Agenus Inc.

Good morning, ladies and gentlemen. Thank you for standing by, and welcome to the Agenus third quarter 2020 conference call and webcast. At this time, all participants are in a listen-only mode. Should you need assistance, please signal a conference specialist by pressing the star key, followed by zero. After today's presentation, there will be an opportunity to ask questions. To ask a question, you may press star, then one on your touch-tone phone. To withdraw your question, press the pound key. Please note, this event is being recorded. I would now like to turn the conference over to Dr. Jennifer Buell, President and Chief Operating Officer of Agenus. Dr. Buell, please go ahead.

Thank you very much, Cheryl. And thank you all for joining us today. Today's call is being webcast. It will be available on our website with our accompanying slide material for replay. Before we start, we'd like 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 filing for more details on these risks. As a reminder, this call is being recorded for audio broadcast. I'm Jennifer Buell, President and Chief Operating Officer of Agenus, We're really delighted to provide an update today on our business. Joining me are Dr. Garo Armen, Chairman and Chief Executive Officer, and Christine Plaskin, Vice President of Finance. Now I'll turn the call over to Garo to highlight our key accomplishments and plans.

Thank you, Jen, and thank you all for your participation in this call. Today I will begin with a recognition of our team's resolve and commitment to deliver for our patients and their families. We have made excellent progress in advancing our lead programs of Spilimab and Zoliferilimab to BLA filings and made important advancements with our next wave of innovations which are in the clinic. This wave of innovations includes Agen 1181, our ST-enhanced next-generation anti-CTLA-4 antibody, our differentiated CD137 agonist, Agen 2373, Agen 1223, our intratumoral Treg depleting bispecific, and Our allogeneic INKT cell therapy for patients with cancer and COVID-19. These achievements have set us up for potentially transformative advances in the treatment and cure of cancers. In the beginning of this year, we hosted an R&D day in New York. We outlined plans that would bring us to our first PLA filing for our lead molecules while also advancing our novel pipeline of differentiated first or best-in-class molecules. We committed to share data readouts from six clinical programs this year. As promised, First, having generated positive clinical data from BALI monotherapy trial of 160 patients, we have initiated a rolling BLA filing with the FDA and paid the filing fee of approximately 2.9 million in the third quarter of this year. Second, we presented impressive data from our BALI plus ZALI 155 patient combination trial. We are in discussions with the agency regarding a potential BLA filing on this one. Third, we have generated clinical response data in our AGEN 1181 phase one trial. Additional clinical response data will be presented by Dr. Steven O'Day at CIDC on November 14. We are particularly excited about this program. Fourth, Clinical data from our AGEN 2373 dose escalation trial is maturing. We will provide an overview of these data at CITSE and expect to present additional data at upcoming conferences. In addition, we expect to start combination trials of AGEN 2373 with our Bostilumab soon. Data from our bispecific antibody agent 1223 is also maturing, and we expect to present clinical data at also upcoming clinical conferences. Sixth, we are delayed in generating clinical data from our very exciting allogeneic INKT cell program due to COVID-19, but we are now screening patients for imminent enrollment. We are particularly excited about this program because one, the ability of INKT cells to kill cancer cells directly as well as by recruiting other components of the immune army. And also two, the ability of INKT cells to kill cells that are infected with viruses such as COVID-19. while also they regulate or modulate immune over activation. This is a very important property of INKT cells beyond activating immune response. And unlike many other cell therapies, we expect to deliver potential benefit to both cancer patients and patients with serious viral infections at a much lower cost. It is also important to note that 13 agenus discovered clinical stage compounds have cleared through initial safety at multiple doses. Our next steps will be the rapid advancement of a number of these programs to combination treatments with our own agents such as Bally and our next gen CTLA-4 antibody Agen 1181. Next, while we are advancing our clinical programs, our innovation engines continue to yield new and exciting products which are rapidly advancing towards the clinic. This year, we submitted seven abstracts to CITSE and all seven were accepted for presentation. Our CITSE presentations include four clinical and three preclinical programs. CITSE, as you know, has become one of the most notable