Protox reports 2009 financial results and achievements

VANCOUVER, March 31 /CNW/ - Protox Therapeutics Inc. (TSX: PRX), a leader in the development of receptor targeted fusion proteins, today released financial results for the year ended December 31, 2009.

"The past year has been witness to some significant advancements at Protox. Most notably, we met the primary endpoint in our Phase 2b double-blinded placebo controlled clinical trial with PRX302 in patients with moderate to severe symptoms associated with BPH. We further demonstrated, from our open label Phase 2a BPH trial, that a single treatment with PRX302 has the potential to provide durable symptomatic improvements that last at least a year. Taken together, these data demonstrate that PRX302 has the potential of improving the lives of millions of men that suffer from BPH without the side effects and morbidity associated with current treatments," said Dr Fahar Merchant, President and CEO of Protox. In addition to the progress that we have made with PRX302 and the BPH program, we have further strengthened our pipeline by extracting full value from our research collaborations and expanding our patent portfolio. Our dedication to the development of PRX302 for BPH and other diseases of the prostate will remain our focus in the year ahead as we build and position PRX302 for a meaningful commercial partnership."

Operational and Financial Highlights

    
    -   In December 2009, the Company completed its multi-centre, double-
        blinded placebo controlled Phase 2b study of PRX302 (study name:
        TRIUMPH) in patients with moderate to severe benign prostatic
        hyperplasia. Positive top-line results from the study were released
        on January 11, 2010 indicated that the TRIUMPH study achieved its
        primary clinical endpoint of a statistically significant improvement
        in International Prostate Symptom Score for patients treated with
        PRX302 versus subjects receiving placebo.

    -   The Company announced positive 12 month data from our open-label
        Phase 2 study of PRX302 in males with moderate to severe benign
        prostatic hyperplasia. The study results indicated that those
        patients who received an optimal dose of PRX302 continued to
        demonstrate significant symptomatic relief at 12 months following a
        single treatment. The results from this study demonstrate the durable
        impact that this novel therapeutic has on potentially improving the
        quality of life of patients suffering with BPH.

    -   Data from the Phase 2 clinical study of PRX302 in patients with
        moderate to severe benign prostatic hyperplasia was presented at the
        2009 Annual Meeting of the American Urological Association, the
        world's largest gathering of urology professionals.

    -   In May 2009, the Company closed a brokered private placement raising
        net proceeds of $2.0 million from the issuance of 8,554,004 common
        shares. Proceeds included approximately $800,000 from the exercise of
        an over-allotment option by the agent.

    -   On March 16, 2010, the Company closed a brokered private placement
        raising net proceeds of $4.8 million from the issuance of 11,285,388
        units at a price of $0.45 per unit. Each Unit is comprised of one
        common share of Protox and one-half of a common share purchase
        warrant. Each whole warrant entitles the holder to purchase one
        common share of Protox at a price of $0.65 for a five year period
        from closing date subject to an acceleration of the expiry date in
        certain circumstances.

    -   An allowance was obtained in Japan by the Japan Patent Office for the
        Company's composition patent of PRX302 and its use in prostate
        cancer. In addition, an allowance in China was obtained for the
        Company's patent covering composition of PRX302 and its use in
        prostate cancer.

    -   The Company and/or its collaborators published or presented 10 papers
        in various peer reviewed journals and international conferences based
        on the Company's PORxin, INxin and HUMxin platforms.

    -   Dr. Alex Giaquinto was appointed to the Board of Directors in June
        2009. 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.

    -   The Company appointed Mr. John Parkinson as Chief Financial Officer
        in March 2009. Previously he was Vice President, Finance at Aspreva
        Pharmaceuticals and prior to that he worked with KPMG for 10 years.
    

Selected Annual Information

    
    -------------------------------------------------------------------------
    Years ended December 31:                  2009         2008         2007
    -------------------------------------------------------------------------
    Net loss (in thousands)             $ (7,944.5)  $ (8,919.1)  $ (7,446.1)
    -------------------------------------------------------------------------
    Loss per share                           (0.10)       (0.12)       (0.13)
    -------------------------------------------------------------------------
    Total assets (in thousands)            2,778.1      8,458.1     12,913.7
    -------------------------------------------------------------------------
    

The net and comprehensive loss reported for the year ended December 31, 2009 ("2009-FY") totaled $7.9 million or $0.10 per share compared to $8.9 million or $0.12 per share for the year ended December 31, 2008 ("2008-FY").

Total expenses for 2009-FY decreased by $1.0 million over the preceding year primarily due to the Company's efforts to focus its resources on the lead program, PRX302 for the treatment of BPH. Activities in the Company's other programs, including its INxin and HUMxin platforms, have been deferred until grant or other sources of financing has been secured. Efforts to reduce costs across all areas of the Company, including general and administration, also were successful in reducing the net loss compared to the prior year.

