VANCOUVER, May 15 /CNW/ - Protox Therapeutics Inc. (TSX: PRX), a leader
in the development of receptor targeted fusion proteins, today announced first
quarter 2009 financial results for the three months ended March 31, 2009.
"During the first quarter we made significant progress in advancing our
lead drug, PRX302, for the treatment of moderate to severe BPH," said Dr.
Fahar Merchant, President and CEO of Protox. "Executing the placebo controlled
BPH study, TRIUMPH, in a timely fashion is our primary goal and we expect to
announce top-line results from this study before the end of this year."
2009 Q1 Highlights
- Commenced enrollment of a multi-centre, double-blinded, placebo
controlled Phase 2 study of PRX302 (study name: TRIUMPH) in subjects
with moderate to severe benign prostatic hyperplasia (BPH). Study
results from TRIUMPH are expected in Q4 2009.
- Appointed Mr. John Parkinson as Chief Financial Officer.
- Presentation on March 19, 2009 by Dr. Peter Pommerville at the 2009
Annual Congress of the European Association of Urology in Stockholm,
Sweden, entitled "A PSA-activated protoxin (PRX302) administered
transperineally to men with symptomatic benign hyperplasia is well
tolerated and exhibits signs of activity".
- Allowance in China of a patent covering composition of PRX302 and its
use in prostate cancer.
- Presented data from the Phase 2 clinical study of PRX302 in patients
with moderate to severe BPH at the 2009 Annual Meeting of the
American Urological Association (AUA), the world's largest gathering
of urology professionals which took place April 25 - 30 in Chicago,
- Allowance in Japan by the Japan Patent Office of a patent covering
composition of PRX302 and its use in prostate cancer.
- Announced intention to raise gross proceeds of up to CDN $1.5 million
through a private placement of common shares with an over-allotment
option to sell additional common shares of the Company for proceeds
of up to another CDN $1.0 million.
For the three months ended March 31, 2009 ("2009 Q1"), the Company earned
interest income of $32,000 compared to $88,000 for 2008 Q1 comparative period.
Interest income and investment returns have declined as a result of lower
balances and lower returns available in the market.
The Company reported a net and comprehensive loss for 2009 Q1 of $2.3
million or ($0.03) per share compared to $2.0 million or ($0.03) per share for
the three months ended March 31, 2008. The $300,000 (15%) increase in net loss
over 2008 Q1 is primarily driven by an increase in research and development
costs as our programs mature.
Research and development ("R&D") costs of $1.6 million were incurred
during 2009 Q1 - a modest increase of $149,000 (10%) over the $1.5 million
incurred for the 2008 Q1 comparative period. The increase for the period
reflects the effect of the continuing maturity of Protox's drug development
and clinical trial activities. Direct costs for our PRX302 clinical programs
for the treatment of BPH and prostate cancer as well as activities associated
with maintaining our PRX321 program totaled $1.2 million compared to $725,000
for 2008 Q1. This increase of $425,000 (58%) is largely driven by the
commencement of enrollment of our TRIUMPH study, a multi-centre, double
blinded, placebo controlled Phase 2 study of PRX302 in subjects with moderate
to severe BPH. This increase is offset by a reduction in internal costs as the
Company concentrates its resources on its lead program, the PRX302 TRIUMPH
study for the treatment of BPH.
General and administrative ("G&A") costs for 2009 Q1 of $619,000
decreased by $111,000 (18%) from $730,000 in the preceding quarter, however,
increased 15% from $540,000 incurred during the 2008 Q1 comparative period.
G&A costs will generally vary from period to period depending on the specific
business development, market research and shareholder relations initiatives
undertaken and related travel required at such time to support the Company's
corporate objectives. The G&A costs incurred in 2009 Q1 reflect the impact of
non-recurring costs of $120,000 associated with the Company's efforts to
consolidate and focus operations on our lead clinical TRIUMPH program.
At March 31, 2009, the Company had cash and cash equivalents of $5.5
million, representing a net decrease of $1.2 million from December 31, 2008.
The Company had working capital of $4.0 million at March 31, 2009, a decrease
of $2.1 million from December 31, 2008.
As at May 15, 2009, the Company has 75,894,044 common shares issued and
outstanding. In addition, the Company has 4,857,500 options outstanding to
purchase common shares of the Company. Of the options currently outstanding,
approximately 3.6 million are exercisable into an equivalent number of common
shares of the Company at exercise prices ranging from $0.52 to $1.00 and with
an average exercise price of $0.81. The Company also has 584,413 warrants
outstanding entitling warrant holders to purchase common shares at a price of
$0.71 and expiry date of May 23, 2010.
For complete financial results, please see our filings at www.sedar.com.
Protox Therapeutics is a leader in advancing novel, receptor targeted
fusion proteins. Two novel drug candidates derived from the company's
INxin(TM) and PORxin(TM) platforms are being developed in three clinical
programs. Protox's lead program, PRX302 (PORxin), is currently being studied
in a Phase 2b placebo controlled trial to treat benign prostatic hyperplasia
(BPH or enlarged prostate). Final positive Phase 2a results treating BPH
patients were released at the end of 2008 and a phase 2a clinical trial
evaluating PRX302 for the treatment of localized prostate cancer is ongoing. 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 and EMEA. Protox is also
collaborating with the U.S. National Institutes of Health (NIH) on a research
program focused on the discovery of next generation fully human targeted
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, Senior Director, Investor
Relations, Protox Therapeutics, (604) 484-0975,
firstname.lastname@example.org; Michael Moore, Investor Relations, Equicom
Group, (416) 815-0700 x 241, email@example.com