Compugen Q1 2025 Earnings Call Transcript

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May 19, 2025

There are 9 speakers on the call.

Operator

Ladies and gentlemen, thank you for joining us today. Welcome to Compugen's First Quarter twenty twenty five Results Conference Call. At this time, all participants are in listen only mode. An audio webcast of this call is available in the Investors section of Compugen's website, w.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. Anat Cohen Dayag, President and Chief Executive Officer and David Silverman, Chief Financial Officer Doctor. Michel Malaire, Chief Medical Officer and Doctor. Arana Burr, Chief Scientific Officer, join us for the Q and A.

Speaker 1

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 their potential outcome, the company's discovery platform, anticipated progress and plans, results and time lines 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 our 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. And with that, I'll turn

Speaker 2

the call over to Anat. Thank you, Yvonne, and a warm welcome to everyone joining our call today. To start, I would like to refer to the announcement we shared few days ago regarding key leadership transitions at Compugen. After fifteen years as President and CEO of the company, I'm very happy to be assuming the newly created position of Executive Chair and to be handing the reins over to the very capable hands of Oranofir. Over the past year, we have accomplished a lot including investing our innovative clinical immunotherapy pipeline, establishing strategic collaboration, building a robust foundation with talented management team and ensuring a cash runway into 2027.

Speaker 2

This is the right moment to pass the leadership to Iran who has been my trusted partner and competent scientific leader for the past five years. We believe this combination of leadership ensures a solid foundation for the company's next phase

Speaker 3

of growth.

Speaker 2

I would also like to thank Paul Sekri, who after eight years will step down as Chair of the Board. Paul has been a great mentor to me and contributed significantly to the success we have achieved at Compugen. On the call today, I will provide an update on progress we have made this quarter in our mission to transform the lives of cancer patients. In the first quarter of twenty twenty five, we continue to advance our early stage and clinical immuno oncology pipeline, Starting with our potential first in class anti PVRIG antibody COM701, we initiated the first sub trial of our adaptive platform trial comparing COM701 maintenance therapy to placebo in sixty patients with relapsed platinum sensitive ovarian cancer. The patients progressing post PARP inhibitor and or bevacizumab or who are not candidates for such treatment represent an area of unmet medical need with no treatment option.

Speaker 2

Our study focuses on helping these women. With the support of our investigators, we're engaged with the site activation and are working diligently to proceed dosing the first patient. We intend to share interim analysis from this sub trial in the second half of twenty twenty six. The clinical trial landscape is evolving following the success of ADCs in platinum resistant ovarian cancer. And ADCs are also being evaluated now earlier in the disease course in patients with platinum sensitive ovarian cancer as replacements to chemotherapy and added to chemotherapy.

Speaker 2

We believe that advancing COM701 in the maintenance setting of platinum sensitive ovarian cancer is where COM701 may present its potential advantages in terms of tolerability and durability. As previously communicated, we believe that showing a three month improvement over the median progression free survival of the placebo would be clinically meaningful. Positive data has the potential to serve as a key catalyst in advancing a broader clinical development program to address a significant unmet medical need. Moving next to the TIGIT landscape. Despite failures in the TIGIT space, it is notable that companies with Fc inactive anti TIGIT like AstraZeneca and Arcus Gilead are advancing their program.

Speaker 2

We have consistently advocated that ST inactive antibodies may serve as the better antibody format for targeting TIGIT. In line with this current clinical trial suggests that Fp inactive anti TIGIT may have a safety advantage in certain patient population which could support a potential efficacy advantage due to patient durability on study treatment. With the multiple Phase III failures in TIGIT studies, despite positive Phase II randomized studies, we believe that only a success in one of the upcoming Phase three trials could validate the TIGIT antibodies as a drug class, change the market sentiment and open to expand their use to less inflamed PD L1 low tumors. So positive TIGIT PD-one data by others may present additional opportunities for us. In addition, our partner AstraZeneca has the largest ongoing Phase three program in the TIGIT space.

