Emyria - A unique data-backed cannabinoid drug development company.
A few notes on Emyria, a company which I believe has potential to be an exceptional performer in 2021.
Corporate Structure
Listed on ASX on 12 Feb 20
Market Cap: $19.3m
Share Price: 8.6c
Shares on Issue: 225.5m, 100m escrowed
Board & MGT: 70.1m shares
Approx. Cash: Circa 5mill
No Debt
EV: $14.3m
Comparable CBD Pharma Companies
Emyria's Drug Development Pipeline
a) EMD-003
- Emyria’s Real World Evidence has identified a unique dose range of cannabidiol that significantly improves mental health (reduces anxiety/ stress/depression symptoms) in a specific patient population. This data has been gathered from patients treated at Emyria’s clinical service subsidiary, Emerald Clinics.
- Program aims to address the growing mental health burden which cost the Australian health system alone, $9.9B AUD in 2017-2018
- Patents have been filed by the company on the back of this data re mental health claims
- Design of Pivotal Registration Trial is underway
b) EMD-004
- Emyria has received strong interest in its CALM-GUT Study from potential participants, where up to 200 people will be included in the study, expected to last 12 months
- Emyria is undertaking this observational study as an important step towards generating evidence of efficacy and safety for routinely prescribed medicinal cannabis for the management of symptoms in patients with irritable bowel syndrome (IBS)
- IBS affects around 11% of the population globally and is a significant unmet need often associated with greater levels of anxiety and lower quality of life measures.
Due to the large amount of high quality data collected by EMD to date, IMO an opportunity exists for the company to become one of the very few to attain TGA/FDA registration for one or more of their CBD products. 75% of recent FDA approvals incorporate real-world evidence and this figure is growing. To put the significance of this into perspective,
currently there is only one (YES ONE!) TGA/FDA approved CBD product, Epidiolex®, which has approval for the management of Dravet and Lennox-Gastaut syndromes. That drug is sold by
GW Pharma with a market cap of 3.68B USD.
All other CBD products accessed by patients in Australia are via the Special Access Scheme, which is niche and expensive, as there is not enough data with these products for governments to subsidise. As a result there are only a total of ~50k CBD prescriptions per year across all indications in Australia at present… now compare that with the 29 million prescriptions for antidepressants/ anxiolytics per year. IMO this is why it is pivotal for CBD companies to progress towards formal registration of their products, which will allow them to be utilised much like any other medication prescribed by a GP.
Therecent TGA Schedule 3 announcement regarding CBD is good news for AustralianCannabis co’s, however what people may have missed is the ongoing strictrequirements for high quality, product-specific, clinical evidence in order toobtain registration of low-dose CBD products as Schedule 3 medicines on theAustralian Register of Therapeutic Goods (ARTG). This means that companieswithout the data to support registration will not be able to dispense theirproducts via Australian pharmacies under S3, and companies with robust clinicaldata (such as Emyria) will be able to access a much larger addressable marketif/when product registration is achieved.
Giventhat EMD began its corporate journey as a clinic and Real World Evidence datacollection co, I believe the company has enormous potential to roll out many more drug development programs targetingunmet medical needs in the coming months/ years.
EMDis also working with Mind Medicine Australia, leaders in psychedelic-assistedtreatment, to advance the delivery of these therapies in Australia. Initialfocus will be specialist-directed use of MDMA assisted therapies for treatmentresistant post-traumatic stress disorder and psilocybin assisted therapies fortreatment resistant depression. IMO lots of potential for EMD to be a leader inthis nascent space, much like cannabis a few years ago. The only other ASXlisted co peer comparison that I can find is IHL (MC ~155mill), which isassessing the efficacy of psilocybin in treating anxiety.
Thereare a number of other aspects of the business not mentioned above (such as theclinic business, data sales to date, remote monitoring/device), however it ismy personal belief that the re-rating of EMD will come primarily from theadvancement of the aforementioned programs, which have the ability tomeaningfully change access to CBD products both in Australia and other majormarkets.
All in my opinion and research. Good luck and please do your own research. 
