Cidara Therapeutics, Inc.

The opinion was based on positive results from the pivotal ReSTORE Phase III clinical trial and supported by the STRIVE Phase II clinical trials and extensive nonclinical development program.2,3If approved by the European Medicines Agency, rezafungin could be the first new treatment option in over 10 years for patients with invasive candidiasis.4 SAN DIEGO and CAMBRIDGE, England, Oct. 13, 2023 (GLOBE NEWSWIRE) -- 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, and Mundipharma today announced that the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion for rezafungin (rezafungin acetate) for the treatment of invasive candidiasis in adults.1 The CHMP based its positive opinion on results from the pivotal ReSTORE Phase III clinical trial, which demonstrated statistical non-inferiority* for rezafungin, dosed once weekly, when compared to the current standard of care, caspofungin, dosed once daily. This finding was supported by the STRIVE Phase II clinical trials and extensive nonclinical development program.2,3 The ReSTORE trial provides evidence of the efficacy and safety of rezafungin as a potential new treatment option for invasive candidiasis with a once-weekly dosing schedule.2 Invasive candidiasis, is a severe, life-threatening infection of the bloodstream and/or deep/visceral tissues.5,6 It affects seriously ill people, especially those with a weakened immune system where the mortality rate can be 40% or more.7,8 There is a clear need for alternative options to treat this disease, particularly as there have been no new treatment options over the last decade.4,9 Professor Oliver Cornely, Head of the European Excellence Centre for Medical Mycology at the University Hospital Cologne, Germany, and Data Review Committee member in the Phase III ReSTORE trial, said, “This positive opinion is welcome news for patients who suffer from invasive candidiasis in the European Union where the mortality rate for patients with invasive candidiasis remains high. A new treatment option for these serious infections is a much-needed addition.” “We would like to thank the CHMP for their careful consideration of the use of rezafungin. This positive opinion represents an important step on the journey towards approval and brings us closer to providing clinicians with an alternative treatment option for invasive Candida infections, giving hope to patients battling this infection and their families,” said Brian Sheehan, Ph.D., Chief Scientific Officer at Mundipharma. “Following the FDA approval of rezafungin in the United States earlier this year, the positive CHMP opinion reinforces the benefit of rezafungin and marks an important milestone in our drive to help patients with deadly Candida infections in the European Union,” said Taylor Sandison, M.D., M.P.H, Chief Medical Officer at Cidara. The CHMP’s positive opinion on rezafungin for the treatment of serious fungal infections, such as invasive candidiasis in adults, will be referred to the European Commission (EC), which will deliver a final decision in approximately two months. Cidara Therapeutics has partnered with Mundipharma, which has commercial rights to rezafungin outside the U.S. and Japan. About invasive candidiasis Invasive candidiasis (IC) continues to be an area of significant unmet need, especially for critically ill patients in hospitals and patients with compromised immune systems. Despite a number of available treatments, the mortality rate for patients with invasive candidiasis is as high as 40%. 7,8 IC is characterised as a severe, life-threatening systemic Candida infection of the bloodstream and/or deep/visceral tissues, known as candidemia and deep-seated tissue candidiasis.10 About rezafungin Rezafungin is a novel once-weekly echinocandin being developed for both the treatment and prevention of serious fungal infections, such as invasive candidiasis and candidemia. Cidara has completed a Phase III clinical trial with rezafungin for the first-line treatment of candidemia and/or invasive candidiasis (ReSTORE trial).11 In this ReSTORE trial, rezafungin met the primary endpoint for the U.S. Food and Drug Administration (FDA) New