BioNxt Solutions: Your chance to get in early on the next biotech blockbuster

The Herculean task

One of the biggest challenges for pharmaceutical companies is the dosage form of their drugs. Many active ingredients are effective, but their administration is torture for patients. Injections are unpleasant, large tablets are difficult to swallow, and chemotherapy often affects healthy cells just as severely as diseased ones. BioNxt Solutions has addressed precisely these pain points and is developing not just one, but two promising solutions that have the potential to reinvent proven drugs.

The convenient pill: A revolution in the form of a dissolvable film

The first major breakthrough is the sublingual thin-film technology, called ODF (Oral Dissolvable Film). In this method, the active ingredient, which is located on a wafer-thin, fast-dissolving film, is released directly into the bloodstream via the oral mucosa. For patients, this means no needles, no swallowing difficulties, faster onset of action, potentially even lower dosages, and greater reliability in administration.

The flagship product in this segment is BNT23001, a cladribine formulation for multiple sclerosis (MS). Cladribine is already on the market as a tablet (Mavenclad® from Merck), but many MS patients suffer from swallowing difficulties. BioNxt elegantly circumvents this problem. The project is in an advanced stage of development, the active ingredient is ready, and preparations for a bioequivalence study in the second half of the year are underway.

But the real strength lies in the scalability of the platform. What works for cladribine can also be transferred to other active ingredients. Here, the Company is currently focusing on semaglutide, the blockbuster active ingredient behind obesity drugs, including Ozempic and Wegovy. BioNxt just announced the successful completion of the proof-of-concept study for a semaglutide dissolvable film. The prototypes impressed with their rapid dissolution and good processability. CEO Hugh Rogers commented, "Achieving such positive proof-of-concept results with the first prototypes is an important milestone for BioNxt."

The Company is thus targeting one of the hottest and fastest-growing markets. Sales of semaglutide alone amounted to over USD 29.3 billion in 2024. A needle-free, discreet, and easy-to-take alternative could revolutionize treatment adherence for millions of patients worldwide and capture a considerable market share.

The precision bomb: Targeted attack on cancer

While the ODF platform revolutionizes convenience, the second technology goes one step further. BioNxt's Targeted Chemotherapy Delivery Platform has the potential to fundamentally change cancer therapy. The principle behind it is as follows: An inactive active ingredient (prodrug) circulates in the body without causing any damage. Only when it encounters a tumor-specific enzyme is it activated directly in the cancerous tissue.

This approach is revolutionary because it directs the destructive power of chemotherapy exactly where it belongs, largely sparing healthy cells. In addition, a dual mechanism is designed to capture unactivated drug components and deliver them back to the tumor. In preclinical studies, this strategy resulted in up to a 10-fold increase in efficacy.

The economic implications are enormous. Over 100 established chemotherapies could be adapted for this platform. More importantly, so-called "shelved drugs," meaning promising active ingredients that were once abandoned due to excessive toxicity, could be given a second chance. The global chemotherapy market is expected to grow to USD 98 billion by 2030. With its innovative platform, BioNxt is positioning itself right at the heart of this megatrend in oncology.

Opportunities for investors: Platform approach instead of individual products

What makes BioNxt so interesting is not a single product, but its platform character. The Company does not develop individual solutions, but technologies that can be applied to dozens of active ingredients. This "licensing and scaling" model offers multiple opportunities:

• Broad IP protection: The Company secures its inventions with a network of broad patents that protect not only an active ingredient, but the entire delivery platform. A European patent is about to be granted, and a fast-track procedure is underway in the US.

• Attractive licensing model: BioNxt does not have to take all drugs through the expensive Phase 3 clinical trials itself. The focus is on licensing the technology to large pharmaceutical or generic drug companies, which saves capital and generates revenue through upfront payments and royalties.

• Takeover fantasy: Large pharmaceutical companies are constantly on the lookout for innovative platforms to replenish their pipelines.

The recent uplisting to the OTCQB market in the US under the symbol "BNXTF" underscores these ambitions. It increases visibility among US investors and opens the door for more institutional participation. Black Research's price target from July is EUR 2.50 (around CAD 4) over a period of up to 18 months. The stock is currently trading at CAD 0.88.

BioNxt Solutions is more than just another biotech start-up. It is an innovative architect for the future of drug delivery. With two disruptive platform technologies addressing large markets, a smart licensing model, and a sharp focus on intellectual property, the Company has maneuvered itself into a unique position. For investors looking to bet on the next big thing in the pharmaceutical industry, BioNxt could offer a compelling and promising opportunity to participate in just that.