Cidara Therapeutics, Inc.

FLORHAM PARK, N.J., April 16, 2025 (GLOBE NEWSWIRE) -- Phathom Pharmaceuticals, Inc. (Nasdaq: PHAT), a biopharmaceutical company focused on developing and commercializing novel treatments for gastrointestinal diseases, today announced the appointment of Ted Schroeder to its Board of Directors. Mr. Schroeder brings more than three decades of experience leading innovative biopharmaceutical companies and has a strong track record of building and scaling commercial organizations, bringing new therapies to market, and successfully guiding companies through key business milestones and strategic transactions. “We are pleased to welcome Ted to the Phathom Board during a pivotal period for the company,” said Michael Cola, Chairman of the Board, Phathom Pharmaceuticals. “Ted is a seasoned biopharma leader with a strong history of developing and commercializing innovative treatments, scaling growth-focused organizations, and creating shareholder value. As Phathom continues to unlock the full potential of VOQUEZNA®, Ted’s deep operational and commercial expertise will be an important asset. We look forward to his insights and partnership as we work to accelerate our commercial momentum and deliver our first-in-class therapies to patients in need.” About Ted SchroederMr. Schroeder served as Chief Executive Officer of Nabriva Therapeutics from 2018 to 2023 and as a director until March 2025, following Nabriva’s acquisition of Zavante Therapeutics, where he was co-founder, President, and CEO. Prior to that, he co-founded Cadence Pharmaceuticals and served as President and CEO until its $1.4 billion acquisition by Mallinckrodt Pharmaceuticals in 2014. Earlier in his career, he held senior leadership roles at Elan Pharmaceuticals, Dura Pharmaceuticals, and Bristol-Myers Squibb. Mr. Schroeder currently serves on the Board of Directors of Cidara Therapeutics (Nasdaq: CDTX) and has previously served on the boards of several public and private life sciences companies, including Otonomy, Collegium Pharmaceutical, Hyperion Therapeutics, Incline Therapeutics, and Trius Therapeutics. He is also a former Chairman of Biocom California and the Antimicrobials Working Group. In 2014, he was named EY Entrepreneur of the Year for the San Diego region and was recognized as a national finalist. He holds a B.S. in Management from Rutgers University. About Phathom Pharmaceuticals, Inc.Phathom Pharmaceuticals is a biopharmaceutical company focused on the development and commercialization of novel treatments for gastrointestinal diseases. Phathom has in-licensed the exclusive rights to vonoprazan, a first-in-class potassium-competitive acid blocker (PCAB) that is currently marketed in the United States as VOQUEZNA® (vonoprazan) tablets for the relief of heartburn associated with Non-Erosive GERD in adults, the healing and maintenance of healing of Erosive GERD in adults and relief of associated heartburn, in addition to VOQUEZNA® TRIPLE PAK® (vonoprazan tablets, amoxicillin capsules, clarithromycin tablets) and VOQUEZNA® DUAL PAK® (vonoprazan tablets, amoxicillin capsules) for the treatment of H. pylori infection in adults. For more information about Phathom, visit the company’s website at www.phathompharma.com follow on LinkedIn and X. MEDIA CONTACTNick Benedetto1-877-742-8466media@phathompharma.com INVESTOR CONTACTEric Sciorilli1-877-742-8466ir@phathompharma.com © 2025 Phathom Pharmaceuticals. All rights reserved.VOQUEZNA, VOQUEZNA DUAL PAK, VOQUEZNA TRIPLE PAK, Phathom Pharmaceuticals, and their respective logos are registered trademarks of Phathom Pharmaceuticals, 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

SAN DIEGO, March 18, 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 two upcoming presentations at the 38th International Conference on Antiviral Research (ICAR). The conference takes place from March 17-21, 2025 in Las Vegas, Nevada. Cidara’s presentations will highlight the study design, demographic information, and preliminary safety data from the ongoing Phase 2b NAVIGATE trial of CD388, as well as dose optimization models for evaluation of CD388 in a Phase 3 study. Presentation details: Title: NAVIGATE: A Phase 2b, Randomized, Double-blind, Placebo-controlled, Multicenter Dose-ranging Study to Evaluate the Efficacy and Safety of CD388, a Novel Long-acting Antiviral Conjugate, for Prevention of Influenza in Subjects not at Risk for Influenza ComplicationsPresenter: James AlexanderAbstract number: 361 Date/Time: Poster Session 1: Tuesday, March 18, 2025, 5:15-6:15pm PT; Poster Session 2: Thursday, March 20, 2025, 9-10am PT Summary: The Phase 2b NAVIGATE trial to evaluate the safety and preventative efficacy of CD388 in a real-world environment completed enrollment of more than 5,000 participants in the United States and the UK. Prior Phase 1 and Phase 2a clinical data have shown that CD388, administered by subcutaneous injection, appeared to be well-tolerated and efficacious in healthy human volunteer studies. The results of the Phase 2b trial will inform dose selection and design for the planned Phase 3 development program. Title: Real World Data-Based Modeling of Seasonal Influenza Variations to Support Clinical Dose Selection of CD388, A Novel Antiviral in Development for Prevention of Seasonal and Pandemic Influenza Presenter: Shawn FlanaganAbstract number: 352 Date/Time: Poster Session 1: Tuesday, March 18, 2025, 6:15-7:15pm PT; Poster Session 2: Thursday, March 20, 2025, 8-9am PT Summary: In trials involving community acquired infections, like influenza, variations in disease incidence over time may complicate interpretation of drug effect in Phase 2 and Phase 3 trials across multiple seasons, especially for long-acting drugs like CD388. Advanced model-based analysis was conducted to improve decision power based on simulated Phase 2 results over different flu seasons. While a standard proportions test was shown to be sensitive to influenza seasonal variations, the model-based analysis was not and increased decision power for clinical dose selection of CD388 for Phase 3. 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, 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