News ReleasesPrinter friendly version Protox Reports 2008 First Quarter Results
Vancouver, British Columbia, May 13, 2008 – Protox Therapeutics Inc. (TSX: PRX), a leader in the development of receptor targeted fusion proteins, today released first quarter 2008 financial results for the 3 months ended March 31, 2008 (2008 Q1).
“Protox made substantial progress during the first quarter highlighted by the release of positive clinical results from our BPH clinical program, the initiation of a Phase 2a study in men with localized recurrent prostate cancer and graduating to the Toronto Stock Exchange,” said Dr. Fahar Merchant, President and CEO of Protox. “We are excited about the coming months as we advance as many as three Phase 2 clinical trials and progress towards several key milestones.”
2008 Q1 HIGHLIGHTS
- Announced positive final results from its PRX302 Phase 1 benign prostatic hyperplasia (BPH) clinical trial.
- Commencement of a multi-center U.S. Phase 2a clinical trial of PRX302 as a treatment for localized, recurrent prostate cancer.
- Commenced trading the Company’s common shares on the Toronto Stock Exchange (TSX) on February 4, 2008 following graduation from the TSX Venture Exchange.
- Presented final data from the Phase 1 clinical study of PRX302 in patients with locally recurrent prostate cancer at the American Society of Clinical Oncology (ASCO) Genitourinary Cancer Symposium.
SUBSEQUENT HIGHLIGHTS
- Received Health Canada and Institutional Review Board (IRB) approvals to proceed with a multi-center Phase 2 clinical trial of PRX302 for the treatment of moderate to severe BPH.
- Announced positive follow-up data from the Phase 1 BPH study of PRX302 showing that long term therapeutic effects continue to be observed at 6 and 9 months following a single treatment.
- Entered into a Cooperative Research and Development Agreement (CRADA) with the U.S. Food and Drug Administration (FDA) to further develop PRX321 and next generation IL-4 receptor targeted fusion proteins.
FINANCIAL RESULTS
Protox has not earned any revenue in any of its previous fiscal years, other than income from interest earned on its cash balances. During 2008 Q1, the Company earned interest income of $0.09 million. Interest income earned during 2008 Q1 approximated the amount earned during 2007 Q1, with average cash balances and rate of returns being similar for both periods.
For 2008 Q1, Protox reported a net loss of $2.0 million or $0.03 per share compared to $1.6 million or $0.03 per share for the three months ended March 31, 2007 comparative period (2007 Q1). The $0.4 million (27%) increase in net loss for 2008 Q1 is primarily attributable to increased research and development costs and advancing the Company’s product pipeline as further discussed below.
Research and development (R&D) costs of nearly $1.46 million were incurred during 2008 Q1 compared to $1.04 million for the 2007 Q1 comparative period. The $0.42 million (40%) R&D cost increase reflects the expanded scope and advancement of Protox’s drug development and clinical activities on a comparative basis. Incremental costs were incurred during 2008 Q1 for CMC (chemistry, manufacturing and control), clinical and regulatory preparatory activities in advance of the anticipated initiation of the Company’s PRX321 Phase 2b (pre-pivotal) study for primary brain cancer in 2008 H2.
Direct costs for the PRX302 prostate cancer and BPH clinical programs and PRX321 Phase 2b (pre-pivotal) study preparatory and CMC activities totaled approximately $0.7 million during 2008 Q1 compared to approximately $0.5 million for 2007 Q1, contributing $0.2 million (40%) to the overall increase in R&D costs for the quarter. A milestone payment relating to the PRX302 prostate cancer program was also a contributing factor to the increase in 2008 Q1 R&D costs. Discovery research costs for 2008 Q1 were $0.17 million compared to $0.1 million for 2007 Q1, reflecting incremental costs associated with additional CRADA activity and the operation of Company’s research lab.
General and administrative (G&A) costs of $0.54 million were incurred during 2008 Q1 representing a 10% increase compared to $0.49 million incurred for the 2007 Q1 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 Q1 G&A costs increase is commensurate with the growth of Protox and its operations and also reflects an increase in business development personnel and activities.
As at March 31, 2008, Protox had cash and cash equivalents of $9.3 million compared to $11.4 million as at December 31, 2007. The Company had working capital of $8.1 million at March 31, 2008, compared to $9.9 million at December 31, 2007. On May 5, 2008, Protox announced it had retained an agent to raise gross proceeds of up to $3.0 million pursuant to a brokered private placement of its common shares at $0.70 per share, with an over-allotment option to raise up to an additional $3.0 million for maximum proceeds of $6.0 million. The brokered private placement is subject to applicable regulatory and TSX approvals. Protox intends to use the net proceeds principally to finance and accelerate its clinical activities.
As at May 13, 2008, the Company has 68,534,433 common shares issued and outstanding. In addition, the Company has 5,571,035 options outstanding to purchase common shares of Protox, including 520,000 options granted to certain officers and employees in February 2008 to purchase common shares at an exercise price of $0.87. Of the options outstanding, approximately 3.3 million are exercisable into an equivalent number of common shares of the Company at exercise prices ranging from $0.10 to $1.00 and with an average exercise price of $0.72. Protox also has 10,938,882 warrants outstanding entitling the warrant holder to purchase common shares with an exercise price of $0.65 per common share and an expiry date of either November 29, 2008 or December 22, 2008 representing potential proceeds of up to $7.1 million.
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
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