Compugen Ltd.

Welcome to the ComputeGen LTD Second Quarter 2025 Financial Results Conference Call. At this time, all participants are in a listen-only mode. An audio webcast of this call is available in the Investments section of ComputeGen's website

www

.cgen.com. As a reminder, today's call is being recorded. I would now like to introduce Yvonne Mocklin, Vice

President, Head of Investor Relations and Corporate Communications. Thank you, Operator, and thank you all for joining us on the call today. Joining me from ComputeGen is Dr. Anath Kholen-Diark, Head of the Chief Executive Officer, and David Sivaman, Chief Financial Officer. Dr. Michelle Morer, Chief Medical Officer, and Dr. Alana Lofair, Chief Scientific Officer, will join us with the Q&A. Before we begin, we would like to remind you that during this call, the company will 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 petition and cash runway. We reached a call from you that said statements reflect only the company's current release, expectations and assumptions, but actual results, performance, or achievements of the company in a different material. These statements are subject to known and unknown lists and uncertainties, and we refer you to our SEC filing for more details on these lists, including the company's most recent annual report on forms for NTS. The company undertakes no obligation to update projections and forward-looking statements in the future. With that, I turn the call over to Anath.

Thank you, John, and a warm welcome to everyone joining our call today. Today marks my last quarterly call as President and CEO of Confidence, and I could not be prouder or more confident if I passed the leadership reins into the exceptional hands of the run. I'm excited at the opportunity to take on the newly created position of Executive Chair, where my focus will be on confidence, corporate strategy, and strategic collaboration. With the leaves, this leadership combination provides a strong foundation for the company's next phase of growth. Before I provide an update on our progress in this quarter, I'd like to first share some high-level reflections on the current landscape, and one of the beliefs confidence is well positioned for future growth. Immunotherapy has been tremendously successful and is extending the lives of many cancer patients, with conclusions standing out as the top-selling drug. However, significant unmet medical needs persist with many patients' key lacking effective treatment options. As a result, we're seeing a shift in how immunotherapy is being approached during the last year. The approach is designed by a focus on novel mechanisms of action, innovative combinations, and new modalities aimed at enhancing the sequence-tracing across multiple cancer sites. This is precisely where confidence differentiated approach aims to create significant value. We're leveraging Unigen, our validated AI, ML-powered computational target discovery platform to identify novel mechanisms to activate the immune system against cancer. In addition, we are advancing our pipeline of differentiated immune oncology therapies with the goal to transform patient outcomes and deliver meaningful clinical and commercial impacts. In the clinic, we have our potential -in-class immune checkpoint inhibitor, COV701, in partnership with the potential for a total of over $1 billion in mass containment and third-worldly computer sales, with both AstraZeneca on -3-Badastolene and Gilead on anti-RAT inviting protein, GS0321. We have a solid benefit with $93.9 million in cash at the end of June 2025 and expected a steady test run rate into 2027. With our leadership expansion, a strategically differentiated pipeline and operational focus with the lead that competent is well positioned to capitalize on potential growth opportunities ahead. Now, turning to the progress we have made this quarter. We continue to advance our new oncology clinical and early-stage pipeline programs, starting with our potential -in-class anti-PVRI antibody COV701. The first case was those in mild ovarian, our main-centimunotherapy trial in protein-sensitive ovarian cancer. We continue to make progress opening sites across the US and Israel, and we aim to share our interim analysis from this sub-trial in the second half of 2026. As a reminder, this is the first sub-trial of our adaptive platform trial, comparing COV701-mantanone therapy to placebo in 60 patients with relapsed platinum-sensitive ovarian cancer. There is an unmet medical need with no standard of care treatment options for this patient population, for those who are not candidates for such treatments. We have observed increased competition in this case, primarily from drug candidates evaluated in the platinum-resistant ovarian cancer study. This reflects the recognized and significant need to improve treatment options for these patients. In this earlier state population, platinum-sensitive ovarian cancer, safety becomes an even more critical consideration along with efficacy, which in the maintenance setting aims specifically on delaying -to-disease progression. We believe that advancing COV701 in the maintenance setting of platinum-sensitive ovarian cancer represents a compelling opportunity to demonstrate its potential advantage in terms of durability of response and survivability. As previously communicated, we view a very large improvement over the need for progression-free survival of the placebo as clinically meaningful. Part of the data from these trials could support a broader clinical development program aimed at addressing the significant unmet medical needs. At ESMO this year, we plan to present a pooled analysis of our three previously reported case-one trials, reflecting clinical benefits of COV701 as monotherapy and in combination with the results of the research in patients with heavily-pretreated platinum-sensitive ovarian cancer. This data forms part of our rationale to advance COV701 in our ongoing platinum-sensitive ovarian cancer adaptive platform file. Moving next to the PG-10 clip. Despite failures in the PG space, it is notable that some companies are advancing differentiated anti-TG programs. For example, OfficeGyriat is advancing an FTE-inactive anti-TG program. In addition, AstraZeneca is advancing Rizogastamide, which is an FTE-reduced -PD-1 TG spike-specific. The TG component of which is derived from Combigen's Conline 02. AstraZeneca has specifically designed and engineered Rizogastamide with a unique mechanism of action to harness cooperative binding of both TG-1 and TG to drive enhanced immune responses. We have consistently advocated that FTE-inactive antibodies may serve as the better antibody form for targeting TG by providing a potential safety advantage in certain patients' populations, which could support a potential TG-safety advantage due to patients' durability on study treatment. We believe that successful phase 3 data would validate TG antibodies as a better contrast, change the market sentiment, and open new opportunities for Combigen as one of the few companies that have an FTE-inactive clinical-based TG antibody combination. Quickly, we continue to believe that -PD-1's low case in combination with the PDRID inhibitor may expand the use of -PD-1 to lessen pain PDR1 low tumor, and positive -PD-1 data may present additional opportunities for us. In addition, earlier this year, our partner AstraZeneca initiated their phase 3 clinical trial with Rizogastamide. As of this year, AstraZeneca presented encouraging early data from trial to evaluating Rizogastamide in combination with the AGC WD-2 in north motilic cancer and in combination with chemotherapy in hepato-biliary cancer. This data, along with the data presented at the World Conference of Lung Cancer and at MOLAF here, highlights Rizogastamide as a potential IO backbone to future drug combinations. Coming up at Edmonday, October, AstraZeneca plans to present longer-term follow-up data evaluating Rizogastamide monotherapy in north motilic cancer at the poster presentation, and first data in bladder cancer in combination with data GFC ebonyl oral test. The potential commercial opportunity for Rizogastamide is substantial, with AstraZeneca estimating -to-gastric PCU revenues target of more than ,000,000. AstraZeneca's broad development strategy for Rizogastamide to replace existing PDR1 and PD-L1 inhibitors represents a significant potential revenue source for us as we are eligible for both future Marston payments and listing the GFC's royalties on future sales. Today, we have received Marston payments of $30.5 million and remain eligible to receive up to $170 million in regulatory and commercial Marston payments. Moving next to DS0321, formerly known as CONCYPOS-3, a potential -in-class NTR 18-14 antibody-licensed adenine. DS0321 represents a novel approach to harnessing pathway biology for the treatment of cancer, potentially overcoming the mutations presented by the administration of therapeutic cytokines. The phase one trial is progressing their strength. Finally, beyond our clinical case programs, we remain committed to advancing our extensive and differentiated early-stage pipeline focused on potential -in-class drugs and novel mechanisms of action designed to activate the immune system against cancer. With a diverse pipeline and strong focus on execution in 2025, we believe CONTIGEN is well positioned for growth. Of course, none of this would be possible without our highly committed TALENT 13 here at CONTIGEN, who continuously performs at the highest levels of excellence. With that, I will hand over to Davey for the financial update before we open the floor for Q&A.

