Biotech
Friday, October 4th, 2024 6:59 pm EDT
Key Points
- Company Expertise: Specializes in sublingual drug formulations, chemotherapy drug manufacturing, and neurological drug development, primarily based in Germany and Canada.
- Product Development Strategy: Focuses on proprietary products with patent protection, reformulating approved drugs for sublingual delivery, requiring only bioequivalence studies. Product commercialization costs between $2-3M USD over 2-4 years.
- Recent Patent Decision & Lead Program: Received preliminary approval for a broad European patent for sublingual chemotherapy drugs targeting neurological disorders. Their lead product is a sublingual Cladribine formulation for MS, with a billion-dollar market potential and human trials starting in early 2025.
BioNxt is striving to have a positive impact on global health
The company is creating potentially life-changing solutions through research, development and collaboration.
Bionxt Solutions (CSE:BNXT) works with promising disrupters in the pharmaceutical industry; accelerates research and technology development; and commercializes products with an entrepreneurial approach and a commitment to efficiency, effectiveness and accessibility.
The company’s network spans Europe and North America with companies at the forefront of diagnostics and drug formulations, and universities specializing in research on the use of psychedelics and cannabinoids.
Their mission is to innovate and commercialize the next-generation pharmaceutical and diagnostic investment opportunities.
BioNxt Solutions Inc. is on the verge of a groundbreaking transformation in the pharmaceutical world, and now is the time for investors to take notice. The company has received a game-changing positive international examination report from the European Patent Office (EPO) for its revolutionary patent application for the sublingual delivery of anticancer drugs. This innovation is specifically designed to target autoimmune neurodegenerative diseases like Multiple Sclerosis (MS) and Myasthenia Gravis (MG), and the potential here is truly astounding. With the European Union patent expected to be granted within the next eight weeks, BioNxt is rapidly moving toward the national phase of the Patent Cooperation Treaty (PCT) patent process, with plans to file in key markets like the U.S., Canada, China, Japan, and Australia.
What makes this achievement even more remarkable is BioNxt’s aggressive strategy to continuously expand its intellectual property portfolio. The company plans to file multiple related provisional patent applications in the European Union, with an expectation of holding three to four patents in major international jurisdictions by late 2025 to early 2026. With patent protection potentially extending to 2045, BioNxt is positioning itself as a long-term leader in the highly lucrative and growing market for neurodegenerative disease treatments.
The Flagship Product: Sublingual Cladribine for MS
The crown jewel in BioNxt’s pipeline is its proprietary, 100% owned sublingual Cladribine formulation, aimed squarely at the $41 billion global MS market. Cladribine tablets are already approved for use in over 75 countries, including the U.S. and European markets, with annual sales exceeding $1 billion USD, according to Merck KGaA. However, BioNxt’s sublingual version is a step beyond, offering a significant advantage over the traditional tablet form. Many MS patients, who often struggle with dysphagia (difficulty swallowing), will benefit immensely from this easily dissolvable sublingual solution.
But it’s not just about convenience—BioNxt’s sublingual Cladribine is backed by science. In the first half of 2024, the company announced outstanding results from both its animal toxicity study and animal pharmacokinetics (PK) study. The toxicity results were perfect, with zero adverse effects, while the PK study showed rapid absorption and bioequivalence with the leading brand-name drug. These positive outcomes set the stage for BioNxt’s next phase of development, including upscaling manufacturing and preparing for a human bioequivalence study scheduled for early Q1 2025. This study, which will be conducted with a European contract research organization, is a major milestone on the path to commercialization.
With the global MS drug market expected to grow to $41 billion USD by 2033, BioNxt’s sublingual Cladribine is positioned to capture a significant share of this booming market. Investors looking for an opportunity in a billion-dollar space should pay close attention.
Expanding Horizons: Myasthenia Gravis (MG)
BioNxt is not stopping at MS. In a strategic expansion, the company has set its sights on Myasthenia Gravis (MG), an autoimmune neuromuscular disease characterized by muscle weakness and fatigue. Like MS patients, many MG patients also suffer from dysphagia, making them prime candidates for BioNxt’s sublingual drug delivery system. The global MG market is expected to reach a staggering $6.7 billion USD by 2032, according to Clinical Trials Arena, and BioNxt’s sublingual chemotherapy formulation for MG is expected to offer a substantial competitive advantage over conventional tablets.
Investors should see this as a golden opportunity. With two high-potential clinical indications—MS and MG—BioNxt is diversifying its pipeline while maintaining focus on delivering innovative solutions to patients with severe, life-altering diseases.
Why Investors Should Be Excited
Beyond its immediate product pipeline, BioNxt is tapping into the growing global demand for treatments targeting central nervous system (CNS) diseases. The increasing prevalence of these disorders is driving investment in new drugs and novel drug delivery systems, and BioNxt is right at the forefront of this movement. According to GMI Market Insights, the CNS drug market is expected to soar to $238.8 billion USD by 2032, and BioNxt’s sublingual technology positions the company to capture a significant piece of this market.
