NASDAQ:CGEN Compugen Q2 2025 Earnings Report $1.45 -0.03 (-2.03%) Closing price 04:00 PM EasternExtended Trading$1.44 0.00 (-0.34%) As of 04:47 PM Eastern Extended trading is trading that happens on electronic markets outside of regular trading hours. This is a fair market value extended hours price provided by Polygon.io. Learn more. ProfileEarnings HistoryForecast Compugen EPS ResultsActual EPS-$0.08Consensus EPS -$0.07Beat/MissMissed by -$0.01One Year Ago EPSN/ACompugen Revenue ResultsActual Revenue$1.26 millionExpected Revenue$3.95 millionBeat/MissMissed by -$2.70 millionYoY Revenue GrowthN/ACompugen Announcement DetailsQuarterQ2 2025Date8/6/2025TimeBefore Market OpensConference Call DateWednesday, August 6, 2025Conference Call Time8:30AM ETConference Call ResourcesConference Call AudioConference Call TranscriptPress Release (8-K)Earnings HistoryCompany ProfilePowered by Compugen Q2 2025 Earnings Call TranscriptProvided by QuartrAugust 6, 2025 ShareLink copied to clipboard.Key Takeaways Positive Sentiment: Compugen announced a leadership transition with Anat Cohen Dayan moving to Executive Chair and the incoming CEO aimed at bolstering corporate strategy and strategic collaborations. Positive Sentiment: The company ended Q2 2025 with $93.9 million in cash and marketable securities, providing a runway into 2027 to fund its clinical and early-stage pipeline. Positive Sentiment: Compugen dosed the first patient in the COM701 maintenance trial for platinum-sensitive ovarian cancer and anticipates an interim analysis in 2026 to evaluate efficacy and safety. Positive Sentiment: Partnerships with AstraZeneca and Gilead offer over $1 billion in potential milestone payments and tiered royalties, while Gilead’s anti-IL-18 program GS-0321 progresses through Phase 1. Negative Sentiment: Revenue declined to $1.3 million in H1 2025 from $6.7 million in H1 2024, and net loss widened to $7.3 million (-$0.08 per share) versus $2.1 million (-$0.02 per share). AI Generated. May Contain Errors.Conference Call Audio Live Call not available Earnings Conference CallCompugen Q2 202500:00 / 00:00Speed:1x1.25x1.5x2xTranscript SectionsPresentationParticipantsPresentationSkip to Participants Operator00:00:00Ladies and gentlemen, thank you for joining us today. Welcome to the Compugen Ltd. Second Quarter twenty twenty five 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 Investors section of Compugen's website, www.cgen.com. Operator00:00:28As a reminder, today's call is being recorded. I would now like to introduce Yvonne Norton, vice president, head of investor relations and corporate communications. Michelle MahlerChief Medical Officer at Compugen00:00:42Thank you, operator, and thank Yvonne NaughtonVP, Head of Investor Relations & Corporate Communications at Compugen00:00:43you all for joining us on the call today. Joining me from Competence for the prepared remarks are doctor Anat Cohen Dayarc, president and chief executive officer and David Sivulman, Chief Financial Officer. Doctor. Michelle Malare, Chief Medical Officer and Doctor. Arana O'Fear, Chief Scientific Officer, will join us for the Q and A. Yvonne NaughtonVP, Head of Investor Relations & Corporate Communications at Compugen00:01:01Before we begin, we'd 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 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 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. With that, I'll turn the call over to Anat. Anat Cohen-DayagCEO, President & Director at Compugen00:01:54Thank you, Yvonne, and a warm welcome to everyone joining our call today. Today marks my last quarterly call as president and CEO of Configen, and I could not be prouder or more confident as I passed the leadership reigns into the exceptional hands of Iran. I'm excited at the opportunity to take on the newly created position of executive chair where my focus will be on competence corporate strategy and strategic collaborations. We believe 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 why we believe Competent is well positioned for future growth. Anat Cohen-DayagCEO, President & Director at Compugen00:02:52Immunotherapy has been tremendously successful and is extending the lives of many cancer patients with KEYTRUDA standing out as the top selling drug. However, significant unmet medical need persists with many patients still lacking effective treatment options. As a result, we're seeing a shift in how immunotherapy is being approached driven by a focus on novel mechanisms of action, innovative combination, and new modalities aimed at enhancing the frequency and safety across multiple cancer sites. This is precisely where Competent's differentiated approach aims to create significant value. We're leveraging UniGen, a validated AIML powered computational target discovery platform to identify novel mechanisms to activate the immune system against cancer. Anat Cohen-DayagCEO, President & Director at Compugen00:03:53In addition, we're advancing our pipeline of differentiated immuno oncology therapies with the goal to transform patient outcomes and deliver meaningful clinical and commercial impact. In the clinic, we have our potential first in class immune checkpoint inhibitor COM701, in addition to validating partnerships with the potential for a total of over $1,000,000,000 in milestone payments and tiered royalties on future sales with both AstraZeneca on bisphosphate grade megastomy and Gilead on anti IL-eighteen binding protein g s zero three two one. We have a solid balance sheet with $93,900,000 in cash at the June 2025 and expected cash run rate into 2027. With our leadership expansion, a strategically differentiated pipeline, and operational focus, we believe that Competent is well positioned to capitalize on potential growth opportunities ahead. Now