Agenus Inc.

Good morning, ladies and gentlemen. Thank you for standing by, and welcome to the Agenis fourth quarter 2020 conference call and webcast. At this time, all participants are in a listen-only mode. If you require operator assistance, please press star, then zero. After today's presentation, there will be an opportunity to ask questions. To ask a question during the Q&A session, you will need to press star, then one. Please note that this event is being recorded and may be used in future Agenis promotional material. I would now like to turn the conference over to John Medina, Director of Investor Relations. John, please go ahead.

Thanks, Liz, and thank you all for joining us today. Today's call is being webcast, and we will be available on our website for replay. Before we start, I just want to quickly introduce myself. I know I've spoken with a number of you already over the last month or so, but I started here at Agenis back in February to help lead the investor relations efforts. Certainly, it's a very promising time for the company. I'm looking forward to being part of the conversations we're having with the investment community. With that said, I just want to remind you that this call will include forward-looking statements, including statements regarding our clinical development, regulatory and commercial plans and timelines, as well as timelines for data release and partnership opportunities. These statements are subject to risks and uncertainties, and we refer you to our SEC filings for more details on these risks. As a reminder, this call is being recorded for audio broadcast. Joining me today are Dr. Gary Warman, Chairman and Chief Executive Officer, Dr. Jennifer Buell, President and Chief Operating Officer, Andy Hurley, Chief Commercial Officer, and Christine Klaskin, Vice President of Finance. Also available during the question and answer session will be Dr. Stephen O'Day, our Chief Medical Officer. Dr. O'Day joined Agenis earlier this year as well, along with a number of other key hires, and brings clinical development expertise to Agenis at this pivotal time. Now I'll turn the call over to Gero to highlight our key accomplishments and our goals for 2021. Gero?

Good morning. Thank you very much. In 2020, our pipeline continued to grow with an arsenal of agents designed to activate the immune system across different types of patients and cancers on one hand, while also addressing immunotherapy resistance pathways across many tumor types on the other. We expect these advances will contribute to the IO field on multiple fronts. For instance, we are advancing AGEN 1181's clinical development and generating responses in patients who are unlikely to otherwise respond to immunotherapy. We expect to advance AGEN 1181 to registrational studies this year. We've also made substantial advances with our TIGIT programs, demonstrating the unique attributes of our bispecific antibody, which is IND ready. One of our notable achievements during 2020 was the completion of patient enrollment and data analysis of our two most clinically advanced agents, Bostilumab, which is our PD-1 antibody, and Zolifilumab, which is our first-generation CTLA-4 antibody. We call these BAL and ZAL for short. We are progressing with the completion of our BLA filing for BAL, and we'll proceed with our strategy regarding a potential BAL plus ZAL filing once BAL's BLA filing has been accepted. It is our aim to use Balthilumab as the foundation for several of our pipeline agents, as well as offer our BAL for use with therapies from other companies which require combination with a PD-1 blocker. Our objective is to rapidly enable synergistic combinations to advance the field. Synergistic combinations for our agents include cell therapies through our subsidiary, Agentis. While we are continuing our allogeneic intelligent INKT cell therapy in patients with COVID-19, we will be advancing these intelligent cells into cancer trials with combinations around midyear. Separately, at a time when the world's need for higher quantities of vaccine production grows, we are advancing our plans for producing high quantities of QS21 adjuvant from a renewable source. QS21 is an antigen-sparing adjuvant. What that means is that a vaccine formulation with QS21 may require as little as 100-fold less antigen to achieve the same immune response. If this proves to be the case for some or most COVID-19 vaccines, you can appreciate the potential implications of QS21 to be able to significantly increase global COVID-19 manufacturing capacity, that is vaccine manufacturing capacity, without the need to add additional antigen production capabilities, which is one of the major bottlenecks of today. Several of these advancements I touched upon represent important milestones. We expect some of those to result in cash accretive corporate transactions starting in the second quarter of this year. In 2020, we built on a genesis foundation of innovation and integration. These are, that is, innovation and integration are the key pillars of our business model. While COVID has posed challenges for many, including a genesis, we were early to anticipate and adjust to life in the very early stages of the pandemic. We've also rapidly adjusted to address new needs such as INKT cell therapy in patients with most severe infections of COVID-19 who are dependent on life support. We published early data from the trial and expect to share more as our trial matures. Our teams are also preparing for the scenario of a rapid or emergency use path for INKT cell therapy should the trial data look encouraging. But with all of these adjustments, our whole mission is unchanged. We will continue to innovate and advance our programs with speed. This requires integrated capabilities to reduce our dependence on outsiders on one hand, but also very importantly, retaining and continuing to acquire high talent. High talent density is key to our ability to deliver innovation. Recently, we welcomed stunning talent into our leadership team, and I will start with Dr. Stephen O'Dea, our chief medical officer, and our chief commercial officer, Andy Hurley. These two professionals are among some of the most respected names in the field. Dr. O'Dea is a pioneer in immuno-oncology. and as a clinical investigator, has been an important contributor to the success we've seen so far with Agen 1181. As we advance in the discovery and development of high-performing immune therapies, and particularly combinations, we need to have formidable players, Dr. Odey, on our team. Dr. Odey played a key role in the successful development of Yervoy and Aptivo. CTLA-4, and PD-1 agents, as well as several other cancer therapies. He has the knowledge and expertise to build on our work with 1181, cemented in place in the IO landscape, and fully maximize the compound's potential as a blockbuster therapy for cancer patients. We have big plans for Agent 1181 and will pursue accelerated pathways to advance the molecule to the market. Andy Hurley will be a key driver of our aspirations to do this. In his role as Chief Commercial Officer, Andy joined us after three decades of building teams and commercializing product in biopharma. With a Balsilumab BLA filing expected in the first half of this year, Andy will help establish Agenis as a commercial company with Balsilumab as a key actor in our plans for our ambitious combination strategies. Given our mission to develop impactful combinations for patients, Agenis requires clinical scientists with extensive and established expertise. Dr. Joe Grossman joined our team as head of exploratory medicine from Harvard and Beth Israel. His specialty includes colorectal and pancreatic cancers. Dr. Grossman will drive our translational medicine strategy, which is a key aspect of a Genesis clinical development strategy. Dr. Jason Paragas, another recent addition to our team, is an expert in data analysis and artificial intelligence. He formerly served with DARPA working on threat detection for the U.S. government and associated defense departments. Jason joined us as Vice President of Strategic Initiatives. Jason will also be working with our team to industrialize and broaden the applications of our vision response prediction technology. Next, Adam Krause joined as Chief Legal and Compliance Officer to ensure our commercial readiness, and Mark Wiles joined as Vice President of Regulatory Affairs. It is a transformative period for Agenis, and the value each of these team members bring will help drive a new level of success for the company. We understand the ambitious scale of our mission as we seek to disrupt an industry that has been challenged with disruptive demands. We believe marshalling the best people and resources is paramount to achieving success. I would now like to turn the call over to our President and Chief Operating Officer, Dr. Jennifer Beal.