Compugen Ltd.

Ladies and gentlemen, thank you for joining us today. Welcome to CompuGen's second quarter 2023 results conference call. At this time, all participants are in a listen-only mode. As a reminder, today's call is being recorded. An audio webcast of this call will be made available on the investor section of CompuGen's website, www.cgen.com. I would now like to introduce Yvonne Naughton, Head of Investor Relations and Corporate Communications. Yvonne, please go ahead.

Thank you, Operator, and thank you all for joining us on the call today. Joining me for confidant for the prepared remarks are Dr. Anak Cohen-Diag, President and Chief Executive Officer, and Alberta Sessa, Chief Financial Officer. Dr. Henry Adewoye, Chief Medical Officer, and Dr. Eran Ophir, Chief Scientific Officer, will join us for the Q&A. Before we begin, we would like to remind you that during this call, the company may make projections or forward-looking statements regarding future events business outlook, research and development efforts and their potential outcome, the capabilities of the company's discovery platform, anticipated progress and plans, results and timelines for its programmes, financial and accounting-related matters, including projected financial information, as well as statements regarding the company's future cash position and other results, and the company's future initiatives. We wish to caution you that such statements reflect only the company's current beliefs, expectations and assumptions. but actual results, performance, or achievements of the company may differ materially. These statements are subject to known and unknown risks and uncertainties, which could cause the company's actual results to differ materially from those projected in such forward-looking statements, and we refer you to the SEC filings for more details on these risks, including the company's most recent annual report on Form 20F, filed with the SEC on February 28, 2023. The company undertakes no obligation to update projections and forward-looking statements in the future. And now I'll turn the call over to Anat.

