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Exhibit 99.1
AVEO Oncology Reports First Quarter 2021 Financial Results
and Provides Business Update
– U.S. Commercial Launch Underway with Fully Deployed Sales Force Following FDA Approval of FOTIVDA® (tivozanib) on March 10, 2021 –
– FOTIVDA Net Product Revenue of $1.1 Million from Initial Distributor Orders in the Last Week of Q1; All Distributors Have Placed Reorders for Q2 –
– Entered Clinical Trial Collaboration and Supply Agreement with Bristol Myers Squibb for Planned Pivotal Phase 3 TiNivo-2 Study of FOTIVDA in Combination with OPDIVO® (nivolumab); Study Anticipated to Commence Mid-2021 –
– Phase 2 Open Label Randomized Study Results of Ficlatuzumab in HNSCC to be Presented at ASCO; Phase 3 Decision Anticipated Mid-2021 –
– Company to Host Conference Call Today at 4:30 p.m. ET –
BOSTON, Mass. – May 10, 2021 – AVEO Oncology (Nasdaq: AVEO), a commercial and clinical development stage biopharmaceutical company, today reported financial results for the first quarter ended March 31, 2021 and provided a business update.
“The first quarter of 2021 was a transformational time for AVEO marked by the U.S. Food and Drug Administration (FDA) approval and launch of FOTIVDA, our first commercial product, and the advancement of our pipeline, all of which is supported by a strong balance sheet,” said Michael Bailey, president and chief executive officer of AVEO. “Our sales team is now fully deployed, and we are encouraged by the early commercial activity supporting the FOTIVDA launch. We look forward to continuing to execute on our goal of establishing FOTIVDA as a standard of care within its renal cell carcinoma (RCC) indication.”
“In parallel, we remain focused on the continued advancement of the remainder of our clinical programs. This includes the evaluation of FOTIVDA in the immunotherapy combination setting, with patient enrollment in the pivotal Phase 3 TiNivo-2 study of FOTIVDA in combination with OPDIVO anticipated to commence mid-year and the Phase 2 hepatocellular carcinoma (HCC) DEDUCTIVE trial reporting encouraging Phase 1b results at ASCO GI earlier this year. Beyond FOTIVDA, we continue to expect several key inflection points with the balance of our clinical pipeline later this year, including a go/no go decision on progressing to a pivotal study for ficlatuzumab in head and neck squamous cell carcinoma (HNSCC), the advancement of our Phase 1 study of AV-380 and an update on potential clinical development plans for AV-203.”
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The $2.3 million decrease was principally related to $3.7 million in costs incurred in the first quarter of 2020 that were not incurred in the first quarter of 2021 related to the tivozanib NDA for RCC, including $0.8 million related to the completion of the NDA submission and the $2.9 million application user fee pursuant to the Prescription Drug User Fee Act that was due upon the filing of the tivozanib NDA on March 31, 2020, and $0.5 million related to lower expenses in connection with the TIVO-3 trial as it nears completion, partially offset by $1.6 million in costs incurred in the first quarter of 2021 that were not incurred in the first quarter of 2020, including $1.1 million related to the conduct of start-up activities for the planned TiNivo-2 trial and $0.5 million related to the medical affairs function in support of the commercial launch of FOTIVDA.
The Loan Agreement includes (i) a financial covenant that we maintain minimum unrestricted cash positions of $10.0 million through the date the Second Tranche funding is received, $15.0 million through the date the Third Tranche funding is received and $10.0 million thereafter through the maturity of the Loan Agreement, and (ii) an operating covenant that we achieve greater than or equal to 75% of our forecasted net product revenues from our sales of tivozanib over a 6-month trailing period, as defined and measured on a monthly basis, commencing upon the earlier to occur of (x) the Third Tranche funding and (y) the month of April 2022.
The 2021 Loan Amendment also (i) increased Tranche Two funding upon achieving Performance Milestone I from $10.0 million to $20.0 million, (ii) increased the amount of net product revenues from sales of FOTIVDA required for us to achieve Performance Milestone II from $20.0 million to $35.0 million, and changed the deadline for achieving Performance Milestone II from December 31, 2021 to April 1, 2022, and (iii) increased the amount of unrestricted cash required for us to satisfy the minimum financial covenant during the period between receiving Tranche Two funding and Tranche Three funding from $10.0 million to $15.0 million.
During the three months ended March 31, 2021, we received approximately $78.0 million in equity and loan funding, including approximately $51.6 million in net proceeds from the sale of approximately 6.9 million shares of our common stock in an underwritten public offering in March 2021, approximately $19.9 million in new loan funding pursuant to the 2020 Loan Amendment and 2021 Loan Amendment with Hercules, net of transaction costs, approximately $3.4 million in net proceeds from the sale of approximately 0.3 million shares of our common stock in March 2021 pursuant to our SVB Leerink Sales Agreement, and approximately $3.1 million in proceeds from the exercise of Offering Warrants.
In 2021, we raised approximately $78.0 million in funding, including approximately $51.6 million in net proceeds from the sale of approximately 6.9 million shares of our common stock in an underwritten public offering in March 2021, approximately $19.9 million in new loan funding pursuant to the 2020 Loan Amendment and 2021 Loan Amendment with Hercules, net of transaction costs, approximately $3.4 million in net proceeds from the sale of approximately 0.3 million shares of our common stock in March 2021 pursuant to our "at-the-market" sales agreement with SVB Leerink LLC, or SVB Leerink, which we refer to as the SVB Leerink Sales Agreement, and approximately $3.1 million in proceeds from the exercise of Offering Warrants.
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Tivozanib expenses decreased by $2.3...Read more
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We sold 470,777 shares, 1,251,555...Read more
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Financial Statements, Disclosures and Schedules
Inside this 10-Q Quarterly Report
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: 0001564590-21-026089
Submitted to the SEC: Mon May 10 2021 4:33:30 PM EST
Accepted by the SEC: Mon May 10 2021
Period: Wednesday, March 31, 2021
Industry: Pharmaceutical Preparations