Cidara Therapeutics, Inc. is a biotechnology company at the forefront of developing novel therapies to combat serious diseases. Through its proprietary Cloudbreak platform, Cidara is pioneering the creation of drug-Fc conjugates (DFCs) - a transformative approach that combines potent disease-targeting activity with immune system engagement in a single long-acting molecule.

Business Overview and History

Cidara was originally incorporated in Delaware in December 2012 as K2 Therapeutics, Inc., with its name changing to Cidara Therapeutics, Inc. in July 2014. The company's mission has been to leverage cutting-edge science to address unmet medical needs, initially focusing on developing antifungal treatments.

In March 2016, Cidara formed a wholly-owned subsidiary, Cidara Therapeutics UK Limited, in England. This was followed by the establishment of another wholly-owned subsidiary, Cidara Therapeutics Ireland Limited, in Ireland in October 2018, with the purpose of developing its product candidates in Europe.

The company's efforts in antifungal treatments culminated in the approval and commercialization of REZZAYO (rezafungin) in 2023 for the treatment of candidemia and invasive candidiasis in adults with limited or no alternative treatment options. This marked Cidara's first commercially approved product in the United States.

In March 2021, Cidara entered into an exclusive, worldwide license and collaboration agreement with Janssen Pharmaceuticals, Inc., one of the Janssen Pharmaceutical Companies of Johnson & Johnson. This partnership was focused on developing and commercializing one or more DFCs based on Cidara's Cloudbreak platform for the prevention and treatment of influenza, including CD388 and CD377. The collaboration enabled the successful completion of Phase 1 and Phase 2a studies for CD388, demonstrating its potential as a highly potent, single-dose preventative against both seasonal and pandemic influenza.

However, in 2023, Janssen's strategic shift led them to deprioritize the CD388 program. Recognizing the transformative opportunity CD388 presented, Cidara acted quickly to reacquire the full rights through a license and technology transfer agreement on April 23, 2024, paying Janssen an upfront fee of $85 million.

Concurrent with the CD388 reacquisition, Cidara closed a $240 million private placement led by prominent life sciences investors. This infusion of capital has enabled the company to initiate a pivotal Phase 2b NAVIGATE trial evaluating CD388 as a single-dose, universal preventative against seasonal influenza A and B.

In a significant strategic move, on April 24, 2024, Cidara entered into an Asset Purchase Agreement with Napp Pharmaceutical Group Limited, an affiliate of Mundipharma Medical Company, pursuant to which Cidara sold all of its rezafungin assets and related contracts. This decision allowed the company to focus its resources on the development of CD388 and other potential DFC candidates from its Cloudbreak platform.

Product Segments

Cidara's operations are primarily focused on two main product segments: the Cloudbreak platform and the rezafungin product (now discontinued).

Cloudbreak Platform

The Cloudbreak platform is Cidara's primary focus and is used to develop drug-Fc conjugate (DFC) immunotherapies. The lead Cloudbreak candidate is CD388, a DFC designed for the prevention and treatment of influenza. In 2024, Cidara completed a Phase 1 clinical trial and a Phase 2a clinical trial of CD388 to evaluate its pre-exposure prophylactic activity against influenza virus. The company initiated the CD388 Phase 2b NAVIGATE study in September 2024, which is a randomized, double-blinded, controlled trial to compare the rates of laboratory-confirmed clinical influenza between different single dose levels of CD388 and placebo over an influenza season. Cidara expects to report topline data from the Phase 2b study in the third quarter of 2025.

In addition to CD388, Cidara's Cloudbreak platform is also being used to develop other DFC product candidates, including CBO421, a DFC targeting CD73 for the treatment of solid tumors. CBO421 received IND clearance from the FDA in July 2024, though the company does not currently plan to initiate clinical trials for any oncology product candidates, and is instead focusing business development discussions on its oncology DFC programs.

Rezafungin (Discontinued)

Rezafungin was Cidara's first commercially approved product in the United States, indicated for the treatment of candidemia and invasive candidiasis in adults with limited or no alternative treatment options. However, in April 2024, Cidara entered into an asset purchase agreement with Napp Pharmaceutical Group Limited to sell all of its rezafungin assets and related contracts. The company determined that the sale of rezafungin represented a strategic shift that would have a major effect on its operations and financial results, and accordingly classified the rezafungin business as discontinued operations.

Financials

As of September 30, 2024, Cidara reported cash and cash equivalents of $127.4 million, which the company expects will provide sufficient liquidity to support its planned operations through the middle of the fourth quarter of 2025. The company's net loss for the nine months ended September 30, 2024 was $117.5 million.

For the nine months ended September 30, 2024, Cidara reported collaboration revenue of $1.3 million, which was related to research and development and clinical supply services provided to Janssen under a prior collaboration agreement. The company also incurred $84.9 million in acquired in-process research and development expenses, primarily related to an $85 million upfront payment made to Janssen to reacquire the rights to CD388. Research and development expenses for the nine-month period were $25 million, and selling, general and administrative expenses were $13.3 million.

In the most recent quarter, Cidara reported no revenue, a net loss of $15.5 million, operating cash flow of -$36.7 million, and free cash flow of -$36.8 million. The company did not provide year-over-year growth figures for the most recent quarter.

Cidara's liquidity position shows a current ratio and quick ratio of 3.54, indicating a strong ability to meet short-term obligations. The company's debt-to-equity ratio is not available, suggesting minimal or no long-term debt.

Quarterly Performance and Outlook

In the third quarter of 2024, Cidara reported a net loss of $16 million, or $2.45 per share. This included a $1.2 million charge related to a 30% workforce reduction as the company streamlined its operations to focus on the clinical development of CD388.

Looking ahead, Cidara has initiated the CD388 Phase 2b NAVIGATE trial, which is designed to enroll 5,000 healthy, unvaccinated adults across the U.S. and U.K. The company expects to report topline data from this study in the third quarter of 2025, which could serve as a significant catalyst if the results demonstrate CD388's potential as a highly effective, single-dose preventative against seasonal influenza.

Geographic Markets

Cidara appears to only sell products in the United States and does not disclose performance by geographic market.

Risks and Challenges

As with any biotechnology company, Cidara faces several risks and challenges. The successful development and commercialization of CD388 is critical to the company's future, and any delays or setbacks in the clinical trial process could have a significant impact on the stock. Additionally, Cidara will need to secure additional funding to advance CD388 beyond the Phase 2b trial, and there is no guarantee that it will be able to do so on favorable terms.

The company also faces competition from other influenza treatments and preventatives, as well as the potential for regulatory hurdles and reimbursement challenges. Cidara's reliance on third-party manufacturers and contractors for key aspects of its operations adds further uncertainty to its business model.

Conclusion

Cidara Therapeutics is a biotechnology company with a bold vision and a unique platform for developing innovative therapies. The reacquisition of CD388 and the successful $240 million private placement have positioned the company to advance this promising influenza drug candidate through a pivotal Phase 2b trial. If the NAVIGATE study data supports CD388's efficacy and safety, Cidara could emerge as a leader in the fight against seasonal and pandemic influenza, a market estimated to be worth billions of dollars annually. While the company faces significant risks and challenges, its innovative Cloudbreak platform and laser-focus on CD388 make it a compelling investment opportunity for those willing to take on the inherent volatility of the biotech sector.