News ReleasesPrinter friendly version
Protox Releases Q2, 2006 Financial Results and Company Highlights
Tuesday, August 29, 2006 - Vancouver, British Columbia - Protox™ Therapeutics Inc. (TSX-V: PRX)
today reported financial results and operating highlights for the second quarter ended June 30, 2006.
“Protox has made considerable progress in recent months, moving ever closer towards becoming a
leader in the development and commercialization of toxin-based targeted therapies for cancer and
other proliferative diseases,” said Dr. Fahar Merchant, President and CEO of Protox. “
With three clinical programs in development and a fourth on the horizon, we are ready to move
to the next tier of corporate growth and to create a world-caliber company capable of
satisfying a wide range of unmet needs by taking full advantage of our core expertise in
this area.”
The recent acquisition of PRX321 from Neurocrine Biosciences Inc. and the United States
Public Health Services complements the company's existing toxin-based PORxin™ technology
and expands the clinical pipeline beyond therapies to treat prostate cancer and benign prostatic
hyperplasia (BPH), to include treatments for brain, lung and kidney cancers. PRX321, lead drug
in the company's INxin™ technology platform, is a Phase II program that has been granted
both Fast Track Designation and Orphan Drug Status by the U.S. Food and Drug Association.
PRX302 is the lead drug in the company's PORxin technology platform.
Q2 Operating Highlights
- In April, preclinical data demonstrating PRX302's validity as a treatment for prostate cancer
and BPH was presented at the 97th Meeting of the American Association of Cancer Research
(AACR) in Washington D.C., the largest gathering of cancer professionals in the world.
- Patient enrolment commenced in May for the Phase I clinical study at Scott & White
Memorial Hospital to evaluate the use of PRX302 in the treatment of localized recurrent
prostate cancer. The study is now in its third cohort of patients and full enrolment is
expected to be completed by the end of 2006. Interim results are expected to be available
in Q4.
- A pre-CTA (Clinical Trial Application) meeting was held with Health Canada in preparation
for a Phase I study into the use of PRX302 in the treatment of benign prostatic hyperplasia.
The CTA will be submitted in Q3 of this year.
- In June, the Company filed a provisional patent application with the United States Patent
and Trademark Office to protect drug candidates generated through the PORxin platform whose
Subsequent Events
- In July, the Company acquired a Phase II therapeutic program, PRX321 (formerly known as
NBI-3001), from Neurocrine BioSciences and the United States Public Health Services.
- The University of Vermont and Urology San Antonio joined lead center Scott & White
in the Phase I prostate cancer study using PRX302.
Financial Results
The loss for the three months ended June 30, 2006 was $1,478,373 ($0.04 per share) compared with a loss of $1,548,762 ($0.07 per share) for the same period last year and a loss of $854,824 ($0.02) for the three months ended March 31, 2006. The increase in the loss for the second quarter of 2006 compared with the first quarter of 2006 is principally attributable to the PRX302 Phase I clinical trial costs for the treatment of localized prostate cancer, which commenced in May 2006.
The loss for the six months ended June 30, 2006 was $2,333,197 ($0.06 per share) compared with a loss of $2,531,675 ($0.11 per share) for the same period last year. The decrease in net loss for the six months ended June 30, 2006 compared with the same period last year is primarily due to the transition of PRX302 from preclinical research to human clinical trials. There were no preclinical costs for PRX302 in the first half of 2006 compared with a significant amount of preclinical and manufacturing costs during the same period last year.
Research and development expenses increased in the quarter ended June 30, 2006 to $774,625 as compared with $421,977 for the first quarter of 2006. The increase in research and development expenditures for the second quarter of 2006 is primarily due to the commencement of the Phase I clinical trial for PRX302 for the treatment of localized prostate cancer.
