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What changed in COMPUGEN LTD's 20-F — 2024 vs 2025

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Paragraph-level year-over-year comparison of COMPUGEN LTD's 2024 and 2025 20-F annual filings, covering the Business, Risk Factors, Legal Proceedings, Cybersecurity, MD&A and Market Risk sections. Every new, removed and edited paragraph is highlighted side-by-side so you can see exactly what management changed in the 2025 report.

+760 added−749 removedSource: 20-F (2026-03-02) vs 20-F (2025-03-04)

Top changes in COMPUGEN LTD's 2025 20-F

760 paragraphs added · 749 removed · 554 edited across 5 sections

Item 3. Legal Proceedings

Legal Proceedings — active lawsuits and investigations

268 edited+89 added−77 removed315 unchanged
Biggest changeIn this respect, as stated above, we are currently facing two outstanding European oppositions filed by GSK and another party, with respect to our European patent relating to anti-PVRIG antibodies competing with COM701; another opposition filed by GSK, in respect to our European patent relating to method of screening for inhibitors of the binding association of PVRIG polypeptide with PVRL2, in which the opposition division of the European Patent Office ruled in our favor and the claims of the patent were maintained in an amended form as specified above and one opposition filed by GSK and another party, with respect to our European patent relating to anti-PVRIG antibodies, in which we prevailed but is under appeal.
Biggest changeIn this respect, as stated above, we are currently facing an appeal before the boards of appeal of the EPO with respect to our granted European broad patent relating to anti-PVRIG antibodies.
If we are unable to maintain our existing agreements or to enter into additional agreements with such third parties, mainly collaborators, in the future, our business will likely be materially harmed. • We rely and expect to continue to rely on third parties to conduct our clinical trials.
If we are unable to maintain our existing agreements or to enter into additional agreements with such third parties, mainly collaborators, in the future, our business will likely be materially harmed. • We rely on and expect to continue to rely on third parties to conduct our clinical trials.
While we currently have two collaborations in effect, one with AstraZeneca and the second with Gilead, the termination of either or both existing or any future collaboration agreements may have varying impacts on our financial position and, specifically, our ability to generate revenue.
While we currently have two collaborations in effect, one with AstraZeneca and the second with Gilead, the termination of either or both existing collaborations or any future collaboration agreements may have varying impacts on our financial position and, specifically, our ability to generate revenue.
If we advance our programs throughout the different clinical development phases (where with respect to GS-0321 (previously COM503), we are only responsible for Phase 1 development), we will need to expand our personnel and operational capabilities to support these activities. We expect to need to raise additional capital in such event.
If we advance our programs throughout the different clinical development phases (where with respect to GS-0321 (previously COM503), we are only responsible for Phase 1 clinical development), we will need to expand our personnel and operational capabilities to support these activities. We expect to need to raise additional capital in such event.
Additionally, other pharmaceutical companies are already clinically investigating their own therapeutic candidates against PVRIG, the target of COM701, or against TIGIT, the target of COM902, and the IL-18 pathway, which GS-0321 (previously COM503) is targeting, which may hamper the enrollment of patients in our trials for COM701, COM902, or GS-0321 (previously COM503) and may present a higher bar for success.
Additionally, other pharmaceutical companies are already clinically investigating their own therapeutic candidates against PVRIG, the target of COM701, or against TIGIT, the target of COM902, and the IL-18 pathway, which GS-0321 (previously COM503) is targeting, which may hamper the enrollment of patients in our trials for COM701, or GS-0321 (previously COM503) and may present a higher bar for success.
If we are unable to identify such additional suitable parties or enter into new agreements on satisfactory terms, or at all, our business will likely be materially harmed. We rely and expect to continue to rely completely on third parties to manufacture and supply our preclinical and clinical drug supplies.
If we are unable to identify such additional suitable parties or enter into new agreements on satisfactory terms, or at all, our business will likely be materially harmed. We rely on and expect to continue to rely completely on third parties to manufacture and supply our preclinical and clinical drug supplies.
We rely and expect to continue to rely on contract manufacturing organizations, or CMOs, and other third-party contractors to manufacture formulations and produce larger scale amounts and/or commercial scale of drug substance and drug products required for any clinical trials that we initiate and other related services.
We rely on and expect to continue to rely on contract manufacturing organizations, or CMOs, and other third-party contractors to manufacture formulations and produce larger scale amounts and/or commercial scale of drug substance and drug products required for any clinical trials that we initiate and other related services.
Our objective under our current and any potential future collaboration agreements is that under these collaborations, we will have the right to receive various forms of revenues from such products or product candidates. To date, we have entered into four collaboration agreements with respect to our pipeline programs, only two of which are currently in effect.
Our objective under our current and any potential future collaborations is that under these collaborations, we will have the right to receive various forms of revenues from such products or product candidates. To date, we have entered into four collaboration agreements with respect to our pipeline programs, only two of which are currently in effect.
Our business is highly dependent upon the continued services of our senior management and key scientific and clinical personnel. While members of our senior management and other key personnel have entered into employment or consulting agreements and non-competition and non-disclosure agreements with us, they can terminate these employment agreements at any time without cause.
Our business is highly dependent upon the continued services of our senior management and key scientific and clinical personnel. While members of our senior management and other key personnel have entered into employment or consulting agreements and non-competition and non-disclosure agreements with us, they can terminate these agreements at any time without cause.
For example, the federal Health Insurance Portability and Accountability Act of 1996, or HIPAA, as amended by the Health Information Technology for Economic and Clinical Health Act, or HITECH, imposes specific requirements relating to the privacy, security, and transmission of individually identifiable health information.
For example, the federal Health Insurance Portability and Accountability Act of 1996, or HIPAA, as amended by the Health Information Technology for Economic and Clinical Health Act, or HITECH, imposes specific requirements relating to privacy, security, and transmission of individually identifiable health information.
Adopting and maintaining AI and ML technologies may increase operational costs due to computing demands and specialized expertise requirements, and even if we are successful in maintaining such technologies, our competitors or other third parties may incorporate AI and ML into their businesses more quickly or more successfully than us, which could impair our ability to compete effectively and adversely affect our results of operations.
Adopting and maintaining AI/ML technologies may increase operational costs due to computing demands and specialized expertise requirements, and even if we are successful in maintaining such technologies, our competitors or other third parties may incorporate AI/ML technologies into their businesses more quickly or more successfully than us, which could impair our ability to compete effectively and adversely affect our results of operations.
These risks, which typically result in very high failure rates even for successful biopharmaceutical companies, include, among others, the possibility that: • we will not be able to discover additional drug targets; • our novel target candidates will prove to be inappropriate for treatment of cancer; • our novel target candidates will prove to be inappropriate for therapeutic product candidates; • our novel target candidates will prove to be inappropriate for immunotherapy; • we will not succeed in selecting the appropriate tumor type, indication or patient population for the therapeutic product candidate; • we will not succeed in developing or choosing the appropriate monoclonal antibody, or mAb, for these targets, or the appropriate mAb isotype, or the appropriate therapeutic lead; • we will not succeed in identifying, validating or developing a biomarker or companion diagnostic for our therapeutic product candidates; • we will not succeed in choosing or developing the appropriate drug modality for these targets or we will not have the expertise to do so; • our therapeutic product candidates will fail to progress to preclinical studies or clinical trials; • our therapeutic product candidates will be found to be therapeutically ineffective; • we will not choose or have access to the right drug combination for our therapeutic product candidates; • we will not select or find the appropriate dosing regimen; • our therapeutic product candidates will be found to be toxic or to have other unacceptable side effects or negative consequences; • our therapeutic product candidates will be inferior, or not show added value, compared to competing products or the standard of care; • our products covered by our collaborations may face internal competition from our partners’ internal pipeline; • we or our collaborators will fail to receive required regulatory approvals; 13 • the discovery of drug targets and the discovery, development or commercialization of our therapeutic product candidates will infringe third-party intellectual property rights; • the development, marketing or sale of our therapeutic product candidates will fail because of our inability or failure to protect or maintain our own intellectual property rights; • once a product is commercially available, there will be little or no demand for it for a number of possible reasons, including lack of acceptance by the medical community or by patients, a very small patient population size, lack of or insufficient coverage and payment by third-party payors, inefficient or insufficient marketing and sales activities or as a result of there being more attractive, less risky or less expensive, products available for the same use; and • the product will be withdrawn from the market, or sales limited due to side effects observed in clinical practice.
These risks, which typically result in very high failure rates even for successful biopharmaceutical companies, include, among others, the possibility that: • we will not be able to discover additional drug targets; • our novel target candidates will prove to be inappropriate for treatment of cancer; • our novel target candidates will prove to be inappropriate for therapeutic product candidates; • our novel target candidates will prove to be inappropriate for immunotherapy; • we will not succeed in selecting the appropriate tumor type, indication or patient population for the therapeutic product candidate; • we will not succeed in developing or choosing the appropriate monoclonal antibody, or mAb, for these targets, or the appropriate mAb isotype, or the appropriate therapeutic lead; • we will not succeed in identifying, validating or developing a biomarker or companion diagnostic for our therapeutic product candidates; • we will not succeed in choosing or developing the appropriate drug modality for these targets or we will not have the expertise to do so; • our therapeutic product candidates will fail to progress to preclinical studies or clinical trials; • our therapeutic product candidates will be found to be therapeutically ineffective; • we will not choose or have access to the right drug combination for our therapeutic product candidates; • we will not select or find the appropriate dosing regimen; • our therapeutic product candidates will be found to be toxic or to have other unacceptable side effects or negative consequences; • our therapeutic product candidates will be inferior, or not show added value, compared to competing products or the standard of care; • our products covered by our collaborations may face internal competition from our partners’ internal pipeline; • we or our collaborators will fail to receive required regulatory approvals; • the discovery of drug targets and the discovery, development or commercialization of our therapeutic product candidates will infringe third-party intellectual property rights; • the development, marketing or sale of our therapeutic product candidates will fail because of our inability or failure to protect or maintain our own intellectual property rights; • once a product is commercially available, there will be little or no demand for it for a number of possible reasons, including lack of acceptance by the medical community or by patients, a very small patient population size, lack of or insufficient coverage and payment by third-party payors, inefficient or insufficient marketing and sales activities or as a result of there being more attractive, less risky or less expensive, products available for the same use; and • the product will be withdrawn from the market, or sales limited due to side effects observed in clinical practice.
Many of our competitors have one or more of the following: • much greater financial, technical and human resources than we have at every stage of the discovery, development, manufacture and commercialization process; • more extensive experience in computational discovery, preclinical testing, conducting clinical trials, obtaining regulatory approvals, and in manufacturing and marketing therapeutics; • more extensive experience in oncology and immuno-oncology and in the fields of therapeutic antibodies; • accessibility to enhanced technologies that may result in better products; • access to and experience in the development of therapeutic modalities that are competitive to mAb therapeutics; • more extensive experience in oncology and immuno-oncology and in the field of target discovery; • more extensive experience in the research and development of biological or genetic markers to determine response of or responders to therapeutic agents or for patient selection; • greater accessibility to data and proprietary data from patients; • access to internally developed, proprietary technologies for the discovery, research, development, or manufacturing of therapeutic agents; • greater resources and means to compete with us on target discovery and as well as in acquiring or generating technologies complementary to, or necessary for, our programs as well as in recruiting and retaining qualified scientific and management personnel and establishing clinical trial sites; • products that have been approved or are in late stages of development and in many cases, PD-1 or PDL-1 inhibitors that are serving or will be serving as the backbone of cancer immunotherapy; • reduced reliance on collaborations or partnerships with third parties in order to further develop and commercialize competitive therapeutic products; and • collaborative arrangements in our target markets with leading companies and research institutions.
Many of our competitors have one or more of the following: • much greater financial, technical and human resources than we have at every stage of the discovery, development, manufacture and commercialization process; • more extensive experience in computational discovery, preclinical testing, conducting clinical trials, obtaining regulatory approvals, and in manufacturing and marketing therapeutics; • more extensive experience in oncology and immuno-oncology and in the fields of therapeutic antibodies; • accessibility to enhanced technologies that may result in better products; • access to and experience in the development of therapeutic modalities that are competitive to mAb therapeutics; • more extensive experience in oncology and immuno-oncology and in the field of target discovery; • more extensive experience in the research and development of biological or genetic markers to determine response of or responders to therapeutic agents or for patient selection; • greater accessibility to data and proprietary data from patients; • access to internally developed, proprietary technologies for the discovery, research, development, or manufacturing of therapeutic agents; • greater resources and means to compete with us on target discovery and as well as in acquiring or generating technologies complementary to, or necessary for, our programs as well as in recruiting and retaining qualified scientific and management personnel and establishing clinical trial sites; 23 • products that have been approved or are in late stages of development and in many cases, PD-1 or PDL-1 inhibitors that are serving or will be serving as the backbone of cancer immunotherapy; • reduced reliance on collaborations or partnerships with third parties in order to further develop and commercialize competitive therapeutic products; and • collaborative arrangements in our target markets with leading companies and research institutions.
Moreover, if we, or any collaborators, are required to conduct additional clinical trials or repeat clinical trials or other testing of our product candidates beyond the trials and testing that we or they contemplate, if we, or they, are unable to successfully complete clinical trials of our product candidates or other testing, or the results of these trials or tests are unfavorable, uncertain or are only modestly favorable, or there are unacceptable safety concerns associated with our product candidates, we, or any collaborators, may, among others: • cease the development of the product candidates; • incur additional unplanned costs; • terminate or amend the respective collaboration, if applicable; 8 • not obtain approval to proceed to next development phase; • be delayed in obtaining marketing approval for our product candidates; • not obtain marketing approval at all; • obtain approval for indications or patient populations that are not as broad as intended or desired; • obtain approval with labeling that includes significant use or distribution restrictions or significant safety warnings, including boxed warnings; • be subject to additional post-marketing testing or other requirements; or • be required to remove the product from the market after obtaining marketing approval.
Moreover, if we, or any collaborators, are required to conduct additional clinical trials or repeat clinical trials or other testing of our product candidates beyond the trials and testing that we or they contemplate, or if we, or they, are unable to successfully complete clinical trials of our product candidates or other testing, or the results of these trials or tests are unfavorable, uncertain or are only modestly favorable, or there are unacceptable safety concerns associated with our product candidates, we, or any collaborators, may, among others: • cease the development of the product candidates; • incur additional unplanned costs; • terminate or amend the respective collaboration, if applicable; • not obtain approval to proceed to next development phase; • be delayed in obtaining marketing approval for our product candidates; • not obtain marketing approval at all; • obtain approval for indications or patient populations that are not as broad as intended or desired; • obtain approval with labeling that includes significant use or distribution restrictions or significant safety warnings, including boxed warnings; • be subject to additional post-marketing testing or other requirements; or • be required to remove the product from the market after obtaining marketing approval.
In order to raise additional capital, we may at any time offer additional ordinary shares or other securities convertible into or exchangeable for our ordinary shares, through our “at the market offering” (ATM) facility pursuant to a sales agreement entered with Leerink Partners, or Leerink, on January 31, 2023 or other manners, at prices that may not be the same as the price paid for our ordinary shares by our shareholders.
In order to raise additional capital, we may at any time offer additional ordinary shares or other securities convertible into or exchangeable for our ordinary shares, through our “at the market offering” (ATM) facility pursuant to a sales agreement entered with Leerink Partners LLC, or Leerink, on January 31, 2023 or other manners, at prices that may not be the same as the price paid for our ordinary shares by our shareholders.
Such misconduct or negligence could result in unauthorized access, misuse, or disclosure of sensitive information, leading to regulatory penalties, lawsuits, and reputational harm. Despite our efforts to implement preventive measures, we cannot guarantee full compliance at all times, which could adversely impact our business operations. 28 We maintain privacy policies and other statements regarding data privacy and security.
Such misconduct or negligence could result in unauthorized access, misuse, or disclosure of sensitive information, leading to regulatory penalties, lawsuits, and reputational harm. Despite our efforts to implement preventive measures, we cannot guarantee full compliance at all times, which could adversely impact our business operations. We maintain privacy policies and other statements regarding data privacy and security.
Related sanctions, export controls or other actions have been or may in the future be initiated by nations including the United States, the European Union or Russia (e.g., potential cyberattacks, disruption of energy flows, etc.), which could adversely affect our business and/or our supply chain, our CROs, CMOs and other third parties with whom we conduct business.
Related sanctions, export controls or other actions have been or may in the future be initiated by nations including the United States, the European Union, China or Russia (e.g., potential cyberattacks, disruption of energy flows, etc.), which could adversely affect our business and/or our supply chain, our CROs, CMOs and other third parties with whom we conduct business.
Such procedures are lengthy, expensive and time consuming, and may have an adverse effect on us. 34 We may not be able to prevent, alone or with our licensees or any future licensees, infringement, misappropriation or other violations of our intellectual property rights, particularly in countries where the laws may not protect those rights as fully as in the United States.
Such procedures are lengthy, expensive and time consuming, and may have an adverse effect on us. We may not be able to prevent, alone or with our licensees or any future licensees, infringement, misappropriation or other violations of our intellectual property rights, particularly in countries where the laws may not protect those rights as fully as in the United States.
Higher costs for goods and services, inflation, deflation, trade tensions, global geopolitical tensions, the imposition of tariffs or other measures that create barriers to or increase the costs associated with international trade, overall economic slowdown or recession and other economic factors in Israel, the United States or in any other markets in which we operate could adversely affect our operations and operating results.
Higher costs for goods and services, inflation, deflation, trade tensions, global geopolitical tensions, the imposition of tariffs or other measures that create barriers to or increase the costs associated with international trade, overall economic slowdown or recession and other economic factors affecting Israel, the United States or any other markets in which we operate could adversely affect our operations and operating results.
If any of these risks should materialize, our business, financial condition and results of operations may be materially harmed. 17 Our existing partnership agreement with AstraZeneca is subject to many risks. In March 2018, we entered into an exclusive license agreement with MedImmune Limited, the global biologics research and development arm of AstraZeneca, which is currently part of AstraZeneca.
If any of these risks should materialize, our business, financial condition and results of operations may be materially harmed. Our existing partnership agreement with AstraZeneca is subject to many risks. In March 2018, we entered into an exclusive license agreement with MedImmune Limited, the global biologics research and development arm of AstraZeneca, which is currently part of AstraZeneca.
This contrasts with some the positive clinical results reported for other drug modalities, specifically ADCs. These third parties also compete with us in recruiting and retaining qualified scientific, drug development and management personnel and advisors, establishing clinical trial sites and patient enrollment for clinical trials, as well as in acquiring technologies complementary to, or necessary for, our programs.
This contrasts with some of the positive clinical results reported for other drug modalities, specifically ADCs. These third parties also compete with us in recruiting and retaining qualified scientific, drug development and management personnel and advisors, establishing clinical trial sites and patient enrollment for clinical trials, as well as in acquiring technologies complementary to, or necessary for, our programs.
For example, many U.S. federal and state and foreign government bodies and agencies have introduced and/or are currently considering additional laws and regulations governing the use of AI technologies. Any such changes could require us to expend significant resources to modify our products, services, or operations to ensure compliance or remain competitive.
For example, many U.S. federal and state and foreign government bodies and agencies have introduced and/or are currently considering additional laws and regulations governing the use of AI/ML technologies. Any such changes could require us to expend significant resources to modify our products, services, or operations to ensure compliance or remain competitive.
To date, we have not actually received any such tax benefits because we have not yet generated any taxable income. 39 It may be difficult to enforce certain U.S. judgments against us, or our officers and directors or to assert U.S. Securities law claims in Israel. We are incorporated under the laws of the State of Israel.
To date, we have not actually received any such tax benefits because we have not yet generated any taxable income. It may be difficult to enforce certain U.S. judgments against us, or our officers and directors or to assert U.S. Securities law claims in Israel. We are incorporated under the laws of the State of Israel.
Even if we are successful in defending against such claims, litigation could result in substantial costs and be a distraction to management and other employees. 36 Patent terms may be inadequate to protect our competitive position on our product candidates for an adequate amount of time. Patents have a limited lifespan.
Even if we are successful in defending against such claims, litigation could result in substantial costs and be a distraction to management and other employees. Patent terms may be inadequate to protect our competitive position on our product candidates for an adequate amount of time. Patents have a limited lifespan.
An adverse outcome in a litigation or proceeding involving our patents could limit our ability to assert our patents against those parties or other competitors and may curtail or preclude our ability to exclude third parties from making and selling similar or competitive products. Any of these occurrences could adversely affect our competitive business position, business prospects and financial condition.
An adverse outcome in litigation or proceeding involving our patents could limit our ability to assert our patents against those parties or other competitors and may curtail or preclude our ability to exclude third parties from making and selling similar or competitive products. Any of these occurrences could adversely affect our competitive business position, business prospects and financial condition.
If our defenses to these claims fail, in addition to requiring us to pay monetary damages, a court could deprive our rights in such technologies or features that are essential to our investigational products, if such technologies or features are found to incorporate or be derived from the proprietary information of third parties and prohibit us from using them.
If our defenses against these claims fail, in addition to requiring us to pay monetary damages, a court could deprive our rights in such technologies or features that are essential to our investigational products, if such technologies or features are found to incorporate or be derived from the proprietary information of third parties and prohibit us from using them.
In addition, supply-chain attacks have increased in frequency and severity, and we cannot guarantee that third parties’ infrastructure in our supply chain or the third parties’ upon whom we rely supply chains have not been or will not be compromised. It may be difficult or costly to detect, investigate, mitigate, contain, and remediate a security incident.
In addition, supply-chain attacks have increased in frequency and severity, and we cannot guarantee that third parties’ infrastructure in our supply chain or the third parties’ upon whom we rely supply chains have not been or will not be compromised. 27 It may be difficult or costly to detect, investigate, mitigate, contain, and remediate a security incident.
In addition, because we do not intend to declare cash dividends on our ordinary shares in the foreseeable future, if our shareholders want to receive funds in respect of our ordinary shares, they must sell their ordinary shares to do so. Our ordinary shares are traded on more than one market and this may result in price variations.
In addition, because we do not intend to declare cash dividends on our ordinary shares in the foreseeable future, if our shareholders want to receive funds in respect of our ordinary shares, they must sell their ordinary shares to do so. 46 Our ordinary shares are traded in more than one market and this may result in price variations.
Patients are unlikely to use our products unless reimbursement is adequate to cover all or a significant portion of the cost of our products. 24 Coverage and reimbursement policies for products can differ significantly from payor to payor as there is no uniform policy of coverage and reimbursement for products among third-party payors in the United States.
Patients are unlikely to use our products unless reimbursement is adequate to cover all or a significant portion of the cost of our products. Coverage and reimbursement policies for products can differ significantly from payor to payor as there is no uniform policy of coverage and reimbursement for products among third-party payors in the United States.
In addition, we may be subject to significant civil, criminal and administrative penalties, damages, fines, disgorgement or imprisonment. 12 We may require companion or complementary diagnostics and/or biomarkers for our clinical trials, or a portion of our clinical trials, and may be required to have such in order to obtain marketing approval or commercialization of our therapeutic programs.
In addition, we may be subject to significant civil, criminal and administrative penalties, damages, fines, disgorgement or imprisonment. We may require companion or complementary diagnostics and/or biomarkers for our clinical trials, or a portion of our clinical trials, and may be required to have such in order to obtain marketing approval or commercialization of our therapeutic programs.
If one or more of these risks or any similar risks should materialize, our business, financial condition and results of operations may be materially harmed. Our computational target discovery activities are primarily focused on the discovery of novel drug target candidates and our therapeutic pipeline is based on our discovered targets.
If one or more of these risks or any similar risks should materialize, our business, financial condition and results of operations may be materially harmed. 15 Our computational drug target discovery activities are primarily focused on the discovery of novel drug target candidates and our therapeutic pipeline is based on our discovered targets.
Our amended and restated Articles of Association provide that unless we consent to an alternative forum, the federal district courts of the United States of America shall be the exclusive forum of resolution of any claims arising under the Securities Act which may impose additional litigation costs on our shareholders.
Our amended and restated Articles of Association provide that unless we consent to an alternative forum, the federal district courts of the United States shall be the exclusive forum of resolution of any claims arising under the Securities Act which may impose additional litigation costs on our shareholders.
Nevertheless, we are responsible for ensuring that each of the clinical trials we pursue is conducted in accordance with the applicable protocol, legal and regulatory requirements and scientific standards, and our reliance on these third parties, including our CROs, will not relieve us of our regulatory responsibilities.
Nevertheless, we are responsible for ensuring that each of the clinical trials we pursue is conducted in accordance with the applicable protocol, legal and regulatory requirements and scientific standards, and our reliance on these third parties, including our CROs, will not relieve us of our regulatory and sponsor responsibilities.
There can be no assurance that we will complete enrollment or have data from the trials when we anticipate or at all or that our data will support the further development of our potential product candidates. We may experience difficulties in patient enrollment in our clinical trials for a variety of reasons.
There can be no assurance that we will complete enrollment or have data from the trial when we anticipate or at all or that our data will support the further development of our potential product candidates. We may experience difficulties in patient enrollment in our clinical trials for a variety of reasons.
If we are unable to compete successfully against existing or potential competitors, our financial results and business may be materially harmed. 23 Healthcare policy is volatile and changes in healthcare policy could increase our expenses, decrease our revenues and impact sales of, and reimbursement for, our products.
If we are unable to compete successfully against existing or potential competitors, our financial results and business may be materially harmed. Healthcare policy is volatile and changes in healthcare policy could increase our expenses, decrease our revenues and impact sales of, and reimbursement for, our products.
Due to inaccuracies or flaws in the inputs, outputs, or logic of the AI/ML, the model could be biased and could lead us to make decisions that could bias certain individuals (or classes of individuals), and adversely impact their rights, employment, and ability to obtain certain pricing, products, services, or benefits.
Due to inaccuracies or flaws in the inputs, outputs, or logic of the AI/ML technologies, the model could be biased and could lead us to make decisions that could bias certain individuals (or classes of individuals), and adversely impact their rights, employment, and ability to obtain certain pricing, products, services, or benefits.
Even if we ultimately prevail in such claims, the monetary cost of such litigation and the diversion of the attention of our management and scientific personnel could outweigh any benefit we receive as a result of the proceedings. Increased progress in our scientific and technological environment may reduce our chances of obtaining a patent.
Even if we ultimately prevail in such claims, the monetary cost of such litigation and the diversion of the attention of our management and scientific personnel could outweigh any benefit we receive as a result of the proceedings. 36 Increased progress in our scientific and technological environment may reduce our chances of obtaining a patent.
Events that may prevent successful or timely commencement and completion of clinical development include: • inability to generate sufficient preclinical, toxicology, or other data to support the initiation of clinical trials; • lack of authorization from regulators or institutional review boards, or IRBs, or ethics committees to allow us or our investigators to amend a clinical trial or commence a clinical trial or conduct a clinical trial at a prospective trial site or continue such clinical trial; 9 • delays in sufficiently developing, characterizing, or controlling a manufacturing process suitable for clinical trials; • inability to generate sufficient quantities or quality of our drug substance or drug product to support the initiation or continuation of clinical trials; • delays in reaching a consensus with collaborators or regulatory agencies on trial design or trial amendment; • delays in reaching agreement on acceptable terms with prospective CROs, and clinical trial sites, the terms of which can be subject to extensive negotiation and may vary significantly among different CROs and clinical trial sites; • significantly increased spendings required by our CROs as compared to our forecasts/projected spendings; • imposition of a temporary or permanent clinical hold by the FDA, or a similar delay imposed by foreign regulatory agencies for a number of reasons, including after review of an IND, other application or amendment; (i) as a result of a new safety finding that presents unreasonable risk to clinical trial participants; (ii) a negative finding from an inspection of our clinical trial operations or trial sites; (iii) developments on trials conducted by competitors for related technology that raises FDA concerns about risk to patients of the technology broadly; or (iv) if FDA finds that the investigational protocol or plan is clearly deficient to meet its stated objectives; • failure of clinical trials of any product candidates to show safety or efficacy, which may result in additional preclinical studies or clinical trials or abandonment of product candidates development programs; • difficulty collaborating with patient groups and investigators; • failure by our CROs, other third parties, or us to adhere to clinical trial and related regulatory requirements; • failure to perform in accordance with the FDA’s Good Clinical Practice, or GCP, requirements, or similar applicable regulatory guidelines in other countries; • failure to perform in accordance with the FDA’s Good Manufacturing Practice, or GMP, requirements, or similar applicable regulatory guidelines in other countries; • the number of patients required for clinical trials of any product candidates may be larger than we anticipate or can financially support, enrollment in these clinical trials may be slower than we anticipate, or participants may drop out of these clinical trials or fail to return for post-treatment follow-up at a higher rate than we anticipate; • delays in having patients complete their participation in a trial or return for post-treatment follow-up; • occurrence of adverse events associated with the product candidate that are viewed to outweigh its potential benefits; • changes in regulatory requirements and guidance that require amending or submitting new clinical protocols; • changes in the standard of care or in the regulatory landscape on which a clinical development plan was based, which may require new or additional trials; • the cost of clinical trials of our product candidates being greater than we anticipate; • clinical trials of our product candidates producing negative or inconclusive results, or early results that will not be repeated in larger or future cohorts or randomized studies, which may result in our decision, or regulators requiring us, to conduct additional clinical trials or abandon product development programs; • choosing the wrong dosing regimen and/or wrong drug combination and/or wrong patient population; • delays or failure to secure supply agreements with suitable reagent suppliers, or any failures by suppliers to meet our quantity or quality requirements for necessary reagents; and • delays in manufacturing, testing, releasing, validating, or importing/exporting sufficient stable quantities of our product candidates for use in clinical trials or the inability to do any of the foregoing.
Events that may prevent successful or timely commencement and completion of clinical development include: • inability to generate sufficient preclinical, toxicology, or other data to support the initiation of clinical trials; • lack of authorization from regulators or institutional review boards, or IRBs, or ethics committees to allow us or our investigators to amend a clinical trial or commence a clinical trial or conduct a clinical trial at a prospective trial site or continue such clinical trial; • delays in sufficiently developing, characterizing, or controlling a manufacturing process suitable for clinical trials; • inability to generate sufficient quantities or quality of our drug substance or drug product to support the initiation or continuation of clinical trials; • delays in reaching a consensus with collaborators or regulatory agencies on trial design or trial amendment; • delays in reaching agreement on acceptable terms with prospective CROs, and clinical trial sites, the terms of which can be subject to extensive negotiation and may vary significantly among different CROs and clinical trial sites; • significantly increased spendings required by our CROs as compared to our forecasts/projected spendings; 11 • imposition of a temporary or permanent clinical hold by the FDA, or a similar delay imposed by foreign regulatory agencies for a number of reasons, including after review of an IND, other application or amendment; (i) as a result of a new safety finding that presents unreasonable risk to clinical trial participants; (ii) a negative finding from an inspection of our clinical trial operations or trial sites; (iii) developments on trials conducted by competitors for related technology that raises FDA concerns about risk to patients of the technology broadly; or (iv) if FDA finds that the investigational protocol or plan is clearly deficient to meet its stated objectives; • failure of clinical trials of any product candidates to show safety or efficacy, which may result in additional preclinical studies or clinical trials or abandonment of product candidates development programs; • difficulty collaborating with patient groups and investigators; • failure by our CROs, other third parties, or us to adhere to clinical trial and related regulatory requirements; • failure to perform in accordance with the FDA’s Good Clinical Practice, or GCP, requirements, or similar applicable regulatory guidelines in other countries; • failure to perform in accordance with the FDA’s Good Manufacturing Practice, or GMP, requirements, or similar applicable regulatory guidelines in other countries; • the number of patients required for clinical trials of any product candidates may be larger than we anticipate or can financially support, site activation or enrollment in these clinical trials may be more time consuming than we anticipate, or participants may drop out of these clinical trials or fail to return for post-treatment follow-up at a higher rate than we anticipate; • delays in having patients complete their participation in a trial or return for post-treatment follow-up; • occurrence of adverse events associated with the product candidate that are viewed to outweigh its potential benefits; • changes in regulatory requirements and guidance that require amending or submitting new clinical protocols; • changes in the standard of care or in the regulatory landscape on which a clinical development plan was based, which may require new or additional trials; • the cost of clinical trials of our product candidates being greater than we anticipate; • clinical trials of our product candidates producing negative or inconclusive results, or early results that will not be repeated in larger or future cohorts or randomized studies, which may result in our decision, or regulators requiring us, to conduct additional clinical trials or abandon product development programs; • choosing the wrong dosing regimen and/or wrong drug combination and/or wrong patient population; • delays or failure to secure supply agreements with suitable reagent suppliers, or any failures by suppliers to meet our quantity or quality requirements for necessary reagents; and • delays in manufacturing, testing, releasing, validating, or importing/exporting sufficient stable quantities of our product candidates for use in clinical trials or the inability to do any of the foregoing.
The risks that we face in connection with our existing collaborations and other business alliances as well as those that we may enter into in the future include, among others, the following: • we may be unable to reach mutually agreeable terms and conditions with respect to potential new collaborations; • we or our current and/or future collaborators may be unable to comply or fully comply with the obligations under collaboration agreements to which we are (or will become) a party, and as a result, we may not generate milestone payments or royalties from such agreements, and our ability to enter into additional agreements may be harmed; • our obligations under existing or future collaboration agreements may harm our ability to enter into additional collaboration agreements; • collaborators generally have significant discretion in electing whether to pursue any of the planned activities and the manner in which it will be done, including the amount and nature of the resources to be devoted to the development and commercialization of our product candidates; • collaborators generally have significant discretion in terminating the collaborations or exercise different rights for scientific, clinical, financial, business or other reasons; • if our current and/or future collaborators breach or terminate an agreement with us, the development and commercialization of our therapeutic product candidates could be adversely affected because at such time we may not have sufficient financial or other resources or capabilities or access to the other partner’s data and drug(s) to successfully develop and commercialize these therapeutics on our own or find other partners or enforce our rights under breached or terminated agreement; • our current and/or future collaborators may require us changing or adopting the trial design to fit their business priorities, standards and other objectives; • changes in a collaborator’s business strategy may negatively affect its willingness or ability to complete its obligations under its arrangement or to continue with its collaboration with us; • our current and/or future collaborators may terminate the program or the agreement and then compete against us in the development or commercialization of similar therapeutics; • disagreements between us and our current and/or future collaborators may lead to delays in, or termination of, the collaboration; • our current and/or future collaborations may face internal competition by their internal pipelines; • prospective collaborators may hesitate to pursue collaborations on novel target candidates that lack robust validation to serve as a basis for the development of therapeutics; and • our current and/or future collaborators may be acquired by, acquire, or merge with, another company, and the resulting entity may have different priorities or competitive products to the collaboration product being developed previously by these collaborators.
