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Attention Business/Financial Editors
Protox Reports 2008 First Quarter Results
VANCOUVER, May 13 /CNW/ - Protox Therapeutics Inc. (TSX: PRX), a leader
in the development of receptor targeted fusion proteins, today released first
quarter 2008 financial results for the 3 months ended March 31, 2008 (2008
Q1).
"Protox made substantial progress during the first quarter highlighted by
the release of positive clinical results from our BPH clinical program, the
initiation of a Phase 2a study in men with localized recurrent prostate cancer
and graduating to the Toronto Stock Exchange," said Dr. Fahar Merchant,
President and CEO of Protox. "We are excited about the coming months as we
advance as many as three Phase 2 clinical trials and progress towards several
key milestones."
2008 Q1 HIGHLIGHTS
<<
- Announced positive final results from its PRX302 Phase 1 benign
prostatic hyperplasia (BPH) clinical trial.
- Commencement of a multi-center U.S. Phase 2a clinical trial of PRX302
as a treatment for localized, recurrent prostate cancer.
- Commenced trading the Company's common shares on the Toronto Stock
Exchange (TSX) on February 4, 2008 following graduation from the TSX
Venture Exchange.
- Presented final data from the Phase 1 clinical study of PRX302 in
patients with locally recurrent prostate cancer at the American
Society of Clinical Oncology (ASCO) Genitourinary Cancer Symposium.
SUBSEQUENT HIGHLIGHTS
- Received Health Canada and Institutional Review Board (IRB) approvals
to proceed with a multi-center Phase 2 clinical trial of PRX302 for
the treatment of moderate to severe BPH.
- Announced positive follow-up data from the Phase 1 BPH study of
PRX302 showing that long term therapeutic effects continue to be
observed at 6 and 9 months following a single treatment.
- Entered into a Cooperative Research and Development Agreement (CRADA)
with the U.S. Food and Drug Administration (FDA) to further develop
PRX321 and next generation IL-4 receptor targeted fusion proteins.
>>
FINANCIAL RESULTS
Protox has not earned any revenue in any of its previous fiscal years,
other than income from interest earned on its cash balances. During 2008 Q1,
the Company earned interest income of $0.09 million. Interest income earned
during 2008 Q1 approximated the amount earned during 2007 Q1, with average
cash balances and rate of returns being similar for both periods.
For 2008 Q1, Protox reported a net loss of $2.0 million or $0.03 per
share compared to $1.6 million or $0.03 per share for the three months ended
March 31, 2007 comparative period (2007 Q1). The $0.4 million (27%) increase
in net loss for 2008 Q1 is primarily attributable to increased research and
development costs and advancing the Company's product pipeline as further
discussed below.
Research and development (R&D) costs of nearly $1.46 million were
incurred during 2008 Q1 compared to $1.04 million for the 2007 Q1 comparative
period. The $0.42 million (40%) R&D cost increase reflects the expanded scope
and advancement of Protox's drug development and clinical activities on a
comparative basis. Incremental costs were incurred during 2008 Q1 for CMC
(chemistry, manufacturing and control), clinical and regulatory preparatory
activities in advance of the anticipated initiation of the Company's PRX321
Phase 2b (pre-pivotal) study for primary brain cancer in 2008 H2.
Direct costs for the PRX302 prostate cancer and BPH clinical programs and
PRX321 Phase 2b (pre-pivotal) study preparatory and CMC activities totaled
approximately $0.7 million during 2008 Q1 compared to approximately
$0.5 million for 2007 Q1, contributing $0.2 million (40%) to the overall
increase in R&D costs for the quarter. A milestone payment relating to the
PRX302 prostate cancer program was also a contributing factor to the increase
in 2008 Q1 R&D costs. Discovery research costs for 2008 Q1 were $0.17 million
compared to $0.1 million for 2007 Q1, reflecting incremental costs associated
with additional CRADA activity and the operation of Company's research lab.
General and administrative (G&A) costs of $0.54 million were incurred
during 2008 Q1 representing a 10% increase compared to $0.49 million incurred
for the 2007 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 2008 Q1 G&A costs
increase is commensurate with the growth of Protox and its operations and also
reflects an increase in business development personnel and activities.
As at March 31, 2008, Protox had cash and cash equivalents of
$9.3 million compared to $11.4 million as at December 31, 2007. The Company
had working capital of $8.1 million at March 31, 2008, compared to
$9.9 million at December 31, 2007. On May 5, 2008, Protox announced it had
retained an agent to raise gross proceeds of up to $3.0 million pursuant to a
brokered private placement of its common shares at $0.70 per share, with an
over-allotment option to raise up to an additional $3.0 million for maximum
proceeds of $6.0 million. The brokered private placement is subject to
applicable regulatory and TSX approvals. Protox intends to use the net
proceeds principally to finance and accelerate its clinical activities.
As at May 13, 2008, the Company has 68,534,433 common shares issued and
outstanding. In addition, the Company has 5,571,035 options outstanding to
purchase common shares of Protox, including 520,000 options granted to certain
officers and employees in February 2008 to purchase common shares at an
exercise price of $0.87. Of the options outstanding, approximately 3.3 million
are exercisable into an equivalent number of common shares of the Company at
exercise prices ranging from $0.10 to $1.00 and with an average exercise price
of $0.72. Protox also has 10,938,882 warrants outstanding entitling the
warrant holder to purchase common shares with an exercise price of $0.65 per
common share and an expiry date of either November 29, 2008 or December 22,
2008 representing potential proceeds of up to $7.1 million.
For complete financial results, please see our filings at www.sedar.com.
About Protox
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. 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 2a
clinical trials evaluating PRX302 (PORxin) for the treatment of localized
prostate cancer and benign prostatic hyperplasia (enlarged prostate) have also
been initiated. 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.
-30-
/For further information: James Beesley, Director, Investor Relations,
Protox Therapeutics, (604) 484-0975, jbeesley@protoxtherapeutics.com; Michael
Moore, Investor Relations, Equicom Group, (416) 815-0700 x 241,
mmoore@equicomgroup.com/
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