Cidara Therapeutics Provides Corporate Update and Reports Second Quarter 2022 Financial Results
SAN DIEGO, Aug. 09, 2022 (GLOBE NEWSWIRE) -- Cidara Therapeutics, Inc. (NASDAQ: CDTX), a biotechnology company developing long-acting therapeutics designed to improve the standard of care for patients facing serious diseases, today reported financial results for the second quarter ended June 30, 2022 and provided an update on its corporate activities and product pipeline.
“We achieved a significant milestone in Cidara’s corporate evolution with the submission of an NDA for rezafungin for the treatment of candidemia and invasive candidiasis,” said Jeffrey Stein, Ph.D., President and Chief Executive Officer of Cidara. “We were also pleased to announce a license agreement with Melinta Therapeutics for the U.S. commercialization of rezafungin for up to $460 million. We expect a PDUFA target action date in the first quarter of 2023.”
Dr. Stein continued, “In our Cloudbreak® program, we continue to advance our Phase 1 trial of CD388, a highly potent long-acting antiviral immunotherapy designed to deliver universal prevention of seasonal and pandemic influenza, which we are conducting in partnership with Janssen. In addition, the compelling preclinical data generated to date from Cloudbreak and presented at our recent R&D Day, highlighted its significant potential in oncology.”
Recent Corporate Highlights
Second Quarter 2022 Financial Results
About Cidara Therapeutics
Cidara is developing long-acting therapeutics designed to improve the standard of care for patients facing serious diseases. The Company’s portfolio is comprised of new approaches aimed at transforming existing prevention and treatment paradigms, first with its lead Phase 3 antifungal candidate, rezafungin, in addition to DFCs targeting viral and oncology diseases from Cidara’s proprietary Cloudbreak platform. Cidara is headquartered in San Diego, California. For more information, please visit www.cidara.com.
This release contains “forward-looking statements” within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended, and such forward-looking statements are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Words such as “expect,” “will” and similar expressions (as well as other words or expressions referencing future events, conditions or circumstances) convey uncertainty of future events or outcomes and are intended to identify these forward-looking statements. Forward-looking statements describe future expectations, plans, results, or strategies, among other things, and in this release include, but are not limited to, statements related to whether the FDA will accept the rezafungin NDA for filing and assign a Prescription Drug User Fee Act (PDUFA) date; whether the rezafungin NDA will be approved in the expected time frame or at all; and the likelihood Melinta will successfully commercialize rezafungin in the U.S. and achieve milestones triggering payments under the License Agreement. Such statements are subject to a multitude of risks and uncertainties that could cause future circumstances, events, or results to differ materially from those projected in the forward-looking statements, such as unanticipated delays in or negative results from Cidara’s preclinical or clinical trials, delays in action by regulatory authorities due to limitations on inspections and other COVID-19-related effects, and impacts of the COVID-19 pandemic or other obstacles on the enrollment of patients or other aspects of CD388 development. These and other risks are identified under the caption “Risk Factors” in Cidara’s most recent Quarterly Report on Form 10-Q and other filings subsequently made with the Securities and Exchange Commission. All forward-looking statements contained in this press release speak only as of the date on which they were made and are based on management’s assumptions and estimates as of such date. Cidara does not undertake any obligation to publicly update any forward-looking statements, whether as a result of the receipt of new information, the occurrence of future events or otherwise.
CIDARA THERAPEUTICS, INC.
Condensed Consolidated Statements of Operations (unaudited)
Condensed Consolidated Balance Sheet Data