HOLON, Israel, Dec. 17, 2025 /PRNewswire/ -- Compugen Ltd. (NASDAQ: CGEN) (TASE: CGEN) a clinical- stage cancer immunotherapy company and a pioneer in predictive computational target discovery powered by AI/ML, today announced that it has agreed with AstraZeneca to monetize a portion of Compugen's rilvegostomig future royalties. Compugen has amended the exclusive license agreement with AstraZeneca, previously entered into in March 2018, to strengthen Compugen's balance sheet and advance its innovative and d ...

Summary of Compugen Conference Call Company Overview - **Company**: Compugen (NasdaqCM:CGEN) - **Industry**: Biotechnology, specifically in immuno-oncology - **Key Focus**: Computational AI-based target discovery for new drug targets Core Points and Arguments 1. **Unique Computational Platform**: Compugen utilizes a validated computational platform to identify first-in-class drug targets in immuno-oncology, including TIGIT and PVRIG [3][4] 2. **Pipeline Assets**: The company has two wholly owned assets, COM-902 (TIGIT blocker) and COM-701 (anti-PVRIG antibody), and has licensed COM-902 to AstraZeneca for use in their bispecific therapy [4][34] 3. **Clinical Trials**: - COM-701 is being evaluated in recurrent platinum-sensitive ovarian cancer, with promising early clinical signals observed, particularly in PD-1 negative patients [5][6][7] - The trial design includes an adaptive approach with a control arm expected to show a median progression-free survival (PFS) of 5.5 months [11][12] - Results from the trial are anticipated in Q1 2027 [12][18] 4. **Biological Mechanism**: PVRIG inhibition is believed to significantly increase T cell presence in the tumor microenvironment, which is critical for efficacy in ovarian cancer [6][9] 5. **Regulatory Considerations**: A three-month improvement in PFS over the control arm could initiate discussions with the FDA regarding accelerated approval due to the unmet need in this patient population [23][24] 6. **Partnership with AstraZeneca**: Compugen has received $30 million in milestones from AstraZeneca and is eligible for an additional $170 million, along with mid-single digit tiered royalties from potential sales of volrustomig [42][44] Additional Important Information 1. **Competitive Landscape**: Compugen is currently the only company with a PVRIG targeting antibody in clinical trials, following GSK's discontinuation of their PVRIG program [28][31] 2. **TIGIT Development**: The company has paused new trials for COM-902 due to ongoing debates in the community regarding TIGIT therapies, but sees future potential based on AstraZeneca's promising results [34][38] 3. **IL-18BP Asset**: Compugen has licensed an IL-18BP blocker to Gilead, which is currently in phase one trials, with a unique mechanism to activate IL-18 in the tumor microenvironment [50][51] 4. **Cash Runway**: Compugen has a cash runway of approximately two years, extending into Q3 2027, allowing for the continuation of current trials without additional income [61] Conclusion Compugen is positioned as a pioneer in computational drug discovery within the immuno-oncology space, with a robust pipeline and strategic partnerships that could lead to significant advancements in cancer treatment. The upcoming trial results and ongoing collaborations will be critical in shaping the company's future trajectory and market position.