Thank you, Ana. I am pleased to say that we are advancing in 2025 with a solid balance sheet. Cast Runway, assuming no further casting flows, is expected to find our operating plant in 2027, and we anticipate using this runway to advance our COM701 Platinum-Sensitive Ovarian Cancer trial and to support the progression of GS0321 in the clinic, together with continued investment in our early-stage pipeline. Going into the details, I will start with our cash balance. As of June 30, 2025, we had approximately $93.9 million in cash, cash equivalent, short-term bank deposits and investments in affordable securities. Revenues for the second quarter of 2025 were approximately $1.3 million, compared to approximately $6.7 million of revenue for the comparable period in 2024. The revenues for the second quarter of 2025 reflect the recognition of portions of both the upfront payment and the randomized fund payment from the license agreement with GLIAD, while in the second quarter of 2024, the reflect portion of the upfront payment from the license agreement with GLIAD and the clinical milestones from the license agreement with AstraZeneca. Expenses for the second quarter of 2025 were in line with our plans. R&D expenses for the second quarter of 2025 were approximately $5.6 million, compared to approximately $6.2 million in the second quarter of 2024. Our GME expenses for both the second quarters of 2025 and 2024 were approximately $2.2 million. For the second quarter of 2025, our net loss was approximately $7.3 million, or 8 cents per basic and diluted share, compared to a net loss of approximately $2.1 million, or 2 cents per basic and diluted share in the second quarter of 2024. With that, I will hand over to the operators who opened the call for questions. Thank

you. Ladies and gentlemen, at this time we will begin the question and answer session. If you have a question, please press star 1. If you wish to be trying from the poll process, please press star 2. If you are using speaker equipment, kindly lift the handbag before pressing the numbers. Please stand by while we poll for your questions.

The

first question will be from Stephen Wiley from CECO. Please go ahead.

