Ann: Drug development webinar presentation, page-4

Hi all,

I logged in for the webinar yesterday and took some notes so wanted to jot them down here for anyone who may have missed it:

The intro was fairly standard around the company, partnerships and board.Following this, some of the upsides from the result were explained by giving relevant examples

·The sustained release is very good.If a patient is taking RX-5 at night then you want that to be being delivered and providing relief throughout those sleeping hours and not just in one sharp spike as we see with Epidyolex.

·The inter-patient variability was superior in RX-5 meaning a more predictable and reliable response and potentially more acceptable/palatable for patients. I would suggest reliability in a medicine and particularly one targeted at being OTC is a huge positive.

·The 100% synthetic nature of RX-5 means there is no THC or heavy metal impurities as there is found in natural cannabidiol oil based drugs.It also means that as there is no need to grow large warehouses of cannabis, which is quite water intensive, synthetic cannabidiol provides a much, ahem, ‘greener’ drug.

·There is an addressable market of around $200m for here in Oz in terms of the psychological distress space. Massive in the US and worldwide.I’ve written $100b in my notes but that might be referring to psychedelics as a whole.

·In terms of those animal models we talked about, Michael spoke a little about the differences seen.He said a canine models weren’t the best reflection of a human model but also went on to say that in the canine tests, RX-5 was delivered when the animal was in a fasted state.With human trials, it was taken with food which affects the bioavailability and thus the results seen.It was taken with food as this is the way it would typically be prescribed for use.The expectation with RX-7 is that we certainly should see higher bioavailability levels compared to Epidyolex.

·Coming soon (Q2 2022) is the phase III for RX-5 and that will be a double blind, randomised trial with 200 people.There will be four weeks of taking the drug and then four weeks of analysis following this.The key outcomes desired being much the same in terms of safety, efficacy, reliability and bioavailability.

·He spoke about some other stuff being considered for the US around the start of animal testing for some of the MDMA analogues and things like this but I had to rush off to an appointment so I’m not a hundy on what my notes are telling me.

All in all, a worthwhile chat and very good to see everything moving in the right direction.