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Aveo Pharmaceuticals Inc (AVEO) SEC Filing 10-K Annual report for the fiscal year ending Saturday, December 31, 2016

Aveo Pharmaceuticals Inc

CIK: 1325879 Ticker: AVEO

Exhibit 99.1

 

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AVEO Reports Full Year 2016 Financial Results and Provides Business Update

CAMBRIDGE, Mass. – March 22, 2017 – AVEO Oncology (NASDAQ: AVEO) today reported financial results for the full year ended December 31, 2016 and provided a business update.

“TIVO-3, our lead clinical program designed to serve as the basis for a potential U.S. registration for tivozanib as a first- and third-line treatment for renal cell cancer, continues to enroll ahead of schedule and has now completed its first safety review,” said Michael Bailey, president and chief executive officer of AVEO. “We look forward to the study’s pre-planned interim futility analysis midyear 2017 and, potentially, to top line results in the first quarter of 2018 and to initial data from our Phase 1 TiNivo study of tivozanib in combination with Opdivo® in the first half of 2017. We also continue to support our partner EUSA Pharma in its efforts to complete the European Marketing Authorization Application review for tivozanib as a first-line treatment for renal cell carcinoma. There remains a significant unmet need for better tolerated therapies in this disease, particularly those that enable combination treatment, and we look forward to receiving tivozanib data and to potential regulatory milestones in the coming quarters.”

Mr. Bailey continued: “We also look forward to several milestones with the balance of our pipeline, including the presentation of data from two investigator sponsored studies of ficlatuzumab, a potential partnership for AV-353, and progress toward the clinic for AV-380 and AV-203.”

Recent Updates

 

    TIVO-3 Enrolling Ahead of Schedule and Passes First Safety Monitoring Committee Safety Review; Pre-Planned Interim Futility Analysis Expected Midyear 2017. In February 2017, AVEO announced that its pivotal, Phase 3 TIVO-3 trial, a randomized, controlled, multi-center, open-label study to compare tivozanib to sorafenib in subjects with refractory advanced renal cell carcinoma (RCC), has successfully completed the first safety review by the study’s Safety Monitoring Committee (SMC). The SMC concluded that no safety concern was observed for tivozanib and recommended that the study replace the small number of patients who dropped out prior to starting treatment. The Company announced just prior to the safety review that the TIVO-3 trial is enrolling substantially ahead of schedule. With the SMC recommendation to replace early dropouts, the Company still expects to complete enrollment in June 2017, ahead of its prior guidance of August 2017. A pre-planned futility analysis of the trial is expected around midyear 2017, with topline data expected in the first quarter of 2018. The TIVO-3 trial, together with the previously completed TIVO-1 trial of tivozanib in the first-line treatment of RCC, is designed to support potential regulatory approval of tivozanib in the U.S. as a third- and first-line treatment for RCC.

 

   

First Patient Dosed in Phase 1/2 TiNivo Trial Evaluating Tivozanib in Combination with Bristol-Myers Squibb’s Opdivo® (nivolumab) in Advanced RCC. AVEO announced today that the first patient has been treated in the Company’s Phase 1/2 TiNivo

 


The following information was filed by Aveo Pharmaceuticals Inc (AVEO) on Wednesday, March 22, 2017 as an 8K 2.02 statement, which is an earnings press release pertaining to results of operations and financial condition. It may be helpful to assess the quality of management by comparing the information in the press release to the information in the accompanying 10-K Annual Report statement of earnings and operation as management may choose to highlight particular information in the press release.

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Inside Aveo Pharmaceuticals Inc's 10-K Annual Report:

Financial Statements, Disclosures and Schedules

Inside this 10-K Annual Report

Document And Entity Information
Consolidated Balance Sheets
Consolidated Balance Sheets (parenthetical)
Consolidated Statements Of Cash Flows
Consolidated Statements Of Comprehensive Loss
Consolidated Statements Of Operations
Consolidated Statements Of Stockholders' (deficit) Equity
Consolidated Statements Of Stockholders' (deficit) Equity (parenthetical)
Assumptions Used In Black Scholes Pricing Model For New Grants (detail)
Basis Of Presentation
Collaborations And License Agreements
Collaborations And License Agreements - Additional Information (detail)
Commitments And Contingencies
Commitments And Contingencies - Additional Information (detail)
Common Stock
Common Stock (tables)
Common Stock - Additional Information (detail)
Company Net Deferred Tax Assets (detail)
Components Of Lease Exit Activity Recorded In Current Liabilities (detail)
Employee Benefit Plan
Employee Benefit Plan - Additional Information (detail)
Facility Lease Exit
Facility Lease Exit (tables)
Facility Lease Exit - Additional Information (detail)
Future Minimum Payments Under Loans Payable (detail)
Income Taxes
Income Taxes (tables)
Income Taxes - Additional Information (detail)
Key Assumptions Used To Value The Pipe Warrants (detail)
Legal Proceedings
Legal Proceedings -additional Information (detail)
Loans Payable
Loans Payable (tables)
Loans Payable - Additional Information (detail)
Organization
Organization - Additional Information (detail)
Other Accrued Liabilities
Other Accrued Liabilities (detail)
Other Accrued Liabilities (tables)
Quarterly Results (unaudited)
Quarterly Results (unaudited) (tables)
Reconciliation Of Expected Income Tax Benefit (detail)
Reconciliation Of Gross Uncertain Tax Positions (detail)
Restricted Stock Activity (detail)
Restructuring Activity Recorded In Operating Expenses And Accrued Expenses (detail)
Significant Accounting Policies
Significant Accounting Policies (policies)
Significant Accounting Policies (tables)
Significant Accounting Policies - Additional Information (detail)
Stock Based Compensation Expense For Equity-classified Awards (detail)
Stock Option Activity (detail)
Stock-based Compensation
Stock-based Compensation (tables)
Stock-based Compensation - Additional Information (detail)
Strategic Restructuring
Strategic Restructuring (tables)
Strategic Restructuring - Additional Information (detail)
Summary Of Assets And Liabilities Measured At Fair Value On Recurring Basis (detail)
Summary Of Cash Equivalents And Marketable Securities (detail)
Summary Of Fair Value Of Company's Warrant Liability (detail)
Summary Of Outstanding Securities Not Included In Computation Of Diluted Net Loss Per Common Share (detail)
Summary Of Quarterly Results (detail)
Ticker: AVEO
CIK: 1325879
Form Type: 10-K Annual Report
Accession Number: 0001564590-17-005015
Submitted to the SEC: Wed Mar 22 2017 4:17:45 PM EST
Accepted by the SEC: Wed Mar 22 2017
Period: Saturday, December 31, 2016
Industry: Pharmaceutical Preparations

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