1,3-beta-glucan synthase

Approval triggered by positive results from ReSTORE Phase III clinical trial Payment will advance Cidara’s Cloudbreak platform for the development of drug-Fc conjugates (DFCs) SAN DIEGO, Feb. 12, 2024 (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, today announced receipt of an $11.14 million milestone payment from Mundipharma following the European approval of REZZAYO™ (rezafungin acetate), a novel, once-weekly echinocandin antifungal approved for the treatment of invasive candidiasis in adults. This approval by the European Commission follows the positive opinion of the Committee for Medicinal Products for Human Use (CHMP) and is based on results from the pivotal ReSTORE Phase III clinical trial, which demonstrated statistical non-inferiority for rezafungin, dosed once weekly, when compared to the standard of care, caspofungin, dosed once daily. The drug was previously approved by the United States Food and Drug Administration (FDA) for the treatment of candidemia and invasive candidiasis in patients with limited or no treatment options. “The European approval of REZZAYO marks a significant milestone for patients who are in need of new treatment options for invasive candidiasis, and we look forward to seeing Mundipharma bring it to the EU market,” said Jeffrey Stein, Ph.D., president and chief executive officer of Cidara. “With the payment we’ve received from this milestone, we remain committed to advancing our Cloudbreak platform to develop targeted immunotherapies for cancer patients.” Cidara is currently advancing its Cloudbreak drug-Fc conjugate (DFC) platform to design targeted immunotherapies that inhibit specific diseases while simultaneously engaging the immune system. Its lead oncology DFC, CBO421, is a potential best-in-class inhibitor of CD73, a validated target highly expressed on tumor cells. An IND is anticipated this year. 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 commercialize in the U.S. and ex-U.S. Cidara is headquartered in San Diego, California. For more information, please visit 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 . 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 an unmet medical need exists for rezafungin, and the likelihood that rezafungin will be prescribed by physicians in the EU or approved for reimbursement by member state authorities. 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 Ritchie LifeSci Advisors 212-915-2578 britchie@lifesciadvisors.com MEDIA CONTACT: Veronica Eames LifeSci Communications 646-970-4682 veames@lifescicomms.com

Approval 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. REZZAYO represents the first new treatment option in over 15 years for patients with invasive candidiasis. Cidara is entitled to receive a milestone payment of approximately $11.14 million from Mundipharma for the European Medicines Agency (EMA) approval. SAN DIEGO, Dec. 22, 2023 (GLOBE NEWSWIRE) -- Cidara Therapeutics Inc. (Nasdaq: CDTX) today announced REZZAYO (rezafungin acetate) has been approved in the European Union (EU) for the treatment of invasive candidiasis in adults. The approval by the European Commission (EC) follows the positive opinion of the Committee for Medicinal Products for Human Use (CHMP) and is based 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. These findings are supported by the positive results of the STRIVE Phase II clinical trial and an extensive nonclinical development program. Invasive candidiasis is a severe, life-threatening infection of the bloodstream and/or deep/visceral tissues. It affects seriously ill people, especially those with a weakened immune system and the mortality rate can be 40% or more. It can place a large burden on the healthcare system, with the potential for extended treatment regimens and long hospital stays. Over the last 15 years, there have been no new treatments and morbidity and mortality rates remain largely the same, indicating the need for alternative treatment options. 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, “There has been a significant global unmet need for treating people with invasive candidiasis. Today’s announcement by the European Commissionmarks an important moment that could enable the healthcare professional community to manage invasive candidiasis patients in a different way using a new treatment option.” Taylor Sandison, M.D. M.P.H, Chief Medical Officer at Cidara, said, “We welcome the European approval, which makes this treatment option available to patients in Europe alongside patients in the United States following the FDA’s approval earlier this year. This is a great step forward on our journey to help patients with serious Candida infections across the globe.” Rezafungin has been granted Orphan Drug Designation for its use in the treatment of invasive candidiasis in the EU. Cidara Therapeutics has partnered with Mundipharma, which has commercial rights to rezafungin outside the U.S. and Japan. Cidara is entitled to receive a milestone payment of approximately $11.14 million from Mundipharma for the European Union (EU) approval of rezafungin in accordance with the terms of the Collaboration and License Agreement, dated September 3, 2019, by and between the Company and Mundipharma. Under the licensing agreement, Cidara remains eligible to receive additional potential payments of up to approximately $470 million upon achievement of development and regulatory milestones planned over the next several years, as well as double-digit royalties in the teens on tiers of annual net sales. 