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CAMBRIDGE, Mass.--([ BUSINESS WIRE ])--AVEO Pharmaceuticals, Inc. (Nasdaq: AVEO) today reported consolidated 2011 financial results and reviewed key progress achieved with its tivozanib and ficlatuzumab development programs in the fourth quarter of 2011.

"Tivozanibas favorable efficacy and tolerability have now been demonstrated in two large, well-controlled studies. We believe the longest median progression-free survival reported to-date in a first-line pivotal trial in treatment nave RCC patients combined with its well-tolerated safety profile positions tivozanib to provide patients with a significantly differentiated treatment option."

aThe recent success of our Phase 3 registration trial of tivozanib in RCC, TIVO-1, marks an important milestone for AVEO as we prepare for our first NDA submission later this year,a said Tuan Ha-Ngoc, president and chief executive officer of AVEO. aTivozanibas favorable efficacy and tolerability have now been demonstrated in two large, well-controlled studies. We believe the longest median progression-free survival reported to-date in a first-line pivotal trial in treatment nave RCC patients combined with its well-tolerated safety profile positions tivozanib to provide patients with a significantly differentiated treatment option.a

Full Year 2011 Financial Results

• Total collaboration revenues for 2011 were $164.8 million compared with $44.7 million for 2010. The primary driver for the increase was revenue recognized in conjunction with AVEOas collaboration agreements with Astellas and Centocor, as well as revenue from OSI primarily related to the exercise of its option to acquire certain rights to our technology platform. These increases were partially offset by the fact that no revenues were earned from Merck as a result of the termination of the companiesa collaboration agreement in December 2010.
• Research and development (R&D) expense for 2011 was $101.7 million compared with $86.3 million for 2010. The increase in R&D expense was primarily due to an increase in contract manufacturing costs for ficlatuzumab and tivozanib, payments to Kyowa Hakko Kirin related to the up-front license payment received from Astellas, as well as an increase in personnel-related expenses mainly due to increased support for tivozanib development activities. These increases were partially offset by reimbursable amounts under the cost sharing provisions of AVEOas collaboration agreement with Astellas.
• General and administrative (G&A) expense for 2011 was $29.2 million compared with $14.8 million for 2010. The increase in G&A expense was primarily driven by non-recurring expenses for strategic, legal and financial advisors incurred in connection with AVEOas collaboration agreement with Astellas, an increase in personnel-related expenses and expenses related to pre-commercialization activities for tivozanib.
• Net income for 2011 was $30.6 million, or basic and diluted earnings per share of $0.77 and $0.74, respectively, compared with a net loss of $58.8 million, or basic and diluted loss per share of $2.30 for 2010.
• AVEO ended 2011 with cash, cash equivalents and marketable securities of $275.4 million.

Financial Guidance

AVEO expects year-end 2012 cash, cash equivalents and marketable securities of at least $120 million, with R&D spending, net of cost sharing with Astellas, of approximately $130 million. AVEO anticipates that this capital is sufficient to fund its operations into the second half of 2013 based on its current operating plans.

Fourth Quarter 2011 Key Accomplishments

• Completed top-line analysis of pivotal tivozanib Phase 3 trial, TIVO-1: Notably, in the fourth quarter, AVEO completed top-line analysis of TIVO-1, a global, randomized, Phase 3, superiority clinical trial evaluating the efficacy and safety of tivozanib compared to sorafenib in 517 patients with advanced renal cell carcinoma (RCC). Top-line data were announced in January 2012 and showed that tivozanib successfully demonstrated superiority over sorafenib in the primary endpoint of progression-free survival (PFS) in TIVO-1. Key top-line findings from TIVO-1 include:
  • Tivozanib demonstrated a statistically significant improvement in PFS with a median PFS of 11.9 months compared to a median PFS of 9.1 months for sorafenib in the overall study population.
  • Tivozanib demonstrated a statistically significant improvement in PFS with a median PFS of 12.7 months compared to a median PFS of 9.1 months for sorafenib in the pre-specified subpopulation of patients who were treatment nave (no prior systemic anti-cancer therapy); this subpopulation was approximately 70% of the total study population and reflects the first-line RCC setting in North America and Europe.
  • Tivozanib demonstrated a well-tolerated safety profile consistent with the Phase 2 experience; the most commonly reported side effect was hypertension, a well-established on-target and manageable effect of VEGFR inhibitors. The side effects commonly associated with other VEGFR inhibitors, such as diarrhea, fatigue and hand-foot syndrome, were notably low.

Based on these data and success of the TIVO-1 trial, AVEO and Astellas are moving forward with plans for submitting the tivozanib NDA in RCC in the third quarter of 2012, with the MAA submission to follow. Detailed findings from TIVO-1 have been submitted for presentation at the 2012 Annual Meeting of the American Society of Clinical Oncology (ASCO) being held June 1-5, 2012 in Chicago.

