Drug Development and Clinical Trials - The company reacquired all rights to develop and commercialize CD388, a drug-Fc conjugate for influenza prophylaxis, through a license and technology transfer agreement with Janssen, resulting in a fee-bearing but royalty-free license[112]. - CD388 has completed two Phase 1 studies and one Phase 2a study, with the Phase 2b NAVIGATE study initiated in September 2024[115]. - The Phase 2a study showed that 21% of subjects receiving CD388 (150 mg) experienced RT-PCR-confirmed influenza infection compared to 50% in the placebo group, with a p-value of 0.0248[123]. - CD388 demonstrated a well-tolerated profile up to a maximum dose of 900 mg, with no serious adverse events reported[117]. - The U.S. FDA granted Fast Track designation to CD388 for preventing influenza A and B in high-risk adults, facilitating expedited development and review[115]. - CD388 is projected to provide seasonal influenza prevention with an extended half-life of 6-8 weeks, as demonstrated in Phase 1 studies[124]. - The oncology DFC candidate CBO421 targeting CD73 received IND clearance in July 2024, although no clinical trials for oncology products are planned at this time[114]. - CBO421, a CD73 inhibitor, received IND clearance in July 2024 and aims to enhance treatment for solid tumors, particularly triple negative breast cancer[128]. - CD388 Phase 2b NAVIGATE study initiated with a target enrollment of 5,000 subjects in the US and UK, with topline data expected in Q3 2025[127]. - The company does not plan to initiate new clinical trials for oncology products at this time but is in discussions for business development in oncology DFC programs[130]. Financial Performance and Funding - As of September 30, 2024, the company reported an accumulated deficit of $559.0 million and cash and cash equivalents of $127.4 million, expected to last through mid-Q4 2025[134]. - Total research and development expenses for Q3 2024 were $12.4 million, an increase from $10.4 million in Q3 2023[139]. - The company plans to fund ongoing operations through cash reserves and potential future equity offerings, with no assurance of additional funding availability[134]. - The company has experienced net losses and negative cash flows since inception, impacting its ability to generate future revenues[135]. - Collaboration revenue was $0 for the three months ended September 30, 2024, down from $9.2 million for the same period in 2023, due to the termination of the Janssen Collaboration Agreement[148]. - For the nine months ended September 30, 2024, collaboration revenue was $1.3 million, a decrease of $19.3 million from $20.5 million in 2023[155]. - Acquired in-process research and development expenses totaled $84.9 million for the nine months ended September 30, 2024, related to an upfront payment under the Janssen License Agreement[156]. - Research and development expenses for the nine months ended September 30, 2024, were $25.0 million, down from $28.8 million in 2023, mainly due to lower nonclinical expenses[157]. - Selling, general and administrative expenses increased to $13.3 million for the nine months ended September 30, 2024, compared to $10.1 million in 2023[158]. - Other income, net for the nine months ended September 30, 2024, was $3.998 million, an increase from $1.468 million in 2023, primarily from interest income[159]. - Net cash used in operating activities was $147.1 million for the nine months ended September 30, 2024, compared to $9.7 million for the same period in 2023, driven by a net loss of $117.5 million[165]. - Net cash provided by financing activities was $238.9 million for the nine months ended September 30, 2024, primarily from the sale of 240,000 shares of Series A Convertible Voting Preferred Stock[167]. - Cash and cash equivalents at the end of the period were $127.4 million as of September 30, 2024, up from $48.7 million at the end of September 2023[164]. - The company has no outstanding loan balances as of September 30, 2024[162]. - The company plans to continue funding its operations through cash on hand and potential future equity offerings or debt financings[169]. Corporate Actions and Market Conditions - A reverse stock split of 1-for-20 was approved to regain compliance with Nasdaq listing requirements, effective April 23, 2024[131]. - The stock market for pharmaceutical and biotechnology companies has seen significant declines, affecting the company's stock price[132]. - A workforce reduction of 20 employees, approximately 30% of the workforce, was completed by November 1, 2024, expected to reduce capital needs related to personnel costs[162]. - The company lost its Form S-3 eligibility for primary and secondary offerings until at least April 16, 2025, due to a failure to timely file its Annual Report[162]. Operational Results - Selling, general and administrative expenses rose to $5.0 million for the three months ended September 30, 2024, up from $3.3 million in 2023, driven by higher audit fees and legal costs[150]. - Loss from discontinued operations was $0.5 million for the three months ended September 30, 2024, a significant improvement from a loss of $5.3 million in the same period in 2023[153]. - Income from discontinued operations was $0.4 million for the nine months ended September 30, 2024, compared to a loss of $2.8 million in 2023, reflecting a positive shift in financial results[154]. - Income from discontinued operations was $0.4 million for the nine months ended September 30, 2024, primarily from $29.3 million in revenue related to the sale of rezafungin assets[161]. - Total net cash used in operating activities from discontinued operations was $18.1 million for the nine months ended September 30, 2024, compared to $9.3 million for the same period in 2023[168].