Moreover, BioNxt’s innovative approach isn’t just a shot in the dark. The company is leveraging already approved drugs, such as Cladribine, to reduce the risk, time, and cost associated with bringing new drugs to market. By focusing on reformulating these proven drugs into sublingual versions, BioNxt can avoid lengthy and expensive safety trials, instead focusing on demonstrating bioequivalence. This streamlined development strategy means that BioNxt can bring products to market faster and at a fraction of the cost of traditional drug development—estimated at $2-3 million USD over 2-4 years.
With a world-class R&D team based in Germany and Canada, BioNxt’s scientific expertise and commercialization strategy are second to none. The company’s focus on sublingual drug delivery isn’t just a technological leap forward—it’s a practical, patient-focused solution that addresses real needs in the market. BioNxt’s products aim to improve the lives of patients suffering from debilitating diseases while offering a lucrative investment opportunity for forward-thinking investors.
A Future-Proof Patent Strategy
BioNxt’s recent patent success with the European Patent Office is just the beginning. The company’s aggressive pursuit of intellectual property rights ensures that it will maintain a strong competitive edge for decades to come. With patent protection extending potentially to 2045, BioNxt is securing its market position in a way that offers long-term value to investors.
As BioNxt continues to expand its patent portfolio, the company is building a robust IP moat that will safeguard its innovative drug formulations from competition. This strategy not only protects BioNxt’s future revenue streams but also increases the company’s attractiveness as a potential acquisition target for larger pharmaceutical companies looking to enter the CNS drug market.
Conclusion: A High-Potential Investment
BioNxt Solutions Inc. is poised for explosive growth, and now is the time for investors to get on board. With its innovative sublingual Cladribine product for MS, the upcoming bioequivalence study in early 2025, and its strategic expansion into the MG market, BioNxt is addressing the needs of millions of patients worldwide while tapping into multi-billion-dollar markets.
The company’s strong patent portfolio, world-class R&D team, and streamlined commercialization strategy offer a unique combination of high growth potential and reduced risk. As the demand for treatments targeting CNS diseases continues to rise, BioNxt is perfectly positioned to become a leader in this space, delivering innovative solutions that improve patient outcomes and drive substantial returns for investors.
Don’t miss out on this exciting opportunity—BioNxt is about to revolutionize the treatment of neurodegenerative diseases, and savvy investors have a chance to be part of this breakthrough.
So why BioNxt (CSE:BNXT)?
Company expertise:
- Sublingual (oral dissolvable) drug formulations and manufacturing (Germany)
- Chemotherapy drug formulation and manufacturing (Germany)
- Neurological drug formulations (Germany/Canada)
Product development strategy:
- Proprietary products (i.e. patent protection)
- Reformulation of already approved drugs (i.e. sublingual product to compete with tablet product)
- Efficacy and safety have already been established with regulatory agencies (short animal studies are voluntary)
- Must only demonstrate bioequivalence (i.e. comparable blood concentration over 1-4 weeks)
- $2-3M US to commercialize a product from R&D to market over a 2-4 year period
Recent patent decision:
- Sep 2024, European Patent Office issued a preliminary patent decision granting BioNxt 100% broad rights to all sublingual formulations using chemotherapy drugs for the treatment of autoimmune neurological disorders (i.e. MS, Myasthenia Gravis, etc.)
- Company plans to file several related provisional patent applications in the EU with three to four patents expected to be on file in multiple major international jurisdictions by late 2025 to early 2026 with potential patent protection extending to 2045
Lead program:
- Sublingual Cladribine product for the treatment of MS
- Cladribine is chemotherapy drug that was formerly approved for treatment of rare forms of cancer (hairy cell leukaemia)
- Cladribine (tablet) for treatment of MS is patented by Merck KGaA until 2027
- 1B+ USD market
- Sublingual delivery mitigates the impact of Dysphagia (difficulty swallowing) which occurs in 50%+ patients
- Animal toxicology study results were excellent – zero indications of toxicity
- Animal PK study results were excellent – highly comparable to tablet form
- Human bioequivalence study planned in EU for Q1 2025 (two week study)
Following program:
- Cannot fully discuss due to confidentiality but it is a sublingual chemotherapy drug for the treatment of Myasthenia Gravis
- MG is an autoimmune and neuromuscular disease characterised by muscle weakness and fatigue
- MG also suffer from Dysphagia (difficulty swallowing)
- global MG market is expected to reach USD 6.7 billion by 2032
Summary:
- World class R&D team based in Germany
- Commercialization strategy has lower technical risk, expedited route to market, and is much cheaper than conventional drug development
- Billion dollar sublingual Cladribine drug under development for MS
- Pipeline of sublingual neurological products in R&D
- Strong and broad patent protection
Here is a video that was done and posted on YouTube about a month ago: https://www.youtube.com/watch?v=K4L31_TYjDw
The company is in the midst of updating all their presentation materials but in the meantime, just so you can put a face to the name, here’s another YouTube video of Dr. Florian Sahr https://www.youtube.com/watch?v=RsiX0TwyE4c
There should be a lot more coming on BNXT so make sure you stay tuned. They’re getting the play going again and remember, this stock used to trade at CDN$3/share, it’s now trading at $0.25. You can see the volume starting to perk up a bit which makes me think that something’s brewing and we need to keep it on our radar screens. Keep an eye on BNXT.
Best,
Editor
The Investors Edge .io
