Announcement PDF Responding to the urgent need for innovation in mental health ASX: EMD ABN 96 625 085 734 2024 ANNUAL REPORT CARE DELIVERY Commenced MDMA-AT trials, opened first Empax Centre TREATMENT DEVLOPMENT Progressed patented MDMA analogue program, secured grants Page 1 ADVANCED THERAPIES, COMPASSIONATE CARE EMYRIA LIMITED ABN 96 625 085 734 CORPORATE DIRECTORY Directors Gregory Hutchinson (Non-Executive Chairman) Dr Michael Winlo (Managing Director) Dr Karen Smith (Non-Executive Director) Professor Sir John Tooke (Non-Executive Director) Dr Mohit Kaushal (Non-Executive Director) Company Secretary Susan Park Principal and Registered Office D2, 661 Newcastle Street, Leederville WA 6007 Telephone: 08 6559 2800 Website: www.emyria.com Email: info@emyria.com Share Registry Automic Pty Ltd Level 5, 191 St Georges Terrace Perth, Western Australia 6000 Auditor Stantons Level 2, 40 Kings Park Road West Perth, Western Australia 6005 Bankers National Australia Bank Level 14, 100 St Georges Terrace Perth, Western Australia 6000 Domestic Stock Exchange Australian Securities Exchange (ASX) Code: EMD Page 2 EMYRIA LIMITED ABN 96 625 085 734 CORPORATE DIRECTORY CONTENTS Directors Gregory Hutchinson (Non-Executive Chairman) Michael Winlo (Managing Director) LetterDr from the Chairman and Managing Director Dr Karen Smith (Non-Executive Director) Directors’ Report Professor Sir John Tooke (Non-Executive Director) Dr Mohit Kaushal (Non-Executive Director) Consolidated Statement of Profit or Loss and Other Comprehensive Income Company Secretaryof Financial Position Consolidated Statement Susan Park Consolidated Statement of Changes in Equity Principal and Registered Office Consolidated StatementStreet, of Cash Flows WA 6007 D2, 661 Newcastle Leederville Notes to the Consolidated Financial Statements Telephone: 08 6559 2800 Website:Entity www.emyria.com Consolidated Disclosure Statements Email: info@emyria.com Directors’ Declaration Share Registry Auditor’s Independence Automic Pty Ltd Declaration Level 5, 191 St Georges Terrace Independent Auditor’s Report Perth, Western Australia 6000 4 6 25 26 27 28 29 64 65 66 67 Additional ASX Information Auditor Stantons Level 2, 40 Kings Park Road West Perth, Western Australia 6005 72 Bankers National Australia Bank Level 14, 100 St Georges Terrace Perth, Western Australia 6000 Domestic Stock Exchange Australian Securities Exchange (ASX) Code: EMD Page 3 EMYRIA LIMITED ABN 96 625 085 734 CHAIR AND MANAGING DIRECTOR’S LETTER For the year ended 30 June 2024 Dear Shareholders, Dear Shareholders, On behalf of the Board of Emyria Limited (Emyria or the Company), we are pleased to On behalf ofCompany’s the Board, 2024 we are pleased to present Emyria’s 2024 Annual Report. present the Annual Report. Positioning for Growth and Impact in Mental Health This financial began with a transformative milestone for mental health care in Australia financialyear year began with a transformative milestone for mental health care in with the On formal pathway for psychedelic-assisted therapy (PAT) established on Australia: July legal 1st, 2023, the formal legal pathway for psychedelic-assisted therapy (PAT) 1was Julyestablished. 2023. Since Since our our founding, founding, Emyria Emyria has has been been pioneering pioneering a a unique unique model model of of direct direct clinical clinical care care and and treatment development in emerging therapeutic fields. Australia’s momentous regulatory change has provided our Company with a significant opportunity to evaluate the potential PATand andtackle tackle serious mental health challenges—now the prevalent most prevalent of PAT serious mental health challenges - now the most chronicchronic health health condition adults and disproportionately affecting younger generations. condition amongamong adults and disproportionately affecting younger generations. To further on on 3 July 2023, the acquisition of the Pax Centre, furtherthis thismission, mission, July 1st, we we announced also acquired the Pax Centre, a leading, a leading, multidisciplinary clinical service specialising in psychological trauma and multidisciplinary clinical service specialising in psychological trauma care and care recovery. recovery. This strategic gave acquisition gave us an immediate foundation to expandWith our This strategic acquisition us an immediate foundation to expand our capabilities. the Pax Centre’s patient base, we were able base, to swiftly capabilities. Withexpertise the Pax and Centre’s expertise and patient we establish were ablethe to Empax swiftly Centre—athe facility uniquely to uniquely deliver and evaluate evidence of establish Empax Centredesigned - a facility designed to PAT—further deliver and evaluate PAT Emyria’s ability to execute on our first-mover strategy in this new therapeutic space. - further evidence of Emyria’s ability to execute on our first-mover strategy in this new therapeutic space. PAT represents a potential breakthrough in mental