Protox reports 2009 third quarter results

VANCOUVER , Nov. 16 /CNW/ - Protox Therapeutics Inc. (TSX: PRX), a leader in the development of receptor targeted fusion proteins, today announced financial results for the third quarter, ended September 30, 2009 .

"During the third quarter we were very pleased to report impressive results from our open-label Phase 2 study of PRX302 for the treatment of moderate to severe benign prostatic hyperplasia, and to announce completion of enrollment in our Phase 2b TRIUMPH trial of PRX302," said Dr. Fahar Merchant , President and CEO of Protox. "In our open label study, patients who received an optimal dose of PRX302 demonstrated a twelve point improvement in the International Prostate Symptom Score (IPSS) after one year following a single treatment, almost double that seen with oral therapies and comparable to many surgical procedures. These very encouraging data have only increased our anticipation for the top-line results from our TRIUMPH study, which are expected within the next 2 months."

Third Quarter 2009 Highlights:

    
    -   Completed patient enrollment in the TRIUMPH Phase 2b study, a
        multi-centre, double-blinded, placebo controlled trial evaluating
        PRX302 in 92 males with moderate to severe benign prostatic
        hyperplasia (BPH). Top line results from the study are anticipated in
        December 2009 or early January 2010.
    -   Announced positive 12 month data from the open-label Phase 2 study of
        PRX302, indicating that males with moderate to severe BPH who
        received an optimal dose of PRX302 continued to demonstrate
        significant symptomatic relief at 12 months following a single
        treatment. No safety issues were identified in this study and no
        sexual dysfunction has been reported in any of the subjects dosed to
        date. Detailed data from this study were presented at the 30th World
        Congress of the Société Internationale d'Urologie Conference on
        November 2nd, 2009.
    

FINANCIAL RESULTS

During the third quarter of 2009 and first nine months of 2009, the Company earned interest income of $3,000 and $46,000 respectively, compared to $91,000 and $229,000 for the corresponding periods in 2008. 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 Q3, 2009 increased over the preceding quarter due to the continuing level of activity in the Company's lead program, PRX302 for the treatment of BPH, with full enrollment of the TRIUMPH study achieved in September 2009 .

For the three months ended September 30, 2009 , the Company reported a net and comprehensive loss of $2.2 million or ( $0.03 ) per share compared with $2.5 million or ( $0.03 ) per share for the three months ended September 30, 2008 . The net loss for the nine months ended September 30, 2009 totaled $6.3 million or ( $0.08 ) per share compared with $6.4 million or ( $0.09 ) per share for the nine months ended September 30, 2008 . The modest decrease in net loss over the comparative period in 2008 was primarily driven by a decrease in research and development costs as the effect of clinical program consolidation takes effect, as well as the impact of efforts to reduce costs across all areas of the Company, including general and administration. This was offset by an increase in stock based compensation during the quarter which resulted from the issuance of 2,155,000 options within Q3, 2009 - the first issuance in 2009.

Research and development ("R&D") costs for Q3, 2009 were $1.5 million compared to $2.0 million for the Q3, 2008. R&D costs for the nine months ended September 30, 2009 were $4.4 million compared to $4.6 million for the nine months ended September 30, 2008 . The decreases for the periods reflect the effect of the consolidation of the research and development programs to focus on the lead BPH program.

Direct costs incurred in Q3, 2009 for the PRX302 clinical programs for the treatment of BPH and prostate cancer as well as activities associated with maintaining the PRX321 program totaled $1.2 million compared with $1.3 million for Q3, 2008. The costs incurred in Q3-08 were spread evenly across our PRX321 and PRX 302 programs, whereas in Q3-2009 over 90% was focused on PRX302, specificly our BPH program. In addition, our efforts to concentrate our resources on our lead program resulted in a decrease in internal costs of $100,000 from Q3-08.

General and administrative ("G&A") costs for Q3, 2009 were $469,000 compared to $480,000 for Q3, 2008. G&A costs for the nine months ended September 30, 2009 were $1.6 million compared with $1.6 million incurred during the nine months ended September 30, 2008 . 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 expenses incurred in Q3, 2009 reflect the reduced costs from the efforts implemented in Q1, 2009 to consolidate and focus operations on the lead clinical BPH program.

At September 30, 2009 , the Company had cash and cash equivalents of $4.1 million , representing a net decrease of $2.6 million from December 31, 2008 . The Company had working capital of $2.4 million at September 30, 2009 , a decrease of $3.8 million from December 31, 2008 . Management believes that current cash resources should enable the Company to execute its core business plan/priority initiatives and meet its projected cash requirements into Q2, 2010.

As at November 13, 2009 the Company has 84,448,048 common shares issued and outstanding. In addition, Protox has 6,397,500 options outstanding to purchase common shares of the Company. Of the options currently outstanding, approximately 3.8 million are exercisable into an equivalent number of common shares of the Company at exercise prices ranging from $0.50 to $1.00 and with an average exercise price of $0.71 . The Company also has 503,653 warrants outstanding which expire on May 20, 2011 entitling warrant holders to purchase common shares at a price of $0.27 and has 584,413 warrants which expire on May 23, 2010 entitling the holder to purchase common shares at an exercise price of $0.71 .

For complete financial results, please see the Company's 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 called TRIUMPH, to treat benign prostatic hyperplasia (BPH or enlarged prostate). Positive Phase 2a results at three months treating BPH patients were released at the end of 2008 and extended data demonstrated durability and efficacy at 12 months. PRX302 is also being evaluated for the treatment of localized prostate cancer. 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, [phone], [email protected]; Michael Moore, Vice President, Investor Relations, Equicom Group, [phone] x 241, [email protected]