F2G secures $100M Series H for fungal infection treatment

Manchester-based F2G has successfully raised an additional $100 million in funding following a Complete Response Letter (CRL) from the U.S. Food and Drug Administration (FDA) for its antifungal drug, olorofim. This financial boost comes just over a year after the FDA's rejection in June 2023. CEO Francesco Maria Lavino revealed plans to resubmit for FDA approval toward the end of 2025, with hopes of securing approval by mid-2026.

The series H financing is divided into two tranches: an initial $62.5 million and an additional $37.5 million contingent on specific milestones. This funding round is notable as private financing rounds are rare at this stage; many biotechs typically go public or get acquired after a fewer number of rounds. Lavino noted that this funding round values the company higher than its last round of $70 million in August 2022, making it an "up round" in a challenging financial environment.

Founded in 1998, F2G has long been a part of the University of Manchester’s incubator facility. Investment in antifungal and anti-infective treatments has traditionally been less robust compared to other drug development areas, but F2G aims to position itself as a rare disease company. “The way we are developing the drug is more like a rare disease product. We are really focusing on infections that had limited or no options,” Lavino explained. He emphasized that many patients are immunocompromised, including leukemia patients, who are at high risk of fatal infections without effective treatment. The company also operates a compassionate use program, receiving daily requests for access to olorofim.

Following the CRL, F2G has engaged with the FDA multiple times, including meetings in October, March, and August. Lavino described the rejection as "relatively benign" and noted that the company and FDA are aligned on a plan for resubmission. The FDA has provided breakthrough therapy designation, aiding these discussions. Lavino stated, “The FDA is still open. We are basically packaging the data in a different way.” The new submission will include data from an open-label Phase 2b study and different historical control data, with approximately 200 patient data points compared to the initial 100.

The Phase 2b study focused on patients with invasive fungal infections lacking treatment options, including rare mold infections like azole-resistant aspergillosis, scedosporiosis, and lomentosporiosis. A Phase 3 study, named OASIS, is currently comparing olorofim to liposomal amphotericin B followed by the standard of care. This study aims to enroll around 225 patients and is expected to complete its primary phase in 12 months.

Shionogi, F2G’s partner for European and Asian markets, is likely to wait for Phase 3 data before seeking approval in Europe. While there is potential for conditional approval in Europe based on Phase 2 results, it is not the company’s baseline strategy. Post FDA approval, F2G may explore further partnerships to expand olorofim's reach into other regions, including Latin America.

The recent funding round, bolstered by new investors like AMR Action Fund and ICG, ensures F2G has sufficient funds to bring olorofim to the U.S. market. Existing supporters such as Novo Holdings, Advent Life Sciences, Sofinnova Partners, and Forbion also contributed to this round, providing the financial stability needed for F2G’s next steps.