Basilea Secures $30 Million BARDA Tranche to Advance Fosmanogepix Phase III Program for Invasive Fungal Infections
核心洞察
Basilea received a $30 million non-dilutive funding tranche from BARDA (搜索) after meeting a prespecified enrollment milestone in its dual Phase III fosmanogepix program.
Total BARDA (搜索) commitments now reach $123 million under an agreement that could provide up to $268 million over 12 years if all extension options are exercised.
Fosmanogepix is a first-in-class antifungal targeting Gwt1 (搜索) with activity against multidrug-resistant Candida auris and azole-resistant Aspergillus, with topline Phase III data expected in H1 2028.
Basilea Pharmaceutica Ltd announced on July 29, 2026 that it has received a $30 million non-dilutive funding tranche from the Biomedical Advanced Research and Development Authority (BARDA (搜索)), part of the U.S. Department of Health and Human Services, to sustain its dual Phase III program for the novel antifungal fosmanogepix. The disbursement was triggered by Basilea meeting a prespecified enrollment milestone in its ongoing registrational studies.
David Veitch, Chief Executive Officer of Basilea, said: "We are very pleased to receive continued support from BARDA (搜索) for the clinical development of fosmanogepix, which has the potential to expand treatment options for patients with invasive fungal infections, including aspergillosis and candidiasis, hence addressing an important unmet medical need."
Funding Structure and BARDA (搜索) Partnership
The new tranche adds to the $93 million already committed by BARDA (搜索) since the signing of the Other Transaction Agreement (OTA) in September 2024, bringing total commitments to $123 million. The OTA carries a potential ceiling of approximately $268 million over up to 12 years if all contract extension options are exercised. BARDA's financial contribution covers approximately 60% of total supported project costs, spanning clinical and regulatory activities for both fosmanogepix and the earlier-stage antifungal BAL2062.
Prior tranches under the agreement included $39 million in July 2025 and $25 million in September 2025. The funding carries no equity dilution for Basilea.
Fosmanogepix: A First-in-Class Antifungal
Fosmanogepix is a first-in-class broad-spectrum antifungal with a novel mechanism of action, inhibiting the fungal enzyme Gwt1 (搜索) — a target distinct from all currently approved antifungal classes, including azoles, echinocandins, and polyenes. Its active moiety has demonstrated activity against common species of Candida and Aspergillus, including multidrug-resistant strains such as Candida auris and Candida glabrata, as well as rare difficult-to-treat molds including Fusarium spp., Scedosporium spp., and some Mucorales fungi.
The compound has been evaluated in Phase II studies and an expanded access program covering more than 250 patients across 11 countries. Fosmanogepix holds Fast Track, Orphan Drug, and Qualified Infectious Disease Product (QIDP) designations from the U.S. Food and Drug Administration across multiple indications.
Ongoing Phase III Program
Two concurrent registrational studies are currently enrolling. The FAST-IC study (NCT05421858), evaluating fosmanogepix in adult patients with candidemia and/or invasive candidiasis (搜索), initiated in September 2024 and is active at more than 100 sites globally. The FORWARD-IM study (NCT06925321), targeting invasive mold infections, launched in July 2025 across an initial 15 sites. Both studies are designed to support a broad treatment label, with topline data anticipated in the first half of 2028 and regulatory submission expected to follow.
Unmet Medical Need
Invasive candidiasis (搜索), including candidemia, represents a significant clinical challenge. Candida species rank as the fourth main cause of bloodstream infections in U.S. hospitals, and the prognosis remains difficult — mortality rates reach as high as 40% even when patients receive antifungal therapy. Invasive aspergillosis (搜索) and rare mold infections predominantly affect immunocompromised patients, including those with hematologic malignancies, transplant recipients, and individuals with other immunodeficiency disorders, and are associated with high morbidity and mortality.
Pipeline and Corporate Outlook
Beyond fosmanogepix, the BARDA (搜索) agreement also covers BAL2062, a first-in-class clinical-stage antifungal derived from a natural product with demonstrated fungicidal activity against Aspergillus spp., including azole-resistant strains. BAL2062 completed Phase I and preclinical profiling in 2025, and Basilea expects to conclude regulatory discussions on its Phase II/III development pathway during 2026.
Basilea's broader pipeline includes ceftibuten-ledaborbactam etzadroxil (搜索), an oral beta-lactam/beta-lactamase inhibitor combination in-licensed from Venatorx Pharmaceuticals (搜索) in August 2025 for complicated urinary tract infections, supported by a separate BARDA (搜索) contract with up to $159 million in potential non-dilutive funding. The company reported cash of CHF 162 million (approximately $180 million) as of December 31, 2025, and guided for approximately 20% growth in both R&D expenditure and operating profit for full-year 2026. Pfizer retains a right of first negotiation for commercializing fosmanogepix upon successful completion of Phase III development.