Core Insights - Compugen Ltd. is a clinical-stage cancer immunotherapy company that utilizes AI/ML driven predictive computational research to enhance understanding of complex cancer biology [1][2]. Group 1: Conference Presentations - Compugen will present at the 2025 Annual Congress of the European Association for Cancer Research in Lisbon, Portugal, from June 16-19, with a poster titled "Prediction of immune evasion and immunotherapy resistance mechanisms associated with distinct TNBC subtypes" [2]. - Another presentation will occur at the International Society for Computational Biology and European Conference on Computational Biology in Liverpool, UK, from July 20-24, featuring a poster titled "Computational prediction of TNBC tumor subtypes from an integrative single cell atlas elucidates immune evasion and immunotherapy resistance mechanisms" [2]. Group 2: Company Overview - Compugen employs a predictive computational discovery platform (UnigenTM) to identify new drug targets and biological pathways for cancer immunotherapy development [3]. - The company has two proprietary product candidates in Phase 1 development: COM701, an anti-PVRIG antibody, and COM902, an antibody targeting TIGIT for solid tumors [3]. - Rilvegostomig, a PD-1/TIGIT bispecific antibody, is in Phase 3 development by AstraZeneca under a licensing agreement [3]. - GS-0321, a high affinity anti-IL-18 binding protein antibody, is also in Phase 1 development and licensed to Gilead [3]. - Compugen's therapeutic pipeline includes early-stage immuno-oncology programs aimed at enhancing anti-cancer immunity [3].

Financial Data and Key Metrics Changes - As of March 31, 2025, the company had approximately $103.7 million in cash, cash equivalents, total bank deposits, and investments in marketable securities [16] - Revenues for Q1 2025 were approximately $2.3 million, a decrease from approximately $2.6 million in Q1 2024 [17] - R&D expenses for Q1 2025 were approximately $5.8 million, down from approximately $6.4 million in Q1 2024 [17] - The net loss for Q1 2025 was approximately $7.2 million, or $0.08 per basic and diluted share, compared to a net loss of approximately $7.3 million in the same period of 2024 [17] Business Line Data and Key Metrics Changes - The company is advancing its clinical immunotherapy pipeline, particularly focusing on the anti-PVRIG antibody COM701, with a sub-trial initiated for patients with relapsed platinum-sensitive ovarian cancer [7][8] - The study aims to demonstrate a three-month improvement over the median progression-free survival compared to placebo, which would be clinically meaningful [9] Market Data and Key Metrics Changes - AstraZeneca has initiated multiple Phase III trials in the TIGIT space, with significant potential revenue opportunities estimated at over $5 billion in lung cancer alone [11] - The eligible lung cancer patient population across G7 countries is estimated to exceed 500,000 patients based on 2025 epidemiological data [11] Company Strategy and Development Direction - The company is focused on advancing its early-stage and clinical immuno-oncology pipeline while ensuring a cash runway into 2027 [5][14] - The leadership transition aims to provide a solid foundation for the company's next growth phase [5][6] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the potential impact of their clinical trials on cancer patients' lives and emphasized the importance of their innovative pipeline [14][15] - The company is committed to advancing its clinical assets and early-stage research pipeline while maintaining a solid balance sheet with no debt [16] Other Important Information - The company has established strategic collaborations and built a robust management team to support its growth initiatives [5] - The clinical trial landscape is evolving, with a focus on the potential advantages of COM701 in the maintenance setting of platinum-sensitive ovarian cancer [9] Q&A Session Summary Question: Impact of Merck's KEYNOTE B96 trial success on the company's strategy in ovarian cancer - Management noted that while Merck's trial is in platinum-resistant ovarian cancer, their study focuses on platinum-sensitive patients, and positive results could open up additional opportunities for COM701 [21][22] Question: Interpretation of Roche's Skyscraper one data regarding TIGIT - Management discussed the challenges faced in the trial and emphasized the importance of patient population and statistical design in interpreting the results [24][26] Question: Data collection on tumor microenvironment features from the COM701 study - The company confirmed that it will collect data to evaluate the tumor microenvironment, with a focus on PVRIG expression and IFN signatures [31] Question: Activity in PD-L1 positive patients and potential combinability with other treatments - Management indicated that they have seen activity in both PD-L1 positive and negative patients, suggesting potential for COM701 in various settings [36][38]

