20-F: Compugen Reports 2025 Profit, Advances Immuno-Oncology Pipeline

Compugen Ltd. reported a net profit of $35.3 million in 2025, driven by significant upfront and milestone payments from strategic partnerships, while advancing its clinical-stage immuno-oncology programs.

Summary

• Compugen Ltd. reported a net profit of approximately $35.3 million for the year ended December 31, 2025, a significant improvement from net losses of $14.2 million in 2024 and $18.8 million in 2023.
• Total revenues for 2025 were approximately $72.8 million, up from $27.9 million in 2024, primarily due to a $65 million upfront payment from AstraZeneca following an amendment to their license agreement.
• Research and development expenses decreased by 8% to approximately $22.8 million in 2025, compared to $24.8 million in 2024, mainly due to winding down prior clinical trials, partially offset by increased expenses for the MAIA-ovarian trial.
• The company's cash, cash equivalents, short-term bank deposits, and marketable securities totaled approximately $145.6 million as of December 31, 2025, up from $103.3 million at the end of 2024.
• Compugen believes its current capital resources are sufficient to fund operations into 2029, without considering additional funds from licensing or financings.
• The MAIA-ovarian trial, evaluating COM701 as a single agent in maintenance therapy for relapsed platinum-sensitive ovarian cancer, is ongoing, with an interim analysis expected in Q1 2027.
• GS-0321 (previously COM503), licensed to Gilead, is in a Phase 1 clinical trial sponsored and conducted by Compugen, assessing it as monotherapy and in combination with zimberelimab in advanced solid tumors.
• Rilvegostomig, a PD-1/TIGIT bispecific antibody derived from Compugen's COM902, is being developed by AstraZeneca and is currently in multiple Phase 1, Phase 2, and Phase 3 clinical trials.
• Compugen has decided not to initiate new clinical trials with COM902 due to recent negative data in the TIGIT field from other companies, including Arcus and Gilead, which discontinued their Phase 3 STAR-221 study due to futility.
• The company's Unigen AI/ML-powered computational discovery platform continues to be utilized to identify novel drug targets and develop therapeutics in immuno-oncology.
• Dr. Anat Cohen-Dayag transitioned from President and CEO to Executive Chair of the Board in September 2025, and Dr. Eran Ophir was appointed President and CEO.
• The company sold a portion of its existing royalty interest in rilvegostomig to AstraZeneca for a $65 million upfront payment in December 2025, and an additional $25 million will be added to the next milestone payment upon BLA acceptance.

Sentiment

Score: 7

Explanation: StockSavvy.ai views this as a positive report, primarily due to the significant net profit and strengthened cash position driven by the AstraZeneca deal, which provides a longer cash runway. While the discontinuation of new COM902 trials is a setback, the continued advancement of COM701 and the partnered rilvegostomig and GS-0321 programs, coupled with the robust AI/ML platform, indicate strategic progress despite inherent industry risks.

Positives

• Achieved a net profit of $35.3 million in 2025, a significant turnaround from previous losses.
• Secured a $65 million upfront payment from AstraZeneca in December 2025 by amending the rilvegostomig license agreement, while retaining the majority of tiered royalties and up to $195 million in future milestones.
• Maintained strong liquidity with $145.6 million in cash, cash equivalents, short-term bank deposits, and marketable securities as of December 31, 2025.
• Extended cash runway into 2029 based on current plans, without needing additional financing or licensing proceeds.
• GS-0321 (previously COM503) is advancing in a Phase 1 clinical trial, with Gilead providing zimberelimab for combination studies.
• Rilvegostomig, developed by AstraZeneca, is progressing in multiple Phase 1, Phase 2, and Phase 3 clinical trials, indicating significant partner commitment.
• Reported favorable safety and toxicity profiles and preliminary signals of antitumor activity for COM701 in Phase 1 clinical trials, supporting its evaluation in the MAIA-ovarian trial.
• The company's Unigen AI/ML platform has successfully identified multiple drug targets (PVRIG, TIGIT, IL-18BP, ILDR2) that have advanced to clinical trials.
• Successfully defended broad claims in a European patent relating to anti-PVRIG antibodies in an EPO opposition hearing in July 2023, and maintained an amended patent for screening anti-PVRIG antibodies in January 2025.