turning to the progress we have made this quarter. Anat Cohen-DayagCEO, President & Director at Compugen00:05:10We continue to advance our immuno oncology clinical and early stage pipeline programs, starting with our potential first in class anti PVRIG antibody COM701. The first patient was dosed in my ovarian, our maintenance immunotherapy trial in platinum sensitive ovarian cancer. We continue to make progress opening sites across The US and Israel, and we aim to share interim analysis from this sub trial in the 2026. As a reminder, this is the first sub trial of our adaptive platform trial comparing COM701 maintenance therapy to placebo in sixty patients with relapsed platinum sensitive ovarian cancer. There is an unmet medical need with no standard of care treatment options for this patient population, progressing post PARP inhibitors and or bevacizumab, or who are not candidates for such treatments. Anat Cohen-DayagCEO, President & Director at Compugen00:06:14We have observed increased competition in this space, primarily from drug candidates evaluated in the platinum resistant ovarian cancer setting. This reflects the recognized and significant need to improve treatment options for these patients. In this earlier stage population, platinum sensitive ovarian cancer, safety becomes an even more critical consideration along with efficacy within the maintenance setting aimed specifically on delaying time to disease progression. We believe that advancing COM701 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 tolerability. As previously communicated, we view a three month improvement over the median progression free survival of the placebo as clinically meaningful. Anat Cohen-DayagCEO, President & Director at Compugen00:07:20Positive data from this trial could support a broader clinical development program aimed at addressing a significant unmet medical need. At ESMO this year, we plan to present a pooled analysis of our three previously reported phase one trials, reflecting clinical benefit of COM701 as monotherapy and in combination in patients with heavily pretreated platinum resistant ovarian cancer. This data form part of our rationale to advance COM701 in our ongoing platinum sensitive ovarian cancer adaptive platform trial. Moving next to the TIGIT landscape. Despite failures in the TIGIT space, it is notable that some companies are advancing differentiated TIGIT programs. Anat Cohen-DayagCEO, President & Director at Compugen00:08:15For example, AlcoGilead is advancing an anti TIGIT program. In addition, AstraZeneca is advancing ribogastomy, which is an anti reduced anti p d one TIGIT bispecific, the t g component of which is derived from Competence COM902. AstraZeneca has specifically designed and engineered ribogastomy with a unique mechanism of action to harness cooperative binding of both p one and TIGIT to drive enhanced immune responses. We've consistently advocated that anti inactive antibodies may serve as the better antibody format for targeting TIGIT by providing a potential safety advantage in certain patient populations, which could support a potential efficacy advantage due to patient durability on study treatment. We believe that successful phase three data would validate TIGIT antibodies as a drug class, change the market sentiment, and open new opportunities for Compugen as one of the few companies that have an active inactive clinical stage kidney antibody coming on to. Anat Cohen-DayagCEO, President & Director at Compugen00:09:37Clinically, we continue to believe that tgp one blockade in combination with the PVRIG inhibitor makes pending use of tgpd1 to less inflamed PD L1 low tumor, and positive tgpd1 data may present additional opportunities for us. In addition, earlier this year, our partner AstraZeneca initiated their tenth phase three clinical trial with ribogastomy. And after this year, AstraZeneca presented encouraging early data from trials evaluating ribogastomy in combination with the ADC data GHD in non small cell lung cancer and in combination with chemotherapy in hepatobiliary cancer. This data, along with the data presented at the World Conference of Lung Cancer and ESMO last year, highlights ribogastomy as a potential IO backbone to future drug combinations. Coming up at ECMO this October, AstraZeneca plans to present longer term follow-up data evaluating ribogastomy monotherapy in non small cell cancer as a poster presentation and first data in bladder cancer in combination with data ZXD as a mini oral session. Anat Cohen-DayagCEO, President & Director at Compugen00:11:06The potential commercial opportunity for rinsagastamir is substantial with AstraZeneca estimating non risk adjusted p q revenues target of more than $5,000,000,000. AstraZeneca's broad development strategy for ribogastinib to replace existing p d one, p d l one inhibitor represents a significant potential revenue source for us as we're eligible for both future milestone payments and mid single digit tiered royalty from future sales. To date, we have received milestone payments of $30,500,000 and remain eligible to receive up to $170,000,000 in regulatory and commercial milestone payments. Moving next to g s zero three two one, formerly known as COM five zero three, a potential first in class anti IL-eighteen binding protein antibody licensed to deal with. D s zero three two one represents a novel approach to harness silencing pathway biology for the treatment of cancer, potentially overcoming the mutations presented by administration of therapeutic cytokines. Anat Cohen-DayagCEO, President & Director at Compugen00:12:26The phase one trial is progressing as planned. Finally, beyond our clinical stage programs, we remain committed to advancing our extensive and differentiated early stage pipeline focused on