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What changed in Immunocore Holdings plc's 10-K — 2024 vs 2025

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Paragraph-level year-over-year comparison of Immunocore Holdings plc's 2024 and 2025 10-K 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.

+585 added−630 removedSource: 10-K (2026-02-25) vs 10-K (2025-02-26)

Top changes in Immunocore Holdings plc's 2025 10-K

585 paragraphs added · 630 removed · 456 edited across 8 sections

Item 1. Business

Business — how the company describes what it does

145 edited+43 added−59 removed281 unchanged
Biggest changeRegulation and Procedures Governing Approval of Medicinal Products in the EU In order to market any product outside of the United States, a company also must comply with numerous and varying regulatory requirements of other countries and jurisdictions regarding quality, safety and efficacy and governing, among other things, clinical trials, marketing authorization, commercial sales and distribution of products.
Biggest changeEven if a product is considered to be a reference product eligible for exclusivity, another company could market a competing version of that product if the FDA approves a full BLA for such product containing the sponsor’s own nonclinical data and data from adequate and well-controlled clinical trials to demonstrate the safety, purity and potency of their product. 24 Table of Contents Regulation and Procedures Governing Approval of Medicinal Products in the EU In order to market any product outside of the United States, a company also must comply with numerous and varying regulatory requirements of other countries and jurisdictions regarding quality, safety and efficacy and governing, among other things, clinical trials, marketing authorization, commercial sales and distribution of products.
An applicant seeking approval to market and distribute a new biologic in the United States generally must satisfactorily complete each of the following steps: • nonclinical laboratory tests, animal studies and formulation studies all performed in accordance with the FDA’s good laboratory practices ("GLP") regulations; • submission to the FDA of an IND application for human clinical testing, which must become effective before human clinical trials may begin; • approval by an institutional review board ("IRB") representing each clinical site before each clinical trial may be initiated; • performance of adequate and well-controlled human clinical trials to establish the safety, potency and purity of the product candidate for each proposed indication, in accordance with Good Clinical Practices ("GCP"); • preparation and submission to the FDA of a BLA for a biological product requesting marketing for one or more proposed indications, including submission of detailed information on the manufacture and composition of the product in clinical development and proposed labeling; • review of the product by an FDA advisory committee, if applicable; 19 Table of Contents • one or more FDA inspections of the manufacturing facility or facilities, including those of third parties, at which the product, or components thereof, are produced to assess compliance with current cGMP, requirements and to assure that the facilities, methods and controls are adequate to preserve the product’s identity, strength, quality and purity; • FDA audits of the clinical study sites to assure compliance with GCPs, and the integrity of clinical data in support of the BLA; • payment of user fees and securing FDA approval of the BLA and licensure of the new biological product; and • compliance with any post-approval requirements, including the potential requirement to implement a Risk Evaluation and Mitigation Strategy ("REMS"), and any post-approval studies required by the FDA.
An applicant seeking approval to market and distribute a new biologic in the United States generally must satisfactorily complete each of the following steps: • nonclinical laboratory tests, animal studies and formulation studies all performed in accordance with the FDA’s good laboratory practices ("GLP") regulations; • submission to the FDA of an IND application for human clinical testing, which must become effective before human clinical trials may begin; • approval by an institutional review board ("IRB") representing each clinical site before each clinical trial may be initiated; • performance of adequate and well-controlled human clinical trials to establish the safety, potency and purity of the product candidate for each proposed indication, in accordance with Good Clinical Practices ("GCP"); • preparation and submission to the FDA of a BLA for a biological product requesting marketing for one or more proposed indications, including submission of detailed information on the manufacture and composition of the product in clinical development and proposed labeling; • review of the product by an FDA advisory committee, if applicable; • one or more FDA inspections of the manufacturing facility or facilities, including those of third parties, at which the product, or components thereof, are produced to assess compliance with current cGMP, requirements and to assure that the facilities, methods and controls are adequate to preserve the product’s identity, strength, quality and purity; • FDA audits of the clinical study sites to assure compliance with GCPs, and the integrity of clinical data in support of the BLA; • payment of user fees and securing FDA approval of the BLA and licensure of the new biological product; and 18 Table of Contents • compliance with any post-approval requirements, including the potential requirement to implement a Risk Evaluation and Mitigation Strategy ("REMS"), and any post-approval studies required by the FDA.
By engineering these TCRs through our ImmTAX platform, we are developing off-the-shelf, bispecific therapeutics, which are able to precisely target a wide range of proteins uniquely expressed by unhealthy and abnormal cells that cannot be targeted by current antibody-based immunotherapies. 4 Table of Contents Our ImmTAX bispecific therapeutics couple the targeting power of these engineered TCRs on one end with the other end displaying pre-optimized effector functions, which have the ability to drive a desired immune response at the site of the disease.
By engineering these TCRs through our ImmTAX platform, we are developing off-the-shelf, bispecific therapeutics, which are able to precisely target a wide range of proteins uniquely expressed by unhealthy and abnormal cells that cannot be targeted by current antibody-based immunotherapies. 4 Table of Contents Our ImmTAX bispecific therapeutics are designed to couple the targeting power of these engineered TCRs on one end with the other end displaying pre-optimized effector functions, which have the ability to drive a desired immune response at the site of the disease.
In addition, the ACA codified case law that a claim including items or services resulting from a violation of the federal Anti-Kickback Statute constitutes a false or fraudulent claim for purposes of the FCA; • HIPAA imposes criminal and civil liability, among other things, for executing, or attempting to execute, a scheme to defraud any healthcare benefit program or making false statements relating to healthcare matters; 32 Table of Contents • the federal Physician Payments Sunshine Act, which requires certain manufacturers of drugs, devices, biologics and medical supplies for which payment is available under Medicare, Medicaid, or the Children’s Health Insurance Program, with specific exceptions, to report annually to the Centers for Medicare & Medicaid Services ("CMS") information related to payments and other transfers of value made to physicians (defined to include doctors, dentists, optometrists, podiatrists and chiropractors), other healthcare professionals (such as physicians assistants and nurse practitioners), and teaching hospitals, and ownership and investment interests held by physicians and their immediate family members; • HIPAA, as amended by the Health Information Technology for Economic and Clinical Health Act, and their implementing regulations, which imposes certain obligations, including mandatory contractual terms, with respect to safeguarding the transmission, security and privacy of individually identifiable health information on covered entities, such as health plans, health care clearinghouses and certain healthcare providers, and their respective business associates that create, receive, maintain or transmit individually identifiable health information for or on behalf of a covered entity, and their subcontractors that use, disclose, access, or otherwise process individually identifiable protected health information; and • state and foreign law equivalents of each of the above federal laws, such as anti-kickback and false claims laws which may apply to items or services reimbursed by any third- party payor, including commercial insurers; state and foreign laws that require pharmaceutical companies to comply with the pharmaceutical industry’s voluntary compliance guidelines and the relevant compliance guidance promulgated by the federal government that otherwise restrict payments that may be made to healthcare providers and other potential referral sources; state and foreign laws that require drug manufacturers to report information related to payments and other transfers of value to physicians and other healthcare providers, drug pricing and/or marketing expenditures; state and local laws requiring the registration of pharmaceutical sales representatives; and state and foreign laws governing the privacy and security of health information in certain circumstances, many of which differ from each other in significant ways and often are not pre-empted by HIPAA, and may not have the same effect, thus complicating compliance efforts.
In addition, the ACA codified case law that a claim including items or services resulting from a violation of the federal Anti-Kickback Statute constitutes a false or fraudulent claim for purposes of the FCA; • the Health Insurance Portability and Accountability Act as amended ("HIPAA") imposes criminal and civil liability, among other things, for executing, or attempting to execute, a scheme to defraud any healthcare benefit program or making false statements relating to healthcare matters; 31 Table of Contents • the federal Physician Payments Sunshine Act, which requires certain manufacturers of drugs, devices, biologics and medical supplies for which payment is available under Medicare, Medicaid, or the Children’s Health Insurance Program, with specific exceptions, to report annually to the Centers for Medicare & Medicaid Services ("CMS") information related to payments and other transfers of value made to physicians (defined to include doctors, dentists, optometrists, podiatrists and chiropractors), other healthcare professionals (such as physicians assistants and nurse practitioners), and teaching hospitals, and ownership and investment interests held by physicians and their immediate family members; • HIPAA, as amended by the Health Information Technology for Economic and Clinical Health Act, and their implementing regulations, which imposes certain obligations, including mandatory contractual terms, with respect to safeguarding the transmission, security and privacy of individually identifiable health information on covered entities, such as health plans, health care clearinghouses and certain healthcare providers, and their respective business associates that create, receive, maintain or transmit individually identifiable health information for or on behalf of a covered entity, and their subcontractors that use, disclose, access, or otherwise process individually identifiable protected health information; and • state and foreign law equivalents of each of the above federal laws, such as anti-kickback and false claims laws which may apply to items or services reimbursed by any third- party payor, including commercial insurers; state and foreign laws that require pharmaceutical companies to comply with the pharmaceutical industry’s voluntary compliance guidelines and the relevant compliance guidance promulgated by the federal government that otherwise restrict payments that may be made to healthcare providers and other potential referral sources; state and foreign laws that require drug manufacturers to report information related to payments and other transfers of value to physicians and other healthcare providers, drug pricing and/or marketing expenditures; state and local laws requiring the registration of pharmaceutical sales representatives; and state and foreign laws governing the privacy and security of health information in certain circumstances, many of which differ from each other in significant ways and often are not pre-empted by HIPAA, and may not have the same effect, thus complicating compliance efforts.
An employee's end of year PDR is used to determine compensation awards so as to drive a pay for performance culture, including annual merit increases, bonuses, and equity awards (offered to every single employee). Our annual bonus budget is approved by the Remuneration Committee after reviewing the Company annual scorecard achievement relative to delivering on company goals.
An employee's end of year PDR is used to determine compensation awards so as to drive a pay-for-performance culture, including annual merit increases, bonuses, and equity awards (offered to every employee). Our annual bonus budget is approved by the Remuneration Committee after reviewing our annual scorecard achievement relative to delivering on company goals.
As we strive each day to deliver our mission, we have built a strong culture rooted in values, as we strive to create a workplace where all belong and can share ideas to drive innovation, and to create an environment where individual contributions and initiatives can be maximized, while fostering a culture of collaboration, based on respect and integrity.
As we strive each day to deliver our mission, we have built a strong culture rooted in values, as we attempt to create a workplace where all belong and can share ideas to drive innovation, and an environment where individual contributions and initiatives can be maximized, while fostering a culture of collaboration, based on respect and integrity.
Our merit budget is approved annually by the Remuneration Committee for base pay adjustments for our global organization, taking into account a variety of factors, including competitive, forward-looking benchmarking data. 38 We believe that continued growth and development are essential to the professional well-being of our team.
Our merit budget is approved annually by the Remuneration Committee for base pay adjustments for our global organization, taking into account a variety of factors, including competitive, forward-looking benchmarking data. We believe that continued growth and development are essential to the professional well-being of our team.
Adoption of price controls and cost-containment measures, and adoption of more restrictive policies in jurisdictions with existing controls and measures, could further limit our net revenue and results. A payor’s decision to provide coverage for a drug product does not imply that an adequate reimbursement rate will be approved.
Adoption of additional price controls and cost-containment measures, and adoption of more restrictive policies in jurisdictions with existing controls and measures, could further limit our net revenue and results. A payor’s decision to provide coverage for a drug product does not imply that an adequate reimbursement rate will be approved.
We always strive to identify ways to improve what we do and how we do. That is why we regularly conduct an employee survey. We have a highly engaged workforce and our 2023 employee survey data had a high response rate and showed an improvement in engagement versus the previous survey conducted in 2021.
We always strive to identify ways to improve what we do and how we do. That is why we regularly conduct an employee survey. We have a highly engaged workforce and our 2023 employee survey data had a high response rate and showed a significant improvement in engagement versus the previous survey conducted in 2021.
We do not currently own or operate manufacturing facilities for the production of clinical or commercial ImmTAX product candidates, and we have no intention to build out our own manufacturing capabilities in the foreseeable future.
We do not currently own or operate manufacturing facilities for the production of clinical or commercial ImmTAX product candidates, and we have no current intention to build out our own manufacturing capabilities in the foreseeable future.
In order to obtain a UK MA to commercialize products in the United Kingdom, an applicant must be established in the United Kingdom and must follow one of the United Kingdom national authorization procedures or one of the remaining post-Brexit international cooperation procedures.
In order to obtain a United Kingdom MA to commercialize products in the United Kingdom, an applicant must be established in the United Kingdom and must follow one of the United Kingdom national authorization procedures or one of the remaining post-Brexit international cooperation procedures.
Many of our competitors, either alone or with their collaborations, have significantly greater financial resources and expertise in research and development, manufacturing, preclinical testing, conducting clinical trials, obtaining regulatory approvals and marketing approved products than we do. Smaller or early-stage companies may also prove to be significant competitors, particularly through collaborative arrangements with large and established companies.
Many of our competitors, either alone or with their collaborations, have significantly greater financial, technical and other resources, and expertise in research and development, manufacturing, preclinical testing, conducting clinical trials, obtaining regulatory approvals and marketing approved products than we do. Smaller or early-stage companies may also prove to be significant competitors, particularly through collaborative arrangements with large and established companies.
Staying in good health, mind and body, is important to us, which is why we offer employees a range of benefits including those to support retirement, health and wellness, maturity and parental benefits and an employee assistance program among other benefits, so that they can thrive at work as well as at home, but have the protection they need, and enjoy all things in life.
Staying in good health, mind and body, is important to us, which is why we offer employees a range of benefits including those to support retirement, health and wellness, maternity and parental benefits and an employee assistance program among other benefits, so that they can thrive at work as well as at home, but have the protection they need, and enjoy all things in life.
Other Member States allow companies to fix their own prices for products but monitor and control prescription volumes and issue guidance to physicians to limit prescriptions. 34 Table of Contents In addition, some Member States may require the completion of additional studies that compare the cost-effectiveness of a particular medicinal product candidate to currently available therapies.
Other Member States allow companies to fix their own prices for products but monitor and control prescription volumes and issue guidance to physicians to limit prescriptions. 33 Table of Contents In addition, some Member States may require the completion of additional studies that compare the cost-effectiveness of a particular medicinal product candidate to currently available therapies.
Furthermore, efforts to ensure that business activities and business arrangements comply with applicable healthcare laws and regulations can be costly. 33 Table of Contents Coverage and Reimbursement Significant uncertainty exists as to the coverage and reimbursement status of KIMMTRAK or any other products for which we may obtain regulatory approval.
Furthermore, efforts to ensure that business activities and business arrangements comply with applicable healthcare laws and regulations can be costly. 32 Table of Contents Coverage and Reimbursement Significant uncertainty exists as to the coverage and reimbursement status of KIMMTRAK or any other products for which we may obtain regulatory approval.
As of the date of this Annual Report, we have commercially launched KIMMTRAK in 24 countries, including the United States, with further commercial launches underway in additional territories where we have received regulatory approval. • KIMMTRAK is also being evaluated for the treatment of 2L+ advanced cutaneous melanoma ("CM").
As of the date of this Annual Report, we have commercially launched KIMMTRAK in 30 countries, including the United States, with further commercial launches underway in additional territories where we have received regulatory approval. • KIMMTRAK is also being evaluated for the treatment of 2L+ advanced cutaneous melanoma ("CM").
Intellectual Property We strive to protect and enhance the proprietary technologies, inventions and improvements that we believe are important to our business, including by seeking, maintaining, enforcing and defending patent rights for our therapeutics and platform, whether developed internally or licensed from third parties.
Intellectual Property We strive to protect and enhance the proprietary technologies, inventions and improvements that we believe are important to our business, including by seeking, maintaining, enforcing and defending patent rights for our therapeutics and platforms, whether developed internally or licensed from third parties.
Risk Factors—Risks Related to Intellectual Property.” Trademarks As of December 31, 2024 , our trademark portfolio contains registrations or registration applications related to our commercial and pipeline products, including KIMMTRAK as well as for IMMUNOCORE, in the United States and other relevant jurisdictions.
Risk Factors—Risks Related to Intellectual Property.” Trademarks As of December 31, 2025 , our trademark portfolio contains registrations or registration applications related to our commercial and pipeline products, including KIMMTRAK as well as for IMMUNOCORE, in the United States and other relevant jurisdictions.
We have not in-licensed any issued patents relating to our product or product candidates. 14 Table of Contents KIMMTRAK (tebentafusp) As of December 31, 2024 , we own granted patents and patent applications covering the composition of matter of our commercial product KIMMTRAK (tebentafusp).
We have not in-licensed any issued patents relating to our product or product candidates. 14 Table of Contents KIMMTRAK (tebentafusp) As of December 31, 2025 , we own granted patents and patent applications covering the composition of matter of our commercial product KIMMTRAK (tebentafusp).
Our oncology portfolio includes numerous pre-clinical to late stage programs, including KIMMTRAK in advanced cutaneous melanoma and adjuvant uveal melanoma, brenetafusp in a Phase 3 clinical trial in first-line advanced cutaneous melanoma and in a Phase 1/2 clinical trial in multiple tumor types, IMC-R117C (PIWIL-1) in a Phase 1/2 clinical trial in advanced solid tumors, including colorectal cancer , IMC-P115C (PRAME-HLE-A02) in a Phase 1 clinical trial for patients with tumors that express PRAME.
Our oncology portfolio includes numerous pre-clinical to late stage programs, including Phase 3 clinical trials of KIMMTRAK (tebentafusp) in advanced cutaneous melanoma and adjuvant uveal melanoma, brenetafusp in a Phase 3 clinical trial in first-line advanced cutaneous melanoma and in a Phase 1/2 clinical trial in multiple tumor types, IMC-R117C (PIWIL-1) in a Phase 1/2 clinical trial in advanced solid tumors, including colorectal cancer, and IMC-P115C (PRAME-HLE-A02) in a Phase 1 clinical trial for patients with tumors that express PRAME.
The FDA and other agencies actively enforce the laws and regulations prohibiting the promotion of off-label uses, and a company that is found to have improperly promoted off-label uses may be subject to significant liability. 24 Table of Contents Orphan Drug Designation Orphan Drug Designation in the United States is designed to encourage sponsors to develop products intended for rare diseases or conditions.
The FDA and other agencies actively enforce the laws and regulations prohibiting the promotion of off-label uses, and a company that is found to have improperly promoted off-label uses may be subject to significant liability. Orphan Drug Designation Orphan Drug Designation in the United States is designed to encourage sponsors to develop products intended for rare diseases or conditions.
Our second candidate in autoimmune diseases, IMC-U120AI, which is also our first non-HLA restricted (i.e., universal for all populations) program is an illustration of how we leverage our platform. 11 Table of Contents Sales and Marketing As of December 31, 2024, we have launched KIMMTRAK in 24 countries, including the United States, Germany, France and a number of other countries, and we are focused on driving increasing awareness and adoption of KIMMTRAK as a treatment for mUM.
Our second candidate in autoimmune diseases, IMC-U120AI, which is also our first non-HLA restricted (i.e., universal for all populations) program, is an illustration of how we leverage our platform. 11 Table of Contents Sales and Marketing As of December 31, 2025, we have launched KIMMTRAK in 30 countries, including the United States, Germany, France and a number of other countries, and we are focused on driving increasing awareness and adoption of KIMMTRAK as a treatment for mUM.
In the same trial, we continue signal detection in metastatic non-small cell lung cancer ("NSCLC") cohorts, including brenetafusp in combination with docetaxel and with osimertinib in earlier-line NSCLC and additional solid tumors.
In the same trial, we continue to evaluate signal detection in metastatic non-small cell lung cancer ("NSCLC") cohorts, including brenetafusp in combination with docetaxel and with osimertinib in earlier-line NSCLC and additional solid tumors.
In addition, in some foreign countries, the proposed pricing must be approved before a product may be lawfully marketed. The requirements governing pricing vary widely from country to country. As of December 31, 2024, we have pricing and reimbursement agreements in more than 20 European and other territories, including Germany and Italy.
In addition, in some foreign countries, the proposed pricing must be approved before a product may be lawfully marketed. The requirements governing pricing vary widely from country to country. As of December 31, 2025, we have pricing and reimbursement agreements in more than 20 European and other territories, including Germany, France, and Italy.
MA holders and/or manufacturing and import authorization holders and/or distribution authorization holders may be subject to civil, criminal or administrative sanctions, including suspension of manufacturing authorization, in case of non-compliance with the EU’s or Member States’ requirements applicable to the manufacturing of medicinal products. Data and Market Exclusivity The EU provides opportunities for data and market exclusivity related to MAs.
MA holders and/or manufacturing and import authorization holders and/or distribution authorization holders may be subject to civil, criminal or administrative sanctions, including suspension of manufacturing authorization, in case of non-compliance with the EU’s or Member States’ requirements applicable to the manufacturing of medicinal products. 27 Table of Contents Data and Market Exclusivity The EU provides opportunities for data and market exclusivity related to MAs.
Our Collaborations and License Agreements BMS Collaboration In February 2024, we entered into a clinical trial collaboration and supply agreement with BMS (the "BMS Agreement") to investigate our ImmTAC bispecific TCR candidate targeting PRAME HLA-A*02:01 brenetafusp in combination with BMS’s nivolumab, in first-line advanced cutaneous melanoma.
Our Collaborations and License Agreements BMS Collaboration In February 2024, we entered into a clinical trial collaboration and supply agreement (the "BMS Agreement") with Bristol-Myers Squibb ("BMS") to investigate our ImmTAC bispecific TCR candidate targeting PRAME HLA-A*02:01 brenetafusp in combination with BMS’s nivolumab, in first-line advanced cutaneous melanoma.
A marketing authorization may be granted only to an applicant established in the EU. 26 Table of Contents The centralized procedure provides for the grant of a single marketing authorization by the European Commission that is valid for the European Economic Area ("EEA") (which is comprised of the 27 Member States plus Norway, Iceland and Liechtenstein).
A marketing authorization may be granted only to an applicant established in the EU. The centralized procedure provides for the grant of a single marketing authorization by the European Commission that is valid for the European Economic Area ("EEA") (which is comprised of the 27 Member States plus Norway, Iceland and Liechtenstein).
In the United States, it is essential to obtain third-party payor coverage policies, coding mechanisms, and adequate payment to expand market acceptance and adoption of KIMMTRAK as a treatment for mUM. In 2024 , we continued working with the U.S. commercial third-party payor community in order to maintain coverage for KIMMTRAK.
In the United States, it is essential to obtain third-party payor coverage policies, coding mechanisms, and adequate payment to expand market acceptance and adoption of KIMMTRAK as a treatment for mUM. We continue working with the U.S. commercial third-party payor community in order to maintain coverage for KIMMTRAK.
A company may voluntarily remove a product from the register of orphan products. Post-approval Requirements Where an MA is granted in relation to a medicinal product in the EU , the holder of the MA is required to comply with a range of regulatory requirements applicable to the manufacturing, marketing, promotion and sale of medicinal products.
A company may voluntarily remove a product from the register of orphan products. 28 Table of Contents Post-approval Requirements Where an MA is granted in relation to a medicinal product in the EU , the holder of the MA is required to comply with a range of regulatory requirements applicable to the manufacturing, marketing, promotion and sale of medicinal products.
All existing marketing authorizations of the EU for centrally authorized products were automatically converted or grandfathered into the United Kingdom’s marketing authorization, effective in Great Britain only, free of charge on January 1, 2021, unless the marketing authorization holder opted-out of this possibility.
Existing EU marketing authorizations for centrally authorized products were automatically converted into United Kingdom’s marketing authorizations, effective in Great Britain only, free of charge on January 1, 2021, unless the marketing authorization holder opted-out of this possibility.
This Certificate and the related conformity assessment process entitles the manufacturer to affix the CE mark to its medical devices after having prepared and signed a related EC Declaration of Conformity. Companion diagnostics must undergo a conformity assessment by a Notified Body.
This Certificate and the related conformity assessment process entitles the manufacturer to affix the CE mark to its medical devices after having prepared and signed a related EC Declaration of Conformity. 29 Table of Contents Companion diagnostics must undergo a conformity assessment by a Notified Body.
We have expanded the ImmTAX platform into autoimmune diseases with the addition of two potential first-in-class new bispecific candidates entering the pipeline: IMC-S118AI, for which we plan to submit a CTA or Investigational New Drug application ("IND") in the second half of 2025, and IMC-U120AI for which we plan to submit a CTA or IND in 2026.
We have expanded the ImmTAX platform into autoimmune diseases with the addition of two potential first-in-class new bispecific candidates entering the pipeline: IMC-S118AI, for which we have submitted a clinical trial application ("CTA") in December 2025, and IMC-U120AI for which we plan to submit a CTA or investigational new drug application ("IND") in the second half of 2026.
