SAN DIEGO, Feb. 28, 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 and full year ended December 31, 2018 and provided an update on its corporate activities and product pipeline.
"Our global Phase 3 ReSTORE trial of rezafungin, for the treatment of patients with candidemia and invasive candidiasis, is enrolling patients and progressing in line with expectations. We also continue to discuss with regulatory authorities our plans for the design and initiation of our Phase 3 ReSPECT prophylaxis trial in patients undergoing allogeneic blood and marrow transplantation," said Jeffrey Stein, Ph.D., president and chief executive officer of Cidara. "In addition, we continue to advance our Cloudbreak antiviral program with development leads that have the potential to offer universal influenza prevention against known seasonal and pandemic influenza strains as well as fast-acting treatment with an expanded window of efficacy compared to existing therapies. We expect to nominate a development candidate from this program at the end of the first quarter."
Fourth Quarter 2018 and Subsequent Highlights
Fourth Quarter and Full Year 2018 Financial Results
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 continues to discuss with regulatory authorities its plans for the design and the initiation of 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 antibody-drug conjugates (ADCs) for serious viral and bacterial infections, including further investigation of the high potency and long half-life observed in its antiviral ADCs 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.
Forward-Looking Statements
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, statements regarding the initiation of rezafungin Phase 3 pivotal trials, the potential for rezafungin to be a novel treatment and prophylactic agent against deadly invasive fungal infections, rezafungin’s potential for expanded utility across patient settings, and the potential of the development leads in the Cloudbreak antiviral program, including with respect to their application and effectiveness in the treatment of influenza. Risks that contribute to the uncertain nature of the forward-looking statements include: 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 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-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
December 31, | |||||||
2018 | 2017 | ||||||
(In thousands) | |||||||
ASSETS | |||||||
Cash, cash equivalents, and short-term investments | $ | 74,562 | $ | 75,314 | |||
Other current assets | 2,567 | 2,356 | |||||
Non-current assets | 1,983 | 1,365 | |||||
Total assets | $ | 79,112 | $ | 79,035 | |||
LIABILITIES AND STOCKHOLDERS' EQUITY | |||||||
Total liabilities | $ | 19,973 | $ | 19,291 | |||
Stockholders' equity | 59,139 | 59,744 | |||||
Total liabilities and stockholders' equity | $ | 79,112 | $ | 79,035 |
Cidara Therapeutics, Inc.
Condensed Consolidated Statements of Operations
Three Months Ended December 31, | Year Ended December 31, | ||||||||||||||
(In thousands, except share and per share data) | 2018 | 2017 | 2018 | 2017 | |||||||||||
Operating expenses: | |||||||||||||||
Research and development | $ | 13,046 | $ | 10,230 | $ | 49,142 | $ | 42,823 | |||||||
General and administrative | 3,552 | 3,229 | 14,143 | 12,898 | |||||||||||
Total operating expenses | 16,598 | 13,459 | 63,285 | 55,721 | |||||||||||
Loss from operations | (16,598 | ) | (13,459 | ) | (63,285 | ) | (55,721 | ) | |||||||
Other income (expense): | |||||||||||||||
Change in fair value of contingent forward purchase obligation | 4,075 | — | 3,851 | — | |||||||||||
Interest income (expense), net | 182 | 31 | 629 | (7 | ) | ||||||||||
Other expense | (1 | ) | — | (211 | ) | — | |||||||||
Total other income (expense) | 4,256 | 31 | 4,269 | (7 | ) | ||||||||||
Net loss | $ | (12,342 | ) | $ | (13,428 | ) | $ | (59,016 | ) | $ | (55,728 | ) | |||
Recognition of beneficial conversion feature | — | — | (10,329 | ) | — | ||||||||||
Net loss attributable to common shareholders | $ | (12,342 | ) | $ | (13,428 | ) | $ | (69,345 | ) | $ | (55,728 | ) | |||
Basic and diluted net loss per common share | $ | (0.44 | ) | $ | (0.69 | ) | $ | (2.76 | ) | $ | (3.18 | ) | |||
Shares used to compute basic and diluted net loss per common share | 27,780,212 | 19,489,375 | 25,142,976 | 17,500,853 |
INVESTOR CONTACT:
Robert H. Uhl
Westwicke Partners, LLC
Managing Director
(858) 356-5932
Robert.Uhl@westwicke.com
MEDIA CONTACT:
Christy Curran
Sam Brown Inc.
(615) 414-8668
ChristyCurran@sambrown.com