NEWARK, Calif., Aug. 10, 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, announced today corporate updates and financial results for the second quarter ended June 30, 2023.
Sujal Shah, President and CEO of CymaBay, stated, “I’m incredibly proud of the progress our teams have made thus far this year as we march towards our key and exciting milestone in the third quarter when we expect to report top-line results from RESPONSE, our global phase 3 registration study of seladelpar in patients with primary biliary cholangitis (PBC). With RESPONSE nearing completion and ASSURE having enrolled over 300 patients to date, we believe the seladelpar development program in PBC is one of the most robust development programs in PBC ever conducted. We continue to believe seladelpar has the potential to be a differentiated second-line treatment option offering patients benefits on markers of disease associated with risk of progression and on symptoms. As announced earlier today, we are now also actively recruiting patients in IDEAL, a study to evaluate seladelpar’s effects on biochemical normalization in PBC patients who only achieve a partial response to first-line treatment. We believe data from IDEAL has the potential to reset expectations for second-line treatment in PBC. In anticipation of a successful data readout in RESPONSE and regulatory acceptance, our organizational build efforts are also underway as we start to put together key components of our commercial and medical affairs infrastructure.”
Corporate Updates:
Financial Updates:
Second Quarter and Six Months Ended June 30, 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 1-877-308-2053 from the U.S. and Canada, or 1-212-231-2921 internationally, Conference ID # 22027740. 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 approval, launch and commercialization of seladelpar or timing or plans in regard thereto, including the timing of the release of top-line data from RESPONSE, as well as statements regarding the Company’s expected cash runway, potential benefits of seladelpar, potential of IDEAL to reset expectations for second-line treatment in PBC, completion of ongoing clinical trials and subsequent regulatory submissions 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; 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 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 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:
Theresa Dolge
Evoke Kyne
(609) 915-2156
This email address is being protected from spambots. You need JavaScript enabled to view it.
Investor Relations Contact:
Hans Vitzthum
LifeSci Advisors, LLC
(617) 430-7578
This email address is being protected from spambots. You need JavaScript enabled to view it.
CymaBay Therapeutics, Inc. | |||||||||||||||
Financial Results | |||||||||||||||
(In thousands, except share and per share information) | |||||||||||||||
Quarter Ended | Six Months Ended | ||||||||||||||
June 30, | June 30, | ||||||||||||||
2023 | 2022 | 2023 | 2022 | ||||||||||||
(unaudited) | (unaudited) | (unaudited) | (unaudited) | ||||||||||||
Collaboration revenue | 31,016 | - | 31,016 | $ | - | ||||||||||
Operating expenses: | |||||||||||||||
Research and development | 19,537 | 17,891 | 38,088 | 36,306 | |||||||||||
General and administrative | 11,578 | 5,878 | 19,902 | 11,965 | |||||||||||
Total operating expenses | 31,115 | 23,769 | 57,990 | 48,271 | |||||||||||
Loss from operations | (99 | ) | (23,769 | ) | (26,974 | ) | (48,271 | ) | |||||||
Other income (expense), net: | |||||||||||||||
Interest income | 2,627 | 321 | 4,640 | 419 | |||||||||||
Interest expense | (4,618 | ) | (3,648 | ) | (9,021 | ) | (7,013 | ) | |||||||
Other income | 1,282 | 2 | 1,769 | 2 | |||||||||||
Total other income (expense), net | (709 | ) | (3,325 | ) | (2,612 | ) | (6,592 | ) | |||||||
Net loss | $ | (808 | ) | $ | (27,094 | ) | $ | (29,586 | ) | $ | (54,863 | ) | |||
Basic and diluted net loss per common share | $ | (0.01 | ) | $ | (0.31 | ) | $ | (0.30 | ) | $ | (0.62 | ) | |||
Weighted average common shares outstanding used to calculate basic and diluted net loss per common share | 102,150,390 | 87,802,939 | 100,072,281 | 87,802,939 | |||||||||||
CymaBay Therapeutics, Inc. | |||||||||||||||
Balance Sheet Data | |||||||||||||||
(in thousands) | |||||||||||||||
June 30, | December 31, | ||||||||||||||
2023 | 2022 | ||||||||||||||
(unaudited) | |||||||||||||||
Cash, cash equivalents and marketable securities | $ | 213,844 | $ | 135,485 | |||||||||||
Working capital | 206,177 | 122,632 | |||||||||||||
Total assets | 226,650 | 141,852 | |||||||||||||
Total liabilities | 118,242 | 105,698 | |||||||||||||
Common stock and additional paid-in capital | 1,010,975 | 909,337 | |||||||||||||
Total stockholders’ equity | 108,408 | 36,154 |
Last Trade: | US$32.48 |
Daily Volume: | 0 |
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