Monday, 27 July 2015

Assignment 1 - Step 2 for comment and feedback

Prana Biotechnology’s History

Prana Biotechnology is an Australian company that is governed by Australian Law and trades in Australian dollars.  It was incorporated in Melbourne, Australia in 1997.  The company is listed on the Australian Securities Exchange (ASX: PBT) in 2000 and listed on the NASDAQ (NASDAQ: PRAN) in 2002.

Prana Biotechnology falls under the Australian Government tax incentive scheme relating to eligible research and development activities, introduced on 1 July 2011.  This means that entities with an aggregated turnover for the income year of less than A$20 million will be entitled to a 45% refundable tax offset.  Here is a link to the announcement that  Prana receives $6.8 million R&D Tax Incentive Refund http://pranabio.com/news/prana-receives-6-8-million-rd-tax-incentive-refund

The earliest beginnings of Prana Biotechnology began in the laboratory of Professor Rudo9lph Tanzi at Massachusetts General Hospital in the 1980’s when he was investigating the molecular and genetic basis of neurological disease.  Prana Biotechnology is developing first-in-class therapies to treat neurodegenerative disease. 

The Company’s lead drug candidate – PBT2 – is being developed for the treatment of Alzheimer’s and Huntington’s diseases.  The Company is targeting lodgment of a New Drug Application for Huntington’s disease in 2016/2017 pending positive trial results.  Prana Biotechnology also has advanced a drug candidate for Parkinson’s disease and other movement disorders (PBT434) and brain cancer (PBT519), which are in pre-clinical toxicology testing.  Development of PBT434 has received funding from the Michael J. Fox Foundation and Parkinson’s UK.

Prana Biotechnology are pleased to announce the Orphan Drug designation by the US Food and Drugs Administration (FDA).  Orphan drug designation is granted to promote the development of drugs for diseases affecting less than 200,000 people 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.

Appointing Professor Ira Shoulson as a non-executive Director is pivotal in charting a course to develop PBT2 as a treatment for Huntington Disease.  Professor Shoulson’s experience and insight as a former FDA advisor will be invaluable during preparation of the End of Phase 2 meeting with the US FDA.  Here is an interview with Professor Ira Shoulson http://www.brr.com.au/event/123434/
Elsevier Business Intelligence named PBT2 as one of the Top 10 Neuroscience projects to watch in the world, this was followed by a report in the Aging Cell journal, which showed PBT2 reversed memory and cognitive loss in aged mice.

Here is a link to a Channel 9 news story that aired regarding the level 3 clinical trial that Prana Biotechnology is working on.  New Alzheimer's Drug News Story 

What Concerns do I have at this Stage?

I am happy with the company that has been selected for me.  I appreciate that it is an Australian company and in a field that I know a little about.  My sister previously worked for Sonic Clinical Trials in Sydney, where she tested all the samples for numerous clinical drug trials and we had some discussions, without breaking any confidentially, on clinical trials.  As a Lions member I have visited the QIMR Berghofer Medical Research Institute at the Royal Brisbane and Woman’s Hospital, Princess Alexandra Hospital Centre’s for Health Research and UQ’s Diamantina Institute, speaking with researchers and listening to lectures on their work.

I’m quite ‘old school’ and like the feel of paper and being able to flick through a large publication such as an annual report and these annual reports are 70 – 116 pages each.  I find that a bit difficult to read on screen.

Formatting of the three different annual reports including the financial reporting is slightly different.  The company has run at a loss for at least the last 4 years.  Not sure how they can keep running.


When entering the financial statements into our company spreadsheet I was wondering if there was a way to link the total of the Reserves from the Statement of Changes in Equity to the Reserves amount in the Balance Sheet.  In the examples that I found the Statement of Changes in Equity wasn’t that detailed as to include the Issued and Unissued Capital and Reserves. 

My nominated company has been operating at a loss for at least the past 5 years.  It seems strange that a company can continue to make such losses and still operate.  Upon further reading, I discovered that they are eligible for the Australian Government tax incentive scheme relating to eligible research and development activities, introduced on 1 July 2011.  This assists them in continuing to operate.  

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