AVEO Pharmaceuticals, Inc.

Good afternoon, and welcome to the Vail Oncology First Quarter 2021 Financial Results Conference Call. At this time, all participants are on a listening mode. After this speaker's presentation, there will be a question and answer session. To ask a question at that time, please press star then 1 on your touchtone telephone. As a reminder, today's conference call is being recorded. I will now turn the conference over to your host, Mr. Eric Lucera, Chief Financial Officer of Vail. Sir, please go ahead.

Thank you, Operator. Good afternoon, and thank you all for joining us on today's call to discuss Aveo's first 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 Needle, Chief Medical Officer. Before we begin today's call, let me remind you that during this discussion, we will 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 expressed in such 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, except as required by law. With that, I'll now turn the call over to our President and Chief Executive Officer, Michael Bailey. Michael. Thank you, Eric, and good afternoon, everyone. Thank you for joining us on today's call. We're excited to have the opportunity today to share with you our progress for the Fatibda launch, as well as the business and financial results for the quarter. During this call, we plan to provide you with our early launch metrics through April 30th in an effort to provide you with a snapshot of our initial launch performance. Before we get into the details of the initial launch metrics, I would like to mention the recent release of abstract titles from ASCO. At this year's meeting, we look forward to presenting updates from the TiVo 3 study that explore long-term patient follow-up, and further highlight FITIVDA's unique tolerability profile. In addition, we are excited to present the results from our randomized confirmatory phase 2 trial for ficlotuzumab plus or minus Erbitux in a population of head and neck patients who have progressed through all available therapies, including platinum, PD-1, and Erbitux. Now turning to the launch of FITIVDA. The first quarter of 2021 has been a truly transformational time for Aveo, marked by U.S. FDA approval of our first commercial product, Fatibda, our differentiated once-daily VEGFR TKI. Fatibda is approved for the treatment of adults with relapse to refractory advanced renal cell carcinoma, or RCC, following two or more prior systemic therapies. Notably, this approval was based on the Phase III TiVo III study, which is the first positive RCC Phase III study in this setting and the first RCC Phase III study to include a predefined subpopulation of patients who received prior immunotherapy, the standard of care in earlier Lyme treatment. Prior to FATIPTA's approval, the therapies used in these settings were typically chosen based on extrapolating clinical data from earlier treatment settings and from clinical data sets that did not include prior immunotherapies. In addition, a large percentage of patients opted out of later Lyme therapy due to concerns with tolerability. With the U.S. FDA approval of FITIVDA, the oncology community now has an evidence-based treatment option with a manageable safety profile to offer patients and help address this significant unmet need. The importance of Fatibda's new role in the treatment paradigm was underscored by its addition to the National Comprehensive Cancer Network's Clinical Practice Guidelines, or NCCN, in March as a recommended regimen for subsequent therapy. With the FDA approval in hand, we were able to rapidly execute on a commercial launch thanks to the hard work of our commercial and medical affairs teams leading up to the FDA's decision, coupled with the full deployment of our sales organization. While it is still early, we are pleased with the initial positive indicators. In an effort to provide you with a snapshot of our preliminary launch performance, I will now turn the call over to Mike Ferrareso to provide an update on the commercial launch. Mike? Thank you, Michael. As Michael mentioned, we are very encouraged by the progress we have seen thus far in the launch of PhotigDuck. We are pleased to share with you results from our first reported quarter as a commercial stage company, as well as some more recent launch insights that we've observed in the second quarter through the end of April. Recall that Fotivda was approved on March 10th, 2021, with commercial availability formally commencing on March 22nd, 2021. For the nine days until the end of the first quarter, net product revenue was $1.1 million, which reflects inventory shipped to distributors and our 15% gross to net estimate. It's important to note that since the close of the first quarter, all of our distributors have reordered product, and in fact, all of them have reordered more than once. Through April 30th, a total of 49 commercial prescriptions have been filled through our specialty pharmacy and specialty distributor partners. And additionally, 75 FOTIVDA-free one-month patient experience starter kit samples have been requested and delivered, representing a potentially important leading indicator for future prescriptions. While we're in the early days of this launch, we believe we are off to a strong start. We continue to focus on educating the community and raising awareness of how FOTIVDA can help fill the unmet need in the treatment continuum. Key to this effort is establishing Fortivda's differentiation, including its distinct characteristics as a potent, highly selective, long half-life VEGF receptor TKI, as well as sharing the unique data set established in TiVo3. Our commercial outreach spans prescribers across all settings, from major academic centers to the community. While the COVID restrictions have slowed our ability to reach all of our customers as quickly as we would like, The reception to Fortivda has been very positive, the unmet need is real, and our reach expands deeper in the RCC market every day we're in the field. As with any new launch, initial prescriptions take time to fill as we establish our reimbursement. We've had very few reimbursement rejections and continue to improve our coverage and thus reduce the time from physician prescription to patient use. Our Quick Start program has been effective at getting patients on active treatment quickly and avoiding any interruption of patient care while benefit verification is underway. I will now turn the call over to Michael Needle to discuss progress with the remainder of our clinical development programs. Michael?

