Berliner Tageblatt - BioNxt's Sublingual Cladribine Program for MS Ready for Next Phase

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 the ability to swallow.

Preclinical studies have demonstrated that BNT23001 achieves high absorption rates and bioequivalence to existing oral therapies, with no adverse toxic 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: [email protected]
Phone: +1 778.598.2698

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 includes certain statements that may be deemed "forward-looking statements". All statements in this release, other than statements of historical facts, that address events or developments that the Company expects to occur, are forward-looking statements. Forward-looking statements are statements that are not historical facts and are generally, but not always, identified by the words "expects", "plans", "anticipates", "believes", "intends", "estimates", "projects", "potential" and similar expressions, or that events or conditions "will", "would", "may", "could" or "should" occur. Forward-looking information in this news release includes the anticipated filing date of the Annual Filings. Although the Company believes the expectations expressed in such forward-looking statements are based on reasonable assumptions, such statements are not guarantees of future performance and actual results may differ materially from those in the forward-looking statements. Factors that could cause the actual results to differ materially from those in forward-looking statements include regulatory actions, market prices, and continued availability of capital and financing, and general economic, market or business conditions. Investors are cautioned that any such statements are not guarantees of future performance and actual results or developments may differ materially from those projected in the forward-looking statements. Forward-looking statements are based on the beliefs, estimates and opinions of the Company's management on the date the statements are made. Except as required by applicable securities laws, the Company undertakes no obligation to update these forward-looking statements in the event that management's beliefs, estimates or opinions, or other factors, should change.

SOURCE: BioNxt Solutions Inc.

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F.Müller--BTB