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AVEO Reports Third Quarter 2013 Financial Results

AVEO Oncology (NASDAQ: AVEO) today reported its third quarter 2013 financial results.

“We continue to execute on the strategy we outlined earlier this year, focusing our resources where the unique insights derived from our proprietary Human Response Platform™ will enable the potential development of therapies for biomarker-defined patient populations,” said Tuan Ha-Ngoc, president and chief executive officer of AVEO. “In the third quarter, we further expanded our pipeline with the nomination of AV-380 as our clinical development candidate for our program focused on cachexia, a serious complication of cancer and a number of chronic diseases that is characterized by symptoms of unintentional weight loss, progressive muscle wasting, and a loss of appetite, and for which there is a high unmet medical need.”

Third Quarter Pipeline Update
  • Phase 2 study of tivozanib in colorectal cancer fully enrolled since first half of 2013: AVEO, and its partner Astellas Pharma, Inc., continue to evaluate tivozanib in a Phase 2 BATON ( Biomarker Assessment of Tivozanib in ONcology) study in patients with advanced metastatic colorectal cancer (CRC). BATON is a series of clinical trials assessing biomarkers in solid tumors that may be predictive of clinical response to tivozanib. Enrollment was completed in the Phase 2 study in patients with CRC earlier this year, and data are anticipated in 2014.
  • Enrollment slower than anticipated in Phase 2 study of tivozanib in breast cancer: AVEO and Astellas continue to evaluate tivozanib in a Phase 2 BATON study in patients with locally recurrent or metastatic triple negative breast cancer (TNBC). Enrollment in this study has been slower than anticipated. AVEO has undertaken additional patient recruitment efforts in support of this study and expects to reassess enrollment rates and the impact on its plans in TNBC in the coming months.
  • Dose-escalation portion of AV-203 Phase 1 study completed: AV-203, AVEO’s antibody targeting the ErbB3 (HER3) receptor, has demonstrated tolerability in the dose-escalation portion of the ongoing Phase 1 study in patients with solid tumors, and the recommended dose for further evaluation has been established. AV-203 is now being evaluated in an expansion cohort in a biomarker-defined patient population.
  • AV-380 nominated the clinical candidate for cachexia program: AVEO has nominated AV-380 as the development candidate for its program focusing on cachexia. AV-380 is an antibody discovered using AVEO’s proprietary Human Response Platform™ that addresses a target believed to be involved in cachexia in patients with cancer and other chronic diseases. Appropriate IND-enabling efforts, including cell line development, have been initiated to begin to prepare AV-380 for future clinical development.

Third Quarter 2013 Financial Results
  • Total collaboration revenue for the third quarter of 2013 was approximately $0.3 million compared with $1.0 million for the third quarter of 2012. The decrease was due to revenue recognized for research funding in the third quarter of 2012 under a collaboration agreement with Centocor Ortho Biotech Inc., which was terminated in December 2012. Revenue recognized during the third quarter of 2013 consisted of the amortization of previously deferred amounts related to AVEO’s collaboration agreements with Biogen Idec International GmbH and Astellas.
  • Research and development (R&D) expense for the third quarter of 2013 was $19.4 million compared with $21.1 million for the third quarter of 2012. The decrease in R&D expense was primarily due to a reduction in personnel-related expenses following the strategic restructurings announced in October 2012 and June 2013 and a decrease in clinical trial and regulatory costs for tivozanib and ficlatuzumab, offset by development costs relating to the manufacture of ficlatuzumab.
  • General and administrative (G&A) expense for the third quarter of 2013 was $4.4 million compared with $9.3 million for the third quarter of 2012. The decrease in G&A expense was primarily due to a reduction in personnel-related expenses following our strategic restructuring announced in June 2013 and a reduction in pre-commercialization costs associated with tivozanib.
  • Net loss for the third quarter of 2013 was $24.3 million, or basic and diluted net loss per share of $0.47, compared with a net loss of $30.1 million, or basic and diluted net loss per share of $0.69 for the third quarter of 2012.
  • AVEO ended the third quarter of 2013 with cash, cash equivalents and marketable securities of $130.4 million.

Financial Guidance

Based on current operating plans, AVEO continues to expect to end 2013 with approximately $115 million in cash, cash equivalents and marketable securities, which the company believes is sufficient to fund its operations through at least the second quarter of 2015.

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