Medlab Clinical - UK compassionate use for alternative to opioids

Medlab Clinical has announced that it has received approval from the UK Medicines and Healthcare Products Regulatory Agency (MHRA) for its lead product NanaBis (NanaDol in the UK) to be used under its Named Patient Program and other compassionate areas. NanaDol, a botanical version of NanaBis as a 50:50 formulation of CBD and THC, has previously shown encouraging Phase I/II data for the treatment of cancer-induced bone pain and a potentially valuable alternative to opioids. We see the MHRA approval as an encouraging development as it allows Medlab to generate additional real-world data to support the anticipated Phase III clinical trial of synthetic NanaBis in FY23. Positive feedback from compassionate use may create patient advocates and key opinion leaders for the drug. In our view, this new approval provides further regulatory validation for Medlab’s NanaBis/NanaDol product and the NanoCelle platform in general. We maintain our valuation of Medlab at A$236.1m or A$103.5/share.