BioNxt Solutions Inc. announced that the toxicity study for its proprietary oral dissolvable film ("ODF") based Cladribine product for the treatment of Multiple Sclerosis ("MS"), first announced November 20, 2023, is now complete. The study was carried out by a European contract research organization in accordance with EU medical regulatory guidelines. Results for the toxicology study are expected in January 2024.

The Company is on schedule for GMP product development and batch production planned for first quarter and second quarter 2024 with the European Investigational Medicinal Product Dossier (IMPD) preparation and submission planned for second quarter 2024. Cladribine is approved for use in over 75 countries, including by the United States Food and Drug Administration ("FDA") and the European Medicines Agency ("EMA"), for several indications, namely highly active forms of relapsing-remitting Multiple Sclerosis ("MS") and certain forms of leukemia. MS represents the market segment for the sale of Cladribine with approximately 2.3 million people living with MS worldwide, with the highest prevalence in North America and Europe, noted by Atlas of MS. The global Multiple Sclerosis drug market is expected to top USD 41 Billion by 2033 according to Market.us.