SAN DIEGO, March 23, 2023 (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 three months and full year ended December 31, 2022 and provided an update on its corporate activities and product pipeline.
“We have completed a transformational 2022 for Cidara and are carrying that momentum into 2023 with the recent U.S. Food and Drug Administration (FDA) approval of rezafungin for the treatment of candidemia and invasive candidiasis in adult patients with limited or no alternative treatment options. This approval enables Cidara to receive a $20.0 million regulatory milestone payment under the terms of our agreement with Melinta Therapeutics,” said Jeffrey Stein, Ph.D., president and chief executive officer of Cidara. “Rezafungin is the first new drug in this indication in over a decade and our U.S. commercial partner, Melinta, is well-positioned to bring rezafungin to the U.S. market. Importantly, under the terms of our agreement with Melinta, Cidara is eligible to receive up to $40.0 million in additional regulatory milestones, and up to $370.0 million in commercial milestones, plus tiered royalties in the low double digits to mid-teens on U.S. net sales of rezafungin. These expected revenues would help advance our Cloudbreak® drug-Fc conjugate (DFC) platform programs and the completion of our ongoing global Phase 3 ReSPECT prophylaxis study.”
Dr. Stein continued, “We are also very pleased with the progress of our Cloudbreak DFC programs. We recently announced promising Phase 2a data for our lead influenza DFC, CD388, partnered with Janssen Pharmaceuticals. In addition, we announced the nomination of our first oncology DFC candidate, CBO-212, and presented preclinical data at the ESMO-TAT conference. We are currently conducting investigational new drug (IND)-enabling activities for CD421, which is an enhanced version of CBO-212. We look forward to providing further updates on these programs later this year as well as data from new oncology and antiviral programs.”
Recent Corporate Highlights
Fourth Quarter and Full Year 2022 Financial Results
Revenue for the year ended December 31, 2022 included $25.9 million of revenue recognized upon transfer of an intellectual property license to Melinta in August 2022. The remaining revenue for the year ended December 31, 2022 relates to the achievement of milestones and ongoing research and development and clinical supply services provided to Mundipharma, Janssen and Melinta of $14.3 million, $23.3 million and $0.8 million, respectively.
Revenue for the year ended December 31, 2021 included $27.0 million of revenue recognized upon transfer of an intellectual property license to Janssen in May 2021. The remaining revenue for the year ended December 31, 2021 relates to the achievement of milestones and ongoing research and development and clinical supply services provided to Mundipharma and Janssen of $13.2 million and $9.4 million, respectively.
About Cidara Therapeutics
Cidara is developing long-acting therapeutics designed to help improve the standard of care for patients facing serious diseases. The Company’s portfolio is comprised of new approaches aimed at transforming existing treatment and prevention 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. “Forward-looking statements” describe future expectations, plans, results, or strategies and are generally preceded by words such as “anticipates,” “believe,” “could,” “expect,” “may,” “plan” or “will”. Forward-looking statements in this release include, but are not limited to, statements related to Melinta’s ability to bring rezafungin to the U.S. market, the completion of the ongoing global Phase 3 ReSPECT prophylaxis study, whether CD388, CD421, or any Cloudbreak DFC candidate will be safe or effective, whether we will submit an IND for CD421, and whether REZZAYO will be prescribed by physicians and reimbursed by public and private payors. 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 Annual Report on Form 10-K for the fiscal year ended December 31, 2022 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 |
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Three months ended December 31, |
Year ended December 31, |
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(In thousands, except share and per share data) | 2022 | 2021 | 2022 | 2021 | |||||||||||
Revenues: | (unaudited) | ||||||||||||||
Collaboration revenue | $ | 10,219 | $ | 7,225 | $ | 64,288 | $ | 49,572 | |||||||
Total revenues | 10,219 | 7,225 | 64,288 | 49,572 | |||||||||||
Operating expenses: | |||||||||||||||
Research and development | 20,058 | 19,013 | 75,520 | 73,087 | |||||||||||
General and administrative | 3,428 | 4,982 | 18,486 | 18,740 | |||||||||||
Total operating expenses | 23,486 | 23,995 | 94,006 | 91,827 | |||||||||||
Loss from operations | (13,267 | ) | (16,770 | ) | (29,718 | ) | (42,255 | ) | |||||||
Other income (expense): | |||||||||||||||
Interest income (expense), net | 162 | (33 | ) | 191 | (212 | ) | |||||||||
Total other income (expense), net | 162 | (33 | ) | 191 | (212 | ) | |||||||||
Loss before income taxes | (13,105 | ) | (16,803 | ) | (29,527 | ) | (42,467 | ) | |||||||
Income tax expense | (272 | ) | — | (272 | ) | — | |||||||||
Net loss and comprehensive loss | $ | (13,377 | ) | $ | (16,803 | ) | $ | (29,799 | ) | $ | (42,467 | ) | |||
Basic and diluted net loss per common share | $ | (0.19 | ) | $ | (0.26 | ) | $ | (0.43 | ) | $ | (0.81 | ) | |||
Shares used to compute basic and diluted net loss per common share | 71,895,890 | 64,475,463 | 69,857,698 | 52,453,452 |
Condensed Consolidated Balance Sheet Data | ||||||
December 31, | ||||||
2022 | 2021 | |||||
(In thousands) | ||||||
Cash, cash equivalents, and restricted cash | $ | 32,731 | $ | 62,273 | ||
Total assets | 47,593 | 75,325 | ||||
Term loan | — | 2,591 | ||||
Total liabilities | 50,497 | 53,752 | ||||
Total stockholders’ equity (deficit) | (2,904 | ) | 21,573 |
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