BARDA Invests Additional USD 39 Million to Accelerate Phase 3 Trials of Basilea’s Fosmanogepix and BAL2062

BARDA Invests Additional USD 39 Million to Accelerate Phase 3 Trials of Basilea’s Fosmanogepix and BAL2062

(IN BRIEF) Basilea Pharmaceutica has secured an extra USD 39 million from BARDA under its Other Transaction Agreement, bringing potential non-dilutive funding to USD 268 million over 12 years. This new tranche will finance the ongoing phase 3 trial of fosmanogepix in yeast infections, initiate a second phase 3 study in mold infections, and prepare for phase 2 development of BAL2062. Both compounds offer novel antifungal mechanisms targeting drug-resistant and rare fungal pathogens, addressing critical needs among immunocompromised patients. Fosmanogepix and BAL2062 already hold multiple FDA designations, underlining their strategic importance. Basilea, a Switzerland-based biopharma listed on SIX: BSLN, markets Cresemba and Zevtera and maintains a robust anti-infective pipeline.

(PRESS RELEASE) ALLSCHWIL, 8-Jul-2025 — /EuropaWire/ — Basilea Pharmaceutica Ltd (SIX: BSLN), a biopharmaceutical company focused on treating severe bacterial and fungal infections, today announced that the U.S. Biomedical Advanced Research and Development Authority (BARDA), part of the Administration for Strategic Preparedness and Response within HHS, has committed an additional USD 39 million to support further development of its novel antifungal candidates fosmanogepix and BAL2062. This funding milestone, awarded under OTA 75A50124C00033 signed on September 30, 2024, brings BARDA’s total potential contribution to approximately USD 268 million as Basilea advances both antifungal and antibacterial programs.

David Veitch, Basilea’s Chief Executive Officer, commented, “We welcome BARDA’s continued investment through this OTA, which enables us to progress fosmanogepix and BAL2062—each boasting unique mechanisms of action—toward approval. These agents offer new hope against aspergillosis, candidiasis, and other life-threatening fungal diseases, particularly in immunocompromised populations such as cancer and transplant patients. The rise of rare mold infections and strains resistant to existing therapies underscores the urgent need for innovative antifungals.”

Veitch added that the USD 39 million tranche will underwrite the ongoing phase 3 trial of fosmanogepix in yeast infections, the imminent launch of a second phase 3 study in mold infections, and preparatory work for a phase 2 study of BAL2062.

This commitment follows the initial USD 29 million BARDA investment at OTA signing in September 2024. Across the OTA’s potential 12-year term, BARDA may fund up to USD 268 million—covering roughly 60% of project costs—contingent upon successful achievement of clinical and regulatory milestones.

About fosmanogepix

Fosmanogepix is a clinical-stage broad-spectrum antifungal. It has a novel mechanism of action and its active moiety has shown activity against common species of Candida and Aspergillus, including multi-drug-resistant strains, such as Candida auris and Candida glabrata, as well as rare difficult-to-treat molds including Fusarium spp., Scedosporium spp., and some fungi from the Mucorales order.1 Fosmanogepix intravenous and oral formulations have been evaluated in clinical phase 2 studies for the treatment of patients with Candidemia, including Candida auris infections, and invasive mold infections.1 A phase 3 study evaluating fosmanogepix in the treatment of adult patients with candidemia and/or invasive candidiasis is ongoing and the initiation of a second phase 3 study, in the treatment of adult patients with invasive mold infections, is expected soon.2 Fosmanogepix has received Fast Track and Orphan Drug designations from the U.S. Food and Drug Administration for a number of indications, and is designated as a Qualified Infectious Disease Product (QIDP).

About BAL2062

BAL2062 is a first-in-class antifungal, derived from a natural product, and has demonstrated fungicidal activity against clinically important molds such as Aspergillus spp., including azole-resistant strains.3 Safety and tolerability have been demonstrated in a previously completed phase 1 study with single and multiple ascending intravenous (i.v.) doses.4 The drug candidate has Qualified Infectious Disease Product (QIDP), Orphan Drug and Fast Track designation from the US Food and Drug Administration (FDA) for invasive aspergillosis.

