Full Press Release Details
Cidara Provides Corporate Update and Reports
Third Quarter 2018 Financial Results
SAN DIEGO, November 8, 2018 - 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, 2018 and provided an update on its corporate activities and product pipeline.
"We made considerable progress during the third quarter of 2018 with the initiation of our Phase 3 ReSTORE trial of rezafungin, for the treatment of invasive candida infections, and the granting by the FDA of Qualified Infectious Disease Product status for our rezafungin prophylaxis development program," said Jeffrey Stein, Ph.D., president and chief executive officer of Cidara. "In addition, we have expanded our Cloudbreak program to encompass antiviral drug applications and strengthened our board with the appointment of David Gollaher as a director of the company. With our ReSTORE trial underway, our efforts are focused on initiating our Phase 3 ReSPECT prophylaxis trial in the first quarter of 2019."
Third Quarter 2018 and Subsequent Highlights
caspofungin in patients with candidemia and/or invasive candidiasis. The primary efficacy endpoint of ReSTORE, which will be used for a U.S. Food and Drug Administration (FDA) New Drug Application submission, is all-cause mortality at day 30. The primary efficacy endpoint for the European Medicines Agency (EMA) is expected to be global response at day 14.
Third Quarter 2018 Financial Results
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, in a Phase 3 clinical trial in the treatment of candidemia and invasive candidiasis and plans to initiate a second Phase 3 trial in the prophylaxis of invasive fungal infections. Rezafungin has improved pharmacokinetics compared to existing echinocandins and the potential for expanded utility across patient settings. It 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 novel Cloudbreak platform to develop antibody-drug conjugates for the treatment of serious viral and Gram-negative bacterial infections. Cloudbreak is the first immunotherapy discovery platform designed specifically to create compounds that directly kill pathogens and also direct a patient's immune cells to attack and eliminate bacterial, fungal or viral 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, and rezafungin's potential for expanded utility across patient settings. 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, 2018 | December 31, 2017 | ||||||
| (In thousands) | (unaudited) | ||||||
| ASSETS | |||||||
| Cash, cash equivalents, and short-term investments | $ | 88,274 | $ | 75,314 | |||
| Other current assets | 3,687 | 2,356 | |||||
| Non-current assets | 848 | 1,365 | |||||
| Total assets | $ | 92,809 | $ | 79,035 | |||
| LIABILITIES AND STOCKHOLDERS' EQUITY | |||||||
| Total liabilities | $ | 22,877 | $ | 19,291 | |||
| Stockholders' equity | 69,932 | 59,744 | |||||
| Total liabilities and stockholders' equity | $ | 92,809 | $ | 79,035 |
Cidara Therapeutics, Inc.
Condensed Consolidated Statements of Operations
| Three Months Ended September 30, | Nine Months Ended September 30, | ||||||||||||||
| (In thousands, except share and per share data) | 2018 | 2017 | 2018 | 2017 | |||||||||||
| Operating expenses: | |||||||||||||||
| Research and development | $ | 11,278 | $ | 9,159 | $ | 36,096 | $ | 32,593 | |||||||
| General and administrative | 3,447 | 3,090 | 10,591 | 9,669 | |||||||||||
| Total operating expenses | 14,725 | 12,249 | 46,687 | 42,262 | |||||||||||
| Loss from operations | (14,725 | ) | (12,249 | ) | (46,687 | ) | (42,262 | ) | |||||||
| Other income (expense): | |||||||||||||||
| Change in fair value of contingent forward purchase obligations | 888 | - | (224 | ) | - | ||||||||||
| Interest income (expense), net | 222 | (8 | ) | 447 | (38 | ) | |||||||||
| Other expense | (4 | ) | - | (210 | ) | - | |||||||||
| Total other income (expense) | 1,106 | (8 | ) | 13 | (38 | ) | |||||||||
| Net loss | (13,619 | ) | (12,257 | ) | (46,674 | ) | (42,300 | ) | |||||||
| Recognition of beneficial conversion feature | - | - | (10,329 | ) | - | ||||||||||
| Net loss attributable to common shareholders | $ | (13,619 | ) | $ | (12,257 | ) | $ | (57,003 | ) | $ | (42,300 | ) | |||
| Basic and diluted net loss per common share | $ | (0.49 | ) | $ | (0.73 | ) | $ | (2.35 | ) | $ | (2.51 | ) | |||
| Shares used to compute basic and diluted net loss per common share | 27,705,472 | 16,864,211 | 24,254,254 | 16,830,749 |
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