Announcement PDF Delivering & developing new treatments for mental health & neurological conditions ASX Announcement | 28 October 2024 Emyria Secures Ethics Endorsement for Psilocybin-Assisted Therapy Program HIGHLIGHTS Emyria’s lead psychiatrists have received endorsement from the ACT Health Ethics Committee for its psilocybin-assisted therapy program. The approval is the first stage of a 2-step evaluation; final approval is still required from Australia’s Therapeutic Goods Administration and is expected within the next month. Recent findings suggest that psilocybin-assisted therapy, with psychological support, leads to long-term improvements in depressive symptoms for treatment-resistant depression. 1 The psilocybin program complements Emyria’s existing MDMA-assisted therapy programs, reinforcing Emyria’s leadership in medication-assisted therapy delivery and development for serious mental health conditions. Emyria Limited (ASX: EMD) (‘Emyria’, or the ‘Company’) is pleased to announce its lead psychiatrists have received endorsement from the ACT Health Ethics Committee, supporting the submission of Authorised Prescriber applications with the TGA for its psilocybin-assisted therapy program targeting treatment-resistant depression. This endorsement is an important step towards expanding Emyria’s capacity to offer innovative mental health treatments directly to eligible patients under TGA’s Authorised Prescriber framework. With TGA approval anticipated in the next month, Emyria will be amongst a select group capable of offering both MDMA- and psilocybin-assisted therapies, to eligible patients, backed by its experience in safe, evidence-based mental health care. Emyria’s founding mission is to maximise patient outcomes by delivering safe and effective therapies, while continuously gathering data to refine and improve our treatment protocols. By expanding into psilocybin-assisted therapy, Emyria aims to not only address critical gaps in care for those with treatment-resistant depression but also to enhance the understanding and effectiveness of innovative mental health treatments. This data-driven approach strengthens Emyria’s commitment to pioneering new options for complex mental health challenges while building a foundation to develop future treatments. Emyria’s Leadership in New Treatment Delivery and Development Following the TGA’s rescheduling of MDMA and psilocybin for PTSD and treatment-resistant depression2, access to these therapies remains limited to clinical trials or specialist psychiatrists who have secured Authorised Prescriber (AP) status. Achieving AP status requires endorsement from an NHMRC-accredited ethics committee or the Royal Australian and New Zealand College of Psychiatrists (RANZCP) and involves submitting a comprehensive care model that includes psychotherapy and patient monitoring. Emyria ASX Announcement | 28 Oct 2024 1 Emyria to Expand Treatment Programs For over a year, Emyria has led the evaluation of a real-world MDMA-assisted therapy program for PTSD 3 from a purpose-built facility 4 and with specially trained clinicians. Adding psilocybin-assisted therapy to this framework demonstrates Emyria’s unique leadership and opportunity to deliver, and advance, new options for major unmet needs in mental health. Recent Research on Psilocybin Therapy for Treatment-Resistant Depression About a third of patients with depression experience treatment-resistant depression), meaning they do not respond to conventional therapies.5 This significant group of treatment-resistant patients highlights the urgent need for alternative treatment options. Recent findings published in The Lancet highlight psilocybin’s potential to provide substantial, long-lasting improvements in depressive symptoms and quality of life for individuals with moderate-to-severe depression, even after other treatments have failed 1. This research supports Emyria’s expansion into psilocybin-assisted therapy, building on our experience with MDMA-assisted therapy and reinforcing our commitment to providing effective options for complex mental health conditions. Emyria’s Managing Director, Dr. Michael Winlo, commented: “This ethics endorsement is a significant milestone in our commitment to delivering effective, evidence-based treatments for patients with complex mental health needs. By expanding into psilocybin-assisted therapy alongside our established MDMA program, Emyria is broadening care options for patients while advancing our mission to continuously improve these treatments and patient outcomes over the long-term. Emyria is uniquely positioned to lead in this space, and we’re excited to build on our experience to dramatically improve health outcomes safely and responsibly.” References: 1. 2. 3. 4. DE, Tommaso Barba, et al Effect of psilocybin versus escitalopram on depression symptom severity in patients with moderate-to-severe major depressive disorder: observational 6-month follow-up of a phase 2, double-blind, randomised, controlled trial, eClinicalMedicine, Volume 76, 2024, 102799, https://doi.org/10.1016/j.eclinm.2024.102799. https://www.tga.gov.au/products/unapproved-therapeutic-goods/mdma-and-psilocybin-hub See ASX release 02 September 2024 See ASX release 09 April 2024 This release has been approved by the Board of Emyria. For further information, investment opportunities, or more about our approach to mental health treatment, please contact: Managing Director Michael Winlo +61 (0) 8 6559 2800 mwinlo@emyria.com Emyria ASX Announcement | 28 Oct 2024 Media Contact Haley Chartres +61 (0) 423 139 163 haley@hck.digital Corporate Advisor Sufian Ahmed +61 (0) 412 316 162 info@62capital.com.au 2 emyria.com Emyria Limited develops and delivers new treatments for mental health and select neurological conditions through through an integrated model of direct clinical services and drug development: generates Emyria Healthcare: Evidence-based treatment for patients not finding relief from conventional care while also helping evaluate emerging new therapies like MDMA-assisted therapy for PTSD Emyria Data: Robust and ethically-sourced Real-World Data gathered with patients and used to improve Emyria’s unique therapy and drug development programs. informs Emyria’s Pipeline: New psychedelic-assisted therapies and drug treatments for mental health and select neurological diseases. 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. Risks associated with the use of Psilocybin and MDMA All medicines carry risks and specialist prescribers, such as registered psychiatrists, are best placed to assess the suitability of a new medication against a patient’s individual circumstances and medical history before proceeding. Adverse effects of psilocybin can include temporary increase in blood pressure and a raised heart rate. Adverse effects of MDMA include high blood pressure, increased pulse rate, faintness, and panic attacks, and in some rare cases it can cause loss of consciousness or trigger seizures. Other side effects include involuntary jaw clenching, decreased appetite, restless legs, nausea, headache, sweating and muscle/joint stiffness. These effects of psilocybin and MDMA are unlikely at low doses in the treatment regimens used in psychedelic-assisted psychotherapy while appropriately managed in a controlled environment with direct medical supervision. Emyria ASX Announcement | 28 Oct 2024 3