Compugen Q4 2024 Earnings Call Transcript

Quartr
Provided by Quartr
March 4, 2025

There are 11 speakers on the call.

Operator

Ladies and gentlemen, thank you for joining us today. Welcome to Compugen's Fourth Quarter and Full Year twenty twenty four 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.

Operator

I would now like to introduce Yvonne Naughton, Vice President, Head of Investor Relations and Corporate Communications. Yvonne, please go ahead.

Speaker 1

Thank you, operator, and thank you all for joining us on the call today. Joining me from Compugen for the prepared remarks are Doctor. Natko Ndiaik, President and Chief Executive Officer and David Sibelman, Chief Financial Officer. Doctor. Michelle Malair, Chief Medical Officer and Doctor.

Speaker 1

Eran O'Fir, will join us for the Q and 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 programs, financial and accounting related matters as well as statements regarding our cash position and cash runway. 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.

Speaker 1

The company undertakes no obligation to update projections and forward looking statements in the future. And with that, I'll turn the call over to Anat.

Speaker 2

Thank you, Yvonne, 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 a triple blockade of PVRIG TIGIT and PD-one with COM701, COM902 and pembrolizumab in platinum resistant ovarian cancer patients who typically do not respond to immunotherapy 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 COM701 is active, resulting durable responses and has a good tolerability profile.

Speaker 2

Based on the totality of the data we've presented to date, including monotherapy and combination data and with the support from ovarian cancer experts, we announced at the end of twenty twenty four that we would advance development of COM701 as maintenance setting of platinum sensitive ovarian cancer has a strong clinical and biological rationale and represents a less competitive landscape. As part of our 2025 strategic priorities, we are on track to initiate in the second quarter of twenty twenty five an adaptive platform trial starting with a randomized double blinded sub trial. The first sub trial will evaluate single agent COM701 as a maintenance therapy versus placebo in a total of sixty patients with platinum sensitive ovarian cancer who are not candidates for bevacizumab or PARP inhibitors. The primary endpoint will be median progression free survival where the placebo benchmark is expected to be approximately six months. We believe that showing a three month improvement over the median progression free survival

Operator

of the

Speaker 2

placebo would be clinically meaningful. We expect to share interim analysis from this sub trial in the second half of twenty twenty twenty six. Positive data may allow us to both engage in discussions with the regulatory authorities on the path for COM701 registration as a single agent and to extend the opportunity for COM701 to serve as a backbone for future drug combinations. Moving next to the TIGIT landscape. In 2024, there have been several setbacks for the TIGIT antibody class resulting in study or program discontinuation, which led to skepticism about the benefit that TIGIT blocker combinations could bring.

Speaker 2

These study discontinuation occurred with Fc FcT antibodies. Setting aside the importance of selecting the appropriate tumor types and patient population that in some cases might not have been an ideal fit for TIGI brokers assessment, we consistently have advocated that FTE inactive antibodies may serve as the better antibody format for targeting TIGI. In line with this, current clinical trials suggest that Fc inactive anti TIGIT may have a safety advantage in certain patient population, which could ultimately support a potential efficacy advantage due to the patient's durability on study treatment. We therefore believe that the current Phase three trial conducted with Fc in active TB antibodies are important to confirm or refute the benefit that TB 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 TIGIT antibody.

Speaker 2

We're one of the few companies with a clinical stage Fc inactive TIGIT antibody COM902. We differentiate ourselves not only by the unique properties of COM902, but also by our clinical strategy. We continue to believe that blocking TIGIT in combination with PD-one blockers may be effective in certain PD L1 high tumors, but we also believe the TIGIT PD1 blockade may need to be combined with the PVRG inhibitor to expand their use to less inflamed PD L1 low tumors. In addition, our partner AstraZeneca has most recently initiated their seven Phase three clinical trial with risvergastomid, their PD-one TIGIT bispecific, 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 rivagastomy combinations versus standard of care with one trial in first line squamous non small cell lung cancer expressing PD L1 and the other trial as first line treatment in HER2 positive gastric cancer.

