VANCOUVER, BC — August 4, 2026 — Leads & Copy — BioNxt Solutions Inc. is advancing its sublingual thin-film drug delivery pipeline across multiple pharmaceutical development programs, including Cladribine for multiple sclerosis, autoimmune diseases, Everolimus, and Semaglutide. The bioscience innovator is also strengthening its intellectual property portfolio and preparing for the next phase of clinical and commercial development.
“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.”
The Company’s lead program is its proprietary sublingual Cladribine oral dissolvable film (ODF) for the treatment of multiple sclerosis (MS). BioNxt has continued advancing activities supporting the transition from pharmaceutical development into clinical execution, including regulatory documentation, analytical and manufacturing preparation, and planning for the Company’s first human bioavailability study. BioNxt believes its sublingual formulation offers a potential improvement in patient convenience through a needle-free, orally dissolving dosage form, while utilizing Cladribine’s established therapeutic profile. The Company is also evaluating strategic commercialization opportunities and discussions with potential development and licensing partners.
Building on the Cladribine platform, BioNxt is assessing additional autoimmune indications where its drug delivery technology may offer clinical and commercial advantages. The Company’s intellectual property portfolio supports potential applications beyond MS, including Myasthenia Gravis and other autoimmune neurological disorders. BioNxt is continuing to assess future development priorities and regulatory pathways for these indications.
Formulation development for BioNxt’s proprietary sublingual Everolimus ODF program is progressing. Everolimus is used in organ transplantation and oncology and is of interest for longevity and healthy aging research. BioNxt is optimizing formulation characteristics and evaluating future preclinical and clinical development pathways.
BioNxt has initiated development of its proprietary sublingual Semaglutide ODF program, expanding into the metabolic disease and GLP-1 therapy markets. The active pharmaceutical ingredient (API) has been ordered, and development activities will commence upon receipt, focusing initially on formulation development and evaluating the suitability of BioNxt’s thin-film platform for peptide-based therapeutics.
The Company is strengthening the intellectual property for its drug delivery platform, having secured patent protection for its core Cladribine thin-film technology in Europe and Eurasia. In the United States, the corresponding patent application is undergoing the U.S. Patent and Trademark Office’s Track One Prioritized Examination program, intended to accelerate review. Additional patent applications are progressing internationally. BioNxt views a robust international patent portfolio as fundamental to maximizing the commercial potential of its programs.
BioNxt is executing a development strategy focused on advancing multiple proprietary pharmaceutical programs through formulation, manufacturing, regulatory preparation, and clinical development. By using a common sublingual thin-film technology platform across neurology, autoimmune diseases, longevity, and metabolic disorders, the Company aims to create long-term value and reduce reliance on a single asset. Further updates are expected as key development, regulatory, intellectual property, and commercial milestones are achieved.
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 targeted chemotherapy platform. With R&D operations in North America and Europe, BioNxt is advancing regulatory approvals and commercialization, primarily in European markets. BioNxt aims to improve healthcare with precise, patient-centric solutions.
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.
Source: BioNxt Solutions Inc.
