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].
Cidara Therapeutics(CDTX) - 2024 Q3 - Quarterly Report