Reported Earnings • Mar 04
First half 2026 earnings released: AU$0.003 loss per share (vs AU$0.002 loss in 1H 2025) First half 2026 results: AU$0.003 loss per share (further deteriorated from AU$0.002 loss in 1H 2025). Revenue: AU$1.55m (up 136% from 1H 2025). Net loss: AU$2.37m (loss widened 145% from 1H 2025). Over the last 3 years on average, earnings per share has increased by 45% per year but the company’s share price has fallen by 39% per year, which means it is significantly lagging earnings. Aankondiging • Nov 20
Emyria Limited has filed a Follow-on Equity Offering in the amount of AUD 8 million. Emyria Limited has filed a Follow-on Equity Offering in the amount of AUD 8 million.
Security Name: Ordinary Shares
Security Type: Common Stock
Securities Offered: 133,333,334
Price\Range: AUD 0.06
Discount Per Security: AUD 0.0036
Transaction Features: Subsequent Direct Listing Aankondiging • Aug 30
Emyria Limited has completed a Follow-on Equity Offering in the amount of AUD 4 million. Emyria Limited has completed a Follow-on Equity Offering in the amount of AUD 4 million.
Security Name: Ordinary Shares
Security Type: Common Stock
Securities Offered: 120,206,872
Price\Range: AUD 0.024
Discount Per Security: AUD 0.00144
Security Features: Attached Options
Security Name: Ordinary Shares
Security Type: Common Stock
Securities Offered: 46,459,795
Price\Range: AUD 0.024
Discount Per Security: AUD 0.00144
Security Features: Attached Options
Transaction Features: Subsequent Direct Listing Reported Earnings • Aug 29
Full year 2025 earnings released: AU$0.007 loss per share (vs AU$0.032 loss in FY 2024) Full year 2025 results: AU$0.007 loss per share (improved from AU$0.032 loss in FY 2024). Revenue: AU$1.39m (down 37% from FY 2024). Net loss: AU$3.14m (loss narrowed 73% from FY 2024). Over the last 3 years on average, earnings per share has increased by 30% per year but the company’s share price has fallen by 43% per year, which means it is significantly lagging earnings. Aankondiging • Aug 28
Emyria Limited, Annual General Meeting, Nov 13, 2025 Emyria Limited, Annual General Meeting, Nov 13, 2025. Location: level 2, 40 kings park road, west perth,western australia Australia New Risk • Jul 05
New major risk - Shareholder dilution The company's shareholders have been substantially diluted in the past year. Increase in shares outstanding: 50% This is considered a major risk. Shareholder dilution occurs when there is an increase in the number of shares on issue that is not proportionally distributed between all shareholders. Often due to the company raising equity capital or some options being converted into stock. All else being equal, if there are more shares outstanding then each existing share will be entitled to a lower proportion of the company's total earnings, thus reducing earnings per share (EPS). While dilution might not always result in lower EPS (like if the company is using the capital to fund an EPS accretive acquisition) in a lot cases it does, along with lower dividends per share and less voting power at shareholder meetings. Currently, the following risks have been identified for the company: Major Risks Earnings have declined by 12% per year over the past 5 years. Shareholders have been substantially diluted in the past year (50% increase in shares outstanding). Minor Risks Share price has been volatile over the past 3 months (14% average weekly change). Revenue is less than US$5m (AU$1.8m revenue, or US$1.2m). Market cap is less than US$100m (AU$17.1m market cap, or US$11.2m). Aankondiging • Jun 18
Emyria Limited has filed a Follow-on Equity Offering in the amount of AUD 4 million. Emyria Limited has filed a Follow-on Equity Offering in the amount of AUD 4 million.
Security Name: Ordinary Shares
Security Type: Common Stock
Securities Offered: 120,206,872
Price\Range: AUD 0.024
Discount Per Security: AUD 0.00144
Security Features: Attached Options
Security Name: Ordinary Shares
Security Type: Common Stock
Securities Offered: 46,459,795
Price\Range: AUD 0.024
Discount Per Security: AUD 0.00144
Security Features: Attached Options
Transaction Features: Subsequent Direct Listing New Risk • Apr 09
New minor risk - Share price stability The company's share price has been volatile over the past 3 months. It is more volatile than 75% of Australian stocks, typically moving 12% a week. This is considered a minor risk. Share price volatility indicates the stock is highly sensitive to market conditions or economic conditions rather than being sensitive to its own business performance, which may also be inconsistent. It also increases the risk of potential losses in the short term as the stock tends to have larger drops in price more frequently than other stocks. Currently, the following risks have been identified for the company: Major Risks Earnings have declined by 12% per year over the past 5 years. Shareholders have been substantially diluted in the past year (34% increase in shares outstanding). Market cap is less than US$10m (AU$14.2m market cap, or US$8.61m). Minor Risks Share price has been volatile over the past 3 months (12% average weekly change). Revenue is less than US$5m (AU$1.8m revenue, or US$1.1m). New Risk • Apr 08
New major risk - Shareholder dilution The company's shareholders have been substantially diluted in the past year. Increase in shares outstanding: 34% This is considered a major risk. Shareholder dilution occurs when there is an increase in the number of shares on issue that is not proportionally distributed between all shareholders. Often due to the company raising equity capital or some options being converted into stock. All else being equal, if there are more shares outstanding then each existing share will be entitled to a lower proportion of the company's total earnings, thus reducing earnings per share (EPS). While dilution might not always result in lower EPS (like if the company is using the capital to fund an EPS accretive acquisition) in a lot cases it does, along with lower dividends per share and less voting power at shareholder meetings. Currently, the following risks have been identified for the company: Major Risks Earnings have declined by 12% per year over the past 5 years. Shareholders have been substantially diluted in the past year (34% increase in shares outstanding). Market cap is less than US$10m (AU$11.3m market cap, or US$6.85m). Minor Risk Revenue is less than US$5m (AU$1.8m revenue, or US$1.1m). New Risk • Feb 28
New major risk - Financial position The company has less than a year of cash runway based on its current free cash flow trend. Free cash flow: -AU$2.0m This is considered a major risk. With less than a year's worth of cash, the company will need to raise capital or take on debt unless its cash flows improve. This would dilute existing shareholders or increase balance sheet risk. Currently, the following risks have been identified for the company: Major Risks Less than 1 year of cash runway based on free cash flow trend (-AU$2.0m free cash flow). Earnings have declined by 12% per year over the past 5 years. Market cap is less than US$10m (AU$15.2m market cap, or US$9.48m). Minor Risks Share price has been volatile over the past 3 months (12% average weekly change). Shareholders have been diluted in the past year (26% increase in shares outstanding). Revenue is less than US$5m (AU$1.8m revenue, or US$1.1m). Aankondiging • Nov 27
Emyria Limited has filed a Follow-on Equity Offering in the amount of AUD 2.525 million. Emyria Limited has filed a Follow-on Equity Offering in the amount of AUD 2.525 million.
