Announcement PDF Appendix 4D Half Year Financial Report Name of entity: ACTINOGEN MEDICAL LIMITED ABN or equivalent company reference: 14 086 778 476 Current Period: 1 July 2025 to 31 December 2025 (Previous corresponding period: 1 July 2024 to 31 December 2024) RESULTS FOR ANNOUNCEMENT TO THE MARKET BRIEF EXPLANATION OF THE ABOVE FIGURES Revenues from ordinary activities relates to interest revenue from cash held in interest-bearing accounts and short-term deposits. The total net loss after tax increased by 39%. The primary expenditure item was Research & Development. Refer to the attached Directors’ Report and financial statements for further information. Details of entities over which control has been gained or lost during the period Not applicable. There has been no entity over which control has been gained or lost during the period. Dividend / Distribution Payments or Reinvestment Plans Not applicable. No dividends have been paid or declared during the half year ended 31 December 2025, in the previous financial year ended 30 June 2025 or in the previous corresponding period. The Company does not propose paying dividends in the immediate future. Associates / Joint Ventures Not applicable. The Company has not engaged in the acquisition of associates, nor has it engaged in any joint ventures in the half year ended 31 December 2025. Foreign Entities Not applicable. Review Conclusion This Report is based on the Interim Financial Report for the half year ended 31 December 2025. The financial report has been subject to a review by an independent auditor and the review is not subject to qualification. Dr Steven Gourlay Managing Director 26 February 2026 Sydney, New South Wales Half year ended 31-12-25 Half year ended 31-12-24 Change % Amount change $ Revenue from ordinary activities 232,920 244,406 -5% (11,486) Loss from ordinary activities after tax attributable to members (11,346,952) (8,168,979) 39% (3,177,973) Net loss for the period attributable to members (11,346,952) (8,168,979) 39% (3,177,973) Net tangible asset per share (a) 0.002 0.007 Interim Report 2026 Page | 2 Contents Operating & financial review 3 Directors’ report 11 Auditor’s independence declaration 12 Statement of comprehensive income 13 Statement of financial position 14 Statement of changes in equity 15 Statement of cash flows 16 Notes to the financial statements 17 Directors’ declaration 24 Independent auditor’s report 25 Corporate directory 27 Disclaimer This Interim Report may contain certain "forward-looking statements" that are not historical facts; are based on subjective estimates, assumptions and qualifications; and relate to circumstances and events that have not taken place and may not take place. Such forward looking statements should be considered “at-risk statements” - not to be relied upon as they are subject to known and unknown risks, uncertainties and other factors (such as significant business, economic and competitive uncertainties / contingencies and regulatory and clinical development risks, future outcomes and uncertainties) that may lead to actual results being materially different from any forward looking statement or the performance expressed or implied by such forward looking statements. You are cautioned not to place undue reliance on these forward-looking statements that speak only as of the date hereof. Actinogen Medical does not undertake any obligation to revise such statements to reflect events or any change in circumstances arising after the date hereof, or to reflect the occurrence of or non-occurrence of any future events. Past performance is not a reliable indicator of future performance. Actinogen Medical does not make any guarantee, representation or warranty as to the likelihood of achievement or reasonableness of any forward-looking statements and there can be no assurance or guarantee that any forward-looking statements will be realised. Page | 3 Operating & financial review 1. PRINCIPAL ACTIVITIES The principal activity of the company during the half year focused on the ongoing clinical development of Xanamem® (emestedastat), a unique inhibitor of the 11β- HSD1 enzyme that achieves target engagement in the brain. It is an oral medication for neurological diseases amenable to its mechanism of controlling cortisol in brain cells. Brain cortisol is associated with a number of neurological diseases, including neurodegenerative diseases such as Alzheimer’s disease (AD) and neuropsychiatric diseases like major depressive disorder (MDD). 