Drug Application (NDA) submission of all-cause mortality at Day 30, and also met the primary endpoint for the European Medicines Agency (EMA) Marketing Authorisation Application (MAA) submission of global cure at Day 14. Both results demonstrated statistical non-inferiority of rezafungin dosed once-weekly versus caspofungin dosed once-daily, the current standard of care. Rezafungin was generally well tolerated and had a similar safety profile to caspofungin.2 Cidara is also currently conducting a second Phase III clinical trial of rezafungin for the prevention of invasive fungal disease in patients undergoing allogeneic blood and marrow transplantation (ReSPECT trial). Rezafungin was first approved for the treatment of candidemia and invasive candidiasis in individuals with limited or no alternative treatment options by the FDA in March 2023.12 About Cidara Therapeutics Cidara 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 cancers and other serious diseases by inhibiting specific disease targets while simultaneously engaging the immune system. In addition, Cidara received FDA approval for REZZAYO™ (rezafungin for injection), which it has licensed to multiple partners to commercialise in the U.S. and ex-U.S. Cidara is headquartered in San Diego, California. For more information, please visit www.cidara.com. About Mundipharma Mundipharma is a global healthcare company with a presence across Africa, Asia Pacific, Canada, Europe, Latin America, and the Middle East. Mundipharma is dedicated to bringing innovative treatments to patients in the areas of pain management, infectious disease and consumer healthcare as well as other severe and debilitating disease areas. Their guiding principles, centred around Integrity and Patient-Centricity, are at the heart of everything they do. For more information visit www.mundipharma.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 harbour 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 an unmet medical need exists for rezafungin; whether it will be approved for marketing in the EU; and the likelihood that rezafungin, if approved in the EU, will be prescribed by physicians or approved for reimbursement. 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. 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 RitchieLifeSci Advisors 212-915-2578britchie@lifesciadvisors.com MEDIA CONTACT: Veronica EamesLifeSci Communications646-970-4682veames@lifescicomms.com References: CHMP Opinion. Available at: https://www.ema.europa.eu/en/medicines/human/summaries-opinion/rezzayo (last accessed October 2023).Thompson GR, et al. Lancet 2023;401(10370):49–59.Soriano A, et al, Patient-level Meta-Analysis of Efficacy and Safety from STRIVE and ReSTORE: Randomized, Double-blinded, Multicenter Phase 2 and Phase 3 Trials of Rezafungin in the Treatment of candidemia and/or invasive candidiasis, Abstract presented at ECCMID 2022.Ham YY, et al. Future Microbiology 2021;16(1):27–36.Pappas PG, et al. Nat Rev Dis Primers 2018;4:18026.CDC. Invasive candidiasis. Available at: https://www.cdc.gov/fungal/diseases/candidiasis/invasive/definition.html (last accessed October 2023).Kullberg BJ, Arendrup MC. N Engl J Med 2015;373:1445–56.Bassetti M, et al. Crit Care 2019;23(1):219.Bassetti M, et al. J Antimicrob Chemother 2018; 73 Suppl 1: i14–i25 doi:10.1093/jac/dkx445.Cortes JA, Corrales IF. Invasive candidiasis: Epidemiology and Risk Factors. November 2018. Available at https://www.intechopen.com/chapters/64365 (last accessed October 2023).Cidara Therapeutics and Mundipharma Announce Positive Topline Results from the Global Phase 3 Pivotal ReSTORE Trial of Rezafungin for the Treatment of Candidemia and invasive candidiasis. Available at https://www.mundipharma.com/Cidara-Therapeutics-and-Mundipharma-Announce-Positive-Topline-Results-from-the-Global-Phase-3-Pivotal-ReSTORE-Trial-of-Rezafungin-for-the-Treatment-of-Candidemia-and-Invasive-Candidiasis (last accessed October 2023).U.S. Food & Drug Administration. Search Orphan Drug Designations and Approvals. Available at: https://www.accessdata.fda.gov/scripts/opdlisting/oopd/detailedIndex.cfm?cfgridkey= 507215 (last accessed October 2023).

