Basilea partners with BARDA for new antifungals and antibacterials, receives initial funding

Basilea Pharmaceutica Ltd, a biopharmaceutical company based in Allschwil, Switzerland, has announced a significant financial commitment from the Biomedical Advanced Research and Development Authority (BARDA). This announcement has led Basilea to revise its financial projections for 2024 upwards.

David Veitch, CEO of Basilea, highlighted the company's long-standing partnership with BARDA, which dates back to 2013. This new agreement, in the form of an Other Transaction Agreement (OTA), will enable Basilea to further its development of novel antifungal and antibacterial treatments. Veitch expressed confidence that this collaboration would help Basilea achieve its goal of becoming a leading company in the anti-infectives market.

The OTA provides for potential non-dilutive funding of up to approximately USD 268 million over a period of up to twelve years. This funding will support the development of Basilea’s innovative antifungal and antibacterial drugs. Initially, BARDA has committed USD 29 million to support the development of two key antifungal candidates in Basilea’s pipeline: fosmanogepix and BAL2062. BARDA’s financial contribution is expected to cover about 60% of the total costs over the duration of the agreement.

This agreement also allows for flexibility in managing the product portfolio. BARDA and Basilea can make joint decisions about which candidates to prioritize based on their performance, technical risk, and programmatic need, thereby optimizing resources and reducing costs and time for both parties.

Reflecting the immediate impact of this OTA, Basilea has updated its financial guidance for the full year 2024. Development costs under the OTA will continue to be reported under research and development expenses, while BARDA’s reimbursements will be categorized as other revenue. This adjustment results in an increase in total revenue and a higher operating result and net profit for 2024. Specifically, Basilea forecasts total revenue to be around CHF 203 million, up from a previous estimate of CHF 196 million, with a net profit projected to reach CHF 60 million, compared to an earlier forecast of CHF 42 million.

Fosmanogepix is a clinical-stage, broad-spectrum antifungal with a novel mechanism of action. It has shown efficacy against various strains of Candida and Aspergillus, including multi-drug-resistant strains like Candida auris and Candida glabrata. The drug is available in both intravenous and oral formulations and has undergone extensive evaluation for safety and efficacy in clinical trials. Basilea plans to initiate a phase 3 study for fosmanogepix in invasive yeast infections soon. The drug has received several designations from the US Food and Drug Administration (FDA), including Fast Track and Orphan Drug status, as well as being classified as a Qualified Infectious Disease Product (QIDP).

BAL2062 is another first-in-class antifungal derived from a natural product. It has demonstrated effectiveness against molds such as Aspergillus spp., including those resistant to azoles. Completed phase 1 studies have shown that BAL2062 is safe and well-tolerated. The drug has also received QIDP, Orphan Drug, and Fast Track designations from the FDA for treating invasive aspergillosis.

Invasive mold infections and invasive candidiasis are life-threatening conditions that predominantly affect immunocompromised patients, such as those with hematologic malignancies or organ transplants. These infections are associated with high morbidity and mortality rates. Invasive candidiasis is particularly concerning in hospital settings, where Candida species rank as one of the leading causes of bloodstream infections.

Basilea, founded in 2000 and headquartered in Switzerland, is dedicated to developing and commercializing innovative drugs for severe bacterial and fungal infections. The company has successfully launched two hospital brands, Cresemba and Zevtera, and continues to advance its portfolio of preclinical and clinical anti-infective assets. Basilea is listed on the SIX Swiss Exchange.