Switzerland-based Basilea Pharmaceutica Ltd (SIX: BSLN) announced a USD 30 million non-dilutive funding tranche from the Biomedical Advanced Research and Development Authority (BARDA) to sustain its dual Phase III program for fosmanogepix, a broad-spectrum antifungal targeting invasive candidiasis and mold infections where mortality rates reach 40% even with existing therapy. The disbursement was triggered by Basilea meeting a prespecified enrollment milestone in its ongoing Phase III studies.
The funding is issued under an existing agreement signed in September 2024, which included earlier tranches of USD 39 million in July 2025 and USD 25 million in September 2025. Total BARDA commitments since the OTA's inception now stand at USD 123 million, against a potential ceiling of approximately USD 268 million over 12 years if all contract extension options are exercised. BARDA's contribution is structured to cover approximately 60% of total supported project costs, spanning clinical and regulatory activities for fosmanogepix and the earlier-stage antifungal BAL2062. The funding carries no equity dilution.
Fosmanogepix is the primary asset supported by this tranche. The compound is currently enrolled in two concurrent registrational studies: the FAST-IC study (Phase III, candidemia and invasive candidiasis), which initiated in September 2024 and is active at more than 100 sites globally, and the FORWARD-IM study (Phase III, invasive mold infections), which launched in July 2025 across an initial 15 sites. Both studies are designed to support a broad treatment label. Topline data from both trials are anticipated in H1 2028, with regulatory submission expected to follow. Fosmanogepix holds Fast Track, Orphan Drug, and Qualified Infectious Disease Product designations from the FDA across multiple indications.
The antifungal drug development landscape for invasive fungal infections remains limited in approved options, with azoles, echinocandins, and polyenes representing the established classes. Fosmanogepix inhibits the fungal enzyme Gwt1, a mechanism distinct from all approved agents, and has demonstrated activity against multidrug-resistant strains including Candida auris and azole-resistant Aspergillus in Phase II studies and an expanded access program covering more than 250 patients across 11 countries. Competing late-stage assets include ibrexafungerp (GlaxoSmithKline/SCYNEXIS) and olorofim (Shionogi/F2G), though fosmanogepix's dual yeast-and-mold coverage differentiates its label ambition.