Berliner Boersenzeitung - BioNxt Initiates GMP Manufacturing of Clinical-Grade Sublingual Cladribine Film Targeting Multiple Sclerosis (MS)

The completed GMP production campaign represents a significant operational milestone for BioNxt's lead development program, BNT23001, a proprietary sublingual Cladribine formulation designed for the treatment of relapsing forms of multiple sclerosis (MS) and other autoimmune neurodegenerative diseases. With this achievement, the Company advances from formulation development and preclinical validation into full clinical-stage execution.

Clinical-Stage Readiness and Trial Preparation

The GMP batch produced at BioNxt's GMP manufacturing partner (CDMO) based in Munich, Germany will serve as the Investigational Medicinal Product (IMP) supply for BioNxt's planned human bioavailability study, CBN26001, an open-label, randomized, two-period crossover trial designed to compare the Company's sublingual Cladribine ODF with the reference product Mavenclad^® (oral Cladribine tablets).

Manufacturing was conducted in accordance with European Union GMP standards, including validated production processes, controlled raw material sourcing, comprehensive in-process controls, and full quality testing and documentation in preparation for Qualified Person release and clinical use. Stability studies have also been initiated.

Completion of GMP manufacturing marks the final technical step prior to clinical trial activation and positions BioNxt for first-in-human dosing for its proprietary ODF formulation. The achievement materially reduces operational risk in the Cladribine program and strengthens the Company's regulatory readiness as it prepares to enter the human clinical phase.

Platform Validation and Strategic Expansion

BioNxt's sublingual Cladribine ODF is designed to address key limitations associated with conventional oral administration, including variability in gastrointestinal absorption, degradation under acidic gastric conditions, transporter-mediated efflux in the upper intestine, and swallowing difficulties that are prevalent among MS patients. By enabling transmucosal absorption via a rapidly dissolving, needle-free sublingual film, the Company aims to provide a patient-friendly alternative that may offer improved compliance and more predictable systemic exposure.

The collaboration with BioNxt's European GMP-certified contract development and manufacturing organization (CDMO) provides the Company with a scalable and regulatory-compliant manufacturing infrastructure capable of supporting future registrational studies and potential commercial-scale production. The established process is designed to enable efficient technology transfer for regional licensing or co-development partnerships, particularly within European markets where BioNxt has recently reinforced its intellectual property portfolio. Completion of GMP manufacturing not only supports the planned clinical trial but also strengthens the Company's position in strategic partnership discussions by demonstrating technical readiness and regulatory execution capability.

"Completing GMP manufacturing of our clinical-grade Cladribine ODF is a defining milestone for BioNxt," said Hugh Rogers, Chief Executive Officer of BioNxt Solutions Inc. "This achievement demonstrates our ability to translate innovative formulation science into regulator-ready clinical supply and brings us closer to generating human data. We believe this milestone substantially advances our strategy to position BioNxt as a leader in next-generation, needle-free drug delivery systems."

The Company expects to provide further updates regarding clinical trial activation and first subject dosing 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 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 news release contains forward-looking statements within the meaning of applicable securities laws. Forward-looking statements are based on management's current expectations, estimates, projections, beliefs, and assumptions as of the date of this release.

Forward-looking statements in this release include, but are not limited to, statements regarding: the negotiation and potential execution of a definitive licensing agreement pursuant to the non-binding letter of intent; the scope, territorial coverage, validity, term, and enforceability of the Company's Eurasian patent; the Company's intellectual property strategy; the continued development of its sublingual cladribine oral thin film (ODF) program; the anticipated timing, design, and conduct of planned human bioequivalence studies; potential regulatory pathways; expansion into additional indications; and potential commercialization, licensing, or partnering activities.

Forward-looking statements are subject to known and unknown risks, uncertainties, and other factors that may cause actual results, performance, or achievements to differ materially from those expressed or implied by such forward-looking statements. These risks and uncertainties include, but are not limited to: the possibility that a definitive agreement may not be executed within the exclusivity period or at all; risks associated with intellectual property protection and enforcement; potential patent opposition or validity challenges; uncertainties relating to regulatory review and approval; scientific, formulation, and development risks; the possibility that preclinical or pharmacokinetic results may not be predictive of human clinical outcomes; risks related to the timing, cost, and results of clinical studies; manufacturing and scale-up risks; reliance on third-party service providers; competitive developments; geopolitical risks in the Eurasian region; and general economic, market, and capital market conditions.

Readers are cautioned not to place undue reliance on forward-looking statements. Except as required by applicable securities laws, BioNxt undertakes no obligation to update or revise any forward-looking statements to reflect new information, future events, or otherwise.

Mavenclad^® is a registered trademark that is not owned by, affiliated with, sponsored by, or associated with BioNxt Solutions Inc.

SOURCE: BioNxt Solutions Inc.

View the original press release on ACCESS Newswire

(S.G.Stein--BBZ)