Basilea - Pivotal Phase 3 trial begins

This morning, Basilea announced the start of its second Phase 3 trial for fosmanogepix, its first-in-class antifungal for the treatment of invasive mould infections.  Fosmanogepix is a key driver of the Basilea investment case, having already demonstrated success in Phase 1 and 2 trials, which largely de-risks the Phase 3 evaluation. Fosmanogepix has obtained Fast Track status from FDA for seven different fungal infections, and we believe that it will be relevant to a broad range of critical fungal pathogens cited by the World Health Organization.

The completion of the Phase 3 study and publication of results are expected in 2028.  

We believe that fosmanogepix's peak sales could ultimately surpass those of Cresemba, which has continued to be tremendously successful for Basilea.  Although Cresemba’s market exclusivity will be lost in Europe and the US during 2027, recent new market growth should help to offset some of the decline in expected revenue. Fosmanogepix is expected to start making a meaningful contribution to Basilea’s top line from 2029.

The importance of Fosmanogepix is highlighted by the commitment of the Biomedical Advanced Research and Development Authority (BARDA). BARDA’s responsibility is to enhance US public health security, and one of its routes is supporting the development of important medicines that address significant emerging infectious diseases. With its provision of up to $268 million of non-dilutive funding over twelve years to support the development of fosmanogepix (and other candidates in Basilea’s pipeline), it gives Basilea significant financial flexibility and strengthens the entire anti-infective franchise. BARDA’s contribution is expected to fund up to 60% of fosmanogepix’s development cost.

We have estimated peak sales of $1.2 billion for fosmanogepix and a DCF-derived fair value of CHF 120 per share.

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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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