Enrollment completed in RESPONSE with 193 patients enrolled in over 20 countries
Conference call and webcast today at 4:30 p.m. ET
NEWARK, Calif., Aug. 11, 2022 (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 second quarter ended June 30, 2022.
Sujal Shah, President and CEO of CymaBay, stated, “We are elated to have finished enrollment in RESPONSE, our second, global Phase 3 study of seladelpar for patients with primary biliary cholangitis (PBC). We enrolled 193 patients across more than 20 countries and would like to thank our patients, their families and all of the clinical-site personnel involved for helping us reach this critical milestone. We anticipate releasing topline data for RESPONSE in the third quarter of 2023. Together with the more than 150 patients that are already enrolled in ASSURE, our long-term extension study, we believe our development program for seladelpar is one of the most robust to be conducted in PBC. We were also pleased to present data at EASL this past June, including two-year treatment data with seladelpar showing it improved the GLOBE PBC score and predicted improved transplant-free survival. Finally, we continue to focus on careful management of expenses which has resulted in a strong balance sheet with $170.8 million of cash, cash equivalents and investments as of June 30, 2022.”
Recent Corporate Highlights
Second Quarter and Six Months Ended June 30, 2022, Financial Results
Conference Call Details
CymaBay will host a conference call today at 4:30 p.m. ET to discuss second 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# 13730902. 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 and the potential benefits to patients, as well as the timing of the release of data from RESPONSE 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 | Six Months Ended | |||||||||||||||||
June 30, | June 30, | |||||||||||||||||
2022 | 2021 | 2022 | 2021 | |||||||||||||||
(unaudited) | (unaudited) | (unaudited) | (unaudited) | |||||||||||||||
Operating expenses: | ||||||||||||||||||
Research and development | $ | 17,891 | $ | 16,745 | $ | 36,306 | $ | 29,127 | ||||||||||
General and administrative | 5,878 | 6,521 | 11,965 | 11,757 | ||||||||||||||
Total operating expenses | 23,769 | 23,266 | 48,271 | 40,884 | ||||||||||||||
Loss from operations | (23,769 | ) | (23,266 | ) | (48,271 | ) | (40,884 | ) | ||||||||||
Other income (expense), net: | ||||||||||||||||||
Interest income | 321 | 44 | 419 | 111 | ||||||||||||||
Interest expense | (3,648 | ) | - | (7,013 | ) | - | ||||||||||||
Other income | 2 | - | 2 | - | ||||||||||||||
Total other income (expense), net | (3,325 | ) | 44 | (6,592 | ) | 111 | ||||||||||||
Net loss | $ | (27,094 | ) | $ | (23,222 | ) | $ | (54,863 | ) | $ | (40,773 | ) | ||||||
Basic and diluted net loss per common share | $ | (0.31 | ) | $ | (0.34 | ) | $ | (0.62 | ) | $ | (0.59 | ) | ||||||
Weighted average common shares | ||||||||||||||||||
outstanding used to calculate | ||||||||||||||||||
basic and diluted net loss per common share | 87,802,939 | 68,985,461 | 87,802,939 | 68,965,885 | ||||||||||||||
CymaBay Therapeutics, Inc. | ||||||||||||||||||
Balance Sheet Data | ||||||||||||||||||
(in thousands) | ||||||||||||||||||
June 30, | December 31, | |||||||||||||||||
2022 | 2021 | |||||||||||||||||
(unaudited) | ||||||||||||||||||
Cash, cash equivalents and marketable securities | $ | 170,757 | $ | 194,602 | ||||||||||||||
Working capital | 154,051 | 172,733 | ||||||||||||||||
Total assets | 177,724 | 202,318 | ||||||||||||||||
Total liabilities | 95,267 | 69,381 | ||||||||||||||||
Common stock and additional paid-in capital | 904,617 | 899,806 | ||||||||||||||||
Total stockholders’ equity | 82,457 | 132,937 |
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