Takeover candidate! Novo Nordisk and Eli Lilly eyeing BioNxt Solutions

Oral version of Ozempic would be revolutionary

BioNxt is tapping into the next billion-dollar market: Last week, the Company received a shipment of semaglutide, the active ingredient contained in Novo Nordisk's blockbuster drugs Ozempic (for diabetes) and Wegovy (for weight loss). These drugs alone generated around USD 12 billion in revenue last quarter. BioNxt now aims to use the active ingredient to develop an oral form of semaglutide. The goal is to increase bioavailability to such an extent that an effective, tablet-like method of administration becomes possible. The active ingredient is to be transported via the oral mucosa in the form of an oral dissolvable film. Work is now underway at the development laboratory in Munich to refine the formulation. If successful, a patent application could be filed as early as the coming quarter. This would position BioNxt as an attractive partner or takeover candidate for major industry players.

Billion-dollar market for weight-loss injections slowed by injections

The market for GLP-1-based obesity therapies such as Ozempic (Novo Nordisk) and Mounjaro (Eli Lilly) is growing rapidly. According to analyst estimates, the drugs are expected to reach a volume of around USD 150 billion by the end of the decade. The market is currently dominated by Novo Nordisk and Eli Lilly. However, numerous companies such as Pfizer, Roche, and Amgen are working on their own preparations. Demand is huge, and the market would already be growing faster today if availability were not limited. Production capacities—including those of suppliers—are not growing fast enough. Almost all approved drugs are administered by weekly injection. Production, including the syringes, is correspondingly complex. In addition, many patients find this form of administration unpleasant or cumbersome. An easy-to-take, safe, and effective oral variant could therefore represent a real revolution: The inhibition threshold for starting therapy would decrease, and the duration of treatment would increase. With a tablet-like form of administration, an innovator such as BioNxt Solutions could cause a sensation and position itself as a partner or takeover candidate in this billion-dollar market.

Flagship project BNT23001 for cladribine sets new standards

The Ozempic project is not the only one with which BioNxt is targeting a billion-dollar market. The Company is also working intensively on its flagship project BNT23001. This is a melt film formulation of cladribine, an already approved therapy for multiple sclerosis. Here, too, BioNxt's innovation lies in releasing cladribine via a sublingual thin-film, placed under the tongue, designed to simplify administration and improve tolerability. In July, the Company presented a successful prototype. This is currently undergoing preclinical testing. Patents have already been obtained in Europe and other key markets. In addition to the cladribine formulation, the patent also covers the use of chemotherapeutic agents in neurological autoimmune diseases. Overall, this opens up exclusivity and licensing opportunities.

In the US, BioNxt has submitted its patent application for BNT23001 under the accelerated "Track One" procedure. Success would have a very positive impact on clinical development and subsequent commercialization.

Increased Visibility and tradability of the share

BioNxt has recently announced measures aimed at increasing both visibility and tradability of its shares - which are already actively traded on Tradegate. As of last Friday, BioNxt shares have been listed on the OTCQB market of the Canadian Securities Exchange. This uplisting from the OTC segment will facilitate access for US investors, while also increasing transparency standards. BioNxt CEO Hugh Rogers stated: "We have built a strong platform over the past 12 months, both in terms of capital markets and with regard to our future product candidates. With three distinct and proprietary sublingual drug development programs currently underway in Europe, and a promising contract for the administration of chemotherapeutic drugs nearing completion here in North America, the Company is well-positioned for value growth over the next 12 months."

Conclusion: Market capitalization with significant upside potential

BioNxt Solutions could become a real stock market rocket for investors in the coming weeks. With a market capitalization of less than EUR 100 million, there is certainly significant upside potential given the expected positive news flow. Even for big pharma, an attractive price premium for a takeover should not be a problem. If a marketable oral version of semaglutide can be developed, it would be a potential game changer in a market that is currently dominated by injections. Novo Nordisk and Eli Lilly are likely to be watching very closely—and investors should do the same.