Compugen Ltd.

Ladies and gentlemen, thank you for joining us today. Welcome to Compugen's second quarter 2024 results conference call. At this time, all participants are in a listen-only mode. An audio webcast of this call is available in the Investors section of Compugen's website, www.cgen.com. As a reminder, today's call is being recorded. I would now like to introduce Yvonne Notten, Head of Investor Relations and Corporate Communications. Yvonne, please go ahead.

Thank you, Yanni, and thank you all for joining us on the call today. Joining me from Compogen for the prepared remarks are Dr. Anat Cohen-Dyack, President and Chief Executive Officer, and Alberto Sessa, Chief Financial Officer. Dr. Michelle Malera, Chief Medical Officer, and Dr. Iran Ofeira, 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, development efforts and the potential outcome, the company's discovery platform, anticipated progress and plans, results and timelines for our programmes, 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 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, 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. The company undertakes no obligation to update projections and forward-looking statements in the future. And with that, I now turn the call over to Anat.

Thank you, Yvonne, and thank you, everyone, for joining us on our second quarter 2024 call. I'm delighted to start this call by congratulating our team for the excellent execution on the high-quality COM543 INV submission, resulting in FDA clearance for initiation of a Phase I trial. COM543 is our differentiated approach to harness cytokine biology to treat cancer, and I'll come back to this later in the call. There have been many developments in the ticket landscape in the last few months, and more are expected by the end of this year. Therefore, I thought it is appropriate to begin by sharing with you how we think about the field. We believe that CompGen is uniquely positioned and differentiated in the pursuit of the DLM1 axis as part of our COM71-COM902 triple combination. I will then cover the progress we have made in the second quarter of this year and move to our planned milestones through the rest of 2024. Starting with the TG competitive landscape, what have we learned so far? First, the benefit of adding TG blockade to PD-1 compared to PD-1 demonstrated in several Phase II randomized clinical trials And TG blockade added a six-month survival benefit in a phase three interim analysis. Second, the benefit of TG blockade was observed mostly in PD-L1 high patient populations. Third, the nature of the TG antibody matters. The use of an FC-enabled antibody may not be tolerable in patients with early stage of disease due to potential immune-mediated safety concerns. And finally, a third component may be needed to be added to TGT and PD-1 blockade to maximize the effect. Some companies are adding chemo or ADC, which may be an option for patients who can tolerate these combinations. Confidence data consistently suggest that PGR-IG co-blockade provides added benefit. We believe an advantage of this choice is the favorable safety profile of IO combinations and the prolonged immune benefit that one might expect to achieve. We therefore believe that the success of the next antitigic studies will be determined by several factors. Firstly, the clinical strategy employed, which includes choice of patient population and combinations used. And secondly, the choice of an anti-tigit, EPSI inactive versus active. Now, elaborating more on why the clinical strategy matters. Based by our innovative research of the PVRIG pathway as part of the genome access, Confidence hypothesis has always been that blocking TG-plus PD-1 alone may not be sufficient and that a third component, PVRIG, may be needed to optimize the potential of TG-10 PD-1 blockade in certain tumor types and patient populations. Confidence data suggests that unlike anti-TG, anti-PVRIG may function across PD-L1 expression levels, and may also extend the response to the PD-1-TGIT non-responsive tumor types and patient populations. We're therefore currently pursuing a triple combination strategy, blocking PVRIG, TGIT, and PD-1, and we pursue this drug combination in tumor types and patient populations that are not responsive to PD-1. This strategy helps us to directly prove a COM71-PVRG-driven effect of a triple combo, even though we employ small single-arm studies. By assessing the non-responsive tumor types, our data will not be attributed to a PD-1 effect, but we also recognize that the signals that we may see in these very hard-to-treat tumor types will not be very high. Of course, this triple combination is also expected to add benefit in inflamed PD-1 responsive settings. In addition, our partner AstraZeneca is advancing development of Rizogastamig, their PD-1-tigid bite-specific, providing a peak revenue target of greater than $5 billion, reflecting the potential of this asset. As the TGIT component of resagastomy is derived from Configent's COM902, this is a potentially significant revenue-generating opportunity for Configent. Elaborating more on the choice of anti-TGITs, not all anti-TGITs are the same. Our CoV-2 anti-FIGIT antibody is an IDG4 antibody, and so it is naturally FC-reduced, chosen with efficacy and safety in mind. We have always said that the FC activity of the antibody should be disabled. The reason for this is simple. FIGIT is highly expressed on CD8 plus