>>HACKENSACK, N.J., May 29, 2002 /PRNewswire-FirstCall from COMTEX/ -- DOV Pharmaceutical, Inc. (Nasdaq: DOVP chart, msgs) today announced its results for the first quarter ending March 31, 2002.
First Quarter 2002 Performance
For the first quarter of 2002, the Company reported a net loss of $3.9 million, or $0.79 per share, compared with a net loss of $1.8 million, or $0.37 per share, for the comparable period last year. At March 31, 2002, cash, cash equivalents and short-term investments totaled $11.4 million, which does not include estimated net proceeds of $59.2 million from the Company's initial public offering completed in April 2002. In addition, per share loss amounts do not include the 5,000,000 shares issued in the initial public offering.
The increase in net loss of $2.1 million for the first quarter 2002 over the first quarter of 2001 was primarily the result of an increase in the Company's operating expenses of $1.3 million as the Company advanced its products through clinical and preclinical trials and the addition of new employees to support the Company's expanded operations, as well as an increase in non-cash interest expense of $668,000.
Recent Highlights
-- In April 2002, the Company initiated a Phase Ib multiple dose-ranging
clinical trial for DOV 216,303, our lead product candidate for the
treatment of depression.
-- In April 2002, the Company competed an initial public offering of
5,000,000 shares of its common stock, at a price of $13 per share, with
estimated net proceeds to the Company of $59.2 million.
-- In May 2002, the Company completed enrollment of its 750-patient
double-blind, placebo-controlled study comparing bicifadine, our lead
product candidate for the treatment of pain, and codeine to placebo in
a severe dental pain model.
"2001, and 2002 to date, has been a time of significant growth and progress for DOV Pharmaceutical. We are pleased that our lead product candidates continue to show strong clinical progress," said Arnold Lippa, Chief Executive Officer. "Our initial public offering provides us with substantial resources for the further advancement of our product candidates in clinical trials. Going forward, the Company is focused on continuing to make advancements with our product pipeline. We expect to have results from our current clinical trial for bicifadine in the third quarter of 2002. During the remainder of 2002, we intend to initiate Phase III studies for bicifadine and DOV diltiazem, our proprietary formulation for the treatment of angina and hypertension. We also expect to complete the Phase II study currently underway for ocinaplon, our product candidate for the treatment of generalized anxiety disorder, as well as complete the Phase Ib study for DOV 216,303 by the end of 2002."
DOV is a biopharmaceutical company focused on the discovery, acquisition, development and commercialization of novel drug candidates for central nervous system, cardiovascular and urological disorders. The Company has five product candidates in clinical trials addressing therapeutic indications with significant unmet needs.
Statements in this press release that are not historical facts constitute 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. These forward-looking statements include statements of our expectations and intentions with respect to the progress of our clinical trial programs for bicifadine, ocinaplon, DOV diltiazem and DOV 216,303. We caution you that forward-looking statements are inherently uncertain and are simply point-in-time estimates based on a combination of facts and factors currently known by us about which we cannot be certain or even relatively certain. Actual results or events will surely differ and may differ materially from our forward-looking statements as a result of many factors, some of which we may not be able to predict or may not be within our control. Such factors may also materially adversely affect our ability to achieve our objectives and to successfully develop and commercialize our product candidates, including our ability to:
* demonstrate the safety and efficacy of product candidates at each stage
of development;
* meet our development schedule for our product candidates, including with
respect to clinical trial initiation, enrollment and completion;
* meet applicable regulatory standards and receive required regulatory
approvals on our anticipated time schedule or at all;
* meet obligations and required milestones under our license and other
agreements;
* obtain substantial additional funds;
* obtain and maintain all necessary patents or licenses; and
* produce drug candidates in commercial quantities at reasonable costs and
compete successfully against other products and companies.
Factors that may cause our actual results to differ materially from our forward-looking statements include (i) one or more of our product candidates could be shown to cause harmful side effects, (ii) one or more of our product candidates may not exhibit the expected therapeutic results, (iii) we or the FDA may suspend one or more of our clinical trials, (iv) patient recruitment may be slower than expected or patients may drop out of our clinical trials, (v) we may not receive regulatory approval for our product candidates or approval may be delayed, (vi) our success depends on the performance of our licensees and collaborative partners, who among other things may not fulfill their obligations to us and, (vii) recent securities class action litigation may cause us to become subject to liability or become a distraction to our management. You should also refer to the risks discussed in our other filings with the Securities and Exchange Commission, including those contained in our final prospectus dated April 24, 2002. We qualify all our forward-looking statements by these cautionary statements. There may also be other material factors that may materially affect our forward-looking statements and our future results. As a result of the foregoing, readers should not place undue reliance on our forward-looking statements. We do not undertake any obligation and do not intend to update any forward-looking statement.
DOV PHARMACEUTICAL, INC.
BALANCE SHEET DATA
December 31, 2001 (1) March 31, 2002
(Unaudited)
Cash and cash equivalents $13,573,707 $11,365,222
Total assets 18,080,029 17,589,511
Long-term debt 12,795,675 13,041,966
Redeemable preferred stock 14,838,159 14,838,159
Total stockholders' deficit (18,036,159) (20,919,102)
(1) Derived from the December 31, 2001 audited financial statements.
STATEMENTS OF OPERATIONS
Three Months Ended March 31,
2001 2002
(Unaudited)
Revenue $416,667 $708,297
Operating expenses:
General and administrative expense 657,064 818,803
Research and development expense 1,065,189 2,251,730
Loss from operations (1,305,586) (2,362,236)
Loss in investment in DOV Bermuda (379,340) (247,614)
Interest income 110,952 61,228
Interest expense (242,379) (910,585)
Other expense, net -- (422,702)
Net loss $(1,816,353) $(3,881,909)
Basic and diluted net loss per share $(0.37) $(0.79)
Weighted average shares used in computing
basic and diluted net loss per share 4,893,833 4,894,238<<
Interestingly, the cash excluding IPO proceeds increased this quarter. Can't expect that to continue, but since they are trading at about a $1.50 below cash -- more than a 20% discount -- I wonder if this one isn't worth a look. Any biofreaks want to pass judgement on their pipe, model, or . . . ?
Cheers, Tuck |
