Emyria to focus on initiating and completing pivotal clinical trials for EMD-003 program and advancing EMD-004 program

Emyria Ltd (ASX:EMD) will continue its focus on initiating and completing pivotal clinical trials for the EMD-003 program, seeking to register a cannabinoid-based medicine with a unique capsule dose form to reduce symptoms of anxiety, depression and stress. The data-backed drug development company is also advancing the EMD-004 program targeting irritable bowel syndrome and scoping pipeline expansion therapeutically (with psychedelic-assisted therapy) and geographically with the US Food and Drug Administration (FDA) pathways. The company will provide further updates to the market accordingly. Starts 2021 with great momentum Emyria managing director Dr Michael Winlo said Emyria had started 2021 with great momentum. “We have secured access to a unique CBD dose product via a partnership with Cann Group," he said. “Combined with our real-world data and drug development expertise, Emyria is well-positioned to commence our pivotal clinical trials, the important first steps towards successful registration of an over-the-counter CBD product with the TGA (Therapeutic Goods Administration). “We have also boosted our advisory teams with the addition of Dr Karen Smith and Dr Richard Magtengaard. “During the quarter, Emyria added two new clinical sites to support our pivotal trial programs and our plans to launch evidence-generating psychedelic-assisted therapy. “Emyria’s core remote monitoring technology was also recognised this quarter with a major grant award from the Western Australian Department of Health in partnership with collaborators at the University of Western Australia. “Finally, Emyria’s revenue figures for the quarter reflect the milestone nature of data deal payments but also our increased focus and investment into developing our primary strategic assets - those are our proprietary data and drug registration programs.” EMD-003 - unique cannabinoid for psychological distress Emyria and Cann Group Ltd (ASX:CAN) will seek accelerated registration of a unique, low-dose, CBD-only capsule with TGA. Successful registration as a Schedule 3 medicine would result in an over-the-counter, pharmacist-only CBD medicine. Emyria will lead the EMD-003 drug development program using Cann Group’s proprietary Gelpell microsphere technology to register a unique capsule form. The collaboration capitalises on a number of registration milestones already met: Real-world clinical data collected on >170 patients already taking the dose form; Pivotal trial protocols developed for target indication; Phase 1 trials already completed for 10mg and 100mg doses of the capsule; and Gelpell has been shown to have 3.5 times the bioavailability of oils (at 100mg) Emerald Clinics expansion The company added Emerald Clinic sites in East Melbourne in Victoria and Perth in Western Australia. New premises in East Melbourne are co-located with Victorian Counselling and Psychological Services, boosting Emyria’s access to mental health services. This also gives further expansion opportunities in planning to support the delivery of evidence-generating psychedelic-assisted therapy trials. It also increases patient access to Emerald Clinics and supports pivotal registration trials planned for EMD-003 targeting unmet needs in mental health. In Perth, it is co-located with West Leederville Private Hospital, where there is potential to double capacity. Additional clinical rooms will also help support the pivotal clinical trials, currently in planning, in support of the registration of EMD-003 and delivery of the grant from the WA Government: Openly - remote monitoring digital health platform Emyria’s Openly was awarded a grant from WA’s Future Health Research and Innovation Fund, aimed at boosting WA’s digital health infrastructure and capacity to manage health challenges like COVID-19. Emyria will take a leadership role in the grant and will lead a multidisciplinary collaboration involving the state’s major health services and universities. The grant will also extend Emyria’s collaboration with Mt Sinai, New York. Strategic advisory expansion In the quarter, the company appointed global pharmaceutical expert Dr Karen Smith to chair Emyria’s strategic advisory board. It also appointed Dr Richard Magtengaard, consultant psychiatrist, to its medical advisory board and support Emyria’s multiple mental health focussed initiatives. Cash Emyria had $3.5 million cash as of March 31, 2021. Subsequent to the quarter, in April, Emyria completed a capital raising of $5 million to accelerate its planned clinical studies and business expansions.