The company's lead candidate is FOTIVDA® (tivozanib) which was granted approval by the U.S. Food and Drug Administration (FDA) in March of 2021 for use in treatment of adult patients with relapsed or refractory advanced renal cell carcinoma (RCC) following two or more prior systemic therapies.
The company described FOTIVDA® (tivozanib) as "an oral, next-generation vascular endothelial growth factor receptor (VEGFR) tyrosine kinase inhibitor (TKI). It is a potent, selective inhibitor of VEGFRs 1, 2, and 3 with a long half-life designed to improve efficacy and tolerability."
Aveo Pharmaceuticals' President and CEO Michael Bailey commented, "We have seen quarter over quarter growth in FOTIVDA® (tivozanib) sales since its commercial launch on March 22, 2021, including closing the year with U.S. net product revenue of $38.9 million for 2021 and $16.8 million of U.S. net product revenue in the fourth quarter of 2021. As we look to 2022, we expect to build on our commercial momentum by continuing to expand our prescriber base and increase the utilization of FOTIVDA in the third-line setting…We believe the long-term progression free survival (PFS) data presented last month at the 2022 American Society of Clinical Oncology Genitourinary Cancers Symposium (ASCO GU) further support the durability of disease control demonstrated by FOTIVDA in the third- and fourth-line treatment setting. "
"As we look ahead to 2022 and beyond, we remain confident that FOTIVDA has the potential to become a standard of care for adult patients with relapsed or refractory (R/R) advanced renal cell carcinoma (RCC) that have received two or more prior systemic treatments," CEO Bailey added.
The company stated that in Q4/21 U.S. net product revenue increased by 17% sequentially to $16.8 million, compared to $14.3 million in Q3/21 driven by FOTIVDA net sales and prescriptions.
The firm noted that since FOTIVDA's commercial launch on March 22, 2021, the product generated $38.9 million in net product revenue thru the end of FY/21. The company stated that it filled 780 commercial prescriptions in Q4/21, up from 619 prescriptions in Q3/21.
The company stated that in Q4/21 it presented positive new five-year follow-up data for PFS at the 2022 ASCO GU Cancers Symposium from its Phase 3 TIVO-3 Clinical Trial of tivozanib in R/R advanced RCC patients. The firm indicated that the new long-term PFS data further supports the durable response and improved PFS previously observed in patients treated with FOTIVDA.
The company listed that the first cohort (A) in its Phase 1b/2 DEDUCTIVE clinical trial of tivozanib in combination with AstraZeneca's IMFINZI® (durvalumab) in metastatic hepatocellular carcinoma (HCC) patients demonstrated a 28% partial response (PR) rate and disease control rate of 72% (PR plus stable disease). The firm is now moving forward with next 20 participants in cohort (B).
Aveo advised that it also initiated a pivotal Phase 3 TiNivo-2 clinical trial in advanced refractory RCC following prior treatment with immunotherapy. The firm stated that the TiNivo-2 study trial is evaluating tivozanib in combination with Bristol Myers Squibb's nivolumab (OPDIVO®),
The company mentioned that it appointed Jeb Ledell to serve in the position of Chief Operating Officer in December 2021. In this role, Ledell will be tasked with overseeing the company's operations and maximizing organizational efficiency in efforts to advancing AVEO's product pipeline.
For FY/21, the company reported total revenue of $42.3 million, compared to $6.0 million in FY/20.
The firm recorded a net loss of $53.3 million, or $1.63 per basic and diluted share in FY/21, compared a net loss of $35.6 million, or $1.66 per share in FY/20.
The company stated that it is well financed to fund operation through the end of FY/22. The company listed that as of December 31, 2021, it had $87.3 million in cash and liquid securities on its balance sheet, and it expects to generate additional cash flow from net product revenues from the sales of FOTIVDA in the U.S.
The company offered some forward guidance and advised that during FY/22 it expects to generate net revenues of $100-110 million from U.S. FOTIVDA sales, with gross margins in the mid-to-high 80th percentile. The firm indicated that for FY/22 it estimates research and development expenses of $60.0-70.0 million for use in supporting its development pipeline.
The company stated that renal cell carcinoma (RCC) is the most prevalent form of kidney cancer, which is one of the top-ten occurring cancers effecting both men and women. The firm noted that in the U.S. around 73,750 new kidney cancer cases are diagnosed each year resulting in 14,830 deaths annually. Aveo added that in late-stage RCC the five-year survival rate is only 13%.
Aveo Pharmaceuticals is headquartered in Boston mass. and is a commercial-stage biopharmaceutical company focused on developing medicines to treat cancer. The company's FOTIVDA® (tivozanib) has been approved by the FDA in the U.S. to treat adult patients with relapsed or refractory advanced renal cell carcinoma (RCC) following two or more prior systemic therapies. The drug was previously approved by the European Union and other EUSA territory countries in August 2017 for treatment of adult patients with advanced RCC.
Aveo Pharmaceuticals started the day with a market cap of around $129.9 million with approximately 34.37 million shares outstanding and a short interest of about 3.5%. AVEO shares opened more than 8% higher today at $4.10 (+$0.32, +8.47%) over Friday's $3.78 closing price. The stock has traded today between $4.01 and $4.71 per share and closed for trading at $4.61 (+$0.83, +21.968%).
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