UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 10-Q
(Mark One)
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x
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QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
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FOR THE QUARTERLY PERIOD ENDED March 31, 2009
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¨
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TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
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FOR THE TRANSITION PERIOD FROM
TO
Commission file number 1-16467
Cortex Pharmaceuticals, Inc.
(Exact name of registrant as specified in its charter)
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Delaware
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33-0303583
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(State or other jurisdiction of
incorporation or organization)
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(I.R.S. Employer
Identification No.)
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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.
51,615,209 shares of Common Stock as of May 8, 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 1-5 of Part II have been omitted because they are not applicable with respect to the current reporting period.
Page 2 of 24
PART I. FINANCIAL INFORMATION
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Item 1.
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Financial Statements
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Cortex Pharmaceuticals, Inc.
Condensed Balance Sheets
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(Unaudited)
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(Note)
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March 31, 2009
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December 31, 2008
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Assets
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Current assets:
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Cash and cash equivalents
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$
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1,621,944
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$
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1,430,886
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Marketable securities
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215,212
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2,710,434
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Other current assets
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229,530
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154,884
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Total current assets
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2,066,686
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4,296,204
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Furniture, equipment and leasehold improvements, net
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757,235
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809,458
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Other
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46,667
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46,667
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$
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2,870,588
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$
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5,152,329
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Liabilities and Stockholders’ Equity
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Current liabilities:
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Accounts payable
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$
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1,838,256
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$
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1,123,015
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Accrued wages, salaries and related expenses
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322,747
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293,746
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Advance for MCI project
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312,728
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311,723
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Deferred rent
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10,849
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27,123
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Total current liabilities
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2,484,580
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1,755,607
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Stockholders’ equity:
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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
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21,703
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21,703
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Common stock, $0.001 par value; shares authorized: 105,000,000; shares issued and outstanding: 47,615,209 (March 31, 2009 and
December 31, 2008)
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47,615
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47,615
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Additional paid-in capital
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112,838,840
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112,686,078
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Unrealized gain (loss), available for sale marketable securities
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1,095
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(3,884
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)
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Accumulated deficit
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(112,523,245
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)
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(109,354,790
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)
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Total stockholders’ equity
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386,008
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3,396,722
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$
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2,870,588
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$
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5,152,329
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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 24
Cortex Pharmaceuticals, Inc.
Condensed Statements of Operations
(Unaudited)
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Three months ended
March 31,
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2009
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2008
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Revenues:
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Research and license revenue
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$
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—
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$
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—
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Grant revenue
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—
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—
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Total revenues
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—
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—
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Operating expenses (A):
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Research and development expenses
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2,114,771
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3,421,488
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General and administrative expenses
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1,068,497
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1,138,039
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Total operating expenses
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3,183,268
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4,559,527
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Loss from operations
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(3,183,268
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(4,559,527
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Interest, net
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14,813
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188,128
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Net loss
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$
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(3,168,455
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)
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$
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(4,371,399
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)
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Basic and diluted net loss per share:
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$
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(0.07
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$
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(0.09
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Shares used in calculating per share amounts
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Basic and diluted
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47,615,209
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47,542,426
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(A) Operating expenses include the following non-cash, stock-based compensation charges:
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Research and development
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$
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84,050
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$
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270,364
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General and administrative
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68,712
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137,153
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$
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152,762
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$
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407,517
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See accompanying notes.
Page 4 of 24
Cortex Pharmaceuticals, Inc.
Condensed Statements of Cash Flows
(Unaudited)
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Three months ended
March 31,
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2009
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2008
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Cash flows from operating activities:
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Net loss
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$
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(3,168,455
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$
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(4,371,399
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Adjustments to reconcile net loss to net cash used in operating activities:
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Depreciation and amortization
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52,223
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47,919
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Stock option compensation expense
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152,762
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407,517
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Changes in operating assets/liabilities:
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Accrued interest on marketable securities
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(1,090
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(17,419
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Accounts receivable
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—
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(6,251
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)
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Other current assets
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(74,646
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)
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(43,210
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Accounts payable and accrued expenses
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727,968
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769,602
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Advance for MCI project and other
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1,590
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(17,843
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)
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Net cash used in operating activities
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(2,309,648
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(3,231,084
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Cash flows from investing activities:
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Purchase of marketable securities
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—
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(1,092,376
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)
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Proceeds from sales and maturities of marketable securities
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2,500,706
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4,030,012
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Purchase of fixed assets
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—
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(118,674
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)
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Net cash provided by investing activities
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2,500,706
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2,818,962
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Increase (decrease) in cash and cash equivalents
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191,058
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(412,122
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)
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Cash and cash equivalents, beginning of period
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1,430,886
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4,020,881
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Cash and cash equivalents, end of period
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$
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1,621,944
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$
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3,608,759
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See accompanying notes.