potential first 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 Competent is well positioned for growth. Of course, none of this would be possible without our highly committed talented team here at Competent, who continuously perform at the highest levels of excellence. With that, I will hand over to David for the financial update before we open the floor for q and a. David SilbermanChief Financial Officer at Compugen00:13:21Thank you, Anat. I am pleased to say that we are advancing in 2025 with a solid balance sheet. Cash runway, assuming no further cash inflows, 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 pipeline. Going into the details, I will start with our cash balance. As of 06/30/2025, we had approximately $93,900,000 in cash, cash equivalents, short term bank deposits and investments in marketable securities. David SilbermanChief Financial Officer at Compugen00:14:03Revenues for the 2025 were approximately $1,300,000 compared to approximately $6,700,000 of revenue for the comparable period in 2024. The revenues for the 2025 reflect the recognition of portions of both the upfront payment and the IND milestone payment from the license agreement with Gilead, while in the 2024, they reflect portion of the upfront payment from the license agreement with Gilead and the clinical milestone from the license agreement with AstraZeneca. Expenses for the 2025 were in line with our plans. R and D expenses for the 2025 were approximately $5,600,000 compared to approximately $6,200,000 in the 2024. Our G and A expenses for both the 2025 and 2024 were approximately $2,200,000 For the 2025, our net loss was approximately $7,300,000 or $08 per basic and diluted share compared to a net loss of approximately $2,100,000 or $02 per basic and diluted share in the 2024. With that, I will hand over to the operator to open the call for questions. Operator00:15:19Thank you. Ladies and gentlemen, at this time, we will begin the question and answer session. If you have a question, please press 1. If you wish to decline from the polling process, please press 2. If you are using speaker equipment, kindly lift the handset before pressing the numbers. Operator00:15:43Please stand by while we poll for your questions. The first question will be from Keaton Wiley from Stifel. Please go ahead. Analyst00:16:07Good morning. This is Toby on for Steve. Thank you for taking our questions. So we we just have two from us. The first one is related to plasma sensitive ovarian cancer trial. Analyst00:16:20Can you please just briefly, like, more of, like, a overall general comment on the ongoing dynamics of patient enrollment? And I don't remember if you guys have actually communicated how many sites you were planning to activate. And I guess what I'm trying to ask you is that what maybe, like, what portion of those sites are currently active so far? And second question is related to the small presentation. I understand that you guys are planning on presenting a proof data analysis. Analyst00:16:55What do you think investors should focus on that presentation? And would you would this presentation actually include any biomarker data analysis? Thank you. Anat Cohen-DayagCEO, President & Director at Compugen00:17:10Thank you, Michelle. Would you like to ask the correct question? Michelle MahlerChief Medical Officer at Compugen00:17:14Yes. 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 and plans, and we are working to continue to meet those. Michelle MahlerChief Medical Officer at Compugen00:17:48Regarding the question on what should be focused on with respect to our presentation at ESMO, The 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 study. So by pulling it, it gives us the opportunity to try and characterize more about the efficacy and the safety and, you know, more of that information will be presented during Admiral. Okay. Susan, are you with us? David SilbermanChief Financial Officer at Compugen00:18:43Hello? Anat Cohen-DayagCEO, President & Director at Compugen00:18:44Yes, please. The is from next Leland Gershell from Oppenheimer. Go ahead, please. Leland GershellMD & Senior Biotechnology Analyst at Oppenheimer & Co. Inc.00:18:56Hey. Thanks for taking my questions. Congrats on all the progress. Manav, just just wanted to ask because we look forward to the upcoming reveal on the troponin ten two m r o three in bladder, which would be, you know, potentially opening that as a another development indication for further advancement. Do you know what we expect to see? Leland GershellMD & Senior Biotechnology Analyst at Oppenheimer & Co. Inc.00:19:19Will it be complete response data, durability data? What what do you envision as the potential for the program to maybe move into further development? Kind of a follow-up. Thank you. Anat Cohen-DayagCEO, President & Director at Compugen00:19:37Thank you, Dylan. And, actually, AstraZeneca did not guide into what they're going to present the test mode for this study or for the other studies. So, obviously, we cannot comment on their behalf. I'll just remind that, you know, and ASCO they presented data for nonstop lung cancer and also for hepatovidia. It's just the data was showing that, you know, it it was encouraging to see that the potential for brinzogastinib to serve an iodexolone as part of the combination. Anat Cohen-DayagCEO, President & Director at Compugen00:20:10The data and letter is going to be in combination with the AC. We're waiting as well. We're looking forward to see the data. But we cannot have guidance sent instead of AC. Leland GershellMD & Senior Biotechnology Analyst at Oppenheimer & Co. Inc.00:20:21Alright. Okay. We look forward to to that. And then if you could just remind us of what you see as as a market opportunity in the platinum sensitive maintenance setting for platinum. Thank you. Anat Cohen-DayagCEO, President & Director at Compugen00:20:35Yeah. Michelle, would you like to do that? Michelle MahlerChief Medical Officer at Compugen00:20:38Yeah. 