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SAN DIEGO, Nov. 03, 2022 (GLOBE NEWSWIRE) -- Cidara Therapeutics, Inc. (NASDAQ: CDTX), a biotechnology company developing long-acting therapeutics designed to help improve the standard of care for patients facing serious diseases, today reported financial results for the third quarter ended September 30, 2022 and provided an update on its corporate activities and product pipeline.
“The FDA’s acceptance of our NDA for priority review for rezafungin marks a significant milestone for Cidara and brings us one step closer to potentially deliver an important treatment option for patients fighting candidemia and invasive candidiasis, which are difficult-to-treat and often deadly,” said Jeffrey Stein, Ph.D., president and chief executive officer of Cidara. “If approved, rezafungin could be the first new drug for the treatment of invasive Candida infections in over a decade. In addition, our balance sheet was recently strengthened by the $11.1 million milestone payment from Mundipharma, and our eligibility to receive additional milestone payments from multiple existing collaborations over the next two years has the potential to further bolster our financial position in a non-dilutive manner.”
Dr. Stein continued, “Our Cloudbreak® program continues to advance, with the recent dosing of the first healthy volunteers in our Phase 2a trial of CD388, a highly potent, long-acting antiviral designed to deliver universal prevention and treatment of seasonal and pandemic influenza, that we are developing in partnership with Janssen. We look forward to providing further updates on this clinical program in the first half of next year.”
Recent Corporate Highlights
Third Quarter 2022 Financial Results
About Cidara Therapeutics
Cidara is developing long-acting therapeutics designed to improve the standard of care for patients facing serious diseases. The Company’s portfolio is comprised of new approaches aimed at transforming existing prevention and treatment paradigms, first with its lead Phase 3 antifungal candidate, rezafungin, in addition to DFCs targeting viral and oncology diseases from Cidara’s proprietary Cloudbreak platform. Cidara is headquartered in San Diego, California. For more information, please visit www.cidara.com.
Forward-Looking Statements
This release contains “forward-looking statements” within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended, and such forward-looking statements are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Words such as “could,” “expect,” “potential,” “will” and similar expressions (as well as other words or expressions referencing future events, conditions or circumstances) convey uncertainty of future events or outcomes and are intended to identify these forward-looking statements. Forward-looking statements describe future expectations, plans, results, or strategies, among other things, and in this release include, but are not limited to, Cidara’s ability to deliver rezafungin as an important treatment option for patients fighting candidemia and invasive candidiasis, the potential for the additional milestone payments from Cidara’s collaborations to bolster its balance sheet, statements related to whether the FDA will accept the rezafungin NDA for filing and assign a Prescription Drug User Fee Act (PDUFA) date; and whether the rezafungin NDA will be approved in the expected time frame or at all. Such statements are subject to a multitude of risks and uncertainties that could cause future circumstances, events, or results to differ materially from those projected in the forward-looking statements, such as unanticipated delays in or negative results from Cidara’s preclinical or clinical trials, delays in action by regulatory authorities due to limitations on inspections and other COVID-19-related effects, and impacts of the COVID-19 pandemic or other obstacles on the enrollment of patients or other aspects of CD388 development. These and other risks are identified under the caption “Risk Factors” in Cidara’s most recent Quarterly Report on Form 10-Q and other filings subsequently made with the Securities and Exchange Commission. All forward-looking statements contained in this press release speak only as of the date on which they were made and are based on management’s assumptions and estimates as of such date. Cidara does not undertake any obligation to publicly update any forward-looking statements, whether as a result of the receipt of new information, the occurrence of future events or otherwise.
INVESTOR CONTACT:
Brian Ritchie
LifeSci Advisors
(212) 915-2578
britchie@lifesciadvisors.com
MEDIA CONTACT:
Patrick Bursey
LifeSci Communications
(203) 430-9545
pbursey@lifescicomms.com
| 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) | 2022 | 2021 | 2022 | 2021 | |||||||||||
| Revenues: | |||||||||||||||
| Collaboration revenue | $ | 40,744 | $ | 7,076 | $ | 54,069 | $ | 42,347 | |||||||
| Total revenues | 40,744 | 7,076 | 54,069 | 42,347 | |||||||||||
| Operating expenses: | |||||||||||||||
| Research and development | 20,041 | 20,505 | 55,462 | 54,074 | |||||||||||
| General and administrative | 5,780 | 4,607 | 15,058 | 13,758 | |||||||||||
| Total operating expenses | 25,821 | 25,112 | 70,520 | 67,832 | |||||||||||
| Income (loss) from operations | 14,923 | (18,036 | ) | (16,451 | ) | (25,485 | ) | ||||||||
| Other income (expense): | |||||||||||||||
| Interest income (expense), net | 55 | (47 | ) | 29 | (179 | ) | |||||||||
| Total other income (expense), net | 55 | (47 | ) | 29 | (179 | ) | |||||||||
| Net income (loss) and comprehensive income (loss) | 14,978 | (18,083 | ) | (16,422 | ) | (25,664 | ) | ||||||||
| Allocation of earnings to participating securities | (3,081 | ) | — | — | — | ||||||||||
| Net income (loss) attributable to common stockholders | $ | 11,897 | $ | (18,083 | ) | $ | (16,422 | ) | $ | (25,664 | ) | ||||
| Basic net earnings (loss) per common share | $ | 0.17 | $ | (0.37 | ) | $ | (0.24 | ) | $ | (0.53 | ) | ||||
| Diluted net earnings (loss) per common share | $ | 0.17 | $ | (0.37 | ) | $ | (0.24 | ) | $ | (0.53 | ) | ||||
| Shares used to compute basic net earnings (loss) per common share | 70,217,985 | 49,533,956 | 69,170,865 | 48,402,095 | |||||||||||
| Shares used to compute diluted net earnings (loss) per common share | 88,592,568 | 49,533,956 | 69,170,865 | 48,402,095 | |||||||||||
| Condensed Consolidated Balance Sheet Data | |||||
| September 30, 2022 | December 31, 2021 | ||||
| (In thousands) | (unaudited) | ||||
| Cash, cash equivalents, and restricted cash | $ | 53,078 | $ | 62,273 | |
| Total assets | 66,858 | 75,325 | |||
| Term loan | — | 2,591 | |||
| Total liabilities | 57,791 | 53,752 | |||
| Total stockholders' equity | 9,067 | 21,573 | |||