• $240 million private placement financing led by RA Capital Management with significant participation by Bain Capital Life Sciences as well as BVF Partners and Canaan Partners to fund Phase 2b clinical trial
• CD388, which is active against all strains of influenza A and B, is being developed for pre-exposure prophylactic treatment
• Company to host business strategy update conference call and webcast today at 4:30 PM ET

SAN DIEGO, April 24, 2024 (GLOBE NEWSWIRE) -- Cidara Therapeutics, Inc. (Nasdaq: CDTX), a biotechnology company using its proprietary Cloudbreak^® platform to develop drug-Fc conjugate (DFC) immunotherapies designed to save lives and improve the standard of care for patients facing serious diseases, today announced that it has entered into a definitive agreement with Johnson & Johnson¹ to reacquire the exclusive global development and commercial rights to CD388, which is in development for the prevention of all strains of influenza A and B.

Concurrent with the acquisition, Cidara closed a definitive agreement for the sale of preferred stock in a private placement led by RA Capital Management, with significant participation from Bain Capital Life Sciences, Biotech Value Fund (BVF), and Canaan Partners. The private placement provides $240 million in gross proceeds that will be used by Cidara to develop CD388 as a universal preventative against seasonal and pandemic influenza A and B, beginning with a Phase 2b clinical trial in the upcoming Northern Hemisphere influenza season. The proceeds from the private placement fund the upfront payment under the agreement with Johnson & Johnson and are expected to provide runway beyond topline data from CD388’s Phase 2b trial.

CD388 is a long-acting antiviral investigational drug invented and developed by Cidara that became the subject of an exclusive worldwide license and collaboration agreement established with Johnson & Johnson in April 2021. In September 2023, Johnson & Johnson delivered to Cidara an Election to Proceed Notice and associated milestone payment for CD388 before beginning a process to transfer its rights and obligations under the agreement to another entity.

In connection with the private placement, Laura Tadvalkar, Ph.D., Managing Director at RA Capital Management, Ryan Spencer, and James Merson, Ph.D. have been appointed to Cidara’s board of directors, while David Gollaher, Ph.D. and Timothy Franson, M.D. will be stepping down. “I thank David and Tim for their invaluable contributions, which have helped facilitate this opportunity for Cidara,” said Jeffrey Stein, Ph.D., President and Chief Executive Officer of Cidara.

Dr. Stein continued, “This reacquisition of CD388, along with the capital to advance it through Phase 2b development, is transformational for Cidara and especially for those who could benefit from a long-acting, universal preventative against all forms of influenza. In our Phase 2b study later this year, we will evaluate the efficacy and safety of CD388 in providing season-long, universal protection from influenza. We believe that CD388 may have significant advantages beyond and in addition to flu vaccines, with the potential for universal protection even in the absence of a robust immune response and without the requirement for seasonal influenza strain prediction.”

All responsibility for future development, manufacturing, and commercialization activities of CD388 will be assumed by Cidara. In exchange for reacquiring the exclusive global development and commercial rights to CD388, Johnson & Johnson has received from Cidara a one-time upfront payment of $85 million and is eligible to receive potential additional development, regulatory, and commercial milestone payments.

“We have followed the development of CD388 over time with great interest,” said Dr. Tadvalkar. “As stage-agnostic company builders, we were excited to catalyze this reacquisition and financing – and to leverage the company-building capabilities of our RAVen incubator to support Cidara.”

“The support from this top-tier syndicate of new and existing investors highlights our enthusiasm and potential for CD388, the most advanced member of our Cloudbreak DFC pipeline and the new focus of the company,” added Dr. Stein. “We expect that the capital infusion from this financing, together with existing cash and the expected near-term cost savings associated with our recently announced divestiture of rezafungin to Mundipharma, positions us well to execute on the CD388 development program and advance the key assets in our pipeline.”

Conference Call and Webcast Details

Cidara will host a business strategy update conference call and webcast today, Wednesday, April 24, 2024, at 4:30 PM ET. Details can be found below.

About CD388

CD388 is an investigational drug-Fc conjugate (DFC) comprised of multiple copies of a potent small molecule neuraminidase inhibitor stably conjugated to a proprietary Fc fragment of a human antibody. DFCs are not vaccines or monoclonal antibodies but are low molecular weight biologics which are designed to function as long-acting small molecule inhibitors. CD388 was designed to provide universal protection against all known strains of seasonal and pandemic influenza with the potential to provide season-long protection with a single subcutaneous or intramuscular administration. Importantly, because CD388 is not a vaccine, its activity is not reliant on an immune response and thereby is expected to be efficacious in individuals regardless of immune status. More information can be found at: https://www.cidara.com/cloudbreak/influenza/.

About Cidara Therapeutics

Cidara is developing immunotherapeutics designed to help improve the standard of care for patients facing serious diseases. The Company’s portfolio comprises new approaches aimed at transforming existing treatment and prevention paradigms, including DFCs from its proprietary Cloudbreak® platform targeting oncologic, viral and autoimmune diseases. Cidara is headquartered in San Diego, California. For more information, please visit www.cidara.com.

About RA Capital

RA Capital Management is a multi-stage investment manager dedicated to evidence-based investing in public and private healthcare, life sciences, and planetary health companies. RA Capital forms and funds innovative companies, from private seed rounds to public follow-on financings, allowing management teams to drive value creation from inception through commercialization. RA Capital's knowledge engine is guided by our TechAtlas internal research division, and our in-house RAVen incubator offers experienced entrepreneurs a collaborative and comprehensive company creation platform to explore both the novel and the re-imagined. For more information, please visit www.racap.com.

Forward-Looking Statements

This release contains “forward-looking statements” within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended, and such forward-looking statements are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. “Forward-looking statements” describe future expectations, plans, results, or strategies and are generally preceded by words such as “anticipates,” “expect,” “may,” “plan” or “will”. Forward-looking statements in this release include, but are not limited to, statements related to the proceeds from the private placement being expected to provide runway beyond topline data from CD388’s Phase 2b trial; the reported transactions being transformational for Cidara; whether CD388 may have significant advantages beyond and in addition to flu vaccines; and Cidara’s ability to execute on the CD388 development program and advance the key assets in its pipeline. Such statements are subject to a multitude of risks and uncertainties that could cause future circumstances, events, or results to differ materially from those projected in the forward-looking statements, such as unanticipated delays in or negative results from Cidara’s pre-clinical or clinical trials, delays in action by regulatory authorities, and obstacles on the enrollment of patients or other aspects of CD388 development. These and other risks are identified under the caption “Risk Factors” in Cidara’s Annual Report on Form 10-K for the fiscal year ended December 31, 2023, and other filings subsequently made with the Securities and Exchange Commission. All forward-looking statements contained in this press release speak only as of the date on which they were made and are based on management’s assumptions and estimates as of such date. Cidara does not undertake any obligation to publicly update any forward-looking statements, whether as a result of the receipt of new information, the occurrence of future events or otherwise.

INVESTOR CONTACT:
Brian Ritchie
LifeSci Advisors
(212) 915-2578
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MEDIA CONTACT:
Michael Fitzhugh
LifeSci Communications
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Jessica Sagers
RA Capital Management
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¹ Agreement between Janssen Pharmaceuticals, Inc., a Johnson & Johnson Company, and Cidara Therapeutics, Inc.