News ReleasesPrinter friendly version PROTOX REPORTS 2007 FINANCIAL RESULTS AND ACHIEVEMENTS
Vancouver, British Columbia, April 15, 2008 – Protox Therapeutics Inc. (TSX: PRX), a leader in the development of receptor targeted fusion proteins, today released year-end financial results for the 12 months ending December 31, 2007.
“We were very active in 2007 on both the corporate and clinical development front, highlighted by very positive clinical results from both our clinical programs for PRX302,” said Fahar Merchant, President and Chief Executive Officer. “In addition to the notable progress of PRX302, we advanced the preparations for our PRX321 Phase 2b study for the treatment of primary brain cancer, strengthened our management team, our intellectual property and our balance sheet, and graduated to the Toronto Stock Exchange. The coming year should be equally as exciting for our shareholders, as we advance multiple Phase 2 programs and progress towards a number of value driving milestones.”
2007 Operating and Financial Highlights
- Completed and reported positive Phase 1 clinical trial data for the treatment of localized, recurrent prostate cancer using PRX302.
- Reported positive Phase 1 interim clinical trial data for the treatment of benign prostatic hyperplasia (BPH) using PRX302.
- Acquired a third complementary technology platform, HUMxin.
- Received $7.6 million in proceeds from the exercise of 11.6 million warrants - 98.5% of the total warrants issued as part of a November 2005 financing.
- Entered into a supply agreement with Dompé for the clinical manufacturing and commercial supply of PRX321.
- Appointed Dr. Martin Gleave MD, FRCSC, FACS, to Chairman of the Protox’s Clinical Advisory Board (Urology).
- Appointed Dr. Samuel Denmeade, co-inventor of PRX302, as Chief Scientific Officer.
- Announced issuance of patent by the U.S. Patent and Trademark Office covering the composition of PRX302 and its use for prostate cancer treatment. Protox has an exclusive worldwide license on this patent.
- Announced a collaborative and clinical development agreement with BrainLAB AG for the use of their proprietary drug delivery software, iPlan® Flow, in the forthcoming PRX321 Phase 2b (pre-pivotal) primary brain cancer clinical trial.
Subsequent Operating and Financial Highlights
- Completed and reported positive Phase 1 clinical trial data for the treatment of BPH using PRX302.
- Initiated Phase 2a clinical trial for the treatment of localized, recurrent prostate cancer using PRX302.
- Initiated Phase 2 clinical trial for the treatment of BPH using PRX302.
- Graduated from TSX Venture Exchange to the Toronto Stock Exchange.
Selected Annual Information
Year ended December 31 |
2007
(audited) |
2006
(audited) |
2005
(audited) |
Interest income |
$ 351,860 |
$ 145,379 |
$ 62,334 |
Net loss |
(7,446,052) |
(5,012,646) |
(5,549,332) |
Net loss per share |
(0.13) |
(0.13) |
(0.22) |
Total assets |
12,913,664 |
11,514,697 |
5,853,003 |
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.
For the year ended December 31, 2007 (2007 FY), the Company earned interest income of $0.35 million and compared to $0.15 million for the 2006 FY comparative period. 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 2007.
During 2007 FY the Company incurred a net loss of $7.4 million or $0.13 per share compared to $5.0 million or $0.13 per share for the year ended December 31, 2006 comparative period (2006 FY). The $2.4 million (49%) increase in net loss for 2007 FY is primarily attributable to increased research and development costs from expanded drug development and clinical activities as further discussed below.
