AVEO Pharmaceuticals, Inc.

Hello, and welcome to the Avail Oncology fourth quarter and full year 2021 financial results and 2022 guidance conference call. At this time, all participants are in listen-only mode. A question and answer session will follow the formal presentation. If anyone should require operator assistance, please press star zero on your telephone keypad. As a reminder, this conference is being recorded. It's now my pleasure to turn the call over to Hans Witzhum of LifeSci Advisors. Hans, please go ahead.

Thank you, Operator. Good morning, and thank you all for joining us on today's call to discuss Aveo's fourth quarter and full year 2021 financial results and 2022 guidance. I am joined today by Michael Bailey, Chief Executive Officer, Mike Ferraresso, Chief Commercial Officer, Eric Lucera, Chief Financial Officer, and Jeb Liddell, Chief Operating 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 annual report on Form 10-K, which is on file with the SEC. that may cause actual results to differ materially from those results 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 will now turn the call over to Aveo's President and Chief Executive Officer, Michael Bailey. Michael?

Thank you, Hans, and thank you to everyone for joining us on today's call. We're excited to share with you the continued progress we made across our portfolio during the fourth quarter of 2021. This past quarter capped what we believe was a successful and especially important year for Aveo, with the launch of our first commercial product, Batibda, or Tivozanib, for patients with relapsed refractory advanced RCC. The fourth quarter of 2021 marks our third full quarter of Fitib to Sale since its launch on March 22, 2021. The past few quarters have been busy as we focused on successfully executing our U.S. commercial strategy, which included hiring and training field teams and building commercial infrastructure, including distribution, patient access, and reimbursement. As a result of the team's execution on the strategic launch plan, we have experienced a steady increase in commercial uptake of Petibda. This positive momentum continued in the fourth quarter as we saw a 26% increase in prescriptions filled in this quarter compared to the third quarter. Once again, achieving our quarter-over-quarter revenue growth goal. We are pleased with these early results and believe that TIVDA's commercial performance to date validates its potential to serve as a standard of care for relapse refractory advanced RCC patients. As we previously indicated, the restrictions related to the ongoing COVID pandemic have impeded our ability to gain in-person access to customers, prescribers, and other healthcare professionals. We believe these access challenges have caused a protracted launch curve to date compared to the pre-COVID open access environment. However, we expect continued quarter-over-quarter growth and remain confident that Fatigda has the potential to become the third and fourth line RCC standard of care. I'd like to conclude my comments on Fatibda's commercial launch by announcing that starting in December 2021 and continuing through January 2022, Fatibda took a leadership position in the share of third and fourth line RCC new patient starts, according to Guy Cubia's brand impact report. As Mike Ferraresa would discuss in detail, this move for Fatibda to earlier line patients is an important part of our long-term strategy as it signals that Fatibda is being more broadly adopted by oncologists for third-line patients, which may also result in an expansion in the average treatment duration over time. As we look towards 2022, we're now in a more informed position to provide U.S. revenue guidance. Specifically, we currently expect to achieve 2022 net sales revenue of Fatibda between $100 to $110 million. Turning to our product development pipeline, we've issued several exciting clinical announcements recently, including positive clinical data updates for TIVDA at both ASCO-GU in February of 22 and ASCO-GI in January of 22. At ASCO-GU, we presented five-year follow-up data for progression-free survival and overall survival from our TIVO3 trial. These data show over five times the PFS rate for tavozinib versus serafinib at the three- and four-year landmarks. Importantly, this prolonged progression-free survival benefit has resulted in the continued improvement of the OS hazard ratio, which now stands at 0.89. At ASCO GI, we presented top-line efficacy and safety data from our Phase II deductive trials. This cohort consisted of 20 patients with advanced unresectable, previously untreated liver cancer, or HCC, who have not previously received treatments. Patients in this cohort were treated with a combination of 0.89 milligrams of tavozinib plus durvalumab. These top line results demonstrated that the combination of the 0.89 milligram of tavozinib and durvalumab was well tolerated, and demonstrated a 28% partial response rate with a median progression-free