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Protox releases 1st Quarter, 2005 financial statements
Monday, May 30, 2005 - Vancouver, British Columbia - Protox Therapeutics Inc.
announced today the release of its year end financial statements for the period
ending March 31, 2005.
"The first quarter of 2005 has been important for Protox as we have made
significant progress on a number of fronts in order to drive our lead product,
PSA-PAH1, toward human clinical trials, for patients with locally recurrent
prostate cancer," stated Fahar Merchant, PhD, President and CEO of the
Company. "We successfully manufactured our first batch of PSA-PAH1 which in
turn enabled us to commence multiple pre-clinical studies on time. The
results we have seen to date have been encouraging and keep us on track to
file our first Investigational New Drug (IND) application with the United States
FDA this summer. We plan to report on additional milestones for the balance
of this year as we focus our efforts to take our lead compound into the clinic.
With our scientific partners and collaborators, we plan to make further progress
this year as we continue to unlock the full commercial potential of the Aerolysin
platform and create value for our shareholders."
Operational highlights for the 1st Quarter include:
The Company achieved a significant manufacturing milestone whereby
we successfully transferred the production process for PSA-PAH1 to the
Waisman Clinical Biomanufacturing Facility (WCBF). Process
development, optimization, scale-up and manufacture of a pre-clinical
batch were all completed during the first quarter of 2005. The ease,
efficiency and economy of our manufacturing process provides
considerable comfort, as this milestone is not trivial for most
biopharmaceutical companies.
The GLP compliant lot of PSA-PAH1 was subsequently used to
commence a number of pre-clinical studies in different animal models
to study toxicology, safety and drug distribution.
Protox exercised its option for an exclusive license agreement with the
National Research Council's Institute of Biological Sciences and the
University of Victoria Innovation and Development Corporation. When
finalized, the license will grant Protox exclusive worldwide rights to
commercialize a genetically modified Aerolysin-antibody construct as a
targeted therapy for the treatment of non-small-cell lung cancer, which
comprises 80% of all lung cancers.
During this period, Protox continued to make progress in conducting
CMC (Chemistry, Manufacturing and Control) and non-clinical studies
required to file the IND with the United States FDA for its lead candidate,
PSA-PAH1. Protox is on schedule to file the IND in the third quarter of
2005.
Financial Statements
The financial results of the Company include the consolidation of Protox
Pharmaceuticals effective as of July 9, 2004.
Net Income
The Company incurred a net loss of $982,913 (or $0.04 per share) for the
quarter ended March 31, 2005. This is compared to a loss of $345,161 (or
$0.03 per share) for the quarter ended March 31, 2004 (Protox Pharma). The
increases in losses are predominantly related to the increase in expenditures
as described above.
All costs incurred in this quarter were within budgeted guidelines established
by management and approved by the Board of Directors of the Company. The
expenses above are in line with the reported use of proceeds in the prospectus
dated June 29, 2004.
Summary of Quarterly Results
The decrease in expenses for the period ended March 31, 2005 compared to
the period ended December 31, 2004 are due mainly to expenditures
associated with the purchase of laboratory supplies and for contract
manufacturing services incurred in the fourth quarter of 2004.
The Company does not anticipate earning any revenue in the foreseeable
future, other than interest revenue earned on its cash balances. In addition,
expenses are expected to significantly increase over the coming quarters due
to increases in research and development expenses and general and
administrative expenses.
Liquidity
As at March 31, 2005, the Company had working capital of $3,455,528. The
Company anticipates that it will have sufficient funds to operate its business for
approximately the next 12 months, based on its current business plan.
ABOUT PROTOX: Protox Therapeutics Inc. is developing novel cancer
therapeutics by engineering the naturally occurring bacterial toxin Aerolysin,
which kills cells by forming pores in them. The Company believes that its
engineering approach will produce targeted cancer therapeutics that have
greater efficacy and fewer side effects than existing cancer treatments.
Company financials for the quarter ended March 31, 2005 and Management's
Discussion and Analysis will be available at www.sedar.com
For more information, contact:
Terry Vanderkruyk
Director, Investor Relations, Protox Therapeutics Inc.
Tel: 604-688-4376
Cell: 604-789-0844
Fax: 604-688-0173
tvanderkruyk@protoxtherapeutics.com
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