Berliner Tageblatt - BioNxt Advances Semaglutide ODF Program into Active Pharmaceutical Development

The advancement represents a significant strategic milestone for BioNxt as the Company applies its expertise in sublingual thin-film drug delivery systems beyond neurological and autoimmune diseases into the rapidly growing global GLP-1 therapeutics market.

Applying BioNxt's Thin-Film Expertise to the Rapidly Growing GLP-1 Market

Semaglutide is the active pharmaceutical ingredient used in leading GLP-1 therapies for obesity, metabolic disorders, and type 2 diabetes - one of the fastest-growing and most commercially significant sectors in global healthcare. Demand for convenient, patient-friendly treatment options continues to accelerate as GLP-1 therapies become increasingly mainstream across chronic disease management and weight-loss applications.

BioNxt is developing a sublingual thin-film formulation designed to dissolve rapidly in the oral cavity, supporting a convenient, portable, and needle-free delivery approach for GLP-1 therapies. The program leverages the Company's extensive experience in oral dissolvable film development, formulation science, and sublingual drug delivery technologies established through previous ODF programs and proprietary platform expertise.

The Company believes next-generation drug delivery technologies capable of improving convenience, portability, and patient adherence may become increasingly important as chronic disease therapies continue shifting toward patient-centric treatment models.

Moving from Concept to Active Pharmaceutical Development

The first phase of the Semaglutide development program is expected to span approximately six to nine months and focuses on formulation development, development of analytical methods, analytical characterization, compatibility testing, and proof-of-concept evaluation activities.

Initial work completed or currently underway includes theoretical formulation studies for sublingual Semaglutide administration, sourcing of active pharmaceutical ingredients and excipients, development of analytical methods for raw materials and finished formulations, compatibility testing of formulation components, and placebo thin-film studies evaluating dissolution and film performance characteristics.

Proof-of-concept studies are expected to begin following receipt of Semaglutide API materials anticipated later this year. Successful early-stage results may support future formulation optimization, scale-up activities, and potential intellectual property development.

Extending BioNxt's Thin-Film Technology into the Future of Chronic Disease Treatment

"Advancing our Semaglutide program into active pharmaceutical development is an important step in the evolution of BioNxt from a single-product story into a broader drug delivery platform company," said Hugh Rogers, CEO of BioNxt Solutions Inc. "Our team has built significant expertise in oral dissolvable film formulation, sublingual delivery systems, and pharmaceutical development through previous ODF programs. We believe this experience creates a strong foundation to evaluate additional high-value therapeutic opportunities such as Semaglutide."

BioNxt's proprietary ODF platform focuses on rapidly dissolving sublingual drug delivery systems designed to improve ease of administration and patient accessibility while potentially addressing limitations associated with traditional oral dosage forms and injectable therapies.

The Company's lead ODF development program for Cladribine has already demonstrated encouraging preclinical pharmacokinetic and tolerability results and is advancing toward human bioequivalence studies for multiple sclerosis treatment. BioNxt believes the technological and manufacturing expertise developed through its Cladribine program creates a strong operational foundation for future ODF candidates across multiple therapeutic indications.

Positioning for the Future of Patient-Centric Drug Delivery

BioNxt's broader platform strategy is focused on developing patient-friendly, needle-free pharmaceutical delivery technologies designed to improve convenience, portability, and treatment adherence. The Company believes rapidly dissolving sublingual films may offer significant advantages for certain patient populations by simplifying administration and reducing barriers associated with conventional dosage forms.

As global healthcare continues shifting toward patient-centric treatment models, BioNxt believes advanced delivery technologies capable of combining pharmaceutical performance with convenience and accessibility may represent a significant long-term market opportunity.

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

Email: [email protected]

Wolfgang Probst, Co-Founder, CFO & Director
Phone +49 151 25284192

Hugh Rogers, Co-Founder, CEO and Director
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 news release contains "forward-looking information" and "forward-looking statements" within the meaning of applicable securities laws (collectively, "forward-looking statements"). Forward-looking statements are based on management's current expectations, estimates, projections, beliefs, and assumptions as of the date of this news release and are subject to a number of risks, uncertainties, and other factors that may cause actual results to differ materially from those expressed or implied herein.

Forward-looking statements in this news release include, but are not limited to, statements regarding the development, advancement, and potential commercialization of the Company's Semaglutide oral dissolvable film ("ODF") program and other drug delivery technologies; the potential applicability, scalability, and performance of the Company's thin-film drug delivery platform across neurological, autoimmune, metabolic, and chronic disease indications; the anticipated timing, scope, and outcomes of formulation development, analytical method establishment, compatibility testing, proof-of-concept studies, scale-up activities, and other research and development initiatives; the potential benefits, performance, convenience, portability, patient adherence, and commercial viability of sublingual drug delivery systems; the Company's intellectual property strategy and ability to obtain, maintain, and enforce patent and other proprietary rights in relevant jurisdictions; potential regulatory pathways and approvals; and potential future commercialization, licensing, manufacturing, partnering, and strategic collaboration opportunities.

Forward-looking statements are subject to known and unknown risks, uncertainties, assumptions, and other factors, many of which are beyond the Company's control, including but not limited to risks related to research and development activities, scientific and technical challenges, formulation and manufacturing difficulties, analytical and proof-of-concept outcomes, scale-up and process development risks, the possibility that preclinical, early-stage, or proof-of-concept results may not be predictive of future results, uncertainties relating to regulatory review and approval processes, intellectual property protection and enforcement risks, reliance on third-party manufacturers, development partners and suppliers, changes in competitive technologies and market conditions, and general economic, financial, and capital market conditions.

There can be no assurance that forward-looking statements will prove to be accurate, and actual results, performance, or achievements may differ materially from those expressed or implied in such statements. 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, whether as a result of new information, future events, or otherwise.

SOURCE: BioNxt Solutions Inc.

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F.Müller--BTB