Parsippany, New Jersey and Ontario, Canada, May 15, 2023 – Melinta Therapeutics, LLC (Melinta) and Xediton Pharmaceuticals Inc (Xediton) today announced they have entered into an exclusive commercialization and licensing agreement for BAXDELA® (delafloxacin), KIMYRSA® (oritavancin), ORBACTIV® (oritavancin) and VABOMERE® (meropenem and vaborbactam), four novel anti-infective products. Under the terms of the agreement, Xediton is responsible for the registration and commercialization of these products in Canada.

“We are very pleased to partner with Melinta to bring these life-saving products to Canada. We believe these products will address unmet needs and will be of tremendous benefit to Canadian patients, particularly in our fight to combat the global threat of antimicrobial resistance. We look forward to the approval and commercialization of BAXDELA, KIMYRSA, ORBACTIV and VABOMERE,” said George Gafrey, President of Xediton. “These products have been approved by the United States Food and Drug Administration for indications that include the treatment of infections caused by organisms on Canada’s Pathogens of Interest List. This will make our subsequent submissions to Health Canada potentially eligible for Priority Review, an expedited regulatory pathway here in Canada.”

“Xediton shares our commitment to ensure that all patients who need our life-saving therapies can get them,” said Christine Ann Miller, President and Chief Executive Officer of Melinta. “We’re thrilled to enter into this partnership with Xediton, a recognized leader in specialty care pharmaceuticals in Canada. We are confident that Xediton brings the right amount of energy and experience to effectively bring our novel anti-infective portfolio to market throughout this region. Xediton has built an impressive business model over the years in both registering and commercializing hospital-based products licensed from the US and we look forward to supporting their continued efforts for commercializing our portfolio as well.”

Inquiries

Melinta Therapeutics
Jisoo Park
Head of Business Development, M&A, and Strategy
+1 908 617 1328
info@melinta.com

Xediton Pharmaceuticals Inc
George Gafrey
President
+1 905 286 9111
info@xediton.com

About Melinta Therapeutics
Melinta Therapeutics provides innovative therapies to people impacted by acute and life-threatening illnesses. Our portfolio currently includes six commercial-stage products: Baxdela® (delafloxacin), Kimyrsa® (oritavancin), Minocin® (minocycline) for Injection, Orbactiv® (oritavancin), RezzayoTM (rezafungin for injection), TOPROL-XL® (metoprolol succinate) and Vabomere® (meropenem and vaborbactam).With an unsurpassed commitment to providers and the patients they serve, we work to ensure that all people who need our therapies can receive them. 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. For additional information, including product and respective important safety information, please visit www.melinta.com.

About Xediton Pharmaceuticals
Xediton Pharmaceuticals is a privately-held specialty pharmaceutical company with a focus on meeting the needs of patients, physicians and partners. Xediton Pharmaceuticals is committed to developing, partnering and making available new and established medicines to promote the health of Canadians. Located in the Greater Toronto Area, Canada, Xediton Pharmaceuticals has products in Oncology, Anti-Infectives, Pain, CNS, GI, Ophthalmology, Renal and CV and has built strong strategic alliances with Global and International Healthcare and pharmaceutical companies.
For more information, please visit www.xediton.com.

– REZZAYO is a novel, once-weekly, next-generation echinocandin indicated for the treatment of candidemia and invasive candidiasis in adults with limited or no alternative treatment options –

– REZZAYO is the first new FDA-approved echinocandin in over a decade –

SAN DIEGO, CA and PARSIPPANY, NJ, March 22, 2023 – Cidara Therapeutics, Inc. (Nasdaq: CDTX) and Melinta Therapeutics, LLC today announced that the U.S. Food and Drug Administration (FDA) approved REZZAYO™ (rezafungin for injection) for the treatment of candidemia and invasive candidiasis in adults with limited or no alternative treatment options. REZZAYO is the first new treatment option approved for patients with candidemia and invasive candidiasis in over a decade.

“The FDA approval of REZZAYO represents a significant milestone for Cidara, and for patients confronted with difficult-to-treat and often deadly candidemia and invasive candidiasis,” said Jeffrey Stein, Ph.D., president and chief executive officer of Cidara. “I am extremely proud of all of the Cidara employees who collectively advanced REZZAYO from preclinical development to NDA approval and am grateful to the many patients and healthcare teams who have participated in the clinical studies of these deadly infections.”

