News ReleasesPrinter friendly version Protox Releases Q3 2007 Financial Results And Company Highlights
Vancouver, British Columbia, November 27, 2007 – Protox Therapeutics Inc. (TSX-V: PRX) today reported financial results and operating highlights for the third quarter ended September 30, 2007.
“We have demonstrated significant progress with our PRX302 product development in recent months, including positive Phase 1 results from both the locally recurrent prostate cancer and BPH clinical studies,” said Dr. Fahar Merchant, President and CEO of Protox. “The progress we’ve shown with these clinical trials, together with our strengthened balance sheet from the successful exercise of the November 2005 warrants, puts us in an excellent position to commence multiple Phase 2 trials in 2008, including a Phase 2b trial of PRX321 for the treatment of primary brain cancer.”
Operating Highlights
- Announced encouraging top-line results from the Phase 1 prostate cancer study, indicating that PRX302 was safe and well tolerated, with the ability to reduce PSA levels and decrease tumour burden in patients with localized recurrent prostate cancer.
- Appointed Dr. Martin Gleave MD, FRCSC, FACS, as Chairman of its Clinical Advisory Board (Urology).
- Announced agreement with Dompé pha.r.ma S.p.A. (Dompé) for the clinical manufacturing and commercial supply of PRX321.
- Presented interim data from the recently completed Phase 1 clinical study testing PRX302 in patients with locally recurrent prostate cancer following radiation failure at the American Urological Association (“AUA”) South Central Section Annual Meeting on September 7, 2007.
- Published a paper entitled “Recombinant prostate-specific antigen proaerolysin shows selective protease sensitivity and cell cytotoxicity” in the peer-reviewed journal, Anti-Cancer Drugs (August 2007; 18(7) 809-816).
Subsequent Highlights
- Completed patient recruitment for the Phase 1 clinical trial of PRX302 in males with benign prostatic hyperplasia (BPH). Also reported positive interim data from this study indicating that PRX302 is safe and well tolerated and shows promising signs of therapeutic activity.
- Announced positive final results from all 24 patients enrolled in the Phase 1 clinical trial of PRX302 in patients with localized, recurrent prostate cancer following radiation failure.
- U.S. Patent and Trademark Office issued U.S. Patent 7,282,476 covering the composition of PRX302, the Company’s lead drug candidate from its PORxinTM technology platform, and its use for the treatment of prostate cancer.
- Received approximately $7.6 million of a potential $7.7 million from the exercise of warrants issued as a result of the two tranches of a unit private placement financing closed on November 4 and 17, 2005.
- Entered into a collaborative research and clinical development agreement with BrainLAB AG for use of the BrainLAB proprietary drug delivery software, iPlan® Flow, in the planned Phase 2b primary brain cancer clinical trial of PRX321.
- Announced the appointment of Dr. Samuel Denmeade, M.D. to the position of Chief Scientific Officer on October 22, 2007.
Financial Results
For the three months ended September 30, 2007 (“Q3 2007”), the Company reported a net loss of $1,709,450 or $0.03 per share, compared to $1,351,490 or $0.04 per share for the three months ended September 30, 2006 (“Q3 2006”) and a net loss of $1,817,019 or $0.03 per share for the preceding quarter ended June 30, 2007 (“Q2 2007”). The net loss for the nine months ended September 30, 2007 (“Q3 YTD 2007”) was $5,133,571 or $0.09 per share compared to $3,684,687 or $0.10 per share for the nine months ended September 30, 2006 (“Q3 YTD 2006”). The $357,960 (26%) and $1,448,884 (39%) increase in net loss for Q3 2007 and Q3 YTD 2007, respectively, is primarily attributable to increased research and development costs from expanded drug development and clinical activities.