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 who have received previously at least two prior lines of platinum chemotherapy, and those patients who are eligible for PARP inhibitors or BEV must have received those to be able to come on to 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 eight to 12,000 patients based on, you know, epidemiology data that's available. I think the other point to highlight is in the event that single agent seven zero one works in maintenance, it opens an avenue for us to also combine with other combinations and go after a much broader ovarian cancer patient population. Michelle MahlerChief Medical Officer at Compugen00:21:43So I think the initial opportunity might seem limited, but the steps that we will take that we are taking gives potential for the broader population. Leland GershellMD & Senior Biotechnology Analyst at Oppenheimer & Co. Inc.00:21:54Perfect. Great. Thank you for taking my question. Anat Cohen-DayagCEO, President & Director at Compugen00:22:00Next question will be from Dana Gravesh from Leerink Partners. Analyst00:22:09Hey, guys. Thanks for the question. You got Bill on for Dana. Just a couple for me. So what expectations do you have from Merck's successful Phase III in ovarian? Analyst00:22:20And how does that change your current approach? And the second question is your current clinical assets provide pretty good validation of your your platform's ability to identify targets. Can you give us a sense of what's coming down the pipeline and when we may expect to hear some details? Thank you. Anat Cohen-DayagCEO, President & Director at Compugen00:22:41Yeah. I guess I'm I guess we have to take the first one and then around the relation the second person. Michelle MahlerChief Medical Officer at Compugen00:22:47Okay. Great. So for the Merck study, it's exciting that they were able to demonstrate that with adding a checkpoint inhibitor to patients' regimen that this both appears as an overall survival advantage. Of course, we haven't seen the data. What I would like to highlight though is the Merck study is focused in platinum resistant patients. Michelle MahlerChief Medical Officer at Compugen00:23:10So it gives us some hint to potential activity or seeing activity in the earlier lines of treatment. But keep in mind, it is a different patient population to where we are going because the patients that we're evaluating in our study are patent sensitive. 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 in the right kind of patient population and the right kind of combination. I hand back to Anat and Mehran about the other question. Eran OphirChief Scientific Officer at Compugen00:23:55Thank you, Michelle. So for the early pipeline, so in these words, using our unigenvalidate protection platform that yielded the the p ver g and and compile of three, and we work hard to bring more assets. For many reasons, including competitive ones, we prefer not to disclose too many details to keep that as far as that at this point in time. But, definitely, this is the work on knowing and our traditional platform, which is validated as assets growth It's working hard to bring more assets in different ways in the new oncology. Analyst00:24:32Got it. Thank you. Anat Cohen-DayagCEO, President & Director at Compugen00:24:38Next question will be from Charles Wallace from HCW. Go ahead, Charles. Analyst00:24:46Hi. Thanks for taking my question. On COM701 and the global maintenance ovarian study, can you provide some more color on the interim analysis that you have planned for the '26? And do you expect at this time that the study will be fully enrolled? Anat Cohen-DayagCEO, President & Director at Compugen00:25:03Thank you. Michelle MahlerChief Medical Officer at Compugen00:25:05Okay. So just to explain again, so this the study is is a adaptive trial design. 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 2026. Yes. The study will be fully enrolled, and the interim analysis is to evaluate for futility and also allow us to characterize magnitude of effect size for code seven zero one. Analyst00:25:49Alright. Thanks for taking my question.Read moreParticipantsExecutivesMichelle MahlerChief Medical OfficerYvonne NaughtonVP, Head of Investor Relations & Corporate CommunicationsAnat Cohen-DayagCEO, President & DirectorDavid SilbermanChief Financial OfficerEran OphirChief Scientific OfficerAnalystsAnalystLeland GershellMD & Senior Biotechnology Analyst at Oppenheimer & Co. Inc.Powered by Earnings DocumentsPress Release(8-K) Compugen Earnings HeadlinesWall Street Zen Downgrades Compugen (NASDAQ:CGEN) to SellAugust 11 at 4:44 AM | americanbankingnews.comNeed To Know: Analysts Just Made A Substantial Cut To Their Compugen Ltd. (NASDAQ:CGEN) EstimatesAugust 9, 2025 | finance.yahoo.comIs Elon's empire crumbling?The Tesla Shock Nobody Sees Coming While headlines scream "Tesla is doomed"... Jeff Brown has uncovered a revolutionary AI breakthrough buried inside Tesla's labs. One that is helping AI escape from our computer screens and manifest itself here in the real world all while creating a 25,000% growth market explosion starting as early as October 23rd.August 14 at 2:00 AM | Brownstone Research (Ad)Compugen: Potential Best-In-Class Anti-PVRIG COM701 Shifts To Targeting PSOC PatientsAugust 8, 2025 | seekingalpha.comCompugen Ltd. (CGEN) Q2 2025 Earnings Call TranscriptAugust 7, 2025 | seekingalpha.comCompugen Reports Second Quarter 2025 ResultsAugust 6, 2025 | prnewswire.comSee More Compugen Headlines Get Earnings Announcements in your inboxWant to stay updated on the latest earnings announcements and upcoming