Form 8-K












Pursuant to Section 13 or 15(d) of

the Securities Exchange Act of 1934

Date of Report (Date of earliest event reported): February 27, 2013



AVEO Pharmaceuticals, Inc.

(Exact Name of Registrant as Specified in Charter)




Delaware   001-34655   04-3581650

(State or Other Jurisdiction

of Incorporation)



File Number)


(IRS Employer

Identification No.)


75 Sidney Street

Cambridge, Massachusetts



  (Address of Principal Executive Offices)   (Zip Code)

Registrant’s telephone number, including area code: (617) 299-5000

(Former Name or Former Address, if Changed Since Last Report)



Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions (see General Instruction A.2. below):


¨ Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)


¨ Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)


¨ Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))


¨ Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))




Forward-Looking Statements

This Form 8-K and the exhibit attached hereto contain forward-looking statements of AVEO Pharmaceuticals, Inc. (“AVEO” or the “Company”) that involve substantial risks and uncertainties. All statements, other than statements of historical facts, contained in this Form 8-K and the exhibit attached hereto, are forward-looking statements. The words “anticipate,” “believe,” “estimate,” “expect,” “intend,” “may,” “plan,” “predict,” “project,” “target,” “potential,” “will,” “would,” “could,” “should,” “continue,” “contemplate,” 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 Company’s planned development, commercialization and manufacturing plans, timelines and strategies for tivozanib; the potential therapeutic advantages and benefits of tivozanib and the Company’s other product candidates; the timing and results of the Company’s ongoing and planned preclinical studies and clinical trials; the potential benefits of the Company’s strategic partnership agreements, its ability to achieve additional payments under these arrangements and its ability to enter into additional arrangements; the Company’s plans to leverage its Human Response Platform to inform clinical development; its intellectual property position and strategies; the expected RCC market and potential of tivozanib to obtain regulatory approval and enter this market; the Company’s anticipated plans for success in the oncology markets; the anticipated dates for the FDA’s ODAC meeting to review the Company’s NDA for tivozanib and the completion of the FDA’s review of the NDA; and the Company having sufficient capital to fund its operations into the second quarter of 2014 and the Company’s estimates for its 2013 expected year-end cash balance.

Actual results or events could differ materially from the plans, intentions and expectations disclosed in the forward-looking statements that the Company makes due to a number of important factors, including risks and uncertainties inherent in pharmaceutical research and development, such as those related to: the Company’s ability to successfully develop, test and gain approval of its product candidates, including regulatory approval of tivozanib to treat advanced RCC; the Company’s ability to obtain, maintain and enforce intellectual property rights; competition; the Company’s dependence on its alliance partners and other third parties; the Company’s ability to obtain necessary financing; adverse economic conditions; and other risk factors discussed in the “Risk Factors” and elsewhere in its Current Report on Form 8-K filed with the Securities and Exchange Commission (the “SEC”) on January 16, 2013 and in its other filings with the SEC. The forward-looking statements in this Form 8-K and the exhibit attached hereto represent the Company’s views as of the date of this Form 8-K. The Company anticipates that subsequent events and development will cause its views to change. However, while it may elect to update these forward-looking statements at some point in the future, it has no current intention of doing so except to the extent required by applicable law. You should, therefore, not rely on these forward-looking statements as representing the Company’s views as of any date subsequent to the date of this Form 8-K.

Item 7.01 Regulation FD Disclosure.

From time to time, the Company intends to conduct meetings with third parties in which its current corporate slide presentation is presented. A copy of this slide presentation, dated February 27, 2013, is attached as Exhibit 99.1 to this Current Report on Form 8-K and the information contained therein is incorporated herein by reference.

The information in this Item 7.01 and Exhibit 99.1 shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”) or otherwise subject to the liabilities of that section, nor shall it be deemed incorporated by reference in any filing under the Securities Act of 1933, as amended, or the Exchange Act, except as expressly set forth by specific reference in such a filing.

Item 9.01 Financial Statements and Exhibits.


  (d) Exhibits

See Exhibit Index attached hereto, which is incorporated by reference herein.


Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.


AVEO Pharmaceuticals, Inc.

/s/ David B. Johnston

Name:   David B. Johnston
Title:   Chief Financial Officer

Date: February 27, 2013






99.1   Presentation dated February 27, 2013.