Financial Data and Key Metrics Changes - As of September 30, 2025, the company had approximately $86 million in cash, cash equivalents, short-term bank deposits, and investments in marketable securities [17] - Revenues for Q3 2025 were approximately $1.9 million, a significant decrease from approximately $17.1 million in Q3 2024 [17] - R&D expenses for Q3 2025 were approximately $5.8 million, down from approximately $6.3 million in Q3 2024 [18] - The net loss for Q3 2025 was approximately $6.98 million, or $0.07 per share, compared to a net profit of approximately $1.28 million, or $0.01 per share in Q3 2024 [18] Business Line Data and Key Metrics Changes - The company is advancing its COM701 trial for platinum-sensitive ovarian cancer, with ongoing efforts to support the Maya ovarian platform trial [12][14] - COM902 is highlighted as one of the only two clinical-stage FC-reduced anti-TIGIT monoclonal antibodies currently in development, fully owned by the company [8] Market Data and Key Metrics Changes - The potential commercial opportunity for Rilvegostomig, a bispecific antibody, is substantial, with AstraZeneca estimating peak year revenue targets of over $5 billion [9] - The company is eligible for regulatory and commercial milestones and tiered royalties from AstraZeneca's broad development program, which includes 11 phase III trials across various cancers [10] Company Strategy and Development Direction - The company emphasizes its pioneering role in computational drug target discovery and aims to leverage its expertise in digital biology to deliver significant patient value [4] - The strategy includes focusing on FC-reduced formats for anti-TIGIT antibodies, with COM902 positioned to capture market interest as new data emerges [8] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the ongoing trials and the potential for COM701 and COM902 to address significant unmet medical needs [12][14] - The company anticipates that the cash runway will support operations into Q3 2027, allowing continued investment in clinical trials and early-stage pipeline development [17] Other Important Information - The company presented a pooled analysis of COM701 at ESMO, demonstrating its clinical benefit in patients with heavily pretreated platinum-resistant ovarian cancer [12][13] - The Maya ovarian platform trial is progressing, with sites activated across the US, Israel, and France, and an interim analysis expected in Q1 2027 [14] Q&A Session Summary Question: What factors influenced the extension of the Maya interim analysis to Q1 2027? - Management indicated that the extension is due to site openings, enrollment rates, and the accumulation of events in the trial [20][22] Question: What are the expectations for the upcoming Arcus-Gilead readout with their TIGIT in gastric cancer? - Management noted that the readout could validate their hypotheses regarding FC-reduced TIGIT antibodies, but emphasized that it is only one trial among many [28][30] Question: What internal thresholds are being considered for the interim update from the Maya ovarian trial? - The company is looking for a clinically meaningful improvement of up to three months above placebo in the trial [35][38] Question: Can COM902 be partnered with another company despite the license agreement with AstraZeneca? - Management confirmed that they fully own COM902 and have no restrictions on pursuing partnerships, allowing for opportunistic decisions based on market developments [42][43] Question: How does the tolerability profile of COM701 influence its use in combination therapies? - Management stated that COM701 is extremely well tolerated as a monotherapy, which supports its potential use in combination therapies [46][47]

Financial Data and Key Metrics Changes - As of September 30, 2025, the company had approximately $86 million in cash, cash equivalents, short-term bank deposits, and investments in marketable securities [17] - Revenues for Q3 2025 were approximately $1.9 million, a significant decrease from approximately $17.1 million in Q3 2024 [17] - R&D expenses for Q3 2025 were approximately $5.8 million, down from approximately $6.3 million in Q3 2024 [18] - The net loss for Q3 2025 was approximately $6.98 million, or $0.07 per share, compared to a net profit of approximately $1.28 million, or $0.01 per share in Q3 2024 [18] Business Line Data and Key Metrics Changes - The company is advancing its COM701 trial for platinum-sensitive ovarian cancer and GS0321 in the clinic, with a focus on early-stage pipeline investments [17][15] - COM902 is highlighted as one of the only two clinical-stage FC-reduced anti-TIGIT monoclonal antibodies currently in development, fully owned by the company [8] Market Data and Key Metrics Changes - The potential commercial opportunity for Rilvegostomig, a bispecific antibody, is estimated to exceed $5 billion in peak year revenue [9] - The ongoing Maya ovarian platform trial is expected to address a significant unmet need for maintenance therapy in platinum-sensitive ovarian cancer [14] Company Strategy and Development Direction - The company emphasizes its pioneering role in computational drug target discovery and aims to leverage its expertise in digital biology to deliver significant patient value [4] - The strategy includes focusing on FC-reduced formats, with COM902 and COM701 positioned as key assets [8][10] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the clinical momentum of their programs and the potential for improved safety profiles with FC-reduced formats [7][8] - The company anticipates cash runway to support operations into Q3 2027, allowing continued investment in key trials [17] Other Important Information - The company presented a pooled analysis of COM701 at ESMO, demonstrating well-tolerated results and durable responses in patients with heavily pretreated platinum-resistant ovarian cancer [12][13] - The interim analysis for the Maya trial is now estimated for Q1 2027, reflecting adjustments based on enrollment and event accumulation [25] Q&A Session Summary Question: What is the reason for the delay in the Maya interim analysis? - Management indicated that the delay is due to factors such as site openings, enrollment rates, and event accumulation, with most sites now activated [22][24] Question: What are the expectations for the upcoming Arcus-Gilead readout? - Management noted that the readout will be significant for validating their hypotheses regarding FC-reduced TIGIT antibodies, regardless of the outcome [29][30] Question: What internal thresholds are being considered for the interim update from Maya ovarian? - The company is looking for a clinically meaningful improvement of up to three months above placebo in the interim analysis [38] Question: Are there any restrictions on partnering COM902? - Management confirmed that there are no restrictions on COM902, allowing for flexibility in potential partnerships [43] Question: How does the tolerability profile of COM701 influence its use in combination therapies? - Management stated that COM701 is extremely well tolerated as a monotherapy, which supports its use in combination therapies [46]

