VANCOUVER, BC — January 19, 2026 — Leads & Copy —
BioNxt Solutions Inc. (CSE:BNXT)(OTCQB:BNXTF)(FSE:BXT) has completed and received preliminary results from its comparative pharmacokinetics (PK) large-mass animal study in pigs. The study measured how efficiently cladribine is absorbed into the bloodstream over time and compared BioNxt’s proprietary orally dissolving film (ODF) with the reference tablet formulation, evaluating the Company’s swallow-free, sublingual ODF formulation for Multiple Sclerosis (MS).
BioNxt reports that the study outcome was successful and supports superior bioavailability for the Company’s cladribine ODF formulation under the study conditions. The Company has initiated a full internal screening and assessment of the final dataset, including calculations and interpretation of key pharmacokinetic parameters. Further information will be provided once BioNxt has completed its comprehensive internal analysis.
The study was initiated in November 2025 and completed in December 2025, with the final dataset now received by the Company for internal analysis.
To evaluate how effectively BioNxt’s swallow-free cladribine ODF delivers cladribine into the bloodstream, the Company conducted a comparative crossover pharmacokinetics study in adult pigs, weighing approximately 40-50 kg. This specific breed of pig is widely used in pharmaceutical research as a non-rodent large-mass preclinical model due to their high physiological, anatomical, and metabolic similarities to humans, particularly in drug absorption and systemic exposure.
The objective was to compare BioNxt’s cladribine 10 mg orally dissolving film (ODF) with the reference name-brand 10 mg tablet, a commercially established Multiple Sclerosis therapy with annual global sales exceeding USD 1 billion and continued double-digit annual growth, with both formulations administered at a single dose equivalent to 5 mg of cladribine per animal. The reference tablet was administered by oral dosing via gavage, while the ODF was placed directly into the oral cavity to support sublingual absorption.
Blood samples were collected before dosing and at several time points over 24 hours following administration to track cladribine levels over time. This allowed BioNxt to measure key performance indicators such as peak concentration, overall exposure, and how long cladribine remained in the body, supporting a clear assessment of bioavailability.
The Company’s study results confirm that enhanced bioavailability achieved through sublingual ODF delivery materially improves delivery efficiency compared with conventional oral administration. By enabling more efficient absorption of cladribine into the bloodstream, the ODF approach supports the achievement of therapeutic exposure with lower overall systemic drug exposure, which is a critical factor in managing tolerability for immunomodulatory therapies such as cladribine.
This improved delivery efficiency directly supports BioNxt’s strategy to reduce unnecessary systemic burden, creating the foundation for a meaningful reduction in dose-related side effects while maintaining pharmacokinetic performance. In addition, the swallow-free, sublingual ODF format offers a more patient-friendly treatment experience, particularly for patients with swallowing difficulties or sensitivity to conventional oral dosage forms.
BioNxt views these findings as a key validation of its ODF drug-delivery platform and a strategically important step in building a differentiated Multiple Sclerosis therapy profile with strong commercial and partnering potential.
Multiple Sclerosis represents a large global market, with approximately 2.3 million people living with MS worldwide and forecasts indicating the global MS drug market is expected to exceed USD 41 billion by 2033. Within this market, Mavenclad® (cladribine tablets) is a well-established high-efficacy therapy with annual global sales exceeding USD 1 billion and sustained double-digit growth, although systemic oral therapy can require monitoring and may be associated with adverse effects that influence real-world adoption.
Cladribine also holds promise for the treatment of additional neurodegenerative diseases, such as Myasthenia Gravis (MG).
BioNxt further confirms that patent protection for its cladribine ODF program has already been confirmed, with additional final (national level) patent grants expected shortly, strengthening the Company’s intellectual property position and supporting potential future licensing and partnering opportunities.
BioNxt has initiated internal screening and full evaluation of the study dataset and expects to provide additional disclosure once final calculations, interpretation, and internal validation are complete. The Company intends to share further updates regarding next development milestones in due course.
BioNxt Solutions Inc. is a bioscience innovator focused on next-generation drug delivery platforms, diagnostic screening systems, and active pharmaceutical ingredient development. Its proprietary platforms include sublingual thin films, transdermal patches, oral tablets, and a new targeted chemotherapy platform designed to deliver cancer drugs directly to tumors while reducing side effects.
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 healthcare by delivering precise, patient-centric solutions that enhance treatment outcomes worldwide.
Hugh Rogers, Co‐Founder, CEO and Director, can be reached by email at investor.relations@bionxt.com or by phone at +1 604.250.6162.
Source: BioNxt Solutions Inc.
