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SAN DIEGO, Aug. 08, 2019 (GLOBE NEWSWIRE) -- Cidara Therapeutics, Inc. (Nasdaq: CDTX), a biotechnology company developing novel anti-infectives, including immunotherapies, today reported financial results for the three months ended June 30, 2019 and provided an update on its corporate activities and product pipeline.
"We have made important advances in both our rezafungin program to treat and prevent fungal disease as well as our Cloudbreak® immunotherapy program for the treatment and prevention of influenza," said Jeffrey Stein, Ph.D., president and chief executive officer of Cidara. “Rezafungin achieved positive topline results in its Phase 2 STRIVE B trial, which adds to the growing body of evidence supporting the efficacy and safety of this once-weekly treatment for candidemia and invasive candidiasis, and we continue to enroll patients in our Phase 3 ReSTORE trial. Our Cloudbreak influenza development candidate represents a truly novel approach that has the potential to provide both single-dose long term protection from, as well as rapid treatment of, influenza infections caused by all seasonal and pandemic strains of the virus. Our vision is to develop it as the first once-per-flu-season drug with universal activity."
Second Quarter 2019 and Subsequent Highlights
Second Quarter 2019 Financial Results
Rezafungin is a novel echinocandin antifungal and the only once-weekly drug candidate being developed for the first-line treatment and prevention of serious invasive fungal infections. Rezafungin has a unique pharmacokinetic profile with a prolonged half-life and front-loaded plasma exposure which, in contrast to all other echinocandins, allows for once-weekly IV therapy for inpatient and outpatient use. The U.S. Food and Drug Administration (FDA) has designated rezafungin as a Qualified Infectious Disease Product (QIDP) with Fast Track status and orphan drug designation related to its use in the treatment of candidemia and invasive candidiasis.
About Cidara Therapeutics
Cidara is a clinical-stage biotechnology company focused on the discovery, development and commercialization of novel anti-infectives that have the potential to transform the standard of care and save or improve patients’ lives. Cidara is currently advancing its novel echinocandin antifungal, rezafungin acetate, in a Phase 3 clinical trial for the first-line treatment of candidemia and/or invasive candidiasis (ReSTORE). A second Phase 3 trial of once-weekly rezafungin for prophylaxis against invasive fungal infections in patients undergoing allogeneic blood and marrow transplantation (ReSPECT) is planned pending adequate funding and approval from the relevant regulatory authorities. In addition to its robust rezafungin clinical program, Cidara is applying its proprietary Cloudbreak® platform to develop antiviral conjugates (AVCs) for the prevention and treatment of influenza and other viral diseases. The Cloudbreak platform is designed to discover compounds that both directly kill pathogens and direct a patient’s immune system to attack and eliminate pathogens. Cidara is headquartered in San Diego, California. For more information, please visit www.cidara.com.
Statements contained in this press release regarding matters that are not historical facts are "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. Because such statements are subject to risks and uncertainties, actual results may differ materially from those expressed or implied by such forward-looking statements. Such statements include, but are not limited to, the potential of Cidara’s anti-infectives to transform the standard of care and save or improve patients’ lives and the anticipated timing of the ReSPECT clinical trial. Risks that contribute to the uncertain nature of the forward-looking statements include: the success and timing of Cidara’s clinical trials; regulatory developments in the United States and foreign countries; changes in Cidara’s plans to develop and commercialize its product candidates; Cidara’s ability to obtain additional financing; Cidara’s ability to obtain and maintain intellectual property protection for its product candidates; and the loss of key scientific or management personnel. These and other risks and uncertainties are described more fully in Cidara’s Form 10-K most recently filed with the United States Securities and Exchange Commission. All forward-looking statements contained in this press release speak only as of the date on which they were made. Cidara undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made.
Cidara Therapeutics, Inc.
Condensed Consolidated Balance Sheets
|June 30, 2019||December 31, 2018|
|Cash, cash equivalents, and short-term investments||$||44,573||$||74,562|
|Other current assets||3,173||2,567|
|LIABILITIES AND STOCKHOLDERS' EQUITY|
|Total liabilities and stockholders' equity||$||51,752||$||79,112|
Cidara Therapeutics, Inc.
Condensed Consolidated Statements of Operations
Three Months Ended
Six Months Ended
|(In thousands, except share and per share data)||2019||2018||2019||2018|
|Research and development||$||10,743||$||11,619||$||23,412||$||24,818|
|General and administrative||3,525||3,533||7,260||7,144|
|Total operating expenses||14,268||15,152||30,672||31,962|
|Loss from operations||(14,268||)||(15,152||)||(30,672||)||(31,962||)|
|Other income (expense):|
|Change in fair value of contingent forward purchase obligations||681||(1,112||)||411||(1,112||)|
|Interest income, net||40||164||153||225|
|Total other income (expense)||721||(1,154||)||564||(1,093||)|
|Net loss attributable to common shareholders||(13,547||)||(16,306||)||(30,108||)||(33,055||)|
|Recognition of beneficial conversion feature||—||(10,329||)||—||(10,329||)|
|Net loss attributable to common shareholders||$||(13,547||)||$||(26,635||)||(30,108||)||(43,384||)|
|Basic and diluted net loss per common share||$||(0.49||)||$||(1.13||)||$||(1.23||)||$||(1.93||)|
|Shares used to compute basic and diluted net loss per common share||27,786,808||23,592,763||24,538,443||22,500,061|
Robert H. Uhl
Sam Brown Inc.