LA JOLLA, Calif., May 13 /PRNewswire/ -- TorreyPines Therapeutics, Inc. (Nasdaq: TPTX) today reported its financial results and accomplishments for the first quarter ended March 31, 2008. For the three-month period, the company posted revenue of $2.0 million and a net loss of $3.9 million. Cash and cash equivalents totaled $25.7 million at March 31, 2008.
"We have been diligently executing on the strategic plan outlined in
February, maximizing the value of our versatile compounds while prudently
managing our resources," said Neil Kurtz, M.D., President and Chief
Executive Officer of TorreyPines. "The role of glutamate in disease has
been garnering much attention, further supporting the value of tezampanel
and NGX426, our two ionotropic glutamate receptor antagonists. We are
focused on developing better alternatives to current therapies and our
pipeline reflects this effort, particularly as we move tezampanel toward
the clinic in muscle spasticity and rigidity, our first non-pain indication
for the drug, and with the recent initiation of a Phase II clinical trial
evaluating NGX267 in xerostomia. Furthermore, the recent clinical guidance
call held with the FDA supports the advancement of tezampanel in acute
First Quarter 2008 and Recent Accomplishments:
-- Held a clinical guidance teleconference with the U.S. Food and Drug
Administration (FDA) and confirmed that it has no objection to
TorreyPines moving forward into Phase III clinical trials for the
treatment of acute migraine with the 40 mg dose of tezampanel. Prior
to initiating any Phase III clinical trials, TorreyPines intends to
hold an end-of-Phase II meeting with the FDA, currently planned for
the second half of 2008, to discuss the overall Phase III program.
-- Completed a Phase I multiple dose clinical trial of tezampanel that
demonstrated the compound to be safe and well-tolerated, supporting the
development of tezampanel in pain and non-pain indications that require
-- Completed dosing of up to 210 mg of NGX426 in a Phase I maximum
tolerated dose trial evaluating the oral prodrug of tezampanel.
Following completion of this trial TorreyPines intends to initiate a
multiple dose clinical trial of NGX426 to support the chronic dosing of
-- Pharmacokinetic data from the ongoing Phase I maximum tolerated dose
trial of NGX426 suggest that 90 mg of NGX426 results in blood levels of
tezampanel that the company believes will prove to be analgesic.
TorreyPines intends to initiate a study in a model of capsaicin-induced
pain to confirm the analgesic activity of NGX426 administered orally,
with data from this study expected by the end of year.
-- Initiated a Phase II study of NGX267 for the treatment of xerostomia,
or dry mouth, secondary to Sjogren's syndrome. Data from this study
are expected by the end of year.
-- Presented animal data on TorreyPines' proprietary gamma secretase
modulator (GSM) compounds at the Keystone Symposium on Alzheimer's
disease. The data demonstrated that TorreyPines' GSM compounds provide
a more selective mechanism than gamma secretase inhibitors.
TorreyPines is developing its GSM compounds as a potential treatment
for Alzheimer's disease.
-- Acquired from Johns Hopkins University the rights to intellectual
property related to the novel use of glutamate receptor antagonists,
including TorreyPines' compounds tezampanel and NGX426, for the
prevention and treatment of stroke, heart attack and other conditions
associated with increased platelet aggregation.
-- Received notification that an abstract describing the results from the
completed Phase IIb clinical trial of tezampanel for the treatment of
acute migraine was accepted for presentation at the 50th Annual
Scientific Meeting of the American Headache Society to be held in
Boston June 26-29, 2008.
Revenue for the three month period ended March 31, 2008, was $2.0 million, compared to revenue of $2.5 million for the same period in 2007. Operating expenses for the quarter ended March 31, 2008, were $6.7 million, with $5.3 million attributable to research and development. This compares to operating expenses of $6.6 million and research and development expenses of $5.2 million for the same period last year. The company reported a net loss for the quarter ended March 31, 2008, of $3.9 million compared to a net loss of $3.3 million for the previous year.
Conference Call/Webcast Information
TorreyPines will host a conference call and Webcast at 11 a.m. EDT today. The audio Webcast can be accessed at http://www.torreypinestherapeutics.com. To participate in this call, dial 719-325-4817 and enter the passcode 2644321. For a limited period following the call, a replay will be available beginning at 2 p.m. EDT. The replay can be accessed by calling 719-457-0820 and entering passcode 2644321.
