory, office and expansion space under an operating lease that
expires May 31, 2009. The commitments under the lease agreement for the remaining nine months of the year ending December 31, 2008 and the five months ending May 31, 2009 are approximately $420,000 and $237,000, respectively. We are
currently evaluating our lease renewal alternatives.
In addition to amounts reflected on the balance sheet as of March 31, 2008, our remaining
commitments for preclinical and clinical studies amount to approximately $2,180,000. Separately, we are committed to approximately $356,000 for sponsored research at academic institutions, of which $263,000 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
As of March 31, 2008, we had a total of 27 full-time research and administrative employees. We anticipate modest increases in
staffing and investments in equipment through the next twelve months.
Page 20 of 24
Outlook
We
anticipate that our cash, cash equivalents and marketable securities will be sufficient to satisfy our capital requirements into 2009. Additional funds will be required to continue operations beyond that time. We may receive additional milestone
payments from the Organon and Servier agreements. However, there is no assurance that we will receive such milestone payments from Organon or Servier. We may also receive funds from the exercise of warrants to purchase shares of our common stock. As
of March 31, 2008, warrants to purchase approximately 13.8 million shares of our common stock were outstanding with a weighted average exercise price of $2.65 per share. If all remaining warrants are fully exercised, of which there can be
no assurance, such exercise would provide approximately $36,500,000 of additional capital.
In order to provide for our longer-term capital requirements,
we are presently seeking additional collaborative or other arrangements with larger pharmaceutical companies. Under these agreements, it is intended that such companies would provide capital to us in exchange for an exclusive or non-exclusive
license or other rights to certain of the technologies and products that we are developing. 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 longer-term funding requirements.
Because there is no assurance that we will
secure additional corporate partnerships, we may seek to raise additional capital through the sale of debt or equity securities. There is no assurance that funds will be available on favorable terms, or at all. If equity securities are issued to
raise additional funds, dilution to existing stockholders is likely to result. Such additional capital would, more importantly, enhance the ability of us to achieve significant milestones in our efforts to develop the A
MPAKINE
technology.
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.
Page 21 of 24
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.
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 do not typically conduct 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 March 31, 2008, our investment
portfolio had a fair value and carrying amount of approximately $10,360,000. If market interest rates were to increase immediately and uniformly by 10% from levels as of March 31, 2008, 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 March 31, 2008, the principal and accrued interest of the advance amounted to approximately $307,000.
|
Item 4.
|
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 (the “CEO”) and Chief Financial
Officer (the “CFO”), as appropriate, to allow timely decisions regarding required disclosure.
Page 22 of 24
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 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.
Page 23 of 24
PART II. OTHER INFORMATION
Exhibits
|
|
|
|
|
10.106
|
|
Amendment No. 3 dated April 17, 2008 to the Consulting Agreement dated April 16, 2004 between the Company and Gary D. Tollefson, M.D., Ph.D.
|
|
|
|
|
10.107
|
|
Severance agreement dated May 2, 2008, between the Company and Steven A. Johnson, Ph.D.
|
|
|
|
|
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.
|
|
|
|
|
|
May 8, 2008
|
|
By:
|
|
/s/ Maria S. Messinger
|
|
|
|
|
|
Maria S. Messinger
|
|
|
|
|
|
Vice President and Chief Financial Officer;
|
|
|
|
|
|
Corporate Secretary
|
|
|
|
|
|
(Chief Accounting Officer)
|
Page 24 of 24
Cortex Pharm (AMEX:COR)
Historical Stock Chart
From Dec 2024 to Jan 2025
Cortex Pharm (AMEX:COR)
Historical Stock Chart
From Jan 2024 to Jan 2025