Page 5 of 24
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 three-month period ended March 31, 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 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 has incurred net losses and cash outflows from operations of $3,168,000 and $2,310,000,
respectively, for the three months ended March 31, 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 registered
direct private offering of convertible preferred stock and warrants to purchase shares of common stock completed in April 2009, as described more fully in Note 2, management believes the Company has adequate financial resources to conduct operations
late into the third 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 24
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 third 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 24
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.
There were no options granted during the three months ended March 31, 2009. For options granted during the three months ended March 31, 2008, the fair value of
each option award was estimated using the Black-Scholes option pricing model and the following assumptions: weighted average risk-free interest rate of 3.0%; dividend yield of 0%; weighted average life of 6.7 years and volatility factor of the
expected market price of the Company’s common stock of 97%.
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 was $0.48.
A summary of option activity for the three months ended March 31, 2009 is as follows:
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Shares
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Weighted
Average
Exercise Price
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Weighted Average
Remaining
Contractual Term
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Aggregate
Intrinsic Value
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Balance, December 31, 2008
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11,554,319
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$
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1.73
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Granted
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—
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—
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Exercised
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—
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—
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Forfeited
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(285,077
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)
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$
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1.09
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Expired
|
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—
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—
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Balance, March 31, 2009
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|
11,269,242
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$
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1.75
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5.6 years
|
|
—
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Exercisable, March 31, 2009
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9,320,379
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$
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1.94
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5.0 years
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|
—
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As of March 31, 2009, there was approximately $516,000 of total unrecognized compensation cost related to
non-vested share-based compensation arrangements. That non-cash cost is expected to be recognized over a weighted-average period of 1.2 years.
The Company
continues to follow EITF Issue 96-18, “Accounting for Equity Instruments that are Issued to Other than Employees for Acquiring, or in Conjunction with Selling Goods and Services,” for stock options and warrants issued to consultants and
other non-employees. In accordance with EITF Issue 96-18, these stock options and warrants issued as compensation for services to be provided to the Company are accounted for based upon the fair value of the services provided or the estimated fair
market value of the option or warrant, whichever can be more clearly determined. The Company recognizes these expenses over the period in which the services are provided. These expenses are non-cash charges and have no impact on the Company’s
available cash or working capital.
There were no stock option exercises during the three months ended March 31, 2009 or 2008. The Company issues new
shares to satisfy stock option exercises.
Page 8 of 24
A summary of warrant activity for the three months ended March 31, 2009 is as follows:
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Shares
|
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Weighted
Average Per Share
Exercise Price
|
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Balance, December 31, 2008
|
|
11,920,628
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|
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$
|
2.67
|
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Granted
|
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—
|
|
|
|
—
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Exercised
|
|
—
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|
|
|
—
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Expired
|
|
(3,976,137
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)
|
|
$
|
3.25
|
|
|
|
|
|
|
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|
|
Balance, March 31, 2009
|
|
7,944,491
|
|
|
$
|
2.38
|
|
|
|
|
|
|
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|
Outstanding warrants as of March 31, 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 March 31, 2009. All other warrants outstanding as
of March 31, 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 prior private placements of the Company’s common stock and warrants to purchase shares of the Company’s common stock completed in January
2004 and December 2004, respectively, the Company entered into agreements that committed it to timely register the shares underlying the issued warrants. Those registration agreements 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 each 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 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 either of such prior transactions.
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.
Page 9 of 24
In connection with its obligation to maintain effectiveness of the registration statements filed with each of the January
2004 and December 2004 transactions, as of March 31, 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 $1,341,000.
Given that the Company did not deem the transfer of consideration under its existing registration payment arrangements as probable as of March 31,
2009 or 2008, no related expense or liability has been recorded during the three-month periods ended March 31, 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 March 31, 2009 and 2008, total comprehensive loss was approximately $3,163,000 and $4,360,000, 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, 2009 and 2008 amounted to approximately $5,000 and $11,000, 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.
Page 10 of 24
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.
Note 2 — Subsequent Event
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.
Subject to certain ownership limitations, the preferred stock is convertible into 8,676,471 common shares of the Company 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 exercisable on or after October 17, 2009 and on or before
October 17, 2012.
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, 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 12 of 24
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 i.v. 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 i.v. 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 and CX2007. 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 exhibits 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.
At the same time, subject to availability of 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
Page 13 of 24
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 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
Page 14 of 24
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 March 31, 2009, there was approximately $516,000 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 1.2 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.
Registration Payment Arrangements
In connection with prior private
placements of our common stock and warrants to purchase shares of our common stock completed in January 2004 and December 2004, respectively, 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 December 2006, the FASB issued FASB Staff Position, or 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 we enter into or modify after the date of
Page 15 of 24
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.