immune oncology conferences in the world, and we look forward to our presentations between November 11 and November 14. In a few moments, Jen will provide you with detailed highlights of these presentations. However, Please be mindful that the full details from these presentations will only be discussed and disclosed at CITC in compliance with CITC disclosure rules. Now let me discuss briefly an important driver of our innovation. It is the Agenus Proprietary Vision Platform which is one of our seven presentations at CITC this year. A week ago, I took a half a day to work in our vision laboratories where we do state-of-the-art research with state-of-the-art equipment and with our exceptional chemo scientists. Here is vision's value for us and also what it does. A genus vision can investigate and many others. Vision allows us to study these T-cells in a simulated human tumor microenvironment. Typically, T-cells go from their naive state to their activated state and then to their efficacious state, otherwise known as tumor killing state. And ultimately, to their non-efficacious or exhausted state. You may have heard the term T-cell exhaustion. That is what this refers to. The vision platform enables the investigation of the effect of therapeutic drugs and genetic interventions to determine how they can enhance the efficacious state of T-cells. So the objective here is to keep T cells in an efficacious state as long as possible or to drive them into that efficacious state. The platform recapitulates known markers of pathology in the tumor microenvironment and helps discover new relevant markers. With all of this, we can investigate, New Hypotheses in Immune Oncology. Agenus Vision is an in vitro translational model of multicellular interaction seen in the in vivo tumor microenvironment and therefore has potential to direct patient-specific therapy by mimicking the tumor biology seen in patient biopsies. In brief, We have designed a proprietary platform where at any given point in time we can intervene with our molecules and other molecules to modulate a model human system to determine the best therapy option for patients. We believe that our vision platform has the potential to transform cumbersome and lengthy clinical trials. into an agile trial matching platform to meaningfully benefit cancer patients. The platform also has potential utility in studying the immune response to infections. Also among recent exciting developments are data presentations by companies who we have our licensed molecules to. For example, at ESMO last month, Merck provided an update on MK4830. This is an anti-ILT4 antibody that a genus discovered and licensed to Merck several years ago. The data with this myeloid targeting molecule generated quite a bit of attention with 11 objective responses including two complete responses and nine partial responses in heavily pretreated patients with advanced solid tumors. Agenus is entitled to an additional 85 million in milestone payments plus royalties from commercial sales of this agent. Also important to note that we have also advanced our own unencumbered myeloid cell targeting programs. We have an undisclosed myeloid cell targeting anybody of our own, which we're targeting to file an IND for next year. In the second quarter of this year, we filed two separate cell therapy INDs, both of which were cleared to proceed to the clinic. We made a strategic decision at the time to prioritize our COVID patient enrollment program and having cleared all institutional requirements, we're in the process of screening patients and expect to dose our first patient imminently. IMK T cells, our invariant natural killer T cells, remember these are T cells, are a unique cell type that combines the features of both innate and adaptive immunity. These lipid ligand binding cells have tumor targeting capabilities without the need for engineering and they also have a natural ability to suppress graft versus host disease. Together, these features underscore the attractive development attributes of INKTs with the benefit of scalability since they are allogeneic. Finally, turning to our most powerful adjuvant asset in our pipeline. QS21 Stimulant Adjuvant is in GSK's Shingles vaccine, the most effective Shingles vaccine with over 90% efficacy and which has achieved blockbuster sales status in its first two years after launch. Although there was an interruption in its sales momentum related to COVID-19 this year, sales seem to be on track and rising, and if they continue with this current trend, it will trigger a milestone payment of $25 million, which could be in 2021. QS21 is clearly the most powerful adjuvant that we know. However, its supply is capped because of the limited supply of its raw material, which comes from a Chilean soapbuck tree. Agenus has been working on a more sustainable supply of feedstock for QS21 Stimulant since 2015. We have addressed this by developing a proprietary renewable source and recently we have validated QS21 Stimulant quality and biologic activity