2. OPERATIONS REVIEW XanaMIA pivotal Alzheimer’s trial progress and commercial readiness preparation Highlights • Completed accelerated enrolment in the XanaMIA phase 2b/3 AD trial, randomizing the final (247th ) participant in December 2025 • Received a positive interim safety and efficacy futility analysis recommendation from the trial’s independent Data Monitoring Committee (DMC) on 30 January 2026 to continue the trial without amendment following a prior positive safety review in November 2025 • Open‑label extension (OLE) phase of the XanaMIA trial to commence Q1 2026, allowing all participants access to active Xanamem 10 mg once daily for a longer treatment period of up to 25 months • Achieved a common understanding with the FDA on the pathway to marketing approval in AD, including agreement on the streamlined design of one further pivotal AD trial of Xanamem 10 mg vs. placebo commencing in 2027 • Successfully completed a pharmacokinetic trial confirming that the intended commercial Xanamem formulation achieves consistent and therapeutic blood concentrations under both fed and fasted conditions, supporting full dosing flexibility • Completed commercial‑grade manufacture of 10mg Xanamem tablets at Catalent (USA) for use in the OLE phase of the XanaMIA trial • Continued commercial readiness activities, including refinement of communication materials for scientific, medical and business audiences, and establishment of a new AD clinical advisory board • Continued strengthening of IP protection through active national phase patent filings • Launched Actinogen’s InvestorHub platform to facilitate direct investor engagement • Received a total of $7.4 million R&D tax incentive cash rebate relating to expenditures in the 2025 financial year.1 XanaMIA phase 2b/3 AD Trial – Enrolment complete and positive interim analysis outcome Enrolment for the pivotal XanaMIA phase 2b/3 Alzheimer’s disease trial was successfully completed in December 2025, with 247 participants recruited across 35 sites in the United States and Australia — exceeding the original target of 220. The trial targets individuals with mild to moderate Alzheimer’s disease and elevated plasma pTau181, a diagnostic biomarker also associated with faster disease progression. A major milestone was achieved on 30 January 2026, when the trial’s independent Data Monitoring Committee completed its fully confidential interim analysis. After reviewing unblinded safety and efficacy futility data covering approximately 37% of the final dataset2 , the DMC recommended that the trial continue without amendment. All Actinogen staff and XanaMIA trial personnel remain fully blinded to participant treatment assignment. The positive interim assessment reinforces confidence in the trial design and supports progression to the topline final results expected in November 2026, following the last patient’s final evaluation visit anticipated in September 2026. Planning has now commenced for a second pivotal Alzheimer’s disease trial. This trial will be similar in design to XanaMIA but larger in scale and is expected to commence in 2027 across multiple countries, including Australia, with the broader program including a limited number of open-label and clinical pharmacology trials conducted in parallel. ® Xanamem is a registered trademark of Actinogen Medical Limited 1 Unless stated otherwise, all financial data is in Australian dollars 2 136 participants with ≥1 efficacy datapoint and 52 who had completed all 36 weeks of treatment Page | 4 XanaMIA trial open‑label extension (OLE) phase to commence in Q1 2026 The open-label extension phase of the XanaMIA AD trial will open during the current quarter (Q1 2026). The OLE allows all participants from the blinded phase to receive Xanamem 10 mg once daily for up to 25 months. This long-term extension is designed to provide access to active Xanamem therapy to all participants and gather extended safety data and observational information on key efficacy endpoints — including CDR-SB,3 cognition, and activities of daily living. Regulatory & development pathway Actinogen’s regulatory position strengthened considerably following its Type C written response meeting with the US Food & Drug Administration (FDA) in September 2025. The FDA and Actinogen established a common understanding of the pathway to potential marketing approval for Xanamem in Alzheimer’s disease, including agreement on regulatory starting materials, drug substance synthesis requirements, and the streamlined design of one additional pivotal clinical trial of Xanamem 10mg vs. placebo, supported by a limited suite of clinical pharmacology and non-clinical studies. The agreements with the FDA’s Neurology-I Division mark a significant milestone for the company as it prepares for the earliest possible US marketing approval submission and subsequent global regulatory filings. Very recently, the FDA announced a policy change to accept one pivotal trial instead of two, provided there is adequate supportive evidence from other sources. Actinogen will explore this opportunity with the FDA as soon as the current XanaMIA trial results are in hand. A similar regulatory interaction with the European Medicines Agency (EMA) will occur in Q2 2026, followed by expected engagement with other regulators. Actinogen’s FDA agreement is aligned with the increasing global urgency to find safer and more effective Alzheimer’s disease therapies given the limited