SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
Pursuant to Section 13 or 15(d)
of the Securities Exchange Act of 1934
Date of Report (Date of earliest event reported): January 4, 2018
AVEO Pharmaceuticals, Inc.
(Exact Name of Registrant as Specified in Charter)
(State or Other Jurisdiction
One Broadway, 14th Floor
|(Address of Principal Executive Offices)||(Zip Code)|
Registrants telephone number, including area code: (617) 588-1960
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))|
Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter).
Emerging growth company ☐
If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐
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, strategy, 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 plans to leverage biomarkers and pursue strategic partnerships for certain of its assets; AVEOs goals, business strategy and potential achievement of milestones; the timing, design and results of preclinical and clinical trials; the timing and outcome of meetings with and applications to regulatory authorities by AVEO and its partners; the competitive landscape and potential markets for AVEOs therapeutic candidates; 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 to successfully implement its strategic plans; AVEOs ability to successfully develop, test and gain regulatory approval of its product candidates, including its companion diagnostics; the potential safety, efficacy, tolerability and other benefits of tivozanib as a single agent or in combination with other therapies; developments, expenses and outcomes related to AVEOs ongoing shareholder litigation; AVEOs ability to obtain necessary financing required to perform its clinical trials and achieve its other goals; AVEOs ability to establish and maintain strategic partnerships; AVEOs ability to obtain and maintain intellectual property rights; competition; AVEOs dependence on its strategic partners and other third parties; adverse general economic and industry conditions; and those risk factors discussed in the Risk Factors and elsewhere in AVEOs Annual Report on Form 10-K for the year ended December 31, 2016 and other periodic filings AVEO makes with the SEC. 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 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.||Regulation FD.|
From time to time, we conduct meetings with third parties in which we utilize a corporate slide presentation. The slide presentation that we expect to utilize in our January 11, 2018 presentation, and related meetings, at the Annual J.P. Morgan Healthcare Conference is attached as Exhibit 99.1 to this Current Report on Form 8-K and is incorporated herein by reference.
The presentation includes an update to our estimated timeline for reporting topline results from the TIVO-3 trial of tivozanib in third-line refractory renal cell carcinoma. We expect to report TIVO-3 topline data, including progression free survival and the trend in overall survival, in the second quarter of 2018.
The presentation also includes other clinical, development, collaboration and financial updates, including the previously reported cash flow impact of the refinancing of our existing debt facility with Hercules Capital, Inc. and its affiliates. The terms of the refinancing enable approximately an additional $12.1 million in cash flow over 2018 and 2019, when compared with the prior loan, and are expected to extend our cash runway into 2019. For the complete terms of the Amended and Restated Loan and Security Agreement, dated December 28, 2017, by and among the Company and the parties thereto, see our Current Report on Form 8-K filed with the Securities and Exchange Commission on January 2, 2018.
We may amend or update this information 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.
|Item 9.01.||Financial Statements and Exhibits.|
|99.1||Corporate Presentation Slide Deck dated January 2018|
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.|
|Date: January 4, 2018|
|President and Chief Executive Officer|