Cidara Therapeutics Provides Corporate Update and Reports

SAN DIEGO, Nov. 03, 2022 (GLOBE NEWSWIRE) — Cidara Therapeutics, Inc. (NASDAQ: CDTX), a biotechnology firm creating long-acting therapeutics designed to assist enhance the usual of take care of sufferers dealing with critical ailments, immediately reported monetary outcomes for the third quarter ended September 30, 2022 and supplied an replace on its company actions and product pipeline.

“The FDA’s acceptance of our NDA for priority review for rezafungin marks a significant milestone for Cidara and brings us one step closer to potentially deliver an important treatment option for patients fighting candidemia and invasive candidiasis, which are difficult-to-treat and often deadly,” stated Jeffrey Stein, Ph.D., president and chief government officer of Cidara. “If approved, rezafungin could be the first new drug for the treatment of invasive Candida infections in over a decade. In addition, our balance sheet was recently strengthened by the $11.1 million milestone payment from Mundipharma, and our eligibility to receive additional milestone payments from multiple existing collaborations over the next two years has the potential to further bolster our financial position in a non-dilutive manner.”

Dr. Stein continued, “Our Cloudbreak® program continues to advance, with the recent dosing of the first healthy volunteers in our Phase 2a trial of CD388, a highly potent, long-acting antiviral designed to deliver universal prevention and treatment of seasonal and pandemic influenza, that we are developing in partnership with Janssen. We look forward to providing further updates on this clinical program in the first half of next year.”

Recent Corporate Highlights

• Announced license settlement with Melinta Therapeutics, LLC: In July 2022, Cidara introduced it entered right into a license settlement with Melinta Therapeutics, LLC (Melinta) underneath which Cidara has granted Melinta an unique license to commercialize rezafungin within the U.S. Under the phrases of the settlement, Cidara obtained a $30.0 million upfront cost and is eligible to obtain $60.0 million in regulatory milestone funds and as much as $370.0 million in business milestone funds, representing a complete potential transaction worth of $460.0 million, plus tiered royalties on U.S. gross sales of rezafungin within the low double digits to mid-teens, topic to offset for sure bills incurred by Melinta. Cidara retains the rights to rezafungin in Japan, whereas Mundipharma retains the business rights to rezafungin exterior the U.S. and Japan.
• Presented at 24^th Annual H.C. Wainwright Global Investment Conference: In September 2022, Dr. Stein participated within the 24^th Annual H.C. Wainwright Global Investment Conference.
• Announced initiation of Phase 2a human viral problem trial of CD388: In September 2022, Cidara introduced the initiation of its Phase 2a trial to guage the pre-exposure prophylactic exercise of CD388 in opposition to influenza virus. The Phase 2a trial, which dosed its first wholesome volunteer in September 2022, is a single-center, randomized, double-blind, placebo-controlled, proof-of-concept examine to evaluate the prophylactic antiviral exercise, security, tolerability and pharmacokinetics of CD388 in opposition to influenza through a human viral problem (influenza) mannequin. Multiple dose ranges of CD388 will likely be evaluated in volunteers who will obtain a single administration of CD388 or placebo previous to influenza viral problem. The trial is predicted to enroll as much as 168 wholesome adults. The examine is being performed underneath an unique worldwide license and collaboration settlement with Janssen, and outcomes are anticipated within the first half of 2023.
• Announced FDA acceptance for precedence assessment of NDA for rezafungin: In September 2022, Cidara introduced that the U.S. Food and Drug Administration (FDA) accepted for submitting and granted Priority Review to its New Drug Application (NDA) for rezafungin for the therapy of candidemia and invasive candidiasis. The FDA has assigned a Prescription Drug User Fee Act (PDUFA) goal motion date of March 22, 2023, enabled by rezafungin’s designation as a Qualified Infectious Disease Product (QIDP) and has indicated that it’s presently planning to carry an advisory committee assembly to debate the appliance. The NDA submission for rezafungin was supported by constructive scientific information from the worldwide ReSTORE Phase 3 and STRIVE Phase 2 scientific trials.
• Received $11.1 million milestone cost from Mundipharma: In October 2022, Cidara introduced the receipt of an $11.1 million milestone cost in September 2022 from Mundipharma underneath the collaboration and licensing settlement established between the 2 firms in September 2019. The cost was made in reference to the European Medicines Agency (EMA) acceptance of the advertising authorization software (MAA) for rezafungin for the therapy of candidemia and invasive candidiasis in grownup sufferers. Cidara is eligible to obtain as much as an combination of $107.6 million in extra growth and regulatory milestone funds from its present collaborations with Mundipharma, Janssen, and Melinta, based mostly on profitable completion of actions deliberate for the subsequent two years.
• Presented new information for rezafungin at IDWeek 2022: In October 2022, Cidara introduced new scientific and preclinical information for rezafungin in six poster displays at IDWeek 2022. Cidara additionally participated in a pipeline symposium targeted on new antimicrobials and ID diagnostics. The information introduced helps the goal product profile of rezafungin as a possible new agent for the therapy and prevention of great fungal infections.

