BioNxt Secures Unitary European Patent for Sublingual Cladribine ODF Platform Across 18 Countries

• On April 7 2026 BioNxt announced that European Patent No. 4539857 obtained unitary effect, granting centralized protection across 18 EU member states for its sublingual cladribine oral thin‑film (ODF) platform.
• The patent became effective March 11 2026 and streamlines enforcement while reducing administrative costs versus national validations.
• Preclinical data show the ODF delivers systemic exposure comparable to the reference product Mavenclad®; a human bioavailability study for lead candidate BNT23001 is underway, advancing the path toward regulatory approval in Europe.

• The unitary patent was anticipated after the European Patent Office’s Decision to Grant (Feb 17 2026) and follows previously announced Eurasian and U.S. Track‑One filings; it does not introduce new financial terms, partnerships, or revenue streams.
• Consequently the news represents an incremental, expected development rather than a surprise that would materially alter the company’s near‑term valuation. It is therefore classified as Routine - Positive.

BioNxt Solutions Inc. develops oral thin‑film (ODF) delivery technologies to reformulate approved active ingredients into swallow‑free, needle‑free formats. Its lead program, BNT23001, is a sublingual cladribine ODF targeting multiple sclerosis (MS); the approach leverages existing FDA/EMA approval of cladribine (Mavenclad®) to pursue a bioequivalence‑driven regulatory path, reducing clinical risk and capital requirements versus de novo drug development.