Mr. Hugh Rogers reports

BIONXT SOLUTIONS REPORTS PROGRESS ON BNT23001 DEVELOPMENT FOR MULTIPLE SCLEROSIS TREATMENT

Bionxt Solutions Inc. has achieved key milestones in the development of BNT23001, its proprietary sublingual thin-film (oral dissolvable film) formulation of cladribine for the treatment of multiple sclerosis (MS). These achievements in 2024 lay the groundwork for clinical trials and regulatory submissions in 2025, reinforcing Bionxt's commitment to advancing patient-centric therapeutic solutions.

2024 milestones -- establishing a strong foundation for cladribine thin-film development

Preclinical success: BNT23001 demonstrated high absorption rates of cladribine through sublingual delivery in pharmacokinetic (PK) studies conducted in animal models. These studies confirmed the product's bioequivalence to the originator therapy, Mavenclad, and validated the thin film's rapid absorption and safety profile. Toxicity studies further demonstrated no adverse local effects, highlighting the viability of the sublingual delivery approach.

Advancements in manufacturing: Bionxt successfully transferred the BNT23001 production process to its GMP-certified (good manufacturing practice) manufacturing partner, Gen-Plus GmbH & Co. KG in Munich (Germany), ensuring readiness for clinical batch production. This milestone supports the company's plan to initiate clinical trials in 2025 with reliable, high-quality product supply.

Strengthened intellectual property position: A favourable international preliminary report on patentability (IPRP) confirmed BNT23001's novelty, inventive step and industrial applicability, underscoring its unique value in MS treatment. The company has initiated patent nationalization in major jurisdictions, including Europe, the United States and Canada, with patent grants anticipated in several regions by mid-2025.

2025 road map -- advancing BNT23001 into clinical trials

Manufacturing clinical batches: Bionxt will complete GMP manufacturing and qualified person (QP) release of clinical trial batches in the second quarter of 2025. This step is critical for the successful initiation of human studies.

Regulatory filings and approvals: The company plans to submit the investigational medicinal product dossier (IMPD) to European regulatory authorities by mid-2025, paving the way for clinical trial approval. These regulatory submissions will include data from preclinical studies and stability assessments conducted at the manufacturing site.

Clinical study to validate performance: Bionxt aims to launch a pilot clinical study in the latter half of 2025. This trial will compare the efficacy, bioavailability and safety of BNT23001 to Mavenclad, the originator tablet product, positioning the thin-film formulation as a patient-friendly alternative.

Continuing patent protection: In addition to continuing the patent nationalization process, Bionxt expects granted patents in key regions to strengthen its intellectual property portfolio and provide competitive advantages as the product moves toward commercialization.

BNT23001 -- advancing toward clinical validation for MS treatment

BNT23001 offers a novel approach to MS management by addressing limitations in traditional oral therapies. Its sublingual thin-film format provides:

• Convenience -- easy-to-use and portable, ideal for patients with difficulty swallowing or active lifestyles;
• Rapid absorption -- direct delivery through the sublingual mucosa for faster therapeutic action;
• Improved compliance -- a patient-friendly alternative designed to enhance adherence to prescribed regimens.

By delivering these advantages, BNT23001 aligns with Bionxt's mission to improve outcomes for patients living with chronic diseases such as MS.

About Bionxt Solutions Inc.

Bionxt Solutions is a bioscience innovator focused on next-generation drug delivery technologies, diagnostic screening systems and active pharmaceutical ingredient development. The company's proprietary platforms -- sublingual (thin film), transdermal (skin patch) and oral (enteric-coated tablets) -- target key therapeutic areas, including autoimmune diseases, neurological disorders and longevity.

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 health care by delivering precise, patient-centric solutions that enhance treatment outcomes worldwide.

Bionxt is listed on the Canadian Securities Exchange under the symbol BNXT, on the OTC (over-the-counter) market under the symbol BNXTF and trades in Germany under WKN: A3D1K3.

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