reports for companies like Compugen? Sign up for Earnings360's daily newsletter to receive timely earnings updates on Compugen and other key companies, straight to your email. Email Address About CompugenCompugen (NASDAQ:CGEN), a clinical-stage therapeutic discovery and development company, researches, develops, and commercializes therapeutic and product candidates in Israel, the United States, and Europe. The company's immuno-oncology pipeline consists of COM701, an anti-PVRIG antibody that is in Phase I clinical study used for the treatment of solid tumors; COM902, a therapeutic antibody targeting TIGIT, which is in Phase I monotherapy clinical study in patients with advanced malignancies through sequential dose escalations; Bapotulimab, a therapeutic antibody targeting ILDR2 that is in Phase I clinical study in patients with naïve head and neck squamous cell carcinoma; and Rilvegostomig, a novel anti-TIGIT/PD-1 bispecific antibody, which is in Phase II clinical study in patients with advanced or metastatic non-small cell lung cancer. Its therapeutic pipeline also includes early-stage immuno-oncology programs focused to address various mechanisms of immune resistance; and COM503, high affinity antibody, which blocks the interaction between IL-18 binding protein and IL-18. The company has collaboration agreement with Bayer Pharma AG for the research, development, and commercialization of antibody-based therapeutics against the company's immune checkpoint regulators; Bristol-Myers Squibb to evaluate the safety and tolerability of COM701 in combination with Bristol-Myers Squibb's PD-1 immune checkpoint inhibitor Opdivo in patients with advanced solid tumors; and Johns Hopkins School of Medicine to evaluate novel T cell and myeloid checkpoint targets. It has license agreement with AstraZeneca for the development of bi-specific and multi-specific immuno-oncology antibody products; and research collaboration with Johns Hopkins University for myeloid. Compugen Ltd. was incorporated in 1993 and is headquartered in Holon, Israel.View Compugen ProfileRead more More Earnings Resources from MarketBeat Earnings Tools Today's Earnings Tomorrow's Earnings Next Week's Earnings Upcoming Earnings Calls Earnings Newsletter Earnings Call Transcripts Earnings Beats & Misses Corporate Guidance Earnings Screener Earnings By Country U.S. Earnings Reports Canadian Earnings Reports U.K. Earnings Reports Latest Articles Brinker Serves Up Earnings Beat, Sidesteps Cost PressuresWhy BigBear.ai Stock's Dip on Earnings Can Be an Opportunity CrowdStrike Faces Valuation Test Before Key Earnings ReportPost-Earnings, How Does D-Wave Stack Up Against Quantum Rivals?Why SoundHound AI's Earnings Show the Stock Can Move HigherAirbnb Beats Earnings, But the Growth Story Is Losing AltitudeDutch Bros Just Flipped the Script With a Massive Earnings Beat Upcoming Earnings Palo Alto Networks (8/18/2025)Home Depot (8/19/2025)Medtronic (8/19/2025)Analog Devices (8/20/2025)Synopsys (8/20/2025)Lowe's Companies (8/20/2025)TJX Companies (8/20/2025)Intuit (8/21/2025)Workday (8/21/2025)Alibaba Group (8/21/2025) Get 30 Days of MarketBeat All Access for Free Sign up for MarketBeat All Access to gain access to MarketBeat's full suite of research tools. 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PresentationSkip to Participants Operator00:00:00Ladies and gentlemen, thank you for joining us today. Welcome to the Compugen Ltd. Second Quarter twenty twenty five 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 Investors section of Compugen's website, www.cgen.com. Operator00:00:28As a reminder, today's call is being recorded. I would now like to introduce Yvonne Norton, vice president, head of investor relations and corporate communications. Michelle MahlerChief Medical Officer at Compugen00:00:42Thank you, operator, and thank Yvonne NaughtonVP, Head of Investor Relations & Corporate Communications at Compugen00:00:43you all for joining us on the call today. Joining me from Competence for the prepared remarks are doctor Anat Cohen Dayarc, president and chief executive officer and David Sivulman, Chief Financial Officer. Doctor. Michelle Malare, Chief Medical Officer and Doctor. Arana O'Fear, Chief Scientific Officer, will join us for the Q and A. Yvonne NaughtonVP, Head of Investor Relations & Corporate Communications at Compugen00:01:01Before we begin, we'd 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 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 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. With that, I'll turn the call over to Anat. Anat Cohen-DayagCEO, President & Director at Compugen00:01:54Thank you, Yvonne, and a warm welcome to everyone joining our call today. Today marks my last quarterly call as president and CEO of Configen, and I could not be prouder or more confident as I passed the leadership reigns into the exceptional hands of Iran. I'm excited at the opportunity to take on the newly created position of executive chair where my focus will be on competence corporate strategy and strategic collaborations. We believe 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 why we believe Competent is well positioned for future growth. Anat Cohen-DayagCEO, President & Director at Compugen00:02:52Immunotherapy has been tremendously successful and is extending the lives of many cancer patients with KEYTRUDA standing out as the top selling drug. However, significant unmet medical need persists with many patients still lacking effective treatment options. As a result, we're seeing a shift in how immunotherapy is being approached driven by a focus on novel mechanisms of action, innovative combination, and new modalities aimed at enhancing the frequency and safety across multiple cancer sites. This is precisely where Competent's