Financial Data and Key Metrics Changes - As of March 31, 2025, the company had approximately $103.7 million in cash, cash equivalents, total bank deposits, and investments in marketable securities [14] - Revenues for Q1 2025 were approximately $2.3 million, a decrease from approximately $2.6 million in Q1 2024 [15] - R&D expenses for Q1 2025 were approximately $5.8 million, down from approximately $6.4 million in Q1 2024 [15] - The net loss for Q1 2025 was approximately $7.2 million, or $0.08 per basic and diluted share, compared to a net loss of approximately $7.3 million in the same period of 2024 [15] Business Line Data and Key Metrics Changes - The company is advancing its clinical immuno-oncology pipeline, particularly focusing on the anti-PVRIG antibody COM701, with a sub-trial initiated for patients with relapsed platinum-sensitive ovarian cancer [6][7] - The study aims to demonstrate a clinically meaningful improvement in median progression-free survival over placebo, targeting a three-month improvement [8] Market Data and Key Metrics Changes - AstraZeneca has initiated multiple Phase III trials in the TIGIT space, with significant potential revenue opportunities estimated at over $5 billion in lung cancer alone [10] - The eligible lung cancer patient population across G7 countries is estimated to exceed 500,000 patients based on 2025 epidemiological data [10] Company Strategy and Development Direction - The company is focused on advancing its early-stage and clinical immuno-oncology pipeline, with a strong emphasis on innovative therapies and strategic collaborations [4][12] - The leadership transition aims to ensure a solid foundation for the company's next phase of growth, with a commitment to addressing significant unmet medical needs in cancer treatment [4][5] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the potential impact of their clinical trials on cancer patients' lives and highlighted the importance of their cash runway extending into 2027 [12][14] - The evolving clinical trial landscape, particularly in the context of ADCs and TIGIT studies, presents both challenges and opportunities for the company [9][10] Other Important Information - The company has a robust foundation with a talented management team and a commitment to advancing its innovative pipeline [4][12] - The cash runway is expected to support the advancement of key clinical trials and early-stage research without additional cash inflows [14] Q&A Session Summary Question: Impact of Merck's KEYNOTE B96 trial success on ovarian cancer strategy - Management noted that the success of Merck's trial indicates benefits from adding immune checkpoint inhibitors to standard care, which could open opportunities for COM701 in similar settings [17][19] Question: Interpretation of Roche's Skyscraper one data regarding TIGIT - Management discussed the challenges faced by the trial and emphasized the importance of patient population and study design in interpreting the results [20][24] Question: Data collection on tumor microenvironment features from the COM701 study - The company confirmed plans to collect data on tumor microenvironment features, although specific details were not disclosed [29][30] Question: Activity in PD-L1 positive patients and combinability with other treatments - Management indicated that COM701 has shown activity in both PD-L1 positive and negative patients, suggesting potential for combination therapies [33][35]

Core Viewpoint - Compugen Ltd. reported its financial results for Q1 2025, highlighting advancements in its clinical pipeline and a solid financial position that supports ongoing operations into 2027 [1][4][5]. Financial Highlights - As of March 31, 2025, Compugen had approximately $103.7 million in cash and cash equivalents, which includes proceeds from an ATM raised in January and February 2025 [4]. - The company reported revenues of approximately $2.3 million for Q1 2025, a decrease from $2.6 million in Q1 2024, primarily due to the recognition of payments from a license agreement with Gilead [8]. - R&D expenses for Q1 2025 were approximately $5.8 million, down from $6.4 million in the same period of 2024, while G&A expenses remained stable at approximately $2.4 million [9]. Clinical Developments - Compugen initiated a randomized placebo-controlled trial for COM701 maintenance therapy in patients with relapsed platinum-sensitive ovarian cancer [2][6]. - The Phase 1 trial for GS-0321, a potential first-in-class anti-IL18BP antibody licensed to Gilead, is ongoing [2][6]. - AstraZeneca expanded its rilvegostomig program to ten Phase 3 trials across various cancers, with plans to present early data at the ASCO 2025 conference [2][7]. Leadership Changes - Upcoming leadership transitions will take effect in September 2025, with Dr. Anat Cohen-Dayag becoming Executive Chair and Dr. Eran Ophir taking over as President and CEO [2][6]. Future Milestones - Compugen expects to dose the first patient in the COM701 trial and continue recruitment for GS-0321 [6]. - Data from interim analysis of COM701 is projected for H2 2026 [7].

