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Aveo Pharmaceuticals Inc (AVEO) SEC Filing 10-K Annual report for the fiscal year ending Sunday, December 31, 2017

Aveo Pharmaceuticals Inc

CIK: 1325879 Ticker: AVEO

 

 

Exhibit 99.1

 

AVEO Reports Full Year 2017 Financial Results and Provides Business Update

CAMBRIDGE, Mass. – March 13, 2018 –

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

“Last year was one of major progress for AVEO, with highlights including the first commercial launch of tivozanib (FOTIVDA®); the completion of the enrollment for TIVO-3, our U.S. registration study; the receipt of promising results from the Phase 1b/2 TiNivo combination trial of tivozanib and nivolumab (OPDIVO®); and progress across our earlier stage pipeline,” said Michael Bailey, president and chief executive officer of AVEO. “These achievements are only the beginning of our effort to unlock the value of tivozanib through registration and development including combination therapy. We also are excited by the potential of our AVEO-developed pipeline candidates, including ficlatuzumab, AV-203, AV-380 and AV-353.  Supporting our multifaceted goals, we have worked to strengthen our executive management team and Board with the appointment of experienced leaders and to reinforce our balance sheet through milestone payments, royalties, the renegotiation of our debt agreement and careful financial stewardship.”

Tivozanib (FOTIVDA®) European Union Update

 

Tivozanib (FOTIVDA®) Launched in Germany, Granted Positive NICE Final Appraisal Determination for the Treatment of Advanced Renal Cell Carcinoma (aRCC) in the UK. In November 2017, AVEO and EUSA Pharma, the licensee for tivozanib in Europe, North and South Africa, Latin America and Australasia, announced the first commercial launch of FOTIVDA® with the initiation of product sales in Germany. In February 2018, AVEO announced that the United Kingdom’s National Institute for Health and Care Excellence (NICE) published a Final Appraisal Determination recommending FOTIVDA® for the first line treatment of adult patients with advanced renal cell carcinoma (aRCC). The positive recommendation was followed by the launch of FOTIVDA® in the United Kingdom and triggered a $2M milestone payment to AVEO from EUSA Pharma. FOTIVDA® was granted European Commission (EC) approval in August 2017 for the treatment of adult patients with aRCC in the European Union plus Norway and Iceland.

Tivozanib TIVO-3 Study North America Update

 

Successfully Completed the TIVO-3 Futility Analysis with No Changes to Study Protocol.  In October 2017, AVEO announced the completion of a pre-planned interim futility analysis of the Phase 3 TIVO-3 trial, the Company’s randomized, controlled, multi-center, open-label study to compare tivozanib to sorafenib (NEXAVAR®) in subjects with aRCC. Based on the results of the futility analysis, which were reviewed by an independent statistician, the study continued as planned without modification. The analysis did not allow for early stopping due to efficacy to assure adequate follow-up for the key secondary endpoint of overall survival. Based on the current rate of progression-free survival (PFS) events, the Company expects the TIVO-3 trial to read out in the second quarter of 2018. The TIVO-3 trial, together with the previously completed TIVO-1 trial of tivozanib in the


The following information was filed by Aveo Pharmaceuticals Inc (AVEO) on Tuesday, March 13, 2018 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 - 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 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)
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, 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: 0001564590-18-005386
Submitted to the SEC: Tue Mar 13 2018 6:06:45 AM EST
Accepted by the SEC: Tue Mar 13 2018
Period: Sunday, December 31, 2017
Industry: Pharmaceutical Preparations

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