SAN DIEGO, Nov. 08, 2017 (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 September 30, 2017 and provided an update on its corporate activities and product pipeline.
“We are pleased to report Cidara’s continued progress during the third quarter of 2017 and subsequently, including receiving clarity on the regulatory path for our planned Phase 3 programs in treatment and prophylaxis for rezafungin acetate, which is our new non-proprietary name for CD101,” said Jeffrey Stein, Ph.D., president and chief executive officer of Cidara. “With topline results from our STRIVE Phase 2 trial for rezafungin in candidemia and invasive candidiasis expected in the first quarter of 2018, coupled with a strengthened cash position after our October PIPE financing, we are a step closer to realizing the potential for rezafungin to improve patients’ lives and to generate value for our stockholders.”
Rezafungin Program Update
Rezafungin (formerly known as CD101) treatment program
Rezafungin prophylaxis program
Non-proprietary name
Other Third Quarter 2017 and Subsequent Highlights
Third Quarter 2017 Financial Results
Webcast and Conference Call
Cidara management will host a webcast and conference call regarding this announcement at 4:05 p.m. EST/1:05 p.m. PST today. The live call may be accessed by dialing 844-358-8763 for domestic callers, or 703-736-7375 for international callers, using conference ID # 2899958. A live webcast of the call will be available online in the investor relations section of Cidara’s website at www.cidara.com and will be archived there for 30 days.
About Cidara Therapeutics
Cidara is a clinical-stage biotechnology company focused on developing new anti-infectives that have the potential to transform the standard of care and save or improve patients’ lives. The company is currently advancing its novel echinocandin antifungal, rezafungin acetate, through Phase 2 and developing CD201, its bispecific antibiotic immunotherapy, for the treatment of multi-drug resistant Gram-negative bacterial infections. Rezafungin has improved pharmacokinetics compared to existing echinocandins and has the potential for expanded utility across patient settings. Rezafungin is the only once-weekly product candidate in development for the treatment and prevention of life-threatening invasive fungal infections. CD201 is the first drug candidate selected from Cidara’s novel Cloudbreak™ platform, the first immunotherapy discovery platform designed specifically to create compounds that directly kill bacterial, fungal or viral pathogens and also direct a patient’s immune cells to attack and eliminate such pathogens. Cidara has received a grant for up to $6.9 million from CARB-X (Combating Antibiotic Resistant Bacteria Accelerator) to advance the development of CD201 and back-up candidates. 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 effectiveness, safety, and other attributes of rezafungin and CD201 and other potential product candidates, including the potential for these compounds to successfully treat or prevent infections, including those caused by resistant pathogens, and potentially transform the way infectious diseases are treated, the design and timing of rezafungin Phase 3 clinical trials, and the potential for the Cloudbreak platform to result in future drug candidates. 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
September 30, 2017 | December 31, 2016 | ||||||
(In thousands) | (unaudited) | ||||||
ASSETS | |||||||
Cash, cash equivalents, and short-term investments | $ | 64,152 | $ | 104,619 | |||
Other current assets | 2,051 | 779 | |||||
Non-current assets | 1,233 | 1,564 | |||||
Total assets | $ | 67,436 | $ | 106,962 | |||
LIABILITIES AND STOCKHOLDERS' EQUITY | |||||||
Total liabilities | $ | 16,863 | $ | 18,783 | |||
Stockholders' equity | 50,573 | 88,179 | |||||
Total liabilities and stockholders' equity | $ | 67,436 | $ | 106,962 | |||
Cidara Therapeutics, Inc.
Condensed Consolidated Statements of Operations
(unaudited)
Three Months Ended September 30, | Nine Months Ended September 30, | ||||||||||||||
(In thousands, except share and per share data) | 2017 | 2016 | 2017 | 2016 | |||||||||||
Operating expenses: | |||||||||||||||
Research and development | $ | 9,159 | $ | 8,729 | $ | 32,593 | $ | 24,389 | |||||||
General and administrative | 3,090 | 3,607 | 9,669 | 9,694 | |||||||||||
Total operating expenses | 12,249 | 12,336 | 42,262 | 34,083 | |||||||||||
Loss from operations | (12,249 | ) | (12,336 | ) | (42,262 | ) | (34,083 | ) | |||||||
Other income (expense): | |||||||||||||||
Interest income (expense), net | (8 | ) | 109 | (38 | ) | 312 | |||||||||
Total other income (expense) | (8 | ) | 109 | (38 | ) | 312 | |||||||||
Net loss | $ | (12,257 | ) | $ | (12,227 | ) | $ | (42,300 | ) | $ | (33,771 | ) | |||
Basic and diluted net loss per share | $ | (0.73 | ) | $ | (0.88 | ) | $ | (2.51 | ) | $ | (2.44 | ) | |||
Shares used to compute basic and diluted net loss per share | 16,864,211 | 13,910,145 | 16,830,749 | 13,863,453 | |||||||||||
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