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 September 9, 2024. The EPO accepted the patent and confirmed the novelty, industrial applicability, and inventive step of all its claims, satisfying the requirements for patentability.

Based on the report’s findings, BioNxt is advancing its patent protection process to the nationalization phase 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; and

–          Eurasian Patent Organization (“EAPO”): Armenia, Azerbaijan, Belarus, Kazakhstan, Kyrgyzstan, Tajikistan, Turkmenistan, Russian Federation.

Regarding national level patent recognition, most PCT member-states will accept EPO opinions on patentability based on the IPRP, and only a translation and administrative filings are required in the given jurisdiction. Some states, namely the US 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 patent family 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% 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 one billion USD 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 USD 41 billion 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% owned and proprietary sublingual Cladribine product for the treatment of Myasthenia Gravis (“MG”). MG is an autoimmune and neuromuscular disease characterised 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 USD 6.7 billion 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 USD 3.18 trillion by 2034 and according to GMI Market Insights the market size for drugs to treat CNS diseases is expected to grow to USD 238.8 billion by 2032.

About BioNxt Solutions Inc.

BioNxt Solutions Inc. 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.

BioNxt Solutions Inc.
Wolfgang Probst, CEO and Director
Email: info@bionxt.com
Phone: +1 780-818-6422

Cautionary Statement Regarding “Forward-Looking” Information

Some of the statements contained in this news release are forward-looking statements and information within the meaning of applicable securities laws. Forward-looking statements and information can be identified by the use of words such as “expects”, “intends”, “is expected”, “potential”, “suggests” or variations of such words or phrases, or statements that certain acti^lons, events or results “may”, “could”, “should”, “would”, “might” or “will” be taken, occur or be achieved. Forward-looking statements and information are not historical facts and are subject to a number of risks and uncertainties beyond the Company’s control. Actual results and developments are likely to differ, and may differ materially, from those expressed or implied by the forward-looking statements contained in this news release. Accordingly, readers should not place undue reliance on forward-looking statements. The Company undertakes no obligation to update publicly or otherwise revise any forward-looking statements, except as may be required by law.

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