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31 August 06
PROGEN’S FINANCIAL YEAR ENDS WITH A POSITIVE OUTLOOK FOR
2007
Key points:
• Accelerated
clinical development of anti-cancer drug PI-88, following a successful
U.S., Food and Drug Administration (FDA) meeting, provides a positive
outlook for 2007
• Cash and cash equivalents at year-end totalled $15.87 million
Brisbane, Australia 31 August 2006. Progen Industries
Limited (ASX: PGL, NASDAQ: PGLAF) today released its financial results
for the year ending 30 June 2006
During the course
of the year we made significant progress marked by several key accomplishments.
Driven by Justus Homburg, the new CEO, Progen has been focusing much of
its resources towards moving its lead anti-cancer drug PI-88 towards commercialisation
as rapidly as possible. Of significance, in May 2006 Progen received guidance
from the FDA on the accelerated progression of PI-88 to a Phase III clinical
trial in liver cancer (hepatocellular carcinoma), saving at least 3 years
in the timeline to drug registration. The Company anticipates the Phase
III trial to commence in the middle of calendar year 2007.
Patient recruitment for the Phase II lung cancer (non-small cell lung
cancer) and the Phase II (stage 1) liver cancer trials has been completed
and the results from these two trials are expected to be announced in
the first quarter of 2007.
Progress was made in our drug discovery program towards selection of a
lead candidate for Phase I clinical trials. The aim is to submit an Investigational
New Drug (IND) application to the FDA by end of the calendar year 2008.
The Company’s strategy to expedite the development of PI-88 contributed
to an increase in operating loss. The financial result was in line with
the Company’s expectation and the broader industry benchmark for
late stage clinical development of a new drug.
Financial year highlights:
• Company revenue was down 7.6% to $2.82 million, compared to $3.05
million for the previous year. This was due primarily to a $523,000 decline
in manufacturing revenues as the division focused on producing clinical
supply of PI-88 along with validation and optimisation of its manufacturing
process
• The operating loss was up 27.2% to $7.61 million compared to $5.98
million last year. The decline in manufacturing revenues played a contributing
factor as did the recognition of a $619,000 impairment loss in relation
to the Company’s equity investment in Medigen. Excluding the impairment
loss in Medigen, Progen’s loss increased 16.9% year-on-year
• Expenses incurred in preparing for potential PI-88 Phase III development
including regulatory and additional animal studies increased by $369,000
• Receipt of a Commercial Ready grant in July 2005 totaling $3.39
million over three years to partially fund our drug discovery efforts
• Net investment in research and development declined 5.4% year-on-year
to $3.14 million as expenditure on the lung cancer trial decreased with
patient recruitment having completed during the year, and melanoma monotherapy
trial completing in the previous reporting period
• Manufacturing result declined $891,000 due to the decrease in
revenues mentioned above and additional costs incurred in scale-up and
optimisation of PI-88 in readiness for Phase III supply of PI-88
* All figures quoted above are in Australian dollars
About Progen:
Progen Industries Limited is an Australian based globally focused biotechnology
company committed to the discovery, development and commercialisation
of small molecule pharmaceuticals for the treatment of cancer and other
serious diseases.
Progen's three key areas of focus are:
- Clinical Development - via a focused clinical
trial programme involving its two compounds PI-88 and PI-166.
- Drug Discovery - projects focusing on the development
of potent, selective inhibitors of carbohydrate-protein interactions,
which are implicated in many disease processes.
- Manufacturing Services – PI-88 manufacturing
development and supply for the clinical program.
Keywords -
Progen, liver cancer, HCC, PI-88, Justus Homburg, FDA
Web links to selected recent
news and other information about Progen:
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