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

PARSIPPANY, N.J.–Melinta Therapeutics, LLC (Melinta), a commercial-stage company providing innovative therapies for acute and life-threatening illnesses, announced today, the presentation of nine scientific presentations with data from its current antibiotic portfolio at Infectious Disease Week (IDWeek) 2022, taking place October 19– 22, 2022, in Washington, D.C. Additionally, new rezafungin clinical and preclinical data will be presented in six poster presentations. As previously announced, Melinta has licensed the U.S. commercial rights to rezafungin, an investigational candidate currently under FDA review, from Cidara Therapeutics.

IDWeek is the combined annual meeting of the Infectious Diseases Society of America (IDSA), the Society for Healthcare Epidemiology of America (SHEA), the HIV Medicine Association (HIVMA), the Pediatric Infectious Diseases Society (PIDS), and the Society of Infectious Diseases Pharmacists (SIDP).

Details of the presentations are provided below. The complete program of titles and abstracts can be accessed on the IDWeek 2022 website at www.idweek.org.

Melinta Portfolio Poster Presentations

Rezafungin Poster Presentations

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.

With an unsurpassed commitment to providers and the patients they serve, Melinta works to ensure that all people who need their therapies can receive them. Melinta focuses its expanding portfolio on serving patients with an unmet need to make the most meaningful impact. Melinta is dedicated to innovation while staying grounded in what matters most: patients. For additional information regarding Melinta’s products, including product indication and important safety information, please visit our website at https://melinta.com.

For additional information regarding Cidara Therapeutics and rezafungin, please visit https://www.cidara.com/.

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

Melinta Therapeutics and Cidara Therapeutics Announce Licensing Agreement to Commercialize Rezafungin in the U.S.

MORRISTOWN, N.J., July 27, 2022 — Melinta Therapeutics, LLC (“Melinta”) and Cidara Therapeutics (“Cidara”) today announced that they have entered into a License Agreement (the “Agreement”) to facilitate a strategic partnership to commercialize rezafungin, a novel, once-weekly echinocandin antifungal in the United States (U.S.). Cidara is developing rezafungin for the treatment of candidemia and invasive candidiasis in adults, as well as for the prophylaxis of invasive fungal infections in adult patients undergoing allogeneic blood and marrow transplantation.

The partnership follows Cidara’s submission of a New Drug Application (NDA) for rezafungin for the treatment of candidemia and invasive candidiasis, for which no new therapies have been approved in over a decade. The U.S. Food and Drug Administration (FDA) has previously granted Qualified Infectious Disease Product (QIDP) designation to rezafungin for injection which confers priority review of the NDA. Additionally, the treatment indication has orphan drug designation. Cidara expects to be assigned a Prescription Drug User Fee Act (PDUFA) target action date in the first quarter of 2023, if the NDA is accepted for review following application validation. Under the terms of the Agreement, Cidara will continue to lead the ongoing global Phase 3 ReSPECT prophylaxis study, as well as the regulatory activities for the approval of rezafungin in both the treatment and prophylaxis indications. The NDA will be transferred to Melinta at the time points as specified in the Agreement.

“The addition of rezafungin expands and diversifies our existing portfolio and serves as fuel for accelerating our long-term growth strategy. By leveraging our expansive commercial infrastructure, we will provide the resources needed to optimize the commercialization of rezafungin and ensure patient access to this life-saving medicine in the U.S.” said Christine Ann Miller, President and Chief Executive Officer, Melinta Therapeutics. “We will continue to aggressively pursue portfolio expansion that aligns with our mission of providing innovative therapies for acute and life-threatening illnesses.”

“With its existing U.S. commercial infrastructure and significant experience in commercializing infectious disease products, including once-weekly antibiotics, Melinta is ideally positioned to bring rezafungin to the U.S. market and patients in need,” said Jeffrey Stein, Ph.D., President and Chief Executive Officer of Cidara.

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).

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.

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. Rezafungin has not been approved for commercial use in any market. 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 thetreatment 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 Qualified Infectious Disease Product (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.

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 that the ReSTORE trial data will support an NDA submission in the U.S. and similar marketing authorization submissions in other countries; the potential timing of such submissions; and the likelihood that rezafungin, if approved, will be prescribed by physicians or included in formularies or treatment guidelines. 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.

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

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 Therapeutics Acquires U.S. Rights to TOPROL-XL® (metoprolol succinate) from New American Therapeutics

MORRISTOWN, N.J., Apr. 6, 2022 — Melinta Therapeutics, LLC (“Melinta”), a commercial-stage company providing innovative therapies for acute and life-threatening illnesses, announced today that it has acquired the U.S. rights to TOPROL-XL® (metoprolol succinate) and its Authorized Generic (AG) through an agreement between Melinta and New American Therapeutics Inc.