In all cases, the clinical studies are conducted in accordance with GCP and the applicable regulatory requirements and the ethical principles that have their origin in the Declaration of Helsinki. Human Capital Resources As of December 31, 2024 , we had 493 full-time employees who work primarily in the United Kingdom and the United States.
In all cases, the clinical studies are conducted in accordance with GCP and the applicable regulatory requirements and the ethical principles that have their origin in the Declaration of Helsinki. Human Capital Resources As of December 31, 2025 , we had 524 full-time employees who work primarily in the United Kingdom and the United States.
The majority of our patents and patent applications are solely owned. The portfolio includes solely owned patents and patent applications directed to our commercial TCR product (KIMMTRAK), our product candidates (including brenetafusp, IMC-M113V, IMC-I109V, IMC-P115C, IMC-R117C, IMC-T119C, IMC-S118AI and IMC-U120AI), and our platform technology used to identify and generate our therapeutic candidates, novel targets, formulations and methods of treatment.
The majority of our patents and patent applications are solely owned. The portfolio includes solely owned patents and patent applications directed to our commercial product KIMMTRAK (tebentafusp), our product candidates (including brenetafusp, IMC-M113V, IMC-I109V, IMC-P115C, IMC-R117C, IMC-T119C, IMC-S118AI and IMC-U120AI), and our platform technologies used to identify and generate our therapeutic candidates, novel targets, formulations and methods of treatment.
(in collaboration with MD Anderson) are conducting Phase 1 clinical trials of PRAME-directed cellular therapies and Immatics has also initiated a Phase 1/2 clinical trial of a PRAME TCRxCD3 half-life extended bispecific approach.
(in collaboration with MD Anderson) are conducting Phase 1 clinical trials of PRAME-directed cellular therapies and Immatics is also conducting a Phase 1/2 clinical trial of a PRAME TCRxCD3 half-life extended bispecific approach.
We are enrolling up to 28 people living with HIV in the multiple ascending dose ("MAD"), part of the trial, to identify a safe and tolerable dosing schedule that could lead to reduction in the viral reservoir and control of HIV after stopping antiretroviral therapies, or functional cure.
We are enrolling people living with HIV in the multiple ascending dose ("MAD") portion of the trial, to identify a safe and tolerable dosing schedule that could lead to reduction in the viral reservoir and control of HIV after stopping antiretroviral therapies, or functional cure.
Our focus is to utilize our commercial capabilities to continue to meet patient demand in our major markets, and to launch in further markets in 2025.
Our focus is to utilize our commercial capabilities to continue to meet patient demand in our major markets, and to launch in further markets in 2026.
ImmTAX pipeline As of December 31, 2024 , we solely own patent families covering the composition of matter of each of our oncology, infectious disease, and autoimmune pipeline candidates, including issued U.S. patents covering the composition of matter of brenetafusp, our PRAME-A02 candidate.
Pipeline Products As of December 31, 2025 , we solely own patent families covering the composition of matter of each of our oncology, infectious disease, and autoimmune pipeline candidates, including issued U.S. patents covering the composition of matter of brenetafusp, our PRAME-A02 candidate.
We also rely on data exclusivity, market exclusivity and patent term extensions where available, including any relevant exclusivity through supplementary protection certificates and orphan or pediatric drug designation. As of December 31, 2024 , our global portfolio comprises over 600 patents and pending applications, including at least 25 issued U.S. patents and more than 300 ex-U.S. patents.
We also rely on data exclusivity, market exclusivity and patent term extensions where available, including any relevant exclusivity through supplementary protection certificates and orphan or pediatric drug designation. As of December 31, 2025 , our global portfolio comprises over 850 patents and pending applications, including at least 25 issued U.S. patents and more than 500 ex-U.S. patents.
Fast Track, Breakthrough Therapy and Priority Review Designations The FDA is authorized to designate certain products for expedited review if they are intended to address an unmet medical need in the treatment of a serious or life-threatening disease or condition.
Fast Track, Breakthrough Therapy and Priority Review Designations The FDA is authorized to designate certain products for expedited review if they are intended to address an unmet medical need in the treatment of a serious or life-threatening disease or condition. These programs are referred to as fast track designation, breakthrough therapy designation and priority review designation.
We also want each individual employee to own their career, contribute to high-performing teams through access to training, continuous learning programs and other development initiatives, as well as constructive feedback. During 2024, we introduced a global bonus structure that aligned all employees in the same job level with the same short-term incentive opportunity.
We also want each individual employee to own their career, contribute to healthy high-performing teams through access to training, continuous learning programs and other development initiatives, as well as constructive feedback. We also have a global bonus structure that aligns all employees in the same job level with the same short-term incentive opportunity.
Brenetafusp, a PRAME-targeted candidate, is being evaluated in an ongoing Phase 3 registrational trial, PRISM-MEL-301, in first-line advanced cutaneous melanoma, after we randomized the first patient in the second quarter of 2024, and we are enrolling patients in multiple expansion arms of the Phase 1/2 clinical trial.
Brenetafusp, a PRAME-targeted candidate, is being evaluated in an ongoing Phase 3 registrational trial, PRISM-MEL-301, in first-line advanced cutaneous melanoma, and we are enrolling patients in multiple expansion arms of the Phase 1/2 clinical trial.
Bribery Act 2010 and the U.K. Proceeds of Crime Act 2002 and possibly other state and national anti-bribery and anti-money laundering laws in countries in which we conduct activities, collectively, Anti-Corruption Laws.
Proceeds of Crime Act 2002 and possibly other state and national anti-bribery and anti-money laundering laws in countries in which we conduct activities, collectively, Anti-Corruption Laws.
Additionally, we have initiated a Phase 1/2 trial with IMC-R117C in advanced gastrointestinal cancers, and a Phase 1 trial with IMC-P115C (PRAME-HLE-A02) in patients with tumors that express PRAME. Finally, we submitted a CTA for IMC-T119C (PRAME-A24). The pipeline also includes additional undisclosed pre-clinical programs.
Additionally, we have initiated a Phase 1/2 trial with IMC-R117C in advanced gastrointestinal cancers, and a Phase 1 trial with IMC-P115C (PRAME-HLE-A02) in patients with tumors that express PRAME. The pipeline also includes additional undisclosed pre-clinical programs.
Ou r current pipeline is below. Our ImmTAC Platform (Oncology) Within our ImmTAC platform, KIMMTRAK is approved in 39 countries for HLA-A*02:01-positive adult patients with unresectable or mUM, and is being evaluated in late-stage trials for adjuvant uveal melanoma and advanced cutaneous melanoma.
Our current pipeline is below. Our ImmTAC Platform (Oncology) Within our ImmTAC platform, KIMMTRAK is approved in 39 countries for HLA-A*02:01-positive adult patients with unresectable or mUM, and is being evaluated in Phase 3 registrational trials for adjuvant uveal melanoma and advanced cutaneous melanoma.
To date, we have treated over 2,000 cancer patients with KIMMTRAK, tebentafusp, and our other ImmTAX product candidates, which we believe is the largest clinical data set of any T cell engager bispecific in solid tumors and any T cell receptor ("TCR") therapeutic.
KIMMTRAK is the lead product from our ImmTAX platform and was the first approved therapy in mUM. To date, we have treated over 2,000 cancer patients with KIMMTRAK (tebentafusp), and our other ImmTAX product candidates, which we believe is the largest clinical data set of any T cell engager bispecific in solid tumors and any T cell receptor ("TCR") therapeutic.
Under the terms of the BMS Agreement, we are sponsoring and funding the registrational Phase 3 clinical trial of brenetafusp in combination with nivolumab in first-line advanced cutaneous melanoma (PRISM-MEL-301), and BMS is providing nivolumab. No monetary consideration is transferred as a result of the BMS Agreement.
Under the terms of the BMS Agreement, we are sponsoring and funding the registrational Phase 3 clinical trial of brenetafusp in combination with nivolumab in first-line advanced cutaneous melanoma (PRISM-MEL-301), and BMS is providing nivolumab.
PIWIL1 is believed to play a role in tumor progression and is expressed across a range of tumors including colorectal, which is historically insensitive to immune checkpoints, as well as other gastrointestinal cancers. PIWIL1 is also reported to be a negative prognostic marker.
PIWIL1 is believed to play a role in tumor progression and is expressed across a range of tumors including colorectal, which is historically insensitive to immune checkpoints, as well as other gastrointestinal cancers. PIWIL1 is also reported to be a negative prognostic marker. We believe IMC-R117C is the first PIWIL1 targeted immunotherapy.
We started enrolling patients in this trial in December 2024. • IMC-R117C , our ImmTAC candidate targeting an optimal HLA-A*02:01 PIWIL1, is being tested in a Phase 1/2 trial (first dose was administered in December 2024) for patients with advanced solid tumors, including colorectal cancer, as a single agent and in combination with standards of care.
We expect to present data from this trial in the second half of 2026. • IMC-R117C , our ImmTAC candidate targeting an optimal HLA-A*02:01 PIWIL1, is being tested in a Phase 1/2 trial (first dose was administered in December 2024) for patients with advanced solid tumors, including colorectal cancer, as a single agent and in combination with standards of care.
Gates Collaboration In September 2017, we entered into a $40 million convertible loan agreement and a global access agreement with the Gates Foundation, pursuant to which we agreed to develop, manufacture and commercialize soluble TCR bispecific therapeutic candidates targeted to neglected diseases, primarily tuberculosis and HIV, with the potential to treat people at an affordable price in developing countries.
No monetary consideration is transferred as a result of the BMS Agreement. 16 Table of Contents Gates Collaboration In September 2017, we entered into a $40 million convertible loan agreement and a global access agreement with the Gates Foundation, pursuant to which we agreed to develop, manufacture and commercialize soluble TCR bispecific therapeutic candidates targeted to neglected diseases, primarily tuberculosis and HIV, with the potential to treat people at an affordable price in developing countries.
A breakdown of revenue from the sale of therapies is presented by country / region based on the location of the customer below (in thousands). 2024 2023 2022 United States $ 226,687 $ 169,791 $ 96,893 Europe 73,224 67,628 42,745 International 10,078 1,316 1,049 Revenue from sale of therapies, net $ 309,989 $ 238,735 $ 140,687 Medison is the exclusive distribution partner for KIMMTRAK in Canada, Australia, New Zealand, Israel, Central and Eastern Europe, South and Central America, and the Caribbean.
A breakdown of revenue from the sale of therapies is presented by country / region based on the location of the customer below (in thousands). 2025 2024 2023 United States $ 256,998 $ 226,687 $ 169,791 Europe 131,422 73,224 67,628 International 11,596 10,078 1,316 Revenue from sale of therapies, net $ 400,016 $ 309,989 $ 238,735 Medison is the exclusive distribution partner for KIMMTRAK in Canada, Australia, New Zealand, Israel, Central and Eastern Europe, South and Central America, and the Caribbean.
We face competition from segments of the pharmaceutical, biotechnology and other related markets that pursue the development of TCR-based therapeutics to address unmet needs in cancer including: Adaptimmune Therapeutics plc, Immatics Biotechnologies GmbH ("Immatics"), Adaptive Biotechnologies Corporation ("Adaptive"), pure MHC, LLC, BioNTech SE, Genentech, Inc. ("Genentech"), Matterhorn Biosciences AG, Enara Bio Limited, Boehringer Ingelheim International GmbH, and Regeneron Pharmaceuticals, Inc.
We face competition from segments of the pharmaceutical, biotechnology and other related markets that pursue the development of TCR-based therapeutics to address unmet needs in cancer including: Adaptimmune Therapeutics plc, Immatics Biotechnologies GmbH ("Immatics"), Adaptive Biotechnologies Corporation ("Adaptive"), pure MHC, LLC, BioNTech SE, Genentech, Inc.
Corporate Information We were originally incorporated under the laws of England and Wales in December 2007 as a private company with limited liability called Immunocore Limited.
We will be conducting our next survey in 2026. Corporate Information We were originally incorporated under the laws of England and Wales in December 2007 as a private company with limited liability called Immunocore Limited.
Our ImmTAV product candidates are bispecific soluble TCR molecules featuring our ImmTAX TCR-based targeting system with high specificity for low-expression viral antigens, combined with the proprietary anti-CD3 effector module for T cell engagement and activation that has been evidenced by our clinical oncology pipeline.
Our ImmTAV pre-clinical and clinical candidates are bispecific soluble TCR molecules featuring our ImmTAX TCR-based targeting system with high specificity for low-expression viral antigens, combined with the proprietary anti-CD3 effector module for T cell engagement and activation that has been evidenced by our clinical oncology pipeline. We shared promising data in 2025 about our programs in HIV and HBV.
These programs are referred to as fast track designation, breakthrough therapy designation and priority review designation. 22 Table of Contents The FDA may designate a product for fast track review if it is intended, whether alone or in combination with one or more other products, for the treatment of a serious or life-threatening disease or condition, and it demonstrates the potential to address unmet medical needs for such a disease or condition.
The FDA may designate a product for fast track review if it is intended, whether alone or in combination with one or more other products, for the treatment of a serious or life-threatening disease or condition, and it demonstrates the potential to address unmet medical needs for such a disease or condition.
Available Information Our Annual Report on Form 10-K, Quarterly Reports on Form 10-Q, Current Reports on Form 8-K, and amendments to reports filed pursuant to Sections 13(a) and 15(d) of the Securities Exchange Act of 1934, as amended (the "Exchange Act"), are filed with the Securities and Exchange Commission (the "SEC").
Our agent for service of process in the United States is Immunocore, LLC. 37 Available Information Our Annual Report on Form 10-K, Quarterly Reports on Form 10-Q, Current Reports on Form 8-K, and amendments to reports filed pursuant to Sections 13(a) and 15(d) of the Securities Exchange Act of 1934, as amended (the "Exchange Act"), are filed with the Securities and Exchange Commission (the "SEC").
Orphan medicinal product designation does not convey any advantage in, or shorten the duration of, the regulatory review and approval process. 29 Table of Contents The period of market exclusivity may, however, be reduced to six years if, at the end of the fifth year, it is established that the product no longer meets the criteria on the basis of which it received orphan medicinal product destination, including where it can be demonstrated on the basis of available evidence that the original orphan medicinal product is sufficiently profitable not to justify maintenance of market exclusivity or where the prevalence of the condition has increased above the threshold.
The period of market exclusivity may, however, be reduced to six years if, at the end of the fifth year, it is established that the product no longer meets the criteria on the basis of which it received orphan medicinal product destination, including where it can be demonstrated on the basis of available evidence that the original orphan medicinal product is sufficiently profitable not to justify maintenance of market exclusivity or where the prevalence of the condition has increased above the threshold.
Biosimilars and Exclusivity The Biologics Price Competition and Innovation Act ("BPCIA") established a regulatory scheme authorizing the FDA to approve biosimilars and interchangeable biosimilars. 25 Table of Contents Under the BPCIA, a manufacturer may submit an application for licensure of a biologic product that is “biosimilar to” or “interchangeable with” a previously approved biological product or “reference product.” For the FDA to approve a biosimilar product, it must find that there are no clinically meaningful differences between the reference product and proposed biosimilar product in terms of safety, purity and potency.
Under the BPCIA, a manufacturer may submit an application for licensure of a biologic product that is “biosimilar to” or “interchangeable with” a previously approved biological product or “reference product.” For the FDA to approve a biosimilar product, it must find that there are no clinically meaningful differences between the reference product and proposed biosimilar product in terms of safety, purity and potency.
A minor proportion of the portfolio, comprising certain older platform IP, is jointly owned in equal share with Adaptimmune. We control the prosecution of the jointly owned patents and patent applications, and we have rights under the joint patents as required to develop and commercialize our therapeutics.
A minor proportion of the portfolio that comprises certain older platform technology IP is also solely owned, with the exception of the one patent family jointly owned in equal share with Adaptimmune. We control the prosecution of this jointly owned patent family, and we have rights under the joint patents as required to develop and commercialize our therapeutics.
We signed the agreement for this EORTC-sponsored trial in 2023. • Brenetafusp, the first PRAME x CD3 ImmTAC bispecific molecule, is being evaluated in patients with first-line advanced CM in our registrational PRISM-MEL-301 Phase 3 clinical trial in combination with nivolumab with a primary endpoint of progression-free survival ("PFS").
We expect the Phase 3 trial to complete enrollment in 2028. • Brenetafusp, the first PRAME x CD3 ImmTAC bispecific molecule, is being evaluated in patients with first-line advanced CM in our registrational PRISM-MEL-301 Phase 3 clinical trial in combination with nivolumab with a primary endpoint of progression-free survival ("PFS").
("TScan") who are developing TCR-based cell therapies; and F. Hoffmann-La Roche Ltd, Amgen, Inc., Genmab, Inc., Molecular Partners AG, 3T Biosciences, Inc., Crossbow Therapeutics, Inc., and CDR-Life Inc. are developing CD3-based TCR bispecific compounds or TCR mimetic antibodies.
("TScan") who are developing TCR-based cell therapies; and Immatics, Molecular Partners AG, 3T Biosciences, Inc., Crossbow Therapeutics, Inc., and CDR-Life Inc. are developing CD3-based TCR bispecific compounds or TCR mimetic antibodies.
We have filed further platform patent families relating to TCR bispecifics with improved therapeutic properties, including formats with extended in vivo half-life and improved anti-CD3 effector functions, as well as therapeutic formats for the treatment of autoimmune indications.
We have filed further platform patent families relating to molecule formats with improved therapeutic properties, including formats with extended in vivo half-life and improved anti-CD3 effector functions, as well as therapeutic formats for the treatment of autoimmune indications. Legacy platform patents include a jointly owned patent family with Adaptimmune.
The U.S. government, state legislatures and foreign governments have shown significant interest in implementing cost-containment programs, including price controls, restrictions on reimbursement and requirements for substitution of generic products for branded prescription drugs.
The U.S. government, state legislatures and foreign governments have shown significant interest in implementing cost-containment programs, including price controls, restrictions on reimbursement and requirements for substitution of generic products for branded prescription drugs. For example, the Inflation Reduction Act of 2022 (“IRA”), among other things, (1) directs the U.S.
The manufacturing of medicinal products in the EU requires a manufacturing authorization and import of medicinal products into the EU requires a manufacturing authorization allowing for import. The manufacturing authorization holder must comply with various requirements set out in the applicable laws of the EU, regulations and guidance, including the EU’s cGMP standards.
The manufacturing authorization holder must comply with various requirements set out in the applicable laws of the EU, regulations and guidance, including the EU’s cGMP standards.
Once the MA is obtained in all Member States and study results are included in the product information, even when negative, the product is eligible for a six-month extension to the SPC if any is in effect at the time of authorization or, in the case of orphan medicinal products, a two-year extension of orphan market exclusivity. 28 Table of Contents Manufacturing Regulation in the EU In addition to an MA, various other requirements apply to the manufacturing and placing on the EU’s market of medicinal products.
Once the MA is obtained in all Member States and study results are included in the product information, even when negative, the product is eligible for a six-month extension to the SPC if any is in effect at the time of authorization or, in the case of orphan medicinal products, a two-year extension of orphan market exclusivity.
We are aware of several other companies with product candidates in clinical development including an anticipated readout from Ideaya Biosciences’ first-line non-HLA-A2 mUM registration Phase 2/3 clinical trial in 2025.
We are aware of several other companies with product candidates in clinical development including an anticipated readout from Ideaya Biosciences’ first-line HLA-A*02:01 negative mUM registrational Phase 2/3 clinical trial in 2026.
For example, the Inflation Reduction Act of 2022 (“IRA”), among other things, (1) directs HHS to negotiate the price of certain single-source drugs and biologics that have been on the market for at least 7 years covered under Medicare (the “Medicare Drug Price Negotiation Program”) and (2) imposes rebates under Medicare Part B and Medicare Part D to penalize price increases that outpace inflation.
Department of Health and Human Services ("HHS") to negotiate the price of certain single-source drugs and biologics that have been on the market for at least 7 years covered under Medicare (the “Medicare Drug Price Negotiation Program”) and (2) imposes rebates under Medicare Part B and Medicare Part D to penalize price increases that outpace inflation.
Of these employees, 299 are engaged in research and development activities and 194 are engaged in commercial, business development, finance, information systems, facilities, human resources or administrative support. Further, we have 110 employees (22%) who hold Ph.D. degrees. None of our employees are subject to collective bargaining agreements. We consider our relationship with our employees to be good.
Of these employees, 276 are engaged in research and development activities and 248 are engaged in commercial, business development, finance, information systems, facilities, human resources or administrative support. Further, we have 132 employees (25%) who hold Ph.D. degrees. None of our employees are subject to collective bargaining agreements.
The criteria are essentially the same as those in the EU, but have been tailored for the market. This includes the criterion that prevalence of the condition in the United Kingdom, rather than the EU, must not be more than five in 10,000.
Instead, the MHRA reviews applications for orphan designation in parallel to the corresponding marketing authorization application. The criteria are essentially the same as those in the EU, but have been tailored for the market. This includes the criterion that prevalence of the condition in the United Kingdom, rather than the EU, must not be more than five in 10,000.
Information contained on, or that can be accessed through, our website is not incorporated by reference into this Annual Report, and you should not consider information on our website to be part of this Annual Report. Our agent for service of process in the United States is Immunocore, LLC.
Information contained on, or that can be accessed through, our website is not incorporated by reference into this Annual Report, and you should not consider information on our website to be part of this Annual Report.
In 2022, we received approval for our lead product, KIMMTRAK, for the treatment of unresectable or metastatic uveal melanoma ("mUM") from the FDA, the European Commission and other health authorities. KIMMTRAK is now approved in 39 countries for the treatment of unresectable or mUM.
In 2022, we received approval for our lead product, KIMMTRAK, for the treatment of unresectable or metastatic uveal melanoma ("mUM") from the FDA, the European Commission and other health authorities. KIMMTRAK is now approved in 39 countries and the Company has commercially launched the product in 30 countries, including the United States, Germany and France, among other territories.
We are dedicated to a culture that ensures we have and develop the best possible talent. Our compensation program, including short-term (bonus) and long-term (equity) incentives, as well as benefits and development opportunities, are designed to allow us to ensure those individuals whose skills are critical to our current and long-term success are attracted to and join Immunocore.
Our compensation program, including short-term (bonus) and long-term (equity) incentives, as well as benefits and development opportunities, are designed to allow us to ensure those individuals whose skills are critical to our current and long-term success are attracted to and join Immunocore.
Chronic HBV There are numerous antiviral therapies approved by the FDA for the treatment of chronic HBV infections. These treatments consist of life-long antiviral therapy to suppress virus replication. This can slow the progression of liver cirrhosis and reduce the incidence of liver cancer, but most patients do not achieve functional cure.
These treatments consist of life-long antiviral therapy to suppress virus replication. This can slow the progression of liver cirrhosis and reduce the incidence of liver cancer, but most patients do not achieve functional cure.
Granted patents have been obtained in major territories including two in the United States and 28 in foreign jurisdictions, including Europe (including United Kingdom, France, Germany, Italy, Spain, Ireland, Denmark and the Netherlands), Australia, Canada, China, Hong Kong, Japan, Mexico, Eurasia and South Africa. These granted patents are set to expire in 2030.
Granted patents have been obtained in major territories including the United States and Europe (including United Kingdom, France, Germany, Italy, Spain, Ireland, Denmark and the Netherlands), as well as other jurisdictions, such as Australia, Canada, China, Hong Kong, Japan, Mexico, Eurasia and South Africa.
By way of example, the California Consumer Privacy Act, as amended by the California Privacy Rights Act ("CCPA"), creates certain privacy rights for California residents and places increased privacy and security obligations on entities that are subject to the law.
These state laws differ from each other, which may complicate compliance efforts. By way of example, the California Consumer Privacy Act, as amended by the California Privacy Rights Act ("CCPA"), creates certain privacy rights for California residents and places increased privacy and security obligations on entities that are subject to the law.
The reference Member State prepares a draft assessment and drafts of the related materials within 120 days after receipt of a valid application. The resulting assessment report is submitted to the concerned Member States who, within 90 days of receipt, must decide whether to approve the assessment report and related materials.
The resulting assessment report is submitted to the concerned Member States who, within 90 days of receipt, must decide whether to approve the assessment report and related materials.
Furthermore, there is no effective vaccine to prevent HIV. We are aware of competitors pursuing a cure (e.g., by targeting the viral reservoir or using therapeutic antibodies to suppress viral relapse) but these are in early-stage clinical trials and have not yet demonstrated functional cure, as opposed to viral control.
We are aware of competitors pursuing a cure (e.g., by targeting the viral reservoir or using therapeutic antibodies to suppress viral relapse) but these are in early-stage clinical trials and have not yet demonstrated functional cure, as opposed to viral control. Chronic HBV There are numerous antiviral therapies approved by the FDA for the treatment of chronic HBV infections.
The FDA may take certain actions with respect to breakthrough therapies, including holding meetings with the sponsor throughout the development process; providing timely advice to the product sponsor regarding development and approval; involving more senior staff in the review process; assigning a cross-disciplinary project lead for the review team; and taking other steps to design the clinical trials in an efficient manner.
The FDA may take certain actions with respect to breakthrough therapies, including holding meetings with the sponsor throughout the development process; providing timely advice to the product sponsor regarding development and approval; involving more senior staff in the review process; assigning a cross-disciplinary project lead for the review team; and taking other steps to design the clinical trials in an efficient manner. 21 Table of Contents The FDA may designate a product for priority review if it is a product that treats a serious condition and, if approved, would provide a significant improvement in safety or effectiveness.
The United Kingdom is now no longer a Member State of the European Union and therefore a “third country”. The United Kingdom’s regulatory framework in relation to clinical trials is governed by the Medicines for Human Use (Clinical Trials) Regulations 2004, as amended, which is derived from the CTD, as implemented into the United Kingdom’s national law through secondary legislation.
The United Kingdom’s regulatory framework in relation to clinical trials is governed by the Medicines for Human Use (Clinical Trials) Regulations 2004, as amended, which is derived from the CTD, as implemented into the United Kingdom’s national law through secondary legislation.
Our regulatory obligations could harm the use or cost of our solution as data protection and privacy laws and regulations around the world continue to evolve. 36 Table of Contents The United Kingdom and member states of the EU (the “Member States”), each may introduce further restrictions on personal data processing, including limitations which could limit our ability to collect, use and share personal data (including health and medical information), or could cause our compliance costs to increase.
The United Kingdom and member states of the EU (the “Member States”), each may introduce further restrictions on personal data processing, including limitations which could limit our ability to collect, use and share personal data (including health and medical information), or could cause our compliance costs to increase.

