U.S. SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
FORM 10-QSB
(Mark One)
* QUARTERLY REPORT UNDER SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT
-----
OF 1934 FOR THE QUARTERLY PERIOD ENDED March 31, 1997
-----------------------
TRANSITION REPORT UNDER SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE
-----
ACT OF 1934 FOR THE TRANSITION PERIOD FROM _____________ TO ____________
COMMISSION FILE NUMBER 0-17951
CORTEX PHARMACEUTICALS, INC.
(EXACT NAME OF SMALL BUSINESS ISSUER AS SPECIFIED IN ITS CHARTER)
Delaware 33-0303583
(STATE OR OTHER JURISDICTION OF (I.R.S. EMPLOYER
INCORPORATION OR ORGANIZATION) IDENTIFICATION NO.)
15241 Barranca Parkway, Irvine, California, 92618
(ADDRESS OF PRINCIPAL EXECUTIVE OFFICES, INCLUDING ZIP CODE)
(714) 727-3157
(ISSUERS'S TELEPHONE NUMBER)
NOT APPLICABLE
----------------------------------
(FORMER NAME, FORMER ADDRESS AND FORMER FISCAL YEAR,
IF CHANGED SINCE LAST YEAR)
Check whether the issuer (1) filed all reports required to be filed by Section
13 or 15(d) of the Exchange Act during the past 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 * NO
----- -----
State the number of shares outstanding of each of the issuer's classes of common
equity, as of the latest practicable date.
9,394,249 shares of Common Stock as of May 6, 1997
Page 1 of 12
CORTEX PHARMACEUTICALS, INC.
INDEX
PAGE NUMBER
-----------
PART I. FINANCIAL INFORMATION
Item 1. Financial Statements
Balance Sheets -- March 31, 1997 and June 30, 1996.......... 3
Statements of Operations -- Three months ended
March 31, 1997 and 1996; nine months ended March 31,
1997 and 1996; and period from inception (February 10, 1987)
through March 31, 1997...................................... 4
Statements of Cash Flows -- Nine months ended
March 31, 1997 and 1996; and period from inception
(February 10, 1987) through March 31, 1997.................. 5
Notes to Financial Statements............................... 7
Item 2. Management's Discussion and Analysis of
Financial Condition and Results of Operations;
Plan of Operation........................................... 8
PART II. OTHER INFORMATION
Item 2. Changes in Securities....................................... 11
Item 5. Other Information........................................... 11
Item 6. Exhibits and Reports on Form 8-K............................ 11
SIGNATURES ................................................................ 12
Page 2 of 12
PART I. FINANCIAL INFORMATION
ITEM 1. FINANCIAL STATEMENTS
CORTEX PHARMACEUTICALS, INC.
(A development stage enterprise)
BALANCE SHEETS
(Unaudited) (Note)
March 31, 1997 June 30, 1996
- ----------------------------------------------------------------------------------------------
Assets
Current assets:
Cash and cash equivalents $ 4,670,303 $ 4,091,550
U.S. government securities -- available for sale -- --
Other current assets 72,530 88,427
------------ ------------
Total current assets 4,742,833 4,179,977
Furniture, equipment and leasehold improvements, net 680,576 807,601
Other 23,130 26,342
------------ ------------
$ 5,446,539 $ 5,013,920
============ ============
LIABILITIES AND STOCKHOLDERS' EQUITY
Current liabilities:
Accounts payable $ 289,488 $ 217,332
Accrued dividends 69,300 64,350
Accrued wages, salaries and related expenses 55,916 40,145
Current obligations under capital leases 3,702 8,501
------------ ------------
Total current liabilities 418,406 330,328
Obligations under capital leases -- 1,499
Note payable to Alkermes, Inc. 1,078,024 1,037,330
Stockholders' equity:
9% cumulative convertible preferred stock, $0.001
par value; $1.00 per share liquidation preference;
shares authorized: 1,250,000; shares issued and
outstanding: 110,000 110,000 110,000
Series B convertible preferred stock, $0.001 par value;
$0.6667 per share liquidation preference; shares
authorized: 3,200,000; shares issued and
outstanding: 150,000 86,810 86,810
Series C convertible preferred stock, $0.001 par value;
$25,000 per share liquidation preference; shares
authorized: 160; shares issued and outstanding: 35
(June 30, 1996) -- 752,476
Series D convertible preferred stock, $0.001 par value;
$10,000 per share liquidation preference, shares
authorized: 500; shares issued and outstanding: 50
(March 31, 1997) 467,221 --
Common stock, $0.001 par value; shares authorized:
20,000,000; shares issued and outstanding:
9,148,727 (March 31, 1997) and 7,495,576
(June 30, 1996) 9,149 7,496
Additional paid-in capital 32,290,631 28,048,414
Unrealized loss on available for
sale U.S. government securities (284) (1,135)
Deficit accumulated during the development stage (29,013,418) (25,359,298)
------------ ------------
Total stockholders' equity 3,950,109 3,644,763
------------ ------------
$ 5,446,539 $ 5,013,920
============ ============
See accompanying notes.