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
Page 16 of 24
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.
From inception (February 10, 1987) through March 31, 2009, we have sustained losses aggregating approximately $110,491,000. 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 ended March 31, 2009 and 2008
For the three months ended March 31, 2009, our net loss of approximately $3,168,000 compares with
a net loss of approximately $4,371,000 for the corresponding prior year period, a decrease of 28%, mostly due to decreased research and development expenses, as explained more fully below.
Our research and development expenses for the three-month period ended March 31, 2009 decreased from approximately $3,421,000 to approximately $2,115,000, or by
38%, from the corresponding prior year period, primarily as a result of preclinical development expenses during the prior year period 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 period during the three months ended March 31, 2009, Dr. Varney’s salary related expenses have been recorded in general and administrative expenses. Along with
amounts for Dr. Varney, recruiting fees
Page 17 of 24
and other non-recurring expenses during the prior year period also contributed to the decrease in personnel-related expenses for our research and development
staff.
Our non-cash stock compensation charges related to research and development for the three months ended March 31, 2009 decreased from
approximately $270,000 to approximately $84,000, or by 69%, 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, 2009 decreased from approximately $1,138,000 to approximately $1,068,000, or by
6%, compared to the corresponding prior year period. Most of this decrease resulted from 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 quarter, when his salary and related costs were recorded with research and development expenses.
Our general and administrative non-cash stock compensation charges for the three months ended March 31, 2009 decreased from approximately $137,000 to approximately $69,000, or by 50%, 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, 2009
decreased from approximately $188,000 to approximately $15,000, or by 92% compared to the corresponding prior year period due to a decrease in cash available for investing.
Liquidity and Capital Resources
Sources and Uses of Cash
From inception (February 10, 1987) through March 31, 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.
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,
Page 18 of 24
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, 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 March 31, 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 March 31, 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.
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.
Page 19 of 24
As of March 31, 2009, we had cash, cash equivalents and marketable securities totaling approximately $1,837,000 and
a working capital deficit of approximately $418,000. 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 three months ended March 31, 2009, net cash used in operating
activities was approximately $2,310,000 and included our net loss for the period of approximately $3,168,000, adjusted for non-cash expenses for depreciation and stock compensation approximating $205,000, and changes in operating assets and
liabilities. 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, 2009, net cash
provided by investing activities approximated $2,501,000 and represented the proceeds from the sales and maturities of marketable securities. 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 approximately $4,030,000, partially offset by the purchases of marketable securities of approximately $1,092,000. Fixed asset purchases for the
prior year period approximated $119,000.
There was no cash provided by or used in financing activities for the three months ended March 31, 2009 or
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 nine months of the year ending December 31, 2009 and the years
ending December 31, 2010, 2011 and 2012 are approximately $410,000, $556,000, $581,000 and $238,000, respectively.
In addition to amounts reflected
on the balance sheet as of March 31, 2009, our remaining commitments for preclinical and clinical studies amount to approximately $1,522,000. Separately, we are committed to approximately $256,000 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
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price for such form of repayment shall initially equal $4.50 per share, subject to adjustment under certain circumstances.
Staffing
Following our recently announced reduction in our
workforce, we had 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 registered direct offering of convertible preferred stock completed in April 2009, as discussed more
fully above, we believe that we have adequate financial resources to conduct our operations late into the third 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.
We incurred net losses of
approximately $3,168,000 during the three months ended March 31, 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.
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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.
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.
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Item 3.
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Quantitative and Qualitative Disclosures About Market Risk
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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, 2009, our investment
portfolio had a fair value and carrying amount of approximately $215,000. If market interest rates were to increase immediately and uniformly by 10% from levels as of March 31, 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
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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, 2009, the principal and
accrued interest of the advance amounted to approximately $313,000.
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Item 4T.
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Controls and Procedures
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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 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
Page 23 of 24
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
Exhibits
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10.113
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Form of Retention Bonus Agreement, dated March 13, 2009, between the Company and each of its executive officers, incorporated by reference to the same numbered Exhibit to the Company’s
Current Report on Form 8-K filed March 19, 2009.
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31.1
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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.
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31.2
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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.
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32
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Certification Pursuant to 18 U.S.C. Section 1350, As Adopted Pursuant to Section 906 of the Sarbanes-Oxley Act of 2002.
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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.
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CORTEX PHARMACEUTICALS, INC.
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May 15, 2009
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By:
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/s/ Maria S. Messinger
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Maria S. Messinger
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Vice President and Chief Financial Officer; Corporate Secretary
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(Chief Accounting Officer)
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Page 24 of 24
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