CAUTIONARY NOTE REGARDING FORWARD-LOOKING STATEMENTS:
This Current Report on Form
8-K
and the exhibit attached hereto contain forward-looking statements of AVEO
Pharmaceuticals, Inc. (AVEO, the Company, or we) that involve substantial risks and uncertainties. All statements, other than statements of historical facts, contained in this Current Report on Form
8-K
and the attached exhibit are forward-looking statements. The words anticipate, believe, estimate, expect, intend, may, plan,
predict, project, target, potential, will, would, could, should, continue, contemplate, seek, look
forward, advance, goal, strategy, promising, opportunity 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: AVEOs goals and business strategy, prospects, plans and objectives; AVEOs plans regarding
potentially submitting a new drug application (NDA) to the U.S. Food and Drug Administration (FDA) for tivozanib; the timing, design and results of preclinical and clinical trials, including AVEOs plans to conduct, and
expectations regarding the timing and potential results of, interim and final overall survival analyses for the Phase 3
TIVO-3
study of tivozanib in RCC; the timing and outcome of meetings with and
applications to regulatory authorities by AVEO and its partners; the competitive landscape for AVEOs therapeutic candidates; AVEOs plans regarding the potential efficacy, safety and tolerability profile of tivozanib, including with
respect to overall survival; and AVEOs estimates for its cash runway.
Actual results or events could differ materially from the plans, intentions
and expectations disclosed in the forward-looking statements AVEO makes due to a number of important factors, including substantial risks and uncertainties relating to: AVEOs ability, and the ability of its licensees, to demonstrate to the
satisfaction of applicable regulatory agencies such as the FDA the safety, efficacy and clinically meaningful benefit of AVEOs product candidates, including, in particular, tivozanib; AVEOs ability to successfully file an NDA for
tivozanib; AVEOs and its collaborators ability to successfully enroll and complete clinical trials; and AVEOs ability to enter into and maintain its third party collaboration and license agreements, and its ability, and the ability
of its strategic partners, to achieve development and commercialization objectives under these arrangements. AVEO faces other risks relating to its business as well, including risks relating to the timing and costs of seeking and obtaining
regulatory approval; AVEOs ability to maintain compliance with regulatory requirements applicable to its product candidates; AVEOs ability to obtain and maintain adequate protection for intellectual property rights relating to its
product candidates; AVEOs ability to successfully implement its strategic plans; AVEOs ability to raise the substantial additional funds required to achieve its goals, including those goals pertaining to the development and
commercialization of tivozanib; unplanned capital requirements; adverse general economic and industry conditions; and those risks discussed in the section titled Risk Factors and Managements Discussion and Analysis of
Financial Condition and Results of OperationsLiquidity and Capital Resources included in AVEOs quarterly and annual reports on file with the SEC and in other filings that AVEO may make with the SEC in the future. All
forward-looking statements contained in this Current Report on
Form 8-K
and the attached exhibit speak only as of the date of this Current Report, and AVEO undertakes no obligation, and specifically
disclaims any obligation, to update any of these statements, except as required by law. You should, therefore, not rely on these forward-looking statements as representing the Companys views as of any date subsequent to the date of this
Current Report.
Item 7.01.
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Regulation FD.
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From time to time, we conduct meetings with third parties in which we utilize a corporate slide presentation. A copy of our current corporate slide
presentation is attached as Exhibit 99.1 to this Current Report on Form
8-K
and is incorporated herein by reference.
The presentation includes detailed analysis of our Phase 3
TIVO-3
study of tivozanib in RCC and collaboration and
financial updates.
We may amend or update the information in this slide presentation at any time and from time to time through another Current Report on
Form
8-K,
a later company filing, or other means.
The information in this Item 7.01 and in 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.