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SAN DIEGO, May 09, 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 March 31, 2019 and provided an update on its corporate activities and product pipeline.
"Cidara made significant progress to begin 2019 by continuing to enroll patients in and advance our global Phase 3 ReSTORE trial of rezafungin for the treatment of patients with candidemia and invasive candidiasis," said Jeffrey Stein, Ph.D., president and chief executive officer of Cidara. “In addition, we nominated CB-012 as the first development candidate from our novel Cloudbreak® antiviral program targeting influenza. We have also remained active in presenting new data at key medical meetings from our rezafungin and Cloudbreak programs as they both continue to progress."
First Quarter 2019 and Subsequent Highlights
First Quarter 2019 Financial Results
Rezafungin is a novel antifungal echinocandin being developed as a once-weekly, high-exposure therapy for the 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. Rezafungin is being developed to address unmet needs in the treatment of candidemia and invasive candidiasis as well as for prophylaxis (prevention) of invasive fungal infections in patients undergoing allogeneic blood and marrow transplantation.
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 treatment of candidemia and invasive candidiasis, and is seeking funding to complete its rezafungin development plans including funding necessary for completion of the first Phase 3 treatment trial and to commence a second Phase 3 trial in the prophylaxis of invasive fungal infections in patients undergoing allogeneic blood and marrow transplantation. Rezafungin is the only once-weekly product candidate in development for the treatment and prevention of life-threatening invasive fungal infections. Cidara also is leveraging its proprietary Cloudbreak® platform to develop antiviral conjugates (AVCs) for serious infections, including further investigation of the high potency and long half-life observed in its AVCs for influenza. 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 for rezafungin to successfully treat or prevent invasive fungal infections and represent an improvement over current approaches, the potential for rezafungin in high-risk patient populations and Cidara’s ability to successfully develop rezafungin. Risks that contribute to the uncertain nature of the forward-looking statements include: Cidara's ability to obtain additional financing; the success and timing of Cidara’s preclinical studies and 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 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-Q 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
|March 31, 2019||December 31, 2018|
|Cash, cash equivalents, and short-term investments||$||57,407||$||74,562|
|Other current assets||2,869||2,567|
|LIABILITIES AND STOCKHOLDERS' EQUITY|
|Total liabilities and stockholders' equity||$||64,313||$||79,112|
Cidara Therapeutics, Inc.
Condensed Consolidated Statements of Operations
Three Months Ended
|(In thousands, except share and per share data)||2019||2018|
|Research and development||$||12,669||$||13,199|
|General and administrative||3,735||3,611|
|Total operating expenses||16,404||16,810|
|Loss from operations||(16,404||)||(16,810||)|
|Other income (expense):|
|Change in fair value of contingent forward purchase obligations||(270||)||—|
|Interest income, net||113||61|
|Total other income (expense)||(157||)||61|
|Net loss attributable to common shareholders||$||(16,561||)||$||(16,749||)|
|Basic and diluted net loss per common share||$||(0.60||)||$||(0.80||)|
|Shares used to compute basic and diluted net loss per common share||27,729,977||20,894,353|
Robert H. Uhl
Sam Brown Inc.