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Actinogen Medical ASX ANNOUNCEMENT Key highlights : • June 2021 Quarterly Activity Report & Appendix 4C Advancing the XanamemⓇ clinical development pipeline , with fully funded Phase II trials : о о о Two - part XanaMIA trial in Mild Cognitive Impairment ( MCI ) due to Alzheimer's disease ( AD ) has commenced in healthy older volunteers and patients with biomarker - confirmed AD XanaFX trial in adolescent patients with Fragile X syndrome ( FXS ) , addressing anxiety , sleep and behavioural problems to commence in 2H CY21 Third indication to be announced in 2H CY21 Commenced Part A XanaMIA trial subsequent to the quarter , following Bellberry Human Research Ethics Committee ( HREC ) approval Signed work orders to engage Avance Clinical and Paratus Clinical to assist in XanaMIA trial • Received positive Pre - Investigational New Drug ( Pre - IND ) feedback advice from the FDA for FXS program • Strong cash position with A $ 13.46m held as at 30 June 2021 Sydney , 22 July 2021. Actinogen Medical ASX : ACW ( ' Actinogen ' or ' the Company ' ) today submitted its quarterly activity report and Appendix 4C for the three - month period ended 30 June 2021 . Advancing clinical development , with multiple clinical trials planned The success of the Phase I XanaHES study cognition data in healthy older patients will be leveraged into an Alzheimer's population , with a two - part Phase II XanaMIA trial advancing in healthy , older volunteers and patients with MCI due to AD . Subsequent to the quarter , Actinogen announced the commencement of Part A of the XanaMIA study , with the first volunteer treated in the trial . This study seeks to assess the efficacy of 5mg and 10mg Xanamem doses compared to placebo in 105 older healthy patients ( aged 50 to 80 years old ) , over 6 weeks , to confirm the minimum effective dose . Part B will be informed by the results of Part A and will investigate the efficacy of Xanamem in patients with MCI confirmed by the presence of positive biomarkers in the blood to be due to early - stage AD . This study will utilise 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 . In parallel , Actinogen remains focused on progressing the study plan for anxiety , sleep and behavioural problems in Fragile X Syndrome ( FXS ) . There are currently no approved treatment options that specifically target these symptoms associated with FXS which have a substantial impact on the day - to - day functioning of patients and their caretakers . The study will be conducted in Australia , and is a randomised , placebo- controlled , double - blind , 12 - week trial investigating the safety and efficacy of Xanamem in male adolescents suffering from FXS . Actinogen is well advanced with the planning for its Phase II XanaFX trial , which is expected to commence in 2H CY21 . Actinogen expects to announce the addition of a third target indication to the clinical development pipeline in 2H CY21 . 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