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Aveo Pharmaceuticals, Inc. (AVEO) SEC Filing 10-Q Quarterly report for the period ending Tuesday, March 31, 2020

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Aveo Pharmaceuticals Inc

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CIK: 1325879 Ticker: AVEO

 

 

Exhibit 99.1

 

AVEO Oncology Reports Full Year 2019 Financial Results and Provides Business Update

CAMBRIDGE, Mass.– March 16, 2020 –

AVEO Oncology (NASDAQ: AVEO) today reported financial results for the full year ended December 31, 2019 and provided a business update.

 

“The coming months will be an important period for AVEO, with filing of a New Drug Application (NDA) for tivozanib as a treatment for relapsed or refractory renal cell carcinoma (RCC) planned for the end of this quarter, and reporting of the final overall survival (OS) update for the TIVO-3 trial expected by June,” said Michael Bailey, president and chief executive officer of AVEO. “As we work toward the potential FDA marketing approval of tivozanib, our attention will turn increasingly to commercialization and potential expanded clinical opportunities, while further advancing the balance of our pipeline. We continue to believe that our tivozanib dataset in RCC, which provides insights into the sequencing of therapies, notably, following immunotherapy, positions tivozanib well within this meaningful and growing relapsed or refractory RCC patient population.”

 

Mr. Bailey added: “In addition, we look forward to continuing to build on the clinical evaluation of tivozanib-immunotherapy (IO) combinations, such as those studied in the TiNivo trial of tivozanib and OPDIVO® (nivolumab) in RCC, for which we reported encouraging final PFS data at last year’s ESMO Conference, and the DEDUCTIVE trial of tivozanib and IMFINZI® (durvalumab) in hepatocellular carcinoma (HCC). With a favorable tolerability profile and results suggesting additive or synergistic activity in both treatment naïve and previously treated RCC patients, our early data support the potential for tivozanib to serve as a TKI companion in combination with IO therapy. Beyond tivozanib, building on promising results seen to date, we look forward to continued progress in the evaluation of ficlatuzumab in multiple clinical trials, including two ongoing randomized Phase 2 trials, one in acute myeloid leukemia (AML) and one in head and neck cancer, with the goal of identifying a pivotal trial design for registration, assuming favorable trial outcomes.”

 

Phase 3 TIVO-3 Trial and North America Regulatory Highlights

 

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Published Data from Phase 3 TIVO-3 Trial in Lancet Oncology. In December 2019, AVEO announced that previously reported data from its positive Phase 3 TIVO-3 trial were published in The Lancet Oncology. The article, titled “Tivozanib versus sorafenib in patients with advanced renal cell carcinoma (TIVO-3): a phase 3, multicentre, randomised, controlled, open-label study”, is available online via this link.”

 

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Presented Updated OS and Subgroup Data from TIVO-3 Trial at the 18th International Kidney Cancer Symposium. In November 2019, AVEO announced updated data from the Phase 3 TIVO-3 trial, including two prespecified subgroup analyses of patients previously treated with a checkpoint inhibitor and a VEGFR TKI, or two VEGFR TKIs. Each of the prespecified subgroups showed superior progression free survival (PFS) and overall response rate, as well as an OS HR below 1, favoring tivozanib.

The following information was filed by Aveo Pharmaceuticals Inc (AVEO) on Monday, March 16, 2020 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-Q Quarterly 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-Q Quarterly Report:

Financial Statements, Disclosures and Schedules

Inside this 10-Q Quarterly Report

Document And Entity Information
Condensed Consolidated Balance Sheets (Unaudited)
Condensed Consolidated Balance Sheets (Unaudited) (Parenthetical)
Condensed Consolidated Statements Of Cash Flows (Unaudited)
Condensed Consolidated Statements Of Comprehensive Income (Loss) (Unaudited)
Condensed Consolidated Statements Of Operations (Unaudited)
Condensed Consolidated Statements Of Stockholders' Equity (Deficit) (Unaudited)
Condensed Consolidated Statements Of Stockholders' Equity (Deficit) (Unaudited) (Parenthetical)
Assumptions Used In Black Scholes Pricing Model For New Grants (Detail)
Basis Of Presentation
Basis Of Presentation - Additional Information (Detail)
Collaborations And License Agreements
Collaborations And License Agreements (Tables)
Collaborations And License Agreements - Additional Information (Detail)
Common Stock
Common Stock - Additional Information (Detail)
Future Minimum Payments Under Loans Payable (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)
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)
Summary Of Assets And Liabilities Measured At Fair Value On Recurring Basis (Detail)
Summary Of Cash, Cash Equivalents And Marketable Securities (Detail)
Summary Of Changes In Accounts Receivable And Contract Liabilities (Deferred Revenue) (Detail)
Summary Of Computation Of Basic And Diluted Net Income (Loss) Per Share (Detail)
Summary Of Fair Value Of Company's Warrant Liability (Detail)
Summary Of Future Minimum Lease Payment (Detail)
Summary Of Outstanding Securities Not Included In Computation Of Diluted Net Loss Per Common Share (Detail)
Summary Of Revenues Earned In Connection With Eusa Agreement Under Asc 606 (Detail)
Summary Of Total Revenues Earned By Partner (Detail)
Ticker: AVEO
CIK: 1325879
Form Type: 10-Q Quarterly Report
Accession Number: 0001564590-20-019921
Submitted to the SEC: Thu Apr 30 2020 6:08:58 AM EST
Accepted by the SEC: Thu Apr 30 2020
Period: Tuesday, March 31, 2020
Industry: Pharmaceutical Preparations

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