Speaker 2

They have most recently initiated their tenth Phase III clinical trial with rilzagostomyc, their P1 TIGIT bispecific, the TIGIT component of which is derived from ORCOM902. Since our last report in March 2025, AstraZeneca has initiated three additional Phase three trials in lung, gastric and now also in a new tumor type endometrial. These new trials are evaluating rilvagastomy as monotherapy and combination therapy. The potential commercial opportunity for rilvagostomy is substantial with AstraZeneca estimating non risk adjusted PK revenue target of more than $5,000,000,000 In lung cancer alone, the eligible lung cancer patient population across G7 based on 2025 EPI data is estimated by AstraZeneca to be over zero five million patients. AstraZeneca's broad development strategy for rilvagostomy to replace existing PD-onePD L1 inhibitors represents a significant potential revenue source

Speaker 3

for

Speaker 2

us as we're eligible for both future milestone payments and mid single digit tiered royalties on future sales. Coming up at ASCO twenty twenty five, AstraZeneca plans to present as a poster the first rilvagostomy ADC combination data from the Phase II TROPEON LUNK-four trial evaluating frontline rilvagostomy in combination with DASODXD in Oslo cell lung cancer. AstraZeneca also plans to present a poster with the first data from the Phase II GEMINI hepatobiliary trial evaluating frontline rilzagostomy in combination with chemotherapy in treatment naive biliary tract cancer. Moving next to GS-three 21 formerly known as COM-five zero three, a potential first in class anti IL-eighteen binding protein antibody licensed to Gilead. GS-three 21 represents a novel way to harness IL-eighteen pathway biology for the treatment of cancer potentially avoiding the challenges presented by administration of therapeutic cytokines.

Speaker 2

The Phase I trial is progressing as planned. Finally, beyond our clinical stage program, our teams are committed to progressing our extensive, innovative and differentiated early stage pipeline focused on potential first in class drugs and novel mechanisms of action aiming to address various mechanisms to enhance anti cancer immunity. With a diverse pipeline and strong focus on execution in 2025, we believe Competent is well positioned for growth. Cash runway, assuming no further cash inflow, is expected to fund our operating plans into 2027 and we anticipate using this runway to advance our COM701 platinum sensitive ovarian cancer trial 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, of this would be possible without our highly committed talented team here at Compugen who continuously perform at the highest levels of excellence.

Speaker 2

I'm excited for 2025 to be another year of advancing our efforts to make a meaningful impact on cancer patient life. With that, I will hand over to David for the financial update before we open the floor for Q and A.

Speaker 4

Thank you, Anat. I am delighted to say that we are advancing in 2025 with a solid balance sheet with no debt and with a cash runway to support our operating plans into 2027. Our cash runway takes into account the planned development of our clinical assets and continued investment in our early innovative pipeline and does not include any additional potential cash inflows. Going into the details, I will start with our cash balance. As of 03/31/2025, we had approximately $103,700,000 in cash, cash equivalents, total bank deposits and investment in marketable securities.

Speaker 4

Revenues for the first quarter of twenty twenty five were approximately $2,300,000 compared to approximately $2,600,000 of revenue for the comparable period in 2024. The revenues in the first quarter of twenty twenty five reflect the recognition of portions of both the upfront payment and the milestone payment from the license agreement with Gilead, while in the first quarter of twenty twenty four, they reflect portions of the upfront payment from the license agreement with Gilead. Expenses for the first quarter of twenty twenty five were in line with our plan. R and D expenses for the first quarter of twenty twenty five were approximately $5,800,000 compared to approximately $6,400,000 in the first quarter of twenty twenty four. Our G and A expenses for both the first quarter of twenty twenty five and 2024 were approximately $2,400,000 For the first quarter of twenty twenty five, our net loss was approximately $7,200,000 or $08 per basic and diluted share compared to a net loss of approximately $7,300,000 basic

Operator

and diluted

Operator

The The first question is from Dana Grayowicz from Leerink Partners.

Speaker 5

Dana, two questions for me more on the competitive landscape. Merck recently announced that KEYNOTE B96 which is a trial Phase III studying pembrolizumab in platinum resistant ovarian cancer was successful and hit on overall survival in patients that have tumors that express PDL-one. I wonder if you could talk about that success and how that could impact if pembro we haven't seen the results, if they ultimately launch pembro in that setting, your strategy in ovarian cancer.

Speaker 6

And then

Speaker 2

I have a follow-up. Michelle, would you like to refer to this?

Speaker 7

Sure. Sure. I'd be happy to refer to it. Thanks for the question, Dana. Yes.

