Compugen Ltd.

Ladies and gentlemen, thank you for standing by. Welcome to Compugen's third quarter 2020 results conference call. At this time, all participants are in a listen-only mode. An audio webcast of this call is available in the investor section of Compugen's website, www.cgen.com. As a reminder, today's call is being recorded. I would now like to introduce Ilana Holzman, Compugen's Director of Investor Relations and Corporate Communications.

Please go ahead. Thank you, Operator, and thank you for joining us today. With me from Compugen are Dr. Anat Cohen-Dayag, President and CEO, Dr. Henry Attaway, Chief Medical Officer, Ari Krashen, CFO and COO, and Dr. Eran Ophir, VP Research and Drug Discovery. Before we begin, I would like to read the following regarding forward-looking statements. During the course of this conference call, the company may make projections and other forward-looking statements regarding future events or future business outlooks. The development efforts and their outcome, our discovery platform, anticipated progress and timeline of our programs, financial and accounting related matters as well as statements regarding our cash position. We wish to caution you that such statements reflect only the company's current expectations and that actual events or results may differ materially. You are kindly referred to the risk factors and cautionary language contained in the documents the company filed with the Securities and Exchange Commission including the company's most recent annual report on Form 20F filed on February 24, 2020. The company undertakes no obligation to update projections or forward-looking statements in the future. I will now turn the call over to Anat.