The risks that we face in connection with our existing collaborations and other business alliances as well as those that we may enter into in the future include, among others, the following: • we may be unable to reach mutually agreeable terms and conditions with respect to potential new collaborations; 4 • we or our current and/or future collaborators may be unable to comply or fully comply with the obligations under collaboration agreements to which we are (or will become) a party, and as a result, we may not generate milestone payments or royalties from such agreements, and our ability to enter into additional agreements may be harmed; • our obligations under existing or future collaboration agreements may harm our ability to enter into additional collaboration agreements; • collaborators generally have significant discretion in electing whether to pursue any of the planned activities and the manner in which it will be done, including the amount and nature of the resources to be devoted to the development and commercialization of our product candidates; • collaborators generally have significant discretion in terminating the collaborations or exercise different rights for scientific, clinical, financial, business or other reasons; • if our current and/or future collaborators breach or terminate an agreement with us, the development and commercialization of our therapeutic product candidates could be adversely affected because at such time we may not have sufficient financial or other resources or capabilities or access to the other partner’s data and drug(s) to successfully develop and commercialize these therapeutics on our own or find other partners or enforce our rights under breached or terminated agreement; • our current and/or future collaborators may require us to change or adopt the trial design to fit their business priorities, standards and other objectives; • changes in a collaborator’s business strategy may negatively affect its willingness or ability to complete its obligations under its arrangement or to continue with its collaboration with us; • our current and/or future collaborators may terminate the program or the agreement and then compete against us in the development or commercialization of similar therapeutics; • disagreements between us and our current and/or future collaborators may lead to delays in, or termination of, the collaboration; • our current and/or future collaborations may face internal competition by their internal pipelines; • prospective collaborators may hesitate to pursue collaborations on novel target candidates that lack robust validation to serve as a basis for the development of therapeutics; and • our current and/or future collaborators may be acquired by, acquire, or merge with, another company, and the resulting entity may have different priorities or competitive products to the collaboration product being developed previously by these collaborators.
Any delays in our preclinical or clinical development programs may harm our business, financial condition and prospects significantly. 10 From time to time, we publicly disclose preliminary data from our ongoing clinical trials. As more patient data become available, the data and the interpretation of the data may change.
Any delays in our preclinical or clinical development programs may harm our business, financial condition and prospects significantly. From time to time, we publicly disclose preliminary data from our ongoing clinical trials. As more patient data become available, the data and the interpretation of the data may change.
This interest may be seen in the increase in the number of companies within the pharmaceutical and biotech industries which focus on this area, including by way of establishing internal AI and/or ML capabilities or receiving investments or entering into partnerships or acquisitions in furtherance thereof.
This interest may be seen in the increase in the number of companies within the pharmaceutical and biotech industries which focus on this area, including by establishing internal AI and/or ML capabilities or receiving investments or entering into partnerships or acquisitions in furtherance thereof.
We may not be entitled to certain Israeli tax benefits. In the future, we may be entitled to benefit from certain Israeli government programs and enjoy certain tax benefits resulting from the ‘Preferred Enterprise’ status, or Preferred Enterprise, we are entitled to under the Israel Law for Encouragement of Capital Investments, 1959, or the Investment Law.
In the future, we may be entitled to benefit from certain Israeli government programs and enjoy certain tax benefits resulting from the ‘Preferred Enterprise’ status, or Preferred Enterprise, we are entitled to under the Israel Law for Encouragement of Capital Investments, 1959, or the Investment Law.
Any such delisting could adversely affect our ability to obtain financing for the continuation of our operations and could result in the loss of confidence of investors, collaborators and employees. Future sales of our ordinary shares or securities convertible or exchangeable for our ordinary shares may depress our share price.
Any such delisting could adversely affect our ability to obtain financing for the continuation of our operations and could result in the loss of confidence of investors, collaborators and employees. 44 Future sales of our ordinary shares or securities convertible or exchangeable for our ordinary shares may depress our share price.
For example, the Federal Trade Commission has required other companies to turn over (or disgorge) valuable insights or trainings generated through the use of AI/ML where they allege the company has violated privacy and consumer protection laws.
For example, the Federal Trade Commission has required other companies to turn over (or disgorge) valuable insights or trainings generated through the use of AI/ML technologies where they allege the company has violated privacy and consumer protection laws.
If we cannot use AI/ML or that use is restricted, our business may be less efficient, or we may be at a competitive disadvantage. Additionally, the complexity and opacity of AI algorithms can lead to unintended consequences or outcomes.
If we cannot use AI/ML technologies or that use is restricted, our business may be less efficient, or we may be at a competitive disadvantage. Additionally, the complexity and opacity of AI/ML algorithms can lead to unintended consequences or outcomes.
Although we have built AI/ML powered predictive computational discovery platform, recently branded as Unigen™, that we believe is required to scientifically validate our novel drug targets and to later translate them into therapeutic antibody development programs, we cannot be assured that our investment in such novel discoveries will result in validated drug targets that will enable the development of effective cancer immunotherapies, nor that we will realize success in product development or our ability to partner and commercialize such opportunities and generate revenues.
Although we have built AI/ML powered computational discovery platform, branded as Unigen, that we believe is required to scientifically validate our novel drug targets and to later translate them into therapeutic antibody development programs, we cannot be assured that our investment in such novel discoveries will result in validated drug targets that will enable the development of effective cancer immunotherapies, nor that we will realize success in product development or our ability to partner and commercialize such opportunities and generate revenues.
Failure or perceived failure by us or the third parties upon whom we rely to comply with U.S. and foreign data privacy or security obligations could result in government enforcement actions (which could include civil or criminal penalties), private litigation or mass arbitration demands, bans on processing personal data, additional reporting requirements or oversight, orders to destroy or not use personal data, and/or adverse publicity and could negatively affect our operating results and business.
Failure or perceived failure by us or the third parties upon whom we rely to comply with U.S., European, Israel and foreign data privacy or security obligations could result in government enforcement actions (which could include civil or criminal penalties), private litigation or mass arbitration demands, bans on processing personal data, additional reporting requirements or oversight, orders to destroy or not use personal data, and/or adverse publicity and could negatively affect our operating results and business.
This may happen if the inputs that the model relied on were inaccurate, incomplete or flawed (including if a bad actor “poisons” the AI/ML with bad inputs or logic), or if the logic of the AI/ML is flawed (a so-called “hallucination”).
This may happen if the inputs that the model relied on were inaccurate, incomplete or flawed (including if a bad actor “poisons” the AI/ML technologies with bad inputs or logic), or if the logic of the AI/ML technologies is flawed (a so-called “hallucination”).
In general, each potential license agreement or other form of collaboration we may enter into will require negotiating with our potential collaborator, a large number of scientific, legal and business terms and conditions that can vary significantly in each instance due to the specific drug target or therapeutic product candidate or candidates involved, the potential market opportunity, the potential collaborator’s licensing, development and business operations and strategy, and competition in the partnering and business development space.
In general, each potential license agreement or other form of collaboration we may enter into will require negotiating with our potential collaborator, a large number of scientific, legal and business terms and conditions that can vary significantly in each instance due to the specific drug target or therapeutic product candidate or candidates involved, the program stage, the potential market opportunity, the potential collaborator’s licensing, development and business operations and strategy, and competition in the partnering and business development space.
Any person or entity purchasing or otherwise acquiring any interest in our share capital shall be deemed to have notice of and to have consented to the choice of forum provisions of our Articles described above.
Any person or entity purchasing or otherwise acquiring any interest in our share capital shall be deemed to have a notice of and to have consented to the choice of forum provisions of our Articles described above.
There may be unforeseen cultural, legal, and operational issues that could arise in clinical trials outside of the United States impacting the timely and successful completion of our clinical trials in such new territories.
There may be unforeseen cultural, legal, and operational issues that could arise in clinical trials outside of the United States impacting the timely and successful completion of our clinical trials in new territories.
These regulations may impose additional compliance obligations related to using, storing, and processing personally identifiable information. 27 In the United States, numerous federal, state, and local laws and regulations, including federal health information privacy laws, state data breach notification laws, state health information privacy laws and federal and state consumer protection laws, that govern the collection, use, disclosure and protection of health-related and other personal data may apply to our operations or the operations of the third parties upon which we rely.
These regulations may impose additional compliance obligations related to using, storing, and processing personally identifiable information. 28 In the United States, numerous federal, state, and local laws and regulations, including federal health information privacy laws, state data breach notification laws, state health information privacy laws and federal and state consumer protection laws, that govern the collection, use, disclosure and protection of health-related and other personal data may apply to our operations or the operations of the third parties upon which we rely.
These obligations may make it harder for us to operate our business, lead to regulatory fines or penalties, prevent or limit our use of AI/ML, or otherwise harm our business.
These obligations may make it harder for us to operate our business, lead to regulatory fines or penalties, prevent or limit our use of AI/ML technologies, or otherwise harm our business.
Insurance coverage is increasingly expensive. We may not be able to maintain insurance coverage at a reasonable cost or in an amount adequate to satisfy any liability that may arise.
Insurance coverage is increasingly expensive. We may not be able to maintain insurance coverage at a reasonable cost or at an amount adequate to satisfy any liability that may arise.
These third parties may not successfully or professionally carry out their contractual duties, comply with regulatory requirements or meet expected deadlines, and we may experience significant delays in the conduct of our clinical trials as well as significant increased expenditures. 1 • Serious adverse events or undesirable side effects or lack of efficacy, may emerge in clinical trials conducted by other companies running clinical trials investigating the same target as us, which could adversely affect our development programs or our capability to enroll patients or partner the program for further development and commercialization. • We are subject to certain manufacturing risks, any of which could either result in additional costs or delays in completing, or ultimately make us unable to complete, the development and commercialization of our product candidates. • There are risks that are inherent in the development and commercialization of novel therapeutic products. • Our approach to the discovery of therapeutic products is based on our AI/ML powered predictive computational discovery platform, recently branded as Unigen™ that is not yet fully proven clinically, and we do not know whether we will be able to discover and develop additional potential product candidates or products of commercial value. • We are focusing our discovery and therapeutic development activities on therapeutic product candidates for uses in immuno-oncology.
These third parties may not successfully or professionally carry out their contractual duties, comply with regulatory requirements or meet expected deadlines, and we may experience significant delays in the conduct of our clinical trials as well as significant increased expenditures. 1 • Serious adverse events or undesirable side effects or lack of efficacy, may emerge in clinical trials conducted by other companies running clinical trials investigating the same target as us, which could adversely affect our development programs or our capability to enroll patients or partner the program for further development and commercialization. • We are subject to certain manufacturing risks, any of which could either result in additional costs or delays in completing, or ultimately make us unable to complete, the development and commercialization of our product candidates. • There are risks that are inherent in the development and commercialization of novel therapeutic products. • Our approach to the discovery of therapeutic products is based on Unigen™, our AI/ML powered computational discovery platform, that is not yet fully proven clinically, and we do not know whether we will be able to discover and develop additional potential product candidates or products of commercial value. • We are focusing our discovery and therapeutic development activities on therapeutic product candidates for use in immuno-oncology.
Food and Drug Administration, or FDA, or other comparable foreign regulatory authorities, or that, even if approval is obtained, such investigational products can be successfully commercialized.
Food and Drug Administration, or FDA, or other comparable foreign regulatory authorities, or that, even if approval is obtained, such products can be successfully commercialized.
Under the supervision and with the participation of our management, including the Chief Executive Officer and the Chief Financial Officer, we carried out an evaluation of the effectiveness of our internal control over financial reporting as of December 31, 2024, using the criteria established in “Internal Control - Integrated Framework” issued by the Committee of Sponsoring Organizations of the Treadway Commission (2013 framework) (the COSO criteria).
Under the supervision and with the participation of our management, including the Chief Executive Officer and the Chief Financial Officer, we carried out an evaluation of the effectiveness of our internal control over financial reporting as of December 31, 2025, using the criteria established in “Internal Control - Integrated Framework” issued by the Committee of Sponsoring Organizations of the Treadway Commission (2013 framework) (the COSO criteria).
We focus on the discovery of drug targets that could serve as the basis for the development of possible treatments for patients non-responsive, refractory or relapsing to existing cancer immunotherapies. In this field, we apply our predictive computational target discovery capabilities, or develop new capabilities, to identify novel drug targets for addressing such unmet patient need.
We focus on the discovery of drug targets that could serve as the basis for the development of possible treatments for patients non-responsive, refractory or relapsing to existing cancer immunotherapies. In this field, we apply our computational discovery capabilities, or develop new capabilities, to identify novel drug targets for addressing such unmet patient need.
There are many risks associated with our decision to focus on immuno-oncology that include, among others: • industry interest in this area or in specific classes/families of drug targets within this area of focus would decrease over time; • the continued fatigue impacting the checkpoint inhibitors field; • other modalities, such as ADC, will continue to show beneficial clinical results in indications in which checkpoint inhibitors have failed; • not being able to discover novel drug targets in this field; • our full scope of target discovery capabilities may not be adequate; • having chosen a therapeutic area with a very high degree of competition; • having chosen a therapeutic area of great biological complexity and with very high failure rates in product development; • not choosing the appropriate drug modality; and • not having sufficient knowledge, expertise, personnel or capabilities in our chosen therapeutic area to identify the right unmet medical needs, or drug targets or drug candidates, or to timely, properly and efficiently validate the targets and/or select the appropriate therapeutic antibody for further development as therapeutic product candidates, or to timely, properly or efficiently further them in development.
There are many risks associated with our decision to focus on immuno-oncology that include, among others: • industry interest in this area or in specific classes/families of drug targets within this area of focus would decrease over time; • the continued fatigue impacting the checkpoint inhibitors field; • other modalities, such as ADCs, will continue to show beneficial clinical results in indications in which checkpoint inhibitors have failed; • not being able to discover novel drug targets in this field; • our full scope of target discovery capabilities may not be adequate; • having chosen a therapeutic area with a very high degree of competition; • having chosen a therapeutic area of great biological complexity and with very high failure rates in product development; • long development time to meet endpoints; • not choosing the appropriate drug modality; and • not having sufficient knowledge, expertise, personnel or capabilities in our chosen therapeutic area to identify the right unmet medical needs, or drug targets or drug candidates, or to timely, properly and efficiently validate the targets and/or select the appropriate therapeutic antibody for further development as therapeutic product candidates, or to timely, properly or efficiently further them in development.
To date, we have entered into four partnership agreements with respect to our therapeutic pipeline programs (of which we currently have two collaborations in effect) under which we have received a total amount of $182.2 million (after $13.5 million withholding taxes), of which $32.0 million was in the form of an equity investment.
To date, we have entered into four partnership agreements with respect to our therapeutic pipeline programs (of which we currently have two collaborations in effect) under which we have received a total amount of $247.2 million (after $13.5 million withholding taxes), of which $32.0 million was in the form of an equity investment.
If our technologies (including those of our vendors and subcontractors) fail to perform as intended, our business, financial condition, and results of operations could be adversely affected. 29 Changes in legal or regulatory frameworks surrounding AI usage may further pose compliance risks or limit the development and application of these technologies.
If our technologies (including those of our vendors and subcontractors) fail to perform as intended, our business, financial condition, and results of operations could be adversely affected. Changes in legal or regulatory frameworks surrounding AI/ML usage may further pose compliance risks or limit the development and application of these technologies.
In addition, we expect to continue to incur net losses in the future due to our anticipated costs and expenses, primarily associated with our research, preclinical and clinical activities. We currently have two therapeutic pipeline program-based partnership agreements in effect, one with AstraZeneca plc, or AstraZeneca, and the second with Gilead Sciences, Inc., or Gilead.
In addition, we expect to continue to incur net losses in the future due to our anticipated costs and expenses, primarily associated with our research and development and preclinical and clinical activities. We currently have two therapeutic program-based partnership agreements in effect, one with AstraZeneca plc, or AstraZeneca, and the second with Gilead Sciences, Inc., or Gilead.
If we or the third parties upon whom we rely experience (or are perceived to have experienced) a security breach or other incident or disruption, we may experience material adverse consequences, including but not limited to, government enforcement actions (e.g., investigations, fines, penalties, audits, and inspections), federal, state and/or foreign data breach notification obligations, additional reporting requirements and/or oversight, restrictions on processing data (including clinical trial data and other personal data), litigation, indemnification obligations, loss of data (including clinical trial data and other sensitive information) or damage to the integrity of that data, negative publicity, reputational harm, monetary fund diversions, interruptions in our operations, financial loss, and other similar harms.
If we or the third parties upon whom we rely experience (or are perceived to have experienced) a security breach or other incident or disruption, which has occurred in the past, we may experience material adverse consequences, including but not limited to, government enforcement actions (e.g., investigations, fines, penalties, audits, and inspections), federal, state and/or foreign data breach notification obligations, additional reporting requirements and/or oversight, restrictions on processing data (including clinical trial data and other personal data), litigation, indemnification obligations, loss of data (including clinical trial data and other sensitive information) or damage to the integrity of that data, negative publicity, reputational harm, monetary fund diversions, interruptions in our operations, financial loss, and other similar harms.
In addition, although we have demonstrated success in validating our predictive computational discovery capabilities with product candidates in human clinical trials, major pharmaceutical companies may be hesitant to enter into early-stage collaborations based on newly discovered targets, more so if discovered by computer prediction and has no or limited published scientific support, as opposed to drug targets backed with human clinical trial data, or product candidates with significant published experimental validation and scientific support.
In addition, although we have demonstrated success in validating our computational discovery capabilities with product candidates in human clinical trials, major pharmaceutical companies may be hesitant to enter into early-stage collaborations based on novel discovered targets, more so if discovered by computer prediction and has no or limited published scientific support, as opposed to drug targets backed with human clinical trial data, or product candidates with significant published experimental validation and scientific support.
In addition, recent political and civil actions in Israel which began in early 2023, resulting from, among other things, proposed changes to certain Israeli constitutional legislation, have had and may continue to have an adverse effect on the Israeli social, economic and political landscape and in turn, on us.
In addition, ongoing political and civil actions in Israel which began in early 2023, resulting from, among other things, proposed changes to certain Israeli constitutional legislation, have had and may continue to have an adverse effect on the Israeli social, economic and political landscape and in turn, on us.
Additionally, since a considerable portion of our expenses such as employees’ salaries are linked to an extent to the rate of inflation in Israel, the dollar cost of our operations is influenced by the extent to which any increase in the rate of inflation in Israel is or is not offset by the devaluation of the NIS in relation to the dollar.
Additionally, since a considerable portion of our expenses such as employees’ salaries are linked to an extent to the rate of inflation in Israel, the dollar cost of our operations is influenced by the extent to which any increase in the rate of inflation in Israel is or is not offset by the depreciation of the NIS in relation to the dollar.
Further, our share price could be subject to significant fluctuations or otherwise be adversely affected by the events, risks and uncertainties of any shareholder activism. General Risks Unfavorable global or domestic political or economic conditions could adversely affect our business, financial condition or results of operations.
Further, our share price could be subject to significant fluctuations or otherwise be adversely affected by the events, risks and uncertainties of any shareholder activism. 47 General Risks Unfavorable global political or economic conditions could adversely affect our business, financial condition or results of operations.
A variety of factors may affect the market price of our ordinary shares including: • global or regional macroeconomic developments; • general market, political and economic conditions in the countries in which Compugen operates, including Israel, outbreak of disease, boycotts, curtailment of trade and other business restrictions and implementation of tariffs and the different effects of the evolving nature of global or regional events, including the current “Swords of Iron” war in Israel; • clinical data disclosed by us, our collaborators or our competitors; • massive purchase or sell of our shares by a large shareholder; • our success (or lack thereof) in entering into collaboration agreements and achieving certain research and developmental milestones thereunder; • our need to raise additional capital and our success or failure in doing so; • achievement or denial of regulatory approvals by us, our collaborators or our competitors; • announcements of technological innovations or new commercial products by our competitors; • trends in share price of companies in our field or industry; • announcement of corporate transactions, merger and acquisition activities or other similar events by companies in our field or industry; • changes and developments effecting our field or industry; • developments concerning our existing or new collaborations; • regulatory developments in the United States, Israel and other countries; • changes in the structure of healthcare payment systems; 44 • delay or failure by us or our collaborators in initiating, completing or analyzing preclinical or clinical trials or the unsatisfactory design or results of such trials; • period to period fluctuations in our results of operations; • changes in estimates by securities analysts; • changes in senior management or the board of directors or changes in the size or structure of the company; • our ability (or lack thereof) to disclose the commercial terms of, or progress under, our collaborations; and • transactions with respect to our ordinary shares by insiders or institutional investors.
A variety of factors may affect the market price of our ordinary shares, including: • global or regional macroeconomic developments; • general market, political and economic conditions in the countries in which Compugen operates, including Israel, outbreak of disease, boycotts, curtailment of trade and other business restrictions and implementation of tariffs and the different effects of the evolving nature of global or regional events, including the current instability in Israel and the Middle East; • clinical data disclosed by us, our collaborators or our competitors; • massive purchase or sell of our shares by a large shareholder; 45 • our success (or lack thereof) in entering into collaboration agreements and achieving certain research and developmental milestones thereunder; • our need to raise additional capital and our success or failure in doing so; • achievement or denial of regulatory approvals by us, our collaborators or our competitors; • announcements of technological innovations or new commercial products by our competitors; • trends in share price of companies in our field or industry; • announcement of corporate transactions, merger and acquisition activities or other similar events by companies in our field or industry; • changes and developments effecting our field or industry; • developments concerning our existing or new collaborations; • regulatory developments in the United States, Israel and other countries; • changes in the structure of healthcare payment systems; • delay or failure by us or our collaborators in initiating, completing or analyzing preclinical or clinical trials or the unsatisfactory design or results of such trials; • period to period fluctuations in our results of operations; • changes in estimates by securities analysts; • changes in senior management or the board of directors or changes in the size or structure of the company; • our ability (or lack thereof) to disclose the commercial terms of, or progress under, our collaborations; and • transactions with respect to our ordinary shares by insiders or institutional investors.
The FDA or other regulatory authorities could require us to conduct additional preclinical studies or added clinical evaluation under any IND, clinical trial agreement or similar regulatory filing, which may lead to delays and increase the costs of our preclinical and clinical development programs.
The FDA or other regulatory authorities could require us to conduct additional preclinical studies or added clinical evaluation under any IND, clinical trial application or similar regulatory filing, which may lead to delays and increase the costs of our preclinical and clinical development programs.
Preclinical and clinical testing are expensive, time consuming, and subject to uncertainty and will require significant additional financial and management resources. As a company, we have limited experience in conducting clinical trials and have never progressed a product candidate through to regulatory approval.
Preclinical and clinical testing are expensive, time consuming, and subject to uncertainty and require significant financial and management resources. As a company, we have limited experience in conducting clinical trials and have never progressed a product candidate through to regulatory approval.
If we were to no longer qualify as a foreign private issuer, we would be required to file periodic reports and registration statements on U.S. domestic issuer forms with the SEC, which are more extensive than the forms available to a foreign private issuer.
If we were to no longer qualify as a foreign private issuer, we would be required to file periodic reports and registration statements on domestic issuer forms with the SEC, which are more extensive than the forms available to a foreign private issuer.
If we, or the third parties we engage for this purpose, are unable to successfully discover, validate and/or develop the required companion diagnostics and/or biomarkers for our clinical programs, or develop with altered specifications, or experience delays in doing so, the development of our clinical candidates may be adversely affected and this can harm our patient selection and our clinical outcome, as well as obtaining marketing authorization for these product candidates.
If we, or the third parties we engage for this purpose, are unable to successfully discover, validate and/or develop the required companion diagnostics and/or biomarkers for our clinical programs, or experience delays in doing so, the development of our clinical candidates may be adversely affected and this can harm our patient selection and our clinical outcome, as well as obtaining marketing authorization for these product candidates.
Technological breakthroughs in new modalities will be a key driver of growth for the biopharma industry over the next decade. Drug discovery and development has undergone an impressive transformation over recent years driven by the emergence of new drug modalities.
Technological breakthroughs in new modalities will be a key driver of growth for the biopharma industry over the next decade. Drug discovery and development have undergone an impressive transformation over recent years driven by the emergence of new drug modalities.
As such, we are exempt from certain provisions under the Exchange Act, applicable to U.S. domestic public companies, including: • the rules under the Exchange Act requiring the filing with the SEC of annual reports on Form 10-K, quarterly reports on Form 10-Q and current reports on Form 8-K; • the sections of the Exchange Act regulating the solicitation of proxies, consents or authorizations in respect of a security registered under the Exchange Act, including extensive disclosure of compensation paid or payable to certain of our highly compensated executives as well as disclosure of the compensation determination process; • the provisions of Regulation FD aimed at preventing issuers from making selective disclosures of material information; and • the sections of the Exchange Act requiring insiders to file public reports of their stock ownership and trading activities and establishing insider liability for profits realized from any “short-swing” trading transaction (a purchase and sale, or sale and purchase, of the issuer’s equity securities within less than six months).
As such, we are exempt from certain provisions under the Exchange Act, applicable to U.S. domestic public companies, including: • the rules under the Exchange Act requiring the filing with the SEC of annual reports on Form 10-K, quarterly reports on Form 10-Q and current reports on Form 8-K; • the sections of the Exchange Act regulating the solicitation of proxies, consents or authorizations in respect of a security registered under the Exchange Act, including extensive disclosure of compensation paid or payable to certain of our highly compensated executives as well as disclosure of the compensation determination process; • the provisions of Regulation FD aimed at preventing issuers from making selective disclosures of material information; and • the sections of the Exchange Act establishing insider liability for profits realized from any “short-swing” trading transaction (a purchase and sale, or sale and purchase, of the issuer’s equity securities within less than six months).
The accommodation of these requirements mandates a thorough consideration of both the scientific and business aspects of each transaction.
The accommodation of these requirements mandates thorough consideration of both the scientific and business aspects of each transaction.
In the event a claim is brought against us, we might be required to pay legal and other expenses to defend the claim, as well as uncovered damages awards resulting from a claim brought successfully against us and retention amounts.
In the event a claim is brought against us, we might be required to pay legal and other expenses to defend the claim, as well as uncovered damage awards resulting from a claim brought successfully against us and retention amounts.
In the event of any of these occurrences, the actual and/or perceived value of a substantial portion of our pipeline would likely be reduced in which case our business may be materially harmed. To date, we have signed four partnership agreements involving our therapeutic product candidates, two of which, one with AstraZeneca and one with Gilead, are in effect.
In the event of any of these occurrences, the actual and/or perceived value of our pipeline would likely be reduced in which case our business may be materially harmed. To date, we have signed four partnership agreements involving our therapeutic product candidates, two of which, one with AstraZeneca and one with Gilead, are in effect.
Since we are a small company with limited human and financial resources, we are not able to work with a large number of collaborators in parallel and/or advance a large number of drug target or therapeutic product candidates in parallel.
Since we are a small company with limited human and financial resources, we are not able to work with a large number of collaborators in parallel and/or advance a large number of drug targets or therapeutic product candidates in parallel.
The success of COM701, COM902 and GS-0321 (previously COM503) (for which we are only responsible for the Phase 1 development) and rilvegostomig which is developed by AstraZeneca is dependent upon several factors, including the following: • the successful clinical trial design (and implementation thereof) and results; 5 • our ability to fund clinical trials designed to obtain regulatory approval and to become commercially successful; • our ability to design trials required to allow for a path for registration or obtain regulatory approval; • the success of trials designed to allow for a path for registration/approval by regulatory authorities; • our selected regulatory strategy; • our timely initiation, enrollment and completion of clinical trials; • the enrolled patient population’s demographics, prior therapy/ies and other patients characteristics, even if they meet the inclusion/exclusion enrollment criteria; • the availability of the patient population selected for enrollment; • the safety, tolerability and efficacy profile, alone or in combination with other approved or investigational products, that is satisfactory to the FDA or comparable foreign regulatory authorities; • the safety, tolerability and efficacy profile, alone or in combination with other approved or investigational products, that fits the competitive treatment landscape/ unmet patients’ need; • selection of drug dosing; • selection of indications; • selection of patient populations; • selection of comparator trial arm(s); • selection of drug(s) for combinations; • access to drugs required for combination studies or approval; • successful identification of biomarkers, including for patient selection; • timely receipt of marketing approvals from applicable regulatory authorities; • the performance of our current and future collaborators, if any; • the extent of any required post-marketing approval commitments to applicable regulatory authorities; • establishment, management and monitoring of CRO arrangements and processes with third-party service providers for conducting the clinical trial; • ability to convince clinical investigators in the potential of our clinical drug candidates and their interest in enrolling patients to our studies; • establishment and monitoring of manufacturing arrangements and processes with third-party service providers and clinical manufacturing organizations for manufacturing drug substance and drug product; • establishment and monitoring of arrangements with third-party suppliers of raw materials and service for fill-finish, packaging and labeling; • stability of our drug substance and drug products; • supply of our drugs in sufficient quantities and quality for our clinical trials; • establishment of arrangements with third-party manufacturers and processes monitoring to obtain commercial quality drug product that is appropriately packaged for sale; • adequate ongoing availability of raw materials and drug product for clinical development and any commercial sales; • protection of our rights in our intellectual property portfolio; • successful launch of commercial sales following any marketing approval and the size of the potential patient population; • a continued acceptable safety profile following any marketing approval; 6 • commercial acceptance by patients, the medical community and third-party payors; and • the success of other anti-PVRIG, anti-TIGIT and anti-IL-18 binding protein pathway molecules.
The success of each of COM701, COM902 and GS-0321 (previously COM503) (for which we are only responsible for Phase 1 clinical development) and rilvegostomig which is developed by AstraZeneca, is dependent upon several factors, including the following: • the successful clinical trial design (and implementation thereof) and results; • ability to fund clinical trials designed to obtain regulatory approval and to become commercially successful; • ability to design trials required to allow for a path for registration or obtain regulatory approval; • the success of trials designed to support for a path for registration/approval by regulatory authorities; • selected regulatory strategy; • timely initiation, enrollment and completion of clinical trials; • the enrolled patient population’s demographics, prior therapy/ies and other patients characteristics, even if they meet the inclusion/exclusion enrollment criteria; • the availability of the patient population selected for enrollment; 7 • the safety, tolerability and efficacy profile, alone or in combination with other approved or investigational products, that is satisfactory for receiving marketing approval by the FDA or comparable foreign regulatory authorities; • the safety, tolerability and efficacy profile, alone or in combination with other approved or investigational products, that fits the competitive treatment landscape/ unmet patients’ need; • adequate selection of drug dosing; • adequate selection of indications; • adequate selection of patient populations and patients’ eligibility within such populations; • adequate selection of comparator trial arm(s); • adequate selection of drug(s) for combinations; • access to drugs required for combination studies or approval; • successful identification of biomarkers, including for patient selection; • timely receipt of marketing approvals from applicable regulatory authorities; • the performance of our current and future collaborators, if any; • the extent of any required post-marketing approval commitments to applicable regulatory authorities; • establishment, management and monitoring of CRO arrangements and processes with third-party service providers for conducting the clinical trial; • ability to convince clinical investigators in the potential of our clinical drug candidates and their interest in enrolling patients to our studies, pace of opening sites and actual enrollment; • establishment and monitoring of manufacturing arrangements and processes with third-party service providers and clinical manufacturing organizations for manufacturing drug substance and drug product; • establishment and monitoring of arrangements with third-party suppliers of raw materials and service for fill-finish, packaging and labeling; • adequate stability of our drug substance and drug products; • supply of our drugs in sufficient quantities and quality for our clinical trials; • establishment of arrangements with third-party manufacturers and processes monitoring to obtain commercial quality drug product that is appropriately packaged for sale; • adequate ongoing availability of raw materials and drug product for clinical development and any commercial sales; • protection of our rights in our intellectual property portfolio; • successful launch of commercial sales following any marketing approval and the size of the potential patient population; • a continued acceptable safety profile following any marketing approval; • commercial acceptance by patients, the medical community and third-party payors; and • the success or failure of other anti-PVRIG, anti-TIGIT and anti-IL-18 binding protein pathway molecules.
Pursuant to the License Agreement, we are responsible for conducting a Phase 1 clinical trial for GS-0321 (previously COM503), including handling the regulatory matters in connection therewith, and will bear the costs of such trial (including the GS-0321 (previously COM503) drug supply), with Gilead having the obligation to provide at no cost zimberelimab antibody for such trial.
Pursuant to the License Agreement, we are responsible for conducting a Phase 1 clinical trial for GS-0321 (previously COM503), including handling the regulatory matters in connection therewith, and will bear the costs of such trial (including the GS-0321 (previously COM503) drug supply), with Gilead having the obligation to provide zimberelimab antibody for such trial.

