Denmark acted as Reference Member State (RMS) in the procedure, with Sweden, Norway, and Germany as Concerned Member States (CMS). The Clinical Trial Application (CTA) was submitted in December 2025. Following responses to Requests for Information from all four countries, full approval has now been granted. The company expects to enroll the first patient in Q2 2026.

The Phase III trial, study code BZ003 or ‘BEAM-Pain’ (BupiZenge Efficacy Assessment in Mucositis-Pain) is a randomized, multi-center, registrational trial evaluating the efficacy and safety of BupiZenge™ versus lidocaine in patients suffering from oral pain due to radiotherapy-induced mucositis (with or without chemotherapy) in head and neck cancer. The trial plans to enroll 150 patients across up to 12 sites in Norway, Sweden, Denmark and Germany. LINK Medical will serve as the clinical Contract Research Organization (CRO).

The CTA approval triggers two committed payments under existing agreements: MSEK 15.1 from strategic investor Sichuan Yangtian Bio-Pharmaceutical Co. Ltd (‘Tranche 4’) and an accelerated €550,000 milestone from European commercialization partner Molteni Farmaceutici S.p.A. Together these milestone receipts will further strengthen the Company’s financial position ahead of trial execution.