VANCOUVER, Aug. 30 /CNW/ - Protox Therapeutics Inc. (TSX-V: PRX) today
reported financial results and operating highlights for the second quarter
ended June 30, 2007.
"The second quarter marked significant advances across all of our
development programs," said Dr. Fahar Merchant, President and CEO of Protox.
"Prominently amongst these accomplishments was the completion of the Phase 1
prostate cancer clinical trial with PRX302 which culminated with the
announcement of promising top-line safety data and encouraging evidence of
therapeutic activity. These data provide us with confidence as we also pursue
the development of PRX302 in patients who suffer from the devastating symptoms
associated with BPH (enlarged prostate). This Phase 1 study is now well
underway and we plan to complete enrollment ahead of schedule. Both BPH and
prostate cancer affect tens of millions of men worldwide and we hope that our
efforts in the commercialization of PRX302 will play a key role in effectively
treating these conditions. Finally, we continue in our efforts to progress the
pre-pivotal Phase 2b trial of PRX321 in patients with late stage brain cancer.
To that end, we have entered into a manufacturing agreement with Dompé in
order to secure a reliable GMP compliant source of PRX321 for global clinical
and commercial supply.
- Enrolled and successfully dosed the first patient in a Phase I
clinical study evaluating PRX302 to treat benign prostatic
- Completed recruitment of patients for Phase 1 clinical study of
PRX302 to treat localized, recurrent prostate 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.
- Announced agreement with Dompé pha.r.ma S.p.A. (Dompé) for the
clinical manufacturing and commercial supply of PRX321.
For the three months ended June 30, 2007 ("Q2 2007"), the Company
reported a net loss of $1,817,019 or $0.03 per share compared to $1,478,373 or
$0.04 per share for the three months ended June 30, 2006 ("Q2 2006") and a net
loss of $1,607,102 or $0.03 per share for the preceding quarter or three
months ended March 31, 2007 ("Q1 2007"). The net loss for the six months ended
June 30, 2007 ("Q2 YTD 2007") was $3,424,121 or $0.06 per share compared to
$2,333,197 or $0.06 per share for the six months ended June 30, 2006 ("Q2 YTD
2006"). The $338,646 (23%) and $1,090,924 (47%) increase in net loss for Q2
2007 and Q2 YTD 2007, respectively, is primarily attributable to increased
research and development costs.
Research and development costs of $1,098,890 were incurred during Q2 2007
compared to $774,625 for the Q2 2006 comparative period and $998,948 during
the preceding quarter Q1 2007. Research and development costs for the Q2 YTD
2007 period totaled $2,140,184 representing a $943,582 (79%) increase from
$1,196,602 incurred during the Q2 YTD 2006 comparative period. The $325,320
(42%) research and development cost increase from Q2 2006 to Q2 2007 reflects
a broader scope of development and clinical activities during the later
period. The $99,942 (10%) increase in research and development costs from Q1
2007 to Q2 2007 is largely attributable to incremental costs for CMC
activities associated with the PRX321 drug product. Similar to Q2 2007, the Q2
YTD 2007 comparative cost increase reflects the expanded scope of Protox's
drug development and clinical trial activities. Q1 2006 was a period of
transition from a preclinical to clinical focus ahead of commencing clinical
General and administration costs of $466,886 were incurred during Q2 2007
compared to $530,061 for the Q2 2006 comparative period and $490,577 during
the most recently completed quarter Q1 2007. General and administration costs
for the Q2 YTD 2007 period totaled $957,462 and declined 2% ($19,441) from
$976,903 for the Q2 YTD 2006 comparative period.
During Q2 2007 and Q2 YTD 2007, the Company earned interest income of
$95,995 and $189,034, respectively, compared to $35,750 and $69,534 for the
respective 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 Q2 2007 and Q2 YTD 2007, the Company recorded cumulative foreign
exchange losses of $173,586 and $190,855, respectively, compared to $60,380
and $33,558 for the respective 2006 comparative periods. The majority of the
foreign exchange losses recorded during 2007 represents unrealized losses in
Q2 2007 on the Company's U.S. dollar reserves due to a near 10% decline in the
value of the U.S dollar.
As at June 30, 2007, the Company had cash and cash equivalents of $7.9
million compared to $9.5 and $10.0 million as at March 31, 2007 and December
31, 2006, respectively. The Company had working capital of $6.5 million at
June 30, 2007, compared to $8.0 and $8.9 million at March 31, 2007 and
December 31, 2006, respectively. During Q2 YTD 2007, a total of $0.7 million
of proceeds were received from the exercise of warrants and additional
proceeds of approximately $0.65 million have been received since the end of Q2
As at August 15, 2007 there were a total of 58,391,413 common shares
(84,286,430 on a fully diluted basis) and no preferred shares outstanding.
For complete financial statements please go to www.sedar.com.
Protox Therapeutics is a leader in advancing novel, targeted protein
toxin therapeutics for the treatment of cancer and other proliferative
diseases. The company is actively developing two distinct but complementary
platforms, INxin(TM) and PORxin(TM), and currently has four clinical programs
in development. A Phase 2a 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 enrollment has
been completed for a Phase I clinical trial into the use of PRX302 (PORxin)
for the treatment of localized prostate cancer. A Phase I clinical study of
PRX302 for the treatment of 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's
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, email@example.com; Michael
Moore, Investor Relations, Equicom Group, (416) 815-0700 x 241,