8-K

 

 

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

WASHINGTON, D.C. 20549

 

 

FORM 8-K

 

 

CURRENT REPORT

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)

 

 

 

Delaware   001-34655   04-3581650

(State or Other Jurisdiction

of Incorporation)

 

(Commission

File Number)

 

(IRS Employer

Identification No.)

 

One Broadway, 14th Floor

Cambridge, Massachusetts

  02142
(Address of Principal Executive Offices)   (Zip Code)

Registrant’s 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

 

Trading

Symbol(s)

 

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: AVEO’s goals and business strategy, prospects, plans and objectives; AVEO’s 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, AVEO’s product candidates; AVEO’s statements regarding the potential efficacy, safety and tolerability profile of tivozanib, including with respect to overall survival; the potential commercial opportunity of tivozanib and AVEO’s other product candidates and AVEO’s 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: AVEO’s 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 AVEO’s product candidates, including, in particular, tivozanib; AVEO’s ability to successfully file an NDA for tivozanib; AVEO’s and its collaborators’ ability to successfully enroll and complete clinical trials; AVEO’s 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; AVEO’s ability to maintain compliance with regulatory requirements applicable to its product candidates; AVEO’s ability to obtain and maintain adequate protection for intellectual property rights relating to its product candidates; AVEO’s ability to successfully implement its strategic plans; AVEO’s 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 “Management’s Discussion and Analysis of Financial Condition and Results of Operations—Liquidity and Capital Resources” included in AVEO’s 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 Company’s 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. 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.

 

(d)    Exhibits
99.1    Corporate Presentation Slide Deck dated November 2019


SIGNATURES

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.
By:  

/s/ Michael Bailey

  Michael Bailey
  President and Chief Executive Officer

Date: November 5, 2019

EX-99.1

Slide 1

AVEO Overview November 2019


Slide 2

Cautionary Note Regarding Forward-Looking Statements


Slide 3


Slide 4

Multiple Potential Opportunities for Value Creation


Slide 5

Financial Highlights


Slide 6

FOTIVDA® (tivozanib) TIVO-3 Pivotal Phase 3 Study


Slide 7

Tivozanib: VEGFR 1, 2 and 3 Tyrosine Kinase Inhibitor


Slide 8

TIVO-3: Study Design


Slide 9

TIVO-3: Superior PFS and ORR*


Slide 10

Progression-Free Survival – Key Subgroups*


Slide 11

Durable Disease Control with Tivozanib (Patients with > 1 year PFS)


Slide 12

Secondary Endpoint – Overall Survival


Slide 13

Pre-NDA Regulatory Feedback and POA


Slide 14

As OS Data Matures HR Improves


Slide 15

Treatment-Related Adverse Events* (≥20% frequency in either arm)


Slide 16


Slide 17

TIVO-3 Conclusions


Slide 18

PD-1 Combination Opportunities


Slide 19

Tivozanib Properties May Provide Advantages in Combination with IO Therapy


Slide 20

Phase 2 Data Presented at ESMO in September 2019


Slide 21

ESMO 2019: Encouraging Safety Results


Slide 22

ESMO 2019: Encouraging Efficacy


Slide 23

Combination of PD-1 + VEGF TKIs: Promising Responses, All Phase 3 Currently 1st Line


Slide 24

TiNivo – Strong Efficacy Seen in Both Treatment Naive and Previously Treated Patients


Slide 25

Immuno-Oncology Clinical Collaboration with AstraZeneca


Slide 26

Tivozanib Commercial Opportunity


Slide 27

If Approved, Significant Potential Commercial Opportunity for Tivozanib in the United States


Slide 28

Potential Relevance of Tivozanib in Refractory RCC


Slide 29

FOTIVDA® Commercialization in EU and ROW


Slide 30

Pipeline and Near-Term Milestones


Slide 31


Slide 32


Slide 33


Slide 34


Slide 35

AVEO Key Near Term Potential Milestones


Slide 36

AVEO Overview November 2019