Research and development expenses for the six months ended June 30, 2006 were $1,196,602 compared with $1,708,956 for the same period last year. The majority of the research and development expenditures for the first six months of 2006 were related to the start up of the Phase I clinical trial for PRX302 and the treatment expenses for the first few patients. Patient enrolment commenced on May 2, 2006 and is expected to be completed by the end of 2006. In contrast, the majority of the expenditures in 2005 were related to the preclinical animal studies and GMP manufacturing of PRX302. Research expenditures for the three and six months ended June 30, 2006 were offset by IRAP funding of $21,030 and $134,365 respectively.
General and administrative expenditures increased to $530,061 in the quarter ended June 30, 2006 compared with $420,019 for the first quarter of 2006. The increase in general and administrative expenses for the second quarter of 2006 is primarily due to costs associated with the AGM held in June 2006, additional travel and legal expenses related to the acquisition of the INxin program and 2005 annual report costs.
General and administrative expenditures for the six months ended June 30, 2006 were $976,903 compared with $603,634 for the same period last year. The increase in general and administrative expenses is primarily due to the change in management in 2005 and additional employees hired to support the Company's programs and business development activities. The Company also incurred additional legal, travel and consulting fees to support the transition from a preclinical stage company to a clinical stage company and to acquire the INxin program.
Stock-based compensation for the three months ended June 30, 2006 amounted to $146,824, compared with $136,459 for the second quarter of 2005, and $285,604 for the six months ended June 30, 2006 compared with $200,682 for the same period last year. The increase in stock-based compensation relates to stock options granted to new employees during 2005 and 2006 as well as additional stock options granted to existing employees and directors in July 2005 and March 2006.
The Company earned $35,750 in interest for the three months ended June 30, 2006, compared with $16,182 for the second quarter of 2005, and $69,534 for the six months ended June 30, 2006 compared with $38,360 for the same period last year. The increase in interest income is a result of higher interest rates and higher average amounts held in interest bearing accounts.
The Company incurred a foreign exchange loss on the US dollar denominated cash and cash equivalents and accounts payable balances of $60,380 for the three months ended June 30, 2006, compared with $17,602 for the second quarter of 2005, and $33,558 for the six months ended June 30, 2006 compared with $18,657 for the same period last year.
Summary of Quarterly Results
Liquidity
As at June 30, 2006, the Company had cash and cash equivalents of $3,781,399 compared with $5,471,804 as at December 31, 2005. As at June 30, 2006, the Company had working capital of $3,284,437 compared with $5,166,583 as at December 31, 2005 and $2,048,193 as at June 30, 2005. The increase in current assets compared with June 30, 2005 is primarily attributable to the non-brokered private placement of $5,619,915, net of cash costs of $251,885, completed in November 2005.
Based on the current business plan, including the acquisition of the INxin program announced on July 20, 2006, the Company anticipates that it will have sufficient funds to operate its business into Q1, 2007. However, the Company's working capital may not be sufficient to meet its stated business objectives in the event of unforeseen circumstances or a change in the strategic direction of the Company. The Company will need to raise further capital in order to extend its research and development programs beyond Q1, 2007. There can be no assurance that the Company will be able to obtain further financing on terms that are acceptable, if at all.
About Protox
Protox Therapeutics is a product-focused clinical-stage company and a leader in advancing novel, targeted protein toxin 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 three clinical programs in development. PRX321 (INxin) has completed a Phase IIa clinical trial for the treatment of primary brain cancer and has received Fast Track Designation and Orphan Drug Status by the US FDA. In addition, PRX321 has also completed a Phase I study in patients with renal cell carcinoma and non-small cell lung cancer. PRX302 (PORxin) is currently enrolling patients with localized prostate cancer in a Phase I clinical trial and is also being developed for the treatment of benign prostatic hyperplasia. For more information go to www.protoxtherapeutics.com.
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:
Anthony Boone
Director, Investor Relations and Corporate Communications, Protox Therapeutics Inc.
Direct: 604-688-4369
Cell: 778-996-4369
Fax: 604-688-0173
aboone@protoxtherapeutics.com
Michael Moore
Investor Relations
The Equicom Group
Direct: 416-815-0700 x 241
mmoore@equicomgroup.com
|