Security Name: Ordinary shares
Security Type: Common Stock
Securities Offered: 43,571,429
Price\Range: AUD 0.035
Discount Per Security: AUD 0.0021
Security Name: Ordinary shares
Security Type: Common Stock
Securities Offered: 28,571,429
Price\Range: AUD 0.035
Discount Per Security: AUD 0.0021
Transaction Features: Subsequent Direct Listing Aankondiging • Oct 11
Emyria Limited, Annual General Meeting, Nov 12, 2024 Emyria Limited, Annual General Meeting, Nov 12, 2024. Location: at the offices of stantons international, level 2, 40 kings park road, west perth, wa, Australia New Risk • Sep 05
New minor risk - Share price stability The company's share price has been volatile over the past 3 months. It is more volatile than 75% of Australian stocks, typically moving 12% a week. This is considered a minor risk. Share price volatility indicates the stock is highly sensitive to market conditions or economic conditions rather than being sensitive to its own business performance, which may also be inconsistent. It also increases the risk of potential losses in the short term as the stock tends to have larger drops in price more frequently than other stocks. Currently, the following risks have been identified for the company: Major Risks Less than 1 year of cash runway based on free cash flow trend (-AU$5.5m free cash flow). Earnings have declined by 23% per year over the past 5 years. Market cap is less than US$10m (AU$14.7m market cap, or US$9.90m). Minor Risks Share price has been volatile over the past 3 months (12% average weekly change). Shareholders have been diluted in the past year (33% increase in shares outstanding). Significant insider selling over the past 3 months (AU$672k sold). Revenue is less than US$5m (AU$2.2m revenue, or US$1.5m). Reported Earnings • Aug 31
Full year 2024 earnings released: AU$0.032 loss per share (vs AU$0.018 loss in FY 2023) Full year 2024 results: AU$0.032 loss per share (further deteriorated from AU$0.018 loss in FY 2023). Revenue: AU$2.20m (up 38% from FY 2023). Net loss: AU$11.5m (loss widened 123% from FY 2023). Over the last 3 years on average, earnings per share has fallen by 11% per year but the company’s share price has fallen by 48% per year, which means it is performing significantly worse than earnings. New Risk • Aug 07
New major risk - Market cap size The company's market capitalization is less than US$10m. Market cap: AU$14.3m (US$9.40m) This is considered a major risk. Companies with a small market capitalization are most likely businesses that have not yet released a product to market or are simply a very small company without a wide reach. Either way, risk is elevated with these companies because there is a chance the product may not come to fruition or the company's addressable market or demand may not be as large as expected. In addition, if the company's size is the main factor, it is less likely to have many investors and analysts following it and scrutinizing its performance and outlook. Currently, the following risks have been identified for the company: Major Risks Earnings have declined by 21% per year over the past 5 years. Market cap is less than US$10m (AU$14.3m market cap, or US$9.40m). Minor Risks Shareholders have been diluted in the past year (33% increase in shares outstanding). Significant insider selling over the past 3 months (AU$672k sold). Revenue is less than US$5m (AU$1.9m revenue, or US$1.3m). Aankondiging • Apr 24
Emyria Limited has filed a Follow-on Equity Offering in the amount of AUD 2.3 million. Emyria Limited has filed a Follow-on Equity Offering in the amount of AUD 2.3 million.
Security Name: Ordinary Shares
Security Type: Common Stock
Securities Offered: 39,600,000
Price\Range: AUD 0.05
Discount Per Security: AUD 0.003
Security Features: Attached Options
Security Name: Ordinary Shares
Security Type: Common Stock
Securities Offered: 6,400,000
Price\Range: AUD 0.05
Discount Per Security: AUD 0.003
Transaction Features: Subsequent Direct Listing New Risk • Feb 29
New major risk - Financial position The company has less than a year of cash runway based on its current free cash flow trend. Free cash flow: -AU$7.0m This is considered a major risk. With less than a year's worth of cash, the company will need to raise capital or take on debt unless its cash flows improve. This would dilute existing shareholders or increase balance sheet risk. Currently, the following risks have been identified for the company: Major Risks Less than 1 year of cash runway based on free cash flow trend (-AU$7.0m free cash flow). Earnings have declined by 21% per year over the past 5 years. Minor Risks Shareholders have been diluted in the past year (26% increase in shares outstanding). Revenue is less than US$5m (AU$1.9m revenue, or US$1.3m). Market cap is less than US$100m (AU$17.2m market cap, or US$11.2m). New Risk • Jan 19
New minor risk - Share price stability The company's share price has been volatile over the past 3 months. It is more volatile than 75% of Australian stocks, typically moving 12% a week. This is considered a minor risk. Share price volatility indicates the stock is highly sensitive to market conditions or economic conditions rather than being sensitive to its own business performance, which may also be inconsistent. It also increases the risk of potential losses in the short term as the stock tends to have larger drops in price more frequently than other stocks. Currently, the following risks have been identified for the company: Major Risk Earnings have declined by 22% per year over the past 5 years. Minor Risks Share price has been volatile over the past 3 months (12% average weekly change). Shareholders have been diluted in the past year (26% increase in shares outstanding). Revenue is less than US$5m (AU$1.6m revenue, or US$1.0m). Market cap is less than US$100m (AU$22.4m market cap, or US$14.7m). Aankondiging • Nov 22
Emyria Limited Appoints Greg Hutchinson as Director Emyria Limited appointed Greg Hutchinson as director effective 21 November 2023. Aankondiging • Nov 15
Emyria Limited Announces Board Changes Emyria Limited announced that Dr. Alistair Vickery has retired from the Board and will shift his expertise from Board responsibilities to concentrate on clinical service expansion, particularly as Emyria advances its MDMA-assisted therapy programs. Dr. Stewart Washer will move to Non-Executive Chairman from Executive Chairman and his salary will move from $200,000 per annum to a total fee of $80,000 per annum and; Dr. Karen Smith to Non-Executive Director with a salary in line with all current Non-Executive Directors. All changes are effective immediately. Aankondiging • Nov 11
Emyria Limited has completed a Follow-on Equity Offering in the amount of AUD 1.678228 million. Emyria Limited has completed a Follow-on Equity Offering in the amount of AUD 1.678228 million.
Security Name: Ordinary Shares
Security Type: Common Stock
Securities Offered: 22,376,378
Price\Range: AUD 0.075
Transaction Features: Rights Offering Aankondiging • Sep 15
Emyria Limited (ASX:EMD) completed the acquisition of The Pax Centre from Glenroyale Pty Ltd and Vivo (WA) Pty Ltd. Emyria Limited (ASX:EMD) signed an agreement to acquire The Pax Centre from Glenroyale Pty Ltd and Vivo (WA) Pty Ltd for AUD 1.7 million in June 2023. The acquisition is valued at $1.7m payable in a combination of shares (76%) and cash (24%) (the Acquisition) and signifies a landmark moment for Emyria's mission to expand and improve mental health care. A cash payment of $400,000, to be paid on a deferred basis on 1 October 2023; And; the issue of 10,236,220 fully paid ordinary shares in Emyria, (Consideration Shares). The acquisition remains subject to the completion of conditions precedent. Emyria completing legal and other relevant due diligence on the Company to its satisfaction. Each Seller executing a voluntary restriction agreement for their respective portion of the Consideration Shares. Each Seller entering into a services agreement and consulting agreement with Emyria to supersede and replace any prior agreements between each Seller and the Company. The parties having obtained all other approvals, consents, or waivers of a third party required to implement the Acquisition. Emyria will raise AUD 3.1 million and use AUD 0.5 million to fund the acquisition. The transaction is expected to complete in Q1 FY24.