health care. Early evidence shows that carefully administered psychoactive medications, alongside skilled and supportive therapy, PAT represents a potential breakthrough in mental health care. Early evidence shows that can lead to transformative patient outcomes. Since Australia is the only country with a legal carefully administered psychoactive medications, alongside skilled and supportive therapy, access pathway for PAT, Emyria compelling opportunity PAT safely and at can lead to transformative patienthas outcomes. Since Australia is to theprovide only country with a legal scale, while also driving ambitious innovation opportunity pipeline of new drugs and This access pathway for PAT,an Emyria has compelling to provide PATtherapies. safely and at is howwhile we aim todriving make immediate and lasting difference in new the lives of and patients. scale, also an ambitious innovation pipeline of drugs therapies. This is how we aim to make immediate and lasting differences in the lives of patients. In fact, the early clinical results from our Post-Traumatic Stress Disorder (PTSD) program have been highly encouraging, especially for patients who have been (PTSD) unresponsive to In fact, the early clinical results from our Post-Traumatic Stress Disorder program conventional treatments. As we continue data with patients engage with have been highly encouraging, especiallyto forgather patients who have beenand unresponsive to major payers, treatments. we are confident can leverage the support for our services executewith our conventional As wewe continue to gather data with patients andtoengage national growth plans and expand access to more patients in need. major payers, we are confident we can leverage the support for our services to execute our national growth plans and expand access to more patients in need. Emyria’s Strategic Milestones Emyria’s Strategic Milestones This year, we made significant progress strengthening our clinical and innovation pipelines: This year, we made significant progress strengthening our clinical and innovation pipelines: • Acquired the Pax Centre and launched the Empax Centre - increasing our PAT • Acquired the Paxdevelopment Centre and launched the Empax Centre - increasing our PAT delivery delivery and capabilities. and development capabilities. • Delivered encouraging early clinical results, laying the foundation for engagement with insurers and payers, which we believe can help further accelerate growth. • Delivered encouraging early clinical results, laying the foundation for engagement with • Advanced our MDMA-inspired drug discovery program, in collaboration with the insurers and payers, which we believe can help further accelerate growth. University of Western Australia, and secured non-dilutive funding. Our CBD assets are alsoour progressing through drug a fullydiscovery funded program with NIH in the USA. • Advanced MDMA-inspired program, inthe collaboration with the University of Western Australia, and secured non-dilutive funding. Our CBD assets are These milestones position us well for future success. With key revenue growth and early also progressing through a fully funded program with the NIH in the USA. cost efficiencies achieved, we believe Emyria is on a path to sustainable profitability. As we scale our clinical services, engage payers, and refine our therapeutic models, we expect to see both operational growth and financial returns. Meanwhile, our unique drug discovery program has the potential to deliver long-term shareholder value. Page 4 Page 4 EMYRIA LIMITED ABN 96 625 085 734 CHAIR AND MANAGING DIRECTOR’S LETTER For the year ended 30 June 2024 Looking Ahead: A Unique Investment Opportunity These milestones position us well for future success. With key revenue growth and early Emyria represents a rare investment are delivering impactful patient care cost efficiencies achieved, we believeopportunity. Emyria is onWe a path to sustainable profitability. today while advancing an innovation pipeline that has the potential to shape the future As we scale our clinical services, engage payers, and refine our therapeutic models, we of mental health treatment. Our PTSD program is growing and the upcoming launch of expect to see both operational growth and financial returns. Meanwhile, our unique drug additional programs, including a program for treatment-resistant depression, means we discovery program has the potential to deliver long-term shareholder value. are well-positioned to expand our impact and serve a larger patient base. Looking Ahead: A Unique Investment Opportunity We are confident that our leadership and track record in this space, combined with Emyria represents a rare investment opportunity. We edge are delivering impactful patient Our Australia’s regulatory advantage, offers a competitive that is difficult to replicate. care today while advancing an innovation pipeline that has the potential to shape the strategy is clear: Expand our clinical