Financial Data and Key Metrics Changes - As of September 30, 2025, the company had approximately $86 million in cash, cash equivalents, short-term bank deposits, and investments in marketable securities [15] - Revenues for Q3 2025 were approximately $1.9 million, a significant decrease from approximately $17.1 million in Q3 2024 [15] - R&D expenses for Q3 2025 were approximately $5.8 million, down from approximately $6.3 million in Q3 2024 [16] - G&A expenses for Q3 2025 were approximately $2.2 million, compared to approximately $2.6 million in the same period in 2024 [16] - The net loss for Q3 2025 was approximately $6.98 million, or $0.07 per share, compared to a net profit of approximately $1.28 million, or $0.01 per share in Q3 2024 [16] Business Line Data and Key Metrics Changes - The company is advancing its COM701 trial for platinum-sensitive ovarian cancer, with interim analysis now expected in Q1 2027 [12][20] - COM902 is highlighted as one of the only two clinical-stage FC-reduced anti-TIGIT monoclonal antibodies currently in development, fully owned by the company [7] - The partnership with AstraZeneca for Rilvegostomig, an FC-reduced anti-PD-1 TIGIT bispecific, is expected to generate substantial revenue, with peak year revenue targets exceeding $5 billion [8] Market Data and Key Metrics Changes - The company is positioned to capture market opportunities as new data emerges, particularly with readouts anticipated from 2026 [7] - The overall survival data from recent trials indicates a median overall survival of 27 months for FC-reduced formats, compared to benchmarks of 15 months or less [8] Company Strategy and Development Direction - The company emphasizes its focus on computational drug target discovery and digital biology, aiming to deliver significant value for patients [4] - The strategy includes five key value drivers, with a strong emphasis on FC-reduced TIGIT programs and the potential of COM902 [7] - The company is committed to delivering breakthroughs in cancer treatment, leveraging its AI/ML-powered discovery engine [10] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the company's strong fundamentals and strategic direction, particularly in the context of evolving clinical data [4] - The management team highlighted the importance of safety and efficacy in their drug development approach, particularly regarding the FC-reduced formats [6] - The company anticipates that the cash runway will support operations into Q3 2027, allowing continued investment in clinical trials and early-stage pipeline development [15][20] Other Important Information - The company presented a pooled analysis of COM701 at ESMO, demonstrating its clinical benefit in heavily pretreated platinum-resistant ovarian cancer [11] - The ongoing Maya ovarian platform trial is seen as a significant opportunity to address unmet medical needs in the treatment of ovarian cancer [12] Q&A Session Summary Question: What caused the extension of the Maya interim analysis to Q1 2027? - The extension is due to factors such as site openings, enrollment rates, and the accumulation of PFS events [17][18] Question: What are the expectations for the upcoming Arcus-Gilead readout with their TIGIT in gastric cancer? - The readout is significant as it will be the first phase three readout for an FC-reduced TIGIT antibody, and its success could validate the company's hypotheses [21][22] Question: What internal thresholds are being looked for from the interim update from Maya ovarian? - The trial is exploratory, aiming to demonstrate single-agent activity, with an improvement of up to three months above placebo being clinically meaningful [25] Question: Can COM902 be partnered with another company despite the license agreement with AstraZeneca? - The company retains full ownership of COM902 and has no restrictions on pursuing partnerships, allowing for flexibility in future collaborations [27] Question: How does the tolerability profile of COM701 influence its use in combination therapies? - COM701 is well tolerated as a monotherapy, which supports its potential use in combination therapies with standard care agents [29]

Core Insights - Compugen reported a quarterly loss of $0.07 per share, better than the Zacks Consensus Estimate of a loss of $0.09, representing an earnings surprise of +22.22% [1] - The company posted revenues of $1.89 million for the quarter ended September 2025, missing the Zacks Consensus Estimate by 14.43% and down from $17.13 million year-over-year [2] - Compugen shares have increased by approximately 5.9% since the beginning of the year, underperforming the S&P 500's gain of 14.4% [3] Earnings Outlook - The company's earnings outlook is crucial for investors, as it includes current consensus earnings expectations for upcoming quarters and any recent changes to these expectations [4] - The current consensus EPS estimate for the next quarter is -$0.09 on revenues of $4.91 million, and for the current fiscal year, it is -$0.34 on revenues of $12.34 million [7] Industry Context - The Medical - Biomedical and Genetics industry, to which Compugen belongs, is currently ranked in the top 36% of over 250 Zacks industries, indicating a favorable outlook compared to the bottom 50% [8] - Empirical research suggests a strong correlation between near-term stock movements and trends in earnings estimate revisions, which can impact Compugen's stock performance [5][6]

