Rezafungin acetate

SAN DIEGO, May 15, 2024 (GLOBE NEWSWIRE) -- 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, today reported financial results for the first quarter ended March 31, 2024, and provided an update on its corporate activities and product pipeline. “Our reacquisition of our CD388 program, which we have developed to date in collaboration with Janssen Pharmaceuticals, Inc., a Johnson & Johnson Company, (Janssen) as a once-per-flu season universal preventative of influenza A and B, along with the divestiture of the rezafungin program to our former partner Mundipharma, enables us to focus all of our development efforts on our Cloudbreak DFC platform,” said Jeffrey Stein, Ph.D., president and chief executive officer of Cidara. “Our priority now is to evaluate the efficacy and safety of CD388 in providing season-long, universal protection from influenza in a Phase 2b study, which we intend to initiate during the upcoming Northern Hemisphere influenza season.” Dr. Stein continued, “Concurrent with the reacquisition of CD388, we closed a $240.0 million private placement led by RA Capital Management, with significant participation from Bain Capital Life Sciences, Biotech Value Fund (BVF), and Canaan Partners. We are thrilled with the substantial investment by this top-tier syndicate of new and existing investors and believe it is indicative of the significant potential of CD388 as a universal preventative of seasonal and pandemic influenza. We believe that CD388 may have significant advantages beyond and in addition to flu vaccines, with the potential for universal protection even in the absence of a robust immune system, and without the requirement for seasonal influenza strain prediction.” Recent Corporate Highlights Reacquired exclusive global development and commercial rights to CD388: In April 2024, Cidara entered into a definitive agreement with Janssen, to reacquire the exclusive global development and commercial rights to CD388, which is in development for the prevention of all strains of influenza A and B. Cidara is finalizing the protocol for a Phase 2b clinical trial, which the Company intends to initiate during the upcoming Northern Hemisphere influenza season. Closed $240.0 million private placement: In April 2024 and in conjunction with the reacquisition of CD388, Cidara closed a definitive agreement for the sale of preferred stock in a $240.0 million private placement led by RA Capital Management, with significant participation from Bain Capital Life Sciences, BVF, and Canaan Partners. The proceeds from the private placement were used to fund the upfront payment of $85.0 million under the agreement with Janssen and the remainder of the gross proceeds of $155.0 million are expected to provide runway beyond topline data from CD388’s planned Phase 2b trial. Divested rezafungin to its former licensee, Mundipharma: In April 2024, Cidara entered into an asset purchase agreement with Napp Pharmaceutical Group Limited, a member of the international network of Mundipharma independent associated companies, for the divestiture of rezafungin. Cidara estimates that it will achieve approximately $128.0 million in cost savings over the patent life of rezafungin. Appointed Laura Tadvalkar, Ph.D., Ryan Spencer, and James Merson, Ph.D., to Board of Directors: In April 2024 and in connection with the private placement, appointed Dr. Tadvalkar, Managing Director at RA Capital Management, Mr. Spencer, Chief Executive Officer and a director of Dynavax Technologies, and Dr. Merson, former Global Therapeutic Area Head for Infectious Diseases at Janssen Research & Development, LLC, to the Company’s Board of Directors, while David Gollaher, Ph.D. and Timothy Franson, M.D., stepped down from the Board. Announced a Reverse Stock Split: On April 12, 2024, Cidara’s Board of Directors approved a 1-for-20 reverse stock split. On April 22, 2024 the Company filed an amendment to its Amended and Restated Certificate of Incorporation to effect a reverse stock split of its issued and outstanding common stock, at a ratio of 1-for-20, and a reduction in the number of authorized shares of common stock, at a ratio that is equal to half of the reverse stock split ratio. The Company’s common stock began trading on a split-adjusted basis commencing upon market open on April 24, 2024 under a new CUSIP number, 171757206, and remain listed on the Nasdaq Capital Market under the symbol “CDTX”. Presented at 34th European Society of Clinical Microbiology and Infectious Diseases (ESCMID) conference: In April 2024, Cidara presented data from the Phase 2a study of CD388, showing the DFC was well tolerated and demonstrated statistically significant antiviral effects when administered as a single subcutaneous dose in healthy volunteers challenged with influenza at the 34th ESCMID conference. The Company also presented data from a Phase 1 single ascending dose study of CD388 which showed the drug has an extended half-life of 6-8 weeks. Presented at AACR Annual Meeting 2024: In April 2024, Cidara presented new data on novel Cloudbreak DFC candidates at the AACR 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. First Quarter 2024 Financial Results Revenue totaled $8.5 million for the three months ended March 31, 2024, compared to $26.1 million for the same period in 2023. Revenue for the three months ended March 31, 2024 related to the achievement of a milestone, ongoing research and development and clinical supply services provided to Mundipharma, Janssen and Melinta, royalty revenue, as well as product revenue related to shipments of REZZAYO naked vials to Mundipharma. Revenue for the three months ended March 31, 