Core Insights - Cidara Therapeutics is presenting clinical data on its influenza drug-Fc conjugate candidate, CD388, at the OPTIONS XII conference, highlighting its safety and pharmacokinetic data [1][2] Group 1: Clinical Data Presentations - An oral presentation will summarize safety data from three clinical trials involving 108 subjects, showing no treatment-emergent adverse events related to dose or administration route, supporting further studies for single-dose prevention of seasonal influenza [3] - A poster presentation will cover pharmacokinetics and safety data from 27 healthy Japanese volunteers, indicating low-to-moderate variability in PK parameters and no significant adverse events, supporting further studies in the Japanese population [4] Group 2: Product Overview - CD388 is an investigational drug-Fc conjugate designed to provide universal protection against seasonal and pandemic influenza with a single administration, functioning as a long-acting small molecule inhibitor [5] - The drug is not reliant on an immune response, making it potentially effective for individuals regardless of immune status [5] Group 3: Company Background - Cidara Therapeutics utilizes its Cloudbreak® platform to develop drug-Fc conjugates, with CD388 being the lead candidate aimed at achieving universal prevention of influenza [6] - The company received Fast Track Designation from the FDA for CD388 and plans to advance it into a Phase 2b trial in the 2024 Northern Hemisphere influenza season [6]

Core Insights - Cidara Therapeutics has initiated the Phase 2b NAVIGATE trial to assess the efficacy and safety of CD388 for pre-exposure prophylaxis of influenza during the current flu season [1][2] - CD388 is designed to provide universal protection against all known strains of seasonal and pandemic influenza, functioning independently of the immune response [3][4] Company Overview - Cidara Therapeutics is a biotechnology company utilizing its proprietary Cloudbreak® platform to develop drug-Fc conjugates (DFCs) aimed at improving treatment for serious diseases [1][5] - The lead DFC candidate, CD388, is a long-acting antiviral that can potentially offer season-long protection against influenza with a single administration [4][5] - CD388 received Fast Track Designation from the FDA in June 2023, and the company plans to advance it into a Phase 2b trial during the 2024 Northern Hemisphere influenza season [5] Clinical Trial Details - The Phase 2b NAVIGATE trial is a randomized, double-blind, controlled study involving 5,000 healthy unvaccinated adults, comparing three dose groups of CD388 against a placebo [2] - Participants will be monitored throughout the influenza season for breakthrough cases, with a focus on laboratory and clinically confirmed influenza rates [2] Product Characteristics - CD388 is a drug-Fc conjugate that combines a potent small molecule neuraminidase inhibitor with a proprietary Fc fragment of a human antibody, designed for long-acting inhibition of viral proliferation [4] - Unlike traditional vaccines, CD388's efficacy does not depend on an immune response, making it suitable for individuals with varying immune statuses [3][4]

SAN DIEGO, Sept. 19, 2024 (GLOBE NEWSWIRE) -- Cidara Therapeutics, Inc. (Nasdaq: CDTX), a biotechnology company using its proprietary Cloudbreak® platform to develop drug-Fc conjugate (DFC) immunotherapies designed to save lives and improve the standard of care for patients facing serious diseases, today announced the appointment of Rick Bright, Ph.D., Philip Krause, M.D., Mario Barro, Ph.D., and Frederick G. Hayden, M.D., FACP to its Scientific Advisory Board (SAB). "We are honored that these four esteemed ...

SAN DIEGO, Sept. 12, 2024 (GLOBE NEWSWIRE) -- Cidara Therapeutics, Inc. (Nasdaq: CDTX), a biotechnology company using its proprietary Cloudbreak® platform to develop drug-Fc conjugate (DFC) immunotherapies designed to save lives and improve the standard of care for patients facing serious diseases, today announced a reduction in its workforce to focus on the clinical development of CD388, the Company's novel DFC candidate for influenza A and B. The planned reduction impacts approximately 30% of the Cidara w ...

SAN DIEGO, Aug. 19, 2024 (GLOBE NEWSWIRE) -- Cidara Therapeutics, Inc. (Nasdaq: CDTX), a biotechnology company using its proprietary Cloudbreak® platform to develop drug-Fc conjugate (DFC) immunotherapies designed to save lives and improve the standard of care for patients facing serious diseases, today announced that Jim Beitel, MBA, has joined the company as its Chief Business Officer ("CBO"). Following recent transactions, Cidara is focused exclusively on advancing its Cloudbreak DFC pipeline, which prov ...

SAN DIEGO, Aug. 13, 2024 (GLOBE NEWSWIRE) -- Cidara Therapeutics, Inc. (Nasdaq: CDTX) (the Company), a biotechnology company using its proprietary Cloudbreak® platform to develop drug-Fc conjugate (DFC) immunotherapies designed to save lives and improve the standard of care for patients facing serious diseases, today reported financial results for the second quarter ended June 30, 2024, and provided an update on its corporate activities and product pipeline. "We continue to focus on our Cloudbreak DFC platf ...

Exhibit 99.1 Cidara Therapeutics Provides Corporate Update and Reports Second Quarter 2024 Financial Results SAN DIEGO, August 13, 2024 — Cidara Therapeutics, Inc. (Nasdaq: CDTX) (the Company), a biotechnology company using its proprietary Cloudbreak platform to develop drug-Fc conjugate (DFC) immunotherapies designed to save lives and improve the standard of care for patients facing serious diseases, today reported financial results for the second quarter ended June 30, 2024, and provided an update on its ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, DC 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 FOR THE QUARTERLY PERIOD ENDED JUNE 30, 2024 ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 FOR THE TRANSITION PERIOD FROM TO Commission file number: 001-36912 CIDARA THERAPEUTICS, INC. (Exact name of registrant as specified in its charter) Delaware 46-1537286 (State or Other Jurisdicti ...

"Our reacquisition of our CD388 program, which we have developed to date in collaboration with Janssen Pharmaceuticals, Inc., a Johnson & Johnson Company, (Janssen) as a once-per-flu season universal preventative of influenza A and B, along with the divestiture of the rezafungin program to our former partner Mundipharma, enables us to focus all of our development efforts on our Cloudbreak DFC platform," said Jeffrey Stein, Ph.D., president and chief executive officer of Cidara. "Our priority now is to evalu ...