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

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.

In this study, the approximately 40% higher AUC observed for BioNxt's sublingual ODF indicates that a greater amount of cladribine reached systemic circulation and was maintained for a longer period compared with conventional oral tablet administration. This finding supports the conclusion that the sublingual delivery approach provides more efficient and consistent overall drug availability under the study conditions. Importantly, improved delivery efficiency may also support dose optimization in future studies, with the potential to reduce systemic drug burden at equivalent therapeutic exposure and, in turn, improve tolerability and reduce side effects, an outcome BioNxt intends to evaluate in planned clinical development.

Robust Preclinical Pig Model with High Translational Relevance

The study was conducted as a single-dose comparative evaluation in adult miniature pigs (40-50kg), a large-mass non-rodent model widely used in pharmaceutical development due to its close anatomical, physiological, and metabolic similarity to humans, particularly with respect to oral and transmucosal drug absorption. Plasma cladribine concentrations were measured over a 48-hour period using validated bioanalytical methods, ensuring high data quality and robustness of the results.

BioNxt compared its proprietary sublingual ODF formulation with an approved generic cladribine tablet equivalent to the established name-brand reference product. To ensure accurate assessment of sublingual absorption, animals were physically restrained during dosing to prevent swallowing and to isolate the transmucosal route of administration. Notably, sublingual ODF administration in animal models is technically more challenging than tablet dosing, further strengthening the significance of the observed exposure advantage.

De-Risking the Transition Toward Human PK Studies

"These final preclinical pig study results validate the efficiency of our proprietary sublingual delivery approach and provide quantitative confirmation that our ODF delivers cladribine more efficiently than conventional oral tablets," said Hugh Rogers, Chief Executive Officer of BioNxt. "With a meaningful increase in systemic drug exposure demonstrated in a robust non-rodent model, we now have strong scientific justification to advance the sublingual ODF formulation into human pharmacokinetic studies as a planned next commercialization step."

Based on the final dataset, BioNxt intends to proceed toward human pharmacokinetic and bioequivalence evaluations while continuing GMP manufacturing and regulatory preparation. The Company believes that improved systemic drug delivery through sublingual administration may support more efficient dosing, reduce variability associated with oral absorption, and offer a swallow-free, needle-free, patient-friendly alternative for individuals living with neurological or neuromuscular conditions.

Beyond Multiple Sclerosis: Platform Potential Across Neuro-Immunological Diseases

While Multiple Sclerosis remains the initial development focus, BioNxt views its sublingual oral dissolvable film (ODF) technology as a scalable delivery platform with potential applications across a broader range of neuro‑immunological and neurological diseases. As a first step beyond MS, the Company believes its cladribine ODF approach may also be applicable to indications such as Myasthenia Gravis (MG), where swallowing difficulties are common and needle‑free, swallow‑free sublingual therapies may offer meaningful clinical advantages.

Beyond individual indications, BioNxt's platform strategy is designed to enable the reformulation of multiple established and late‑stage drug candidates, particularly in chronic diseases where adherence, tolerability, and ease of administration are critical. Because the ODF platform focuses on optimizing the delivery of active ingredients that are already approved and widely used in clinical practice, development efforts can concentrate on pharmacokinetics, bioequivalence, and patient usability rather than on new molecular discovery. Taken together, this approach may allow for more streamlined regulatory development pathways compared with new molecular entities, subject to regulatory review, while significantly expanding the addressable market opportunity.

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 andtrades 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: +1 780-818-6422

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 within the meaning of applicable Canadian securities laws. Forward-looking information includes, but is not limited to, statements regarding the interpretation and significance of the Company's preclinical study results; the potential advantages of BioNxt's sublingual oral dissolvable film (ODF) technology; the planned progression into human pharmacokinetic and bioequivalence studies; the potential applicability of the Company's drug-delivery platforms to additional therapeutic indications; and statements regarding future development, regulatory, commercialization, licensing, or partnering activities.

Forward-looking information is based on management's current expectations, assumptions, and beliefs as of the date of this press release. Such information is subject to a number of risks, uncertainties, and other factors, many of which are beyond the Company's control, that may cause actual results to differ materially from those expressed or implied. These risks and uncertainties include, but are not limited to, scientific and preclinical development risks; the possibility that results observed in animal studies may not be predictive of human outcomes; the timing, cost, conduct, and results of future studies or clinical trials; manufacturing and scale-up risks; reliance on third-party service providers; regulatory and approval risks; intellectual property risks; competitive developments; and general economic and capital market conditions.

Readers are cautioned not to place undue reliance on forward-looking information. Except as required by applicable securities laws, BioNxt 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. BioNxt Solutions Inc. is not affiliated with, sponsored by, or associated with Merck KGaA.

SOURCE: BioNxt Solutions Inc.

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P. Rasmussen--BTZ