Protox reports 2009 second quarter results

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 the presentation of our Phase 2 BPH data at both the American and Canadian Urological Association conferences," said Dr. Fahar Merchant, President and CEO of Protox. "With several data driven catalysts and milestones on the near-term horizon, including 12 month results from our Phase 2 open-label BPH study followed by TRIUMPH Phase 2b BPH data before the years end, we are very excited about unlocking the value in PRX302." 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 Association (CUA). - 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. FINANCIAL RESULTS 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 the market. 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 climate. 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 clinical program. 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 studies. 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 ]. 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. 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: James Beesley, Senior 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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Protox reports 2009 second quarter results