TOPROL-XL®, approved by the FDA in 1992, is a cardioselective beta-blocker indicated for the treatment of hypertension, alone or in combination with other antihypertensives; the long-term treatment of angina pectoris; and the treatment of stable, symptomatic (NYHA class II or III) heart failure of specific origins.

Said Christine Ann Miller, President and Chief Executive Officer, Melinta Therapeutics, “This acquisition immediately expands and diversifies our existing portfolio and serves as fuel for accelerating our long-term growth strategy and enhancing our profitability. We will continue to aggressively pursue portfolio expansion that aligns with our mission of providing innovative therapies for acute and life-threatening illnesses.”

“We are extremely proud of our work to provide access to this life saving medication,” said Michael Anderson, CEO, New American Therapeutics. “Melinta shares this same commitment to patient access. And they demonstrate that commitment through an impressive supply chain and distribution network that ensures this medication will continue to be available for those patients who need it.”

Melinta has begun the integration process to bring TOPROL-XL® into the company’s existing production, distribution and commercialization structure to ensure this important medication will continue to be made available without interruption.

Terms of the transaction were not disclosed.

About Melinta Therapeutics

Melinta Therapeutics, LLC provides innovative therapies to people impacted by acute and life-threatening illnesses. Our portfolio currently includes five commercial-stage antibiotics: BAXDELA® (delafloxacin), KIMYRSA™ (oritavancin), MINOCIN® (minocycline) for Injection, ORBACTIV® (oritavancin), and VABOMERE® (meropenem and vaborbactam) and a commercial-stage cardiovascular product: TOPROL-XL® (metoprolol succinate). 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. Visit www.melinta.com for more information.

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

Contact Information:
Susan Blum
Chief Financial Officer
Melinta Therapeutics, LLC
908-617-1300
info@melinta.com

About TOPROL-XL® (metoprolol succinate)
TOPROL-XL® is a beta-adrenergic blocker indicated for the treatment of:

IMPORTANT SAFETY INFORMATION
Contraindications

Warnings and Precautions

Adverse Reactions
Most common adverse reactions: tiredness, dizziness, depression, shortness of breath, bradycardia, hypotension, diarrhea, pruritus, rash.

Melinta Therapeutics Announces Appointment of Peter Piliero as Vice President of Medical Affairs

MORRISTOWN, N.J., Mar. 14, 2022 — Melinta Therapeutics, LLC (“Melinta”), a commercial-stage company providing innovative therapies for acute and life-threatening illnesses, announces the appointment of Dr. Peter Piliero as Vice President of Medical Affairs, effective today.

Dr. Piliero, an Infectious Disease specialist and global Medical Affairs leader, joins Melinta under the leadership of President and Chief Executive Officer Christine Ann Miller. In this role, Dr. Piliero will be responsible for the development and implementation of integrated medical plans for Melinta’s portfolio. Additionally, Dr. Piliero will help Melinta continue to stand out as a thought leader in the important conversations happening in scientific and medical communities today.

“As Melinta continues its legendary journey serving patients with critical, unmet needs, I am excited to welcome Pete to the team. With his depth of medical and scientific experience and proven track record leading high-performing teams, I know he’ll be an incredible asset in driving growth and guiding Melinta’s public discussions as we shape the future of acute care,” Ms. Miller said.

Dr. Piliero joins Melinta from GSK Consumer Healthcare, where he led Medical Affairs Americas. Prior to that role, he held significant clinical and leadership positions at Boehringer Ingelheim, Merck and Mallinckrodt. At these organizations, he led global Medical Affairs teams in various therapeutic areas, including Virology, Immunology, CNS, Metabolism and Women’s Health.

Prior to joining the pharmaceutical industry, Dr. Piliero was Associate Professor of Medicine at Albany Medical College. He practiced there for 11 years as an Infectious Disease and HIV specialist, providing patient care and directing the Clinical Pharmacology Studies Unit.

Since 2017, Dr. Piliero has been an active member of the Medical Affairs Professional Society. He is currently a member of the Board of Directors and the Vice Chair of the Executive Committee.

“I am honored to work alongside this truly committed team to achieve our vision – ensuring that all patients with life-threatening illnesses who need our innovative therapies will receive them,” Dr. Piliero said. “I look forward to developing and executing strategic medical plans, leading scientific communications, generating new evidence and ensuring trusted communications with external stakeholders to pave the way for improved patient outcomes.”

About Melinta Therapeutics

Melinta Therapeutics, LLC provides innovative therapies to people impacted by acute and life-threatening illnesses. Our portfolio currently includes five commercial-stage antibiotics: Baxdela® (delafloxacin), Kimyrsa™ (oritavancin), Minocin® (minocycline) for Injection, Orbactiv® (oritavancin), 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. Visit our website for more information.

Melinta Contact Information
Susan Blum
Chief Financial Officer
Melinta Therapeutics
(312) 767-0296
info@melinta.com