Berliner Tageszeitung - BioNxt Reports Successful Final In-Vivo Dosing Study Results Supporting Superior Bioavailability of Cladribine Sublingual ODF

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.

"We are extremely encouraged by the successful outcome of this study," said Hugh Rogers, CEO at BioNxt. "The results reinforce our belief that sublingual ODF delivery can materially improve the efficiency of cladribine administration and may ultimately support better patient tolerability and adoption. We look forward to sharing additional details once our complete internal analysis is finalized. The data from this study is critical to optimize the dosing parameters in our upcoming human bioequivalence study."

Study Overview: Comparative Pharmacokinetics Study in Pigs

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.

To track cladribine levels over time, blood samples were collected before dosing and at several time points over 24 hours following administration. 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 study was initiated in November 2025 and completed in December 2025, with the final dataset now received by the Company for internal analysis.

Potential to Reduce Side Effects and Lower Required Active Ingredient

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.

Strategic Significance: Addressing a Large and Growing MS Market

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).

Patent Position Strengthened - Final Granting Expected Shortly

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.

Next Steps and Upcoming Updates

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.

About BioNxt Solutions Inc.

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.

BioNxt is listed on the Canadian Securities Exchange: BNXT, OTC Markets: BNXTF and trades in Germany under WKN: A3D1K3. To learn more about BioNxt, please visit www.bionxt.com.

Investor Relations & Media Contact

Hugh Rogers, Co‐Founder, CEO and Director
Email: [email protected]
Phone: +1 604.250.6162

Web: www.bionxt.com
LinkedIn: https://www.linkedin.com/company/bionxt‐solutions
Instagram: https://www.instagram.com/bionxt

Cautionary Statement Regarding "Forward‐Looking" Information

This press release contains "forward-looking information" and "forward-looking statements" within the meaning of applicable Canadian securities laws (collectively, "forward-looking information"). Forward-looking information includes, but is not limited to, statements regarding the Company's cladribine sublingual orally dissolving film ("ODF") program; the interpretation, significance, and implications of the final results received from the Company's comparative in-vivo pharmacokinetics study; the completion of the Company's internal screening, calculations, and analysis of the study dataset; the timing and content of future updates or disclosures; expectations regarding enhanced bioavailability, improved delivery efficiency, reduced systemic exposure, reduced side effects, and/or reduced required active ingredient levels; statements regarding the anticipated timing and outcome of patent granting; statements regarding the commercial relevance of comparator products; and statements regarding potential future commercialization, licensing, or partnering opportunities.

Forward-looking information is based on management's reasonable assumptions, expectations, estimates, and projections as of the date of this press release. Such statements are inherently subject to a number of risks, uncertainties, and other factors- many of which are beyond the Company's control-that may cause actual results, performance, or achievements to differ materially from those expressed or implied by such forward-looking information. These risks and uncertainties include, but are not limited to: risks related to the Company's ability to complete, validate, and interpret its internal review and calculations; the possibility that additional analysis or interpretation of the study data may yield different conclusions than those currently expected; scientific, technical, and preclinical development risks; the risk that in-vivo or animal study results may not be predictive of human outcomes; the timing, cost, conduct, and results of future studies and potential clinical trials; manufacturing, formulation, and scale-up risks; reliance on third-party contract research organizations, laboratories, and manufacturing partners; regulatory risks and the ability to obtain and maintain required approvals; intellectual property risks, including the timing, scope, validity, and enforceability of patent protection; competitive developments; and general economic, financial, and capital market conditions.

Readers are cautioned not to place undue reliance on forward-looking information. Although the Company believes that the expectations and assumptions reflected in such statements are reasonable, there can be no assurance that they will prove to be correct. Except as required by applicable securities laws, the Company undertakes no obligation to update or revise any forward-looking information, whether as a result of new information, future events, or otherwise.

Mavenclad^® is a registered trademark of Merck KGaA and is not affiliated with or developed by BioNxt Solutions Inc.

SOURCE: BioNxt Solutions Inc.

View the original press release on ACCESS Newswire

A. Madsen--BTZ