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NEWARK, Calif., Nov. 08, 2017 (GLOBE NEWSWIRE) -- CymaBay Therapeutics, Inc. (NASDAQ:CBAY), a clinical-stage biopharmaceutical company focused on developing therapies for liver and other chronic diseases with high unmet need, today announced financial results and a corporate update for the three and nine months ended September 30, 2017.
“Positive interim data announced in the third quarter from the ongoing Phase 2 study of seladelpar in patients with Primary Biliary Cholangitis, or PBC, transformed CymaBay in several important ways,” said Sujal Shah, President and Chief Executive Officer of CymaBay Therapeutics. “The data announced from this study to date support the potential for seladelpar to offer improved efficacy and better tolerability as a second line treatment for PBC. We look forward to sharing these results with the regulatory authorities in the U.S. and Europe with the goal of advancing seladelpar into Phase 3 for PBC in 2018. With more than $100 million in cash on hand at September 30, we now have sufficient resources to begin the next stage of development for seladelpar in PBC and to initiate a proof of concept study of seladelpar in NASH.”
Third Quarter 2017 and Recent Business Highlights
Third Quarter 2017 Financial Results
Nine-Month Period Ended September 30, 2017 Financial Results
Conference Call Details
CymaBay management will host a conference call today at 4:30 p.m. ET to discuss third quarter 2017 financial results and provide a business update. To access the live conference call, please dial 877-407-0784 from the U.S. and Canada, or 201-689-8560 internationally, Conference ID# 13671795. To access the live and subsequently archived webcast of the conference call, go to the Investors section of the company's website at http://ir.cymabay.com/events.
CymaBay Therapeutics, Inc. (CBAY) is a clinical-stage biopharmaceutical company focused on developing therapies for liver and other chronic diseases with high unmet medical need. Seladelpar is a potent and selective agonist of PPARδ, a nuclear receptor that regulates genes involved in bile acid/sterol, lipid and glucose metabolism and inflammation. Seladelpar is currently in development for the treatment of patients with the autoimmune liver disease, primary biliary cholangitis (PBC) and nonalcoholic steatohepatitis (NASH). Two Phase 2 studies of seladelpar established proof of concept in PBC. CymaBay is currently planning to advance development of seladelpar into Phase 3 for PBC and Phase 2 for NASH. Arhalofenate is a potential urate-lowering anti-flare therapy that has been found to reduce painful flares in joints while at the same time lowering serum uric acid by promoting excretion of uric acid by the kidney. This dual action addresses both the signs and symptoms of gout while managing the underlying pathophysiology of hyperuricemia. Arhalofenate has been licensed in the U.S. to Kowa Pharmaceuticals America, Inc. CymaBay retains full development and commercialization rights for arhalofenate outside the U.S.
The statements in this press release regarding the potential for seladelpar to treat PBC and NASH, the potential benefits to patients, and the expectations regarding future clinical trials are forward looking statements that are subject to risks and uncertainties. Actual results and the timing of events regarding the further development of seladelpar could differ materially from those anticipated in such forward-looking statements as a result of risks and uncertainties, which include, without limitation, risks related to: the success, cost and timing of any of CymaBay's product development activities, including clinical trials; effects observed in trials to date which may not be repeated in the future; any delays or inability to obtain or maintain regulatory approval of CymaBay's product candidates in the United States or worldwide; and the ability of CymaBay to obtain sufficient financing to complete development, regulatory approval and commercialization of its product candidates in the United States and worldwide. Additional risks relating to CymaBay are contained in CymaBay's filings with the Securities and Exchange Commission, including without limitation its most recent Quarterly Report on Form 10-Q, Annual Report on Form 10-K and other documents subsequently filed with or furnished to the Securities and Exchange Commission. CymaBay disclaims any obligation to update these forward-looking statements except as required by law.
For additional information about CymaBay visit www.cymabay.com.
LifeSci Advisors, LLC
|CymaBay Therapeutics, Inc.|
|(In thousands, except share and per share information)|
|Three Months Ended||Nine Months Ended|
|September 30,||September 30,|
|Research and development||4,184||3,534||12,269||12,093|
|General and administrative||2,210||2,130||9,493||6,806|
|Total operating expenses||6,394||5,664||21,762||18,899|
|Loss from operations||(6,394||)||(5,664||)||(16,969||)||(18,899||)|
|Other income (expense):|
|Other income (expense), net||(1,798||)||81||(4,996||)||43|
|Basic net loss per common share||$||(0.21||)||$||(0.25||)||$||(0.71||)||$||(0.84||)|
|Diluted net loss per common share||$||(0.21||)||$||(0.25||)||$||(0.71||)||$||(0.84||)|
|Weighted average common shares outstanding used to calculate basic net loss per common share||40,035,690||23,447,003||31,848,536||23,447,003|
|Weighted average common shares outstanding used to calculate diluted net loss per common share||40,035,690||23,447,003||31,848,536||23,447,003|
|CymaBay Therapeutics, Inc.|
|Balance Sheet Data|
|(In thousands, except share and per share amounts)|
|September 30,||December 31,|
|Cash, cash equivalents and short-term investments||$||102,169||$||16,994|
|Common stock and additional paid-in capital||531,990||426,897|
|Total stockholders’ equity||86,504||3,937|
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