Mr. Hugh Rogers reports

BIONXT REPORTS SUCCESSFUL RESULTS FROM ODF CLADRIBINE PK STUDY

Bionxt Solutions Inc. has completed and received results from the comparative pharmacokinetic (PK) study for its oral dissolvable film (ODF)-based proprietary cladribine product for the treatment of multiple sclerosis (MS). The animal PK study results are highly promising and demonstrated comparable rapid absorption and systemic exposure between the company's ODF product and the name-brand reference drug in all samples.

"These results are a significant milestone for Bionxt. We have demonstrated that our ODF platform is an effective drug delivery system for cytostatic drugs via transmucosal absorption," said Hugh Rogers, chief executive officer of Bionxt. "With our recently obtained toxicology data, the PK results allow us to strengthen the company's cladribine ODF patent position and proceed immediately to a PK study in humans. These exciting results validate the potential for Bionxt to immediately expand into additional ODF drug formulations for similar, high-value and highly toxic drugs."

Bionxt is developing a 100-per-cent-owned and proprietary hybrid-generic ODF cladribine dosage form, directed at the 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 $1-billion (U.S.). 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 $41-billion (U.S.) by 2033 according to Market.us.

The comparative PK study was carried out by a European contract research organization in accordance with EU (European Union) medical regulatory guidelines using animal models and a single administration of either sublingual (ODF) or oral (tablet) cladribine. Blood testing and analysis were carried out predose and at up to six time points after administration using blood aliquots. The animal PK study results closely follows the unanimously successful results of the ODF cladribine animal toxicity study, announced Feb. 7, 2024: Positive results were observed in all study participants with no adverse clinical abnormalities or indications of toxicity observed in the study after consecutive days of dosing.

Bionxt has accelerated its cladribine ODF program in a priority manner with GMP (good manufacturing practices) product development and batch production planned for Q1 and Q2 2024, with the European Investigational Medicinal Product Dossier (IMPD) preparation and submission planned for Q2 2024.

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.

Bionxt's wholly owned subsidiary is a German narcotics manufacturer, developer and researcher located in the district of Biberach, Baden-Wurttemberg, Germany. For over a decade, the company and its team have been leaders in the design, testing and manufacture of innovative, non-invasive drug delivery systems, particularly transdermal patches and sublingual strips for the delivery of active pharmaceutical ingredients for the treatment of pain and neurological conditions. According to Precedence Research, the global pharmaceutical drug delivery market size was valued at $1,525-billion (U.S.) in 2022 and expected to surpass approximately $2,047-billion (U.S.) by 2030.

About Bionxt Solutions Inc.

Bionxt is a bioscience accelerator focused on next-generation drug formulations and delivery systems, diagnostic screening tests, and new active pharmaceutical production and evaluation, including: precision transdermal and oral dissolvable drug formulations; rapid, low-cost infectious disease and oral health screening tests; and standardization and clinical evaluation of emerging active pharmaceutical ingredients for neurological applications. The company has research and development operations in North America and Europe, with an operational focus in Germany, and is currently focused on regulatory approval and commercialization of medical products for European markets.

We seek Safe Harbor.