Protox reports first quarter 2010 financial results

VANCOUVER, May 13 /CNW/ - Protox Therapeutics Inc. (TSX: PRX), a leader in the development of receptor targeted fusion proteins, today released financial results for the first quarter 2010, ended March 31, 2010.

"The first quarter of 2010 marked significant achievements for the company, namely the announcement of positive top-line results from the TRIUMPH study and the subsequent completion of a five million dollar financing," said Dr. Fahar Merchant, President and CEO of Protox. "In April we announced a strong regional partnership with Kissei Pharmaceutical Co. in Japan for the PRX302 prostate programs. This transaction provides the company with non-dilutive cash and represents strong technology validation for PRX302 given Kissei's established leadership in the Japanese urology market."

    
    Q1 2010 Highlights

       -  Announced positive top-line results from the TRIUMPH study showing
          that it had achieved its primary clinical endpoint of a
          statistically significant improvement in International Prostate
          Symptom Score (IPSS) for subjects treated with PRX302 versus
          subjects receiving placebo.
       -  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.

    Highlights Subsequent to Quarters End

       -  On April 29, 2010, the Company announced that it had entered into a
          US $75 million license agreement with Kissei Pharmaceutical Co.,
          Ltd. for the development and commercialization of PRX302 in Japan
          for BPH, prostate cancer and other diseases of the prostate.


    FINANCIAL RESULTS
    -------------------------------------------------------------------------
    Three months ended:   Mar 31 2010  Dec 31 2009  Sep 30 2009  Jun 30 2009
    -------------------------------------------------------------------------
    Interest income              $0.5        $ 1.3        $ 3.3       $ 10.4
    Total expenses            1,638.0      1,719.3      2,191.7      1,814.7
    Net loss                 (1,637.5)    (1,717.9)    (2,189.9)    (1,812.2)

    Loss per share              (0.02)       (0.02)       (0.03)       (0.02)
    -------------------------------------------------------------------------
    Three months ended:   Mar 31 2009  Dec 31 2008  Sep 30 2008  Jun 30 2008
    -------------------------------------------------------------------------
    Interest income            $ 32.5       $ 63.9       $ 90.8       $ 50.0
    Total expenses            2,296.0      2,555.6      2,587.0      1,936.9
    Net loss                 (2,263.5)    (2,491.7)    (2,496.1)    (1,886.7)
    Loss per share              (0.03)       (0.03)       (0.03)       (0.03)
    -------------------------------------------------------------------------
    

The Company has not earned any revenue in any of its previous fiscal years, other than income from interest earned on the Company's investment balances.

Expenses, in particular R&D costs, are influenced by a number of factors including the scope of clinical development and research programs pursued; the type and size of clinical trials undertaken; the number of clinical trials that are active during a particular period of time; the rate of patient enrollment; and are ultimately a function of decisions made to continue the development and testing of a product candidate based on supporting safety and efficacy from clinical trial results. Consequently, expenses vary from period to period. G&A expenses will be dependent on the personnel and infrastructure required to support the corporate, clinical and business development objectives and initiatives of the Company.

Total expenses for the three months ended March 31, 2010 ("2010-Q1") decreased over the comparative quarter in 2009 as the Company had significantly reduced clinical activity in 2010-Q1 compared to the comparative quarter as the double-blinded placebo controlled TRIUMPH study had completed enrolment and there were no other on-going clinical trials enrolling subjects during this period.

The Company reported a net and comprehensive loss of $1.6 million or $0.02 per share in 2010-Q1 compared to $2.3 million or $0.03 per share for the three months ended March 31, 2009 ("2009-Q1"). The decrease of $0.6 million in net loss over the comparative period in 2009 was primarily driven by the decrease in research and development activity due primarily to the completion of enrolment in the TRIUMPH study, as well as the impact of our efforts to reduce costs across all areas of the Company, including general and administration. This was partially offset by an increase in stock based compensation during 2010-Q1 which resulted from the issuance of 2,405,000 options in the latter half of 2009.

Research and development ("R&D") costs of $1.0 million were incurred during 2010-Q1: a decrease of $606,000 (38%) from $1.6 million incurred in the 2009-Q1 comparative period. The decrease for the period reflects the effect of the consolidation of our research and development programs to focus on our lead BPH program and the completion of enrolment in the double-blinded placebo controlled TRIUMPH study.

Direct costs incurred in 2010-Q1 for our PRX302 clinical programs for the treatment of BPH and prostate cancer as well as activities associated with maintaining our PRX321 program totaled $748,000 compared to $1.4 million for 2009-Q1.

2010-Q1 general and administrative costs of $567,000 decreased slightly from $619,000 in the 2009-Q1 comparative period. 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 2010-Q1 were reduced as a result of the measures implemented through 2009 to consolidate and focus available resources on our lead clinical BPH program, TRIUMPH, offset by the higher level of activities in 2010-Q1 relating to the successful pursuit of additional financing and our first licensing agreement.

At March 31, 2010, the Company had cash and cash equivalents of $5.2 million, representing a net increase of $3.4 million from December 31, 2009. The Company had working capital of $4.2 million at March 31, 2010, an increase of $3.4 million from December 31, 2009.

As at May 13, the Company has 96, 301,477 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 and with an average exercise price of $0.69.

The Company also has 6,919,015 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. 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), achieved its primary clinical endpoint 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 EMA. 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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