Ladies and gentlemen, thank you for joining us today. Welcome to Compugen's First 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 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 from Compugen for the prepared remarks are Dr. Anat Cohen-Dayag, President and Chief Executive Officer; and Alberto Sessa, Chief Financial Officer. Dr. Michelle Mahler, 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 of forward-looking statements regarding future events, business outlook, development efforts and their potential outcome, the company's discovery platform, anticipated progress and plans, results and timelines for 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 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 20-F. The company undertakes no obligation to update projections and forward-looking statements in the future. With that, I now turn the call over to Anat.

Thank you, Yvonne, and thank you everyone for joining us on our first quarter 2024 call. Today, I will cover the significant progress we have made across our pipeline in the first quarter of this year, and I will then move to our planned catalyst through the rest of 2024. But before I go there, I thought I would start on a question which we frequently get asked, is Compugen an AI company? And the answer is yes. Compugen is a pioneer in computational discovery of novel drug targets, and not just in theory, but in practice, which is a significant differentiator. We successfully moved our newly discovered drug targets from computer prediction to drug discovery to preclinical and clinical trials, continuously feeding our own pipeline with potential significant opportunities to address cancer immunotherapy resistance. The Gilead deal on COM503 highlights the most recent asset discovered through our computational discovery capability. Our discovery platform is a validated AI/ML powered platform. This platform is the engine fueling our competitive advantage and pipeline and has already delivered multiple fully-owned clinical programs, multiple validating strategic partnerships, and multiple early-stage undisclosed assets, which are expected to feed our future pipeline and opportunity to deliver long-term value creation. We plan to speak more on our discovery platform at future events. So now I will move to the focus of today's call. In the first quarter of the year, we again executed on our promises. Firstly, at the annual ASCO conference in June, we will present preliminary anti-tumor activities of COM701 in combination with COM902 and pembrolizumab in patients with MSS-CRC and liver metastasis from our ongoing proof of concept study. Secondly, we completed enrollment of more than 20 patients in our platinum-resistant ovarian cancer study, and we're on track to report initial findings in the…

Thank you, Anat. I'm happy to summarize our financial results. I will start with our cash balance. As of March 31, 2024, we had approximately $101. 3 million in cash compared with approximately $51.1 million as of December 31, 2023. This cash balance includes $60 million upfront payment from Gilead related to the licensing of COM503 and $10 million milestone payments from AstraZeneca on dosing the first patient in the Phase 3 trial in biliary tract cancer. We recognize the importance of cash efficiency and we are disciplined in how we deploy our cash reserves while making sure we focus on reaching key milestones. We have a cash runaway into 2027 taking into account the expected milestones payment of $30 million from Gilead for COM503 IND clearance expected in the second half of 2024. It is important to emphasize that this does not include any additional potential cash inflow from our partners. I remind you that the company has no debts. Revenue for Q1 2024 were approximately $2.6 million compared to no revenue for the comparable period in 2023. The revenue reflects recognition of a portion of the upfront payment from the license agreement with Gilead. Expenses for the first quarter of 2024 were in line with our plans. R&D expenses for the first quarter of 2024 were $6.4 million, reduced from $7.4 million in the first quarter of 2023. Our G&A expenses for the first quarter of 2024 were $2.4 million compared to $2.6 million in the first quarter of 2023. For the first quarter of 2024, net loss was $7.3 million, or $0.08 per basic and diluted share, compared to a net loss of $9.3 million or $0.11 per basic and diluted share in the first quarter of 2023. With that, I will hand back to Anat to summarize.

Thank you, Alberto. To summarize, Compugen stands out as a clinical stage immuno-oncology target discovery pioneer. We're differentiated by our validated discovery platform, which is powered by the mix of human expertise with AI and machine learning to fuel our first-in-class pipeline. We're on track to deliver a catalyst-rich 2024 across our diversified pipeline and planning to present data for our COM701, COM902 triple combination at ASCO in MSS-CRC, as well as data from our platinum-resistant ovarian cancer at the end of the year. We are planning to submit COM503 for IND in the second half of this year and are advancing our planning for the initiation of Phase 1 for this program. With the pipeline that is being advanced internally and by our partners, this is an exciting time for Compugen, and we believe that we have the fundamentals in place to bring value to our shareholders and cancer patients. I am proud of what we are achieving here at Compugen. I would like to thank all our Compugen colleagues for their collaborative spirit and daily dedication, resulting in a well-executed first quarter of the year and setting us up for future success. With that, I will turn the call over for questions. Operator?