effectiveness of currently available treatments. The FDA’s feedback also supports commercial and partnering discussions by providing external validation of Xanamem’s late-stage development pathway and the feasibility of an efficient route to marketing approvals. Successful pharmacokinetic trial A clinical pharmacokinetic trial completed in August 2025 confirmed that the intended commercial Xanamem tablet formulation achieves consistent therapeutic blood levels in both fed and fasted states. These results demonstrate full dosing flexibility—an important consideration for real-world treatment adherence — and support continuation of the 10 mg once-daily dosing regimen across all ongoing and planned clinical studies. Manufacturing (CMC) The company continued to advance its Chemistry, Manufacturing and Controls (CMC) program - a critical component of late-stage clinical development. During the period, Actinogen successfully imported a scaled-up batch of drug substance into the United States for commercial-grade tablet manufacture. Catalent (USA) subsequently used this material to produce 10 mg tablets intended for the OLE phase and broader late-stage development requirements. Commercial Planning & Partnering Actinogen continued to invest strategically in its commercial readiness as the Xanamem program advances toward key value- inflection milestones. Activities included refinement of communication materials for medical, scientific, investor and corporate audiences, incorporating insights from independent market research and external expert input. The company also convened its inaugural Alzheimer’s Disease Clinical Advisory Committee — comprising nine globally recognised AD experts — to guide ongoing clinical and commercial planning. Partnering engagement remains active, with growing interest from regional and global parties as the XanaMIA trial approaches topline final results in November 2026 and now carries a positive DMC interim analysis recommendation. Intellectual Property The company continues to enhance long-term protection for Xanamem through active national-phase patent prosecution covering novel methods of use, manufacturing processes, and chemical matter. These new applications are designed to extend exclusivity well beyond statutory data-exclusivity periods. Together with existing granted patents, Actinogen maintains a robust IP portfolio that supports commercial viability and future partnering or market entry. Investor engagement Actinogen launched its InvestorHub platform in September 2025 to strengthen transparency and extend direct communication and engagement with investors. The site provides consolidated access to announcements, presentations and a direct Q&A interface with company management. Access the platform at: https://investors.actinogen.com.au/ 3 CDR-SB is the Clinical Dementia Rating Scale – Sum of Boxes Page | 5 R&D tax incentive rebate The company received the final $1.9 million cash instalment of its FY25 R&D tax incentive rebate in early February 2026, bringing the total FY25 R&D expenditure rebate received in FY26 to $7.4 million. These funds continue to provide valuable non‑dilutive support for Actinogen’s late‑stage clinical development program. Scientific, clinical and industry engagement Actinogen maintained a strong presence at major scientific, clinical and investor conferences during the first half of FY26, including the Alzheimer’s Association International Conference (AAIC 2025) in Toronto, the Bioshares Biotech Summit in Hobart, and the Canaccord Drug & Device Conference. In Q4 2025, the senior management team also participated in the BIO Europe partnering conference in Vienna and the Bell Potter Virtual Healthcare Conference in Australia. In January 2026, senior leadership attended the Sachs Neuroscience Innovation Forum in San Francisco and held extensive meetings during JPM Week to broaden global networks and deepen interest in the company’s rapidly advancing Alzheimer’s program. These engagements continue to highlight the company’s clinical development progress and Xanamem’s differentiated mechanism of action, while supporting sustained investor education and brand visibility. For further information on all the above milestones and events, please refer to the ASX announcements tab at the Actinogen InvestorHub: https://investors.actinogen.com.au/announcements Page | 6 3. FINANCIAL REVIEW (a) Financial Performance The financial performance of the company for the half year ended 31 December 2025 is as follows: Half year ended Half year ended 31/12/2025 $ 31/12/2024 $ Revenue and other income ($) 2,107,063 244,406 Net loss after tax ($) (11,346,952) (8,168,979) Loss per share (cents) (0.36) (0.28) Dividend ($) - - (b) Financial Position The financial position of the company as at 31 December 2025 is as follows: As at As at 31/12/2025 30/06/2025 $ $ Cash and cash equivalents 6,531,460 16,504,230 Net assets / Total equity 8,368,615 18,335,903 Contributed equity 116,196,238 115,726,615 