Announcement PDF Actinogen Medical Limited ACN 086 778 476 Suite 901, Level 9, 109 Pitt Street, Sydney NSW 2000 +61 2 8964 7401 | actinogen.com.au 1 ASX ANNOUNCEMENT Actinogen presents at BIO-Europe partnering conference in Vienna Sydney, 3 November 2025. Actinogen Medical ASX: ACW (“ACW” or “the Company”) is pleased to announce that that its Chief Executive Officer, Dr Steven Gourlay, and Chief Commercial Officer, Mr Andy Udell, will be attending the BIO1 Europe partnering conference (BIO-Europe 2025) in Vienna, Austria this week. BIO-Europe 2025, running from November 3 to 5, is Europe’s largest partnering event and brings together global business leaders including senior executives and business development teams from leading biotech and pharmaceutical companies, investors and other industry experts. Dr Gourlay and Mr Udell will engage with international investors and potential biopharma partners throughout the conference to discuss Actinogen’s late-stage clinical trial program in Alzheimer’s disease (AD) and the enormous market potential for Xanamem®. Actinogen is currently conducting a pivotal phase 2b/3 AD trial, the results of which could be transformational for the Company, and this is reflected in the meetings scheduled at the conference. The search for innovative therapies that could be used either alone or in combination for the treatment of Alzheimer’s is a significant priority for the pharma/biotech industry. The presentation slides are attached to this announcement and a brief video commentary from Dr Gourlay is shown with this announcement on our InvestorHub. Actinogen CCO Mr Andy Udell commented: “We are delighted to share our progress at BIO-Europe 2025. Following a successful meeting with the FDA on Xanamem’s path to approval and completion of screening in our phase 2b/3 pivotal trial for Alzheimer’s disease, we’ve now entered the final stages of development -- with interim results due early next year and topline final results mid-Q4 2026. We look forward to a full slate of meetings with industry leaders and potential industry partners with a focus on exploring value-add regional collaborations to accelerate our progress.” View this announcement on our InvestorHub: https://investors.actinogen.com.au/link/PQ5jbP ENDS Investors Media Dr. Steven Gourlay Michael Roberts George Hazim CEO & Managing Director Investor Relations Media & Public Affairs Australia P: +61 2 8964 7401 M: +61 423 866 231 M: +61 417 516 262 E. steven.gourlay@actinogen.com.au E. michael.roberts@actinogen.com.au E: georgehazim@mediaaffairs.com.au 1 The Biotechnology Innovation Organization (BIO) is the world’s largest advocacy association for biotechnology and the producer of the convention. ® Xanamem is a registered trademark of Actinogen Medical Limited. Actinogen Medical Limited ACN 086 778 476 Suite 901, Level 9, 109 Pitt Street, Sydney NSW 2000 +61 2 8964 7401 | actinogen.com.au 2 Announcement authorised by the Disclosure Committee of Actinogen Medical Limited About Actinogen Medical Actinogen Medical (ACW) is an ASX-listed, biotechnology company developing a novel therapy for neurological and neuropsychiatric diseases associated with dysregulated brain cortisol. There is a strong association between cortisol and detrimental changes in the brain, affecting cognitive function, harm to brain cells and long-term cognitive health. Cognitive function means how a person understands, remembers and thinks clearly. Cognitive functions include memory, attention, reasoning, awareness and decision-making. Actinogen is currently developing its lead compound, Xanamem, as a promising new therapy for Alzheimer’s Disease and Depression and hopes to study Fragile X Syndrome and other neurological and psychiatric diseases in the future. Reducing cortisol inside brain cells could have a positive impact in these and many other diseases. The cognitive dysfunction, behavioural abnormalities, and neuropsychological burden associated with these conditions is debilitating for patients, and there is a substantial unmet medical need for new and improved treatments. Clinical Trials The XanaMIA Phase 2b/3 Alzheimer’s disease trial is a double-blind, 36-week