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Item 4. Mine Safety Disclosures

Mine Safety Disclosures — required of mining issuers

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Biggest changeFor example, the IRA, among other things, (i) directs the Secretary of HHS to negotiate the price of certain high-expenditure, single-source drugs that have been on the market for at least 7 years and biologics that have been on the market for at least 11 years covered under Medicare Part B and Medicare Part D, and subjects drug manufacturers to civil monetary penalties and a potential excise tax by offering a price that is not equal to or less than the negotiated “maximum fair price” under the law, or the Medicare Drug Price Negotiation Program, and (ii) imposes rebates under Medicare Part B and Medicare Part D to penalize price increases that outpace inflation.
Biggest changeIn addition, HHS has been empowered to negotiate the price to negotiate the price of certain single-source biologics that have been on the market for at least eleven (11) years covered under Medicare as part of the Medicare Drug Price Negotiation Program.
Rilvegostomig, a PD-1/TIGIT bispecific antibody with a TIGIT component that is derived from our COM902 program, is being developed by AstraZeneca pursuant to an exclusive license agreement between us and AstraZeneca and is being evaluated in multiple Phase 3 clinical trials and in multiple Phase 2 and Phase 1 clinical trials.
Rilvegostomig, a PD-1/TIGIT bispecific antibody with a TIGIT component that is derived from our COM902 program, is being developed by AstraZeneca pursuant to an exclusive license agreement between us and AstraZeneca and is being evaluated in multiple Phase 3, Phase 2 and Phase 1 clinical trials.
The inflammasome-induced pro-inflammatory cytokine, IL-18, is present at high levels in the tumor microenvironment, where it is expected to naturally activate anti-tumor effector cells, such as T and NK cells. Nevertheless, IL-18 is one of the rare cytokines that is naturally blocked by an endogenous high affinity inhibitor, called IL-18BP.
The inflammasome-induced pro-inflammatory cytokine, IL-18, is present at high levels in the tumor microenvironment, where it is expected to naturally activate anti-tumor effector cells, such as T and NK cells. Nevertheless, IL-18 is one of the rare cytokines that is naturally blocked by an endogenous high affinity inhibitor, called IL-18BP.
From these massive datasets, our platforms analyze characteristics, such as gene structure, protein domains, predicted cellular localization, expression pattern, as well as other characteristics to identify potential druggable targets and predict their biological functions.
From these massive datasets, our platforms analyze characteristics, such as gene structure, protein domains, predicted cellular localization, expression pattern, as well as other characteristics to identify potential druggable targets and predict their expression pattern and biological functions.
AstraZeneca has the right to create multiple products under this license and is solely responsible for all research, development and commercial activities under the agreement.
AstraZeneca has the right to create multiple products under this license agreement and is solely responsible for all research, development and commercial activities under the license agreement.
In both investments, the share price paid by Bristol Myers Squibb represented a 33% premium over the closing price of our ordinary shares on the last trading day immediately prior to the execution of the applicable securities purchase agreement. In these two investments, we issued to Bristol Myers Squibb 4,757,058 ordinary shares aggregately.
In both investments, the share price paid by Bristol Myers Squibb represented a 33% premium over the closing price of our ordinary shares on the last trading day immediately prior to the execution of the applicable securities purchase agreement. In these two investments, we issued Bristol Myers Squibb 4,757,058 ordinary shares aggregately.
We entered into agreements with certain CMOs for the manufacturing and respective analytics of COM701, COM902 and GS-0321 (previously COM503). Our manufacturing strategy is currently structured to support the current clinical development of COM701 and COM902 and GS-0321 (previously COM503) (for which we are responsible for the Phase 1 development).
We entered into agreements with certain CMOs for the manufacturing and respective analytics of COM701, COM902 and GS-0321 (previously COM503). Our manufacturing strategy is currently structured to support the current clinical development of COM701 and COM902 and GS-0321 (previously COM503) (for which we are responsible for the Phase 1 clinical development).
Risk Factors - Risks Related to Our Dependence on Third Parties - We rely and expect to continue to rely completely on third parties to manufacture and supply our preclinical and clinical drug supplies.
Risk Factors - Risks Related to Our Dependence on Third Parties - We rely on and expect to continue to rely completely on third parties to manufacture and supply our preclinical and clinical drug supplies.
By applying the integration of Unigen TM with our ground-breaking immuno-oncology research and drug development expertise, we aim to identify biomarkers that can help us predict which patients are most likely to respond to our novel therapies. This long-term approach also seeks to improve the probability of success of our clinical studies.
By applying the integration of Unigen with our ground-breaking immuno-oncology research and drug development expertise, we aim to identify biomarkers that can help us predict which patients are most likely to respond to our novel therapies. This long-term approach also seeks to improve the probability of success of our clinical studies.
We face, and expect to continue to face, ongoing competition from entities that discover novel targets and develop novel products, and that have therapeutic product candidates or products that address the same drug targets or act by similar, or possibly identical, mechanism of action (MOA) as well as by different mechanisms but address the same drug target or patient population or unmet clinical need.
We face, and expect to continue to face, ongoing competition from entities that discover novel targets and develop novel products, and that have therapeutic product candidates or products that address the same drug targets or act by similar, or possibly identical, mechanism of action as well as by different mechanisms but address the same drug target or patient population or unmet clinical need.
ORGANIZATIONAL STRUCTURE We were incorporated under the laws of the State of Israel on February 10, 1993, as Compugen Ltd., which is both our legal and commercial name. Compugen USA, Inc., our wholly owned subsidiary, was incorporated in Delaware in March 1997 and is qualified to do business in California. D.
ORGANIZATIONAL STRUCTURE We were incorporated under the laws of the State of Israel on February 10, 1993, as Compugen Ltd., which is both our legal and commercial name. Compugen USA, Inc., our wholly owned subsidiary, was incorporated in Delaware in March 1997 and is qualified to do business in California. 64 D.
Based on preclinical data these combinations may be clinically important for enhancing anti-tumor immune response and expanding the patient population responsive to checkpoint inhibition. 53 We discovered TIGIT in 2009 with our immune checkpoint computational discovery capabilities through which PVRIG was also discovered.
Based on preclinical data these combinations may be clinically important for enhancing anti-tumor immune response and expanding the patient population responsive to checkpoint inhibition. We discovered TIGIT in 2009 with our immune checkpoint computational discovery capabilities through which PVRIG was also discovered.
These assets include the intellectual property rights subsisting in our proprietary know-how and trade secrets underlying our predictive biology capabilities and discovery capabilities, our patents and patent applications, particularly with respect to our discovered proteins, therapeutic and diagnostic product candidates. We seek to vigorously protect our rights and interests in our intellectual property.
These assets include the intellectual property rights subsisting in our proprietary know-how and trade secrets underlying our biology capabilities and discovery capabilities, our patents and patent applications, particularly with respect to our discovered proteins, therapeutic and diagnostic product candidates. We seek to vigorously protect our rights and interests in our intellectual property.
The generated data is added to the Unigen TM platform databases and then analyzed computationally to identify potential biomarkers for patient selection and used in discovery projects aimed at uncovering potential novel drug targets.
The generated data is added to the Unigen platform databases and then analyzed computationally to identify potential biomarkers for patient selection and used in discovery projects aimed at uncovering potential novel drug targets.
Our business could be harmed if those third parties fail to provide us with sufficient quantities of drug product or fail to do so at acceptable quality and quantity levels, prices or timelines.” 60 Government Regulation Regulation of Therapeutic Product Candidates In the United States, the FDA regulates pharmaceutical and biologic products under the Federal Food, Drug, and Cosmetic Act, or FDCA, the Public Health Service Act, other statutes and regulations and implementing regulations.
Our business could be harmed if those third parties fail to provide us with sufficient quantities of drug product or fail to do so at acceptable quality and quantity levels, prices or timelines.” 59 Government Regulation Regulation of Therapeutic Product Candidates In the United States, the FDA regulates pharmaceutical and biologic products under the Federal Food, Drug, and Cosmetic Act, or FDCA, the Public Health Service Act, other statutes and regulations and implementing regulations.
Risk Factors - Risks Related to Competition and Commercialization - We operate in a highly competitive and rapidly changing industry which may result in others discovering, developing or commercializing competing products ahead of us or more successfully than we do.” We anticipate that we will face intense and increasing competition as advanced technologies or new therapy modalities become available. 59 Intellectual Property Rights Our intellectual property assets are our principal assets.
Risk Factors - Risks Related to Competition and Commercialization - We operate in a highly competitive and rapidly changing industry which may result in others discovering, developing or commercializing competing products ahead of us or more successfully than we do.” We anticipate that we will face intense and increasing competition as advanced technologies or new therapy modalities become available. 58 Intellectual Property Rights Our intellectual property assets are our principal assets.
We, or our collaborators, will be required to obtain coverage and reimbursement for these tests separate and apart from the coverage and reimbursement we seek for our product candidates, once approved. Non-U.S.
We, or our collaborators, will be required to obtain coverage and reimbursement for these tests separate and apart from the coverage and reimbursement we seek for our product candidates, once approved. 63 Non-U.S.
Rilvegostomig is currently being evaluated by AstraZeneca in multiple Phase 3 clinical trials and multiple Phase 2 and Phase 1 clinical trials with the first patient having been dosed in the first Phase 3 clinical trial in December 2023. • GS-0321 (previously COM503) - a therapeutic antibody targeting IL-18 binding protein GS-0321 (previously COM503) is a potential first-in-class high affinity antibody, which blocks the interaction between interleukin-18 binding protein (IL18BP) and interleukin 18 (IL-18).
Rilvegostomig is currently being evaluated by AstraZeneca in multiple Phase 3, Phase 2 and Phase 1 clinical trials, with the first patient dosed in the first Phase 3 clinical trial in December 2023. • GS-0321 (previously COM503) - a therapeutic antibody targeting IL-18 binding protein GS-0321 (previously COM503) is a potential first-in-class high affinity antibody, which blocks the interaction between interleukin-18 binding protein (IL18BP) and interleukin 18 (IL-18).
COM701 Clinical Programs In September 2018, we dosed our first patient in the Phase 1 clinical trial of COM701 and through December 31, 2024, we conducted multiple Phase 1 studies across tumor types, patient populations and combinations. Below is a table showing key COM701 expansion cohorts efficacy data as monotherapy and in combinations disclosed in scientific conferences.
COM701 Clinical Programs In September 2018, we dosed our first patient in the Phase 1 clinical trial of COM701 and through December 31, 2025, we conducted multiple Phase 1 studies across tumor types, patient populations and combinations. Below is a table showing key COM701 expansion cohorts efficacy data as monotherapy and in combinations disclosed in scientific conferences.
In certain circumstances, Gilead may assume the role of conducting the Phase 1 clinical trial. Upon completion of the Phase 1 clinical trial for GS-0321 (previously COM503), we will initiate the transfer of development activities related to GS-0321 (previously COM503) to Gilead, following which, Gilead will have sole responsibility to develop and commercialize the Licensed Products.
In certain circumstances, Gilead may assume the role of conducting the Phase 1 clinical trial. Upon completion of the Phase 1 clinical trial for GS-0321 (previously COM503), we are required to initiate the transfer of development activities related to GS-0321 (previously COM503) to Gilead, following which, Gilead will have sole responsibility to develop and commercialize the Licensed Products.
Liquidity and Capital Resources.” 58 Competition The biotechnology and pharmaceutical industries are highly competitive and characterized by the rapid evolution of new technologies and the adoption of new therapies. Additionally, the oncology therapeutic space, represents the therapeutic area with what we believe to be one of the highest industry focus and investment.
Liquidity and Capital Resources.” 57 Competition The biotechnology and pharmaceutical industries are highly competitive and characterized by the rapid evolution of new technologies and the adoption of new therapies. Additionally, the oncology therapeutic space, represents the therapeutic area with what we believe to be one of the highest industry focus and investment.
We have demonstrated the applicability of our discovery approach in computationally identifying multiple in-silico targets, including PVRIG, TIGIT, IL-18BP and ILDR2, the first three now serve as the targets for therapeutic antibodies currently being evaluated in the clinic by us and others.
We have demonstrated the applicability of our computationally discovery approach in identifying multiple drug targets, including PVRIG, TIGIT, IL-18BP and ILDR2, the first three now serve as the targets for therapeutic antibodies currently being evaluated in the clinic by us and others.
Under the terms of the license agreement, we granted an exclusive license to AstraZeneca to use our monospecific antibodies that bind to TIGIT, including COM902, for the development of bi-specific and multi-specific antibody products, excluding such bi-specific and multi-specific antibodies that also bind to PVRIG, PVRL2 and/or TIGIT.
Under the terms of the license agreement, as amended, we granted an exclusive license to AstraZeneca to use our monospecific antibodies that bind to TIGIT, including COM902, for the development of bi-specific and multi-specific antibody products, excluding such bi-specific and multi-specific antibodies that also bind to PVRIG, PVRL2 and/or TIGIT.
We believe that our computational capabilities, and specifically our Unigen TM platform, provide us with a competitive advantage in predicting protein functions and linking proteins to specific mechanisms and diseases, and as a result, predicting novel immuno-oncology drug targets.
We believe that our computational capabilities, and specifically our Unigen platform, provide us with a competitive advantage in predicting protein functions and expression and linking proteins to specific mechanisms and diseases, and as a result, predicting novel immuno-oncology drug targets.
Risk Factors - Risks Related to Competition and Commercialization - We operate in a highly competitive and rapidly changing industry which may result in others discovering, developing or commercializing competing products ahead of us or more successfully than we do.” Our discovery program depends, in large part, on our computational discovery capabilities in integration with our immuno-oncology experimental capabilities and drug development capabilities as well as our proprietary data to make inventions and establish intellectual property rights in our drug target candidates and product candidates.
Risk Factors - Risks Related to Competition and Commercialization - We operate in a highly competitive and rapidly changing industry which may result in others discovering, developing or commercializing competing products ahead of us or more successfully than we do.” Our discovery programs depend, in large part, on our computational discovery capabilities in integration with our immuno-oncology experimental capabilities and drug development capabilities as well as our proprietary data to make inventions and establish intellectual property rights in our drug target candidates and product candidates.
COM902 was shown to have superior binding affinity to T cells with similar and or greater in vitro function compared to several clinical anti-TIGIT antibodies. COM902 is a mouse-cross reactive Ab and inhibited tumor growth and increased survival when combined with anti-PVRIG or anti-PD-[L]1 antibodies in in-vivo studies.
COM902 was shown to have superior binding affinity to T cells with similar and or greater in vitro function compared to several clinical anti-TIGIT antibodies. COM902 is a mouse-cross reactive Ab and inhibited tumor growth and increased survival when combined with anti-PVRIG or anti-PD-L1 antibodies in in-vivo studies.
Immuno-oncology therapies that overcome immune suppression by stimulating responses directed to cancer cells are emerging as a powerful means of counteracting the cellular mechanisms that enable the growth and spread of tumors. Immuno-oncology agents are expanding as a potential path to durable and long-lasting responses in certain patients.
Immuno-oncology therapies that overcome immune suppression by stimulating responses directed to cancer cells have emerged as a powerful means of counteracting the cellular mechanisms that enable the growth and spread of tumors. Immuno-oncology agents are expanding as a potential path to durable and long-lasting responses in certain patients.
Our web address is www.cgen.com . Information contained on our website does not constitute a part of this Annual Report. The SEC maintains an internet site, http://www.sec.gov that contains reports, proxy and information statements, and other information regarding issuers that file electronically with the SEC.
Our web address is www.cgen.com . Information contained on our website does not constitute a part of this Annual Report. The SEC maintains an internet site, http://www.sec.gov that contains reports, proxy and information statements, and other information regarding issuers that file electronically with the SEC. Neither such internet addresses are a part of this Annual Report.
The patents issued in the U.S. and Europe for COM701 and COM902 were issued between 2017 and 2024 and should expire no earlier than 2036.
The patents issued in the U.S. and Europe for COM701 and COM902 were issued between 2017 and 2025 and should expire no earlier than 2036.
BUSINESS OVERVIEW Summary We are a clinical-stage therapeutic discovery and development company utilizing our AI/ML powered predictive computational discovery platform, recently branded as Unigen TM , to identify novel drug targets and to develop therapeutics in the field of cancer immunotherapy. Our innovative immuno-oncology pipeline consists of four clinical stage programs, COM701, COM902, rilvegostomig and GS-0321 (previously COM503).
BUSINESS OVERVIEW Summary We are a clinical-stage therapeutic discovery and development company utilizing Unigen™, our AI/ML powered computational discovery platform, to identify novel drug targets and to develop therapeutics in the field of cancer immunotherapy. Our innovative immuno-oncology pipeline consists of four clinical-stage programs: COM701, COM902, rilvegostomig and GS-0321 (previously COM503).
As of February 1, 2025, we had over 184 pending patent applications that have been filed in the United States, Europe and in other territories as well as pending patent applications that have been filed under the Patent Cooperation Treaty for which we have not yet designated the countries of filing.
As of February 1, 2026, we had over 142 pending patent applications that have been filed in the United States, Europe and in other territories as well as pending patent applications that have been filed under the Patent Cooperation Treaty for which we have not yet designated the countries of filing.
Integrating cutting edge computational capabilities with ground-breaking immuno-oncology research and drug development expertise is our differentiator and has enabled us to advance drug targets from computer prediction through successful preclinical studies to the clinic. Therefore, we believe that we are uniquely positioned to discover and develop potential novel, first-in-class treatment options for cancer patients.
Integrating cutting edge computational capabilities with ground-breaking immuno-oncology research and drug development expertise is our differentiator and has enabled us to advance drug targets from computer prediction through successful preclinical studies to the clinic. Therefore, we believe that we are uniquely positioned to discover and develop innovative treatment options for cancer patients.
In connection with such license agreement, AstraZeneca developed rilvegostomig, a novel PD-1/TIGIT bi-specific antibody with a TIGIT component that is derived from our COM902 and entered the clinic in September 2021 and initiated Phase 3 with first patient dosing in December 2023. 57 We received a $10 million upfront payment and are eligible to receive up to $200 million in development, regulatory and commercial milestones for the first product as well as mid-single-digit tiered royalties on future product sales, out of which we accrued $2 million in 2020 as a preclinical milestone, $6 million in 2021 as a clinical milestone (triggered by the dosing of the first patient in a Phase 1/2 clinical trial evaluating rilvegostomig), additional $7.5 million in 2022 as a clinical milestone (triggered by the dosing of the first patient in its ARTEMIDE Phase 2 clinical trial evaluating rilvegostomig), additional $10 million in 2023 as a clinical milestone (triggered by the dosing of the first patient in its ARTEMIDE-Bil01 Phase 3 clinical trial evaluating rilvegostomig), and an additional $5 million in 2024 (triggered by dosing of the first patient in the second Phase 3 clinical trial evaluating rilvegostomig).
In connection with such license agreement, AstraZeneca developed rilvegostomig, a novel PD-1/TIGIT bi-specific antibody with a TIGIT component that is derived from our COM902 and entered the clinic in September 2021 and initiated Phase 3 with first patient dosing in December 2023. 56 From the date of the license agreement until the recent amendment thereto dated December 16, 2025, we received a $10 million upfront payment and were eligible to receive up to $200 million in development, regulatory and commercial milestones for the first product as well as mid-single-digit tiered royalties on future product sales, out of which we accrued $2 million in 2020 as a preclinical milestone, $6 million in 2021 as a clinical milestone (triggered by the dosing of the first patient in a Phase 1/2 clinical trial evaluating rilvegostomig), an additional $7.5 million in 2022 as a clinical milestone (triggered by the dosing of the first patient in its ARTEMIDE Phase 2 clinical trial evaluating rilvegostomig), an additional $10 million in 2023 as a clinical milestone (triggered by the dosing of the first patient in its ARTEMIDE-Bil01 Phase 3 clinical trial evaluating rilvegostomig), and an additional $5 million in 2024 (triggered by dosing of the first patient in the second Phase 3 clinical trial evaluating rilvegostomig).
We have developed predictive drug target discovery capabilities that leverage the power of computational modeling, guided by our scientific expertise and extensive public and proprietary datasets, to identify novel drug targets towards the development of new cancer immunotherapy treatments.
We have developed drug target discovery capabilities that leverage the power of AI/ML based computational algorithms, guided by our scientific expertise and extensive public and proprietary datasets, to identify novel drug targets towards the development of new cancer immunotherapy treatments.
Our multi-omics data analysis is designed to identify novel drug target candidates, which are generally difficult to identify using traditional experimental approaches. We believe that our cutting-edge computational capabilities integrated with our ground-breaking immuno-oncology research and drug development expertise is a key differentiator from others employing computational discovery approaches.
Our multi-omics datasets and analysis are designed to identify novel drug target candidates, which are generally difficult to identify using traditional experimental approaches or literature mining. We believe that our cutting-edge AI/ML powered computational capabilities integrated with our ground-breaking immuno-oncology research and drug development expertise is a key differentiator from others employing computational discovery approaches.
Our broadly applicable predictive drug target discovery capabilities employ a suite of cloud-based computational solutions and purpose-built algorithms to sort through both public and proprietary datasets encompassing genomics, single cell and spatial transcriptomics, proteomics and machine learning based analysis of IHC images.
Our broadly applicable computational drug target discovery capabilities employ a suite of cloud-based solutions and purpose-built algorithms to sort through both public and proprietary datasets encompassing genomics, single cell RNA sequencing, proteomics and spatial transcriptomics, combined with machine learning based analysis of tissue spatial images.
This is done through the extensive use of confidentiality agreements and assignment agreements with our employees, consultants and third parties as well as by technological means. We use license agreements both to access third-party technologies and to grant licenses to third parties to exploit our intellectual property rights. We are currently party to several oppositions in different stages.
This is done through the extensive use of confidentiality agreements and assignment agreements with our employees, consultants and third parties as well as by technological means. We use license agreements both to access third-party technologies and to grant licenses to third parties to exploit our intellectual property rights.
Tumor Treatment Median prior lines Best Response Description Reference Platinum resistant ovarian cancer COM701 6 across indications 1/6 ORR (16.6%) 4/6 DCR (66%) 1 PR >18 months~* in immune desert TME ASCO 2021 COM701 + nivolumab 6 2/20 ORR (10%) 9/20 DCR (45%) 1 PR in patient refractory to nivolumab ESMO IO 2022 COM701 + nivolumab + BMS-986207 4 4/20 ORR (20%) 9/20 DCR (45%) 3 PR >16 months* ESMO IO 2022 SITC 2023 COM701 + pembrolizumab +COM902 4 4/24 ORR (17%) 11/24 DCR (46%) 5 patients on treatment for >200 days SITC 2024 MSS CRC with liver metastases COM701 + nivolumab 4 2/17 ORR (12%) 4/17 DCR (24%) 1 PR in patient with immune desert TME 1 PR >11 months SITC 2022 COM701+ COM902+ pembrolizumab 3 1/15 ORR (7%) 6/15 DCR (40%) 1 PR > 9 months* in patient who had PD on chemo + bev (post data cut patient reassessed as non- target liver lesion of uncertain etiology at baseline) 2 SD >7 months* ASCO 2024 ICI experienced NSCLC COM701 ± nivolumab 6, ≥ 2 prior ICI 5/7 DCR (71%) 3 SD on COM701 monotherapy ESMO IO 2022 Recurrent metastatic MSS endometrial cancer COM701 + nivolumab + BMS-986207 2, 33% prior PD1x 2/9 ORR (22%) 4/9 DCR (44%) 1 PR in patient refractory to lenvatinib/ pembrolizumab ASCO 2023 Metastatic breast cancer COM701 + nivolumab 5 2/17 ORR (12%) 5/17 DCR (30%) 1 CR > 21 months*, low immunogenic HER2 negative tumor SITC 2023 In connection with the table above, BMS-986207 is Bristol Myers Squibb anti-TIGIT; ICI is Immune checkpoint inhibitor; CR is Complete Response; PR is Partial Response; SD is Stable Disease; PD is Progressed Disease; ORR is Overall Response Rate; DCR is Disease Control Rate. *Ongoing at time of data cut-off; ~ means that patient had primary peritoneal cancer. 52 Clinical data disclose from COM701 related studies in 2024 (covered in the table above as well) : On June 1, 2024, at the American Society of Clinical Oncology (ASCO) annual meeting in Chicago, Illinois we presented a poster with new clinical data on COM701 (anti-PVRIG) in triple combination with COM902 (anti-TIGIT) and pembrolizumab in microsatellite stable colorectal cancer (MSS-CRC).
