News ReleasesPrinter friendly version PROTOX REPORTS 2006 FINANCIAL RESULTS AND ACHIEVEMENTS
Vancouver, British Columbia, April 27, 2007 – ProtoxTM Therapeutics Inc. (TSX-V:PRX) today released year-end financial statements for the 12 months ending December 31, 2006.
“2006 was a transformative year for Protox,” said Dr. Fahar Merchant, President and Chief Executive Officer. “Over the course of 12 months we have made the transition from pre-clinical promise to encouraging interim clinical results with our flagship drug candidate, PRX302 in prostate cancer. Today we have two therapeutic platforms comprising multiple indications and clinical data for over 100 patients. These accomplishments will create enduring value for the company and set the stage for continued progress over the coming year.”
Operating Highlights
- On January 26, 2006 the US Food and Drug Administration approved an Investigational New Drug submission for PRX302 to treat localized recurrent prostate cancer and on May 2, 2006 the first patient was dosed at Scott & White Memorial Hospital. Three additional sites have since joined the trial including M.D. Anderson Cancer Centre, University of Vermont and Urology San Antonio.
- The PORxin™ patent family was further strengthened with the filing in June 2006 of a provisional patent application with the United States Patent and Trademark Office to protect drug candidates generated through the platform whose binding sites are altered to target certain types of cells including cancer cells. The PORxin platform was also enhanced with three scientific presentations at two international cancer conferences during the year.
- On July 20, 2006 the Company acquired a second technology platform from Neurocrine Biosciences Inc. and the US Public Health Service. The lead drug candidate, PRX321, has been studied in 72 patients in Phase I and IIa clinical trials for brain cancer and 14 patients in a Phase I trial to treat solid tumours. The compound is potentially indicated for up to a dozen different cancer indications.
- The Company received approval from Health Canada on October 11, 2006 to initiate a Phase I clinical trial of PRX302 for benign prostatic hyperplasia (BPH or enlarged prostate). The trial was initiated on March 28, 2007 at two sites, in Victoria, British Columbia and Kitchener, Ontario, and the first patient was dosed on April 23, 2007.
- In late 2006 the Company raised gross proceeds of $10,049,750 in a brokered private placement of common share units to further the development of programs for PRX302 and PRX321 and for general corporate purposes.
- Promising interim results from the Phase I prostate cancer trial, reported on January 18, 2007, indicated 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.
Financial Results & Capital Resources
For the year ended December 31, 2006 (“2006”), the Company:
- Incurred a net loss of $5,012,646 ($0.13 per share), a 10% decrease from $5,549,332 ($0.22 per share) for the year ended December 31, 2005 (“2005”).
- Earned interest income of $145,378, a 133% increase from 2005, due to higher cash balances from financing.
- Reduced total operating expenses by 8% to $5,112,068 from $5,568,225 incurred in 2005. Operating expenses for 2006 included R&D costs of $2,860,665, a 20% decrease from $3,555,987 in 2005. This decrease in R&D reflects a shift from preclinical to clinical activities. Costs for the Prostate Cancer Phase I clinical trial, initiated in May 2006, totaled approximately $0.8 million and discovery research costs were approximately $0.5 million compared to $0.4 million in 2005. Costs associated with additional personnel to manage and execute the Company’s expanded R&D and clinical trial initiatives as well as initial INxin™ license fees offset a portion of the $2 million reduction in preclinical testing and manufacturing costs from 2005.
- Incurred G&A expenses of $2,159,784 compared to $1,941,235 for 2005. The increase is primarily due to an increase in personnel and travel costs in support of the Company’s expanded activities in 2006.
The Company does not anticipate earning any revenue in the foreseeable future, other than interest revenue earned on cash balances. Operating expenses are expected to significantly increase during 2007 in conjunction with the advancement of the Company’s PRX301 and PRX321 clinical programs.
At December 31, 2006, the Company had cash resources of $9,977,259 and working capital of $8,918,615. Subsequently, the Company has raised an additional $583,000 from the exercise of outstanding share purchase warrants. The Company believes it will have sufficient resources to execute its current business plan up to mid 2008. Thereafter, additional capital will be required to further advance the Company’s R&D programs through to commercialization. The exercise of outstanding stock options and warrants represents potential additional funding of up to $18 million.
About Protox
Protox Therapeutics is a leader in advancing novel, targeted therapeutics for treatment of cancer and other proliferative diseases. The company is actively developing two distinct but complementary platforms, INxin and PORxin, and currently has four clinical programs in development. A Phase IIa clinical trial into the use of 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. In addition, a Phase I trial has been completed for PRX321 to treat patients with renal cell carcinoma and non-small cell lung cancer. Patient enrolment is underway for two Phase I clinical trials using PRX302 (PORxin) for prostatic disease: one to treat localized prostate cancer and the other to treat benign prostatic hyperplasia.
For further information contact:
James Beesley
Director, Investor Relations
Protox Therapeutics
604-688-0199
jbeesley@protoxtherapeutics.com
Michael Moore
Investor Relations
Equicom Group
416-815-0700 x 241
mmoore@equicomgroup.com
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