Core Insights - Cidara Therapeutics, Inc. has made significant progress with its long-lasting flu prophylactic candidate, CD388, as indicated by positive Phase 2b trial results [1] Company Summary - Cidara Therapeutics is a biotechnology company based in San Diego, focusing on innovative treatments [1] - The company has received a "Buy" rating since February 2025, reflecting confidence in its product pipeline [1] Industry Context - The advancements in flu prophylactics, particularly with CD388, highlight the ongoing innovation within the biotech sector, especially in preventive treatments [1]

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, Inc. plans to initiate an underwritten public offering to sell $250 million of its common stock, with a potential additional 15% option for underwriters [1][2] Group 1: Offering Details - The public offering is subject to market conditions and other factors, with no assurance on completion or terms [1] - The offering is made under a shelf registration statement filed with the SEC on May 8, 2025, and declared effective on May 15, 2025 [3] - Joint book-running managers for the offering include J.P. Morgan, Morgan Stanley, Guggenheim Securities, and Cantor Fitzgerald [2] Group 2: Company Overview - Cidara Therapeutics utilizes its proprietary Cloudbreak® platform to develop drug-Fc conjugate (DFC) therapeutics, with a focus on antiviral and oncology applications [5] - The lead DFC candidate, CD388, aims for universal prevention of seasonal and pandemic influenza and received Fast Track Designation from the FDA in June 2023 [5] - Cidara completed enrollment for its Phase 2b NAVIGATE trial in December 2024 and received investigational new drug application clearance for CBO421 targeting solid tumors in July 2024 [5]

Core Insights - Cidara Therapeutics, Inc. (CDTX) stock surged over 90% following the release of positive topline results from its Phase 2b NAVIGATE trial for CD388, aimed at preventing seasonal influenza in healthy unvaccinated adults aged 18 to 64 [1][6] Study Results - The NAVIGATE trial met its primary endpoint, showing statistically significant prevention efficacy (PE) across all three dose groups, with evaluations conducted over 24 weeks [2] - The highest dose group (450 mg) achieved a 76.1% prevention efficacy, while the 300 mg and 150 mg doses demonstrated 61.3% and 57.7% efficacy, respectively, all statistically significant compared to placebo [3] - Secondary endpoints were also met, including efficacy at specific temperature thresholds and maintenance of PE for up to 28 weeks [2] Safety and Tolerability - CD388 was well-tolerated across all doses, with no unexpected dose-limiting treatment-emergent adverse events reported [3][4] - No serious drug-related adverse events were observed, and injection site reaction rates were consistent across all dose groups [4] Regulatory Actions - Cidara has submitted a request to the FDA for an end of Phase 2 meeting to discuss the results and the design of the upcoming Phase 3 trial [5]

NASDAQ: CDTX JUNE 2025 NAVIGATE Ph 2B June 23, 2025 Forward-looking Statements These slides contain forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. The words "may," "will," "estimate," "plan", "anticipate," "expect," "potential," "could," "project," and similar expressions (including the negative thereof), are intended to identify forward-looking statements. Because such statements are subject to risks and uncertainties, actual results may differ materi ...

Cidara Therapeutics (CDTX) Update / Briefing June 23, 2025 08:30 AM ET Speaker0 Greetings. Welcome to Sadara Therapeutics announces positive top line results from its phase two b NAVIGATE trial evaluating CD388, a nonvaccine preventative of seasonal influenza. At this time, all participants will be in listen only mode. A question and answer session will follow today's formal presentation. Reminder, this conference is being recorded. At this time, I'll hand the conference over to Brian Ritchie with Investor ...

Core Insights - Cidara Therapeutics announced positive topline results from its Phase 2b NAVIGATE trial for CD388, demonstrating significant efficacy in preventing symptomatic influenza in healthy adults [1][7] - CD388 showed protection rates of 76%, 61%, and 58% for doses of 450mg, 300mg, and 150mg respectively, compared to placebo [1][2] - The drug was well-tolerated with no safety signals observed, and an end of Phase 2 meeting request has been submitted to the FDA [1][5] Efficacy Results - The primary efficacy analysis indicated that the prevention efficacy for the 450mg group was 76.1%, 61.3% for the 300mg group, and 57.7% for the 150mg group, with p-values of <0.0001, 0.0024, and 0.0050 respectively [2][4] - Key secondary endpoints also showed significant efficacy, with the 450mg group achieving a prevention efficacy of 76.1% for participants with temperatures ≥37.8°C [3][4] Safety and Tolerability - Safety data indicated no unexpected dose-limiting treatment-emergent adverse events across all dose groups, with injection site reactions being similar to placebo [5][6] - The overall safety profile of CD388 was consistent across all treatment arms, reinforcing its potential as a well-tolerated option for influenza prevention [5][6] Future Plans - Cidara plans to present additional results from the NAVIGATE trial at scientific conferences in 2025 and is preparing for a Phase 3 trial [6][7] - The company has engaged with the FDA to discuss the Phase 2b results and the design of the upcoming Phase 3 trial [7][12] About CD388 - CD388 is a drug-Fc conjugate designed to provide long-acting protection against all strains of seasonal and pandemic influenza with a single administration [9][12] - Unlike vaccines, CD388's efficacy is not reliant on an immune response, making it suitable for individuals regardless of their immune status [9][12]

This is my 4th coverage of Cidara Therapeutics (NASDAQ: CDTX ). At the time of writing, CDTX is trading at around +90% since my last coverage. CDTX has always been a long-term investment for me as explained in prior articles, but the Seeking Alpha's Disclosure: Past performance is no guarantee of future results. No recommendation or advice is being given as to whether any investment is suitable for a particular investor. Any views or opinions expressed above may not reflect those of Seeking Alpha as a whole ...