Accumulated losses (107,815,050) (96,468,098) Page | 7 4. MATERIAL RISKS In addition to risks associated with any business there are specific, material risks that, either individually or in combination, may materially and adversely affect the future operating and financial performance and prospects of Actinogen and the value of its shares. Some of these risks may be mitigated by Actinogen’s internal controls and processes but some are outside the control of Actinogen, its directors and management. The material risks identified by management are described below: Risk Implication Mitigation Research and Development Activities Actinogen’s future success is dependent on the performance of Actinogen’s lead molecule, Xanamem, in clinical trials and whether it proves to be a safe and effective treatment. Xanamem is an experimental product in late-stage clinical development. Product commercialization resulting in potential product sales revenues are likely to be some years away without any guarantee that it will be successful. It requires additional research and development, including ongoing clinical evaluation of safety and efficacy in clinical trials and regulatory approval prior to marketing authorization. Until Actinogen is able to provide further clinical evidence of the ability of Xanamem to improve outcomes in patients, the future success of its technology remains speculative. Research and development risks include uncertainty of the outcome of results, difficulties or delays in development and generally the uncertainty that surrounds the scientific development of pharmaceutical products. Mitigation measures include ‘following the science’ of the data generated for Xanamem to date, hiring expert clinical development professionals to design, oversee and analyse the trial program, engagement of leading contract research organisations to manage components of the trials and drive recruitment as well as engagement of well-qualified clinical sites experienced in clinical trial execution and in the relevant therapeutic areas. Regulatory Approvals Actinogen operates within a highly regulated industry, relating to the manufacture, distribution and supply of pharmaceutical products. There is no guarantee that Actinogen will obtain the required approvals, licenses and registrations from relevant regulatory authorities in jurisdictions in which it operates. The commencement of clinical trials may be delayed and Actinogen may incur further costs if the Food and Drug Administration (FDA) and other regulatory agencies are tardy or observe deficiencies that require resolution or request additional studies be conducted in addition to those that are currently planned. A change in regulation may also adversely affect Actinogen’s ability to commercialize and manufacture its treatments. Mitigation measures include operating under a US FDA Investigational New Drug (IND) process, engagement of suitably qualified and experienced persons with expertise in the regulation of small molecule therapies, establishing relationships with regulators to facilitate feedback and guidance from them, regular review of evolving regulatory requirements and analysis of the company’s activities and plans against regulatory expectations in key jurisdictions, and ensuring that the expectations and uncertainties related to regulatory approvals, and the timing of such approvals, are included in business plans. Intellectual Property Securing rights in technology and patents is an integral part of securing potential product value in the outcomes of biotechnology research and development. Competition in retaining and sustaining protection of technology and the complex nature of technologies can lead to patent disputes. Actinogen’s success depends, in part, on its ability to obtain patents, maintain trade secret protection and operate without infringing the proprietary rights of third parties. Because the patent position of biotechnology companies can be highly uncertain and frequently involves complex legal and factual questions, neither the breadth of claims allowed in biotechnology patents, nor their enforceability can be predicted. There can be no assurance that any patents which Actinogen may own, access or control will afford Actinogen commercially significant protection of its technology or its products or have commercial application or that access to these patents will mean that Actinogen will be free to commercialize its technology. Competitors may file patents which could limit the company's freedom to operate for its technologies. The granting of a patent does not guarantee that the rights of others are not infringed or that competitors will not develop technology or products to avoid Actinogen's patented technology. Actinogen’s current patenting strategies do not cover all countries which may lead to generic competition arising in those markets. Mitigation measures include use of expert patent attorneys, regular review of the relevant patent