AVEO third quarter total collaboration revenues increase to $6.2 million

AVEO PharmaceuticalsNov 4 2010

AVEO Pharmaceuticals, Inc. (NASDAQ: AVEO), a biopharmaceutical company focused on discovering, developing and commercializing cancer therapeutics, today announced updated financial guidance and third quarter financial results, as well as recent developments.

"During the third quarter, we achieved two significant developments - completing enrollment of TIVO-1, our Phase 3 clinical trial of tivozanib in patients with advanced kidney cancer, which advances the expected timeline for top-line data for TIVO-1 by six months to mid-2011, and regaining worldwide rights to AV-299, our internally-discovered anti-HGF antibody," said Tuan Ha-Ngoc, president and chief executive officer of AVEO. "We now have two late-stage, unencumbered assets with potential to advance toward commercialization. We believe that these events, coupled with the proceeds from our recently-completed private placement, position AVEO well for achieving our vision of becoming a fully integrated cancer therapeutics company and making a meaningful contribution to the treatment of patients with cancer."

Financing and Financial Guidance

• On October 29, 2010, the company announced that it had entered into a definitive agreement with respect to the private placement of 4.5 million shares of its unregistered common stock at $13.50 per share to a group of institutional and accredited investors. AVEO completed the private placement on November 3, 2010, resulting in approximately $57 million in net proceeds to AVEO.
• With the net proceeds from the private placement financing, AVEO expects to end 2010 with at least $100 million in cash and marketable securities.

Third Quarter 2010 Financial Results

• AVEO ended the third quarter of 2010 with cash and marketable securities of $87.0 million.
• Total collaboration revenues for the third quarter of 2010 were $6.2 million compared with $5.9 million for the third quarter of 2009.
• Research and development (R&D) expense for the third quarter of 2010 was $20.3 million compared with $16.5 million for the same period of 2009. The increase in R&D spending was primarily driven by clinical costs associated with TIVO-1, AVEO's global Phase 3 clinical trial of tivozanib in patients with advanced RCC, which commenced enrollment in February 2010.
• General and administrative expense was $3.6 million for the third quarter of 2010 compared with $2.5 million for the third quarter of 2009. The primary driver of the increase in spending was personnel-related expenses.
• Net loss for the third quarter of 2010 was $18.6 million, or $0.60 per common share (based on 30.9 million weighted average shares outstanding), compared with $13.8 million, or $8.56 per common share, for the third quarter of 2009 (based on 1.6 million weighted average shares outstanding). The difference in the number of weighted average shares outstanding primarily resulted from AVEO's initial public offering in March 2010, as well as the conversion of all preferred stock to common stock.

Recent Developments

• Completed Enrollment of TIVO-1: In August, AVEO announced that it achieved its enrollment target for TIVO-1 in patients with advanced renal cell carcinoma (RCC). AVEO initiated patient enrollment in TIVO-1 in February of this year and successfully reached the target enrollment of 500 patients six months ahead of schedule. The company expects top-line data from this trial in mid-2011.
• Presented Previously Announced Phase 2 Tivozanib Data at IKCS and ESMO: AVEO presented previously announced data from the Phase 2 randomized discontinuation trial with tivozanib showing that the median progression-free survival (PFS) achieved by patients with advanced clear cell RCC who had undergone a prior nephrectomy was 14.8 months. This is the same patient population being studied in the TIVO-1 Phase 3 trial. Median PFS among all 272 patients in the Phase 2 trial was 11.8 months. Off-target toxicities commonly associated with other VEGF-directed targeted therapies, such as mucositis, fatigue and hand-foot syndrome, were notably low during treatment with tivozanib in the Phase 2 trial.
• Regained Worldwide Rights to AV-299: In September, AVEO announced that it regained worldwide rights from Merck (through its subsidiary, Schering Corporation) to develop and commercialize AV-299, AVEO's anti-hepatocyte growth factor (HGF) antibody candidate, effective as of December 27, 2010. AV-299 is a potent, anti-HGF antibody that was discovered by AVEO through its Human Response Platform™. Data from Phase 1 clinical trials of AV-299 indicate the potential for a favorable tolerability profile and good combinability with EGFR inhibitors, erlotinib (Tarceva^®) and gefitinib (Iressa^®). In June 2010, AVEO initiated a Phase 2 clinical trial evaluating AV-299 in combination with gefitinib versus gefitinib monotherapy in patients with non-small cell lung cancer (NSCLC). In conjunction with the Phase 2 trial initiation, AVEO received an $8.5 million milestone payment from Merck under the terms of the collaboration agreement. As of the effective date of the return of right from Merck, the company will be responsible for future development, manufacturing and commercialization funding for the AV-299 program. Top-line efficacy data from the AV-299 Phase 2 trial are expected in 2012.
• Awarded approximately $733,000 in Grants under Patient Protection and Affordable Care Act: In November, AVEO was informed that it has been awarded three separate grants totaling approximately $733,000 under the Patient Protection and Affordable Care Act of 2010. These grants support both clinical and pre-clinical development activities related to tivozanib, AV-299, as well as AVEO's discovery stage programs and proprietary Human Response Platform™.

Upcoming Activities

AVEO expects to present at the following investor conferences:

• 22^nd Annual Piper Jaffray Health Care Conference, New York City, November 30-December 1, 2010
• J.P. Morgan SMid Cap Conference, New York City, December 2-3, 2010
• Deutsche Bank's 2010 BioFEST, Boston, December 14-15, 2010

AVEO expects to have a presence at the following oncology meetings:

• 28^th Annual Chemotherapy Foundation Symposium (CFS), New York City, November 9-13, 2010
• 22^nd Annual Symposium of the European Organization for Research and Treatment of Cancer-National Cancer Institute-American Association for Cancer Research (EORTC-NCI-AACR), Berlin, Germany, November 16-19, 2010
• 33^rd Annual San Antonio Breast Cancer Symposium (SABCS), San Antonio, Texas, December 8-12, 2010