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): November 5, 2019
AVEO Pharmaceuticals, Inc.
(Exact Name of Registrant as Specified in its 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
(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))
Securities registered pursuant to Section 12(b) of the Act:
Title of each class
Name of each exchange
on which registered
|Common Stock, $0.001 par value||AVEO||Nasdaq Capital Market|
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, 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 communications with, and 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 its plans and expectations regarding the results of overall survival analyses for the Phase 3 TIVO-3 study of tivozanib in advanced or metastatic renal cell carcinoma (RCC); the timing and outcome of meetings with and applications to regulatory authorities by AVEO and its partners; the competitive landscape for, and the potential utility of, AVEOs product candidates; AVEOs statements regarding the potential efficacy, safety and tolerability profile of tivozanib, including with respect to overall survival; the potential commercial opportunity of tivozanib and AVEOs other product 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, 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; 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; 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 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 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.|| |
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 clinical, 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.
|Item 9.01.|| |
Financial Statements and Exhibits.
|99.1||Corporate Presentation Slide Deck dated November 2019|
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.|
|President and Chief Executive Officer|
Date: November 5, 2019
AVEO Overview November 2019
Cautionary Note Regarding Forward-Looking Statements
Multiple Potential Opportunities for Value Creation
FOTIVDA® (tivozanib) TIVO-3 Pivotal Phase 3 Study
Tivozanib: VEGFR 1, 2 and 3 Tyrosine Kinase Inhibitor
TIVO-3: Study Design
TIVO-3: Superior PFS and ORR*
Progression-Free Survival – Key Subgroups*
Durable Disease Control with Tivozanib (Patients with > 1 year PFS)
Secondary Endpoint – Overall Survival
Pre-NDA Regulatory Feedback and POA
As OS Data Matures HR Improves
Treatment-Related Adverse Events* (≥20% frequency in either arm)
PD-1 Combination Opportunities
Tivozanib Properties May Provide Advantages in Combination with IO Therapy
Phase 2 Data Presented at ESMO in September 2019
ESMO 2019: Encouraging Safety Results
ESMO 2019: Encouraging Efficacy
Combination of PD-1 + VEGF TKIs: Promising Responses, All Phase 3 Currently 1st Line
TiNivo – Strong Efficacy Seen in Both Treatment Naive and Previously Treated Patients
Immuno-Oncology Clinical Collaboration with AstraZeneca
Tivozanib Commercial Opportunity
If Approved, Significant Potential Commercial Opportunity for Tivozanib in the United States
Potential Relevance of Tivozanib in Refractory RCC
FOTIVDA® Commercialization in EU and ROW
Pipeline and Near-Term Milestones
AVEO Key Near Term Potential Milestones
AVEO Overview November 2019