Emyria Limited (ASX:EMD) completed the acquisition of The Pax Centre from Glenroyale Pty Ltd and Vivo (WA) Pty Ltd on September 13, 2023. Reported Earnings • Sep 01
Full year 2023 earnings released: AU$0.018 loss per share (vs AU$0.027 loss in FY 2022) Full year 2023 results: AU$0.018 loss per share (improved from AU$0.027 loss in FY 2022). Revenue: AU$1.59m (down 13% from FY 2022). Net loss: AU$5.13m (loss narrowed 30% from FY 2022). Over the last 3 years on average, earnings per share has increased by 5% per year but the company’s share price has fallen by 3% per year, which means it is significantly lagging earnings. Aankondiging • Aug 31
Emyria Limited, Annual General Meeting, Nov 16, 2023 Emyria Limited, Annual General Meeting, Nov 16, 2023, at 09:00 W. Australia Standard Time. Location: at the offices of Stantons International at Level 2, 40 Kings Park Road West Perth Western Australia Australia New Risk • Aug 29
New minor risk - Financial data availability The company's latest financial reports are more than 6 months old. Last reported fiscal period ended December 2022. This is considered a minor risk. If the company has not reported its earnings on time, it may have been delayed due to audit problems or it may be finding it difficult to reconcile its accounts. Currently, the following risks have been identified for the company: Major Risks Less than 1 year of cash runway based on free cash flow trend (-AU$9.2m free cash flow). Earnings have declined by 29% per year over the past 5 years. Minor Risks Latest financial reports are more than 6 months old (reported December 2022 fiscal period end). Shareholders have been diluted in the past year (12% increase in shares outstanding). Revenue is less than US$5m (AU$1.8m revenue, or US$1.1m). Market cap is less than US$100m (AU$25.3m market cap, or US$16.3m). Aankondiging • Aug 21
Emyria Limited Announces Strategic Board Transition Emyria Limited announced a strategic Board transition to bolster its clinical service growth in mental health, welcoming Dr. Mohit Kaushal as a Non-Executive Director. This change facilitates the transition of Matthew Callahan from a director of the Company to a unpaid advisory role where he will continue to provide strategic support for Emyria. Dr. Kaushal's appointment underscores Emyria's commitment to transforming mental health care by integrating state-of-the-art, multidisciplinary clinics alongside proprietary therapy development. As the global demand for mental health services rises, innovative new approaches - like psychedelic-assisted therapy - are gaining interest. The recent landmark decision by Australia to legalise the use of MDMA and psilocybin for PTSD and treatment-resistant depression, effective from July 1st, 2023 2 has created a unique opportunity for Emyria to harness its strengths in clinical service delivery, Real-World Data collection, and therapy development. Dr Kaushal's track record in scaling tech-integrated clinical services directly supports Emyria'. mission to lead the delivery and development of promising mental health interventions, globally. Dr. Mohit Kaushal's noteworthy affiliations encompass roles at Humedica (acquired by Optum Health), Rxante (acquired by Millennium), Change Healthcare (acquired by Emdeon), Universal American (NYSE:UAM) acquired by WellCare (NYSE:WCG), CitiusTech (acquired by Baring), Gravie, Insight Psychiatry, Wellframe (acquired by HealthEdge), Elation Health, The Oncology Institute (NASDAQ:TOI) and Oak Street Health. Oak Street Health, under Dr. Kaushal's stewardship culminated in a $10.6 Billion acquisition by CVS Health in 2023. Oak Street's technology-empowered, personalised care framework resonates with Emyria's vision for mental health. During his time in the Obama administration, Dr. Kaushal was a member of the White House Health IT task force; a cross agency team implementing the technology aspects of the Accountable Care Act (ACA) and testified to Congress on the application of technology and payment reform to the Medicare population. Dr. Kaushal also built and led the first dedicated health care team at the Federal Communications Commission, where his team initiated collaboration with the Food and Drug Administration (FDA) for the regulatory streamlining of converged telecommunications, data analytics and medical devices leading to the release of the mobile medical applications guidance by the FDA. In addition, his team reformed the Rural Healthcare fund to create the Healthcare Connect Fund, which aligned the funding mechanism with wider health care payment policy and technology reform. In addition, Dr. Kaushal is an Adjunct Professor at Stanford University within the Biomedical Data Science Department. Dr. Kaushal continues to be active within public policy and is aScholar in Residence at the Duke Margolis Center for Health Policy. He was previously a Visiting Scholar at the Brookings Institution. He has also been appointed to the FDASIA Workgroup of the Health IT Policy Committee and to the National Committee on Vital and Health Statistics, advising HHS on Data Access and Use. An ER physician by training, Dr. Kaushal also holds an MBA from Stanford and an MD with distinction as well as a BSc from Imperial College, London. Aankondiging • Jul 04
Emyria Limited (ASX:EMD) signed an agreement to acquire The Pax Centre from Glenroyale Pty Ltd for AUD 1.7 million. Emyria Limited (ASX:EMD) signed an agreement to acquire The Pax Centre from Glenroyale Pty Ltd for AUD 1.7 million on June 3, 2023. The acquisition is valued at $1.7m payable in a combination of shares (76%) and cash (24%) (the Acquisition) and signifies a landmark moment for Emyria's mission to expand and improve mental health care. A cash payment of $400,000, to be paid on a deferred basis on 1 October 2023; And; the issue of 10,236,220 fully paid ordinary shares in Emyria, (Consideration Shares). The acquisition remains subject to the completion of conditions precedent. Emyria completing legal and other relevant due diligence on the Company to its satisfaction. Each Seller executing a voluntary restriction agreement for their respective portion of the Consideration Shares. Each Seller entering into a services agreement and consulting agreement with Emyria to supersede and replace any prior agreements between each Seller and the Company. The parties having obtained all other approvals, consents, or waivers of a third party required to implement the Acquisition. Aankondiging • Feb 13
Emyria Limited Secures Clinical-Grade MDMA Supply for Aust Patients Emyria Limited has secured a supply of clinical-grade MDMA for an initial cohort of Australian patients through Canadian manufacturer PharmAla, and facilitated by Mind Medicine Australia, when the rescheduling of MDMA comes into effect, July 1, 2023. The procurement of patient-ready, GMP-grade MDMA is highly challenging due to strict Good Manufacturing Practice standards, US supply quota restrictions and limited global manufacturers. PharmAla is one of the only companies able to export GMP-grade MDMA. Emyria intends to make the MDMA available to partner psychiatrists with Authorised Prescriber status or under ethics-approved clinical trials, and is actively collaborating with clinical partners to ensure their readiness for MDMA-assisted therapy by supporting clinician training and data monitoring. Australia will be one of the first countries to allow patient access to MDMA-assisted therapy. Securing a reliable, clinical-grade supply of MDMA poses significant challenges due to its highly regulated nature, requiring specialised knowledge, licences, and permissions from regulators and law enforcement. The supply agreement with PharmAla helps ensure Emyria's clinical partners will be ready to support safe and scalable MDMA-assisted therapy while complying with TGA restrictions regarding Authorised Prescriber status. The recent rescheduling of MDMA by the TGA following applications by Mind Medicine Australia also opens a pathway to registration and reimbursement for Emyria's MDMA-inspired compounds, which are being developed with the University of Western Australia for a range of neuropsychiatric disorders. Emyria is advancing its drug discovery program in Australia and the United States to identify novel, MDMA-like compounds with therapeutic potential, while collaborating with local clinical partners to improve patient access and ongoing research. Aankondiging • Feb 08
Emyria Limited Expands MDMA Programs Following Landmark TGA Decision Emyria Limited is well positioned to accelerate patient access to MDMA-assisted therapies following recent TGA regulation changes down-scheduling MDMA and psilocybin to Schedule 8 medicines from July 1st, 2023. A similar rescheduling of medicinal cannabis from Schedule 9 to Schedule 8 occurred in 2016. This protocol can now be adapted to support specialist psychiatrists meet the requirements for Authorised Prescriber status. This process requires an evaluation by a Human Research Ethics Committee. To date, Emerald Clinics (Emyria's clinical service subsidiary) has successfully applied for 16 Authorised Prescriber determinations relating to the provision of unregistered cannabinoid medicines to patients with unmet needs. In addition, Emyria and the University of Western Australia launched an MDMA-inspired drug discovery program. The partnership has now developed, screened and filed IP for over 140 proprietary, neurologically active and novel MDMA-like compounds with the potential to become registered treatments for a range of neuropsychiatric disorders and new psychedelic treatments. add psilocybin and MDMA to Schedule 8, permitting their use as Controlled Drugs only for treatment-resistant depression (TRD) and post-traumatic stress disorder (PTSD), respectively add entries in Appendix D to restrict access to the substances under Schedule 8: they can only be prescribed for the above conditions by specialist psychiatrists who have obtained approval to use the substances for treating these conditions from a human research ethics committee (HREC), and then been authorised by the TGA under the Authorised Prescriber Scheme to prescribe the substances for these conditions they can also be used in clinical trials into these conditions (they are currently only accessible for clinical trials as Schedule 9 substances)the possession of the substances as Schedule 8 drugs without authority will be illegal (for example, possession other than in accordance with a legal prescription). The rescheduling of MDMA opens a pathway to registration and reimbursement for MDMA and its analogues. Emyria will collaborate with clinical partners to improve patient access and ongoing research while continuing the drug discovery program in Australia and the United States to identify novel, MDMA-like compounds with the greatest therapeutic potential. Aankondiging • Jan 30
