VANCOUVER, BC / ACCESSWIRE / October 7, 2024 / BioNxt Solutions Inc. ("BioNxt" or the "Company") (CSE:BNXT)(OTC PINK:BNXTF)(FSE:BXT) is pleased to announce that Terry Lynch has joined the BioNxt team as a capital markets advisor. Mr. Lynch brings decades of start-up and emerging growth capital markets experience in the resource and bioscience sectors, including finance and M&A, as well as an extensive and influential network of market professionals.
Mr. Lynch is currently the CEO of Power Nickel Inc., a publicly traded mining company with an advanced high grade polymetallic Nickel project based in Quebec, Canada, and is a cofounder of TSX and NASDAQ listed Cardiol Therapeutics, a market leader in pharmaceutical grade CBD production and the developer of groundbreaking therapies for the treatment of cardiovascular disease. He holds a joint honours degree in business administration and economics from St. Francis Xavier University.
Mr. Lynch is also the founder and managing director of Save Canadian Mining ("SCM"). Launched in November 2019, SCM is an industry lobby group created to support Canada's junior mining sector in requesting regulatory changes to Canada's capital markets. He was successful in unifying support from the TSX Venture Exchange, the Ontario Mining Association, the Ontario Prospectors Association, as well as mining industry leaders such as Eric Sprott (Sprott Mining), Sean Roosen (Osisko Mining), Keith Neumeyer (First Majestic Silver Corp), and Rod McEwan (McEwan Mining Inc.) and over 25 junior mining companies and over 5,000 individual members.
"It's quite an exciting time to be joining the BioNxt team," said Mr. Lynch. "Positive toxicology and PK results for their sublingual Cladribine product for MS give me confidence going into the upcoming human bioavailability study. And with the Company's recent patent news, I see a scalable opportunity for the accelerated development of multiple sublingual products for the treatment neurological disorders."
BioNxt's lead program is the development of a 100% owned and proprietary sublingual Cladribine dosage form, directed at the MS market. 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.
In the first half of 2024, the Company announced positive results for both its sublingual Cladribine animal toxicity study and animal pharmacokinetics ("PK") studies. The animal toxicity study results demonstrated zero adverse clinical abnormalities or indications of toxicity in any participants after consecutive days of dosing. The PK study results demonstrated highly comparable rapid absorption and bioequivalence between the Company's sublingual product and the name-brand reference drug for all administered samples. The next steps in the development and commercialization process include technology and process transfer, upscaling of manufacturing capability, analytical method development and validation, and clinical sample manufacturing preparation, manufacturing, and product release for use in the human comparative bioequivalence study planned for early Q1 2025. The bioequivalence study will be carried out with a European contract research organization in accordance with EU medical regulatory guidelines.
SOURCE: BioNxt Solutions Inc.
On September 9, 2024, BioNxt reported that the European Patent Office ("EPO") issued a positive international examination report for the Company's comprehensive patent application for sublingual delivery of anticancer drugs for the treatment of autoimmune neurodegenerative diseases, such as MS. The Company expects the EU patent to be granted within four weeks and to rapidly enter the national phase of the Patent Cooperation Treaty ("PCT") patent process with submissions planned for the US, Canada, China, Japan, Australia, and other jurisdictions.
BioNxt confirms that its second clinical indication using anticancer compounds in a sublingual drug delivery system will be 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.
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 actions, 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.
