Berliner Tageszeitung - BioNxt Provides Development, Intellectual Property and Commercial Update Across Sublingual Drug Delivery Pipeline

"Our vision has always been to build a differentiated pharmaceutical platform capable of improving the delivery of established therapies across multiple high-value therapeutic areas," said Hugh Rogers, Chief Executive Officer of BioNxt Solutions. "During the past several months we have continued executing against that strategy through scientific development, manufacturing preparation, intellectual property expansion and pipeline diversification. We believe these achievements position BioNxt for an important next stage of growth as we advance toward clinical evaluation and future commercialization."

Cladribine Program Advancing Toward Clinical Development

BioNxt's lead program remains its proprietary sublingual Cladribine oral dissolvable film ("ODF") for the treatment of multiple sclerosis (MS).

Over the past several months, the Company has continued advancing activities supporting the transition from pharmaceutical development into clinical execution. Current activities include regulatory documentation, analytical and manufacturing preparation, and planning for the Company's first human bioavailability study.

BioNxt believes its proprietary sublingual formulation has the potential to improve patient convenience by providing a needle-free, orally dissolving dosage form while leveraging the established therapeutic profile of Cladribine.

The Company also continues evaluating strategic commercialization opportunities and discussions with potential development and licensing partners to maximize the long-term value of the program.

Expanding Opportunities in Autoimmune Diseases

Building upon the Cladribine platform, BioNxt continues evaluating additional autoimmune indications where its proprietary drug delivery technology may provide meaningful clinical and commercial advantages.

The Company's intellectual property portfolio supports potential applications beyond multiple sclerosis, including Myasthenia Gravis and other autoimmune neurological disorders. BioNxt continues assessing future development priorities and regulatory pathways for these additional indications.

Everolimus Program Progress

BioNxt continues advancing formulation development for its proprietary sublingual Everolimus ODF program.

Everolimus is an established pharmaceutical used in organ transplantation and oncology and has attracted increasing scientific interest for potential applications in longevity and healthy ageing research. The Company continues optimizing formulation characteristics while evaluating future preclinical and clinical development pathways.

Semaglutide Program Initiated

BioNxt has initiated development of its proprietary sublingual Semaglutide ODF program, expanding its platform into one of the world's fastest-growing pharmaceutical markets.

The active pharmaceutical ingredient (API) has been ordered, and development activities are being prepared to commence upon receipt. Initial work will focus on formulation development and evaluating the suitability of BioNxt's proprietary thin-film platform for peptide-based therapeutics.

The program represents an important strategic expansion of the Company's platform into metabolic disease and GLP-1 therapies.

Strengthening Global Intellectual Property

BioNxt continues strengthening the intellectual property foundation supporting its proprietary drug delivery platform.

The Company has secured patent protection for its core Cladribine thin-film technology in both Europe and Eurasia, representing the culmination of several years of scientific research, formulation development and intellectual property strategy. These patent grants establish an important foundation for future clinical development, commercial partnerships and licensing opportunities.

In the United States, the Company's corresponding patent application continues under the U.S. Patent and Trademark Office's Track One Prioritized Examination program, which is intended to accelerate examination and final disposition. Additional patent applications continue progressing through examination in other key international jurisdictions.

BioNxt believes a robust international patent portfolio is fundamental to maximizing the commercial potential of both its lead Cladribine program and future pipeline assets developed using its proprietary sublingual drug delivery platform.

Building a Diversified Pharmaceutical Pipeline

BioNxt continues executing a disciplined development strategy focused on advancing multiple proprietary pharmaceutical programs through formulation, manufacturing, regulatory preparation and clinical development.

By leveraging a common sublingual thin-film technology platform across multiple therapeutic areas-including neurology, autoimmune diseases, longevity and metabolic disorders-the Company aims to create multiple long-term value creation opportunities while reducing reliance on a single development asset.

The Company expects to provide additional updates as key development, regulatory, intellectual property and commercial milestones are achieved.

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 more selectively to tumors with the goal of reducing systemic exposure.

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 & 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 known and unknown risks, uncertainties and other factors that may cause actual results or events to differ materially from those expressed or implied by such forward-looking statements.

Forward-looking statements in this news release include, but are not limited to, statements regarding the development, advancement, regulatory pathway and potential commercialization of the Company's pharmaceutical pipeline, including its Cladribine, Everolimus, Semaglutide and other sublingual thin-film programs; the advancement of additional autoimmune disease programs; planned formulation, manufacturing, preclinical and clinical development activities; regulatory submissions and approvals; human bioavailability studies; commercialization, licensing and strategic partnering opportunities; the potential therapeutic and commercial advantages of the Company's proprietary drug delivery platform; the examination, prosecution and potential grant of pending patent applications, including the Company's U.S. Track One prioritized patent application; the scope and value of the Company's intellectual property portfolio; and the anticipated timing and achievement of future development milestones.

SOURCE: BioNxt Solutions Inc.

View the original press release on ACCESS Newswire

A. Williams--BTZ