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Aveo Pharmaceuticals, Inc. (AVEO) SEC Filing 10-Q Quarterly Report for the period ending Thursday, September 30, 2021

Aveo Pharmaceuticals Inc

CIK: 1325879 Ticker: AVEO

aeo.jpg
Exhibit 99.1
AVEO Oncology Reports Third Quarter 2021 Financial Results and Provides Business
Update

– Total Q3 2021 Revenue of $15.2 Million Includes
FOTIVDA® (tivozanib) U.S. Net Product Revenue of $14.3 Million –

– Enrollment Open for Pivotal Phase 3 TiNivo-2 Clinical Trial of FOTIVDA® (tivozanib)
in Combination with OPDIVO® (nivolumab) –

– Ficlatuzumab and ERBITUX® (cetuximab) Granted Fast Track Designation by the U.S.
FDA for R/R HNSCC; Potential Registrational Clinical Trial Expected to Commence in
1H 2023 –

– Company to Host Conference Call Today at 4:30 p.m. ET –

BOSTON, Mass. – November 8, 2021 – AVEO Oncology (Nasdaq: AVEO), a commercial stage, oncology-focused biopharmaceutical company, today reported financial results for the third quarter ended September 30, 2021 and provided a business update.

“During the third quarter, we continued to see strong commercial uptake for FOTIVDA®, further underscoring the significant unmet medical need that exists in the indicated treatment population. FOTIVDA has been well received by oncologists treating relapsed or refractory (R/R) renal cell carcinoma (RCC), noting both the durable responses and tolerability profile as attractive for their third-line patients. We believe FOTIVDA has the potential to serve as a standard of care for these later line patients,” said Michael Bailey, president and chief executive officer of AVEO. “Opening enrollment for our pivotal Phase 3 TiNivo-2 trial of tivozanib and nivolumab marks an important milestone in our efforts to assess tivozanib’s potential as an earlier line of therapy and in the immunotherapy combination setting.”

Mr. Bailey continued: “Following the recent receipt of Fast Track Designation (FTD) from the U.S. Food and Drug Administration (FDA) for ficlatuzumab and cetuximab in relapsed or recurrent head and neck squamous cell carcinoma (R/R HNSCC), we believe the clinical development of ficlatuzumab is well positioned to advance in this important potential new treatment option. We expect to commence manufacturing of ficlatuzumab clinical supply in the second quarter of 2022, with the initiation of a potential registrational clinical trial in the human papillomavirus negative (HPV-) HNSCC patient population anticipated in the first half of 2023.”

Third Quarter 2021 and Recent Highlights

Strong Third Quarter Sales Growth for U.S. Commercial Launch of FOTIVDA for the Treatment of Adult Patients with R/R Advanced RCC Following Two or More Prior Systemic Therapies.
U.S. net product revenue for the third quarter of 2021 was $14.3 million, which reflects inventory shipped to distributors and a gross-to-net estimate of 16% during the quarter.


The following information was filed by Aveo Pharmaceuticals Inc (AVEO) on Monday, November 8, 2021 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

Cover Page
Condensed Consolidated Balance Sheets
Condensed Consolidated Balance Sheets (Parenthetical)
Condensed Consolidated Statements Of Cash Flows
Condensed Consolidated Statements Of Comprehensive Income (Loss)
Condensed Consolidated Statements Of Operations
Condensed Consolidated Statements Of Stockholders' Equity
Condensed Consolidated Statements Of Stockholders' Equity (Parenthetical)
Basis Of Presentation
Collaborations And License Agreements
Collaborations And License Agreements (Tables)
Collaborations And License Agreements - Additional Information (Details)
Collaborations And License Agreements - Summary Of Changes In Accounts Receivable And Contract Liabilities (Deferred Revenue) (Details)
Common Stock
Common Stock (Details)
Hercules Loan Facility
Hercules Loan Facility (Tables)
Hercules Loan Facility - Additional Information (Details)
Hercules Loan Facility - Future Minimum Payments Under Loans Payable (Details)
Legal Proceedings
Legal Proceedings (Details)
Organization
Organization (Details)
Other Accrued Liabilities
Other Accrued Liabilities (Details)
Other Accrued Liabilities (Tables)
Significant Accounting Policies
Significant Accounting Policies (Policies)
Significant Accounting Policies (Tables)
Significant Accounting Policies - Additional Information (Details)
Significant Accounting Policies - Key Assumptions Used To Value The Warrants (Details)
Significant Accounting Policies - Schedule Of Collaborative Revenues Under Collaboration Agreement (Details)
Significant Accounting Policies - Schedule Of Provision On Discounts And Allowances By Category (Details)
Significant Accounting Policies - Stock Based Compensation Expense For Equity-Classified Awards (Details)
Significant Accounting Policies - Summary Of Assets And Liabilities Measured At Fair Value On Recurring Basis (Details)
Significant Accounting Policies - Summary Of Cash, Cash Equivalents And Marketable Securities (Details)
Significant Accounting Policies - Summary Of Fair Value Of Company's Warrant Liability (Details)
Significant Accounting Policies - Summary Of Net Product Revenues Earned (Details)
Significant Accounting Policies - Summary Of Outstanding Securities Not Included In Computation Of Diluted Net Loss Per Common Share (Details)
Significant Accounting Policies - Summary Of Percentage Of Total Product Revenues (Details)
Stock-Based Compensation
Stock-Based Compensation (Tables)
Stock-Based Compensation - Additional Information (Details)
Stock-Based Compensation - Assumptions Used In Black Scholes Pricing Model For New Grants (Details)
Stock-Based Compensation - Stock Option Activity (Details)
Ticker: AVEO
CIK: 1325879
Form Type: 10-Q Quarterly Report
Accession Number: 0001628280-21-022223
Submitted to the SEC: Mon Nov 08 2021 4:16:28 PM EST
Accepted by the SEC: Mon Nov 08 2021
Period: Thursday, September 30, 2021
Industry: Pharmaceutical Preparations

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