Page 1

Actinogen ASX ANNOUNCEMENT September 2021 Quarterly Activity Report and Appendix 4C Sydney , 20 October 2021. 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 2021 . Key highlights : • • • Advancing the Xanamem® clinical development pipeline : о Part A of the two - part XanaMIA trial in Mild Cognitive Impairment ( MCI ) due to Alzheimer's Disease ( AD ) commenced in healthy older volunteers with more than 50 % of the planned 105 participants enrolled during the quarter O XanaFX trial in adolescent patients with Fragile X Syndrome ( FXS ) , addressing cognition , anxiety , sleep and behavioural problems to commence as planned in 2H CY21 under a US FDA Investigational New Drug ( IND ) regulatory approval A third disease indication , adding further diversification to the Phase 2 program , to be announced in the current ( December ) quarter Filed Investigational New Drug ( IND ) submission to the US FDA for FXS program Received notification from the Brazilian Patent and Trademark Office of grant of patent application for Xanamem Cash balance of A $ 11.82 million at 30 September 2021 . R & D tax incentive rebate of A $ 1.43 million received subsequent to quarter - end . Advancing the clinical development pipeline through multiple clinical trials Actinogen remains focused on excellent clinical development , designed to deliver " multiple shots on goal " with timely and high - quality confirmation of clinical efficacy and safety in each of its disease programs . The Company is conducting its lead programs under a US Investigational New Drug ( IND ) process to ensure the highest standards of regulatory compliance for clinical development , non - clinical studies and manufacturing . Alzheimer's Disease Program - XanaMIA Trial The enrolment of the first patient in Part A of the XanaMIA trial was announced on 15 July 2021 . This trial seeks to assess the efficacy of 5mg and 10mg Xanamem doses on cognition ( ability to remember and think ) compared to placebo in 105 older healthy patients ( aged 50 to 80 years old ) , over six weeks , to confirm the minimum effective dose . It is being conducted at four¹ outpatient sites in Australia . This trial will use the Cogstate Neuropsychological Test Battery , supplemented by the Digit Symbol Substitution Test ( iDSST ) which has been recognised in the past by the FDA as an appropriate endpoint for a cognitive marketing claim . Enrolment was approximately 55 % complete at the end of September and exceeds 65 % at the date of this announcement . It is expected to be completed during the current ( December ) quarter . Xanamem is a registered trademark of Actinogen Medical Limited . 1 Subsequent to the end of the quarter a second site was added in Queensland , taking the total active sites to five to mitigate the potential risk of slower than expected enrolments at NSW sites due to COVID - 19 restrictions . ACTINOGEN MEDICAL LIMITED TRADING AS ACTINOGEN MEDICAL ACN 086 778 476 ASX | ACW Suite 901 , Level 9 , 109 Pitt Street , Sydney NSW 2000 AUSTRALIA TELEPHONE +61 2 8964 7401 WEB www.actinogen.com.au