AVEO Reports Third Quarter 2013 Financial Results

  AVEO Reports Third Quarter 2013 Financial Results

Business Wire

CAMBRIDGE, Mass. -- November 7, 2013

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

“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.

About AVEO

AVEO Oncology (NASDAQ: AVEO) is a cancer therapeutics company committed to
discovering and developing targeted therapies designed to provide substantial
impact in patients’ lives by addressing unmet medical needs. AVEO’s
proprietary Human Response Platform 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
company’s website at www.aveooncology.com.

Cautionary Note Regarding Forward-Looking Statements

This press release contains forward-looking statements of AVEO within the
meaning of The Private Securities Litigation Reform Act of 1995 that involve
substantial risks and uncertainties. All statements, other than statements of
historical facts, contained in this press release are forward-looking
statements. The words “anticipate,” “believe,” “estimate,” “expect,” “intend,”
“may,” “plan,” “target,” “potential,” “could,” “should,” “seek,” 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: AVEO’s plans to leverage its Human Response
Platform to develop targeted agents for specific patient populations; AVEO’s
plans to advance its preclinical and clinical development programs, including
its plans to assess its TNBC program and its plans to develop AV-380; and
AVEO’s estimates for its 2013 year-end cash balance and its estimate with
respect to the availability of cash to fund its operating plans through at
least the second quarter of 2015. 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: AVEO’s ability to execute on its revised
business plan and manage the impact of unplanned operating expenses; AVEO’s
ability to successfully enroll and complete clinical trials and preclinical
studies of its product candidates; AVEO’s ability to demonstrate to the
satisfaction of the FDA, or equivalent foreign regulatory agencies, the
safety, efficacy and clinically meaningful benefit of its product candidates;
AVEO’s ability to achieve and maintain compliance with all regulatory
requirements applicable to its product candidates; AVEO’s ability to obtain
and maintain adequate protection for intellectual property rights relating to
its product candidates and technologies; developments and expenses related to
AVEO’s ongoing shareholder litigation and SEC inquiry; AVEO’s ability to raise
the substantial additional funds required to achieve its goals; adverse
general economic and industry conditions; competitive factors; AVEO’s ability
to maintain its strategic partnerships and relationships, including its
collaboration with Astellas; and those risks discussed in the section titled
“Risk Factors” included in AVEO’s most recent Quarterly Report on Form 10-Q
and in its other filings with the SEC. The forward-looking statements in this
press release represent AVEO’s 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 AVEO’s views as of any date subsequent to the date
of this press release.

AVEO Pharmaceuticals, Inc.
Condensed Consolidated Statements of Operations
(In thousands, except per share amounts)
                         For the Three Months        For the Nine Months
                         Ended September 30,         Ended September 30,
                          2013        2012        2013        2012    
Collaboration revenue    $ 323         $ 1,018       $ 970         $ 3,755
Operating expenses:
Research and               19,414        21,099        56,579        67,325
General and                4,440         9,300         24,213        27,469
Restructuring             77          -           8,013       -       
                           23,931        30,399        88,805        94,794
Loss from operations       (23,608 )     (29,381 )     (87,835 )     (91,039 )
Other income and
Other income               32            46            (120    )     279
(expense), net
Interest expense           (756    )     (888    )     (2,451  )     (2,613  )
Interest income           26          101         102         459     
Other expense, net         (698    )     (741    )     (2,469  )     (1,875  )
Net loss                  (24,306 )   $ (30,122 )    (90,304 )   $ (92,914 )
Net loss per share -     $ (0.47   )   $ (0.69   )   $ (1.78   )   $ (2.14   )
basic and diluted
Weighted average
number of common          51,443      43,430      50,719      43,336  
shares outstanding

AVEO Pharmaceuticals, Inc.
Consolidated Balance Sheet Data
(In thousands)
                                                September 30,     December 31,
                                                    2013              2012
Cash, cash equivalents and marketable           $   130,362       $   160,602
Accounts receivable                                 8,893             20,649
Prepaid expenses and other current assets           7,232             9,430
Property and equipment, net                         12,766            12,867
Other assets                                       3,861            3,921
Total assets                                    $   163,114       $   207,469
Liabilities and stockholders’ equity
Accounts payable and accrued expenses           $   18,291        $   30,171
Total loans payable                                 21,592            26,037
Total deferred revenue                              18,715            19,685
Total deferred rent                                 17,468            11,400
Other liabilities                                   1,238             1,238
Stockholder's equity                               85,810           118,938
Total liabilities and stockholders’ equity      $   163,114       $   207,469


AVEO Oncology
David Johnston, 617-299-5810
Pure Communications
Dan Budwick, 973-271-6085
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