VANCOUVER, April 27 /CNW/ - Protox(TM) Therapeutics Inc. (TSX-V:PRX)
today released year-end financial statements for the 12 months ending
December 31, 2006.
"2006 was a transformative year for Protox," said Dr. Fahar Merchant,
President and Chief Executive Officer. "Over the course of 12 months we have
made the transition from pre-clinical promise to encouraging interim clinical
results with our flagship drug candidate, PRX302 in prostate cancer. Today we
have two therapeutic platforms comprising multiple indications and clinical
data for over 100 patients. These accomplishments will create enduring value
for the company and set the stage for continued progress over the coming
- On January 26, 2006 the US Food and Drug Administration approved an
Investigational New Drug submission for PRX302 to treat localized
recurrent prostate cancer and on May 2, 2006 the first patient was
dosed at Scott & White Memorial Hospital. Three additional sites have
since joined the trial including M.D. Anderson Cancer Centre,
University of Vermont and Urology San Antonio.
- The PORxin(TM) patent family was further strengthened with the filing
in June 2006 of a provisional patent application with the United
States Patent and Trademark Office to protect drug candidates
generated through the platform whose binding sites are altered to
target certain types of cells including cancer cells. The PORxin
platform was also enhanced with three scientific presentations at two
international cancer conferences during the year.
- On July 20, 2006 the Company acquired a second technology platform
from Neurocrine Biosciences Inc. and the US Public Health Service.
The lead drug candidate, PRX321, has been studied in 72 patients in
Phase I and IIa clinical trials for brain cancer and 14 patients in a
Phase I trial to treat solid tumours. The compound is potentially
indicated for up to a dozen different cancer indications.
- The Company received approval from Health Canada on October 11, 2006
to initiate a Phase I clinical trial of PRX302 for benign prostatic
hyperplasia (BPH or enlarged prostate). The trial was initiated on
March 28, 2007 at two sites, in Victoria, British Columbia and
Kitchener, Ontario, and the first patient was dosed on April 23,
- In late 2006 the Company raised gross proceeds of $10,049,750 in a
brokered private placement of common share units to further the
development of programs for PRX302 and PRX321 and for general
- Promising interim results from the Phase I prostate cancer trial,
reported on January 18, 2007, indicated that PRX302 was safe and
well-tolerated with the ability to reduce PSA levels and decrease
tumour burden in patients with localized recurrent prostate cancer.
Financial Results & Capital Resources
For the year ended December 31, 2006 ("2006"), the Company:
- Incurred a net loss of $5,012,646 ($0.13 per share), a 10% decrease
from $5,549,332 ($0.22 per share) for the year ended December 31,
- Earned interest income of $145,378, a 133% increase from 2005, due to
higher cash balances from financing.
- Reduced total operating expenses by 8% to $5,112,068 from $5,568,225
incurred in 2005. Operating expenses for 2006 included R&D costs of
$2,860,665, a 20% decrease from $3,555,987 in 2005. This decrease in
R&D reflects a shift from preclinical to clinical activities. Costs
for the Prostate Cancer Phase I clinical trial, initiated in May
2006, totaled approximately $0.8 million and discovery research costs
were approximately $0.5 million compared to $0.4 million in 2005.
Costs associated with additional personnel to manage and execute the
Company's expanded R&D and clinical trial initiatives as well as
initial INxin(TM) license fees offset a portion of the $2 million
reduction in preclinical testing and manufacturing costs from 2005.
- Incurred G&A expenses of $2,159,784 compared to $1,941,235 for 2005.
The increase is primarily due to an increase in personnel and travel
costs in support of the Company's expanded activities in 2006.
SUMMARY OF QUARTERLY RESULTS
2006, THREE MONTHS
ENDED, (UNAUDITED) DEC 31 SEP 30 JUN 30 MAR 31
Interest income $ 42,853 $ 32,991 $ 35,750 $ 33,783
Total expenses $ 1,370,812 $ 1,384,481 $ 1,514,123 $ 888,607
Net loss $ (1,327,959) $ (1,351,490) $ (1,478,373) $ (854,824)
per share $ (0.03) $ (0.04) $ (0.04) $ (0.02)
2005, THREE MONTHS
ENDED, (UNAUDITED) DEC 31 SEP 30 JUN 30 MAR 31
Interest income $ 15,079 $ 8,895 $ 16,182 $ 22,178
Total expenses $ 1,582,563 $ 1,455,246 $ 1,562,306 $ 1,003,506
Net loss $ (1,570,622) $ (1,447,035) $ (1,548,762) $ (982,913)
per share $ (0.05) $ (0.06) $ (0.07) $ (0.04)
The Company does not anticipate earning any revenue in the foreseeable
future, other than interest revenue earned on cash balances. Operating
expenses are expected to significantly increase during 2007 in conjunction
with the advancement of the Company's PRX301 and PRX321 clinical programs.
At December 31, 2006, the Company had cash resources of $9,977,259 and
working capital of $8,918,615. Subsequently, the Company has raised an
additional $583,000 from the exercise of outstanding share purchase warrants.
The Company believes it will have sufficient resources to execute its current
business plan up to mid 2008. Thereafter, additional capital will be required
to further advance the Company's R&D programs through to commercialization.
The exercise of outstanding stock options and warrants represents potential
additional funding of up to $18 million.
Protox Therapeutics is a leader in advancing novel, targeted therapeutics
for treatment of cancer and other proliferative diseases. The company is
actively developing two distinct but complementary platforms, INxin and
PORxin, and currently has four clinical programs in development. A Phase IIa
clinical trial into the use of PRX321 (INxin) for the treatment of primary
brain cancer has been completed and the drug has received Fast Track
Designation and Orphan Drug Status from the US FDA. In addition, a Phase I
trial has been completed for PRX321 to treat patients with renal cell
carcinoma and non-small cell lung cancer. Patient enrolment is underway for
two Phase I clinical trials using PRX302 (PORxin) for prostatic disease: one
to treat localized prostate cancer and the other to treat benign prostatic
NO REGULATORY AUTHORITY HAS APPROVED OR DISAPPROVED THE CONTENT OF THIS
RELEASE. THE TSX VENTURE EXCHANGE DOES NOT ACCEPT RESPONSIBILITY FOR THE
ADEQUACY OR ACCURACY OF THIS RELEASE.
Certain statements included in this press release may be considered
forward-looking. Such statements involve known and unknown risks,
uncertainties and other factors that may cause actual results, performance or
achievements to be materially different from those implied by such statements,
and therefore these statements should not be read as guarantees of future
performance or results. All forward-looking statements are based on Protox'
current beliefs as well as assumptions made by and information currently
available to Protox and relate to, among other things, anticipated financial
performance, business prospects, strategies, regulatory developments, market
acceptance and future commitments. Readers are cautioned not to place undue
reliance on these forward-looking statements, which speak only as of the date
of this press release. Due to risks and uncertainties, including the risks and
uncertainties identified by Protox in its public securities filings; actual
events may differ materially from current expectations. Protox disclaims any
intention or obligation to update or revise any forward-looking statements,
whether as a result of new information, future events or otherwise.
For further information:
For further information: James Beesley, Director, Investor Relations,
Protox Therapeutics, (604) 484-0975, firstname.lastname@example.org,
www.protoxtherapeutics.com; Michael Moore, Investor Relations, Equicom Group,
(416) 815-0700 x 241, email@example.com