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Protox Releases Financial Statements and Reviews Achievements for 2005
Friday, April 28, 2006 - Vancouver, British Columbia - Protox Therapeutics Inc.
(TSX-V: PRX) announced today the release of its year end financial statements for
the period ending December 31, 2005.
“2005 was a very successful year for Protox as we delivered on the promise to take
our lead compound, PRX302, into the clinic,” stated Dr. Fahar Merchant, President and
CEO of Protox. “We look forward to continuing the momentum with the initiation of a
second clinical program for this compound before year end.”
2005 Operational Highlights
- The Company completed all pre-clinical studies necessary to support an Investigational
New Drug (IND) Application with the U.S. Food and Drug Administration (FDA) using PRX302
for the treatment of localized recurrent prostate cancer. The IND was subsequently
filed on December 14 and received approval on January 16, 2006.
- In support of the IND and in preparation for the Phase I clinical trial, the Company
completed cGMP (current Good Manufacturing Practices) compliant manufacturing and
related CMC (chemistry, manufacturing and control) activities for PRX302. In doing so,
enough material was produced to carry out clinical trials for prostate cancer and a
second indication under development, benign prostatic hyperplasia (BPH or prostate
enlargement).
- On October 20th, the Company entered into a clinical trial agreement with Scott &
White Memorial Hospital and Clinic in Texas to become the lead center for the Phase
I clinical study of PRX302 for localized recurrent prostate cancer. The first patient
is expected to be treated in the second quarter of 2006.
- Protox’s intellectual property portfolio was strengthened in 2005 by the filing of
two important provisional patent applications with the U.S. Patent and Trademark
Office. Both patent applications expand the protection for the Company’s novel
PORxin™ candidates, allowing for the development or partnering of the PORxin™ pipeline
for indications beyond prostate cancer, including BPH.
- In November, the Company completed an oversubscribed non-brokered private placement
of 11,743,600 units at a price of $0.50 per unit for total gross proceeds of $5,871,800.
Each unit comprised one common share and one common share purchase warrant. Each
warrant entitles the holder to purchase one common share of Protox Therapeutics Inc.
at a price of $0.65 for a period of 24 months from the closing date of the private placement.
Financial Statements
Results of operations for the year ended December 31, 2005
For the year ended December 31, 2005 the Company reported a net loss of $5,549,332
($0.22 per share) compared to a net loss of $2,984,815 ($0.17 per share) for the year
ended December 31, 2004. The Company earned $62,334 in interest income for the year
ended December 31, 2005 compared with $37,065 in the prior year.
For the year ended December 31, 2005 research and development expenses were $3,555,987
compared with $2,023,144 for the prior year. The increase in research and development
expenses of $1,532,843 is primarily due to the costs associated with the manufacturing
of our drug, PRX302, the formal preclinical studies required to submit an Investigational
New Drug (IND) application to the Food and Drug Administration of the United States of
America (FDA) for PRX302 to treat localized recurrent prostate cancer, and the regulatory
costs associated with completing the IND, which was submitted on December 14, 2005.
For the year ended December 31, 2005 general and administrative expenses were $1,976,632
compared with $998,785 for the prior year. The increase in general and administration
expenses of $977,847 is primarily due to additional non-cash stock based compensation
recorded in 2005 relating to the change in management personnel and additional employees
hired in the second half of 2004 and in 2005 to support the development of the Company’s
programs.
The Company does not anticipate earning any revenue in the foreseeable future, other
than interest revenue earned on invested funds. In addition, expenses are expected to
remain at similar levels over the coming quarters as the Company proceeds with the
clinical trials for prostate cancer, preparation of the BPH program for clinical trials
and key activities associated with the Company's research programs.
Summary of Financial Results
Liquidity and capital resources
As at December 31, 2005, the Company had cash and cash equivalents of $5,471,804 as
compared with $4,911,490 as at December 31, 2004. As at December 31, 2005, the Company
had working capital of $5,166,583. The increase in current assets can predominantly
be attributed to the non-brokered private placement of $5,619,915, net of cash costs
of $251,885, completed in November 2005.
Based on its working capital position as at December 31, 2005, the proceeds received
from the private placement financing in November, 2005, and its current business plan,
the Company anticipates that it will have sufficient funds to operate its business
into Q2, 2007. However, the Company's working capital may not be sufficient to meet
its stated business objectives in the event of unforeseen circumstances or a change
in the strategic direction of the Company. The Company will need to raise further
capital in order to advance its research & development programs to commercialization.
There can be no assurance that the Company will be able to obtain further financing
on terms that are acceptable, if at all.
About Protox Therapeutics:
Protox Therapeutics is a product-focused development-stage company and a leader in
advancing novel, targeted protein toxin therapeutics for treatment of cancer and
other diseases. Through the company’s PORxin™ technology platform,
therapeutic candidates are generated by engineering the naturally occurring protein,
pro-aerolysin. These proteins become potent anti-cancer agents when activated at a
tumor site by specific proteases produced by cancer cells. Once activated, the drug
punches holes in the cancer cells causing the contents to leak out and ultimately,
cell death. Protox has received clearance from the FDA to commence Phase 1 clinical
trials with the lead compound, PRX302, for the treatment of localized prostate cancer.
PRX302 is also being developed for treatment of benign prostatic hyperplasia.
For more information, contact:
Elayne Wandler
Director, Investor Relations and Corporate Communications, Protox Therapeutics Inc.
Direct: 604-688-4369
Cell: 778-865-0172
Fax: 604-688-0173
ewandler@protoxtherapeutics.com
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