Earnings release
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ABN: 32 006 340 567 1 July 30, 2025 ASX and NASDAQ ASX Announcement Quarterly Activity Report Q4 FY25 Recent Activity Reduction in staff of approximately 85% & of 50% the Board of Directors Completed operational spending associated with ShORe and COAST clinical trials Company remains in active negotiation with DFA investors Opthea remains in trading suspension Opthea Limited (ASX: OPT, NASDAQ:OPT) (“Opthea” or “the Company”), today released its Quarterly Activity Report and Appendix 4C for the twelve-month period ended June 30, 2025 (“Q4 FY25”). Opthea is a clinical-stage biopharmaceutical company. Opthea's focus has been on the development and commercialisation of OPT-302 that targets VEGF-C and VEGF-D. As a result of the COAST Phase 3 trial and the ShORe Phase 3 trial not meeting their primary endpoints, Opthea and the investors (“DFA Investors”) under the Company’s Development Funding Agreement (“DFA”) agreed to discontinue the development program of sozinibercept in wet AMD with immediate effect. Opthea continues active discussion with the DFA Investors, pursuant to and as required under the DFA, to explore possible options to deliver the best outcome for the Company and its shareholders. In light of these matters, there remains material uncertainty as to Opthea’s ability to continue as a going concern. Opthea remains in a trading suspension. During Q4 FY 25 the company negotiated the termination of all contracts associated with the ShORe and COAST clinical trials. This quarter reflects operational expenses associated with those programs where in future quarters the company will not incur material expenses associated with them. For personal use only
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Rule 4.7B ABN: 32 006 340 567 Third Quarter Financial Performance & Cash Flow Opthea’s cash balance at 30 June 2025 was US$48.4m, down from US$101.4m in the prior quarter ending 31 March 2025, primarily reflecting the operational spend for the quarter of US$52.9m closing out the two pivotal clinical trials and the reduction in staff of approximately $50M. Cash receipts for the quarter were US$0.7m, which is 62% of the previous quarter’s US$1.2m. This is a consequence of the varying interest on cash holdings. The net operating cash outflow for the period was US$53.5m. The prior period net operating cash outflow was US$32.4m. Research and development costs for the quarter were US$39.8m, 156% of the previous quarter (Q3 FY25: US$25.5m). Administration costs in Q4 FY25 were US$0.8m and were 44% of the previous quarter (Q3 FY25: US$1.7m). Personnel costs of US$13.8m were up 226% on the previous quarter of US$6m. In accordance with ASX Listing Rule 4.7C.3, cash paid for Directors and Non-Executive Directors in Q4 FY25 amounted to US$107k in aggregate which includes director fees and customary reimbursement of applicable costs. Development Funding Agreement and Financial Resources The Company had US$48.4 million in cash at June 30, 2025. As previously disclosed, the Company remains in active negotiations with its DFA Investors, pursuant to and as required under the DFA, to explore possible options to deliver an outcome that is in the best interest of the Company and its shareholders. Authorized for release by CEO Fred Guerard, PharmD, CEO. Enquiries Email: info@opthea.com About Opthea Opthea (ASX:OPT; NASDAQ:OPT) is a biopharmaceutical company. Opthea's focus has been on the development and commercialisation of OPT-302 that targets VEGF-C and VEGF-D. To learn more, visit our website at www.opthea.com and follow us on X and LinkedIn. For personal use only
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Rule 4.7B ABN: 32 006 340 567 Forward-Looking Statements This ASX announcement contains certain forward-looking statements, including within the meaning of the US Private Securities Litigation Reform Act of 1995. The words “expect”, “believe”, “should”, “could”, “may”, “will”, “plan” and other similar expressions are intended to identify forward-looking statements. Forward-looking statements in this ASX announcement include statements regarding possible outcomes in connection with the DFA and Opthea’s ability to continue as a going concern. Forward-looking statements, opinions and estimates provided in this ASX announcement are based on assumptions and contingencies which are subject to change without notice, as are statements about market and industry trends, which are based on interpretations of current conditions. Forward-looking statements are provided as a general guide only and should not be relied upon as an indication or guarantee of future performance. They involve known and unknown risks and uncertainties and other factors, many of which are beyond the control of Opthea and its directors and management and may involve significant elements of subjective judgment and assumptions as to future events that may or may not be correct. These statements may be affected by a range of variables which could cause actual results or trends to differ materially, including but not limited to future capital requirements, the development, testing, production, marketing and sale of drug treatments, regulatory risk and potential loss of regulatory approvals, clinical research organization and labor costs, intellectual property protections, and other factors that are of a general nature which may affect the future operating and financial performance of the Company including risk factors set forth in Opthea’s Annual Report on Form 20-F filed with the US Securities and Exchange Commission (the “SEC”) on August 30, 2024, and other future filings with the SEC. Actual results, performance or achievements may vary materially from any projections and forward-looking statements and the assumptions on which those statements are based. Subject to any continuing obligations under applicable law or any relevant ASX listing rules, Opthea disclaims any obligation or undertaking to provide any updates or revisions to any forward-looking statements in this ASX announcement to reflect any change in expectations in relation to any forward-looking statements or any change in events, conditions or circumstances on which any such statement is based, except as otherwise required by applicable law. For personal use only
