AI fantasy at biotech innovators: BioNxt, Roche, Merck & Co.

BioNxt improves existing active ingredients

BioNxt specializes in novel drug delivery systems, such as thin, dissolvable films for sublingual administration and transdermal patches. Instead of developing its own active ingredients, BioNxt reformulates existing, proven drugs into more patient-friendly dosage forms. The goal is to increase therapy adherence and patient comfort by making medications easier to use. For example, BioNxt is developing dissolvable active ingredient films for oral intake of known active ingredients and patches that can replace regular tablet dosing. Improved adherence (therapy compliance) leads to fewer treatment discontinuations and lower follow-up costs. In some cases, the new dosage forms may even lead to more efficient dosing - this is the case, for example, when a patch delivers the daily dose gradually, so patients no longer need to swallow tablets multiple times a day. Such solutions can help to avoid dosing errors, especially in elderly patients, children, or the chronically ill.

BioNxt is currently in the clinical development phase and is focusing on therapeutic areas in neurology, immunology, and oncology. One important project is BNT23001. This is an orally dissolvable thin-film formulation of cladribine for the treatment of multiple sclerosis. Cladribine is an already approved active ingredient for MS and is available as a tablet. BioNxt aims to administer the active ingredient using a sublingual film, thus offering MS patients the advantages outlined above. A large-scale animal bioequivalence study is scheduled to be completed this fall with the aim of determining optimal dosages and bioavailability for the comparative study in humans that is planned to follow. At the same time, BioNxt is pushing ahead with patent applications for this technology in key markets such as the EU, Canada, Australia, Japan, and the US.

Dissolvable thin-film instead of weight-loss injections: Is a huge market emerging here?

Another promising candidate is semaglutide, an orally dissolvable thin-film formulation for the treatment of obesity. With this project, BioNxt aims to make popular weight loss drugs such as Ozempic and Wegovy, which currently require injection, available as oral thin-films that dissolve on the oral mucosa. If BioNxt's researchers are successful, the Company could secure patents for this innovative delivery method. With the global market for obesity therapies booming and studies showing that injections are increasingly associated with poor patient adherence, a huge market could emerge for BioNxt.**

By focusing on already known active ingredients in new formulations, the Company saves both time and money. According to BioNxt CEO Hugh Rogers, this approach allows new products to be brought to market much faster and at a fraction of the usual cost. Specifically, development phases can be completed in 2 to 4 years, rather than over a decade, without the need to invest hundreds of millions of dollars. Potential partners are also likely to find BioNxt's offering attractive. Companies such as Roche are always on the lookout for new revenue drivers. The Swiss pharma giant is known for blockbuster drugs like Herceptin (breast cancer), Rituxan (blood cancer), and Avastin (chemotherapy combination). These blockbusters have generated billions in revenue, but their patents are nearing expiration. The same applies to other drugs. One example is the cancer drug Keytruda from Merck & Co., whose patent protection will expire in a few years. Keytruda currently accounts for around one-third of Merck & Co.'s revenue.** To reduce the risk of Keytruda's patent protection expiring, Merck & Co. is focusing on acquisitions, research partnerships, and AI. This strategy aims to accelerate the discovery of the next generation of blockbuster drugs.

BioNxt with AI potential – Stock has come back

An AI-related acquisition also seems conceivable for BioNxt. CEO Rogers hinted at this during the latest edition of the International Investment Forum (IIF). AI is used in many different ways in research. At BioNxt, the technology could help advance several promising projects in parallel or identify new active ingredients that could benefit from innovative dosage forms. BioNxt's stock is one of the winners of the year. Recently, however, the stock has fallen back a little. Given the lower risk compared to biotech companies with only a single project, the shorter development timelines, and the promising candidates, investors may want to take a closer look at the Company. One opportunity to do so is the recent presentation by CEO Rogers at the IIF in early October. The upcoming study results also provide a reason to examine the Company's business model more closely.