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Item 1A. Risk Factors

Risk Factors — what could go wrong, per management

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Biggest changeIn addition, as a public limited company incorporated in England and Wales, we will only be able to make a distribution if the amount of our net assets is not less than the aggregate of our called-up share capital and undistributable reserves and if, and to the extent that, the distribution does not reduce the amount of those assets to less than that aggregate. 107 Table of Contents Although we do not have any present plans to declare or pay any dividends, in the event we declare and pay any dividend, the depositary for the ADSs has agreed to pay to holders of our ADSs the cash dividends or other distributions it or the custodian receives on our ordinary shares or other deposited securities after deducting its fees and expenses and applicable taxes required to be withheld in connection with any such dividend distribution.
Biggest changeAlthough we do not have any present plans to declare or pay any dividends, in the event we declare and pay any dividend, the depositary for the ADSs has agreed to pay to holders of our ADSs the cash dividends or other distributions it or the custodian receives on our ordinary shares or other deposited securities after deducting its fees and expenses and applicable taxes required to be withheld in connection with any such dividend distribution.
The total addressable market opportunity for KIMMTRAK and our programs will ultimately depend upon, among other things, acceptance by the medical community and patient access, product pricing and reimbursement as well as expansion into additional markets.
The total addressable market opportunity for KIMMTRAK and our other programs will ultimately depend upon, among other things, acceptance by the medical community and patient access, product pricing and reimbursement as well as expansion into additional markets.
If a patent holder believes our product or product candidate infringes on its patent, the patent holder may sue us even if we have received patent protection for our technology. Moreover, we may face patent infringement claims from non-practicing entities that have no relevant revenue and against whom our own patent portfolio may thus have no deterrent effect.
If a patent holder believes our product or product candidate infringes on its patent, the patent holder may sue us even if we have received patent protection for our technology. Moreover, we may face patent infringement claims from non-practicing entities that have no relevant product revenue and against whom our own patent portfolio may thus have no deterrent effect.
In addition, the government may assert that a claim including items and services resulting from a violation of the federal Anti-Kickback Statute constitutes a false of fraudulent claim for purposes of the False Claims Act; 93 Table of Contents • the federal Health Insurance Portability and Accountability Act of 1996 ("HIPAA") imposes criminal and civil liability for, among other things, executing a scheme to defraud any healthcare benefit program, or knowingly and willfully falsifying, concealing or covering up a material fact or making any materially false statement in connection with the delivery of or payment for healthcare benefits, items or services; similar to the federal Anti-Kickback Statute, a person or entity does not need to have actual knowledge of the statute or specific intent to violate it in order to have committed a violation; • the federal physician payment transparency requirements, sometimes referred to as the “Sunshine Act” under the ACA, require certain manufacturers of drugs, devices, biologics and medical supplies that are reimbursable under Medicare, Medicaid, or the Children’s Health Insurance Program to report to CMS information related to transfers of value made to physicians (currently defined to include doctors, dentists, optometrists, podiatrists and chiropractors), other healthcare professionals (such as physician assistants and nurse practitioners), and teaching hospitals, as well as ownership and investment interests of such physicians and their immediate family members; • HIPAA, as amended by the Health Information Technology for Economic and Clinical Health Act of 2009 and its implementing regulations, impose obligations on certain covered entity healthcare providers, health plans, and healthcare clearinghouses as well as their business associates that perform certain services involving the use or disclosure of individually identifiable health information and their subcontractors that use, disclose or otherwise process individually identifiable health information, including mandatory contractual terms, with respect to safeguarding the privacy, security and transmission of individually identifiable health information; and • analogous state and foreign laws and regulations, such as state and foreign anti-kickback and false claims laws may apply to sales or marketing arrangements and claims involving healthcare items or services reimbursed by non-governmental third-party payors, including private insurers.
In addition, the government may assert that a claim including items and services resulting from a violation of the federal Anti-Kickback Statute constitutes a false of fraudulent claim for purposes of the False Claims Act; • the federal Health Insurance Portability and Accountability Act of 1996 ("HIPAA") imposes criminal and civil liability for, among other things, executing a scheme to defraud any healthcare benefit program, or knowingly and willfully falsifying, concealing or covering up a material fact or making any materially false statement in connection with the delivery of or payment for healthcare benefits, items or services; similar to the federal Anti-Kickback Statute, a person or entity does not need to have actual knowledge of the statute or specific intent to violate it in order to have committed a violation; • the federal physician payment transparency requirements, sometimes referred to as the “Sunshine Act” under the ACA, require certain manufacturers of drugs, devices, biologics and medical supplies that are reimbursable under Medicare, Medicaid, or the Children’s Health Insurance Program to report to CMS information related to transfers of value made to physicians (currently defined to include doctors, dentists, optometrists, podiatrists and chiropractors), other healthcare professionals (such as physician assistants and nurse practitioners), and teaching hospitals, as well as ownership and investment interests of such physicians and their immediate family members; • HIPAA, as amended by the Health Information Technology for Economic and Clinical Health Act of 2009 and its implementing regulations, impose obligations on certain covered entity healthcare providers, health plans, and healthcare clearinghouses as well as their business associates that perform certain services involving the use or disclosure of individually identifiable health information and their subcontractors that use, disclose or otherwise process individually identifiable health information, including mandatory contractual terms, with respect to safeguarding the privacy, security and transmission of individually identifiable health information; and 93 Table of Contents • analogous state and foreign laws and regulations, such as state and foreign anti-kickback and false claims laws may apply to sales or marketing arrangements and claims involving healthcare items or services reimbursed by non-governmental third-party payors, including private insurers.
We may be required to repurchase for cash all, or to facilitate the purchase by a third party of all, the shares of our company held by the Bill & Melinda Gates Foundation if we default under the global access commitments agreement, which could have an adverse impact on us and limit our ability to make distributions to our shareholders.
We may be required to repurchase for cash, or to facilitate the purchase by a third party of, all the shares of our company held by the Bill & Melinda Gates Foundation if we default under the global access commitments agreement, which could have an adverse impact on us and limit our ability to make distributions to our shareholders.
Any future collaborations we enter into, may pose a number of risks, including the following: • collaborators have significant discretion in determining the efforts and resources that they will apply to these collaborations; • collaborators may not perform their obligations as expected; • collaborators may not pursue development and commercialization of any product candidates that achieve regulatory approval or may elect not to continue or renew development or commercialization programs based on clinical trial results, changes in the collaborators’ strategic focus or available funding, or external factors, such as an acquisition, that divert resources or create competing priorities; • collaborators may delay clinical trials, provide insufficient funding for a clinical trial program, stop a clinical trial or abandon a product candidate, repeat or conduct new clinical trials or require a new formulation of a product candidate for clinical testing; • collaborators could independently develop, or develop with third parties, products that compete directly or indirectly with our products or product candidates if the collaborators believe that competitive products are more likely to be successfully developed or can be commercialized under terms that are more economically attractive than ours; this may also happen if the collaborators’ development of competing products is substantially faster than our development timelines; 65 Table of Contents • collaborators may not further develop product candidates developed by us or co-developed with us under the collaboration; • product candidates discovered in collaboration with us may be viewed by our collaborators as competitive with their own product candidates or products, which may cause collaborators to cease to devote resources to the commercialization of our product candidates; • a collaborator with marketing and distribution rights to one or more of our product candidates that achieve regulatory approval may not commit sufficient resources to the marketing and distribution of such product or products; • disagreements with collaborators, including disagreements over proprietary rights, contract interpretation or the preferred course of development, might cause delays or termination of the research, development or commercialization of product candidates, might lead to additional responsibilities for us with respect to product candidates, or might result in litigation or arbitration, any of which would be time-consuming and expensive; • collaborators have certain defined rights to change or expand the scope of development programs during the course of the collaboration.
Any future collaborations we enter into, may pose a number of risks, including the following: • collaborators have significant discretion in determining the efforts and resources that they will apply to these collaborations; • collaborators may not perform their obligations as expected; • collaborators may not pursue development and commercialization of any product candidates that achieve regulatory approval or may elect not to continue or renew development or commercialization programs based on clinical trial results, changes in the collaborators’ strategic focus or available funding, or external factors, such as an acquisition, that divert resources or create competing priorities; 62 Table of Contents • collaborators may delay clinical trials, provide insufficient funding for a clinical trial program, stop a clinical trial or abandon a product candidate, repeat or conduct new clinical trials or require a new formulation of a product candidate for clinical testing; • collaborators could independently develop, or develop with third parties, products that compete directly or indirectly with our products or product candidates if the collaborators believe that competitive products are more likely to be successfully developed or can be commercialized under terms that are more economically attractive than ours; this may also happen if the collaborators’ development of competing products is substantially faster than our development timelines; • collaborators may not further develop product candidates developed by us or co-developed with us under the collaboration; • product candidates discovered in collaboration with us may be viewed by our collaborators as competitive with their own product candidates or products, which may cause collaborators to cease to devote resources to the commercialization of our product candidates; • a collaborator with marketing and distribution rights to one or more of our product candidates that achieve regulatory approval may not commit sufficient resources to the marketing and distribution of such product or products; • disagreements with collaborators, including disagreements over proprietary rights, contract interpretation or the preferred course of development, might cause delays or termination of the research, development or commercialization of product candidates, might lead to additional responsibilities for us with respect to product candidates, or might result in litigation or arbitration, any of which would be time-consuming and expensive; • collaborators have certain defined rights to change or expand the scope of development programs during the course of the collaboration.
We may experience delays in completing our pre-clinical studies and initiating or completing clinical trials, and we may experience numerous unforeseen events during, or as a result of, any future clinical trials that we could conduct that could delay or prevent our ability to receive marketing approval or commercialize our product candidates, including: • regulators, IRBs, or ethics committees may not authorize us or our investigators, or provide the required positive opinion, to commence a clinical trial or conduct a clinical trial at a prospective trial site; • we may experience delays in reaching, or fail to reach, agreement on acceptable terms with prospective trial sites and prospective CROs, the terms of which can be subject to extensive negotiation and may vary significantly among different CROs and trial sites; • clinical trials of our product candidates may produce negative or inconclusive results, and we may decide, or regulators may require us, to conduct additional pre-clinical studies or clinical trials or we may decide to abandon product development programs; • the number of patients required for clinical trials of our product candidates may be larger than we anticipate, 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; • our third-party contractors may fail to comply with regulatory requirements or meet their contractual obligations to us in a timely manner, or at all, or may deviate from the clinical trial protocol or drop out of the trial, which may require that we add new clinical trial sites or investigators; 52 Table of Contents • we may elect to, or regulators or IRBs or ethics committees may require us or our investigators to, suspend or terminate clinical research for various reasons, including noncompliance with regulatory requirements or a finding that the participants are being exposed to unacceptable health risks; • the cost of clinical trials of our product candidates may be greater than we anticipate; • the supply or quality of our product candidates or other materials necessary to conduct clinical trials of our product candidates may be insufficient or inadequate; and • our product candidates may have undesirable side effects or other unexpected characteristics, causing us or our investigators, regulators or IRBs or ethics committees to suspend or terminate the trials, or reports may arise from pre-clinical or clinical testing of other cancer therapies that raise safety or efficacy concerns about our product candidates.
We may experience delays in completing our pre-clinical studies and initiating or completing clinical trials, and we may experience numerous unforeseen events during, or as a result of, any future clinical trials that we could conduct that could delay or prevent our ability to receive marketing approval or commercialize our product candidates, including: • regulators, IRBs, or ethics committees may not authorize us or our investigators, or provide the required positive opinion, to commence a clinical trial or conduct a clinical trial at a prospective trial site; • we may experience delays in reaching, or fail to reach, agreement on acceptable terms with prospective trial sites and prospective CROs, the terms of which can be subject to extensive negotiation and may vary significantly among different CROs and trial sites; • clinical trials of our product candidates may produce negative or inconclusive results, and we may decide, or regulators may require us, to conduct additional pre-clinical studies or clinical trials or we may decide to abandon product development programs; • the number of patients required for clinical trials of our product candidates may be larger than we anticipate, 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; • our third-party contractors may fail to comply with regulatory requirements or meet their contractual obligations to us in a timely manner, or at all, or may deviate from the clinical trial protocol or drop out of the trial, which may require that we add new clinical trial sites or investigators; 49 Table of Contents • we may elect to, or regulators or IRBs or ethics committees may require us or our investigators to, suspend or terminate clinical research for various reasons, including noncompliance with regulatory requirements or a finding that the participants are being exposed to unacceptable health risks; • the cost of clinical trials of our product candidates may be greater than we anticipate; • the supply or quality of our product candidates or other materials necessary to conduct clinical trials of our product candidates may be insufficient or inadequate; and • our product candidates may have undesirable side effects or other unexpected characteristics, causing us or our investigators, regulators or IRBs or ethics committees to suspend or terminate the trials, or reports may arise from pre-clinical or clinical testing of other cancer therapies that raise safety or efficacy concerns about our product candidates.
We believe that the degree of continued market acceptance and our ability to continue to generate revenues from KIMMTRAK will depend on a number of factors, including: • timing of competitive medicines; • continued efficacy and safety of KIMMTRAK; • continued projected growth of the markets in which KIMMTRAK competes; • the extent to which physicians diagnose and treat the conditions that KIMMTRAK is approved to treat; • prevalence and severity of any side effects; • if and when we are able to obtain regulatory approvals for additional indications for KIMMTRAK; • continued acceptance by patients, physicians and applicable specialists; • availability of, and ability to maintain, coverage and adequate reimbursement and pricing from government and other third-party payors; • potential or perceived advantages or disadvantages of KIMMTRAK over alternative treatments, including cost of treatment and relative convenience and ease of administration; • strength of sales, marketing and distribution support; • the price of KIMMTRAK, both in absolute terms and relative to alternative treatments; • impact of past and limitation of future medicine price increases; • our ability to maintain a continuous supply of KIMMTRAK for commercial sale; • the effect of current and future healthcare laws; • disruptions caused by health pandemics or epidemics, including the extent to which physicians and patients delay visits or writing or filling prescriptions for KIMMTRAK; • the performance of third-party distribution partners, over which we have limited control; and • medicine labeling or medicine insert requirements of the FDA or other regulatory authorities 41 Table of Contents Our ability to grow KIMMTRAK sales will be affected by the success of our sales, access, marketing and medical strategies.
We believe that the degree of continued market acceptance and our ability to continue to generate revenues from KIMMTRAK will depend on a number of factors, including: • timing of competitive medicines; • continued efficacy and safety of KIMMTRAK; • continued projected growth of the markets in which KIMMTRAK competes; • the extent to which physicians diagnose and treat the conditions that KIMMTRAK is approved to treat; 39 Table of Contents • prevalence and severity of any side effects; • if and when we are able to obtain regulatory approvals for additional indications for KIMMTRAK; • continued acceptance by patients, physicians and applicable specialists; • availability of, and ability to maintain, coverage and adequate reimbursement and pricing from government and other third-party payors; • potential or perceived advantages or disadvantages of KIMMTRAK over alternative treatments, including cost of treatment and relative convenience and ease of administration; • strength of sales, marketing and distribution support; • the price of KIMMTRAK, both in absolute terms and relative to alternative treatments; • impact of past and limitation of future medicine price increases; • our ability to maintain a continuous supply of KIMMTRAK for commercial sale; • the effect of current and future healthcare laws; • disruptions caused by health pandemics or epidemics, including the extent to which physicians and patients delay visits or writing or filling prescriptions for KIMMTRAK; • the performance of third-party distribution partners, over which we have limited control; and • medicine labeling or medicine insert requirements of the FDA or other regulatory authorities Our ability to grow KIMMTRAK sales will be affected by the success of our sales, access, marketing and medical strategies.
Accordingly, we expect that we will be subject to additional risks related to operating in foreign countries, including: • differing regulatory requirements in foreign countries; • unexpected changes in tariffs, trade barriers, price and exchange controls and other regulatory requirements; • differing standards for the conduct of clinical trials; • increased difficulties in managing the logistics and transportation of storing and shipping product candidates produced in the United States or elsewhere and shipping the product candidate to patients in other countries; 58 Table of Contents • import and export requirements and restrictions; • economic weakness, including inflation, or political instability in foreign economies and markets, particularly in light of global macroeconomic conditions; • compliance with tax, employment, immigration and labor laws for employees living or traveling abroad; • foreign taxes, including withholding of payroll taxes; • foreign currency fluctuations, which could result in increased operating expenses and reduced revenue, and other obligations incident to doing business in another country; • difficulties staffing and managing foreign operations; • workforce uncertainty in countries where labor unrest is more common than in the United Kingdom or the United States; • differing payor reimbursement regimes, governmental payors or patient self-pay systems, and price controls; • potential liability under the FCPA, the U.K.
Accordingly, we expect that we will be subject to additional risks related to operating in foreign countries, including: • differing regulatory requirements in foreign countries; • unexpected changes in tariffs, trade barriers, price and exchange controls and other regulatory requirements; • differing standards for the conduct of clinical trials; 55 Table of Contents • increased difficulties in managing the logistics and transportation of storing and shipping product candidates produced in the United States or elsewhere and shipping the product candidate to patients in other countries; • import and export requirements and restrictions; • economic weakness, including inflation, or political instability in foreign economies and markets, particularly in light of global macroeconomic conditions; • compliance with tax, employment, immigration and labor laws for employees living or traveling abroad; • foreign taxes, including withholding of payroll taxes; • foreign currency fluctuations, which could result in increased operating expenses and reduced revenue, and other obligations incident to doing business in another country; • difficulties staffing and managing foreign operations; • workforce uncertainty in countries where labor unrest is more common than in the United Kingdom or the United States; • differing payor reimbursement regimes, governmental payors or patient self-pay systems, and price controls; • potential liability under the FCPA, the U.K.
Our future funding requirements will depend on many factors, including, but not limited to: • our ability to continue to execute our commercialization strategies for KIMMTRAK and, if approved, our other product candidates; 42 Table of Contents • progress, timing, scope and costs of our clinical trials, including the ability to timely initiate clinical sites, enroll subjects and manufacture product candidates for our ongoing, planned and potential future clinical trials; • time and costs required to perform research and development to identify and characterize new product candidates from our research programs; • the time and cost necessary to pursue regulatory authorizations and approvals that may be required by regulatory authorities to execute clinical trials or commercialize our products; • our ability to have clinical and commercial products successfully manufactured consistent with FDA, European Commission and other authorities’ regulations; • amount of sales and other revenues from product candidates that we may commercialize, if any, including the selling prices for such potential products and the availability of adequate third-party coverage and reimbursement for patients; • sales and marketing costs associated with commercializing our products, if approved, including the cost and timing of scaling our marketing and sales capabilities; • cost of building, staffing and validating our manufacturing processes, which may include capital expenditure; • terms and timing of any revenue we may receive under existing or future collaborations; • costs of operating as a public company; • time and cost necessary to respond to technological, regulatory, political and market developments; • costs of filing, prosecuting, defending and enforcing any patent claims and other intellectual property rights; • the impact of global and macroeconomic factors, including supply chain disruptions, fluctuating interest rates and volatility in the capital markets; • costs, associated with, and terms and timing of, any future any potential acquisitions, strategic collaborations, licensing agreements or other arrangements that we may establish; and • inability of clinical sites to enroll patients as healthcare capacities are required to cope with natural disasters, epidemics or other health system emergencies.
Our future funding requirements will depend on many factors, including, but not limited to: • our ability to continue to execute our commercialization strategies for KIMMTRAK and, if approved, our other product candidates; • progress, timing, scope and costs of our clinical trials, including the ability to timely initiate clinical sites, enroll subjects and manufacture product candidates for our ongoing, planned and potential future clinical trials; • time and costs required to perform research and development to identify and characterize new product candidates from our research programs; • the time and cost necessary to pursue regulatory authorizations and approvals that may be required by regulatory authorities to execute clinical trials or commercialize our products; • our ability to have clinical and commercial products successfully manufactured consistent with FDA, European Commission and other authorities’ regulations; • amount of sales and other revenues from product candidates that we may commercialize, if any, including the selling prices for such potential products and the availability of adequate third-party coverage and reimbursement for patients; • sales and marketing costs associated with commercializing our products, if approved, including the cost and timing of scaling our marketing and sales capabilities; • cost of building, staffing and validating our manufacturing processes, which may include capital expenditure; • terms and timing of any revenue we may receive under existing or future collaborations; • costs of operating as a public company; • time and cost necessary to respond to technological, regulatory, political and market developments; • costs of filing, prosecuting, defending and enforcing any patent claims and other intellectual property rights; • the impact of global and macroeconomic factors, including supply chain disruptions, fluctuating interest rates and volatility in the capital markets; • costs, associated with, and terms and timing of, any future any potential acquisitions, strategic collaborations, licensing agreements or other arrangements that we may establish; and • inability of clinical sites to enroll patients as healthcare capacities are required to cope with natural disasters, epidemics or other health system emergencies.
All of these milestones are based on a variety of assumptions, which may cause the timing of achieving the milestones to vary considerably from our estimates, including: • our available capital resources or capital constraints we experience; • the rate of progress, costs, and results of our clinical trials and research and development activities, including the extent of scheduling conflicts with participating clinicians and collaborators; • our ability to identify and enroll patients who meet clinical trial eligibility criteria; • our receipt of approvals by the FDA, European Commission and comparable foreign regulatory authorities, and the timing thereof; • other actions, decisions, or rules issued by regulators; • our ability to access sufficient, reliable, and affordable supplies of materials used in the manufacture of our product candidates; • our ability to manufacture and supply clinical trial materials to our clinical sites on a timely basis; • the efforts of our collaborators with respect to the commercialization of our approved products, if any; and 57 Table of Contents • the securing of, costs related to, and timing issues associated with, commercial product manufacturing, as well as sales and marketing activities.
All of these milestones are based on a variety of assumptions, which may cause the timing of achieving the milestones to vary considerably from our estimates, including: • our available capital resources or capital constraints we experience; • the rate of progress, costs, and results of our clinical trials and research and development activities, including the extent of scheduling conflicts with participating clinicians and collaborators; • our ability to identify and enroll patients who meet clinical trial eligibility criteria; • our receipt of approvals by the FDA, European Commission and comparable foreign regulatory authorities, and the timing thereof; • other actions, decisions, or rules issued by regulators; • our ability to access sufficient, reliable, and affordable supplies of materials used in the manufacture of our product candidates; • our ability to manufacture and supply clinical trial materials to our clinical sites on a timely basis; 54 Table of Contents • the efforts of our collaborators with respect to the commercialization of our approved products, if any; and • the securing of, costs related to, and timing issues associated with, commercial product manufacturing, as well as sales and marketing activities.
In addition to the factors discussed in this “Risk Factors” section and elsewhere in this Annual Report, these factors include but not limited to: • our failure to successfully execute our commercialization strategy with respect to KIMMTRAK; • actions or announcements by third-party or government payors with respect to coverage and reimbursement of KIMMTRAK; • adverse regulatory decisions, or our ability to obtain regulatory approval of, tebentafusp in other jurisdictions or for other indications, or any of our other product candidates; • adverse results or delays in pre-clinical studies or clinical trials; • reports of adverse events in products similar or perceived to be similar to those we are developing or clinical trials of such products; • an inability to obtain additional funding on favorable terms or at all, including as a result of recently worsening macroeconomic conditions; • failure by us to successfully develop and commercialize our product candidates; • failure by us to maintain our existing strategic collaborations or enter into new collaborations; • failure by us to identify additional product candidates for our pipeline; • failure by us or our licensors and strategic partners to prosecute, maintain, protect or enforce our intellectual property and proprietary rights; • disputes or other developments relating to intellectual and other proprietary rights, including litigation; • matters and our ability to obtain patent and other intellectual property protection for our technologies; • changes in laws or regulations applicable to future products; • an inability to obtain adequate product supply for our product candidates or the inability to do so at acceptable prices; • the introduction of new products, services or technologies by our competitors; • failure by us to meet or exceed financial projections we may provide to the public; • failure by us to meet or exceed the financial projections of the investment community; • the perception of the pharmaceutical industry by the public, legislatures, regulators and the investment community; • changes in the structure of healthcare payment systems; • inability to obtain adequate commercial supply for any approved product or inability to do so at acceptable prices; • announcements of significant acquisitions, strategic partnerships, joint ventures or capital commitments by us, our strategic partner or our competitors; 103 Table of Contents • inability to comply with our debt covenants and to make payments as they become due; • additions or departures of key scientific or management personnel; • significant lawsuits, including patent or shareholder litigation; • changes in the market valuations of similar companies; • general economic, industry, political and market conditions, including, but not limited to, the war in Ukraine, the conflict in the Middle East, global geopolitical tension, changes in inflation and interest rates, supply chain disruptions, and volatility in the capital markets; • sales of our ADSs or ordinary shares by us or our shareholders in the future; • the trading volume of our ADSs; and • other events or factors, many of which are beyond our control.
