CAUTIONARY NOTE REGARDING FORWARD-LOOKING STATEMENTS:
This Current Report on Form
8-K
contains forward-looking statements of AVEO Pharmaceuticals, Inc. (AVEO,
we, our or us) that involve substantial risks and uncertainties. All statements, other than statements of historical facts, contained in this Current Report on Form
8-K
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; and the European Medicines Agencys (the EMA) potential
regulatory actions regarding tivozanib.
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 and the EMA 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; competitive factors; and those risks discussed in the sections 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 U.S. Securities and Exchange Commission (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
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 AVEOs views as of any date subsequent to the date of this Current Report.
In August 2017, the European Commission granted marketing authorization for tivozanib to our licensee, EUSA Pharma (UK) Limited (EUSA), in all 28
countries of the European Union, Norway and Iceland. Tivozanib is sold under the brand name FOTIVDA and is approved for the first-line treatment of adult patients with advanced or metastatic renal cell carcinoma (RCC) and for adult
patients who are vascular endothelial growth factor receptor and mTOR pathway
inhibitor-naïve
following disease progression after one prior treatment with cytokine therapy for RCC.
As previously disclosed, the Committee for Medicinal Products for Human Use (CHMP) of the EMA, as part of its post-authorization monitoring
procedures, requested the topline data results from our
TIVO-3
trial. In addition, the CHMP requested data analyses to explain the discordance between the final progression-free survival (PFS)
results (HR 0.73) and the preliminary OS results (HR 1.12) in the
TIVO-3
trial.
Following its review, the CHMP
has determined that the analyses of various factors that may have impacted the preliminary OS data do not fully explain the discordance, and that more mature OS data is required prior to drawing a conclusion. Similar to the FDA, the CHMP accepted
the proposal to conduct an additional interim OS analysis in August 2019. The CHMP further provided that regulatory action should be considered if the August 2019 interim OS analysis confirms a negative trend in OS.