On April 22, 2024 Cidara Therapeutics, Inc. (Nasdaq: CDTX) (the Company), a biotechnology company using its proprietary Cloudbreak platform to develop drug-Fc conjugate (DFC) immunotherapies designed to save lives and improve the standard of care for patients facing serious diseases, reported financial results for the fourth quarter and full year ended December 31, 2023 and provided an update on its corporate activities and product pipeline (Press release, Cidara Therapeutics, APR 22, 2024, View Source [SID1234642192]).
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"2023 included significant accomplishments throughout our business within both our Cloudbreak drug-Fc conjugate (DFC) and our REZZAYO (rezafungin) programs," said Jeffrey Stein, Ph.D., president and chief executive officer of Cidara. "With respect to our DFC platform, we continue to generate and present compelling data from our oncology programs as well as our CD388 influenza program partnered with Janssen. We have multiple key catalysts expected this year, including the filing of an Investigational New Drug Application (IND) in mid-2024 for CBO421, a potential best-in-class inhibitor of CD73. We recently presented promising new data on CD73/PD-1 multispecific DFC, CCR5-targeting DFC and CBO421 at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting."
Dr. Stein continued, "Most recently, REZZAYO was approved in the European Union (EU) and United Kingdom (UK) for the treatment of invasive candidiasis in adults, earning milestone payments of approximately $11.1 million and $2.8 million, respectively. In addition, enrollment was completed in the Phase 3 ReSTORE trial in China evaluating the efficacy and safety of rezafungin as a treatment for candidemia and invasive candidiasis, bringing us one step closer to making this important drug available to an even broader global patient population."
Recent Corporate Highlights
Presented at AACR (Free AACR Whitepaper) Annual Meeting 2024: In April 2024, Cidara presented promising new data on novel Cloudbreak DFC candidates at the AACR (Free AACR Whitepaper) Annual Meeting. The Company delivered four poster presentations highlighting the data on the Company’s multispecific CD73/PD-1 DFC, its CCR5-targeting DFC, and CBO421, its lead oncology DFC candidate targeting CD73.
Presented at IDWeek 2023: In October 2023, Cidara presented new preclinical and clinical data on Novel Cloudbreak Influenza Drug-Fc Conjugate CD388 at IDWeek 2023.
Presented at ESMO (Free ESMO Whitepaper) Immuno-Oncology Annual Congress: In December 2023, Cidara presented new preclinical data on its novel Cloudbreak, multi-specific CD73/PD-1 targeting DFC candidate at the ESMO (Free ESMO Whitepaper) Immuno-Oncology (IO) Annual Congress. The Company also presented new preclinical data on Cloudbreak CBO421, its first-in-class CD73-targeting DFC.
Presented at SITC (Free SITC Whitepaper)’s 38th Annual Meeting: In November 2023, Cidara presented new preclinical data on Cloudbreak CBO421 at the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper)’s 38th Annual Meeting.
Received EU and UK approval for REZZAYO for the treatment of invasive candidiasis in adults: In December 2023 and January 2024, Cidara and Mundipharma announced REZZAYO had been approved in the EU and UK, respectively, for the treatment of invasive candidiasis in adults. Cidara received a milestone payment of approximately $11.1 million from Mundipharma in February 2024 for the EU approval of rezafungin and received a milestone payment of approximately $2.8 million from Mundipharma in April 2024 for the UK approval of rezafungin, in accordance with the terms of the Collaboration and License Agreement, dated September 3, 2019, by and between the Company and Mundipharma.
Completed enrollment in the Phase 3 ReSTORE trial of rezafungin in China: In December 2023, Cidara and Mundipharma announced the completion of enrollment in the Phase 3 ReSTORE trial in China evaluating the efficacy and safety of rezafungin as a treatment for candidemia and invasive candidiasis. The portion of the trial conducted in China included 52 patients diagnosed with candidemia and/or invasive candidiasis. ReSTORE (NCT03667690) is a global, randomized, double-blind, controlled Phase 3 pivotal clinical trial evaluating the efficacy and safety of once-weekly intravenous dosing of rezafungin compared to once-daily dosing of caspofungin, the current standard of care, to treat patients with candidemia and/or invasive candidiasis. Data from this study are expected in the second quarter of 2024.
Named San Diego Metro Area Top Workplace: In November 2023, Cidara was named a Top Workplace by The San Diego Union-Tribune for the sixth year, ranking among the top 100 companies.
Fourth Quarter and Full Year 2023 Financial Results
Revenue totaled $17.6 million and $63.9 million for the three months and full year ended December 31, 2023, respectively, compared with $10.2 million and $64.4 million for the same periods in 2022.
Revenue for the year ended December 31, 2023 related to the achievement of milestones and ongoing research and development and clinical supply services provided to Mundipharma, Janssen and Melinta of $16.4 million, $23.3 million and $19.7 million, respectively, $0.2 million in royalty revenue recognized following initiation of the commercial launch of REZZAYO in the U.S. on July 31, 2023, as well as product revenue of $4.3 million related to shipments of REZZAYO naked vials to Melinta and Mundipharma.
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 related to the achievement of milestones and ongoing research and development and clinical supply services provided to Mundipharma, Janssen and Melinta of $14.3 million, $23.5 million and $0.8 million, respectively.
Cash and cash equivalents totaled $35.8 million as of December 31, 2023, compared with $32.7 million as of December 31, 2022.
As of December 31, 2023, Cidara had 90,601,999 shares of common stock outstanding, and 2,104,472 shares of Series X Convertible Preferred Stock outstanding, which are convertible into 21,044,720 shares of common stock.
Cost of product revenue was $1.5 million for the year ended December 31, 2023 and primarily consisted of direct material costs, third-party manufacturing costs and indirect overhead costs associated with the manufacture, quality assessment and delivery of REZZAYO naked vials shipped to Melinta and Mundipharma. Prior to regulatory approval, all direct and indirect manufacturing costs were charged to research and development expense in the period incurred.
Research and development expenses were $14.7 million and $68.5 million for the three months and full year ended December 31, 2023, respectively, compared to $20.1 million and $77.4 million for the same periods in 2022. The decrease in research and development expenses for the full year ended December 31, 2023 compared to the full year ended December 31, 2022 is primarily due to lower clinical expenses associated with the rezafungin clinical trials and lower consulting and personnel costs, offset by higher clinical expenses associated with our Cloudbreak platform.
Selling, general and administrative (SG&A) expenses were $5.4 million and $18.3 million for the three months and full year ended December 31, 2023, respectively, compared to $3.6 million and $20.5 million for the same periods in 2022. The decrease in SG&A expenses for the full year ended December 31, 2023 compared to the full year ended December 31, 2022 is primarily due to lower consulting, personnel and legal costs, and lower amortization of contract costs related to obtaining the Melinta License Agreement, offset by higher selling expenses related to REZZAYO.
Net loss for the three months ended December 31, 2023 was $3.2 million, compared to a net loss of $13.6 million for the three months ended December 31, 2022. Net loss for the full year ended December 31, 2023 was $22.9 million, compared to a net loss of $33.6 million for the year ended December 31, 2022.
Restatement of Consolidated Financial Statements
The financial results included herein and the financial statements included in our Annual Report on Form 10-K for the fiscal year ended December 31, 2023 (the Form 10-K) have been restated to account for indirect taxes that led to understatements of accrued liabilities and operating expenses, as more fully described in our Current Report on Form 8-K filed with the United States (U.S.) Securities and Exchange Commission (the SEC) on April 16, 2024 and in the Form 10-K.