Mr. Hugh Rogers reports

BIONXT ADVANCES "MELT IN YOUR MOUTH" CLADRIBINE FORMULATION TO IMPROVE TREATMENT FOR MS PATIENTS WITH DYSPHAGIA

Bionxt Solutions Inc. is advancing the development of a next-generation melt-in-your-mouth cladribine formulation, built on the company's proprietary oral dissolvable film (ODF) drug delivery system. The technology is designed for rapid, sublingual (under-the-tongue) absorption of medication and aims to improve treatment access and comfort for people living with multiple sclerosis (MS). Bionxt's lead program, BNT23001, is being developed as a swallow-free alternative to cladribine tablets, which generated $1.28-billion (U.S.) in global sales in 2024.

Cladribine (Mavenclad) is an established therapy for MS; however, many patients struggle with difficulty swallowing tablets, a symptom that is both common and often underrecognized. For these individuals, pill-based medication can lead to coughing, choking, anxiety and missed doses -- all of which reduce treatment consistency and therapeutic effectiveness.

Bionxt's melt-in-your-mouth ODF is engineered to dissolve in seconds under the tongue, eliminating the need to swallow and offering a needle-free, patient-friendly method of administration. The approach aims to enhance treatment adherence, safety and overall quality of life for MS patients who face challenges with tablet-based medication.

Swallowing difficulties: a hidden barrier in multiple sclerosis treatment

Swallowing problems (dysphagia) are common in MS but often overlooked. A recent meta-analysis of more than 10,800 MS patients found that approximately 45 per cent experience dysphagia during the course of their disease (2023, Journal of Clinical Neuroscience). Additional clinical studies using instrumental swallowing assessments have reported abnormalities in over 50 per cent of patients, including cases not detected through self-report.

For these individuals, tablets may feel stuck, provoke coughing or choking, or require repeated attempts to swallow -- turning a simple daily task into a persistent source of stress.

As swallowing becomes more difficult or unsafe, patients may delay doses, avoid medication altogether or require caregiver assistance. By removing the need to swallow, Bionxt's melt-in-your-mouth cladribine ODF is being developed specifically to address this barrier and help maintain consistent, safe access to cladribine therapy.

Significant market opportunity for a patient-friendly cladribine format

The global cladribine market is expanding rapidly. Merck KGaA's cladribine tablets (Mavenclad) generated over $950-million (U.S.) in the first three quarters of 2025, reflecting strong, continuing demand across the United States and Europe. The company reported record quarterly sales in 2025 and continues to expect growth in Europe, although a recent U.S. patent decision could open the door to generic competition beginning in 2026.

According to Cladribine Market Research Report 2033 from Dataintelo, the global cladribine market was valued at $1.2-billion (U.S.) in 2023 and is projected to reach $2.5-billion (U.S.) by 2032, representing a robust 8.5-per-cent CAGR (compound annual growth rate) driven by rising MS prevalence and interest in innovative drug delivery formats.

At the same time, the oral transmucosal drug delivery market -- including sublingual and buccal systems -- is expected to grow from $45.8-billion (U.S.) in 2025 to nearly $96.8-billion (U.S.) by 2033. As a low-dose molecule well suited to Bionxt's melt-in-your-mouth ODF technology, cladribine sits at the intersection of two fast-growing global markets, offering a significant opportunity to modernize and differentiate an established therapy.

"Taking a tablet should not be a barrier to treatment," said Hugh Rogers, chief executive officer of Bionxt Solutions. "Our melt-in-your-mouth cladribine film is designed specifically for MS patients who struggle to swallow pills. We are addressing a meaningful unmet need by making an important therapy easier, safer and more accessible in everyday life."

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 the OTC Markets under the symbol BNXTF and trades in Germany under WKN: A3D1K3.

We seek Safe Harbor.