differentiated approach aims to create significant value. We're leveraging UniGen, a validated AIML powered computational target discovery platform to identify novel mechanisms to activate the immune system against cancer. Anat Cohen-DayagCEO, President & Director at Compugen00:03:53In addition, we're advancing our pipeline of differentiated immuno oncology therapies with the goal to transform patient outcomes and deliver meaningful clinical and commercial impact. In the clinic, we have our potential first in class immune checkpoint inhibitor COM701, in addition to validating partnerships with the potential for a total of over $1,000,000,000 in milestone payments and tiered royalties on future sales with both AstraZeneca on bisphosphate grade megastomy and Gilead on anti IL-eighteen binding protein g s zero three two one. We have a solid balance sheet with $93,900,000 in cash at the June 2025 and expected cash run rate into 2027. With our leadership expansion, a strategically differentiated pipeline, and operational focus, we believe that Competent is well positioned to capitalize on potential growth opportunities ahead. Now turning to the progress we have made this quarter. Anat Cohen-DayagCEO, President & Director at Compugen00:05:10We continue to advance our immuno oncology clinical and early stage pipeline programs, starting with our potential first in class anti PVRIG antibody COM701. The first patient was dosed in my ovarian, our maintenance immunotherapy trial in platinum sensitive ovarian cancer. We continue to make progress opening sites across The US and Israel, and we aim to share interim analysis from this sub trial in the 2026. As a reminder, this is the first sub trial of our adaptive platform trial comparing COM701 maintenance therapy to placebo in sixty patients with relapsed platinum sensitive ovarian cancer. There is an unmet medical need with no standard of care treatment options for this patient population, progressing post PARP inhibitors and or bevacizumab, or who are not candidates for such treatments. Anat Cohen-DayagCEO, President & Director at Compugen00:06:14We have observed increased competition in this space, primarily from drug candidates evaluated in the platinum resistant ovarian cancer setting. This reflects the recognized and significant need to improve treatment options for these patients. In this earlier stage population, platinum sensitive ovarian cancer, safety becomes an even more critical consideration along with efficacy within the maintenance setting aimed specifically on delaying time to disease progression. We believe that advancing COM701 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 tolerability. As previously communicated, we view a three month improvement over the median progression free survival of the placebo as clinically meaningful. Anat Cohen-DayagCEO, President & Director at Compugen00:07:20Positive data from this trial could support a broader clinical development program aimed at addressing a significant unmet medical need. At ESMO this year, we plan to present a pooled analysis of our three previously reported phase one trials, reflecting clinical benefit of COM701 as monotherapy and in combination in patients with heavily pretreated platinum resistant ovarian cancer. This data form part of our rationale to advance COM701 in our ongoing platinum sensitive ovarian cancer adaptive platform trial. Moving next to the TIGIT landscape. Despite failures in the TIGIT space, it is notable that some companies are advancing differentiated TIGIT programs. Anat Cohen-DayagCEO, President & Director at Compugen00:08:15For example, AlcoGilead is advancing an anti TIGIT program. In addition, AstraZeneca is advancing ribogastomy, which is an anti reduced anti p d one TIGIT bispecific, the t g component of which is derived from Competence COM902. AstraZeneca has specifically designed and engineered ribogastomy with a unique mechanism of action to harness cooperative binding of both p one and TIGIT to drive enhanced immune responses. We've consistently advocated that anti inactive antibodies may serve as the better antibody format for targeting TIGIT by providing a potential safety advantage in certain patient populations, which could support a potential efficacy advantage due to patient durability on study treatment. We believe that successful phase three data would validate TIGIT antibodies as a drug class, change the market sentiment, and open new opportunities for Compugen as one of the few companies that have an active inactive clinical stage kidney antibody coming on to. Anat Cohen-DayagCEO, President & Director at Compugen00:09:37Clinically, we continue to believe that tgp one blockade in combination with the PVRIG inhibitor makes pending use of tgpd1 to less inflamed PD L1 low tumor, and positive tgpd1 data may present additional opportunities for us. In addition, earlier this year, our partner AstraZeneca initiated their tenth phase three clinical trial with ribogastomy. And after this year, AstraZeneca presented encouraging early data from trials evaluating ribogastomy in combination with the ADC data GHD in non small cell lung cancer and in combination with chemotherapy in hepatobiliary cancer. This data, along with the data presented at the World Conference of Lung Cancer and ESMO last year, highlights ribogastomy as a potential IO backbone to future drug combinations. Coming up at ECMO this October, AstraZeneca plans to present longer term follow-up data evaluating ribogastomy monotherapy in non small cell cancer as a poster presentation and first data in bladder cancer in combination with data ZXD as a mini oral session. Anat Cohen-DayagCEO, President & Director at Compugen00:11:06The potential commercial opportunity for rinsagastamir is substantial with AstraZeneca