Protox Therapeutics Inc. (the "Company" or "Protox") (TSX: PRX), a leader in the development of receptor targeted therapeutic fusion proteins, today announced financial results and achievements for the year ended December 31, 2010.
"2010 was transformative for Protox across all fronts commencing with very positive clinical data, followed by a valuable partnership with a leading Japanese pharmaceutical company and culminating with a significant financial commitment by a major private equity group," said Dr. Fahar Merchant, President and CEO of Protox. "Our first placebo controlled study with PRX302 met its primary end-point demonstrating that PRX302 has the potential of improving the lives of millions of men that suffer from benign prostatic hyperplasia. The strength of these data was demonstrated by our announcement of a US $75 million license agreement with Kissei Pharmaceuticals for the development and commercialization of PRX302 in Japan. Further validation of the potential promise of PRX302 was confirmed by entering into a $35 million investment agreement with Warburg Pincus, a leading global private equity firm. The development and financial partnerships that we executed on the back of positive clinical data has solidified the Company's ability to effectively conduct further development and commercialization of PRX302 for the treatment of BPH."
Operational and Financial Highlights (up to and including March 28, 2011)
- Positive top-line results were announced in January 2010 from the Company's multi-centre, double-blinded placebo controlled Phase 2b study of PRX302 (study name: TRIUMPH) in patients with moderate to severe benign prostatic hyperplasia (BPH). The study achieved its primary clinical endpoint of a statistically significant improvement in International Prostate Symptom Score ("IPSS") at day 90 for subjects treated with PRX302 versus subjects receiving placebo.
- Positive six month data from the TRIUMPH study were released in June 2010 and continued to be impressive, showing a sustained improvement in all efficacy measures following a single treatment, which is consistent with earlier open-label studies.
- On March 16, 2010, the Company closed a brokered private placement raising net proceeds of $4.8 million from the issuance of 11,285,388 units at a price of $0.45 per unit.
- Secured a US $75 million license agreement with Kissei Pharmaceutical Co. for the development and commercialization of PRX302 in Japan for BPH, prostate cancer and other diseases of the prostate. Under terms of the agreement, Protox received an upfront payment of US $3 million and is eligible to receive milestone payments of up $72 million upon achievement of specific development, regulatory and commercial milestones.
- Entered into a $35 million investment agreement with Warburg Pincus, a leading global private equity firm. Under the terms of the agreement Warburg has committed to invest up to CDN $35 million for the issuance of units at a price of $0.40 per unit. The company received the first $10 million tranche in November 2010.
- In conjunction with the investment by Warburg Pincus, the Company welcomed Dr. Lars Ekman (Chairman), Dr. Nishan DeSilva, Mr. Jonathan Leff, Mr. Amit Sobti and Mr. William Rohn to the Board of Directors and Drs. Jim Miller, Alex Giaquinto and Avtar Dhillon stepped down from the Board.
- Presented top-line data from PRX302 clinical trials at the 2010 Annual Meeting of the American Urological Association, the world's largest gathering of urology professionals.
- Publication of positive safety and efficacy results from the open-label Phase 1 and 2 BPH trials in the top-tier Journal, European Urology.
Selected Annual Information
In thousands, except per share data
Protox reported a net loss of $4.5 million ($0.05 per share) for the year ended December 31, 2010 compared to a loss of $7.9 million ($0.10 per share) for the year ended December 31, 2009, representing a year over year decrease in net loss of $3.4 million.
Total expenses for the year ended December 31, 2010 decreased by $727,000 over the comparative year. This was driven by a reduction in research and development expenditures with the completion of the active phase of our TRIUMPH study as well as efforts to manage costs across the Company.
The Company earned US$3.0 million (CAD $3.0 million) in license revenue during the year as a result of the Kissei license agreement. The payment triggered a royalty payment to John Hopkins University and the University of Victoria of $210,000 under the terms of our PORxin license agreement for BPH. The company has not earned any revenue in its previous fiscal years, other than interest earned on the Company's investment balance.
In the future, the Company is eligible to earn up to US$72 million in milestone payments in addition to product supply revenues as well as double digit royalties on sales of PRX302 in Japan.
Research and development costs for the year ended December 31, 2010 were $4.4 million, representing a $1.1 million (20%) decrease from the $5.5 million incurred during the year ended December 31, 2009. This reflects the effects of the consolidation of our research and development programs to focus on the lead BPH program and the maturing of the Company's current BPH trial as the active phase of our lead trial was completed during 2010 - the double-blinded placebo controlled TRIUMPH study - compared to three active trials in 2009. With the Warburg Pincus Financing, the Company plans to initiate additional BPH clinical studies and as such, development costs associated with clinical trials, drug manufacturing and regulatory activities are expected to increase in 2011.
General and administrative costs for the year ended December 31, 2010 were $2.4 million, an increase of $271,000 (12%) from the $2.1 million incurred during the year ended December 31, 2009. The increase in general and administrative costs reflects the significant efforts undertaken in 2010 to secure the regional license arrangement with Kissei and the two separate elements of financing closed in 2010. The higher costs associated with these activities was partially offset by our efforts to consolidate and focus operations on our lead clinical BPH program and the Company's continued efforts to stabilize and reduce overhead costs in the future.
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