Thank you, Mike. While we are keenly focused on executing on Fortivita's launch, we continue to make meaningful progress advancing the bounds of our clinical pipeline. In addition to the current monotherapy approval, we are also focused on the evaluation of tavazanid in the immunotherapy combination setting. The introduction of immunotherapy VEGF receptor TKI combinations marked a significant evolution in the treatment landscape of first-line RCC. We believe that this benefit could extend to the relapse refractory setting with an effective, well-tolerated combination. In March, we were pleased to announce our clinical trial collaboration and supply agreement with Bristol-Myers Squibb to evaluate tavazanib in combination with nivolumab or Opdivo, Bristol-Myers Squibb's anti-PD-1 therapy. In the planned phase three Tenevo 2 trial for patients with advanced relapsed or refractory RCC following prior immunotherapy exposure. Recall that we previously assessed this combination in the Phase 1-2 Tenevo study, which demonstrated favorable tolerability and prolonged PFS in both treatment-naive and previously treated patients with advanced RCC. We look forward to furthering our understanding of the activity and tolerability of this combination following prior immunotherapy. We recently received FDA feedback on the trial design, and we are working with the agency to finalize the study design. We are targeting to commence enrollment in Tenevo 2 in mid-2021. We also remain on track to complete enrollment later this year in the Phase 2 portion of the Phase 1b2 deductive trial of Tavazavib in combination with Dervolumab or Infimzi, AstraZeneca's PD-L1 therapy in patients with hepatocellular carcinoma or HCC. At the ASCO GI Cancer Symposium in January, we shared data from the phase 1B portion of the trial. No dose-limiting toxicities were observed with the combination, which demonstrated a 29% partial response rate and 71% disease control rate. These findings were compatible with the bevacizumab and atezolizumab combination, which is an emerging standard in the care of the same setting. With a five-year survival rate of less than 5%, Advanced or metastatic HCC represents an area of high unwritten need. We believe Tavazinib has the potential to serve as an attractive VEGF receptor TKI to be used in combination with immunotherapy in this disease. Moving to Ficlotuzumab, our HGF-C med inhibitor, in January we announced completion of enrollment in the randomized confirmatory phase 2 study of Ficlotuzumab as a single agent or in combination with cetuximab or Erbitux, an EGFR-targeted antibody in metastatic head and neck squamous cell carcinoma patients who have failed prior immunotherapy, chemotherapy, and cetuximab. This study was designed to confirm findings from a Phase I-II study of ficoetuzumab and cetuximab, where the combination was well-tolerated and resulted in a disease control rate of 67%, as well as prolonged PFS and OS compared to historical control. We will present results from the Phase 2 study at the upcoming ASCO meeting in June with a Phase 3 go-no-go decision for ficletuzumab in head and neck squamous cell cancer to follow. As a reminder, in September 2020, we regained full global rights to ficletuzumab and have initiated clinical manufacture to supply the potential phase three clinical trial in head and neck squamous cell cancer and consider additional development beyond that. Progress also continues for our early stage programs, AV380 and AV203. For AV380, our GDF15 inhibitory antibody that we are developing as a potential treatment for cancer cachexia, a phase one study in healthy volunteers is now underway following the FDA's acceptance of our IMB application earlier this year and will guide us on our safety and dosing profile ahead of our advance into cancer patients. Finally, for AV203, our ERB3 inhibitory antibody, in March we were pleased to share that we will regain full global rights to AV203 following the voluntary termination of our collaboration and license agreement with Cambridge. We expect to provide an update on clinical development plan in the second half of this year. With that, I will hand the call over to Eric to discuss first quarter 2021 financial results. Eric?