Berliner Boersenzeitung - BioNxt Advances Semaglutide as First Application of Broad GLP-1 ODF Platform Strategy

Semaglutide as Lead Candidate for GLP-1 Platform Validation

BioNxt is currently in early-stage development of its semaglutide ODF program, with initial formulation work underway, including preliminary feasibility and exploratory proof-of-concept evaluations. Semaglutide, a leading GLP-1 receptor agonist widely used in the treatment of type 2 diabetes and obesity, has been selected as the Company's lead candidate to support the development of a next-generation sublingual oral thin-film (ODF) approach for peptide therapeutics.

The Company believes that semaglutide represents an ideal model compound due to its strong clinical profile, large and rapidly growing global market, and well-established regulatory pathway. By exploring feasibility with semaglutide, BioNxt is establishing the foundation for potential broader application of thin-film delivery approaches to peptide-based therapeutics.

The program remains in an early stage of development, and further work is required to validate formulation performance, bioavailability, and delivery characteristics.

Expansion Toward a GLP-1 and Peptide Delivery Platform

BioNxt's strategic focus extends beyond a single-product development model. The Company is advancing a next-generation ODF formulation approach designed to enable the sublingual delivery of complex peptide drugs, including GLP-1 receptor agonists.

Building on its early work with semaglutide, BioNxt is evaluating the potential to expand this approach to additional compounds within the GLP-1 class, including next-generation therapies such as tirzepatide and established molecules like liraglutide. These compounds share structural and pharmacological characteristics that may be compatible with BioNxt's formulation strategy.

The Company's development efforts are focused on identifying and optimizing carrier systems and film compositions capable of supporting the delivery of large, sequence-based peptide molecules. This program is expected to generate new intellectual property covering formulation, carrier systems, and peptide delivery mechanisms.

Upon further validation, BioNxt intends to pursue a broader intellectual property strategy targeting delivery technologies and potential multi-compound applications within the GLP-1 category and other peptide-based therapeutic areas.

Large and Rapidly Expanding Market Opportunity

The global market for GLP-1 receptor agonists is one of the fastest-growing segments in the pharmaceutical industry, driven by rising prevalence of obesity and type 2 diabetes, as well as expanding clinical use in cardiometabolic care. According to Fortune Business Insights, the global GLP-1 receptor agonist market was valued at USD 62.83 billion in 2025 and is projected to grow to USD 254.19 billion by 2034, representing a 16.8% CAGR.

Semaglutide remains the leading commercial benchmark in the category. In its 2024 Annual Report, Novo Nordisk reported Ozempic sales of approximately USD 17.4 billion and Rybelsus sales of approximately USD 3.4 billion in 2024, while total obesity-care sales, including Wegovy and Saxenda, reached approximately USD 9.4 billion.

BioNxt believes that alternative, patient-friendly delivery formats such as sublingual oral thin films may play an important role in the next phase of market evolution, particularly by improving convenience, adherence, and accessibility compared to injectable therapies.

Platform Strategy and Commercial Outlook

BioNxt is positioning itself as a platform developer focused on drug delivery innovation rather than active pharmaceutical ingredient discovery. The Company's development approach is designed to enable lifecycle management opportunities for established drugs, support new formulations for approved compounds, and facilitate potential licensing and partnership agreements with pharmaceutical companies.

By combining a non-invasive, needle-free delivery approach with formulation-driven intellectual property, BioNxt aims to create a scalable and commercially attractive platform that can be applied across multiple therapeutic areas, with an initial focus on metabolic and peptide-based indications.

Semaglutide represents the first step in this strategy, serving as an initial validation candidate for the broader platform concept.

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 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 development and advancement of the Company's semaglutide oral thin-film (ODF) program; the ability of the Company's ODF platform to support the delivery of GLP-1 receptor agonists and other peptide-based therapeutics; the potential expansion of the platform to additional compounds, including tirzepatide, liraglutide, and other peptide drugs; the Company's intellectual property strategy, including the development and protection of formulation and delivery technologies; the anticipated timing, scope, and outcomes of further research and development activities; potential regulatory pathways; and potential commercialization, licensing, or partnering opportunities.

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: risks associated with research and development activities; scientific, formulation, and technical challenges; the possibility that early-stage results may not be predictive of future outcomes; uncertainties relating to regulatory review and approval; risks related to intellectual property protection and enforcement; potential patent challenges; manufacturing and scale-up risks; reliance on third-party partners and service providers; competitive developments in the GLP-1 and peptide therapeutics market; 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.

SOURCE: BioNxt Solutions Inc.

View the original press release on ACCESS Newswire

(F.Schuster--BBZ)