“We are very pleased with our accomplishments over the past year. 2008 marked the release of impressive data from both our Phase 1 and Phase 2 studies of PRX302 for the treatment of moderate to severe benign prostatic hyperplasia (BPH),” said Dr. Fahar Merchant, President and Chief Executive Officer. “This year, completion of our placebo controlled Phase II study for BPH (TRIUMPH) will position us a step closer to validating the PRX302 program with potential partners. Executing and reporting data from the TRIUMPH study before the end of 2009 is therefore our primary goal, and if successful, we may be on the verge of something truly exciting.”
2008 Operational and Financial Highlights
• Reported positive Phase 1 clinical results using PRX302 for the treatment of BPH and subsequently reported additional positive twelve month data from this trial.
• Initiated an open label Phase 2 clinical trial using PRX302 for the treatment of BPH and subsequently announced positive data in the fourth quarter.
• Commenced patient enrolment in the US for a Phase 2a trial using PRX302 for the treatment of localized, recurrent prostate cancer.
• Received Orphan Medicinal Product Designation by EMEA for PRX321 for the treatment of brain cancer. • Graduated from the TSX Venture Exchange to the Toronto Stock Exchange.
• Raised approximately $4.8 million from a private placement financing.
• Appointed pharmaceutical industry veteran Dr. Jack Geltosky to the Board of Directors.
• Subsequent to the end of the year, initiated the double-blinded, placebo controlled Phase 2 TRIUMPH study evaluating PRX302 for the treatment of BPH. Study results are expected before the end of 2009.
The Company has not earned any revenue in any of its previous fiscal years, other than income from interest earned on the Company's cash balances.
The net and comprehensive loss reported for the year ended December 31, 2008 (“2008 FY”) totaled $8.9 million or $0.12 per share compared to $7.4 million or $0.13 per share for the year ended December 31, 2007 (“2007 FY”).
Research and development (“R&D”) costs for the 2008 FY period totaled $6.2 million representing a $1.3 million (27%) increase from $4.9 million incurred during the 2007 FY comparative period. The increase reflects the continuing effect of the expanded scope and advancement of Protox’s drug development and clinical trial activities.
2008 FY general and administrative (“G&A”) costs of $2.3 million increased 14% from $2.0 million for the 2007 FY comparative period reflecting a one-time listing fee of $0.1 million and related costs associated with the Company’s graduation from the TSX Venture Exchange to the Toronto Stock Exchange early in 2008 Q1 and an increase in business development personnel and activities.
For the three months ended December 31, 2008 (“2008 Q4”), the Company incurred a net and comprehensive loss of $2.5 million or $0.03 per share compared to $2.3 million or $0.03 per share for the three months ended December 31, 2007 comparative period (“2007 Q4”). The 8% net increase was largely driven by foreign exchange losses.
R&D costs of $1.6 million incurred during 2008 Q4 declined 6% from $1.7 million for the 2007 Q4. Quarter to quarter R&D costs will routinely vary due to both the variable nature and timing of activities for all active and planned clinical trials at any given time. 2008 Q4 G&A costs of $0.73 million increased 16% from $0.63 million in 2007 Q4. In an effort to bolster potential exercise success of warrants (that were expiring December 2008) amidst unprecedented capital markets turmoil, additional investor relations initiatives were undertaken during the quarter. These activities as well as the cost of senior business development personnel hired during 2008 accounted for the relative increase in G&A costs.
During 2008 Q4, the Company earned interest income of $0.06 million compared to $0.10 million for 2007 Q4. The decline was the combined effect of the decreased available investment grade instrument yields as well as a lower average balance of funds to invest than in 2007. During 2008 Q4, the Company recorded foreign exchange losses of $0.15 million compared to nominal losses for 2007 Q4. The increase is attributable to an approximate 20% decline in the Canadian dollar against the U.S. dollar from 2007 Q4 to 2008 Q4.
As at December 31, 2008, the Company had cash and cash equivalents of $7.3 million, representing a net decrease of $4.1 million from December 31, 2007. The Company had working capital of $6.2 million at December 31, 2008, a decrease of $3.7 million from December 31, 2007. During May 2008, the Company closed a brokered private placement raising $4.8 million from the issuance of 6.9 million common shares. Management believes that current cash resources should enable the Company to execute its core business plan / priority initiatives and meet its projected cash requirements to the end of 2009.
As at March 23, 2009, the Company has 75,894,044 common shares issued and outstanding. In addition, the Company has 4,857,500 options outstanding to purchase common shares of the Company. The Company also has 584,413 warrants outstanding.
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™ and PORxin™ 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). Final positive Phase 2a results treating BPH patients were recently released 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.