treatment, placebo-controlled, parallel group design trial in 220 patients with mild to moderate AD and progressive disease, determined by clinical criteria and confirmed by an elevated level of the pTau181 protein biomarker in blood. Patients receive Xanamem 10 mg or placebo, once daily, and its ability to slow progression of Alzheimer’s disease is assessed with a variety of endpoints. The primary endpoint of the trial is the internationally-recognized CDR-SB (Clinical Dementia Rating scale – Sum of Boxes). The trial is being conducted in Australia and the US. The trial will be fully enrolled by the end of 2025 with initial results from an interim analysis in late January 2026 and final topline results in mid Q4 2026. The XanaMIA-OLE Alzheimer’s disease open-label extension is an open-label phase of up to 25 months treatment where all participants will receive active Xanamem 10 mg once daily. The trial will evaluate safety and a limited number of efficacy endpoints such as the CDR-SB. The trial will commence in Q1 2026 and be open to all former and current participants in the XanaMIA Phase 2b/3 trial. The XanaCIDD Phase 2a depression trial was a double-blind, six-week proof-of-concept, placebo-controlled, parallel group design trial in 167 patients with moderate, treatment-resistant depression and a degree of baseline cognitive impairment. Participants were evenly randomized to receive Xanamem 10 mg once daily or placebo, in most cases in addition to their existing antidepressant therapy, and effects on cognition and depression were assessed. Trial results were reported in August 2024 and showed clinically and statistically significant benefits on depression symptoms with positive effects on the MADRS scale (a validated scale of depression symptom measurement) and the PGI-S (a valid patient reported assessment of depression severity). Cognition improved markedly and to a similar extent in both Xanamem and placebo groups. About Xanamem (emestedastat) Xanamem’s novel mechanism is to control elevated levels of cortisol (aka the “stress hormone”) in the brain through the inhibition of the cortisol synthesis enzyme, 11β-HSD1, without affecting production of cortisol by the adrenal glands which is essential for the body’s normal functioning. Xanamem is a first-in-class, once-a-day pill designed to deliver high levels of cortisol control in key areas of the brain related to Alzheimer’s and other diseases such as the hippocampus and frontal cortex. To view Xanamem’s two-minute Mechanism of Action video, click here. Chronically elevated cortisol is associated with progression in Alzheimer’s Disease and excess cortisol is known to be toxic to brain cells. Cortisol itself is also associated with depressive symptoms and when targeted via other mechanisms has shown some promise in prior clinical trials. The recent XanaCIDD trial demonstrated clinically and sometimes statistically significant benefits on depressive symptoms, further validating the cortisol control mechanism for the Xanamem 10 mg oral daily dose. The Company has studied 11β-HSD1 inhibition by Xanamem in approximately 400 volunteers and patients in eight clinical trials. Xanamem has a promising safety profile and has demonstrated clinical activity in patients with depression, patients with biomarker-positive Alzheimer’s disease and cognitively normal volunteers. High levels of target engagement in the brain with doses as low as 5 mg daily have been demonstrated in a human PET imaging study. Actinogen Medical Limited ACN 086 778 476 Suite 901, Level 9, 109 Pitt Street, Sydney NSW 2000 +61 2 8964 7401 | actinogen.com.au 3 Xanamem is an investigational product and is not approved for use outside of a clinical trial by the FDA or by any global regulatory authority. Xanamem® is a trademark of Actinogen Medical. Disclaimer This announcement and attachments 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. ACTINOGEN MEDICAL ENCOURAGES ALL CURRENT INVESTORS TO GO PAPERLESS BY REGISTERING THEIR DETAILS WITH THE DESIGNATED REGISTRY SERVICE PROVIDER, AUTOMIC GROUP. Oral Xanamem® (emestedastat) Controlling brain cortisol to slow progression in Alzheimer’s disease and treat