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 ...

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. announced a pooled analysis supporting the anti-tumor activity and safety profile of COM701 in heavily pre-treated patients with platinum-resistant ovarian cancer, published as an abstract by the European Society of Medical Oncology (ESMO) [1][2][3] Company Developments - The pooled analysis included 60 evaluable patients from prior COM701 Phase 1 clinical trials, focusing on clinical benefits and progression-free survival data [2][3] - COM701 demonstrated good tolerance and durable responses, especially in patients without liver metastases, indicating a potential for lower disease burden and less immunosuppressive tumor microenvironment [3] - Compugen is conducting the MAIA-ovarian trial to evaluate COM701 as maintenance therapy in relapsed platinum-sensitive ovarian cancer, with an interim analysis planned once data from approximately 60 participants is available [3][6] Future Plans - The MAIA-ovarian trial aims to assess the median progression-free survival, with sites activated in the U.S., Israel, and France to support enrollment [3][6] - Compugen anticipates interim analysis results by the end of 2026, with sufficient cash flow to support operations into 2027 [3][6] Industry Context - ESMO 2025 will feature presentations from companies with differentiated Fc-reduced TIGIT programs, including oral presentations from Compugen's partner AstraZeneca [5]

Core Insights - Compugen Ltd. reported its financial results for Q2 2025, highlighting advancements in its immuno-oncology pipeline and a solid financial position with cash expected to fund operations into 2027 [1][4][7]. Corporate Update - The company has initiated the MAIA-ovarian trial, dosing the first patient with COM701 for maintenance therapy in relapsed platinum-sensitive ovarian cancer [2][5]. - Compugen plans to present pooled analysis data from three Phase 1 trials of COM701 at the upcoming ESMO 2025 conference [2][6]. - The Phase 1 trial for GS-0321, an anti-IL18BP antibody licensed to Gilead, is ongoing [2][5]. - AstraZeneca's rilvegostomig program, which includes ten active Phase 3 trials, is progressing well, with data presentations planned for ESMO 2025 [2][6]. Financial Highlights - As of June 30, 2025, Compugen had approximately $93.9 million in cash and cash equivalents, sufficient to fund operations into 2027 [7]. - The company reported revenues of approximately $1.3 million for Q2 2025, a decrease from $6.7 million in Q2 2024, primarily due to the timing of milestone payments [8]. - R&D expenses for Q2 2025 were approximately $5.6 million, down from $6.2 million in the same period of 2024 [9]. - The net loss for Q2 2025 was approximately $7.3 million, compared to a net loss of $2.1 million in Q2 2024 [9]. Future Milestones - Upcoming presentations at ESMO 2025 will include data on COM701 and rilvegostomig, with further data expected in H2 2026 [6][3].

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].

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]