Core Viewpoint - Cidara Therapeutics, Inc. has announced a public offering of 7,954,546 shares of its common stock priced at $44.00 per share, aiming to raise approximately $350 million in gross proceeds before expenses [1][2]. Group 1: Offering Details - The offering is expected to close on June 26, 2025, subject to customary closing conditions [2]. - Cidara has granted underwriters a 30-day option to purchase an additional 1,193,181 shares at the public offering price [2]. - J.P. Morgan, Morgan Stanley, Guggenheim Securities, and Cantor are acting as joint book-running managers for the offering [3]. Group 2: Regulatory Information - The offering is made pursuant to a shelf registration statement filed with the SEC on May 8, 2025, and declared effective on May 15, 2025 [4]. Group 3: Company Overview - Cidara Therapeutics utilizes its proprietary Cloudbreak® platform to develop drug-Fc conjugate (DFC) therapeutics, with its lead candidate CD388 aimed at universal prevention of influenza [6]. - CD388 received Fast Track Designation from the FDA in June 2023, and the company completed enrollment for its Phase 2b NAVIGATE trial in December 2024 [6]. - Cidara is also developing additional DFCs for oncology, including CBO421, which targets CD73 in solid tumors [6].

Core Viewpoint - Cidara Therapeutics is hosting a virtual R&D day to discuss its long-acting antiviral drug CD388, aimed at providing universal influenza protection with a single administration [1][2]. Group 1: Event Details - The virtual R&D day is scheduled for May 22, 2025, from 10:00 to 11:30 AM ET [1]. - Key opinion leaders Fred Hayden, MD, and Rick Bright, PhD, will participate alongside company management [2]. Group 2: CD388 Overview - CD388 is a drug-Fc conjugate designed to offer long-lasting protection against all known strains of seasonal and pandemic influenza [7]. - It is not a vaccine but a low molecular weight biologic that does not rely on an immune response, making it effective regardless of an individual's immune status [7]. - The drug aims to provide season-long protection with a single subcutaneous or intramuscular dose [7]. Group 3: Clinical Trials and Commercial Potential - The ongoing Phase 2b NAVIGATE trial is a key focus, with updates on the statistical analysis plan for evaluating efficacy results expected [3]. - The event will also cover the commercial opportunity and competitive landscape for CD388, as well as prospects for pandemic influenza [3]. - CD388 received Fast Track Designation from the FDA in June 2023, and enrollment for the Phase 2b trial was completed in December 2024 [9].

Core Viewpoint - Cidara Therapeutics is hosting a virtual R&D day to discuss its long-acting antiviral drug CD388, aimed at providing universal influenza protection with a single administration [1][2][3] Group 1: Event Details - The virtual R&D day is scheduled for May 22, 2025, from 10:00 to 11:30 AM ET [1] - Key opinion leaders Fred Hayden, MD, and Rick Bright, PhD, will participate alongside company management [2] - A live Q&A session will follow the formal presentations [4] Group 2: CD388 Overview - CD388 is a drug-Fc conjugate designed to provide long-acting antiviral protection against seasonal and pandemic influenza [7][9] - It is not a vaccine but a low molecular weight biologic that does not rely on an immune response, making it effective regardless of an individual's immune status [7] - The drug aims to offer season-long protection with a single subcutaneous or intramuscular dose [7] Group 3: Clinical Trials and Commercial Potential - The ongoing Phase 2b NAVIGATE trial is being reviewed, with updates on the statistical analysis plan for efficacy results [3] - The company has completed enrollment for the Phase 2b NAVIGATE trial as of December 2024 [9] - CD388 received Fast Track Designation from the FDA in June 2023, indicating its potential commercial opportunity [9]

Core Insights - Cidara Therapeutics reported financial results for Q1 2025, highlighting ongoing developments in its CD388 program and the Phase 2b NAVIGATE clinical trial [1][6][11] Recent and Expected Corporate Highlights - The data cutoff for the Phase 2b NAVIGATE trial was established on April 30, 2025, with top-line results expected in late June 2025 [2][4][5] - CD388 is positioned as a differentiated therapeutic option for influenza prevention, with discussions ongoing with the U.S. FDA regarding the statistical analysis plan [2][5] - Preclinical data published in Nature Microbiology indicates CD388's potential as a universal antiviral for influenza prevention [4][5] - Two posters on CD388 were presented at the 38th International Conference on Antiviral Research in March 2025, showcasing study design and preliminary safety data [5] - Recent promotions within the company include Nicole Davarpanah as Chief Medical Officer and Corrina Pavetto as Senior Vice President, Clinical Development [5] Financial Results - Cash, cash equivalents, and restricted cash totaled $174.5 million as of March 31, 2025, down from $196.2 million at the end of 2024 [11][16] - Collaboration revenue was zero for Q1 2025, compared to $1.0 million in Q1 2024, following the termination of the Janssen Collaboration Agreement [11] - R&D expenses increased to $24.6 million in Q1 2025 from $5.9 million in Q1 2024, primarily due to the ongoing Phase 2b NAVIGATE study [11][14] - General and administrative expenses rose to $6.2 million in Q1 2025 from $3.6 million in Q1 2024, driven by higher personnel costs [11][14] - The net loss for Q1 2025 was $23.5 million, compared to a net loss of $10.3 million in Q1 2024 [11][14]

Core Insights - Cidara Therapeutics has announced the promotion of Nicole Davarpanah to Chief Medical Officer and Corrina Pavetto to Senior Vice President of Clinical Development, effective May 1, 2025, during a critical phase of their influenza antiviral candidate CD388's development [1][2] Company Developments - The promotions are significant as Cidara advances its influenza antiviral candidate CD388 through the Phase 2b NAVIGATE trial and prepares for Phase 3 [2] - Dr. Davarpanah has over a decade of clinical development experience, previously holding leadership roles at Genentech/Roche, where she was responsible for early-stage molecules' advancement through clinical development and FDA approval [2][3] - Ms. Pavetto brings over 25 years of experience in clinical research and regulatory affairs, with a focus on infectious diseases, and has previously supported influenza antiviral and vaccine development at BARDA [4] Product Pipeline - Cidara's lead drug-Fc conjugate candidate, CD388, is designed for universal prevention of seasonal and pandemic influenza with a single dose by inhibiting viral proliferation [5] - CD388 received Fast Track Designation from the FDA in June 2023, and the company completed enrollment of its 5,000 patient Phase 2b NAVIGATE trial in December 2024 [5]