T cells and NK cells. cells that are key for antitumor activity, and you therefore want to avoid depleting them. In addition, FC-silent antitigit avoids peripheral T-rate depletion that can lead to immune-related adverse effects. Notably, recent data may suggest that an FC-active antitigit antibody may not be tolerable in patients with early stage of disease due to immune-mediated safety concerns. Moving now to the progress we have made in the second quarter of the year, continuing our track record in delivering our plans, we again executed on our promises. Firstly, we're delighted that the FDA has cleared the IMD application to initiate a Phase I trial for COM503, our potential first-in-class high-affinity anti-ALA team-binding protein antibody licensed to Gilead. ID clearance, which triggered a right to a $30 million milestone payment from Gilead, further transcends our balance sheet with an expected cash runway into 2027. We're well advanced in our planning and currently on track to initiate the phase one trials for COM503 in solid tumors in the fourth quarter of 2024. Advancing COM503 to phase one adds to the multiple clinical programs discovered through our predictive computational discovery platform, where we unlock the science and advance the clinical trials. Secondly, We are on track to report data from our COM701, COM902, and pembrolizumab triple combination proof-of-concept study in patients with platinum-resistant ovarian cancer in the fourth quarter of this year, and I will come back to this shortly. Finally, in the second quarter of 2024, we were excited to see that our partner AstraZeneca announced the further advancement of the development of rilvogastamide, the PD-1-tigit bispecific, where the tigit component is derived from compaginus com902, into its third phase retrial, Destiny BTC, which will assess rilvogastamide and the ADC and HER2 versus standard-of-care chemotherapy and the anti-PD-L1 durvalumab for first-line locally advanced or metastatic HER2-expressing biliary tract cancer. As a reminder, the other phase III trials initiated by AstraZeneca are in lung cancer as part of an IO-ADC regimen and in adjuvant biliary tract cancer. We believe these advancements reinforce our partnering strategy designed to expand the opportunity for our pipeline programs, including Common O2. This brings us closer to potential additional milestone payments in an aggregate amount of up to $200 million and future mid-single-digit tiered royalties presenting together a significant potential revenue source for our company. To date, we have received around $40 million in upfront payment and milestone payments. Moving on now to what is planned for the rest of the year, I'm coming back to the presentation of our data in platinum-resistant ovarian cancer, which is on track for the fourth quarter of 2024, and our plan to present this data at a medical conference. We believe that the totality of the data we have reported to date in platinum-resistant ovarian cancer patients is encouraging. In the prior cohort of patients, our investigators were excited to report durable shrinking or stabilization of tumors in some of the patients who had previously progressed on all available treatment options. we presented a 20% overall response rate, with some patients responding for over 16 months, which is favorable considering the median duration of response for chemotherapy is around 3 to 4 months, and in ADC is around 6.9 months. Responses were also achieved in the hard-to-treat high-grade serous adenocarcinoma patients along with a favorable safety profile. To remind you, ovarian cancer was pre-identified using our computational capabilities even before we treated patients as high priority target indication for PVRIG blockade. Of note, we also previously presented data showing COM7-1 immunotherapy activity in a patient with ovarian cancer whose tumor microenvironment was immune desert. This patient had a partial response of more than 18 months. In the fourth quarter, we plan to present the baseline characteristics, safety, overall response rate, disease control rate, initial biomarker data, if any, and preliminary data on duration of responses for COM701, COM902, and pembrolizumab combination. In relation to baseline characteristics, these platinum-resistant ovarian cancer patients were heavily pretreated, exhausting all other treatment options, and the number of patients were ADC-experienced, reflecting the changing treatment landscape and the hard-to-treat patient populations. Given that the only other treatment option for these patients would have been chemotherapy, we believe that it is the most relevant benchmark. As we have previously communicated, our goal is to assess whether we can demonstrate a similar clinical benefit to what we observed in the prior cohort. We believe, repeating it in a larger total number of patients, would confirm COM71 combinations are active. There is a significant unmet medical need for women with ovarian cancer who could benefit from alternative potentially safe, efficacious, and durable treatment options. We intend to share our plans or next steps for our COM71 combinations at the time of data presentation. Finally, In the second half of this year, our partner AstraZeneca anticipates data from Phase 1-2 Artemide 01 trial and the poster presentation from Phase 2 Gemini gastric trial, which was accepted at ESMO 2024. With that, I will hand over to Alberto for the financial update.