BioNxt Advances Semaglutide Oral Dissolvable Film (ODF) Program with Successful Proof-of-Concept and Prototype Development

Rhea-AI Summary

BioNxt Solutions (OTCQB:BNXTF) has successfully completed proof-of-concept trials for its Semaglutide oral dissolvable film (ODF) program at its German subsidiary, Vektor Pharma TF GmbH. The company developed promising prototypes showing rapid disintegration, homogeneous film quality, good manufacturability, and favorable mechanical properties.

The company plans to file a patent application in the coming months and will proceed with formulation optimization, stability studies, and scale-up work. A preclinical animal study is planned for early 2026, followed by a pilot clinical study targeted for the second half of 2026.

This development aims to provide an alternative to existing Semaglutide treatments (Ozempic® and Rybelsus®), which generated over $29.3 billion in sales in 2024. The ODF format is designed to offer a non-invasive, accessible alternative to current injectable and tablet options.

Positive

• None.

Negative

• Product still in early development stage with no clinical validation yet
• Significant timeline to market with clinical trials not starting until late 2026
• Will face competition from established Semaglutide products (Ozempic and Rybelsus)

VANCOUVER, BC / ACCESS Newswire / September 15, 2025 / BioNxt Solutions Inc. ("BioNxt" or the "Company") (CSE:BNXT)(OTCQB:XPHYF)(FSE:4XT) is pleased to announce the successful completion of proof-of-concept trials for its Semaglutide oral dissolvable film ("ODF") program at Vektor Pharma TF GmbH ("Vektor Pharma"), the Company's wholly owned German subsidiary.

Over the past several weeks, multiple proprietary film platforms were evaluated at Vektor Pharma. One of these in-house platforms achieved highly promising results, generating first prototypes of Semaglutide-ODF formulations with strong performance characteristics. The prototypes demonstrated rapid disintegration, homogeneous film quality, good processability during manufacturing, and favorable mechanical properties. These results confirm the suitability of BioNxt's thin film technology for complex peptide formulations and provide a solid foundation for further development.

This achievement marks a key advancement in the program and provides positive momentum as the project advances into its next stage.

"Achieving positive proof-of-concept results with first prototypes in-hand represents an important milestone for BioNxt," said Hugh Rogers, CEO of BioNxt Solutions. "These results validate our approach and allow us to proceed with greater confidence as we optimize the formulation, secure intellectual property, and prepare for preclinical testing."

Patent Filing and Next-Stage Development

Building on the successful prototypes, BioNxt is preparing to file a patent application for the Semaglutide ODF in the coming months. Under the supervision of Vektor Pharma, development will now transition toward refining the formulation to optimize performance and absorption potential, while also initiating stability studies, advancing scale-up work, and preparing the product for preclinical evaluation.

These efforts are expected to continue through late 2025 and will culminate in a preclinical animal study anticipated to begin in early 2026. The study will evaluate the pharmacological performance and overall suitability of the product. Looking further ahead, BioNxt intends to manufacture an Investigational Medicinal Product (IMP) to support a pilot clinical study targeted for the second half of 2026.

Addressing the Expanding GLP-1 Market

Semaglutide, currently marketed under the brand names Ozempic® and Rybelsus®, is a GLP-1 receptor agonist approved for type 2 diabetes and obesity. Global demand for GLP-1 therapies is expanding rapidly, with Semaglutide alone generating more than USD 29.3 billion in sales in 2024. BioNxt's oral thin film delivery format is designed to offer patients a non-invasive, accessible, and compliance-friendly alternative to existing injectable and tablet-based options.

Semaglutide represents the lead candidate in BioNxt's GLP-1 ODF portfolio, which is expected to include additional GLP-1-based therapies developed on the Company's proprietary thin film platform.

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 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: +1 604.250.6162

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" within the meaning of applicable Canadian securities laws (collectively, "forward-looking information"). Forward-looking information includes, but is not limited to, statements related to the Company's oral thin film (ODF) development program for Semaglutide; the anticipated timing and outcomes of formulation studies; the potential for future patent filings; market growth projections; and the broader applicability of the Company's drug delivery technologies.

Forward-looking information is based on management's reasonable assumptions, expectations, estimates, and projections as of the date of this press release. Such statements are subject to various known and unknown risks, uncertainties, and other factors - many of which are beyond the Company's control - that may cause actual results, performance, or achievements to differ materially from those expressed or implied by such forward-looking information. These risks and uncertainties include, but are not limited to: scientific and technical development risks; manufacturing and scalability risks; intellectual property protection; regulatory approval processes; competition in the GLP-1 drug market; and general economic, financial, and market conditions.

Readers are cautioned not to place undue reliance on forward-looking information. Although the Company believes the expectations and assumptions reflected in such statements are reasonable, there can be no assurance that they will prove to be correct. Except as required by applicable securities laws, the Company undertakes no obligation to update or revise any forward-looking information, whether as a result of new information, future events, or otherwise.

Ozempic® and Rybelsus® are registered trademarks of Novo Nordisk A/S and are not affiliated with or developed by BioNxt Solutions Inc.

SOURCE: BioNxt Solutions Inc.

View the original press release on ACCESS Newswire

FAQ

What is BioNxt's (BNXTF) new development in Semaglutide delivery?

BioNxt has successfully developed prototypes of Semaglutide oral dissolvable films (ODF) that showed promising characteristics including rapid disintegration and good manufacturability.

When will BioNxt begin clinical trials for its Semaglutide ODF?

BioNxt plans to begin preclinical animal studies in early 2026, followed by a pilot clinical study in the second half of 2026.

What advantages does BioNxt's Semaglutide ODF offer over existing treatments?

The ODF format aims to provide a non-invasive, accessible, and compliance-friendly alternative to current injectable (Ozempic) and tablet-based (Rybelsus) options.

How big is the market opportunity for BioNxt's Semaglutide product?

The market is substantial, with Semaglutide products generating over $29.3 billion in sales in 2024.

What are the next steps in BioNxt's Semaglutide ODF development?

BioNxt plans to file a patent application, optimize formulation, conduct stability studies, advance scale-up work, and prepare for preclinical evaluation through late 2025.