Emyria Limited Announces Commencement of First Dosing for Pivotal EMD-RX5 Phase 3 Trial Emyria Limited announced that the first patients have been successfully dosed in its Phase 3 clinical trial for EMD-RX5. This marks an important milestone in the development of EMD-RX5 as the first potential over-the-counter (OTC) treatment for the symptoms of psychological distress. The trial, which is being conducted nationwide across 9 trial sites, is designed to evaluate the safety and efficacy of EMD-RX5 in patients with symptoms of psychological distress such as mild anxiety and stress. The trial is expected to enrol and dose 300 patients in H1, 2023 and, pending clinically significant results, will support a submission to the TGA. 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. 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. Aankondiging • Nov 28
Emyria Limited Announces Its Acceptance into the Preclinical Screening Platform for Pain Program Emyria Limited announced its acceptance into the Preclinical Screening Platform for Pain Program. The chart shows the oral morphine equivalent daily dose ("oMEDD") for a cohort of 220 patients presenting at Emyria's Emerald Clinics with a "HIGH" opioid consumption rating defined as a daily requirement above 160mg. oMEDD scores were derived by examining linked community pharmacy dispensing data from NostraData/IQVIA in the 12 months prior and 12 months after starting care at Emerald Clinics. The analysis reveals that these patients had a stable oMEDD scores in the 12months prior to treatment but experienced a significant average reduction of 30% in their daily oMEDD scores. Board Change • Nov 16
Less than half of directors are independent Following the recent departure of a director, there is only 1 independent director on the board. The company's board is composed of: 1 independent director. 5 non-independent directors. Member of Medical Advisory Board & Independent Non-Executive Director John Tooke was the last independent director to join the board, commencing their role in 2020. The company's minority of independent directors is a risk according to the Simply Wall St Risk Model. Aankondiging • Oct 18
Emyria Limited and The University of Western Australia Expands Unique MDMA Emyria Limited announced positive progress of its preclinical MDMA-inspired drug discovery program with partner, the University of Western Australia and led by medicinal chemistry expert, Dr. Matt Piggott. Emyria and UWA have been actively growing and screening a unique drug-discovery pipeline of novel MDMA analogues to identify new chemical entities and drug candidates with the potential to address major unmet needs in mental health and neurological disorders. Emyria previously secured exclusive rights to all MDMA-like compounds created under the partnership with Prof. Piggott and UWA. Additional compound synthesis and screening is ongoing and a fourth batch of 14 unique compounds, inspired by previous screening results, was recently prepared and shipped for preliminary screening with Eurofins. This brings the total number of unique compounds in the library to over 140. 5 high priority compounds have been shipped to the USA for evaluation with specialist neuroscience CRO, PsychoGenics and additional metabolic studies have commenced with an Australian CRO to help determine the metabolic half-life of a priority set of compounds. Aankondiging • Sep 26
Emyria Expands Clinical Sites for EMD-RX5 Phase 3 Trial Emyria Limited announced it has qualified 8 sites across Australia to support the pivotal Phase 3 clinical trial of EMD-RX5, its first Ultra-Pure cannabinoid treatment. Results from the Phase 3 trial are expected to support an initial registration of EMD-RX5 as a Schedule 3, over-the-counter treatment with Australia's Therapeutic Goods Administration (TGA). A further 4 sites have been identified for qualification if required. Emyria's nationwide clinical service subsidiary, Emerald Clinics, continues to support patient recruitment. EMD-RX5 - a unique, Ultra-Pure CBD capsule EMD-RX5 was developed to overcome many of the limitations with commonly available cannabinoid medicines and has been clinically demonstrated to have excellent safety, tolerability, bioavailability and low patient variability in a head-to-head comparison with the only registered CBD medicine in the world - Epidyolex. EMD-RX5 is a proprietary capsule formulation of Ultra-Pure CBD with the potential to address multiple clinical indications and with the required purity to pursue registration opportunities across multiple major global markets. Target indication - Psychological distress: Psychological distress describes a set of mental and physical symptoms such as anxiety, stress, depression, sleep disturbance and gastrointestinal upset that, at any one time, can affect up to 15% of the adult population. Psychological distress has a higher incidence rate in rural patients and patients with chronic disease. Overall the incidence of psychological distress is believed to be increasing. There is currently no over-the-counter treatment for psychological distress. Aankondiging • Aug 31
Emyria Limited, Annual General Meeting, Oct 25, 2022 Emyria Limited, Annual General Meeting, Oct 25, 2022. Agenda: To consider re-election of directors. Reported Earnings • Aug 30
Full year 2022 earnings released: AU$0.027 loss per share (vs AU$0.022 loss in FY 2021) Full year 2022 results: AU$0.027 loss per share (down from AU$0.022 loss in FY 2021). Revenue: AU$1.82m (down 7.8% from FY 2021). Net loss: AU$7.33m (loss widened 49% from FY 2021). Aankondiging • Aug 17
Emyria Limited Receives Ethics Approval for Pivotal EMD-RX5 Phase 3 Trial Emyria Limited announced it has received Human Research Ethics Committee (HREC) approval to commence a pivotal Phase 3 clinical trial of its Ultra-Pure CBD candidate, EMD-RX5. Successful completion of the Phase 3 trial will support the registration of EMD-RX5 with the Therapeutic Goods Administration (TGA) as a schedule 3, over-the-counter treatment (OTC) for the symptoms of psychological distress. The study's primary endpoints are changes in validated psychological distress symptom scores. Secondary endpoints include validated measures of sleep, pain and other quality oflife scores. The Phase 3 trial is a multi-center, double-blind, randomised, placebo-controlled trial and will be conducted under Australia's Clinical Trials Notification (CTN) Scheme. This means Emyria will now notify the TGA of HREC approval and complete local site initiation activities. The first site to receive ethics approval is the Hatherley Medical Centre under the direction of Principal Investigator Dr. Zachary Nathan. Additional clinical sites will be opened and managed across Australia by leading Site Management Organisation, Clinitrials. Emyria's clinical service subsidiary, Emerald Clinics, willassist with patient recruitment for the study. Aankondiging • Aug 05
Emyria Limited Announces Initiation of Human Cell-Line Preclinical Studies to Advance Its Mdma-Inspired Drug Discovery Partnership with the University of Western Australia Emyria Limited announced the initiation of human cell-line preclinical studies to advance its MDMA-inspired drug discovery partnership with the University of Western Australia. Emyria aims to develop new analogues inspired by MDMA. Like MDMA, its analogues are small, orally absorbed and central-nervous penetrating molecules that interact with a variety of targets in the brain and peripheral tissues and therefore hold promise as new treatmentsfor a range of neurological and non-neurological disorders. Emyria has created and screened over 125 MDMA-inspired analogues led by Professor Matt Piggott in partnership with the University of Western Australia. Prof. Piggott is anexpert in medicinal chemistry and an international leader in modifying MDMA to create novel analogues with therapeutic potential. Based on initial screening, Emyria has identified three potential therapeutic areas for itsMDMA-inspired drug discovery program: treatments for major mental health disorders where more potent and shorter-acting MDMA-like treatments, when given alongside psychological therapy, may offer advantages over standard MDMA in drug-assisted therapy; treatments for neurological disorders where selective neurological receptor effects are desired and; treatments for non-neurological disorders where selective activity at peripheral (non-brain) targets are of interest Preclinical studies are now commencing for leading drug candidates in each therapeutic area. The first preclinical program will explore the antifibrotic potential of a priority set of novel MDMA analogues.Some compounds structurally related to MDMA are known to increase the risk of developing heart valvulopathy (a fibrotic disorder). As a result, initial safety tests are conducted on each new MDMA-like analogue in order to screen out compounds that pose the greatest risk of inducing fibrosis. However, these same screens can also identify novel compounds with the potential to address or, possibly reverse, fibrosis. Initial screening of the MDMA analogue library identified a number of novel compounds with potential anti-fibrotic activity. To evaluate the therapeutic potential of these compounds further Emyria has engaged the Institute of Respiratory Health (IRH) in Western Australia to conduct a series of human cell line assays under the leadership of Associate Professors Steven Mutsaers and Cecilia Prêle. These assays will evaluate the ability of the new compounds to inhibit "fibroblast to myofibroblast" differentiation and collagen deposition in normal human lung fibroblast cell lines. These assays may reveal potential to treat diseases involving fibrosis, the thickening or scarring of tissue. Initial results are expected 2 months from study commencement and the project will be funded from the payments already provided to UWA. Aankondiging • Jul 18
Emyria Limited Announces Positive Progress of its Preclinical MDMA Analogue Medicine Program Emyria Limited announced positive progress of its preclinical MDMA analogue medicine program with partner, the University of Western Australia. Emyria's next-generation MDMA drug discovery is being led by Professor Matt Piggott, of the University of Western Australia (UWA). Prof. Piggott is an international leader in medicinal chemistry and expert in adapting the unique structures of MDMA. Emyria previously secured exclusive rights to all MDMA-like compounds created under the partnership with Prof. Piggott and UWA, starting with an initial library of more than 100 novel MDMA analogues created over more than 10 years. Emyria and UWA have been actively growing and screening this unique drug-discovery pipeline to identify new chemical entitiesand drug candidates with the potential to address major unmet needs in mental health and neurological disorders. 19 new compounds have been created in this third batch generated since the inception of the partnership. This brings the library size to >125 novel MDMA-like compounds; additional designand synthesis is ongoing and guided by screening results. Three drug discovery priority areas have been identified for the ongoing synthesis program and associated intellectual property (IP) strategy: Drug-assisted psychotherapy for major mental health disorders (next-generation MDMA analogues) where shorter-acting MDMA may be desirable; Novel, small molecule treatments for neurological disorders such as Parkinson's disease; and Treatments for non-neurological disorders where selective activity at peripheral serotonin receptors is of interest. Further testing is in planning to identify lead compounds in each focus area. Aankondiging • May 26
