Earnings release
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Avecho Biotechnology Limited | ASX: AVE | ACN: 056 482 403 | ABN: 32 056 482 403 Unit 8A, 2A Westall Road, Hallmarc Business Park, Clayton VIC Australia 3168 avecho.com.au ASX Announcement 29 January 2026 Avecho Quarterly Activities Report and Appendix 4C Key Highlights CBD insomnia trial recruiting remaining patients in early 2026 for interim analysis $2.5 million raised to accelerate commercial manufacturing for CBD insomnia product Cash balance as at 31 December 2025 was $4.7M with an estimated $1.8M 1 in R&D tax credits forecast for Q2 2026. United States Patent and Trademark Office and the European Patent Office have allowed patent applications covering Avecho’s proprietary CBD TPM® soft-gel capsule Melbourne, Australia, 29 January 2026: Avecho Biotechnology Limited (ASX: AVE) (“Avecho” or “the Company”) is pleased to present its Quarterly Activities Report and Appendix 4C for the quarter ended 31 December 2025. Avecho CEO Dr Paul Gavin said: “We are entering a particularly exciting period for Avecho as we approach the completion of dosing for the interim analysis of our Phase III CBD insomnia trial. With the majority of participants now dosed, the end of recruitment is in sight and the significance of this milestone is tangible across the organisation. The interim analysis represents a major clinical and commercial catalyst for Avecho, and a compelling opportunity to create value for our shareholders. After years of disciplined development, we are now close to a defining moment for the Company.” Phase III CBD insomnia trial advances toward interim analysis Avecho reported continued progress in recruitment for the interim analysis cohort of its pivotal Phase III clinical trial evaluating its CBD TPM® soft-gel capsule for the treatment of insomnia. As at 18 December 2025, a total of 190 patients had been dosed with study medication, representing the majority of the approximately 210 participants required for the planned interim analysis. Recruitment has continued into early 2026 to enrol the remaining participants. The Company noted that the pace of recruitment reflects the highly specific inclusion and exclusion criteria designed to select the patient population most appropriate for assessing the product’s efficacy and safety, which is intended to maximise the likelihood of a successful clinical outcome. Once recruitment is complete, Avecho will move to the final steps required to conduct the interim analysis, with formal timelines to be confirmed at that point. The Company is targeting completion of the interim analysis in the first half of 2026, which is expected to represent a major clinical and commercial inflection point for the CBD TPM® program. Avecho raises $2.5 million to accelerate commercial manufacturing for CBD insomnia product Avecho announced it had secured firm commitments from institutional and sophisticated investors to raise $2.5 million via a placement in October 2025, providing funding to accelerate commercial manufacturing activities required to support a future TGA submission and commercial supply of its 1 Estimated R&D Credit amounts is unaudited. These amounts are based on management’s preliminary assessments and may be subject to change following the completion of the Company’s audit and finalisation of its financial statements. Investors are advised to exercise caution when relying on this information, as actual results may differ materially from the unaudited figures disclosed. For personal use only
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Avecho Biotechnology Limited | ASX: AVE | ACN: 056 482 403 | ABN: 32 056 482 403 Unit 8A, 2A Westall Road, Hallmarc Business Park, Clayton VIC Australia 3168 avecho.com.au lead CBD TPM® soft-gel capsule for insomnia. The Company completed the placement on 3 November 2025. Proceeds from the Placement are being used to bring forward and complete critical manufacturing activities required for regulatory approval and future commercialisation. These include manufacturing registration batches for long-term stability testing, scaling up production to commercial batch sizes, finalising regulatory manufacturing documentation, and producing capsules for use in the second Phase III CBD insomnia trial patient cohort. Funding will also support ongoing trial costs through to the interim analysis. The accelerated manufacturing program is designed to position Avecho to lodge a TGA submission as soon as possible following a successful Phase III outcome, while also preparing for future commercial supply in Australia and potential expansion into additional markets, including through ongoing licensing discussions. US and European patent allowances secured for CBD soft-gel formulation In December, the Company announced that both the United States Patent and Trademark Office and the European Patent Office have allowed its patent applications covering the Company’s proprietary CBD TPM® soft-gel capsule, which is currently in Phase III clinical development for the treatment of insomnia. The allowed patents cover Avecho’s novel oral cannabinoid formulation that combines its Tocopheryl Phosphate Mixture (TPM®) delivery technology with cannabinoids and lipids to improve the solubility, stability and absorption of CBD and other cannabinoids. The scope of the claims also extends beyond CBD to include other cannabinoids, supporting potential future non-core commercial opportunities. With all substantive examination hurdles now cleared, Avecho expects the patents to be formally granted by the end of FY26. Once granted, they will provide intellectual property protection for the CBD TPM® soft-gel capsule in the United States and Europe until at least 2040, strengthening the Company’s competitive position in two of the world’s largest pharmaceutical markets. Corporate and Financial Update At 31 December 2025, Avecho held a cash balance of $4.7 million. Payments to related parties and their associates during the quarter, as outlined in Section 6 of the accompanying Appendix 4C, totalled approximately $67K. During the quarter, the Company invested $1,846K (YTD: $4,293K) in R&D clinical activities primarily toward advancing the Phase III insomnia trial and supporting the related manufacturing and regulatory activities. Quarterly operating costs are not expected to remain at this level in coming months as the value for the quarter to 31 December 2025 included several significant trial and support costs. These timing differences for payments have skewed the cash flow runway reported in section 8.5 (2.11 quarters) which is not consistent with the Company's budget or operational expectations. For enquiries, please contact Dr Paul Gavin Chief Executive Officer Avecho Biotechnology Limited +61 3 9002 5000 This announcement has been authorised by the Board of Directors of Avecho Biotechnology Limited. For personal use only