landscape, filing of additional patents and maintenance of patents in a broad geography covering major pharmaceutical markets. The company also has significant protection by virtue of data exclusivity regimes, which in most countries afford extensive multi- year protection from the date a marketing approval is obtained in relation to data generated in the clinical and non-clinical trial processes undertaken in the process of obtaining such an approval. Page | 8 Risk Implication Mitigation Partnership Model While undertaking its phase 2/3 clinical program the company is actively pursuing value-add partnership(s) to expand the trial program further and secure commercialization pathways in one or more territories. This model, which typically involves entering into commercial arrangements with other companies in which Actinogen would license its Xanamem technology to the partner in one or more indications and/or geographies and the partner assumes some or all responsibility for progressing, and paying for, the clinical trials and eventual commercialization. This strategy involves the risk that the company will lose some or all control of the development timetable of its products to its commercial partner(s), which may give rise to an unanticipated delay in any commercial returns. Further, the company may be unable to enter into arrangements with suitable commercial partners in respect of relevant indications. If either of these outcomes occurred, the company’s business and operations may be adversely affected. Mitigation measures employed by the company include using expert business development professionals to build relationships with potential partners, performing rigorous due diligence, ensuring that the commercial terms negotiated are fair and utilising expert legal advice to ensure that appropriate warranties and commitments are included in contracts, and that the contracts reflect the agreed commercial position. The company has proven its ability to continue to obtain funding to pursue its drug development programs using its own resources, without being reliant on obtaining one or more partners. The company also seeks to form partnerships with relevant regulatory agencies including the FDA, EMA, and MHRA. Manufacturing The company’s products are manufactured using a specialised manufacturing process at an expert third party facility, as is the norm in the industry. An inability of these third-party contract manufacturing organisations to continue to manufacture the company’s products in a timely, economical and/or consistent manner, including any scale up of manufacturing processes, or to maintain legally compliant manufacturing to maintain product supply, could adversely impact on the progress of the company’s development programs and potentially on the financial performance of the company. Mitigation measures include performing rigorous due diligence on contract manufacturers, engaging contract manufacturers with strong track records and sufficient capability to meet the company’s foreseeable needs, employing senior managers responsible for managing and monitoring the performance of contract manufacturers, gradually scaling up batch production runs to ensure scalability and maintenance of quality systems and related documentation. Fundraising risk Actinogen is reliant upon fundraising to fund its operations. Funds may be available in the future from grants, development and commercial partnerships, tax incentives and capital markets but are not guaranteed. Capital market volatility may impact Actinogen’s ability to raise future funds. Currency market fluctuations could impact the amount of funding required where expenditure is denominated in currencies other than the Australian dollar. Mitigation measures include prudent cash flow forecasting, potential filing of grant applications, key management focus on partnership relationships, use of specialist advisors in tax, business development and investor relations, maintaining high quality analyst coverage, frequent communications to retail and institutional investors and having a presence at many scientific and business conferences. The company has a track record of successfully raising new equity and debt funding, as well as obtaining R&D Tax Incentive rebates under the AusIndustry and Australian Taxation Office R&D incentive scheme. Page | 9 5. BUSINESS STRATEGY & OUTLOOK Actinogen’s FY2026 strategic priorities remain focused on four core elements: • Accelerating clinical development of Xanamem in Alzheimer’s disease • Advancing commercial readiness to prepare the market for Xanamem and support partnering • Scaling manufacturing and strengthening patent protection • Proactively engaging with prospective development and commercial partners Accelerating clinical development of Xanamem in Alzheimer’s disease Following the release of the 2025 Annual Report, enrolment in the pivotal XanaMIA phase 2b/3 Alzheimer’s disease (AD) trial was completed in December 