Emyria Limited Reports Positive Phase 1 Trial Data for EMD-RX5 Indicating Ideal Bioavailability, Safety and Tolerability Among 12 Healthy and Demographically Diverse Volunteer Subjects Emyria Limited reported positive Phase 1 trial data for EMD-RX5 indicating ideal bioavailability, safety and tolerability among 12 healthy and demographically diverse volunteer subjects. Compared to Epidyolex, the sole CBD-only medicine registered with the TGA and FDA, EMD-RX5 provides equivalent total drug exposures over 24 hours with a more predictable and sustained drug release. These results confirm EMD-RX5's suitability as a multi-indication treatment of chronic conditions and support Emyria's initial over-the-counter drug registration program targeting the symptoms of psychological distress. EMD-RX5 was also shown to provide more than twice the bioavailability of other, plant-derived CBD products in Australia with published pharmacokinetic data, helping further differentiate Emyria's growing ultra-pure cannabinoid drug development and global registration programs." Clinical advantages of Emyria's ultra-pure CBD revealed in Phase 1 trial EMD-RX5's proprietary capsule formulation demonstrated excellent safety and tolerability with no notable adverse events or gastrointestinal upset. EMD-RX5 was bioequivalent to Epidyolex® in total drug exposure (bioavailability) providing potential for Emyria to leverage prior data on Epidyolex® to support drug development and registration efforts in the USA. EMD-RX5 is estimated to have more than twice the bioavailability of other Australian CBD products with published pharmacokinetic data. EMD-RX5 also showed: lower drug concentration variability between participants meaning EMD-RX5 has more predictable dosing characteristics (fewer "highs" and "lows") higher CBD exposures 3 and 8 hours post dosing meaning CBD levels are sustained for longer providing an ideal dosing profile for Emyria's initial target clinical indications and supporting once to twice daily dosing. Next steps and additional drug development progress EMD-RX5 will now advance to pivotal Phase 3 clinical trials to support the TGA registration of EMD-RX5 as an over-the-counter (OTC) treatment for the symptoms of psychological distress. Psychological distress affects 15% of the adult population but has no OTC treatment available. EMD-RX7, targeting prescription-only high dose CBD indications, begins production for Phase 1 trials next quarter and further proprietary ultra-pure cannabinoid-based dose forms are in planning guided by the Australian Emyria Clinical e-Registry (AECeR) co-created with patients cared for at its subsidiary - Emerald Clinics. The Company continues to advance planning to pursue FDA registration targets in addition to exploring partnerships that can accelerate benefits to patients and create shareholder value. Aankondiging • May 12
Emyria Limited Receives Further Positive MDMA Analogue Screening Results Emyria Limited announce positive progress on its MDMA analogue development program being run in partnership with the University of Western Australia (UWA). 16 of 17 compounds sent from the second batch of analogues successfully passed screening with Eurofins at the test concentrations, meaning these compounds showed no evidence of interactions with one or more of the enzymes or cell receptors ("anti-targets") that can beassociated with unwanted clinical side effects. These positive results bring the total count of successfully screened MDMA analogues to date to 83 out of 85. Additional preclinical screening is now being planned with a leading CRO who will perform a number of assays to evaluate the solubility, partition coefficients and metabolic stability of each compound. These assays can help to predict absorption and brain uptake rates andhelp identify compounds that are similar to MDMA in potency but with faster onset and shorter half-lives, which may be more suitable for clinical applications. Leading MDMA analogues will undergo more sophisticated pharmacokinetic studies, whichis important in helping select compounds for further in vivo efficacy studies. Board Change • Apr 27
Less than half of directors are independent There are 5 new directors who have joined the board in the last 3 years. Of these new board members, 1 was an independent director. The company's board is composed of: 5 new directors. 7 experienced directors. No highly experienced directors. 1 independent director (5 non-independent directors). Executive Chairman Stewart Washer is the most experienced director on the board, commencing their role in 2018. Member of Medical Advisory Board & Independent Non-Executive Director John Tooke was the last independent director to join the board, commencing their role in 2020. The following issues are considered to be risks according to the Simply Wall St Risk Model: Minority of independent directors. Lack of board continuity. Lack of experienced directors. Aankondiging • Apr 14
Emyria Limited Announces EMD-RX5 Dosing to Complete for Phase 1 Clinical Trial Emyria Limited announce that participant dosing of EMD-RX5 is complete. A final data report is due next month. Emyria's EMD-RX5 capsules were uniquely developed to: Meet FDA requirements for ingredient purity by using ultra-pure CBD, Improve the bioavailability of CBD, Create a palatable dose form for patients As a result, Emyria believes EMD-RX5 has the potential to address multiple clinical indications as a registered medicine where low doses of CBD appear to be effective. Emyria is initially targeting the registration of EMD-RX5 with Australia's Therapeutic Goods Administration (TGA) as an over-the-counter (Schedule 3) treatment for the symptoms of psychological distress before commencing other registration programs with the same dose form. The symptoms of psychological distress can present as sleep disturbance, gastrointestinal upset and mild anxiety. These symptoms are estimated to affect about 15% of the adult population with a higher prevalence in patients with chronic disease. There is currently no over-the-counter treatment available for the symptoms of psychological distress. A pivotal Phase 3 clinical trial to support the registration of EMD-RX5 has been planned and is expected to commence immediately following the successful completion of the Phase 1 study. Leading Contract Research Organisation (CRO) and Site Management Organisation (SMO), Clinitrials, have recently been appointed to manage the Pivotal Phase 3 across 5-6 sites in Australia. Aankondiging • Apr 07
Emyria Limited Commences Dosing for EMD-RX5 Phase 1 Human Clinical Trial Emyria Limited announced that participant dosing has commenced for a Phase 1 trial comparing EMD-RX5 with Epidyolex. EMD-RX5 is Emyria's first solid, oral dose form of ultra-pure CBD. Recent pharmacokinetic (PK) studies comparing EMD-RX5 to Epidyolex oil demonstrated that EMD-RX5 had higher bioavailability compared to Epidyolex. Epidyolex is sold by Jazz Pharmaceuticals and is the only registered CBD medicine with both the TGA and FDA. EMD-RX5 is Emyria's first ultra-pure CBD biopharmaceutical with the potential to address multiple clinical indications. EMD-RX5 is initially seeking registration as a low-dose, Schedule 3, "over-the-counter" CBD treatment for the symptoms ofpsychological distress, a condition affecting nearly 15% of adults and with no approved over-the-counter treatment. A pivotal, Phase 3 clinical trial has been developed and expected to run across multiple independent clinical sites across Australia. Emyria's wholly-owned clinical servicesubsidiary, already operating across Australia, is expected to assist in accelerating recruitment by helping identify suitable patients who will then be referred for formal screening at the independent sites. Phase 1 clinical trials are also in planning for EMD-RX7, Emyria's second, ultra-pure CBD dose form targeting prescription indications where higher CBD exposures are required. Aankondiging • Mar 10
Emyria Limited Commences for the EMD-RX5 Clinical Development Program Emyria Limited announced participant recruitment, screening and consenting has commenced for the EMD-RX5 clinical development program. EMD-RX5 is an ultra-pure, highly bioavailable cannabidiol (CBD) capsule with potential to become a registered treatment for multiple indications. EMD-RX5 is the Company's first, proprietary cannabinoid-based medical treatment. Emyria is initially seeking registration of EMD-RX5 with the TGA as a low-dose, Schedule 3, "over-the-counter" CBD treatment for the symptoms of psychological distress. Psychological distress is a common mental health problem affecting 15% of Australian adults [1] with a rising prevalence.Psychological distress is a state of emotional suffering typically characterised by symptoms of depression and anxiety which often coexists with a wide range of chronic conditions [2]. There is currently no over-the-counter treatment for the relief of short-term symptoms of psychological distress. The full, end-to-end EMD-RX5 development program - encompassing proprietaryformulation design, at-scale GMP manufacturing and all clinical trials - has been designed to meet the registration requirements of both the TGA and FDA. Recent pharmacokinetic (PK) studies comparing EMD-RX5 to Epidyolex oil demonstrated that EMD-RX5 had a higher bioavailability profile compared to Epidyolex. Epidyolex is sold by Jazz Pharmaceuticals and is the only registered CBD medicine with both the TGA and FDA. The pivotal Phase 3 clinical trial protocol required for registration has already been developed and, pending successful ethics approval, is expected to commence immediately following the Phase 1 trial. Analysis of Emyria's extensive and proprietary Real World Data has informed the selection of the target indication for EMD-RX5 and therefore a Phase 2 study is not anticipated to be required for registration. Ongoing analysis of Emyria's Real World Data is also informing adjacent indications for EMD-RX5 and additional dose form opportunities for Emyria's expanding drug product pipeline. Aankondiging • Mar 04