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Avecho Biotechnology Limited | ASX: AVE | ACN: 056 482 403 | ABN: 32 056 482 403 Unit 8A, 2A Westall Road, Hallmarc Business Park, Clayton VIC Australia 3168 avecho.com.au About Avecho Avecho Biotechnology Limited develops and commercialises innovative Human and Animal Health products using its proprietary drug delivery system called Tocopheryl Phosphate Mixture (TPM®). TPM® is derived from Vitamin E using unique, proprietary and patented processes and is proven to enhance the solubility and oral, dermal and transdermal absorption of drugs and nutrients. Avecho’s lead asset is a proprietary cannabidiol (“CBD”) TPM soft-gel capsule demonstrated to increase CBD absorption. The CBD soft-gel capsule is currently undergoing Phase III clinical development for the treatment of insomnia. See more here - avecho.com.au About Insomnia Insomnia is a sleep disorder defined as dissatisfaction with sleep quantity or quality associated with difficulty initiating sleep, difficulty maintaining sleep and the inability to return to sleep on awakening. It can manifest as a primary indication or be symptom of other disorders, including anxiety and depression. Chronic insomnia is the most prevalent manifestation, characterised by insomnia symptoms occurring at least three nights per week and for at least three months. Consequences of insomnia include daytime sleepiness, poor memory function, decline in concentration with negative impacts on social and work activities. Approximately 10-30% of the global population have symptoms of insomnia, with 10-15% classified as chronic 2. Based on the current global population, up to 237M people are affected by insomnia, with the sleep economy and sleep aids market estimated to reach US$950Bn by 20323. In Australia, as many as ~60% of the population have at least some symptoms of insomnia with a total cost to the Australian economy estimated to be A$19.1 billion 4. In August 2023, the Australian Government issued a statement indicating that sleep health should be considered a national priority as important as fitness and nutrition5. About Avecho’s Phase III Trial Program The Company is currently conducting a pivotal (Phase III), multi-centre, randomized, double-blind, placebo-controlled clinical trial evaluating the efficacy and safety of CBD TPM soft-gel capsules in adults for use in the reduction of insomnia severity. The trial is the largest of its kind testing cannabidiol, taking place at multiple sites around Australia. Aided by advice from international sleep and regulatory experts, the trial has been designed to meet the requirements of the Australian Therapeutic Goods Administration (“TGA”), US Food and Drug Agency and the European Medicines Agency. Trial Participants will be randomly assigned to one of three groups to receive nightly doses of either 75mg or 150mg of CBD, or a placebo for eight weeks. Participants will use validated questionnaires and daily sleep diaries over the course of the study to record the duration and quality of their sleep. Further information about the study can be found at ClinicalTrials.gov (Study Identifier: NCT05840822). A successful Phase III trial is Avecho’s final clinical step in support of a submission to the TGA for pharmaceutical registration of the CBD TPM soft-gel capsule for the management of insomnia. This opportunity is particularly significant in Australia, where regulatory changes in 2020 allow for over-the- counter sales of CBD products direct from pharmacy without a prescription, provided they gain appropriate approvals. Avecho has an opportunity to be the first in this area as no other Phase III CBD trials in Australia have succeeded. Initial projections estimated the Australian over-the-counter CBD market would grow to over US$125M per annum6. 2 https://www.thegoodbody.com/insomnia-statistics/ 3 https://finance.yahoo.com/news/sleep-economy-sleep-aids-market-133100851.html 4https://www.deloitte.com/au/en/services/economics/analysis/rise-try-to-shine.html 5https://www.health.gov.au/sites/default/files/2023-08/bedtime-reading-inquiry-into-sleep-health-awareness- in-australia.pdf 6 Fresh Leaf Analytics, Australian Medicinal Cannabis Market, H1 2021 For personal use only
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Avecho Biotechnology Limited | ASX: AVE | ACN: 056 482 403 | ABN: 32 056 482 403 Unit 8A, 2A Westall Road, Hallmarc Business Park, Clayton VIC Australia 3168 avecho.com.au Forward-Looking Statements Certain statements in this announcement are forward looking statements. Forward-looking statements can generally be identified by the use of words such as “anticipate”, “estimate”, “expect”, “project”, “intend”, “plan”, “believe”, “target”, “may”, “assume” and words of similar import. These forward- looking statements speak only as at the date of this announcement. These statements are based on current expectations and beliefs and, by their nature, are subject to a number of known and unknown risks and uncertainties that could cause the actual results, performances and achievements to differ materially from any expected future results, performance or achievements expressed or implied by such forward looking statements. No representation, warranty