George Thompson, M.D., principal investigator in the ReSTORE trial and professor of clinical medicine at the University of California, Davis, School of Medicine, added, “The FDA approval of REZZAYO is tremendous news for those of us who have been hoping for a new option to treat our patients with these deadly fungal infections. Based on the totality of clinical data generated, REZZAYO has the potential to simplify the management of invasive candidiasis and enhance the continuity of echinocandin care.”

The FDA approval of once-weekly REZZAYO was based on clinical data from Cidara’s global ReSTORE Phase 3 trial and supported by the STRIVE Phase 2 clinical trial and extensive non-clinical development program. In clinical studies, REZZAYO, dosed once-weekly, met the FDA and EMA primary endpoints, demonstrating statistical non-inferiority versus caspofungin, a current once-daily standard of care. In addition, overall rates of adverse events and serious adverse events were comparable in patients receiving REZZAYO and caspofungin, while rates of adverse events leading to study drug discontinuation were also similar for REZZAYO and caspofungin. Based on Qualified Infectious Disease Product (QIDP) designation, REZZAYO was approved under Priority Review.

Christine Ann Miller, president and chief executive officer of Melinta Therapeutics, added, “We are thrilled that the FDA has approved REZZAYO, and are firmly committed to offering this innovative therapy to address unmet medical needs and simplify the treatment for patients suffering from invasive Candida infections. We intend to leverage our expansive commercial infrastructure and experience launching anti-infective drugs into acute care settings. We are working closely with Cidara and anticipate bringing REZZAYO, a differentiated once-weekly treatment to patients, this summer.”

Last year, Melinta announced that it had acquired the exclusive rights to commercialize REZZAYO in the U.S. from Cidara. Cidara retains the rights to rezafungin in Japan and has licensed the commercial rights to Melinta Therapeutics in the U.S. and Mundipharma in all other geographies. The European Medicines Agency (EMA) accepted the marketing authorization application (MAA) for rezafungin in August 2022 and it is currently under review.

About REZZAYO™ (rezafungin for injection)

REZZAYO (rezafungin for injection) is a novel once-weekly echinocandin approved in the United States for the treatment of candidemia and invasive candidiasis in adults. REZZAYO is currently being studied for the prevention of invasive fungal diseases in adults undergoing allogeneic blood and marrow transplantation. The structure and properties of REZZAYO are specifically designed to improve upon a clinically validated mechanism.

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
REZZAYO is contraindicated in patients with known hypersensitivity to rezafungin or other echinocandins.

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.

REZZAYO may cause photosensitivity. Advise patients to use protection from sun exposure and other sources of UV radiation.

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.

Most common adverse reactions (incidence ≥ 5%) are hypokalemia, pyrexia, diarrhea, anemia, vomiting, nausea, hypomagnesemia, abdominal pain, constipation, and hypophosphatemia.

Please see the full Prescribing Information for REZZAYO (rezafungin for injection), available at www.rezzayo.com.

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 treatment and prevention paradigms leveraging drug-Fc conjugates (DFCs) targeting viral and oncological diseases from Cidara’s proprietary Cloudbreak® platform. Cidara is headquartered in San Diego, California. For more information, please visit www.cidara.com.

About Melinta Therapeutics
Melinta Therapeutics, LLC provides innovative therapies to people impacted by acute and life-threatening illnesses. Our commercial portfolio currently includes the newly approved REZZAYO (rezafungin for injection), in addition to six commercial-stage products: Baxdela® (delafloxacin), Kimyrsa® (oritavancin), Minocin® (minocycline) for Injection, Orbactiv® (oritavancin), TOPROL-XL® (metoprolol succinate) and Vabomere® (meropenem and vaborbactam).

With an unsurpassed commitment to providers and the patients they serve, we work to ensure that all people who need our therapies can receive them. 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. For additional information, including product and respective important safety information, please visit our website.

TOPROL-XL® is a registered trademark of the AstraZeneca group of companies.

