BioNxt Solutions Inc Stock Price, News & Analysis

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.

BioNxt Solutions has announced a non-brokered private placement of debenture units to raise up to $2.5 million. Each debenture unit consists of $0.50 in principal amount, bearing an 8% annual interest rate for two years, and is convertible into common shares. The units also include one Common Share purchase warrant exercisable at $0.60 for two years.

The company may pay interest through common shares at $0.50 per share. Additionally, BioNxt plans to issue up to 400,000 compensation warrants at $0.50 per warrant to eligible finders, along with up to 8% finder's fee in cash. All securities will have a four-month and one-day hold period from issuance. The offering's completion is subject to regulatory approvals.

BioNxt Solutions (CSE:BNXT)(OTC:BNXTF) has clarified its January 31, 2025 news release regarding promotional activities. The company has engaged two firms for investor relations services:

1. Apaton Finance GmbH will provide services from February-June 2025 for two payments of €10,000 each, plus 50,000 stock options at $0.50 per share. Services include brand visibility enhancement and German market investor engagement.

2. Cayo Ventures GmbH will provide German language engagement and digital marketing services from February-March 2025 for €20,000 per week (subject to company discretion), plus 150,000 stock options at $0.50 per share.

Both option grants vest 25% quarterly over 12 months with a two-year exercise period and are subject to a four-month hold period.

BioNxt Solutions has announced a 90-day strategic plan focusing on three key initiatives. First, the company has completed national-level patent filings in major markets including the US, Canada, Australia, Europe, and Japan, following a positive examination report from the European Patent Office for its sublingual anticancer drug delivery system.

Second, BioNxt is preparing to commence a human bioequivalence study for BNT23001, its lead Multiple Sclerosis treatment utilizing a sublingual thin-film formulation of Cladribine. The study is expected to last less than 30 days and will serve as a proof-of-concept for the company's autoimmune disease product pipeline.

Third, the company plans to expand into the longevity and anti-aging market, which is projected to reach $93 billion by 2027. BioNxt is developing proprietary sublingual and oral drug products targeting benefits such as slowing ovarian aging, extending fertility, and promoting healthy aging.

BioNxt Solutions (CSE:BNXT)(OTC:BNXTF) has announced its relocation to the Gen-Plus Contract Research and Development Organization in Munich, Germany, with operations set to begin on March 1, 2025. The move provides access to a 1,000-square-meter research facility equipped with state-of-the-art technologies for high-potency active pharmaceutical ingredients and GMP-compliant processes.

The strategic relocation aims to enhance R&D capabilities, particularly in drug delivery systems, neurodegenerative disease therapeutics, and next-generation biomedical technologies. The facility features specialized equipment for solid and semi-solid dosage forms and drug printing capabilities. The Munich location also offers opportunities for collaboration with leading research institutions, biotech firms, and academic experts.

BioNxt Solutions has expanded its intellectual property portfolio by filing new international patents for sublingual delivery technologies targeting autoimmune neurodegenerative diseases. Following a positive International Preliminary Report on Patentability from the European Patent Office in September 2024, the company has initiated national-level filings in the US, Canada, Europe, and Japan.

The company's lead product, BNT23001, is a sublingual thin-film formulation of Cladribine for Multiple Sclerosis treatment. Preclinical studies have shown high absorption rates and bioequivalence to existing oral therapies. Clinical trials are planned for 2025, pending regulatory approval. BioNxt is also developing Cladribine formulations for Myasthenia Gravis, targeting a market projected to reach $6.7 billion by 2032.

BioNxt Solutions has reported significant progress in developing BNT23001, a sublingual thin-film formulation of Cladribine for Multiple Sclerosis treatment. In 2024, the company achieved key milestones including successful preclinical trials showing high absorption rates and bioequivalence to Mavenclad®, transfer of production to GMP-certified manufacturer Gen-Plus GmbH, and favorable patent reports.

For 2025, BioNxt plans to complete GMP manufacturing of clinical trial batches in Q2, submit regulatory filings by mid-year, and launch a pilot clinical study in the second half comparing BNT23001 to Mavenclad®. The product offers advantages including convenient administration, rapid absorption through sublingual delivery, and improved patient compliance.