SAN DIEGO, July 20, 2023 (GLOBE NEWSWIRE) -- Cidara Therapeutics, Inc. (Nasdaq: CDTX), a biotechnology company developing long-acting therapeutics designed to help improve the standard of care for patients facing serious diseases, today provided an update on the status of its ongoing CD388 program for prevention of influenza A and B, which is the subject of an exclusive worldwide license and collaboration agreement with Janssen Pharmaceuticals, Inc. (Janssen), one of the Janssen Pharmaceutical Companies of Johnson & Johnson. As part of a recent prioritization of its R&D business, Janssen has announced its intention to discontinue internal development of the majority of its infectious disease pipeline, including JNJ-0953 (CD388). However, at this time, Janssen has not informed Cidara of any intention to terminate the agreement between the two parties. Cidara continues to work in collaboration with Janssen to complete the Phase 1 (NCT05285137 and NCT05619536) and Phase 2a (NCT05523089) clinical trials and will be reimbursed for all ongoing development activities by Janssen as per the Janssen Collaboration Agreement.
Under the Janssen Collaboration Agreement, within 90 days after Cidara delivers the complete CD388 Phase 2a data package to Janssen (currently anticipated later this year) (the Election Period), Janssen is required to notify Cidara whether it will proceed with clinical development. If Janssen delivers an Election to Proceed, it is obligated at its sole expense to diligently continue development and commercialization either itself or through a third party to whom it sublicenses or assigns the rights. If Janssen sublicenses or assigns the rights to a third party, then all terms under the current Janssen Collaboration Agreement will survive without modification. Should Janssen not provide an Election to Proceed within the Election Period, Cidara would have the right to terminate the agreement and retain the CD388 program, including all data and materials funded by Janssen's investment in the program.
"Based on the positive interim Phase 2a data, the competitive landscape and substantial market opportunity, we remain excited for the significant potential of CD388 in the prevention of influenza A and B, whether we or another party further advances this promising asset," said Jeffrey Stein, President and CEO of Cidara Therapeutics.
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 comprises new approaches aimed at transforming existing treatment and prevention paradigms, including drug-Fc conjugates (DFCs) from its proprietary Cloudbreak® platform targeting oncologic and viral diseases. In addition, Cidara recently received FDA approval for REZZAYO (rezafungin for injection), which it has licensed to multiple partners to commercialize in the U.S. and ex-U.S. Cidara is headquartered in San Diego, California. For more information, please visit www.cidara.com.
Forward-Looking Statements
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 whether Cidara will deliver the Phase 2a data package later this year, whether Janssen will elect to proceed with further development of CD388, whether Janssen will choose to sublicense or assign its rights to CD388, and whether clinical development of CD388 will be continued by Janssen, Cidara, or a third party. 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.
INVESTOR CONTACT:
Brian Ritchie
LifeSci Advisors
(212) 915-2578
britchie@lifesciadvisors.com
MEDIA CONTACT:
Veronica Eames
LifeSci Communications
646-970-4682
veames@lifescicomms.com
