Compugen Ltd. Price & Performance (CGEN)

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 [indiscernible] The Compugen undertakes no obligation to update projections and forward looking statements the future. And with that, turn the call over to Anash. Thank you, Ron. And a warm welcome to everyone joining our call today.

On today's call, I will highlight some of our key achievements in 2024 and outline our strategic priorities for 2025. Starting with our potential first in class anti PVRIG COM701. In 2024, we presented data showing the treatment with the triple blockade of PVRIG TIGIT and PD-one with COM701, COM902 and pembrolizumab platinum resistant ovarian cancer patients who typically do not respond to [indiscernible] resulted in encouraging durable responses and was well tolerated. As of mid February twenty twenty five, a few patients remained on study treatment. The data from this study is important because it is consistent with data we previously presented and further demonstrates Compugen is active resulting durable responses and has a good tolerability profile. Based on the totality of the data we've presented including monotherapy and combination data, and with the support from ovarian cancer ex we announced at the end of twenty twenty four then we would advance development of COM701 as a maintenance treatment option for patients with platinum sensitive ovarian cancer. We believe that advancing COM701 in this maintenance setting of platinum sensitive ovarian cancer, has a strong clinical and biological rationale represents a less competitive landscape.

As part of our 2025 strategic priorities, [indiscernible] We are on track to initiate in the second quarter of twenty twenty five an adaptive platform trial starting with a randomized double blinded The first sub trial will evaluate single agent COM701 a maintenance therapy versus placebo in a total of sixty patients with platinum sensitive ovarian cancer, who are not candidates for bivacizumab or PARP inhibitors. The primary endpoint [indiscernible] where the placebo benchmark is expected to be approximately six months. [indiscernible] that showing a three month improvement over the median progression free survival of the placebo [indiscernible] be clinically meaningful We expect to share interim analysis from this sub trial the second half of twenty twenty six. [indiscernible] may allow us to both engage in discussions with the regulatory authorities on a path for COM701's registration as a single agent, and to extend the opportunity for COM701 to serve as the backbone for future drug combinations. Moving next to the TEG landscape. In 2024, there have been several setbacks for the TGT antibody class resulting in study or program discontinuations, which led to skepticism about the benefit These study discontinuations occurred with FC activated Setting aside the importance of selecting the appropriate tumor types, and patient populations that in some cases might not have been an ideal fit for TD Brokers' assessment We consistently have advocated [indiscernible] may serve as the better antibody format for targeting TEGS.

In line with this, current clinical trials [indiscernible] may have a safety advantage in certain patient populations [indiscernible] [indiscernible] a potential efficacy advantage due to the patient's durability on study treatment. We therefore believe [indiscernible] conducted with Fc inactive TB antibodies are important to confirm or refute the benefit that TIGIT blocker combinations could bring. If success is achieved, by one of these upcoming Phase three trials, it could validate TIGIT antibodies as a drug class and open new opportunities for Compugen based on our TEGIT antibody. We're one of the few companies with a clinical stage Fc inactive TEGF antibody [indiscernible] We differentiate ourselves not only by the unique properties of Compugen, but also by our clinical strategy. We continue to believe that blocking TIZZY in combination with PD-one blockers may be effective in certain PD L1 high tumors. But we also believe the TGP1 blockade may need to be combined with the PVRIG inhibitor to expand their use to lessen PD L1 lung tumors. In addition, our partner of Sverdica has most recently initiated their seven Phase three clinical [indiscernible] the TIGIT component of which is derived from our COM902. Since we last reported in November 2024, AstraZeneca has initiated two Phase three trials Evaluating rivagustomy combinations versus standard of care.

With one trial in first line squamous non small cell lung cancer, expressing PD L1 In the other tribes, is first line treatment in HER2 positive gastric cancer. AstraZeneca's broad development strategy for vagostomy to replace existing PD-one or PD L1 inhibitors represents a significant potential revenue source for Compugen as we're eligible for both [indiscernible] and mid single digit tiered royalties on future sales. In 2024, AstraZeneca presented promising risagostomy data at the World Conference of Lung Cancer and ESMO, Showing promising efficacy and the manageable safety profile in both lung and gastrointestinal cancer. In 2025, AstraZeneca plans to share early data on the combination of rivagostomy with their ADC. Moving next to GS three twenty one previously named Comfacto III. As a reminder, GS-three twenty one a potential first in class anti IL-eighteen binding protein antibody License to Gilead represents another way to harness IL-eighteen pathway biology for the treatment of cancer using an antibody against IL-eighteen binding protein, and therefore potentially avoiding the challenges presented by administration of therapeutic cytokines. The license by Gilead of GS-three twenty one further validates our computational discovery research and drug development capabilities. It is Also, a testament to the differentiation of our antibody program targeting the IL-eighteen binding protein.

