PROSPECTUS SUPPLEMENT SUMMARY
This summary does not contain all of the information that you should consider before investing in our common stock. You should read this entire prospectus
supplement and the accompanying prospectus carefully, including the financial statements and other information incorporated by reference in this prospectus supplement and the accompanying prospectus, before making an investment decision. In
addition, please read the Risk Factors section of this prospectus supplement beginning on page S-8 and the risk factors contained in our Annual Report on Form
10-K for the year ended December 31, 2019 and our Quarterly Report on Form 10-Q for the quarter ended March 31, 2020.
Overview
We are a biopharmaceutical company developing
and seeking to commercialize our pipeline of product candidates designed to provide a better life for patients with cancer. Our strategy is to focus our efforts and resources toward development and commercialization of our product candidates in
North America while leveraging partnerships to support development and commercialization in other geographies.
Our lead candidate is tivozanib (FOTIVDA®), a vascular endothelial growth factor receptor, or VEGFR, tyrosine kinase inhibitor, or TKI, which is approved in the European Union, or the EU, the United Kingdom, Norway, New Zealand and
Iceland for the treatment of adult patients with advanced renal cell carcinoma, or RCC. We are working to develop and commercialize tivozanib in North America as a treatment for RCC and hepatocellular carcinoma, or HCC, and are studying tivozanib in
combination with immune checkpoint inhibitors for the treatment of RCC and HCC in phase 2 trials.
In March 2020, we submitted an application for
marketing approval, or NDA, to the U.S. Food and Drug Administration, or FDA, for tivozanib as a treatment for relapsed or refractory RCC. In June 2020, the FDA accepted our NDA for substantive review and assigned it a Prescription Drug User Fee
Act, or PDUFA, target date of March 31, 2021. The FDA also notified us that it does not currently plan to convene an Oncologic Drugs Advisory Committee meeting in connection with its review.
Our pipeline of product candidates also includes ficlatuzumab, a hepatocyte growth factor, or HGF, inhibitory monoclonal antibody, which is in a randomized
phase 2 confirmatory study for the potential treatment of squamous cell carcinoma of the head and neck, or HNSCC, and has previously reported promising early clinical data in HNSCC, acute myeloid leukemia, or AML, and pancreatic cancer. Our
earlier-stage pipeline under development includes AV-203, an anti-ErbB3 monoclonal antibody, as a potential oncology treatment; AV-380, a humanized IgG1 inhibitory monoclonal antibody targeting growth differentiation factor 15, or GDF15, a divergent
member of the TGF-ß family, for the potential treatment of cancer cachexia; and AV-353, a monoclonal antibody that targets the Notch 3 pathway.
Tivozanib
Tivozanib is a potent, selective and long
half-life inhibitor of all three vascular endothelial growth factor, or VEGF, receptors and is designed to optimize VEGF blockade while minimizing off-target toxicities, resulting in demonstrated improved
anti-tumor activity, as measured by progression-free survival, or PFS, overall response rate, or ORR, and duration of response, and tolerability, as measured by the need for significantly fewer dose reductions and interruptions due to adverse
events, compared to a non-selective VEGFR TKI, sorafenib.
Our NDA submission is based on our TIVO-3 trial, a phase 3 randomized, controlled, multi-center, open-label clinical trial comparing tivozanib to an approved therapy, sorafenib (Nexavar®) as a third- and fourth-line treatment for RCC, and
supported by data from three additional trials, including an active comparator-controlled supportive