AVEO Pharmaceuticals, Inc.

Good afternoon, thank you for standing by, and welcome to the Aveo Oncology Second Quarter 2021 Financial Results Call. At this time, all participants are in a listen-only mode. After the speaker presentation, there will be a question and answer session. To ask a question during the session, you will need to press star one on your telephone. If you require any further assistance, please press star, then zero. I would now like to hand the conference over to your speaker, Mr. Eric Lucero, Chief Financial Officer of Aveo. Please go ahead.

Thank you, Operator. Good afternoon, and thank you all for joining us on today's call to discuss Aveo's second quarter 2021 financial results and business update. I'm joined today by Michael Bailey, Chief Executive Officer, Mike Ferraresso, Chief Commercial Officer, and Dr. Michael Neal, Chief Medical Officer. Before we begin today's call, let me remind you that during this discussion, we'll be making forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. These forward-looking statements are subject to important risks and uncertainties, including those that are detailed in today's press release and in the risk factors section of our most recent quarterly report on Form 10Q, which is on file with the SEC that may cause actual results to differ materially from those results expressed in Schultz's statements. Furthermore, we caution you that these forward-looking statements represent our views only as of today, and we do not assume any obligation to update these statements, whether as a result of new information, future events, or otherwise, as except as noted and may be required by law. With that, I will now turn the call over to our President and Chief Executive Officer, Michael Bailey. Michael.

Thank you, Eric, and thank you to everyone for joining us on today's call. The second quarter marked our first full quarter as a commercial stage company, and we're excited to share with you the continued progress we have made with the launch of Fatibda, or Tuvozanib, our first commercial product, as well as the progress with the rest of our pipeline and our financial results for the quarter. Today, we are pleased to report our first full quarter of Fatibda sales, which reflect a rapid commercial uptake since it was launched on March 22nd. I can say with confidence that we believe that we are off to a strong start. As many of you already know, Fatibda is an oral, once a day, VEGFR TKI approved in the U.S. for the treatment of adults with relapse or refractory advanced renal cell carcinoma, or RCC, following two or more prior systemic therapies. This approval was based on the Phase III TiVo III study. The first positive RCC Phase III study in this highly refractory setting and the first phase three study to incorporate a predefined subpopulation of patients who had received prior immunotherapy, which reflects the new standard of care in earlier lines of treatment. It is important to note that prior to FATIVDA, therapies used in these settings were often chosen based on extrapolation of clinical data from treatment and early line settings. as well as from clinical data that did not include a meaningful subpopulation of patients who received prior immunotherapy. Furthermore, due to a lack of robust prospective data in this refractory setting, coupled with tolerability concerns of other available treatment options, we know that a large percentage of patients choose to opt out of continuing on to later line therapy. Now, with the UF FDA approval for FATIVDA, the oncology community is able to offer patients an evidence-based treatment option with a favorable tolerability profile to address these significant unmet needs. While this positive Phase III data has supported the successful launch to date by differentiating FITIVDA from other available treatment options, I am pleased to say that we continue to gain valuable data from the TEVO3 trial. For example, At the 2021 ASCO annual meeting in June, we were pleased to share long-term efficacy follow-up and additional tolerability data from the TiVo3 study. Specifically, patients treated with Pitivna demonstrated a durability of response of over 20 months, more than two times that of serotonin, with the overall survival hazard ratio relative to serotonin continuing to improve with longer follow-up. In addition, an analysis of treatment emergent adverse events showed longer time to onset and a lower rate of dose reductions for these adverse events related to tibozanib as compared with serotonin. We believe these data continue to demonstrate a durability of response with FITIVDA as well as favorable tolerability profile that we know are important considerations for patients and physicians in the selection of later lines of therapy. With that setting the stage for this quarterly update, I'd like to turn the call over to Mike Barrasso to walk us through a more detailed commercial update, including second quarter metrics.