In addition to the factors discussed in this “Risk Factors” section and elsewhere in this Annual Report, these factors include but not limited to: • our failure to successfully execute our commercialization strategy with respect to KIMMTRAK; • actions or announcements by third-party or government payors with respect to coverage and reimbursement of KIMMTRAK; • adverse regulatory decisions, or our ability to obtain regulatory approval of, tebentafusp in other jurisdictions or for other indications, or any of our other product candidates; • adverse results or delays in pre-clinical studies or clinical trials; • reports of adverse events in products similar or perceived to be similar to those we are developing or clinical trials of such products; • an inability to obtain additional funding on favorable terms or at all, including as a result of recently worsening macroeconomic conditions; • failure by us to successfully develop and commercialize our product candidates; • failure by us to maintain our existing strategic collaborations or enter into new collaborations; • failure by us to identify additional product candidates for our pipeline; • failure by us or our licensors and strategic partners to prosecute, maintain, protect or enforce our intellectual property and proprietary rights; • disputes or other developments relating to intellectual and other proprietary rights, including litigation; • matters and our ability to obtain patent and other intellectual property protection for our technologies; • changes in laws or regulations applicable to future products; • an inability to obtain adequate product supply for our product candidates or the inability to do so at acceptable prices; • the introduction of new products, services or technologies by our competitors; • failure by us to meet or exceed financial projections we may provide to the public; • failure by us to meet or exceed the financial projections of the investment community; 101 Table of Contents • the perception of the pharmaceutical industry by the public, legislatures, regulators and the investment community; • changes in the structure of healthcare payment systems; • inability to obtain adequate commercial supply for any approved product or inability to do so at acceptable prices; • announcements of significant acquisitions, strategic partnerships, joint ventures or capital commitments by us, our strategic partner or our competitors; • inability to comply with our debt covenants and to make payments as they become due; • additions or departures of key scientific or management personnel; • significant lawsuits, including patent or shareholder litigation; • changes in the market valuations of similar companies; • general economic, industry, political and market conditions, including, but not limited to, those resulting from the war in Ukraine, the conflict in the Middle East, global geopolitical tension, changes in inflation and interest rates, supply chain disruptions, and volatility in the capital markets; • sales of our ADSs or ordinary shares by us or our shareholders in the future; • the trading volume of our ADSs; and • other events or factors, many of which are beyond our control.
In addition, regional healthcare authorities and individual hospitals are increasingly using bidding procedures to determine what pharmaceutical products and which suppliers will be included in their prescription drug and other healthcare programs. These measures could reduce the ultimate demand for KIMMTRAK and our product candidates, if approved, or put pressure on our product pricing.
Regional healthcare authorities and individual hospitals are increasingly using bidding procedures to determine what pharmaceutical products and which suppliers will be included in their prescription drug and other healthcare programs. These measures could reduce the ultimate demand for KIMMTRAK and our product candidates, if approved, or put pressure on our product pricing.
If we make incorrect determinations regarding the market potential of our product candidates, abandon products that we have devoted significant resources toward in favor of other product candidates, or misread trends in the biopharmaceutical industry, in particular for our lead product candidate, our business, financial condition and results of operations could be materially adversely affected.
If we make incorrect determinations regarding the market potential of our product candidates, abandon or pause products that we have devoted significant resources toward in favor of other product candidates, or misread trends in the biopharmaceutical industry, in particular for our lead product candidate, our business, financial condition and results of operations could be materially adversely affected.
If we enter into arrangements with third parties to perform sales, marketing and distribution services, our revenue from sale of therapies or the profitability to us from these revenue streams is likely to be lower than if we were to market and sell any product candidates that we develop ourselves.
If we enter into arrangements with third parties to perform sales, marketing and distribution services, our revenue from sale of therapies or the profitability from these revenue streams is likely to be lower than if we were to market and sell any product candidates that we develop ourselves.
Patent and Trademark Office ("USPTO"), or its global equivalents, are often narrowed by the time they issue, if they issue at all. Accordingly, it is possible that that our present or future pending patent applications (whether owned or licensed) will not lead to issued patents.
Patent and Trademark Office ("USPTO"), or its global equivalents, are often significantly narrowed by the time they issue, if they issue at all. Accordingly, it is possible that our present or future pending patent applications (whether owned or licensed) will not lead to issued patents.
Because we expect sales of KIMMTRAK and our other product candidates, if approved, to generate substantially all of our revenue for the foreseeable future, the failure of our product candidates to find or maintain market acceptance would harm our business and could require us to seek additional financing.
Because we expect sales of KIMMTRAK and our other product candidates, if approved, to generate substantially all of our revenue for the foreseeable future, the failure of our medicines to find or maintain market acceptance would harm our business and could require us to seek additional financing.
Frustrating actions would include, for example, lengthening the notice period for directors under their service contract or agreeing to sell off material parts of the target group. • Stringent and detailed requirements are laid down for the disclosure of dealings in relevant securities during an offer, including the prompt disclosure of positions and dealing in relevant securities by the parties to an offer and any person who is interested (directly or indirectly) in 1% or more of any class of relevant securities. 112 Table of Contents • Employees of both the offeror and the offeree company and the trustees of the offeree company’s pension scheme must be informed about an offer.
Frustrating actions would include, for example, lengthening the notice period for directors under their service contract or agreeing to sell off material parts of the target group. • Stringent and detailed requirements are laid down for the disclosure of dealings in relevant securities during an offer, including the prompt disclosure of positions and dealing in relevant securities by the parties to an offer and any person who is interested (directly or indirectly) in 1% or more of any class of relevant securities. 110 Table of Contents • Employees of both the offeror and the offeree company and the trustees of the offeree company’s pension scheme must be informed about an offer.
In addition, there can be no assurance that we will be able to rapidly identify, design and synthesize the necessary compounds or that these or other problems related to the development of this novel mechanism will not arise in the future, which may cause significant delays or raise problems we may not be able to resolve. 48 Table of Contents Regulatory approval of novel product candidates such as ours can be more expensive, riskier and take longer than for other, more well-known or extensively studied pharmaceutical or biopharmaceutical product candidates due to our and regulatory authorities’ lack of experience with them.
In addition, there can be no assurance that we will be able to rapidly identify, design and synthesize the necessary compounds or that these or other problems related to the development of this novel mechanism will not arise in the future, which may cause significant delays or raise problems we may not be able to resolve. 45 Table of Contents Regulatory approval of novel product candidates such as ours can be more expensive, riskier and take longer than for other, more well-known or extensively studied pharmaceutical or biopharmaceutical product candidates due to our and regulatory authorities’ lack of experience with them.
We anticipate that our expenses will increase substantially if, and as, we: • further commercialize KIMMTRAK and any future product candidate for which we may obtain marketing approval in the United States and expanded territories and countries; • continue our ongoing and planned development of our clinical stage programs and our preclinical pipeline assets; • initiate pre-clinical studies and clinical trials for any additional product candidates that we may pursue in the future; • seek regulatory approvals for our existing and potential future product candidates that successfully complete clinical trials; • build a portfolio of product candidates through the discovery, development, or acquisition or in-license of drugs, product candidates or technologies; • maintain, protect, enforce and expand our intellectual property portfolio; • acquire or in-license other product candidates, intellectual property and technologies; • hire additional clinical, regulatory, scientific and sales and marketing personnel; • add operational, financial and management information systems and personnel, including personnel to support commercial development of KIMMTRAK, our product development and planned future commercialization efforts of existing and future product candidates; and • incur additional legal, accounting and other expenses associated with operating as a public company.
We anticipate that our expenses will increase substantially if, and as, we: • further commercialize KIMMTRAK and any future product candidate for which we may obtain marketing approval in the United States and expanded territories and countries; • continue our ongoing and planned development of our clinical stage programs and our preclinical pipeline assets; • initiate pre-clinical studies and clinical trials for any additional product candidates that we may pursue in the future; • seek regulatory approvals for our existing and potential future product candidates that successfully complete clinical trials; • build a portfolio of product candidates through the discovery, development, or acquisition or in-license of drugs, product candidates or technologies; • maintain, protect, enforce and expand our intellectual property portfolio; • acquire or in-license other product candidates, intellectual property and technologies; • hire additional clinical, regulatory, scientific and sales and marketing personnel; 38 Table of Contents • add operational, financial and management information systems and personnel, including personnel to support commercial development of KIMMTRAK, our product development and planned future commercialization efforts of existing and future product candidates; and • incur additional legal, accounting and other expenses associated with operating as a public company.
If we or any of our third-party manufacturers encounter such difficulties, our ability to provide supply of our product candidates for clinical trials or our products for patients, if approved, could be delayed or stopped, or we may be unable to maintain a commercially viable cost structure. 59 Table of Contents Before we can begin commercial manufacture of our products, regulatory authorities must approve marketing applications that identify manufacturing facilities operated by us or third-party manufacturers that have passed regulatory inspection and manufacturing processes that are acceptable to the regulatory authorities.
If we or any of our third-party manufacturers encounter such difficulties, our ability to provide supply of our product candidates for clinical trials or our products for patients, if approved, could be delayed or stopped, or we may be unable to maintain a commercially viable cost structure. 56 Table of Contents Before we can begin commercial manufacture of our products, regulatory authorities must approve marketing applications that identify manufacturing facilities operated by us or third-party manufacturers that have passed regulatory inspection and manufacturing processes that are acceptable to the regulatory authorities.
If our trademarks and trade names are not adequately protected, then this may impede our ability to build and sustain name recognition in our markets of interest and our business may be adversely affected. We may rely on trademarks and trade names to protect our business.
We may rely on trademarks and trade names to protect our business. If our trademarks and trade names are not adequately protected, this may impede our ability to build and sustain name recognition in our markets of interest and our business may be adversely affected.
In addition, approval of our product candidates could be delayed or refused for many reasons, including the following: • the FDA or comparable foreign regulatory authorities may disagree with the design or implementation of our or our collaborators’ clinical trials; • we or our collaborators may be unable to demonstrate to the satisfaction of the FDA or comparable foreign regulatory authorities that our product candidates are safe, pure, potent and have a favorable risk/benefit profile for any of their proposed indications; • the results of clinical trials may not meet the level of statistical significance required by the FDA or comparable foreign regulatory authorities for approval; • the FDA or comparable foreign regulatory authorities may disagree with our interpretation of data from pre-clinical programs or clinical trials; • data collected from clinical trials of product candidates may not be sufficient to the satisfaction of the FDA or comparable foreign regulatory authorities to support the submission of a BLA or other comparable submission in foreign jurisdictions or to obtain regulatory approval in the United States or elsewhere; • manufacturing processes or facilities or those of the third-party manufacturers we use may not be adequate to support approval of our product candidates; and 81 Table of Contents • the approval policies or regulations of the FDA or comparable foreign regulatory authorities may significantly change in a manner rendering our clinical data insufficient for approval.
In addition, approval of our product candidates could be delayed or refused for many reasons, including the following: • the FDA or comparable foreign regulatory authorities may disagree with the design or implementation of our or our collaborators’ clinical trials; • we or our collaborators may be unable to demonstrate to the satisfaction of the FDA or comparable foreign regulatory authorities that our product candidates are safe, pure, potent and have a favorable risk/benefit profile for any of their proposed indications; • the results of clinical trials may not meet the level of statistical significance required by the FDA or comparable foreign regulatory authorities for approval; • the FDA or comparable foreign regulatory authorities may disagree with our interpretation of data from pre-clinical programs or clinical trials; • data collected from clinical trials of product candidates may not be sufficient to the satisfaction of the FDA or comparable foreign regulatory authorities to support the submission of a BLA or other comparable submission in foreign jurisdictions or to obtain regulatory approval in the United States or elsewhere; • manufacturing processes or facilities or those of the third-party manufacturers we use may not be adequate to support approval of our product candidates; and • the approval policies or regulations of the FDA or comparable foreign regulatory authorities may significantly change in a manner rendering our clinical data insufficient for approval.
Factors that may inhibit our efforts to commercialize our product candidates on our own include: • the inability to recruit, train and retain adequate numbers of effective sales and marketing personnel; • the inability of sales personnel to obtain access to physicians or educate adequate numbers of physicians on the benefits of prescribing any future product that we may develop; • the lack of complementary treatments to be offered by sales personnel, which may put us at a competitive disadvantage relative to companies with more extensive product lines; • evolving social media practices and the risk of noncompliance with regulations applicable to our business, as well as the spread of negative publicity regarding our products or product candidates on various social media channels; and • unforeseen costs and expenses associated with creating an independent sales and marketing organization.
Factors that may inhibit our efforts to commercialize our product candidates on our own include: • the inability to recruit, train and retain adequate numbers of effective sales and marketing personnel; • the inability of sales personnel to obtain access to physicians or educate adequate numbers of physicians on the benefits of prescribing any future product that we may develop; 43 Table of Contents • the lack of complementary treatments to be offered by sales personnel, which may put us at a competitive disadvantage relative to companies with more extensive product lines; • evolving social media practices and the risk of noncompliance with regulations applicable to our business, as well as the spread of negative publicity regarding our products or product candidates on various social media channels; and • unforeseen costs and expenses associated with creating an independent sales and marketing organization.
At our 2024 Annual General Meeting of Shareholders, the quorum requirement in our articles of association was amended to at least one-third of the number of issued shares (excluding any shares held as treasury shares) entitled to vote on the business to be transacted. 113 Table of Contents As an English public limited company, certain capital structure decisions will require shareholder approval, which may limit our flexibility to manage our capital structure.
At our 2024 Annual General Meeting of Shareholders, the quorum requirement in our articles of association was amended to at least one-third of the number of issued shares (excluding any shares held as treasury shares) entitled to vote on the business to be transacted. 111 Table of Contents As an English public limited company, certain capital structure decisions will require shareholder approval, which may limit our flexibility to manage our capital structure.
Accordingly, our future results could be harmed by a variety of factors, including: • economic weakness, including inflation, or political instability in particular non-U.S. economies and markets; • differing and changing regulatory requirements for product approvals; • differing jurisdictions could present different issues for securing, maintaining or obtaining freedom to operate in such jurisdictions; • potentially reduced protection for intellectual property and proprietary rights; • difficulties in compliance with different, complex and changing laws, regulations and court systems of multiple jurisdictions and compliance with a wide variety of foreign laws, treaties and regulations; • changes in global regulations and customs, tariffs and trade barriers; • changes in non-U.S. currency exchange rates of the pound sterling, U.S. dollar, euro and currency controls; • changes in a specific country’s or region’s political or economic environment, including the longer-term implications of Brexit; • trade protection measures, import or export licensing requirements or other restrictive actions by governments; 100 Table of Contents • differing reimbursement regimes and price controls in certain non-U.S. markets; • negative consequences from changes in tax laws; • compliance with tax, employment, immigration and labor laws for employees living or traveling abroad, including, for example, the variable tax treatment in different jurisdictions of options or restricted share units granted under our share option schemes or equity incentive plans; • workforce uncertainty in countries where labor unrest is more common than in the United States; • litigation or administrative actions resulting from claims against us by current or former employees or consultants individually or as part of class actions, including claims of wrongful terminations, discrimination, misclassification or other violations of labor law or other alleged conduct; • difficulties associated with staffing and managing international operations, including differing labor relations; • production shortages resulting from any events affecting raw material supply or manufacturing capabilities abroad; and • business interruptions resulting from geo-political actions, including war and terrorism, or natural disasters including earthquakes, typhoons, floods and fires.
Accordingly, our future results could be harmed by a variety of factors, including: • economic weakness, including inflation, or political instability in particular non-U.S. economies and markets; • differing and changing regulatory requirements for product approvals; • differing jurisdictions could present different issues for securing, maintaining or obtaining freedom to operate in such jurisdictions; • potentially reduced protection for intellectual property and proprietary rights; • difficulties in compliance with different, complex and changing laws, regulations and court systems of multiple jurisdictions and compliance with a wide variety of foreign laws, treaties and regulations; 69 Table of Contents • changes in global regulations and customs, tariffs and trade barriers; • changes in exchange rates of the pound sterling, U.S. dollar and euro; • changes in a specific country’s or region’s political or economic environment; • trade protection measures, import or export licensing requirements or other restrictive actions by governments; • differing reimbursement regimes and price controls in certain non-U.S. markets; • negative consequences from changes in tax laws; • compliance with tax, employment, immigration and labor laws for employees living or traveling abroad, including, for example, the variable tax treatment in different jurisdictions of options or restricted share units granted under our share option schemes or equity incentive plans; • workforce uncertainty in countries where labor unrest is more common than in the United States; • litigation or administrative actions resulting from claims against us by current or former employees or consultants individually or as part of class actions, including claims of wrongful terminations, discrimination, misclassification or other violations of labor law or other alleged conduct; • difficulties associated with staffing and managing international operations, including differing labor relations; • production shortages resulting from any events affecting raw material supply or manufacturing capabilities abroad; and • business interruptions resulting from geo-political actions, including war and terrorism, or natural disasters including earthquakes, typhoons, floods and fires.
The degree of market acceptance of our product candidates, if approved for commercial sale, will depend on a number of factors, including: • the clinical indications for which our product candidates are approved; • physicians, hospitals, cancer treatment centers, and patients considering our product candidates as a safe and effective treatment; • hospitals and cancer treatment centers establishing the infrastructure required for the administration of the product candidate; • the potential and perceived advantages of our product candidates over alternative treatments; • the prevalence and severity of any side effects, including cytokine release syndrome ("CRS"), for which KIMMTRAK has a boxed warning recommending at least 16 hours of patient monitoring after each of the first three infusions, and as clinically indicated thereafter; • product labeling or product insert requirements of the FDA, the European Commission or other regulatory authorities; • limitations or warnings contained in the labeling approved by the FDA or the European Commission ; • the timing of market introduction of our product candidates compared to competitive products; • the cost of treatment in relation to alternative treatments; • the amount of upfront costs or training required for physicians to administer our product candidates; • the pricing of our products and the availability of coverage and adequate reimbursement by third-party payors and government authorities; • the willingness of patients to pay out-of-pocket in the absence of comprehensive coverage and adequate reimbursement by third-party payors and government authorities; • relative convenience and ease of administration, including as compared to alternative treatments and competitive therapies; and 47 Table of Contents • the effectiveness of our sales and marketing efforts and distribution support.
The degree of market acceptance of KIMMTRAK or any of our product candidates, if approved for commercial sale, will depend on a number of factors, including: • the clinical indications for which our medicines are approved; • physicians, hospitals, cancer treatment centers, and patients considering our medicines as a safe and effective treatment; • hospitals and cancer treatment centers establishing the infrastructure required for the administration of the medicine; • the potential and perceived advantages of our medicines over alternative treatments; • the prevalence and severity of any side effects, including cytokine release syndrome ("CRS"), for which KIMMTRAK has a boxed warning recommending at least 16 hours of patient monitoring after each of the first three infusions, and as clinically indicated thereafter; • product labeling or product insert requirements of the FDA, the European Commission or other regulatory authorities; • limitations or warnings contained in the labeling approved by the FDA or the European Commission; • the timing of market introduction of our medicines compared to competitive products; • the cost of treatment in relation to alternative treatments; • the amount of upfront costs or training required for physicians to administer our medicines; • the pricing of our products and the availability of coverage and adequate reimbursement by third-party payors and government authorities; • the willingness of patients to pay out-of-pocket in the absence of comprehensive coverage and adequate reimbursement by third-party payors and government authorities; 44 Table of Contents • relative convenience and ease of administration, including as compared to alternative treatments and competitive therapies; and • the effectiveness of our sales and marketing efforts and distribution support.
If patients are unwilling to participate in our studies for any reason, the timeline for recruiting patients, conducting studies and obtaining regulatory approval of potential products may be delayed. 53 Table of Contents We may also engage third parties to develop companion diagnostics for use in our clinical trials, but such third parties may not be successful in developing such companion diagnostics, furthering the difficulty in identifying patients with the targeted genetic mutations for our clinical trials.
If patients are unwilling to participate in our studies for any reason, the timeline for recruiting patients, conducting studies and obtaining regulatory approval of potential products may be delayed. 50 Table of Contents We may also engage third parties to develop companion diagnostics for use in our clinical trials, but such third parties may not be successful in developing such companion diagnostics, furthering the difficulty in identifying patients with the targeted genetic mutations for our clinical trials.
See also “ We intend to develop tebentafusp, brenetafusp and our other programs, and potentially future product candidates, in combination with other therapies, which exposes us to additional risks. ” 54 Table of Contents As is the case with many treatments for cancer, infectious diseases and autoimmune diseases, it is likely that there may be side effects associated with the use of our product candidates.
See also “ We intend to develop tebentafusp, brenetafusp and our other programs, and potentially future product candidates, in combination with other therapies, which exposes us to additional risks. ” 51 Table of Contents As is the case with many treatments for cancer, infectious diseases and autoimmune diseases, it is likely that there may be side effects associated with the use of our product candidates.
In addition, many of the factors that cause, or lead to, a delay in the commencement or completion of clinical trials may also ultimately lead to the denial of regulatory approval of our product candidates. 55 Table of Contents Our product candidates may cause undesirable side effects or have other properties that could halt their clinical development, prevent their regulatory approval, require expansion of the trial size, limit their commercial potential, or result in significant negative consequences.
In addition, many of the factors that cause, or lead to, a delay in the commencement or completion of clinical trials may also ultimately lead to the denial of regulatory approval of our product candidates. 52 Table of Contents Our product candidates may cause undesirable side effects or have other properties that could halt their clinical development, prevent their regulatory approval, require expansion of the trial size, limit their commercial potential, or result in significant negative consequences.
If we experience delays in obtaining approval or if we fail to obtain approval of our product candidates, the commercial prospects for our product candidates may be harmed and our ability to generate revenues will be materially impaired. 51 Table of Contents Positive results from early pre-clinical studies of our product candidates are not necessarily predictive of the results of later pre-clinical studies and any future clinical trials of our product candidates.
If we experience delays in obtaining approval or if we fail to obtain approval of our product candidates, the commercial prospects for our product candidates may be harmed and our ability to generate revenues will be materially impaired. 48 Table of Contents Positive results from early pre-clinical studies of our product candidates are not necessarily predictive of the results of later pre-clinical studies and any future clinical trials of our product candidates.
Any cross-reactivity that impacts patient safety could materially impact our ability to advance our product candidates into clinical trials or to proceed to marketing approval and commercialization. 56 Table of Contents We intend to develop tebentafusp, brenetafusp and our other programs, and potentially future product candidates, in combination with other therapies, which exposes us to additional risks.
Any cross-reactivity that impacts patient safety could materially impact our ability to advance our product candidates into clinical trials or to proceed to marketing approval and commercialization. 53 Table of Contents We intend to develop tebentafusp, brenetafusp and our other programs, and potentially future product candidates, in combination with other therapies, which exposes us to additional risks.
In the event that this changes, or if the interpretation and application of the Takeover Code by the Panel on Takeovers and Mergers (the "Takeover Panel") changes (including changes to the way in which the Takeover Panel assesses the application of the Takeover Code to English companies whose shares are listed outside of the United Kingdom), the Takeover Code may apply to us in the future. 111 Table of Contents The Takeover Code provides a framework within which takeovers of companies are regulated and conducted.
In the event that this changes, or if the interpretation and application of the Takeover Code by the Panel on Takeovers and Mergers (the "Takeover Panel") changes (including changes to the way in which the Takeover Panel assesses the application of the Takeover Code to English companies whose shares are listed outside of the United Kingdom), the Takeover Code may apply to us in the future. 109 Table of Contents The Takeover Code provides a framework within which takeovers of companies are regulated and conducted.
We have entered into agreements with Syneos Health, Inc.("Syneos"), Medison, and other third parties, to develop our commercial infrastructure for the commercial launch and continued sale of KIMMTRAK, including to potentially retain, train and deploy a direct sales force, but we do not have control over third parties beyond contractual agreements.
