Xdivane (nivolumab biosimilar) / Xbrane - LARVOL DELTA

Xbrane has entered into an agreement to sell XB003 (Cimzia biosimilar candidate) and parts of its organization to Alvotech for a total consideration of SEK 275 million (Xbrane Press Release) - "Xbrane Biopharma...has entered into an agreement to sell XB003 (biosimilar candidate to Cimzia) and parts of its organization, including approximately 40 employees and laboratory equipment, to Alvotech for a total consideration of approximately SEK 275 million. XB003 is the most advanced biosimilar candidate to Cimzia under development, representing approx. 25% of the competitive adjusted adressable market of Xbranes portfolio...Closing of the transaction is subject to approval from Xbrane's shareholders at an Extraordinary General Meeting (the 'EGM') to be held on 14 April 2025 as well as FDI approval...Xbrane will retain Ximluci (biosimilar to Lucentis) and Xdivane (biosimilar candidate to Opdivo)....A service agreement will be established between the parties under which Xbrane can get support from the transitioned part of the organization. The reduction in Xbrane's organization will reduce annual fixed costs by approximately SEK 120 million."

Commercial • Diabetic Macular Edema • Diabetic Retinopathy • Head and Neck Cancer • Immunology • Kidney Cancer • Liver Cancer • Psoriasis • Rheumatoid Arthritis • Skin Cancer • Wet Age-related Macular Degeneration

XBRANE PROVIDES UPDATE FROM SCIENTIFIC ADVICE WITH US FDA ON XDIVANE (OPDIVO BIOSIMILAR CANDIDATE) (Xbrane Press Release) - "Xbrane Biopharma AB...has received scientific advice from the US Food and Drug Administration (FDA) on the development of its Opdivo biosimilar candidate Xdivane. FDA concurs with EMAs previous feedback, finding Xbranes proposed streamlined clinical development plan adequate to support a future Biologics License Application (BLA)....Xdivane is one out of few Opdivo biosimilar candidates available for out-licensing on path to 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 in 2023 and expected to grow to 14 billion USD by 2028....The clinical design also limits the number of patients having to be recruited and hence makes it feasible to finalize the trial in time to support submission of a BLA latest Q4 2027."

FDA event • FDA filing • Patent • Sales projection • Oncology

XBRANE PROVIDES UPDATE ON THE ONGOING OUT-LICENSING OF XDIVANE (NIVOLUMAB BIOSIMILAR CANDIDATE) AND XB003 (CIMZIA BIOSIMILAR CANDIDATE) AND ITS FINANCIAL POSITION (Xbrane Press Release) - "As communicated on 1 August 2024 and given the previously communicated delay in FDA approval of Ximluci and the unforeseen termination of the license agreement with Biogen, Xbrane Biopharma AB (publ) ('Xbrane' or the 'Company') has initiated a process to out-license both Xdivane™ and XB003 for purposes of ensuring financing until envisioned positive operational cash-flow in Q2 2025. It has now become obvious that the company needs to finalize one of the above-mentioned license deals at satisfactory terms prior to the end of October 2024 to fulfill the Company's working capital requirements from beginning of November 2024 and onwards.....imzia is a TNF inhibitor used in treatment of mainly rheumatoid arthritis and psoriasis with annual sales of about € 2 billion with a niche position in pregnant and breast-feeding women....The program is ready to initiate clinical trials during 2025."

Licensing / partnership • New trial • Immunology • Oncology • Psoriasis • Rheumatoid Arthritis