BioNxt Solutions Inc. has executed an agreement to carry out its comparative drug absorption study for the Company's transdermal ("TDS") Rotigotine patch for the treatment of Parkinson's disease. BioNxt has also commenced the manufacture of clinical samples for use in the study which is planned for early Second Quarter 2023. The Company has finalized its plans for the human bioavailability study to be carried out by a qualified European contract research organization.

The comparative study is designed as a randomized, crossover, twoperiod, single dose pilot study to assess the relative bioavailability, skin adhesion and skin tolerance of BioNxt's new formulation compared to the name brand product. The study will be carried out in Europe in accordance with Good Clinical Practice (GCP) and the European Medical Agency (EMA) Guideline on quality of transdermal patches. The Company has also commenced the manufacture of transdermal clinical samples based on the TDS platform technology developed by its wholly owned German subsidiary, Vektor Pharma TF GmbH ("Vektor").

BioNxt is working to develop inhouse commercial manufacturing capabilities at its German drug development facility. This will include EU GMPapproved manufacturing and packaging equipment as well as a certified manufacturing line capable of producing pivotal trial materials compliant with commercial regulatory approval applications and final commercial products (transdermal and oral dissolvable). The Company expects to make further announcements regarding its commercialization capabilities over the coming months.

Rotigotine is a nonergoline dopamine agonist approved for the treatment of Parkinson's disease and restless legs syndrome (RLS) in Europe and the United States. The active pharmaceutical ingredient is not well absorbed via oral delivery and is formulated as a oncedaily TDS patch to increase bioavailability and provide a controlled and steady supply of the drug over the course of 24 hours. The therapeutic market for Parkinson's disease is over 10 million people worldwide and growing.

The top selling name brand product launched by the originator in 2007 independently sold over USD 375 million of its Rotigotine TDS patches in 2021. According to Wissen Market Research, total global sales for Rotigotine patches were approximately USD 518 million in 2021 with the market expected to surpass USD 766 million by 2030. BioNxt's Rotigotine transdermal patch is one product based on its 100% owned platform technology which represents a scalable opportunity for additional TDS drug development and manufacturing programs. According to Research and Markets, the global transdermal skin patch market had a value of nearly USD 6.5 billion in 2020 while Kuick Research, Pharmaceutical and Healthcare, estimates the market will reach approximately USD 20 billion by 2028.