Cidara Therapeutics(US:CDTX)2025-11-06 21:25Clinical Development - The company has completed two Phase 1 studies and one Phase 2a study of CD388, with positive topline results announced for the Phase 2b NAVIGATE study involving 5,041 subjects, demonstrating a prevention efficacy of 76.1% for the 450 mg dose group [210][211]. - The NAVIGATE study met its primary endpoint, showing statistically significant prevention efficacy across all dose groups, with no unexpected adverse events reported [210][217]. - The company plans to initiate a Phase 1 vaccine interaction study and a Phase 2 repeat dose study of CD388 in mid-November 2025 [209]. - The ANCHOR study has a target enrollment of 6,000 participants, with over 50% enrolled as of November 2025, and expected completion by December 2025 [222]. - The interim analysis of the ANCHOR study is scheduled for the first quarter of 2026 to assess trial size and determine the need for additional enrollment [222]. Regulatory Designations - The FDA granted Fast Track designation to CD388 in June 2023 and Breakthrough Therapy designation in October 2025, aimed at expediting the development and review process for the drug [201]. Financial Performance - As of September 30, 2025, the company reported an accumulated deficit of $743.7 million and expects to continue incurring net losses [226]. - The company had cash, cash equivalents, restricted cash, and available-for-sale investments totaling $476.5 million as of September 30, 2025, sufficient to fund operations through the Phase 3 development program [227]. - Research and development expenses for the three months ended September 30, 2025, were $35.5 million, an increase of $23.1 million compared to the same period in 2024 [246]. - Acquired in-process research and development expenses were $45.0 million for the three months ended September 30, 2025, related to a milestone under the Janssen License Agreement [247]. - Total R&D expenses for the nine months ended September 30, 2025, were $84.9 million, up from $25.0 million in 2024, mainly due to the NAVIGATE study and ANCHOR study preparations [256]. Funding and Agreements - The company raised $240 million in gross proceeds from a private placement in April 2024, with $85 million allocated for the upfront payment under the Janssen License Agreement, and additional funding secured from subsequent placements and a public offering [202]. - A contract with BARDA was established in September 2025, providing potential payments of up to $339.2 million, including base period funding of approximately $58.1 million over 24 months [205]. - The BARDA Agreement includes an estimated funding of $58.1 million over 24 months for CD388 manufacturing and clinical trials, with potential additional funding of up to $281.1 million [223]. Stock and Market Performance - The company has 42,017,928 shares of common stock equivalents outstanding as of September 30, 2025 [225]. - The stock market for pharmaceutical and biotechnology companies has experienced significant volatility, impacting market prices unrelated to operating performance [224]. - The company completed a Public Offering in June 2025, raising approximately $402.5 million from the sale of 9,147,727 shares at $44.00 per share [267]. Cash Flow and Operating Activities - Net cash used in operating activities for the nine months ended September 30, 2024 was $117.5 million, adjusted for $5.2 million of non-cash operating activities and $34.8 million of changes in operating assets and liabilities [275]. - The primary use of cash for all periods presented was to fund R&D activities, which are expected to continue to increase in the foreseeable future [276]. - Net cash provided by financing activities during the nine months ended September 30, 2025 included net proceeds of $376.9 million from the sale of 9,147,727 shares of common stock at $44.00 per share [278]. - The absence of cash outflows from discontinued operations is expected to reduce operating cash outflows from continuing operations [281]. - The company plans to fund losses from operations through cash, cash equivalents, restricted cash, and available-for-sale investments, as well as future equity offerings and debt financings [282].