Cidara Therapeutics to Participate in World Health Organization Meeting on H5N1 Influenza Preparedness and Response

March 19, 2025 08:00 ET | Source: Cidara Therapeutics, Inc. SAN DIEGO, March 19, 2025 (GLOBE NEWSWIRE) -- Cidara Therapeutics, Inc. (Nasdaq: CDTX), a biotechnology company using its proprietary Cloudbreak® platform to develop drug-Fc conjugate (DFC) immunotherapies, today announced participation in the “Other pharmaceuticals as preventive tools” panel at a World Health Organization (WHO) global meeting on H5N1 influenza preparedness and response. The meeting, titled “What research is important to prepare and respond to H5N1 influenza outbreaks,” will be held virtually on March 19, 2025, from 1:00-7:15pm Central European Time (CET)/5:00-11:15am Pacific Time (PT), and the panel discussion will take place from 6:30-7:00 pm CET/10:30-11:00am PT. “Global discussion forums are critical for the development of effective treatments to combat outbreaks of influenza, including the growing threat of H5N1,” said Les Tari, Ph.D., chief scientific officer of Cidara. “As the virus spreads, the need for robust strategies to prevent and respond to flu outbreaks is becoming increasingly critical. Our long-acting antiviral influenza preventative, CD388, currently in a 5,000 subject Phase 2b study, shows promise as a new modality that has demonstrated potent activity against all influenza A and B strains, including H5N1, in preclinical studies. I look forward to discussing the potential of CD388 with global leaders as a universal preventative of influenza outbreaks.” H5N1 is one of several influenza viruses that causes a highly infectious respiratory disease in birds called avian influenza (or "bird flu"). Infections in mammals, including humans, have also been documented. Meeting details: Influenza H5 pathogens have been included in the list of priority pathogens by the WHO R&D Blueprint for Epidemics. To coordinate efforts for research preparedness of H5N1 outbreaks, this global consultation will review current and novel vaccines and preventive pharmaceuticals. The key objectives of this meeting are to identify knowledge gaps and priority research questions, outline regulatory pathways for mRNA vaccines and other novel approaches, and review other therapeutics, including monoclonal antibodies and long-acting antivirals. About CD388CD388 is an investigational drug-Fc conjugate (DFC) comprised of multiple copies of a potent small molecule neuraminidase inhibitor stably conjugated to a proprietary Fc fragment of a human antibody. DFCs are not vaccines or monoclonal antibodies but are low molecular weight biologics which are designed to function as long-acting small molecule inhibitors. CD388 was designed to provide universal protection against all known strains of seasonal and pandemic influenza with the potential to provide season-long protection with a single subcutaneous or intramuscular administration. Importantly, because CD388 is not a vaccine, its activity is not reliant on an immune response and thereby is expected to be efficacious in individuals regardless of immune status. More information can be found at: https://www.cidara.com/cloudbreak/influenza/. About Cidara TherapeuticsCidara Therapeutics is using its proprietary Cloudbreak® platform to develop novel drug-Fc conjugates (DFCs) comprising targeted small molecules or peptides coupled to a proprietary human antibody fragment (Fc). Cidara’s lead DFC candidate, CD388, is a long-acting antiviral designed to achieve universal prevention of seasonal and pandemic influenza with a single dose by directly inhibiting viral proliferation. In June 2023, CD388 was granted Fast Track Designation by the U.S. Food and Drug Administration (FDA), and the Company announced completion of enrollment of its Phase 2b NAVIGATE trial in December 2024. Additional DFCs have been developed for oncology and in July 2024 Cidara received IND clearance for CBO421 which is intended to target CD73 in solid tumors. Cidara is headquartered in San Diego, California. For more information, please visit www.cidara.com. Forward-Looking StatementsThis 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,” “intends,” “believes,” “may,” “plan” or “will”. Forward-looking statements in this release include, but are not limited to, statements related to the potential of and future plans for CD388, whether CD388 will have activity against H5N1 and other potential pandemic influenza strains, and promising CD388 clinical data generated to date. 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 clinical trials and other risks related to clinical development, delays in action by regulatory authorities, other obstacles on the enrollment of patients or other aspects of CD388 or other DFC development and other risks and uncertainties associated with Cidara’s business in general. These and other risks are identified under the caption “Risk Factors” in Cidara’s Annual Report on Form 10-K for the fiscal year ended December 31, 2024 and other filings subsequently made with the SEC. 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 RitchieLifeSci Advisors(212) 915-2578britchie@lifesciadvisors.com MEDIA CONTACT:Michael FitzhughLifeSci Communications(628) 234-3889mfitzhugh@lifescicomms.com

Cidara Therapeutics to Participate in World Health Organization Meeting on H5N1 Influenza Preparedness and Response

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