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 REZZAYO will be commercially available for patients during summer 2023, whether REZZAYO, if available, will be prescribed by physicians or will represent an important treatment option for patients with serious fungal infections. 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 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 rezafungin 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:
Veronica Eames
LifeSci Communications
646-970-4682
veames@lifescicomms.com

Melinta Contact:
Susan Blum
908-617-1300
info@melinta.com

FDA decision expected by PDUFA target action date of March 22, 2023

If approved, rezafungin will be the first new drug for the treatment of candidemia and invasive candidiasis in over a decade

SAN DIEGO and PARSIPPANY, N.J., January 24, 2023 – Cidara Therapeutics, Inc. (Nasdaq: CDTX) and Melinta Therapeutics, LLC today announced that the U.S. Food and Drug Administration (FDA) Antimicrobial Drugs Advisory Committee voted favorably 14 to 1 that Cidara, as part of its New Drug Application (NDA), provided sufficient evidence supporting a favorable benefit-risk assessment for a limited use indication for rezafungin for the treatment of candidemia and invasive candidiasis in adult patients with limited or no alternative treatment options.

“We are extremely pleased that the FDA’s advisory committee has recommended that the FDA approve rezafungin for difficult-to-treat and often deadly candidemia and invasive candidiasis,” said Jeffrey Stein, Ph.D., president and chief executive officer of Cidara. “This positive recommendation is a significant step towards our goal of providing a once-weekly treatment option for patients with invasive Candida infections, for which no new drugs have been approved in over a decade. We believe rezafungin, if approved, could provide an effective new alternative for patients battling these potentially deadly diseases. We want to thank the many patients and healthcare teams who have participated in the clinical studies of these deadly infections, and we look forward to working with the FDA as it completes its review of our application.”

The Committee’s positive vote was based on clinical data from the Cidara’s global ReSTORE Phase 3 and supported by the STRIVE Phase 2 clinical trials and extensive non-clinical development program. Rezafungin dosed once-weekly demonstrated statistical non-inferiority versus caspofungin, the current standard of care, dosed once-daily, meeting the primary endpoints for both the FDA and the European Medicines Agency (EMA).

“The Committee’s robust discussion was an important step in the FDA’s review of rezafungin. We are pleased that the Committee recognized the unmet need that rezafungin will address in the treatment of candidemia and invasive candidiasis. We remain committed to working closely with our partner Cidara in securing FDA approval of rezafungin,” Christine Ann Miller, president and chief executive officer of Melinta Therapeutics, added. “We also look forward to leveraging our established commercial infrastructure and experience in marketing infectious disease products, especially within the hospital and acute care settings, to make rezafungin available to healthcare providers and their patients, if approved.”

The FDA is not bound by the Advisory Committee’s recommendations, but generally takes the recommendation into consideration when making its decision. Cidara’s NDA for rezafungin was accepted for filing and granted Priority Review by the FDA on September 20, 2022. The FDA has assigned a Prescription Drug User Fee Act (PDUFA) target action date of March 22, 2023, enabled by rezafungin’s designation as a Qualified Infectious Disease Product (QIDP).

Last year, Melinta announced that it had acquired the exclusive rights to commercialize rezafungin in the U.S. from Cidara. Cidara retains the rights to rezafungin in Japan and has licensed the commercial rights to Melinta Therapeutics in the U.S. and Mundipharma in all other geographies. The European Medicines Agency (EMA) accepted the marketing authorization application (MAA) for rezafungin in August 2022 and it is currently under review.

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 treatment and prevention paradigms, first with its lead Phase 3 antifungal candidate, rezafungin, in addition to drug-Fc conjugates (DFCs) targeting viral and oncological diseases from Cidara’s proprietary Cloudbreak® platform. Cidara is headquartered in San Diego, California. For more information, please visit www.cidara.com.

About Melinta Therapeutics
Melinta Therapeutics, LLC provides innovative therapies to people impacted by acute and life-threatening illnesses. Our portfolio currently includes six commercial-stage products: Baxdela® (delafloxacin), Kimyrsa® (oritavancin), Minocin® (minocycline) for Injection, Orbactiv® (oritavancin), TOPROL-XL® (metoprolol succinate) and Vabomere® (meropenem and vaborbactam). Melinta also has a licensing agreement in place with Cidara Therapeutics securing the rights to market and distribute the development candidate, rezafungin in the United States.