Core Viewpoint - Compugen Ltd. is set to release its first quarter 2025 financial results on May 19, 2025, and will host a conference call for a corporate update [1]. Company Overview - Compugen is a clinical-stage cancer immunotherapy company that utilizes its predictive computational discovery platform, Unigen™, to identify new drug targets and biological pathways [3]. - The company has two proprietary product candidates in Phase 1 development: COM701, an anti-PVRIG antibody, and COM902, an antibody targeting TIGIT for solid tumors [3]. - Rilvegostomig, a PD-1/TIGIT bispecific antibody, is in Phase 3 development by AstraZeneca under a licensing agreement [3]. - GS-0321, a high affinity anti-IL-18 binding protein antibody, is also in Phase 1 development and licensed to Gilead [3]. - Compugen's therapeutic pipeline includes early-stage immuno-oncology programs aimed at enhancing anti-cancer immunity [3]. - The company is headquartered in Israel with additional offices in San Francisco, CA, and its shares are listed on Nasdaq and the Tel Aviv Stock Exchange under the ticker symbol CGEN [3].

Company Overview - Compugen Ltd. is a clinical-stage cancer immunotherapy company specializing in computational target discovery [3] - The company utilizes its predictive computational discovery platform, UnigenTM, to identify new drug targets and biological pathways for cancer immunotherapies [3] - Compugen has two proprietary product candidates in Phase 1 development: COM701, an anti-PVRIG antibody, and COM902, an antibody targeting TIGIT for solid tumors [3] Upcoming Events - Compugen will participate in several virtual investor conferences in April 2025, including: - H.C. Wainwright 2nd Annual AI Based Drug Discovery & Development Conference on April 2, 2025, with a fireside chat at 9:30 am ET [1] - 24th Annual Needham Virtual Healthcare Conference on April 7, 2025, with a fireside chat at 8:00 am ET [2] - Stifel's 2025 Virtual Targeted Oncology Forum on April 9, 2025, with a fireside chat at 12:00 pm ET [2] - Live webcasts of the fireside chats will be available on Compugen's Investor Relations website, with replays accessible after the events [2] Product Development - Rilvegostomig, a PD-1/TIGIT bispecific antibody, is in Phase 3 development by AstraZeneca under a license agreement [3] - GS-0321 (previously COM503), an anti-IL-18 binding protein antibody, is in Phase 1 development and licensed to Gilead [3] - The company has a pipeline of early-stage immuno-oncology programs aimed at enhancing anti-cancer immunity [3]

