Full Press Release Details
Cidara Provides Corporate Update and Reports
Second Quarter 2018 Financial Results
SAN DIEGO, August 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 June 30, 2018 and provided an update on its corporate activities and product pipeline.
"The financing commitments we secured in the second quarter provide significant funding for the company, including support for the Phase 3 clinical trials of rezafungin for the treatment of candidemia and invasive candidiasis and prophylaxis of invasive fungal infections," said Jeffrey Stein, Ph.D., president and chief executive officer of Cidara. "With this solid financial underpinning, we expect to begin the ReSTORE Phase 3 treatment trial in the third quarter of 2018, and, subsequently, the ReSPECT Phase 3 prophylaxis trial once the study design is finalized based on pending discussions with regulatory authorities and collaborators. We also made a number of presentations at scientific conferences, including ECCMID, ASM, ICHS and ISHAM, of preclinical and clinical data, which demonstrate our confidence in the safety and efficacy of rezafungin as a potentially novel, effective and much needed antifungal treatment."
Second Quarter 2018 and Subsequent Highlights
on this meeting, the company is continuing preparations for the ReSTORE Phase 3 clinical trial, with study recruitment starting in the third quarter of 2018.
Second 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, formerly known as CD101, through clinical trials. 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. The company's Phase 2 STRIVE clinical trial of rezafungin met its primary safety and efficacy objectives, and provides support for Cidara to initiate Phase 3 pivotal trials in the treatment of candidemia and invasive candidiasis, and the prophylaxis of invasive fungal infections. Cidara also is leveraging its novel Cloudbreak platform to develop antibody-drug conjugates for the treatment of multi-drug resistant 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, Cidara's ability to commence Phase 3 clinical trials, the timing of those clinical trials, the potential for rezafungin to successfully treat or prevent invasive fungal infections and represent an improvement over current approaches, and Cidara's ability to successfully complete development of rezafungin. 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
| June 30, 2018 | December 31, 2017 | ||||||
| (In thousands) | (unaudited) | ||||||
| ASSETS | |||||||
| Cash, cash equivalents, and short-term investments | $ | 103,200 | $ | 75,314 | |||
| Other current assets | 2,794 | 2,356 | |||||
| Non-current assets | 1,014 | 1,365 | |||||
| Total assets | $ | 107,008 | $ | 79,035 | |||
| LIABILITIES AND STOCKHOLDERS' EQUITY | |||||||
| Total liabilities | $ | 24,870 | $ | 19,291 | |||
| Stockholders' equity | 82,138 | 59,744 | |||||
| Total liabilities and stockholders' equity | $ | 107,008 | $ | 79,035 |
Cidara Therapeutics, Inc.
Condensed Consolidated Statements of Operations
| Three Months Ended June 30, | Six Months Ended June 30, | ||||||||||||||
| (In thousands, except share and per share data) | 2018 | 2017 | 2018 | 2017 | |||||||||||
| Operating expenses: | |||||||||||||||
| Research and development | $ | 11,619 | $ | 13,191 | $ | 24,818 | $ | 23,434 | |||||||
| General and administrative | 3,533 | 3,424 | 7,144 | 6,579 | |||||||||||
| Total operating expenses | 15,152 | 16,615 | 31,962 | 30,013 | |||||||||||
| Loss from operations | (15,152 | ) | (16,615 | ) | (31,962 | ) | (30,013 | ) | |||||||
| Other expense: | |||||||||||||||
| Change in fair value of contingent forward purchase obligation | (1,112 | ) | - | (1,112 | ) | - | |||||||||
| Interest income (expense), net | 164 | (30 | ) | 225 | (30 | ) | |||||||||
| Other expense | (206 | ) | - | (206 | ) | - | |||||||||
| Total other expense | (1,154 | ) | (30 | ) | (1,093 | ) | (30 | ) | |||||||
| Net loss | (16,306 | ) | (16,645 | ) | (33,055 | ) | (30,043 | ) | |||||||
| Recognition of beneficial conversion feature | (10,329 | ) | - | (10,329 | ) | - | |||||||||
| Net loss attributable to common shareholders | $ | (26,635 | ) | $ | (16,645 | ) | $ | (43,384 | ) | $ | (30,043 | ) | |||
| Basic and diluted net loss per common share | $ | (1.13 | ) | $ | (0.99 | ) | $ | (1.93 | ) | $ | (1.79 | ) | |||
| Shares used to compute basic and diluted net loss per common share | 23,592,763 | 16,831,960 | 22,500,061 | 16,813,759 |
Westwicke Partners, LLC