Note: The balance sheet as of June 30, 1996 has been derived from the audited
financial statements at that date.
Page 3 of 12
CORTEX PHARMACEUTICALS, INC.
(A development stage enterprise)
STATEMENTS OF OPERATIONS
(Unaudited)
Period from
inception
(February 10,
Three months ended Nine months ended 1987) through
March 31, March 31, March 31,
--------------------- --------------------- -------------
1997 1996 1997 1996 1997
- ------------------------------------------------------------------------------------------------------------------------
Revenues:
Research and license revenue
under an agreement with
Alkermes, Inc. $ -- $ -- $ -- $ -- $ 3,600,000
Grant revenue -- -- -- -- 94,717
----------- ------------ ----------- ----------- ------------
Total revenues -- -- -- -- 3,694,717
Operating expenses:
Research and development 827,111 760,890 2,489,584 2,033,806 21,458,696
General and administrative 366,635 441,276 1,270,740 1,252,451 11,321,299
Settlement with Alkermes, Inc. -- -- -- -- 1,227,977
----------- ------------ ----------- ----------- ------------
Total operating expenses 1,193,746 1,202,166 3,760,324 3,286,257 34,007,972
----------- ------------ ----------- ----------- ------------
Loss from operations $(1,193,746) (1,202,166) (3,760,324) (3,286,257) (30,313,255)
Interest income, net 42,126 56,882 106,204 116,716 1,439,511
----------- ------------ ----------- ----------- ------------
Net loss $(1,151,620) $(1,145,284) $(3,654,120) $(3,169,541) $(28,873,744)
=========== =========== =========== =========== ============
Weighted average common
shares outstanding 8,402,320 6,536,803 7,899,585 6,260,152
=========== =========== =========== ===========
Net loss per share $ (0.14) $ (0.18) $ (0.46) $ (0.51)
=========== =========== =========== ===========
See accompanying notes.
Page 4 of 12
CORTEX PHARMACEUTICALS, INC.
