Basilea - Further BARDA payments

Basilea announced this morning that it has received a further $25 million in non-dilutive funding from BARDA to support the development of the novel antifungals fosmanogepix and BAL2062. For us, the disclosure that the payment has been received, as a pre-specified enrollment threshold has been met in the ongoing Phase 3 candidaemia/invasive candidiasis trial, is both encouraging and reassuring. As a reminder, this funding is received as part of the OTA, which is up to $268 million over 12 years, and was awarded in September 2024. Overall, funding from BARDA is expected to cover approximately 60% of ongoing development costs.

With the Phase 3 programme for fosmanogepix now fully underway, we look forward to data emerging from the candidaemia/invasive candidiasis study and the invasive moulds (open-label) study to confirm the excellent profile of

fosmanogepix suggested by the Phase 2 data within the 2028 timeframe.

In the interim, we also look forward to more data generated by the expanded access programme, which has already demonstrated the utility of fosmanogepix to treat previously intractable fungal infections. Basilea has recently reported that fosmanogepix has been used in over 300 patients in over 10 countries with infections, including aspergillosis and Candida infections, as well as invasive fusariosis and rare but life-threatening moulds.

Further data generated from additional expanded access programmes could provide additional insight into the activity of fosmangepix, complementing the data generated in the clinical trial setting. This could potentially expand its commercial potential and help save lives, particularly where existing treatments have failed or where no suitable treatment is available. Our own peak sales forecast of c. $1.2bn reflects the attractive profile of fosmanogepix, including its activity against most of the important fungal infections highlighted by WHO.

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Basilea Pharmaceutica is a client of Calvine Partners, and as such, this publication is not independent and should be considered a marketing communication under FCA Rules. None of the information in this publication should be considered as any form of advice.

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