MELBOURNE, Australia--(BUSINESS WIRE)--Prana Biotechnology (ASX:PBT/NASDAQ:PRAN) has released its half year investor report for the six months to December 31, 2015.
Results and Review of Operations
The Group reported a loss for the half-year of A$2,854,825 (2014: A$1,252,695). The loss is after fully expensing all research and development costs.
Review of Operations
Detailed below is an update on the status of the Group’s development projects and overall operations for the half-year ended 31 December, 2015.
The Group’s 30 June 2015 Annual Report contains detailed background information relating to its operations including its research and development projects and collaboration partners and should be read in conjunction with this report.
PBT2 Huntington disease clinical development update
In February 2015 we reported that the US Food and Drug Administration (FDA) had placed PBT2 on Partial Clinical Hold (PCH) based on particular non-clinical neurotoxicology findings in a dog study which limit the dose of PBT2 that we can use in future trials. Our focus has been on creating a strong technical and safety data package in response to the PCH. This is a comprehensive and lengthy process that has required substantial input from our clinical and non-clinical teams and collaborators. It is essential that this submission presents sufficient data to enable the FDA to give guidance on the next steps required to lift the PCH and it remains a priority for the Group.
Meanwhile planning continues for the next stage in global development with PBT2 to confirm its clinical benefit as a treatment for cognitive impairment, a disabling and cardinal feature of Huntington disease. The award of Orphan designation by the FDA and the European Commission supports our mission to help patients for whom there is no effective treatment. We are planning to submit a regulatory package to selected national authorities and the European Medicines Agency (EMA) incorporating the data prepared for our response to the FDA to facilitate the commencement of a clinical trial in Huntington disease.
PBT434 Movement Disorder clinical candidate update
It 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 α-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 α-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 Program
New 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.
The 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.
On 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.pdf
Mr Geoffrey Kempler
Executive Chairman and Chief Executive Officer
Dated: The 25th Day of February 2016