Cidara Therapeutics Q3 2024 Financial Results and Corporate Update

Cidara Therapeutics, Inc., a San Diego-based biotechnology firm, has announced its financial results for the third quarter ending September 30, 2024, and updates on its corporate activities and product pipeline. The company is utilizing its Cloudbreak® platform to develop drug-Fc conjugate (DFC) immunotherapies aimed at improving treatments for severe illnesses.

A significant milestone for Cidara this quarter is the commencement of the Phase 2b NAVIGATE clinical trial, which evaluates the efficacy and safety of CD388 for pre-exposure prophylaxis of seasonal influenza. According to Jeffrey Stein, Ph.D., the company's president and CEO, this trial signifies a crucial clinical achievement. The trial aims to enroll 5,000 healthy, unvaccinated adults not at risk of influenza complications, with participants being monitored through the influenza season for breakthrough cases. The trial includes U.S. and UK sites, comparing laboratory-confirmed influenza rates among various CD388 doses and a placebo group.

In addition to this, Cidara highlighted CD388 in two significant presentations at the 2024 IDWeek Conference. In October 2024, data from a Phase 2a human challenge study demonstrated that a single subcutaneous dose of CD388 administered five days before influenza exposure effectively prevented symptomatic disease. This finding supports the potential for a single seasonal dose of CD388. Data from the Phase 1 trial examining the safety and pharmacokinetics of CD388 were also presented, indicating that CD388 was quickly absorbed and maintained target exposure levels without major safety concerns.

Further, CD388 was featured in presentations at the 2024 OPTIONS XII for the Control of Influenza conference. Safety and pharmacokinetic data from three clinical trials were discussed, showing consistent results between Japanese and Western participants. The findings suggest that CD388 is well tolerated, supporting its further study in preventing seasonal influenza in various populations.

The company continues to strengthen its expertise with the addition of four experts to its Scientific Advisory Board (SAB) in September 2024. The new members, including Rick Bright, Ph.D., Philip Krause, M.D., Mario Barro, Ph.D., and Frederick Hayden, M.D., FACP, bring extensive knowledge in infectious diseases, pandemic preparedness, and regulatory processes. Their insights will be pivotal as Cidara advances its CD388 clinical trials.

Jim Beitel joined Cidara as Chief Business Officer in August 2024, bringing over two decades of experience in corporate development within the life sciences sector. His background includes strategy, business development, commercialization, and finance, which will be instrumental in driving Cidara's future growth.

Cidara has also undergone a workforce restructuring, reducing its workforce by approximately 30% to focus on the clinical development of CD388. This move is expected to significantly lower capital needs related to personnel costs.

Financially, Cidara reported cash and cash equivalents totaling $127.4 million as of September 30, 2024, up from $35.8 million on December 31, 2023. Revenue for the third quarter of 2024 was zero, and $1.3 million for the nine months ended September 30, 2024, down from $9.2 million and $20.5 million for the same periods in 2023. The revenue decrease is attributed to the termination of the collaboration agreement with Janssen upon the effectiveness of a new license and technology transfer agreement.

Research and development expenses for the third quarter of 2024 were $12.4 million, compared to $10.4 million in the same period of 2023. This increase is primarily due to higher costs associated with the CD388 Phase 2b NAVIGATE study and personnel-related expenses. For the nine months ending September 30, 2024, research and development expenses decreased to $25.0 million from $28.8 million in the previous year, attributed to lower nonclinical expenses associated with the Cloudbreak platform.

Selling, general, and administrative (SG&A) expenses rose to $5.0 million in the third quarter of 2024, from $3.3 million in the same period in 2023, driven by consulting, personnel, and legal costs.

Cidara completed the sale of its rezafungin assets to Napp Pharmaceutical Group Limited on April 24, 2024. This sale represented a strategic shift with substantial impacts on Cidara's operations and financial results, classifying the financial results of rezafungin as discontinued operations.

Net loss for the third quarter of 2024 was $15.9 million, compared to $9.1 million in the same period in 2023. For the nine months ending September 30, 2024, the net loss was $117.5 million, a significant increase from $19.7 million in 2023.

Cidara Therapeutics continues to advance its innovative therapeutic programs, aiming to address serious diseases with its novel DFC candidates like CD388, while strategically managing its resources to support these developments.