Emyria Limited Ethics Approval Receives for EMD-RX5 Phase 1 Study Emyria Limited announced an update on the clinical development program for EMD-RX5. Emyria has received ethics approval for its Phase 1 clinical trial of EMD-RX5, the Company's first ultra-pure, high-bioavailability cannabidiol (CBD) capsule. The Phase 1 trial is an important first step towards registration and will evaluate the bioavailability of EMD-RX5 as compared to Epidyolex in a crossover design with 12 healthy volunteers. EMD-RX5 is initially seeking registration as a low-dose, Schedule 3, "over-the-counter" CBD treatment for the symptoms of psychological distress (previously referred to as the EMD-003 program). Recent pharmacokinetic (PK) studies compared the EMD-RX5 capsule to Epidyolex oil. Epidyolex is sold by Jazz Pharmaceuticals and is the only registered CBD medicine with both the TGA and FDA. Those studies demonstrated that EMD-RX5 had a higher bioavailability profile compared to Epidyolex. Manufacturing of commercial quantities of GMP-grade EMD-RX5 is currently underway to ensure sufficient quantity of trial material available to cover all pivotal clinical trials (both Phase 1 and Phase 3) as required for the Company's first TGA registration program. Emyria has successfully completed the site initiation visit for EMD-RX5 at leading Phase 1 clinical trial site, CMAX. Participant recruitment is expected to commence imminently, with dosing of EMD-RX5 to follow. A provisional patent has been filed to cover Emyria's proprietary formulation of EMD-RX5. Emyria's proprietary Real-World Data (RWD) guided the development of EMD-RX5, which the Company believes has the potential to become a registered treatment for multiple indications. Additional cannabinoid dose forms are currently in planning, also guided and informed by Emyria's growing RWD. Highlights: Emyria has received ethics approval for its Phase 1 clinical trial of EMD-RX5, a proprietary, highly bioavailable oral formulation of ultra-pure CBD The Phase 1 clinical trial of EMD-RX5 will assess the safety and bioavailability of EMD-RX5 compared to Epidyolex - the only CBD-only medicine formally registered with the TGA and the FDA EMD-RX5 dose form has potential to support multiple TGA and FDA registration programs, including an over-the-counter (Schedule 3), CBD treatment for the symptoms of psychological distress Commercial-scale GMP manufacturing of EMD-RX5 is underway, ensuring sufficient quantity of trial material for all trials required for registration. This includes the current Phase 1 trial and the pivotal Phase 3 trial to follow Site initiation visit completed at CMAX, in preparation for trial commencement Provisional patent has been filed for the EMD-RX5 formulation; additional proprietary cannabinoid formulations are currently in development. Aankondiging • Feb 22
Emyria Limited Announces Substantial Expansion of Proprietary MDMA Analogue Library Being Created with the University of Western Australia Emyria Limited announced a substantial expansion of a proprietary MDMA analogue library being created with the University of Western Australia. Emyria secured exclusive rights to a library of more than 100 novel MDMA analogues from the University of Western Australia creating a unique drug-discovery pipeline. 17 novel MDMA analogues have been uniquely synthesised and characterised, informed by the recent successful screening of the first batch of 68 compounds. A method to separate racemic library compounds into distinct enantiomers (i.e two mirror image structures that can exist alone or together as molecules) has been developed. Emyria, with its partner UWA, are applying this process to its current library of compounds. Such resolution could effectively double the size of the entire MDMA analogue library; individual enantiomers also have reduced potential for off-target side effects. A second batch of compounds is being prepared for shipping and screening this week, following the positive initial MDMA-analogue screening results received in December 2021. Initial results expected by the end of the current quarter. Aankondiging • Jan 20
Emyria Limited Announces Phase 1 Clinical Trials to Commence for Its Leading Ultra-Pure CBD Drug Candidate, Referred to as EMD-RX5 Emyria Limited announced that Phase 1 clinical trials are to commence for its leading ultra-pure CBD drug candidate, referred to as EMD-RX5. EMD-RX5 is a proprietary, highly bioavailable oral CBD formulation developed to meet the strict product purity requirements of both the TGA in Australia and the FDA in the USA. EMD-RX5 is expected to be a candidate treatment for multiple clinical indications. Pure CBD is structurally and biochemically identical to plant-derived CBD [1] and also: tasteless and odourless; highly stable at room temperature and; free from the impurities associated with plant-derived CBD (such as heavy metals, pesticide residues and multiple other cannabinoids including undetectable levels of THC). The Phase 1 clinical trial of EMD-RX5 will be conducted at CMAX Clinical Research (CMAX) following ethics approval and will assess the safety and bioavailability of EMD-RX5 compared to Epidyolex - the only CBD-only medicine formally registered with the TGA and the FDA. Recruitment is expected to commence in first quarter of 2022. Recently completed animal studies evaluating EMD-RX5 suggest that it has improved bioavailability compared to Epidyolex meaning it may deliver more CBD to a patient at equivalent prescribed doses. Improved bioavailability means a higher active drug exposure is achieved for patients at lower ingested doses. Aankondiging • Nov 22
Emyria Limited announced that it expects to receive AUD 5 million in funding from Tattarang Pty Ltd Emyria Limited announced a private placement of 20,000,000 shares at a price of AUD 0.25 per share for the gross proceeds of AUD 5,000,000 to new investor Tattarang Pty Ltd on November 22, 2021. The company will also issue 10,000,000 options to Tattarang Pty Ltd. The Options will have an exercise price of AUD 0.40 per Option and an expiry date of 5.00pm (AWST) 2 years from the date of issue. The Options will be issued for no additional consideration. On post completion, the investor will hold will hold an interest of approximately 7.3% stake in the company. The transaction is expected to be closed on November 24, 2021. Reported Earnings • Oct 04
Full year 2021 earnings released: AU$0.022 loss per share (vs AU$0.03 loss in FY 2020) The company reported a solid full year result with reduced losses, improved revenues and improved control over expenses. Full year 2021 results: Revenue: AU$1.98m (up 95% from FY 2020). Net loss: AU$4.91m (loss narrowed 6.3% from FY 2020). Aankondiging • Sep 24
Emyria Limited Provides Novel Mdma Analogue Screening Program Advanced Update Emyria Limited reported that the first batch of MDMA analogues - exclusively optioned to Emyria - demonstrate excellent purity and stability at room temperature. The purity checks were conducted with nuclear-magnetic resonance (NMR) spectroscopy and further confirmation was completed with high performance liquid chromatography (HPLC). These analyses confirm the high purity and stability of the first 50% of the MDMA analogue library, which is required prior to advancing the screening process. Further testing is now being finalised for the remainder of the library while this first batch of compounds is being prepared for neurological receptor target screening. Discussions have also advanced with a major pharmaceutical discovery and screening company, specialising in comprehensive drug candidate selection and an initial set of neurological targets and anti-targets has been selected in collaboration with Emyria's key advisors The planned drug candidate screening panels will provide a comprehensive selection of key in vitro assays and safety models that will help support the prioritisation and progression of the most promising drug candidates within the MDMA library. Screening results can also assist in the consideration of suitable clinical indications for the compounds. Reported Earnings • Sep 01
Full year 2021 earnings released: AU$0.022 loss per share (vs AU$0.03 loss in FY 2020) The company reported a solid full year result with reduced losses, improved revenues and improved control over expenses. Full year 2021 results: Revenue: AU$1.98m (up 95% from FY 2020). Net loss: AU$4.91m (loss narrowed 6.3% from FY 2020). Aankondiging • Aug 13
Emyria Executes Pure CBD Agreement with Altasciences to Accelerate FDA and TGA Cannabinoid Registration Programs Emyria Limited has engaged AltaSciences to deliver a range of proprietary, synthetic cannabinoid-based capsules utilising a unique drug delivery approach. These capsules will become the foundation for Emyria's cannabinoid drug development programs targeting registration with the TGA and FDA, leading with the EMD-003 over-the-counter program. The new capsules are being developed to meet both TGA and FDA quality standards and are likely to be much more cost effective than the previous supply options considered and will allow Emyria to retain 100% ownership of all commercialisation rights and revenues. By selecting synthetic CBD, Emyria has ensured that its drug development programs, and Australian-based clinical trials, can also support the pursuit of FDA registration following TGA registration. There is no pharmacological difference in vitro in the antiproliferative, anti-inflammatory, or permeability effects of purified botanical CBD versus pure synthetic CBD [1]. Further, the development benefits and cost savings that synthetic drug material provides are substantial. The synthetic platform under development is expected to support multiple drug registration programs with the TGA and FDA. Emyria's EMD-003 is a Schedule 3, low-dose cannabidiol drug registration program and will be the first to make use of the new pure synthetic dose form. EMD-003 is targeting the symptoms of psychological distress. Aankondiging • Jun 15
Emyria Advances EMD-004 Program Towards Registration Emyria Limited announced further intellectual property (IP) has been filed in support of its EMD-004 drug development program targeting the symptoms of irritable bowel syndrome (IBS). IBS is a group of symptoms that occur together, including repeated pain in abdomen and changes in bowel movements, which may be diarrhea, constipation, or both. With IBS, have these symptoms without any visible signs of damage or disease in digestive tract which is why the condition can be challenging to diagnose and treat. IBS affects around 11% of the population globally and is a significant unmet need often associated with greater levels of anxiety and lower quality of life measures. There are currently no approved drug treatments for IBS. The new IP was filed after extensive analysis of Emyria's proprietary clinical data (Emyria Data). Emyria Data is deep clinical data collected with consenting patients who obtained relief from their IBS condition while being treated at Emyria's wholly-owned, nationwide clinical subsidiary - Emerald Clinics. EMD-004 is Emyria's second drug development program to be launched following analysis of Emyria Data. A large observational study involving IBS patients is currently underway a cross Emerald Clinics.