Thank you, Yvonne. Good morning and good afternoon, everyone, and welcome to our second quarter 2023 update. At Compugen, our goal is to transform the treatment of cancer patients who have no effective treatment options by discovering novel drug targets and developing potential first-in-class drugs. On this front, we were efficiently executing on our differentiated clinical approach to evaluate the benefit of our chemotherapy-free triple cancer immunotherapy combination of COM701, COM902, and pembrolizumab, blocking free pathways of the DYNAM-AXIS, PVRIG, TGIS, and PD-1. At ASCO this year, we were excited to see the positive momentum and interest of the industry and the scientific community in targeting the DYNAM-1-AXIS as a potential novel approach in treating cancer, reflected by our own data and data presented by others. including AstraZeneca, Roche, and Arcus Gilead. Looking at the totality of the data we have presented to date in how to treat cancer patients, there was enthusiasm among those we spoke with regarding responses demonstrated with our triple combination approach in patients with microsatellite stable endometrial cancer who had failed standard of care including prior PEMBRO and lenvatinib treatment. For these patients, there were no other treatment options. In nine patients, we showed an overall response rate of 22% and a disease control rate of 44%. The responses were durable and supported by immune activation better than what one would expect for an anti-PD-1 alone. This endometrial data is consistent with the anti-tumor activity we reported for COM7-1-based combinations in patients with other hard-to-treat tumors, including microsatellite-stable colorectal cancer, platinum-resistant ovarian cancer, and checkpoint-inhibitor-experienced non-small cell and cancer patients. Reflecting on the totality of the data to date in patients typically not responsive to standard of care, including immunotherapy, our data suggests that our COM701-based combinations have the potential to offer a treatment option with a favorable safety profile for how to treat patients across the spectrum of PD-L1 expression levels, in patients who are anti-PD-1 treatment refractory pointing to a potential COM701-mediated mechanism of action. Our immediate focus is on expanding our data into indications, platinum-resistant ovarian cancer and MSS colorectal cancer, while continuing to invest in biomarker discovery, which is important in efficiently setting our development path forward. However, we believe that the therapeutic potential of COM701 as part of the DENM1 axis may be much broader than these two indications. As mentioned earlier, AstraZeneca presented clinical results at ASCO on rilvergostomy, a PD-1-tigit bispecific antibody derived from our COM902, establishing its safety and pharmacokinetic profile, and showing antitumor activity in patients previously exposed to checkpoint inhibitors and usually not responsive to immunotherapy. AstraZeneca continues to advance relvigostomy development in multiple studies, including a Phase II trial in checkpoint inhibitor or naive non-small cell and cancer patients, and a Phase II trial in hepatobiliary cancer, and previously announced plans to initiate a Phase III trial this year. We know that not all anti-TGITs are designed the same, and like COM902, which is an anti-TGIT with reduced epithelial function, Rilvegastamig was engineered to have an inactive FC domain to enhance antitumor activity. Another program in this FC inactive or reduced effector function camp is Arcus Antitigit. At ASCO, Arcus Gilead showed continued improvement in progression-free survival versus blocking PD-1 alone, with a potentially better safety profile to what has been shown to date with FC-active anti-TGIT. Another session that gained great interest at ASCO was Roche TGIT liver cancer data. This is the third randomized trial showing the benefit of adding an anti-TGIT to standard of care. Blocking TGIT resulted in a four times greater overall response rate and a doubling the progression-free survival on top of standard of care. And Roche has initiated a phase three trial in first-line hepatocellular cancer based on these results. We were pleased that the discussions of Roche's presentation highlighted the potential significance of adding PVRLG blockade in hepatocellular cancer. This is another hard-to-treat indication which may serve as a fit for COM701 treatment. The important role of PVRIG was also called out in another ASCO session on novel approaches to checkpoint inhibitors, in which The presenter was intrigued by our data presented by Dr. Mike Uverman from MD Anderson at FITC last year, showing that blocking PVRIG in combination with PD-1 led to responses in unexpected diseases like microsatellite-stable colorectal cancer. It is great to see an increased awareness of PVRIG role in cancer immunotherapy. It is important to highlight COMPIGEN's differentiated approach and how we stand out among all the players. Firstly, we have always said that blocking TIGIT may not be enough and that PVRIG may be needed. Our discovery of PVRIG and the extensive research we have conducted to test the effect of unlocking its biological function as a new drug target in the context of the genome axis supports the need to block it. This belief is consistently being reinforced as we roll out our clinical data across multiple indications. Secondly, we believe we have a potentially best-in-class reduced FC-effector function antitigid. The data available today suggest that FC design of the TGIT antibody may either not matter or it may be better to have a reduced or inactive FC domain as we have. And finally, with COM701 and COM902, our two wholly owned PVRIG and TGIT programs were the leaders in the unique chemotherapy-free triple combination approach of blocking three genome axis immune checkpoints, PVRIG, CGIT, and PD-1, with initial clinical data to support our hypothesis. Along with a very successful ASCO, I would like to refer to additional progress we have made in the first half of the year. We're advancing patient enrollment in our two follow-on proof-of-concept studies, Enrollment in the NSS CRC study is on track to be completed by the end of the year. Enrollment is slower than planned in the platinum-resistant ovarian cancer study, but we believe we can catch up on enrollment with a planned activation of additional sites. As a reminder, the goal of these studies is to obtain more data help us better understand the contribution of components, and build on extensive biomarker work to identify the patients most likely to respond. We believe that this strategy provides the fastest way to efficiently set our development path forward and to potentially de-risk our lead assets, COM701 and COM902, in these two indications. In May of this year, we presented data on our potential first-in-class anti-IL-18 binding protein antibody, CONFIFO3, at the CIMT Conference, Europe's annual immunology conference. We believe there is excitement around our innovative approach leading to the development of this CONFIFO3 program and its potential in addressing immunotherapy resistance. Finally, on the progress in the first half of 2023, we were delighted with the favorable ruling of the European Patent Office to uphold the broad claims in our PDR IG patent. This ruling of the European Patent Office is a win for our innovation. The discovery of PDR IG's role as a novel immune checkpoint and a drug target for cancer. As a company that excels in the discovery of new drug targets, we harness a broad pattern strategy that takes advantage of our novel target discovery capability. Now moving on to what you should expect to see from us over the second half of the year. First, we plan to report initial findings from our ongoing proof of concept studies by the end of the year and final data at a medical conference in 2024. Second, we're expecting to present new translational and initial biomarker data and long-term patient follow-up from our platinum-resistant ovarian cancer studies presented at ECMO-IO last year. as well as additional data from our COM503 preclinical program all by the end of the year. We also plan to present new data from the metastatic breast cancer study of 17 patients treated with COM701 and Evolumab. Patients were enrolled into this cohort regardless of their ER, PR, and HER2 status. These patients were heavily pretreated and had exhausted all available standard treatments, which could include immune checkpoint inhibitors and ADCs. Before handing over to Alberto, I will touch briefly on our finances, and then Alberto will go into the details. We have an expected cash runway for at least the end of 2024, which we believe is sufficient to support all planned operations and reach milestones to potentially de-risk our lead assets, COM701 and COM902. In terms of future funding, non-dilutive funding of our pipeline assets is our priority. On this front, it is worth noting that the trend in immunotherapy is to combine and treat earlier And we believe the profile of our lead assets, COM701 and COM902, make them ideal combination candidates to be used in earlier treatment settings. Additionally, there is increasing excitement around the potential of IL-18 pathway modulation in immuno-oncology. And with COM503, we're happy that we have a differentiated approach to potentially harness this cytokine biology for optimal use in treating cancer. Finally, through our partnership with AstraZeneca, we may become eligible for future milestone payments. And with that, I will hand over to Alberto for the financial update.