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%. 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. 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 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 . 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, and the likelihood that rezafungin will be prescribed by physicians in the EU or approved for reimbursement by member state authorities. 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 Ritchie LifeSci Advisors 212-915-2578 britchie@lifesciadvisors.com MEDIA CONTACT: Veronica Eames LifeSci Communications 646-970-4682 veames@lifescicomms.com

Brexafemme complements GSK’s industry-leading infectious disease portfolio with an FDA approved treatment for vulvovaginal candidiasis SCYNEXIS will receive an upfront payment of $90 million with future performance-based milestone payments and tiered royalties SCYNEXIS retains rights to all other assets derived from enfumafungin, with GSK having a right of first negotiation to these pre-clinical and discovery stage assets SCYNEXIS to host an investor call and webcast at 8:30 a.m. EDT today GSK plc (LSE/NYSE: GSK) and SCYNEXIS, Inc. (NASDAQ: SCYX), today announced they have entered into an exclusive licence agreement for Brexafemme (ibrexafungerp tablets), a US FDA approved, first-in-class antifungal for the treatment of vulvovaginal candidiasis (VVC) and for reduction in the incidence of recurrent VVC (RVVC). This exclusive licence agreement gives GSK rights to commercialise Brexafemme for VVC and RVVC while continuing to develop ibrexafungerp, which is in phase III clinical trials for the potential treatment of invasive candidiasis (IC), a life-threatening fungal infection. Infectious diseases and HIV represent around two-thirds of GSK’s pipeline. Brexafemme complements GSK’s first or best-in-class portfolio alongside late-stage antibiotics gepotidacin, potentially the first novel antibiotic for uncomplicated urinary tract infections (uUTI) in over 20 years, and tebipenem, a potential new treatment of complicated urinary tract infections (cUTI). Luke Miels, Chief Commercial Officer, GSK said: “The challenge of antimicrobial resistance includes increasing rates of multi-drug resistant fungal infections. Brexafemme is a novel, approved antifungal medicine with a broad spectrum of activity against existing and emerging resistant strains of fungi. In addition, the transaction consolidates GSK’s synergistic portfolio of innovative late-stage antibiotics.” VVC affects up to 75% of women at least once, with 40-45% having two or more episodesi. Brexafemme has a distinct mechanism of action whereby it kills the fungus, as opposed to some antifungals which inhibit fungal growth. It is the only oral antifungal US FDA-approved treatment for VVC and reduction of RVVC. With rates of resistance to other antifungal treatments rising, Brexafemme addresses a clear unmet need for new oral treatments. David Angulo, M.D., President and Chief Executive Officer of SCYNEXIS said: “This agreement represents a major milestone for SCYNEXIS, maximising Brexafemme’s commercial potential in VVC and further validating our vision of the critical role for this first-in-class antifungal in invasive infections. We are thrilled to partner with GSK on this high-potential asset and will continue progressing ibrexafungerp’s phase III programme in invasive candidiasis (IC).” IC is a life-threatening infection that affects the blood or internal organs. There are around 750,000 cases of IC every year worldwide.ii In the US, it is one of the most common causes of bloodstream infections in hospitalised patients and can lead to more extended hospital stays and higher associated costs. Financial terms Under the terms of the agreement, GSK will make an upfront payment to SCYNEXIS of $90 million, plus additional potential milestone-based payments totalling $503 million. GSK will pay up to $245.5 million if specific development, regulatory, and commercial milestones associated with the IC indication are successfully completed. A further $15 million milestone will be paid upon successful US FDA approval of an additional indication. GSK will pay sales-related milestone payments based on achieving a certain