Mr. Hugh Rogers reports

BIONXT'S SUBLINGUAL CLADRIBINE PROGRAM FOR MS READY FOR NEXT PHASE

Bionxt Solutions Inc. has received the active pharmaceutical ingredient (API) for its lead product candidate, BNT23001. This proprietary sublingual thin-film formulation of cladribine is being developed for the treatment of multiple sclerosis (MS).

The delivery of the cladribine API enables the commencement of clinical batch manufacturing in collaboration with Bionxt's European contract research and development partner, Gen-Plus GmbH & Co. KG, based in Munich, Germany. This milestone supports the company's plan to initiate a human bioequivalence study in the second half of 2025.

BNT23001 is designed to offer a patient-friendly alternative to traditional oral cladribine tablets, such as Mavenclad, by providing a rapidly dissolving sublingual film. This delivery method aims to enhance patient compliance, particularly for individuals with MS who experience dysphagia, a common symptom affecting the ability to swallow.

Preclinical studies have demonstrated that BNT23001 achieves high absorption rates and bioequivalence to existing oral therapies, with no adverse toxic effects observed. These findings support the progression to human bioequivalence studies.

Bionxt has also made significant strides in securing intellectual property rights for BNT23001. The company has initiated patent nationalization processes in key jurisdictions, including Europe, the United States and Canada, with patent grants anticipated by mid-2025.

"The receipt of the cladribine API is a pivotal step forward in our mission to develop innovative, patient-centric therapies for MS," said Hugh Rogers, chief executive officer of Bionxt Solutions. "We are committed to advancing BNT23001 through clinical development and bringing this novel treatment option to patients worldwide."

About Bionxt Solutions Inc.

Bionxt Solutions is a bioscience innovator focused on next-generation drug delivery technologies, diagnostic screening systems and active pharmaceutical ingredient development. The company's proprietary platforms -- sublingual (thin film), transdermal (skin patch) and oral (enteric-coated tablets) -- target key therapeutic areas, including autoimmune diseases, neurological disorders and longevity.

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 under the symbol BNXT and on the OTC (over-the-counter) market under the symbol BNXTF and trades in Germany under WKN: A3D1K3.

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