Xbrane Biopharma

Xdivane™ is one out of few Opdivo® biosimilar candidates available for out-licensing that runs according to a timeline that would enable a launch upon Loss of Exclusivity in US in December 2028. Opdivo is a so called immune-oncology drug (PD1 inhibitor) used in treatment of different cancers, with sales of approx. 8 billion USD globally during 2023, expected to grow to 14 billion USD by 20281. The program is de-risked as scale-up of the drug substance production process is completed to commercial scale, analytical similarity to the reference product demonstrated and scientific advice on a streamlined clinical development plan received from both EMA and FDA.

XB003 is a biosimilar candidate referencing Cimzia® - a € 2 billion TNF inhibitor used in treatment of mainly rheumatoid arthritis and psoriasis with a niche position in pregnant and breast-feeding women. Xbrane has developed XB003 basd on its patented platform technology enabling high yield/low-cost production and successfully scaled up the production process to clinical scale. Further has analytical similarity to the reference product been demonstrated and Scientific Advice with EMA and FDA on the clinical development plan expected in Q1 2025.

Xbrane is running an active out-licensing process for both Xdivane™ and XB003, with multiple interested potential partners involved, supported by a reputable life science advisor. The company has reached agreement negotiation stage with Xdivane™ and received the first non-binding proposals on XB003. Further, Xbrane has, via agreed prolonged payment plans vs. main suppliers, extended the timing until end of November 2024 when an agreement needs to be finalized to, via an expected upfront payment, fulfill the Company's working capital requirements. Xbranes board and management is optimistic, given the advanced stage of agreement negotiation, to be able to close a partnership with Xdivane™ before the end of November 2024.