Earnings release
Page 1
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 September 2026 quarterly activity report and Appendix 4C Sydney, 19 October 2026. Actinogen Medical ASX: ACW (“ACW” or “the Company”) is pleased to announce the release of its quarterly activity report and Appendix 4C for the three- month period ended 30 September 2026. Highlights: • Pivotal Alzheimer’s disease XanaMIA trial remains on track for topline final results in November this year following the completion of the last patient visit in late September • Strong ongoing enrolment in open- label extension (OLE) phase of the trial with 8 7% of main trial participants choosing to immediately continue in the OLE where they receive active Xanamem ® therapy • Manuscript entitled “ The role of cortisol in CNS disease - 11β-HSD1 inhibition as a potential new therapeutic strategy for Alzheimer's disease and Major Depressive Disorder ” accepted for on- line pre- publication in the peer-review journal Clinical and Translational Neuroscience and can be accessed here: https://www.preprints.org/manuscript/202610.1646/v1 • A successful Clinical Trials Scien ce Forum webinar held in August entitled “ The future of Alzheimer’s disease treatment” featuring US Alzheimer’s expert Professor Marwan Sabbagh • Exercise and underwriting of unlisted options during September provided an additional $5.3 million of funding • New patents granted covering Xanamem treatment for cognitively normal people in Australia and Israel and manufacturing in China and Chile with patent expiry dates of 2040 and 2041 respectively • September-end cash balance of $15.9m together with expected net proceeds of ~$6m from the accrued R&D tax rebate provides a pro-forma cash balance of ~$21.9m , which gives the Company runway well beyond XanaMIA trial final results to late CY2027 or into CY2028, assuming any new trials are substantially funded via partnerships • Up to $ 22.5m in additional funding may be received from listed option exercise (expiry dates May and September 2027).1 Pivotal XanaMIA phase 2b/3 Alzheimer’s disease (AD) trial remains on track for topline results in November following final participant visit • The Company's pivotal XanaMIA phase 2b/3 Alzheimer's disease trial continued to progress during the quarter, with treatment and follow -up activities proceeding as planned across participating clinical sites until the last patient visit was completed in late September • The trial remains on track to deliver topline final results in November this year • The key focus ahead of the November trial results announcement is to finalise high-quality data from the trial while planning streamlined pathways to the fastest possible regulatory approvals for Xanamem • Preparations are underway for follow-on regulatory interactions and development activities that will allow the Company to move confidently into the final pivotal trial of Xanamem in AD if XanaMIA topline results are positive in November, most likely in partnership with one or more development partners. ® Xanamem is a registered trademark of Actinogen Medical Limited 1 ASX listed option series ACWOD expires 31 May 2027 and series ACWOC expires 30 September 2027
Page 2
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 XanaMIA AD trial open‑label extension advances • Enrolment in the OLE phase of the XanaMIA Alzheimer's disease trial continued to advance strongly during the September quarter. There are now 160 patients on treatment, with an 87% rollover rate for participants completing the main trial and commencing the OLE. • The OLE enables all current and former participants , who have completed the randomized phase of the pivotal XanaMIA AD trial, the opportunity to receive active Xanamem 10 mg once daily for up to 25 months, with no placebo control group • This long-term extension is designed to provide access to active Xanamem therapy for all randomized trial participants and gather extended safety data and observational information on key efficacy endpoints — including CDR-SB,2 cognition, and activities of daily living • Available data from the OLE phase will be reviewed at the same time as XanaMIA topline final results in November. Clinical Trials Science Forum on the future of Alzheimer’s disease treatment • In mid-August the Company held another of its Clinical Trials Science Forum plain-English webinars. Chief Commercial Officer, Andy Udell moderate d a discussion on the future of Alzheimer's disease treatment with Professor Marwan Sabbagh, an internationally recognized neurologist and Alzheimer's disease specialist, along with the Company’s CMO Dr Dana Hilt and CEO, Dr Steven Gourlay • The webinar provides investors and other stakeholders with expert clinical perspectives on how Alzheimer's diagnosis and treatment are evolving, and what those changes could mean for future therapeutic approaches. The conversation also explores the rapidly evolving Alzheimer's treatment landscape, real -world experience with anti -amyloid therapies, the potential impact of blood- based biomarkers, and what physicians seek in next-generation Alzheimer’s therapies such as Xanamem. • A recording of the webinar is available on the Company’s InvestorHub at https://tinyurl.com/yubcs5jr. Commercial planning and partnering activities • Presented a Xanamem poster describing the baseline and screening characteristics of the XanaMIA pivotal trial and hosted an exhibit booth focussed on the unique nature of Xanamem’s cortisol control mechanism at the Alzheimer’s Association International Conference (AAIC), a leading global forum for Alzheimer’s research and clinical advances, increasing the program’s visibility among the international scientific and clinical community • Engaged with leading Alzheimer’s researchers and clinicians at AAIC to discuss