Announced top-line results from RESPONSE Phase 3 study in PBC where seladelpar met the primary and two key secondary endpoints with high statistical significance.
Seladelpar granted revised Breakthrough Therapy Designation for the treatment of PBC including pruritus in patients without cirrhosis or with compensated cirrhosis and are inadequate responders to or intolerant to UDCA.
Announced oral late-breaking presentation of results from the RESPONSE global Phase 3 study evaluating seladelpar for Primary Biliary Cholangitis at The Liver Meeting® 2023.
Completed a public offering of common stock and pre-funded warrants with net proceeds of $242.8 million.
Initiated AFFIRM, a Phase 3b/4 study evaluating the effect of seladelpar on clinical outcomes in patients with cirrhosis due to PBC.
Conference call and webcast today at 4:30 p.m. ET
NEWARK, Calif., Nov. 07, 2023 (GLOBE NEWSWIRE) -- CymaBay Therapeutics, Inc. (NASDAQ: CBAY), a biopharmaceutical company focused on innovative therapies for patients with liver and other chronic diseases, today announced corporate updates and financial results for the third quarter ended September 30, 2023.
Sujal Shah, President and CEO of CymaBay, stated, “This past quarter has been a momentous one for CymaBay where we achieved multiple significant milestones advancing us towards our goal of improving lives of people living with PBC. The consistency and depth of the clinical data set generated from Phase 2, ENHANCE and now RESPONSE demonstrates that seladelpar has the potential to be the first ever approved treatment for patients with PBC to significantly reduce both markers related to the risk of disease progression and symptoms. I am incredibly proud of the team here at CymaBay and commend them for the progress they helped achieve and equally grateful to patients and patient advocacy groups, their caregivers and our investigators for their partnership and support. We are eager to continue the positive momentum and are working diligently on our near-term milestones for seladelpar.”
Corporate Updates:
Financial Updates:
Third Quarter and Nine Months Ended September 30, 2023 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 1-877-407-0784 from the U.S. and Canada, or 1-201-689-8560 internationally, Conference ID #13740701. 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 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 X (formerly 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, as well as statements regarding the Company’s expected cash runway, potential benefits of seladelpar, the ability to enroll and/or complete the AFFIRM study, 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
[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, | ||||||||||||||||
2023 | 2022 | 2023 | 2022 | ||||||||||||||
(unaudited) | (unaudited) | (unaudited) | (unaudited) | ||||||||||||||
Collaboration revenue | - | - | 31,016 | $ | - | ||||||||||||
Operating expenses: | |||||||||||||||||
Research and development | 19,962 | 15,459 | 58,050 | 51,765 | |||||||||||||
General and administrative | 12,245 | 5,904 | 32,147 | 17,869 | |||||||||||||
Total operating expenses | 32,207 | 21,363 | 90,197 | 69,634 | |||||||||||||
Loss from operations | (32,207 | ) | (21,363 | ) | (59,181 | ) | (69,634 | ) | |||||||||
Other income (expense), net: | |||||||||||||||||
Interest income | 3,170 | 677 | 7,810 | 1,096 | |||||||||||||
Interest expense | (4,843 | ) | (3,819 | ) | (13,864 | ) | (10,832 | ) | |||||||||
Other income | (2 | ) | - | 1,767 | 2 | ||||||||||||
Total other income (expense), net | (1,675 | ) | (3,142 | ) | (4,287 | ) | (9,734 | ) | |||||||||
Net loss | $ | (33,882 | ) | $ | (24,505 | ) | $ | (63,468 | ) | $ | (79,368 | ) | |||||
Basic and diluted net loss per common share | $ | (0.32 | ) | $ | (0.28 | ) | $ | (0.62 | ) | $ | (0.90 | ) | |||||
Weighted average common shares | |||||||||||||||||
outstanding used to calculate | |||||||||||||||||
basic and diluted net loss per common share | 105,717,996 | 87,804,272 | 101,974,866 | 87,803,388 | |||||||||||||
CymaBay Therapeutics, Inc. | |||||||||||||||||
Balance Sheet Data | |||||||||||||||||
(in thousands) | |||||||||||||||||
September 30, | December 31, | ||||||||||||||||
2023 | 2022 | ||||||||||||||||
(unaudited) | |||||||||||||||||
Cash, cash equivalents and marketable securities | $ | 438,778 | $ | 135,485 | |||||||||||||
Working capital | 427,993 | 122,632 | |||||||||||||||
Total assets | 451,048 | 141,852 | |||||||||||||||
Total liabilities | 124,857 | 105,698 | |||||||||||||||
Common stock and additional paid-in capital | 1,262,578 | 909,337 | |||||||||||||||
Total stockholders’ equity | 326,191 | 36,154 | |||||||||||||||
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