Mr. Hugh Rogers reports

BIONXT INITIATES GMP MANUFACTURING OF CLINICAL-GRADE SUBLINGUAL CLADRIBINE FILM TARGETING MULTIPLE SCLEROSIS (MS)

Bionxt Solutions Inc. has successfully completed good manufacturing practice (GMP) manufacturing of its clinical-grade sublingual Cladribine oral thin film (ODF) at its GMP manufacturing partner (CDMO) based in Munich, Germany.

The completed GMP production campaign represents a significant operational milestone for Bionxt's lead development program, BNT23001, a proprietary sublingual Cladribine formulation designed for the treatment of relapsing forms of multiple sclerosis (MS) and other autoimmune neurodegenerative diseases. With this achievement, the company advances from formulation development and preclinical validation into full clinical-stage execution.

Clinical-stage readiness and trial preparation

The GMP batch produced at Bionxt's GMP manufacturing partner (CDMO) based in Munich, Germany, will serve as the investigational medicinal product (IMP) supply for Bionxt's planned human bioavailability study, CBN26001, an open-label, randomized, two-period crossover trial designed to compare the company's sublingual Cladribine ODF with the reference product Mavenclad (oral Cladribine tablets).

Manufacturing was conducted in accordance with European Union GMP standards, including validated production processes, controlled raw material sourcing, comprehensive in-process controls, and full quality testing and documentation in preparation for qualified person release and clinical use. Stability studies have also been initiated.

Completion of GMP manufacturing marks the final technical step prior to clinical trial activation and positions Bionxt for first-in-human dosing for its proprietary ODF formulation. The achievement materially reduces operational risk in the Cladribine program and strengthens the company's regulatory readiness as it prepares to enter the human clinical phase.

Platform validation and strategic expansion

Bionxt's sublingual Cladribine ODF is designed to address key limitations associated with conventional oral administration, including variability in gastrointestinal absorption, degradation under acidic gastric conditions, transporter-mediated efflux in the upper intestine and swallowing difficulties that are prevalent among MS patients. By enabling transmucosal absorption via a rapidly dissolving, needle-free sublingual film, the company aims to provide a patient-friendly alternative that may offer improved compliance and more predictable systemic exposure.

The collaboration with Bionxt's European GMP-certified contract development and manufacturing organization (CDMO) provides the company with a scalable and regulatory-compliant manufacturing infrastructure capable of supporting future registrational studies and potential commercial-scale production. The established process is designed to enable efficient technology transfer for regional licensing or co-development partnerships, particularly within European markets where Bionxt has recently reinforced its intellectual property portfolio. Completion of GMP manufacturing not only supports the planned clinical trial but also strengthens the company's position in strategic partnership discussions by demonstrating technical readiness and regulatory execution capability.

"completing GMP manufacturing of our clinical-grade Cladribine ODF is a defining milestone for Bionxt," said Hugh Rogers, chief executive officer of Bionxt Solutions. "This achievement demonstrates our ability to translate innovative formulation science into regulator-ready clinical supply and brings us closer to generating human data. We believe this milestone substantially advances our strategy to position Bionxt as a leader in next-generation, needle-free drug delivery systems."

The company expects to provide further updates regarding clinical trial activation and first subject dosing in due course.

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 tumours 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 healthcare by delivering precise, patient-centric solutions that enhance treatment outcomes worldwide.

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