Negatives

• Incurred accumulated deficit of $453.4 million as of December 31, 2025, despite the 2025 net profit.
• Decision not to initiate new clinical trials with COM902 due to recent negative data in the TIGIT field from other companies (Arcus and Gilead), indicating limited near-term value potential for this program.
• Reliance on third parties for clinical trials and manufacturing introduces risks of delays, increased costs, or failure to meet deadlines and quality standards.
• The company has a limited operating history with respect to partnering and commercialization, with no products approved for commercialization to date.
• Financial and other income decreased by 21% in 2025 due to lower cash balances, lower interest rates, and lower yield on marketable securities.
• The company is exposed to exchange rate fluctuations between the U.S. dollar and the New Israeli Shekel, which can adversely affect operating results.
• The ongoing geopolitical instability in Israel and the Middle East poses risks to operations, including potential disruptions and employee military service obligations.

Risks

• History of losses and expectation to incur future losses, with no assurance of achieving or sustaining profitability.
• Need to raise additional funds in the future, with potential for dilution of existing shareholders if equity is sold, or operational curtailment if funds are unavailable.
• Business model's success in generating substantial revenues from collaborations is not assured, and termination of existing or future agreements could materially harm financial position.
• Dependence on collaboration agreements with third parties, who may not pursue planned activities, comply with obligations, or may terminate agreements for various reasons.
• High dependence on the success of COM701, COM902, GS-0321 (previously COM503), and rilvegostomig, with clinical trials facing inherent risks of failure in safety and/or efficacy.
• Clinical development is a lengthy, expensive, and uncertain process, with potential for substantial delays or inability to complete trials on expected timelines.
• Preliminary clinical data may change as more patient data become available, potentially altering interpretations and final results.
• Reliance on third parties to conduct clinical trials, who may not carry out duties successfully, comply with regulations, or meet deadlines, leading to delays and increased expenditures.
• Serious adverse events or lack of efficacy in clinical trials by other companies investigating the same targets (e.g., TIGIT) could adversely affect Compugen's development programs, patient enrollment, or partnering capabilities.
• Manufacturing risks, including product loss, contamination, degradation, equipment failure, or supply disruptions, could lead to additional costs or delays in commercialization.
• Inherent risks in developing and commercializing novel therapeutic products, including failure to discover additional targets, select appropriate indications/patient populations, or develop effective antibodies.
• Unigen AI/ML platform is not yet fully proven clinically, and may not consistently discover and develop commercially valuable product candidates, or may provide biased decisions or errors.
• Focus on immuno-oncology means failure of current candidates or shifts in industry interest could materially harm the business.
• Failure to establish and maintain effective internal control over financial reporting could lead to material misstatements or reporting failures.
• Requirement for companion or complementary diagnostics/biomarkers for clinical trials and marketing approval, with failure to develop or obtain regulatory clearance harming patient selection and clinical outcomes.
• Highly competitive and rapidly changing industry, with larger competitors having greater resources and expertise, potentially developing competing products more successfully.
• Information technology systems, or those of third parties, are vulnerable to failures or security breaches, leading to business disruption, regulatory actions, litigation, and reputational harm, especially given operations in Israel.
• Stringent and changing data privacy and security obligations, including new AI regulations, could lead to enforcement actions, litigation, and negatively affect operating results.
• If patent protection is not sufficiently broad or is lost, ability to prevent competitors from commercializing similar products would be adversely affected, as seen with ongoing EPO oppositions.
• Need to obtain additional licenses for third-party technology, which may not be available or only on commercially unreasonable terms.
• Risk of infringing third-party intellectual property rights, leading to litigation, damages, or inability to commercialize products.
• Lawsuits to protect or enforce patents or other intellectual property can be expensive, time-consuming, and unsuccessful.
• Increased scientific and technological progress may reduce chances of obtaining patents due to higher inventiveness bar and prior art.
• Claims for remuneration or royalties for assigned service invention rights by employees under Israeli law could result in litigation.
• Non-compliance with governmental patent agency requirements could reduce or eliminate patent protection.
• Reliance on trade secrets and proprietary know-how, which are difficult to protect and enforce against disclosure or misappropriation.
• Conditions in Israel and the Middle East, including armed conflicts and political instability, may adversely affect operations, employee availability, and financial markets.
• Adverse effects from exchange rate fluctuations between the U.S. dollar and the New Israeli Shekel, particularly on NIS-denominated expenses.
• Potential loss of Israeli tax benefits if conditions under the Investment Law are not met.
• Difficulty enforcing U.S. judgments against the company or its non-U.S. officers and directors in Israel.
• Shareholder activism could divert management attention, create uncertainty, and incur significant expenses.
• Unfavorable global political or economic conditions, including inflation, trade tensions, and conflicts, could adversely affect business.
• ESG matters and perceived failures in performance could adversely affect brand, reputation, and partnerships.
• Subject to U.S. and foreign import/export controls, trade sanctions, tariffs, anti-corruption, and anti-money laundering laws, with potential for criminal liability and business harm.
• Climate change or related legal/regulatory measures may increase costs or disrupt operations.

