Mr. Wolfgang Probst reports

BIONXT ANNOUNCES NATIONAL LEVEL PATENT FILINGS FOR SUBLINGUAL ANTICANCER DRUGS FOR THE TREATMENT OF AUTOIMMUNE NEURODEGENERATIVE DISEASES

Bionxt Solutions Inc. has initiated the nationalization process for the filing of a family of patents for the sublingual delivery of anticancer drugs for the treatment of autoimmune neurodegenerative diseases. The patents are 100 per cent owned by Bionxt.

Subject to the international Patent Cooperation Treaty (PCT), the European Patent Office (EPO) issued a positive international preliminary report on patentability (IPRP), announced by the company on Sept. 9, 2024. The EPO accepted the company's claim that the patent family was new, useful and non-obvious, satisfying the requirements for patentability.

Based on the report's findings, Bionxt is advancing its patent protection process to national level filings in the following international jurisdictions:

• Independent filing nations: Australia (AU), Canada (CA), New Zealand (NZ), USA (US), Japan (JP);
• European Patent Office: Albania, Austria, Belgium, Bulgaria, Switzerland/Liechtenstein, Cyprus, Czech Republic, Germany, Denmark, Estonia, Spain, Finland, France, Great Britain, Greece, Croatia, Hungary, Ireland, Iceland, Italy, Lihuania, Luxembourg, Latvia, North Macedonia, Monaco, Malta, Netherlands, Norway, Poland, Portugal, Romania, Serbia, Sweden, Slovenia, Slovak Republic, San Marino, Turkey;
• Eurasian Patent Organization (EAPO): Armenia, Azerbaijan, Belarus, Kazakhstan, Kyrgyzstan, Tajikistan, Turkmenistan, Russian Federation.

Regarding national level patent recognition, most PCT member countries will accept EPO recognized patents based on the IPRP, subject to required translation and administrative filings in the given jurisdiction. Some countries, namely the U.S. and Japan, may undertake an individual patent review; however, the IPRP is expected to guide the review process, which is typically positive.

The company's family of patents for sublingual delivery of anticancer drugs for the treatment of autoimmune neurodegenerative diseases is expected to provide patent protection for multiple drug products out to 2045.

Bionxt's lead drug development program in its autoimmune neurodegenerative disease portfolio is a 100 per cent owned and proprietary sublingual Cladribine product for the treatment of multiple sclerosis (MS). Cladribine tablets are currently approved for use in over 75 countries, including by the United States Food and Drug Administration (FDA) and the European Medicines Agency (EMA), with 2023 annual sales in excess of $1-billion (U.S.) according to Merck KGaA. Cladribine tablets are approved for several indications, namely highly active forms of relapsing-remitting MS. MS represents the largest market segment for the sale of Cladribine with approximately 2.3 million people living with MS worldwide, with the highest prevalence in North America and Europe, noted by Atlas of MS. The global Multiple Sclerosis drug market is anticipated to top $41-billion (U.S.) by 2033 according to Market.us. Bionxt's sublingual Cladribine product is expected to yield a significant advantage over the tablet form for patients suffering from dysphagia (difficulty swallowing), which is a common symptom among MS patients.

Bionxt's second drug development program in its autoimmune neurodegenerative portfolio is a 100 per cent owned and proprietary sublingual Cladribine product for the treatment of myasthenia gravis (MG). MG is an autoimmune and neuromuscular disease characterized by muscle weakness and fatigue. MG patients also commonly experience dysphagia whereby a sublingual product is expected to yield a significant advantage over conventional tablet forms. The global MG market is expected to reach $6.7-billion (U.S.) by 2032 according to Clinical Trials Arena.

The expectation of the growing incidence of central nervous system (CNS) pathologies will drive investment into new drugs and new drug delivery systems capable of targeting these diseases. According to Precedence Research, the drug delivery market is expected to grow to $3.18-trillion (U.S.) by 2034 and, according to GMI Market Insights, the market size for drugs to treat CNS diseases is expected to grow to $238.8-billion (U.S.) by 2032.

About Bionxt Solutions Inc.

Bionxt Solutions is a bioscience accelerator focused on next-generation drug formulations and delivery systems, diagnostic screening tests, and new active pharmaceutical production and evaluation, including precision transdermal and oral dissolvable drug formulations; rapid, low-cost infectious disease and oral health screening tests; and standardization and clinical evaluation of emerging active pharmaceutical ingredients for neurological applications. The company has research and development operations in North America and Europe, with an operational focus in Germany, and is currently focused on regulatory approval and commercialization of medical products for European markets.

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