Full Press Release Details
CIDARA PROVIDES CORPORATE UPDATE AND REPORTS THIRD QUARTER 2019 FINANCIAL RESULTS
SAN DIEGO, Nov. 7, 2019 - 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, 2019 and provided an update on its corporate activities and product pipeline.
"The last several months represent a truly transformative period for Cidara. Our partnership with Mundipharma validated the significant commercial potential of rezafungin and provides financial and other resources that enable us to continue to execute on our clinical programs," said Jeffrey Stein, Ph.D., president and chief executive officer of Cidara. "This key partnership was established shortly following the positive results from the Phase 2 STRIVE B trial, in which rezafungin met all of its objectives for efficacy, safety and tolerability in the treatment of patients with candidemia and/or invasive candidiasis. Moreover, we continued to highlight the compelling preclinical data generated to date from our Cloudbreak immunotherapy program for influenza at multiple scientific conferences."
Recent Corporate Highlights
with rezafungin had numerically improved outcomes as compared to caspofungin across all efficacy measures at the dosing regimen chosen for the ReSTORE Phase 3 trial.
Third Quarter 2019 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 first-line treatment of candidemia
and/or invasive candidiasis (ReSTORE) and plans to commence a second Phase 3 trial of once-weekly rezafungin for prophylaxis against invasive fungal infections in patients undergoing allogeneic blood and marrow transplantation (ReSPECT) initially in Europe and Canada. In addition to its robust rezafungin clinical program, Cidara is applying its proprietary Cloudbreak platform to develop antiviral conjugates (AVCs) for the prevention and treatment of influenza and other viral diseases. 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, Cidara's ability to successfully develop novel anti-infectives, including rezafungin or AVCs from the Cloudbreak program, whether the Mundipharma collaboration validates the commercial potential of rezafungin and/or will benefit Cidara's financial profile, and whether Cidara will be able to complete the development of rezafungin, meet its obligations under the Mundipharma collaboration and/or receive additional payments from Mundipharma. Risks that contribute to the uncertain nature of the forward-looking statements include: the success and timing of Cidara's 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-K 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, 2019 | December 31, 2018 | ||||
| (In thousands) | (unaudited) | ||||
| ASSETS | |||||
| Cash, cash equivalents, and short-term investments | 73,824 | 74,562 | |||
| Other current assets | 3,664 | 2,567 | |||
| Non-current assets | 4,208 | 1,983 | |||
| Total assets | 81,696 | 79,112 | |||
| LIABILITIES AND STOCKHOLDERS' EQUITY | |||||
| Total liabilities | 32,734 | 19,973 | |||
| Stockholders' equity | 48,962 | 59,139 | |||
| Total liabilities and stockholders' equity | 81,696 | 79,112 |
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) | 2019 | 2018 | 2019 | 2018 | |||||||||||
| Revenues: | |||||||||||||||
| Collaboration Revenue | $ | 19,100 | $ | - | $ | 19,100 | $ | - | |||||||
| Total revenues | 19,100 | - | 19,100 | - | |||||||||||
| Operating expenses: | |||||||||||||||
| Research and development | 11,499 | 11,278 | 34,911 | 36,096 | |||||||||||
| General and administrative | 4,573 | 3,447 | 11,833 | 10,591 | |||||||||||
| Total operating expenses | 16,072 | 14,725 | 46,744 | 46,687 | |||||||||||
| Income (loss) from operations | 3,028 | (14,725 | ) | (27,644 | ) | (46,687 | ) | ||||||||
| Other income (expense): | |||||||||||||||
| Change in fair value of contingent forward purchase obligations | - | 888 | 411 | (224 | ) | ||||||||||
| Interest income, net | 11 | 222 | 164 | 447 | |||||||||||
| Other income (expense) | - | (4 | ) | - | (210 | ) | |||||||||
| Total other income | 11 | 1,106 | 575 | 13 | |||||||||||
| Net income (loss) | $ | 3,039 | $ | (13,619 | ) | $ | (27,069 | ) | $ | (46,674 | ) | ||||
| Basic earnings (loss) per common share | $ | 0.08 | $ | (0.49 | ) | $ | (1.08 | ) | $ | (2.35 | ) | ||||
| Diluted earnings (loss) per common share | $ | 0.08 | $ | (0.49 | ) | $ | (1.08 | ) | $ | (2.35 | ) | ||||
| Shares used to compute basic net income (loss) per common share | 33,006,280 | 27,705,472 | 25,011,576 | 24,254,254 | |||||||||||
| Shares used to compute diluted net income (loss) per common share | 38,687,937 | 27,705,472 | 25,011,576 | 24,254,254 |
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