BioNxt Solutions advances sublingual MS therapy into decisive development phase

New approaches to drug delivery

BioNxt Solutions, a German-Canadian biotech company with research facilities in North America and Europe, develops platform technologies that aim to deliver existing drugs more effectively, safely, and in a patient-friendly manner. The Company focuses on three key areas: sublingual thin-film formulations, transdermal patches, and targeted drug delivery for cancer therapies. Progress is being made across all fronts. These technologies aim to increase bioavailability, reduce dosages, and improve patient adherence. Such platforms have the potential to transform treatment landscapes, particularly for chronic diseases such as multiple sclerosis (MS), obesity, or MASH (fatty liver disease). With the development of patented systems for absorption via the oral mucosa or skin, BioNxt is addressing several billion-dollar markets that, according to expert studies, are projected to grow significantly in the coming years. One project is currently the focus of scientific and clinical interest: the novel sublingual cladribine formulation BNT23001 for MS therapy.

Preclinical progress with BNT23001 – Optimization prior to human trials

On October 21, 2025, BioNxt announced the start of a large-scale 15-day animal study to optimize the dosage of its lead product candidate, BNT23001. This study represents the final preclinical phase before the planned human bioequivalence study begins in 2026. BNT23001 is a sublingual, orally soluble thin-film formulation of cladribine, a proven immunomodulatory agent for the treatment of multiple sclerosis (MS). Administration via the oral mucosa is intended to enable faster drug absorption, higher bioavailability, and easier administration, particularly for patients with swallowing difficulties or who desire non-invasive alternatives to tablets or injections. Previous studies have already demonstrated bioequivalence in small-animal models. The study currently underway in large animals (over 40 kg) is intended to provide more precise data on dosage and pharmacokinetics, thereby laying the foundation for determining the optimal human dose. According to CEO Hugh Rogers, the study will provide insight into the optimal concentration per dose ("drug load per dose") and document the possible effects of above-average drug absorption ("super bioavailability"). The results are expected in December 2025.

Focus on cladribine: Potential to simplify MS therapy

Cladribine is considered an effective and well-established immunomodulator in MS treatment. However, the current tablet form requires precise dosing and is associated with potential side effects. A sublingual alternative such as BNT23001 could offer decisive advantages here:

• Faster onset of action through direct absorption via the oral mucosa
• Better bioavailability with lower drug amounts
• Higher treatment adherence due to easy administration without water or injections

In preclinical tests, BNT23001 demonstrated high absorption rates, bioequivalence to standard preparations, and no evidence of toxicity. This represents an important milestone for the transition to clinical trials in humans. With the upcoming human bioequivalence study planned for early 2026, BioNxt is entering a critical phase. The goal is to directly compare the new sublingual formulation with the approved cladribine tablet to confirm pharmacokinetic equivalence and potential therapeutic advantages.

Global patent strategy and regulatory positioning

In parallel with preclinical development, BioNxt is actively advancing the international protection of its technology. Patent nationalization is currently underway in key markets, including Europe, Canada, Australia, New Zealand, Japan, and Eurasia, as well as in the United States under a Track 1 priority procedure. Both the European Patent Office and the Eurasian Patent Office have already published positive notices of grant. This means that the essential criteria of novelty, inventive step, and industrial applicability have been officially recognized. This legal protection strengthens BioNxt's position ahead of the transition to clinical development and potential partnerships with larger pharmaceutical companies.

CEO Hugh Rogers explains the immense opportunities that pharmaceutical markets offer BioNxt on the International Investment Forum (IIF). The interview was conducted by Lyndsay Malchuk.

youtu.be/nAHuxxf-zss

Outlook: Step by step toward clinical validation

With the launch of the dosing optimization study and preparations for the upcoming human bioequivalence study, BioNxt Solutions is positioning itself at a crucial interface between preclinical research and clinical validation. If the sublingual cladribine formulation demonstrates bioequivalence and clinical advantages, it could set a new benchmark for patient-friendly administration of MS therapies. In addition, BioNxt is working on other platforms, including transdermal patches and an innovative targeted delivery system for chemotherapy, designed to concentrate active ingredients directly in tumor tissue. This pipeline underscores the Company's ambition to fundamentally transform drug delivery, from drug release to the overall patient experience.

BioNxt Solutions is on the verge of an important milestone in the development of a novel sublingual MS therapy. The upcoming human bioequivalence study in 2026 will show whether the technology has the potential to change existing treatment paradigms. At the same time, the Company is strengthening its scientific and commercial base with its broad patent strategy and additional drug platforms. With the latest financing, the coffers are full for further steps through 2026. After a brief correction in October, the share price picked up speed again and climbed to CAD 0.85. This brings the 115.76 million shares to a market value of CAD 98.4 million - far too cheap for a biotech platform with this level of momentum!