Emyria Data is one of the largest and highest quality real-world clinical data sets in the world covering the long-term safety and efficacy of pharmaceutical-grade cannabinoid-based
medicines prescribed for thousands of patients with unmet needs. Aankondiging • May 05
Emyria Limited and Mind Medicine Australia Launch MDMA-Assisted Therapy Program for PTSD Emyria Limited announced the launch of EMDMA-001, a psychedelic-assisted therapy program targeting Posttraumatic Stress Disorder (PTSD) developed with partner Mind Medicine Australia. As a first step, and pending ethics approval, Emyria will Sponsor a major, independently monitored, clinical trial targeting treatment resistant PTSD with evidence-based MDMA-assisted therapy. A key priority of this first program is to help evaluate the long-term safety, efficacy and cost benefits of MDMA-assisted psychotherapy. Such evidence is needed, along with fit-for-purpose clinical infrastructure and trained therapists in order to deliver psychedelic-assisted care in a safe, standardised and scalable way. Emyria's clinical advisory, site network and data infrastructure is uniquely positioned to support safe and scalable psychedelic-assisted therapy, much like company have demonstrated and accomplished with cannabinoid medicines. EMDMA-001 to address major challenges in MDMA-assisted therapy Novel research and specialised training are needed because of the way MDMA-assisted therapy is delivered. The treatment is unlike traditional psychotherapy or psychopharmacology. The psychotherapy is deeply intertwined with pharmacological intervention. In general, MDMA-assisted therapy involves three general stages: Preparation - in which the therapist and patient get to know one another and build trust. Administration & Monitoring - the patient, usually lying down and wearing an eye mask, is given a dose of MDMA and supported by two therapists during each session - which can last 6 to 8 hours. Integration - the next day, and at weekly intervals for on average 3 occasions, the patient and therapist discuss the experience and how to integrate any insights into behavioural change. Some patients may need to repeat the cycles above and a clinical service must be prepared to support patients through the full experience and beyond. Given the length of individual therapy sessions and the fact some patients may need to repeat part, or all of these cycles, there is a major need for properly prepared clinical services and specially trained psychotherapists to support psychedelic-assisted therapy at scale. Further, any future regulation of these therapies is likely to consider the capabilities of the clinical service providing these treatments. Reported Earnings • Feb 25
First half 2021 earnings released: AU$0.01 loss per share (vs AU$0.016 loss in 1H 2020) The company reported a solid first half result with reduced losses, improved revenues and improved control over expenses. First half 2021 results: Revenue: AU$1.15m (up 165% from 1H 2020). Net loss: AU$2.07m (loss narrowed 3.2% from 1H 2020). Aankondiging • Feb 22
Emyria Limited Announces the Appointment of Dr. Karen Smith to Chair the Company's Strategic Advisory Board Emyria Limited announced the appointment of Dr. Karen Smith to Chair Emyria's Strategic Advisory Board. Dr. Smith has held key Chief Executive Officer and Chief Medical Officer roles at some of the most innovative Biotech and Pharmaceutical development companies in the world including holding the role of CMO and Head of R&D at Jazz Pharmaceuticals. In addition to Emyria's Scientific Advisory Board, Dr. Smith serves as Chief Medical Officer of Emergent BioSolutions. Dr. Smith is also a Director at Antares Pharmaceuticals - developing novel drug delivery technologies and Sangamo Therapeutics and Acceleron Pharmaceuticals - both developing novel treatments for rare diseases, and TeeFib developing novel treatments for Fibrosis. Is New 90 Day High Low • Feb 15
New 90-day high: AU$0.23 The company is up 231% from its price of AU$0.071 on 17 November 2020. The Australian market is up 7.0% over the last 90 days, indicating the company outperformed over that time. It also outperformed the Healthcare industry, which is up 1.0% over the same period. Aankondiging • Feb 05
Emyria Limited Wins Digital Health Monitoring Grant with UWA Emyria Limited announced that their advanced remote monitoring digital health platform and service - Openly - will play a central role in a recently awarded grant from Western Australia's Future Health Research and Innovation Fund. The aims of the grant are to evaluate the utility of advanced digital health monitoring in vulnerable patient populations, to improve engagement amongst aged and ethnic populations and to improve mental health evaluation and monitoring for those under remote care. 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. Openly supports digital health and wellness screening using smart mobile devices and backed by Emyria's clinical team. Openly was initially developed to assist with contactless remote COVID-19 screening and management. On 15 September 2020, was registered as a Class 1 medical device with the Australian Therapeutic Goods Administration (TGA). Openly helps collect real-world clinical information from individuals remotely such as heart rate and heart rate variability. This information is presented to a clinical team who can act on that information. When vital signs such as heart rate variability change from baseline it can signal early infection or mental distress. Emyria has been developing digital health and remote monitoring technologies to improve the care of patients with unmet needs. Aankondiging • Feb 01
Emyria Limited Appoints Dr Richard Magtengaard, to Its Medical Advisory Board Emyria Limited announce the appointment of Consultant Psychiatrist Dr Richard Magtengaard, to its Medical Advisory Board. The appointment will support Emyria's multiple mental health focussed initiatives targeting unmet needs in mental health. This includes an initial drug development program -EMD-003 - targeting psychological distress and the symptoms of anxiety, depression and stress as well as the development of an evidenced-based psychedelic-assisted therapy program for patients with major mental health concerns partnership with Mind Medicine Australia to (see ASX release 19 NOV 20). Dr Magtengaard is currently the Director of the Military Trauma Recovery Programme across 2 busy sites of care, namely Marian Centre Hospital (a 69 bed Tier 1 DVA Accredited private hospital) and Salvado (an interdisciplinary setting for specialist care). Aankondiging • Jan 06
Emyria Limited to Pursue Registration of EMD-003 with Australia's Therapeutic Goods Administration in 2021 Emyria Limited will pursue the registration of EMD-003 with Australia's Therapeutic Goods Administration (TGA) in 2021. EMD-003 is Emyria's first cannabinoid-based medicine to have been developed following an extensive analysis of data gathered from its clinical subsidiary - Emerald Clinics. Emerald Clinics' doctors provide long-term, individualised care for unresolved patient conditions. By tracking important clinical changes using a bespoke digital health platform, Emyria has created an ethical source of unique data covering a wide variety of patients, products and formulations. Analysis of these data reveal unique product and dose-response insights for certain patient populations and conditions. The development of EMD-003 demonstrates that, as Emyria's database grows, it becomes an increasingly valuable source of high-quality clinical evidence and intellectual property with the potential to support multiple IP-backed drug registration programs. In the first half of 2021, Emyria intends to commence the pivotal registration study for EMD-003 - a cannabinoid-based medicine focussed on unmet needs targeting the treatment of psychological distress and the symptoms of anxiety, depression and stress for certain patient populations. The EMD-003 registration program, if successful, has been designed to deliver a new, registered medicine for the treatment of psychological distress and symptoms of depression, anxiety and stress. TGA Registration plan: To date, only 1 cannabinoid-based medicine has been formally registered with the TGA - GW Pharma's, Epidyolex - a CBD-only medicine for the "adjunctive therapy of seizures associated with Lennox-Gastaut syndrome (LGS) or Dravet syndrome (DS)". All other cannabinoid-based medicines are available only via Special Access Schemes, Authorised Prescribers or clinical trials. On December 15, 2020, the TGA announced a final ruling that would allow low-dose CBD (<150mg) to be registered as a Schedule 3 medication, emphasising