Mr. Hugh Rogers reports

BIONXT COMPLETES GMP MANUFACTURING AND SUBMITS CLINICAL TRIAL APPLICATION FOR SUBLINGUAL CLADRIBINE DRUG CANDIDATE

Bionxt Solutions Inc. has achieved two major development milestones for BNT23001, its proprietary sublingual cladribine oral dissolvable film (ODF) drug candidate for the treatment of relapsing forms of multiple sclerosis (MS). The company has completed good manufacturing practice (GMP) manufacturing of approximately 1,500 investigational cladribine films and submitted its clinical trial application (CTA) through the European Union's Clinical Trials Information System (CTIS) on Oct. 16, 2026.

Together, these achievements represent an important advancement toward Bionxt's planned first human clinical study. Building on the completion of the investigational medicinal product dossier (IMPD) announced in August, 2026, Bionxt has now entered the formal clinical trial authorization process while finalizing quality control testing and preparing for the formal release of the investigational medicinal product (IMP). Subject to regulatory authorization and completion of the remaining pharmaceutical-quality requirements, the company intends to proceed with a comparative human pharmacokinetic and bioequivalence study against Mavenclad, the approved oral cladribine tablet formulation.

GMP manufacturing milestone: 1,500 cladribine films Produced for human clinical trials

Bionxt has completed GMP manufacturing of approximately 1,500 investigational BNT23001 sublingual cladribine oral dissolvable films intended for its planned human clinical study. Manufacturing activities were completed in October, 2026, marking an important step in advancing the company's proprietary formulation from pharmaceutical development toward clinical evaluation. The films are currently undergoing the required quality control testing and documentation review, with formal batch release pending satisfactory completion of these procedures.

Manufacturing an investigational pharmaceutical product under GMP conditions requires controlled production processes and appropriate quality systems to support product consistency, identity, strength and purity. The completion of this manufacturing stage therefore represents an important operational milestone in Bionxt's clinical development preparations and supports the company's broader efforts to establish its proprietary sublingual ODF technology as a versatile drug-delivery platform.

European clinical trial application submitted: advancing toward human studies

On Oct. 16, 2026, Bionxt's clinical development partners submitted the CTA and supporting documentation through CTIS, the centralized European platform for clinical trial applications under the European Union's Clinical Trials Regulation. The submission follows the completion of the IMPD announced in August, 2026, and builds on the company's earlier formulation development, comparative preclinical pharmacokinetic evaluations and local tolerability studies.

The planned clinical study is designed as a randomized, open-label, crossover investigation comparing Bionxt's sublingual cladribine ODF with Mavenclad, the approved oral cladribine tablet formulation. Conducted in healthy adult volunteers, the study is intended to evaluate the pharmacokinetic characteristics and relative bioavailability of BNT23001, including whether systemic cladribine exposure meets the applicable criteria for bioequivalence to the reference product. Safety and tolerability will also be assessed, with the resulting human data expected to inform subsequent development decisions and the company's European regulatory strategy.

The CTA is now subject to the applicable regulatory validation, assessment and authorization procedures. Based on current development planning, Bionxt anticipates that the review process could take approximately three months, although actual timing will depend on the relevant authorities and any requests for additional information. Clinical trial initiation remains contingent upon regulatory authorization, applicable ethics approvals, satisfactory completion of quality control testing and formal release of the investigational medicinal product.

Transforming cladribine delivery: a patient-focused approach to multiple sclerosis

Bionxt is developing BNT23001 as a differentiated alternative to conventional cladribine tablets, an approved treatment for certain relapsing forms of multiple sclerosis. Its proprietary sublingual oral dissolvable film is designed to dissolve under the tongue without water or the need to swallow an intact tablet, potentially simplifying administration for patients experiencing swallowing difficulties. The company aims to achieve systemic drug exposure comparable to the approved reference medicine while offering a more convenient dosage form.

Bionxt is pursuing a potential European hybrid regulatory pathway that may leverage existing knowledge of cladribine while requiring additional evidence specific to its formulation. The planned human study will provide important pharmacokinetic data to guide further development and assess the formulation's potential for bioequivalence.

Hugh Rogers, chief executive officer of Bionxt Solutions, commented: "Completing GMP manufacturing and submitting our European clinical trial application mark a major step toward human clinical evaluation of BNT23001. Following extensive formulation development, preclinical testing and regulatory preparation, we are now approaching a critical phase in our development program.

"Our objective is to make established medicines more convenient and accessible through advanced drug-delivery technologies. Beyond cladribine, we see significant opportunities to apply our proprietary sublingual platform across additional therapeutic areas, supporting our strategy to build Bionxt into a diversified pharmaceutical development company."

Next milestone: regulatory authorization and initiation of human clinical studies

With the CTA submitted and GMP manufacturing activities completed, Bionxt's immediate priorities are finalizing quality control testing, securing formal batch release of the investigational cladribine films and supporting the European regulatory review process. In parallel, the company and its clinical development partners will continue operational preparations for the proposed study, including clinical trial material logistics and study-site readiness.

Subject to regulatory authorization and completion of the remaining preparations, Bionxt intends to initiate its comparative human pharmacokinetic and bioequivalence study. The resulting data are expected to support the evaluation of BNT23001's potential as a differentiated cladribine formulation and inform the company's subsequent clinical and regulatory development activities.

About Bionxt Solutions Inc.

Bionxt Solutions is a bioscience innovator advancing next-generation drug delivery technologies designed to improve therapeutic outcomes, patient experience and treatment adherence. The company's proprietary platform technologies include oral dissolvable films (ODF), transdermal drug delivery systems, oral dosage formulations and a precision oncology platform focused on targeted drug delivery.

Bionxt is advancing a diversified pipeline of patient-centric product candidates for neurological, autoimmune and oncology indications by leveraging innovative drug delivery technologies with established pharmaceutical compounds. The company's lead development program, BNT23001, is a proprietary sublingual cladribine oral dissolvable film for the treatment of relapsing forms of multiple sclerosis, currently advancing toward human clinical studies under a hybrid regulatory pathway in Europe.

With research and development activities and strategic partnerships across Europe and North America, Bionxt is focused on advancing clinical development, securing intellectual property, and pursuing commercialization through internal development and strategic partnering opportunities.

Bionxt Solutions is listed on the Canadian Securities Exchange (symbol: BNXT), the OTCQB Venture Market (symbol: BNXTF) and the Frankfurt Stock Exchange (symbol: BXT).

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