Medlab Clinical - Observational trials to support development

Medlab Clinical has announced it has received ethics approval to conduct two new observational clinical trials in Australia for its lead developmental programmes, NanaBis and NanoCBD. The studies aim to investigate the long-term efficacy, tolerability and safety profiles of the products in the target populations. In our view these studies are an important milestone in the clinical progression of NanaBis and NanoCBD as, assuming positive readouts, the results will help generate data packages to support future regulatory approvals. We believe this will be of particular importance for NanaBis, Medlab’s lead asset, which is anticipated to begin FDA Phase III studies for the treatment of cancer-related bone pain in mid-2023. Additional real-world data would also potentially help expansion into a broader indication for chronic pain management. Recruitment for both studies will commence in H222. We maintain our valuation of Medlab at A$236.1m or A$103.5/share.