Xanamem and developments in the evolving treatment landscape, and continued discussions with key opinion leaders and advisory board members to inform clinical and commercial planning • Advanced partnering readiness ahead of the XanaMIA topline results and continued discussions with potential global and regional commercialization partners regarding Xanamem’s development and commercial opportunity. New patent prosecution • Continued national phase patent prosecution continued with the first grants received for n ew patents covering 1) Xanamem treatment for cognitively normal people in Australia and Israel and 2) manufacturing in China and Chile, with patent expiry dates of 2040 and 2041 respectively. Presented at international and Australian conferences • In early August , the Company’s CEO Dr Steven Gourlay provided an important corporate presentation entitled Advancing Oral Xanamem in Alzheimer’s disease at the annual Bioshares Biotech Summit in Queenstown, N ew Zealand. Dr Gourlay’s presentation highlighted the strong scientific rationale for 2 CDR-SB is the Clinical Dementia Rating Scale – Sum of Boxes
Page 3
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 controlling cortisol in the brain with Xanamem in Alzheimer’s disease patients and the unique nature of this mechanism of action • In September, the Company’s CMO, Dr Dana Hilt, gave an academic oral presentation entitled Controlling cortisol in CNS1 disease – Xanamem;® a selective 11β-HSD1 inhibitor as a potential new therapeutic for neuropsychiatric diseases to the 6th International Conference on Cognitive and Behavioral Neurosciences in Paris, France. Finances – September cash position provides cash runway to late CY2027 or into CY2028 • September-end cash balance of $15.9 million together with expected net proceeds of ~$6 million from the accrued R&D tax rebate provides a pro- forma cash balance of ~$21.9 million, which gives the Company runway well beyond XanaMIA trial final results to late CY2027 or into CY2028, assuming any new trials are substantially funded via partnerships • Leading up to September 15 two tranches of unlisted options were partially exercised by holders and the shortfall was underwritten, providing $5.3 million of funding in total • As previously announced, the accrued R&D tax rebate is $10.8 million. After repaying loan funding advanced against the R&D tax rebate, the Company anticipates net cash inflow of approximately $6 million • In addition, up to $22.5 million may be received from listed option exercise in 2027 (expiry dates May and September 2027) • Operating expenditure of $6.2 million was incurred during the September quarter, with the majority of spend associated with the XanaMIA clinical trial and with robust participation in the OLE phase of the trial. With the trial rapidly approaching its conclusion and as final invoicing from vendors and sites close out over the coming months, future quarterly cash burn related to the trial will begin to rapidly abate • Consistent with ASX Listing Rule 4.7c.3, item 6 of the attached Appendix 4C of the cashflow report for the quarter included payments to Related Parties of $0.34 million, comprising the salary and FY26 bonus for the CEO/Managing Director, fees paid to Non-Executive Directors, and superannuation. Actinogen CEO and MD, Dr Steven Gourlay said: “Xanamem is a leading and unique oral therapy in late-stage clinical development for Alzheimer’s disease with the potential to become a transformational treatment option for patients and their families living with this devastating condition. Our current focus is to deliver high-quality pivotal trial results in November while at the same time planning for the future activities and development partnerships needed to get Xanamem approved as soon as possible by regulators around the world." View this announcement on our InvestorHub: https://investors.actinogen.com.au/link/Pb6mGP ENDS Investors Media Dr Steven Gourlay Michael Roberts George Hazim CEO & Managing Director Communications 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 Announcement authorised by the Board of Actinogen Medical Limited
Page 4
Actinogen Medical Limited ACN 086 778 476 Suite 901, Level 9, 109 Pitt Street, Sydney NSW 2000 +61 2 8964 7401 | actinogen.com.au 4 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 . It has also conducted a phase 2 trial in patients with cognitive impairment and depression and may 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 neuropsyc hological 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 247 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 and is now closed to participant recruitment. It has passed an independent Data Monitoring Committee safety and efficacy futility review and final topline results are expected in November 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 evaluates safety and a limited number of efficacy endpoints such as the CDR -SB. The trial commenced in March 2026 and is 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. The peer-reviewed publication relating to this trial can be accessed for free via this link: https://tinyurl.com/ckm63z63. 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 animation, 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 more than 500 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 level s of target engagement in the brain with doses as low as 5 mg daily have been demonstrated in a human PET imaging study.
Page 5
Actinogen Medical Limited ACN 086 778 476 Suite 901, Level 9, 109 Pitt Street, Sydney NSW 2000 +61 2 8964 7401 | actinogen.com.au 5 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 uncertai nties / 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 circ umstances 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.
