Actively recruiting patients in two global, clinical studies evaluating seladelpar in primary biliary cholangitis (PBC):
Two pipeline programs also in clinical development in 2021:
Conference call and webcast today at 4:30 p.m. ET
NEWARK, Calif., March 25, 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 fourth quarter and fiscal year ended December 31, 2020.
In the fourth quarter of 2020 and through early March 2021, CymaBay made significant progress reinitiating the development program for seladelpar in primary biliary cholangitis (PBC). With multiple clinical sites activated, patient recruitment is underway in RESPONSE, a global Phase 3 registrational study evaluating seladelpar in patients with PBC. In addition, we have also initiated ASSURE, an open-label, long-term study of seladelpar in patients with PBC intended to collect additional safety data to support registration.
Sujal Shah, President and CEO of CymaBay, stated, “One year ago today, our work towards finding novel treatments for patients with chronic, inflammatory and metabolic diseases was on hold as we completed the important work of ensuring patient safety before moving forward. Today we have four active clinical studies ongoing across three programs. We continue to make great progress towards restarting our seladelpar development program with RESPONSE as we execute on a focused strategy to complete late-stage development of seladelpar for patients with PBC. Results from our previous Phase 3 study in PBC, ENHANCE, presented at The Liver Meeting® 2020, highlighted the anti-cholestatic, anti-inflammatory and anti-pruritic effects of seladelpar in patients with PBC that we believe support the potential for seladelpar to address key unmet needs for patients suffering from this disease. In addition to our core focus in PBC, we continue to evaluate seladelpar for other indications and are excited about our early-stage pipeline maturing in the coming months.”
Recent Corporate Highlights
Fourth Quarter and Year Ended December 31, 2020 Financial Results
Conference Call Details
CymaBay will host a conference call today at 4:30 p.m. ET to discuss fourth quarter and fiscal year end 2020 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# 13715944. 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 developing therapies for liver and other chronic diseases with high unmet medical need. CymaBay is developing seladelpar, a potent, selective, orally active PPARδ agonist for patients with primary biliary cholangitis (PBC). Seladelpar has received an orphan designation from the US Food and Drug administration (FDA) and the European Medicine Agency (EMA). Seladelpar also received Breakthrough Therapy Designation from the FDA for early stage PBC and PRIority MEdicines (PRIME) status from the EMA. CymaBay is currently commencing a global, Phase 3 registration study of seladelpar for PBC. This study is a 52-week, placebo-controlled, randomized, Phase 3 study to evaluate the safety and efficacy of seladelpar (RESPONSE) in patients with PBC. For more information about RESPONSE, please visit: www.pbcstudies.com.
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, CymaBay’s ability to fund current and planned clinical trials and 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; 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:
Glenn Silver
Lazar-FINN Partners
(973) 818-8198
Glenn.silver@finnpartners.com
Investor Relations Contact:
Hans Vitzthum
LifeSci Advisors, LLC
(617) 430-7578
Hans@LifeSciAdvisors.com
CymaBay Therapeutics, Inc. | |||||||||||||||
Financial Results | |||||||||||||||
(In thousands, except share and per share information) | |||||||||||||||
Quarter Ended | Year Ended | ||||||||||||||
December 31, | December 31, | ||||||||||||||
2020 | 2019 | 2020 | 2019 | ||||||||||||
(unaudited) | (unaudited) | ||||||||||||||
Operating expenses: | |||||||||||||||
Research and development | $ | 10,688 | $ | 20,937 | $ | 35,882 | $ | 83,837 | |||||||
General and administrative | 5,186 | 4,532 | 17,425 | 19,238 | |||||||||||
Restructuring (benefit) charges | (1 | ) | 5,075 | (705 | ) | 5,075 | |||||||||
Total operating expenses | 15,873 | 30,544 | 52,602 | 108,150 | |||||||||||
Loss from operations | (15,873 | ) | (30,544 | ) | (52,602 | ) | (108,150 | ) | |||||||
Other income: | |||||||||||||||
Interest income | 122 | 1,131 | 1,616 | 5,342 | |||||||||||
Total other income | 122 | 1,131 | 1,616 | 5,342 | |||||||||||
Net loss | $ | (15,751 | ) | $ | (29,413 | ) | $ | (50,986 | ) | $ | (102,808 | ) | |||
Basic and diluted net loss per common share | $ | (0.23 | ) | $ | (0.43 | ) | $ | (0.74 | ) | $ | (1.53 | ) | |||
Weighted average common shares | |||||||||||||||
outstanding used to calculate | |||||||||||||||
basic and diluted net loss per common share | 68,917,646 | 68,749,075 | 68,893,127 | 67,033,046 | |||||||||||
CymaBay Therapeutics, Inc. | |||||||||||||||
Balance Sheet Data | |||||||||||||||
(in thousands) | |||||||||||||||
December 31, | December 31, | ||||||||||||||
2020 | 2019 | ||||||||||||||
Cash, cash equivalents and marketable securities | $ | 146,323 | $ | 190,945 | |||||||||||
Working capital | 141,728 | 185,287 | |||||||||||||
Total assets | 153,825 | 205,727 | |||||||||||||
Total liabilities | 11,119 | 19,379 | |||||||||||||
Common stock and additional paid-in capital | 819,556 | 812,140 | |||||||||||||
Total stockholders’ equity | 142,706 | 186,348 | |||||||||||||
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