NEWARK, Calif., Nov. 09, 2016 (GLOBE NEWSWIRE) -- CymaBay Therapeutics, Inc. (NASDAQ:CBAY), a clinical-stage biopharmaceutical company focused on developing therapies for indications with high unmet medical need, including rare and orphan diseases, today provided recent corporate highlights and announced financial results for the quarter and nine months ended September 30, 2016.
"We made considerable progress during the third quarter with MBX-8025,” said Dr. Harold Van Wart, Chief Executive Officer of CymaBay Therapeutics. “Earlier in the year, we demonstrated proof-of-concept with MBX-8025 in primary biliary cholangitis (PBC) and we look forward to sharing these data with the clinical community in a late-breaking oral presentation at the American Association for the Study of Liver Diseases (AASLD) meeting in Boston on November 15. Following our discussions with the FDA, we have completed the design of a second Phase 2 study for MBX-8025, with the goal of identifying the doses to carry forward into Phase 3. We are planning to initiate this Phase 2 study before year end.”
Recent Business Highlights
MBX-8025 - An oral, potent and selective PPARδ agonist that has a number of pharmacological actions that may be useful in the treatment of multiple diseases with high unmet medical need, including primary biliary cholangitis (PBC) and nonalcoholic steatohepatitis (NASH).
Arhalofenate - An oral, once-daily dual-acting drug candidate for gout that lowers serum uric acid (sUA) through a uricosuric effect and has an anti-inflammatory (anti-IL-1β) activity that suppresses flares.
Third Quarter Ended September 30, 2016 Financial Results
Nine-Month Period Ended September 30, 2016 Financial Results
CymaBay management will host a conference call today at 4:30 p.m. ET to discuss third quarter 2016 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. 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. A replay of the webcast will be available on the company's website for 14 days following the live event.
CymaBay Therapeutics, Inc. (CBAY) is a clinical-stage biopharmaceutical company developing therapies to treat diseases with high unmet medical need, including serious rare and orphan disorders. MBX-8025 is a potent, selective, orally active PPARδ agonist. CymaBay has recently a Phase 2 study of MBX-8025 in patients with primary biliary cholangitis as well as a pilot Phase 2 study in patients with homozygous familial hypercholesterolemia, establishing proof-of-concept in both indications. Previously, a Phase 2 study of MBX-8025 in patients with mixed dyslipidemia established that it has an anti-atherogenic lipid profile. Arhalofenate, CymaBay’s other product candidate, is a potential Urate-Lowering Anti-Flare Therapy that has completed five Phase 2 studies in gout patients. Arhalofenate has been found to reduce painful flares in joints while at the same time 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.
The statements in this press release, including those statements regarding the structure and conduct of clinical trials, future performance of CymaBay's product candidates, the potential of MBX-8025 to treat primary biliary cholangitis or nonalcoholic steatohepatitis, the potential of arhalofenate to treat gout, the therapeutic and commercial potential of CymaBay’s product candidates, and any of the targeted indications for the potential future development or commercialization of CymaBay’s product candidates are forward looking statements that are subject to risks and uncertainties. Actual results and the timing of events regarding the further development of CymaBay’s product candidates 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 of MBX-8025 and arhalofenate; 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 Annual Report on Form 10-K and Quarterly Report on Form 10-Q 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.
|CymaBay Therapeutics, Inc.|
|(In thousands, except share and per share information)|
|Three Months Ended||Nine Months Ended|
|September 30,||September 30,|
|Research and development||$||3,534||$||4,528||$||12,093||$||12,975|
|General and administrative||2,130||2,201||6,806||7,075|
|Total operating expenses||5,664||6,729||18,899||20,050|
|Loss from operations||(5,664||)||(6,729||)||(18,899||)||(20,050||)|
|Other income (expense):|
|Other income (expense), net||81||1,083||43||10,985|
|Basic net loss per common share||$||(0.25||)||$||(0.27||)||$||(0.84||)||$||(0.55||)|
|Diluted net loss per common share||$||(0.25||)||$||(0.27||)||$||(0.84||)||$||(0.58||)|
|Weighted average common shares outstanding used to calculate basic net loss per common share||23,447,003||21,674,742||23,447,003||17,368,309|
|Weighted average common shares outstanding used to calculate diluted net loss per common share||23,447,003||21,674,742||23,447,003||17,384,000|
|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||$||23,134||$||41,480|
|Common stock and additional paid-in capital||426,221||424,424|
|Total stockholders’ equity||10,212||28,115|
Last updated on: 10/11/2016
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