(A development stage enterprise)
STATEMENTS OF CASH FLOWS
(Unaudited)
Period from
inception
Nine months ended (February 10,
March 31, 1987) through
--------------------------- March 31,
1997 1996 1997
- --------------------------------------------------------------------------------------------------------------------
Cash flows from operating activities:
NET LOSS $(3,654,120) $ (3,169,541) $(28,873,744)
Adjustments to reconcile net loss to
net cash used in operating activities:
Depreciation and amortization 150,090 173,055 1,259,112
Settlement with Alkermes, Inc. -- -- 1,227,977
Changes in operating assets/liabilities:
Accounts payable and accrued expenses 87,927 (175,276) 345,404
Accrued interest on U.S. government securities (11,822) (64,012) (161,678)
Other current assets 15,897 (35,147) (91,804)
Realized loss on sale of U.S. government securities -- 969 54,317
Stock option compensation expense -- 42,109 555,809
Stock issued for services -- -- 28,750
Reduction in note receivable from former
officer--compensation expense -- -- 22,600
Changes in other assets and other long term liabilities 40,694 25,747 86,013
----------- ------------ ------------
NET CASH USED IN OPERATING ACTIVITIES (3,371,334) (3,202,096) (25,547,244)
----------- ------------ ------------
Cash flows from investing activities:
U.S. government securities--available-for-sale--
Purchases (937,327) (13,102,660) (37,083,743)
Proceeds from sales 950,000 14,887,736 37,190,820
Purchase of fixed assets (23,065) (28,038) (1,910,412)
Sale of fixed assets -- 2,777 10,236
Decrease (increase) in--
Other assets 3,212 (529) (39,870)
Note receivable from former officer -- -- (100,000)
----------- ------------ ------------
NET CASH PROVIDED BY (USED IN) INVESTING ACTIVITIES (7,180) 1,759,286 (1,932,969)
----------- ------------ ------------
Cash flows from financing activities:
Proceeds from issuance of common stock 243,929 428,436 21,922,929
Proceeds from issuance of Series D
convertible preferred stock 3,719,636 -- 3,719,636
Proceeds from issuance of Series C
convertible preferred stock -- 3,576,543 3,576,543
Proceeds from issuance of Series B
convertible preferred stock -- -- 1,841,108
Proceeds from issuance of 9% preferred stock -- -- 1,076,588
Proceeds from subordinated convertible note -- -- 208,333
Payment of 9% preferred stock dividends -- -- (110,250)
Redemption of 9% preferred stock -- -- (63,750)
Redemption of common stock -- -- (350)
Principal payments on capitalized leases (6,298) (5,715) (20,271)
----------- ------------ ------------
NET CASH PROVIDED BY FINANCING ACTIVITIES 3,957,267 3,999,264 32,150,516
----------- ------------ ------------
Increase (decrease) in cash and cash equivalents 578,753 2,556,454 4,670,303
Cash and cash equivalents, beginning of period 4,091,550 149,880 --
----------- ------------ ------------
Cash and cash equivalents, end of period $ 4,670,303 $ 2,706,334 $ 4,670,303
=========== ============ ============
See accompanying notes. (Continued ...)
Page 5 of 12
CORTEX PHARMACEUTICALS, INC.
(A development stage enterprise)
STATEMENTS OF CASH FLOWS
(Unaudited, Continued)
Period from
inception
Nine months ended (February 10,
March 31, 1987) through
----------------------- March 31,
1997 1996 1997
Supplemental schedule of non-cash investing
and financing activities:
Accretion of 9% preferred stock $ -- $ -- $ 139,674
Conversion of 9% preferred stock to common stock -- 388,700 1,311,686
Conversion of Series B preferred stock
to common stock -- 217,027 1,754,273
Conversion of Series C preferred stock
to common stock 537,483 2,085,433 3,439,890
Conversion of Series D preferred stock
to common stock 3,252,414 -- 3,252,414
Capital lease obligation incurred to lease equipment -- -- 23,973
See accompanying notes.
Page 6 of 12
CORTEX PHARMACEUTICALS, INC.
(A development stage enterprise)
NOTES TO FINANCIAL STATEMENTS
Period from Inception (February 10, 1987) through March 31, 1997
(Unaudited)
Note 1 -- Basis of Presentation
The accompanying unaudited condensed financial statements have been prepared in
accordance with generally accepted accounting principles for interim financial
information and the instructions to Form 10-QSB and Item 310(b) of Regulation S-
B. Accordingly, they do not include all of the information and footnotes
required by generally accepted accounting principles 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 and nine-month periods
ended March 31, 1997 are not necessarily indicative of the results that may be
expected for the year ending June 30, 1997. For further information, refer to
the financial statements and notes thereto included in the Company's 1996 Annual
Report on Form 10-KSB. Certain previously reported amounts have been
reclassified to conform with the June 30, 1996 and March 31, 1997 presentation.