About invasive mold infections

Invasive aspergillosis and invasive infections with rare molds (e.g., Fusarium spp., Scedosporium spp., and Mucorales fungi) are life-threatening infections that predominantly affect immunocompromised patients, including patients with hematologic malignancies (blood cancer), transplant patients, or patients with other immunodeficiency disorders. These infections are associated with high morbidity and mortality.5, 6

About invasive candidiasis

Invasive candidiasis, including deep-seated tissue candidiasis and candidemia, is an increasingly important nosocomial infection, especially in patients hospitalized in intensive care units. Candida species are ranked as the fourth main cause of bloodstream infections in hospitals in the US.7 The prognosis of invasive candidiasis remains difficult, with a reported mortality rate for invasive candidiasis as high as 40%, even when patients receive antifungal therapy.8

About Basilea

Basilea is a commercial-stage biopharmaceutical company founded in 2000 and headquartered in Switzerland. We are committed to discovering, developing and commercializing innovative drugs to meet the needs of patients with severe bacterial and fungal infections. We have successfully launched two hospital brands, Cresemba for the treatment of invasive fungal infections and Zevtera for the treatment of bacterial infections. In addition, we have preclinical and clinical anti-infective assets in our portfolio. Basilea is listed on the SIX Swiss Exchange (SIX: BSLN). Please visit basilea.com.

Disclaimer

This communication expressly or implicitly contains certain forward-looking statements, such as “believe”, “assume”, “expect”, “forecast”, “project”, “may”, “could”, “might”, “will” or similar expressions concerning Basilea Pharmaceutica Ltd, Allschwil and its business, including with respect to the progress, timing and completion of research, development and clinical studies for product candidates. Such statements involve certain known and unknown risks, uncertainties and other factors, which could cause the actual results, financial condition, performance or achievements of Basilea Pharmaceutica Ltd, Allschwil to be materially different from any future results, performance or achievements expressed or implied by such forward-looking statements. Basilea Pharmaceutica Ltd, Allschwil is providing this communication as of this date and does not undertake to update any forward-looking statements contained herein as a result of new information, future events or otherwise.

This project has been funded in part with federal funds from the U.S. Department of Health and Human Services (HHS); Administration for Strategic Preparedness and Response (ASPR); Biomedical Advanced Research and Development Authority (BARDA), under OT number: 75A50124C00033. The contract and federal funding are not an endorsement of the study results, product, or company.

This ad hoc announcement can be downloaded from www.basilea.com.

References

1. K. J. Shaw, A. S. Ibrahim. Fosmanogepix: A Review of the First-in-Class Broad Spectrum Agent for the Treatment of Invasive Fungal Infections. Journal of Fungi (Basel) 2020 (6), 239
2. FAST study (candidemia/invasive candidiasis): ClinicalTrials.gov identifier NCT05421858; FORWARD study (invasive mold infections): ClinicalTrials.gov identifier NCT06925321
3. K. J. Shaw. GR-2397: Review of the Novel Siderophore-like Antifungal Agent for the Treatment of Invasive Aspergillosis. Journal of Fungi (Basel) 2022 (8), 909
4. ClinicalTrials.gov identifier NCT02956499: M. P. Mammen, D. Armas, F. H. Hughes et al. First-in-Human Phase 1 Study To Assess Safety, Tolerability, and Pharmacokinetics of a Novel Antifungal Drug, VL-2397, in Healthy Adults. Antimicrobial Agents and Chemotherapy 2019 (63), e00969-19
5. J. Cadena, G. R. Thompson 3rd, T. F. Patterson. Aspergillosis: Epidemiology, Diagnosis, and Treatment. Infectious Disease Clinics of North America 2021 (35), 415-434
6. M. Slavin, S. van Hal, T. C. Sorrell et al. Invasive infections due to filamentous fungi other than Aspergillus: epidemiology and determinants of mortality. Clinical Microbiology and Infection 2015 (21), 490.e1-490.e10
7. Candidemia (Blood Infection) and Other Candida Infections. 2019 Factsheet by the American Thoracic Society: www.thoracic.org/patients/patient-resources/resources/candidemia.pdf (Accessed: July 07, 2025)
8. B. J. Kullberg, M. C. Arendrup. Invasive Candidiasis. The New England Journal of Medicine 2015 (373), 1445-1456

Media Contact:

Peer Nils Schröder, PhD
Head of Corporate Communications & Investor Relations
Basilea Pharmaceutica International Ltd, Allschwil
Hegenheimermattweg 167b
4123 Allschwil
Switzerland
Phone: +41 61 606 1102
E-mail: media_relations@basilea.com
investor_relations@basilea.com

SOURCE: Basilea Pharmaceutica Ltd