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"The past several months have been extremely productive as we further ourtransition to a development-only company," said Ev Graham, acting ChiefExecutive Officer of TorreyPines Therapeutics. "We held a successful End ofPhase II meeting with the U.S. Food & Drug Administration (FDA) for tezampaneland believe we are well positioned to seek a corporate partner to continue itsdevelopment. In addition, we continued to execute on our strategic plan bycompleting three transactions involving some of the Company's non-core assets.Looking ahead, we are on track to announce results from two clinical trials bythe end of the year."
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Upcoming Clinical Milestones:
-- Results from a Phase I clinical trial to evaluate the analgesic effectof NGX426, the oral prodrug of tezampanel, are on schedule to be announced inDecember 2008. The study is designed to evaluate the effect of NGX426 onhyperalgesia, an abnormally increased pain state, and allodynia, painresulting from normally non-painful stimuli, when induced by intradermalinjections of capsaicin.
-- Results from a Phase IIa study evaluating NGX267, a muscarinic agonist,as a potential treatment for xerostomia, are on schedule to be announced inDecember 2008. This study is designed to evaluate three doses of NGX267 andplacebo in a four-way cross-over design in patients with xerostomia secondaryto Sjogren's syndrome. The focus of an October 7, 2008 article in The New YorkTimes, Sjogren's syndrome is one of the three most common autoimmunedisorders, afflicting approximately three million Americans.
Recent Accomplishments:
-- Held a successful End-of-Phase II meeting with the FDA for tezampanel.Based on a review of the Phase II data, the FDA agreed that TorreyPines mayinitiate a Phase III program for tezampanel in acute migraine. The timing forinitiation of a Phase III trial is dependent on TorreyPines securing adevelopment partner for the program.
-- Repositioned the Company, transitioning from a discovery anddevelopment organization to a development-only company. As a result,TorreyPines streamlined its operations through the shut down of its discoveryoperations and expanded its business development activities to include out-licensing its two discovery programs.
-- In October 2008, TorreyPines announced two business developmentagreements: Cenomed Biosciences, LLC acquired the worldwide development rightsheld by TorreyPines to phenserine, Posiphen(TM) and bisnorcymcerine for use incounterterrorism and chemical defense. In another agreement, CalciMedica, Inc.exercised its option to acquire additional intellectual property pertaining toSTIM1and CRAC channel inhibitors for use in CNS disorders.
-- On November 10, 2008 TorreyPines announced the sale of its Alzheimer'sdisease genetics research program to Eisai Co., Ltd. for a $1.5 million cashpayment. This agreement, combined with the out-licensing agreements completedin October 2008, reflects TorreyPines' strategic commitment to monetize non-core assets and focus resources on advancing its clinical stage productcandidates.
Financial Results
Revenue for the three month period ended September 30, 2008 was $1.2million compared to revenue of $2.5 million for the same period in 2007.Operating expenses for the quarter ended September 30, 2008 were $6.1 million,with $5.0 million attributable to research and development. This compares tooperating expenses of $9.5 million and research and development expenses of$8.2 million for the same period last year. The Company reported a net lossfor the quarter ended September 30, 2008 of $5.4 million compared to a netloss of $6.8 million for the same period last year.
Revenue for the nine month period ended September 30, 2008 was $4.5million compared to revenue of $7.4 million for the same period in 2007.Operating expenses for the nine month period were $20.1 million, with $15.7million attributable to research and development. This compares to operatingexpenses of $24.6 million and research and development expenses of $20.4million for the same nine month period last year. The Company reported a netloss for the nine months ended September 30, 2008 of $16.7 million compared toa net loss of $15.2 million for the same period last year.
About TorreyPines Therapeutics, Inc.
TorreyPines Therapeutics, Inc. is a biopharmaceutical company committed toproviding patients with better alternatives to existing therapies through theresearch, development and commercialization of small molecule compounds. Thecompany's goal is to develop versatile product candidates each capable oftreating a number of acute and chronic diseases and disorders such asmigraine, chronic pain, muscle spasticity, xerostomia and cognitive disorders.The company is currently developing three product candidates: two ionotropicglutamate receptor antagonists and one muscarinic receptor agonist. Furtherinformation is available at www.torreypinestherapeutics.com.
