Cidara Therapeutics Announces Q2 2024 Financial Results and Corporate Update

Cidara Therapeutics, Inc. (Nasdaq: CDTX), a biotechnology company based in San Diego, recently announced its financial results for the second quarter ending June 30, 2024. The company also provided an update on its activities and product pipeline. Cidara is prominently utilizing its proprietary Cloudbreak® platform to develop drug-Fc conjugate (DFC) immunotherapies aimed at enhancing the treatment standards for serious diseases.

Dr. Jeffrey Stein, Cidara's president and CEO, highlighted the company's focus on the Cloudbreak DFC platform, particularly the advancement of CD388. This long-acting influenza drug candidate is designed to offer season-long, universal protection against influenza. A Phase 2b study to evaluate CD388's efficacy and safety is scheduled to begin in the fall of 2024, during the Northern Hemisphere influenza season, with plans to enroll 4,000 subjects in the United States and 1,000 in the United Kingdom. Dr. Stein emphasized CD388's potential to provide long-term protection against both seasonal and pandemic influenza strains with a single dose per season, presenting a significant advantage over traditional vaccines.

In a series of strategic moves, Cidara reacquired the exclusive global development and commercial rights to CD388 from J&J Innovative Medicine in April 2024. This agreement allows Cidara to proceed with the Phase 2b trial set for late 2024. The reacquisition was supported by a $240 million private placement involving major investors such as RA Capital Management, Bain Capital Life Sciences, Biotech Value Fund, and Canaan Partners. The funds raised were allocated towards the $85 million upfront payment to J&J, with the remaining $155 million expected to support the trial until topline data is available.

Additionally, in April 2024, Cidara entered into an asset purchase agreement with Napp Pharmaceutical Group Limited for the divestiture of its rezafungin assets. This move is projected to save Cidara approximately $128 million over the patent life of rezafungin. Following the satisfaction of required performance obligations under a transition services agreement, Mundipharma, Napp's parent company, forgave an $11.1 million development milestone advance previously made to Cidara.

Cidara also reported receiving investigational new drug application (IND) clearance for CBO421 in July 2024.

Financially, Cidara reported revenues of $0.3 million and $1.3 million for the three and six months ending June 30, 2024, respectively. This is a significant drop from the $5.1 million and $11.3 million reported for the same periods in 2023. The decrease is attributed to the termination of the Janssen Collaboration Agreement, which was replaced by the Janssen License Agreement in April 2024. As of June 30, 2024, Cidara's cash and cash equivalents totaled $164.4 million, up from $35.8 million at the end of 2023.

Research and development expenses were $6.7 million for the quarter, down from $8.7 million in the same period in 2023, largely due to decreased nonclinical expenses. However, selling, general, and administrative expenses increased to $4.7 million from $3.2 million, reflecting higher consulting, personnel, and legal costs.

The sale of rezafungin represented a significant strategic shift, impacting Cidara's operations and financial results. The net income from discontinued operations for the second quarter was $3.0 million, compared to a net loss of $7.5 million in the same period in 2023.

Overall, Cidara reported a net loss of $91.2 million for the second quarter of 2024, a substantial increase from the $13.6 million net loss in the same period of 2023. No shares of common stock were sold during this period under the at-the-market sales agreement.

As of June 30, 2024, Cidara had 4,568,991 shares of common stock outstanding, with additional shares of Series A and Series X Convertible Preferred Stock that are convertible into common shares. Following shareholder approval in July 2024, Cidara issued 2,469,250 shares of common stock upon the automatic conversion of 35,275 shares of Series A Convertible Voting Preferred Stock, bringing the total outstanding common shares to 7,038,241.

Cidara Therapeutics continues to leverage its Cloudbreak® platform to develop innovative DFCs aimed at addressing serious diseases, with a particular focus on enhancing the standard of care for patients.