Speaker 7

So this study is in platinum resistant ovarian cancer. It's in third line. So it is in an earlier stage setting of patients in the disease process, whereas our study is in platinum sensitive, but we're also looking at second and third line patients. So I'm quite encouraged by their announcement because it means that there is benefit being seen by adding an immune checkpoint inhibitor to, standard of care agents. And in the event that our study demonstrates activity it opens up additional opportunities to be able to combine our COM701 in these settings and also help drive taking it further to a broader population.

Speaker 5

Great. And then I wonder, we talked about TIGIT and FC competent or incompetent. I wonder if could talk about your interpretation of Roche's Skyscraper one data. What about the data specifically gives you confidence that the failure of that TIGIT was due to its Fc competency and not simply that TIGIT antagonism adds incremental clinical benefit?

Speaker 7

I'm going to make oh, you're to take it, Eren. Okay, go ahead. No, I'd go after you.

Speaker 8

Sure. So, yeah, what we see is I think what we tend to see from this TD trial with the FC Active. We see that even in this trial, even though the complication of the FC Active and high discontinuation rate, we still see activity. We definitely see numerical activity. But overall in this study, in the patient population that they chose, also they had higher rates of brain metastases in these patients compared to previous trials and CT scan, for example.

Speaker 8

The statistical plan maybe was a bit challenging, maybe also the number of patients. So I think we know that TIGIT in contrast to mice, TIGIT blockade is not causing complete melting of all tumors. But we know it's active. And now, this just matter. So if you have an active Fc and you have high discontinuation rate, it matters.

Speaker 8

As a reminder, ourselves, AstraZeneca, ARCUS have a non active Fc. And then also, if the right tissue population is critically important, the statistical design. So I think what you are encouraged to see, again, is definitely an activity of TIGITs that when it's added to PD-one, we see numerically that there is longer oversurvival, longer PFS, higher ORR. It was not sufficient in this study, in this size, in this patient population, and with the high discontinuation rate typical to have selective TIGIT to lead to approval. And we definitely are eager to see how the coming trials with FC non active digits will turn up.

Speaker 8

Michel?

Speaker 7

So I agree with what Eran said and I think that they are definite nuggets in terms of the type of patients between the CityScape study and the Skyscraper study, and I think the populations were not different, sorry, were not the same. So the activity seen in the one study did not translate into the second study. So I think there's still more to be learned. And again, I think that the discontinuation rate in Skyscraper one as well as the, number of patients with metastases to the brain and liver, probably also, impacted their data and outcomes.

Speaker 2

And I'll add just one more thing that I think the safety or the tolerability of the FC disabled may also turn these assets not it may not only affect the discontinuation and then the efficacy, but it may also turn them to be more combinable. And I think that with the next studies that are being done testing also combinations with chemo combinations with ABCs that may be very relevant. And on this front I think that only Phase III data will make a difference I think that we have a lot of Phase II data that are showing in randomized studies that are showing that the TIGIT addition to PD-one adds value. And I think that the only thing that we matter is to see see a very good Phase III data.

Speaker 2

Hopefully with the FC disabled either from ACOS first and then from AstraZeneca beyond '26. Only positive data will change the sentiment Great. Thank you guys.

Operator

The next question is from Rohan Masur of Oppenheimer. Please go ahead.

Speaker 6

Hi, thanks for taking the question. This is Roland on for Leith and Gershell. Just a couple from me. One was do you plan to collect data on the tumor microenvironment features from the seven zero one study like PVRIG expression or IFN signatures? And the other would be as you think about the maintenance setting for platinum resistant patients, what would you like to see from a clinically meaningful perspective on PFS benefit?

Speaker 6

Thank you.

Speaker 7

To answer your first question, we will definitely be collecting data to be able to evaluate the tumor microenvironment. We do have a biomarker plan but I'm not going to comment further on the details since it's not in the public domain. And regarding the maintenance setting, so in platinum sensitive which is where our maintenance study is taking place, we do know from multiple phase three benchmark studies, both for bevacizumab as well as for the PARP inhibitors, the progression free survival in patients on all of those placebo arms, whether they were in second line treatment or third line treatment, tended to range between 5.4 and, five point eight months. There was one outlier of three point eight months which had to do with the baseline genetic makeup of the patient population. So we feel that an improvement that exceeds around three months would be clinically meaningful.