depression Corporate Presentation (Bio-Europe) November 2025 ® Xanamem is a registered trademark of Actinogen Medical Limited Disclaimer • This presentation has been prepared by Actinogen Medical Limited. (“Actinogen” or the “Company”) based on information available to it as at the date of this presentation. The information in this presentation is provided in summary form and does not contain all information necessary to make an investment decision. • This presentation does not constitute an offer, invitation, solicitation or recommendation with respect to the purchase or sale of any security in Actinogen, nor does it constitute financial product advice or take into account any individual’s investment objectives, taxation situation, financial situation or needs. An investor must not act on the basis of any matter contained in this presentation but must make its own assessment of Actinogen and conduct its own investigations. Before making an investment decision, investors should consider the appropriateness of the information having regard to their own objectives, financial situation and needs, and seek legal, taxation and financial advice appropriate to their jurisdiction and circumstances. 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There is no guarantee that Actinogen will obtain the required approvals, licences and registrations from the relevant authorities in jurisdictions in which it operates. Actinogen or others could identify product and efficacy issues relating to the safety of our technology. Accordingly, all forward looking statements are based on numerous assumptions regarding the Company’s present and future business strategies and the political and economic environment in which Actinogen will operate in the future, which are subject to change without notice. Past performance is not necessarily a guide to future performance and no representation or warranty is made as to the likelihood of achievement or reasonableness of any forward looking statements or other forecast. There is no guarantee that Actinogen will achieve its stated objectives/milestones, that any of its forecasts will be met or that forward looking statements will be realised. You are cautioned not to place undue reliance on these forward-looking statements that speak only as of the date hereof, and we do not undertake any obligation to revise and disseminate forward-looking statements to reflect events or circumstances after the date hereof, or to reflect the occurrence of or non-occurrence of any events. • Neither Actinogen nor any other entity or person in or associated with Actinogen guarantee any return (whether capital or income) or generally the performance of Actinogen or the price at which its securities may trade. 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Corporate Presentation Bio-Europe Nov 2025 2 Corporate Presentation Bio-Europe Nov 2025 3 Overview Xanamem: Clear pathway to Alzheimer’s approval 4 • FDA confirms development pathway to US marketing approval using one additional pivotal trial of 10 mg vs. placebo and open-label safety studies • Clear guidance on minimal ancillary nonclinical and clinical pharmacology work • Agreement on key manufacturing items • Ongoing XanaMIA clinical trial: • Brisk enrolment at 35 clinical centers in US and Australia – screening now closed • Excellent safety profile maintained • Interim analysis of safety and efficacy futility in Jan 2026 • On-track for topline final results in mid Q4 2026 (n~240) • Open-label extension phase to open Q1 2026 • Phase 3 planning commencing in parallel with discussions re potential partnerships Corporate Presentation Bio-Europe Nov 2025 Phase 2b/3 pivotal trial on track, FDA agreement streamlines development First-in-class therapy with strong IP and large market potential Novel 11β-HSD1 cortisol control mechanism, oral, attractive safety profile • Brain cortisol has been proposed as pathogenic mechanism in Alzheimer’s & major depressive disorder • Unique brain-penetrant tissue cortisol synthesis inhibitor that leaves adrenal cortisol synthesis unaffected Patent/data protection and advanced manufacturing • Composition of matter protection to 