BioNxt Solutions Announces ODF Cladribine Update and Financing

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VANCOUVER, BC / ACCESSWIRE / April 25, 2024 / BioNxt Solutions Inc. ("BioNxt" or the "Company") (CSE:BNXT)(OTCQB:BNXTF)(FSE:BXT) is pleased to announce that its Cladribine program is advancing to human comparative bioavailability studies in Europe. The Company is reviewing proposals from several contract research organizations to carry out the studies in accordance with EU medical regulatory guidelines. The recent success of both the Company's ODF Cladribine toxicity and comparative pharmacokinetic ("PK") studies and industry interest have set high expectations for the upcoming comparative bioavailability study. Further details on the study will be released in due course.

BioNxt is developing a 100% owned and proprietary ODF Cladribine dosage form, directed at the multiple sclerosis ("MS") market. Cladribine tablets are currently approved for use in over 75 countries, including by the United States Food and Drug Administration ("FDA") and the European Medicines Agency ("EMA"), with annual sales in excess of one billion USD. Cladribine tablets are approved for several indications, namely highly active forms of relapsing-remitting MS and certain forms of leukemia. MS represents the largest 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.

The Company has filed Cladribine ODF-related provisional patent applications with three to four patent applications expected to be on file in major international jurisdictions by late 2024 to early 2025 with potential patent protection extending to 2044.

The Company is also pleased to announce a non-brokered private placement of up to 6,000,000 common shares of the Company (the "Common Shares") at a price of $0.27 per Common Share for gross proceeds of up to $1,620,000 (the "Offering"). The Company intends to use the net proceeds from the Offering for research, development, and commercialization programs and general working capital purposes. The Offering may close on one or more dates as the Company may determine.