Research and development ("R&D") costs for the 2009-FY period totaled $5.5 million representing a $681,000 (11%) decrease from $6.2 million incurred during the 2008-FY comparative period, reflecting the effects of the consolidation of our research and development programs to focus on the lead BPH program.

Clinical and regulatory costs incurred in 2009 for our PRX302 clinical programs for the treatment of BPH and prostate cancer as well as basic maintenance activities associated with our reduced PRX321 program totaled $4.8 million compared to $4.9 million for 2008. The decrease is driven by the significant drop in our non-BPH programs from the previous year with the narrowing of the Company's focus to the core BPH program, offset by the high costs of the TRIUMPH study which was initiated and completed during 2009.

Research and development costs are expected to decrease in 2010 as our overall clinical activity will decline as we concentrate our effort on regulatory activities associated with preparing our BPH program for a phase 3 program and to be partner-ready.

2009-FY general and administrative ("G&A") costs of $2.1 million decreased $186,000 (8%) from the $2.3 million incurred during 2008-FY. General and administrative 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 general and administrative costs incurred in 2009 reflect the shift in efforts implemented in the first quarter of 2009 to consolidate and focus operations on our lead clinical BPH program and the Company's efforts to stabilize and reduce overhead costs in the future. This reduction in G&A costs will provide the Company with more resources to focus on the completion of its clinical programs. General and administrative costs are expected to continue to decline in 2010.

Summary of Quarterly Results

Summary of quarterly results for the eight quarters to December 31, 2009 (unaudited, in thousands, except per share data):

    
    -------------------------------------------------------------------------
                           December 31  September 30    June 30     March 31
    Three months ended:        2009         2009          2009        2009
    -------------------------------------------------------------------------
    Interest income        $        1   $        3   $       10   $       32
    Total expenses              1,719        2,211        1,814        2,296
    Net loss                   (1,717)      (2,150)      (1,812)      (2,263)

    Loss per share              (0.02)       (0.03)       (0.02)       (0.03)
    -------------------------------------------------------------------------
                           December 31  September 30    June 30     March 31
    Three months ended:        2008         2008          2008        2008
    -------------------------------------------------------------------------
    Interest income        $       63   $       90   $       50   $      87
    Total expenses              2,555        2,587        1,936       2,132
    Net loss                   (2,491)      (2,496)      (1,886)     (2,044)

    Loss per share              (0.03)       (0.03)       (0.03)      (0.03)
    -------------------------------------------------------------------------
    

The Company reported a net and comprehensive loss of $1.7 million or $0.02 per share in the three months ended December 31, 2009 ("2009-Q4") compared to $2.5 million or $0.03 per share for the three months ended December 31, 2008 ("2008-Q4") - a drop of $774,000 and a drop of $433,000 over the previous quarter. The reduction from the comparative qyuarter in 2008 is a result of the Company's focus on the core BPH program as well as non-recurring clinical drug supply costs incurred in 2008-Q4 with respect to the then planned PRX321 study of GBM.

Research and development costs for the quarter ended December 31, 2009 dropped from 2008-Q4 by $447,000 to $1.2 million reflecting the maturing effects of the consolidation of our research and development programs to focus on the lead BPH program. We exited the quarter with one active clinical program, BPH TRIUMPH study, compared to three active programs in the last quarter of 2008.

General and administrative costs were $206,000 lower in 2009-Q4 as compared to 2008-Q4 as the cost reduction programs introduced early in 2009 matured.

As at March 31, 2010, the Company has 96,037,698 common shares issued and outstanding. In addition, the Company has 6,647,500 options outstanding to purchase common shares of the Company. Of the options currently outstanding, approximately 3.9 million are exercisable into an equivalent number of common shares of the Company at exercise prices ranging from $0.50 to $1.00

The Company also has 7,151,073 common share purchase warrants outstanding which expire between May 2010 and March 2015 and entitle warrant holders to purchase common shares at a prices ranging between $0.27 and $0.71. The weighted average warrant price is $0.60 and the weighted average remaining term is 4.1 years. Furthermore, 6,367,269 of these common share purchase warrants are subject to an acceleration of the expiry date if the closing price of the underlying Common Shares is higher than $1.75 per common share for a period of 10 consecutive trading days.

For complete financial results, please see our filings at www.sedar.com.

About Protox Therapeutics

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), has announced positive results from its Phase 2b placebo controlled trial called TRIUMPH, to treat benign prostatic hyperplasia (BPH or enlarged prostate). In addition to these positive results, data from the Phase 2a study demonstrated durability 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.

SOURCE Sophiris Bio, Inc.

For further information: 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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Sophiris Bio, Inc.

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