VANCOUVER, Aug. 14 /CNW/ - Protox Therapeutics Inc. (TSX: PRX), a leader
in the development of receptor targeted fusion proteins, today announced
second quarter 2009 financial results for the six months ended June 30, 2009.
"Protox made substantial progress during the second quarter highlighted
by the addition of Dr. Giaquinto to our board of directors, completion of a
private placement financing and continued enrollment in the double blinded,
placebo controlled BPH study (TRIUMPH)," said Dr. Fahar Merchant, President
and CEO of Protox. "We are excited and look forward to the potential of
unlocking substantial value in the PRX302 BPH program as we announce key data
driven catalysts and milestones in the next two quarters particularly the 12
month Phase 2 open-label BPH results followed by the TRIUMPH Phase 2b BPH
2009 Q2 Highlights
- Announced brokered private placement raising net proceeds of
$2.0 million from the issuance of 8,554,004 common shares. Gross
proceeds included approximately $800,000 from the exercise of an
over-allotment option by the agent.
- Presented data from the Phase 2 clinical study of PRX302 in patients
with moderate to severe benign prostatic hyperplasia (BPH) at the
2009 Annual Meeting of the American Urological Association (AUA).
- Additional data from the Phase 2 clinical study of PRX302 in patients
with moderate to severe benign prostatic hyperplasia (BPH) was
presented at the 2009 Annual Meeting of the Canadian Urological
- Obtained an allowance by the Japan Patent Office for a patent
covering composition of PRX302 and its use in prostate cancer.
- Appointed Dr. Alex Giaquinto to the Board of Directors. Dr. Giaquinto
is a 35 year veteran of the pharmaceutical industry during which time
he held a number of senior regulatory affairs positions with
Schering-Plough and was instrumental in numerous new drug
applications and other regulatory filings with the FDA.
During 2009 Q2 and 2009 YTD, the Company earned interest income of
$10,000 and $42,000 respectively, compared to $50,000 and $138,000 for the
corresponding 2008 comparative periods. Interest income earned during a
particular period or between periods is a function of investment products,
interest rate and/or investment yields available when funds become available
for reinvestment as well as average cash balances invested. Consequently,
interest income and investment returns have declined as a result of lower
balances available to earn investment income, and lower returns available in
Total expenses in 2009 Q2 were lower than the preceding two quarters due
to the Company's efforts to focus its resources on the development of its lead
program, PRX302 for the treatment of BPH, in response to the current economic
For the three months ended June 30, 2009, the Company reported a net and
comprehensive loss of $1.8 million or $0.02 per share compared to $1.9 million
or $0.03 per share for the three months ended June 30, 2008 comparative period
("2008 Q1"). The net loss for the six months ended June 30, 2009 ("2009 YTD")
totaled $4.1 million or $0.05 per share compared to $3.9 million or $0.06 per
share for the six months ended June 30, 2008. The modest increase in net loss
over the comparative periods in 2008 is primarily driven by the initiation of
our TRIUMPH study in the first quarter of 2009 which increased our research
and development costs. This increase was partially offset by reduced
infrastructure costs as we consolidate and focus operations on our lead
Research and development ("R&D") costs of nearly $1.3 million were
incurred during 2009 Q2 - an increase of $77,000 (6%) over the $1.2 million
incurred for the 2008 Q2 comparative period. The increase for the period
reflects the effect of the continuing maturity of Protox's drug development
and clinical trial activities and increased number of patients enrolled in our
Direct costs incurred in 2009 Q2 for our PRX302 clinical programs for the
treatment of BPH and prostate cancer as well as activities associated with
maintaining our PRX321 program totaled $1.1 million compared to $600,000 for
2008 Q2. This increase is largely driven by the commencement of enrollment of
the TRIUMPH study. 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.
For the six months ended June 30, 2009, R&D costs totaled $2.9 million
representing a $200,000 (9%) increase from $2.6 million incurred during the
comparative 2008 period. The increase reflects the advancement of our clinical
programs, primarily the commencement of enrollment of the TRIUMPH study.
2009 Q2 general and administrative ("G&A") costs of $498,000 decreased by
$121,000 (20%) from $619,000 in the preceding quarter and decreased 9% from
$546,000 incurred during the 2008 Q2 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 higher G&A costs incurred in 2009 Q1 included non-recurring
costs associated with our efforts to consolidate and focus operations on our
lead clinical TRIUMPH program.
G&A costs for the six months ended June 30, 2009 of $1.1 million were
only marginally higher than the $1.1 million incurred during the 2008 YTD
comparative period. The Company anticipates that cost savings efforts
implemented in 2009 will result in lower future G&A costs while the Company
focuses on completion of its lead clinical program in BPH.
At June 30, 2009, the Company had cash and cash equivalents of $5.6
million, representing a net decrease of $1.1 million from December 31, 2008.
The Company had working capital of $4.03 million at June 30, 2009, a decrease
of $1.9 million from December 31, 2008.
As at the date of this report, the Company has 84,448,048 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 3,600,000 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.
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). 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 therapeutics.
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