SAN DIEGO, Oct. 11, 2023 (GLOBE NEWSWIRE) -- Cidara Therapeutics Inc. (Nasdaq: CDTX), a biotechnology company using its proprietary Cloudbreak® platform to develop drug-Fc conjugate (DFC) therapies designed to save lives and improve the standard of care for patients facing serious diseases, today announced new data on its drug-Fc conjugate (DFC) candidate, CD388, at IDWeek 2023. The conference is taking place both in-person at the Boston Convention and Exhibition Center in Boston, MA and virtually from October 11 – 15, 2023. “It is important to highlight these new data demonstrating the safety, efficacy and tolerability of CD388 in preventing influenza A and B,” said Jeffrey Stein, Ph.D. president and chief executive officer of Cidara. “These data support the conclusions drawn from the Phase 2a study, additional data from which will be disclosed at an upcoming conference, that CD388 has the potential to offer true universal protection for patients regardless of their immune status. These data continue to support the unique approach of our Cloudbreak platform which aims to design DFCs that may safely and effectively prevent and treat serious diseases such as influenza and cancer.” CD388 is being developed for the universal protection of influenza A and B under an exclusive worldwide collaboration agreement with Janssen Pharmaceuticals, Inc. (Janssen), a Johnson & Johnson company. Janssen recently delivered its Election to Proceed Notice for CD388 with the intent to transfer its rights and obligations to another entity. Presentation details are summarized below: Title: In Vivo Efficacy of CD388, a Novel Drug Fc-Conjugate (DFC), Against Seasonal Subtypes of Influenza in Prophylaxis in Immune Competent Mice, and in a Severe Immunodeficient (SCID) Mouse Model Presenter: James Levin, Ph.D., Cidara Therapeutics Session Title: Experimental Therapeutics Session Location: 102 AB Date and Time: October 14, 2023, 10:30AM – 11:45 AM ET Title: Single Ascending Dose Safety, Tolerability, and Pharmacokinetics of Subcutaneous and Intramuscular CD388, a Novel Long-acting Drug-Fc Conjugate for Universal Prevention of Seasonal and Pandemic Influenza Presenter: Shawn Flanagan, Ph.D., Cidara Therapeutics Session Title: New Antimicrobial Drug Development Session Location: Hall B&C Date and Time: October 14, 2023, 12:15– 1:30 PM ET Title: Efficacy of CD388, a Novel Drug Fc-Conjugate (DFC), is Driven by the Small Molecule Neuraminidase Inhibitor (NAI) Presenter: James Levin, Ph.D., Cidara Therapeutics Session Title: Antimicrobial Novel Agents Session Location: Hall B&C Date and Time: October 14, 2023, 12:15PM – 1:30PM ET 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 cancers and other serious diseases by inhibiting specific disease targets while simultaneously engaging the immune system. In addition, Cidara received FDA approval for REZZAYO™ (rezafungin for injection), which it has licensed to multiple partners to commercialize in the U.S. and ex-U.S. 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,” “believe,” “could,” “expect,” “may,” “plan” or “will”. Forward-looking statements in this release include, but are not limited to, statements related to whether Janssen or an assignee will conduct additional clinical trials of CD388, and whether CD388 will ultimately be proven safe or effective for prevention of influenza infection or any indication. 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: Veronica Eames LifeSci Communications (646) 970-4682 veames@lifescicomms.com

REZZAYO receives product-specific J-Code and is granted NTAP PARSIPPANY, N.J.--(BUSINESS WIRE)-- Melinta Therapeutics (Melinta), a commercial-stage company providing innovative therapies for acute and life-threatening illnesses, today announced expanded reimbursement and access for REZZAYO™ (rezafungin for injection). REZZAYO, the first new treatment option approved for adult patients with candidemia and invasive candidiasis in over a decade, has been commercially available in the U.S. since July. The Centers for Medicare & Medicaid Services (CMS) issued a permanent product-specific J-Code (J0349, Injection, rezafungin, 1 mg) for REZZAYO injection effective October 1, 2023. CMS also granted a new technology add-on payment (NTAP) for REZZAYO for eligible participating hospitals when Medicare patients are treated in the inpatient acute care hospital setting. “We are very excited to share the news of the issuance of the J-Code and the NTAP for REZZAYO,” said Christine Ann Miller, Melinta President and CEO. “These two important milestones will help facilitate