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

Aveo Pharmaceuticals Inc

CIK: 1325879 Ticker: AVEO

 

 

Exhibit 99.1

AVEO Oncology Reports Second Quarter 2021 Financial Results and Provides Business Update

 

Total 2Q 2021 Revenue of $7.6 Million Includes
FOTIVDA® (tivozanib) U.S. Net Product Revenue of $6.7 Million –

 

– Pivotal Phase 3 TiNivo-2 Trial of FOTIVDA in Combination with OPDIVO® (nivolumab) on Track to Initiate Enrollment in 3Q 2021 –

 

– COVID-19 Related Manufacturing Supply Shortages to Push Potential  

Registrational Study Start for Ficlatuzumab to 2023 -

 

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

  

BOSTON, Mass. – August 5, 2021 – AVEO Oncology (Nasdaq: AVEO), a commercial stage, oncology-focused biopharmaceutical company, today reported financial results for the second quarter ended June 30, 2021, and provided a business update.

 

“We are pleased to report our first full quarter of FOTIVDA sales, which reflect its commercial uptake since being launched on March 22, 2021. The strength of our early commercial launch reflects the execution of our commercial organization and highlights the high unmet need that exists in the indicated treatment population,” said Michael Bailey, president and chief executive officer of AVEO. “As the first therapy approved specifically for adults with relapsed or refractory advanced renal cell carcinoma (RCC) following two or more prior systemic therapies, we believe FOTIVDA could become a standard of care in this setting and look forward to building on our positive momentum in the coming quarters. Supporting the potential future growth of FOTIVDA, our clinical strategy for an immunotherapy combination is moving forward, with the start of enrollment for the pivotal Phase 3 TiNivo-2 trial of FOTIVDA and OPDIVO expected in the third quarter of this year, an important step forward in our strategy to assess its potential in earlier lines of therapy.”

 

Mr. Bailey continued: “With respect to ficlatuzumab, while we and our clinical collaborators are very encouraged with the data in head and neck squamous cell carcinoma (HNSCC) presented at this year’s American Society of Clinical Oncology (ASCO) Annual Meeting, due to the shortage of required key raw materials and manufacturing supplies also used in COVID-19 vaccine manufacturing, we currently anticipate the potential start date for a registrational study in this indication to be pushed back from the first half of 2022 into 2023. In the interim, we will continue our dialogue with our contract manufacturer regarding timing of drug supply and regulators to identify the optimal registrational study design for the program and look forward to providing updates on this, and any potential partnering discussions, in the coming quarters.”

 


The following information was filed by Aveo Pharmaceuticals Inc (AVEO) on Thursday, August 5, 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

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 (Unaudited)
Condensed Consolidated Statements Of Stockholders' Equity (Unaudited) (Parenthetical)
Assumptions Used In Black Scholes Pricing Model For New Grants (Detail)
Basis Of Presentation
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)
Hercules Loan Facility
Hercules Loan Facility (Tables)
Hercules Loan Facility - Additional Information (Detail)
Key Assumptions Used To Value The Warrants (Detail)
Legal Proceedings
Legal Proceedings - Additional Information (Detail)
Organization
Organization - Additional Information (Detail)
Other Accrued Liabilities
Other Accrued Liabilities (Detail)
Other Accrued Liabilities (Tables)
Schedule Of Collaborative Revenues Under Collaboration Agreement (Detail)
Schedule Of Provision On Discounts And Allowances By Category (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)
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 Fair Value Of Company's Warrant Liability (Detail)
Summary Of Net Product Revenues Earned (Detail)
Summary Of Outstanding Securities Not Included In Computation Of Diluted Net Loss Per Common Share (Detail)
Summary Of Outstanding Securities Not Included In Computation Of Diluted Net Loss Per Common Share (Parenthetical) (Detail)
Summary Of Percentage Of Total Product Revenues (Detail)
Summary Of Revenues Earned In Connection With Eusa Agreement Under Asc 606 (Detail)

Material Contracts, Statements, Certifications & more

Aveo Pharmaceuticals Inc provided additional information to their SEC Filing as exhibits

Ticker: AVEO
CIK: 1325879
Form Type: 10-Q Quarterly Report
Accession Number: 0001564590-21-041703
Submitted to the SEC: Thu Aug 05 2021 5:04:49 PM EST
Accepted by the SEC: Thu Aug 05 2021
Period: Wednesday, June 30, 2021
Industry: Pharmaceutical Preparations

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