Research and development costs of $1,045,269 were incurred during Q3 2007 compared to $851,924 for the Q3 2006 comparative period and $1,098,890 during the preceding quarter, Q2 2007. Research and development costs for the Q3 YTD 2007 period totaled $3,185,453 representing a $1,136,927 (55%) increase from $2,048,526 incurred during the Q3 YTD 2006 comparative period. Similar to Q3 2007, the Q3 YTD 2007 comparative cost increase reflects the expanded scope of Protox’s drug development and clinical trial activities. Q3 YTD 2007 R&D costs reflect three full quarters of PRX302 Phase 1 prostate cancer clinical trial costs versus one and a half quarters for Q3 YTD 2006 as the study was initiated in mid Q2 2006. In addition, incremental costs have been incurred during Q3 YTD 2007 leading up to the initiation near the end of Q1 2007 of the Company’s PRX302 Phase 1 BPH clinical and for PRX321 CMC activities in advance of an anticipated H1 2008 PRX321 Phase 2b study for primary brain cancer. Direct costs for the prostate cancer and BPH Phase 1 clinical studies and PRX321 Phase 2b preparatory activities totaled approximately $1,876,000 during Q3 YTD 2007 compared to approximately $1,199,000 for Q3 YTD 2006, contributing $677,000 (60%) to the overall increase in R&D costs.
General and administration costs of $427,477 were incurred during Q3 2007 representing a 4% increase compared to $409,656 incurred for the Q3 2006 comparative period. On a Q3 YTD basis, total general and administration costs of $1,384,939 for the current fiscal year closely approximated the costs of $1,386,559 incurred during the Q3 YTD 2006 comparative period.
During Q3 2007 and Q3 YTD 2007, the Company earned interest income of $63,692 and $252,725, respectively, compared to $32,991 and $102,525 for the corresponding 2006 comparative periods. The increase in interest income is the result of higher interest rates earned on higher average amounts held in interest bearing accounts or investments during the periods.
During Q3 2007 and Q3 YTD 2007, the Company recorded cumulative foreign exchange losses of $125,540 and $316,394, respectively, compared to $8,363 and $41,921 for the corresponding 2006 comparative periods. During Q3 2007, the U.S. dollar declined approximately 7% against the Canadian dollar contributing toward the overall year-to-date decline of approximately 15% as of September 30, 2007.
As at September 30, 2007, the Company had cash and cash equivalents of $6.4 million compared to $7.9 and $10.0 million as at June 30, 2007 and December 31, 2006, respectively. The Company had working capital of $5.9 million at September 30, 2007, compared to $6.5 million at the end of the preceding quarter and $8.9 million at December 31, 2006. Excluding warrant and option exercise proceeds of $0.9 million received, the Company consumed cash of $2.4 million during Q3 2007 to finance continuing operations compared to $1.5 million for Q3 2006. Following the exercise of approximately $7.6 million of a potential $7.7 million worth of warrants issued as a result of the two tranches of a unit private placement financing closed on November 4 and 17, 2005, the Company’s current cash position is approximately $12.0 million.
As at November 23, 2007, the Company had approximately 68.5 million common shares issued and outstanding. In addition, the Company had 4.9 million options to purchase common shares of the Company outstanding, of which approximately 2.5 million were exercisable into an equivalent number of common shares of the Company at exercise prices ranging from $0.10 to $1.00 and an average exercise price of $0.71.
For complete financial statements please go to www.sedar.com.
About Protox
Protox Therapeutics is a leader in advancing novel, targeted protein toxin therapeutics for the treatment of cancer and other proliferative diseases. Two novel drug candidates derived from the company’s INxin™ and PORxin™ platforms are being developed in three clinical programs. 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. Phase 1 clinical trials evaluating PRX302 (PORxin) have been completed for the treatment of localized prostate cancer and benign prostatic hyperplasia (enlarged prostate).
NO REGULATORY AUTHORITY HAS APPROVED OR DISAPPROVED THE CONTENT OF THIS RELEASE. THE TSX VENTURE EXCHANGE DOES NOT ACCEPT RESPONSIBILITY FOR THE ADEQUACY OR ACCURACY OF THIS RELEASE.
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 contact:
James Beesley
Director, Investor Relations
Protox Therapeutics
604-688-0199
jbeesley@protoxtherapeutics.com
Michael Moore
Investor Relations
The Equicom Group
416-815-0700 x 241
mmoore@equicomgroup.com
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