services, engage payers to scale, and leverage datafuture of mental health treatment. Our PTSD program is growing and the upcoming driven insights to continue refining both therapies and medications. This combination of launch of additional programs, including a program treatment-resistant depression,for immediate impact and long-term potential makes for Emyria a compelling investment those looking support a company withour a powerful mission the capability to deliver means we areto well-positioned to expand impact and serveand a larger patient base. strong financial returns. We are confident that our leadership and track record in this space, combined with Australia’s regulatory advantage, offers a competitive edge that is difficult to replicate. Thank you for your continued support. Our strategy is clear: Expand our clinical services, engage payers to scale, and leverage data-driven insights to continue refining both therapies and medications. This Sincerely, combination of immediate impact and long-term potential makes Emyria a compelling investment for those looking to support a company with a powerful mission and the capability to deliver strong financial returns Thank you for your continued support. Greg Hutchinson Non-Executive Chair Yours sincerely, Michael Winlo Managing Director Greg Hutchinson Greg Hutchinson Michael Winlo Non-Executive Chair Managing Director Page 5 Page 5 EMYRIA LIMITED ABN 96 625 085 734 DIRECTORS’ REPORT For the year ended 30 June 2024 The directors present their report for Emyria Limited (“Emyria” or “the Company”) and its subsidiaries (“the Group”) for the financial year ended 30 June 2024. Directors The names of the directors in office at any time during or since the end of the year ended are: Mr Gregory Hutchinson Dr Michael Winlo Dr Karen Smith Professor Sir John Tooke Dr Mohit Kaushal Dr Stewart Washer Mr Matthew Callahan Professor Dr Alistair Vickery Non-Executive Chairman (appointed 21 November 2023) Managing Director Non-Executive Director Non-Executive Director Non-Executive Director (appointed 21 August 2023) Non-Executive Chairman (since 13 November 2023 before resigning 21 November 2023) Non-Executive Director (resigned 22 August 2023) Executive Medical Director (resigned 13 November 2023) Review of operations The principal continuing activity of the Group is delivering and developing new treatments for unmet needs in mental health and select neurological conditions guided by Real-World Data collected with patients across its wholly owned clinical service subsidiaries. Significant changes in state of affairs During the reporting period, the Group's principal activity has been the delivery and development of new treatments for unmet needs in mental health and select neurological conditions. The Group’s innovation pipeline comprises medication-assisted treatment programs and biopharmaceuticals, specifically novel MDMA analogues and Ultra-Pure CBD capsules. The Group’s innovation pipeline is informed by Real-World Data gathered from patients across its wholly-owned clinical service subsidiaries. The Group has strategically concentrated on advancing the development and commercialisation of these proprietary medicines, while simultaneously launching its MDMA-assisted therapy program to broaden its impact in the mental healthcare sector. Benefiting from its extensive experience in collecting data while working with newly rescheduled medicines, the Group responded strategically to pivotal regulatory changes allowing MDMA and psilocybin to be prescribed as legal medicines in Australia from July 1, 2023. The Group is poised to become a leader in the evolving field of psychedelic-assisted therapies. Key Milestones for Emyria: Clinical Expansion and Research • September 2023: Emyria completes the acquisition of Mind Body Consulting Pty Ltd, trading as the Pax Centre: o The Pax Centre is a top-tier multidisciplinary service specialising in psychological trauma care. This strategic acquisition strengthens Emyria’s leadership in psychedelic-assisted therapy, enhances clinical revenue potential, and supports robust data collection for the Group’s drug development programs. • October 2023: Emyria achieves key milestones in its MDMA-assisted therapy (MDMA-AT) program: o Ethics endorsement received from an NHMRC-accredited ethics committee for MDMA-AT trials. o Health Canada approval granted for MDMA import, supporting up to 70 patients. o First participant safely dosed under the new TGA regulatory framework, marking a significant milestone for the program and Emyria’s ability to collect real-world data. Page 4 Page 6 EMYRIA LIMITED ABN 96 625 085 734 DIRECTORS’ REPORT For the year ended 30 June 2024 • April 2024: Emyria opens the Empax Centre: o A state-of-the-art facility dedicated to advanced mental health treatment and research, including MDMA-assisted therapy for PTSD. o The Centre is led by Australia’s first authorised MDMA-AT prescribers with potential for national and global