We have entered into agreements with Syneos Health, Inc.("Syneos"), Er-Kim, Medison, and other third parties, to develop our commercial infrastructure for the commercial launch and continued sale of KIMMTRAK, including to potentially retain, train and deploy a direct sales force, but we do not have control over third parties beyond contractual agreements.
The continuing efforts of the government, insurance companies, managed care organizations and other payors of healthcare services to contain or reduce costs of healthcare and/or impose price controls may adversely affect: • the demand for our current or future product candidates, if we obtain regulatory approval; • our ability to set a price that we believe is fair for our products; • our ability to obtain coverage and adequate reimbursement for a product; • our ability to generate revenue and achieve or maintain profitability; • the level of taxes that we are required to pay; and • the availability of capital.
The continuing efforts of the government, insurance companies, managed care organizations and other payors of healthcare services to contain or reduce costs of healthcare and/or impose price controls may adversely affect: • the demand for our current or future product candidates, if we obtain regulatory approval; • our ability to set a price that we believe is fair for our products; • our ability to obtain coverage and adequate reimbursement for a product; • our ability to generate revenue and achieve or maintain profitability; 92 Table of Contents • the level of taxes that we are required to pay; and • the availability of capital.
With respect to the building of our ImmTAX platform, we consider trade secrets and know-how to be one of our primary intellectual property assets. We seek to protect our proprietary technology and processes, in part, by entering into confidentiality agreements with our collaborators, scientific advisors, employees, CROs and consultants, and invention assignment agreements with our consultants and employees.
With respect to the building of our ImmTAX platform, we consider trade secrets and know-how to be our primary intellectual property. We seek to protect our proprietary technology and processes, in part, by entering into confidentiality agreements with our collaborators, scientific advisors, employees, CROs and consultants, and invention assignment agreements with our consultants and employees.
This may impact our ongoing requirement for investment and the timeframes within which additional investment is required. 110 Table of Contents Changes and uncertainties in the tax system in the countries in which we have operations, could materially adversely affect our financial condition and results of operations, and reduce net returns to our shareholders.
This may impact our ongoing requirement for investment and the timeframes within which additional investment is required. 108 Table of Contents Changes and uncertainties in the tax system in the countries in which we have operations, could materially adversely affect our financial condition and results of operations, and reduce net returns to our shareholders.
If we are a PFIC for any taxable year during which a U.S. investor holds our ordinary shares or ADSs, then regardless of whether we continue to qualify as a PFIC, the U.S. holder may be subject to adverse tax consequences, including ineligibility for any preferred tax rates on capital gains or on actual or deemed dividends, interest charges on certain taxes treated as deferred and additional reporting requirements. 109 Table of Contents Based on our analysis of our activities and the composition of our income and assets, we believe that we were not a PFIC for our taxable year ended December 31, 2024 .
If we are a PFIC for any taxable year during which a U.S. investor holds our ordinary shares or ADSs, then regardless of whether we continue to qualify as a PFIC, the U.S. holder may be subject to adverse tax consequences, including ineligibility for any preferred tax rates on capital gains or on actual or deemed dividends, interest charges on certain taxes treated as deferred and additional reporting requirements. 107 Table of Contents Based on our analysis of our activities and the composition of our income and assets, we believe that we were not a PFIC for our taxable year ended December 31, 2025 .
For example, in February 2024, we entered into a clinical trial collaboration and supply agreement with Bristol-Myers Squibb ("BMS"), pursuant to which we will sponsor and fund the PRISM-MEL-301 clinical trial of our candidate brenetafusp + BMS’s nivolumab versus a control arm of either nivolumab or nivolumab + BMS’s relatlimab, depending on the country where the patient is enrolled, in first line advanced cutaneous melanoma, and BMS will provide nivolumab.
For example, in February 2024, we entered into a clinical trial collaboration and supply agreement with BMS, pursuant to which we will sponsor and fund the PRISM-MEL-301 clinical trial of our candidate brenetafusp + BMS’s nivolumab versus a control arm of either nivolumab or nivolumab + BMS’s relatlimab, depending on the country where the patient is enrolled, in first line advanced cutaneous melanoma, and BMS will provide nivolumab.
We may focus our efforts and resources on potential product candidates or other potential programs that ultimately prove to be unsuccessful. 49 Table of Contents Clinical product development involves a lengthy and expensive process, with an uncertain outcome.
We may focus our efforts and resources on potential product candidates or other potential programs that ultimately prove to be unsuccessful. 46 Table of Contents Clinical product development involves a lengthy and expensive process, with an uncertain outcome.
Securing regulatory approval requires the submission of extensive pre-clinical and clinical data and supporting information to the various regulatory authorities for each therapeutic indication to establish the product candidate’s safety and efficacy. Securing regulatory approval also requires the submission of information about the product manufacturing process to, and inspection of manufacturing facilities by, the relevant regulatory authority.
Obtaining regulatory approval requires the submission of extensive pre-clinical and clinical data and supporting information to the various regulatory authorities for each therapeutic indication to establish the product candidate’s safety and efficacy. Obtaining regulatory approval also requires the submission of information about the product manufacturing process to, and inspection of manufacturing facilities by, the relevant regulatory authority.
We may also face greater than expected difficulty in manufacturing our product candidates. 50 Table of Contents The process of obtaining regulatory approvals, both in the United States, the EU and other territories, is expensive and often takes many years.
We may also face greater than expected difficulty in manufacturing our product candidates. 47 Table of Contents The process of obtaining regulatory approvals, both in the United States, the EU and other territories, is expensive and often takes many years.
Over the long term, if we are unable to successfully register our trademarks and trade names and establish name recognition based on effective use of our trademarks and trade names, then we may not be able to compete effectively and our business may be adversely affected.
Over the long term, if we are unable to successfully register our trademarks and trade names and establish name recognition based on effective use of our tr ademarks and trade names, then we may not be able to compete effectively and our business may be adversely affected.
Further, there are no assurances that patients receiving our products with co-morbid diseases not previously studied, will not experience new or different serious adverse events in the future. 83 Table of Contents The prescribing information for KIMMTRAK includes warnings and precautions for various toxicities, as well as a boxed warning related to the risk of cytokine release syndrome ("CRS").
Further, there are no assurances that patients receiving our products with co-morbid diseases not previously studied, will not experience new or different serious adverse events in the future. The prescribing information for KIMMTRAK includes warnings and precautions for various toxicities, as well as a boxed warning related to the risk of cytokine release syndrome ("CRS").
Before we can commercialize further product candidates, we must obtain marketing approval. Currently, the majority of our product candidates are in development, and we have not received approval to market any of our product candidates from regulatory authorities, with the exception of KIMMTRAK.
Before we can commercialize further product candidates, we must obtain marketing approval. Currently, the majority of our product candidates are in development, and we have not received approval to market any of our product candidates from regulatory authorities, with the exception of KIMMTRAK for mUM.
Moreover, we may not be able to locate suitable acquisition opportunities and this inability could impair our ability to grow or obtain access to technology or products that may be important to the development of our business. Our insurance policies are expensive and protect only from some business risks, which leaves us exposed to significant uninsured liabilities.
Moreover, we may not be able to locate suitable acquisition opportunities and this inability could impair our ability to grow or obtain access to technology or products that may be important to the development of our business. 99 Table of Contents Our insurance policies are expensive and protect only from some business risks, which leaves us exposed to significant uninsured liabilities.
With respect to our commercial portfolio, we may not be able to manufacture KIMMTRAK successfully with a commercially viable process or at a scale large enough to support its commercial markets or at acceptable margins. The development of commercially viable manufacturing processes typically is very difficult to achieve and is often very expensive and may require extended periods of time.
With respect to our commercial portfolio, we may not be able to manufacture KIMMTRAK successfully with a commercially viable process or at a scale large enough to support its commercial markets or at acceptable margins. 57 Table of Contents The development of commercially viable manufacturing processes typically is very difficult to achieve and is often very expensive and may require extended periods of time.
Any of the foregoing could have a material adverse effect on our business, financial condition, results of operations, and prospects. 71 Table of Contents If we or our third-party suppliers use hazardous, non-hazardous, biological or other materials in a manner that causes injury or violates applicable law, we may be liable for damages.
Any of the foregoing could have a material adverse effect on our business, financial condition, results of operations, and prospects. If we or our third-party suppliers use hazardous, non-hazardous, biological or other materials in a manner that causes injury or violates applicable law, we may be liable for damages.
If one of our collaborators terminates its agreement with us, we may find it more difficult to attract new collaborators. 66 Table of Contents For some of our product candidates, we may in the future determine to collaborate with additional pharmaceutical and biotechnology companies for development and potential commercialization of therapeutic products. We face significant competition in seeking appropriate collaborators.
If one of our collaborators terminates its agreement with us, we may find it more difficult to attract new collaborators. For some of our product candidates, we may in the future determine to collaborate with additional pharmaceutical and biotechnology companies for development and potential commercialization of therapeutic products. We face significant competition in seeking appropriate collaborators.
If we cannot successfully manage the promotion of our product candidates, if approved, we could become subject to significant liability, which would materially adversely affect our business and financial condition. 84 Table of Contents We are subject to stringent and changing laws, regulations, and rules, contractual obligations, industry standards, policies and other obligations related to data privacy and security.
If we cannot successfully manage the promotion of our product candidates, if approved, we could become subject to significant liability, which would materially adversely affect our business and financial condition. We are subject to stringent and changing laws, regulations, and rules, contractual obligations, industry standards, policies and other obligations related to data privacy and security.
We are subject to data privacy and security obligations such as various laws, regulations, guidance, industry standards, external and internal policies, contracts and other obligations that govern the processing of personal data by us and on our behalf. In particular, as a company established in the United Kingdom, our processing of personal data is subject to the U.K.
We are subject to data privacy and security obligations such as various laws, regulations, guidance, industry standards, external and internal policies, contracts and other obligations that govern the processing of personal data by us and on our behalf. 84 Table of Contents In particular, as a company established in the United Kingdom, our processing of personal data is subject to the U.K.
Furthermore, it is impossible to predict when or if tebentafusp for the treatment of advanced melanoma or adjuvant uveal (ocular) melanoma, brenetafusp , IMC-I109V, IMC-M113V, IMC-P115C, IMC-T119C, IMC-R117C, IMC-S118AI, or IMC-U120AI, or any of our future product candidates, will prove effective and safe in humans or will receive regulatory approval.
For example, it is impossible to predict when or if tebentafusp for the treatment of advanced melanoma or adjuvant uveal (ocular) melanoma, brenetafusp , IMC-I109V, IMC-M113V, IMC-P115C, IMC-R117C, IMC-S118AI, or IMC-U120AI, or any of our future product candidates, will prove effective and safe in humans or will receive regulatory approval.
The disaster recovery and business continuity plans we have in place may prove inadequate in the event of a serious disaster or similar event. Although we have limited business interruption insurance policies in place, any interruption could come with high costs for us, as salaries and loan payments would usually continue.
The disaster recovery and business continuity plans we have in place may prove inadequate in the event of a serious disaster or similar event. 96 Table of Contents Although we have limited business interruption insurance policies in place, any interruption could come with high costs for us, as salaries and loan payments would usually continue.
Uncertainties resulting from the initiation and continuation of patent litigation or other proceedings could have a material adverse effect on our ability to compete in the marketplace. 77 Table of Contents We may not be able to effectively enforce our intellectual property and proprietary rights throughout the world.
Uncertainties resulting from the initiation and continuation of patent litigation or other proceedings could have a material adverse effect on our ability to compete in the marketplace. We may not be able to effectively enforce our intellectual property and proprietary rights throughout the world.
We also rely on trade secrets, know-how and continuing technological innovation to develop and maintain our proprietary and intellectual property position. The patent position of biotechnology and pharmaceutical companies generally is highly uncertain, involves complex legal and factual questions and is often the subject of litigation.
We also rely on trade secrets, know-how and continuing technological innovation to develop and maintain our proprietary and intellectual property position. 71 Table of Contents The patent position of biotechnology and pharmaceutical companies generally is highly uncertain, involves complex legal and factual questions and is often the subject of litigation.
We rely and expect to continue to rely on CROs, medical institutions, clinical investigators, contract laboratories and other third parties to conduct or otherwise support clinical trials for our product candidates, including our TEBE-AM Phase 3 advanced melanoma tebentafusp trial, our EORTC-sponsored ATOM Phase 3 trial of KIMMTRAK in adjuvant uveal (ocular) melanoma, our PRISM-MEL-301 Phase 3 clinical trial of brenetafusp in first line advanced cutaneous melanoma, our Phase 1/2 clinical trial of brenetafusp in multiple solid tumors, our Phase 1 clinical trial of IMC-M113V in people who live with HIV, and our Phase 1 clinical trial of IMC-I109V in people who live with HBV.
We rely and expect to continue to rely on CROs, medical institutions, clinical investigators, contract laboratories and other third parties to conduct or otherwise support clinical trials for our product candidates, including our TEBE-AM Phase 3 advanced melanoma tebentafusp trial, our EORTC-sponsored ATOM Phase 3 trial of KIMMTRAK in adjuvant uveal (ocular) melanoma, our PRISM-MEL-301 Phase 3 clinical trial of brenetafusp in first line advanced cutaneous melanoma, our Phase 1/2 clinical trial of brenetafusp in multiple solid tumors, our Phase 1/2 clinical trial of IMC-M113V in people who live with HIV, and our Phase 1 trial with IMC-R117C in colorectal cancer.
When taken in combination with the enhanced relief available on our R&D expenditures, we expect a long-term rate of corporation tax lower than the statutory to apply to us. If, however, there are unexpected adverse changes to the U.K.
When taken in combination with the enhanced relief available on our R&D expenditures, we maintain long-term rate of corporation tax lower than the statutory to apply to us. If, however, there are unexpected adverse changes to the U.K.
Business—Our Collaborations and License Agreements—Gates Collaboration.” 72 Table of Contents Other parties may have developed technologies that are related or competitive to our own, and such parties may have filed or may file patent applications, or may have received or may receive issued patents, claiming inventions that may overlap or conflict with those claimed in our own patent applications or issued patents, with respect to either the same methods or formulations or the same subject matter.
Business—Our Collaborations and License Agreements—Gates Collaboration.” Other parties may have developed technologies that are related or competitive to our own, and such parties may have filed or may file patent applications, or may have received or may receive issued patents, claiming inventions that may overlap or conflict with those claimed in our own patent applications or issued patents, with respect to either the same methods or formulations or the same subject matter.
Further, we may experience delays in developing and deploying remedial measures and patches designed to address identified vulnerabilities. Vulnerabilities could be exploited and result in a security incident. 98 Table of Contents Any of the previously identified or similar threats could cause a security breach or other interruption.
Further, we may experience delays in developing and deploying remedial measures and patches designed to address identified vulnerabilities. Vulnerabilities could be exploited and result in a security incident. Any of the previously identified or similar threats could cause a security breach or other interruption.
We utilize a hybrid model that includes an in-house sales force in the United States and contracted resources in the United States and Europe, and we have engaged third parties and may engage additional third parties to provide services related to the marketing of KIMMTRAK.
We utilize a hybrid model that includes an in-house sales force in the United States and contracted resources in the United States and Europe, and we have engaged third parties and may engage additional third parties to provide services related to the marketing of KIMMTRAK and our product candidates.
Consequently, we may not be able to prevent third parties from practicing our inventions in all countries outside the United States. Competitors may use our technologies and/or conduct research and development activities in jurisdictions where we have not obtained patent protection or in jurisdictions where research and development safe harbor laws exist to develop their own products.
Consequently, we may not be able to prevent third parties from practicing our inventions in all countries outside the United States. 77 Table of Contents Competitors may use our technologies and/or conduct research and development activities in jurisdictions where we have not obtained patent protection or in jurisdictions where research and development safe harbor laws exist to develop their own products.
Additionally, our European patents may be involved in opposition proceedings at the European Patent Office, challenging the validity of those patents. Opposition proceedings may involve issues including, but not limited to, priority, patentability of the claims involved, and certain procedural formalities.
For example, our European patents may be involved in opposition proceedings at the European Patent Office, challenging the validity of those patents. Opposition proceedings may involve issues including, but not limited to, priority, patentability of the claims involved, and certain procedural formalities.
While we have implemented security measures designed to protect our information technology systems and data, there can be no assurance that these measures will be effective. We have not always been able in the past to protect against security breaches (for example, we experienced two minor phishing attacks in 2018 and 2019).
While we have implemented security measures designed to protect our information technology systems and data, there can be no assurance that these measures will be effective. We have not always been able in the past to protect against security breaches (for example, we were impacted by two minor phishing attacks in 2018 and 2019).
Our products, even if approved for commercial sale by the FDA, the European Commission or other comparable regulatory authorities, may not achieve or maintain market acceptance among physicians, patients, hospitals, including pharmacy directors, and third-party payors and, ultimately, may not become or remain commercially successful.
KIMMTRAK and our other product candidates, even if approved for commercial sale by the FDA, the European Commission or other comparable regulatory authorities, may not achieve or maintain market acceptance among physicians, patients, hospitals, including pharmacy directors, and third-party payors and, ultimately, may not become or remain commercially successful.
We expect to continue to expand our development, commercial and regulatory capabilities and have recently developed sales, marketing and distribution capabilities, and as a result, we may encounter difficulties in managing our growth, which could disrupt our operations. As of December 31, 2024 , we had 493 full-time employees.
We expect to continue to expand our development, commercial and regulatory capabilities and have recently developed sales, marketing and distribution capabilities, and as a result, we may encounter difficulties in managing our growth, which could disrupt our operations. As of December 31, 2025 , we had 524 full-time employees.
In addition, there could be an impact on our international operations because of the conflict in the Middle East, because our distributor outside the US and Western Europe has significant exposure in the region.
In addition, there could be an impact on our international operations because of the conflict in the Middle East, because our distributor outside the United States and Western Europe has significant exposure in the region.
If a court were to find either choice of forum provision contained in our articles of association to be inapplicable or unenforceable in an action, we may incur additional costs associated with resolving such action in other jurisdictions, which could adversely affect our results of operations and financial condition.
If a court were to find either choice of forum provision contained in our articles of association to be inapplicable or unenforceable in an action, we may incur additional costs associated with resolving such action in other jurisdictions, which could adversely affect our results of operations and financial condition. 112 Table of Contents Item 1B.
Under the Code, we will be a PFIC, for any taxable year in which (1) 75% or more of our gross income consists of passive income or (2) 50% or more of the value of our assets (generally determined in the basis of a weighted quarterly average) consists of assets that produce, or are held for the production of, passive income (including cash).
Under the Internal Revenue Code of 1986, as amended (the "Code"), we will be a PFIC, for any taxable year in which (1) 75% or more of our gross income consists of passive income or (2) 50% or more of the value of our assets (generally determined in the basis of a weighted quarterly average) consists of assets that produce, or are held for the production of, passive income (including cash).
As of December 31, 2024 , our executive officers, directors and current beneficial owners of five percent or more of our ordinary shares and their respective affiliates beneficially owned, in the aggregate, approximately 60% of our outstanding ordinary shares (including ordinary shares in the form of ADSs).
As of December 31, 2025 , our executive officers, directors and current beneficial owners of five percent or more of our ordinary shares and their respective affiliates beneficially owned, in the aggregate, approximately 64% of our outstanding ordinary shares (including ordinary shares in the form of ADSs).
We may benefit in the future from the United Kingdom’s “patent box” regime, which allows certain profits attributable to revenues from patented products (and other qualifying income) to be taxed at an effective rate of 10% by giving an additional tax deduction.
We are able to benefit from the United Kingdom’s “patent box” regime, which allows certain profits attributable to revenues from patented products (and other qualifying income) to be taxed at an effective rate of 10% by giving an additional tax deduction.
To date, we have invested substantially all of our efforts and financial resources to identify, acquire intellectual property for, and develop our ImmTAX platform technology and our programs, including conducting pre-clinical studies, as well as early- and late-stage clinical trials, and providing general and administrative support for these operations.
To date, we have invested substantially all of our efforts and financial resources to identify, acquire intellectual property for, and develop our ImmTAX platform technology and our programs, including conducting pre-clinical studies, as well as early- and late-stage clinical trials and commercialization of KIMMTRAK that emerged from the ImmTAX platform and providing general and administrative support for these operations.
While we have established commercial teams, we expect to develop these teams further and otherwise continue to develop commercialization strategies in order to continue to successfully commercialize KIMMTRAK in the longer term. There are many factors that could cause commercialization of KIMMTRAK to be unsuccessful, including many that are outside our control.
We expect to develop our commercial teams further and to continue to develop commercialization strategies in order to continue to successfully commercialize KIMMTRAK in the longer term. There are many factors that could cause commercialization of KIMMTRAK to be unsuccessful, including many that are outside our control.
We have invested, and expect to continue to invest, significant financial and management resources to further develop internal sales, distribution and marketing capabilities, some of which, in territories prior to any confirmation that tebentafusp will be approved in that territory.
We have invested, and expect to continue to invest, significant financial and management resources to further develop internal sales, distribution and marketing capabilities of product candidates, some of which in territories prior to any confirmation that the product candidate will be approved in that territory.
While we plan to pursue additional regulatory approvals, it is uncertain whether tebentafusp will receive further marketing approval beyond the approval which KIMMTRAK has received in the United States, the EU, Canada and certain other territories.
While we plan to pursue additional regulatory approvals, it is uncertain whether we will receive further marketing approval for tebentafusp beyond the approval we have received for KIMMTRAK for mUM in the United States, the EU, Canada and certain other territories.
Our patent portfolio may not provide us with any meaningful protection or prevent competitors from designing around our patent claims to circumvent our patents or any patents we may license now or in the future by developing similar or alternative technologies or products in a non-infringing manner.
Even if unchallenged, our patent portfolio may not provide us with any meaningful protection or prevent competitors from designing around our patent claims to circumvent our patents or any patents we may license by developing similar or alternative technologies or products in a non-infringing manner.
We have only recently begun to generate revenues and therefore we may be a PFIC for any taxable year in which we do not generate sufficient amounts of active income to offset our passive financing income. Therefore, we cannot give any assurance regarding our PFIC status for the current or any future taxable year.
We may be a PFIC for any taxable year in which we do not generate sufficient amounts of active income to offset our passive financing income. Therefore, we cannot give any assurance regarding our PFIC status for the current or any future taxable year.
At a general meeting of shareholders held on February 3, 2021, we obtained authority from our shareholders to allot new shares or to grant rights to subscribe for or to convert any security into shares in the company up to a maximum aggregate nominal amount of £150,000 for a period of five years from the date of such general meeting of shareholders, which authorization will need to be renewed upon expiration (i.e., at least every five years) but may be sought more frequently for additional five-year terms (or any shorter period).
At our 2025 Annual General Meeting held on May 15, 2025, we obtained authority from our shareholders to allot new shares or to grant rights to subscribe for or to convert any security into shares in the company up to a maximum aggregate nominal amount of £150,000 for a period ending on May 14, 2030, which authorization will need to be renewed upon expiration (i.e., at least every five years) but may be sought more frequently for additional five-year terms (or any shorter period).
Competing products may gain faster or greater market acceptance than our products, if any, and medical advances or rapid technological development by competitors may result in our product candidates becoming non-competitive or obsolete before we are able to recover our research and development and commercialization expenses.
Competing products may gain faster or greater market acceptance than our products, if any, and medical advances or rapid technological development by competitors, including increased use of artificial intelligence-based technologies, may result in our product candidates becoming non-competitive or obsolete before we are able to recover our research and development and commercialization expenses.
Moreover, disputes may arise regarding intellectual property subject to a collaboration or licensing agreement, including: • the scope of rights granted under the agreement and other interpretation-related issues; • the extent to which our technology and processes infringe on intellectual property of the counterparty that is not subject to the agreement; • the sublicensing of patent and other intellectual or proprietary rights under our collaborative development relationships; • our diligence obligations under the agreement and what activities satisfy those diligence obligations; • the inventorship and ownership of inventions and know-how resulting from the joint creation or use of intellectual property by our counterparty and us and our partners; and • the priority of invention of patented technology. 79 Table of Contents These agreements may be complex, and certain provisions in such agreements may be susceptible to multiple interpretations.
Moreover, disputes may arise regarding intellectual property subject to a collaboration or licensing agreement, including: • the scope of rights granted under the agreement and other interpretation-related issues; • the extent to which our technology and processes infringe on intellectual property of the counterparty that is not subject to the agreement; • the sublicensing of patent and other intellectual or proprietary rights under our collaborative development relationships; • our diligence obligations under the agreement and what activities satisfy those diligence obligations; • the inventorship and ownership of inventions and know-how resulting from the joint creation or use of intellectual property by our counterparty and us and our partners; and • the priority of invention of patented technology.
We rely on CROs and other third parties to conduct our Phase 1, Phase 2 and Phase 3 pivotal clinical trials and expect to rely on CROs and other third parties to conduct future clinical trials, as well as investigator-sponsored clinical trials of our product candidates.
We rely on CROs and other third parties to conduct our clinical trials and expect to rely on CROs and other third parties to conduct future clinical trials, as well as investigator-sponsored clinical trials of our product candidates.

