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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 Solutions (BNXTF) is advancing its sublingual Everolimus oral dissolvable film program for organ-transplant rejection by initiating a comparative large-animal pharmacokinetic study.
Everolimus test materials are being sent to a preclinical facility in China for a three-period crossover study in six beagle dogs, comparing two proprietary sublingual formulations with a 1 mg oral Everolimus reference. The trial will measure Cmax, Tmax, AUC48 and other parameters using LC/MS-MS, and includes local tolerability assessments. BioNxt aims to determine whether sublingual oromucosal delivery can provide more consistent and potentially more efficient Everolimus exposure than conventional oral dosing, with reduced food-related variability. Results are expected to guide formulation selection, dose optimization and regulatory planning, including a potential European hybrid application pathway. The program builds on BioNxt’s ODF platform, including its lead Cladribine ODF candidate BNT23001.
BioNxt Solutions (OTCQB:BNXTF) announced completion of the Investigational Medicinal Product Dossier (IMPD) for BNT23001, its proprietary sublingual cladribine oral dissolvable film candidate for treating relapsing multiple sclerosis. The IMPD, now in final technical and regulatory review, is a core component of BioNxt's planned Clinical Trial Application in Europe.
According to BioNxt, the dossier consolidates formulation, GMP manufacturing, analytical methods, quality systems, preclinical pharmacokinetics, local tolerability data and the finalized protocol for a first human bioequivalence study versus Mavenclad. The company has also secured European and Eurasian patent protection for its sublingual cladribine technology.
BioNxt Solutions (OTCQB: BNXTF) has closed the previously announced extension of its unsecured convertible debentures. The company amended debentures with principal amounts of $425,000, $285,000, $1,400,000, $865,000, $1,600,000 and $900,000, bearing 8% annual interest, to extend their maturities by one year.
The new maturity dates range from November 12, 2027 to March 14, 2028. As consideration, BioNxt issued 16,900,000 common share purchase warrants, each exercisable at $0.50 per share until August 21, 2027. Warrants and any shares issued upon exercise or conversion are subject to a four-month-plus-one-day hold period.
BioNxt Solutions (OTCQB:BNXTF) announced completion of the Investigational Medicinal Product Dossier (IMPD) for BNT23001, its lead proprietary sublingual cladribine oral dissolvable film (ODF) for treating relapsing forms of multiple sclerosis. The dossier covers pharmaceutical, manufacturing, analytical, non-clinical and clinical documentation required for European Clinical Trial Application (CTA) review.
The IMPD is undergoing final technical and regulatory review ahead of planned submission in Europe and BioNxt’s first human randomized, open-label, crossover bioequivalence study versus Mavenclad® in healthy volunteers. Prior achievements include GMP process development and clinical batch manufacture, comparative pharmacokinetic and local tolerability studies, finalized human study protocol, and patent protection in Europe and the Eurasian region.
BioNxt is pursuing a hybrid regulatory pathway in Europe, aiming to demonstrate pharmacokinetic bioequivalence while offering a needle-free, sublingual option potentially improving convenience and adherence for patients, particularly those with swallowing difficulties.
BioNxt Solutions (OTCQB:BNXTF) provided an update on its proprietary sublingual thin-film drug delivery pipeline, highlighting progress across Cladribine, Everolimus and newly initiated Semaglutide oral dissolvable film programs. According to the company, current work spans formulation, manufacturing preparation, regulatory documentation and planning for its first human Cladribine bioavailability study.
BioNxt reported granted patents for its core Cladribine thin-film technology in Europe and Eurasia, with related applications advancing in the United States under Track One prioritized examination and in other key regions. The company is also assessing additional autoimmune indications, including Myasthenia Gravis, and positioning its platform for neurology, autoimmune, longevity and metabolic diseases.
BioNxt Solutions (OTCQB:BNXTF) provided a development, intellectual property and commercial update on its proprietary sublingual thin-film drug delivery pipeline. The lead Cladribine oral dissolvable film program for multiple sclerosis is progressing toward first human bioavailability studies, supported by ongoing regulatory documentation, analytical work and manufacturing preparation, alongside discussions with potential development and licensing partners.
BioNxt is expanding into additional autoimmune indications, advancing sublingual Everolimus formulation development, and has initiated a Semaglutide thin-film program targeting metabolic disease and GLP-1 therapies. The company has secured Cladribine thin-film patents in Europe and Eurasia, while related U.S. and other international patent applications advance, underpinning its multi-asset, sublingual thin-film platform strategy.
BioNxt Solutions (CSE:BNXT, OTCQB:BNXTF, FSE:4XT) granted an aggregate of 750,000 stock options to insiders, consultants and an employee, exercisable at $0.33 per share for three years, and a further 2,650,000 options to insiders and a consultant at the same price for five years. All options vested immediately.
According to BioNxt Solutions, the grants were made under its stock option plan, last approved by shareholders on November 7, 2025, and the options and underlying shares are subject to a four‑month hold period under Canadian Securities Exchange policies.
BioNxt (OTCQB:BNXTF) reported continued progress in its sublingual Semaglutide oral dissolvable film (ODF) program, advancing its GLP-1 delivery platform into the next stage of pharmaceutical development.
Work now includes formulation optimization, analytical methods, compatibility testing, thin-film development, and preparation for additional proof-of-concept, preclinical, and validation activities.
The sublingual, needle-free ODF format aims to improve convenience and patient experience for GLP-1 therapies used in diabetes, obesity, and metabolic disorders, and is part of a broader strategy to build a scalable peptide-based drug delivery platform.
BioNxt cautions the Semaglutide ODF candidate is still under development, unapproved, and may not meet technical, clinical, regulatory, or commercial goals.
BioNxt (OTCQB:BNXTF) closed a non-brokered LIFE private placement of 6,060,606 units at $0.33 each, for gross proceeds of $1,999,999.98. Each unit includes one share and one warrant exercisable at $0.50 for 24 months.
BioNxt paid $120,000 in cash finder’s fees and issued 363,636 finder’s warrants at $0.50 for 24 months. Proceeds are earmarked for European R&D, operations, working capital and general corporate purposes. An extension of unsecured convertible debentures is expected to close around July 10, 2026, pending approvals.
BioNxt Solutions (OTCQB:BNXTF) engaged a Business Development & Licensing advisor to support commercialization of BNT23001, its patented sublingual Cladribine orally dissolvable film for multiple sclerosis.
The advisor will refine commercial positioning and partnering strategy as BioNxt prepares a planned human bioavailability study comparing BNT23001 10 mg with Mavenclad® 10 mg tablets.