scalability. • June 2024: Empax Centre selected as key trial site for Transcend Therapeutics’ “IMPACT-2” PTSD study: o Selection underlines the Centre’s advanced research capabilities and infrastructure. o Emyria expected to earn market-rate fees for specialist work performed during the trial. Authorised Prescriber Approvals • October 2023 - April 2024: Emyria expands its team of authorised prescribers for MDMA-AT: o October 2023: Emyria’s key specialist psychiatrist receives AP approval from the TGA. o April 2024: Emyria’s second psychiatrist, the first female AP for MDMA-AT in Australia, is approved, increasing the company’s capacity for trials and patient care. Strategic Funding • July 2023 - April 2024: Emyria secures significant funding to expand clinical services and drug development: o September 2023: $2M raised from sophisticated investors. o April 2024: $2.3M raised through firm commitments from investors with funds allocated to the Empax Centre and drug development efforts. Directors participation includes $320,000. Drug Development Progress • March 2024: A favourable search report from an international patent examiner: o Confirms the novelty and potential patentability of Emyria's novel MDMA analogues, with key candidates moving into animal efficacy studies. • March 2024: Emyria’s drug candidates, RX7/9, successfully completed safety assessments: o As part of a fully funded preclinical program managed by the NIH, Emyria’s drug assets RX7/9 advanced to animal efficacy studies, with results expected in H2 CY24. o Emyria and Aspen Pharmacare Australia amicably concluded their partnership related to RX5, with Aspen remaining open to potential collaborations on Emyria’s other drug assets. Industry Recognition and New Collaborations • April 2024: Emyria selected by Reach Wellness to lead MDMA-AT research for first responders with PTSD. o The study, subsidised by Reach Wellness, aims to demonstrate the safety, effectiveness, and scalability of Emyria’s MDMA-AT model, with a fundraising target of $1.5M for the initial cohort. Board and Key Management Changes • August 2023: Dr. Mohit Kaushal is appointed as a Non-Executive Director: o Dr Kaushal brings extensive expertise in clinical transformation, digital health, and strategic investments, aligning with Emyria's vision for future growth and innovation in mental health care following resignation of Non-Executive Director Matthew Callahan. • November 2023: Emyria announces the redundancy of the Executive Medical Director role as part of its strategic restructuring efforts. Page 5 Page 7 EMYRIA LIMITED ABN 96 625 085 734 DIRECTORS’ REPORT For the year ended 30 June 2024 Events after reporting date July 2024: Emyria, in collaboration with the University of Western Australia (UWA), was awarded a $499,411 Innovation Grant from the Future Health Research and Innovation Seed Fund. The grant will support the advancement of Emyria’s proprietary MDMA analogue drug development program, targeting mental health and neurodegenerative diseases, including Parkinson’s. The program, directed by Associate Professor Matt Piggott, a leading expert in MDMA-inspired drug discovery, will also facilitate international collaborations and further the development of potential new treatments for PTSD. There are no other matters or circumstances that have arisen since the end of the financial year which have significantly affected or may significantly affect the operations of the Group, the results of those operations, or the state of affairs of the Group in future financial periods. Future development, prospects and business strategy The Group plans to continue its pioneering work in the healthcare landscape by integrating its core competencies in patient treatment, clinical data capture, and drug development. We aim to become industry leaders in delivering and developing promising, proprietary treatments for major unmet needs in mental health and select neurological conditions. A key short-term focus will be the integration and value optimisation of our clinical services, particularly the Empax Centre which is uniquely resourced to significantly advance the provision of wraparound mental health care, particularly psychedelic-assisted therapies, and increase clinical billing revenues and clinical data collection. Concurrently, the Group is laying the groundwork for robust data capture across it’s broadened clinical service activities to inform and accelerate future drug and therapy development. The Group will continue to advance its novel MDMA analogues and Ultra-Pure CBD capsules leveraging non-dilutive funding where possible. Business risks Access to Capital: Emyria's business model necessitates ongoing investment in clinical trials and other areas of research and development. While we anticipate generating revenue from our clinical services, these earnings may not be sufficient to cover the full scope of business expenses and required investments. As such, Emyria will