Cidara Therapeutics Q1 2024 Financial Results and Corporate Update

28 June 2024

May 15, 2024 – Cidara Therapeutics, Inc. (Nasdaq: CDTX) reported its financial results for the first quarter ending March 31, 2024, and provided an update on its corporate activities and product pipeline. The company is applying its proprietary Cloudbreak® platform to develop drug-Fc conjugate (DFC) immunotherapies aimed at significantly improving patient care for serious diseases.

CEO Jeffrey Stein, Ph.D., highlighted the strategic shift following the reacquisition of the CD388 program from Janssen Pharmaceuticals, Inc., which is part of Johnson & Johnson. CD388 is being developed as a universal preventative treatment for influenza A and B, intended for once-per-season administration. This reacquisition, along with the divestiture of the rezafungin program to Mundipharma, allows Cidara to concentrate its efforts on the Cloudbreak DFC platform. The company plans to begin a Phase 2b clinical trial for CD388 during the upcoming Northern Hemisphere influenza season to evaluate its efficacy and safety in providing universal protection from influenza.

Dr. Stein also announced the closing of a $240.0 million private placement led by RA Capital Management, with significant participation from Bain Capital Life Sciences, Biotech Value Fund (BVF), and Canaan Partners. This funding underscores the potential of CD388, which could offer universal protection against influenza without the need for annual strain prediction or a robust immune system. 

In April 2024, Cidara finalized a definitive agreement with Janssen to reacquire the exclusive global development and commercial rights to CD388. The Phase 2b clinical trial protocol is being finalized, with the study expected to commence during the next influenza season.

The $240.0 million private placement was part of the strategy to fund the reacquired CD388 program. This financing was crucial for the upfront payment of $85.0 million to Janssen, with the remaining $155.0 million expected to support the company beyond the Phase 2b trial's top-line data.

Cidara also divested its rezafungin program to Mundipharma in April 2024. This divestiture is projected to save approximately $128.0 million over the patent life of rezafungin.

In connection with the private placement, Cidara appointed three new members to its Board of Directors: Dr. Laura Tadvalkar of RA Capital Management, Ryan Spencer, CEO of Dynavax Technologies, and Dr. James Merson, former Global Therapeutic Area Head for Infectious Diseases at Janssen Research & Development. Simultaneously, David Gollaher, Ph.D., and Timothy Franson, M.D., stepped down from the Board.

Additionally, on April 12, 2024, Cidara’s Board approved a 1-for-20 reverse stock split, effective April 22, 2024. The company’s stock began trading on a split-adjusted basis on April 24, 2024, under a new CUSIP number but remained listed on Nasdaq under the symbol “CDTX”.

At the 34th European Society of Clinical Microbiology and Infectious Diseases (ESCMID) conference in April 2024, Cidara presented data from the Phase 2a study of CD388, which demonstrated significant antiviral effects and good tolerability in healthy volunteers. Also, at the AACR Annual Meeting 2024, Cidara showcased new data on several novel Cloudbreak DFC candidates, emphasizing their potential in oncology.

First-quarter financial results for 2024 showed revenues of $8.5 million, down from $26.1 million in the same period the previous year. The decrease primarily reflects the timing of milestone achievements and various research, development, and supply services. Research and development expenses were $11.6 million, down from $18.9 million, while selling, general, and administrative expenses rose to $6.0 million from $4.5 million. The net loss for the quarter was $10.3 million, compared to a net income of $3.0 million in the first quarter of 2023.

As of March 31, 2024, Cidara held $29.0 million in cash and cash equivalents, a decrease from $35.8 million at the end of 2023. The company had 4,561,696 shares of common stock outstanding and 2,104,472 shares of Series X Convertible Preferred Stock, convertible into 1,052,236 shares of common stock.

Cidara Therapeutics continues to leverage its Cloudbreak® platform to develop innovative DFC immunotherapies, aiming to advance the standard of care for patients with severe diseases.

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