or assurance (express or implied) is given or made by Avecho that the forward-looking statements contained in this announcement are accurate, complete, reliable or adequate or that they will be achieved or prove to be correct. Except for any statutory liability which cannot be excluded, Avecho and its respective officers, employees and advisers expressly disclaim any responsibility for the accuracy or completeness of the forward-looking statements and exclude all liability whatsoever (including negligence) for any direct or indirect loss or damage which may be suffered by any person as a consequence of any information in this announcement or any error or omission therefrom. Subject to any continuing obligation under applicable law or relevant listing rules of the ASX, Avecho disclaims any obligation or undertaking to disseminate any updates or revisions to any forward-looking statements in these materials to reflect any change in expectations in relation to any forward-looking statements or any change in events, conditions or circumstances on which any statement is based. Nothing in these materials shall under any circumstances create an implication that there has been no change in the affairs of Avecho since the date of the announcement. Avecho’s major projects include delivering TPM enhanced injectable, oral and topical products for the human health market, including the recently announced application of TPM to cannabinoids. The Company is also developing TPM® to enhance feed efficiency and health of livestock. For personal use only
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Rule 4.7B ASX Listing Rules Appendix 4C (17/07/20) Page 1 + See chapter 19 of the ASX Listing Rules for defined terms. Appendix 4C Quarterly cash flow report for entities subject to Listing Rule 4.7B Name of entity AVECHO BIOTECHNOLOGY LIMITED ABN Quarter ended (“current quarter”) 32 056 482 403 31 December 2025 Consolidated statement of cash flows Current quarter $A’000 Year to date (12 months) $A’000 1. Cash flows from operating activities 347 6,491 1.1 Receipts from customers 1.2 Payments for (1,846) (4,293) (a) research and development (b) product manufacturing and operating costs (48) (348) (c) advertising and marketing - - (d) leased assets - - (e) staff costs* (159) (675) (f) administration and corporate costs (g) patent portfolio costs (484) (26) (1,627) (148) 1.3 Dividends received (see note 3) - - 1.4 Interest received 2 10 1.5 Interest and other costs of finance paid - (3) 1.6 Income taxes paid - - 1.7 Government grants and tax incentives - 652 1.8 Other (EMDG) - - 1.9 Net cash from / (used in) operating activities (2,214) 59 *A percentage of staff costs are reallocated to payments for research and development, and product manufacturing and operating costs. 2. Cash flows from investing activities - - 2.1 Payments to acquire or for: (h) entities (i) businesses - - (j) property, plant and equipment - - (k) investments - - (l) intellectual property - - 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) Page 2 + See chapter 19 of the ASX Listing Rules for defined terms. Consolidated statement of cash flows Current quarter $A’000 Year to date (12 months) $A’000 (m) other non-current assets - - 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 - - 3. Cash flows from financing activities 2,500 2,500 3.1 Proceeds from issues of equity securities (excluding convertible debt securities) 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 (187) (187) 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(a) Other – Payment of principal element of lease liabilities (22) (84) 3.9(b) Others - - 3.10 Net cash from / (used in) financing activities 2,291 2,229 4. Net increase / (decrease) in cash and cash equivalents for the period 4,586 2,375 4.1 Cash and cash equivalents at beginning of period 4.2 Net cash from / (used in) operating activities (item 1.9 above) (2,214) 59 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) Page 3 + See chapter 19 of the ASX Listing Rules for defined terms. Consolidated statement of cash flows Current quarter $A’000 Year to date (12 months) $A’000 4.3 Net cash from / (used in) investing activities (item 2.6 above) - - 4.4 Net cash from / (used in) financing activities (item 3.10 above) 2,291 2,229 4.5 Effect of movement in exchange rates on cash held - - 4.6 Cash and cash equivalents at end of period 4,663 4,663 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 $A’000 Previous quarter $A’000 5.1 Bank balances 4,663 4,586 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) 4,663 4,586 6. Payments to related parties of the entity and their associates Current quarter $A'000 6.1 Aggregate amount of payments to related parties and their associates included in item 1 (67) 6.2 Aggregate amount of payments to related parties and their associates included in item 2 - 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. 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) Page 4 + 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 $A’000 Amount drawn at quarter end $A’000 7.1 Loan facilities - - 7.2 Credit standby arrangements - - 7.3 Other (please specify) - - 7.4 Total financing facilities - - 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. N/A 8. Estimated cash available for future operating activities $A’000 8.1 Net cash from / (used in) operating activities (item 1.9) (2,214) 8.2 Cash and cash equivalents at quarter end (item 4.6) 4,663 8.3 Unused finance facilities available at quarter end (item 7.5) - 8.4 Total available funding (item 8.2 + item 8.3) 4,663 8.5 Estimated quarters of funding available (item 8.4 divided by item 8.1) 2.11 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: N/A 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: N/A 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: N/A 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) Page 5 + 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: 29 January 2026 Authorised by: By the Board of Avecho Biotechnology Limited (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