BioNxt Reports Final Preclinical Results Demonstrating Approximately 40% Higher Cladribine Delivery for the Treatment Multiple Sclerosis (MS)

VANCOUVER, BC / ACCESS Newswire / January 21, 2026 / BioNxt Solutions Inc. ("BioNxt" or the "Company") (CSE:BNXT)(OTCQB:BNXTF)(FSE:BXT) is pleased to report final results from a preclinical pig study demonstrating that its proprietary needle-free, swallow-free sublingual oral dissolvable film (ODF) cladribine formulation for the treatment of Multiple Sclerosis (MS) achieved significantly higher systemic drug delivery than a conventional oral tablet formulation of cladribine, such as those used in commercially successful therapies such as Mavenclad, which has reported annual global sales exceeding USD 1.2 billion and sustained double-digit growth.

The results represent an important development milestone for BioNxt, demonstrating in a robust large-mass non-rodent model that reformulating cladribine as a sublingual oral dissolvable film can materially improve systemic drug delivery compared with conventional oral tablet dosing. By directly comparing two fundamentally different routes of administration under controlled conditions, the study helps de-risk the clinical development and commercialization pathway and supports the rationale for advancing the sublingual ODF formulation into human pharmacokinetic studies.

Final Study Results Validate the Efficiency of BioNxt's Sublingual Delivery Approach

The completed preclinical pig study showed that BioNxt's cladribine sublingual oral dissolvable film achieved meaningfully higher systemic drug availability than the conventional oral tablet formulation. Systemic exposure was assessed over a 48-hour period using AUC (0-48 h), a widely accepted calculated measure based on repeated blood concentration measurements that reflects how much drug reaches the bloodstream and how long it remains there. Under the study conditions, BioNxt's proprietary sublingual ODF delivered approximately 40% higher cladribine exposure, highlighting a clear and clinically relevant improvement in delivery efficiency.

Quantitatively, the mean AUC (0-48 h) for the sublingual ODF was 39.46 ng·h/mL, compared with 28.11 ng·h/mL for the oral tablet formulation. This difference demonstrates a substantial increase in total drug exposure over time following sublingual administration and provides a robust, data-driven foundation for the observed delivery advantage.

Interpreting Systemic Drug Exposure Over Time

AUC is a calculated value based on repeated blood measurements taken over time after drug administration. It summarizes all measured drug concentrations into a single number that reflects how much of a drug reaches the bloodstream and how long it remains systemically available. Unlike a single peak measurement, AUC captures both the extent of absorption and the duration of exposure, making it the most informative pharmacokinetic parameter for comparing how effectively different formulations or routes of administration deliver a drug.