PBT434 Movement Disorder clinical candidate updateIt has been previously reported that PBT434 is neuroprotective having demonstrated significant preservation of the substantia nigra, a brain region containing dopaminergic neurons responsible for motor coordination. This has translated into improved motor function, coordination and cognition in multiple mouse models of Parkinson's disease. Apart from exploring Parkinsonian Movement Disorders, Prana has advanced this program with 'proof of concept' mouse models of atypical Parkinsonian conditions. Specifically, in some conditions such as Multiple System Atrophy and Dementia with Lewy Bodies, there is an overabundance of the protein a-synuclein in the brain, which is associated with neurodegeneration and loss of motor and cognitive capacity. PBT434 has been shown to decrease insoluble forms of a-synuclein, and promote neuronal preservation with consequent improvement in motor and cognitive function. Movement Disorders typified by the over accumulation of toxic forms of tau protein in the brain include Corticobasal Degeneration and Progressive Supranuclear Palsy. Our mouse modeling has now confirmed a significant decrease in tau deposition and improvement in motor and cognitive function.A comprehensive International Council for Harmonisation of Technical Requirements for Human Use (ICH) compliant IND-enabling non-clinical program has been conducted to evaluate PBT434's pharmacologic, pharmacokinetic and toxicological profile. PBT434 has been shown to be well tolerated with limited toxicity. Preparation for a regulatory submission to enable first in man studies is underway. These Phase I trials will investigate safety, tolerability, pharmacokinetics, pharmacodynamics and putative biomarkers of PBT434. They will provide the data required to progress to Phase II testing in an atypical Parkinsonian disease. Pipeline development from Translational Biology ProgramNew and exciting development candidates from Prana's Metal-Protein Attenuating Compounds (MPAC) have emerged over the reporting period. These MPACs have demonstrated a number of key attributes required to tackle neurodegenerative processes including: the ability to reduce metal mediated oxidative and nitrosative stress, inhibit target protein oligomer aggregation and restore neuronal interconnections. The new candidates arose from novel discovery chemistry to create new chemical entities within three promising chemical scaffolds that show desirable MPAC qualities, are bioavailable and brain penetrable. These candidates began their efficacy profiling in animal models, including models of Movement Disorders and neurodegeneration during the reporting period. CashThe Group's cash on hand as at 31 December, 2015 totaled A$29.1 million. In addition, the Group has recorded a Trade Receivable at 31 December, 2015 in the amount of A$9.24 million from the Australian Tax Office. This amount comprises of A$6.46 million in respect of its 2015 R&D tax incentive claim and A$2.78 million in respect of its 2016 R&D tax incentive claim. The Group expects to receive these amounts during the 12 months ended 30 June 2016 and 2017, respectively. CorporateOn 6 November, 2015 the Group was notified by the Listing Qualifications Department of NASDAQ that it was non-compliant with NASDAQ's requirement that listed securities maintain a minimum bid price of US$1.00 per share. The Group has a compliance period of 180 days (until 2 May, 2016) to regain compliance with the minimum bid price requirement and may be eligible for an additional 180 day extension (until 29 October, 2016) if it does not regain compliance. The Group is considering all available options to correct the minimum bid price deficiency. Auditor's Independence Declaration A copy of the Auditor's independence declaration as required under section 307C of the Corporations Act 2001 is set out on the following page. This report is made in accordance with a resolution of the Board of Directors.
To access the auditor's report and full financial statements please visit http://www.asx.com.au/asxpdf/20160225/pdf/435cgvffh06gk3.pdfMr Geoffrey Kempler Executive Chairman and Chief Executive Officer MelbourneDated: The 25 th Day of February 2016