NEWARK, Calif., March 16, 2023 (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 year and fourth quarter ended December 31, 2022.
Sujal Shah, President and CEO of CymaBay, stated, “We are off to a fast start in 2023 after making significant progress in 2022 in our development program evaluating seladelpar for patients with primary biliary cholangitis (PBC). Since completing enrollment in RESPONSE, our global phase 3 registration study, in July 2022, we presented data at The Liver MeetingÒ, licensed rights to develop and commercialize seladelpar for patients with PBC in Japan to Kaken and secured additional funding that extends our runway through the third quarter of 2024. These accomplishments set up the remainder of 2023, during which we intend to manufacture commercial supplies, complete our plans for launch and marketing, and finish clinical development, which we expect to provide major catalysts in the second half of the year.”
2022 and Recent Corporate Highlights
Clinical Development:
Presentations and Publications:
Corporate Updates and Business Development:
Financial Updates:
Fourth Quarter and Year Ended December 31, 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 877-407-0784 from the U.S. and Canada, or 201-689-8560 internationally, Conference ID # 13736281. 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, manufacturing and commercial plans, and the timing of the release of seladelpar clinical data are forward-looking statements that are subject to risks and uncertainties. Actual outcomes and results and the timing of events 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 product development activities; effects observed in trials to date that may not be repeated in the future; any delays or inability to obtain or maintain regulatory approval of product candidates; and the ability to obtain sufficient financing to complete development, regulatory approval and commercialization of product candidates. 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 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 | Year Ended | ||||||||||||||||
December 31, | December 31, | ||||||||||||||||
2022 | 2021 | 2022 | 2021 | ||||||||||||||
(unaudited) | (unaudited) | ||||||||||||||||
Operating expenses: | |||||||||||||||||
Research and development | $ | 16,230 | $ | 18,405 | $ | 67,995 | $ | 64,542 | |||||||||
General and administrative | 7,247 | 6,104 | 25,116 | 23,040 | |||||||||||||
Total operating expenses | 23,477 | 24,509 | 93,111 | 87,582 | |||||||||||||
Loss from operations | (23,477 | ) | (24,509 | ) | (93,111 | ) | (87,582 | ) | |||||||||
Interest expense, net: | |||||||||||||||||
Interest income | 919 | 27 | 2,017 | 167 | |||||||||||||
Interest expense | (4,075 | ) | (2,061 | ) | (14,907 | ) | (2,583 | ) | |||||||||
Total interest expense, net | (3,156 | ) | (2,034 | ) | (12,890 | ) | (2,416 | ) | |||||||||
Net loss | $ | (26,633 | ) | $ | (26,543 | ) | $ | (106,001 | ) | $ | (89,998 | ) | |||||
Basic and diluted net loss per common share | $ | (0.30 | ) | $ | (0.34 | ) | $ | (1.21 | ) | $ | (1.27 | ) | |||||
Weighted average common shares | |||||||||||||||||
outstanding used to calculate | |||||||||||||||||
basic and diluted net loss per common share | 87,806,063 | 77,198,483 | 87,804,063 | 71,055,331 | |||||||||||||
CymaBay Therapeutics, Inc. | |||||||||||||||||
Balance Sheet Data | |||||||||||||||||
(in thousands) | |||||||||||||||||
December 31, | December 31, | ||||||||||||||||
2022 | 2021 | ||||||||||||||||
Cash, cash equivalents and marketable securities | $ | 135,485 | * | $ | 194,602 | ||||||||||||
Working capital | 122,632 | 172,733 | |||||||||||||||
Total assets | 141,852 | 202,318 | |||||||||||||||
Total liabilities | 105,698 | 69,381 | |||||||||||||||
Common stock and additional paid-in capital | 909,337 | 899,806 | |||||||||||||||
Total stockholders’ equity | 36,154 | 132,937 | |||||||||||||||
* Does not include net proceeds of $92.4 million received from our January 2023 equity financing and a $34.2 million upfront license payment received from the Kaken collaboration agreement. |
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