Harish Shantharam, proven leader in building financial organizations to prepare for successful commercialization, appointed as Chief Financial Officer
Results from ENHANCE phase 3 global study of seladelpar in patients with PBC published in Hepatology
Completed a public equity offering totaling net proceeds of $92.4 million
Entered into a collaboration and license agreement with Kaken Pharmaceutical Co., Ltd.
Conference call and webcast today at 4:30 p.m. ET
NEWARK, Calif., May 15, 2023 (GLOBE NEWSWIRE) -- CymaBay Therapeutics, Inc. (NASDAQ: CBAY), a biopharmaceutical company focused on developing innovative therapies for liver and other chronic diseases, today announced corporate updates and financial results for the first quarter ended March 31, 2023.
Sujal Shah, President and CEO of CymaBay, stated, “In a year with RESPONSE pivotal phase 3 data fast approaching, we have already achieved a number of key goals thus far in 2023. In January, we licensed rights to Kaken Pharmaceutical Company to develop and commercialize seladelpar for patients with PBC in Japan and strengthened our balance sheet with a successful financing. In April, we announced that the ENHANCE phase 3 trial results were published in Hepatology, a preeminent medical journal in the field of liver disease. Last week, we announced the appointment of Harish Shantharam as Chief Financial Officer. These accomplishments set up the remainder of 2023 as we look to share data from RESPONSE, manufacture commercial supplies of seladelpar, prepare regulatory filings and advance our pre-commercial planning. We look forward to sharing updates across all of these activities through the remainder of the year.”
Corporate Updates:
Financial Updates:
First Quarter Ended March 31, 2023 Financial Results
Conference Call Details
CymaBay will host a conference call today at 4:30 p.m. ET to discuss first quarter financial results and provide a business update. To access the live conference call, please dial 1-844-825-9789 from the U.S. and Canada, or 1-412-317-5180 internationally, Conference ID #10178303. 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 investigational 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 | ||||||||
March 31, | ||||||||
2023 | 2022 | |||||||
(unaudited) | (unaudited) | |||||||
Operating expenses: | ||||||||
Research and development | $ | 18,551 | $ | 18,415 | ||||
General and administrative | 8,324 | 6,087 | ||||||
Total operating expenses | 26,875 | 24,502 | ||||||
Loss from operations | (26,875 | ) | (24,502 | ) | ||||
Other income (expense), net: | ||||||||
Interest income | 2,013 | 98 | ||||||
Interest expense | (4,403 | ) | (3,365 | ) | ||||
Other income | 487 | - | ||||||
Total other income (expense), net | (1,903 | ) | (3,267 | ) | ||||
Net loss | $ | (28,778 | ) | $ | (27,769 | ) | ||
Basic and diluted net loss per common share | $ | (0.29 | ) | $ | (0.32 | ) | ||
Weighted average common shares outstanding used to calculate basic and diluted net loss per common share | 97,971,081 | 87,802,939 | ||||||
CymaBay Therapeutics, Inc. | ||||||
Balance Sheet Data | ||||||
(in thousands) | ||||||
March 31, | December 31, | |||||
2023 | 2022 | |||||
(unaudited) | ||||||
Cash, cash equivalents and marketable securities | $ | 236,365 | $ | 135,485 | ||
Working capital | 196,220 | 122,632 | ||||
Total assets | 245,319 | 141,852 | ||||
Total liabilities | 141,130 | 105,698 | ||||
Common stock and additional paid-in capital | 1,005,894 | 909,337 | ||||
Total stockholders’ equity | 104,189 | 36,154 |
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