3 minute read
Emyria
DR MICHAEL WINLO
MANAGING DIRECTOR
(ASX:EMD)
◾ Company Name: Emyria ◾ Company ASX code: EMD ◾ Key areas: Ultra-Pure Cannabinoid-based medical treatments, MDMA-inspired drug discovery, Real-World Data (RWD), specialist clinics ◾ Key Personnel: Dr Stewart Washer, Executive Chairman | Dr Michael Winlo, Managing Director | Dr Karen Smith, Executive Director ◾ Locations: Perth, Australia ◾ Market Cap as of 15/09/22: $68.75M ◾ 52 Week share price as of 15 September: $0.170 - $0.505 ◾ Company Website: www.emyria.com
COMPANY PROFILE
Emyria is an award-winning, clinicalstage biotech focused on accelerating the development of new treatments for unmet clinical needs. The company’s threepronged strategy involves collecting and analysing real-world data, using this data to improve formulations of and find new indications for select medications, and collaborating with leading institutions to develop life-changing treatments.
Emyria, one of three health and biotech companies to receive a significant multimillion dollar cash injection from Andrew Forrest’s private investment vehicle Tattarang, is kicking goals toward its endgame of creating a more efficient drug development system.
The company gathers ethically sourced evidence from patients across five independent Australian clinical sites, and that real-world data on over 6,000 patients is providing deep treatment and drug development insights.
In just eight months, the company has developed a proprietary Ultra-Pure CBD capsule, EMD-RX5, and demonstrated its safety, tolerability and performance compared to the global leading registered CBD medication, Epidyolex.
Emyria is preparing to begin phase three clinical trials of EMD-RX5 in FY23, after the drug received Human Research Ethics Committee approval, in parallel with the development of a second UltraPure CBD capsule, EMD-RX7.
The company is targeting global registration opportunities for these candidates as over-the-counter (OTC) and prescription-only medicines.
These EMD-RX cannabinoids will be among the first to achieve Australian OTC registration, a market worth +$200M a year. The company would then seek regulatory approval in other major markets including the US, which opens up a +US$1B a year opportunity.
Emyria has also made strides in its MDMA analogue program and has initiated pre-clinical studies. In 2021, the company partnered with elite Western Australian university to initiate the New Drug Development Program that aims to establish a large drug candidate library.
The library now comprises over 120 novel MDMA-like compounds, with three drug discovery priority areas identified. These priority areas include drug-assisted psychotherapy for major mental health disorders and novel, small molecule treatments for neurological disorders such as Parkinson’s disease. 2022 has been a defining year for Emyria, with the company named as one of ACS’ Digital Disruptors after its Openly digital solution took out the title of ICT Service Transformation for the Digital Consumer. Openly is a mobile phone app that can track vital signs via a user’s smartphone camera.
Emyria also bolstered its board and international reach by tapping global bio-pharmaceutical expert Dr Karen Smith to join its board. Dr Smith is a biotech/pharmaceutical executive, director and clinical/scientific advisor in the US, Europe, Canada, and Asia.
Her breadth of experience covers over 100 clinical trials and 20+ major regulatory approvals in multiple jurisdictions including FDA (USA), EMA (Europe), TGA (Australia), ANVISA (Brazil), and PMDA (Japan), leading to product launches across diverse therapeutic areas such as oncology, rare disease, cardiology, dermatology, neuroscience, and anti-infectives.
At the helm is Stanford University educated Dr Michael Winlo, who prior to joining Emyria served as CEO of Linear Clinical Research. Before that he lived in Silicon Valley where he worked for Palantir, helping major healthcare institutions in the US and UK solve complex data integration and analysis challenges.
Emyria is also backed by a board with drug registration and deep biotech experience which has built an extensive portfolio of real-world data and drug candidates that have outperformed in safety and efficacy tests.
KEY INVESTMENT HIGHLIGHTS
JULY 18, 2022: Emyria and the University of Western Australia make drug discovery. and development progress by expanding their proprietary MDMA analogue library. AUGUST 16, 2022: Human Research Ethics Committee approval granted, allowing Emyria to begin pivotal phase three trial of its Ultra-Pure CBD candidate, EMD-RX5. AUGUST 18, 2022: Emyria and the University of Western Australia receive positive screening results from the third batch of MDMA analogues sent to Eurofins.