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-11 and the risk factors contained in our Annual Report on Form
10-K for the year ended December 31, 2020.
Overview
We are an oncology-focused biopharmaceutical company committed to delivering medicines that provide a better life for cancer patients. Our strategy is to focus
our resources toward the development and commercialization of our product candidates in North America, while leveraging partnerships to support development and commercialization in other geographies.
On March 10, 2021, the U.S. Food and Drug Administration, or FDA, approved FOTIVDA in the United States for the treatment of adult patients with relapsed or
refractory advanced renal cell carcinoma following two or more prior systemic therapies. FOTIVDA is an oral, next-generation vascular endothelial growth factor receptor, or VEGFR, tyrosine kinase inhibitor, or TKI. The approval of FOTIVDA is based
on our pivotal phase 3 randomized, controlled, multi-center, open-label clinical trial comparing tivozanib to an approved therapy, Nexavar® (sorafenib), in renal cell carcinoma, or RCC,
patients whose disease had relapsed or become refractory to two or three prior systemic therapies, which we refer to as the TIVO-3 trial. The approval is also supported by three additional trials in RCC and includes safety data from over 1,000
clinical trial subjects.
FOTIVDA is commercially available in the United States as of March 22, 2021.
FOTIVDA is also approved and commercialized through our development partner EUSA Pharma (UK) Limited, or EUSA, in the United Kingdom, Germany, Spain and
certain other countries in their territory, for the treatment of adult patients with advanced RCC who are VEGFR pathway inhibitor-naïve and are either untreated or who have failed prior therapy with interferon alpha (IFN-a) or interleukin-2
(IL-2).
Based on FOTIVDAs demonstrated anti-tumor activity, tolerability profile and reduction of regulatory T-cell production, we are studying
FOTIVDA in combination with immune checkpoint inhibitors for the treatment of RCC and hepatocellular carcinoma, or HCC, in phase 2 clinical trials. We recently announced our entry into a collaboration with Bristol Myers Squibb, or BMS, to conduct a
phase 3 study of FOTIVDA in combination with OPDIVO® (nivolumab), BMSs anti-PD-1 therapy, in patients with advanced relapsed or refractory RCC following prior immunotherapy exposure.
Our pipeline of product candidates includes ficlatuzumab, a potent humanized immunoglobulin G1, or IgG1, monoclonal antibody that targets hepatocyte
growth factor, or HGF. We previously reported promising early clinical data on ficlatuzumab in squamous cell carcinoma of the head and neck, or HNSCC, pancreatic cancer and acute myeloid leukemia, or AML. We are currently conducting a randomized
phase 2 confirmatory study of ficlatuzumab for the potential treatment of HNSCC and expect to receive topline data in the middle of 2021.
Our pipeline of
product candidates also includes worldwide rights to AV-380, a potent humanized IgG1 monoclonal antibody that targets growth differentiation factor 15, or GDF15. In December 2020, the FDA accepted our
investigational new drug application, or IND, for AV-380 for the potential treatment of cancer cachexia, and we have initiated a phase 1 clinical trial in healthy subjects.