Tumor Treatment Median prior lines Best Response Description Reference Platinum resistant ovarian cancer COM701 6 across indications 1/6 ORR (16.6%) 4/6 DCR (66%) 1 PR >18 months~* in immune desert TME ASCO 2021 COM701 + nivolumab 6 2/20 ORR (10%) 9/20 DCR (45%) 1 PR in patient refractory to nivolumab ESMO IO 2022 COM701 + nivolumab + BMS-986207 4 4/20 ORR (20%) 9/20 DCR (45%) 3 PR >16 months* ESMO IO 2022 SITC 2023 COM701 + pembrolizumab +COM902 4 4/24 ORR (17%) 11/24 DCR (46%) 5 patients on treatment for >200 days SITC 2024 MSS CRC with liver metastases COM701 + nivolumab 4 2/17 ORR (12%) 4/17 DCR (24%) 1 PR in patient with immune desert TME 1 PR >11 months SITC 2022 COM701+ COM902+ pembrolizumab 3 1/15 ORR (7%) 6/15 DCR (40%) 1 PR > 9 months* in patient who had PD on chemo + bev (post data cut patient reassessed as non- target liver lesion of uncertain etiology at baseline) 2 SD >7 months* ASCO 2024 ICI experienced NSCLC COM701 ± nivolumab 6, ≥ 2 prior ICI 5/7 DCR (71%) 3 SD on COM701 monotherapy ESMO IO 2022 Recurrent metastatic MSS endometrial cancer COM701 + nivolumab + BMS-986207 2, 33% prior PD1x 2/9 ORR (22%) 4/9 DCR (44%) 1 PR in patient refractory to lenvatinib/ pembrolizumab ASCO 2023 Metastatic breast cancer COM701 + nivolumab 5 2/17 ORR (12%) 5/17 DCR (30%) 1 CR > 21 months*, low immunogenic HER2 negative tumor SITC 2023 In connection with the table above, BMS-986207 is Bristol Myers Squibb anti-TIGIT; ICI is Immune checkpoint inhibitor; CR is Complete Response; PR is Partial Response; SD is Stable Disease; PD is Progressed Disease; ORR is Overall Response Rate; DCR is Disease Control Rate. *Ongoing at time of data cut-off; ~ means that patient had primary peritoneal cancer. 52 Clinical data disclose from COM701 related studies in 2025 (covered in the table above as well) : On October 18, 2025, at the European Society of Medical Oncology (ESMO) in Berlin, Germany, we presented a poster of pooled analysis of previously presented data reflected in the table above (with an additional year of follow-up), supporting the anti-tumor activity and safety profile of COM701 in heavily pre-treated patients with platinum resistant ovarian cancer (PROC).
Our Strategy We aim to transform patient lives by developing first-in-class therapeutics in the field of cancer immunotherapy based on our AI/ML powered predictive computational discovery platform, named Unigen TM .
Our Strategy We aim to transform patient lives by developing innovative therapeutics in the field of cancer immunotherapy based on Unigen, our AI/ML powered computational discovery platform.
This again may serve for the identification of potential biomarkers and may also inform us on the suggested mechanism of action of our drug candidates. Early-Stage Pipeline Immuno-oncology represents a paradigm shift in the treatment of cancer, and biological drugs blocking immune checkpoint targets have already resulted in long-term patient survival in certain cancer types.
This again may serve for the identification of potential biomarkers and may also inform us on the suggested mechanism of action of our drug candidates. Early-Stage Pipeline Immuno-oncology had made a breakthrough in the treatment of cancer, and biological drugs blocking immune checkpoint targets or directly activating immune cells have resulted in long-term patient survival in certain cancer types.
We employ and leverage our key differentiator, the integration of cutting edge computational capabilities with ground-breaking immuno-oncology research and drug development expertise – in the competitive landscape of immuno-oncology to build our pipeline with potential first-in-class drugs: • We discover novel drug targets with the potential to address the unmet need of patients non-responsive to current cancer immunotherapies • We harness our Unigen TM capabilities to inform our target validation and drug development process; and • We apply our capabilities to inform on the program’s mechanism of action, relevant indication/patient population, drug combinations and potential biomarker that may fit for future patient selection. 49 We believe that the totality of these capabilities uniquely positions us in the discovery and the development of first-in-class drugs for cancer immunotherapy.
We employ and leverage our key differentiator, the integration of cutting edge computational capabilities with groundbreaking immuno-oncology research and drug development expertise, in the competitive landscape of immuno-oncology to build our pipeline with innovative drugs: • We discover novel drug targets with the potential to address the unmet need of patients non-responsive to current cancer immunotherapies • We harness our Unigen capabilities to inform our target experimental validation and drug development process; and • We apply our capabilities to inform on the program’s mechanism of action, relevant indication/patient population, drug combinations and potential biomarker that may fit for future patient selection.
In addition, we may be subject to U.S. federal, U.S. state and foreign laws that require us to report information related to certain payments and other transfers of value to certain health care professionals, as well as ownership and investment interests in our company held by those health care professionals and their immediate family members, and data security and privacy laws that restrict our practices with respect to the use and storage of certain data. 62 Efforts to ensure that our current and future business arrangements with third parties comply with applicable healthcare laws and regulations may involve substantial costs.
In addition, we may be subject to U.S. federal, U.S. state and foreign laws that require us to report information related to certain payments and other transfers of value to certain health care professionals, as well as ownership and investment interests in our company held by those health care professionals and their immediate family members, and data security and privacy laws that restrict our practices with respect to the use and storage of certain data.
Despite their potential, current checkpoint inhibitors are limited to a few targets and are only effective in certain patients and in certain cancers. We believe that the identification of novel drug targets has the potential to broaden the reach of cancer immunotherapies to more types of cancers and many more patients.
Despite their potential, current immuno-oncology agents are limited to a few targets and are only effective in certain patients and in certain cancers. We believe that the identification of novel drug targets with a unique and differentiated mechanism of action has the potential to broaden the reach of cancer immunotherapies to more types of cancer and many more patients.
This analysis is thereafter validated experimentally, and the validated data is used for indication selection for our clinical trials. 55 Secondly, the identification of potential biomarkers for future patient selection. In this approach, we are using various cutting-edge technologies and methodologies on both biopsies, liquid biopsies, and blood samples. The different technologies may include immunohistochemistry, transcriptomic, genomic and proteomic analysis.
Secondly, the identification of potential biomarkers for future patient selection. In this approach, we are using various cutting-edge technologies and methodologies on both biopsies, liquid biopsies, and blood samples. The different technologies may include immunohistochemistry, transcriptomic, genomic and proteomic analysis.
To our knowledge, there are no environmental issues that affect our use of the properties that we lease. ITEM 4A. UNRESOLVED STAFF COMMENTS None
Compugen USA, Inc. no longer leases office space. To our knowledge, there are no environmental issues that affect our use of the properties that we lease. ITEM 4A. UNRESOLVED STAFF COMMENTS None
We believe that this advantage is made possible by building an integrated immuno-oncology platform for predictive discovery based on the integration of scientific understanding and predictive models as well as our unique team of multidisciplinary research scientists, who have vast experience in computational discovery, including developing and handling advance data science approaches, and who over time discovered four drug targets that entered clinical trials and have generated peer reviewed publications in scientific journals.
We believe that this advantage is made possible by building an integrated immuno-oncology platform for discovery based on cutting-edge AI/ML powered computational capabilities integrated with our ground-breaking immuno-oncology research and drug development expertise, as well as our unique team of multidisciplinary research scientists, who have vast experience in computational discovery, including developing and handling advance data science approaches, and who over time discovered several drug targets that entered clinical trials and have generated peer reviewed publications in scientific journals.
Our data suggests that PVRIG has a unique biology, differentiated from other checkpoints. PVRIG is dominantly expressed in stem-like memory T cells (TSCM) and PVRL2 is expressed in dendritic cells. Therefore, PVRIG blockade might induce potent induction of T cell numbers in tumors and unleash antitumor immunity also in indications less responsive to other checkpoint inhibitors, such as ovarian cancer.
PVRIG is dominantly expressed in stem-like memory T cells (TSCM) and PVRL2 is expressed in dendritic cells as well as tumor cells. Therefore, PVRIG blockade might induce potent induction of T cell numbers in tumors and unleash antitumor immunity also in indications less responsive to other checkpoint inhibitors, such as ovarian cancer.
The Phase 1 clinical trial is design to assess the safety and tolerability of GS-0321 (previously COM503) as monotherapy and in combination with zimberelimab in participants with advanced solid tumors.
GS-0321 (previously COM503) is licensed to Gilead and is being developed by us in a Phase 1 clinical trial. The Phase 1 clinical trial is designed to assess the safety and tolerability of GS-0321 (previously COM503) as monotherapy and in combination with zimberelimab in participants with advanced solid tumors.
GS-0321 (previously COM503) was designed to free natural IL-18 activity in the tumor microenvironment by releasing it from IL-18BP, where it can potentiate anti-tumor immune responses, potentially overcoming the limitations of systemically administered cytokines.
GS-0321 (previously COM503) was designed to free natural IL-18 activity in the tumor microenvironment by releasing it from IL-18BP, where it can potentiate anti-tumor immune responses, potentially overcoming the limitations of systemically administered cytokines. GS-0321 (previously COM503) is licensed to Gilead and is being developed by us in a Phase 1 clinical trial.
We are responsible for conducting a Phase 1 clinical trial for GS-0321 (previously COM503), including handling the regulatory matters in connection therewith, and will bear the costs of such trial (including the GS-0321 (previously COM503) drug supply), with Gilead providing at no cost its anti-PD-1 antibody, zimberelimab, for such trial.
We are responsible for conducting the Phase 1 clinical trial for GS-0321 (previously COM503), including handling the regulatory matters in connection therewith, and are bearing the costs of such trial (including the GS-0321 (previously COM503) drug supply), with Gilead having the obligation to provide us its anti-PD-1 antibody, zimberelimab, for such trial.
Two programs that we are pursuing internally, COM701, a potential first-in-class anti-PVRIG antibody, and COM902, a potential best-in-class therapeutic anti-TIGIT antibody, are in Phase 1 clinical trials and have been evaluated for the treatment of solid tumors as a monotherapy and in combination of dual (PVRIG/PD-1, PVRIG/TIGIT) and triple (PVRIG/PD-1/TIGIT) blockade.
COM701, a potential first-in-class anti-PVRIG antibody, and COM902, a potential best-in-class therapeutic anti-TIGIT antibody, have been evaluated for the treatment of solid tumors as monotherapy and in combinations of dual (PVRIG/PD-1, PVRIG/TIGIT) and triple (PVRIG/PD-1/TIGIT) blockade.
Other Healthcare Laws Our current and future business operations, including, among other things, our clinical research activities and our business and financial arrangements and relationships with healthcare providers, physicians and other parties through which we may market, sell and distribute our products, once approved, may be subject to extensive U.S. federal, U.S. state and foreign healthcare fraud and abuse, transparency, and data privacy and security laws.
The FDA does not regulate the behavior of physicians in their choice of treatments, but the FDA does restrict manufacturer’s communications on the subject of off-label use of their products. 61 Other Healthcare Laws Our current and future business operations, including, among other things, our clinical research activities and our business and financial arrangements and relationships with healthcare providers, physicians and other parties through which we may market, sell and distribute our products, once approved, may be subject to extensive U.S. federal, U.S. state and foreign healthcare fraud and abuse, transparency, and data privacy and security laws.
We may also seek co-development arrangements pursuant to which we would further advance partnered programs under any such partnership in order to potentially retain a higher share of proceeds from future collaborations. 56 Gilead License Agreement On December 18, 2023, we entered into the License Agreement, pursuant to which we granted Gilead an exclusive license under our preclinical antibody program against IL-18 binding protein and all intellectual property rights subsisting therein, to use, research, develop, manufacture and commercialize products, including GS-0321 (previously COM503), and additional products that may be so developed by Gilead, together with GS-0321 (previously COM503), referred to herein as the Licensed Products.
Gilead License Agreement On December 18, 2023, we entered into the license agreement, pursuant to which we granted Gilead an exclusive license under our preclinical antibody program against IL-18 binding protein and all intellectual property rights subsisting therein, to use, research, develop, manufacture and commercialize products, including GS-0321 (previously COM503), and additional products that may be so developed by Gilead, together with GS-0321 (previously COM503), referred to herein as the Licensed Products.
During the term of the License Agreement, we are prohibited from researching, developing, making and commercializing any compounds, molecules, products or treatment methods that are directed to IL-18 or any companion diagnostics for an IL-18 product.
Such transfer may also take place under certain circumstances prior to the completion of the Phase 1 clinical trial. During the term of the license agreement, we are prohibited from researching, developing, making and commercializing any compounds, molecules, products or treatment methods that are directed to IL-18 or any companion diagnostics for an IL-18 product.
As of February 1, 2025, we had a total of 62 issued and allowed patents, of which 15 are U.S. patents, 6 are European patents and additional 41 patents in other territories. Our issued and allowed patents expire between 2028 and 2038.
As of February 1, 2026, we had a total of 78 issued and allowed patents, of which 16 are U.S. patents, 7 are European patents and additional 55 patents in other territories. Our issued and allowed patents expire between 2036 and 2038.
We currently apply these capabilities in three different areas. Firstly, we are computationally analyzing omics data using our Unigen TM platform to identify tumor indications in which the pathway of our target plays a role.
We currently apply these capabilities in three different areas. 54 Firstly, we are computationally analyzing omics data using our Unigen platform to identify tumor indications in which the pathway of our target plays a role. This analysis is thereafter validated experimentally, and the validated data is used for indication selection for our clinical trials.
The global immune checkpoint inhibitors market size is estimated at $50.28 billion in 2024 and is anticipated to reach around $229.60 billion by 2034, expanding at a compounded annual growth rate of 16.40% from 2024 to 2034, as reported by Precedence Research. The immune system is naturally programmed to seek out and destroy abnormal cells.
According to Precedence Research, the global immune checkpoint inhibitors market size is estimated at $58.53 billion in 2025 and is projected to reach approximately $229.60 billion by 2034, reflecting a compound annual growth rate (CAGR) of 16.40% from 2025 to 2034. The immune system is naturally programmed to seek out and destroy abnormal cells.
We have the right to continue the development and commercialization of bapotulimab, should we choose to do so. Research Focus - Immuno-Oncology Our research and development efforts focus on identifying novel drug targets and developing first-in-class therapeutics in the field of cancer immunotherapy. 50 Cancer immunotherapies represent a significant commercial market.
Research Focus - Immuno-Oncology Our research and development efforts focus on identifying novel drug targets and developing innovative therapeutics in the field of cancer immunotherapy. Cancer immunotherapies continue to represent a rapidly expanding commercial market.
Human clinical trials are typically conducted in three phases that may overlap or be combined: • Phase 1: The product candidate is initially introduced into healthy human subjects and tested for safety, dosage tolerance, absorption, metabolism, distribution and excretion.
Protocols detail, among other things, the objectives of the trial, dosing procedures, subject selection and exclusion criteria, and the parameters to be used to monitor subject safety and determine efficacy. 60 Human clinical trials are typically conducted in three phases that may overlap or be combined: • Phase 1: The product candidate is initially introduced into healthy human subjects and tested for safety, dosage tolerance, absorption, metabolism, distribution and excretion.
Clinical Development In March 2020, we dosed our first patient in the Phase 1 clinical trial of COM902. COM902 was primarily evaluated in combination with COM701.
The TIGIT discovery was published by us in October 2009 in the Proceedings of the National Academy of Sciences (PNAS). 53 Clinical Development In March 2020, we dosed our first patient in the Phase 1 clinical trial of COM902. COM902 was primarily evaluated in combination with COM701.
PROPERTY, PLANTS AND EQUIPMENT In December 2015, we moved to our facilities in Holon, Israel where we leased an aggregate of approximately 35,250 square feet of office, biology laboratory facilities and warehouse.
PROPERTY, PLANTS AND EQUIPMENT In December 2015, we moved to our facilities in Holon, Israel where we leased an aggregate of approximately 35,250 square feet of office, biology laboratory facilities and warehouse. Following the exercise of our first and second option, we lease 30,140 square feet under that lease that will expire on March 14, 2031.
Therapeutic Pipeline • COM701 - a therapeutic antibody targeting PVRIG Pathway expression and preclinical data COM701 is a potentially first-in-class humanized antibody that binds with high affinity to PVRIG, a novel immune checkpoint target candidate discovered by Compugen, blocking the interaction with its ligand, PVRL2.
Our discovery strategy is focused on the discovery of novel drug targets which may provide new cancer immunotherapies for enhancing anti-tumor immune responses in cancer patients. 51 Therapeutic Pipeline • COM701 - a therapeutic antibody targeting PVRIG Pathway expression and preclinical data COM701 is a potentially first-in-class humanized antibody that binds with high affinity to PVRIG, a novel immune checkpoint target candidate discovered by us, blocking the interaction with its ligand, PVRL2.
This subsidiary did not have any significant operations from 2008 to March 2012. Principal Capital Expenditures In the years ended December 31, 2024, 2024 and 2022, our capital expenditures were 0.1 million, $0.2 million and $0.4 million, respectively. As of December 31, 2024, we had no significant commitments for capital expenditures. B.
Principal Capital Expenditures In the years ended December 31, 2025, 2024 and 2023, our capital expenditures were $0.3 million, $0.1 million and $0.2 million, respectively. As of December 31, 2025, we had no significant commitments for capital expenditures. B.
Neither such internet addresses are a part of this Annual Report. 48 Our agent for service of process in the United States is Compugen USA, Inc., our wholly owned U.S. subsidiary located at 225 Bush Street, Suite 348, San Francisco, CA 94104, which was incorporated in Delaware in March 1997 and is qualified to do business in California.
Our agent for service of process in the United States is Compugen USA, Inc., our wholly owned U.S. subsidiary located at 101 Montgomery Street, San Francisco, CA 94104, which was incorporated in Delaware in March 1997 and is qualified to do business in California. This subsidiary did not have any significant operations from 2008 to March 2012.
These studies are intended to establish the overall risk-benefit ratio of the product and provide an adequate basis for product labeling and approval. 61 Progress reports detailing the results of the clinical trials must be submitted at least annually to the FDA and safety reports for serious and unexpected adverse events must be submitted to the FDA and the investigators more frequently.
Progress reports detailing the results of the clinical trials must be submitted at least annually to the FDA and safety reports for serious and unexpected adverse events must be submitted to the FDA and the investigators more frequently.
COM902 blocks the interaction of TIGIT with PVR, its ligand. COM902 is potential best-in-class antibody with a non-active Fc tail. COM902 prevents depletion of major TIGIT + expressing lymphocytes (NK, CD4 and CD8 T cells), supporting rationale for selecting a high affinity anti-TIGIT antibody with an IgG4 backbone and low Fc effector function.
COM902 prevents depletion of major TIGIT + expressing lymphocytes (NK, CD4 and CD8 T cells), supporting rationale for selecting a high affinity anti-TIGIT antibody with an IgG4 backbone and low Fc effector function. Phase 1 clinical trials for COM902 were initiated in March 2020.
In addition, AstraZeneca is also running several Phase 1 and 2 clinical trials with rilvegostomig in additional indications. • GS-0321 (previously COM503) is a potential first-in-class high affinity antibody, which blocks the interaction between interleukin-18 binding protein (IL18BP) and interleukin-18 (IL-18).
AstraZeneca initiated its first Phase 3 clinical trial at the end of 2023, dosing its first patient in December 2023 and rilvegostomig is currently being evaluated in multiple Phase 3, Phase 2 and Phase 1 clinical trials. • GS-0321 (previously COM503) is a potential first-in-class high affinity antibody, which blocks the interaction between interleukin-18 binding protein (IL18BP) and interleukin-18 (IL-18).
GS-0321 (previously COM503) our potential first-in-class high affinity antibody, which blocks the interaction between IL-18 binding protein and IL-18, is licensed to Gilead and is being developed by us in a recently initiated Phase 1 clinical trial. In addition, we have an early-stage immuno-oncology therapeutic pipeline that consists of research programs aiming to address various mechanisms to enhance anti-cancer immunity.
GS-0321 (previously COM503) our potential first-in-class high affinity antibody, which blocks the interaction between IL-18 binding protein and IL-18, is licensed to Gilead and is being evaluated in a Phase 1 clinical trial that we sponsor and are conducting by us.
The Budget Control Act of 2011, triggered automatic reduction to several government programs, including reductions to Medicare payments to providers, which went into effect in April 2013 and will remain in effect until 2032, unless additional congressional action is taken. 63 Additionally, there has been increasing legislative and enforcement interest in the United States with respect to drug pricing practices.
The Budget Control Act of 2011, triggered automatic reduction to several government programs, including reductions to Medicare payments to providers, which went into effect in April 2013 and will remain in effect until 2032, unless additional congressional action is taken. The current administration is pursuing policies to reduce regulations and expenditures across government agencies including at the U.S.
For information regarding the evaluation of COM902 in combination with COM701, see “COM701 Clinical Programs” above. • Rilvegostomig - a therapeutic PD-1/TIGIT bi-specific antibody with a TIGIT component that is derived from our COM902 Rilvegostomig is a PD-1/TIGIT bi-specific antibody with a TIGIT component that is derived from our COM902 being developed by AstraZeneca pursuant to an exclusive license between us and AstraZeneca.
This decision may be revisited pending further data disclosure regarding TIGIT by other companies. • Rilvegostomig - a therapeutic PD-1/TIGIT bi-specific antibody with a TIGIT component that is derived from our COM902 Rilvegostomig is a PD-1/TIGIT bi-specific antibody with a TIGIT component that is derived from our COM902 being developed by AstraZeneca pursuant to an exclusive license between us and AstraZeneca.
United States and other governmental agencies may also impose restrictions on the use of data derived from human or other tissue samples. Regulations Concerning the Use of Animals in Research We also are subject to various laws and regulations regarding laboratory practices and the use of animals in our research.
Regulations Concerning the Use of Animals in Research We also are subject to various laws and regulations regarding laboratory practices and the use of animals in our research.
In our clinical therapeutic pipeline, our most advanced programs are: • COM701 is our internal lead immuno-oncology pipeline program. COM701 is a humanized antibody that binds with high affinity to PVRIG, a novel immune checkpoint target candidate discovered by us that blocks the interaction with its ligand, PVRL2.
COM701 is a humanized antibody that binds with high affinity to PVRIG, a novel immune checkpoint target candidate discovered by us that blocks the interaction with its ligand, PVRL2. Our data suggest that PVRIG has a unique biology, differentiated from other checkpoints.
Our business model is to selectively enter into collaborations for our novel targets and drug product candidates at various stages of research and development under various revenue-sharing arrangements.
In addition, we have an early-stage immuno-oncology therapeutic pipeline that consists of research programs aiming to address various mechanisms to enhance anti-cancer immunity. 49 Our business model is to selectively enter into collaborations for our novel targets and drug product candidates at various stages of research and development under various revenue-sharing arrangements.
Phase 1 clinical trials for COM902 were initiated in March 2020. • Rilvegostomig is a PD-1/TIGIT bispecific antibody with a TIGIT component that is derived from COM902 and is being developed by AstraZeneca pursuant to an exclusive license agreement with AstraZeneca.
This decision may be revisited pending further data disclosure regarding TIGIT by other companies. 50 • Rilvegostomig is a PD-1/TIGIT bispecific antibody with a TIGIT component that is derived from COM902 and is being developed by AstraZeneca pursuant to an exclusive license agreement with AstraZeneca.
The antibodies designed to block these targets are or have been evaluated in clinical trials by us (COM701, COM902 and GS-0321 (previously COM503)) or by our partners (bapotulimab and rilvegostomig).
The antibodies designed to block these targets are or have been evaluated in clinical trials by us (COM701, COM902 and GS-0321 (previously COM503)) or by our partners (bapotulimab and rilvegostomig). 55 Business Strategy and Partnerships Our business strategy includes entering into various forms of revenue-sharing collaborations with pharmaceutical or biotechnology partners for our novel drug targets and product candidates at various stages of research and development.
Our access and use of these samples are subject to government regulation, in the United States, Israel and elsewhere and may become subject to further regulation. The use of clinical data associated with human tissue samples is also heavily regulated in the United States, Israel and elsewhere.
The use of clinical data associated with human tissue samples is also heavily regulated in the United States, Israel and elsewhere. United States and other governmental agencies may also impose restrictions on the use of data derived from human or other tissue samples.
Potential revenue sources in line with this business strategy could include upfront fees, research funding, in-kind funding, milestones payments, license fees, royalties and other revenue sharing payments.
Additionally, our discovery capabilities designed to feed our internal pipeline may allow for future research and discovery collaborations aimed at harnessing our capabilities towards a potential partner’s pipeline needs. Potential revenue sources in line with this business strategy could include upfront fees, research funding, in-kind funding, milestones payments, license fees, royalties and other revenue sharing payments.
Our potential competitors are also comprised of companies that discover and develop monoclonal antibody therapies and/or therapeutic proteins to novel targets, and/or other modalities, including cell therapies for oncology diseases.
Our potential competitors are also comprised of companies that discover and develop monoclonal antibody therapies and/or therapeutic proteins to novel targets, and/or other modalities, including bi-specifics and tri-specifics antibodies, T cell engagers (TCE), cell therapies, ADCs, small molecules such as protein degraders, molecular glues, and oligonucleotides based mRNA therapeutics.
Coverage and reimbursement policies for products can differ significantly from payor to payor as there is no uniform policy of coverage and reimbursement for products among third party payors in the United States. Further, coverage policies and third-party payor reimbursement rates may change at any time.
Coverage and reimbursement policies for products can differ significantly from payor to payor as there is no uniform policy of coverage and reimbursement for products among third party payors in the United States. Additionally, the containment of healthcare costs has become a priority of federal and state governments, and the prices of drugs have been a focus in this effort.
Therefore, this unique expression pattern and resulted biology might enable PVRIG blockade to be active in patients with less inflamed tumors, such as ovarian cancer. In addition, expression studies showed that PVRIG, TIGIT, and their respective ligands, are expressed in a broad variety of tumor types, with ovarian cancer having one of the highest expressions of the pathway.
In addition, expression studies showed that PVRIG and its ligand, PVRL2, are expressed in a broad variety of tumor types, with ovarian cancer having one of the highest expressions of the pathway.

