Better than BioNTech, Evotec & Co.? BioNxt Solutions faces key milestones and is considering an AI takeover – Stock in an upward trend

Business model: Manageable, diversified, and scalable

In an interview with the International Investment Forum (IIF), CEO Hugh Rogers emphasized BioNxt Solutions' unique positioning in the biotech sector. He hinted at a potential acquisition in the field of artificial intelligence. Unlike many of its competitors, the Company does not develop completely new active ingredients. Instead, it reformulates already approved drugs using its proprietary sublingual, orally dissolvable platform technology. This approach reduces development risks, saves time and costs, and accelerates the path to market maturity. While conventional biotech projects often take more than 10 years and require over USD 100 million, Rogers stated that BioNxt can bring new products to market within just 2 to 4 years — and at a fraction of the cost.

Cladribine formulation in the critical phase

The first key project is a sublingual cladribine formulation for the treatment of multiple sclerosis and other autoimmune diseases. The dissolvable thin-film is designed to make administration significantly easier for patients. Patent applications in key international markets such as the European Union, Canada, Australia, Eurasia, New Zealand, and Japan are already underway, as is a Track One priority application in the US. The large-scale crossover bioequivalence study in animals is expected to be completed in November, with results available in December. Before the comparative bioequivalence study in humans begins next year, the goal is to obtain critical data to optimize the drug dose and assess the potentially significantly higher bioavailability.

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Commercialization via licensing or acquisition by big pharma

Regarding the long-term strategy, CEO Hugh Rogers stated that BioNxt intends to focus on research, patents, and early clinical development. Subsequent commercialization is planned through licensing agreements or acquisitions by larger pharmaceutical companies. With its platform technology and intellectual property rights, Rogers believes the Company is "well-positioned for potential deals." BioNxt is therefore positioning itself as an agile biotech company that combines innovation with economic efficiency, thereby bridging the gap between academic research and industrial-scale production. BioNxt could also rely on artificial intelligence (AI) for further development in the future. To this end, a potential acquisition in North America is currently under consideration.

In the spotlight of Big Pharma: Sublingual thin-film for Ozempic

Another promising candidate from BioNxt is the sublingual thin-film formulation of Ozempic (semaglutide). This innovative approach aims to disrupt the multi-billion-dollar obesity market, one of the most dynamic sectors in the pharmaceutical industry. According to analysts, companies like Novo Nordisk and Eli Lilly & Co. could generate annual sales of around USD 150 billion by the end of the decade. Until now, almost all preparations have had to be injected – an obstacle for many patients. BioNxt's goal is to develop an oral dosage form that absorbs the active ingredient through the oral mucosa. If this step is successful, a patent could soon follow – a milestone that would make the Company highly attractive for partnerships with industry giants or even potential acquisitions.

BioNxt CEO Hugh Rogers provided an exciting insight into the Company in an IIF interview. The strategy appears compelling, with the cladribine formulation potentially becoming the first in-house development to be partnered soon, and the stock is also showing sustainable positive performance.