Announcement PDF ASX Announcement 31 Jan 2023 Emyria accepted into National Institutes of Health (NIH) program; completes $3m placement; expands MDMA-analogue library, commences Phase 3 trial recruitment Emyria Limited (ASX: EMD) (Emyria or the Company), a clinical stage biotech, is pleased to report on the Company’s activities for the quarter ending December 31, 2022. HIGHLIGHTS FOR THE DECEMBER QUARTER Accepted into the NIH HEAL Initiative® National Institute of Neurological Disorders and Stroke (NINDS) Preclinical Screening Platform for Pain (PSPP) program. NINDS is part of the U.S. National Institutes of Health (NIH), and the leading funder of neurological research in the USA: ● The PSPP will evaluate Emyria’s proprietary formulations of Ultra-Pure cannabinoids for suitability as treatments for pain ● Emyria will focus its EMD-RX7 program on US-FDA registration pathways (See ASX release 28 Nov 2022) Expanded our MDMA-analogue library with partners UWA to over 140 proprietary, neurologically active compounds. ● 14 compounds were shipped for safety screening with Eurofins ● 5 compounds sent to Psychogenics in the USA for advanced preclinical screening. ● Additional metabolic studies commenced with an Australian CRO to help evaluate the half-lives of a set of “MDMA 2.0” compounds in mice, rat and human liver cells. (See ASX release 18 Oct 2022) Commenced recruitment for pivotal Phase 3 clinical trial of EMD-RX5 After receipt of ethics approval last quarter, recruitment and planning for a Phase 3 trial of EMD-RX5 got underway ahead of the trial’s dosing commencement in Jan 2023. Completed a $3m placement supported by existing shareholders including Tenmile Funds raised from the placement will be used to: ● Advance the Phase 3 clinical trial supporting registration and commercialisation activities of EMD-RX5 as an over-the-counter treatment with the TGA ● Support the ongoing development of EMD-RX7, Emyria’s high dose CBD ● Advance multiple preclinical screening programs for Emyria’s novel MDMA-inspired drug discovery program being developed with the University of Western Australia ● Business development and working capital (See ASX release 23 Nov 2022) [1] Australian Institute of Health and Welfare 2018. Australia’s health 2018. Australia’s health series no. 16. AUS 221. Emyria ASX Announcement | 31 Jan 2023 1 Emyria’s Managing Director, Dr. Michael Winlo, said: “We closed 2022 with a lot of momentum in our drug development programs with the successful initiation of recruitment for our Phase 3 clinical trial for our leading asset, EMD-RX5, and the expansion of our preclinical R&D pipeline of MDMA analogues. Emyria also strengthened its network of world-leading research partners via acceptance into a prestigious program managed by the NIH and we boosted our cash position with the closing of a $3 million placement setting us up for a strong 2023 and beyond.” CORPORATE Emyria had $2.7m cash available on hand as of 31 December 2022. Subsequent to the closing of the quarter, the Company received its R&D refund of $2.1m. The board of directors were paid $333,000 for the quarter ended 31 December 2022 (as disclosed in section 6 of the 4C quarterly report) comprising wages, fees and superannuation. OUTLOOK Advancing the registration and commercialisation of Emyria’s proprietary drug products is the Company’s top priority in 2023. Active recruitment and dosing for the Company’s pivotal Phase 3 clinical trial of EMD-RX5 is underway. Identifying commercial partners for the EMD-RX5 platform will be a major focus for the company over the coming months. Emyria expects to advance its partnership with the NIH to evaluate the potential of its proprietary Ultra-Pure CBD formulations to address pain and opioid dependence indications. Additional US-focussed registration programs are expected to be initiated with Emyria’s prescription strength Ultra-Pure CBD formulations, like EMD-RX7. Further, Emyria will continue to advance the most promising MDMA analogue candidates within three leading clinical series; (1) faster-acting MDMA for MDMA-assisted therapy, (2) movement disorder treatments (eg. Parkinson’s) and (3) 5HT2B antagonist treatments for fibrosis. The Company notes the TGA is also expected to deliver a final notice on the rescheduling application of MDMA on February 8th, 2023. - This release has been approved by