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Item 5. Market for Registrant's Common Equity

Market for Common Equity — stock, dividends, buybacks

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Biggest changeWhile these downgrades did not have an immediate nor direct impact on us, an extended period of economic disruption, including a continued market downfall in Israel, which may be impacted by such downgrades, by future downgrades, by the continuing armed conflict between Israel and its surrounding countries, including as a result of the “Swords of Iron” war and the political and civil actions in Israel which began in early 2023, resulting from, among other things, proposed changes to certain Israeli constitutional legislation, as well as a continued market downfall in the United States or any other major market in which we or our partners operate, could materially affect our ability to secure additional funds and could further materially affect our business, strategy, results of operations and financial condition. 74 To date, our operations and business have not been materially impacted by the hostilities involving Israel, including the “Swords of Iron” war and the additional armed conflicts between Israel and its surrounding countries (including Iran, Hezbollah (a Shia Islamist political party and militant group based in Lebanon), the Houthi movement which controls parts of Yemen, and Iranian-backed militias in Syria), nor by the political and social condition in Israel, including the effects of the ICJ Interim Ruling and the recent political and civil actions in Israel which began in early 2023, resulting from, among other things, proposed changes to certain Israeli constitutional legislation.
Biggest changeWhile these downgrades and negative outlook as of late 2025 did not have an immediate nor direct impact on us, an extended period of economic disruption, including a continued market downfall in Israel, which may be impacted by such downgrades or by some agencies maintaining negative outlook, by future downgrades, by the continuing instability in Israel and the Middle East and its surrounding countries, including as a result of the armed conflicts in the region and the political and civil actions in Israel which began in early 2023, resulting from, among other things, proposed changes to certain Israeli constitutional legislation, as well as other global conflicts, such as the recent developments between the U.S. and Venezuela, the conflict between Russia and Ukraine, and the inner tensions in Iran and their potential global impact, or as a continued market downfall in the United States or any other major market in which we or our partners operate, could materially affect our ability to secure additional funds and could further materially affect our business, strategy, results of operations and financial condition.
Rilvegostomig, a PD-1/TIGIT bispecific antibody with a TIGIT component that is derived from our COM902 program, is being developed by AstraZeneca pursuant to an exclusive license agreement between us and AstraZeneca and is being evaluated in multiple Phase 3 clinical trials and in multiple Phase 2 and Phase 1 clinical trials.
Rilvegostomig, a PD-1/TIGIT bispecific antibody with a TIGIT component that is derived from our COM902 program, is being developed by AstraZeneca pursuant to an exclusive license agreement between us and AstraZeneca and is being evaluated in multiple Phase 3, Phase 2 and Phase 1 clinical trials.
However, we cannot guarantee that we will be able to obtain financing through the issuance of any of the above arrangements on reasonable terms. Unfavorable Global or Domestic Political or Economic Conditions The global economy continues to experience significant volatility, and the economic environment may continue to be, or become, less favorable than that of past years.
However, we cannot guarantee that we will be able to obtain financing through the issuance of any of the above arrangements on reasonable terms. 73 Unfavorable Global or Domestic Political or Economic Conditions The global economy continues to experience significant volatility, and the economic environment may continue to be, or become, less favorable than that of past years.
We have elected to implement the 2011 Amendment and we currently have a Preferred Enterprise. In December 2016, the Economic Efficiency Law (Legislative Amendments for Applying the Economic Policy for the 2017 and 2018 Budget Years), 2016 which includes Amendment 73 to the Law, or Amendment 73, was published.
We have elected to implement the 2011 Amendment and we currently have a Preferred Enterprise. 68 In December 2016, the Economic Efficiency Law (Legislative Amendments for Applying the Economic Policy for the 2017 and 2018 Budget Years), 2016 which includes Amendment 73 to the Law, or Amendment 73, was published.
Includes the first and second five-year option periods of the lease of the Israeli facility. The first option was exercised during 2020. (2) Severance pay obligations to our Israeli employees. For more information, see “Item 6. Directors, Senior Management and Employees – D.
Includes the first and second five-year option periods of the lease of the Israeli facility. The first option was exercised during 2020 and the second option was exercised during 2025. (2) Severance pay obligations to our Israeli employees. For more information, see “Item 6. Directors, Senior Management and Employees – D.
Financial and other income increased by 62% to approximately $5.2 million in 2024 up from approximately $3.2 million in the comparable period of 2023. The increase was mainly attributed to higher cash balances which resulted in higher financial income. Taxes on Income.
Financial and other income increased by 62% to approximately $5.2 million in 2024 up from approximately $3.2 million in the comparable period of 2023. The increase was mainly attributed to higher cash balances which resulted in higher financial income. Taxes on Income, net.
Employees.” The above table does not include royalties that we may be required to pay to the IIA. For more information, see “Item 5. Operating and Financial Review and Prospects - C.
Employees.” 71 The above table does not include royalties that we may be required to pay to the IIA. For more information, see “Item 5. Operating and Financial Review and Prospects - C.
We believe that we have sufficient cash and cash equivalents, short-term bank deposits and investment in marketable securities in order to sustain our operations into 2027, 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 we have sufficient cash and cash equivalents, short-term bank deposits and investment in marketable securities in order to sustain our operations 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.
In addition to the impact on our cash and cash equivalents, rising interest rates, or the perception thereof, may have wide economic impacts, including an adverse impact on capital markets, the price of our shares and on supplies that we require to conduct our different operations. For more information regarding interest rate risk please see “Item 11.
In addition to the impact on our cash and cash equivalents, rising interest rates, or the perception thereof, may have wide economic impacts, including an adverse impact on capital markets, the price of our shares and on supplies that we require to acquire for our different operations. For more information regarding interest rate risk please see “Item 11.
The principal source of cash provided by financing activities in 2024 and 2023 was proceeds received from sale of ordinary shares through the Sales Agreement with Leerink. 71 Net Liquidity Liquidity refers to the liquid financial assets available to fund our business operations and pay for near-term obligations.
The principal source of cash provided by financing activities in 2025, 2024 and 2023 was proceeds received from sale of ordinary shares through the Sales Agreement with Leerink. Net Liquidity Liquidity refers to the liquid financial assets available to fund our business operations and pay for near-term obligations.
The annual limitation may result in the expiration of net operating losses before utilization. For a description of Israel government policies that affect our research and development expenses, and the financing of our research and development, see “Item 5. Operating and Financial Review and Prospects - C. Research and Development, Patents and Licenses - The Israel Innovation Authority.” B.
The annual limitation may result in the expiration of net operating loss before utilization. For a description of Israel government policies that affect our research and development expenses, and the financing of our research and development, see “Item 5. Operating and Financial Review and Prospects - C. Research and Development, Patents and Licenses - The Israel Innovation Authority.” B.
Quantitative And Qualitative Disclosures About Market Risk – Interest Rate Risk.” Trend Towards Biologics Biologics (monoclonal and bispecific antibodies, ADCs, enzymes and engineered proteins) represent one of the fastest growing segments in the drug industry, making up 31% of FDA approved drugs in 2023 and 32% in 2024.
Quantitative And Qualitative Disclosures About Market Risk – Interest Rate Risk.” Trend Towards Biologics Biologics (monoclonal and bispecific antibodies, ADCs, enzymes and engineered proteins) represent one of the fastest growing segments in the drug industry, making up 31% of FDA approved drugs in 2023, 32% in 2024, and 25% in 2025.
However, if our plans change or if our burn-rate increases, our cash balances may only be sufficient for a shorter period of time. For a detailed description of our cash and cash equivalents position, see “Item 5. Operating and Financial Review and Prospects - B. Liquidity and Capital Resources.” 66 Years Ended December 31, 2024 and 2023 Revenues.
However, if our plans change or if our burn-rate increases, our cash balances may only be sufficient for a shorter period of time. For a detailed description of our cash and cash equivalents position, see “Item 5. Operating and Financial Review and Prospects - B. Liquidity and Capital Resources.” Years Ended December 31, 2025 and 2024 Revenues.
Additional potential sources of cash may include proceeds generated from agreements with collaborators and other third parties with respect to our novel targets and therapeutic drug candidates and proceeds from issuance of ordinary shares pursuant to our equity plans, and issuance of ordinary shares from financing transactions.
Additional potential sources of cash may include proceeds generated from agreements with collaborators and other third parties with respect to our novel targets and therapeutic drug candidates and proceeds from issuance of ordinary shares pursuant to our equity plans, from the Sales Agreement and other financing transactions.
The table below summarizes our contractual obligations as of December 31, 2024, and should be read together with the accompanying comments that follow.
The table below summarizes our contractual obligations as of December 31, 2025, and should be read together with the accompanying comments that follow.
Any dividends distributed to “foreign companies”, as defined in the Law, deriving from income from the Technological Enterprises will be subject, under certain conditions, including holding at least 90% of the share capital, to tax at a rate of 4%. As of December 31, 2024, our net operating loss carry-forward for Israeli tax purposes amounted to approximately $413.9 million.
Any dividends distributed to “foreign companies”, as defined in the Law, deriving from income from the Technological Enterprises will be subject, under certain conditions, including holding at least 90% of the share capital, to tax at a rate of 4%. As of December 31, 2025, our net operating loss carry-forward for Israeli tax purposes amounted to approximately $381.4 million.
We focus our efforts on the development of our discovery capabilities and related technologies, and the discovery and validation of our drug targets and the preclinical and clinical development of the respective therapeutic product. Our pipeline programs are continuously evolving, and we expect that in 2025 our research and development expenses will continue to be our major operating expense.
We focus our efforts on the development of our discovery capabilities and related technologies, and the discovery and validation of our drug targets and the preclinical and clinical development of the respective therapeutic products. Our pipeline programs are continuously evolving, and we expect that in 2026 our research and development expenses will continue to be our major operating expense.
License Agreement AstraZeneca License Agreement On March 30, 2018, we and AstraZeneca, entered into an exclusive license agreement to enable the development of bi-specific and multi-specific immuno-oncology antibody products based on the Company’s monospecific antibodies that bind to TIGIT, including COM902, pursuant to which the Company received an upfront payment of $10 million and is eligible to receive up to $200 million in development, regulatory and commercial milestones for the first product as well as mid-single-digit tiered royalties on future product sales, out of which we accrued $2 million in 2020 as a preclinical milestone, $6 million in 2021 as a clinical milestone (triggered by the dosing of the first patient in a Phase 1/2 clinical trial evaluating rilvegostomig), $7.5 million in 2022 as a clinical milestone (triggered by the dosing of the first patient in its ARTEMIDE Phase 2 clinical trial evaluating rilvegostomig), $10 million in 2023 as a clinical milestone (triggered by the dosing of the first patient in its ARTEMIDE-Bil01 Phase 3 clinical trial evaluating rilvegostomig), and an additional $5 million in 2024 (triggered by dosing of the first patient in the second Phase 3 clinical trial evaluating rilvegostomig).
This registration statement was declared effective by the SEC on June 27, 2023. 69 License Agreement AstraZeneca License Agreement On March 30, 2018, we and AstraZeneca, entered into an exclusive license agreement to enable the development of bi-specific and multi-specific immuno-oncology antibody products based on the Company’s monospecific antibodies that bind to TIGIT, including COM902, pursuant to which the Company received an upfront payment of $10 million and was eligible to receive up to $200 million in development, regulatory and commercial milestones for the first product as well as mid-single-digit tiered royalties on future product sales, out of which we accrued $2 million in 2020 as a preclinical milestone, $6 million in 2021 as a clinical milestone (triggered by the dosing of the first patient in a Phase 1/2 clinical trial evaluating rilvegostomig), $7.5 million in 2022 as a clinical milestone (triggered by the dosing of the first patient in its ARTEMIDE Phase 2 clinical trial evaluating rilvegostomig), $10 million in 2023 as a clinical milestone (triggered by the dosing of the first patient in its ARTEMIDE-Bil01 Phase 3 clinical trial evaluating rilvegostomig), and an additional $5 million in 2024 (triggered by dosing of the first patient in the second Phase 3 clinical trial evaluating rilvegostomig).
Approximately $0.3 million of these losses are available to offset any future U.S. taxable income of our U.S. subsidiary and will expire between 2027 and 2032. 69 Use of our U.S. net operating losses may be subject to substantial annual limitation due to the “change in ownership” provisions of the Code and similar state provisions.
Approximately $0.3 million of this loss are available to offset any future U.S. taxable income of our U.S. subsidiary and will expire between 2027 and 2032. Use of our U.S. net operating loss may be subject to substantial annual limitation due to the “change in ownership” provisions of the Code and similar state provisions.
Integrating cutting edge computational capabilities with ground-breaking immuno-oncology research and drug development expertise is our differentiator and has enabled us to advance drug targets from computer prediction through successful preclinical studies to the clinic. Therefore, we believe that we are uniquely positioned to discover and develop potential novel, first-in-class treatment options for cancer patients. A.
Integrating cutting edge computational capabilities with ground-breaking immuno-oncology research and drug development expertise is our differentiator and has enabled us to advance drug targets from computer prediction through successful preclinical studies to the clinic. Therefore, we believe that we are uniquely positioned to discover and develop innovative treatment options for cancer patients. A.
In the future, if and when we generate taxable income, our effective tax rate may be influenced by, among others: (a) the split of taxable income between the various tax jurisdictions; (b) the availability of tax loss carry forwards, R&D credits carry forwards and the extent to which valuation allowance has been recorded against deferred tax assets; (c) the tax benefits we will be entitled to pursuant to the Investment Law; and (d) the changes in the exchange rate of the dollar to the NIS.
The corporate tax rate in Israel was 23% in 2025, 2024 and 2023. 67 In the future, if and when we generate taxable income, our effective tax rate may be influenced by, among others: (a) the split of taxable income between the various tax jurisdictions; (b) the availability of tax loss carry forwards, R&D credits carry forwards and the extent to which valuation allowance has been recorded against deferred tax assets; (c) the tax benefits we will be entitled to pursuant to the Investment Law; and (d) the changes in the exchange rate of the dollar to the NIS.
GS-0321 (previously COM503), our potential first-in-class high affinity antibody, which blocks the interaction between IL-18 binding protein and IL-18, is licensed to Gilead and is being developed by us in a recently initiated Phase 1 clinical trial. In addition, we have an early-stage immuno-oncology therapeutic pipeline that consists of research programs aiming to address various mechanisms to enhance anti-cancer immunity.
GS-0321 (previously COM503), our potential first-in-class high-affinity antibody, which blocks the interaction between IL-18 binding protein and IL-18, is licensed to Gilead and is being evaluated in a Phase 1 clinical trial that we sponsor and conduct. In addition, we have an early-stage immuno-oncology therapeutic pipeline that consists of research programs aiming to address various mechanisms to enhance anti-cancer immunity.
We are currently pursuing clinical development of our internal programs COM701 and COM902 as well as GS-0321 (previously COM503) on behalf of our partner, Gilead, for which we are only responsible for the Phase 1 development.
We are currently pursuing clinical development of our internal program COM701 as well as GS-0321 (previously COM503) on behalf of our partner, Gilead, for which we are only responsible for the Phase 1 development.
As of December 31, 2024, 53 of our employees were engaged in research and development on a full-time basis. This represents approximately 70% of our entire work force at that time.
As of December 31, 2025, 53 of our employees were engaged in research and development on a full-time basis. This represents approximately 71% of our entire work force at that time.
We account for forfeitures as they occur. The value of the pro-rata portion of the award, assuming no forfeiture, is recognized in our consolidated statement of comprehensive loss as an expense over the requisite service periods. Upon forfeiture the expense is adjusted so that expense is recognized for the portion of the award that actually vested.
The value of the pro-rata portion of the award, assuming no forfeiture, is recognized in our consolidated statement of comprehensive loss as an expense over the requisite service periods. Upon forfeiture the expense is adjusted so that expense is recognized for the portion of the award that actually vested.
Under Israeli law, these net operating losses may generally be carried forward indefinitely and offset against certain future taxable income. As of December 31, 2024, the net operating loss carry-forward of our U.S. subsidiary for federal income tax purposes amounted to approximately $1.4 million.
Under Israeli law, this net operating loss may generally be carried forward indefinitely and offset against certain future taxable income. As of December 31, 2025, the net operating loss carry-forward of our U.S. subsidiary for federal income tax purposes amounted to approximately $1.5 million.
These liquid financial assets mostly consist of cash and cash equivalents as well as short-term bank deposits and investment in marketable securities. As of December 31, 2024, we had cash and cash equivalents, short-term bank deposits and investment in marketable securities of approximately $103.3 million compared to approximately $50.7 million on December 31, 2023.
These liquid financial assets mostly consist of cash and cash equivalents as well as short-term bank deposits and investment in marketable securities. As of December 31, 2025, we had cash and cash equivalents, short-term bank deposits and investment in marketable securities of approximately $145.6 million compared to approximately $103.3 million on December 31, 2024.
OPERATING RESULTS Overview Since our inception, we have incurred significant losses and, as of December 31, 2024, we had an accumulated deficit of $488.8 million. We expect to continue to incur net losses in the foreseeable future.
OPERATING RESULTS Overview Since our inception, we have incurred significant losses and, as of December 31, 2025, we had an accumulated deficit of $453.4 million. We expect to continue to incur net losses in the foreseeable future.
We evaluate on an on-going basis these estimates, mainly related to share-based payments, deferred participation in research and development expenses, revenue recognition, and research and development expenses. We base our estimates on our experience and on various assumptions that we believe are reasonable under the circumstances.
We evaluate on an on-going basis these estimates, mainly related to revenue recognition and share-based payments. 74 We base our estimates on our experience and on various assumptions that we believe are reasonable under the circumstances.
See Note 2j to our 2024 consolidated financial statements. 76 In December 2023, following entrance into license agreement with Gilead, we assessed the promises under the license agreement and concluded that its promise to deliver the GS-0321 (previously COM503) License, the promise to perform IND research and development activities and Phase 1 research and development activities represented separate performance obligations in the license agreement.
In December 2023, following entrance into license agreement with Gilead, we assessed the promises under the license agreement and concluded that its promise to deliver the GS-0321 (previously COM503) License, the promise to perform IND research and development activities and Phase 1 research and development activities represented separate performance obligations in the license agreement.
Net Loss per share. Net loss per share was 16 cents per basic and diluted share in 2024, compared with 21 cents per basic and diluted share in the comparable period of 2023. Years Ended December 31, 2023 and 2022 Revenues.
Net profit per share was 38 cents per basic share in 2025, compared with net loss of 16 cents per basic share in the comparable period of 2024, and net profit per share was 38 cents per diluted share in 2025, compared with net loss of 16 cents per diluted share in the comparable period of 2024. 66 Years Ended December 31, 2024 and 2023 Revenues.
Research and development expenses were our major operating expenses representing approximately 71% of total operating expenses in 2024 and approximately 78% in 2023 and approximately 73% 2022. Our research and development expenses, net, were approximately $24.8 million in 2024, approximately $34.5 million in 2023 and approximately $30.6 million in 2022.
Research and development expenses were our major operating expenses representing approximately 71% of total operating expenses in 2025 and in 2024 and approximately 78% in 2023. Our research and development expenses, net, were approximately $22.8 million in 2025, approximately $24.8 million in 2024, and approximately $34.5 million in 2023.
Increase in net cash provided by operating activities in 2024 compared to 2023 was mainly due to $91.5 million derived from upfront payment and clinical milestones payments collected from Gilead and from AstraZeneca, net of withholding taxes, offset by increase in operating expenses (including cost of revenues) on cash basis.
Decrease in net cash provided by operating activities in 2025 compared to 2024 was mainly due to $65 million derived from upfront payment collected from AstraZeneca in 2025, compared with $91.5 million derived from upfront payment and clinical milestones payments collected from Gilead and from AstraZeneca, net of withholding taxes in 2024, offset by operating expenses on cash basis.
In December 2020 the program under the exclusive license agreement with AstraZeneca achieved a preclinical milestone and in September 2021, November 2022, December 2023 and May 2024 such program achieved clinical milestones and in connection with such milestones, we recognized revenues in an amount of $2 million, $6 million, $7.5 million, $10 million and $5 million, in the years 2020, 2021, 2022, 2023 and 2024, respectively, in accordance with the criteria prescribed under ASC 606.
In December 2020 the program under the exclusive license agreement with AstraZeneca achieved a preclinical milestone and in September 2021, November 2022, December 2023 and May 2024 such program achieved clinical milestones and in connection with such milestones, we recognized revenues in an amount of $2 million, $6 million, $7.5 million, $10 million and $5 million, in the years 2020, 2021, 2022, 2023 and 2024, respectively, and in 2025 we amended the license agreement with AstraZeneca and sold a portion of our royalty interest to AstraZeneca, leading to revenue recognition of $65 million, all in accordance with the criteria prescribed under ASC 606.
Net Cash Used in Operating Activities Net cash provided by operating activities was approximately $49.6 million in 2024, compared with net cash used in operating activities of approximately $35.9 million in 2023 and approximately $34.1 million in 2022.
Net Cash Used in or Provided by Operating Activities Net cash provided by operating activities was approximately $31.6 million in 2025, compared with approximately $49.6 million in 2024 and net cash used in operating activities of approximately $35.9 million in 2023.
Governmental Policies that Materially Affected or Could Materially Affect Our Operations Our income tax obligations consist of those of Compugen Ltd. in Israel and of Compugen USA, Inc. in its taxing jurisdictions. The corporate tax rate in Israel was 23% in 2024, 2023 and 2022.
Governmental Policies that Materially Affected or Could Materially Affect Our Operations Our income tax obligations consist of those of Compugen Ltd. in Israel and of Compugen USA, Inc. in its taxing jurisdictions.
For the year ended December 31, 2023, and for the year ended December 31, 2024 and for the period between January 1, 2025 and February 28, 2025, the Company sold 2,612,822, 292,728 and 3,961,641 ordinary shares, respectively, pursuant to the Sales Agreement, for gross proceeds of approximately $3.6 million, $0.6 million, and $9.1 million, respectively, and net proceeds (after deducting commissions paid) of approximately $3.5 million, $0.6 million, and $8.9 million respectively.
For the year ended December 31, 2025, December 31, 2024, and December 31, 2023, the Company sold 4,862,076, 292,728, and 2,612,822 ordinary shares, respectively, pursuant to the Sales Agreement, for gross proceeds of approximately $10.9 million, $0.6 million, and $3.6 million, respectively, and net proceeds (after deducting expenses and commissions paid) of approximately $10.5 million, $0.5 million, and $3.1 million respectively.
Net Cash Provided by Investing Activities Net cash used in investing activities was approximately $46.3 million in 2024, compared with net cash provided by investing activities of approximately $35.5 million in 2023 and approximately $37.1 million in 2022.
Net Cash Used in or Provided by Investing Activities Net cash provided by investing activities was approximately $30.0 million in 2025, compared with net cash used in approximately $46.3 million in 2024 and net cash provided by investing activities of approximately $35.5 million in 2023.
We determined that the license granted was a functional license since the underlying intellectual property has significant standalone functionality 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.
To determine the estimated standalone selling price of the Phase 1 research and development activities obligation, we estimated the standalone selling price of the underlying performance obligations and estimated the probability of our performance of such obligations. 75 We determined that the license granted was a functional license since the underlying intellectual property has significant standalone functionality 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.
In 2024, AstraZeneca provided a non-risk adjusted peak year revenue target for rilvegostomig of over $5 billion. 70 Gilead License Agreement On December 18, 2023, we and Gilead, entered into an exclusive license agreement, or the License Agreement, pursuant to which we granted Gilead an exclusive license under our preclinical antibody program against IL-18 binding protein and all intellectual property rights subsisting therein, to use, research, develop, manufacture and commercialize products, including our GS-0321 (previously COM503) product candidate, or together, the GS-0321 (previously COM503), and additional products that may be developed by Gilead, together with GS-0321 (previously COM503), the Licensed Products.
Gilead License Agreement On December 18, 2023, we and Gilead, entered into an exclusive license agreement, pursuant to which we granted Gilead an exclusive license under our preclinical antibody program against IL-18 binding protein and all intellectual property rights subsisting therein, to use, research, develop, manufacture and commercialize products, including our GS-0321 (previously COM503) product candidate, or together, the GS-0321 (previously COM503), and additional products that may be developed by Gilead, together with GS-0321 (previously COM503), the Licensed Products.
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 enter into revenue-sharing partnering agreements with pharmaceutical companies with respect to our product candidates at the various development stages. 72 Research and Development Grants We have participated in programs offered by the IIA that support research and development activities.
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.
These benefits should result in income recognized by us being taxed at a lower rate. However, these benefits may not be applied to reduce the U.S. federal tax rate for any income that our U.S. subsidiary may generate. 68 In April 2005, substantive amendments to the Investment Law came into effect.
These benefits should result in income recognized by us being taxed at a lower rate. However, these benefits may not be applied to reduce the U.S. federal tax rate for any income that our U.S. subsidiary may generate. Certain amendments to the Investment Law became effective in January 2011, or the 2011 Amendment.
Two programs that we are pursuing internally, COM701, a potential first-in-class anti-PVRIG antibody, and COM902, a potential best-in-class therapeutic anti-TIGIT antibody, are in Phase 1 clinical trials and have been evaluated for the treatment of solid tumors as a monotherapy and in combination of dual (PVRIG/PD-1, PVRIG/TIGIT) and triple (PVRIG/PD-1/TIGIT) blockade.
COM701, a potential first-in-class anti-PVRIG antibody, and COM902, a potential best-in-class therapeutic anti-TIGIT antibody, have been evaluated for the treatment of solid tumors as monotherapy and in combinations of dual (PVRIG/PD-1, PVRIG/TIGIT) and triple (PVRIG/PD-1/TIGIT) blockade.
Actual results may differ from these estimates under different assumptions or conditions. 75 Share Based Payments We account for stock-based compensation in accordance with ASC 718, “Compensation - Stock Compensation”, or ASC 718, which requires companies to estimate the fair value of equity-based payment awards on the date of grant using an option-pricing model.
Share Based Payments We account for stock-based compensation in accordance with ASC 718, “Compensation - Stock Compensation”, or ASC 718, which requires companies to estimate the fair value of equity-based payment awards on the date of grant using an option-pricing model. We account for forfeitures as they occur.
Capital Resources In 2024, our primary sources of cash were mainly: • cash at hand and yield on investment of such cash balances; • cash received from our partners, Gilead and AstraZeneca; and • proceeds from ordinary shares sold through the Sales Agreement with Leerink. We used these funds primarily to finance our business operations.
Capital Resources In 2025, our primary sources of cash were mainly: • cash received from our partner, AstraZeneca; • proceeds from ordinary shares sold through the Sales Agreement with Leerink; and • cash at hand and yield on investment of such cash balances.
Exchange rates can be volatile and a substantial change in foreign currencies against the dollar could increase or reduce the Company’s expenses and net loss and impact the comparability of results from period to period. The appreciation (devaluation) of the dollar against the NIS was 0.6%, 3.1% and 13.2% in 2024, 2023 and 2022, respectively.
Exchange rates can be volatile and a substantial change in foreign currencies against the dollar could increase or reduce the Company’s expenses and net loss and impact the comparability of results from period to period.
As of December 31, 2024, we received grants from the IIA in the principal amount of approximately $7.3 million.
As of December 31, 2025, we received grants from the IIA in the principal amount of approximately $7.3 million that are subject to royalty payment to the IIA.
Payments due by period (US$ in thousands) Total Less than 1 year 1-3 years 3-5 years More than 5 years Operating Lease Obligations (1) 3,608 650 1,149 1,129 680 Accrued Severance Pay, net (2) 340 - - - 340 Total 3,948 650 1,149 1,129 1,020 (1) Consists of operating leases for our facilities and for motor vehicles.
Payments due by period (US$ in thousands) Total Less than 1 year 1-3 years 3-5 years More than 5 years Operating Lease Obligations (1) 3,538 721 1,394 1,292 131 Accrued Severance Pay, net (2) 244 - - - 244 Total 3,782 721 1,394 1,292 375 (1) Consists of operating leases for our facilities and for motor vehicles.
ITEM 5. OPERATING AND FINANCIAL REVIEW AND PROSPECTS The following discussion of our operating and financial review and prospects should be read in conjunction with our consolidated financial statements and related notes, prepared in accordance with U.S.
ITEM 5. OPERATING AND FINANCIAL REVIEW AND PROSPECTS The following discussion of our operating and financial review and prospects should be read in conjunction with our consolidated financial statements and related notes, prepared in accordance with U.S. GAAP as of December 31, 2025, and with any other financial data included elsewhere in this Annual Report .
The fair value of RSUs is the fair value of the ordinary share at the date of grant. 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. Revenue Recognition Our revenues are generated mainly from collaborative and license agreements.
The fair value of RSUs is the fair value of the ordinary share at the date of grant. Share-based compensation expense recognized under ASC 718 was approximately $1.9 million, $3.0 million and $3.6 million for the years ended December 31, 2025, 2024 and 2023, respectively. 76
We incurred net losses of approximately $14.2 million in 2024, approximately $18.8 million in 2023 and approximately $33.7 million in 2022. We expect to continue to incur net losses for the foreseeable future due in part to the costs and expenses associated with our research, discovery and development activities.
We expect to continue to incur net losses for the foreseeable future due in part to the costs and expenses associated with our research, discovery and development activities.
Increase in net cash used in investing activities in 2024 compared to 2023 was mainly due to net upfront and milestone payments received from Gilead and AstraZeneca. Net Cash Provided by Financing Activitie s Net cash provided by financing activities was approximately $0.6 million in 2024, approximately $3.1 million in 2023 and approximately $0.4 million in 2022.
Increase in net cash provided by investing activities in 2025 compared to 2024 was mainly due to increase in our cash and cash equivalents. Net Cash Provided by Financing Activitie s Net cash provided by financing activities was approximately $10.6 million in 2025, approximately $0.6 million in 2024 and approximately $3.1 million in 2023.
We have two partnerships in place, one with AstraZeneca, who is developing rilvegostomig, an anti PD-1/TIGIT bispecific antibody with a TIGIT-specific component that is derived from our COM902 antibody and is in multiple Phase 3 clinical trials and other earlier phases, and the second, with Gilead, pursuant to the License Agreement for our GS-0321 (previously COM503) program, with the first patient having been dosed in January 2025.
We have two partnerships in place, one with AstraZeneca, who is developing rilvegostomig, an anti PD-1/TIGIT bispecific antibody with a TIGIT-specific component that is derived from our COM902 antibody and is in multiple Phase 3, Phase 2 and Phase 1 clinical trials, and the second, with Gilead, pursuant to a license agreement for our GS-0321 (previously COM503) program, which is currently in Phase 1 clinical trial. 65 We incurred net profit of approximately $35.3 million in 2025, and net loss of approximately $14.2 million in 2024 and approximately $18.8 million in 2023.
During the year ended December 31, 2024, the Company recognized $22,864 of license, IND services and Phase 1 services revenues, and during the year ended December 31, 2023, the Company recognized $23,459 of license revenues. The Company included deferred revenues of $9,632 in current liabilities and $34,045 in non-current liabilities.
During the year ended December 31, 2025, the Company recognized $7,764 of Phase 1 services revenues, during the year ended December 31, 2024, the Company recognized $22,864 of license, IND services and Phase 1 services revenues, and during the year ended December 31, 2023, the Company recognized $23,459 of license revenues.
We believe that our existing cash, 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 2027 based on our current plans. We believe that our working capital is sufficient for our present requirements.
We believe that our existing cash, cash equivalents, short-term bank deposits and investment in marketable securities will be sufficient to fund our operations over the next 12 months.
Research and development expenses, as a percentage of total operating expenses, were 78% in 2023 compared to 73% in 2022. Marketing and Business Development Expenses . Marketing and business development expenses decreased by 74% and totaled in approximately $0.2 million in 2023 compared with approximately $0.9 million in the comparable period of 2022.
Marketing and business development expenses decreased by 6% to approximately $0.5 million in 2025 compared with approximately $0.6 million in the comparable period of 2024. Marketing and business development expenses, as a percentage of total operating expenses, were 2% in both 2025 and 2024. General and Administrative Expenses.
We developed the estimated standalone selling price for the IND research and development activities using a “cost plus” reasonable margin approach. To determine the estimated standalone selling price of the Phase 1 research and development activities obligation, we estimated the standalone selling price of the underlying performance obligations and estimated the probability of our performance of such obligations.
We developed the estimated standalone selling price for the IND research and development activities using a “cost plus” reasonable margin approach.
Revenues for the year ended December 31, 2023, were approximately $33.5 million, compared with $7.5 million in the comparable period of 2022.
Revenues for the year ended December 31, 2025, were approximately $72.8 million, compared with $27.9 million in the comparable period of 2024.
The results of our estimates form the basis for our management’s judgments about the carrying values of assets and liabilities that are not readily apparent from other sources.
The results of our estimates form the basis for our management’s judgments about the carrying values of assets and liabilities that are not readily apparent from other sources. Actual results may differ from these estimates under different assumptions or conditions. Revenue Recognition Our revenues are generated mainly from collaborative and license agreements.
We expect that our sources of cash for 2025 will include cash at hand at the end of 2024.
We used these funds primarily to finance our business operations. 70 We expect that our sources of cash for 2026 will include cash at hand at the end of 2025.
See Note 8b to our 2024 consolidated financial statement. We have not applied for additional grants from the IIA for research and technological development since 2012. The Israel Innovation Authority The government of Israel encourages research and development projects in Israel through the IIA, pursuant to and subject to the provisions of the R&D Law.
The Israel Innovation Authority The government of Israel encourages research and development projects in Israel through the IIA, pursuant to and subject to the provisions of the R&D Law.
The revenues for 2023 include the portion of the upfront payment from the license agreement with Gilead allocated to the license and the clinical milestone from the license agreement with AstraZeneca in the amount of $10.0 million, while the revenues for 2022 reflect the previous clinical milestones from the license agreement with AstraZeneca. Cost of Revenues.
The revenues for 2025 include the upfront payment from AstraZeneca in the amount of $65 million following the amendment of the license agreement with them and the portion of the upfront payment and the IND milestone payment from the license agreement with Gilead allocated to the Phase 1 research and development activities, while the revenues for 2024 reflect the portion of the upfront payment and the IND milestone payment from the license agreement with Gilead allocated to the IND and Phase 1 research and development activities and to the license granted to Gilead, in addition to the clinical milestone from the license agreement with AstraZeneca in the amount of $5 million.
GAAP as of December 31, 2024, and with any other financial data included elsewhere in this Annual Report . 65 Background We are a clinical-stage therapeutic discovery and development company utilizing our AI/ML powered predictive computational discovery platform, recently branded as Unigen TM , to identify novel drug targets and to develop therapeutics in the field of cancer immunotherapy.
Background We are a clinical-stage therapeutic discovery and development company utilizing Unigen™, our AI/ML powered computational discovery platform, to identify novel drug targets and to develop therapeutics in the field of cancer immunotherapy. Our innovative immuno-oncology pipeline consists of four clinical-stage programs: COM701, COM902, rilvegostomig and GS-0321 (previously COM503).
With respect to the Company’s requirement to pay royalties, in February 2025, the IIA approved that the Company will be required to pay royalties from all revenues of the Company, other than from income derived from sales associated with products related to IL-18BP (which currently include, GS-0321 (previously COM503)). 73 In addition, the Company participated in four MAGNET Consortium programs - Drugs and Diagnostic Kits, or DAAT Consortium, Tevel Biotechnology Consortium, Pharmalogica Consortium and Rimonim Consortium – for which it received from the IIA a total amount of approximately $2.1 million, and in two MAGNETON programs, for which it received from the IIA approximately $0.5 million.
Therefore, our contingent obligation for royalties, net of royalties already paid or accrued in the sum of approximately $4.4 million, along with the accumulated LIBOR/SOFR interest to date of approximately $5.4 million, totaled to approximately $8.3 million as of December 31, 2025. 72 With respect to the Company’s requirement to pay royalties, in February 2025, the IIA approved that the Company will be required to pay royalties from all revenues of the Company, other than from income derived from sales associated with products related to IL-18BP (which currently include, GS-0321 (previously COM503)).
The decrease is mainly due to headcount reduction. Marketing and business development expenses, as a percentage of total operating expenses, were 1% in 2023 compared to 2% in 2022. General and Administrative Expenses. General and administrative expenses during 2023 decreased by 6% and totaled approximately $9.7 million in 2023 compared with approximately $10.3 million in the comparable period of 2022.
General and administrative expenses, as a percentage of total operating expenses, were 28% in 2025 and 27% in 2024. Financial and Other Income, net. Financial and other income decreased by 21% to approximately $4.1 million in 2025 from approximately $5.2 million in the comparable period of 2024.
During the year ended December 31, 2023, the Company had approximately $2.0 million in cost of revenues compared with approximately $1.0 million cost of revenues in the comparable period of 2022. Cost of revenues for the years ended December 31, 2023 and 2022, represent milestone and royalty payments in connection with our revenues. 67 Research and Development Expenses, net.
Cost of Revenues. During the year ended December 31, 2025, cost of revenues was approximately $9.3 million compared with approximately $7.9 million cost of revenues in the comparable period of 2024.
Financial and other income increased by 85% to approximately $3.2 million in 2023 up from approximately $1.7 million in the comparable period of 2022. The increase is attributed mainly to increased interest income due to higher interest rates in the market offset by a lower level of cash and deposits balances. Taxes on Income.
The decrease was mainly attributed to lower cash balances during most of the year and lower interest rates and lower yield on marketable securities leading to lower accretion and financial income. Taxes on Income, net. Taxes on income were approximately $0.1 million in 2025 compared with approximately $4.5 million in the comparable period of 2024.
Removed
Our innovative immuno-oncology pipeline consists of four clinical stage programs, COM701, COM902, rilvegostomig and GS-0321 (previously COM503).
Added
The last patient in the clinical trial evaluating the triple combination treatment of COM701, COM902 and pembrolizumab (initiated in 2023), received the last dose in January 2026.
Removed
We have two ongoing clinical trials that were both initiated in 2023 (with enrollment completed) evaluating the triple combination treatment of COM701, COM902 and pembrolizumab, one in platinum resistant ovarian cancer and the other in microsatellite stable colorectal cancer, both of which have together a few patients on treatment as of the middle of February 2025.
Added
Currently, the only clinical trial we are sponsor and conduct is a blinded randomized ovarian cancer platform trial evaluating COM701 as a single agent in maintenance therapy in relapsed platinum sensitive ovarian cancer (named MAIA-ovarian trial) and we expect an interim analysis from this trial in the first quarter of 2027.
Removed
In addition, we are initiating our new adaptive platform trial in relapsed platinum sensitive ovarian cancer. In this trial we will first evaluate COM701 as a monotherapy randomized to placebo in double-blinded sub-trial 1 in total of 60 patients.
Added
Cost of revenues for the year ended December 31, 2025, represents the cost of Phase 1 activities related to the license agreement with Gilead and royalties to the Israeli Innovation Authority, or the IIA, in connection with our revenues, while cost of revenues for the year ended December 31, 2024, represents the cost of IND and Phase 1 activities related to the license agreement with Gilead and royalties to the IIA in connection with our revenues from AstraZeneca, offset by royalty reversal in 2024 due to exemption from royalties on IL-18BP received from the IIA.
Removed
We plan to start enrollment to this sub-trial in the second quarter of 2025 and we expect to share interim analysis data from this sub-trial in the second half of 2026.
Added
Research and Development Expenses, net. Research and development expenses during 2025 decreased by 8% and totaled approximately $22.8 million compared with approximately $24.8 million in the comparable period of 2024.
Removed
While our Unigen TM platform has potentially broad applicability and is not limited to a certain indication or therapeutic field, we are focusing our efforts on the discovery of novel drug targets for the development of novel therapeutic antibodies for cancer, in which we believe there is a significant unmet medical need for cancer patients.
Added
The decrease was mainly due to lower clinical expenses resulting from winding down prior clinical trials, partially offset by an increase in clinical expenses related to MAIA-ovarian trial initiated in 2025. Research and development expenses, as a percentage of total operating expenses, were 71% in 2025 and in 2024. Marketing and Business Development Expenses .
Removed
We have discovered novel targets through our Unigen TM platform with four different product candidates currently being clinically evaluated, potentially supporting the power and validity of our computational capabilities.
Added
General and administrative expenses during 2025 decreased by 6% to approximately $8.9 million in 2025 compared with approximately $9.4 million in the comparable period of 2024. The decrease during 2025 was mainly attributed to lower D&O insurance premium costs coupled with lower legal fees partially offset by higher salary related expenses.
Removed
Research and development expenses during 2023 increased by 12% and totaled approximately $34.5 million compared with approximately $30.6 million in the comparable period of 2022. The increase is mainly due to lower amortization of the deferred participation in R&D expenses following the termination of the agreement with Bristol Myers Squibb offset by a decrease in headcount related expenses.

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Item 6. [Reserved]

Selected Financial Data — reserved (removed by SEC in 2021)

