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CymaBay Announces Second Quarter 2015 Financial Results

20:00 EDT 9 Aug 2015 | Marketwired

NEWARK, CA--(Marketwired - August 10, 2015) - CymaBay Therapeutics, Inc. (NASDAQ: CBAY), a clinical-stage biopharmaceutical company developing therapies to treat metabolic diseases with high unmet medical need, today announced financial results for the second quarter ended June 30, 2015.

"We continue to make significant progress with our arhalofenate and MBX-8025 clinical programs," said Harold Van Wart, President and Chief Executive Officer of CymaBay. "The positive Phase 2 results we announced earlier in the year demonstrating arhalofenate's potential use in combination with febuxostat were presented at the European Congress of Rheumatology (EULAR) in June. These data along with the positive results from our Phase 2b flare study demonstrate arhalofenate's competitive target profile as a well tolerated, differentiated and convenient potential therapy for gout patients. We believe arhalofenate could define a new class of gout drugs that we refer to as Urate Lowering Anti-Flare Therapies (ULAFTs). We have begun preparations for our end-of-Phase 2 meeting with the FDA that is scheduled for the third quarter.

"For MBX-8025, enrollment is progressing well in a Phase 2 study in homozygous familial hypercholesterolemia (HoFH)," continued Dr. Van Wart. "We currently anticipate topline HoFH data by year-end. In addition, we are planning to initiate a Phase 2 study with MBX-8025 in a second indication, primary biliary cirrhosis (PBC), before year-end. Finally, we strengthened our balance sheet in July through a successful public offering of common stock which generated approximately $21.3 million in net proceeds."

SECOND QUARTER 2015 AND RECENT CORPORATE HIGHLIGHTS

FINANCIAL HIGHLIGHTS FOR THE THREE MONTHS ENDED JUNE 30, 2015

FINANCIAL HIGHLIGHTS FOR THE SIX MONTHS ENDED JUNE 30, 2015

Conference Call Details

The company will hold a conference call at 4:30 EST / 1:30 PST, today August 10, 2015. To access the live conference call, please dial 877-407-0784 from the U.S. and Canada, or 201-689-8560 internationally, and use Conference ID #13616458. 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.

Cautionary Statements

The statements in this press release, including those statements regarding any future clinical trials, future performance of CymaBay's product candidates, the potential of arhalofenate to treat gout, the therapeutic and commercial potential of arhalofenate and MBX-8025, and the anticipated timing and therapeutic and commercial potential of the product candidates of CymaBay Therapeutics, Inc. are forward looking statements that are subject to risks and uncertainties. Actual results and the timing of events regarding the further development of arhalofenate and MBX-8025 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 any future clinical trials of arhalofenate and MBX-8025; any delays or inability to obtain or maintain regulatory approval of CymaBay's product candidates in the United States or worldwide; the ability of CymaBay to attract funding partners or collaborators with development, regulatory and commercialization expertise; 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; and the market potential for CymaBay's product candidates. Additional risks relating to CymaBay are contained in CymaBay's Annual Report on Form 10-Q, filed with the Securities and Exchange Commission on May 11, 2015. CymaBay disclaims any obligation to update these forward-looking statements except as required by law.

About CymaBay

CymaBay Therapeutics, Inc. (CBAY) is a clinical-stage biopharmaceutical company developing therapies to treat metabolic diseases with high unmet medical need, including serious rare and orphan disorders. Arhalofenate, the company's lead product candidate, has shown two therapeutic actions in a single drug in multiple Phase 2 gout studies. In gout patients, arhalofenate is intended to prevent painful flares in joints while at the same time promoting excretion of uric acid by the kidney, thereby addressing both the signs and symptoms of gout and the hyperuricemia that is the root cause of the disease. CymaBay's second product candidate, MBX-8025 is a potent, selective, orally active PPARδ agonist. A Phase 2 study of MBX-8025 in patients with mixed dyslipidemia established that it has an anti-atherogenic lipid profile. CymaBay has initiated a pilot study of MBX-8025 in patients with homozygous familial hypercholesterolemia.

For additional information about CymaBay visit www.cymabay.com.

Sujal Shah CymaBay Therapeutics, Inc. (510) 293-8800 Hans VitzthumLifeSci Advisors, LLC212-915-2568 NEXT ARTICLE

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