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Item 1C. Cybersecurity

Cybersecurity — threats and controls disclosure

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Biggest changeThe board of directors’ audit and compliance committee is responsible for overseeing our cybersecurity risk management processes, including oversight and mitigation of risks from cybersecurity threats. Our cybersecurity risk assessment and management processes are implemented and maintained by certain members of our management, including our CIO, who has over 15 years of experience in IT management.
Biggest changeThe board of directors’ audit and compliance committee is responsible for overseeing our cybersecurity risk management processes, including oversight and mitigation of risks from cybersecurity threats. 113 Table of Contents Our cybersecurity risk assessment and management processes are implemented and maintained by certain members of our management, including our CIO, who has over 15 years of experience in IT management.
Our CIO reports directly to our leadership team and provides regular reports. 115 Table of Contents Our CIO is responsible for hiring appropriate personnel, helping to integrate cybersecurity risk considerations into our overall risk management strategy, and communicating key priorities to relevant personnel.
Our CIO reports directly to our leadership team and provides regular reports. Our CIO is responsible for hiring appropriate personnel, helping to integrate cybersecurity risk considerations into our overall risk management strategy, and communicating key priorities to relevant personnel.

Item 2. Properties

Properties — owned and leased real estate

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Biggest changeIn addition, we lease an aggregate of approximately 36,000 square feet of office space in Conshohocken, Pennsylvania, and Rockville and Gaithersburg, Maryland. We also lease approximately 240 square feet of office space in Dublin, Ireland and approximately 120 square feet in Suurstoffi, Switzerland.
Biggest changeIn addition, we lease an aggregate of approximately 45,000 square feet of office space in Radnor, Pennsylvania, and Rockville and Gaithersburg, Maryland. We also lease approximately 240 square feet of office space in Dublin, Ireland and approximately 120 square feet in Suurstoffi, Switzerland.

Item 3. Legal Proceedings

Legal Proceedings — active lawsuits and investigations

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Biggest changeItem 3. Legal Proceedings From time to time, we may become involved in other legal proceedings arising in the ordinary course of our business. We do not currently have any pending litigation that, separately or in the aggregate, would, in the opinion of management, have a material adverse effect on our results of operations, financial condition or cash flows.
Biggest changeItem 3. Legal Proceedings From time to time, we may become subject to arbitration, litigation or claims arising in the ordinary course of business. We are not currently a party to any arbitration or legal proceeding that, if determined adversely to us, would have a material adverse effect on our business, operating results or financial condition.
The results of any current or future litigation cannot be predicted with certainty, and regardless of the outcome, litigation can have an adverse impact on us because of defense and settlement costs, diversion of management resources and other factors. Item 4. Mine Safety Disclosures Not applicable. PART II
The results of any future claims or proceedings cannot be predicted with certainty, and regardless of the outcome, litigation can have an adverse impact on us because of defense and litigation costs, diversion of management resources, and other factors. Item 4. Mine Safety Disclosures Not applicable. PART II

Item 5. Market for Registrant's Common Equity

Market for Common Equity — stock, dividends, buybacks

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Biggest changeOur ADSs each represent one ordinary share of Immunocore Holdings plc and began trading on the Nasdaq Global Select Market on February 5, 2021 under the symbol “IMCR”.
Biggest changeOur ADSs each represent one ordinary share of Immunocore Holdings plc and are traded on the Nasdaq Global Select Market under the symbol “IMCR”. 114 Table of Contents Holders As of February 19, 2026, there were approximately 30 holders of record of our ordinary shares and 3 holders of record of our ADSs.
Performance Graph The graph below shows a comparison, from February 5, 2021 (the date our ADSs commenced trading on Nasdaq) through December 31, 2024, of the cumulative total return to stockholders of our ADSs relative to the Nasdaq Composite Index and the Nasdaq Biotech Index. 117 Table of Contents The graph assumes that $100 was invested in each of our ADSs, the Nasdaq Composite Index and the Nasdaq Biotech Index at their respective closing prices on February 5, 2021 and assumes reinvestment of gross dividends.
Performance Graph The graph below shows a comparison, from February 5, 2021 (the date our ADSs commenced trading on Nasdaq) through December 31, 2025, of the cumulative total return to stockholders of our ADSs relative to the Nasdaq Composite Index and the Nasdaq Biotech Index. 115 Table of Contents The graph assumes that $100 was invested in each of our ADSs, the Nasdaq Composite Index and the Nasdaq Biotech Index at their respective closing prices on February 5, 2021 and assumes reinvestment of gross dividends.
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Prior to that date, there was no public trading market for ADSs or ordinary shares. 116 Table of Contents Holders As of February 20, 2025, there were approximately 30 holders of record of our ordinary shares and 3 holders of record of our ADSs.