estimating non risk adjusted p q revenues target of more than $5,000,000,000. AstraZeneca's broad development strategy for ribogastinib to replace existing p d one, p d l one inhibitor represents a significant potential revenue source for us as we're eligible for both future milestone payments and mid single digit tiered royalty from future sales. To date, we have received milestone payments of $30,500,000 and remain eligible to receive up to $170,000,000 in regulatory and commercial milestone payments. Moving next to g s zero three two one, formerly known as COM five zero three, a potential first in class anti IL-eighteen binding protein antibody licensed to deal with. D s zero three two one represents a novel approach to harness silencing pathway biology for the treatment of cancer, potentially overcoming the mutations presented by administration of therapeutic cytokines. Anat Cohen-DayagCEO, President & Director at Compugen00:12:26The phase one trial is progressing as planned. Finally, beyond our clinical stage programs, we remain committed to advancing our extensive and differentiated early stage pipeline focused on potential first 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 Competent is well positioned for growth. Of course, none of this would be possible without our highly committed talented team here at Competent, who continuously perform at the highest levels of excellence. With that, I will hand over to David for the financial update before we open the floor for q and a. David SilbermanChief Financial Officer at Compugen00:13:21Thank you, Anat. I am pleased to say that we are advancing in 2025 with a solid balance sheet. Cash runway, assuming no further cash inflows, 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 pipeline. Going into the details, I will start with our cash balance. As of 06/30/2025, we had approximately $93,900,000 in cash, cash equivalents, short term bank deposits and investments in marketable securities. David SilbermanChief Financial Officer at Compugen00:14:03Revenues for the 2025 were approximately $1,300,000 compared to approximately $6,700,000 of revenue for the comparable period in 2024. The revenues for the 2025 reflect the recognition of portions of both the upfront payment and the IND milestone payment from the license agreement with Gilead, while in the 2024, they reflect portion of the upfront payment from the license agreement with Gilead and the clinical milestone from the license agreement with AstraZeneca. Expenses for the 2025 were in line with our plans. R and D expenses for the 2025 were approximately $5,600,000 compared to approximately $6,200,000 in the 2024. Our G and A expenses for both the 2025 and 2024 were approximately $2,200,000 For the 2025, our net loss was approximately $7,300,000 or $08 per basic and diluted share compared to a net loss of approximately $2,100,000 or $02 per basic and diluted share in the 2024. With that, I will hand over to the operator to open the call for questions. Operator00:15:19Thank you. Ladies and gentlemen, at this time, we will begin the question and answer session. If you have a question, please press 1. If you wish to decline from the polling process, please press 2. If you are using speaker equipment, kindly lift the handset before pressing the numbers. Operator00:15:43Please stand by while we poll for your questions. The first question will be from Keaton Wiley from Stifel. Please go ahead. Analyst00:16:07Good morning. This is Toby on for Steve. Thank you for taking our questions. So we we just have two from us. The first one is related to plasma sensitive ovarian cancer trial. Analyst00:16:20Can you please just briefly, like, more of, like, a overall general comment on the ongoing dynamics of patient enrollment? And I don't remember if you guys have actually communicated how many sites you were planning to activate. And I guess what I'm trying to ask you is that what maybe, like, what portion of those sites are currently active so far? And second question is related to the small presentation. I understand that you guys are planning on presenting a proof data analysis. Analyst00:16:55What do you think investors should focus on that presentation? And would you would this presentation actually include any biomarker data analysis? Thank you. Anat Cohen-DayagCEO, President & Director at Compugen00:17:10Thank you, Michelle. Would you like to ask the correct question? Michelle MahlerChief Medical Officer at Compugen00:17:14Yes. 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 and plans, and we are working to continue to meet those. Michelle MahlerChief Medical Officer at Compugen00:17:48Regarding the question on what should be focused on with respect to our presentation at ESMO, The 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 study. So by pulling it, it gives us the opportunity to try and characterize more about the efficacy and the safety and, you know, more of that information will be presented during Admiral. Okay. Susan, are you with us? David SilbermanChief Financial Officer at Compugen00:18:43Hello? Anat Cohen-DayagCEO, President & Director at Compugen00:18:44Yes, please. The is from next Leland Gershell from Oppenheimer. Go ahead, please. Leland GershellMD & Senior Biotechnology Analyst at Oppenheimer & Co. Inc.00:18:56Hey. Thanks for taking my questions. Congrats on all the progress. Manav, just just wanted to ask because we look forward to the upcoming reveal on the troponin ten two m r o three in bladder, which would be, you know, potentially opening that as a another development indication for further advancement. Do you know what we expect to see? Leland GershellMD & Senior Biotechnology Analyst at Oppenheimer & Co. Inc.00:19:19Will it be complete response data, durability data? What what do you