Welcome to our dedicated page for BioNxt Solutions news (Ticker: BNXTF), a resource for investors and traders seeking the latest updates and insights on BioNxt Solutions stock.
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) 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.
BioNxt Solutions (OTCQB:BNXTF) has begun a 15-day dosing optimization crossover study for BNT23001, a sublingual cladribine thin-film for multiple sclerosis, marking the final preclinical step before human testing.
The large-mass animal study starts within two weeks, runs ~3 weeks, expects completion in November and results in December, ahead of a comparative human bioequivalence trial planned for early 2026. Small-animal tests showed bioequivalence and no toxicity. Patent nationalization is advancing with EPO and Eurasian intent-to-grant communications and a US Track One filing.
BioNxt (OTCQB:BNXTF) launched a 15-day large-mass animal crossover bioequivalence study for BNT23001, its sublingual cladribine thin-film, to refine dosing prior to a human comparative bioequivalence study planned for early 2026.
The animal study will begin in the next 2–3 weeks, run for 15 days, is expected to complete in November 2025, and results are expected in December 2025. A prior small-mass (40 kg) animal study reportedly confirmed dosage bioequivalence and guided dosing direction.
BNT23001 aims for improved bioavailability, faster onset, and easier dosing for patients with dysphagia. The company is pursuing patent nationalization in key markets; the European Patent Office and Eurasian Patent Office issued notices of intentions to grant, and a Track One priority filing is active in the United States.
BioNxt (OTCQB:BNXTF) advised shareholders that its 2025 annual general meeting will be held in person on November 7, 2025 at 10:00 a.m. (Vancouver). Due to the Canada Post strike, shareholders are directed to electronic copies of the Notice of Meeting, Information Circular and proxy via SEDAR+ and the company website, or to contact Investor Relations for copies.
The company outlined alternative proxy submission methods (fax, hand delivery, online via Computershare) and a 48-hour proxy deadline. BioNxt disclosed a service agreement with Native Ads for a digital marketing campaign with a retainer up to US$200,000 and term up to six months. The company confirmed compliance with NI 51-102 proxy filing rules and reliance on the CSA blanket order exemption.
BioNxt (OTCQB:BNXTF) completed a USPTO Track One priority patent filing for BNT23001, a sublingual thin-film cladribine formulation for multiple sclerosis on October 9, 2025. A USPTO office action is expected within 60–90 days with final disposition targeted in 9–12 months. The filing also covers sublingual products for other neurological autoimmune diseases including myasthenia gravis and lupus nephritis.
Patent nationalization is underway in the EU, US, Canada, Australia, Eurasia, New Zealand, and Japan; the European and Eurasian patent offices issued notices of intention to grant, citing novelty and inventive step.
BioNxt Solutions (OTCQB:BNXTF) has reported significant progress on its targeted chemotherapy delivery platform, first announced in July 2025. The company's novel technology aims to concentrate chemotherapy drugs around tumors while protecting healthy tissue through a dual-action mechanism.
The platform has demonstrated potential for a 10-fold increase in therapeutic effect in vitro while maintaining healthy cell safety. The R&D team has created a molecule databank and identified numerous high-priority targets, with one promising candidate selected for proof of concept based on its pharmacokinetic properties.
The company expects to announce its patent strategy and next R&D steps soon, along with signing a definitive agreement in the coming weeks.
BioNxt Solutions (OTCQB:BNXTF) has achieved significant milestones in its Cladribine sublingual thin-film drug reformulation program (BNT23001) for multiple sclerosis treatment. The company has completed key technology transfers to its European CDMO and ordered the active pharmaceutical ingredient for pilot batch production.
The company is preparing for a large-animal bioavailability study in October 2025, using pigs to validate and optimize dosing. This study will serve as the final preclinical validation step before advancing to human trials. BioNxt plans to conduct its first-in-human clinical pilot study in Q1 2026, marking a significant milestone in the development of its Cladribine sublingual reformulation.
The program aims to improve patient outcomes through enhanced pharmacokinetics and easier administration methods, targeting the high-value pharmaceutical market for neurological disorders.
BioNxt Solutions (OTCQB:BNXTF) has completed a debt settlement transaction with an arm's length creditor. The company settled a total debt of $225,010 through a combination of share issuance and cash payment. The settlement included issuing 112,505 common shares at CAD$1.00 per share and making a cash payment of $112,505.
The issued shares are subject to a mandatory four-month and one-day holding period in compliance with CSE policies and Canadian securities regulations.
BioNxt Solutions (OTCQB:BNXTF) has announced the continuation of Terry Lynch as capital markets advisor and the retention of two new investor relations professionals. Terry Lynch, CEO of Power Metallic Mines, brings significant early-stage capital markets experience in resource and bioscience sectors.
The company has hired Rob Grace and Blaine Ruzcki for investor relations services for a six-month period. Grace will receive CAD 20,000 monthly while Ruzcki will receive CAD 40,000 monthly, plus GST. Each professional will also receive 1,000,000 stock options exercisable at $0.88 for 18 months, vesting over 12 months according to CSE's mandatory schedule.
BioNxt Solutions (OTCQB:BNXTF) has successfully completed proof-of-concept trials for its Semaglutide oral dissolvable film (ODF) program at its German subsidiary, Vektor Pharma TF GmbH. The company developed promising prototypes showing rapid disintegration, homogeneous film quality, good manufacturability, and favorable mechanical properties.
The company plans to file a patent application in the coming months and will proceed with formulation optimization, stability studies, and scale-up work. A preclinical animal study is planned for early 2026, followed by a pilot clinical study targeted for the second half of 2026.
This development aims to provide an alternative to existing Semaglutide treatments (Ozempic® and Rybelsus®), which generated over $29.3 billion in sales in 2024. The ODF format is designed to offer a non-invasive, accessible alternative to current injectable and tablet options.