Speaker 3

Great. Thank you.

Operator

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

Speaker 3

Hey guys, good morning. Thanks for taking my questions. Just want to tag on to Dana's question about B96. Can you remind us, does seven work with that? Have you seen specifically activity in PD L1 positive patients?

Speaker 3

Just wondering if I know there are B96s in the platinum resistant setting, but I'm just wondering if you had seen that and maybe can make some read throughs into what the combinability would look like in the event that more guests that you want approved in the setting in the late line setting too. Secondly, the PD-one VEGF bispecifics a lot of interest these days. I have a multipart question for you on DAS, if I may. One, have you looked at what adding VEGF does to TIGIT plus PD-one? And can you talk about any synergies that you've observed?

Speaker 3

Does the FC inactive strategy makes sense here too? Have you discussed any of this data with your partners at AZ? Thank you.

Speaker 7

So I will take some of your question and then defer to Eran for further input. So to start with the question about activity in patients that are PD L1, whether they're positive or negative. So in our platinum resistant data, we have presented in the past that we see activity both in PD L1 positive and negative patients. And it's one of the reasons why we believe that when we use COM701, it tends to be a PVRIG mediated activity because traditionally single agent PD-one inhibition in platinum resistant patients has not been very effective. As far as the PD-one VEGF, I'm going to have Eran comment.

Speaker 8

Thank you, Michelle, and thank you, Ashika, the question. So just to add a bit about the PD L1. So what is really interesting and what we have shown quite extensively that PVRIG biology is very different from PD-one from TIGIT and other checkpoints. And that is the reason why we think that we see this unique activity in places where checkpoints are typically not working, including in PD L1 negative patients. We even have a monotherapy activity of COM701 alone in a patient with a PD L1 negative tumor microenvironment.

Speaker 8

So definitely, we think that this will explain why PIVRAG could be active. And now, when we have some signal of activity of PD-one blockade in the last line in combination with chemo, we definitely think that it could be that when COM701 would be added potentially also to PD-one, we can now treat also patients which are PD-one negative that would not respond probably to go to PD-one alone. About the PD-one VEGF, so VEGF in general has a mechanism in addition to the angiogenic effect to increase T cell infiltration. So mechanistically point of view, this could definitely it goes along with the biology of BVR IG blockade that increased T cell infiltration with other mechanisms. We didn't publish any data on this regard, but it definitely could be a mechanism that would complement specifically PVRIG biology in addition to the other activities it's doing with any other checkpoints.

Speaker 8

And I don't think specifically the FC active or non active will matter mechanistically. But since the FC active have again some safety challenges, and since it's yet to be seen if the PD-one VEGF bispecific indeed really solves the BEV side effects, so the combination of what could be still some toxic agent like PD-one VEGF with another a bit toxic agent like FC active TIGIT could be challenging. So we think that here as well, it would be preferable to combine any kind of this agent including PD-one VEGF with an FC non active TIGIT.

Operator

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

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Key Takeaways

  • Leadership transition: Anat Cohen‐Dayag will become Executive Chair and Orna Ofir will assume the role of CEO as Compugen secures a cash runway into 2027.
  • COM701 (anti-PVRIG): The first sub-trial in platinum-sensitive relapsed ovarian cancer has been activated with dosing planned imminently and an interim analysis expected in H2 2026 targeting a ≥3-month PFS improvement.
  • Fc-inactive anti-TIGIT strategy: Compugen highlights safety and durability advantages of Fc-inactive formats and benefits from AstraZeneca’s multiple Phase III trials of the rilvagostomab bispecific (incorporating Compugen’s ORCOM902) with >$5 billion lung cancer revenue potential.
  • GS-3121 (anti-IL-18BP): The novel first-in-class IL-18 binding protein antibody licensed to Gilead is advancing on schedule through its Phase I trial as a unique approach to modulating the IL-18 pathway in cancer.
  • Q1 2025 financials: Compugen reported $103.7 million in cash and equivalents, $2.3 million in revenues, a net loss of $7.2 million, and reaffirms funding of its clinical and early-stage pipeline into 2027.
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Earnings Conference Call
Compugen Q1 2025
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