2036 in all major markets, newer patents to 2044 • Data exclusivity protects Xanamem data from use by others for 5 to 10 years from approval • Manufacturing process scaled up and patented, tablets manufactured in US by Catalent Large clinical and commercial opportunities • No other brain-penetrant cortisol control drugs in development • Multiple clinical trials showing treatment benefits • First to be awarded INN and USAN names1 • 2025 estimated 7.2 million Alzheimer’s patients in the US alone with the cost to treat $384 billion2 5 Corporate Presentation Bio-Europe Nov 2025 1. Xanamem’s International Nonproprietary Name (INN) , emestedastat, was awarded by a naming committee of the World Health Organization: “-stedastat” chosen for the first time for all 11β-HSD1 inhibitors; USAN (United States Adopted Name) 2. U.S. burden of Alzheimer’s disease, related dementias to double by 2060 | CDC Online Newsroom | CDC and The Cost of Dementia in 2025 - April 23, 2025 - USC Schaeffer 6 Management Team Experienced board and management team Board of Directors Dr. Geoff Brooke Chairman MBBS; MBA Dr. Steven Gourlay CEO & MD MBBS; FRACP; PhD; MBA Mr. Malcolm McComas Non-Executive Director BEc, LLB; FAICD; SF Fin Dr. George Morstyn Non-Executive Director MBBS; PhD; FRACP CD Dr. Nicki Vasquez Non-Executive Director PhD Dr. Dana Hilt Chief Medical Officer MD Dr. Steven Gourlay CEO & MD Will Souter Chief Financial Officer BComm, LLB Andrew Udell Chief Commercial Officer MBA Cheryl Townsend VP Clinical Operations RN, M Health Law Fujun Li Head of Manufacturing PhD Michael Roberts Head of IR & Comms B.Ec (Hons), CPA, FFIN Corporate Presentation Bio-Europe Nov 2025 What Actinogen is looking for in a regional partner • Strong interest in a new oral disease-modifying therapy for Alzheimer’s • Track record of successful collaborations • Regional commercial, clinical development and regulatory capabilities • Openness to exploring other indications after pivotal trial XanaMIA results • Customary deal structure with upfront, milestones and royalties • Sublicensing rights to be negotiated • Willingness to close a deal in the coming months 7 Corporate Presentation Bio-Europe Nov 2025 8 Xanamem Corporate Presentation Bio-Europe Nov 2025 Clinically validated and differentiated Alzheimer's program  Mouse experimental studies, brain cortisol levels & human clinical trials validate cortisol as a target for the treatment of AD  Excellent safety profile, 400+ patients treated, no related serious adverse events  Fully brain-penetrant oral therapy clearly demonstrated on brain PET scan imaging  Positive clinical data demonstrated in phase 2 trials in patients with biomarker-elevated Alzheimer’s and moderately severe depression  Differentiated from antibody drugs: oral pill, suitable for general practice use, no invasive monitoring  Open INDs and collaborative FDA engagement 9 Corporate Presentation Bio-Europe Nov 2025 Xanamem’s unique mechanism of action animation 10 Corporate Presentation Bio-Europe Nov 2025 Click here for animation video Controlling brain cortisol2 has potential durable benefits Xanamem controls cortisol by inhibition of 11β-HSD11 11 SLOW changes in gene expression and protein synthesis over days to weeks lead to durable “low stress” settings RAPID changes in kinases, cell function, neurotransmitters over hours to days lead to short-term “low stress” settings “Lower stress” longer term e.g. • Improving neural circuitry • Generating new brain cells • Ideal receptor configurations “Lower stress” shorter term e.g. • Reducing inflammation • Improving neurotransmitter balance • Decreasing cell death 1. For a comprehensive review of 11β-HSD1 see Seckl J. 2024 2. Ramamoorthy & Cidlowski 2016 Reduction of “stress response” in brain Corporate Presentation Bio-Europe Nov 2025 Other 11β-HSD1 enzyme inhibitors have not achieved adequate brain levels Xanamem extensively binds to the 11β-HSD1 enzyme throughout the brain, with high post-treatment effects (absence of color) after 7 days at all doses, slightly less at a 5 mg dose. This is consistent with full hormonal pharmacodynamic activity seen in clinical trials with doses as low as 5 mg. SUVRcarotid 