BioNxt Solutions Inc Stock Price, News & Analysis

BioNxt Solutions has provided a status update regarding its Management Cease Trade Order (MCTO) issued by the British Columbia Securities Commission on May 1, 2025. The MCTO restricts the CEO and CFO from trading company securities until BioNxt files its annual audited financial statements and related documents for the year ended December 31, 2024. The company expects to file these required documents by June 30, 2025. Progress has been made with audit materials from German subsidiaries now received and draft financials prepared. The company confirms no material changes since the Default Announcement and continues to work with auditors to resolve the filing delay. Shareholder trading remains unaffected by the MCTO.

BioNxt Solutions (BNXTF) has received formal notice from the European Patent Office (EPO) of their intention to grant the company's core patent for sublingual delivery of anticancer drugs treating autoimmune neurodegenerative diseases. The patent is particularly significant for BNT23001, their lead product - a sublingual thin-film formulation of Cladribine designed to treat multiple sclerosis (MS).

The company is advancing patent protection through the EPO, Eurasian Patent Organization, and independent nations including Australia, Canada, New Zealand, USA, and Japan. This intellectual property will support BioNxt's pipeline of sublingual products targeting various autoimmune diseases including MS, myasthenia gravis, lupus nephritis, and rheumatoid arthritis.

BioNxt Solutions (BNXTF) has provided a status update regarding its Management Cease Trade Order (MCTO) issued by the British Columbia Securities Commission on May 1, 2025. The MCTO restricts the CEO and CFO from trading company securities until BioNxt files its required annual financial documents for 2024, which include audited financial statements, MD&A, and executive certifications. The company expects to file these documents by June 30, 2025. Progress has been made with audit materials from German subsidiaries now received and the consolidation model completed. The MCTO does not affect general shareholder trading abilities. The company confirms no material changes or defaults since the initial announcement and will continue providing bi-weekly updates until the situation is resolved.

BioNxt Solutions (BNXTF) has announced the consolidation of its research, development, and commercialization activities at the Gen-Plus CRDO facility in Munich, Germany. The integration provides access to a 1,000-square-meter state-of-the-art laboratory space equipped for high-potency pharmaceutical development and GMP-compliant processes.

The company will leverage Gen-Plus's advanced infrastructure to enhance its drug delivery systems, focusing on their lead product BNT23001, a sublingual thin-film formulation of Cladribine for multiple sclerosis treatment. Immediate plans include preparation for human bioequivalence studies, including placebo trials, product transfer, manufacturing upscaling, and analytical validation.

BioNxt Solutions (BNXTF) has received acceptance of its first national level patent filing from the Eurasian Patent Organization (EAPO). The patent, which previously received a positive international examination report from the European Patent Office in September 2024, covers sublingual delivery of anticancer drugs for treating autoimmune neurodegenerative diseases.

The patent notably includes BioNxt's lead product, BNT23001, a sublingual thin-film formulation of Cladribine for multiple sclerosis treatment. The EAPO protection extends across eight member states: Armenia, Azerbaijan, Belarus, Kazakhstan, Kyrgyzstan, Russia, Tajikistan, and Turkmenistan. The company is also pursuing patent protection in Australia, Canada, New Zealand, USA, and Japan to support commercialization opportunities for its pipeline of sublingual products targeting various autoimmune diseases.

BioNxt Solutions (OTC:BNXTF) has announced a delay in filing its 2024 annual financial statements, management discussion and analysis, and CEO/CFO certifications. The company missed the April 30, 2025 deadline due to delays in receiving required financial information. BioNxt expects to complete the Annual Filings by June 28, 2025. As a result, a management cease trade order (MCTO) has been imposed against the CEO and CFO, restricting them from trading company securities until the filings are completed, with a deadline of June 30, 2025. The company will follow Alternative Information Guidelines and confirms no other undisclosed material information.

BioNxt Solutions (CSE:BNXT, OTC:BNXTF) is advancing preparations for a human bioequivalence study of its lead Multiple Sclerosis treatment, BNT23001. The product is a proprietary sublingual thin-film formulation of Cladribine designed to treat MS.

The company has acquired the necessary Cladribine active pharmaceutical ingredient to complete technology transfer with Gen-Plus, its European Contract Research and Development Organization in Munich, Germany. The upcoming bioequivalence study is expected to be completed in under 30 days once initiated.

Preclinical studies have shown high absorption rates and bioequivalence compared to existing oral tablet therapies. BNT23001's sublingual thin-film format offers key advantages including convenient administration, rapid absorption through sublingual mucosa, and improved patient compliance.

BioNxt Solutions has successfully closed the final tranche of its fully subscribed convertible debenture unit private placement, raising total gross proceeds of $2.5 million. The offering consisted of two tranches: first tranche of 3.2 million units for $1.6 million and second tranche of 1.8 million units for $900,000.

Each debenture unit includes a $0.50 principal amount of 8.0% unsecured convertible debentures and one common share purchase warrant. The warrants are exercisable at $0.60 per share until February/March 2027. The debentures are convertible into common shares at $0.50 per share before maturity.

The company paid $200,000 in fees and issued 400,000 finder's warrants to Canaccord Genuity Corp. Net proceeds will fund product development, commercialization, IP filings, debt repayment, and working capital.

BioNxt Solutions has successfully closed the first tranche of its non-brokered private placement, raising $1.6 million through convertible debenture units. Each unit comprises a $0.50 principal amount of 8.0% unsecured convertible debentures and one common share purchase warrant.

The debentures feature an 8.0% annual interest rate, payable at maturity in two years, and are convertible to common shares at $0.50 per share. Warrants are exercisable at $0.60 per share until February 28, 2027.

As part of the offering, the company paid $128,000 in cash fees and issued 256,000 finder warrants to Canaccord Genuity Corp. The proceeds will fund product development, commercialization, intellectual property filings, debt repayment, and working capital.