NEWARK, Calif., Nov. 14, 2022 (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 corporate updates and financial results for the third quarter ended September 30, 2022.
Sujal Shah, President and CEO of CymaBay, stated, “Early in the third quarter we completed enrollment in RESPONSE, our global registration study of seladelpar in patients with PBC. This achievement was a direct result of the tireless efforts of our teams and the relationships we have been fortunate to leverage among partners, health care providers and patient advocacy groups around the world. In addition to clinical presentations highlighting some of the important benefits of seladelpar for patients, we connected with all of these groups at The Liver Meeting® last week and are aligned, coordinated and energized to deliver on transformational catalysts that lie ahead of us in 2023. With over 300 patients with PBC taking seladelpar daily across our active clinical studies, we continue to execute on what we believe is the most robust development program in PBC being conducted today. Our focus at CymaBay is clear and will remain so as we drive towards sharing top-line data from RESPONSE in the third quarter of 2023.”
Recent Corporate Highlights
Third Quarter and Nine Months Ended September 30, 2022, Financial Results
Conference Call Details
CymaBay will host a conference call today at 4:30 p.m. ET to discuss third quarter financial results and provide a business update. To access the live conference call, please dial 855-327-6837 from the U.S. and Canada, or 631-891-4304 internationally, Conference ID #10020554. 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.
About CymaBay
CymaBay Therapeutics, Inc. is a clinical-stage biopharmaceutical company focused on improving the lives of people with liver and other chronic diseases that have high unmet medical need through a pipeline of innovative therapies. Our deep understanding of the underlying mechanisms of liver inflammation and fibrosis, and the unique targets that play a role in their progression, have helped us receive breakthrough therapy designation (U.S. Food and Drug Administration), PRIority MEdicines status (European Medicines Agency) and orphan drug status (U.S. and Europe) for seladelpar, a first-in-class treatment for people with primary biliary cholangitis (PBC). Our evidence-based decision-making and commitment to the highest quality standards reflect our relentless dedication to the people, families and communities we serve. To learn more, visit www.cymabay.com and follow us on Twitter and LinkedIn.
Cautionary Statements
Any statements made in this press release regarding the potential for seladelpar to treat PBC and potentially improve clinical symptoms of the disease, the potential benefits to patients and the anticipated timing of the release of clinical data 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; and effects observed in trials to date that may not be repeated in the future. 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, its Quarterly Reports 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.
Public Relations Contact:
Glenn Silver
Lazar-FINN Partners
(973) 818-8198
[email protected]
Investor Relations Contact:
Hans Vitzthum
LifeSci Advisors, LLC
(617) 430-7578
[email protected]
CymaBay Therapeutics, Inc. | |||||||||||
Financial Results | |||||||||||
(In thousands, except share and per share information) | |||||||||||
Quarter Ended | Nine Months Ended | ||||||||||
September 30, | September 30, | ||||||||||
2022 | 2021 | 2022 | 2021 | ||||||||
(unaudited) | (unaudited) | (unaudited) | (unaudited) | ||||||||
Operating expenses: | |||||||||||
Research and development | $ | 15,459 | $ | 17,010 | $ | 51,765 | $ | 46,137 | |||
General and administrative | 5,904 | 5,179 | 17,869 | 16,936 | |||||||
Total operating expenses | 21,363 | 22,189 | 69,634 | 63,073 | |||||||
Loss from operations | (21,363) | (22,189) | (69,634) | (63,073) | |||||||
Other income (expense), net: | |||||||||||
Interest income | 677 | 29 | 1,098 | 140 | |||||||
Interest expense | (3,819) | (522) | (10,832) | (522) | |||||||
Total other income (expense), net | (3,142) | (493) | (9,734) | (382) | |||||||
Net loss | $ | (24,505) | $ | (22,682) | $ | (79,368) | $ | (63,455) | |||
Basic and diluted net loss per common share | $ | (0.28) | $ | (0.33) | $ | (0.90) | $ | (0.92) | |||
Weighted average common shares | |||||||||||
outstanding used to calculate | |||||||||||
basic and diluted net loss per common share | 87,804,272 | 69,022,937 | 87,803,388 | 68,985,112 | |||||||
CymaBay Therapeutics, Inc. | |||||||||
Balance Sheet Data | |||||||||
(in thousands) | |||||||||
September 30, | December 31, | ||||||||
2022 | 2021 | ||||||||
(unaudited) | |||||||||
Cash, cash equivalents and marketable securities | $ | 153,415 | $ | 194,602 | |||||
Working capital | 142,413 | 172,733 | |||||||
Total assets | 159,247 | 202,318 | |||||||
Total liabilities | 99,069 | 69,381 | |||||||
Common stock and additional paid-in capital | 906,976 | 899,806 | |||||||
Total stockholders’ equity | 60,178 | 132,937 | |||||||
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