access to this innovative treatment option in both inpatient and outpatient settings. For Melinta, this is a significant step toward realizing our vision that all patients who need our therapies will receive them.” A permanent J-Code plays a pivotal role in establishing reimbursement for medical products and services, offering a standardized way to identify the drug across various payers. The unique J-Code can be used for REZZAYO in all outpatient treatment settings. The NTAP, in turn, will provide eligible, participating hospitals with an incremental payment for REZZAYO in addition to the standard Medicare Severity Diagnostic Related Group (MS-DRG) reimbursement for inpatient Medicare cases beginning October 1, 2023. Under NTAP, this additional payment is the lesser of 75% of the costs of REZZAYO, or 75% of the amount by which the costs of the qualifying case exceed the MS-DRG payment, up to a maximum payment of $4,387.50 for a patient treated with REZZAYO per qualifying case. REZZAYO was granted Qualified Infectious Disease Product (QIDP) designation and was approved by the U.S. Food and Drug Administration under Priority Review on March 22, 2023. Last year, Melinta acquired the exclusive rights to commercialize REZZAYO in the U.S. from Cidara Therapeutics. Once-weekly REZZAYO has been available by prescription since July 31, 2023. While echinocandins have been available since the early 2000’s, their use has been primarily limited to the hospital inpatient setting due to their requirement of daily IV infusions. In contrast, REZZAYO is administered as a once-weekly infusion, which may allow appropriate patients to leave the hospital sooner to continue their treatment at home, potentially reducing the burden on patients and the healthcare system. “REZZAYO offers a needed option for physicians, and those patients who may be able to transition out of the hospital sooner. The J-Code and NTAP will support broader access to this innovative treatment for patients suffering from invasive Candida infections,” said John Harlow, Melinta’s Chief Commercial Officer. “This is another opportunity for Melinta to deliver on our mission to provide innovative therapies to people impacted by acute and life-threatening illnesses.” About REZZAYO™ (rezafungin for injection) INDICATIONS AND USE REZZAYO is an echinocandin antifungal indicated in patients 18 years of age or older who have limited or no alternative options for the treatment of candidemia and invasive candidiasis. Approval of this indication is based on limited clinical safety and efficacy data. REZZAYO has not been studied in patients with endocarditis, osteomyelitis, and meningitis due to Candida. IMPORTANT SAFETY INFORMATION Contraindications REZZAYO™ is contraindicated in patients with known hypersensitivity to rezafungin or other echinocandins. Warnings and Precautions Infusion-related Reactions: REZZAYO™ may cause infusion-related reactions, including flushing, sensation of warmth, urticaria, nausea, or chest tightness. If these reactions occur, slow or pause the infusion. Photosensitivity: REZZAYO™ may cause photosensitivity. Advise patients to use protection from sun exposure and other sources of UV radiation. Hepatic Adverse Reactions: Abnormalities in liver tests have been seen in clinical trial patients treated with REZZAYO™. Monitor patients who develop abnormal liver tests and evaluate patients for their risk/benefit of continuing REZZAYO™ therapy. Adverse Reactions Most common adverse reactions (incidence ≥ 5%) are hypokalemia, pyrexia, diarrhea, anemia, vomiting, nausea, hypomagnesemia, abdominal pain, constipation, and hypophosphatemia. Please see full Prescribing Information for REZZAYO™ (rezafungin for injection), available at . About Melinta Therapeutics Melinta Therapeutics is a biopharmaceutical company dedicated to providing innovative therapies to people impacted by acute and life-threatening illnesses. We focus our expanding portfolio on serving patients with an unmet need because that’s how we make the most meaningful impact. At Melinta, we’re visionaries dedicated to innovation while staying grounded in what matters most: patients. Our portfolio currently includes seven commercial-stage products: BAXDELA® (delafloxacin), KIMYRSA® (oritavancin), MINOCIN® (minocycline) for Injection, ORBACTIV® (oritavancin), REZZAYO™ (rezafungin for injection), TOPROL-XL® (metoprolol succinate) and VABOMERE® (meropenem and vaborbactam). For more information about Melinta Therapeutics, our commitment to patients, and to learn about our portfolio of therapies, visit Melinta.com.