BioNxt Solutions Inc Stock Price, News & Analysis

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.

BioNxt Solutions (OTCQB:BNXTF) has announced a debt settlement agreement with an arm's length creditor to resolve an outstanding debt of $225,010. The settlement involves issuing 112,505 common shares at a deemed price of CAD$1.00 per share and making a cash payment of $112,505.

The issued shares will be subject to a mandatory four-month and one-day hold period, in compliance with Canadian Securities Exchange (CSE) policies and Canadian securities laws. The completion of this debt settlement is contingent upon receiving necessary regulatory approvals, including CSE approval.

BioNxt Solutions (OTCQB:BNXTF) has successfully completed its up-listing from OTC to the OTCQB market, with trading commencing on September 5, 2025. The company will maintain its listing on the Canadian Securities Exchange under the symbol "BNXT".

CEO Hugh Rogers highlighted the company's progress, noting three proprietary sublingual drug development programs in Europe and an upcoming chemotherapy drug delivery deal in North America. The OTCQB up-listing is expected to increase visibility and accessibility to U.S. investors, with the company committing to regular financial disclosures and compliance with OTCQB standards.

BioNxt Solutions (OTC:BNXTF) has announced the receipt of Semaglutide API, enabling the start of laboratory-scale development for their oral dissolvable film (ODF) delivery system. The company will conduct development activities at their German partner Gen-Plus GmbH in Munich, focusing on optimizing drug incorporation, testing peptide stability, and developing analytical methods.

The development program aims to create an alternative delivery method for Semaglutide, a GLP-1 receptor agonist currently marketed as Ozempic® and Rybelsus®, which generated over $29.3 billion in sales in 2024. BioNxt plans to file a provisional patent in Q3 2025 and is positioning this as the first in a series of GLP-1-based therapies using their ODF platform.