the Board of Emyria. - FOR FURTHER INFORMATION Dr. Michael Winlo Managing Director +61 (0) 8 6559 2800 mwinlo@emyria.com Lexi O’Halloran Investor Relations +61 (0) 404 577 076 investors@emyria.com Emyria ASX Announcement | 31 Jan 2023 Andrew Williams Media Relations +61 (0) 412 614 125 awilliams@emyria.com Sufian Ahmad Corporate Advisor +61 (0) 412 316 162 info@62capital.com.au 2 UPCOMING DRUG DEVELOPMENT MILESTONES DRUG DEVELOPMENT NEW DRUG DISCOVERY CLINICAL PROGRAMS Ultra-Pure cannabinoid delivery platform PRE-CLINICAL PROGRAM MDMA-like analogues EMD-RX5 “direct-to-consumer” EMD-RX7 “prescription medicine” MDMA-like drug development Formulation optimisation Formulation optimisation Continuous creation & screening Phase 1 study Phase 1 First patent family filed Ethics approved for Phase 3 Pre-IND (FDA) US-focused preclinical program Phase 3 commencement Pivotal trials Metabolic studies Regulatory submission Preclinical assays (multiple animal models) Commercial strategy Australia Human cell line assays Commercial strategy Europe Commercial strategy USA Advanced assay development Lead selection Phase 1 trials ABOUT EMYRIA | emyria.com Global commercial strategy Emyria Limited is a clinical drug development and care delivery company focused on accelerating drug development and improving patient outcomes in neuroscience and mental health via: ● Drug Development: Emyria is developing multiple, proprietary, Ultra-Pure cannabinoid dose forms suitable for registration against multiple indications. Emyria’s first dose form, EMD-RX5, is in Phase 3 trials. ● New Drug Discovery: Inspired by MDMA, Emyria is developing one of the world’s largest libraries of MDMA-like compounds with partner, the University of Western Australia. ● Proprietary Real-World Data (RWD): Emyria gathers robust and ethically-sourced data with patients cared for at Emyria’s own specialist clinical service (Emerald Clinics). Emyria RWD can help support drug development and care model improvement. EMYRIA’S INTERACTIVE INVESTOR HUB Investorhub.emyria.com Interact with Emyria’s announcements and updates by asking questions and comments, which our team can respond to where possible. CAUTIONARY NOTE ON FORWARD-LOOKING STATEMENTS Any statements in this press release about future expectations, plans and prospects for the Company, the Company’s strategy, future operations, and other statements containing the words “anticipate,” “believe,” “estimate,” “expect,” “intend,” “may,” “plan,” “predict,” “project,” “target,” “potential,” “will,” “would,” “could,” “should,” “continue,” and similar expressions, constitute forward-looking statements. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including: the Company’s ability to successfully develop its product candidates and timely complete its planned clinical programs and the Company’s ability to obtain marketing approvals for its product candidates. In addition, the forward-looking statements included in this press release represents the Company’s views as of the date hereof. The Company anticipates that subsequent events and developments will cause the Company’s views to change. However, while the Company may elect to update these forward-looking statements at some point in the future, the Company specifically disclaims any obligation to do so. These forward-looking statements should not be relied upon as representing the Company’s views as of any date subsequent to the date hereof. Emyria ASX Announcement | 31 Jan 2023 3 Rule 4.7B Appendix 4C Quarterly cash flow report for entities subject to Listing Rule 4.7B Name of entity EMYRIA LIMITED ABN Quarter ended (“current quarter”) 96 625 085 734 31 December 2022 Consolidated statement of cash flows Current quarter $A’000 1. Cash flows from operating activities 1.1 Receipts from customers 1.2 Payments for Year to date (6 months) $A’000 557 937 (a) research and development (641) (998) (b) product manufacturing and operating costs (458) (1,023) (c) advertising and marketing (52) (118) (d) leased assets (100) (208) (e) staff costs (529) (998) (f) (355) (950) administration and corporate costs 1.3 Dividends received (see note 3) - - 1.4 Interest received 4 7 1.5 Interest and other costs of finance paid - - 1.6 Income taxes paid - - 1.7 Government grants and tax incentives - - 1.8 Other (provide details if material) - - 1.9 Net cash from / (used