commercial performance of up to $242.5 million, and mid-single digit to mid-teen digit tiered royalties on the totality of sales across all indications (in both cases with the top tier based on achieving net sales greater than $1 billion). GSK will also receive an exclusive licence to develop ibrexafungerp and commercialise Brexafemme in all countries except the greater China region and certain other countries already out-licensed by SCYNEXIS to third parties. Under the licence agreement, SCYNEXIS will continue executing the phase III programme for IC and other ongoing trials. SCYNEXIS retains rights to all other assets derived from enfumafungin. As part of this exclusive licence agreement, GSK has been granted a right of first negotiation to these compounds. This agreement is conditional upon customary conditions including review by the appropriate regulatory agencies under the Hart-Scott-Rodino Act. Aquilo Partners, L.P. is acting as financial advisor and Cooley LLP as legal advisor to SCYNEXIS on this transaction. About Brexafemme (ibrexafungerp tablets) Brexafemme (ibrexafungerp tablets) is a novel oral glucan synthase inhibitor with a broad spectrum of activity including against emerging resistant threats. Its mechanism of action is similar to echinocandins, with fungicidal action against yeast (meaning it kills the fungus), versus fluconazole which is fungistatic (meaning it inhibits fungal growth). It was first approved in the US in 2021 for the treatment of VVC and is the first and only oral antifungal approved for both the treatment of VVC and the reduction of the incidence of RVVC. Brexafemme has proven activity against WHO-designated priority fungal pathogens such as Candida albicans. In addition, ibrexafungerp has shown activity against Candida auris, another WHO-designated priority fungal pathogen. About VVC and RVVC VVC is a widespread vaginal infection primarily caused by a fungus called Candida albicans. Surveys suggest that VVC affects up to 75% of women once in their life, and 40%–45% have two or more episodesi. RVVC is a debilitating, long-term condition that can severely affect the quality of life of affected women. Although not life-threatening, VVC does cause severe itching, soreness, and vaginal irritation, interfering with normal sexual relations. These symptoms and manifestations are considerably magnified when attacks are frequent and recurrent and when the disease is refractory to conventional therapy.iii For the 30% of patients with complicated VVC, which includes recurrent, azole-resistant or refractory VVC, there are limited treatment options, with current guidelines limited to using the same treatment for a longer duration.iii About IC IC is a life-threatening fungal infection caused by Candida that affects the blood or internal organs. In the US, it is one of the most common causes of bloodstream infections in hospitalised patients, leading to longer hospital stays, higher associated costs, and death. People at risk include patients with a prolonged stay in an Intensive Care Unit and those with a weakened immune system, e.g., chemotherapy or organ transplant.iv About SCYNEXIS SCYNEXIS, Inc. (NASDAQ: SCYX) is a biotechnology company pioneering innovative medicines to help millions of patients worldwide overcome and prevent difficult-to-treat infections that are becoming increasingly drug-resistant. SCYNEXIS scientists are developing the company’s lead asset, ibrexafungerp (formerly known as SCY-078), as a broad-spectrum, systemic antifungal for multiple fungal indications in both the community and hospital settings. The U.S. Food and Drug Administration (FDA) approved BREXAFEMME® (ibrexafungerp tablets) on June 1, 2021, for its first indication in vulvovaginal candidiasis (VVC), followed by a second indication on November 30, 2022, for reduction in the incidence of recurrent VVC. Late-stage clinical investigation of ibrexafungerp for the treatment of life-threatening invasive fungal infections in hospitalized patients is ongoing. Additional assets derived from enfumafungin are currently in pre-clinical and discovery phase. For more information, visit www.scynexis.com. GSK in infectious diseases Infectious diseases and HIV represent around two-thirds of GSK’s pipeline and its primary focus for R&D. In antibiotics, gepotidacin is a late-stage potential treatment for uncomplicated urinary tract infections (uUTI) and could be the first novel oral antibiotic for uUTI in more than 20 years. In addition, in September 2022, GSK entered into an exclusive licence agreement with Spero Therapeutics, Inc. to add tebipenem HBr, another late-stage antibiotic and potential treatment for complicated urinary tract infections (cUTI), to its pipeline. About GSK GSK is a global biopharma company with a purpose to unite science, technology, and talent to get ahead of disease together. Find out more at gsk.com/company.