Earnings release
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Actinogen Medical ASX ANNOUNCEMENT December 2020 Quarterly Activity Report & Appendix 4C Sydney , 29 January 2020. Actinogen Medical ASX : ACW ( ' ACW ' or ' the Company ' ) today submitted its quarterly activity report and Appendix 4C for the three - month period ended 31 December 2020 . Key highlights : • • Xanamem ™ clinical development plans for the two fully funded trials progressed during the quarter : ○ XanaMIA phase II trial in patients with Mild Cognitive Impairment due to Alzheimer's disease ○ XanaFX phase II trial in patients with Fragile X syndrome selected as a new target indication , addressing anxiety , sleep and behavioural problems Two new patent applications filed to strengthen and extend IP portfolio • Ongoing focus on business development activities , including a presentation at Switzer Small and Micro Cap Investor Day Strong cash position with ~ $ 12.9m held as at 31 December 2020 , including funds received during the quarter from the placement ( ~ $ 6.0m ) , entitlement offer ( ~ $ 1.4m ) and a R & D tax incentive rebate for FY20 ( ~ $ 2.9m ) Advancing clinical development – planning for multiple clinical trials Actinogen continued to focus on the development of Xanamem as a treatment for Alzheimer's disease ( AD ) . The Company is building on the positive XanaHES results , in which a significant improvement in multiple cognition domains was achieved in healthy elderly volunteers , by planning a new Xanamem study in an AD patient population . The XanaMIA phase II clinical trial in patients with Mild Cognitive Impairment ( MCI ) due to AD is designed to demonstrate the safety , tolerability and efficacy of Xanamem in this early stage of the Alzheimer's disease spectrum . This patient population represents a significant unmet clinical need and commercial opportunity . In parallel , Actinogen made significant progress with anxiety , sleep and behavioural problems in Fragile X syndrome ( FXS ) being added to the development pipeline . The selection of Fragile X syndrome follows significant clinical interest in evaluating Xanamem across a range of a medical conditions associated with raised cortisol . There are currently no approved treatment options that specifically target these symptoms associated with FXS . Both the pharmacological properties of Xanamem and the current understanding of FXS pathology strongly support Xanamem as a potential treatment option for these symptoms . XanaFX , is a double - blind placebo - controlled trial investigating the treatment of Xanamem in ~ 40 male adolescents with FXS . The trial will be conducted by the Murdoch Children's Research Institute and the Royal Children's Hospital . During the quarter , Dr. Bill Ketelbey presented an update on Actinogen's clinical development on a conference call on 19 October , including further details on the XanaMIA and XanaFX trials . A recording of the webcast presentation can be found on Actinogen's website through this link : https://actinogen.com.au/investor- centre / # investor - updates New patent applications to strengthen IP portfolio Actinogen filed two new patent applications for lead drug Xanamem which could extend its patent life protection until 2040. The first application seeks to provide patent protection to a method of treating cognitive decline . This patent is supported by the statistically significant results of the Phase I XanaHES trial , which 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