Berliner Tageszeitung - Semaglutide API Delivery Enables Start of Lab-Scale ODF Development at BioNxt

In collaboration with its qualified supply partners, BioNxt has secured high-purity Semaglutide as the central compound for its proprietary ODF formulation program. The API's fundamental physical and chemical properties - such as solubility, molecular stability, and loading capacity - are foundational to formulation design and product performance. With the API now in hand, BioNxt's formulation team is executing pre-formulation and lab-scale trials to optimize delivery parameters.

Initial research and development efforts will focus on optimizing drug incorporation within the sublingual thin film matrix, characterizing disintegration time, testing peptide stability under formulation conditions, and developing analytical methods to ensure uniformity, controlled release, and shelf-life performance.

"Having the API in-house allows us to translate theory into practice," said Hugh Rogers, CEO at BioNxt Solutions. "We're focused on generating reliable data to inform formulation refinement and position the project for patent protection in the coming quarter."

Gen Plus: BioNxt's European Drug Development Hub

All laboratory development activities for the Semaglutide oral film are being conducted at Gen-Plus GmbH, BioNxt's German drug development partner, located in Munich, Germany. Gen-Plus is a licensed drug developer and manufacturer specializing in pharmaceutical thin film formulations and novel dosage forms.

Gen-Plus provides GMP-aligned laboratory infrastructure, in-house expertise in polymer science and peptide formulation, and regulatory readiness for clinical development in the European Union. The Munich facility serves as BioNxt's core technical center for thin film research, formulation prototyping, and early-stage product development. The Semaglutide program builds on Gen-Plus's proven experience in oral and transdermal delivery technologies for both small molecules and complex biologics.

Advancing Toward Prototype and Patent

With laboratory work now underway, the next milestones in the development timeline include completion of formulation trials, characterization of peptide stability, and production of first-generation film prototypes. These efforts will generate the technical foundation required to support a provisional patent filing planned for the third quarter of 2025.

Semaglutide, currently marketed under the brand names Ozempic® and Rybelsus®, is a leading GLP-1 receptor agonist approved for the treatment of type 2 diabetes and obesity. Global demand for GLP-1 therapies is growing rapidly, with Semaglutide accounting for more than USD 29.3 billion in sales in 2024. BioNxt's oral thin film version is intended to improve accessibility and patient compliance through a non-invasive delivery format. Semaglutide is the first in a planned series of GLP-1-based therapies being developed using BioNxt's proprietary ODF 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: [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" 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

O. Karlsson--BTZ