continue to depend on external financing through equity or debt to sustain the business. Any limitations on our ability to secure the necessary funding could adversely impact our operational sustainability and delay our path to profitability. Clinical trials: Clinical trials inherently come with elements of risk, including the potential for negative, inconclusive, or non-efficacious results. These factors can significantly impact the commercial potential and profitability of our MDMA—assisted therapy trials as well as our evaluation of our drug assets comprising UltraPure CBD capsules (EMD-RX7, and EMD-RX9) and proprietary MDMA analogues. The enrolment of patients into trials is susceptible to delays due to various challenges such as the supply chain disruptions, economic downturns, and difficulties in hiring qualified staff. Regulatory approvals, importation, and customs requirements can further delay the progression of clinical trials. Data obtained from clinical trials can also be interpreted differently by different stakeholders, including regulatory authorities. This could potentially delay, limit, or prevent the receipt of regulatory approvals. Moreover, Phase 3 clinical trial data may not necessarily be indicative of the results obtained upon completion or in future stages. Interpreting masked data is subject to further analysis once unmasked, and negative outcomes at any stage could inhibit further development, limit commercial potential, or impede marketing approval. Lastly, our Ultra-Pure CBD capsules and MDMA analogues are subject to stringent safety and efficacy assessments. Failure to demonstrate a strong safety profile or sufficient therapeutic efficacy in future clinical studies could hinder their ongoing clinical development and market release. Delays in patient recruitment or challenges in securing clinical locations may also impact the timeline of our clinical programs. Page 6 Page 8 EMYRIA LIMITED ABN 96 625 085 734 DIRECTORS’ REPORT For the year ended 30 June 2024 Clinical Data: Emyria holds sensitive clinical data that is susceptible to cybersecurity risks, including potential attacks or breaches from both internal and external parties. These breaches could occur whether access to the data is authorised or unauthorised. Consequently, there's a risk that sensitive information may be publicly exposed or permanently lost. Any such cybersecurity attack or data breach could impact Emyria's compliance with relevant data protection or privacy legislation. Non-compliance with such legislation could lead to penalties, attract negative publicity, and adversely affect the company's brand and reputation. Research and Development: The future success of Emyria is closely tied to the outcomes of clinical trials for our medication-assisted programs as well as our proprietary MDMA analogues, and their eventual approval as safe and effective treatments. These programs are currently in various stages of clinical development, and the possibility of commercialisation, which would generate sales and revenue, remains uncertain and potentially years away. Continued progress requires further research and development, including ongoing evaluation of safety and efficacy in clinical trials, followed by regulatory approval prior to marketing authorisation and payer coverage for clinical services. Drug development is an inherently high-risk endeavour. Until Emyria can provide further clinical evidence supporting the efficacy of its treatments in improving patient outcomes, the success of these products remains speculative. Risks associated with research and development include, but are not limited to, uncertain outcomes, delays in development, and general scientific uncertainties surrounding the development of novel pharmaceutical products. Materialisation of any of these risks could significantly impede Emyria's progress and adversely affect its future financial performance. Patient Safety in Clinical Services: Emyria provides comprehensive clinical care to patients with severe mental health issues, including the provision of emerging treatments such as psychedelic-assisted therapy. The vulnerable nature of this patient population elevates the importance of maintaining stringent safety protocols. There is an inherent risk associated with any medical intervention and thorough patient evaluations and informed consent are crucial. Despite these precautions, there can be no assurance that adverse events will not occur. Such events could have legal repercussions, attract negative publicity, and harm Emyria’s brand and financial standing. Ensuring the competence and suitability of clinicians is crucial. All clinicians must be rigorously vetted, trained in the specialised treatments offered, and supervised to maintain the highest standards of care. Failure to adequately vet and train clinicians could result in suboptimal treatment outcomes and potentially, legal ramifications. Regulatory Approval: Emyria operates in a