Third Quarter 2022 Financial Results

• Revenue totaled $40.7 million and $54.1 million for the three and 9 months ended September 30, 2022, in contrast with $7.1 million and $42.3 million for a similar intervals of 2021. Revenue for the three and 9 months ended September 30, 2022 included $25.9 million of income acknowledged upon switch of an mental property license to Melinta in August 2022. Revenue for the 9 months ended September 30, 2021 included $27.0 million of income acknowledged upon switch of an mental property license to Janssen in May 2021. The remaining income for all intervals pertains to the achievement of milestones and ongoing analysis and growth and scientific provide companies supplied to Mundipharma, Janssen and Melinta.
• Cash and money equivalents totaled $53.1 million as of September 30, 2022, in contrast with money, money equivalents and restricted money of $62.3 million as of December 31, 2021.
• Research and growth bills had been $20.0 million and $55.5 million for the three and 9 months ended September 30, 2022, in comparison with $20.5 million and $54.1 million for a similar intervals in 2021. The analysis and growth bills for all intervals primarily relate to scientific bills related to the rezafungin scientific trials and drug manufacturing prices, in addition to scientific bills related to the Cloudbreak antiviral platform.
• General and administrative bills had been $5.8 million and $15.1 million for the three and 9 months ended September 30, 2022, in comparison with $4.6 million and $13.8 million for a similar interval in 2021.
• Net earnings for the three months ended September 30, 2022 was $15.0 million, in comparison with a web lack of $18.1 million for a similar interval in 2021. For the 9 months ended September 30, 2022 and 2021, web loss was $16.4 million and $25.7 million, respectively.
• As of September 30, 2022, Cidara had 71,181,197 shares of widespread inventory excellent, and 1,818,472 shares of Series X Convertible Preferred Stock excellent, that are convertible into 18,184,720 shares of widespread inventory.

About Cidara Therapeutics

Cidara is creating long-acting therapeutics designed to enhance the usual of take care of sufferers dealing with critical ailments. The Company’s portfolio is comprised of latest approaches aimed toward reworking present prevention and therapy paradigms, first with its lead Phase 3 antifungal candidate, rezafungin, along with DFCs concentrating on viral and oncology ailments from Cidara’s proprietary Cloudbreak platform. Cidara is headquartered in San Diego, California. For extra data, please go to www.cidara.com.

Forward-Looking Statements

This launch incorporates “forward-looking statements” throughout the which means 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 secure harbor provisions of the Private Securities Litigation Reform Act of 1995. Words resembling “could,” “expect,” “potential,” “will” and comparable expressions (in addition to different phrases or expressions referencing future occasions, situations or circumstances) convey uncertainty of future occasions or outcomes and are meant to determine these forward-looking statements. Forward-looking statements describe future expectations, plans, outcomes, or methods, amongst different issues, and on this launch embody, however are usually not restricted to, Cidara’s skill to ship rezafungin as an necessary therapy choice for sufferers combating candidemia and invasive candidiasis, the potential for the extra milestone funds from Cidara’s collaborations to bolster its stability sheet, statements associated as to whether the FDA will settle for the rezafungin NDA for submitting and assign a Prescription Drug User Fee Act (PDUFA) date; and whether or not the rezafungin NDA will likely be authorised within the anticipated time-frame or in any respect. Such statements are topic to a mess of dangers and uncertainties that might trigger future circumstances, occasions, or outcomes to vary materially from these projected within the forward-looking statements, resembling unanticipated delays in or detrimental outcomes from Cidara’s preclinical or scientific trials, delays in motion by regulatory authorities on account of limitations on inspections and different COVID-19-related results, and impacts of the COVID-19 pandemic or different obstacles on the enrollment of sufferers or different facets of CD388 growth. These and different dangers are recognized underneath the caption “Risk Factors” in Cidara’s most up-to-date Quarterly Report on Form 10-Q and different filings subsequently made with the Securities and Exchange Commission. All forward-looking statements contained on this press launch communicate solely as of the date on which they had been made and are based mostly on administration’s assumptions and estimates as of such date. Cidara doesn’t undertake any obligation to publicly replace any forward-looking statements, whether or not because of the receipt of latest data, the incidence of future occasions or in any other case.

INVESTOR CONTACT:
Brian Ritchie
LifeSci Advisors
(212) 915-2578
[email protected]

MEDIA CONTACT:
Patrick Bursey
LifeSci Communications
(203) 430-9545
[email protected]