Emyria Ltd (ASX:EMD) is in a strong financial position to deliver on drug registration priorities this year, with an operating profit of $100,000 and operating sales of $1.1 million reported in the six months to December 31, 2020.
The company’s total cash in hand at the end of the year 2020 was around $4.8 million, an increase of 32% compared to $3.7 million on December 31, 2019.
Looking ahead for 2021, the company is focused on the registration of its EMD-003 treatment for mental health, trial recruitment for its EMD-004 treatment for IBS, and the development of its remote monitoring platform Openly.
Targeting EMD-003 registration
Emyria’s candidate for mental health, EMD-003, is a leading cannabinoid drug program seeking registration as a Schedule 3 medicine and aims to treat psychological distress and the symptoms of anxiety, depression and stress for certain patient populations.
Managing director Michael Winlo said: “Our first program EMD-003, is targeting registration as a Schedule 3 cannabidiol (CBD) medicine and will benefit from the TGA decision to de-schedule low-dose CBD.
“Schedule 3 medicines are managed by Pharmacists, are available over-the-counter and do not require a prescription from a doctor.
“We are focused on delivering and completing the required pivotal clinical trials required to successfully register EMD-003 and further expanding our clinical services nationally to meet demand.”
Data analysed by Emyria’s identified specific patient populations that appear to have a safe and favourable response to specific doses of CBD.
EMD-004 trial recruitment
The company’s other drug candidate EMD-004 is a cannabinoid-based medicine focused on treating symptoms associated with irritable bowel syndrome - a large unmet need.
IBS is common and affects around 3 out of every 10 people, however in Australia, there are no medicines designed specifically for the condition.
Emyria’s observational trial on IBS has ethics approval and recruiting is currently underway.
Openly remote monitoring platform
The company plans to support strategic development into its remote monitoring platform - Openly - with an application for Class II TGA registration submitted in the December quarter for the platform’s smartphone-led heart rate and heart rate variability measurement technology.
These vital sign measures are related to psychological distress - which can be early signs of infection or mental health changes and could be important to the development of EMD-003.
The company also continues to work with Mt Sinai hospital (NY) on the development of this technology and has applied for several grants to further develop Openly and its application to mental health.
Mind Medicine Australia partnership
The company is also working on a design care model describing how psychedelic-assisted therapies could be delivered safely to patients with major mental health concerns.
Mind Medicine Australia will provide the company access to its international network of experts, clinical trainers and treatment model strategies.
The model will start with psilocybin and MDMA-assisted therapies and draw on pivotal research conducted recently in North America and Europe.
Emyria will also apply its remote monitoring technology and lead the construction of a longitudinal data registry.
Real-world data registry
The registry will collect real-world clinical data on diagnoses, concomitant medications, dosing information and patient responses to psychedelic-assisted treatments as measured using validated clinical and patient-reported endpoints.
The data will support ongoing research into the safety, effectiveness and cost benefits of psychedelic-assisted therapies for major mental health concerns compared to current alternatives.
Winlo said: “Emyria’s strategic investments into growing and improving our data asset were validated by the launch of our own, independent, drug development programs targeting major under-served medical needs.
“Each program is being backed by IP and insights from the internal analysis performed on our proprietary data asset.
"In addition, our TGA-registered remote monitoring system and service, Openly, was recognised in a major successful grant award and we continue to expand our care model to promising new therapy areas with a partnership with Mind Medicine Australia.
“Meanwhile, patient demand for our care model continues to increase which led to record clinic utilisation and our first operational profit for the quarter and a strong cash position.”