Note 2 -- Development Stage Enterprise
From inception (February 10, 1987) through March 31, 1997, the Company has
generated only modest operating revenues and has incurred losses aggregating
$28,873,744. As of March 31, 1997, the Company had working capital of
$4,324,427, which will enable the Company to maintain its planned operations
into the first calendar quarter of 1998. Over the longer term, successful
completion of the Company's development program and its transition, ultimately,
to attaining profitable operations is dependent upon obtaining additional
financing adequate to fulfill its research and development activities, and
achieving a level of revenues adequate to support the Company's cost structure.
Note 3 -- Private Placement
On October 15, 1996, the Company completed the first tranche of a three-tranche
Regulation D private placement of Series D Preferred Stock ("Series D
Preferred"). The Company sold 100 shares of Series D Preferred at a price of
$10,000 per share, for gross proceeds of $1,000,000. A second tranche of 150
shares of Series D Preferred was sold on January 9, 1997, and the third tranche
of 150 shares was sold on February 12, 1997. Gross proceeds of $1,500,000 were
received in each of the second and third tranches. The Series D Preferred is
convertible at an effective per share conversion price that is the lower of (i)
110% of the average closing bid price for the five trading days immediately
preceding the closing date ($2.9425, $4.52375 and $4.63375 for the first, second
and third tranches, respectively) or (ii) that price that is 18% below the
average closing bid price for the five trading days immediately preceding the
conversion date, in each case subject to adjustment at the rate of six percent
per annum based on the length of the period from issuance of the Series D
Preferred until its conversion. As of March 31, 1997, the Series D Preferred
shares from the first and second tranches and 100 of the Series D Preferred
shares from the third tranche had been converted into 1,187,915 shares of the
Company's Common Stock.
Page 7 of 12
ITEM 2. MANAGEMENT'S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION
AND RESULTS OF OPERATIONS; PLAN OF OPERATION
The following discussion and analysis should be read in conjunction with the
Financial Statements and Notes thereto appearing elsewhere in this report, and
with "Management's Discussion and Analysis of Financial Condition and Results of
Operations" presented in the Company's 1996 Annual Report on Form 10-KSB.
INTRODUCTORY NOTE
This Quarterly Report on Form 10-QSB contains certain forward-looking statements
within the meaning of Section 27A of the Securities Act of 1933 and Section 21E
of the Securities Exchange Act of 1934 and the Company intends that such
forward-looking statements be subject to the safe harbors created thereby. These
forward-looking statements relate to (i) future research plans and expenditures,
(ii) potential collaborative arrangements, and (iii) the need for, and
availability of, additional financing.
The forward-looking statements included herein are based on current expectations
that involve a number of risks and uncertainties. These forward-looking
statements are based on assumptions regarding the Company's business and
technology, which 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 the control of the Company. Although the Company believes 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 the Company or
any other person that the objectives or plans of the Company will be achieved.
RESULTS OF OPERATIONS
From inception (February 10, 1987) through March 31, 1997, the Company's revenue
has consisted of (i) $3,600,000 of license fees and research and development
funding from January 1992 through June 1993 under an earlier agreement with
Alkermes, Inc., (ii) net interest income aggregating $1,439,511, and (iii)
$94,717 of grant revenue.
From inception (February 10, 1987) through March 31, 1997, the Company has
sustained losses aggregating $28,873,744. Continuing losses are anticipated over
the next several years, as the Company's ongoing operating expenses for
preclinical research and early clinical development will only be offset, if at
all, by license fees, milestone payments, research support payments and/or other
revenues under planned strategic alliances that the Company is seeking with
larger pharmaceutical companies for the later stages of clinical development,
manufacturing and marketing of its products. The nature and timing of payments
to Cortex under these planned strategic alliances, if and as entered into, is
likely to significantly affect the Company's operations, and to produce
substantial period-to-period fluctuation in reported financial results. Over the
longer term, the Company will be dependent upon successful commercial
development of its products by its prospective partners to attain profitable
operations from product royalties or other revenues based on product sales.
