Cidara Therapeutics Receives $20 Million Milestone Payment Following FDA Approval of REZZAYO™

Rhea-AI Summary

Cidara Therapeutics (Nasdaq: CDTX) has announced the FDA approval of REZZAYO™ (rezafungin for injection), a novel once-weekly echinocandin for treating candidemia and invasive candidiasis. The company received a $20 million milestone payment from Melinta Therapeutics, which acquired U.S. commercialization rights for REZZAYO. This marks the first new echinocandin approved in over a decade, addressing urgent treatment needs. Cidara is also eligible for an additional $47 million in milestones from existing partnerships based on successful completion of planned activities. With a year-end cash balance of $32.7 million and additional funding, Cidara aims to extend its cash runway. The company continues advancing its drug-Fc conjugate programs in oncology and autoimmune indications, with positive data from a Phase 2a trial.

Positive

• FDA approval of REZZAYO™ opens new market opportunities.
• Cidara received a $20 million milestone payment from Melinta, enhancing cash flow.
• Eligibility for an additional $47 million in non-dilutive capital strengthens financial position.
• Successful Phase 2a trial data supports ongoing drug-Fc conjugate development.

Negative

• Approval based on limited clinical safety and efficacy data raises caution.
• REZZAYO not studied in certain severe conditions, limiting its use.

– U.S. launch of REZZAYO by Melinta expected in mid-2023 –
– Company eligible to receive up to an additional $47 million in milestones from multiple existing partnerships based on successful completion of activities planned over the next year –

SAN DIEGO, April 24, 2023 (GLOBE NEWSWIRE) -- Cidara Therapeutics, Inc. (Nasdaq: CDTX), a biotechnology company developing long-acting therapeutics designed to save lives and improve the standard of care for patients facing serious diseases, today announced receipt of a $20 million milestone payment from Melinta Therapeutics following the U.S. Food and Drug Administration (FDA) approval of REZZAYO™ (rezafungin for injection), a novel, once-weekly echinocandin antifungal approved for the treatment of candidemia and invasive candidiasis.

Last month, REZZAYO became the first new FDA-approved echinocandin in over a decade for once weekly use in adults with limited or no alternative treatment options. The approval was based on positive data from Cidara’s global ReSTORE Phase 3 trial and supported by the STRIVE Phase 2 clinical trial and extensive non-clinical development program. Last year, Melinta acquired exclusive rights to commercialize REZZAYO in the U.S. from Cidara.

“We look forward to Melinta bringing REZZAYO to the U.S. market, which is in urgent need of new treatment options for patients with often deadly fungal infections. Receipt of this milestone payment is an important next step in redirecting Cidara’s focus to our Cloudbreak^® drug-Fc conjugate (DFC) programs in oncologic and autoimmune indications,” said Jeffrey Stein, Ph.D., president and chief executive officer of Cidara. “With the $20 million milestone payment from Melinta, Cidara remains eligible to receive additional non-dilutive capital of up to approximately $47 million in development and regulatory milestones from our existing partnerships based on successful completion of activities planned for the next year. The Company’s 2022 year-end cash balance of $32.7 million, this $20 million milestone payment from Melinta, and proceeds from the recent financing and at-the-market offerings, along with the eligibility to receive non-dilutive capital of approximately $47 million from existing partnerships over the next year, has the potential to extend our cash runway without the need to rely on equity markets to raise additional capital in the near-term.”

Cidara is currently advancing its Cloudbreak^® DFC program in an ongoing Phase 2a trial being conducted in collaboration with Janssen that is evaluating the pre-exposure prophylactic activity of CD388 against the H3N2 influenza A virus strain. The Company recently announced positive interim efficacy and safety data from the Phase 2a study. Cidara is additionally advancing its first oncology DFC candidate, CD421, a first-in-class inhibitor of CD73, with an IND anticipated in 2024.

About Cidara Therapeutics
Cidara is developing long-acting therapeutics designed to 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 drug-Fc conjugates (DFCs) from its proprietary Cloudbreak^® platform targeting oncologic and viral diseases. In addition, Cidara recently received FDA approval for REZZAYO™ (rezafungin for injection), which it has licensed to multiple partners to commercialize in the U.S. and ex-U.S. Cidara is headquartered in San Diego, California. For more information, please visit www.cidara.com.

About REZZAYO™ (rezafungin for injection)
REZZAYO (rezafungin for injection) is a novel once-weekly echinocandin approved in the United States for the treatment of candidemia and invasive candidiasis in adults. REZZAYO is currently being studied for the prevention of invasive fungal diseases in adults undergoing allogeneic blood and marrow transplantation. The structure and properties of REZZAYO are specifically designed to improve upon a clinically validated mechanism.

INDICATIONS AND USE
REZZAYO is an echinocandin antifungal indicated in patients 18 years of age or older who have limited or no alternative options for the treatment of candidemia and invasive candidiasis. Approval of this indication is based on limited clinical safety and efficacy data.

REZZAYO has not been studied in patients with endocarditis, osteomyelitis, and meningitis due to Candida.

IMPORTANT SAFETY INFORMATION
REZZAYO is contraindicated in patients with known hypersensitivity to rezafungin or other echinocandins.

REZZAYO may cause infusion-related reactions, including flushing, sensation of warmth, urticaria, nausea, or chest tightness. If these reactions occur, slow or pause the infusion.

REZZAYO may cause photosensitivity. Advise patients to use protection from sun exposure and other sources of UV radiation.

Abnormalities in liver tests have been seen in clinical trial patients treated with REZZAYO. Monitor patients who develop abnormal liver tests and evaluate patients for their risk/benefit of continuing REZZAYO therapy.

Most common adverse reactions (incidence 5%) are hypokalemia, pyrexia, diarrhea, anemia, vomiting, nausea, hypomagnesemia, abdominal pain, constipation, and hypophosphatemia.

Please see the full Prescribing Information for REZZAYO (rezafungin for injection), available at www.rezzayo.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,” “believe,” “could,” “expect,” “may,” “plan” or “will”. Forward-looking statements in this release include, but are not limited to, statements related to Melinta’s ability to launch rezafungin in the U.S., the completion of the ongoing global Phase 3 ReSPECT prophylaxis study, whether CD388, CD421, or any Cloudbreak DFC candidate will be safe or effective, whether we will submit an IND for CD421, and whether we will receive any of the milestone payments for which we are eligible in the next year. 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 preclinical or clinical trials, delays in action by regulatory authorities due to limitations on inspections and other COVID-19-related effects, and impacts of the COVID-19 pandemic or other 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, 2022 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
britchie@lifesciadvisors.com

Media Contact:
Veronica Eames
LifeSci Communications
646-970-4682
veames@lifescicomms.com

FAQ

What is REZZAYO™ and its importance?

REZZAYO™ (rezafungin for injection) is a novel echinocandin approved for treating candidemia and invasive candidiasis, representing the first new treatment option in over a decade.

What are the financial implications for CDTX after the milestone payment?

Cidara received a $20 million milestone payment from Melinta, contributing to a cash balance of $32.7 million and eligibility for an additional $47 million in milestones.

When is the U.S. launch of REZZAYO™ expected?

The U.S. launch of REZZAYO by Melinta is expected in mid-2023.

What are the ongoing programs at Cidara Therapeutics?

Cidara is advancing its Cloudbreak® drug-Fc conjugate programs, including ongoing trials for CD388 against H3N2 influenza and CD421 for oncology.