Summary of Sadara Therapeutics Investor Day Company Overview - **Company**: Sadara Therapeutics - **Focus**: Development of CD388, a potential universal flu vaccine aimed at providing broad protection against influenza strains and addressing unmet medical needs in vulnerable populations [1][2][3] Key Points and Arguments CD388 Development - CD388 is designed to provide universal protection against all influenza strains, targeting a population of over 50 million people in the U.S. who do not adequately respond to existing vaccines [7][8] - The drug is a DFC (drug Fc conjugate) combining a potent small molecule inhibitor of neuraminidase with a human antibody fragment, allowing for efficacy without requiring an immune response [9][11] - The drug has been validated through partnerships and has completed multiple phases of clinical trials, with a significant financing of $240 million to advance its development [12][14] Market Opportunity - The commercial opportunity for CD388 is substantial, with market research indicating a large potential market for a product that can effectively address influenza [5] - The CDC reported significant influenza-related morbidity and mortality, highlighting the inadequacy of current vaccines and antivirals [15][16] Clinical Trials and Efficacy - The NAVIGATE Phase 2b study enrolled over 5,000 healthy adults and aims to evaluate the efficacy, safety, and pharmacokinetics of CD388 [36][37] - The primary endpoint focuses on preventive efficacy, defined by specific clinical criteria reflecting the drug's mechanism of action [38][39] - The study's statistical plan allows for a group dose analysis, enhancing the power of the study to detect efficacy [42][48] Regulatory Path and Future Studies - CD388 has received fast track designation from the FDA, with plans for a Phase 3 study targeting high-risk populations [49][50] - The Phase 3 study will include a larger population and aims to confirm the efficacy observed in Phase 2b, with a timeline for potential regulatory approval by 2029 [53][54] Additional Insights Influenza Season Impact - The previous influenza season was severe, with 47 million illnesses, 610,000 hospitalizations, and 27,000 deaths reported in the U.S. [23][24] - Vaccine effectiveness was moderate, with uptake rates remaining low despite universal recommendations [27][28] Pandemic Preparedness - CD388 is positioned as a strategic asset for both seasonal and pandemic influenza, offering long-lasting protection without relying on immune memory [62][63] - The potential for CD388 to be deployed immediately during a pandemic is emphasized, filling gaps left by current vaccines and antivirals [66][70] Market Segmentation - Patient segmentation analysis indicates a significant population with moderate to severe comorbidities, highlighting the need for effective influenza prevention strategies in these groups [77] Conclusion - Sadara Therapeutics is advancing CD388 as a promising solution to address the significant unmet needs in influenza prevention, with a robust clinical development plan and a clear regulatory pathway aimed at high-risk populations. The potential market opportunity is substantial, given the current limitations of existing vaccines and antivirals.

Summary of Cidara Therapeutics (CDTX) Conference Call Company Overview - Cidara Therapeutics is focused on developing CD388, a long-acting antiviral drug targeting influenza, utilizing its Cloudbreak platform technology [2][3] - CD388 is currently in a 5,000 subject Phase 2B study [3] Core Technology and Product - CD388 is a drug Fc conjugate (DFC), combining a potent small molecule inhibitor (zanamivir) with an Fc fragment of a human antibody, designed for extended half-life and high exposure [3][4] - The drug targets neuraminidase, an enzyme essential for influenza viral exit from cells, aiming to provide universal protection against all flu strains [5][6] - Unlike traditional vaccines, CD388 does not require annual manufacturing adjustments based on circulating strains, making it a potentially more stable option [6] Clinical Development and Efficacy - CD388 has shown a 57% placebo-adjusted efficacy in Phase 2A human challenge studies, indicating its effectiveness in preventing influenza proliferation [17][21] - The drug is designed to be administered once at the beginning of the flu season, providing long-term protection [5][15] - The Phase 2B study is expected to yield results that could be compared favorably against traditional vaccines, which have an average efficacy of about 40% [22] Regulatory and Market Considerations - The company is in alignment with the FDA regarding the statistical analysis plan for the Phase 2B study, which is crucial for evaluating the results [27][40] - Cidara is targeting high-risk and immunocompromised populations for Phase 3 trials, where traditional vaccines have low efficacy (0-20%) [40] Market Opportunity - The total addressable market (TAM) for CD388 is estimated to include approximately 50 million patients in the U.S. alone, with potential pricing similar to Bifortis at around $500 per injection [44][45] - This could translate into a multibillion-dollar commercial opportunity given the size of the target population and expected pricing [45] Financial and Operational Preparedness - Cidara ended Q1 with approximately $175 million in cash, which is expected to last until the end of 2027, absent the initiation of a Phase 3 study [46] - The company is exploring various financing options, including capital markets and structured financing, to support Phase 3 preparations [46] - Drug supply for Phase 3 is ready, with plans to assume the highest dose for the study [47] Additional Insights - The Phase 2B study is designed to assess the drug's ability to prevent severe influenza symptoms, which is a critical outcome for its success [18][19] - The company is preparing for potential challenges in the upcoming flu season, which could impact trial outcomes and timelines [24][38]