Announcement PDF ASX Announcement 23 Mar 2023 Strong recruitment for EMD-RX5 Phase 3 trial HIGHLIGHTS Phase 3 trial on track to conclude July 2023; To date: ● 50 patients currently dosed; ● 83 additional patients waiting for final eligibility assessment ahead of dosing ● 1,830 patients registered for pre-screening, demonstrating strong patient demand Recruitment and dosing expected to accelerate supported by Emyria’s Emerald Clinics and final two sites (of a total of 9), and based in ACT and SA, to commence dosing this week EMD-RX5 has a Large Potential Patient Market: Mild anxiety and stress affect up to 15% of the adult population 1, with a higher prevalence in patients with chronic disease, such as chronic pain, which affects around 2.8 million adults in Australia 2 ; No OTC treatment currently available for Emyria’s initial target indication; EMD-RX5 has the potential to address a significant unmet need in the OTC market as well as expand to other markets and indications Emyria Limited (ASX: EMD), (Emyria or the Company) a clinical stage biotech, is pleased to share that 50 patients have been successfully enrolled and over 100 patients successfully screened in a pivotal Phase 3 clinical trial to support the registration of EMD-RX5 as an over-the-counter medicine. Emyria’s OTC trial program is on track to complete recruitment by July 2023 with a clinical efficacy read-out anticipated in the subsequent month. EMD-RX5 is Emyria’s first, Ultra-Pure CBD capsule targeting TGA registration as an over-the-counter (OTC) treatment for the symptoms of mild stress and anxiety for patients with a chronic health condition. EMD-RX5 is a solid capsule of Ultra-Pure CBD, a preferred dosage form for patients and prescribers. % Patients on Phase 3 Clinical Trial (and estimated) 100 Patients dosed & on-trial Waiting final eligibility check 75 50 Projected enrollments Additional 83 patients screened & waiting to be dosed in subsequent months (- 43 % of target dosed or waiting) 25 0 Jan Feb Mar Apr May Jun Jul Dosing started Jan 31 5 sites open Emyria ASX Announcement | 23 Mar 2023 7 sites open (as of 23 March) All 9 sites open 1 Towards an OTC medication Currently, the market for registered CBD medicine is dominated by Jazz Pharmaceuticals' Epidyolex oil, a prescription medication for rare seizure disorders that generates over AUD$1B in annual sales globally. 3 While the TGA has allowed low dose CBD (<150mg/day) to be registered as an OTC medicine since December 2020, no CBD product has yet achieved this registration. 4 Emyria's EMD-RX5 is a proprietary formulation of Ultra-Pure CBD and has been developed as a potential over-the-counter CBD medication. EMD-RX5 development was based on insights from Emyria's unique Real-World Data gathered with over 8,000 patients prescribed pharmaceutical-grade cannabinoid medicines at their clinical service subsidiary, Emerald Clinics. Notably, EMD-RX5 contains no THC or impurities, and requires less cost, energy, and water to produce than plant-based CBD products. In a head-to-head PK study EMD-RX5 demonstrated excellent bioavailability, safety, tolerability, and lower dose variability compared to Epidyolex oil. 5 Emyria’s initial target indication is to treat the symptoms of mild anxiety and stress in patients with a chronic condition. Anxiety and stress affect up to 15% of the adult population with a higher prevalence in patients with chronic disease, such as chronic pain which affects around 2.8 million adults in Australia. 1, 2 Emyria’s Real World Data suggests up to 50% of patients with Chronic Pain experience anxiety and stress symptoms. There is currently no OTC treatment for these symptoms and Emyria sees a significant opportunity for EMD-RX5 to address this unmet need in the OTC market. EMD-RX5 is the only CBD medication targeting the symptoms of anxiety and stress and is aiming to be the first to market. 1. 2. 3. 4. 