Bradmer Pharmaceuticals Inc., a clinical oncology company specializing in the development and commercialization of cancer therapies, today announced its 2008 third quarter operational and financial results.
Operational Highlights
During the three months ended September 30, 2008 and the period subsequent to this date, the Company achieved the following milestones related to its operations and its lead drug, Neuradiab, which is being studied in the Phase III GLASS-ART Trial:
- Maintained budgetary control and reduced quarterly spending;
- Signed clinical study contracts with nine of the initial 16 sites under active consideration and activated an initial cohort of five sites, while advancing a pipeline of additional sites in the US through the contractual, training and regulatory process;
- Initiated dialog with Health Canada for study expansion into key Canadian sites with the support of the Canadian Brain Cancer consortium;
- Enrolled the first group of patients in the GLASS-ART Trial and successfully dosed patients with Neuradiab at multiple sites;
- Announced new data from the most recent Phase II trial indicating that the mean time to progression free survival was 77 weeks, which compares favorably with other published results in newly diagnosed GBM;
- Evaluated a series of technical steps that may allow a two week extension of the shelf life of Neuradiab beyond the current six-day specification; and
- Appointed Dr. Donald Kufe, Professor of Medicine, Harvard Medical School and Director, Experimental Therapeutics Program, Dana- Farber/Harvard Cancer Center and Charles James Lilly, CA, a senior partner with a public accounting firm, to the Board of Directors of the Company.
"The treatment of the initial patients in the Phase III trial of Neuradiab represents a major accomplishment in that we have demonstrated the technical feasibility of taking our Duke-developed drug for GBM to a multi-center trial," said Alan M. Ezrin, Ph.D., President and Chief Executive Officer of Bradmer. "During these difficult economic times our burn-rate has reflected the control we have exhibited over our resources and the focus and execution we have for the GLASS-ART Trial. The significant expense of setting up the trial is behind us and we have developed agreements with our key vendors that are largely tied to the pace of enrollment and milestones achieved. Now that patient enrollment is ongoing at the initial sites, we continue to expand the active sites with more than 30 centers projected to complete the process of qualification, training and initiation in the coming months. The run-in phase of the study targeting the enrollment of 60 patients is proceeding well with no serious limitations or issues. We look forward to our initial submission to the Drug Safety Monitoring Board and the Food and Drug Administration to report protocol compliance. Successful execution of the run-in phase will demonstrate to potential partners that the trial is appropriately designed and is being conducted in a manner that is likely to provide a definitive answer on the benefit of Neuradiab in the newly diagnosed GBM population."
Financial Highlights
Amounts in US dollars, unless specified otherwise, and results expressed in accordance with Canadian Generally Accepted Accounting Principles (Canadian GAAP).
For the three-month period ended September 30, 2008, the Company recorded a net loss of $2,627,000, or $0.19 per share, based on the weighted average outstanding shares of 13,488,215. This compares to a net loss of $2,284,000, or $0.17 per share for the three-month period ended September 30, 2007, based on the weighted average outstanding shares of 13,568,215.
For the nine-month period ended September 30, 2008, the Company recorded a net loss of $9,202,000, or $0.68 per share, based on the weighted average outstanding shares of 13,488,215. This compares to a net loss of $5,919,000, or $0.60 per share for the nine-month period ended September 30, 2007, based on the weighted average outstanding shares of 9,922,276. The change in net loss related to planned research and development spending with regard to the Company's lead clinical program, Neuradiab, as it enrolled the first patients in the clinical trial, as well as to the growth in the Company's administrative functions in anticipation of the clinical trial launch.
Research and development expenses for the third quarter of 2008 were $1,908,000, an increase of $150,000 from $1,758,000 in the same period of 2007. The increase was primarily due to increased support costs from the Company's clinical research organization (CRO), ICON Clinical Research, for the Phase III clinical development program. The expenses incurred in 2008 were primarily related to drug manufacturing contracts of $231,000, as well as amounts expensed to clinical research organizations of $745,000. During the period, Bradmer expanded drug manufacturing analytical support and secured the agreement of a cohort of sites to participate in the clinical trial.
General and administrative expenses were $768,000 in the third quarter of 2008, a decrease of $54,000 from $822,000 in 2007. The portion of stock-based compensation, a noncash item, included in general and administrative expenses was $84,000 for the quarter, unchanged from the same period in 2007. Interest income decreased to $69,000 for the quarter from $239,000 in the same period of 2007. The reduction was due to the lower cash balances in 2008 and the significant decline in interest rates over the past year.
As at September 30, 2008, Bradmer had available cash and cash equivalents and short-term investments totaling $11,247,000 as compared with $19,469,000 as at December 31, 2007. The decrease in cash was related to the operating costs incurred in the first nine months of the year. The Company expects that cash on hand at September 30, 2008 will be sufficient to fund operations through the next 12 months and beyond, inclusive of clinical trial an infrastructure costs during such period. -- www.cnxmarketlink.com
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