Good morning. This is Julian for the CECO. Thank you for taking our questions. So we just have two from us. The first one is related to swapping sensitive or over-encountered child. Can you please give the ability, more like the overall general comment on the ongoing dynamics of patient involvement? And I don't remember if you guys have actually communicated how many sites you guys are planning to activate. And I guess what I'm trying to ask you is what may be the, what portion of those sites are currently active so far? And second question is related to the ESMO presentation. I understand that you guys are planning on presenting a proof data analysis. What do you think investors should focus on that presentation? And would you, would this presentation actually include any biomass data analysis? Thank you. Then we

will be back to the questions.

Yes, I will be happy to answer those questions. So at this point in time we have not disclosed the number of sites that we are using for the trial, but we have open sites in both the US and in Israel. And we are actively enrolling with a high level of investigator enthusiasm. And we do have aggressive, you know, we have aggressive timelines and times that we are working to continue to meet those. Regarding the question on what should be focused on with respect to our presentation as ESMO, one of the things that we were trying to focus on was understand deeper about the patients that had had a response on our prior studies. So by pulling this, it gives us the opportunity to try and characterize more about the efficacy and the safety and more of that information will be presented during ESMO.

Okay, Stephen, are you with us?

Hello?

Yes, please. The next question is from Leland Dershow from Oppenheimer. Go ahead,

please. Hey, thank you for your questions. Congrats on all the progress. I just wanted to ask if you look forward to the upcoming reveal on the trophium of Tantrumor-03 in bladder, which will be essentially opening that as another development indication for further advancement, do you know the expected thing will be complete response data, durability data? Data, what do you envision as the potential for the program to maybe move into further development and other follow-up? Thank you.

Thank you, Leland. Actually, I think I did not dive into what they're going to present with ESMO for this study or for the other studies, so obviously we cannot comment on their behalf. I just remind that you always ask for data for not only Tantrumor and also for the type of videos, but the data is showing that it was encouraging to see that the potential for the vasocimid to serve and I hope that's going to be part of the combination. The data in bladder is going to be in combination with the HEC. We're waiting as well. We're looking forward to the data, but we cannot have guidance on the spells for HEC.

All right. Okay. We look forward to that. And if you could just remind us of what you see as a market opportunity in the platinum-sensitive mandum setting for certain elements. Thank you.

Yeah, Michelle, good opportunity there. Yeah. So, the initial opportunity is based on patients who are in second line or third line requiring maintenance. The study is requiring patients who have received previously at least two prior lines of platinum chemotherapy, and those patients who are eligible for PARP inhibitors or BERs must have received those to be able to come onto the clinical trial. So, this brings us to a mix between both patients who would be eligible for maintenance in both second and third line, and that's approximately 80,000 to 12,000 patients based on epidemiology data that's available. I think the other point to highlight is in the event that single agent 701 works in maintenance, it opens an avenue for us to also combine with other combinations and go after a much broader or very intensive patient population. So, I think the initial opportunity might seem limited, but the steps that we are taking give potential for the broader population.

Perfect. Great. Thank you for taking your questions.

Next question will be from Dana Graebusch from Lurink Partners.

Hey, guys. Thanks for the question. You got Bill on first, Dana. Just a couple for me. So, what expectations do you have from Merck's successful phase three in ovarian, and how does that change your current approach? And the second question is your current clinical assets provide for evaluation of your agent platform's ability to identify targets. Can you give us a sense of what's coming down the pipeline and what you may expect to get some details? Thank you.

Yeah, I guess I'll just take the first one and then around with the second question.

Okay, great. So, for the Merck study, it's exciting that they were able to demonstrate that with adding a checkpoint inhibitor to patients' residents, there's both a PFS and overall survival advantage. Of course, we haven't seen the data, but I would like to highlight though is the Merck study is focused on platinum-resistant patients. So, it gives us some hints to potential activity or pain activity in the earlier lines of treatment that, keep in mind, it is a different patient population to where we're going, because the patients that we're evaluating in our study are So, it doesn't specifically change our approach at this point in time. It's just, it's nice to see that there is still potential for checkpoint inhibitors in the right kind of patient population and the right kind of combination. I'll hand back to Anas and then I'll run about the other questions.

Thank you, sir. So, for the early pipeline, so indeed we're using a traditional, validated traditional platform that uses either G and contact with G and we work hard to bring more assets. For many reasons, including competitive ones, we've turned off so many details to keep that as far as the point in time. But definitely, this is a more convoying and a traditional platform which is validated and adapted around the world is working hard to bring more assets in different ways. Thank you, Dr.

Moury. Next question will be from Charles Waller from HCW. Go ahead, Charles.

Hi, thanks for taking my question. On Tom 701 and the Global Maintenance of Variance Study, can you provide some more color in the interim analysis that you have planned for the second half of 26th? And do you expect at this time that the study will be fully enrolled? Thank you.

So, just to explain again, so this study is an adaptive algorithm and because we're looking for a three month improvement, we still believe that the interim analysis would happen as we've already previously guided in terms of second half of 2026. Yes, the study will be fully enrolled and the interim analysis is to evaluate for security and also allow us to characterize magnitude of the fixed file.