[Operator Instructions] The first question is from Stephen Willey of Stifel. Please go ahead.

Hi, guys. This is [indiscernible] on for Steve. Thank you for taking my question and congrats on the progress. We just have two questions on our end. The first one is related to colorectal trials. So I know that ASCO abstracts will be available this week, but when it comes to the actual presentation, how much additional incremental detail should we expect in the actual presentation versus abstract? And following this presentation, what would be a path forward for this study? And second question would be related to COM503. Do you think you will disclose any clinical data following IND submission for these assets? Thank you.

So maybe -- thank you. And maybe I'll start with the second question for COM503. This decision of disclosing clinical data from a Phase 1 study will be taken in collaboration with Gilead. This is an asset that was licensed to Gilead and I cannot commit on their behalf and will give some guidance when we know. But obviously before that, we will need to file the IND and initiate the study, which filing is expected in the second half of this year. For the CRC data, yes, the abstract is going to be out this week and the presentation of data will be June 1st for Compugen. It will be data worth of 20 patients enrolled and we’ll share the antitumor reactivity, durability, translational data, safety, et cetera, and obviously patient baseline characteristics. And as we've already stated, the data is supportive of anti-tumor activity of COM701, is supportive of COM701 mechanism of action, PVRIG biology, but we believe based on the data, and this is the guidance that we shared today, it was important for us to share the guidance at the time that we know what is the decision that we've already took is that we believe that IO-IO only combinations would not be the right way to target MSS-CRC with liver met population, which as you know, and this line consists of 70% of the patient population. We believe that that's not the right path and we decide that while there could be a path forward for COM701 in MSS-CRC with liver met, maybe in other combinations or maybe even in earlier lines, we're not taking this path forward at this point in time.

Thank you.

Thank you.

Thank you. The next question is from Asthika Goonewardene of Truist Securities. Please go ahead.

Hi, guys. Good morning, and thanks for taking my question. So maybe I want to just dig in a little bit more here on colorectal and I'd like for maybe you and Aran to comment on what you think is missing here. It sounds like you're resilient that 701 biology is active, but maybe if you can help us understand what did you need more immune activation and less maybe less checkpoint blockade but maybe more debulking, what exactly was the missing link here given the encouraging activity we saw earlier for this approach? And then beyond ovarian for 701, 902, how should we think about the other avenues that you're going to pursue this combination? Is there -- is your next priority to maybe revive efforts in CRC but with a different combination to maybe address what's missing or have you identified another tumor type that you would like to take this into? Thanks.

Okay. Thanks, Asthika. I'll start by saying that, look, we can't get really to the specifics of the data, and maybe this discussion will be worth to be taken following the presentation in June 1st. Maybe Eran wants to add, but I'll just say that with IO only, we believe that what we see is not enough in order to pursue. But maybe, Eran, do you want to say anything about it more than that?

Yeah. So with the unique biology of PVRIG and what you have seen previously, definitely with the activity in places where normally checkpoints are not working in MSS-CRC, with liver metastasis, immune modulation, increase in T cells. But we've seen it in part of the patients, right? And eventually to move forward, you need to have sufficient activity in sufficient amount of the patients to really consider to go towards approval. And as you understand, what we see in a pure IO combination of the triplet. In this very difficult and not immunogenic indication, what you have seen is not enough to convince ourselves to move forward as is. And yes, as discussed, maybe not at this point in time, but there are other rational-based combinations that could be employed to increase IO activity in this kind of difficult indication that is something to consider for the future but again not at this point in time.