5 mg Xanamem Baseline After 7 days of daily dosing 10 mg Xanamem 20 mg Xanamem Human PET study shows full target engagement 12 Journal of Alzheimer’s Disease 97 (2024) 1463–1475 Brain 11-Hydroxysteroid Dehydrogenase Type 1 Occupancy by Xanamem Assessed by PET in Alzheimer’s Disease and Cognitively Normal Individuals Victor L. Villemagne, Vincent Dor, Lee Chong, Michael Kassiou, Rachel Mulligan, Azadeh Feizpour, Jack Taylor, Miriam Roesner, Tamara Miller and Christopher C. Rowe Corporate Presentation Bio-Europe Nov 2025 Alzheimer’s disease program 13 Corporate Presentation Bio-Europe Nov 2025 Alzheimer’s disease market is large and growing Strong cortisol control scientific rationale to address huge unmet medical need • Cortisol levels elevated in brain fluid in early AD • Chronic corticosteroid treatment leads to hippocampal atrophy and cognitive impairment • Elevated cortisol levels are associated with clinical progression • Alzheimer’s disease mouse model: 30–60% inhibition of 11β-HSD1 provides full neuroprotection • AD phase 2a trial shows slowed disease progression in biomarker-positive patients • Safe & effective oral therapy is “holy grail” Growing Alzheimer’s Disease market – U.S. Large, unsatisfied and growing market Rationale 14 Corporate Presentation Bio-Europe Nov 2025 15 Drugs targeting other mechanisms like Xanamem are needed Anti-amyloid therapy modestly slows AD progression Ideally patients with AD would not worsen on treatment at all -3 -2.5 -2 -1.5 -1 -0.5 0 0.5 donanemab all placebo all halt progression Worsening of CDR-SB over 18 months 0.7 point benefit of donanemab @18 months Worse performance Ideal trajectory with disease stabilization 1.8-point unmet need despite anti-amyloid therapy 0.1-point benefit 12 weeks Corporate Presentation Bio-Europe Nov 2025 16 Large Xanamem benefit in high pTau181 patients Phase 2a biomarker study: major slowing of CDR-SB decline over 12 weeks (n=34) Journal of Alzheimer’s Disease 100 (2024) 139–150 Plasma pTau181 Predicts Clinical Progression in a Phase 2 Randomized Controlled Trial of the 11-HSD1 Inhibitor Xanamem® for Mild Alzheimer’s Disease Jack Taylor, Mark Jaros, Christopher Chen, John Harrison and Dana Hilt 0.36 0.98 0 0.2 0.4 0.6 0.8 1 1.2 1.4 Baseline Week 12 Xanamem Placebo 0.6-point benefit @12 weeks Xanamem vs. Placebo • Mean 0.6 units • Median 0.8 units • p = 0.09 • Cohen’s d = 0.4 CDR-SB units Change from Baseline (SE) Worse performance Corporate Presentation Bio-Europe Nov 2025 Interim analysis late January 2026, topline final results mid Q4 2026 17 NIA-AA=National Institute of Aging - Alzheimer’s Association; CDR-SB Clinical Dementia Rating Scale – Sum of Boxes 40 Weeks -4 0 36 Weeks 10mg Xanamem Placebo Screening from Dec 23 Double-blind, randomised treatment period (n ~ 240) Interim analysis late January 2026 ~50% trial data Follow-up & open label Key Inclusion Criteria Primary Endpoint Key Secondary Endpoints Implementation • Blood pTau biomarker positive • Mild-moderate Alzheimer’s by NIA-AA criteria • CDR-SB (functional and cognitive measure) @36 weeks • Cognitive Test Battery (7 cognitive measures well- validated in the Alzheimer’s field) • Amsterdam Activity of Daily Living (functional measure) • Enrolment at 15 Australian & 20 US sites • Likely final enrolment ~240 (was 220) Q4 2025 • Interim analysis late Jan 2026 for safety & efficacy futility • Open-label extension Q1 2026 XanaMIA phase 2b/3 trial in Alzheimer’s disease Corporate Presentation Bio-Europe Nov 2025 Commercial readiness 18 Corporate Presentation Bio-Europe Nov 2025 Direct insights from the front line of Alzheimer’s care Physician perspectives on current practice, unmet needs, and future therapies* • Market research with over 100 general neurologists and dementia/geriatric specialists • Representative of the AD-treating physician population as it relates to geography and practice type, and: • 18 mean years in practice • 94% of time in clinical practice setting • Mean of 222 Alzheimer’s patients (median: 175) under personal care (per physician) Current Market Perceptions: 19 Bio-Europe Nov Corporate Presentation 2025 * Spherix Global Insights: Market Dynamics and Custom Research 