Speaker 2

AstraZeneca's broad development strategy for risvergastomy to replace existing PD-one or PD L1 inhibitors represents a significant potential revenue source for Compugen as we're eligible for both future milestone payments and mid single digit tiered royalties on future sales. In 2024, AstraZeneca presented promising risorgastomic 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 risvergastomib with their ABCs. Moving next to GS0321, previously named COM543. As a reminder, GS-three twenty one, a potential first in class anti IL-eighteen binding protein antibody licensed to Gilead represents another way to harness IL-eighteen pathway biology for the treatment of cancer by using an antibody against IL-eighteen binding protein and therefore potentially avoiding the challenges presented by administration of therapeutic cytokines.

Speaker 2

The license by Gilead of GS-three 21 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 GS-three twenty one and the first patient was dosed in early January twenty twenty five.

Speaker 2

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 teams are working on multiple innovative undisclosed research programs. These efforts leverage computational predictions to identify novel ways to activate antitumor immunity. This work is powered by Unigine, our computational prediction discovery platform already validated by our multiple clinical stage potential 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.

Speaker 2

With a diverse pipeline and strong focus on execution in 2025, we 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-three twenty one in the clinic together with continued investment in our early stage research pipeline. Of course, none of this will be possible without our extraordinary team here at Compugen who continuously performed at the highest levels 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.

Speaker 3

Thank you, Anat. I'm delighted to say that we're advancing into 2025 with a solid balance sheet with no debt and with a cash runway to support our operating plans into 2027. Going into the details, I will start with our cash balance. 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 December 2023 and the $30,000,000 milestone payment for its IND clearance in 2024 after withholding taxes at source on those payments.

Speaker 3

In addition to $15,000,000 in milestone payments from AstraZeneca on building the first patient in the first and second major indications for we believe costuming in Phase three trials. Our cash runway takes into account the planned development of our clinical assets and 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. Moving to expenses, R and D expenses for the fourth quarter of twenty twenty four and for the year ended 12/31/2024 were 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.

Speaker 3

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 GS-three twenty one, partially offset by 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 periods 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 was approximately $14,200,000 or approximately $0.16 per basic and diluted share compared with a net loss of approximately $18,800,000 or approximately $0.21 per basic and diluted share in the comparable period in 2023. With that, I will hand over to the operator to open the call for questions.

Speaker 3

Thank

Operator

you. The first question is from Ashnika Gvardin of Truist Securities. Please go ahead.

Speaker 4

Hi, this is Karina from Truist. I had a question on AstraZeneca's recent, they announced the initiation of Phase three endometrial study for the B7 H4 DC PSAM. They're evaluating in the Phase onetwo BLUE STAR as a monotherapy and in combo to the filabicostomic. Can you confirm whether relabicostomic will be included in the Phase three study design?

Speaker 2

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 pivotal trials that they opened across indications. And as you know, they stated that they will open up to 10 trials.

Speaker 2

They're really moving forward faster, aggressively testing risagastomir with ADCs, with chemo as a standalone. We just need to wait and see.

Speaker 4

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?

Speaker 2

So they were in a minute that relate to contribution of efficacy, but they are they stated that they will present data during 2025 from the combination of risagastomib with ADC. So this is expected. I don't know to say more about the contribution of risagastomide as part of the ABCs, but they did present data from risagastomide in noncocetine cancer and in gastric cancer. So I think that the data is showing promising efficacy and safety profile.

Speaker 4

Okay. And a follow-up is, which of the ongoing Phase three trials is expected read out first and the anticipated timeline for that?

Speaker 2

So again, they AstraZeneca did not share any information about this. If you look at their deck from the investor call, they are referring to the Phase III trials as beyond '26, but we cannot relate to more than that.

Speaker 4

Okay. Thank you so much.

Speaker 2

Thank you.

Operator

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

Speaker 5

Hi. Thanks for the question. I wonder if you could talk more about your design of the ovarian study. Understand that it's randomized in twenty patients. Can you help us understand what it's powered to show in terms of PFS hazard ratio?

Speaker 5

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

Speaker 2

Michelle?