With an unsurpassed commitment to providers and the patients they serve, we work to ensure that all people who need our therapies can receive them. 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. For additional information, including product and respective important safety information, please visit our website.

TOPROL-XL® is a registered trademark of the AstraZeneca group of companies.

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 the FDA will complete its review in accordance with PDUFA goals, whether rezafungin will ultimately be approved for commercialization in the U.S., and if approved whether rezafungin will be viewed as an important treatment option by physicians treating adult patients with serious fungal infections. 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 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 rezafungin 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.

Cidara Investor Contact:
Brian Ritchie
LifeSci Advisors
(212) 915-2578
britchie@lifesciadvisors.com

Cidara Media Contact:
Patrick Bursey
LifeSci Communications
(203) 430-9545
pbursey@lifescicomms.com

Melinta Contact:
Susan Blum
908-617-1300
info@melinta.com

WASHINGTON, Jan. 17, 2023 /PRNewswire/ — The Antimicrobials Working Group (AWG), an industry-led coalition of antimicrobial companies, announced today the appointment of Christine Ann Miller, President and Chief Executive Officer of Melinta Therapeutics, as Board Chair of AWG effective immediately. Ms. Miller replaces Ted Schroeder, Chief Executive Officer of Nabriva Therapeutics, who has completed his term as Chair.

“I feel so privileged to take on this role at such an important inflection point for the industry. The threat of antimicrobial resistance has never been higher so it will take strong partnerships and collaborations to drive positive impact for patients,” said Christine Ann Miller, incoming Chair. “I look forward to working with our Executive Committee and Board, stakeholder partners, the Biden-Harris Administration, and Congress on near & long-term solutions necessary to continue advancing innovation in the antimicrobial ecosystem. AWG is committed to addressing the critical issues in the antimicrobial marketplace and ensuring patients will always have access to the right drug, for the right bug, at the right time.”

Christine Ann Miller is an accomplished global pharmaceutical executive with more than 20 years of experience in life sciences. Since August 2020, Ms. Miller has served as President and Chief Executive Officer, and board member for Melinta Therapeutics, a commercial-stage company providing innovative therapies for acute and life-threatening illnesses. Previously, she led the global and U.S. product portfolio for Sandoz and has held leadership roles in R&D operations and supply chain management at Actavis. Ms. Miller’s robust career has included more than 50 product launches, strategic acquisitions, and successful business transformations. She holds an MBA and a Master’s in Technology Management at Stevens Institute of Technology and a B.S. in Chemical Engineering from Rensselaer Polytechnic Institute.

All pharmaceutical and biotechnology companies developing new antimicrobial therapeutics and diagnostic devices are eligible for consideration of membership in AWG. If you are interested in learning more about becoming a member of AWG, get in touch here.

About The Antimicrobials Working Group
AWG was founded in 2012 with the vision of utilizing collective power to improve the regulatory, investment, and commercial environment for emerging infectious disease companies. Today, AWG is comprised of thirteen antimicrobials companies: Acurx Pharmaceuticals, Inc., Cidara Therapeutics Inc., CorMedix Inc., Crestone, Inc., Entasis Therapeutics Inc., Iterum Therapeutics Ltd., Melinta Therapeutics LLC, Nabriva Therapeutics US Inc., Paratek Pharmaceuticals Inc., Qpex Biopharma, Inc., SCYNEXIS Inc., UTILITY therapeutics Ltd., and Venatorx Pharmaceuticals, Inc.

For more information, visit: www.antimicrobialsworkinggroup.org

About The Conafay Group
The Conafay Group, led by Stephen R. Conafay, Principal, is a life-sciences government relations firm based in Washington D.C. that serves as Washington counsel and coalition manager for AWG.

For more information, visit: www.conafaygroup.com

SOURCE Antimicrobials Working Group (AWG)

Competition To Focus On Improving Diverse Patients’ Access to Treatment
And Responses to Treatment for Antimicrobial Resistance

PARSIPPANY, N.J.–Melinta Therapeutics, LLC (Melinta), a commercial-stage company providing innovative patient care therapies for acute and life-threatening illnesses, is partnering with OptimizeRx Corp. (OptimizeRx) in an Innovate4Outcomes event – a healthcare design thinking-inspired event.

