VANCOUVER, Nov. 27 /CNW/ - Protox Therapeutics Inc. (TSX-V: PRX) today
reported financial results and operating highlights for the third quarter
ended September 30, 2007.
"We have demonstrated significant progress with our PRX302 product
development in recent months, including positive Phase 1 results from both the
locally recurrent prostate cancer and BPH clinical studies," said Dr. Fahar
Merchant, President and CEO of Protox. "The progress we've shown with these
clinical trials, together with our strengthened balance sheet from the
successful exercise of the November 2005 warrants, puts us in an excellent
position to commence multiple Phase 2 trials in 2008, including a Phase 2b
trial of PRX321 for the treatment of primary brain cancer."
- Announced encouraging top-line results from the Phase 1 prostate
cancer study, indicating 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.
- Appointed Dr. Martin Gleave MD, FRCSC, FACS, as Chairman of its
Clinical Advisory Board (Urology).
- Announced agreement with Dompé pha.r.ma S.p.A. (Dompé) for the
clinical manufacturing and commercial supply of PRX321.
- Presented interim data from the recently completed Phase 1 clinical
study testing PRX302 in patients with locally recurrent prostate
cancer following radiation failure at the American Urological
Association ("AUA") South Central Section Annual Meeting on
September 7, 2007.
- Published a paper entitled "Recombinant prostate-specific antigen
proaerolysin shows selective protease sensitivity and cell
cytotoxicity" in the peer-reviewed journal, Anti-Cancer Drugs
(August 2007; 18(7) 809-816).
- Completed patient recruitment for the Phase 1 clinical trial of
PRX302 in males with benign prostatic hyperplasia (BPH). Also
reported positive interim data from this study indicating that PRX302
is safe and well tolerated and shows promising signs of therapeutic
- Announced positive final results from all 24 patients enrolled in the
Phase 1 clinical of PRX302 in patients with localized, recurrent
prostate cancer following radiation failure.
- U.S. Patent and Trademark Office issued U.S. Patent 7,282,476
covering the composition of PRX302, the Company's lead drug candidate
from its PORxin(TM) technology platform, and its use for the
treatment of prostate cancer.
- Received approximately $7.6 million of a potential $7.7 million from
the exercise of warrants issued as a result of the two tranches of a
unit private placement financing closed on November 4 and 17, 2005.
- Entered into a collaborative research and clinical development
agreement with BrainLAB AG for use of the BrainLAB proprietary drug
delivery software, iPlan(R) Flow, in the planned Phase 2b primary
brain cancer clinical trial of PRX321.
- Announced the appointment of Dr. Samuel Denmeade, M.D. to the
position of Chief Scientific Officer on October 22, 2007.
For the three months ended September 30, 2007 ("Q3 2007"), the Company
reported a net loss of $1,709,450 or $0.03 per share, compared to $1,351,490
or $0.04 per share for the three months ended September 30, 2006 ("Q3 2006")
and a net loss of $1,817,019 or $0.03 per share for the preceding quarter
ended June 30, 2007 ("Q2 2007"). The net loss for the nine months ended
September 30, 2007 ("Q3 YTD 2007") was $5,133,571 or $0.09 per share compared
to $3,684,687 or $0.10 per share for the nine months ended September 30, 2006
("Q3 YTD 2006"). The $357,960 (26%) and $1,448,884 (39%) increase in net loss
for Q3 2007 and Q3 YTD 2007, respectively, is primarily attributable to
increased research and development costs from expanded drug development and
Research and development costs of $1,045,269 were incurred during Q3 2007
compared to $851,924 for the Q3 2006 comparative period and $1,098,890 during
the preceding quarter, Q2 2007. Research and development costs for the Q3 YTD
2007 period totaled $3,185,453 representing a $1,136,927 (55%) increase from
$2,048,526 incurred during the Q3 YTD 2006 comparative period. Similar to Q3
2007, the Q3 YTD 2007 comparative cost increase reflects the expanded scope of
Protox's drug development and clinical trial activities. Q3 YTD 2007 R&D costs
reflect three full quarters of PRX302 Phase 1 prostate cancer clinical trial
costs versus one and a half quarters for Q3 YTD 2006 as the study was
initiated in mid Q2 2006. In addition, incremental costs have been incurred
during Q3 YTD 2007 leading up to the initiation near the end of Q1 2007 of the
Company's PRX302 Phase 1 BPH clinical and for PRX321 CMC activities in advance
of an anticipated H1 2008 PRX321 Phase 2b study for primary brain cancer.
Direct costs for the prostate cancer and BPH Phase 1 clinical studies and
PRX321 Phase 2b preparatory activities totaled approximately $1,876,000 during
Q3 YTD 2007 compared to approximately $1,199,000 for Q3 YTD 2006, contributing
$677,000 (60%) to the overall increase in R&D costs.
General and administration costs of $427,477 were incurred during Q3 2007
representing a 4% increase compared to $409,656 incurred for the Q3 2006
comparative period. On a Q3 YTD basis, total general and administration costs
of $1,384,939 for the current fiscal year closely approximated the costs of
$1,386,559 incurred during the Q3 YTD 2006 comparative period.
During Q3 2007 and Q3 YTD 2007, the Company earned interest income of
$63,692 and $252,725, respectively, compared to $32,991 and $102,525 for the
corresponding 2006 comparative periods. The increase in interest income is the
result of higher interest rates earned on higher average amounts held in
interest bearing accounts or investments during the periods.
During Q3 2007 and Q3 YTD 2007, the Company recorded cumulative foreign
exchange losses of $125,540 and $316,394, respectively, compared to $8,363 and
$41,921 for the corresponding 2006 comparative periods. During Q3 2007, the
U.S. dollar declined approximately 7% against the Canadian dollar contributing
toward the overall year-to-date decline of approximately 15% as of
September 30, 2007.
As at September 30, 2007, the Company had cash and cash equivalents of
$6.4 million compared to $7.9 and $10.0 million as at June 30, 2007 and
December 31, 2006, respectively. The Company had working capital of
$5.9 million at September 30, 2007, compared to $6.5 million at the end of the
preceding quarter and $8.9 million at December 31, 2006. Excluding warrant and
option exercise proceeds of $0.9 million received, the Company consumed cash
of $2.4 million during Q3 2007 to finance continuing operations compared to
$1.5 million for Q3 2006. Following the exercise of approximately $7.6 million
of a potential $7.7 million worth of warrants issued as a result of the two
tranches of a unit private placement financing closed on November 4 and 17,
2005, the Company's current cash position is approximately $12.0 million.
As at November 23, 2007, the Company had approximately 68.5 million
common shares issued and outstanding. In addition, the Company had 4.9 million
options to purchase common shares of the Company outstanding, of which
approximately 2.5 million were exercisable into an equivalent number of common
shares of the Company at exercise prices ranging from $0.10 to $1.00 and an
average exercise price of $0.71.
For complete financial statements please go to www.sedar.com.
Protox Therapeutics is a leader in advancing targeted toxin therapeutics
for the treatment of cancer and other proliferative diseases. Two novel drug
candidates derived from the company's INxin(TM) and PORxin(TM) platforms are
being developed in three clinical programs. A Phase 2a clinical trial
evaluating 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. Phase 1 clinical trials evaluating PRX302 (PORxin)
have been completed for the treatment of localized prostate cancer and benign
prostatic hyperplasia (enlarged prostate).
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; Michael
Moore, Investor Relations, Equicom Group, (416) 815-0700 x 241,