Milestone payment triggered by European Medicines Agency acceptance of marketing authorization application for rezafungin
Company eligible to receive up to an additional $108M in milestones from multiple existing partnerships based on successful completion of activities planned for the next two years
SAN DIEGO, Oct. 04, 2022 — 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 announced receipt of an $11 million milestone payment from Mundipharma under the licensing agreement established between the two companies in September 2019. The payment was made in association with the European Medicines Agency (EMA) acceptance of the marketing authorization application (MAA) for rezafungin for the treatment of candidemia and invasive candidiasis in adult patients.
“With the $11 million milestone payment from Mundipharma, Cidara remains eligible to receive additional non-dilutive capital of up to approximately $108 million in development and regulatory milestones from our existing partnerships based on successful completion of activities planned for the next two years,” said Jeffrey Stein, Ph.D., President and Chief Executive Officer of Cidara. “If received, these payments have the potential to significantly bolster the Company’s financial position to more rapidly advance our key Cloudbreak programs and complete the ongoing Phase 3 ReSPECT trial and are in addition to any commercial milestones or royalties that Cidara is eligible to receive from these partnerships over the same time period.”
Cidara retains the rights to rezafungin in Japan and has licensed the commercial rights to Melinta Therapeutics in the U.S. and Mundipharma Medical in all other geographies.
Rezafungin is a novel once-weekly echinocandin being developed for both the treatment and prevention of serious fungal infections, such as candidemia and invasive candidiasis. The structure and properties of rezafungin are specifically designed to improve upon a clinically validated mechanism intended to enhance its efficacy and safety potential for patients. Cidara has completed a Phase 3 clinical trial with rezafungin for the treatment of candidemia and/or invasive candidiasis (ReSTORE trial) and is currently conducting a second Phase 3 clinical trial of rezafungin for the prevention of invasive fungal disease in patients undergoing allogeneic blood and marrow transplantation (ReSPECT trial). Rezafungin has been designated a QIDP with Fast Track status by the FDA, and has been granted Orphan Drug Designation for its use in the treatment of invasive candidiasis in both the U.S. and EU.
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 treatment and prevention paradigms, first with its lead Phase 3 antifungal candidate, rezafungin, in addition to drug-Fc conjugates (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. “Forward-looking statements” describe future expectations, plans, results, or strategies and are generally preceded by words such as “anticipates,” “expect,” “may,” “plan” or “will”. Forward-looking statements in this release include, but are not limited to, statements related to our expectations whether we will receive any additional milestone payments for which we are eligible under current license agreements; whether any milestones will be received within two years; the likelihood that Janssen elects to proceed with development of CD388 following completion of the Phase 2a trial, whether any milestones we receive will enable us to progress the ReSPECT trial and Cloudbreak development. 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 pre-clinical 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 rezafungin 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.