Financial Data and Key Metrics Changes - As of December 31, 2024, the company had approximately $103.3 million in cash, cash equivalents, short-term bank deposits, and investments in marketable securities, which includes a $60 million upfront payment from Gilead and a $30 million milestone payment for IND clearance [22][23] - The company reported approximately $1.5 million in revenues for Q4 2024 and approximately $27.9 million for the full year 2024, compared to approximately $33.5 million for the same periods in 2023 [24] - R&D expenses for Q4 2024 were approximately $5.9 million, down from approximately $10.9 million in Q4 2023, while total R&D expenses for the year were approximately $24.8 million compared to $34.5 million in 2023 [25] - The net loss for Q4 2024 was approximately $6.1 million, or approximately $0.07 per share, compared to a net income of approximately $9.7 million, or approximately $0.11 per share in Q4 2023 [26] Business Line Data and Key Metrics Changes - The company is advancing the development of COM701 as a maintenance treatment option for patients with platinum-sensitive ovarian cancer, with plans to initiate a randomized, double-blinded sub-trial in Q2 2025 [8][9] - GS-0321, a potential first-in-class anti-IL-18 binding protein antibody, has progressed with a Phase I trial initiated in early January 2025, following a $30 million milestone payment from Gilead for FDA IND clearance [18] Market Data and Key Metrics Changes - The company noted that the TIGIT antibody class faced setbacks in 2024, leading to skepticism about the efficacy of TIGIT blocker combinations, but emphasized the potential of Fc inactive TIGIT antibodies [11][12] - AstraZeneca has initiated multiple Phase III trials for rilvegostomig, which is derived from the company's COM902, representing a significant potential revenue source through milestone payments and royalties [15][16] Company Strategy and Development Direction - The company aims to leverage its computational discovery platform, Unigen, to identify novel ways to activate antitumor immunity and advance its pipeline [19][20] - The strategic priority for 2025 includes efficient execution of clinical trials and continued investment in early-stage research, with a cash runway expected to last into 2027 [20] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism for 2025, highlighting the potential impact of their programs on cancer patients' lives and the importance of their team in achieving these goals [21] - The company is focused on advancing its clinical assets and maintaining a solid balance sheet with no debt [22] Other Important Information - The company has a diverse pipeline and is well-positioned for growth, with a strong focus on execution in 2025 [20] Q&A Session Summary Question: Can you confirm whether [indiscernible] will be included in the Phase III study design? - Management stated they cannot comment on AstraZeneca's undisclosed plans but are pleased with the progress of their pivotal trials [30] Question: Can we expect any near-term data from AstraZeneca that could clarify the contribution to efficacy for the TIGIT part? - Management indicated that AstraZeneca plans to present data during 2025 from the combination of rilvegostomig with ADCs [32] Question: Can you talk more about your design of the ovarian study? - The study is an exploratory Phase Ib study, not powered to detect a full pivotal trial improvement, but designed to evaluate single-agent activity [37] Question: What are your expectations for the rate of enrollment? - Management expects a rapid enrollment rate due to limited clinical trials available for the specific patient population [65]

Financial Data and Key Metrics Changes - As of December 31, 2024, the company had approximately $103.3 million in cash, cash equivalents, short-term bank deposits, and investments in marketable securities, which includes a $60 million upfront payment from Gilead and a $30 million milestone payment for IND clearance [23] - The company reported approximately $1.5 million in revenues for Q4 2024 and approximately $27.9 million for the full year 2024, compared to approximately $33.5 million for the same periods in 2023 [24] - R&D expenses for Q4 2024 were approximately $5.9 million, down from approximately $10.9 million in Q4 2023, while total R&D expenses for the year were approximately $24.8 million compared to $34.5 million in 2023 [25] - The net loss for Q4 2024 was approximately $6.1 million, or approximately $0.07 per share, compared to a net income of approximately $9.7 million, or approximately $0.11 per share, in Q4 2023 [26] Business Line Data and Key Metrics Changes - The company is advancing the development of COM701 as a maintenance treatment option for patients with platinum-sensitive ovarian cancer, with plans to initiate a randomized, double-blinded sub-trial in Q2 2025 [8][9] - GS-0321, a potential first-in-class anti-IL-18 binding protein antibody, has progressed with a Phase I trial initiated in early January 2025, following a $30 million milestone payment from Gilead for FDA IND clearance [18] Market Data and Key Metrics Changes - The company noted that the TIGIT antibody class faced setbacks in 2024, leading to skepticism about the efficacy of TIGIT blocker combinations, but emphasized the potential of Fc inactive anti-TIGIT antibodies [11][12] - AstraZeneca has initiated multiple Phase III trials for rilvegostomig, which is derived from the company's COM902, representing a significant potential revenue source through milestone payments and royalties [15] Company Strategy and Development Direction - The company aims to leverage its computational discovery platform, Unigen, to identify novel ways to activate antitumor immunity and advance its pipeline [19][20] - The strategic priority for 2025 includes efficient execution of clinical trials and continued investment in early-stage research, with a cash runway expected to last into 2027 [20] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism for 2025, highlighting the potential impact of their clinical programs on cancer patients' lives and the importance of their extraordinary team [21] - The company is focused on advancing its programs and believes it is well-positioned for growth, despite the competitive landscape in the oncology sector [20] Other Important Information - The company has a solid balance sheet with no debt and a cash runway to support its operating plans into 2027 [22] Q&A Session Summary Question: Inquiry about AstraZeneca's Phase III study design - Management stated they cannot comment on AstraZeneca's unpublished plans but are pleased with the initiation of pivotal trials [30] Question: Expectations for near-term data from AstraZeneca - Management indicated that AstraZeneca plans to present data during 2025 from the combination of rilvegostomig with ADCs [32] Question: Design of the ovarian study and its statistical power - The study is exploratory and not powered for full pivotal trial analysis, using Bayesian statistics to evaluate improvement probabilities [37][38] Question: Balance between study arms and patient eligibility criteria - The study will enroll patients who are not recommended for standard maintenance treatments, ensuring a more well-defined patient population [42] Question: Rate of enrollment in the studies - Management expects a rapid enrollment rate due to limited clinical trials available for the specific patient population [65] Question: Interim analysis triggers and futility thresholds - The interim analysis will be event-driven and based on follow-up, with a futility boundary established for evaluation [72][73]

