AVEO third quarter net loss increases to $23.8 million

AVEO Pharmaceuticals, Inc. (NASDAQ: AVEO) today reported consolidated financial results for the third quarter of 2011 and provided an update on the tivozanib clinical program.

“The last few months have been focused on executing on our business and clinical development strategies, and I am very pleased with our continued progress on all fronts”

"The last few months have been focused on executing on our business and clinical development strategies, and I am very pleased with our continued progress on all fronts," said Tuan Ha-Ngoc, president and chief executive officer of AVEO. "Importantly, based on the most recent review of the event data in our ongoing Phase 3 trial of tivozanib, TIVO-1, we believe we are on track to reach the necessary number of events in the fourth quarter, which means we now expect to announce top-line data in the first quarter of 2012."

TIVO-1 is AVEO's pivotal, global Phase 3 trial comparing the efficacy and safety of tivozanib to sorafenib (Nexavar^®) in patients with advanced renal cell carcinoma. In addition to TIVO-1, AVEO and Astellas Pharma Inc., its collaborator, continue to plan to expand the development of tivozanib in colorectal and breast cancers independent of TIVO-1 data. Astellas and AVEO expect to initiate a Phase 2 clinical trial of tivozanib in patients with colorectal cancer this year. Due to a supply shortage of a combination agent, AVEO and Astellas expect to initiate a clinical trial of tivozanib in patients with breast cancer in 2012.

In addition, AVEO is continuing to make progress in the ongoing clinical development of ficlatuzumab, its novel HGF/c-MET pathway inhibitor currently being evaluated in a Phase 2 trial as first-line therapy in patients with both wild-type and mutant EGFR non-small cell lung cancer in combination with gefitinib versus gefitinib monotherapy. AVEO completed enrollment of 188 patients in the Phase 2 trial earlier this year, and the company remains on track to announce data from the Phase 2 trial in 2012.

Third Quarter 2011 Financial Results

• Total collaboration revenues for the third quarter ended September 30, 2011 were $3.6 million compared with $6.2 million for the third quarter of 2010. The primary driver for the decrease was a reduction in revenue recognized in conjunction with AVEO's collaboration agreements with OSI and Merck as a result of the completion of work with OSI and termination of the agreement with Merck. The decrease in revenue was partially offset by research and development (R&D) funding from Centocor Ortho Biotech Inc.
• R&D expense for the third quarter of 2011 was $20.1 million compared with $20.3 million for the third quarter of 2010. The decrease in R&D expense was primarily due to reimbursable amounts under the cost sharing provisions of AVEO's collaboration agreement with Astellas, partially offset by an increase in expenses mainly related to tivozanib.
• General and administrative (G&A) expense for the third quarter of 2011 was $6.6 million compared with $3.6 million for the third quarter of 2010. The increase in G&A expense was primarily driven by an increase in personnel-related expenses and expenses related to pre-commercialization activities for tivozanib.
• Net loss for the third quarter of 2011 was $23.8 million, or basic and diluted net loss per share of $0.55 compared with a net loss of $18.6 million, or basic and diluted net loss per share of $0.60 for the third quarter of 2010.
• AVEO ended the third quarter of 2011 with cash, cash equivalents and marketable securities of $296.4 million.

Financial Guidance

AVEO continues to expect to end 2011 with at least $230 million in cash, cash equivalents and marketable securities. AVEO anticipates that this capital should allow it to fund its current operating plan beyond 2012.

Upcoming Activities

AVEO expects to present at the following oncology medical meetings:

• 3rd European Multidisciplinary Meeting on Urologic Cancers (EMUC) Conference, Barcelona, Spain, November 4-6, 2011
• AACR-NCI-EORTC International Conference on Molecular Targets and Cancer Therapeutics, San Francisco, November 12-16, 2011