In 2024, we also made great progress on GS-three twenty one, In the third quarter of twenty twenty four, we received a $30,000,000 milestone payment from Gilead for achieving the FDA IND clearance. In the fourth quarter of twenty twenty four, we initiated the Phase one trial for GSK which and the first patient was dosed in early January twenty twenty five. As part of our strategic priorities in 2025, we're focused on the efficient execution of the GS three twenty one Phase one trial.

Finally, beyond our clinical stage program, our talented team are working on multiple innovative undisclosed research programs. These efforts leverage computational predictions to identify novel ways to activate anti This work is powered by Unigene, our computational prediction discovery platform already validated by our multiple clinical stage [indiscernible] first and best in class antibodies as well as our partnerships with AstraZeneca and Gilead. It is a strategic priority for us to advance our programs to continue to feed our own pipeline. With a diverse pipeline, and strong focus on execution in 2025, believe Compugen is well positioned for growth.

Cash runway assuming no further cash inflows, is expected to last into 2027, and we anticipate using this runway to advance the projected COM701 single agent sub trial interim analysis and to support the progression of GS [indiscernible] [indiscernible] [indiscernible] in our early stage research pipeline.

Of course, none of this would be possible without our extraordinary team here at Compugen. Who continuously performs at the highest level of excellence. I'm excited for 2025 to be another year of advancing our efforts to make a meaningful impact on cancer patients' lives. With that, I will hand over to David for the financial update before we open the floor for Q and A, Thank you, Annette.

I'm delighted to say that we're advancing into 2025 a solid balance sheet. And with a cash runway to support our operating plans into 2027. Going into the details, I will start with our cash balance. [indiscernible] As of 12/31/2024, we had approximately $103,300,000 in cash cash equivalents, short term bank deposits and investments in marketable securities. The cash balance at the end of twenty twenty four includes the $60,000,000 upfront payment from Gilead for the licensing of GS three twenty one in the suburb 2023 and the $30,000,000 milestone payment for its IND clearance in 2024. After withholding taxes at source on those payments. In addition to $15,000,000 in milestone payments from AstraZeneca, on building the first patient in the first and second major indications for revalgustumming in Phase three trials.

Our cash runway takes into account the planned development of our clinical assets continued investment in our early innovative pipeline.

On the revenues front, we reported approximately $1,500,000 in revenues for the fourth quarter of twenty twenty four, and approximately $27,900,000 for the year ended 12/31/2024, Compared to approximately $33,500,000 in revenues for each of the comparable periods in 2023. Revenues for 2024 include the portion of the upfront payment and the IND milestone payment forms a license agreement with Gilead, and the $5,000,000 clinical milestone payment from AstraZeneca. [indiscernible] Moving to expenses. R and D expenses for the fourth quarter of twenty four and for the year ended 12/31/2024, approximately $5,900,000 and $24,800,000 respectively compared with approximately $10,900,000 and $34,500,000 for the comparable periods in 2023. The decrease in 2024 was mainly due to the classification of expenses related to GS-three 21 to cost of revenues and to lower CMC and IND enabling activities related to GSE 31 partially offset an increase in clinical expenses. Our G and A expenses for the fourth quarter of twenty twenty four and for the year ended 12/31/2024 were approximately $2,200,000 and $9,400,000 respectively compared with approximately $2,500,000 and $9,700,000 for the comparable period in 2023. Finally, on net loss. For the fourth quarter of twenty twenty four, we reported a net loss of approximately $6,100,000 or approximately $0.07 per basic and diluted share compared to a net income of approximately $9,700,000 or approximately $0.11 per basic and diluted share in the comparable period of 2023.

Net loss for the year ended 12/31/2024 approximately $14,200,000 or approximately $0.16 per basic and diluted share compared with a net loss of approximately $18,800,000 We approximately $0.21 per basic and diluted share in the comparable period in '20 With that, I will hand over to the operator to open the call for questions. Thank you. Ladies and gentlemen, at this time, we will begin the question and answer session. The first question is from Ashikha Goodwarden of Truist Securities. Please go ahead.

Hi, this is Karina. From Choice I had a question on AstraZeneca's recent they announced the initiation of Phase three endometrial study?