envision as the potential for the program to maybe move into further development? Kind of a follow-up. Thank you. Anat Cohen-DayagCEO, President & Director at Compugen00:19:37Thank you, Dylan. And, actually, AstraZeneca did not guide into what they're going to present the test mode for this study or for the other studies. So, obviously, we cannot comment on their behalf. I'll just remind that, you know, and ASCO they presented data for nonstop lung cancer and also for hepatovidia. It's just the data was showing that, you know, it it was encouraging to see that the potential for brinzogastinib to serve an iodexolone as part of the combination. Anat Cohen-DayagCEO, President & Director at Compugen00:20:10The data and letter is going to be in combination with the AC. We're waiting as well. We're looking forward to see the data. But we cannot have guidance sent instead of AC. Leland GershellMD & Senior Biotechnology Analyst at Oppenheimer & Co. Inc.00:20:21Alright. Okay. We look forward to to that. And then if you could just remind us of what you see as as a market opportunity in the platinum sensitive maintenance setting for platinum. Thank you. Anat Cohen-DayagCEO, President & Director at Compugen00:20:35Yeah. Michelle, would you like to do that? Michelle MahlerChief Medical Officer at Compugen00:20:38Yeah. 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 who have received previously at least two prior lines of platinum chemotherapy, and those patients who are eligible for PARP inhibitors or BEV must have received those to be able to come on to 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 eight to 12,000 patients based on, you know, epidemiology data that's available. I think the other point to highlight is in the event that single agent seven zero one works in maintenance, it opens an avenue for us to also combine with other combinations and go after a much broader ovarian cancer patient population. Michelle MahlerChief Medical Officer at Compugen00:21:43So I think the initial opportunity might seem limited, but the steps that we will take that we are taking gives potential for the broader population. Leland GershellMD & Senior Biotechnology Analyst at Oppenheimer & Co. Inc.00:21:54Perfect. Great. Thank you for taking my question. Anat Cohen-DayagCEO, President & Director at Compugen00:22:00Next question will be from Dana Gravesh from Leerink Partners. Analyst00:22:09Hey, guys. Thanks for the question. You got Bill on for Dana. Just a couple for me. So what expectations do you have from Merck's successful Phase III in ovarian? Analyst00:22:20And how does that change your current approach? And the second question is your current clinical assets provide pretty good validation of your your platform's ability to identify targets. Can you give us a sense of what's coming down the pipeline and when we may expect to hear some details? Thank you. Anat Cohen-DayagCEO, President & Director at Compugen00:22:41Yeah. I guess I'm I guess we have to take the first one and then around the relation the second person. Michelle MahlerChief Medical Officer at Compugen00:22:47Okay. Great. So for the Merck study, it's exciting that they were able to demonstrate that with adding a checkpoint inhibitor to patients' regimen that this both appears as an overall survival advantage. Of course, we haven't seen the data. What I would like to highlight though is the Merck study is focused in platinum resistant patients. Michelle MahlerChief Medical Officer at Compugen00:23:10So it gives us some hint to potential activity or seeing activity in the earlier lines of treatment. But keep in mind, it is a different patient population to where we are going because the patients that we're evaluating in our study are patent sensitive. 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 in the right kind of patient population and the right kind of combination. I hand back to Anat and Mehran about the other question. Eran OphirChief Scientific Officer at Compugen00:23:55Thank you, Michelle. So for the early pipeline, so in these words, using our unigenvalidate protection platform that yielded the the p ver g and and compile of three, and we work hard to bring more assets. For many reasons, including competitive ones, we prefer not to disclose too many details to keep that as far as that at this point in time. But, definitely, this is the work on knowing and our traditional platform, which is validated as assets growth It's working hard to bring more assets in different ways in the new oncology. Analyst00:24:32Got it. Thank you. Anat Cohen-DayagCEO, President & Director at Compugen00:24:38Next question will be from Charles Wallace from HCW. Go ahead, Charles. Analyst00:24:46Hi. Thanks for taking my question. On COM701 and the global maintenance ovarian study, can you provide some more color on the interim analysis that you have planned for the '26? And do you expect at this time that the study will be fully enrolled? Anat Cohen-DayagCEO, President & Director at Compugen00:25:03Thank you. Michelle MahlerChief Medical Officer at Compugen00:25:05Okay. So just to explain again, so this the study is is a adaptive trial design. 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 2026. Yes. The study will be fully enrolled, and the interim analysis is to evaluate for futility and also allow us to characterize magnitude of effect size for code seven zero one. Analyst00:25:49Alright. Thanks for taking my question.Read moreParticipantsExecutivesMichelle MahlerChief Medical OfficerYvonne NaughtonVP, Head of Investor Relations & Corporate CommunicationsAnat Cohen-DayagCEO, President & DirectorDavid SilbermanChief Financial OfficerEran OphirChief Scientific OfficerAnalystsAnalystLeland GershellMD & Senior Biotechnology Analyst at Oppenheimer & Co. Inc.Powered by