News ReleasesPrinter friendly version Protox Releases Q2 2007 Financial Results And Company Highlights
Vancouver, British Columbia, August 30, 2007 – Protox Therapeutics Inc. (TSX-V: PRX) today reported financial results and operating highlights for the second quarter ended June 30, 2007.
“The second quarter marked significant advances across all of our development programs,” said Dr. Fahar Merchant, President and CEO of Protox. “Prominently amongst these accomplishments was the completion of the Phase 1 prostate cancer clinical trial with PRX302 which culminated with the announcement of promising top-line safety data and encouraging evidence of therapeutic activity. These data provide us with confidence as we also pursue the development of PRX302 in patients who suffer from the devastating symptoms associated with BPH (enlarged prostate). This Phase 1 study is now well underway and we plan to complete enrollment ahead of schedule. Both BPH and prostate cancer affect tens of millions of men worldwide and we hope that our efforts in the commercialization of PRX302 will play a key role in effectively treating these conditions. Finally, we continue in our efforts to progress the pre-pivotal Phase 2b trial of PRX321 in patients with late stage brain cancer. To that end, we have entered into a manufacturing agreement with Dompé in order to secure a reliable GMP compliant source of PRX321 for global clinical and commercial supply.
Operating Highlights
- Enrolled and successfully dosed the first patient in a Phase I clinical study evaluating PRX302 to treat benign prostatic hyperplasia (BPH).
- Completed recruitment of patients for Phase 1 clinical study of PRX302 to treat localized, recurrent prostate cancer.
Subsequent 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.
- Announced agreement with Dompé pha.r.ma S.p.A. (Dompé) for the clinical manufacturing and commercial supply of PRX321.
Financial Results
For the three months ended June 30, 2007 (“Q2 2007”), the Company reported a net loss of $1,817,019 or $0.03 per share compared to $1,478,373 or $0.04 per share for the three months ended June 30, 2006 (“Q2 2006”) and a net loss of $1,607,102 or $0.03 per share for the preceding quarter or three months ended March 31, 2007 (“Q1 2007”). The net loss for the six months ended June 30, 2007 (“Q2 YTD 2007”) was $3,424,121 or $0.06 per share compared to $2,333,197 or $0.06 per share for the six months ended June 30, 2006 (“Q2 YTD 2006”). The $338,646 (23%) and $1,090,924 (47%) increase in net loss for Q2 2007 and Q2 YTD 2007, respectively, is primarily attributable to increased research and development costs.
Research and development costs of $1,098,890 were incurred during Q2 2007 compared to $774,625 for the Q2 2006 comparative period and $998,948 during the preceding quarter Q1 2007. Research and development costs for the Q2 YTD 2007 period totaled $2,140,184 representing a $943,582 (79%) increase from $1,196,602 incurred during the Q2 YTD 2006 comparative period. The $325,320 (42%) research and development cost increase from Q2 2006 to Q2 2007 reflects a broader scope of development and clinical activities during the later period. The $99,942 (10%) increase in research and development costs from Q1 2007 to Q2 2007 is largely attributable to incremental costs for CMC activities associated with the PRX321 drug product. Similar to Q2 2007, the Q2 YTD 2007 comparative cost increase reflects the expanded scope of Protox’s drug development and clinical trial activities. Q1 2006 was a period of transition from a preclinical to clinical focus ahead of commencing clinical trials.
General and administration costs of $466,886 were incurred during Q2 2007 compared to $530,061 for the Q2 2006 comparative period and $490,577 during the most recently completed quarter Q1 2007. General and administration costs for the Q2 YTD 2007 period totaled $957,462 and declined 2% ($19,441) from $976,903 for the Q2 YTD 2006 comparative period.
During Q2 2007 and Q2 YTD 2007, the Company earned interest income of $95,995 and $189,034, respectively, compared to $35,750 and $69,534 for the respective 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 Q2 2007 and Q2 YTD 2007, the Company recorded cumulative foreign exchange losses of $173,586 and $190,855, respectively, compared to $60,380 and $33,558 for the respective 2006 comparative periods. The majority of the foreign exchange losses recorded during 2007 represents unrealized losses in Q2 2007 on the Company’s U.S. dollar reserves due to a near 10% decline in the value of the U.S dollar.
As at June 30, 2007, the Company had cash and cash equivalents of $7.9 million compared to $9.5 and $10.0 million as at March 31, 2007 and December 31, 2006, respectively. The Company had working capital of $6.5 million at June 30, 2007, compared to $8.0 and $8.9 million at March 31, 2007 and December 31, 2006, respectively. During Q2 YTD 2007, a total of $0.7 million of proceeds were received from the exercise of warrants and additional proceeds of approximately $0.65 million have been received since the end of Q2 2007.
As at August 15, 2007 there were a total of 58,391,413 common shares (84,286,430 on a fully diluted basis) and no preferred shares outstanding.
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. The company currently has four programs in clinical development based on two distinct but complementary platforms, INxin™ and PORxin™. A Phase 2a clinical trial evaluating PRX321 (INxin) for the treatment of primary brain cancer has been completed and the product candidate has received Fast Track Designation and Orphan Drug Status from the US FDA. In addition, a Phase 1 clinical trial evaluating PRX321 for the treatment of patients with renal cell carcinoma and non-small cell lung cancer has been completed. Patient enrollment has been completed for a Phase 1 clinical trial evaluating PRX302 (PORxin) for the treatment of localized prostate cancer. A Phase 1 clinical trial evaluating PRX302 for the treatment of benign prostatic hyperplasia (enlarged prostate) is ongoing.
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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