Research and development (R&D) costs of nearly $4.9 million were incurred during 2007 FY compared to $2.7 million for the 2006 FY comparative period. The $2.2 million (83%) R&D cost increase reflects the expanded scope of Protox’s drug development and clinical activities. This includes the effect of the initiation of a new PRX302 Phase 1 clinical trial for the treatment of BPH (mid 2007 Q2) and additional chemistry and manufacturing controls (CMC) activities related to advancing the PRX321 clinical program (acquired during 2006 Q3) over and above the ongoing PRX302 Phase 1 prostate cancer study. 2007 FY R&D costs reflect three full quarters of PRX302 Phase 1 prostate cancer clinical trial costs versus one and a half quarters for 2006 FY as the study was initiated in mid 2006 Q2 and substantially completed by the end of 2007 Q3. In addition, incremental costs have been incurred for CMC, clinical and regulatory preparatory activities in support of the anticipated initiation of a PRX321 Phase 2b study for primary brain cancer in 2008 H2.
Direct costs for the prostate cancer and BPH Phase 1 clinical studies and PRX321 Phase 2b preparatory and CMC activities totaled approximately $3.0 million during 2007 FY compared to approximately $1.5 million for 2006 FY, contributing $1.5 million (68%) to the overall increase in R&D costs. Other contributing factors to the increase in 2007 FY R&D costs were: i) incremental compensation costs associated with hiring more personnel ($0.3 million impact); ii) more travel ($0.1 million impact) to support the Company’s expanded clinical and development activities; iii) full year amortization effect of the INxin technology acquired subsequent to 2006 Q2 ($0.1 million impact); and iv) no grants were received in 2007 compared to 2006 ($0.15 million impact). Discovery research costs for the 2007 FY and the 2006 FY comparative period were similar with both approximating $0.5 million.
General and administrative (G&A) costs of $2.0 million were incurred during 2007 FY representing a 9% increase compared to $1.8 million incurred for the 2006 FY 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 2007 FY G&A costs increase is commensurate with the growth of the Company and its operations over the last year.
Summary of Quarterly Results
(unaudited) |
2007 Q4 |
2007 Q3 |
2007 Q2 |
2007 Q1 |
Interest income |
$ 99,134 |
$ 63,692 |
$ 95,995 |
$ 93,039 |
Total expenses |
2,411,616 |
1,773,141 |
1,913,014 |
1,700,141 |
Net loss |
(2,312,482) |
(1,709,449) |
(1,817,019) |
(1,607,102) |
Net loss per share |
(0.04) |
(0.03) |
(0.03) |
(0.03) |
(unaudited) |
2006 Q4 |
2006 Q3 |
2006 Q2 |
2006 Q1 |
Interest income |
$ 42,854 |
$ 32,991 |
$ 35,750 |
$ 33,783 |
Total expenses |
1,370,812 |
1,384,481 |
1,514,123 |
888,607 |
Net loss |
(1,327,959) |
(1,351,490) |
(1,478,373) |
(854,824) |
Net loss per share |
(0.03) |
(0.04) |
(0.04) |
(0.02) |
Expenses, in particular R&D costs, are influenced by a number of factors including the scope of clinical development and research programs pursued; the stage, i.e. Phase 1, 2 or 3, of clinical trials undertaken; the number of clinical trials that are active during a particular period of time; the rate of patient enrollment; and ultimately are a function of decisions made to continue the development and testing of a product candidate based on supporting safety and efficacy from clinical trial results. Consequently, expenses may or will vary from period to period. G&A expenses will be dependent on the personnel and infrastructure required to support the corporate, clinical and business development objectives and initiatives of the Company, however, no material increase in G&A costs is expected over the short term.
Total expenses during 2007 Q4 were higher than the prior quarters during 2007 primarily due to incremental PRX321 CMC costs, more specifically, costs relating to the commencement of the manufacture of a Good Manufacturing Practices (GMP) batch of PRX321 product and the associated technology transfer activities during 2007 Q4 (approximately $0.6 million impact).
As at December 31, 2007, the Company had cash and cash equivalents of $11.4 million compared to $10.0 million as at December 31, 2006. The Company had working capital of $9.9 million at December 31, 2007, compared to $8.9 million at December 31, 2006.
As at April 14, 2008 there were a total of 68,534,433 common shares issued and outstanding.
In addition, the Company has 5,561,035 options outstanding to purchase common shares of the Company, 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 $0.73. The Company 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.
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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