Item 7. Management's Discussion & Analysis

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

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Biggest changeThis decrease was due to our February 2023 agreement with Genentech, under the terms of our Genentech Collaboration, to close the Phase 1 clinical trial and for the parties to fulfill the remaining obligations in relation to the trial. 123 Table of Contents R&D Expenses The following table summarizes our R&D expenses (in thousands): Year ended December 31, 2024 2023 Increase / (decrease) % Increase / (decrease) External R&D expenses: PRAME programs $ 90,377 $ 54,761 $ 35,616 65 % Tebentafusp programs 31,166 16,024 15,142 94 % Infectious disease programs 6,662 5,111 1,551 30 % All other external clinical and pre-clinical costs 23,747 23,215 532 2 % Total external R&D expenses 151,952 99,111 52,841 53 % Internal R&D expenses: Salaries and other employee-related costs 43,706 38,182 5,524 14 % Share-based compensation expense 7,771 6,467 1,304 20 % All other internal R&D costs 28,328 26,074 2,254 9 % U.K.
Biggest changeR&D Expenses The following table summarizes our R&D expenses (in thousands): Year Ended December 31, 2025 2024 Increase / (decrease) % Increase / (decrease) External R&D expenses: PRAME programs $ 82,594 $ 90,377 $ (7,783) (9) % Tebentafusp programs 40,824 31,166 9,658 31 % Infectious disease programs 6,450 6,662 (212) (3) % All other external clinical and preclinical costs 59,716 23,747 35,969 151 % Total external R&D expenses 189,584 151,952 37,632 25 % Internal R&D expenses: Salaries and other employee-related costs 49,898 43,706 6,192 14 % Share-based compensation expense 8,776 7,771 1,005 13 % All other internal R&D costs 33,821 28,328 5,493 19 % U.K.
Foreign currency (loss) gain The (loss) gain arises on a variety of items, including on U.S. dollar monetary assets and liabilities held by our main operating subsidiary in the United Kingdom, including our cash and cash equivalents.
Foreign currency (loss) gain Foreign currency (loss) gain arises on a variety of items, including on U.S. dollar monetary assets and liabilities held by our main operating subsidiary in the United Kingdom, including our cash and cash equivalents.
Our future funding requirements will depend on and could increase significantly as a result of many factors, including: • the progress, timing, scope and costs of our clinical trials, including the ability to timely initiate clinical sites, enroll subjects and manufacture soluble bispecific TCR product candidates for our ongoing, planned and potential future clinical trials; • the time and costs required to perform R&D to identify and characterize new product candidates from our research programs; • the time and cost necessary to obtain regulatory authorizations and approvals that may be required by regulatory authorities to execute clinical trials or commercialize our products; • the amount of sales and other revenues from KIMMTRAK in the United States, Europe, and other regions, if approved; • our ability to successfully commercialize our other product candidates; • our ability to have clinical and commercial products successfully manufactured consistent with FDA, regulations of the EU and other authorities’ regulations; • the amount of sales and other revenues from product candidates that we may commercialize, if any, including the selling prices for such potential products and the availability of adequate third-party coverage and reimbursement for patients; • the sales and marketing costs associated with commercializing our products, if approved, including the cost and timing of building our marketing and sales capabilities; • the cost of building, staffing and validating our manufacturing processes, which may include capital expenditure; • the continued costs of operating as a public company; • the time and cost necessary to respond to technological, regulatory, political and market developments; • the costs of filing, prosecuting, defending and enforcing any patent claims and other intellectual property rights; • the costs, associated with, and terms and timing of, any future any potential acquisitions, strategic collaborations, licensing agreements or other arrangements that we may establish; and • the inability of clinical sites to enroll patients as healthcare capacities are required to cope with natural disasters, epidemics or other health system emergencies.
Our future funding requirements will depend on and could increase significantly as a result of many factors, including: • the progress, timing, scope and costs of our clinical trials, including the ability to timely initiate clinical sites, enroll subjects and manufacture soluble bispecific TCR product candidates for our ongoing, planned and potential future clinical trials; • the time and costs required to perform R&D to identify and characterize new product candidates from our research programs; • the time and cost necessary to obtain regulatory authorizations and approvals that may be required by regulatory authorities to execute clinical trials or commercialize our products; • the amount of sales and other revenues from KIMMTRAK in the United States, Europe, and other regions, if approved; • our ability to successfully commercialize our other product candidates; • our ability to have clinical and commercial products successfully manufactured consistent with FDA, regulations of the EU and other authorities’ regulations; • the amount of sales and other revenues from product candidates that we may commercialize, if any, including the selling prices for such potential products and the availability of adequate third-party coverage and reimbursement for patients; • the sales and marketing costs associated with commercializing our products, if approved, including the cost and timing of building our marketing and sales capabilities; • the cost of building, staffing and validating our manufacturing processes, which may include capital expenditure; • the continued costs of operating as a public company; • the time and cost necessary to respond to technological, regulatory, political and market developments; • the costs of filing, prosecuting, defending and enforcing any patent claims and other intellectual property rights; • the costs, associated with, and terms and timing of, any future potential acquisitions, strategic collaborations, licensing agreements or other arrangements that we may establish; and • the inability of clinical sites to enroll patients as healthcare capacities are required to cope with natural disasters, epidemics or other health system emergencies.
As we continue to grow, launch further products or expand our operations in other countries, we may determine that it is necessary to enter into further lease agreements, which would further increase our cash outflows. Further obligations or commitments in the near term relate to our capital expenditure requirements for the purpose of improving our leased facilities.
As we continue to grow, launch further products or expand our operations in other countries, we may determine that it is necessary to enter into further lease agreements, which would increase our cash outflows. Further obligations or commitments in the near term relate to our capital expenditure requirements for the purpose of improving our leased facilities.
Income tax benefit (expense) We are subject to corporate taxation in the United Kingdom and our wholly-owned subsidiaries are subject to corporate taxation in the United States, Ireland and Switzerland. Due to the nature of our business and on a consolidated basis, we have generated losses since inception.
Income tax benefit (expense) We are subject to corporate taxation in the United Kingdom and our wholly-owned subsidiaries are subject to corporate taxation in the United States, Ireland and Switzerland. Due to the nature of our business and on a consolidated basis, we have generated cumulative losses since inception.
However, it is not possible to predict the amount of future payments under these agreements due to the conditional nature of our obligations and the unique facts and circumstances involved in each particular agreement. 129 Table of Contents Financing obligations Under the terms of our agreement with the Gates Foundation, we are required to develop, manufacture and commercialize soluble TCR bispecific therapeutic candidates targeted to mutually agreed neglected diseases, currently HIV, with the potential to treat people at an affordable price in developing countries.
However, it is not possible to predict the amount of future payments under these agreements due to the conditional nature of our obligations and the unique facts and circumstances involved in each particular agreement. 126 Table of Contents Financing obligations Under the terms of our agreement with the Gates Foundation, we are required to develop, manufacture and commercialize soluble TCR bispecific therapeutic candidates targeted to mutually agreed neglected diseases, currently HIV, with the potential to treat people at an affordable price in developing countries.
Furthermore, our operating plans may change in the future, and we may need additional funds to meet operational needs and capital requirements associated with such operating plans. 128 Table of Contents Until we can generate sufficient revenue to finance our cash requirements, which we may never do, we expect to finance our future cash needs through a combination of public or private equity offerings, debt financings, collaborations, strategic alliances, licensing arrangements and other marketing or distribution arrangements as well as grant funding.
Furthermore, our operating plans may change in the future, and we may need additional funds to meet operational needs and capital requirements associated with such operating plans. 125 Table of Contents Until we can generate sufficient revenue to finance our cash requirements, which we may never do, we expect to finance our future cash needs through a combination of public or private equity offerings, debt financings, collaborations, strategic alliances, licensing arrangements and other marketing or distribution arrangements as well as grant funding.
Our expenses will also increase if, and as, we: • pursue further approval and commercialization of KIMMTRAK in additional indications and territories; • continue to advance the development of our clinical trials and pre-clinical programs; • continue to invest in our soluble TCR platforms to conduct research to identify novel technologies; • change or add additional suppliers; • add additional infrastructure to our quality control, quality assurance, legal, compliance and other groups to support our operations as we progress product candidates toward commercialization; • seek to attract and retain skilled personnel; • create additional infrastructure to further support our operations as a public company listed in the United States and our product development and planned future commercialization efforts; • seek marketing approvals and reimbursement for our other product candidates; • further develop a sales, marketing and distribution infrastructure to further commercialize any products for which we may obtain marketing approval; • seek to identify and validate additional product candidates; • acquire or in-license other product candidates and technologies; • maintain, protect, defend, enforce and expand our intellectual property portfolio; and • experience any delays, interruptions or encounter issues with any of the above, including any delays or other impacts as a result of the war in Ukraine, the conflict in the Middle East, global geopolitical tension, worsening macroeconomic conditions, including supply chain disruptions, fluctuations in interest rates, rising inflation, and tariffs, or health epidemics or pandemics.
Our expenses will continue to increase if, and as, we: • pursue further approval and commercialization of KIMMTRAK in additional indications and territories; • continue to advance the development of our clinical trials and preclinical programs; • continue to invest in our soluble TCR platforms to conduct research to identify novel technologies; • change or add additional suppliers; • add additional infrastructure to our quality control, quality assurance, legal, compliance and other groups to support our operations as we progress product candidates toward commercialization; • seek to attract and retain skilled personnel; • create additional infrastructure to further support our operations as a public company listed in the United States and our product development and planned future commercialization efforts; • seek marketing approvals and reimbursement for our other product candidates; • further develop a sales, marketing and distribution infrastructure to further commercialize any products for which we may obtain marketing approval; • seek to identify and validate additional product candidates; • acquire or in-license other product candidates and technologies; • maintain, protect, defend, enforce and expand our intellectual property portfolio; and • experience any delays, interruptions or encounter issues with any of the above, including any delays or other impacts as a result of the war in Ukraine, the conflict in the Middle East, global geopolitical tension, worsening macroeconomic conditions, including supply chain disruptions, fluctuations in interest rates, rising inflation, tariffs and other trade barriers, or health epidemics or pandemics.
However, for certain preclinical programs and other research spend incurred externally, such spend is not assigned to individual programs. Internal R&D expenses primarily relate to personnel-related costs, facilities, information technology used in R&D activities and laboratory consumables. Due to the cross functional expertise of our people, it is not possible to provide a breakdown of internal costs by program.
However, for certain preclinical programs and other research spend incurred externally, such spend is not assigned to individual programs. Internal R&D expenses primarily relate to employee-related costs, facilities, information technology used in R&D activities and laboratory consumables. Due to the cross functional expertise of our people, it is not possible to provide a breakdown of internal costs by program.
Leveraging our proprietary, flexible, off-the-shelf ImmTAX ( I mmune m obilizing m onoclonal T CRs A gainst X disease) platform, we are developing a deep pipeline in multiple therapeutic areas, including clinical stage programs in oncology and infectious disease, advanced pre-clinical programs in autoimmune disease and earlier pre-clinical programs across three therapeutic areas.
Leveraging our proprietary, flexible, off-the-shelf ImmTAX ( I mmune m obilizing m onoclonal T CRs A gainst X disease) platform, we are developing a deep pipeline in multiple therapeutic areas, including clinical stage programs in oncology and infectious disease, advanced preclinical programs in autoimmune disease and earlier preclinical programs across three therapeutic areas.
These estimates consider contractual and statutory requirements, the expected payor and patient mix, sell-through data, our customers’ inventory levels, anticipated demand and the volume of customer purchase orders, internal data, and other information provided by our customers and third-party logistics providers, and, in certain countries including France, pricing negotiations.
These estimates consider contractual and statutory requirements, the expected payor and patient mix, sell-through data, our customers’ inventory levels, anticipated demand and the volume of customer purchase orders, internal data, and other information provided by our customers and third-party logistics providers, and in certain countries, pricing negotiations.
Research and development tax credits As a company that carries out extensive R&D activities, we benefit from the U.K. R&D tax regime. For the periods ending December 31, 2024, 2023 and 2022 we claimed credits under the Research and Development Expenditure Credit ("RDEC") program and these credits are presented as a reduction to R&D expenses.
Research and development tax credits As a company that carries out extensive R&D activities, we benefit from the U.K. R&D tax regime. For the periods ending December 31, 2025, 2024 and 2023, we claimed credits under the Research and Development Expenditure Credit ("RDEC") program and these credits are presented as a reduction to R&D expenses.
Additionally, if and as we receive further regulatory approvals of product candidates, we anticipate an increase in personnel-related costs and expenses in connection with our commercial operations. We have experienced, and may continue to experience, increased personnel-related costs attributable to offering and maintaining competitive salaries and other impacts due to global inflation.
Additionally, if and as we receive further regulatory approvals of product candidates, we anticipate an increase in employee-related costs and expenses in connection with our commercial operations. We have experienced, and may continue to experience, increased employee-related costs attributable to offering and maintaining competitive salaries and other impacts due to global inflation.
We currently have no ongoing material financing commitments, such as lines of credit or guarantees, that are expected to affect our liquidity over the next five years, other than our lease obligations and supplier purchase commitments in the normal course of business.
Other than the above indebtedness, we currently have no ongoing material financing commitments, such as lines of credit or guarantees, that are expected to affect our liquidity over the next five years, other than our lease obligations and supplier purchase commitments in the normal course of business.
We apply judgement to assess internal targets, pricing information of other therapies approved for sale in France, information obtained from price negotiations of KIMMTRAK in other countries, and information connected with KIMMTRAK’s safety profile when forming our estimated rebate deduction from revenue.
We applied judgement to assess internal targets, pricing information of other therapies approved for sale in France, information obtained from price negotiations of KIMMTRAK in other countries, and information connected with KIMMTRAK’s safety profile when forming our estimated rebate deduction from revenue.
We believe our expected values of accruals reported in the Consolidated Balance Sheet are materially appropriate; however, due to the uncertainties and judgements outlined above, it is possible eventual amounts could significantly differ to these estimates.
We believe our expected values of accruals reported in the Consolidated Balance Sheet are materially appropriate; however, due to the uncertainties and judgments outlined above, it is possible eventual amounts could significantly differ to these estimates.
The preparation of the consolidated financial statements requires us to make judgements, estimates and assumptions that affect the value of assets and liabilities—as well as contingent assets and liabilities—as reported on the balance sheet date, and revenues and expenses arising during the fiscal year.
The preparation of the consolidated financial statements requires us to make judgments, estimates and assumptions that affect the value of assets and liabilities—as well as contingent assets and liabilities—as reported on the balance sheet date, and revenues and expenses arising during the fiscal year.
We are progressing three late-stage clinical programs within our ImmTAC ( I mmune m obilizing m onoclonal T CRs A gainst C ancer) portfolio, including KIMMTRAK and PRAME-targeted brenetafusp. Since our inception, we have focused on organizing and staffing our company, raising capital, performing research and development activities to advance our research, development and technology, and commercializing KIMMTRAK.
We are progressing three late-stage clinical programs within our ImmTAC ( I mmune m obilizing m onoclonal T CRs A gainst C ancer) portfolio, including KIMMTRAK and PRAME-targeted brenetafusp. Since our inception, we have focused on organizing and staffing our company, raising capital, performing research and development activities to advance our research, development and technology, and commercialization of KIMMTRAK.
GAAP. This section of our Annual Report on Form 10-K discusses our financial condition and results of operations for the fiscal years ended December 31, 2024 and 2023, and year-to-year comparisons between fiscal 2024 and fiscal 2023.
GAAP. This section of our Annual Report on Form 10-K discusses our financial condition and results of operations for the fiscal years ended December 31, 2025 and 2024, and year-to-year comparisons between fiscal 2025 and fiscal 2024.
On February 2, 2024, we completed a private offering of $402.5 million aggregate principal amount of the Notes, including the exercise in full of the initial purchasers’ option to purchase up to an additional $52.5 million principal amount of Notes.
In February 2024, we completed a private offering of $402.5 million aggregate principal amount of the Notes, including the exercise in full of the initial purchasers’ option to purchase up to an additional $52.5 million principal amount of Notes.
Our Key Collaboration Agreements BMS Collaboration In February 2024, we entered into a clinical trial collaboration and supply agreement with BMS (the "BMS Agreement") to investigate our ImmTAC bispecific TCR candidate targeting PRAME HLA-A*02:01, brenetafusp (previously IMC-F106C), in combination with BMS’s nivolumab, in first-line advanced cutaneous melanoma.
Our Key Collaboration Agreements BMS Collaboration In February 2024, we entered into a clinical trial collaboration and supply agreement with BMS (the "BMS Agreement") to investigate our ImmTAC bispecific TCR candidate targeting PRAME HLA-A*02:01, brenetafusp, in combination with BMS’s nivolumab, in first-line advanced cutaneous melanoma.
Since inception, we have raised funds through our initial public offering, private placements of our ordinary and preferred shares, debt financings, revenue and historical payments from our collaboration partners.
We have raised funds through our initial public offering, private placements of our ordinary and preferred shares, debt financings, revenue and historical payments from our collaboration partners.
Further information on estimates is provided under the section below headed, “ Critical Accounting Estimates ”. Collaboration revenue Historically, collaboration revenue arose under our collaboration agreements with Genentech and Lilly and consisted of non-refundable upfront payments, development milestone payments as well as reimbursement of certain research and development expenses.
Further information on estimates is provided under the section below headed, “ Critical Accounting Estimates ”. Collaboration revenue Historically, collaboration revenue arose under our collaboration agreements and consisted of non-refundable upfront payments, development milestone payments as well as reimbursement of certain research and development expenses.
A discussion of our financial condition and results of operations for the fiscal year ended December 31, 2022 and year-to-year comparisons between fiscal 2023 and fiscal 2022 that are not included in this Annual Report on Form 10-K can be found in “Management’s Discussion and Analysis of Financial Condition and Results of Operations” in Part II, Item 7 of our Annual Report on Form 10-K for the fiscal year ended December 31, 2023, filed with the SEC on February 28, 2024. 118 Table of Contents Overview We are a commercial stage biotechnology company pioneering and delivering transformative immunomodulating medicines to radically improve outcomes for patients with cancer, infectious diseases, and autoimmune diseases.
A discussion of our financial condition and results of operations for the fiscal year ended December 31, 2023 and year-to-year comparisons between fiscal 2024 and fiscal 2023 that are not included in this Annual Report on Form 10-K can be found in “Management’s Discussion and Analysis of Financial Condition and Results of Operations” in Part II, Item 7 of our Annual Report on Form 10-K for the fiscal year ended December 31, 2024, filed with the SEC on February 26, 2025. 116 Table of Contents Overview We are a commercial stage biotechnology company pioneering and delivering transformative immunomodulating medicines to radically improve outcomes for patients with cancer, infectious diseases, and autoimmune diseases.
Analysis of further legislative requirements, sales volumes and the expected benefit of KIMMTRAK to patients in France is also required in the assessment of rebates payable.
Analysis of further legislative requirements, sales volumes and the expected benefit of KIMMTRAK to patients in France was also required in the assessment of rebates payable.
Contractual Obligations Leases and manufacturing As part of our ongoing operations, we have material contractual lease obligations over expected lease terms of several years and expiry dates extending to 2043 primarily for our most significant facilities in the United Kingdom. These obligations and potential obligations could result in payments of up to $65.6 million.
Contractual Obligations Leases and manufacturing As part of our ongoing operations, we have material contractual lease obligations over expected lease terms of several years and expiry dates extending to 2043 primarily for our most significant facilities in the United Kingdom. These obligations and potential obligations could result in payments of up to $66.0 million.
Based on our current operating plans, we expect that our existing cash and cash equivalents and marketable securities balances, along with anticipated revenue from KIMMTRAK and the cash proceeds from our February 2024 Notes offering, will enable us to fund our operating expenses and capital expenditure requirements for at least twelve months from the date of filing of this Annual Report.
Based on our current operating plans, we expect that our existing cash and cash equivalents and marketable securities balances, along with anticipated revenue from KIMMTRAK, will enable us to fund our operating expenses and capital expenditure requirements for at least twelve months from the date of filing of this Annual Report.
A 20% increase or decrease in estimates of expected rebate and chargeback percentages for amounts payable to governments or government agencies for the critical estimates described above would have resulted in a $20.8 million reduction or increase, respectively, in revenue from sale of therapies, net reported in the Consolidated Statements of Operations and Comprehensive Loss for the year ended December 31, 2024.
A 20% increase or decrease in estimates of expected rebate and chargeback percentages for amounts payable to governments or government agencies for the critical estimates described above would have resulted in a $2.0 million reduction or increase, in Revenue from sale of therapies, net reported in the Consolidated Statements of Operations and Comprehensive Loss for the year ended December 31, 2025.
After accounting for tax credits receivable, there were accumulated tax losses available for carry forward in the United Kingdom of $277.4 million as of December 31, 2024 . A full valuation allowance is recognized in respect of accumulated tax losses and other temporary differences in the United Kingdom because future profits are not sufficiently certain.