Page 6
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 ACTINOGEN MEDICAL LIMITED ABN Quarter ended (“current quarter”) 14 086 778 476 30 September 2026 Current quarter $A’000 Year to date (3 months) $A'000 1 Cash flows from operating activities 1.1 Receipts from customers - - 1.2 Pa yme nts for - (a) research and development (4,332) (4,332) (b) product manufacturing and operating costs - (c ) adv er tising and mar keting - (d) leased assets - (e) s taff cos ts (1,641) (1,641) (f) administr ation and c or por ate c osts (546) (546) 1.3 Div idends receiv ed (see note 3) - 1.4 Interest receiv ed 184 184 1.5 Interest and other costs of finance paid (7) (7) 1.6 Inc ome tax es paid - 1.7 Government grants and tax incentives - 1.8 Other (wor king c apital mov ements) 136 136 1.9 Net cash from / (used in) operating activities (6,206) (6,206) 2 Cash flows from investing activities 2.1 Pa yments to a cqui re or for: (a) entities - - (b) businesses - - (c) property, plant and equipment - - (d) investments - - (e) intellec tual pr oper ty - - (f) other non-current assets - - 2.2 Proceeds from disposal of: - (a) entities - - (b) businesses - - (c) property, plant and equipment - - (d) investments - - (e) intellec tual pr oper ty - - (f) other non-current assets - - 2.3 C ash flows fr om loans to other entities - - 2.4 Div idends receiv ed (see note 3) - - 2.5 Other (pr ov ide details if mater ial) - - 2.6 Net cash from / (used in) investing activities - - Consolidated statement of cash flows
Page 7
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. 3 Cash flows from financing activities 3.1 Proceeds from issues of equity securities (excluding convertible debt securities) 987 987 3.2 Proceeds from issue of conv ertible debt securities - - 3.3 Proceeds from exercise of options 4,566 4,566 3.4 Tr ansac tion c osts r elated to issues of equity sec ur ities or convertible debt securities (217) (217) 3.5 Proceeds from borrowi ngs - - 3.6 Repayment of borrowings - - 3.7 Tr ansac tion c osts r elated to loans and bor r owings - - 3.8 Dividends paid - - 3.9 Other (applic ation for ex er c ise of options not y et allotted) - 3.10 Net cash from / (used in) financing activities 5,336 5,336 4 Net increase / (decrease) in cash and cash equivalents for the period 4.1 Cash and cash equivalents at beginning of period 16,735 16,735 4.2 Net c ash fr om / (used in) oper ating ac tiv ities (item 1 .9 abov e) (6,206) (6,206) 4.3 Net c ash fr om / (used in) inv esting ac tiv ities (item 2 .6 abov e) - - 4.4 Net c ash fr om / (used in) financ ing ac tiv ities (item 3 .1 0 abov e) 5,336 5,336 4.5 Effect of movement/adjustment in exchange rates on cash held - - 4.6 Cash and cash equivalents at end of period 15,865 15,865 5 Reconciliation of cash and cash equivalents at the end of the quarter (as shown in the consolidated s tatement of cas h flows ) to the related items in the accounts 5.1 Bank balanc es 5,365 2,735 5.2 C all deposits 10,500 14,000 5.3 Ba nk overdra fts - - 5.4 Other - - 5.5 Cash and cash equivalents at end of quarter (should equal item 4.6 above) 15,865 16,735 Current quarter $A’000 Previous quarter $A’000 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 assoc iates inc luded in item 1 337 6.2 Aggregate amount of payments to related parties and their assoc iates inc luded 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. Payments relate to salaries & fees paid to Directors of the Company during the quarter.
Page 8
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. 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. 7.1 Loan fac ilities 4,320 - 7.2 Credit standby arrangements - - 7.3 Other (please specify ) - - 7.4 Total financing facilities 4,320 - 7.5 Unused financing facilities available at quarter end - 7.6 8 Estimated cash available for future operating activities $A’000 8.1 Net c ash fr om / (used in) oper ating ac tiv ities (item 1 .9 ) (6,206) 8.2 Cash and cash equivalents at quarter end (item 4.6) 15,865 8.3 Unused financ e fac ilities av ailable at quar ter end (item 7 .5 ) - 8.4 Total av ailable funding (item 8 .2 + item 8 .3 ) 15,865 8.5 Estimated quarters of funding available (item 8.4 divided by item 8.1) 2.56 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 quar ter s, please pr ov ide answer s 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? Ans wer: 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? Ans wer: 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? Ans wer: 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. 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, inc lude a note pr ov iding details of those fac ilities as well. In an earlier quarter (31/3/26), the Company borrowed $4.32m in non-dilutive funding from Endpoints Capital under a funding facility secured against the Company’s FY26 Research and Development Tax Incentive ("RDTI"). The interest rate is 15.1% per annum and repayment is the earlier of either: the date that the FY26 R&D Refund is received or the applicable maturity da te, thi s bei ng 31 December 2026. Total facility amount at quarter end $A’000 Amount drawn at quarter end $A’000
Page 9
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. 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: 19 October 2026 Authorised by: By the Board (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.