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Cidara Therapeutics (CDTX) delivers innovative solutions for serious infectious diseases through its Cloudbreak® platform, which engineers targeted immunotherapies and anti-infectives. This page provides investors and healthcare professionals with essential updates on clinical developments, regulatory milestones, and strategic initiatives.
Access real-time announcements about CDTX's pipeline candidates, antiviral DFC advancements, and partnership agreements. Our curated collection includes press releases on trial results, FDA interactions, and research collaborations – all critical for evaluating the company's progress in addressing unmet medical needs.
Key updates cover three focus areas: clinical trial phases for antifungal/antiviral therapies, technology licensing deals involving the Cloudbreak® platform, and financial developments impacting R&D priorities. Bookmark this resource to monitor how CDTX's dual approach of direct pathogen targeting and immune system engagement evolves across influenza, oncology, and fungal infection programs.
Cidara Therapeutics (CDTX) has published preclinical data for CD388, their influenza drug-Fc conjugate (DFC), in Nature Microbiology. The study demonstrates CD388's potential as a universal preventative treatment for both influenza A and B strains.
The research highlights CD388's key capabilities including:
- Potent activity against all influenza strains, including H5N1 (bird flu)
- Effectiveness against neuraminidase inhibitor-resistant strains
- Low resistance development potential
- Similar efficacy in both immune-competent and immune-compromised models
The company is currently conducting a Phase 2b NAVIGATE trial with approximately 5,000 subjects to evaluate CD388 as a single-dose preventative treatment for seasonal influenza in healthy unvaccinated adults during the 2024-2025 flu season.
Cidara Therapeutics (CDTX) reported its Q4 and full year 2024 financial results, marking a transformational year with significant developments. The company completed enrollment of 5,000 subjects in its Phase 2b NAVIGATE trial for CD388, a long-acting universal influenza preventative drug.
Key financial highlights include: Cash position of $196.2 million as of December 31, 2024, bolstered by a $105.0 million private placement in November 2024 and earlier $240.0 million raised in April. Collaboration revenue decreased to $1.3 million for 2024 from $23.3 million in 2023. R&D expenses increased to $71.9 million in 2024 from $36.8 million in 2023.
The company reacquired rights to the CD388 program and may consider an early analysis of efficacy data in first half 2025 due to severe flu season. Net loss widened to $169.8 million in 2024 from $22.9 million in 2023, primarily due to increased R&D expenses and an $85.0 million upfront payment to Janssen.
Cidara Therapeutics (CDTX) has appointed Frank Karbe as Chief Financial Officer, effective February 24, 2025, succeeding Preetam Shah. Karbe brings over 25 years of leadership experience in the biopharma industry, with a strong track record in transitioning companies from R&D to commercialization.
The appointment comes as Cidara advances its long-acting influenza antiviral drug CD388 through the Phase 2b NAVIGATE study. Karbe's recent achievements include serving as CEO of Better Therapeutics, where he secured the first FDA authorization for a digital therapeutic treating type 2 diabetes. At Myovant Sciences, he helped scale the company to 500+ employees with two FDA-approved products, raising over $2 billion and securing a $4 billion Pfizer partnership. Previously, at Exelixis, he led the company's transformation from discovery to commercialization.
Cidara Therapeutics (Nasdaq: CDTX), a biotechnology company leveraging its proprietary Cloudbreak® platform to develop drug-Fc conjugate (DFC) immunotherapies, has announced its participation in the upcoming Guggenheim Securities SMID Cap Biotech Conference.
The company's President and CEO, Jeffrey Stein, Ph.D., will engage in a fireside chat on Wednesday, February 5, 2025, at 1:30 PM ET. The presentation will be available via webcast and can be accessed through a provided link. A replay will be accessible in the Investors section of Cidara's website for 90 days following the event.
Additionally, Cidara will conduct one-on-one investor meetings during the conference. Interested investors should contact their Guggenheim representative to arrange meetings.
Cidara Therapeutics (CDTX) has completed enrollment of 5,000 subjects in its Phase 2b NAVIGATE trial, evaluating CD388 for pre-exposure prophylaxis of seasonal influenza. The study, conducted across US and UK clinical sites, is designed to assess the efficacy and safety of CD388 as a long-acting, universal influenza preventative.
The randomized, double-blind, controlled trial involves healthy, unvaccinated adult subjects not at risk of influenza complications. Participants receive single doses of CD388 (150mg, 300mg, or 450mg) or placebo at the start of flu season and are monitored for breakthrough cases throughout the season. The trial will evaluate safety, pharmacokinetics, and rates of laboratory and clinically confirmed influenza.
Cidara Therapeutics (CDTX) has announced a $105 million private placement led by new investor Venrock Healthcare Capital Partners, with participation from both new and existing life sciences-focused investors. The company will issue approximately 3.89 million shares of common stock at $14.912 per share and pre-funded warrants for 3.15 million shares at $14.9119 per warrant. The placement is expected to close around November 25, 2024. The proceeds will be used to fund research and development of product candidates, working capital, and general corporate purposes. RBC Capital Markets acted as sole placement agent, while Guggenheim Securities served as financial advisor.
Cidara Therapeutics (CDTX) has announced its participation in the Evercore 7th Annual HealthCONx Conference. The company's President and CEO, Jeffrey Stein, Ph.D., will engage in a fireside chat on Tuesday, December 3, 2024, at 7:55 AM ET. The presentation will be available via webcast, with a 90-day replay accessible in the Investors section of Cidara's website. The company, which develops drug-Fc conjugate immunotherapies through its proprietary Cloudbreak® platform, will also conduct one-on-one investor meetings during the event.
Cidara Therapeutics (CDTX) reported Q3 2024 financial results and corporate updates. Key highlights include the initiation of Phase 2b NAVIGATE trial for CD388, their influenza prevention drug candidate. The company reported cash and equivalents of $127.4 million as of September 30, 2024. Revenue was zero for Q3 2024, compared to $9.2 million in Q3 2023. Net loss increased to $16.0 million for Q3 2024. The company implemented a 30% workforce reduction to focus on CD388 development. The company presented positive Phase 2a and Phase 1 trial data for CD388 at multiple conferences, demonstrating its potential for single-dose seasonal flu protection.
Cidara Therapeutics (Nasdaq: CDTX) has announced its participation in two major investor conferences in November 2024. CEO Jeffrey Stein will present at the Guggenheim Securities Healthcare Innovation Conference on November 11 at 1:30 PM ET in a fireside chat format, which will be available via webcast. The company will also attend the Jefferies London Healthcare Conference from November 19-21.
The Guggenheim presentation will be accessible through a webcast link and remain available for replay on Cidara's website for 90 days. The company, which develops drug-Fc conjugate immunotherapies through its Cloudbreak® platform, will conduct one-on-one investor meetings at both events.
Cidara Therapeutics announced two presentations on its drug-Fc conjugate, CD388, at IDWeek 2024. The presentations will highlight clinical data on safety, pharmacokinetics, and prophylactic activity of CD388 for influenza prevention. An oral presentation will discuss CD388's prophylactic activity in a Phase 2a human challenge study, where a single dose prevented symptomatic disease in subjects who seroconverted after influenza challenge. A poster presentation will cover a study evaluating CD388's safety, tolerability, and pharmacokinetics in healthy subjects. Results showed rapid absorption, slow elimination, and potential for seasonal influenza prevention with one dose. No safety concerns or anti-drug antibody formation were observed, supporting annual use.