On December 1, 2022, healthcare providers, pharmaceutical and medical technology manufacturers, healthcare marketing and advertising professionals, and others in the life sciences industry will collaborate in the virtual, half-day experience to explore antimicrobial resistance (AMR). AMR has been identified by the World Health Organization as one of the top ten global public health threats facing humanity.

AMR is exacerbated by siloed care delivery pathways and the social determinants of health, including treatment resistance, challenges in developing new therapies, provider education, and healthcare access inequities¹. A recent study in The Lancet estimated some 5 million global deaths were associated with bacterial AMR in 2019, in addition to its many other harmful impacts on human health and longevity.

“This event will help identify new approaches to improving the care of patients worldwide who experience AMR,” said Christine Ann Miller, President and Chief Executive Officer of Melinta. “As this year’s participants collectively generate new ideas, creative innovations and conceptual approaches to reducing AMR’s prevalence and impact, Melinta’s focus will continue to be ensuring that patients’ needs, including access to life-saving therapies, are always at the forefront.”

On the day of the event, participants will be divided into multi-disciplinary teams and learn which of three systemic patient care challenges associated with AMR they will tackle. Six teams, two for each challenge, will work together to envision future approaches to resolve this worldwide patient care issue. Teams will pitch their ideas to a panel of judges with the aim of creating a business case for further development.
The teams will tackle three challenges:

• How can the healthcare community better support healthcare providers engaged in patient care at all levels prevent, promptly diagnose, and treat AMR?
• How can providers stimulate innovations that benefit all patients in the antibacterial pipeline?
• How can providers improve AMR medical support in low-resource communities and underserved populations to achieve parity in patient care practices and outcomes?

“Complex global challenges such as AMR require new thinking about, and approaches to, patient care,” said Miller. “Too many patients do not have access to the innovative therapies they require. With this event, we hope to jump start the collaborative thinking about patient care, including access to care, that these disparities demand. Melinta looks forward to seeing the ideas that emerge from this year’s event in our aligned quest to improve outcomes for patients in need.”

There is no cost to this event, but registration is required. Visit this link to request an invitation to participate in this event.

About Melinta Therapeutics

Melinta Therapeutics, LLC provides innovative therapies to people impacted by acute and life-threatening illnesses. Our portfolio currently includes six commercial-stage products: Baxdela® (delafloxacin), Kimyrsa® (oritavancin), Minocin® (minocycline) for Injection, Orbactiv® (oritavancin), TOPROL-XL® (metoprolol succinate) and Vabomere® (meropenem and vaborbactam). Melinta also has a licensing agreement in place with Cidara Therapeutics securing the rights to market and distribute development candidate rezafungin in the United States. For more information regarding Melinta’s products, including product indication and important safety information, please visit our website.

TOPROL-XL® is a registered trademark of the AstraZeneca group of companies.

Contact Information:
Susan Blum
(312) 767-0296
info@melinta.com

¹ Global burden of bacterial antimicrobial resistance in 2019: a systematic analysis. Lancet. 2022; 399: 629-655.

Publication details the efficacy and safety of rezafungin dosed once-weekly versus the current of care dosed once-daily

Rezafungin PDUFA target action date is scheduled for March 22, 2023

SAN DIEGO and PARSIPPANY, N.J., Nov. 28, 2022 — Cidara Therapeutics, Inc. (NASDAQ: CDTX) and Melinta Therapeutics, LLC today announced the peer-reviewed publication of data from the completed pivotal ReSTORE Phase 3 clinical trial evaluating the efficacy and safety of its once-weekly antifungal candidate rezafungin as a potential treatment for candidemia and invasive candidiasis. The data, published in The Lancet titled, “Rezafungin versus caspofungin for treatment of candidaemia and invasive candidiasis (ReSTORE): a multicentre, double-blind, double-dummy, randomised phase 3 trial,” demonstrate the statistical noninferiority of rezafungin dosed once-weekly, versus the current standard of care caspofungin, dosed once-daily.

“We are proud to have our Phase 3 clinical data published in one of world’s highest-impact academic medical journals, The Lancet, providing detailed results to the scientific and physician communities and showcasing the efficacy and safety of rezafungin,” said Jeffrey Stein, Ph.D., president and chief executive officer of Cidara. “These data demonstrate that rezafungin dosed once-weekly was noninferior to caspofungin dosed once-daily, an important achievement that has the potential to transform the treatment landscape for invasive fungal infections. We believe that rezafungin could have a significant impact on the lives of patients battling difficult-to-treat and often deadly Candida infections.”

