F2G Secures $100M to Advance Olorofim Development and Commercialization in the US

F2G Ltd, a clinical-stage biopharmaceutical company based in Manchester, United Kingdom, revealed a significant $100 million financing round. This round is spearheaded by new investor AMR Action Fund and co-led by ICG Life Sciences, with notable contributions from existing investors such as Novo Holdings, Advent Life Sciences, Sofinnova Partners, Forbion, Blue Owl Healthcare Opportunities, Morningside Ventures, Brace Pharmaceuticals, and Merifin Capital.

The new funding will be pivotal for F2G as it aims to wrap up the late-stage development, pursue regulatory approval, and prepare for the commercialization of olorofim, a groundbreaking oral antifungal drug. This drug targets invasive aspergillosis (IA) and other severe fungal infections. Notably, Henry Skinner, Ph.D., CEO of AMR Action Fund, and Toby Sykes, Ph.D., Managing Director of ICG Life Sciences, will join F2G's Board of Directors. The financing transaction is still subject to the customary Foreign Direct Investment (FDI) clearance by Austrian authorities, where F2G operates a wholly-owned subsidiary, and is expected to finalize in the last quarter of 2024.

Olorofim stands out as the first orotomide antifungal, marking a new class of antifungal agents. It has earned the unique distinction of being the sole antifungal to receive a Breakthrough Therapy Designation for multiple uses by the US Food and Drug Administration (FDA). Unlike current antifungal treatments, olorofim works through an innovative mechanism by inhibiting the pyrimidine synthesis pathway, leading to its fungicidal effectiveness. The drug is expected to fill the treatment gap for patients suffering from severe, rare fungal diseases that are unresponsive to existing treatments.

Francesco Maria Lavino, CEO of F2G, expressed his excitement about this significant capital infusion and the collaboration with AMR Action Fund and ICG. He highlighted the expertise that Dr. Skinner and Dr. Sykes would bring to the Board as the company approaches a vital phase of its growth. Lavino emphasized that this period is crucial for finalizing olorofim's development and commercialization, especially in the US. If approved, olorofim will introduce a new class of antifungal agents with a unique mechanism and address pressing needs in conditions associated with high morbidity and mortality.

Dr. Skinner noted the increasing threat of fungal infections globally, which disproportionately affect vulnerable populations. He lamented the slow pace of innovation in antifungal therapies despite the growing resistance and limitations of current treatments. Dr. Skinner expressed his enthusiasm for supporting F2G in developing this much-needed therapy and navigating the regulatory approval process.

Dr. Sykes also commented on the rising challenges posed by emerging and spreading fungal pathogens. He underscored the urgent need for advanced antifungal treatments and expressed confidence that investments in new drug candidates like olorofim could bridge critical gaps in patient care, significantly impacting patients, caregivers, and healthcare systems.

F2G is deeply involved in discovering and developing innovative treatments for life-threatening invasive fungal infections. With operations spanning the UK, US, and Austria, the company has introduced orotomide antifungal agents, which target a crucial enzyme in the de novo pyrimidine biosynthesis pathway, offering a new mechanism compared to existing antifungal treatments.

Olorofim, formerly known as F901318, is currently undergoing a Phase 2b open-label study and a global Phase 3 trial comparing it to liposomal amphotericin B followed by standard care for invasive fungal diseases. The drug has received orphan drug status from both the European Medicines Agency and the FDA for various severe fungal infections and has been designated a Qualified Infectious Disease Product (QIDP) for several conditions, including invasive aspergillosis.

Invasive aspergillosis, caused by Aspergillus mold species, poses a severe health risk, especially to immunocompromised individuals, with a mortality rate surpassing 80% in high-risk groups. This makes the development and approval of new treatments like olorofim critically important.