Financial Performance - Compugen reported approximately $1.9 million in revenues for Q3 2025, a decrease of 88.9% compared to $17.1 million in Q3 2024[7] - Compugen reported a net loss of approximately $6.98 million in Q3 2025, compared to a net profit of approximately $1.28 million in Q3 2024[9] - Total assets as of September 30, 2025, were approximately $97.8 million, down from $115 million at the end of 2024[17] Expenses - R&D expenses for Q3 2025 were approximately $5.8 million, down from $6.3 million in Q3 2024, reflecting a 7.9% reduction[8] - General and administrative expenses were approximately $2.2 million in Q3 2025, compared to $2.6 million in Q3 2024, a decrease of 15.4%[9] Cash Position - As of September 30, 2025, Compugen had approximately $86.1 million in cash and cash equivalents, expected to fund operations into Q3 2027[5] - Approximately 0.8 million shares were sold through the ATM facility in October 2025, contributing net proceeds of approximately $1.6 million[6] Strategic Initiatives - The company is advancing its differentiated IO pipeline and leveraging its AI/ML powered computational discovery platform Unigen™[3] - Interim analysis for the ongoing MAIA-ovarian platform trial evaluating COM701 is now estimated for Q1 2027[4] - Compugen's partnership with AstraZeneca and Gilead offers over $1 billion in potential milestones and royalties[3]

Core Insights - Compugen Ltd. reported its third quarter 2025 financial results, highlighting a significant decrease in revenue compared to the same period in 2024, alongside advancements in its clinical pipeline and a strong cash position [1][5][3]. Financial Performance - Revenue for Q3 2025 was approximately $1.9 million, a decrease from $17.1 million in Q3 2024, primarily due to the recognition of upfront and milestone payments from Gilead [5]. - Research and Development (R&D) expenses were approximately $5.8 million in Q3 2025, down from $6.3 million in Q3 2024 [6]. - General and Administrative (G&A) expenses were approximately $2.2 million in Q3 2025, compared to $2.6 million in Q3 2024 [6]. - The net loss for Q3 2025 was approximately $6.98 million, or $0.07 per share, contrasting with a net profit of approximately $1.28 million, or $0.01 per share, in Q3 2024 [7]. Clinical Developments - Compugen's COM701, an Fc-reduced anti-PVRIG antibody, showed promising Phase 1 data at ESMO 2025, indicating it is well tolerated and delivers durable responses in heavily pretreated platinum-resistant ovarian cancer patients [2][4]. - The ongoing MAIA-ovarian platform trial is evaluating COM701 maintenance therapy in platinum-sensitive ovarian cancer, with interim analysis expected in Q1 2027 [4]. - AstraZeneca presented positive results for its rilvegostomig program at ESMO 2025, reinforcing the potential of Fc-reduced anti-TIGIT antibodies [2][4]. Financial Position - As of September 30, 2025, Compugen had approximately $86.1 million in cash and cash equivalents, sufficient to fund operations into Q3 2027 [3]. - The company has no debt and recently raised approximately $1.6 million through the sale of shares [3]. Strategic Partnerships - Compugen has established partnerships with AstraZeneca and Gilead, which could provide over $1 billion in potential milestones and royalties, enhancing the company's financial outlook and pipeline development [2][3].

Core Insights - Compugen Ltd. is a clinical-stage cancer immunotherapy company that utilizes AI/ML for predictive computational drug target discovery [3][4] - The company will participate in a fireside chat at the Stifel 2025 Healthcare Conference on November 11, 2025 [1] - Compugen has two proprietary product candidates in Phase 1 development: COM701 and COM902, targeting cancer treatment [3] Company Overview - Compugen is headquartered in Israel with additional offices in San Francisco, CA [3] - The company is listed on Nasdaq and the Tel Aviv Stock Exchange under the ticker symbol CGEN [3] - Compugen's therapeutic pipeline includes early-stage immuno-oncology programs aimed at activating the immune system against cancer [3] Upcoming Events - A live webcast of the fireside chat will be available on the Investor Relations section of Compugen's website [2] - A replay of the event will also be accessible after the live session [2] Product Development - COM701 is a potential first-in-class anti-PVRIG antibody, while COM902 is a potential best-in-class 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]

Core Insights - Compugen Ltd. is set to release its third quarter 2025 financial results on November 10, 2025, before U.S. markets open, followed by a conference call at 8:30 AM ET to discuss the results and provide a corporate update [1]. Company Overview - Compugen is a clinical-stage cancer immunotherapy company that utilizes a predictive AI/ML-powered computational discovery platform named Unigen to identify new drug targets and biological pathways for cancer immunotherapies [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, while GS-0321, an 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 activating the immune system against cancer [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].