highly regulated sector concerning the manufacture, distribution, and supply of pharmaceutical products as well as the use of experimental treatments like psychedelic-assisted therapies. Achieving and maintaining the necessary approvals, licences, and registrations from relevant regulatory authorities across various jurisdictions is not guaranteed. There may be instances where agencies like the Therapeutic Goods Administration (TGA) or Food and Drug Administration (FDA) identify deficiencies requiring resolution or request additional studies or approvals beyond what is currently planned. This could result in delays and increased costs for our clinical trials as well as our care programs. Emyria also faces the risk of policy, regulation, and legislative changes in all jurisdictions where it operates. Failure to secure or sustain required approvals or adapt to regulatory changes could adversely impact Emyria's ability to commercialise and manufacture its treatments. Commercial Risk: Emyria may explore various corporate opportunities, such as acquisitions, licensing, or partnerships to advance its reach in mental health care delivery and drug development programs. There is no guarantee that any such opportunities can be finalised on commercially acceptable terms. Even if terms for licensing and partnerships are agreed upon, unforeseen factors related to the environment, technology, or market conditions may impede the performance of distributors and collaborators in delivering contracted outcomes. Moreover, the future success of Emyria hinges on market acceptance and client retention. This involves convincing prospective clients and partners of the efficacy of Emyria's products and services. Information Technology: Emyria is dependent on robust information technology, software, data centres, and communication systems for its operations. The systems are susceptible to various risks, including disruptions, failures, service outages, or data corruption, which could occur due to computer viruses, malware, internal or external misuse, cyber-attacks, or other disruptions like natural disasters and power outages. A disruption to Page 7 Page 9 EMYRIA LIMITED ABN 96 625 085 734 DIRECTORS’ REPORT For the year ended 30 June 2024 any of these platforms or systems could have a significant adverse impact on Emyria's operations. Competition: The healthcare, biotechnology and pharmaceutical sectors are highly competitive and subject to rapid technological changes, both in Australia and internationally. Emyria faces competition from existing alternative treatments as well as from companies developing new products and services targeting similar medical conditions. There is no assurance that Emyria will be able to successfully compete in this landscape. Some of these competing companies may possess or develop technologies that are superior to Emyria's, or have substantially greater financial, technical, and human resources. As a result, Emyria's services, expertise, or products could be rendered obsolete, less attractive, or uneconomical due to advances in technology or alternative approaches developed by Emyria's competitors. Intellectual Property (IP): The acquisition and maintenance of intellectual property rights are crucial for safeguarding the potential value generated from biotechnology research and development. Emyria's success partially hinges on its capacity to secure patents, maintain trade secret protection, and operate without violating the intellectual property rights of third parties. However, the biotechnology sector is often fraught with complex and uncertain legal and factual questions surrounding patent positions. As such, there is no guarantee that Emyria's existing or future patents will provide commercially significant protection or that they will not infringe upon the rights of others. Additionally, patent disputes can arise due to the complex nature of the technologies involved. The issuance of a patent is not an assurance against the competitive technologies that may bypass Emyria's patented technology. Furthermore, Emyria's patent strategies may not offer global coverage, leaving room for generic competition in some markets. Manufacturing: The scaling up of manufacturing processes to support Phase 3 clinical studies requires ongoing validation and Process Performance Qualification (PPQ). There is a risk that PPQ may reveal technical issues that could affect the project's timeline and feasibility. These difficulties may include failure to produce materials meeting regulatory specifications for human administration or insufficient product yield to support both clinical studies and planned commercialisation. Any unforeseen challenges in the manufacturing process, such as changes in manufacturing methods, disruptions in supply chains, shortages of input materials, or changes in arrangements with third-party manufacturers, could negatively impact Emyria's profitability in the future. Commercialisation: While