Company Performance - Compugen reported a quarterly loss of $0.07 per share, matching the Zacks Consensus Estimate, compared to earnings of $0.11 per share a year ago, indicating a significant decline [1] - The company posted revenues of $1.47 million for the quarter ended December 2024, missing the Zacks Consensus Estimate by 91.58%, and a sharp decrease from year-ago revenues of $33.46 million [2] - Over the last four quarters, Compugen has surpassed consensus EPS estimates two times and topped consensus revenue estimates just once [2] Stock Movement and Outlook - Compugen shares have increased by approximately 18.3% since the beginning of the year, contrasting with a -0.5% decline in the S&P 500 [3] - The company's earnings outlook is mixed, with the current consensus EPS estimate for the coming quarter at -$0.05 on $5 million in revenues, and -$0.12 on $33.58 million in revenues for the current fiscal year [7] - The Zacks Rank for Compugen is currently 3 (Hold), indicating that shares are expected to perform in line with the market in the near future [6] Industry Context - Compugen operates within the Zacks Medical - Biomedical and Genetics industry, which is currently ranked in the top 29% of over 250 Zacks industries [8] - Empirical research suggests a strong correlation between near-term stock movements and trends in earnings estimate revisions, which can impact investor sentiment and stock performance [5]

Currency Impact - The appreciation (devaluation) of the dollar against the NIS was 0.6%, 3.1%, and 13.2% in 2024, 2023, and 2022, respectively [436]. - Assuming a 10% devaluation of the dollar against the NIS, the company would experience an increase in net loss of approximately $1.5 million [436]. Revenue Recognition - The company recognized revenues of $2 million, $6 million, $7.5 million, $10 million, and $5 million in connection with milestones achieved from a license agreement with AstraZeneca for the years 2020, 2021, 2022, 2023, and 2024, respectively [449]. - During the year ended December 31, 2024, the company recognized $22,864 of license, IND services, and Phase 1 services revenues [455]. - Deferred revenues included $9,632 in current liabilities and $34,045 in non-current liabilities [455]. - The company determined that the license granted was a functional license and recognized the entirety of the initial transaction price allocated to the license performance obligation during the year ended December 31, 2023, in the amount of $23.5 million [453]. Share-Based Compensation - Share-based compensation expense recognized under ASC 718 was approximately $3.0 million, $3.6 million, and $4.3 million for the years ended December 31, 2024, 2023, and 2022, respectively [445]. Research and Development Expenses - There was no amortization of participation in research and development expenses for the year ended December 31, 2024, while for the years 2023 and 2022 such expenses were approximately $0.3 million and $6.0 million, respectively [459]. Market Trends - Biologics represented 31% of FDA approved drugs in 2023 and 32% in 2024, indicating a growing market segment [438]. Financial Risks - The company is subject to interest rate risk, which could impact financial income and net loss due to volatility in interest rates [437].