125 edited+67 added−44 removed114 unchanged
Biggest changeEquity In addition to the cash compensation detailed above, at the 2024 Annual General Meeting of Shareholders held on September 12, 2024, or the 2024 AGM, our shareholders approved, following previous resolutions made by our compensation committee and the board of directors, and consistent with our Compensation Policy, that each non-executive director is entitled to a yearly grant of options to purchase the Company’s ordinary shares, so that in the first year of service as a director, each non-executive director shall be entitled to a one-time grant of 50,000 options, or Initial Equity Grant, and, in addition, to a yearly grant of 25,000 options in each of the following years of service, or the Annual Equity Grant, as detailed below. 85 The grant date of each Initial Equity Grant is the date of appointment for service as director, whether initially appointed by the Board or by the general meeting of shareholders, with an exercise price equal to the closing price of the Company’s ordinary shares on the Nasdaq on the last trading day prior to the date of their initial appointment to serve on the Board.
Biggest changeEquity In addition to the cash compensation detailed above, at the 2024 Annual General Meeting of Shareholders held on September 12, 2024, or the 2024 AGM, our shareholders approved, following previous resolutions made by our compensation committee and the board of directors, and consistent with our Compensation Policy, that each non-executive director is entitled to a yearly grant of options to purchase the Company’s ordinary shares, so that in the first year of service as a director, each non-executive director shall be entitled to a one-time grant of 50,000 options, or Initial Equity Grant, and, in addition, to a yearly grant of 25,000 options in each of the following years of service, or the Annual Equity Grant, pursuant to the detailed below (including with respect to the issuance of RSUs).
We have a compensation committee consisting of three directors, Mr. Sanford (Sandy) Zweifach, who serves as the chairman of our compensation committee, Dr. Kinneret Livnat Savitzky and Eran Perry. Each member of our compensation committee is an ‘independent director’ in accordance with the Nasdaq listing standards.
We have a compensation committee consisting of three directors, Mr. Sanford (Sandy) Zweifach, who serves as the chairman of our compensation committee, Dr. Kinneret Livnat Savitzky and Mr. Eran Perry. Each member of our compensation committee is an ‘independent director’ in accordance with the Nasdaq listing standards.
Related Party Transactions.” Shareholders Duties Pursuant to the Companies Law, a shareholder has a duty to: (i) act in good faith in fulfilling his obligations towards the company and the other shareholders; (ii) refrain from abusing his or her power with respect to the company, including, when voting at a general meeting with respect to the following matters: (a) an amendment to the company’s articles of association; (b) an increase of the company’s authorized share capital; (c) a merger; or (d) approval of interested party transactions that require shareholders’ approval.
Related Party Transactions.” Shareholders’ Duties Pursuant to the Companies Law, a shareholder has a duty to: (i) act in good faith in fulfilling his obligations towards the company and the other shareholders; (ii) refrain from abusing his or her power with respect to the company, including, when voting at a general meeting with respect to the following matters: (a) an amendment to the company’s articles of association; (b) an increase of the company’s authorized share capital; (c) a merger; or (d) approval of interested party transactions that require shareholders’ approval.
Our Articles provide that, subject to the provisions of the Companies Law, we may indemnify any of our Office Holders for all liabilities and expenses incurred by them arising from or as a result of any act (or omission) carried out by them as Office Holders of the Company, including as follows: • For any monetary liabilities or obligations imposed on our Office Holder in favor of another person pursuant to a court judgment, including a compromise judgment or an arbitrator’s decision approved by a court; • For any payments which our Office Holder is obligated to make to an injured party as set forth in Section 52(54)(a)(1)(a) of the Israeli Securities Law and expenses the Office Holder incurred in connection with a proceeding under Chapters H’3, H’4 or I’1 of the Israeli Securities Law, including reasonable litigation expenses, including attorney’s fees, or in connection with Article D of Chapter Four of Part Nine of the Companies Law; 89 • For reasonable litigation expenses, including attorney’s fees, incurred by the Office Holder in consequence of an investigation or proceeding instituted against the Office Holder by an authority that is authorized to conduct such investigation or proceeding, and which was concluded without filing of an indictment against the Office Holder and without imposing on the Office Holder a financial obligation in lieu of criminal proceedings, or which was concluded without filing of an indictment against the Office Holder but with imposing on such Office Holder a financial obligation in lieu of criminal proceedings in respect of an offense that does not require proof of criminal intent or in connection with a financial sanction; For the purposes hereof: (i) “a proceeding that concluded without filing an indictment in a matter in respect of which an investigation was conducted”; and (ii) “financial obligation in lieu of a criminal proceeding”, shall have the meanings specified in Section 260(a)(1A) of the Companies Law; • For reasonable litigation expenses, including attorney’s fees, incurred by the Office Holder or which the Office Holder is ordered to pay by a court, in a proceeding filed against the Office Holder by the Company or on its behalf or by another person, or in a criminal action of which the Office Holder is acquitted, or in a criminal action in which the Office Holder is convicted of an offense that does not require proof of criminal intent; • For expenses incurred by our Office Holder in connection with a proceeding under Chapter G’1, of the Restrictive Trade Law, including reasonable litigation expenses, including attorney’s fees; and • For any other liability, obligation or expense indemnifiable or which our Officer Holders may from time to time be indemnifiable by law.
Our Articles provide that, subject to the provisions of the Companies Law, we may indemnify any of our Office Holders for all liabilities and expenses incurred by them arising from or as a result of any act (or omission) carried out by them as Office Holders of the Company, including as follows: • For any monetary liabilities or obligations imposed on our Office Holder in favor of another person pursuant to a court judgment, including a compromise judgment or an arbitrator’s decision approved by a court; • For any payments which our Office Holder is obligated to make to an injured party as set forth in Section 52(54)(a)(1)(a) of the Israeli Securities Law and expenses the Office Holder incurred in connection with a proceeding under Chapters H’3, H’4 or I’1 of the Israeli Securities Law, including reasonable litigation expenses, including attorney’s fees, or in connection with Article D of Chapter Four of Part Nine of the Companies Law; • For reasonable litigation expenses, including attorney’s fees, incurred by the Office Holder in consequence of an investigation or proceeding instituted against the Office Holder by an authority that is authorized to conduct such investigation or proceeding, and which was concluded without filing of an indictment against the Office Holder and without imposing on the Office Holder a financial obligation in lieu of criminal proceedings, or which was concluded without filing of an indictment against the Office Holder but with imposing on such Office Holder a financial obligation in lieu of criminal proceedings in respect of an offense that does not require proof of criminal intent or in connection with a financial sanction; For the purposes hereof: (i) “a proceeding that concluded without filing an indictment in a matter in respect of which an investigation was conducted”; and (ii) “financial obligation in lieu of a criminal proceeding”, shall have the meanings specified in Section 260(a)(1A) of the Companies Law; • For reasonable litigation expenses, including attorney’s fees, incurred by the Office Holder or which the Office Holder is ordered to pay by a court, in a proceeding filed against the Office Holder by the Company or on its behalf or by another person, or in a criminal action of which the Office Holder is acquitted, or in a criminal action in which the Office Holder is convicted of an offense that does not require proof of criminal intent; • For expenses incurred by our Office Holder in connection with a proceeding under Chapter G’1, of the Restrictive Trade Law, including reasonable litigation expenses, including attorney’s fees; and • For any other liability, obligation or expense indemnifiable or which our Officer Holders may from time to time be indemnifiable by law.
Our Articles provide that, subject to the provisions of the Companies Law, we may enter into contracts to insure the liabilities of our Office Holders for any liabilities or expenses incurred by or imposed upon them as a result of any act (or omission) carried out by them as our Office Holders, including with respect to any of the following: • a breach of duty of care to us or to another person; • a breach of duty of loyalty to us, provided that the Office Holder acted in good faith and had reasonable grounds to assume that such act would not prejudice our interests; • monetary liabilities or obligations imposed upon him or her in favor of another person; • A payment which the Office Holder is obligated to make to an injured party as set forth in Section 52(54)(a)(1)(a) of the Securities Law, and expenses that the Office Holder incurred in connection with a proceeding under Chapters H’3, H’4 or I’1 of the Securities Law, including reasonable litigation expenses, including attorney’s fees, or in connection with Article D of Chapter Four of Part Nine of the Companies Law; and • Expenses incurred by the Office Holder in connection with a proceeding under Chapter G’1, of the Israel Restrictive Trade Practices Law, 5748-1988, or Restrictive Trade Law, including reasonable litigation expenses, including attorney’s fees.
Our Articles provide that, subject to the provisions of the Companies Law, we may enter into contracts to insure the liabilities of our Office Holders for any liabilities or expenses incurred by or imposed upon them as a result of any act (or omission) carried out by them as our Office Holders, including with respect to any of the following: • a breach of duty of care to us or to another person; • a breach of duty of loyalty to us, provided that the Office Holder acted in good faith and had reasonable grounds to assume that such act would not prejudice our interests; 89 • monetary liabilities or obligations imposed upon him or her in favor of another person; • A payment which the Office Holder is obligated to make to an injured party as set forth in Section 52(54)(a)(1)(a) of the Securities Law, and expenses that the Office Holder incurred in connection with a proceeding under Chapters H’3, H’4 or I’1 of the Securities Law, including reasonable litigation expenses, including attorney’s fees, or in connection with Article D of Chapter Four of Part Nine of the Companies Law; and • Expenses incurred by the Office Holder in connection with a proceeding under Chapter G’1, of the Israel Restrictive Trade Practices Law, 5748-1988, or Restrictive Trade Law, including reasonable litigation expenses, including attorney’s fees.
The duty of loyalty requires an Office Holder to act in good faith and for the benefit of the company and includes the duty to: • refrain from any act involving a conflict of interest between the fulfillment of his or her position in the company and the fulfillment of any other position or his or her personal affairs; • refrain from any act that is competitive with the business of the company; 95 • refrain from exploiting any business opportunity of the company with the aim of obtaining a personal gain for himself or herself or for others; and • disclose to the company all relevant information and provide it with all documents relating to the company’s affairs which the Office Holder obtained due to his or her position in the company.
The duty of loyalty requires an Office Holder to act in good faith and for the benefit of the company and includes the duty to: • refrain from any act involving a conflict of interest between the fulfillment of his or her position in the company and the fulfillment of any other position or his or her personal affairs; • refrain from any act that is competitive with the business of the company; • refrain from exploiting any business opportunity of the company with the aim of obtaining a personal gain for himself or herself or for others; and • disclose to the company all relevant information and provide it with all documents relating to the company’s affairs which the Office Holder obtained due to his or her position in the company.
Prior to starting in industry in 2011, Dr. Mahler trained at Memorial Sloan Kettering Cancer Center and New York Presbyterian Hospital/Weill Cornell. She also spent time at Columbia Presbyterian and Mount Sinai Medical Center in New York. Dr. Mahler obtained her medical degree from University of the Witwatersrand, South Africa and is a board-certified pediatric hematologist and oncologist.
Prior to starting in industry in 2011, Dr. Mahler trained at Memorial Sloan Kettering Cancer Center and New York Presbyterian Hospital/Weill Cornell. She also spent time at Columbia Presbyterian and Mount Sinai Medical Center in New York. Dr. Mahler obtained her medical degree from University of the Witwatersrand, South Africa and is a board-certified pediatric hematologist and oncologist. 79 Dr.
Cohen-Dayag’s employment without advance notice and that Dr. Cohen-Dayag may resign with advance notice of only two (2) months in the event of resignation for “good reason” (as such term is defined in her employment agreement as shall be in effect from time to time). Upon termination, Dr. Anat Cohen-Dayag will be entitled to receive certain payments associated with termination.
Cohen-Dayag’s employment without advance notice and that Dr. Cohen-Dayag may resign with advance notice of only two (2) months in the event of resignation for “good reason” (as such term is defined in her employment agreement as shall be in effect from time to time). Upon termination, Dr. Anat Cohen-Dayag is entitled to receive certain payments associated with termination.
Silberman holds degrees in accounting and management from the French Ministry of Higher Education and Research and is a certified public accountant in Israel. 80 Dr. Michelle Mahler joined Compugen in October 2023 as Vice President of Clinical Development and was promoted to Chief Medical Officer, effective March 1, 2024. Before joining Compugen, Dr.
Silberman holds degrees in accounting and management from the French Ministry of Higher Education and Research and is a certified public accountant in Israel. Dr. Michelle Mahler joined Compugen in October 2023 as Vice President of Clinical Development and was promoted to Chief Medical Officer, effective March 1, 2024. Before joining Compugen, Dr.
Livnat Savitzky held various R&D management positions at BioLineRX and Compugen. Dr. Livnat Savitzky holds a B.Sc. in Biology from The Hebrew University of Jerusalem, and an M.S.c and Ph.D. with distinction in Human Genetics from Tel Aviv University. Eran Perry joined Compugen’s Board of Directors in July 2019. Mr.
Livnat Savitzky held various R&D management positions at BioLineRX and Compugen. Dr. Livnat Savitzky holds a B.Sc. in Biology from The Hebrew University of Jerusalem, and an M.S.c and Ph.D. with distinction in Human Genetics from Tel Aviv University. Eran Perry joined the Board of Directors in July 2019. Mr.
Tali Yaron is not an employee, affiliate or Office Holder of the Company, or affiliated with the Company’s external auditor. Fiduciary Duties and Approval of Related Party Transactions Under Israeli Law Fiduciary Duties of Office Holders The Companies Law codifies the fiduciary duties that Office Holders owe to a company. All persons listed in the table under “Item 6.
Tali Yaron is not an employee, affiliate or Office Holder of the Company, or affiliated with the Company’s external auditor. 95 Fiduciary Duties and Approval of Related Party Transactions Under Israeli Law Fiduciary Duties of Office Holders The Companies Law codifies the fiduciary duties that Office Holders owe to a company. All persons listed in the table under “Item 6.
In the case of our Office Holders, other than the chief executive officer, assuming that the bonus terms conform to the Compensation Policy, the annual bonus objectives and subsequent payment scores are determined by the compensation committee and board of directors, while the bonus terms for our chief executive officer generally require the additional approval by our shareholders.
In the case of our Office Holders, other than the chief executive officer and our Executive Chair of the Board, assuming that the bonus terms conform to the Compensation Policy, the annual bonus objectives and subsequent payment scores are determined by the compensation committee and board of directors, while the bonus terms for our chief executive officer and our Executive Chair of the Board generally require the additional approval by our shareholders.
Nomination and Corporate Governance Committee The Nasdaq Listing Rules require that director nominees be selected or recommended for the board’s selection either by a nomination committee composed solely of independent directors, or by a majority of independent directors, in a vote in which only independent directors participate, subject to certain exceptions. Mr.
Nomination and Corporate Governance Committee and Lead Independent Director The Nasdaq Listing Rules require that director nominees be selected or recommended for the board’s selection either by a nomination committee composed solely of independent directors, or by a majority of independent directors, in a vote in which only independent directors participate, subject to certain exceptions. Mr.
Such benefits and perquisites may include, to the extent applicable to the respective Covered Office Holder, bonuses, payments, contributions and/or allocations for savings funds, pension, severance, vacation, car or car allowance, medical insurances and benefits, risk insurance (e.g., life, disability, accident), phone, convalescence pay, payments for social security, tax gross-up payments and other benefits and perquisites consistent with the Company’s policies. 4) Amounts reported in this column represent the expense recorded in our financial statements for the year ended December 31, 2024, with respect to options to purchase our ordinary shares and RSUs granted to our Covered Office Holders.
Such benefits and perquisites may include, to the extent applicable to the respective Covered Office Holder, bonuses, payments, contributions and/or allocations for savings funds, pension, severance, vacation, car or car allowance, medical insurances and benefits, risk insurance (e.g., life, disability, accident), phone, convalescence pay, payments for social security, tax gross-up payments and other benefits and perquisites consistent with the Company’s policies. 4) Amounts reported in this column represent the expense recorded in our financial statements for the year ended December 31, 2025, with respect to options to purchase our ordinary shares and RSUs granted to our Covered Office Holders.
Accordingly, the appointment of our external auditor is approved by our shareholders at the audit committee’s recommendation and its compensation for audit and non-audit services is approved by the board of directors following the audit committee’s recommendation. 93 We have adopted a charter for the audit committee, which sets forth the purpose and responsibilities of such committee.
Accordingly, the appointment of our external auditor is approved by our shareholders at the audit committee’s recommendation and its compensation for audit and non-audit services is approved by the board of directors following the audit committee’s recommendation. We have adopted a charter for the audit committee, which sets forth the purpose and responsibilities of such committee.
These equity grants will expire ten years after the grant date, unless they expire earlier in accordance with the terms of the 2010 Plan or the terms of the option agreement to be entered into between the Company and Dr. Cohen-Dayag.
These equity grants expire ten years after the grant date, unless they expire earlier in accordance with the terms of the 2010 Plan or the terms of the option agreement to be entered into between the Company and Dr. Cohen-Dayag.
Cohen-Dayag will be entitled to a special termination payment (in addition to the Termination Payment) in an amount equal to six (6) monthly salaries. 88 In addition, upon Dismissal, or in the event of a “change of control”, all outstanding unvested options granted to Dr.
Cohen-Dayag will be entitled to a special termination payment (in addition to the Termination Payment) in an amount equal to six (6) monthly salaries. In addition, upon Dismissal, or in the event of a “change of control”, all outstanding unvested options granted to Dr.
For purposes of all matters related to external directors, a shareholder is presumed to be a controlling shareholder if the shareholder holds 50% or more of the voting rights in the company or has the right to appoint the majority of the directors of the company or its chief executive officer.
For all purposes related to external directors, a shareholder is presumed to be a controlling shareholder if the shareholder holds 50% or more of the voting rights in the company or has the right to appoint the majority of the directors of the company or its chief executive officer.
We generally provide our employees with benefits and working conditions beyond the required minimum. Our employees are not represented by a labor union. We have written employment contracts (including signed offers of employment) with each of our employees. 97 E.
We generally provide our employees with benefits and working conditions beyond the required minimum. Our employees are not represented by a labor union. We have written employment contracts (including signed offers of employment) with each of our employees. E.
Cohen-Dayag will be entitled to exercise all outstanding vested options (including those vested as a result of such accelerated vesting) for a period of one (1) year from the date of termination of her employment, provided that such period does not extend beyond ten (10) years from the date of grant. Dr.
Cohen-Dayag will be entitled to exercise all outstanding vested options (including those vested as a result of such accelerated vesting) for a period of one (1) year from the date of termination of her employment, provided that such period does not extend beyond ten (10) years from the date of grant. 86 Compensation to Dr.
Individual Compensation of Covered Office Holders The table below outlines the compensation granted to our five most highly compensated Office Holders (as such term is defined in the Companies Law - see below under “Approvals Required for Office Holders Terms of Office and Employment”) with respect to the year ended December 31, 2024.
Individual Compensation of Covered Office Holders The table below outlines the compensation granted to our five most highly compensated Office Holders (as such term is defined in the Companies Law - see below under “Approvals Required for Office Holders Terms of Office and Employment”) with respect to the year ended December 31, 2025.
Silberman served from 2021 to 2024 as Chief Financial Officer of Oramed Pharmaceuticals (NASDAQ: ORMP, TASE: ORMP), a pharmaceutical company engaged in the research and development of innovative pharmaceutical solutions with a technology platform that allows for the oral delivery of therapeutic proteins. Prior to joining Oramed Pharmaceuticals as Chief Financial Officer in 2021, Mr.
Silberman served as Chief Financial Officer of Oramed Pharmaceuticals (NASDAQ: ORMP, TASE: ORMP), a pharmaceutical company engaged in the research and development of innovative pharmaceutical solutions with a technology platform that allows for the oral delivery of therapeutic proteins. Prior to joining Oramed Pharmaceuticals in 2021, Mr.
In addition, any controlling shareholder, any shareholder who knows that it possesses power to determine the outcome of a shareholder vote and any shareholder who, pursuant to the provisions of a company’s articles of association has the power to appoint or prevent the appointment of an office holder in the company, is under a duty of fairness towards the company.
In addition, any controlling shareholder, any shareholder who knows that it possesses power to determine the outcome of a shareholder vote and any shareholder who, pursuant to the provisions of a company’s articles of association has the power to appoint or prevent the appointment of an office holder in the company or other power against the company, is under a duty of fairness towards the company.
Prior to this, he was President and CFO of Epoch Biosciences, which was acquired by Nanogen. Currently Mr. Zweifach serves as the Chairman of the Board of Directors of Carisma Therapeutics, Inc., President and CBO and member of the Board of Directors of IMIDomics, Inc. and a member of the Board of Directors of Essa Pharma, Inc.
Prior to this, he was President and CFO of Epoch Biosciences, which was acquired by Nanogen. Currently Mr. Zweifach serves as the Chairman of the board of directors of Carisma Therapeutics, Inc., President and CBO and member of the board of directors of IMIDomics, Inc. and a member of the board of directors of Essa Pharma, Inc. In addition, Mr.
Our directors are elected at the annual general meeting for a term of approximately one year, ending at the annual general meeting immediately following the annual general meeting at which they were elected or upon earlier termination in circumstanced referred to under the Companies Law or our Articles.
Our directors are elected at the annual general meeting for a term of approximately one year, ending at the annual general meeting immediately following the annual general meeting at which they were elected or upon earlier termination in circumstances referred to under the Companies Law or our Articles.
All amounts reported in the table reflect the cost to the Company, as recognized in our financial statements for the year ended December 31, 2024. We refer to the five individuals for whom disclosure is provided herein as our “Covered Office Holders”.
All amounts reported in the table reflect the cost to the Company, as recognized in our financial statements for the year ended December 31, 2025. We refer to the five individuals for whom disclosure is provided herein as our “Covered Office Holders”.
The shares that may be issued under these options are deemed to be outstanding for the purpose of computing the percentage of ownership of such individual or group but are not deemed to be outstanding for the purpose of computing the percentage of ownership of the other individual or group shown in the table.
The shares that may be issued under these options and RSUs are deemed to be outstanding for the purpose of computing the percentage of ownership of such individual or group but are not deemed to be outstanding for the purpose of computing the percentage of ownership of the other individual or group shown in the table.
F. DISCLOSURE OF A REGISTRANT’S ACTION TO RECOVER ERRONEOUSLY AWARDED COMPENSATION. Not applicable. 99
F. DISCLOSURE OF A REGISTRANT’S ACTION TO RECOVER ERRONEOUSLY AWARDED COMPENSATION. Not applicable.
We comply with such Nasdaq independence requirement, as each of our directors, other than Dr. Anat Cohen-Dayag, who also serves as our president and chief executive officer, has been determined by our board of directors to meet the Nasdaq independence requirements.
We comply with such Nasdaq independence requirement, as each of our directors, other than Dr. Eran Ophir, who also serves as our President and Chief Executive Officer and Dr. Anat Cohen-Dayag, who serves as the Executive Chair of our Board, has been determined by our board of directors to meet the Nasdaq independence requirements.
Paul Sekhri) On August 6, 2018, our shareholders approved, following previous resolutions made by our audit committee (then sitting as a compensation committee) and the board of directors, and consistent with our Compensation Policy, to compensate each of our non-executive directors whether currently in office or appointed in the future, excluding the Chairman of the Board (each a “non-executive director”) as follows: Cash Fee (i) an annual fee of $45,000; and (ii) an additional annual amount to be paid to non-executive directors for service as members on each of the Company’s committees, as follows: (a) Audit Committee - $2,500 for a member, or $5,000 for the chairperson; (b) Compensation Committee - $2,000 for a member, or $4,000 for the chairperson; and (c) Nomination and Governance Committee - $1,000 for a member, or $3,000 for the chairperson.
Compensation Paid to our Non-Executive Directors On August 6, 2018, our shareholders approved, following previous resolutions made by our audit committee (then sitting as a compensation committee) and the board of directors, and consistent with our Compensation Policy, to compensate each of our non-executive directors whether currently in office or appointed in the future as follows: Cash Fee (i) an annual fee of $45,000; and (ii) an additional annual amount to be paid to non-executive directors for service as members on each of the Company’s committees, as follows: (a) Audit Committee - $2,500 for a member, or $5,000 for the chairperson; (b) Compensation Committee - $2,000 for a member, or $4,000 for the chairperson; and (c) Nomination and Governance Committee - $1,000 for a member, or $3,000 for the chairperson.
Each annual equity grant will vest over a four-year period as follows: twenty five percent (25%) will vest on the last day of the quarter one calendar year from the date of grant; and an additional 6.25% will vest each quarter thereafter for the next 36 months.
Each annual equity grant vests over a four-year period as follows: twenty five percent (25%) vests on the last day of the quarter one calendar year from the date of grant; and an additional 6.25% vests each quarter thereafter for the next 36 months.
For information regarding home country practices followed by us see “Item 16G - Corporate Governance”. Board of Directors Our Articles provide that we may have no less than five nor more than fourteen directors. Currently our board of directors consists of seven members.
For information regarding home country practices followed by us see “Item 16G - Corporate Governance”. 91 Board of Directors Our Articles provide that we may have no less than five nor more than fourteen directors. Currently our board of directors consists of eight members.
Our directors may further be appointed by the board of director and in this case shall hold office until the end of the immediately following annual general meeting or upon earlier termination in circumstanced referred to under the Companies Law or our Articles.
Our directors may further be appointed by the board of directors and in this case shall hold office until the end of the immediately following annual general meeting or upon earlier termination in circumstances referred to under the Companies Law or our Articles.
In August 2011 she was appointed Vice President, Research and Discovery and in 2018, Dr. Levine was appointed as Senior Vice President, Technology Innovation. Dr. Levine holds a B.Sc. in Biology, a M.Sc. in Biochemistry and a Ph.D. in Biochemistry, all from the Tel Aviv University, Israel.
In August 2011, she was appointed as Vice President, Research and Discovery. In 2018, Dr. Levine was appointed as Senior Vice President, Technology Innovation. Dr. Levine holds a B.Sc. in Biology, an M.Sc. in Biochemistry and a Ph.D. in Biochemistry, all from Tel Aviv University. Dr.
In 2004, she was appointed Director of Therapeutic Selection & Validation, which position she held until 2007 when she was appointed Director of Therapeutic Discovery. In 2009, she was appointed Executive Director of Research & Development. From January 2010 to August 2011, she held the position of Vice President, Research and Development.
In 2004 she was appointed as Director of Therapeutic Selection & Validation, a position she held until 2007 when she was appointed as Director of Therapeutic Discovery. In 2009, she was appointed as Executive Director of Research & Development. From January 2010 to August 2011, she held the position of Vice President, Research and Development.
The Companies Law requires that all variable compensation of directors and chief executive officers be based on measurable criteria, with the exception of a non-substantial portion of up to 3 monthly salaries, which should take into consideration the applicable Office Holder’s contribution to the company.
Variable Compensation and Annual Cash Bonuses of Office Holders . The Companies Law requires that all variable compensation of directors and chief executive officers be based on measurable criteria, with the exception of a non-substantial portion of up to 3 monthly salaries, which should take into consideration the applicable Office Holder’s contribution to the company.
Except as set forth in the table below, none of those directors or senior management members beneficially owns ordinary shares and/or ordinary shares underlying options and/or RSUs amounting together to 1% or more of the outstanding ordinary shares. The following table sets forth certain information as of February 28, 2025, regarding the beneficial ownership by our directors and senior management.
Except as set forth in the table below, none of those directors or senior management members beneficially owns ordinary shares and/or ordinary shares underlying options and/or RSUs amounting together to 1% or more of the outstanding ordinary shares. The following table sets forth certain information as of February 20, 2026, regarding the beneficial ownership by our directors and senior management.
“Terms of Office and Employment” means the terms of office and employment of our Office Holders, including exemption and release of the Office Holder from liability for breach of his or her duty of care to the Company, an undertaking to indemnify the Office Holder, post factum indemnification or insurance; any grant, payment, remuneration, compensation, or other benefit provided in connection with termination of service and any benefit, other payment or undertaking to provide any payment as aforesaid.
“Terms of Office and Employment” means the terms of office and employment of our Office Holders, including exemption and release of the Office Holder from liability for breach of his or her duty of care to the Company, an undertaking to indemnify the Office Holder, post factum indemnification or insurance; any grant, payment, remuneration, compensation, or other benefit provided in connection with termination of service and any benefit, other payment or undertaking to provide any payment as aforesaid. 82 Compensation for Office Holders subordinated to the Chief Executive Officer.
Compensation for Office Holders subordinated to the Chief Executive Officer. The Terms of Office and Employment of Office Holders (other than directors and the chief executive officer) require the approval of the compensation committee and the board of directors, in that order, provided that such terms are in line with the company’s compensation policy.
The Terms of Office and Employment of Office Holders (other than directors and chief executive officer) require the approval of the compensation committee and the board of directors, in that order, provided that such terms are in line with the company’s compensation policy.
In addition, he sits on several other private boards and has advisory roles with two investment funds. Earlier in his career, Mr. Zweifach was a Certified Public Accountant (US) for Coopers & Lybrand and held various investment banking positions focusing on biotech.
Zweifach sits on several other private boards of directors and has advisory roles with two investment funds. Earlier in his career, Mr. Zweifach was a Certified Public Accountant (US) for Coopers & Lybrand and held various investment banking positions focusing on biotech.