2023 related to the achievement of a milestone and ongoing research and development and clinical supply services provided to Mundipharma, Janssen and Melinta. Cash and cash equivalents totaled $29.0 million as of March 31, 2024, compared with $35.8 million as of December 31, 2023. Cost of product revenue was $1.6 million for the three months ended March 31, 2024, 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 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 $11.6 million for the three months ended March 31, 2024, compared to $18.9 million for the same period in 2023. The decrease in research and development expenses for the three months ended March 31, 2024, compared to the three months ended March 31, 2023 is primarily due to lower clinical expenses associated with the rezafungin clinical trials, lower clinical expenses associated with our Cloudbreak platform and lower personnel costs. Selling, general and administrative (SG&A) expenses were $6.0 million for the three months ended March 31, 2024, compared to $4.5 million for the same period in 2023. The SG&A expenses for all periods primarily relate to consulting, personnel and legal costs. Net loss for the three months ended March 31, 2024 was $10.3 million, compared to a net income of $3.0 million for the same period in 2023. During the three months ended March 31, 2024, Cidara did not sell shares of common stock pursuant to its at-the-market sales agreement. As of March 31, 2024, Cidara had 4,561,696 shares of common stock outstanding and 2,104,472 shares of Series X Convertible Preferred Stock outstanding, which are convertible into 1,052,236 shares of common stock. About Cidara Therapeutics Cidara Therapeutics is using its proprietary Cloudbreak® platform to develop novel drug-Fc conjugates (DFCs). These targeted immunotherapies offer the unique opportunity to create “single molecule cocktails” comprised of targeted small molecules and peptides coupled to a human antibody fragment (Fc). DFCs are designed to save lives and improve the standard of care for patients facing serious diseases by inhibiting specific disease targets while simultaneously engaging the immune system. Cidara is headquartered in San Diego, California. For more information, please visit 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,” “expect,” “may,” “plan” or “will”. Forward-looking statements in this release include, but are not limited to, statements related to whether we will start a Phase 2b clinical trial for CD388 in 2024, whether CD388 will be shown to have advantages beyond and in addition to flu vaccines, and whether CD388 will ultimately be approved for commercial sale by regulators in the U.S. or any country or will generate any revenue. 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, and other obstacles on the enrollment of patients or other aspects of CD388, or other DFC 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 SEC. 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: Michael Fitzhugh LifeSci Communications mfitzhugh@lifescicomms.com CIDARA THERAPEUTICS, INC. Condensed Consolidated Statements of Operations (unaudited) Three Months Ended March 31, (In thousands, except share and per share data) 2024 2023 Revenues: Collaboration revenue $ 5,637 $ 26,107 Product revenue 2,826 — Total revenues 8,463 26,107 Operating expenses: Cost of product revenue 1,563 — Research and development 11,593 18,869 Selling, general and administrative 5,998 4,457 Total operating expenses 19,154 23,326 Income (loss) from operations (10,691 ) 2,781 Other income, net: Interest income, net 365 232 Total other income, net 365 232 Net income (loss) and comprehensive income (loss) (10,326 ) 3,013 Allocation of earnings to participating securities — (636 ) Net income (loss) attributable to common stockholders $ (10,326 ) $ 2,377 Basic net earnings (loss) per common share $ (2.28 ) $ 0.60 Diluted net earnings (loss) per common share $ (2.28 ) $ 0.60 Shares used to compute basic net earnings (loss) per common share 4,537,782 3,932,050 Shares used to compute diluted net earnings (loss) per common share 4,537,782 5,059,514 Condensed Consolidated Balance Sheet Data March 31, 2024 December 31, 2023 (In thousands) (unaudited) Cash and cash equivalents $ 29,018 $ 35,778 Total assets 52,716 67,030 Total liabilities 70,496 75,240 Total stockholders’ equity (deficit) (17,780 ) (8,210 )

- $240 million private placement financing led by RA Capital Management with significant participation by Bain Capital Life Sciences as well as BVF Partners and Canaan Partners to fund Phase 2b clinical trial - CD388, which is active against all strains of influenza A and B, is being developed for pre-exposure prophylactic treatment - Company to host business strategy update conference call and webcast today at 4:30 PM ET April 24, 2024 -- Cidara Therapeutics, Inc. (Nasdaq: CDTX), 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, today announced that it has entered into a definitive agreement with Johnson & Johnson1 to reacquire the exclusive global development and commercial rights to CD388, which is in development for the prevention of all strains of influenza A and B. Concurrent with the acquisition, Cidara closed a definitive agreement for the sale of preferred stock in a private placement led by RA Capital Management, with significant participation from Bain Capital Life Sciences, Biotech Value Fund (BVF), and Canaan Partners. The private placement provides $240 million in gross proceeds that will be used by Cidara to develop CD388 as a universal preventative against seasonal and pandemic influenza A and B, beginning with a Phase 2b clinical trial in the