- Full year revenue of $176,842, down 51% on prior corresponding period (pcp)
- Fully year loss after tax of $5,885,069, down 56% on pcp
- Cash position at June 30, 2015, of $34.9 million
- Cash receivable of $6.5 million for R&D tax incentive for eligible activities incurred in fiscal year 2015
Using this model, preliminary studies suggest PBT2 can prevent tangles in brain cells and increase neuronal cell viability.Huntington disease research and development Following last year's announcement of encouraging results from the Reach2HD trial in Huntington disease, Prana attracted one of the world's foremost experts in Huntington disease to the Board of Directors. Professor Ira Shoulson has played a key role in planning Prana's next Huntington disease trial and in positioning PBT2 for successful commercialisation. PBT2 was granted Orphan drug designation in United States and Europe. In the United States, Orphan drug designation entitles Prana to seven years of market exclusivity for the use of PBT2 in the treatment of Huntington disease; protocol assistance by the FDA to optimize drug development in the preparation of a dossier that will meet regulatory requirements; and reduced fees associated with applying for market approval. In Europe, 10 years of commercial protection is provided. PBT2 has the potential to be the first drug approved to treat the cognitive problems of Huntington disease patients and to enjoy a substantial period of exclusive protection associated with Orphan disease designation. Based on the emerging strong safety profile for PBT2, Prana is crafting a robust safety monitoring plan for future trials in Huntington disease. These plans will be submitted to the FDA as part of Prana's response to the PCH. The combined FDA safety and data information package will be used in submissions to European and other regulators to support global development plans and prospective marketing approvals. Along with the assembly of safety analyses to the FDA, Prana is continuing to plan for the Phase 3 program for Huntington disease and, in particular, the design of the program to confirm clinical benefit with PBT2. Movement Disorder research and development & Translational Biology programs Prana has a library of more than 2000 Metal-Protein Attenuating Compounds (MPAC) which address Alzheimer's-like changes in the brain. MPACs do this by preventing a build-up of beta-amyloid deposits which destroy cognitive function.
Prana has continued to develop its 'two tier' research program structure, to (i) undertake new MPAC design and synthesis and (ii) undertake 'translational' animal modelling programs to test and validate new candidate MPACs as potential development leads.Studies have shown lead MPAC PBT434 to be well tolerated with limited toxicity. It is anticipated that subject to regulatory approval, PBT434 will commence its Phase 1 program during 2016 in healthy volunteers to investigate safety, tolerability, pharmacokinetics, pharmacodynamics and putative biomarkers of PBT434. Overall, Prana's MPAC pipeline, headed by lead compounds PBT2 and PBT434, is evolving rapidly to offer late and early stage disease modifying therapeutic strategies to treat the unmet medical needs in neurodegeneration. The annual report is available at www.pranabio.com