About TorreyPines Therapeutics
TorreyPines Therapeutics, Inc. is a biopharmaceutical company committed to providing patients with better alternatives to existing therapies through the research, development and commercialization of small molecule compounds. The company's goal is to develop versatile product candidates each capable of treating a number of acute and chronic diseases and disorders such as migraine, chronic pain, muscle spasticity and rigidity, xerostomia and cognitive disorders. The company is currently developing four product candidates: two ionotropic glutamate receptor antagonists and two muscarinic receptor agonists. Further information is available at http://www.torreypinestherapeutics.com.
This press release contains forward-looking statements or predictions.
Such forward-looking statements include, but are not limited to, statements
regarding the plans for holding an end of Phase II meeting with the FDA,
anticipated timing for initiating a Phase II clinical trial of tezampanel
for treatment of muscle spasticity and rigidity, anticipated timing for
initiating a multiple dose clinical trial of NGX426, the potential for
tezampanel and NGX426 as treatments for acute migraine and other
indications, the potential for NGX426 to be analgesic, the anticipated
timing of results for the NGX426 study in a model of capsaicin-induced
pain, the plans for expanding the clinical profile of tezampanel, the
potential for NGX267 as a treatment for xerostomia, the anticipated timing
of results from the study of NGX267 as a treatment for xerostomia, the
potential for the gamma secretase modulator compounds to treat Alzheimer's
disease and the potential for NGX426 to treat stroke, heart attack and
other conditions associated with increased platelet aggregation. Such
statements are subject to numerous known and unknown risks, uncertainties
and other factors, which may cause TorreyPines' actual results to be
materially different from historical results or from any results expressed
or implied by such forward-looking statements, including whether any
preclinical studies or clinical trials, either ongoing or conducted in the
future, will prove successful, and if successful, whether the results can
be replicated; whether safety and efficacy profiles of any of the company's
product candidates will be established, or if established, will remain the
same, be better or worse in future clinical trials, if any; whether
pre-clinical results will be substantiated by ongoing or future clinical
trials, if any, or whether any of the company's product candidates will be
able to improve the signs or symptoms of their respective clinical
indication; whether any of the company's product candidates will support a
filing for marketing approval, will be approved by the regulatory
authorities, or if approved, will prove competitive in the market; or
whether the necessary financing to support the company's product
development programs will be available. In particular there is no guarantee
that clinical trials of any of the company's product candidates will be
completed on schedule or that results of these clinical trials will be
reported within the anticipated timeframe, that tezampanel or NGX426 will
successfully treat migraine and/or other indications for which they are
developed, that the End of Phase II meeting will be held in the anticipated
time frame, that NGX267 will successfully treat xerostomia secondary to
Sjogren's syndrome, that the company's gamma secretase modulators will be
able to successfully treat Alzheimer's disease or that TorreyPines will be
able to complete the necessary development work and receive regulatory
approval for tezampanel, NGX426 or NGX267. These and other risks which may
cause results to differ are described in greater detail in the "Risk
Factors" section of TorreyPines' annual report on Form 10-K for the year
ended December 31, 2007 and TorreyPines other SEC reports. The
forward-looking statements are based on current information that is likely
to change and speak only as of the date hereof.
Company Contact: Media Contact:
Craig Johnson David Schull
TorreyPines Therapeutics, Inc. Russo Partners, LLC
858-623-5665, x158 212-845-4271
TorreyPines Therapeutics, Inc.
Condensed Consolidated Balance Sheets
March 31, December 31,
Cash and cash equivalents $ 25,665 $ 32,500
Prepaid expenses and other current assets 543 835
Total current assets 26,208 33,335
Long-term assets 5,846 5,317
Total assets $ 32,054 $ 38,652
Liabilities and stockholders' equity
Current liabilities $ 8,142 $ 9,036
Debt and other long-term liabilities 47 973
Deferred revenue 900 2,183
Total liabilities 9,089 12,192
Total stockholders' equity 22,965 26,460
Total liabilities and stockholders' equity $ 32,054 $ 38,652
TorreyPines Therapeutics, Inc.
Condensed Consolidated Statements of Operations
(in thousands, except per share amounts)
Three months ended
Revenue $ 2,046 $ 2,463
Research and development 5,260 5,177
General and administrative 1,448 1,395
Total operating expenses 6,708 6,572
Loss from operations (4,662) (4,109)
Other income (expense)
Interest income 217 608
Interest expense (147) (238)
Other income (expense), net 699 458
Total other income 769 828
Net loss $ (3,893) $ (3,281)
Basic and diluted net loss per share $ (0.25) $ (0.21)
Weighted average shares used in the
computation of basic and diluted net loss
per share 15,739,646 15,688,079
|SOURCE TorreyPines Therapeutics, Inc.|
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