from this source. Further, we entered a contract this month to scale up the production of QS21 Stimulant from this source material with Phyton Biotech. And now a few words about our manufacturing and supply chain. Now, to some of you, manufacturing supply may be in the background, but it is critically important in advancing programs. Without it, we certainly could not have achieved the number of R&D filings and the advancement in the clinic. On the topic of sustainable supply, this pandemic has heightened everyone's awareness on the importance of access to material. We have now seen First hand, the value of independence in manufacturing and supply. While we didn't anticipate this pandemic, we did anticipate the need for fully integrated capabilities for a sustainable supply of goods and materials to complement our innovations. All for the purpose of benefiting patients with a sense of urgency, which requires speed and innovation Our research productivity and pipeline has yielded more than 20 novel programs with 15 INDs filed in four years. This productivity would not have been possible without our manufacturing and supply team at Agenus West, especially in this world when access to manufacturing slots is getting scarcer. Timelines are being delayed and material is more difficult to access. Our internal manufacturing and CNC capabilities give us the freedom and flexibility to accelerate our development programs as well as provide access for our current and future partners. And we have done some of this in the past couple of years. That is manufactured product for our partners. Our Agenis West team has delivered more than 11 GMP batches for our own use and for partners in just the last few years alone. And lastly, an update on our partnerships. As I mentioned earlier, our innovation engine has given rise to 15 clinical stage programs with seven of those advancing through strategic collaborations with Merck, Gilead, Eurogen, Insight, and most recently with Beta Pharmaceuticals. Beta is a China-based pharmaceutical company to whom we have licensed greater China rights for our PD-1 and our first-generation CTLA-4. That's Bao and Zhao. These partnerships have generated substantial financial value for us with the additional value expending access to our innovations to patients at an accelerated pace which would not have been possible with our own capabilities alone. This strategy has allowed us to nearly double the number of molecules advancing in clinical development by leveraging the support and infrastructure of our collaborators. While we ultimately endeavor to retain all rights to our innovations, in the near term, balancing between retaining rights to some of our agents with an emphasis on U.S. rights and out-licensing others with an emphasis on ex-U.S. rights is prudent for us fiscally, as well as it's responsible for advancing our innovations into the grid. Thus, partnering collaborations and innovative transactions are core to our strategy. This strategy has generated more than $575 million of income to us in the past five years to help fund our operations. As part of this strategy to maximize the value of our own IO portfolio going forward, we will also provide access to others who can advance clinical programs in combination with some of their own agents with our products such as PD-1 and CTLA-4 while we retain full rights to these commercialization of our products. This will help accelerate the pace of market expansion of our molecules in addition to IO-IO combinations with also non-immuno-oncology agents, which is a very substantial market. Today we announce first of these collaborations with Rotterfarm Biotech. Rotterfarm is a leading, innovative Italian biotech company dedicated to drug discovery and development with a pipeline of new chemical entities, that is small molecules, as well as biotherapeutics. Through this collaboration, Rotterfarm will evaluate the safety and efficacy of CR6068, Rotterfarm's important EP4 receptor antagonist, with Bulfilumab in patients with advanced mismatch repair, proficient and microcephalite-stable Metastatic colorectal cancer. I realize that's a mouthful, but it's an accurate description of the reality for these cancers. A development area of high unmet need, that is, and where immunotherapies alone have not demonstrated significant clinical benefits so far. The trial is expected to commence this year. Lastly, as of today, We are in active discussions under CDA with nine major pharma and biotech companies for potential out-licensing transactions. This is the most, by the way, most breadth of companies that we have had ongoing active discussions with. These could result in the infusion of significant amounts of cash. We will update you appropriately if and when some of these transactions come to fruition. And now I will turn the call over to Jen to provide you with a summary of data from ESMO, our commercial launch readiness plans, and the upcoming data from CIDC, without violating the disclosure rules, of course. Jen?