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 127.4 million, expected to last through mid-Q4 2025[134]. - Total research and development expenses for Q3 2024 were 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 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 19.3 million from 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 28.8 million in 2023, mainly due to lower nonclinical expenses[157]. - Selling, general and administrative expenses increased to 10.1 million in 2023[158]. - Other income, net for the nine months ended September 30, 2024, was 1.468 million in 2023, primarily from interest income[159]. - Net cash used in operating activities was 9.7 million for the same period in 2023, driven by a net loss of 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 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 3.3 million in 2023, driven by higher audit fees and legal costs[150]. - Loss from discontinued operations was 5.3 million in the same period in 2023[153]. - Income from discontinued operations was 2.8 million in 2023, reflecting a positive shift in financial results[154]. - Income from discontinued operations was 29.3 million in revenue related to the sale of rezafungin assets[161]. - Total net cash used in operating activities from discontinued operations was 9.3 million for the same period in 2023[168].
Cidara Therapeutics(CDTX) - 2024 Q3 - Quarterly Report