BioNxt Receives Milestone EPO Decision to Grant European Patent for Sublingual Cladribine Drug Delivery Technology for Multiple Sclerosis

Executive Summary

• European Patent Office issued a Decision to Grant European Patent No. 4539857 covering BioNxt’s sublingual cladribine oral thin‑film (ODF) technology, effective upon publication on March 11, 2026.
• The patent provides potential protection in up to 39 EPC contracting states and extends through at least June 14, 2043, strengthening BioNxt’s IP position for its BNT23001 program and supporting licensing/partnership discussions.
• The grant complements recent Eurasian Patent Organization approval and a U.S. “Fast‑Track” filing, expanding the company’s global patent estate as it prepares human bioequivalence studies for multiple sclerosis and other autoimmune indications.

Key Details

• Patent Information: European Patent No. 4539857 covering sublingual cladribine ODF technology; publication of grant in European Patent Bulletin (Bulletin 26/11) on 2026‑03‑11.
• Geographic Scope: Up to 39 EPC contracting states upon validation and payment of renewal fees.
• Term: Extends through at least 2043‑06‑14, subject to national requirements.
• Strategic Importance: Core component of BioNxt’s European commercialization strategy; enhances IP position for licensing and partnership opportunities.
• Related IP Milestones:
• Prior “Intention to Grant” communication from EPO.
• Final patent grant from Eurasian Patent Organization covering eight member states.
• U.S. Track‑One “Fast‑Track” filing (October 2025) for prioritized USPTO examination.
• Product Focus: Patent protects sublingual delivery of cladribine for multiple sclerosis and other autoimmune/neurodegenerative indications (e.g., Myasthenia Gravis).
• Clinical Development: BioNxt is preparing a human bioequivalence study for lead candidate BNT23001; preclinical data showed increased systemic exposure versus oral tablet.
• Management Quote: CEO Hugh Rogers highlighted the milestone’s relevance to Europe‑centric commercialization and ongoing licensing discussions.

Notable Quotes

“The European patent decision represents an important milestone for BioNxt… Securing patent protection in this region strengthens our global intellectual property position and supports our ongoing licensing and partnership discussions.” – Hugh Rogers, CEO

All forward‑looking statements are subject to risks and uncertainties detailed in the release.