5. https://www.aihw.gov.au/reports/burden-of-disease/abds-impact-and-causes-of-illness-and-death-in-aus/summary AIHW “Chronic Pain In Australia” (published May 2020) https://investor.jazzpharma.com/news-releases/news-release-details/jazz-pharmaceuticals-announces-full-year-and-fourth-quarter-2022 https://www.tga.gov.au/news/media-releases/over-counter-access-low-dose-cannabidiol See ASX release 25 May 2022 Emyria ASX Announcement | 23 Mar 2023 2 KEY PHASE 3 INFORMATION: Study design, product and participant details: A multi-site, parallel-arm, randomised, double blind, placebo-controlled study to investigate the effect of EMD-RX5 on symptoms of psychological distress in adults with chronic pain. 300 participants aged 18-70 with symptoms of stress and a background of chronic pain will be randomised to one month of treatment with either 50mg EMD-RX5, 150mg EMD-RX5 or matching placebo. Primary endpoint: To determine the effect of EMD-RX5 treatment on symptoms of psychological distress in participants with chronic pain through change in self-reported DASS-21 score from baseline to Week 4. Patient registration: https://trials.evrima.com/stress-anxiety-medical-study “An accessible, convenient and effective over-the-counter treatment for psychological distress could have a significant impact on the quality of life and health outcomes for patients, especially those with chronic disease. We are very pleased that patient recruitment for our clinical trial is strong and I look forward to updating the market as our program advances ” - Emyria’s Managing Director, Dr Michael Winlo - This release has been approved by the Board of Emyria. - FOR FURTHER INFORMATION Dr. Michael Winlo Managing Director +61 (0) 8 6559 2800 mwinlo@emyria.com Lexi O’Halloran Investor Relations +61 (0) 404 577 076 investors@emyria.com Emyria ASX Announcement | 23 Mar 2023 Andrew Williams Media Relations +61 (0) 412 614 125 awilliams@emyria.com Sufian Ahmad Corporate Advisor +61 (0) 412 316 162 info@62capital.com.au 3 UPCOMING MILESTONES CLINICAL PROGRAMS “direct-to-consumer” “prescription medicine” PRE-CLINICAL + THERAPY PROGRAMS New Drug Discovery MDMA-assisted therapy Formulation optimisation (RX5) Formulation optimisation (RX7) Continuous creation & screening Protocol developed Phase 1 study done Phase 1 First patent family filed Clinical partnerships Phase 3 commencement Pre-IND (FDA) US-focused preclinical program Real-World Data system Regulatory submission Pivotal trials Metabolic studies MDMA supply secured Lead selection Therapist training Phase 1 trials First patient Global commercial strategy Global commercial strategy Commercial strategy Australia Commercial strategy Europe Commercial strategy USA ABOUT EMYRIA | emyria.com Emyria Limited is a clinical drug development and care delivery company focused on accelerating drug development and improving patient outcomes in neuroscience and mental health via: ● Drug Development: Emyria is developing multiple, proprietary, Ultra-Pure cannabinoid dose forms suitable for registration against multiple indications. Emyria’s first dose form, EMD-RX5, is in Phase 3 trials. ● New Drug Discovery: Inspired by MDMA, Emyria is developing one of the world’s largest libraries of MDMA-like compounds with partner, the University of Western Australia. ● Proprietary Real-World Data (RWD): Emyria gathers robust and ethically-sourced data with patients cared for at Emyria’s own specialist clinical service (Emerald Clinics). Emyria RWD can help support drug development and care model improvement. EMYRIA’S INTERACTIVE INVESTOR HUB Investorhub.emyria.com Interact with Emyria’s announcements and updates by asking questions and comments, which our team can respond to where possible. CAUTIONARY NOTE ON FORWARD-LOOKING STATEMENTS Any statements in this press release about future expectations, plans and prospects for the Company, the Company’s strategy, future operations, and other statements containing the words “anticipate,” “believe,” “estimate,” “expect,” “intend,” “may,” “plan,” “predict,” “project,” “target,” “potential,” “will,” “would,” “could,” “should,” “continue,” and similar expressions, constitute forward-looking statements. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including: the Company’s ability to successfully develop its product candidates and timely complete its planned clinical programs and the Company’s ability to obtain marketing approvals for its product candidates. In addition, the forward-looking statements included in this press release represents the Company’s views as of the date hereof. The Company anticipates that subsequent events and developments will cause the Company’s views to change. However, while the Company may elect to update these forward-looking statements at some point in the future, the Company specifically disclaims any obligation to do so. These forward-looking statements should not be relied upon as representing the Company’s views as of any date subsequent to the date hereof. Emyria ASX Announcement | 23 Mar 2023 4