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- Funds to support the advancement of SF001, a next-generation polyene antifungal designed for reduced toxicity NEW YORK, June 17, 2024 /PRNewswire/ -- Elion Therapeutics ("Elion", formerly Sfunga Therapeutics), a biotechnology company dedicated to transforming the treatment of life-threatening invasive fungal infections (IFIs), announced today it has closed a $81 million Series B funding round led by Deerfield Management ("Deerfield") and the AMR Action Fund. Additional investors include Illinois Ventures. Continue Reading Deerfield Logo (PRNewsfoto/Deerfield Management) Elion's clinical-stage candidate, SF001, a next-generation polyene antifungal, completed a first-in-human single-ascending dose study and is now being evaluated in a multiple-ascending dose study. The active molecule is a novel analog of the antifungal amphotericin B (AmB), rationally designed to mitigate systemic toxicities. In 2023, SF001 received Qualified Infectious Disease Product (QIDP) and Fast Track designations from the U.S. Food and Drug Administration (FDA) for early antifungal therapy of presumed invasive fungal disease and treatment of invasive aspergillosis. "Invasive fungal infections have reached historic levels of concern, largely due to increased medical reliance on biologic immunosuppression, more people with severe pulmonary disease at risk of IFI, and increased exposures associated with environmental changes," said Kieren Marr, M.D., M.B.A., Elion's President and Chief Medical Officer. "As we move into the next stage of our clinical program, we're optimistic about the potential of SF001 to deliver antifungal treatment with reduced toxicity and the potential to address critical challenges with currently available options." Elion is led by Dr. Marr and a highly experienced team of experts who have been instrumental in the development of most currently available antifungal agents. Dr. Marr, co-founder of Elion and international expert in fungal diseases, served as Director of Transplant and Oncology Infectious Diseases at Johns Hopkins University School of Medicine until 2022, when she became Elion's Chief Medical Officer and recruited the leadership team as it stands today. "The speed of development of SF001 to date has been impressive and is a testament to the world-class leadership team established at Elion," said James Flynn, Managing Partner, Deerfield Management. "Fungal infections are a growing medical concern globally, and we have an opportunity with this therapeutic candidate to address millions of disease cases and preventable deaths that occur every year. We are excited to support this mission and confident that this financing will provide the runway to achieve Elion's clinical development goals." "With resistance to existing antifungals growing and infection rates increasing, it is essential that we develop effective therapies for patients in need," said AMR Action Fund CEO Henry Skinner, PhD, MBE. "The World Health Organization recently identified four fungal pathogens that it considers a 'critical priority,' including Aspergillus fumigatus. We are pleased to support the team at Elion and believe their work could deliver an important treatment for patients suffering from devastating fungal infections." ABOUT INVASIVE FUNGAL INFECTIONS More than 150 million people suffer from serious fungal infections worldwide. Severe, life-threatening fungal infections result in approximately 2.5 million annual deaths globally. IFIs typically occur in individuals with compromised immune systems due to HIV/AIDS, cancer therapies or organ transplants, or those with severe lung disease, especially those caused by influenza and SARS CoV-2 infections. Only four classes of antifungal drugs are currently available, and antifungal resistance, organ toxicities, and drug-drug interactions complicate IFI treatment. This group of drugs includes AmB, a highly efficacious natural product widely used since the 1950s to treat a variety of fungal infections. However, AmB also causes kidney impairment, occurring in up to 80 percent of patients. SF001 was rationally designed to mitigate renal toxicities through increased specificity to fungal cells. ABOUT ELION THERAPEUTICS Elion Therapeutics is a cutting-edge biotechnology company dedicated to transforming the treatment of life-threatening IFIs. Elion was founded on the belief that mechanistic insights enable targeted optimizations of natural products. Today, Elion is advancing the first polyene antifungal rationally designed to mitigate toxicities and potentially transform the future of polyene therapy. For more information, please visit . ABOUT DEERFIELD MANAGEMENT Deerfield is an investment management firm committed to advancing healthcare through investment, information and philanthropy. The Firm works across the healthcare ecosystem to connect people, capital, ideas and technology in bold, collaborative and inclusive ways. For more information, please visit . Deerfield contact: Rachel Pelletier [email protected] (440) 409-6274 SOURCE Deerfield Management

Elion Therapeutics has closed an $81-million series B round led by Deerfield Management and the AMR Action Fund to advance SF001, its Phase I polyene antifungal candidate engineered as a potentially less toxic analogue of the widely used medicine amphotericin B (AmB). Illinois Ventures also participated in the financing."The speed of development of SF001 to date has been impressive," said James Flynn, managing partner at Deerfield. "Fungal infections are a growing medical concern globally, and we have an opportunity with this therapeutic candidate to address millions of disease cases and preventable deaths that occur every year."Specific targeting of fungal cellsCurrently, only four classes of antifungal drugs are available, but drawbacks such as resistance, organ toxicities and drug interactions complicate treatment. AmB, a natural product widely used since the 1950s to treat various fungal infections, is known for its high efficacy, but also carries a significant risk of kidney impairment, occurring in up to 80% of patients. Elion – originally formed back in 2019 as Sfunga Therapeutics – says SF001 has been designed to mitigate these renal toxicities while maintaining potency through more specific targeting of fungal cells.The fundraise comes amid growing recognition of the threat posed by invasive fungal infections and the need for new treatments. The World Health Organization recently identified four "critical group" pathogens that it considers a priority, including Aspergillus fumigatus, Candida albicans, Candida auris and Cryptococcus neoformans.In 2023, SF001 received qualified infectious disease product (QIDP) and fast-track designations from the FDA for early antifungal therapy of presumed invasive fungal disease and treatment of invasive aspergillosis. The drug, administered by intravenous infusion, has completed a first-in-human single-ascending dose study and is now being evaluated in a multiple-ascending dose trial. An oral formulation is currently in the feasibility phase, according to the company's website.Meanwhile, Deerfield recently appointed Frank Nestle, former chief scientific officer at Sanofi, to spearhead the firm's therapeutic discovery and development operations.