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Rule 4.7B ABN: 32 006 340 567 Appendix 4C Quarterly cash flow report for entities subject to Listing Rule 4.7B Name of entity OPTHEA LIMITED. ABN Quarter ended (“current quarter”) ARBN 672 254 027 June 30, 2025 Consolidated statement of cash flows Current quarter $US’000 Year to date (12 months) $US’000 1. Cash flows from operating activities 1.1 Receipts from customers 1.2 Payments for (a) research and development (39,785) (133,900) (b) product manufacturing and operating costs (c) advertising and marketing (d) leased assets (e) staff costs (13,772) (29,150) (f) administration and corporate costs (782) (11,634) 1.3 Dividends received (see note 3) 1.4 Interest received 730 5,715 1.5 Interest and other costs of finance paid (4) (8) 1.6 Income taxes paid 16 (240) 1.7 Government grants and tax incentives - 10,398 1.8 Other (provide details if material) 64 189 1.9 Net cash from / (used in) operating activities (53,533) (158,630) 2. Cash flows from investing activities (-) (13) 2.1 Payments to acquire or for: (a) entities (b) businesses (c) property, plant and equipment (d) investments (e) intellectual property (f) other non-current assets For personal use only
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Appendix 4C Quarterly cash flow report for entities subject to Listing Rule 4.7B ASX Listing Rules Appendix 4C (17/07/20) + See chapter 19 of the ASX Listing Rules for defined terms. Consolidated statement of cash flows Current quarter $US’000 Year to date 12 months) $US’000 2.2 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 (-) (13) 3. Cash flows from financing activities 3.1 Proceeds from issues of equity securities (excluding convertible debt securities) - 34,796 3.2 Proceeds from issue of convertible debt securities 3.3 Proceeds from exercise of options - 51 3.4 Transaction costs related to issues of equity securities or convertible debt securities 3.5 Proceeds from borrowings - - 3.6 Repayment of borrowings 3.7 Transaction costs related to loans and borrowings 3.8 Dividends paid 3.9 Other (provide details if material) (15) (93) 3.10 Net cash from / (used in) financing activities (15) 34,754 4. Net increase / (decrease) in cash and cash equivalents for the period 4.1 Cash and cash equivalents at beginning of period 101,352 172,471 4.2 Net cash from / (used in) operating activities (item 1.9 above) (53,533) (158,630) 4.3 Net cash from / (used in) investing activities (item 2.6 above) (-) (13) For personal use only
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Appendix 4C Quarterly cash flow report for entities subject to Listing Rule 4.7B ASX Listing Rules Appendix 4C (17/07/20) + See chapter 19 of the ASX Listing Rules for defined terms. Consolidated statement of cash flows Current quarter $US’000 Year to date (12 months) $US’000 4.4 Net cash from / (used in) financing activities (item 3.10 above) (15) 34,754 4.5 Effect of movement in exchange rates on cash held 639 (139) 4.6 Cash and cash equivalents at end of period 48,443 48,443 5. Reconciliation of cash and cash equivalents at the end of the quarter (as shown in the consolidated statement of cash flows) to the related items in the accounts Current quarter $US’000 Previous quarter $US’000 5.1 Bank balances 14,030 34,413 50,530 50,822 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) 48,443 101,352 6. Payments to related parties of the entity and their associates Current quarter $US'000 6.1 Aggregate amount of payments to related parties and their associates included in item 1 6.2 Aggregate amount of payments to related parties and their associates included in item 2 - Cash Paid for Directors and Non-Executive Directors in quarter 3 amounted to US$138k which includes salaries, travel and reimbursement of any costs. For personal use only
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Appendix 4C Quarterly cash flow report for entities subject to Listing Rule 4.7B ASX Listing Rules Appendix 4C (17/07/20) + See chapter 19 of the ASX Listing Rules for defined terms. 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 $US’000 Amount drawn at quarter end $US’000 7.1 Loan facilities 170,000 170,000 7.2 Credit standby arrangements - - 7.3 Other (please specify) - - 7.4 Total financing facilities 170,000 170,000 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. In August 2022, Opthea entered into a Development Funding Agreement (DFA), The last tranche and option of the DFA was drawn in December 2023 for a total capital funding of US$170m. Only upon regulatory approval is the Company obligated to pay up to 4.0x the investment amount via a 7% royalty on net sales and certain milestone payments. Opthea accounts for the DFA on its balance sheet as the accreted value based on implied non-cash interest, adjusted for fair market changes if required. 8. Estimated cash available for future operating activities $US’000 8.1 Net cash from / (used in) operating activities (item 1.9) (53,533) 8.2 Cash and cash equivalents at quarter end (item 4.6) 48,443 8.3 Unused finance facilities available at quarter end (item 7.5) - 8.4 Total available funding (item 8.2 + item 8.3) 48,443 8.5 Estimated quarters of funding available (item 8.4 divided by item 8.1) 0.9 (A) The company remains in active negotiations with the Development Fund Investors; the outcome of these discussions may or may not have an impact on the remaining cash runway (A) The future cash burn is expected to decrease due to the discontinuation of the Shore and Coast development program. Of the $53m of operating expenses for the quarter approximate $50m is attributed to one off cost associated with concluding the current trial and reduction in force of about 85% 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 anticipated net operating cash flows are expected to decline significantly, as all external contracts have been finalized and closed, and operations are currently functioning with reduced staffing levels while evaluating the next phase of Opthea. 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: Company is assessing its next steps 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: The company anticipates that it will successfully sustain its operations in alignment with its revised business goals. (A) For personal use only
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Appendix 4C Quarterly cash flow report for entities subject to Listing Rule 4.7B ASX Listing Rules Appendix 4C (17/07/20) + See chapter 19 of the ASX Listing Rules for defined terms. 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. For personal use only
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Appendix 4C Quarterly cash flow report for entities subject to Listing Rule 4.7B ASX Listing Rules Appendix 4C (17/07/20) + See chapter 19 of the ASX Listing Rules for defined terms. 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: July 30, 2025 Authorised by: Frederic Guerard CEO (Name of body or officer authorising release – see note 4) 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. For personal use only