Future Outlook

Compugen expects to continue incurring net losses in the foreseeable future due to ongoing research, discovery, and development activities. The company believes its existing cash and equivalents are sufficient to fund operations into 2029, without considering additional funds from licensing or financings. Future success is dependent on discovering promising drug targets, advancing internal pipeline candidates, and securing revenue-sharing partnerships. The company will continue to focus on immuno-oncology, but acknowledges risks associated with industry shifts and competition. Interim analysis for the MAIA-ovarian trial is expected in Q1 2027.

Management Comments

• We believe that our existing cash and cash equivalents, short-term bank deposits and investment in marketable securities will be sufficient to fund our operations over the next 12 months.
• We believe we will meet longer-term expected future cash requirements into 2029 based on our current plans, without considering the possible receipt of any additional funds, such as proceeds from existing or additional licensing and/or collaborative agreements, or from financings.
• We believe that our future success will depend, in large part, on our ability to discover promising drug target candidates and therapeutic product candidates and to successfully advance the research and development of certain of our product candidates in our internal pipeline towards preclinical and clinical studies and to successfully develop these products or enter into revenue-sharing partnering agreements with pharmaceutical companies with respect to them at the various development stages and eventually the success of such products.
• We currently believe that COM902 has a limited potential to create near-term value to us and we therefore do not plan to initiate new clinical trials with COM902. This decision may be revisited pending further data disclosure regarding TIGIT by other companies.

Industry Context

StockSavvy.ai notes that Compugen operates in the highly competitive and rapidly evolving immuno-oncology and AI/ML drug discovery sectors. The global immune checkpoint inhibitors market is projected to grow significantly, from $58.53 billion in 2025 to $229.60 billion by 2034, indicating strong underlying market demand. However, the filing highlights increasing competition from large pharmaceutical companies, biotech firms, and academic institutions, many with greater resources. The recent failures in the TIGIT field, such as Arcus Biosciences and Gilead's Phase 3 STAR-221 study discontinuation, underscore the high-risk nature of drug development in this space and directly impacted Compugen's decision regarding COM902. The rise of new drug modalities like ADCs and T-cell engagers also intensifies competition, raising the bar for differentiation for traditional antibody therapies. The increasing interest and investment in AI/ML for drug discovery, with new companies and partnerships emerging (e.g., Cartography, Caris Life Sciences, InSilico Medicine), suggests that Compugen's Unigen platform faces growing competition in its core differentiator. The surge in China's biotech sector, with increased out-licensing deals and clinical trial activity, further heightens global competitive pressures.

Comparison to Industry Standards

• Compugen's net profit of $35.3 million in 2025 contrasts with the typical losses seen in early-stage biotech companies, indicating successful monetization of intellectual property through partnerships, particularly the AstraZeneca deal.
• The discontinuation of Arcus and Gilead's Phase 3 STAR-221 study for a domvanalimab-based combination in upper gastrointestinal cancers due to futility directly influenced Compugen's decision to halt new COM902 trials, reflecting a broader industry challenge in the TIGIT pathway.
• Rilvegostomig, a PD-1/TIGIT bispecific antibody derived from Compugen's COM902, is being evaluated by AstraZeneca in multiple Phase 3, Phase 2, and Phase 1 clinical trials. This advancement to Phase 3 by a major pharmaceutical partner like AstraZeneca is a significant validation, especially given the recent setbacks in the TIGIT field by competitors such as Roche (SKYSCRAPER06/07/03/14 failures) and Merck (Keyvibe-008/010/002 failures).
• The MAIA-ovarian trial for COM701 in relapsed platinum-sensitive ovarian cancer faces competition from studies like AbbVie's mirvetuximab + bevacizumab (GLORIOSA), Merck's sacituzumab tirumotecan (TroFuse-022/ENGOT-ov84/GOG-3103), and Genmab's Rina-S Plus Standard of Care (RAINFOL-04), highlighting the crowded nature of this indication.
• In the IL-18 pathway, GS-0321 (previously COM503) is less advanced than competitors like Simcha Therapeutics' ST-067 (DR-18) and Bright Peak Therapeutics' BPT-567, which are already in Phase 1/2 trials, and several IL-18 armored CAR-T therapies from institutions like the University of Pennsylvania and Memorial Sloan Kettering Cancer Center.
• The company's reliance on its Unigen AI/ML platform for target discovery is in line with a growing industry trend, but faces competition from other AI/ML-focused companies like Cartography, Caris Life Sciences, and InSilico Medicine, which are also securing deals in immuno-oncology target discovery.