in) operating activities (1,574) (3,351) 2. Cash flows from investing activities 2.1 Payments to acquire or for: (a) entities - - (b) businesses - - (2) (11) - - (582) (1,274) - - (c) property, plant and equipment (d) investments (e) intellectual property (f) other non-current assets ASX Listing Rules Appendix 4C (17/07/20) + See chapter 19 of the ASX Listing Rules for defined terms. Page 1 Appendix 4C Quarterly cash flow report for entities subject to Listing Rule 4.7B Consolidated statement of cash flows 2.2 Current quarter $A’000 Year to date (6 months) $A’000 Proceeds from disposal of: (a) entities - - (b) businesses - - (c) property, plant and equipment - - (d) investments - - (e) intellectual property - - (f) - - other non-current assets 2.3 Cash flows from loans to other entities - - 2.4 Dividends received (see note 3) - - 2.5 Other (provide details if material) - - 2.6 Net cash from / (used in) investing activities (584) (1,285) 3. Cash flows from financing activities 3.1 Proceeds from issues of equity securities (excluding convertible debt securities) 2,850 2,850 3.2 Proceeds from issue of convertible debt securities - - 3.3 Proceeds from exercise of options - - 3.4 Transaction costs related to issues of equity securities or convertible debt securities (170) (170) 3.5 Proceeds from borrowings - 800 3.6 Repayment of borrowings - - 3.7 Transaction costs related to loans and borrowings - - 3.8 Dividends paid - - 3.9 Other – net payments from cash backed guarantees - - 3.10 Net cash from / (used in) financing activities 2,680 3,480 4. Net increase / (decrease) in cash and cash equivalents for the period 4.1 Cash and cash equivalents at beginning of period 2,202 3,879 (1,574) (3,351) (584) (1,285) 4.2 Net cash from / (used in) operating activities (item 1.9 above) 4.3 Net cash from / (used in) investing activities (item 2.6 above) ASX Listing Rules Appendix 4C (17/07/20) + See chapter 19 of the ASX Listing Rules for defined terms. Page 2 Appendix 4C Quarterly cash flow report for entities subject to Listing Rule 4.7B Consolidated statement of cash flows 4.4 Net cash from / (used in) financing activities (item 3.10 above) 4.5 Effect of movement in exchange rates on cash held 4.6 5. Current quarter $A’000 Year to date (6 months) $A’000 2,680 3,480 -1 - Cash and cash equivalents at end of period 2,723 2,723 Reconciliation of cash and cash equivalents Current quarter $A’000 Previous quarter $A’000 at the end of the quarter (as shown in the consolidated statement of cash flows) to the related items in the accounts 5.1 Bank balances 2,723 2,202 5.2 Call deposits - - 5.3 Bank overdrafts - - 5.4 Other (provide details) - - 5.5 Cash and cash equivalents at end of quarter (should equal item 4.6 above) 2,723 2,202 6. Payments to related parties of the entity and their associates 6.1 Aggregate amount of payments to related parties and their associates included in item 1 333 6.2 Aggregate amount of payments to related parties and their associates included in item 2 - Current quarter $A'000 Note: if any amounts are shown in items 6.1 or 6.2, your quarterly activity report must include a description of, and an explanation for, such payments. ASX Listing Rules Appendix 4C (17/07/20) + See chapter 19 of the ASX Listing Rules for defined terms. Page 3 Appendix 4C Quarterly cash flow report for entities subject to Listing Rule 4.7B 7. Financing facilities Note: the term “facility’ includes all forms of financing arrangements available to the entity. Add notes as necessary for an understanding of the sources of finance available to the entity. Total facility amount at quarter end $A’000 Amount drawn at quarter end $A’000 800 800 7.1 Loan facilities 7.2 Credit standby arrangements - - 7.3 Other (please specify) - - 7.4 Total financing facilities 800 800 7.5 Unused financing facilities available at quarter end 7.6 Include in the box below a description of each facility above, including the lender, interest rate, maturity date and whether it is secured or unsecured. If any additional financing facilities have been entered into or are proposed to be entered into after quarter end, include a note providing details of those facilities as well. - Emyria set up a loan facility in July 2022 for $800,000 with Radium Capital secured against its R&D Tax Incentive claim with an interest rate of 14% per annum. The facility was fully utilised at 31 December and was repaid in January 2023. 