Under the Companies Law, an interested party or an Office Holder of a company, or a relative of an interested party or of an Office Holder of a company, as well as the company’s external auditor or any one on behalf of the external auditor may not serve as a company’s internal auditor.
Under the Companies Law, an interested party or an Office Holder of a company, or a relative of an interested party or of an Office Holder of a company, as well as the company’s external auditor or anyone on behalf of the external auditor may not serve as a company’s internal auditor.
Ms. Tali Yaron of Brightman, Almagor, Zohar & Co., a member firm of Deloitte Touche Tohmatsu, has served as our internal auditor since 2023 (replacing a different partner at Brightman Almagor Zohar & Co., a member firm of Deloitte Touche Tohmatsu during 2023). Ms.
Ms. Tali Yaron of Brightman, Almagor, Zohar & Co., a member firm of Deloitte Touche Tohmatsu, has served as our internal auditor since 2023 (replaced a different partner at Brightman Almagor Zohar & Co., a member firm of Deloitte Touche Tohmatsu). Ms.
In August 2023, our board of directors decreased the number of shares available under the 2010 Plan by 500,000 and in July 2024 our board of directors increased the number of shares reserved under the 2010 Plan by 300,000.
In August 2023, our board of directors decreased the number of shares available under the 2010 Plan by 500,000, in July 2024 our board of directors increased the number of shares reserved under the 2010 Plan by 300,000, and in August 2025 our board of directors increased the number of shares reserved under the 2010 Plan by additional 200,000 shares.
The options granted in each respective year shall be subject to the terms and conditions applicable to options granted under the 2010 Plan (or any other option plan adopted by the Company).
The options granted in each respective year are subject to the terms and conditions applicable to options granted under the 2010 Plan (or any other option plan adopted by the Company).
Since our board of directors determined to opt out of the requirement to elect and have external directors and composition criteria of the audit committee and compensation committee under the Companies Law pursuant to the relief available under the Alleviation Regulations, as further detailed in this Item below under “Board Practices - External Directors and Independent Directors Under the Companies Law”, we are not subject to such bulletins or staff position statements. 84 Variable Compensation and Annual Cash Bonuses of Office Holders .
Since our board of directors determined to opt out of the requirement to elect and have external directors and composition criteria of the audit committee and compensation committee under the Companies Law pursuant to the relief available under the Alleviation Regulations, as further detailed in this Item below under “Board Practices - External Directors and Independent Directors Under the Companies Law”, we are not subject to such bulletins or staff position statements.
Further, the annual cash bonus of each of our Office Holders who is not a director is determined according to a formula that is consistent with the Compensation Policy and that links the bonus payment score to measurable and qualitative objectives relating to both the Company’s performance and to the performance by each such Office Holder of his responsibilities.
Further, the annual cash bonus of each of our Office Holders who is not a director is determined according to a formula that is consistent with the Compensation Policy and that links the bonus payment score to measurable and qualitative objectives relating to both the Company’s performance and to the performance by each such Office Holder of his or her responsibilities (and with respect to our Executive Chair of the Board, to measurable and qualitative objectives relating to the Company’s performance).
Board Committees Audit Committee The Companies Law requires public companies such as ours to appoint an audit committee, the responsibilities of which include, among other things: (i) identifying flaws in the management of the company’s business, among other things, in consultation with the company’s internal auditor or external auditor, and making recommendations to the board of directors as to how to correct them, (ii) reviewing and considering certain related party transactions and certain actions involving conflicts of interest (as well as deciding whether certain actions specified in the Companies Law are considered material or non-material and whether certain transactions are considered exceptional or ordinary), (iii) establishing procedures to be followed with respect to related party transactions with a “controlling shareholder” (where such are not extraordinary transactions), which may include, where applicable, the establishment of a competitive process for such transaction, under the supervision of the audit committee, or individual, or other committee or body selected by the audit committee, in accordance with criteria determined by the audit committee, (iv) determining procedures for approving certain related party transactions with a “controlling shareholder”, which were determined by the audit committee not to be extraordinary transactions, but which were also determined by the audit committee not to be negligible transactions, (v) reviewing the internal auditor’s work program performance, examining the company’s internal control structure and processes and determining whether the internal auditor has the requisite tools and resources required to perform his or her role, (vi) examining the external auditor’s scope of work as well as the external auditor’s fees and providing its recommendations to the appropriate corporate organ, (vii) overseeing the accounting and financial reporting processes of the Company, and (viii) providing arrangements regarding employee complaints with respect to flaws in the management of the Company’s business and the protection to be provided to such employees.
Board Committees Audit Committee The Companies Law requires public companies such as ours to appoint an audit committee, the responsibilities of which include, among other things: (i) identifying flaws in the management of the company’s business, among other things, in consultation with the company’s internal auditor or external auditor, and making recommendations to the board of directors as to how to correct them, (ii) reviewing and considering certain related party transactions and certain actions involving conflicts of interest (as well as deciding whether certain actions specified in the Companies Law are considered material or non-material and whether certain transactions are considered exceptional or ordinary), (iii) establishing procedures to be followed with respect to related party transactions with a “controlling shareholder” (where such are not extraordinary transactions), which may include, where applicable, the establishment of a competitive process for such transaction, under the supervision of the audit committee, or individual, or other committee or body selected by the audit committee, in accordance with criteria determined by the audit committee, (iv) determining procedures for approving certain related party transactions with a “controlling shareholder”, which were determined by the audit committee not to be extraordinary transactions, but which were also determined by the audit committee not to be negligible transactions, (v) reviewing the internal auditor’s work program performance, examining the company’s internal control structure and processes and determining whether the internal auditor has the requisite tools and resources required to perform his or her role, (vi) examining the external auditor’s scope of work as well as the external auditor’s fees and providing its recommendations to the appropriate corporate organ, (vii) overseeing the accounting and financial reporting processes of the Company, and (viii) providing arrangements regarding employee complaints with respect to flaws in the management of the Company’s business and the protection to be provided to such employees. 93 Under the Nasdaq Listing Rules, we are required to maintain an audit committee that operates under a formal written charter and has certain responsibilities and authority, including being directly responsible for the appointment, compensation, retention and oversight of the work of our external auditor.
All numbers quoted in the table are inclusive of options to purchase shares that are exercisable within 60 days after February 28, 2025, and RSUs that are vested during such period.
All numbers quoted in the table are inclusive of options to purchase shares that are exercisable within 60 days after February 20, 2026, and RSUs that are vested during such period.
In order to align such grants (including the exercise price and vesting period) with the annual grant of options to other executive Office Holders (for whom shareholder approval is not required), our shareholders resolved that the annual grant to Dr.
Additionally, as approved at the 2025 AGM, in order to align such grants (including the exercise price and vesting period) with the annual grant of options to other executive Office Holders (for whom shareholder approval is not required), our shareholders resolved that the annual grant to Dr.
Previously, at Pierre Fabre Oncology R&D, he acted as Director, Pharmacokinetics/Pharmacodynamics, overseeing also translational, biomarker-related activities. Before that Dr. Ferre was in charge of oncology preclinical pharmacokinetics. Dr.
Previously, at Pierre Fabre Oncology R&D, he acted as Director, Pharmacokinetics/Pharmacodynamics, overseeing also translational, biomarker-related activities. Before that Dr. Ferre was in charge of oncology Preclinical Pharmacokinetics. Dr. Ferre was initially trained as a veterinary doctor.
We have adopted a charter for the compensation committee, which sets forth the purpose and responsibilities of such committee. Under the Nasdaq Listing Rules, we are required to maintain a compensation committee consisting of at least two independent directors (as defined under the Nasdaq Listing Rules).
Compensation - Approvals Required for Office Holders Terms of Office and Employment”). 94 We have adopted a charter for the compensation committee, which sets forth the purpose and responsibilities of such committee. Under the Nasdaq Listing Rules, we are required to maintain a compensation committee consisting of at least two independent directors (as defined under the Nasdaq Listing Rules).
EMPLOYEES The following table sets out the number of our full-time employees engaged in specified activities, at the end of the fiscal years 2024, 2023 and 2022 (the numbers include employees of our wholly owned U.S. subsidiary Compugen USA, Inc.): December 31, 2024 December 31, 2023 December 31, 2022 Research & Development 52 46 46 Administration, Accounting and Operations 21 21 21 Marketing and Business Development 1 1 2 Total 74 68 69 In addition to the headquarters in Holon, Israel, we maintain a subsidiary in the U.S.
EMPLOYEES The following table sets out the number of our full-time employees engaged in specified activities, at the end of the fiscal years 2025, 2024 and 2023 (the numbers include employees of our wholly owned U.S. subsidiary Compugen USA, Inc.): December 31, 2025 December 31, 2024 December 31, 2023 Research & Development 53 52 46 Administration, Accounting and Operations 21 21 21 Marketing and Business Development 1 1 1 Total 75 74 68 97 In addition to the headquarters in Holon, Israel, we have a team in the U.S.
From 2010 to 2016, Dr. Livnat Savitzky served as CEO of BioLineRX Ltd., a Nasdaq-listed drug development company focused on oncology and immunology. During her tenure, BioLineRX signed a strategic collaboration with Novartis as well as licensing agreements with Merck (MSD), Genentech and others. Prior to being appointed CEO of BioLineRX, Dr.
Livnat Savitzky served as Chief Executive Officer of BioLineRX Ltd., a Nasdaq-listed drug development company focused on oncology and immunology. During her tenure, BioLineRX signed a strategic collaboration with Novartis as well as licensing agreements with Merck (MSD), Genentech and others. Prior to being appointed Chief Executive Officer of BioLineRX, Dr.
The Companies Law provides that a company may not insure, exempt or indemnify an Office Holder for any breach of his or her liability arising from any of the following: • a breach by the Office Holder of his or her duty of loyalty, except that the company may enter into an insurance contract or indemnify an Office Holder if the Office Holder acted in good faith and had a reasonable basis to believe that the act would not prejudice the company; • a breach by the Office Holder of his or her duty of care if such breach was intentional or reckless, but unless such breach was solely negligent; • any act or omission done with the intent to derive an illegal personal benefit; or • any fine, civil fine, financial sanction or monetary settlement in lieu of criminal proceedings imposed on such Office Holder. 90 Administrative Enforcement The Israeli Securities Law includes an administrative enforcement procedure that may be used by the Israeli Securities Authority, to enhance the efficacy of enforcement in the securities market in Israel.
The Companies Law provides that a company may not insure, exempt or indemnify an Office Holder for any breach of his or her liability arising from any of the following: • a breach by the Office Holder of his or her duty of loyalty, except that the company may enter into an insurance contract or indemnify an Office Holder if the Office Holder acted in good faith and had a reasonable basis to believe that the act would not prejudice the company; • a breach by the Office Holder of his or her duty of care if such breach was intentional or reckless, but unless such breach was solely negligent; • any act or omission done with the intent to derive an illegal personal benefit; or • any fine, civil fine, financial sanction or monetary settlement in lieu of criminal proceedings imposed on such Office Holder.
Approvals Required for Office Holders Terms of Office and Employment”). 98 If a grantee of options leaves his or her employment or other relationship with us, or if his or her relationship with us is terminated without cause (and other than by reason of death or disability, as defined in the 2010 Plan), the term of his or her unexercised options will generally expire in 90 days, unless determined otherwise by our board of directors.
If a grantee of options leaves his or her employment or other relationship with us, or if his or her relationship with us is terminated without cause (and other than by reason of death or disability, as defined in the 2010 Plan), the term of his or her unexercised options will generally expire in 90 days, unless determined otherwise by our board of directors.
Paul Sekhri, who serves as the chairman of our nomination and corporate governance committee, Dr. Kinneret Livnat Savitzky and Mr. Sanford (Sandy) Zweifach, each an independent director, are the members of our nomination and corporate governance committee, which, among other responsibilities, recommends director nominees for our board’s approval.
Gilead Halevy, who serves as the chairman of our nomination and corporate governance committee and who is also our lead independent director, Dr. Kinneret Livnat Savitzky and Mr. Sanford (Sandy) Zweifach, each an independent director, are the members of our nomination and corporate governance committee, which, among other responsibilities, recommends director nominees for our board’s approval.
Zweifach was also a Partner at Reedland Capital Partners, a boutique investment bank, where he headed its life sciences M&A and advisory efforts. Prior to this, he was CEO of Pathways Diagnostics, a biomarker development company. Mr.
Zweifach was also a Partner at Reedland Capital Partners, a boutique investment bank, from 2005 to 2010, where he headed its life sciences M&A and advisory efforts. Prior to this, he was Chief Executive Officer of Pathways Diagnostics, a biomarker development company. Mr.
Cohen-Dayag under the Equity Framework shall have a one-year exercise period following the termination of her employment as the Company’s chief executive officer, other than in the event of termination for “cause” (as defined in her employment agreement as shall be in effect from time to time).
Ophir under the Equity Framework shall have a one-year exercise term following the termination of his employment as the Company’s Chief Executive Officer, other than in the event of termination for “cause” (as defined in his employment agreement as shall be in effect from time to time).
Under the Companies Law, the compensation committee may need to seek the approval of the board of directors and the shareholders for certain compensation-related decisions (see “Item 6 - Directors, Senior Management and Employees - B. Compensation - Approvals Required for Office Holders Terms of Office and Employment”).
Under the Companies Law, the compensation committee may need to seek the approval of the board of directors and the shareholders for certain compensation-related decisions (see “Item 6 - Directors, Senior Management and Employees - B.
Cohen-Dayag shall be eligible to receive an annual cash bonus of up to nine monthly salaries for each of the calendar years 2024, 2025 and 2026, without the need for further shareholder approval, subject to meeting the specific performance criteria determined by the compensation committee and board with respect to each such year, in accordance with the objectives and terms thereof and the continuous employment of Dr.
Cohen-Dayag shall be eligible to receive an annual cash bonus of up to nine monthly salaries for each of the calendar years 2024, 2025 and 2026 (which eligibility for 2026 was replaced with her eligibility to cash bonus in her capacity as Executive Chair at the 2025 AGM, as further detailed below), without the need for further shareholder approval, subject to meeting the specific performance criteria determined by the compensation committee and board with respect to each such year, in accordance with the objectives and terms thereof and the continuous employment of Dr.
The duty of care requires an Office Holder to act with the standard of skills with which a reasonable Office Holder in the same position would have acted under the same circumstances.
An Office Holder’s fiduciary duties consist of a duty of care and a duty of loyalty. The duty of care requires an Office Holder to act with the standard of skills with which a reasonable Office Holder in the same position would have acted under the same circumstances.
Anat Cohen-Dayag will be entitled to participate in the ESPP or any other employee share purchase plan(s) that may be adopted by the Company from time to time until the end of 2026, as long as the fair market value of the benefit provided to her under such employee share purchase plan(s) (determined by the Company at the beginning of the respective offering period) in any given twelve (12) month period does not exceed ten percent (10%) of her annual base salary.
Ophir will also be entitled to participate until the end of 2027 in the Company’s 2021 Employee Share Purchase Plan or any other employee share purchase plan(s) that may be adopted by the Company from time to time (the “ESPP”), as long as the fair market value of the benefit provided to him under such ESPP (determined by the Company at the beginning of the respective offering period) in any given twelve (12) month period does not exceed ten percent (10%) of his gross annual base salary.
On December 31, 2022, 57 of our employees were located in Israel, 8 were located in the United States and 4 employees were located in Europe; on December 31, 2023, 58 of our employees were located in Israel, 7 were located in the United States and 3 employees were located in Europe and on December 31, 2024, 66 of our employees were located in Israel, 5 were located in the United States and 3 employees were located in Europe.
On December 31, 2025, 69 of our employees were located in Israel, 4 were located in the United States and 2 employees were located in Europe; on December 31, 2024, 66 of our employees were located in Israel, 5 were located in the United States and 3 employees were located in Europe, and on December 31, 2023, 58 of our employees were located in Israel, 7 were located in the United States and 3 employees were located in Europe.
Accordingly, at the 2024 AGM, our shareholders approved the grant of a special cash bonus in the amount of NIS 202,000 (approximately $79,140 based on the NIS/USD representative rate used in connection with the 2024 AGM) to Dr. Cohen-Dayag in connection with her significant contribution to the engagement with Gilead in the License Agreement.
Accordingly, at the 2024 AGM, our shareholders approved the grant of a special cash bonus in the amount of NIS 202,000 (approximately $79,140 based on the NIS/USD representative rate used in connection with the 2024 AGM) to Dr.
The Company believes that it therefore must offer its Office Holders compensation terms that are competitive with the compensation standards that exist in the companies with whom it competes for such talents. 83 In accordance with the Companies Law, an Israeli public company’s compensation policy and any amendments thereto must be approved by the board of directors, after considering the recommendations of the compensation committee, and generally by a special majority of our shareholders, or a Special Majority, which include (i) at least a majority of the shareholders who are not controlling shareholders and who do not have a personal interest in the matter, present and voting (abstentions are disregarded), or (ii) the non-controlling shareholders and shareholders who do not have a personal interest in the matter who were present and voted against the matter hold two percent or less of the voting power of the company.
In accordance with the Companies Law, an Israeli public company’s compensation policy and any amendments thereto must be approved by the board of directors, after considering the recommendations of the compensation committee, and generally by a special majority of our shareholders, or a Special Majority, which include (i) at least a majority of the shareholders who are not controlling shareholders and who do not have a personal interest in the matter, present and voting (abstentions are disregarded), or (ii) the non-controlling shareholders and shareholders who do not have a personal interest in the matter who were present and voted against the matter hold two percent or less of the voting power of the company.
Taxation of Equity Granted under our 2010 Plan and ESPP to Israeli Grantees Our board of directors elected the “Capital Gains Track” (as defined in Section 102(b) (2) of the Tax Ordinance) for the grant of equity under the 2010 Plan and ESPP to Israeli grantees who are eligible for grant under said Section 102 of the Tax Ordinance.
As of December 31, 2025, there were no ordinary shares available for issuance under the ESPP. 99 Taxation of Equity Granted under our 2010 Plan and ESPP to Israeli Grantees Our board of directors elected the “Capital Gains Track” (as defined in Section 102(b) (2) of the Tax Ordinance) for the grant of equity under the 2010 Plan and ESPP to Israeli grantees who are eligible for grant under said Section 102 of the Tax Ordinance.
These options granted in these equity grants will have an exercise price equal to the closing price of the Company’s ordinary shares on Nasdaq on the last trading day prior to the approval of each year’s grant by the board of directors.
The options granted in these equity grants have an exercise price equal to the closing price of the Company’s ordinary shares on Nasdaq on the last trading day prior to the approval of each year’s grant by the board of directors (other than with respect to the grant for 2025, as detailed above).
At the Company’s Annual General Meeting of Shareholders for 2020, held on September 16, 2020, or the 2020 AGM, and the 2024 AGM, our shareholders approved, following previous resolutions made by our compensation committee and the board of directors, and consistent with our Compensation Policy, that the compensation committee and the board may issue to all non-executive directors RSUs or other equity awards which are not options, or Other Equity in connection with the Initial Equity Grant and the Annual Equity Grant, and that each such grants shall be adjusted, on a pro rata basis, to give effect to the relative portion of each type of equity awarded.
To the extent legally available and applicable, such options will be granted to the non-executive directors through a trustee under Section 102 of the Israel Income Tax Ordinance [New Version], 5721-1961, or the Tax Ordinance, under the capital gains route. 84 At the Company’s Annual General Meeting of Shareholders for 2020, held on September 16, 2020, or the 2020 AGM, and the 2024 AGM, our shareholders approved, following previous resolutions made by our compensation committee and the board of directors, and consistent with our Compensation Policy, that the compensation committee and the board may issue to all non-executive directors RSUs or other equity awards which are not options, or Other Equity in connection with the Initial Equity Grant and the Annual Equity Grant, and that each such grants shall be adjusted, on a pro rata basis, to give effect to the relative portion of each type of equity awarded.
As of December 31, 2024, options to purchase 8,655,721 ordinary shares at a weighted average exercise price of approximately $4.31 per share and 317,350 RSUs were outstanding (i.e., were granted but not canceled, expired nor exercised) under the 2010 Plan and 891,922 ordinary shares remained available for future grant under the 2010 Plan.
As of December 31, 2025, options to purchase 8,628,743 ordinary shares at a weighted average exercise price of approximately $4.05 per share and 567,400 RSUs were outstanding (i.e., were granted but not canceled, expired nor exercised) under the 2010 Plan and 718,981ordinary shares remained available for future grant under the 2010 Plan.
In addition to each person listed in the table under “Item 6. Directors, Senior Management and Employees - A. Directors and Senior Management”, two other individuals have been Office Holders as of December 31, 2024.
In addition to each person listed in the table under “Item 6. Directors, Senior Management and Employees - A. Directors and Senior Management”, three additional individuals were Office Holders as of December 31, 2025.
None of our directors is party to a service contract with us that provides for any severance or similar benefits upon termination of his or her service, other than our president and chief executive officer, Dr. Anat Cohen-Dayag, with whom we entered into an employment agreement. For additional information on the employment agreement entered into with Dr.
None of our directors is party to a service contract with us that provides for any severance or similar benefits upon termination of his or her service, other than our President and Chief Executive Officer, Dr. Eran Ophir and our Executive Chair of the Board, Dr. Anat Cohen-Dayag, with whom we have employment agreements in place.
Extraordinary transactions of a public company with a controlling shareholder or in which a controlling shareholder has a personal interest, as well as any engagement by a public company of a controlling shareholder or of such controlling shareholder’s Relative, directly or indirectly, with respect to the provision of services to the company, and, if such person is also an Office Holder of such company, with respect to such person’s Terms of Office and Employment as an Office Holder, and if such person is an employee of the company but not an Office Holder, with respect to such person’s employment by the company, generally require the approval of each of the audit committee (or with respect to Terms of Office and Employment, the compensation committee), the board of directors and the shareholders of the company, in that order.
For this purpose, a ‘controlling shareholder’ is a shareholder who has the ability to direct the activities of a company, including a shareholder or a group of shareholders who together own 25% or more of the voting rights if no other shareholder holds more than 50% of the voting rights. 96 Extraordinary transactions of a public company with a controlling shareholder or in which a controlling shareholder has a personal interest, as well as any engagement by a public company of a controlling shareholder or of such controlling shareholder’s Relative, directly or indirectly, with respect to the provision of services to the company, and, if such person is also an Office Holder of such company, with respect to such person’s Terms of Office and Employment as an Office Holder, and if such person is an employee of the company but not an Office Holder, with respect to such person’s employment by the company, generally require the approval of each of the audit committee (or with respect to Terms of Office and Employment, the compensation committee), the board of directors and the shareholders of the company, in that order.
Any extraordinary transactions with a controlling shareholder or in which a controlling shareholder has a personal interest with a term of more than three years generally need to be brought for re-approval in accordance with the above procedure every three years, unless the audit committee determines that the duration of the transaction is reasonable given the circumstances related thereto and has been approved by the shareholders for such longer duration. 96 Pursuant to regulations promulgated under the Companies Law, certain transactions with a controlling shareholder or his or her Relative, or with directors, that would otherwise require approval of a company’s shareholders may be exempt from shareholder approval upon certain determinations of the audit committee or the compensation committee and board of directors.
Any extraordinary transactions with a controlling shareholder or in which a controlling shareholder has a personal interest with a term of more than three years generally need to be brought for re-approval in accordance with the above procedure every three years, unless the audit committee determines that the duration of the transaction is reasonable given the circumstances related thereto and has been approved by the shareholders for such longer duration.
Anat Cohen-Dayag, who also serves as our chief executive officer, meets the ‘independent directors’ criteria under the Companies Law. 92 Independent Directors Under the Nasdaq Listing Rules In addition to the requirements of the Companies Law as described above, since our shares are listed on The Nasdaq Capital Market, pursuant to the Nasdaq Listing Rules, a majority of our directors must be independent (as defined under the Nasdaq Listing Rules).
Independent Directors Under the Nasdaq Listing Rules In addition to the requirements of the Companies Law as described above, since our shares are listed on The Nasdaq Capital Market, pursuant to the Nasdaq Listing Rules, a majority of our directors must be independent (as defined under the Nasdaq Listing Rules).
The Company may undertake to indemnify an office holder as mentioned above: (a) prospectively, provided that with respect of the first act (financial liability) the undertaking is limited to events which in the opinion of the board of directors are foreseeable in light of the Company’s actual operations when the undertaking to indemnify is given, and to an amount or criteria set by the board of directors as reasonable under the circumstances, and further provided that such events and amount or criteria are set forth in the undertaking to indemnify, and (b) retroactively.
The Company may undertake to indemnify an office holder as mentioned above: (a) prospectively, provided that with respect of the first act (financial liability) the undertaking is limited to events which in the opinion of the board of directors are foreseeable in light of the Company’s actual operations when the undertaking to indemnify is given, and to an amount or criteria set by the board of directors as reasonable under the circumstances, and further provided that such events and amount or criteria are set forth in the undertaking to indemnify, and (b) retroactively. 90 Indemnification letters, covering indemnification of those liabilities discussed above, were granted to each of our present Office Holders and were amended at the Company’s Annual General Meeting of Shareholders for 2021, held on September 2, 2021.
Out of the outstanding options: (i) options to purchase 1,038,750 ordinary shares, with a weighted average exercise price of $5.70 per share, were exercisable as of December 31, 2024; and (ii) options to purchase 476,250 ordinary shares, with a weighted average exercise price of $1.86 per share, had not vested as of December 31, 2024.
Out of the outstanding options: (i) options to purchase 1,140,607 ordinary shares, with a weighted average exercise price of $5.04 per share, were exercisable as of December 31, 2025; and (ii) options to purchase 374,693 ordinary shares, with a weighted average exercise price of $1.43 per share, had not vested as of December 31, 2025.
Each compensation committee member must also be deemed by our board of directors to meet the enhanced independence requirements for members of the compensation committee under the Nasdaq Listing Rules, which requires, among other things, that our board of directors considers the source of each such committee member’s compensation in considering whether he or she is independent. 94 The compensation committee composition requirements referred to under Section 118A of the Companies Law are not applicable to the Company as our board of directors, as part of its decision to opt out of the requirement to elect external directors pursuant to the relief available under the Alleviation Regulations, also opted out of such composition requirements on the basis that the Company complies, and will continue to comply, with the Nasdaq majority board independence requirement and with US Securities Law and Nasdaq Listing Rules concerning the composition of the compensation committee, as described above.
The compensation committee composition requirements referred to under Section 118A of the Companies Law are not applicable to the Company as our board of directors, as part of its decision to opt out of the requirement to elect external directors pursuant to the relief available under the Alleviation Regulations, also opted out of such composition requirements on the basis that the Company complies, and will continue to comply, with the Nasdaq majority board independence requirement and with US Securities Law and Nasdaq Listing Rules concerning the composition of the compensation committee, as described above.
Zweifach is a senior executive with over 32 years of experience in the life sciences industry. He has extensive experience in corporate partnering, business development, operations, private and public investing, and capital raising. Mr. Zweifach founded and served as CEO of both Nuvelution Pharma, Inc. and Ascendancy Healthcare, Inc. Mr.
He has extensive experience in corporate partnering, business development, operations, private and public investing, and capital raising. Mr. Zweifach founded and served as Chief Executive Officer of both Nuvelution Pharma, Inc. and Ascendancy Healthcare, Inc. Mr.
Compugen 2010 Share Incentive Plan On July 25, 2010, our board of directors adopted the 2010 Plan which was also approved by our shareholders on May 12, 2011.
In addition to the discussion below, see Note 9 to our 2025 consolidated financial statements. Compugen 2010 Share Incentive Plan On July 25, 2010, our board of directors adopted the 2010 Plan which was also approved by our shareholders on May 12, 2011.
If applicable, the equity grants will be granted through a trustee under Section 102 of the Tax Ordinance and, in accordance with the Company’s previous election in this regard, be subject to the capital gains route for tax purposes. All vested options and Other Equity (to the extent applicable) granted to Dr.
These equity grants will be granted through a trustee under Section 102 of the Tax Ordinance and, in accordance with the Company’s previous election in this regard, be subject to the capital gains route for tax purposes. All other terms applying to the equity specified above (e.g., acceleration) shall apply to the Chair Equity Framework. (iv) Dr.