And then actually it takes me to your second question about additional tumor types. I think that, with the data that we have in hand on COM701 activity in non-inflamed tumor types, across indications where PD-1 is really not -- the populations are not responsive to PD-1 inhibition or very -- or responsive to a very low extent. We have data across indications and COM701 is active. Other than putting the resources and focusing now on platinum-resistant ovarian cancer, which we really have a package of data and additional 20 or more than 20 patients' worth of data will really help us make a decision about how to move forward there. I think that the field is open for us for different types of paths. In the non-inflamed indications, Also in the inflamed indications, obviously we've never tested inflamed indications and we had a reason why we didn't do it. PVRIG biology gave us an ad in this non-inflamed limitations and we could prove COM701 activity in combination in single-arm studies without asking the question, is it PD-1 inhibition that is generating this activity? And we could do all the work and show in [indiscernible] that this is a comfortable mechanism of action. And also another path is to combine with the non-IO combinations. But really, we are now at the stage that we're focusing in platinum-resistant ovarian cancer and we will make the decisions during the year how we move forward in this indication.

And maybe I would just add that in addition to what we're focusing on at the moment, you pre-identify a few indications with dominant PVRIG pathway. Ovarian is one of those, but there are other indications, for example, like non-small cell lung cancers, and I've mentioned more inflamed settings. So definitely there are multiple opportunities and combining this with the safety profile of COM701 that really will enable us safe combinations maybe in other indications, maybe in early lines. So again, the opportunities are there and there are quite a few, but we are focusing now on the ovarian cancer which we have seen until now quite promising data.

Thanks guys.

The next question is from Daina Graybosch of Leerink. Please go ahead.

Hi. Thank you for the question. I'm going to continue this line of discussion on your strategy for PVRIG going forward. And in ovarian in particular, I wonder how you're considering combining with other standard of care agents like chemotherapy or VEGF, bevacizumab. And just reflecting on the path in colorectal, there's one path that is seeing if you can get a pure IO therapy to work, and there's another path others have taken in these difficult tumors to do combination, and of course to get that signal that it's a different kind of study. I wonder how you're considering that. And it reminds me that at one point you had planned a chemo combination, I think, in lung cancer. And I'm not sure you ever started enrolling that. So again, remind us why you didn't start enrolling that and what a path -- specific path you would see among cancer should we get to that point? Thank you.

Thank you, Daina. I'll start and Eron and Michelle, feel free to chime in. I'll start with the ovarian. First I'll say that you've asked us about combinations and first I'll say that we're focused on this IO combination that we're pursuing now. And with the package of data that we have, with the initial biomarker correlations, we feel that if data will repeat itself, we'll see clinical benefits, and there is a path forward for us targeting different types of patient populations, those that are progressing on ADCs and those that are -- or standard of care, and those that are ineligible. Having said that, it is true that combination with chemo, VEGF, ADCs may be relevant. And this is really based on the mechanism of action of PVRIG being combined with the cytotoxic agent and also from the safety profile as Eran mentioned to Asthika. So, this is on the ovarian front and while we will focus on ovarian and get the data from this study, we can decide how we move forward taking into consideration the competitive landscape, obviously, in ovarian cancer. And with CRC, and as I said, I’ll let Eran, Michelle, as they want on each of the indications. But in CRC, I think that while we see a possibility of moving forward in this indication in combination with standard of care, again here mechanistically and safety-wise or in earlier lines, I think that the risk profile, and this is for this stage of the company, the risk profile in MSS-CRC, with liver met, is a profile that we saw that at this time we shouldn't focus on total resources, but still this door is open to being pursued in the future. So that's for CRC.

Anat, I didn’t ask about CRC. I asked about non-small cell lung cancer. What would be potential for there?

Sorry.

That's okay.

Sorry. Yeah. And this is correct that we planned at a certain point in time to move based on the data that we had that Eran mentioned, data in patients that already experienced checkpoint blockade. We had very nice data, seven patients though, but very nice data, and we thought of pursuing non-small cell lung cancer with chemotherapy as a small study. The reason that we decided to focus on the non-flamed indications at the end of the day was the fact that we were with the cash limitations that we had at that time, we decided to focus on indications where we will not need large studies in order to prove the activity of COM701 combinations. Single arm, small study that we can tease out the contribution of COM701 quickly and move forward. And this is still on the table and as I said, as a company in general, we're thinking about indications that we can pursue internally by ourselves, and indications that we may pursue, as I was saying all the time, partnering is also a priority for us, and larger indications that could be pursued in partnerships. And, Eran, Michelle, anything to add in ovarian and non-small cell lung cancer combinations?