Christine Ann Miller, president and chief executive officer of Melinta Therapeutics, added, “We are very pleased with the publication of the ReSTORE trial results in The Lancet, which like the Phase 2 study, demonstrate a consistent efficacy and safety profile of rezafungin as compared to caspofungin. We look forward to leveraging our established commercial infrastructure and experience in marketing infectious disease products, especially within the hospital and acute care settings, to make rezafungin available to physicians and their patients with candidemia and invasive candidiasis if approved.”

Melinta announced earlier this year that it had acquired the exclusive rights to commercialize rezafungin in the U.S. from Cidara.

Cidara reported positive topline results from ReSTORE in December 2021. 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 Authorization Application (MAA) submission of global cure at Day 14. In the study, researchers evaluated one 400 milligram (mg) dose of rezafungin for the first week followed by 200 mg of rezafungin dosed once-weekly for up to four weeks in total. Rezafungin was generally well tolerated and had a similar safety profile to caspofungin.

The FDA has accepted for filing and granted Priority Review to Cidara’s NDA for rezafungin for the treatment of candidemia and invasive candidiasis. The FDA has assigned a Prescription Drug User Fee Act (PDUFA) target action date of March 22, 2023, enabled by rezafungin’s designation as a Qualified Infectious Disease Product (QIDP) and has indicated that the application will be discussed during a scheduled meeting of the Antimicrobial Drugs Advisory Committee on January 24, 2023.

Cidara retains the rights to rezafungin in Japan and in addition to licensing the commercial rights to Melinta in the U.S., has licensed the commercial rights in all other geographies to Mundipharma.

About Rezafungin
Rezafungin is a novel once-weekly echinocandin being developed for both the treatment and prevention of serious fungal infections, such as candidemia and invasive candidiasis. The structure and properties of rezafungin are specifically designed to improve upon a clinically validated mechanism intended to enhance its efficacy and safety potential for patients. Cidara has completed a Phase 3 clinical trial with rezafungin for the treatment of candidemia and/or invasive candidiasis (ReSTORE trial) and is currently conducting a second Phase 3 clinical trial of rezafungin for the prevention of invasive fungal disease in patients undergoing allogeneic blood and marrow transplantation (ReSPECT trial). Rezafungin has been designated a QIDP with Fast Track status by the FDA, and has been granted Orphan Drug Designation for its use in the treatment of invasive candidiasis in both the U.S. and EU.

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 treatment and prevention paradigms, first with its lead Phase 3 antifungal candidate, rezafungin, in addition to drug-Fc conjugates (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.

About Melinta Therapeutics
Melinta Therapeutics, LLC provides innovative therapies to people impacted by acute and life-threatening illnesses. Our portfolio currently includes six commercial-stage products: Baxdela® (delafloxacin), Kimyrsa® (oritavancin), Minocin® (minocycline) for Injection, Orbactiv® (oritavancin), TOPROL-XL® (metoprolol succinate) and Vabomere® (meropenem and vaborbactam). Melinta also has a licensing agreement in place with Cidara Therapeutics securing the rights to market and distribute the development candidate, rezafungin in the United States.

With an unsurpassed commitment to providers and the patients they serve, we work to ensure that all people who need our therapies can receive them. 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. For additional information, including product and respective important safety information, please visit our website.

TOPROL-XL® is a registered trademark of AstraZeneca Pharmaceuticals LP and is used with permission.

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 our expectations regarding whether the FDA will approve the filed rezafungin NDA on or around the PDUFA target action date or at all, whether the ReSPECT trial for prophylaxis will be completed, if rezafungin is approved in the U.S., when a commercial launch of rezafungin will occur. 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 pre-clinical 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 rezafungin 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.

CIDARA INVESTOR CONTACT:
Brian Ritchie
LifeSci Advisors
(212) 915-2578
britchie@lifesciadvisors.com

CIDARA MEDIA CONTACT:
Patrick Bursey
LifeSci Communications
(203) 430-9545
pbursey@lifescicomms.com

MELINTA CONTACT:
Susan Blum
908-617-1300
info@melinta.com