"We have successfully transitioned Neuradiab from a Phase II compound with compelling results at a single site to a cGMP manufactured compound in a multi-center Phase III trial under a rigorous protocol. We focused specifically on reducing risk in the critical areas of manufacturing, regulatory and clinical operations," said Alan M. Ezrin, Ph.D., President and Chief Executive Officer of Bradmer. "We have initiated enrollment of patients across multiple sites and demonstrated those sites are adhering to the protocol as designed. However, the delay we have experienced in the 60-patient run-in phase has placed significant pressure on our capital resources which necessitated the strategic review by the Board."
Amounts in US dollars, unless specified otherwise, and results expressed in accordance with Canadian Generally Accepted Accounting Principles (Canadian GAAP).
For the year ended December 31, 2008, Bradmer recorded a net loss of $11,529,000 or $0.85 per common share, compared to a net loss of $9,436,000 or $0.87 per common share for the year ended December 31, 2007. The increased loss in 2008 was primarily related to planned research and development spending with regard to the Corporation's lead clinical program, Neuradiab, in preparation for the Phase III clinical trial, as well as the growth in Bradmer's administrative functions in anticipation of the clinical trial launch.
Research and development expenses totaled $8,327,000 in fiscal 2008, compared to $7,256,000 in fiscal 2007. The increase was primarily due to increased compensation costs for the larger clinical staff amounting for $1,004,000 compared to $311,000 for 2007. The expenses incurred in 2008 for drug manufacturing contracts amounted to $3,351,000 compared to $3,970,000 in 2007. Amounts expensed to clinical research organizations were $2,350,000 in 2008, compared to $
|SOURCE Bradmer Pharmaceuticals Inc.|
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