8. Estimated cash available for future operating activities $A’000 8.1 Net cash from / (used in) operating activities (item 1.9) (1,574) 8.2 Cash and cash equivalents at quarter end (item 4.6) 2,723 8.3 Unused finance facilities available at quarter end (item 7.5) 8.4 Total available funding (item 8.2 + item 8.3) 2,723 8.5 Estimated quarters of funding available (item 8.4 divided by item 8.1) 1.73 - Note: if the entity has reported positive net operating cash flows in item 1.9, answer item 8.5 as “N/A”. Otherwise, a figure for the estimated quarters of funding available must be included in item 8.5. 8.6 If item 8.5 is less than 2 quarters, please provide answers to the following questions: 8.6.1 Does the entity expect that it will continue to have the current level of net operating cash flows for the time being and, if not, why not? Answer: The company received its R&D tax refund ($2.1m) in January 2023 which will reduce the net operating cash flows in the March 2023 quarter, otherwise the current level of net operating cash flows is expected to continue. 8.6.2 Has the entity taken any steps, or does it propose to take any steps, to raise further cash to fund its operations and, if so, what are those steps and how likely does it believe that they will be successful? Answer: Yes. The company has received its R&D Tax refund in January 2023 for $2.1m. 8.6.3 Does the entity expect to be able to continue its operations and to meet its business objectives and, if so, on what basis? Answer: Yes, based on R&D Tax refund. Note: where item 8.5 is less than 2 quarters, all of questions 8.6.1, 8.6.2 and 8.6.3 above must be answered. ASX Listing Rules Appendix 4C (17/07/20) + See chapter 19 of the ASX Listing Rules for defined terms. Page 4 Appendix 4C Quarterly cash flow report for entities subject to Listing Rule 4.7B Compliance statement 1 This statement has been prepared in accordance with accounting standards and policies which comply with Listing Rule 19.11A. 2 This statement gives a true and fair view of the matters disclosed. Date: 31 January 2023 Authorised by: By the Board Notes 1. This quarterly cash flow report and the accompanying activity report provide a basis for informing the market about the entity’s activities for the past quarter, how they have been financed and the effect this has had on its cash position. An entity that wishes to disclose additional information over and above the minimum required under the Listing Rules is encouraged to do so. 2. If this quarterly cash flow report has been prepared in accordance with Australian Accounting Standards, the definitions in, and provisions of, AASB 107: Statement of Cash Flows apply to this report. If this quarterly cash flow report has been prepared in accordance with other accounting standards agreed by ASX pursuant to Listing Rule 19.11A, the corresponding equivalent standard applies to this report. 3. Dividends received may be classified either as cash flows from operating activities or cash flows from investing activities, depending on the accounting policy of the entity. 4. If this report has been authorised for release to the market by your board of directors, you can insert here: “By the board”. If it has been authorised for release to the market by a committee of your board of directors, you can insert here: “By the [name of board committee – eg Audit and Risk Committee]”. If it has been authorised for release to the market by a disclosure committee, you can insert here: “By the Disclosure Committee”. 5. If this report has been authorised for release to the market by your board of directors and you wish to hold yourself out as complying with recommendation 4.2 of the ASX Corporate Governance Council’s Corporate Governance Principles and Recommendations, the board should have received a declaration from its CEO and CFO that, in their opinion, the financial records of the entity have been properly maintained, that this report complies with the appropriate accounting standards and gives a true and fair view of the cash flows of the entity, and that their opinion has been formed on the basis of a sound system of risk management and internal control which is operating effectively. ASX Listing Rules Appendix 4C (17/07/20) + See chapter 19 of the ASX Listing Rules for defined terms. Page 5