Berliner Tageblatt - BioNxt Accelerates ODF for Multiple Sclerosis Toward Human Clinical Study with >40% Bioavailability Improvement and Myasthenia Gravis Expansion

The results strengthen confidence in BioNxt's sublingual oral thin film platform and mark an important inflection point in the Company's development strategy. Development focus now moves toward human clinical study, which is expected to be more streamlined and efficient because cladribine is an already approved active pharmaceutical ingredient, allowing the Company's clinical work to concentrate on demonstrating bioavailability and bioequivalence rather than repeating large-scale safety and efficacy trials.

Advancing Toward Human Clinical Study in Multiple Sclerosis

With formulation and preclinical validation having exceeded expectations, BioNxt is now progressing its lead cladribine oral thin film program for Multiple Sclerosis toward a first human clinical study. Current activities are focused on clinical planning, manufacturing readiness, and regulatory alignment to support a disciplined transition into human-focused development.

The Company is working closely with an experienced clinical research organization (CRO) to support study design, operational execution, and regulatory compliance. This collaboration is intended to de-risk timelines and ensure high-quality execution as the Multiple Sclerosis program advances toward clinical evaluation.

Capital-Efficient Path Toward Commercialization

BioNxt's development strategy leverages the established clinical and safety profile of cladribine, an already approved therapy with significant commercial precedent. By combining a proven active pharmaceutical ingredient with a differentiated oral thin film delivery format, the Company believes it is pursuing a capital-efficient and execution-driven pathway toward potential commercialization and partnering opportunities.

The oral thin film platform is designed to improve patient adherence, simplify administration, and enhance real-world treatment usability, particularly in chronic and neurological diseases where swallowing difficulties and treatment fatigue are common.

Expansion into Myasthenia Gravis Enabled by Study Results

Importantly, the strength of the recent study results also enables the expansion of BioNxt's cladribine ODF strategy into Myasthenia Gravis (MG), a rare, chronic autoimmune neuromuscular disease in which the immune system disrupts communication between nerves and muscles. MG is characterized by fluctuating muscle weakness that commonly affects the eyes, face, throat, and limbs, often leading to difficulty swallowing, speaking, and chewing, as well as severe fatigue.

Myasthenia Gravis is a rare but serious autoimmune neuromuscular disease that affects an estimated 1.4 million people worldwide, based on global prevalence analyses published in peer-reviewed epidemiology studies.

These symptoms can make conventional oral tablet administration challenging for many patients, contributing to treatment burden and adherence issues. BioNxt believes its sublingual, needle-free oral thin film delivery format may be particularly well suited for MG patients by simplifying administration and reducing reliance on swallowing intact tablets.

BioNxt is repurposing the same cladribine drug and oral thin film delivery technology for MG, allowing the Company to build on existing formulation knowledge and development progress. Because both indications utilize the same active ingredient and delivery platform, BioNxt believes the MG program may follow an accelerated and capital-efficient development pathway relative to a de novo drug program.

According to GlobalData, the Myasthenia Gravis market across the seven major markets (7MM) is forecast to reach approximately USD 6.7 billion by 2032, driven by improved diagnosis rates and the introduction of newer, disease-modifying therapies.

Addressing Large Autoimmune Markets

BioNxt's lead product candidate, BNT23001, is being developed as a sublingual cladribine oral thin film for Multiple Sclerosis (MS), with the objective of providing a swallow-free alternative to oral cladribine tablets such as Mavenclad®. Merck KGaA reported 2024 Mavenclad® net sales of more than USD 1 billion (€1,062 million), and GlobalData estimates the Multiple Sclerosis market generated USD 32.8 billion in 2024 across 68 markets and is projected to reach USD 41.2 billion by 2034.

Together, the MS and MG programs highlight the scalability of BioNxt's oral thin film platform and its potential to support multiple high-value autoimmune indications using a focused, platform-driven development strategy.

Strategic Outlook

With its lead cladribine program in Multiple Sclerosis accelerating toward human clinical study and expansion into Myasthenia Gravis, BioNxt is entering a phase increasingly defined by execution, timelines, and platform-driven value creation. The Company believes this approach positions it well to advance clinical development while maintaining capital discipline and strategic flexibility.

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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D.Schneider--BTB