Thank you, Ilana. Good morning and good afternoon, everyone, and welcome to our third quarter 2020 corporate and financial update. As Ilana mentioned, With me today are Dr. Henry Adewoye, our Chief Medical Officer, Ari Krashen, our CFO and COO, and Dr. Eran Ophir, our VP of Research and Drug Discovery. After my corporate highlights, Henry will review the progress across our clinical programs, followed by Ari's review of our financial statements and position. We will all be available for the Q&A session. Throughout the third quarter of 2020, we continue to advance our clinical programs and execute on our differentiated clinical development strategy with two ongoing clinical programs, COM701 and COM902. For these, we currently have four clinical studies, the COM701 Monotherapy Expansion Study and The Doe Descalation Study of COM701 with Bristol-Marie-Squibb's Obdivo for which we have completed enrollment and continue to collect data from patients on study treatment The Triple Combination Study of COM701 with Obdivo and Bristol-Marie-Squibb's anti-tigit antibody and the COM902 Monotherapy Study Our clinical strategy is designed to evaluate the role of the denim axis in immuno-oncology along with a new PVRIG pathway biology that we have identified in order to develop new cancer immunotherapy treatments for patient populations unresponsive to existing drugs. I am pleased with our progress keeping these multiple studies on track, especially in these unusual times. With encouraging data We are confident in our approach and in our candidates and strategic clinical path forward. Before I turn the call over to Henry to discuss these trials, I would like to highlight some recent accomplishments that support our unique path and strategy. As a reminder, the foundation of our clinical strategy is our computational discovery of two immune checkpoints in the denim axis, PVRIG and TIGIT. Building on these discoveries and based on our extensive and pioneering research of the denim axis, we believe that these two checkpoint pathways are parallel and complementary inhibitory pathways in the denim axis. We have also identified, along with data from others, that there is an intersection between these two pathways and the PD-1 pathway. Further, our data suggests that these three inhibitory pathways have different dominance in different tumor types and patient populations. Accordingly, various patient populations may require the blockade of different combinations of the three pathways This is the underlying rationale for our multiple ongoing clinical studies in various tumor types, all based on the translation of our considerable scientific knowledge of the denim axis, which we continue to expand in our company. In line with this, in our last call, I discussed the growing body of evidence that supports the distinct nature of PVRIG and TIGIT. Although these are two complementary pathways, the two targets bind different ligands, have differing levels of expression and dominance across tumor types, and have differential expression across immune cell types. This further supports their non-redundant role and our overall drug combination hypothesis and strategy. As we are continually working to drive a deeper understanding of the denim axis in cancer immunotherapy, in order to further support the strong scientific foundation that has been integral to our efforts and continuously feed our clinical strategy, we were pleased to present new research data at the 2020 TD Therapies Digital Summit held at the end of October. This research further supports the distinct biology of PVRIG and TIGIT and the biological rationale of our combination strategy to maximize clinical responses. These data show that PVRIG is expressed on stem-like memory T-cells or TSCM cells that can differentiate into effector T-cells which can directly eliminate tumor cells. Notably, these results indicating PVRIG expression on these cells add to the prior belief that TGIT and PD-1 were the main checkpoints expressed on these cells. TSCM are of growing interest in the field for their possible role in response to immune checkpoint blockade. To complement this finding, we also reported that PVRL2, the ligand of PVRIG, is expressed on specialized cells involved in T-cell proliferation, activation, and infiltration into tumors and is also expressed in PD-L1 low, less inflamed tumors. Specifically, PPRL2 is abundantly expressed across dendritic cell types which are associated with efficient T-cell activation as well as tertiary lymphoid structures in two more beds where local T-cell priming occur and which have been previously shown to be associated with response to cancer immunotherapy. This data demonstrates for the first time that in addition to TIGIT and PD-1, PVRIG and its ligand PVRL2 are also expressed in and likely play a role in The activity of these increasingly important cells involved in driving an anti-cancer immune response. In addition, these results suggest that PVRIG inhibition may enhance T cell priming and infiltration into inflamed as well as into less inflamed tumors, potentially rendering these tumors more prone to checkpoint blockade. Importantly, Our results provide additional evidence that PVRIG and TGIT have distinct expression patterns and levels of dominance in different tumor types, reinforcing our hypothesis that different cancers or patient populations may require different drug combinations to address these three pathways. You can find the complete presentation given at the TGIT Therapies Digital Summit in the publication section on our website. So how does all this science translate to the clinic? This quarter, we were incredibly proud to announce the first patient dose in our biomarker-driven triple combination study, a Phase I-II study, which is evaluating COM701 in combination with Bristol-Mers Squibb's Opdivo and their anti-tigit antibody. The initiation of this trial was a particularly meaningful milestone for COMPIGEN as it marks the clinical evaluation of our underlying science. While combinations of TIGIT and PD-1 inhibitors are being evaluated by others, we are uniquely addressing what we believe is a key component in the genome axis. We believe that the simultaneous blockade of PVRIG, TIGIT, and PD-1 may be required to provide the anti-tumor immune response needed to address non-responsive patient populations in cancers where the three pathways are dominant. Importantly, to the best of our knowledge, as the only company with a clinical asset targeting PVRIG and as a leader in the PVRIG space, we are currently the only company capable of applying this approach and testing this hypothesis. were incredibly excited to get started and look forward to providing guidance on our first anticipated data readout from this study in our year-end earning call. As we shared last quarter, we completed enrollment in the fifth and last cohort of the combination dose escalation study of COM701 with Opdivo, and we continue to collect data from patients still on study treatment. We are also on track with patient enrollment in our COM701 monotherapy expansion cohort and we look forward to providing data from these studies in the first half of 2021. Moving next to COM902, our anti-TG therapeutic antibody. Our dose escalation study of COM902 is ongoing and we expect to present initial data from the study next year. We also intend to share further information about our development plan for COM902 beyond the dose escalation stage in our year-end earning call. We have been watching the excitement around TIDID grow over the past months and we are pleased to see the clinical validation of this new checkpoint pathway. We believe these data provide important validation of our discovery platform as we were among the first groups to discover TIGIT. It also increases our confidence in our overall hypothesis and triple pathway blockade study. In summary, we're highly encouraged by our clinical and preclinical data, which together support our clinical combination strategy and which we believe has the potential to broaden the therapeutic benefit of checkpoint inhibitors to tumor types where they have previously not been successful. Our two clinical stage assets targeting both PVRAG and TIGIT allow us to fully exploit the potential of blocking these pathways, which we believe may ultimately be required to drive robust immune responses in certain tumor types. We look forward to continued progress and leveraging our position in the field. The third competent discovered target being evaluated in the clinic is IL-DR2. This program is being developed by Bayer under a research and collaboration agreement. The Phase 1 study is designed to evaluate Bay-195254 as first-in-class anti-IL-DR2 antibody as monotherapy and in combination with Keytruda in patients with advanced solid tumors. Bayer recently updated that the expansion will fully focus on head and neck squamous cell carcinoma. Based on observations during dose escalation, the evolving treatment landscape in immunosensitive solid tumors, and their supportive preclinical data, Bayer decided to focus on treating IO-naive first-line head and neck squamous cell carcinoma patients with a combination of Bay 190-5254 and Keytruda. We continue to be encouraged by Bayer's commitment to this program and we look forward to Bayer providing additional data on their progress. Moving next to touch upon some corporate highlights from the quarter, we were very pleased to announce the expansion of our patent portfolio for COM902 with new U.S. and Chinese composition of matter patents. These patents relate to the composition of matter of COM902 alone or in combination with a second antibody targeting an immune checkpoint including PD-1 and PVRIG, specifically COM701. This patent further strengthens our IP portfolio for COM902 which is now covered by Composition of Matter and Use Patents in both US and Europe. We were also thrilled to strengthen our incredible scientific advisory board with the appointment of immuno-oncology pioneer, Dr. Nils Lundberg. Dr. Lundberg has over 30 years of experience in the biopharmaceutical industry and his career laid the early foundation for cancer immunotherapy, translating checkpoint inhibition to new therapeutics that have transformed the cancer treatment landscape for millions of patients. We are honored to have him with us and grateful he will be sharing his expertise as we work to advance our programs and vision of expanding the reach of immunotherapies. We look forward to 2021 as we continue to gather more data on patients from our ongoing clinical trials, which we believe will provide additional insights into the role of PVRIG within the DNAM access pathway. We are grateful to our team, partners, investigators, and shareholders and look forward to continued progress. With that, I will turn the call over to Henry to review our clinical programs.