News ReleasesPrinter friendly version Protox Reports 2008 Second Quarter Results
Vancouver, British Columbia, August 11, 2008 – Protox Therapeutics Inc. (TSX: PRX), a leader in the development of receptor targeted fusion proteins, today released second quarter 2008 financial results for the three months ended June 30, 2008 (“2008 Q2”).
“Protox continues to build on the success of the first quarter as the Company enrolls patients in two Phase 2 clinical trials of PRX302 for prostate cancer and benign prostatic hyperplasia (BPH). With the successful financing completed in May, Protox has been able to expedite the PRX302 BPH program and expect to complete enrollment ahead of schedule.” said Dr. Fahar Merchant, President and CEO of Protox. “Furthermore, Protox looks forward to commencing the Phase 2b pre-pivotal PRX321 recurrent brain cancer trial in the second half of this year
2008 Q2 Highlights
- Granted Orphan Drug Designation for PRX321 for the treatment of glioma, the most common and aggressive type of brain cancer, by the European Medicines Agency (EMEA)
- Closed a brokered private placement of common shares for gross proceeds totaling approximately $4.8 million, including $1.8 million from the exercise of an over-allotment option by the agent
- Encouraging early data from the PRX302 Phase 1 BPH clinical study was presented by Principal Investigator Dr. Pommerville at the 2008 Annual Meeting of the American Urological Association (AUA) held in Orlando, Florida
- Announced positive data from the Phase 1 BPH study demonstrating that PRX302 provides safe and durable symptomatic relief for at least 6 months following a single treatment
- Following Health Canada and IRB approvals, commenced patient dosing in a Phase 2 clinical trial of PRX302 for the treatment of BPH
- Commenced patient dosing for a Phase 2a study of PRX302 for the treatment of localized recurrent prostate cancer
- Entered into a collaboration with Dr. Raj Puri of the FDA under the terms of a CRADA for further development of PRX321 and novel IL-4 receptor targeted therapeutics
FINANCIAL RESULTS
Protox has not earned any revenue in any of its previous fiscal years, other than income from interest earned on the Company's cash balances. During 2008 Q2 and the six months ended June 30, 2008 (“2008 YTD”) the Company earned interest income of $0.05 million and $0.14 million, respectively, compared to $0.1 million and $0.19 million for the corresponding 2007 comparative periods. The decrease in interest income is directly attributable to lower interest rates available for both interest bearing short-term investments and accounts earned during 2008 on average cash balances approximating those during the first half of 2007.
The Company reported a net loss for 2008 Q2 of $1.9 million or $0.03 per share compared to $1.8 million or $0.03 per share for the three months ended June 30, 2007 comparative period (“2007 Q2”). The net loss for 2008 YTD totaled $3.9 million or $0.06 per share compared to $3.4 million or $0.06 per share for the six months ended June 30, 2006 (“2007 YTD”).
Research and development (“R&D”) costs of nearly $1.2 million were incurred during 2008 Q2 compared to $1.1 million for the 2007 Q2 comparative period. Although similar in amount, 2008 Q2 R&D costs reflect expenditures related to the PRX302 BPH and prostate cancer Phase 2 clinical trials as well as CMC, clinical and regulatory preparatory activities for the anticipated PRX321 recurrent GBM Phase 2b study, as compared to ongoing study costs for the BPH and prostate cancer Phase 1 clinical trials that were active during the comparative 2007 Q2 period.
R&D costs for the 2008 YTD period totaled $2.6 million representing an approximate $0.5 million (24%) increase from $2.1 million incurred during the 2007 YTD comparative period. The increase reflects the carry-over effect of the expanded scope of Protox’s drug development and clinical trial activities during 2008 Q1, during which incremental costs were incurred for the PRX321 program relating to the anticipated 2008 H2 recurrent GBM Phase 2b study whereas there were no related activities during 2007 Q1.
Direct costs for the PRX302 prostate cancer and BPH clinical programs, including 2 active Phase 2 clinical trials, and PRX321 recurrent GBM Phase 2b study preparatory and CMC drug supply activities increased to approximately $0.6 million during 2008 Q2 from approximately $0.5 million for 2007 Q2, contributing 46% of the overall quarter-to-quarter increase in R&D costs. Discovery research costs for 2008 Q2 were $0.22 million compared to $0.16 million for 2007 Q2, reflecting incremental costs associated with additional CRADA and collaborative research activity.
General and administrative (G&A) costs for 2008 Q2 remained steady from last quarter at $0.55 million, however, increased 17% from $0.47 million incurred during the 2007 Q2 comparative period. YTD G&A costs have also increased but slightly less at 13% to $1.1 million from $0.96 million for the 2007 YTD comparative period. G&A 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 2008 Q2 and 2008 YTD G&A costs increase is commensurate with the growth of the Company and its operations and also reflects an increase in business development personnel and activities.
During 2008 Q2 and 2008 YTD, the Company recorded nominal foreign exchange losses as the relative value of the U.S. and Canadian dollar changed marginally. However, during the 2007 Q2 and 2007 YTD comparative periods, $0.17 and $0.19 million of losses were recorded respectively with the majority representing unrealized losses on the Company’s then more significant U.S. dollar reserves due to an approximate 10% relative decline in the value of the U.S. dollar during 2007 Q2 alone. With U.S. dollar reserves considerably less as at June 30, 2008 compared to a year ago, the majority of the unrealized losses previously provided for as of 2007 Q2 have now been realized in the normal course of operations from the payment of ongoing U.S. dollar denominated expenses. The foreign exchange loss or gain recorded for a particular period and difference between comparative periods is a function of prevailing foreign exchange rates in effect at such time compared to the comparative period(s) as well as the amount of net financial assets or liabilities held or transacted during the subject periods.
At June 30, 2008, the Company had cash and cash equivalents of $11.4 million, mirroring closely the balance as at December 31, 2007. The Company had working capital of $10.8 million at June 30, 2008, an increase of $0.9 million from the December 31, 2007 year end. During 2008 Q2 the Company closed a brokered private placement of its common shares raising approximately $4.8 million from the issuance of approximately 6.9 million common shares. Gross proceeds included approximately $1.8 million from the exercise of an over-allotment option by the agent. The additional cash resources from the successful private placement will enable the Company to accelerate clinical programs and development activities.
As at August 11, 2008, the Company has 75,843,943 common shares issued and outstanding. In addition, the Company has 5,441,035 options outstanding to purchase common shares of the Company. Of the options currently outstanding, approximately 3.4 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 $0.79. The Company also has warrants outstanding entitling warrant holders to purchase common shares as follows: i) 10,938,882 warrants with an exercise price of $0.65 per common share and an expiry date of either November 29, 2008 or December 22, 2008 and ii) 584,413 warrants with an exercise price of $0.71 and expiry date of May 23, 2010.
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. 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 2a clinical trials evaluating PRX302 (PORxin) for the treatment of localized prostate cancer and benign prostatic hyperplasia (enlarged prostate) have also been initiated. 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.
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
|
