Jul 7, 2025 in Press Releases

API Delivery Initiates Next Phase for BioNxt’s Sublingual Cladribine Multiple Sclerosis Program

Vancouver, BC – July 7, 2025 – BioNxt Solutions Inc. (CSE: BNXT | OTC: BNXTF | FSE: BXT), a bioscience innovator specializing in advanced drug delivery systems, is pleased to announce the receipt of the active pharmaceutical ingredient (API) for its lead product candidate, BNT23001. This proprietary sublingual thin-film formulation of cladribine is being developed for the treatment of multiple sclerosis (MS).

The delivery of the cladribine API enables the commencement of clinical batch manufacturing in collaboration with BioNxt’s European contract research and development partner, Gen-Plus GmbH & Co KG, based in Munich, Germany.This milestone supports the company’s plan to initiate a human bioequivalence study in the second half of 2025.

BNT23001 is designed to offer a patient-friendly alternative to traditional oral cladribine tablets, such as Mavenclad®, by providing a rapidly dissolving sublingual film. This delivery method aims to enhance patient compliance, particularly for individuals with MS who experience dysphagia, a common symptom affecting swallowing.

Preclinical studies have demonstrated that BNT23001 achieves high absorption rates and bioequivalence to existing oral therapies, with no adverse local effects observed. These findings support the progression to human bioequivalence studies.

BioNxt has also made significant strides in securing intellectual property rights for BNT23001. The company has initiated patent nationalization processes in key jurisdictions, including Europe, the United States, and Canada, with patent grants anticipated by mid-2025.

“The receipt of the cladribine API is a pivotal step forward in our mission to develop innovative, patient-centric therapies for MS,” said Hugh Rogers, CEO of BioNxt Solutions. “We are committed to advancing BNT23001 through clinical development and bringing this novel treatment option to patients worldwide.”

About BioNxt Solutions Inc.

BioNxt Solutions Inc. is a bioscience innovator focused on next-generation drug delivery technologies, diagnostic screening systems, and active pharmaceutical ingredient development. The Company’s proprietary platforms – Sublingual (Thin-Film), Transdermal (Skin Patch), and Oral (Enteric-Coated Tablets) – target key therapeutic areas, including autoimmune diseases, neurological disorders, and longevity. 

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: investor.relations@bionxt.com
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” and “forward-looking statements” (collectively, “forward-looking statements”) within the meaning of applicable Canadian securities legislation and the U.S. Private Securities Litigation Reform Act of 1995. Forward-looking statements include, but are not limited to, statements regarding: the development of BioNxt Solutions Inc.’s sublingual cladribine product candidate (BNT23001); the anticipated timing and outcome of clinical batch manufacturing and human bioequivalence studies; the potential regulatory pathway and approval of BNT23001; the commercial viability, safety, and efficacy of the product candidate; the advantages of thin-film drug delivery for multiple sclerosis patients; the company’s intellectual property strategy and expected patent grants; and the anticipated growth and size of the multiple sclerosis treatment market.

Forward-looking statements are based on management’s current expectations, estimates, projections, beliefs, and assumptions as of the date hereof, and are subject to known and unknown risks, uncertainties, and other factors that may cause actual results, performance, or achievements to be materially different from those expressed or implied by such forward-looking statements. These risks and uncertainties include, but are not limited to: risks associated with product research and development; clinical trial risks, including design, initiation, timing, costs, and results; risks related to the manufacturing and supply chain for active pharmaceutical ingredients; the ability to obtain necessary regulatory approvals; competition from existing treatments such as Mavenclad® and other oral or injectable MS therapies; risks related to intellectual property protection and enforcement; changes in market conditions; and other risk factors described from time to time in the company’s public filings with applicable securities regulatory authorities.

Readers are cautioned not to place undue reliance on forward-looking statements. BioNxt disclaims any obligation to update or revise any forward-looking statements, whether as a result of new information, future events, or otherwise, except as required by law.

Mavenclad® is a registered trademark of Merck KGaA, Darmstadt, Germany. It is not affiliated with or endorsed by BioNxt Solutions Inc.