2025, with 247 participants recruited across 35 sites in the United States and Australia - above the original target of 220 participants. A major milestone was achieved on 30 January 2026, when the trial’s independent Data Monitoring Committee (DMC) completed its confidential interim analysis of safety and efficacy futility and recommended the trial continue without amendment.4 The positive recommendation reinforces confidence in the trial design and supports continuation to topline final results expected in November 2026, following the last patient’s final evaluation visit anticipated in September 2026. In September 2025, the company also achieved a common understanding with the FDA on the regulatory pathway to marketing approval in AD including the streamlined design of one more, final pivotal clinical AD trial of Xanamem 10 mg vs. placebo beginning in 2027. A similar engagement with the European Medicines Agency will take place during the second half of the financial year. Key features of the current XanaMIA phase 2b/3 trial include: • Targeted enrolment of the same patient population in whom a large Xanamem treatment benefit on the Clinical Dementia Rating Scale – Sum of Boxes (CDR-SB) endpoint was observed in a prospective reanalysis of the prior XanADu phase 2a trial (the analysis used available data from 72 patients with mild or moderate AD, 34 of whom had elevated pTau181 protein in the blood) • Reduced high screen failure costs traditionally associated with AD trials through rapid, cost-efficient pre-screening of potential participants using blood pTau181 • A 36-week blinded treatment period, designed to demonstrate a clinical benefit for Xanamem versus placebo, after which all participants will have the opportunity to receive active Xanamem 10mg once daily in the OLE phase commencing Q1 2026, allowing collection of longer‑term safety and efficacy observational data • Rigorous rater training and standardization to minimize variance in key endpoints such as the CDR-SB primary endpoint • ‘Hands on’ clinical operations managed in Australia, complemented by select US contractors to optimize quality, timelines and cost. Planning has commenced for the second pivotal AD trial, similar in design to XanaMIA but larger in scale. This trial is expected to commence in 2027 across multiple countries including Australia, with a limited number of open-label and clinical pharmacology trials conducted in parallel. Plan for commercial readiness to prepare the market for Xanamem and support future partnerships Consistent with its late stage of clinical development position, Actinogen has progressed qualitative and semi-quantitative assessment of Xanamem’s Target Product Profile across key markets, initially focused on the United States. Activities completed to date include: • Appointed Mr Andrew (Andy) Udell as Chief Commercial Officer in October 2024, based in the US • Unique INN and USAN name emestedastat granted for Xanamem • Convened an Advisory Board meeting of key opinion leaders to review the XanaCIDD phase 2a depression data • Established an Alzheimer’s Disease Clinical Advisory Committee, comprising nine globally recognised AD experts, to guide ongoing AD clinical and commercial planning • Engaged with key US Alzheimer’s opinion leaders at International scientific meetings, US clinical sites and through direct interactions • Developed a high-tech educational animation illustrating Xanamem’s novel mechanism of action and its differentiated therapeutic profile • Conducted in-depth qualitative and quantitative market research with neurologists and high-volume AD-treating physicians to assess reaction to Xanamem’s draft Target Product Profile, current treatment dynamics and Xanamem’s potential value proposition. 4 All Actinogen staff and XanaMIA trial personnel remain fully blinded to participant treatment assignment. Page | 10 Scale up manufacturing and enhance patent protection Actinogen continued to advance its Chemistry, Manufacturing and Controls (CMC) program, an essential component of late-stage clinical development. Significant progress was achieved during FY2025 in scaling the synthesis of Xanamem’s Active Pharmaceutical Ingredient (API). More than 15 kg of API was successfully manufactured with improved yield by Asymchem, a highly respected manufacturer. Previously, the largest API batch size produced was 3.2 kg. Further API manufacturing runs are planned for 2027. The scaled-up drug substance batch was imported into the United States and used by Catalent (USA) to manufacture commercial-grade 10 mg tablets for the OLE phase trial and broader late-stage requirements. In parallel, the company progressed national phase patent filings covering multiple manufacturing process patents and a patent for the tablet formulation. Proactively engage with prospective development and commercial partners Actinogen continues to actively engage potential partners - large and small, regional and global – who have an interes