upcoming Northern Hemisphere influenza season. The proceeds from the private placement fund the upfront payment under the agreement with Johnson & Johnson and are expected to provide runway beyond topline data from CD388’s Phase 2b trial. CD388 is a long-acting antiviral investigational drug invented and developed by Cidara that became the subject of an exclusive worldwide license and collaboration agreement established with Johnson & Johnson in April 2021. In September 2023, Johnson & Johnson delivered to Cidara an Election to Proceed Notice and associated milestone payment for CD388 before beginning a process to transfer its rights and obligations under the agreement to another entity. In connection with the private placement, Laura Tadvalkar, Ph.D., Managing Director at RA Capital Management, Ryan Spencer, and James Merson, Ph.D. have been appointed to Cidara’s board of directors, while David Gollaher, Ph.D. and Timothy Franson, M.D. will be stepping down. “I thank David and Tim for their invaluable contributions, which have helped facilitate this opportunity for Cidara,” said Jeffrey Stein, Ph.D., President and Chief Executive Officer of Cidara. Dr. Stein continued, “This reacquisition of CD388, along with the capital to advance it through Phase 2b development, is transformational for Cidara and especially for those who could benefit from a long-acting, universal preventative against all forms of influenza. In our Phase 2b study later this year, we will evaluate the efficacy and safety of CD388 in providing season-long, universal protection from influenza. We believe that CD388 may have significant advantages beyond and in addition to flu vaccines, with the potential for universal protection even in the absence of a robust immune response and without the requirement for seasonal influenza strain prediction.” All responsibility for future development, manufacturing, and commercialization activities of CD388 will be assumed by Cidara. In exchange for reacquiring the exclusive global development and commercial rights to CD388, Johnson & Johnson has received from Cidara a one-time upfront payment of $85 million and is eligible to receive potential additional development, regulatory, and commercial milestone payments. “We have followed the development of CD388 over time with great interest,” said Dr. Tadvalkar. “As stage-agnostic company builders, we were excited to catalyze this reacquisition and financing – and to leverage the company-building capabilities of our RAVen incubator to support Cidara.” “The support from this top-tier syndicate of new and existing investors highlights our enthusiasm and potential for CD388, the most advanced member of our Cloudbreak DFC pipeline and the new focus of the company,” added Dr. Stein. “We expect that the capital infusion from this financing, together with existing cash and the expected near-term cost savings associated with our recently announced divestiture of rezafungin to Mundipharma, positions us well to execute on the CD388 development program and advance the key assets in our pipeline.” Conference Call and Webcast Details Cidara will host a business strategy update conference call and webcast today, Wednesday, April 24, 2024, at 4:30 PM ET. Details can be found below. Date:Wednesday, April 24, 2024 Time:4:30 PM ET Conference Call Details: Toll-free: 1-877-407-4018 International: 1-201-689-8471 Conference ID: 13746332 Call me™ Feature (avoid waiting for operator):Click Here Webcast:Webcast Link – Click Here CD388 is an investigational drug-Fc conjugate (DFC) comprised of multiple copies of a potent small molecule neuraminidase inhibitor stably conjugated to a proprietary Fc fragment of a human antibody. DFCs are not vaccines or monoclonal antibodies but are low molecular weight biologics which are designed to function as long-acting small molecule inhibitors. CD388 was designed to provide universal protection against all known strains of seasonal and pandemic influenza with the potential to provide season-long protection with a single subcutaneous or intramuscular administration. Importantly, because CD388 is not a vaccine, its activity is not reliant on an immune response and thereby is expected to be efficacious in individuals regardless of immune status. More information can be found at: https://www.cidara.com/cloudbreak/influenza/. Cidara is developing immunotherapeutics designed to help improve the standard of care for patients facing serious diseases. The Company’s portfolio comprises new approaches aimed at transforming existing treatment and prevention paradigms, including DFCs from its proprietary Cloudbreak® platform targeting oncologic, viral and autoimmune diseases. Cidara is headquartered in San Diego, California. For more information, please visit www.cidara.com. RA Capital Management is a multi-stage investment manager dedicated to evidence-based investing in public and private healthcare, life sciences, and planetary health companies. RA Capital forms and funds innovative companies, from private seed rounds to public follow-on financings, allowing management teams to drive value creation from inception through commercialization. RA Capital's knowledge engine is guided by our TechAtlas internal research division, and our in-house RAVen incubator offers experienced entrepreneurs a collaborative and comprehensive company creation platform to explore both the novel and the re-imagined. For more information, please visit www.racap.com. 1 Agreement between Janssen Pharmaceuticals, Inc., a Johnson & Johnson Company, and Cidara Therapeutics, Inc. The content above comes from the network. if any infringement, please contact us to modify.