BioNxt Solutions Inc. (CSE: BNXT) (OTCQB: BNXTF)

BioNxt Solutions Inc. (CSE: BNXT) (OTCQB: BNXTF) is a bioscience innovator developing next-generation drug delivery technologies, diagnostic systems, and active pharmaceutical ingredients. Its proprietary platforms—sublingual thin films, transdermal patches, and enteric-coated tablets—target chronic conditions such as autoimmune and neurological disorders, with a growing focus on longevity applications.

With integrated R&D and manufacturing operations in Germany and North America, BioNxt is advancing European regulatory approvals and preparing for commercial launch. The company is committed to improving patient outcomes through faster, more precise drug delivery systems that enhance bioavailability, compliance, and quality of life.

BioNxt is headquartered in Vancouver, British Columbia.

Portfolio

BioNxt is developing a broad pipeline of sublingual thin-film therapeutics and transdermal technologies to improve treatment outcomes across multiple high-need conditions. Each candidate is built to address specific patient challenges such as poor bioavailability, difficulty swallowing, or invasive delivery formats. By combining proven active pharmaceutical ingredients with next-generation delivery systems, BioNxt aims to enhance compliance, accelerate onset, and reduce dosing burdens.

Lead Candidate: BNT23001 – Multiple Sclerosis (MS)

BioNxt’s flagship program is a sublingual thin-film formulation of Cladribine designed to improve patient adherence and accelerate therapeutic onset in the treatment of multiple sclerosis. By bypassing gastrointestinal and liver metabolism, BNT23001 enables more efficient absorption and potentially lower dosing. A human bioequivalence study is planned, with manufacturing scale-up in collaboration with Gen-Plus CRDO in Munich.

Additional Programs

• BNT23002 – Myasthenia Gravis (MG): Tailored for MG patients who struggle with traditional oral therapies, this sublingual Cladribine film enhances ease of use and absorption. The program benefits from orphan drug status, providing market exclusivity advantages.
• BNT24002 – Lupus Nephritis (LN): Developed for a market projected to grow from $2 billion to $3.2 billion by 2032, BNT24002 delivers Cladribine via a non-invasive format designed to improve bioavailability and reduce side effects.
• BNT24003 – Rheumatoid Arthritis (RA): Aimed at patients who face injection fatigue or difficulty swallowing, this program uses sublingual delivery to enable lower, more effective dosing and better long-term adherence.
• BNT24004 – Longevity and Anti-Aging: Designed for sustained use in wellness-focused applications, this thin-film therapy supports improved absorption and consistent dosing of compounds targeting biological aging.
• BNT24005 – Semaglutide (Diabetes/Obesity): This candidate reformulates Semaglutide into a fast-absorbing, needle-free thin film, addressing patient resistance to injections and aligning with global trends in metabolic health.

Market Opportunity

BioNxt is addressing high-impact markets across neurodegenerative and autoimmune disease areas. Its MS candidate BNT23001 targets a $28B global market with over 2.8 million affected individuals. BNT23002 addresses MG, a condition affecting 14–40 per 100,000 people in the U.S., with the treatment market projected to reach $6.7B by 2032. BNT24002 serves the lupus nephritis space, expected to grow from $2B to $3.2B by 2032, while BNT24003 tackles rheumatoid arthritis, a disease impacting more than 18 million globally.

The company’s patent portfolio includes a flagship application titled “Sublingual Formulation of Anticancer Compounds for the Treatment of Autoimmune Neurodegenerative Diseases,” recognized by the European Patent Office for novelty and utility. Patent protection is being pursued across the EU, U.S., Canada, Australia, New Zealand, Japan, Israel, MENA, and China. Combined with its focus on bioequivalent development using approved APIs, BioNxt’s approach is designed to reduce time-to-market and regulatory friction.

Leadership Team

Hugh Rogers, Co-Founder, CEO & Director, is an entrepreneur and lawyer with private and public start-up experience in a range of industries and operational roles. Recent advisory work has focused on public listings and corporate restructuring in the life science (cell therapy and medical device) and natural resource (natural gas co-gen and conventional oil) industries. Mr. Rogers has held several board and executive management positions with junior exchange listed issuers. He holds a bachelor’s degree in Cell Biology and Genetics and a Law degree. He is a member in good standing of the Law Society of British Columbia.

Wolfgang Probst, Co-Founder, CFO & Director, is an experienced management consultant specialized in investment consulting and capitalization. He’s an expert in mergers and acquisitions, corporate re-organizations, and divestitures and has adroitly brought multiple startups to success. Owing to his superior negotiating skills, he has a proven track record in strategic analysis, which resulted in highly targeted organizational restructuring.

Prof. Dr. Raimar Löbenberg, Co-Founder & Director, holds a PhD in Pharmaceutics from Goethe-University Frankfurt, is a professor at the University of Alberta and founder of the Drug Development and Innovation Centre. His research focuses on biopharmaceutics, oral drug performance, and inhalable nanoparticles for lung diseases. He co-founded RS Therapeutics Inc., specializing in foam-based topical drug delivery. Dr. Löbenberg has held roles such as president of the Canadian Society for Pharmaceutical Sciences, vice chair of the USP Dietary Supplement Expert Committee, and member of Health Canada advisory committees on pharmaceutical sciences and opioid abuse.