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BioNxt Solutions Inc. reports developments in bioscience and advanced drug delivery systems, with recurring updates on sublingual oral thin films, transdermal skin patches, oral enteric-coated tablets, diagnostic screening systems and active pharmaceutical ingredient development. Its lead program, BNT23001, is a proprietary sublingual cladribine oral thin film designed for relapsing forms of multiple sclerosis and other autoimmune neurodegenerative diseases.
Company news also covers patent protection for its oral thin-film technology, GMP manufacturing of clinical-grade cladribine film through a European CDMO, semaglutide as an initial GLP-1 oral thin-film application, commercialization planning, and capital-structure actions such as shares issued to settle debt.
BioNxt (OTCQB:BNXTF) signed a non-binding LOI on February 5, 2026 to secure exclusive rights to a third‑party chaperone-enabled drug delivery technology for oral dissolvable thin films. The deal would grant BioNxt IP ownership within the oral field, a development roadmap, patent filing plans in the US and Europe, and a right of first refusal for non-oral formats. The transaction is subject to definitive agreements and may not close as contemplated.
BioNxt (OTCQB:BNXTF) reported preclinical results showing a >40% improvement in bioavailability for its lead cladribine oral thin film (ODF) versus conventional formulations, supporting progression toward a first human clinical study in Multiple Sclerosis.
The company is focusing on clinical planning, manufacturing readiness, and regulatory alignment with CRO support, and is expanding the ODF strategy into Myasthenia Gravis. Market context cited: Mavenclad® 2024 net sales >USD 1 billion and MS market USD 32.8B (2024).
BioNxt (OTCQB:BNXTF) reported final preclinical pig study results on January 21, 2026 showing its proprietary sublingual oral dissolvable film (ODF) formulation of cladribine achieved approximately 40% higher systemic exposure than a conventional oral tablet over 48 hours. Mean AUC(0-48h) was 39.46 ng·h/mL for the sublingual ODF versus 28.11 ng·h/mL for the tablet. The single-dose study used adult miniature pigs (40-50 kg) with controlled restraint to isolate transmucosal absorption. BioNxt says the data support advancing the ODF to human pharmacokinetic and bioequivalence studies while continuing GMP manufacturing and regulatory preparation.
BioNxt (OTCQB:BNXTF) completed a comparative pharmacokinetics study in adult pigs (Nov–Dec 2025) evaluating its swallow-free sublingual 10 mg cladribine ODF versus a reference 10 mg tablet, with each dose administered as a 5 mg-equivalent per animal. Blood sampling over 24 hours produced preliminary results the company says support superior bioavailability for the ODF under study conditions. BioNxt has begun full internal analysis of the final dataset and expects to disclose detailed PK calculations later. The company also confirmed patent protection for the cladribine ODF program with national grants expected shortly and plans a human bioequivalence study to optimize dosing.
BioNxt Solutions (OTCQB:BNXTF) announced progress for its rapid-dissolving, sublingual thin-film drug platform targeting swallowing difficulties common in chronic autoimmune diseases.
Key facts: BioNxt received a Eurasian patent for BNT23001 valid through 2043 covering >200 million people, completed GMP clinical batch manufacturing, and plans a comparative human bioequivalence study in Q1 2026. The drug references cladribine tablets (Mavenclad) which exceeded $1.0B annual sales, supporting commercial potential for a swallow-free alternative.
BioNxt Solutions (OTCQB:BNXTF) is advancing a next‑generation "Melt in Your Mouth" cladribine oral dissolvable film (ODF), BNT23001, designed for rapid sublingual absorption to help multiple sclerosis (MS) patients with dysphagia who struggle to swallow tablets.
The company cites a meta‑analysis finding ~45% of MS patients experience dysphagia and notes cladribine tablets generated ~USD 1.28 billion in 2024. Market data show cladribine sales of >USD 950M through Q3 2025 and a projected cladribine market CAGR of 8.5% to 2032; the oral transmucosal market is forecast to grow from USD 45.8B (2025) to USD 96.8B (2033).
BioNxt Solutions (OTCQB:BNXTF) signed a letter agreement with a European chemotherapy company to acquire 100% of IP rights to a novel sublingual high‑potency formulation for oncology and immunosuppressant uses.
Under the agreement the Codeveloper will receive a 20% royalty on license fees, capped at USD 50,000,000 aggregate. The parties plan prototype development, IP filings, preclinical and clinical studies, and regulatory filings, and aim to execute a definitive IP and collaboration agreement within 60 days. BioNxt expects to file provisional patents for the product by year‑end, positioning the program alongside its cladribine sublingual thin‑film lead program.
The release cites a market estimate: the global immunosuppressant market reaching USD 61.05 billion in 2025.
BioNxt (OTCQB:BNXTF) announced that the Eurasian Patent Organization granted Patent No. 051510 (issued November 14, 2025) covering sublingual delivery of anticancer drugs, including BioNxt's lead candidate BNT23001, a sublingual cladribine thin-film for multiple sclerosis. The patent provides protection across all eight EAPO member states—Armenia, Azerbaijan, Belarus, Kazakhstan, Kyrgyzstan, Russia, Tajikistan, and Turkmenistan—covering a combined population of more than 200 million, and is valid through June 14, 2043.
BioNxt said an ongoing two-week large-mass animal bioequivalence study is underway and a human bioequivalence study is planned. The company noted an EPO Intention to Grant and ongoing Track One U.S. priority filing plus nationalization efforts in Canada, Australia, New Zealand, and Japan as part of its global IP and commercialization strategy.
BioNxt Solutions (OTCQB:BNXTF) announced that its German subsidiary received an "Intention to Grant" from the European Patent Office for European patent application no. 23 729 446.7 covering a sublingual cladribine thin-film for multiple sclerosis. Combined with an EAPO "Readiness to Grant," filings could provide potential protection across up to 54 jurisdictions and an addressable population of nearly 1 billion people, subject to national validation and maintenance. The patents claim a cladribine-cyclodextrin complex thin film intended for rapid transmucosal absorption. BioNxt is also pursuing U.S., North America, and Japan filings, completing a large-mass animal bioequivalence study, and planning a human bioequivalence trial while seeking co-development and out-licensing partners.
BioNxt (OTCQB:BNXTF) received a Readiness to Grant notice from the Eurasian Patent Organization for a patent family covering sublingual delivery of anticancer drugs aimed at treating autoimmune neurodegenerative diseases, including BioNxt's lead product BNT23001 (sublingual Cladribine for MS).
The company will pay a publication fee this week to secure formal grant in the EAPO region, which covers 8 countries (Armenia, Azerbaijan, Belarus, Kazakhstan, Kyrgyzstan, Russia, Tajikistan, Turkmenistan) representing a combined population of >200,000,000. BioNxt is days away from starting a two-week large-mass animal bioequivalence study to set dosing for an upcoming human bioequivalence study, and is pursuing patent nationalization in the EU, US (Track One), Canada, Australia, New Zealand, and Japan.