Secured up to $100 million of additional development funding through a non-dilutive financing transaction with Abingworth
Actively recruiting patients in two global, clinical studies evaluating seladelpar in PBC
Conference call and webcast today at 4:30 p.m. ET
NEWARK, Calif., Aug. 12, 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 second quarter ended June 30, 2021.
In July 2021, CymaBay announced a development funding agreement with Abingworth, pursuant to which CymaBay will receive up to $100 million of funding for seladelpar development costs, of which $75 million will be received in three installments over approximately six months. CymaBay has an option to receive an additional $25 million within approximately two months of the completion of enrollment of CymaBay’s Phase 3 RESPONSE clinical trial. In exchange, CymaBay will make fixed payments spread over a six-year period based on regulatory approval in the U.S. or the E.U. after the first such regulatory approval is obtained, as well as pay fixed and capped sales milestones based on U.S. product sales. CymaBay has the ability to accelerate payment at a reduced amount upon regulatory approval and in the event of a change of control of CymaBay. CymaBay retains upside potential for seladelpar in the U.S. along with full worldwide commercial rights.
CymaBay also continued to make progress conducting the development program for seladelpar in primary biliary cholangitis (PBC). Additional clinical sites were activated in North America and Europe during the second quarter in RESPONSE, a global Phase 3 registrational study evaluating seladelpar in patients with PBC, and in ASSURE, an open-label, long-term study of seladelpar in patients with PBC intended to collect additional safety data to support registration. Enrollment of patients in both of these studies continued through the second quarter and is expected to increase as more sites are activated through the rest of 2021.
Sujal Shah, President and CEO of CymaBay, stated, “In addition to adding experienced talent across the functional areas vital to getting seladelpar to patients, we were thrilled to have secured the additional funding needed to complete Phase 3 development of seladelpar in PBC through a non-dilutive, risk-sharing funding agreement with Abingworth. Abingworth has had a long history of funding innovative companies in life sciences and shares our belief that seladelpar has the opportunity to meaningfully improve the care of patients with PBC. This strategic funding agreement further strengthens our balance sheet and allows us to maintain our dedicated focus on completing development of seladelpar to deliver value to patients and shareholders.”
Recent Corporate Highlights
Second Quarter and Six Months Ended June 30, 2021 Financial Results
Conference Call Details
CymaBay will host a conference call today at 4:30 p.m. ET to discuss second 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# 13720877. 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 | Six Months Ended | |||||||||||||||
June 30, | June 30, | |||||||||||||||
2021 | 2020 | 2021 | 2020 | |||||||||||||
(unaudited) | (unaudited) | (unaudited) | (unaudited) | |||||||||||||
Operating expenses: | ||||||||||||||||
Research and development | $ | 16,745 | $ | 7,942 | $ | 29,127 | $ | 17,451 | ||||||||
General and administrative | 6,521 | 3,210 | 11,757 | 7,628 | ||||||||||||
Total operating expenses | 23,266 | 11,152 | 40,884 | 25,079 | ||||||||||||
Loss from operations | (23,266 | ) | (11,152 | ) | (40,884 | ) | (25,079 | ) | ||||||||
Interest income | 44 | 426 | 111 | 1,265 | ||||||||||||
Net loss | $ | (23,222 | ) | $ | (10,726 | ) | $ | (40,773 | ) | $ | (23,814 | ) | ||||
Basic and diluted net loss per common share | $ | (0.34 | ) | $ | (0.16 | ) | $ | (0.59 | ) | $ | (0.35 | ) | ||||
Weighted average common shares | ||||||||||||||||
outstanding used to calculate | ||||||||||||||||
basic and diluted net loss per common share | 68,985,461 | 68,885,108 | 68,965,885 | 68,883,783 | ||||||||||||
CymaBay Therapeutics, Inc. | ||||||||||||||||
Balance Sheet Data | ||||||||||||||||
(in thousands) | ||||||||||||||||
June 30, | December 31, | |||||||||||||||
2021 | 2020 | |||||||||||||||
(unaudited) | ||||||||||||||||
Cash, cash equivalents and marketable securities | $ | 106,134 | $ | 146,323 | ||||||||||||
Working capital | 104,854 | 141,728 | ||||||||||||||
Total assets | 117,041 | 153,825 | ||||||||||||||
Total liabilities | 9,947 | 11,119 | ||||||||||||||
Common stock and additional paid-in capital | 824,724 | 819,556 | ||||||||||||||
Total stockholders’ equity | 107,094 | 142,706 |
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