survival of 7.3 months and a one-year overall survival rate of 76%, which we believe positioned the combination well relative to other VEGF immune checkpoint inhibitor combinations in this setting. In conclusion, we believe these new data further support the future development of Tivozanib as an attractive VEGFR TKI for use in combination with Dervolumab in first-line advanced unresectable HCC patients, as well as provide further evidence of Fatibda's activity and selective profile that conveys the potential to reduce off-target toxicities. The deductive trial is currently enrolling a second cohort of patients that have previously received treatment with bevacizumab and atezolizumab. We expect this cohort will enroll another 20 subjects. We believe these data present an opportunity to generate the first clinical trial data in the emerging population of advanced unresectable HCC patients who have previously been treated with bevacizumab and atezolizumab. We recently amended the dosing in the Tenevo 2 trial to now use the 0.89 milligram Tobozanib dose in the combination arm. This change is based in part on the promising HCC-IO combination results I just covered using the 0.89 milligram dose of Tobozanib to optimize the potential risk-benefit profile for Tenevo, which we believe is also consistent with the FDA's recent guidance for companies to investigate optimal combination dosing. In addition, we recently entered into a clinical trial collaboration and supply agreement to evaluate Tobozonib in combination with NKT2152, NICANG's novel HIF-2-alpha inhibitor. which is an emerging target of interest in RCC. We believe that this new collaborative initiative with NICANG has the potential to further establish Fatibda as the combination VEGFR TKI of choice, and importantly, will only slightly increase our 2022 Tivozanib R&D spend. Eric will provide additional color on the 2022 OPEX guidance in a moment. Turning to phycotuzumab, We believe this asset is well positioned to potentially address the significant unmet medical need that exists for patients with HPV negative recurrent or metastatic head and neck cancer. A patient population is prognosis is very challenging. After being granted fast track designation by the FDA in the fourth quarter of 2021, We announced in January that we have entered into a clinical trial collaboration and supply agreement with Merck KGA Darmstadt, Germany, to evaluate ficletuzumab in combination with erbitux or cetuximab, an EGFR-targeted antibody, in patients with recurrent or metastatic head and neck squamous cell carcinoma. We also recently announced that we have started scaling up the manufacturing for ficletuzumab and expect to complete manufacturing drug substance for the clinical supply in the second quarter of 2022. This initiative will be followed by standard drug stability studies and drug preparation of the final clinical trial materials, which we expect will enable the initiation of the potential registration clinical trial in the first half of 23. In the meantime, the company expects to finalize the potential pivotal clinical trial design in consultation with the FDA, as well as to continue ongoing partnership discussions. For AV380, our anti-GDF15 antibody, we completed the enrollment of the healthy subject study in the fourth quarter of 2021. Initial data observed satisfactory drug safety and a reduction in the GDF-15 in subjects, and there were no drug-related adverse events identified. Though operational errors at the trial site caused data integrity concerns and are being discussed with the FDA to confirm the suitability of the data for regulatory purposes and our ability to publish the data from this trial. We do not expect the data quality issues in the Phase 1 clinical trial to impact our plan to initiate a Phase 1B clinical trial in cancer patients during the second half of this year. Finally, we recently announced a preclinical collaboration with Actinium to potentially expand our portfolio of oncology assets by creating a new ERBB3 antibody radioconjugate, or ARC. We believe in addition to the progress with the Fatibda launch, we continue to successfully advance our pipeline efforts to support future growth. In order to help manage the development of our pipeline in December, we appointed Jeb Liddell as Chief Operating Officer. Jeb is responsible for overseeing operational functions key to maximizing our organizational efficiency, advancing our pipeline, and escalating our strategic partnering initiatives in support of our three wholly owned antibody clinical stage product candidates. I am pleased to report that we believe that he has already made a positive impact on the company over the past few months by leveraging his experience leading organizations through changes in scale and that he is a valuable new member of the executive team. I'd like to now turn the call over to Mike Ferraresso to walk us through more detailed commercial update including fourth quarter 2021 metrics. Mike?