(Source: MARKETWIRE)

Molecular Insight Pharmaceuticals, Inc. (NASDAQ: MIPI) today announced the financial results for the second quarter ended June 30, 2009. In a conference call scheduled for today at 9:00 a.m., Eastern Time, the Company will discuss these financial results in detail and provide an update on the progress of its clinical programs.
Financial Highlights of the Second Quarter 2009
Three Months Ended June 30, 2009 Compared to Three Months Ended June 30, 2008
For the second quarter 2009, the Company reported a net loss of ($16.6) million or ($0.66) per share on a basic and diluted basis, compared to a net loss of ($21.0) million, or ($0.84) per share on a basic and diluted basis in the second quarter of 2008. Total revenue for the second quarter of 2009 and for the second quarter of 2008 was $0.1 million. This revenue is representative of various Research and Development grants and the timing of grant-related activities.
Operating expenses for the second quarter reflected a 28% decrease from the same period of the previous year. Research and Development expenses, which represent 60% of total operating expenses in the second quarter of 2009, were $7.1 million as compared to $10.1 million for the same period last year. Key components of this decrease were: the completion of the Zemiva(TM) Phase 2 trial, reduced activity costs for Onalta(TM) and Solazed(TM) and reduction in non-core development expenditures. These decreases were offset by an increase in spending for preclinical trials for Trofex(TM) and manufacturing preparation costs for the commercial supply and manufacture of Azedra.
Operating expenses also reflected a 26% decrease in general and administrative ("G&A") expenses. G&A expenses were $4.7 million for the second quarter of 2009, compared to $6.4 million in the second quarter of 2008. This decrease, which is indicative of the cost-cutting initiatives put in place at the end of 2008, is due primarily to a reduction in costs associated with legal fees, the use of consultants, and a workforce reduction. The reduction in expenses has had no negative effect on the implementation of core development programs.
Other expense (net) was $5.0 million for the three months ended June 30, 2009, as compared to $4.7 million for the same three-month period in 2008. The increase in other expense (net) was due primarily to lower yields on our investments offset by a decrease in interest expense for the second quarter of 2009 when compared to the second quarter of 2008.
Six Months Ended June 30, 2009 Compared to Six Months Ended June 30, 2008
For the six months ended June 30, 2009, the Company reported a net loss of ($31.9) million or ($1.27) per share on a basic and diluted basis, compared to a net loss of ($40.8) million, or ($1.63) per share on a basic and diluted basis in the first six months of 2008. Total revenue for the six months ended June 30, 2009 was approximately $0.3 million compared to total revenue of approximately $0.2 million in the first six months of 2008. The Company received funding under various Research and Development grants. This increase in revenue for the first six months of 2009 is due primarily to the receipt of three new grants in late 2008 and the timing of grant-related activities.
Operating expenses for the six months ended June 30, 2009 reflected a 30% decrease from the same period of the previous year. Research and Development expenses, which represent 59% of total operating expenses in the six-month period in 2009, were $13.1 million as compared to $20.1 million for the same period last year. Key components of this decrease were: the completion of the Zemiva Phase 2 trial, reduced activity costs for Solazed and reduction in non-core development expenditures. These decreases were offset by an increase in spending for preclinical trials for Trofex and manufacturing preparation costs for the commercial supply and manufacture of Azedra. Operating expenses also reflected a 21% decrease in G&A expenses. G&A expenses were $9.1 million for the six-month period in 2009, compared to $11.5 million in the six-month period in 2008. This decrease, which is indicative of the cost-cutting initiatives put in place at the end of 2008, is due primarily to a reduction in costs associated with legal fees, the use of consultants, and a workforce reduction. The reduction in expenses has had no negative effect on the implementation of core development programs. Other expense (net) was $10.0 million for the six months ended June 30, 2009, as compared to $9.3 million of other expense for the same six-month period in 2008.
The increase in other expense (net) was due primarily to lower yields on our investments offset by a decrease in interest expense for the six months ended June 30, 2009 when compared to the same period in the prior year.
At June 30, 2009 the Company had approximately $82.4 million in cash, cash equivalents, and short-term investments which are invested in U.S. Treasury securities. Further, as of June 30, 2009, there were 25,241,411 shares of common stock outstanding.
Four Molecular Insight Programs in Pivotal Trials
"Today, Molecular Insight has four clinical programs in pivotal stages of development and there was progress throughout the product pipeline during the second quarter," said Daniel L. Peters, President and Chief Executive Officer. "The Company is conducting Azedra pivotal trials for both adult pheochromocytoma and pediatric neuroblastoma neuroendocrine tumor indications. Molecular Insight is pursuing a Special Protocal Assessment (SPA) from the Federal Drug Administration (FDA) for a pivotal Phase 2 neuroblastoma trial. Having received the European Medicines Agency approval of our protocol, an Onalta Phase 3 pivotal trial in carcinoid patients can be initiated."
Azedra Advances to Phase 2 Clinical Trial
In March, Molecular Insight received a Special Protocol Assessment letter from FDA approving the design of the pivotal Phase 2 trial for registration of Azedra (Ultratrace(TM) Iobenguane I 131). If successful, this promising candidate would be the first anti-cancer therapy in the United States indicated for the treatment of pheochromocytoma, a type of neuroendocrine cancer. For patients with this malignant disease, for whom surgery is not an option, the five-year survival rate is less than 50%.
The Azedra trial IB-12B will be conducted in 58 adults (evaluable) with pheochromocytoma, with an expected enrollment of about 75.