that all "applications to register a Schedule 3 low-dose CBD preparation on the ARTG would involve assessment of safety and efficacy data to support the proposed dose and indication". While the TGA decision could allow patients to purchase registered CBD products as Pharmacist Only medications, high quality, dose-, product- and indication-specific clinical evidence is crucial for any registration effort. In light of this regulatory framework, Emyria is uniquely placed to utilise its large body of clinical data to assist in the registration of EMD-003 and other cannabinoid medicines. In anticipation of the TGA ruling, Emyria conducted an in-depth analysis of its own data, published literature and patent landscape. Subsequently the Company filed unique IP which covers the use of specific doses of CBD at or below the 150mg dose for a set of medical indications and patient cohorts. Emyria is now further analysing its data to refine the pivotal registration clinical trials which are expected to commence in first half of 2021. A final evidence package to support registration with the TGA is expected to be completed in second half of 2021. In parallel to the TGA-registration plan described above, Emyria will also design its EMD-003 registration studies to meet the requirements of other global regulatory bodies. This approach will provide the company the ability to subsequently apply for EMD-003 pharmaceutical registration within other major markets and jurisdictions. Aankondiging • Dec 23
Emyria Limited has completed a Follow-on Equity Offering in the amount of AUD 1.2 million. Emyria Limited has completed a Follow-on Equity Offering in the amount of AUD 1.2 million.
Security Name: Ordinary Shares
Security Type: Common Stock
Securities Offered: 14,117,647
Price\Range: AUD 0.085
Discount Per Security: AUD 0.0051
Transaction Features: Subsequent Direct Listing Aankondiging • Nov 25
Emyria Limited Launches Drug Development Program Based on RWE Emyria Limited announced the launch of its initial drug development program focused on mental health. The decision to launch Emyria's drug development program was made following a deep, longitudinal analysis of Emyria's extensive RWE data assets which have been co-developed with patients that have been treated by Emyria's Emerald Clinics service. The analysis revealed statistically significant dose-response data in a target patient population using a series of globally validated mental health measures (including DASS-21 and BPI outlined below). These data insights effectively replace the need for exploratory therapeutic clinical trials, and provide quality safety and efficacy data that will allow registration trials to be accelerated as the effective dose range and target patient population has now been identified from the aggregated patient usage data. Data insights - The RWE insights have been generated from statistical analysis from more than 3,000 anonymised patients that have been carefully clinically monitored at Emerald Clinics. As is typical, each patient has completed a series of validated clinical assessments to clarify diagnosis, monitor for changes to clinical signs, symptoms, quality of life, precise treatment dose taken, adverse events and concomitant medications to name a few. On average, over 150 data points are collected per visit from each patient. As outlined in below, patients in the cohort analysis were regularly administered the DASS-21 (Depression Anxiety, Stress Scale - 21 elements). This test is a quantitative measure of distress. It examines three seperate, but interrelated areas: depression, anxiety and stress. Each of these three subscales also includes various items ranging from skeletal muscle effects to situational anxiety and nervous arousal for example. Data generated from the study analysis showed highly statistically significant improvements in the anxiety component of patients' DASS-21 scores (P<0.001) when treated with selected doses of cannabidiol. This is particularly pertinent in the sub-population treated, all of which were not able to improve their anxiety measures using standard of care treatments prior to their referral to Emerald Clinics. Aankondiging • Nov 19
Emyria Limited Partners with Mind Medicine Australia Emyria Limited announce a partnership with Mind Medicine Australia to co- develop a gold-standard and data-driven clinical model for the safe provision of psychedelic-assisted therapies in Australia. Under the terms of the partnership, Emyria will design a care model describing how psychedelic-assisted therapies could be delivered safely to patients with major mental health concerns, pending the successful rescheduling of psilocybin and MDMA by the TGA. Mind Medicine Australia will provide access to its international network of experts, clinical trainers and treatment model strategies. The model will start with psilocybin and MDMA-assisted therapies and draw on pivotal research conducted recently in North America and Europe. Emyria will also apply its remote monitoring technology and lead the construction of a longitudinal data registry. The registry will collect real world clinical data on diagnoses, concomitant medications, dosing information and patient responses to psychedelic-assisted treatments as measured using validated clinical and patient-reported endpoints. The data will support ongoing research into the safety, effectiveness and cost benefits of psychedelic-assisted therapies for major mental health concerns compared to current alternatives. Both parties will contribute in-kind to the partnership. Commercial opportunities that may arise from the development of these therapies will be negotiated on a case-by-case basis. Recent Insider Transactions • Nov 17
Executive Chairman recently bought AU$61k worth of stock On the 12th of November, Stewart Washer bought around 775k shares on-market at roughly AU$0.079 per share. This was the largest purchase by an insider in the last 3 months. Stewart has been a buyer over the last 12 months, purchasing a net total of AU$108k worth in shares. Aankondiging • Nov 09
Emyria Limited Enters Data Deal with Zelira to Support Autism Trial Emyria Limited announced that it has been selected to conduct an observational trial for patients diagnosed with Autism Spectrum Disorder (ASD) treated with Zelira's HOPETM range of products. The observational trial will be one of the largest medicinal cannabis studies ever undertaken involving a specific range of products in patients diagnosed with ASD. The study design will facilitate strategic engagement with key stakeholders in the Autism community and streamline patient access via Emyria's national network of specialist medical clinics Emerald Clinics. These efforts will complement and augment the recent launch of HOPETM in the Australian market. Under the terms of the agreement, Emyria will provide Zelira with real-world longitudinal data collected from ASD patients prescribed a HOPETM product. Data will include efficacy and safety insights relating to co-morbidities, concomitant medications, dosing information and patient responses to HOPETM treatment as measured using standard ASD clinical and behavioural endpoints. Zelira will pay Emyria fees of $115,000 over the first 6 months as well as a subscription fee for each patient enrolled in the study, up to a maximum of 150 participants. The term of the agreement is for 12 months with an option to extend the subscription fees on an ongoing basis. Aankondiging • Oct 03
Zelira Therapeutics Ltd Enters into Agreement with Emyria Ltd Zelira Therapeutics Ltd. announced it has entered into an agreement with Emyria Ltd. to collect data from patients treated with ZenivolTM in Emyria's network of specialist medical clinics. Under the terms of the agreement Emyria will provide access to real-world longitudinal data collected from patients prescribed ZenivolTM for treatment of chronic insomnia and related conditions. De-identified patient data will include details regarding diagnosis and co-morbidities, concomitant medications, dosages prescribed to patients and their responses to ZenivolTM treatment assessed using various clinical and subjective endpoints including the Insomnia Severity Index (ISI) questionnaire. Zelira will pay Emyria an upfront fee of $50,000 along with a subscription fee for each patient enrolled in the study, up to a maximum of 100 participants. The term of the agreement is for 12 months with an option to extend the subscription fees on an ongoing basis. Aankondiging • Sep 07
Emerald Clinics Limited to Report Fiscal Year 2020 Results on Oct 30, 2020 Emerald Clinics Limited announced that they will report fiscal year 2020 results on Oct 30, 2020 