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Item 7. Management's Discussion & Analysis

Management's Discussion & Analysis (MD&A) — revenue / margin commentary

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Biggest changeRELATED PARTY TRANSACTIONS Other than as set forth below and transactions related to compensation (including insurance, indemnification and exemption) of our executive officers and directors as described under “Item 6. Directors, Senior Management and Employees - B. Compensation” since January 1, 2024, we have not entered into any material related party transaction. C. INTERESTS OF EXPERTS AND COUNSEL Not applicable.
Biggest changeRELATED PARTY TRANSACTIONS Other than as set forth below and transactions related to engagement with an compensation (including insurance, indemnification and exemption) of our executive officers and directors as described under “Item 6. Directors, Senior Management and Employees - B. Compensation” since January 1, 2025, we have not entered into any material related party transaction. C.
ITEM 7. MAJOR SHAREHOLDERS AND RELATED PARTY TRANSACTIONS A. MAJOR SHAREHOLDERS As of February 28, 2025 we are not aware of any beneficial owner of more than 5% of our outstanding ordinary shares.
ITEM 7. MAJOR SHAREHOLDERS AND RELATED PARTY TRANSACTIONS A. MAJOR SHAREHOLDERS As of February 20, 2026 we are not aware of any beneficial owner of more than 5% of our outstanding ordinary shares.
As of February 28, 2025, there were a total of 35 holders of record of our ordinary shares, of which 22 were registered with addresses in the United States. Such United States holders were, as of such date, the holders of record of more than 99.0% of our outstanding ordinary shares.
As of February 20, 2026, there were a total of 33 holders of record of our ordinary shares, of which 20 were registered with addresses in the United States. Such United States holders were, as of such date, the holders of record of more than 99% of our outstanding ordinary shares.