Speaker 6

Sure. Hi, Dana. The design of the study is still an exploratory Phase 1b study. So it's not powered to detect and improvement in terms of a full like a full pivotal trial. It's designed to be able to allow us to evaluate the single agent activity of COM701 so that we will be able to outline or accelerate a pathway to an approval.

Speaker 6

So the design that we're using is used quite frequently at this point in time in Phase II drug development or Phase I B Phase II drug development with an adaptive trial design. And we're using Bayesian statistics to be able to evaluate what the probability is of improvement by more than three months when you compare the active arm to the placebo.

Speaker 2

And then I'll just add with respect to a larger study, obviously, if we will see we anticipate to have the interim analysis in the second half of twenty twenty six if you will see that there is a reason for us to add more patients and turn into a larger study that's also something that we can do. But we decided that we'll focus our resources on trying to see if what we believe should work in platinum sensitive maintenance setting is delivering the data that we expect to see.

Speaker 5

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 the patients can be not eligible for bev and not eligible for Park. 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 to that?

Speaker 6

Okay. So the study is going to enroll patients who have already in a PR or CR following the platinum chemotherapy and their patients who would not be recommended to get standard of care maintenance. So if they are eligible to get bev, they will get bev beforehand. If not, they won't be seeing bev. Similarly, if they meet the criteria for the label and guidelines to get PARP inhibitors, they will.

Speaker 6

So this effectively captures what would be considered the third line patient population. And by virtue of the fact that they've been able to tolerate chemotherapy, you're already collecting for a more well patient population. We have a stratification factor when we randomize. So that is how we will achieve balance between the arms. And even though there's a two to one randomization, the stratification is for PARP inhibitor use.

Speaker 6

So patients who have not seen PARP inhibitors are placed differently in terms of the analysis. And let me know if I've answered all the questions we had on that. I'm happy to go in.

Speaker 4

Got it. I guess just

Speaker 5

one more follow-up. Why prior parf as your stratification versus anything else?

Speaker 6

Because the biology is slightly different among the patients with Hash PoP inhibitor use and so that has the potential to result in an imbalance at the time of analysis. So patients who have PoP inhibitors can often can often be the ones that remain platinum sensitive with multiple relapses more often than patients who have seen data flows on that or who have not been treated at all with their full POTS.

Speaker 2

Right. Thank you.

Operator

The next question is from Leland Gershell of Oppenheimer. Please go ahead.

Speaker 7

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 is interest in evaluating this asset in hematologic malignancies and or with maybe combination with firstly cotuximab just given other campaigns in the past along the IL-eighteen access that have looked at those candidates in such settings? Thank you.

Speaker 2

Yes. This is Actually, I'll let Iran I'll just say we obviously, a later on related from the biology perspective, what could be done. Obviously, we cannot go beyond what's written in clinicaltrials.gov in the description of the study with the solid tumors. But Iran, go ahead.

Speaker 8

Yes, it's an interesting question. Obviously, it's right that in the past IL team has shown some combination with Rituximab. For us, we're focusing now in solid tumors. This is where we did most of our research. This is where we saw the observations of this unique activity specifically inside the tumor microenvironment in order to be periphery.

Speaker 8

So, metallurgical could be interesting. But as Anat mentioned, the focus now in solid tumors, we think we have an edge there versus other ILT agents. And yes, this is where we go first.

Speaker 7

Great. Thanks. And then just with respect to the study in platinum sensitive, if you could just remind us, it's an adaptive platform trial, just what the adaptive nature of that design is? Thank you.

Speaker 6

Sure. So it's adaptive because it allows we declare upfront that we would add additional arms to the study or after our interim analysis there's an opportunity as Anat alluded to that we could also increase the sample size. So those are the adaptations and it allows us to be able to be much more flexible in terms of what our next steps will be pending the interim analysis data.

Speaker 7

Okay. I guess just to follow on to the earlier question, have you indicated what sample size you may be looking to raise the size of the trial to?

Speaker 6

No, it will be dependent on the magnitude of effect size that we get at the interim analysis.

Speaker 7

Got it. Great. Thanks very much.

