Forget weight loss injections! BioNxt Solutions is unsettling Big Pharma, but could become an important partner

One platform, many active ingredients: The technology behind the vision

Imagine if you could simply place your medication on your tongue like a piece of sugar. It dissolves within seconds, and the active ingredient is absorbed directly into the bloodstream via the oral mucosa without passing through the stomach and liver. BioNxt Solutions is pursuing this vision with its oral dissolvable film (ODF) platform. For investors, it is the vision of a technological leap that could turn a small biotech company into a sought-after partner for the pharmaceutical giants.

The Company has not limited itself to a single active ingredient. Instead, it acts as a specialized developer of delivery systems. Its innovation is the platform itself. "We have built a great platform over the past 12 months, both in terms of capital markets and our future product candidates. With three distinct and proprietary programs for the development of sublingual drugs currently underway in Europe and a promising contract for the delivery of chemotherapeutic drugs nearing completion here in North America, the Company is well positioned for value growth over the next 12 months," confirms CEO Hugh Rogers. This flexibility opens up several opportunities.

Cladribine for MS: Proof of concept within reach

The most prominent approach concerns the active ingredient cladribine for the treatment of multiple sclerosis (MS). The market for MS therapies is huge and growing steadily. The issue is that many patients suffer from swallowing difficulties, which makes it difficult for them to take conventional tablets. BioNxt elegantly circumvents this problem. Its sublingual cladribine film, called BNT23001, requires no water and no swallowing. The efficacy of the active ingredient is already known, which significantly shortens the development path. The decisive factor is proof of bioequivalence - the film works just as well as the tablet. If this is successful, there would be little standing in the way of approval.

The strategic protection of this technology is already well advanced. The core patents have already been accepted in Europe and Eurasia, and a fast-track procedure is underway in the US, which could lead to a decision by spring 2026. It is important to note that patent protection applies not only to cladribine but also to the application of the platform for an entire class of neurological indications. This creates a competitive advantage that extends far beyond a single product.

The partnership with Gen-Plus: Expertise from Munich

The importance of the German partner Gen-Plus cannot be overstated. Gen-Plus provides GMP-compliant laboratory infrastructure and contributes crucial expertise in the fields of polymer science and peptide formulation. This partnership enables BioNxt to pursue a rapid and regulatory-compliant development process aligned with European standards - all without the need for heavy capital investments in infrastructure. It is an asset-light approach that helps conserve the Company's capital.

Semaglutide delivery: Entry into the billion-dollar GLP-1 market

The biggest buzz right now is the entry into the ultimate hype market: GLP-1 receptor agonists like semaglutide, known as Ozempic or Wegovy. There has recently been a decisive momentum in development: On September 2, BioNxt announced that it had received the high-purity active ingredient semaglutide. This delivery marks the start of practical laboratory work.

"Now that we have the active ingredient available on site, we can put theory into practice," said CEO Rogers. Preformulations and tests are now underway in the laboratories of German partner company Gen-Plus, a licensed developer of pharmaceutical thin-film formulations. The team is characterizing the stability of the peptide and working on optimizing the film matrix. The specific goal is to file a provisional patent application in the third quarter of 2025.

The market for these active ingredients is estimated at over USD 150 billion by 2030. The key problem here is also the application. Most preparations have to be injected. According to figures, treatment adherence drops to around 32% after just one year. A non-invasive alternative is the "Holy Grail." The logic behind BioNxt's approach is compelling: The Company does not want to replace the active ingredient, but instead radically improve its dosage form.

OTCQB listing: Greater visibility for US investors

In parallel with its technical development, BioNxt is also optimizing its capital market presence. Since September 5, the Company's shares have been listed not only on the open OTC Pink Market, but also on the higher-quality OTCQB Market in the US under the symbol "BNXTF." This uplisting is more than just a symbolic act.

It subjects the Company to stricter transparency and reporting requirements, making it investable for a broader, more institutional audience in the US. Increased attention and improved liquidity could support the share price in the long term. Analysts at Black Research have given the stock a "Strong Buy" rating and see a price target of EUR 2.50. The stock is currently trading at EUR 0.602, which corresponds to approximately CAD 0.94.

BioNxt Solutions is not about inventing the next blockbuster drug - it is focused on delivering existing ones better. Recent developments reinforce this strategy. The delivery of semaglutide is driving the highly anticipated project forward, while the OTCQB listing is increasing its reach among investors. The Company's asset-light approach is strategically clever - it reduces development risks and costs while positioning BioNxt as an attractive partner or takeover target for large pharmaceutical companies. For risk-aware investors, this presents an opportunity to get in early on a platform that has the potential to transform how treatments are delivered.