Over 100 clinical sites now activated in RESPONSE Phase 3 registration study of seladelpar for patients with primary biliary cholangitis (PBC)
Additional data from prior studies of seladelpar in patients with PBC to be featured at The Liver Meeting® November 12-15, 2021 held by the American Association for the Study of Liver Diseases (AASLD)
CymaBay to host Post-AASLD KOL call on November 15 at 4:30pm ET
Conference call and webcast today at 4:30 p.m. ET
NEWARK, Calif., Nov. 10, 2021 (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, 2021.
Sujal Shah, President and CEO of CymaBay, stated, “The third quarter of 2021 included key accomplishments that position CymaBay for long-term success. The non-dilutive, risk-sharing development financing agreement signed with Abingworth in July supports the completion of our ongoing phase 3 program for seladelpar in PBC. We now have over 100 sites activated across over 20 countries in our global registration study, RESPONSE, and expect these efforts to continue and ultimately drive the completion of enrollment in the first half of 2022. We are excited to also share additional data from our prior studies in PBC at The Liver Meeting® 2021 that demonstrate improved benefit of seladelpar between one to two years of treatment and differentiation from other existing treatments in a population of patients with more advanced disease.”
“As we approach the end of 2021, we are well positioned to deliver on our central focus of improving the lives of patients with PBC. Although the pandemic has presented our entire industry with evolving challenges, I am confident we have assembled talent across the organization that will allow us to achieve both our near term goals and our vision of establishing a pipeline of opportunities for patients with unmet need. I’m also proud of the relationships we have established with patient communities, the medical community and high quality investors that all support the work we are dedicated to day in and day out.”
Upcoming and Recent Corporate Highlights
Third Quarter and Nine Months Ended September 30, 2021 Financial Results
Conference Call Details
CymaBay will host a conference call today at 4:30 p.m. ET to discuss third quarter 2021 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# 13723498. 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 and accompanying conference call regarding the potential for seladelpar to treat PBC and potentially improve clinical symptoms of the disease, the potential benefits to patients, CymaBay’s expectations and plans regarding its current and future clinical trials, including the timing of enrollment in RESPONSE, the impact of the COVID pandemic on the enrollment timeline for CymaBay’s clinical trials, CymaBay’s ability to fund current and planned clinical trials, the funding expected to be provided by Abingworth and payment schedule, as well as CymaBay’s anticipated cash runway 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; the potential termination of the agreement with Abingworth; the ability of CymaBay to meet its obligations under the agreement with Abingworth; the potential emergence of other COVID variants 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, 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.
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, | |||||||||||||||
2021 | 2020 | 2021 | 2020 | |||||||||||||
(unaudited) | (unaudited) | (unaudited) | (unaudited) | |||||||||||||
Operating expenses: | ||||||||||||||||
Research and development | $ | 17,010 | $ | 7,743 | $ | 46,137 | $ | 25,194 | ||||||||
General and administrative | 5,179 | 3,907 | 16,936 | 11,535 | ||||||||||||
Total operating expenses | 22,189 | 11,650 | 63,073 | 36,729 | ||||||||||||
Loss from operations | (22,189 | ) | (11,650 | ) | (63,073 | ) | (36,729 | ) | ||||||||
Other income (expense), net: | ||||||||||||||||
Interest income | 29 | 229 | 140 | 1,494 | ||||||||||||
Interest expense | (522 | ) | - | (522 | ) | - | ||||||||||
Total other income (expense), net | (493 | ) | 229 | (382 | ) | 1,494 | ||||||||||
Net loss | $ | (22,682 | ) | $ | (11,421 | ) | $ | (63,455 | ) | $ | (35,235 | ) | ||||
Basic and diluted net loss per common share | $ | (0.33 | ) | $ | (0.17 | ) | $ | (0.92 | ) | $ | (0.51 | ) | ||||
Weighted average common shares | ||||||||||||||||
outstanding used to calculate | ||||||||||||||||
basic and diluted net loss per common share | 69,022,937 | 68,887,092 | 68,985,112 | 68,884,894 | ||||||||||||
CymaBay Therapeutics, Inc. | ||||||||||||||||
Balance Sheet Data | ||||||||||||||||
(in thousands) | ||||||||||||||||
September 30, | December 31, | |||||||||||||||
2021 | 2020 | |||||||||||||||
(unaudited) | ||||||||||||||||
Cash, cash equivalents and marketable securities | $ | 113,788 | * | $ | 146,323 | |||||||||||
Working capital | 107,835 | 141,728 | ||||||||||||||
Total assets | 122,902 | 153,825 | ||||||||||||||
Total liabilities | 35,844 | 11,119 | ||||||||||||||
Common stock and additional paid-in capital | 827,372 | 819,556 | ||||||||||||||
Total stockholders’ equity | 87,058 | 142,706 | ||||||||||||||
* Does not include $25 million received from Abingworth on November 5, 2021. |
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