Operator

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

Speaker 9

Michelle, just one or two follow ups on the same topic. One is, what are your expectations for rate of enrollment? Importantly, when do you think you could reach roughly 60 patients in total? And the second is, in a real world setting, what's the rough percentage of patients that actually don't see bef or part in the platinum sensitive setting? Thank you.

Speaker 6

Okay. So in terms of I'll take your first question. The second question first. And I'm going to ask you to repeat the first question. I apologize.

Speaker 6

So the percentage of patients, if a patient is eligible for a PARP inhibitor, meaning that they have one of the mutations associated with the response, they're absolutely treated. And so that's really driven by the underlying genetics of the patient population. And offhand, I think it's about a third of patients that have the mutations. Among the patients who are eligible for bevacizumab, there's a lot of different factors that will be taken into consideration. However, in the clinical trial, patients that had a very high risk disease and high risk for disease aggression.

Speaker 6

They had, when we did the 24 trials, the progression free survival was adding bevacizumab was improved. But except for the patient population that had high risk features, there wasn't an improvement in overall survival. So they are a group of patients that are not always treated upfront in the first line setting with bevacizumab. And there are investigators who elect to hold off treatment until the patient has platinum resistant disease. I'm not so clear exactly what percentage of patients that is, but it tends to be a smaller percent than what we would expect.

Speaker 6

And we know that in the third line patient population, about forty percent of those patients who relapse off the second line remain platinum sensitive. The rest become platinum resistant.

Speaker 9

Thank you. The first question was rate of enrollment in the study.

Speaker 2

Okay.

Speaker 6

So from all the investigators that are in touch with us with respect to participation, is there's a lot of support for the study to enroll rapidly. One of the reasons being is that there aren't too many other clinical trials right now open for this specific patient population. So it would appear that we should have a pretty fast rate of enrollment. And as we have stated before, our plan is to have an internal analysis in the next year.

Speaker 9

Thanks, Michelle.

Operator

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

Speaker 10

Yes, good morning. Thanks for taking the questions. Maybe just to follow-up on the Study one question. So can you speak to what specifically triggers the interim analysis that will be conducted in the study? Is it an event rate driven analysis?

Speaker 10

And I guess is there also a predefined futility threshold that will be evaluated at time of this interim?

Speaker 6

Yes. There is a futility rate based on the assumption that often nine months of follow-up after we enroll the last patient in, we will evaluate the big the big registration studies and big clinic cooperative group studies, the median progression free survival is approximately six months. Okay. There are some outliers in that approximation. There's one study where it was 8.4 and one study was three point eight months.

Speaker 6

But when you put all the data together, it's approximately six months. So we are looking for a three month and we do have a futility boundary. And the way we will analyze this using Bayesian statistics will be to say what is the probability of seeing an improvement of three months at the time that we look at the interim analysis. We will also follow the events. So if we are hitting an event driven improvement before we get to the planned interim analysis, we will then potentially also consider unblinding the study at that point.

Speaker 6

But that's why we will have an interim an independent data review committee data as the study progresses.

Speaker 10

Okay. So the interim is triggered by PFS event rate not by some prespecified?

Speaker 6

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 particular follow-up and the hypothesis, we will then look at potentially cutting the data. And if we meet either the feasibility boundary or we exceed it from the point of view that we are positive with the greater than eighty percent chance of that observation, then we will consider that the study is positive or at least the interim analysis is positive and then take additional steps to move forward.

Speaker 10

Okay, got it. And then just quickly on the O-three twenty one dose escalation study, can you speak to whether pre or post treatment biopsies are mandatory? And then just what PD data will you be collecting both in the tumor and I guess also the periphery to confirm on target activity? Thanks.

Speaker 6

So I can't speak to all the minute details within that question. I can only speak to what we have in clinicalfiles.gov. That should suffice to say, we do have certain we do have certain cohorts that we will obtain on treatment biopsy

Speaker 4

so that we will be

Speaker 6

able to look more deeply into some of the pharmacodynamic processes of the compound.

Speaker 10

Okay. Thanks for taking the questions.

Operator

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.

Powered by Quartr
Earnings Conference Call
Compugen Q4 2024
00:00 / 00:00