• Initiated enrollment in tivozanib Phase 2 trial in patients with colorectal cancer, BATON-CRC: In December 2011,AVEO announced the initiation of patient enrollment in an open-label, multicenter, randomized Phase 2 clinical trial, called BATON-CRC, evaluating tivozanib in combination with modified FOLFOX6 (mFOLFOX6) compared to bevacizumab in combination with mFOLFOX6 as first-line therapy in patients with advanced metastatic colorectal cancer (CRC). BATON-CRC, which is being led by AVEOas collaborator Astellas, is the second trial to be initiated as part of the BATON (Biomarker Assessment of Tivozanib in ONcology) program, a series of clinical trials to assess tivozanib efficacy and biomarkers in solid tumors.
• Entered into manufacturing agreement for ficlatuzumab with Boehringer Ingelheim: In December 2011,AVEO announced it entered into an agreement with Boehringer Ingelheim for large-scale process development and clinical manufacturing of ficlatuzumab, AVEOas novel HGF inhibitory antibody that is currently being evaluated in a Phase 2 clinical trial as first-line therapy in combination with gefitinib versus gefitinib monotherapy in patients with non-small cell lung cancer. AVEO retains all rights to the development and commercialization of ficlatuzumab.

Upcoming Activities

AVEO expects to present at the following investor conferences:

• Leerink Swann 2012 Global Healthcare Conference, February 15-16, 2012 in New York City.
• Citi 2012 Global Health Care Conference, February 27-29, 2012 in New York City.
• 2012 RBC Capital Marketsa Global Healthcare Conference, February 28-29, 2012 in New York City.
• Cowen and Company32^nd AnnualHealth Care Conference, March 5-7, 2012 in Boston, Mass.

Todayas Conference Call and Webcast Reminder

The AVEO management team will host a conference call at 10:00 a.m. (EST) today. The call can be accessed by dialing 1-866-800-8652 (domestic) or 1-617-614-2705 (international) five minutes prior to the start of the call and providing the passcode 29955196. A replay of the call will be available approximately two hours after the completion of the call and can be accessed by dialing 1-888-286-8010 (domestic) or 1-617-801-6888 (international), providing the passcode 99138406. The replay will be available for two weeks from the date of the live call.

A live, listen-only webcast of the conference call can also be accessed by visiting the investors section of the AVEO website atinvestor.aveopharma.com. A replay of the webcast will be archived on the company's website for two weeks following the call.

About AVEO

AVEO Pharmaceuticals (Nasdaq: AVEO) is a cancer therapeutics company committed to discovering, developing and commercializing targeted therapies to impact patientsa lives. AVEOas proprietary Human Response Platforma" provides the company unique insights into cancer biology and is being leveraged in the discovery and clinical development of its cancer therapeutics. For more information, please visit the companyas website at www.aveopharma.com.

Cautionary Note Regarding Forward-Looking Statements

This press release contains forward-looking statements of AVEO that involve substantial risks and uncertainties. All statements, other than statements of historical facts, contained in this press release are forward-looking statements, within the meaning of The Private Securities Litigation Reform Act of 1995. The words aanticipate,a abelieve,a aestimate,a aexpect,a aintend,a amay,a aplan,aatarget,a apotential,a acould,a ashould,a aseek,a or the negative of these terms or other similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. These forward-looking statements include, among others, statements about: the potential for tivozanib to bea differentiated treatment option for patients; AVEOas continued advancement of its clinical programs; AVEOas plans to file for regulatory approval of tivozanib in the U.S. and the E.U.; AVEOas estimates for its 2012 financial performance (including its expected year-end cash balance) and AVEOas estimates regarding its ability to fund its future operations. Actual results or events could differ materially from the plans, intentions and expectations disclosed in the forward-looking statements that AVEO makes due to a number of important factors, including risks relating to: difficulties, delays or failures in AVEOas ability to successfully research, develop or obtain and maintain regulatory approvals for tivozanib, ficlatuzumab and AVEOas other product candidates; the possibility that tivozanib will not achieve the regulatory approvals required for its successful commercialization either in the U.S. or abroad; potential delays in data availability from ficlatuzumab; potential delays in the initiation of other clinical trials of tivozanib; AVEOas inability to obtain and maintain adequate protection for intellectual property rights relating to AVEOas product candidates and technologies; unplanned operating expenses; AVEOas inability to raise substantial additional funds to achieve its goals; adverse general economic and industry conditions and those risks discussed in the section titled aRisk Factorsa and elsewhere in AVEOas most recent Quarterly Report on Form 10-Q and in its other filings with the Securities and Exchange Commission. The forward-looking statements in this press release represent AVEOas views as of the date of this press release. AVEO anticipates that subsequent events and developments will cause its views to change. However, while AVEO may elect to update these forward-looking statements at some point in the future, it specifically disclaims any obligation to do so. You should, therefore, not rely on these forward-looking statements as representing AVEOas views as of any date subsequent to the date of this press release.