Management Changes

Corporate Governance

Legal Proceedings

• Currently not a party to any legal or arbitration proceedings that management believes would have a significant effect on financial position or profitability.
• Facing an appeal before the board of appeal of the European Patent Office (EPO) regarding a granted European broad patent relating to anti-PVRIG antibodies, with an oral hearing planned for May 28, 2026.
• Successfully defended an opposition by GSK in January 2025, with the EPO opposition division upholding an amended patent relating to methods of screening for anti-PVRIG antibodies that inhibit PVRIG polypeptide with PVRL2 binding association; this decision is final.
• Successfully defended two other European oppositions by GSK and another party regarding anti-PVRIG antibodies competing with COM701, with the EPO opposition division upholding the patent in an amended form in December 2025; the opponent may appeal this decision.

Related Party Transactions

• Received research and development services related to cancer studies in animal models, and breeding and maintenance of animals (mice) from Ramot at Tel-Aviv University Ltd. for approximately $139,000 in 2025, $141,000 in 2024, and $147,000 in 2023. This transaction was at arm's length.

Stakeholder Impact

• **Shareholders:** Experienced dilution from past equity sales and may face further dilution from future capital raises. The net profit in 2025 and extended cash runway are positive for shareholder value, but the halt of new COM902 trials and ongoing TIGIT field challenges could impact future growth prospects. Geopolitical risks in Israel and market volatility could affect share price.
• **Employees:** The company's ability to hire and retain key scientific and management personnel is crucial, especially in a competitive industry and given the instability in Israel. Share-based compensation plans are in place to incentivize employees. Changes in management roles, including the CEO and Executive Chair, indicate strategic leadership adjustments.
• **Customers/Partners (AstraZeneca, Gilead):** The successful progression of partnered programs (rilvegostomig, GS-0321) and the upfront/milestone payments demonstrate value creation from collaborations. The decision on COM902 reflects responsiveness to clinical data, which could impact future partnership opportunities for similar targets.
• **Creditors:** The strong cash position and extended cash runway reduce immediate concerns about the company's ability to meet its obligations.
• **Regulatory Bodies:** The company is subject to extensive U.S., Israeli, and European regulations for drug development, manufacturing, and data privacy. Compliance with these regulations is critical to avoid penalties and ensure product approval.

Next Steps

• Interim analysis from the MAIA-ovarian trial for COM701 is expected in the first quarter of 2027.
• Continue to conduct the Phase 1 clinical trial for GS-0321 (previously COM503) as monotherapy and in combination with zimberelimab.
• Initiate transfer of development activities for GS-0321 to Gilead upon completion of the Phase 1 clinical trial.
• Monitor further data disclosure regarding TIGIT by other companies to potentially revisit the decision on COM902 clinical trials.
• AstraZeneca will continue to evaluate rilvegostomig in multiple Phase 3, Phase 2, and Phase 1 clinical trials.
• Potential receipt of up to $195 million in future regulatory and commercial milestones for rilvegostomig, including an additional $25 million upon the first acceptance of the Biologics License Application (BLA).
• Continue to identify novel drug targets and develop innovative therapeutics in immuno-oncology using the Unigen platform.
• Potentially seek additional capital through equity issuance or other financing arrangements as needed for future operations or strategic considerations.

Key Dates

Recommendation

Compugen's 2025 net profit and extended cash runway are significant positives, demonstrating successful monetization of its intellectual property through strategic partnerships like the AstraZeneca deal. The advancement of COM701 and the partnered rilvegostomig and GS-0321 programs provides a solid pipeline. However, the decision to halt new COM902 trials due to broader TIGIT field setbacks, coupled with the inherent high risks of clinical development, intense industry competition, and geopolitical instability in Israel, introduce considerable uncertainty. While the company has strong liquidity, its long-term profitability remains unproven, and future capital raises are anticipated. A 'hold' recommendation is appropriate as the positive financial performance and pipeline progress are balanced by significant development and market risks, suggesting investors should await further clinical data and sustained profitability before making more aggressive investment decisions.

Keywords

Immuno-oncology, Cancer immunotherapy, AI/ML drug discovery, Unigen platform, COM701, PVRIG antibody, Ovarian cancer, GS-0321, IL-18 binding protein, Gilead Sciences, Rilvegostomig, PD-1/TIGIT bispecific antibody, AstraZeneca, Clinical trials, Biotechnology, Pharmaceuticals, SEC filing, Financial results, Partnerships, Intellectual property, Israel Innovation Authority