Mr. Hugh Rogers reports

BIONXT ENGAGES BUSINESS DEVELOPMENT & LICENSING ADVISORS FOR COMMERCIALIZATION OF PATENTED SUBLINGUAL CLADRIBINE ODF

Bionxt Solutions Inc. has commenced work with a business development and licensing (BD&L) specialist adviser to support the commercialization and partnering strategy for BNT23001, the company's patented proprietary sublingual cladribine orally dissolvable film (ODF) formulation for the treatment of multiple sclerosis (MS).

BNT23001 is designed as a differentiated alternative to conventional tablet-based cladribine therapy, including Mavenclad, by offering a thin, dissolvable film placed under the tongue. The company believes this delivery format may be particularly relevant for MS patients who experience difficulty swallowing, also known as dysphagia. Mavenclad, the oral cladribine MS therapy developed by Merck KGaA, generated reported global revenues of approximately 1.2 billion euros/$1.4-billion (U.S.) in 2025, reflecting continued growth and strong demand across major markets including North America and Europe.

Commercialization initiatives

Bionxt believes the timing is appropriate to advance commercialization planning for BNT23001, the company's patented sublingual cladribine ODF program for multiple sclerosis. The initiative will focus on evaluating potential licensing, co-development, regional commercialization and strategic partnership opportunities.

The BD&L adviser will support Bionxt in refining the program's commercial positioning, identifying potential pharmaceutical partners, evaluating transaction structures and preparing for future business development engagement.

"Engaging a BD&L adviser is an important step in the commercial planning process for our cladribine ODF program," said Hugh Rogers, chief executive officer and co-founder of Bionxt Solutions. "As we prepare for the planned human bioavailability study, our strategy is to ensure that BNT23001 is positioned effectively for potential pharmaceutical partners."

Human bioavailability study preparation

Bionxt has prepared a planned human bioavailability study designed to compare cladribine ODF 10 milligrams with the approved reference product Mavenclad 10 mg tablets. The study is expected to assess key pharmacokinetic parameters, including total drug exposure, peak plasma concentration and time to peak concentration, while also monitoring safety and tolerability.

Next steps

Bionxt continues to prepare for its planned human bioavailability study while working with its BD&L adviser to develop partnering materials, identify potential pharmaceutical partners, analyze comparable transactions, assess priority territories and evaluate suitable deal structures.

There can be no assurance that the BD&L adviser engagement or strategic evaluation process will result in a licensing transaction, co-development agreement, commercialization agreement or other business arrangement.

About Bionxt Solutions Inc.

Bionxt Solutions is a bioscience innovator focused on next-generation drug delivery platforms, diagnostic screening systems and active pharmaceutical ingredient development. Its proprietary platforms include sublingual thin films, transdermal patches, oral tablets and a new targeted chemotherapy platform designed to deliver cancer drugs directly to tumors while reducing side effects.

With research and development operations in North America and Europe, Bionxt is advancing regulatory approvals and commercialization efforts, primarily focused on European markets. Bionxt is committed to improving health care by delivering precise, patient-centric solutions that enhance treatment outcomes worldwide.

Bionxt is listed on the Canadian Securities Exchange: BNXT, OTC Markets: BNXTF and trades in Germany under WKN: A3D1K3.

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