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Actinogen Medical ASX ANNOUNCEMENT March 2021 Quarterly Activity Report & Appendix 4C Sydney , 21 April 2021. Actinogen Medical ASX : ACW ( ' ACW ' or ' the Company ' ) today submitted its quarterly activity report and Appendix 4C for the three - month period ended 31 March 2021 . Key highlights : • • • • Xanamem ™ clinical development plans progressing as planned , with two fully funded Phase II trials expected to commence in CY21 : о XanaMIA trial in patients with Mild Cognitive Impairment due to Alzheimer's disease о XanaFX trial in adolescent patients with Fragile X syndrome , addressing anxiety , sleep , and behavioural problems Awarded Rare Paediatric Disease Designation for Xanamem in FXS by the US FDA Appointment of Dr. Steven Gourlay as Actinogen's new Chief Executive Officer and Managing Director , bringing over 30 years of experience in the development of novel therapeutics Strong cash position with A $ 15.23m held as at 31 March 2021 , including funds raised during the quarter from the Entitlement Offer Shortfall Placement ( A $ 3.55m ) Advancing clinical development – planning for multiple clinical trials Actinogen continues to focus on the development of its lead drug , Xanamem , as a treatment for multiple indications . The Company is leveraging the positive Phase | XanaHES results , in which a significant improvement in multiple cognition domains was achieved in healthy older volunteers , into an Alzheimer's population with a Phase II XanaMIA trial planned to target patients with mild cognitive impairment ( MCI ) due to Alzheimer's Disease ( AD ) . The Phase I trial achieved efficacy results with the Cogstate Cognitive Test Battery ( ' Cogstate ' ) , a sensitive and modern testing tool , which can now be used in future studies . The XanaMIA trial is expected to commence in CY21 . In parallel , Actinogen remains focused on progressing study planning for anxiety , sleep and behavioural problems in Fragile X syndrome ( FXS ) . These symptoms have a substantial impact on day - to - day functioning of patients and their carers and there are currently no approved treatment options that specifically target these symptoms associated with FXS . Actinogen is well advanced with the planning for its Phase II XanaFX , with the trial expected to commence in H2 CY21 . The trial will investigate the treatment of Xanamem in male adolescents ( age 12-18 ) with FXS and will evaluate the safety and efficacy of Xanamem on dimensions of anxiety , sleep and behavioural problems . For more information on the upcoming clinical studies and development plan , please refer to Actinogen's Strategic Update and Investor Presentation to be released today . FDA awarded Rare Paediatric Disease Designation ( RPDD ) for Xanamem in FXS During the quarter , Xanamem was awarded RPDD by the FDA for treatment of FXS in patients under the age of 18. The RPDD program is designed to incentivise the development of drugs for rare childhood illnesses , such as FXS , with potential clinical , development and commercial benefits . This includes priority review and therefore faster clinical development and commercialisation of Xanamem . In addition , if Xanamem is first registered in the US for FXS Actinogen may receive a Priority Review Voucher ( PRV ) from the FDA , which can 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