This press release contains forward-looking statements or predictions.Such forward-looking statements include, but are not limited to, statementsregarding the timing for initiating a Phase III program for tezampanel inacute migraine, the potential for tezampanel and NGX426 as treatments foracute migraine and other indications, the potential for NGX426 to beanalgesic, the anticipated timing of results for the NGX426 study in a modelof capsaicin-induced pain, the potential for NGX267 as a treatment forxerostomia secondary to Sjogren's syndrome, the anticipated timing of resultsfrom the study of NGX267 as a treatment for xerostomia secondary to Sjogren'ssyndrome, and the ability to partner any of the company's product candidatesor programs. Such statements are subject to numerous known and unknown risks,uncertainties and other factors, which may cause TorreyPines' actual resultsto be materially different from historical results or from any resultsexpressed or implied by such forward-looking statements, including whether anypreclinical studies or clinical trials, either ongoing or conducted in thefuture, will prove successful, and if successful, whether the results can bereplicated; whether safety and efficacy profiles of any of the company'sproduct candidates will be established, or if established, will remain thesame, 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 toimprove the signs or symptoms of their respective clinical indication; whetherany of the company's product candidates will support a filing for marketingapproval, will be approved by the regulatory authorities, or if approved, willprove competitive in the market; or whether the necessary financing to supportthe company's product development programs will be available. In particularthere is no guarantee that clinical trials of any of the company's productcandidates will be completed on schedule or that results of these clinicaltrials will be reported within the anticipated timeframe, that tezampanel orNGX426 will successfully treat migraine and/or other indications for whichthey are developed, that NGX267 will successfully treat xerostomia secondaryto Sjogren's syndrome, that TorreyPines will be able to complete the necessarydevelopment work and receive regulatory approval for tezampanel, NGX426 orNGX267 or that TorreyPines will be able to reach agreement with a partner forany of the product candidates or programs on terms that are acceptable toTorreyPines. These and other risks which may cause results to differ aredescribed in greater detail in the "Risk Factors" section of TorreyPines'annual report on Form 10-K for the year ended December 31, 2007 andTorreyPines other SEC reports. The forward-looking statements are based oncurrent information that is likely to change and speak only as of the datehereof.TorreyPines Therapeutics, Inc. Condensed Consolidated Balance Sheets (in thousands) September December 30, 31, 2008 2007 (Unaudited) Assets Current assets Cash and cash equivalents $14,256 $32,500 Prepaid expenses and other current assets 720 835 Total current assets 14,976 33,335 Long-term assets 3,326 5,317 Total assets $18,302 $38,652 Liabilities and stockholders' equity Current liabilities $5,793 $9,036 Debt and other long-term liabilities 2,468 973 Deferred revenue - 2,183 Total liabilities 8,261 12,192 Total stockholders' equity 10,041 26,460 Total liabilities and stockholders' equity $18,302 $38,652 TorreyPines Therapeutics, Inc. Condensed Consolidated Statements of Operations (in thousands, except per share amounts) (Unaudited) Three Months Ended Nine Months Ended September 30, September 30, 2008 2007 2008 2007 Revenue License and option fees $460 $1,700 $2,193 $5,100 Research funding 763 762 2,288 2,288 Total revenue 1,223 2,462 4,481 7,388 Operating expenses: Research and development 4,978 8,161 15,729 20,390 General and administrative 1,127 1,351 4,326 4,209 Total operating expenses 6,105 9,512 20,055 24,599 Loss from operations (4,882) (7,050) (15,574) (17,211) Other income (expense) Interest income 87 504 417 1,699 Interest expense (64) (192) (321) (646) Other income (expense), net (535) (36) (1,259) 945 Total other income (expense) (512) 276 (1,163) 1,998 Net loss $(5,394) $(6,774) $(16,737) $(15,213) Basic and diluted net loss per share $(0.34) $(0.43) $(1.06) $(0.97) Weighted average shares used in the computation of basic and diluted net loss per share 15,754,058 15,733,970 15,747,269 15,711,212 Company contact: Investor contact: Craig Johnson Rhonda Chiger TorreyPines Therapeutics, Inc. Rx Communications Group 858-623-5665 X158 (917) 322-2569 [email protected] [email protected]
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