Page 8 of 12
The loss for the three-month period ended March 31, 1997 of $1,151,620 compares
with a net loss of $1,145,284 for the corresponding prior year period. The loss
for the nine-month period ended March 31, 1997 was $3,654,120, compared to a
loss of $3,169,541 for the corresponding prior year period. Higher levels of
research and development spending were responsible for the increases in the
current year periods.
Research and development expenses increased from $760,890 to $827,111, or by
$66,221 (9%), during the three-month period ended March 31, 1997 compared to the
corresponding prior year period. The same expenses increased from $2,033,806 to
$2,489,584, or by $455,778 (22%), during the nine-month period ended March 31,
1997 compared to the prior year period. Additions to the scientific employee
complement and a resultant increase in spending for laboratory supplies
contributed most of the increases. Expenses for the three months ended March 31,
1997 also include costs related to the commencement of Phase I/IIa human
clinical testing in the United States in February 1997, partially offset by
lower spending for patent legal fees and travel and a temporary decline in
sponsored research. For the nine-month period ended March 31, 1997, the
additional personnel and laboratory supplies expenses combined with higher
outlays for sponsored research to produce the increase over the prior year
period.
General and administrative expenses decreased from $441,276 to $366,635, or by
$74,641 (17%) during the three-month period ended March 31, 1997 compared to the
corresponding prior year period. Most of the decrease represents higher salary
and related expenses in the prior year due to one-time payments to a former
officer. For the nine-months ended March 31, 1997, general and administrative
expenses of $1,270,740 were materially consistent with the $1,252,451 recorded
for the prior year period.
The Company believes that inflation and changing prices have not had a material
impact on its ongoing operations to date.
PLAN OF OPERATION; LIQUIDITY AND CAPITAL RESOURCES
Cortex has funded its organizational and research and development activities
primarily from the issuance of equity securities, with net proceeds from such
issuances from inception (February 10, 1987) through March 31, 1997 aggregating
$32 million. An additional $3.6 million in research and license payments was
received from Alkermes, Inc. between January 1992 and June 1993 in connection
with a development and license agreement with that firm. Interest income from
inception through March 31, 1997, which approximates funds received, was $1.4
million.
As of March 31, 1997, the Company had cash, cash equivalents and short-term
investments totaling $4.7 million and working capital of $4.3 million. In
comparison, as of June 30, 1996, the Company had cash, cash equivalents and
short-term investments totaling $4.1 million and working capital of $3.8
million. The increases were attributable to net proceeds of $3.7 million
received from the private placement of Series D Preferred Stock (Note 3 "Private
Placement"), partially offset by amounts required to fund operating losses and
purchase capital equipment. From inception (February 10, 1987) through March 31,
1997, net expenditures for furniture, equipment and leasehold improvements
aggregated $1.9 million.
Page 9 of 12
The Company leases approximately 30,000 square feet of research laboratory,
office and expansion space under an operating lease that expires May 31, 1999,
with an additional five-year option at 95% of the then fair market rental rate.
The commitments under the lease agreement for the years ending June 30, 1997,
1998 and 1999 are $229,000, $234,000 and $220,000, respectively.
As of March 31, 1997, Cortex had outstanding 110,000 shares of 9% cumulative
convertible preferred stock, which accrue cumulative dividends semi-annually at
an annual rate of $0.09 per share. To conserve capital for operations, the
Company has elected not to distribute the dividends that have accrued from June
15, 1990. Accrued and unpaid dividends as of March 31, 1997 were $69,300.
In connection with the settlement in October 1995 of a license dispute with
Alkermes, Inc. the Company issued to Alkermes a $1,000,000 three-year promissory
note accruing interest semi-annually at the then federal funds rate. The Company
also agreed to pay Alkermes a graduated royalty on calpain inhibitor development
proceeds, as defined and subject to certain limitations.
Over the next twelve months, the Company plans to conduct additional preclinical
and Phase I/II clinical studies on its AMPAKINE compounds. These planned
research and development activities involve a twelve-month expenditure of
approximately $4 million. Significant investments in plant or equipment or
substantial changes to staffing levels are not contemplated under current
spending plans for the next twelve months. As of March 31, 1997, Cortex had 20
full-time employees and one part-time employee.