For the B7H4 DCP [indiscernible] they're evaluating in the Phase onetwo Bluestar as a monotherapy and in combo to pelvic gastomic Can you confirm whether relogostomy will be included in the Phase three study design?

Hi, Karena. Actually, we cannot relate to anything that AstraZeneca did not put in the public domain. So I think that we cannot address this question. We're very happy with the seven people tribes that they opened, the cross invitations and as you know, they stated that they will open up to 10 trials. They're really moving forward fast, aggressively aggressively testing veragastomig with ABCs, with chemo, as a standalone we just need to wait and see.

Okay. And I had a follow-up. Can we expect any near term data from them that could clarify contribution to efficacy? For the TIGIT part So they were in a minute I'll relate to contribution of the ticket but they are they've stated that they will present data during 2025. From the combination of rizagastomig with ADC, So this is and [indiscernible] don't know to say more about the contribution of Will the Gulf to make as part of the ABCs. But they did present data from risagostomy, the non small cell lung cancer and in gastric So I think that the data is [indiscernible] [indiscernible] and the safety profile.

Okay. And a follow-up is which of the ongoing Phase three trials is expected to read out first?

And anticipated timeline for that So again, daily AstraZeneca did not share any information about this. If you you look at their deck from the investor call, they are referring to the Phase [indiscernible] is beyond 20 but we cannot relate to more than that.

Okay.

You so much.

Thank you.

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

Hi.

Thanks for the question.

Wonder if you could talk more about your design of the ovarian study. Understand that it's randomized in 20 patients. Can you help us understand what it's powered to show? In terms of PFS hazard ratio.

And given it's are you going to ensure you have balanced between the two arms and why not so for a larger to help ensure baseline balance.

Sure. Hi, Dana. The design of the It's [indiscernible] exploratory Phase 1b So it's not Howard And improvements in [indiscernible] designed to be able allow us to evaluate the seven zero one [indiscernible] to and a [indiscernible] the design that we're using is [indiscernible] frequently at this [indiscernible] drug development or Phase 1b Phase. Just [indiscernible] With an adaptive trial design. And we're using VADIUM [indiscernible] To be able evaluate what the probability is It's by more than three months When you compare the Etsebonde to the And then I'll just add with respect to larger study. Obviously, if we will see we anticipate to have the interim analysis the second half of twenty twenty six, if you will see, that there is there is a reason for us to add more patients and turn into a larger study, that's also something that we can that we can do. But we decided that we'll focus our resources on trying to see if we believe should work in platinum sensitive maintenance setting is delivering the data that we Can you talk about how you're going to help both arms be balanced and maybe I'll add on a second question to this.

You said that patients can be not eligible for Feb and not eligible for part How does that bias this patient group to performance status or any other sort of clinical disease or patient characteristics With that particular criteria And are there benefits and risks [indiscernible] Okay. So the [indiscernible] [indiscernible] patients who have already in a PROF [indiscernible] who would not be [indiscernible] To get So they've if they are eligible to get BIV, they will get BIV.

Beforehand. If not, they won't Similarly, it's They meet the criteria for the label and [indiscernible] ARP inhibitors, they will this affects captures what would be considered the third line patients up and by virtue of the fact that have been able to tolerate chemotherapy You're ready selecting for a more well patient population? We do have a stratification that when we randomized. So that is how we will achieve [indiscernible] the arms And even though there's a two:one randomization, the stratification [indiscernible] So patients who have not [indiscernible] EBITDA is Please [indiscernible] In terms of [indiscernible] Let me know if the bonds are all the questions you had on there. [indiscernible] Got it. I guess just one more follow-up. Why prior to Parfa as your stratification anything else?

Because the biology is slightly ASH CARK inhibitor use and [indiscernible] [indiscernible] the time of analysis So patients who have TAV inhibitors can [indiscernible] [indiscernible] [indiscernible] more often than patients [indiscernible] been treated at all with [indiscernible] The next question is from Leland Gershell of Oppenheimer. Please go ahead.

Hey, good morning. Thanks for the update and for taking our questions. Just one from us. Just on 03/21. Just curious in addition to studying this in advanced solid tumors, just wondering if there's interest evaluating this asset in hematologic malignancies maybe combination with [indiscernible] other campaigns in the past along the IL-eighteen access that have looked [indiscernible] those candidates in such settings. Thank you.

Yes. This is an interesting question. [indiscernible] we obviously a letter on relates to it from the biology perspective what could be done. Obviously, we cannot go beyond what written in the clinicaltrips.gov in the description of the study with a solid tumors, but Erhan, go ahead.

