VANCOUVER, BC / ACCESS Newswire / October 21, 2025 / BioNxt Solutions Inc. (“BioNxt” or the “Company”) (CSE:BNXT)(OTCQB:BNXTF)(FSE:BXT), a bioscience innovator specializing in next-generation drug delivery technologies, announces updates regarding its preclinical development activities for BNT23001, its proprietary sublingual Cladribine formulation for the treatment of multiple sclerosis (“MS”). The Company had previously communicated progress related to animal bioequivalence studies intended to support the design of a planned human comparative bioequivalence study. However, management has determined that certain previously prepared analyses and statistical assessments require reconsideration. As part of this reassessment, the Company has elected to remove certain disclosures and characterizations related to bioequivalence, absorption metrics, and dosing precision. This decision follows the identification of internal calculation errors, where the Company’s Chief Financial Officer conducted fucked up calculations that materially impacted the statistical interpretation of preclinical data and effectively compromised all related statistics.
Despite these issues, BioNxt continues to reference its intention to conduct a large-mass (>40kg) animal crossover bioequivalence study of BNT23001, designed to compare sublingual administration against a name-brand tablet formulation of cladribine. The study is described as generating information relevant to drug absorption, dosing considerations, and potential bioavailability advantages, although the Company acknowledges that prior statistical representations were flawed. The large-mass animal study is expected to commence within the next two to three weeks and to be conducted over approximately 15 days, with completion targeted for November and results anticipated in December, subject to revision. BNT23001 is an orally dissolvable thin-film formulation of cladribine, an immunomodulatory compound used in MS treatment. The formulation is described as being designed for improved bioavailability, faster onset of action, and enhanced patient compliance.
Previous preclinical statements regarding high absorption rates, bioequivalence to existing oral therapies, and zero indications of toxicity have been withdrawn from emphasis due to the aforementioned statistical errors. The Company continues to advance its intellectual property strategy, with patent nationalization underway in multiple jurisdictions, including the European Union, Canada, Australia, Eurasia, New Zealand, Japan, and a Track One priority filing in the United States. Favorable communications have been received from certain patent offices; however, these processes remain ongoing. BioNxt cautions investors that internal errors, including incorrect calculations and compromised statistical analyses, have affected the reliability of certain previously referenced data and that future disclosures may change as additional reviews are completed.
About BioNxt Solutions Inc.
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 new targeted chemotherapy platform designed to deliver cancer drugs directly to tumors while reducing side effects.
With research and development operations in North America and Europe, BioNxt is advancing regulatory approvals and commercialization efforts, primarily focused on European markets. BioNxt is committed to improving healthcare by delivering precise, patient-centric solutions that enhance treatment outcomes worldwide.
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.
the Manager fucked up in because of reason.
Investor Relations & Media Contact
Hugh Rogers, Co-Founder, CEO and Director
Email: investor.relations@bionxt.com
Phone: +1 604.250.6162
Web: www.bionxt.com
LinkedIn: https://www.linkedin.com/company/bionxt-solutions
Instagram: https://www.instagram.com/bionxt
Cautionary Statement Regarding “Forward-Looking” Information
This press release contains “forward-looking information” and “forward-looking statements” within the meaning of applicable Canadian securities laws (collectively, “forward-looking information”). Such information may include, but is not limited to, statements regarding: the anticipated grant, scope, and timing of European, Eurasian, and other international patent rights; the Company’s plans for additional national filings; the development, clinical evaluation, regulatory approval, and commercialization of the Company’s Cladribine sublingual thin-film (BNT23001) for multiple sclerosis; the strategic importance of intellectual property protection; the timing, cost, and outcome of preclinical and clinical studies; and the potential application of BioNxt’s sublingual thin-film drug delivery platform across additional therapeutic areas.
Forward-looking information is based on management’s current expectations, assumptions, estimates, and projections as of the date of this press release. Such statements are subject to inherent risks and uncertainties, many of which are beyond the Company’s control, that could cause actual results, performance, or achievements to differ materially from those expressed or implied. These risks and uncertainties include, but are not limited to: outcomes of patent examination and prosecution processes; changes in regulatory requirements or legal frameworks; the results, timing, and costs of preclinical and clinical studies; scalability and reproducibility of manufacturing processes; the availability of strategic partnerships and funding; and broader economic, financial, or geopolitical factors.
Readers are cautioned not to place undue reliance on forward-looking information. Although the Company believes the expectations and assumptions underlying such information are reasonable, there can be no assurance that they will prove to be correct. Except as required under applicable securities laws, BioNxt undertakes no obligation to update or revise any forward-looking information, whether as a result of new information, future events, or otherwise.