2025 “I think eventually what will happen is that we're not going to be just treating patients with an amyloid remover, but also anti-neuroinflammation, mitochondrial enhancers, synaptic enhancers and so on and so on, in order to actually stop or substantially slow down the progression of the disease.” Strong physician response to Xanamem’s target profile Over half of their current AD patients fall within Xanamem’s addressable market 20 Corporate Presentation Bio-Europe Nov 2025 Driving awareness of Xanamem and cortisol biology Expanding education, engagement and visibility • Educational need identified: Qualitative research and advisory boards revealed limited physician understanding of the role of cortisol in the brain and its link to Alzheimer’s pathology • Action taken: Developed a concise two-minute animation explaining Xanamem’s unique “cortisol control” mechanism of action • Scientific presence: Active participation at major Alzheimer’s conferences, including a booth at AAIC and presence at CTAD and other key global meetings • KOL engagement: Ongoing collaboration with leading neurologists and psychiatrists through advisory boards, 1:1 discussions, and planning for future review papers and publications • Broader awareness: Continuing to elevate Xanamem’s visibility and differentiation through consistent medical, scientific, and educational initiative 21 Corporate Presentation Bio-Europe Nov 2025 Depression program 22 Corporate Presentation Bio-Europe Nov 2025 There remains significant unmet need in depression Xanamem’s unique mechanism and safety differentiate it from older drugs • More than 50 years of research associates cortisol with depression • Elevated CSF and plasma cortisol levels associated with diagnosis, treatment outcomes and relapse • Positive effects of cortisol receptor antagonism reported with mifepristone3 • Now positive phase 2a data on depressive symptoms for Xanamem (MADRS, PGI-S) Scientific rationale U.S. Depression market large unmet need • 21M patients have had ≥ 1 MDD episode • Two-thirds with an episode with severe impairment in the past year • 61% of all adults with MDD episodes receive treatment • ≥365 M prescriptions per year 23 A safe, durably effective and combinable small molecule is a very attractive product profile for depression AND Alzheimer’s 3. Ding et al 2021 Corporate Presentation Bio-Europe Nov 2025 -12 -10 -8 -6 -4 -2 0 Baseline Week 2 Week 4 Week 6 Week 10 Major depressive disorder phase 2a: benefit also seen in patients taking background SSRI anti-depressant (n=76) 24 EOT 2.6-point difference Cohen’s d = 0.38 p = 0.15 PT 4.2-point difference Cohen’s d = 0.64 p = 0.03 Abbreviations: SSRI, selective serotonin reuptake inhibitor Corporate Presentation Bio-Europe Nov 2025 MADRS LS mean change from baseline (± SE) Xanamem (n=37) Placebo (n=39) ON TREATMENT FOLLOW UP BETTER Phase 2a depression symptom benefits (2024) - major scientific and drug development achievement 25 • Clinically and statistically significant treatment benefits on depressive symptoms • Predominantly co-treated population with moderate MDD • Consistent depression efficacy across subgroups • Xanamem was safe and well tolerated (n=165 treated) with no observed suicide risk or withdrawal syndrome • The trial was well-conducted with no major differences between Australia and the UK or at high enrolling clinical sites • Benefits on depression are a desirable feature for an Alzheimer’s drug • Funding for the next depression trial being investigated with potential partners and/or granting bodies Corporate Presentation Bio-Europe Nov 2025 Further XanaCIDD phase 2a depression trial results shown in the Appendix Data support further MDD development and are also positive for Alzheimer’s Conclusion 26 Corporate Presentation Bio-Europe Nov 2025 On track to deliver transformative Alzheimer’s data 27 • On-track with XanaMIA trial in patients with mild-moderate Alzheimer’s disease  FDA confirms development pathway to US marketing approval  Full enrolment of 220 (now ~240) participants in Q4 2025  Interim analysis of safety & efficacy futility late Jan 2026, topline final results Q4 2026 • Positive phase 2a depressio