Yes, it's an interesting question. Obviously, [indiscernible] For us, focusing now on solid tumors. This is where we did most of our research. This is where we saw the observations of this activity specifically inside the tumor microenvironment and not the periphery. So meturgical is could be interesting, but as Anat mentioned, the focus now solid tumors. We think we have an edge there versus other IL-ten agents. And this is where we go [indiscernible] Great.

Thanks. And then just with respect to the study in platinum [indiscernible] If you could just remind us, it's an adaptive platform trial, just what the adaptive nature of that design is you.

So it's adaptive because it allows we declare a that we would add additional arms After our interim analysis, there is another Anas alluded to that we could also increase the So those are the ADAP [indiscernible] [indiscernible] allows us be able pending the interim analysis Okay. I guess just in a follow on to the the earlier question, have you indicated what sample size you may be looking to raise the size of the trial to?

No, it will just it will be dependent on the magnitude of a [indiscernible] Got it.

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

Michelle, just one or two follow ups on the same [indiscernible] One is what Great. Importantly, when do you think you could reach roughly 60 patients in total.

And the second is in a real world setting, what what's the rough percentage of patients that actually don't see BEF [indiscernible] [indiscernible] platinum sensitive Thank you.

Okay.

So in terms of our ticket I'm going to take the second question All right.

And I'm going to ask you [indiscernible] the first question. I apologize. So the percentage of patients is [indiscernible] if a patient is eligible for a POC inhibitor, meaning the of the [indiscernible] [indiscernible] And so that's really driven by the underlying Genetics of the [indiscernible] [indiscernible] [indiscernible] have the mutations. Among the patients that get who are eligible to [indiscernible] there's a lot of different factors that will be Expiration However, in the clinical trials [indiscernible] and high risk for this aggression, [indiscernible] [indiscernible] for the patient population that had high risk wasn't an improvement in overall survival. So they are a group of patients that are not With treated up in the first line setting with Bev Does the net [indiscernible] there are investigators who elect until the patient has [indiscernible] Yeah. It was a [indiscernible] Not clear exactly what That is [indiscernible] [indiscernible] about forty percent it's [indiscernible] [indiscernible] [indiscernible] Platinum rest [indiscernible] Thank you. The first question was of enrollment So from all the investigators that that are in touch with us [indiscernible] Did you participation. There's a lot of to enroll rapidly. One of the reasons being is That's too many other clinical [indiscernible] Now for this [indiscernible] Would appear that we should have a rate of enrollment?

And As we have Thanks, Michelle.

The next question is from Stephen Wiley of Stifel. Please go ahead.

Yes, good morning. Thanks for taking the questions. Maybe just to follow-up on the sub study one question. So Can you speak to what specifically triggers the interim analysis that will be conducted in the study? Is it in the Henry, driven analysis? And I guess is there also a predefined few utility threshold? [indiscernible] That will be evaluated at time of Yes.

There is a [indiscernible] [indiscernible] [indiscernible] [indiscernible] Follow-up After we enrolled the last we will evaluate because we know so let me take a step back and Because we know that the patients don't skip [indiscernible] [indiscernible] medium progression free survival, when you look across all the big [indiscernible] and big cooperative groups [indiscernible] The median progression free survival is approx Okay. There are some outliers There's one study where it was a performance and one But when you put all the data [indiscernible] Let me So we are looking for a We do have a We do have a futility boundary and the way we will analyze this [indiscernible] [indiscernible] What is the [indiscernible] three months At the that we look at Interim analysis We will also follow the events [indiscernible] If we are hitting an event driven in [indiscernible] [indiscernible] We will then potentially all unblinding the [indiscernible] But why we will have an interim an independent data review committee to speaking at the data as Okay. So being terms triggered by PFS better rate, not by some pre specified It's a combination.

So we have the event rate and we also are triggering it based on follow-up.

So once we know that we've gone According to the We will then look at either the utility boundary or we [indiscernible] From the point of view that we are positive greater than 80% And chance of that observation, then we will positive or at least interim analysis [indiscernible] Okay, got it. And then just quickly on the OTH-three 21 dose escalation study.

Can you speak [indiscernible] biopsies are mandatory And then just what PD data will you be collecting in the tumor and I guess also the periphery to on target. Thanks. [indiscernible] minute details [indiscernible] In that I can only to what we've [indiscernible] [indiscernible] We do have We do have [indiscernible] [indiscernible] that we will be able Also [indiscernible] Thank you. This concludes the Q and A session in Compugen's Investor Relations Conference Call. Thank you for your participation. You may go ahead and disconnect.