Go ahead. I was just going to emphasize again what you were saying, Anat, because when we look across the indications that we've presented data in, we definitely do see a effect driven by COM701. So I think that there are opportunities even within other indications like endometrial, breast where we've presented data before and we are considering a lot of different options to have a more robust sort of strategy moving forward.

And I think at this point in time, we're focusing on the pure IO. We have strong data from preclinical to clinical. This is really strong immune-modulating regime that have an excellent safety profile. It's chemo-free, it's really attractive, and the data we've seen and are now in ovarian and some of the other indications really pushes us to continue and explore this IO pure combination. But again, doing other combinations if we need, or maybe in some indication in which we'll need it is definitely an approach and there's a rationale for that. I mean, the unique biology of PVRIG, the ability to prime new T cells is there is a rationale to combine with ADCs of chemotherapy with the enhanced immunogenicity [indiscernible] enhanced. There's rationale to combine with [BEV] (ph) with the effects of T cell infiltration. So moving forward, we definitely consider the data, the indication, and other rational-based indications that we may consider in the future.

Great. Thanks.

The next question is from Tony Butler of Rodman & Renshaw. Please go ahead.

Good morning and thank you. Anat, with respect to the ovarian cancer data set that's forthcoming, will data also include patients who are actually segmented by positivity with PVRL2? That's Part A of that question. Number two is, you mentioned a biomarker strategy, I believe, for moving forward with a larger potentially registrational trial. Have you settled on, and this may be for Eran, have you settled on an H score, as I recall, those individuals who had clinical benefit had H scores that were, I guess, relatively high, 300 or so? And then the third point is, while I assume all ovarian cancer patients will have had BEV, is there a reason why they would not want to stay on BEV, even if in fact it has marginal activity certainly of single agent? Thank you very much. And one last point. Is 20% the hurdle rate that for which we should be looking toward or forward toward the fourth quarter for that data set? Thanks.

Thank you, Tony. So I'll let Michelle answer the [best] (ph) question. I'll start with what you asked about the biomarker and let Eran relate to the H score. First, I'll say that in terms of the data, yes we present data that relates to the activity, to the efficacy, the durability, translational, the data that we'll have in hand. We also anticipate to share PVRL2 or biomarker data, obviously pending on data, the work in progress now and with the data that we have in hand, we present what we have in hand. I will say before I let Eran relate to the H score, I will say that we will look at the data and different bars of data will allow us to make a decision, do we go with or without the biomarker? We're not limiting ourselves to a biomarker. This is an enrichment strategy that may help. It will depend on the data that we have in hand, but we are not really going to study that will not be biomarker. Reason, maybe a study that will still continue to assess the biomarker findings. It really depends on the data that we have in hand. And Eran, do you want to take the H-score one?

Yes, so yes, Tony, remember it correctly. This is a very important observation from our previous study in which we showed that the patient who responded had clinical benefit from the treatment of the COM701 combination had higher H score of PVRL2 and this opened the door for a potential biomarker, yes, to enrich for this patient to have long, durable responses and then, of course, to move the registration faster and all the benefits of having a biomarker. So this work is ongoing also in this study. To define the cutoff, obviously, we need to show also in this study that the phenomena repeats itself. We need to really define looking, and now we have much more patients combining the studies together. We can really look at the totality of the data, the response rate, the correlation to the ACE score and then to define the actual cutoff if and when we will move forward with a biomarker selected study. So this is ongoing. Yes.

Do you want me to comment on the BEV?

Yeah, Michelle, go ahead.

Yeah, so in the initial lines of treatment in these patients, they do get bevacizumab together with platinum. Platinums are basically the mainstay of therapy in the ovarian cancer population. Generally, if a patient does relapse following a full regimen, which includes bevacizumab maintenance, they may get put onto the PARP inhibitors as second line, or sometimes they'll do it the other way around. They generally are not repeated. They might repeat BEV, but it's really more repeating the platinum agents until the patient becomes resistant. So that's defined by a platinum-free interval of six months or less. And the patients that have been enrolled on our studies so far are the platinum-resistant patient population.

Thank you very much.

This concludes the Q&A session and Compugen's investor conference call. Thank you for your participation. You may go ahead and disconnect.