Cortex anticipates that its existing cash, cash equivalents and short-term
investments, combined with a modest amount of anticipated interest income, will
be sufficient to satisfy its capital requirements into early calendar 1998 under
current spending plans. Additional funds will be required to continue operations
beyond that time.
In order to provide resources for both its short and long-term spending
requirements, the Company is presently seeking collaborative or other
arrangements with larger pharmaceutical companies, under which it is intended
that such companies would provide additional capital to the Company in exchange
for exclusive or non-exclusive license or other rights to certain of the
technologies and products the Company is developing. However, competition for
such arrangements is intense, with a large number of biopharmaceutical companies
attempting to secure alliances with more established pharmaceutical companies.
Although the Company is engaged in discussions with candidate companies, there
can be no assurance that an agreement or agreements will arise from these
discussions in a timely manner, or at all. Accordingly, the Company is exploring
the possibility of raising additional capital through the sale of debt or equity
securities. If the Company proceeds with a debt or equity financing, there can
be no assurance that the funds 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.
The Company's 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 the possibilities that any or all of the
proposed products will be found to be ineffective or toxic, or otherwise fail to
receive necessary regulatory clearances, that the
Page 10 of 12
proposed products, although effective, will be uneconomical to market, that
third parties may now or in the future hold proprietary rights that preclude the
Company from marketing them, or that third parties will market a superior or
equivalent product. Accordingly, the Company is unable to predict whether its
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, the Company
does not expect to be able to commercialize any therapeutic drug for at least
five years, either directly or through its corporate partners or licensees.
There can be no assurance that the Company's proposed products will prove to be
safe or effective or receive regulatory approvals that are required for
commercial sale.
PART II. OTHER INFORMATION
ITEM 2. CHANGES IN SECURITIES
On October 15, 1996 the Company entered into an agreement to sell 400 shares of
Series D Preferred Stock to a single purchaser (the "Purchaser") for $10,000 per
share in reliance on the private placement exemption of Section 4(2) of the
Securities Act. The Purchaser represented that it was an accredited investor,
acquiring the shares of Series D Preferred Stock for its own account for
investment purposes as a principal and without a view towards immediate resale
on distribution. The shares were not offered to the Purchaser through any
general solicitation. The Company sold the first tranche of 100 shares of Series
D Preferred Stock on October 15, 1996, the second tranche of 150 shares of
Series D Preferred Stock on January 9, 1997, and the third tranche of 150 shares
of Series D Preferred Stock on February 12, 1997. The shares of Common Stock
issuable upon conversion of the Series D Preferred Stock were registered for
resale under the Securities Act under a Registration Statement declared
effective on December 26, 1996. As of March 31, 1997, 350 shares of Series D
Preferred Stock had been converted into 1,187,915 shares of Common Stock. See
Note 3 to the Financial Statements in Item 1 of Part 1 of this Quarterly Report
on Form 10-QSB.
ITEM 5. OTHER INFORMATION
On January 14, 1997, Jerome M. Arnold resigned as a director of the Company to
avoid any potential conflicts of interest in connection with his
responsibilities as an executive recruiter.
ITEM 6. EXHIBITS AND REPORTS ON FORM 8-K
(a) Exhibits
EXHIBIT
NUMBER DESCRIPTION
---------------------------------------------------------------------------
27 Financial Data Schedule
(b) Reports on Form 8-K
No reports on Form 8-K were filed during the quarter ended March 31,
1997.
Page 11 of 12
SIGNATURES
In accordance with the requirements of the Exchange Act, the registrant caused
this report to be signed on its behalf by the undersigned, thereunto duly
authorized.
CORTEX PHARMACEUTICALS, INC.
May 9, 1997 By: /s/ D. SCOTT HAGEN
--------------------------------------------
D. Scott Hagen
Vice President and Chief Financial Officer;
Corporate Secretary
(Principal Financial and Accounting Officer)
Page 12 of 12