After accounting for tax credits receivable, there were accumulated tax losses available for carry forward in the United Kingdom of $525.5 million as of December 31, 2025 . A full valuation allowance is recognized in respect of accumulated tax losses and other temporary differences in the United Kingdom because future profits are not sufficiently certain.
Foreign Currency (Loss) Gain For the year ended December 31, 2024 , foreign currency loss was $3.4 million compared to a loss of $13.2 million for the year ended December 31, 2023 .
Foreign Currency (Loss) Gain For the year ended December 31, 2025 , foreign currency gain was $2.2 million compared to a loss of $3.4 million for the year ended December 31, 2024 .
Our income tax benefit (expense) represents the sum of income taxes payable in the United States, Ireland and Switzerland, offset by deferred tax credits arising on deferred tax assets generated. Unsurrendered tax losses are carried forward to be offset against future taxable profits.
Our income tax benefit (expense) represents the sum of income taxes payable in the United States, Ireland and Switzerland, offset by movements in our deferred tax assets. Unsurrendered tax losses are carried forward to be offset against future taxable profits.
These are included within Accrued expenses and other current liabilities in the Consolidated Balance Sheet as of December 31, 2024.
These amounts are included within Accrued expenses and other current liabilities in the Consolidated Balance Sheet as of December 31, 2025.
Recently Issued and Adopted Accounting Pronouncements We discuss the effect of recently issued and adopted pronouncements in Note 2 to the consolidated financial statements. 131 Table of Contents
Recently Issued and Adopted Accounting Pronouncements We discuss the effect of recently issued and adopted pronouncements in Note 2 to the consolidated financial statements.
In order to support our continued commercialization and global expansion of KIMMTRAK and our substantial increase in planned R&D expenses, and operating as a public company, we expect that we will continue to incur significant selling, distribution, commercial, accounting, audit, legal, regulatory, compliance, director and officer insurance costs, as well as investor and public relations expenses.
In order to support our continued commercialization and global expansion of KIMMTRAK, R&D activities and our operations as a public company, we expect that we will continue to incur selling, distribution, commercial, accounting, audit, legal, regulatory, compliance, director and officer insurance costs, as well as investor and public relations expenses.
R&D tax credits under the SME program with effect from 2023. 121 Table of Contents Under the RDEC program, tax credits for qualifying R&D expenses incurred prior to April 1, 2023 are granted at a headline rate of 13% and can generate cash rebates of up to 10.5% of qualifying R&D expenses.
Under the RDEC program, tax credits for qualifying R&D expenses incurred prior to April 1, 2023 are granted at a headline rate of 13% and can generate cash rebates of up to 10.5% of qualifying R&D expenses.
Liquidity and Capital Resources Sources of Liquidity Although we have recorded revenue from the sale of therapies in the year ended December 31, 2024 , we have continued to incur operating losses and cumulative negative cash flows from our operations since our inception.
Liquidity and Capital Resources Sources of Liquidity Although we have recorded revenue from the sale of therapies, we have continued to incur operating losses and cumulative negative cash flows from our operations since our inception.
Judgment is applied to consider the relevance and reliability of information used to make these estimates. Judgment is also required in determining expected rebate percentages for the amount of net revenue from sale of therapies in France. Rebates payable are subject to a high degree of estimation uncertainty.
Judgment is applied to consider the relevance and reliability of information used to make these estimates. Judgment has historically been made in determining expected rebate percentages for the amount of net revenue from sale of therapies in France. Rebates payable were subject to a high degree of estimation uncertainty.
For other European markets, where the price is open to negotiation, judgements are made in line with expected pricing outcomes. Our total accrued revenue deductions as of December 31, 2024 were $110.9 million, including amounts of $103.9 million for the critical estimates subject to greater estimation uncertainty and judgments described above.
For other European markets, where the price is open to negotiation, judgments are made in line with expected pricing outcomes. Our total accrued revenue deductions as of December 31, 2025 were $132.8 million, including amounts of $10.2 million for the critical estimates subject to greater estimation uncertainty and judgments described above.
Research and development expenses Research and development ("R&D") expenses consist primarily of costs incurred for current or planned investigations undertaken with the prospect of gaining new scientific or technical knowledge and understanding and consist primarily of personnel-related costs, including salaries and share-based compensation expense, costs associated with clinical trial activities undertaken by contract research organizations ("CROs"), and external manufacturing costs associated with R&D undertaken by contract manufacturing organizations ("CMOs"), laboratory consumables, internal clinical trial expenses, payments for purchased rights and milestones in connection with third-party in-process R&D agreements, costs associated with maintaining laboratory equipment, costs associated with our R&D facilities, including a reasonable allocation of overhead costs, and reductions from expenses for R&D tax credits.
R&D expenses consist primarily of employee-related costs, including salaries and share-based compensation expense, costs associated with clinical trial activities undertaken by contract research organizations ("CROs"), and external manufacturing costs associated with R&D undertaken by contract manufacturing organizations ("CMOs"), laboratory consumables, internal clinical trial expenses, payments for purchased rights and milestones in connection with third-party in-process R&D agreements, costs associated with maintaining laboratory equipment, costs associated with our R&D facilities, including a reasonable allocation of overhead costs, and reductions from expenses for R&D tax credits.
We have launched KIMMTRAK in 24 countries globally through December 31, 2024, with further commercial launches planned in additional territories where KIMMTRAK is approved . KIMMTRAK is the lead product from our ImmTAX platform and was the first approved therapy in mUM.
We have commercially launched KIMMTRAK in 30 countries globally including the United States, Germany and France through December 31, 2025, with further commercial launches planned in additional territories where KIMMTRAK is approved. KIMMTRAK is the lead product from our ImmTAX platform and was the first approved therapy in mUM.
Moreover, we have based our estimates on assumptions that may prove to be wrong, and we could use our available capital resources sooner than we currently expect. 127 Table of Contents We held cash and cash equivalents of $455.7 million and marketable securities of $364.6 million as of December 31, 2024 .
Moreover, we have based our estimates on assumptions that may prove to be wrong, and we could use our available capital resources sooner than we currently expect. We held cash and cash equivalents of $467.7 million and marketable securities of $396.4 million as of December 31, 2025 .
Revenue from the sale of therapies, net increased in the year ended December 31, 2024 as compared to December 31, 2023 , due primarily to increased volume in the United States and global country expansion, as we continued our commercialization efforts.
Revenue from the sale of therapies, net increased in the year ended December 31, 2025 as compared to December 31, 2024 due primarily to increased volume in the United States and Europe as well as global country expansion.
Interest income Interest income arises on cash balances and short-term money market funds. Our interest income may fluctuate depending on the movement of interest rates and our total amount of cash and cash equivalents.
Interest income Interest income arises on cash balances and short-term money market funds. Our interest income may fluctuate depending on the movement of interest rates and our total amount of cash and cash equivalents. Interest expense Interest expense represents costs under our interest-bearing loans and borrowings under the effective interest method.
Existing circumstances and assumptions about future developments, however, may change due to market changes or circumstances arising that are beyond our control. Hence, estimates may vary from the actual values. 130 Table of Contents The estimates and underlying assumptions are reviewed on an ongoing basis.
Existing circumstances and assumptions about future developments, however, may change due to market changes or circumstances arising that are beyond our control. Hence, estimates may vary from the actual values. The estimates and underlying assumptions are reviewed on an ongoing basis. Revisions to accounting estimates are recognized in the period in which they become known and are applied prospectively.
We have incurred amounts totaling $2.8 million under the Gadeta Collaboration as of December 31, 2024. Critical Accounting Estimates Our consolidated financial statements as of December 31, 2024 and 2023 , and for the years ended 2024, 2023 and 2022 have been prepared in accordance with U.S. GAAP.
Critical Accounting Estimates Our consolidated financial statements as of December 31, 2025 and 2024 , and for the years ended 2025, 2024 and 2023 have been prepared in accordance with U.S. GAAP.
These net losses were $51.1 million, $55.3 million and $52.5 million, for the years ended December 31, 2024, 2023 and 2022 , respectively. As of December 31, 2024, our accumulated deficit was $795.8 million.
We had net losses of $35.5 million, $51.1 million and $55.3 million, for the years ended December 31, 2025, 2024 and 2023 , respectively. As of December 31, 2025, our accumulated deficit was $831.3 million.
The following table summarizes the primary sources and uses of cash for each period presented (in thousands): Year ended December 31, 2024 2023 Cash and cash equivalents at beginning of the year $ 442,626 $ 402,472 Net cash provided by operating activities 26,061 2,940 Net cash used in investing activities (355,129) (5,425) Net cash provided by financing activities 343,881 34,346 Net foreign exchange difference on cash held (1,708) 8,293 Cash and cash equivalents at end of the year $ 455,731 $ 442,626 Net cash provided by our operating activities was $26.1 million for the year ended December 31, 2024, compared to $2.9 million for the year ended December 31, 2023.
Cash Flows The following table summarizes the primary sources and uses of cash and cash equivalents for each period presented (in thousands): Year Ended December 31, 2025 2024 Cash and cash equivalents at beginning of the year $ 455,731 $ 442,626 Net cash (used in) provided by operating activities (10,712) 26,061 Net cash used in investing activities (16,340) (355,129) Net cash provided by financing activities 12,371 343,881 Net foreign exchange difference on cash held 26,659 (1,708) Cash and cash equivalents at end of the year $ 467,709 $ 455,731 Net cash used in operating activities was $10.7 million for the year ended December 31, 2025, compared to net cash provided by operating activities of $26.1 million for the year ended December 31, 2024.
We have an accumulated deficit of $795.8 million as of December 31, 2024 . 125 Table of Contents Since our inception, we have funded our operations primarily with proceeds from sales of equity securities, product sales, debt financing, and historical payments from collaboration partners .
We have an accumulated deficit of $831.3 million as of December 31, 2025 . 122 Table of Contents Since our inception, we have funded our operations primarily with proceeds from sales of equity securities, revenue from sale of therapies, debt financings, and historical payments from collaboration partners .
Revisions to accounting estimates are recognized in the period in which they become known and are applied prospectively. Expected rebate and chargeback percentage for revenue deductions Since approval of KIMMTRAK in 2022, we have a short history of actual rebate claims or chargebacks, and such information may have limited predictive value.
Expected rebate and chargeback percentage for revenue deductions Since approval of KIMMTRAK in 2022, we have a short history of actual rebate claims or chargebacks, and such information may have limited predictive value.
Income Tax Benefit (Expense) For the year ended December 31, 2024 , the income tax benefit amounted to $1.9 million compared to a benefit of $5.6 million for the year ended December 31, 2023.
Income Tax Benefit (Expense) For the year ended December 31, 2025 , our income tax expense was $16.4 million compared to a benefit of $1.9 million for the year ended December 31, 2024.
Our estimate of these rebates represents the difference between the expected agreed price for the commercial sale of KIMMTRAK in France, which is subject to negotiation, and the initial price of tebentafusp and KIMMTRAK until this price is agreed.
Our estimate of these rebates represented the difference between the expected agreed price for the commercial sale of KIMMTRAK in France, which has historically been subject to negotiation, and the initial price of tebentafusp and KIMMTRAK until we completed price negotiations in France in the first quarter of 2025.
These obligations and potential obligations could result in payments of up to $27.7 million, and are expected to increase as we continue to advance the development of our brenetafusp program in 2024 and beyond.
These obligations and potential obligations could result in payments of up to $19.0 million, and are expected to increase as we continue to advance our pipeline in 2026 and beyond.
As of December 31, 2023, we determined our performance obligation under the collaboration with Genentech was complete. 120 Table of Contents Operating Expenses Cost of revenue from sale of therapies Cost of revenue from sale of therapies represents production costs including raw materials, external manufacturing costs, and other costs incurred in bringing inventories to their location and condition prior to sale.
We have no continuing performance obligations under our historical collaboration agreements. 118 Table of Contents Operating Expenses Cost of revenue from sale of therapies Cost of revenue from sale of therapies represents production costs including raw materials, external manufacturing costs, and other costs incurred in bringing inventories to their location and condition prior to sale.
We recognize net revenue from sale of therapies at the point in time that control transfers to a customer, which is typically on delivery to our distributors and healthcare providers. We also operate under consignment arrangements where control passes when our distributors take KIMMTRAK out of consignment inventory.
Components of Results of Operations Revenue Revenue from sale of therapies, net Revenue from sale of therapies, net relates to the sale of KIMMTRAK following marketing approval. We recognize net revenue from sale of therapies at the point in time that control transfers to a customer, which is typically on delivery to our distributors and healthcare providers.
The at-the-market facility has been registered under the Securities Act pursuant to our Registration Statement on Form S-3ASR (File No. 333-278120) . As of December 31, 2024 , no issuances or sales had been made pursuant to the Sales Agreement. In February 2024, we completed a private offering of $402.5 million aggregate principal amount of the Notes.
The at-the-market facility has been registered under the Securities Act of 1933 as amended, pursuant to our Registration Statement on Form S-3ASR (File No. 333-278120) . As of December 31, 2025 , no issuances or sales have been made pursuant to the Sales Agreement.
We expect to continue to incur significant losses in the foreseeable future and expect our expenses to increase in connection with our ongoing activities, particularly as we continue to commercialize KIMMTRAK in additional territories, continue our research and development programs and the advancement of our product candidates through preclinical and clinical development, and seek regulatory approval and pursue commercialization of any approved product candidates.
The decrease was primarily due to the net cash proceeds of $389.1 million from the offering of the Notes, partially offset by the $52.1 million Pharmakon loan repayment in 2024. 123 Table of Contents Future Capital Requirements We expect to continue to incur significant operating losses in the foreseeable future and expect our expenses to increase in connection with our ongoing activities, particularly as we continue to commercialize KIMMTRAK in additional territories, continue our research and development programs and the advancement of our product candidates through preclinical and clinical development, and seek regulatory approval and pursue commercialization of any approved product candidates.
The amount of revenue recognized reflects the consideration to which we expect to be entitled, net of estimated deductions for rebates, chargebacks and product returns.
We also operate under consignment arrangements where control passes when our distributors take KIMMTRAK out of consignment inventory. The amount of revenue recognized reflects the consideration to which we expect to be entitled, net of estimated deductions for rebates, chargebacks and product returns.
For critical estimates reported at the end of December 31, 2023 where the uncertainty remains unresolved, additional information in the year ended December 31, 2024, resulted in a change in estimate of an additional $18.1 million of net increase to our total accrued revenue deductions as of December 31, 2024.
For critical estimates reported at the end of December 31, 2024 , additional information including completing price negotiations in France and Germany in the year ended December 31, 2025, resulted in a change in estimate of a $6.0 million net decrease to our total accrued revenue deductions as of December 31, 2025.
As of December 31, 2024 and 2023 , we had cash and cash equivalents of $455.7 million and $442.6 million, respectively, and marketable securities of $364.6 million and $0, respectively.
As of December 31, 2025 and 2024 , we had cash and cash equivalents of $467.7 million and $455.7 million, respectively, and marketable securities of $396.4 million and $364.6 million, respectively. Our working capital was $750.0 million as of December 31, 2025 as compared to $717.7 million as of December 31, 2024 .
For the year ended December 31, 2024 , interest expense was $18.8 million compared to $5.2 million for the year ended December 31, 2023 and the increase was primarily related to interest arising on the Notes and the loss on extinguishment of our Pharmakon Loan Agreement of $3.9 million in 2024.
For the year ended December 31, 2025 , interest expense was $12.2 million compared to $18.8 million for the year ended December 31, 2024 and the decrease was primarily related to interest on the Pharmakon Loan which was repaid in November 2024.
Net cash used in investing activities was $355.1 million for the year ended December 31, 2024, compared to $5.4 million for the year ended December 31, 2023.
Net cash used in investing activities was $16.3 million for the year ended December 31, 2025, compared to $355.1 million for the year ended December 31, 2024. The decrease is predominantly due to higher purchases of marketable securities in the year ended December 31, 2024.
Because of the numerous risks and uncertainties associated with research, development and commercialization of pharmaceutical product candidates, we are unable to estimate the exact amount of our working capital requirements.
Given our need for additional financing to support the long-term clinical development of our programs, we intend to consider additional financing opportunities when market terms are favorable to us. 124 Table of Contents Because of the numerous risks and uncertainties associated with research, development and commercialization of pharmaceutical product candidates, we are unable to estimate the exact amount of our working capital requirements.
We are subject to state government Medicaid programs and other qualifying federal and state programs in the United States requiring rebates to be paid to participating state and local government entities, depending on the eligibility and circumstances of patients treated with KIMMTRAK after we have sold vials to specialty distributors.
The proportion of sales subject to a rebate or chargeback is inherently uncertain and estimates are based on internal assumptions, which may change as we develop more product experience, and third-party data, which we assess for reliability and relevance. 127 Table of Contents We are subject to state government Medicaid programs and other qualifying federal and state programs in the United States requiring rebates to be paid to participating state and local government entities, depending on the eligibility and circumstances of patients treated with KIMMTRAK after we have sold vials to specialty distributors.
Comparison of the Years ended December 31, 2024 and 2023 Revenue The following table summarizes our total revenue (in thousands): Year ended December 31, 2024 2023 Increase / (decrease) % Increase / (decrease) Revenue from sale of therapies, net $ 309,989 $ 238,735 $ 71,254 30 % Collaboration revenue 213 10,693 (10,480) (98) % Total revenue $ 310,202 $ 249,428 $ 60,774 24 % Revenue from sale of therapies, net Revenue from sale of therapies, net is presented by country / region based on location of the end customer below (in thousands) : Year ended December 31, 2024 2023 Increase / (decrease) % Increase / (decrease) United States $ 226,687 $ 169,791 $ 56,896 34 % Europe 73,224 67,628 5,596 8 % International 10,078 1,316 8,762 666 % Revenue from sale of therapies, net $ 309,989 $ 238,735 $ 71,254 30 % For the year ended December 31, 2024 , we generated net revenue from sale of therapies of $310.0 million due to the sale of KIMMTRAK, of which $226.7 million was in the United States, $73.2 million in Europe (including the impact of a net increase in estimated reserves related to prior periods of $18.1 million) and $10.1 million in International.
The effective rate of tax for relevant streams of revenue for companies receiving this relief is 10%. 120 Table of Contents Comparison of the Years ended December 31, 2025 and 2024 Revenue The following table summarizes our total revenue (in thousands): Year Ended December 31, 2025 2024 Increase / (decrease) % Increase / (decrease) Revenue from sale of therapies, net $ 400,016 $ 309,989 $ 90,027 29 % Collaboration revenue — 213 (213) (100) % Total revenue $ 400,016 $ 310,202 $ 89,814 29 % Revenue from sale of therapies, net Revenue from sale of therapies, net is presented by country / region based on location of the end customer in the table below (in thousands) : Year Ended December 31, 2025 2024 Increase / (decrease) % Increase / (decrease) United States $ 256,998 $ 226,687 $ 30,311 13 % Europe 131,422 73,224 58,198 79 % International 11,596 10,078 1,518 15 % Revenue from sale of therapies, net $ 400,016 $ 309,989 $ 90,027 29 % For the year ended December 31, 2025 , we generated net revenue from sale of therapies of $400.0 million due to the sale of KIMMTRAK, of which $257.0 million was in the United States, $131.4 million in Europe, including the impact of a net decrease in estimated reserves related to prior periods of $6.0 million, and $11.6 million in International.
R&D tax credit regime introduced restrictions on the tax relief that can be claimed for expenses incurred on subcontracted R&D activities or externally provided workers, where such subcontracted activities are not carried out in the United Kingdom or such workers are not subject to U.K. payroll taxes, subject to limited exceptions.
R&D tax credit regime introduced restrictions on the tax relief that can be claimed for expenses incurred on subcontracted R&D activities or externally provided workers, where such subcontracted activities are not carried out in the United Kingdom or such workers are not subject to U.K. payroll taxes, subject to limited exceptions. 119 Table of Contents Selling, general and administrative expenses Selling, general and administrative ("SG&A") expenses consist primarily of employee-related costs, including salaries and share-based compensation expense, for selling, corporate and other administrative and operational functions including finance, legal, human resources, commercial-related expenses, information technology, as well as a proportion of facility-related costs.
The net cash used in investing activities increased for the year ended December 31, 2024 due to purchases of marketable securities of $350.0 million. 126 Table of Contents Net cash provided by our financing activities during the year ended December 31, 2024 was $343.9 million as compared to $34.3 million for the year ended December 31, 2023.
Net cash provided by our financing activities during the year ended December 31, 2025 was $12.4 million as compared to $343.9 million for the year ended December 31, 2024.
The Notes will accrue interest payable semiannually in arrears on February 1 and August 1 of each year, beginning on August 1, 2024, at a rate of 2.50% per year. On November 8, 2024, we repaid in full the loan outstanding under the Pharmakon Loan Agreement, terminating all obligations.
The Notes are senior, unsecured obligations of the Company and will mature on February 1, 2030, unless earlier converted, redeemed or repurchased. The Notes will accrue interest payable semiannually in arrears on February 1 and August 1 of each year, beginning on August 1, 2024, at a rate of 2.50% per year.
The Notes will accrue interest payable semiannually in arrears on February 1 and August 1 of each year, beginning on August 1, 2024, at a rate of 2.50% per year. Part of the proceeds were used to repay in full loans outstanding under our loan agreement with Pharmakon (the “Pharmakon Loan Agreement”).
The Notes will accrue interest payable semiannually in arrears on February 1 and August 1 of each year, beginning on August 1, 2024, at a rate of 2.50% per year. See Note 7. “Interest-bearing loans and borrowings” of the notes to our consolidated financial statements in Part IV of this Annual Report for further information.
We have based this estimate on assumptions that may prove to be wrong, and we could use our capital resources sooner than we expect. Given our need for additional financing to support the long-term clinical development of our programs, we intend to consider additional financing opportunities when market terms are favorable to us.
We have based this estimate on assumptions that may prove to be wrong, and we could use our capital resources sooner than we expect.
In addition, there was an increase in the number of employees in business support functions to support our growing pipeline and global commercial expansion. Other administrative expenses increased by $2.0 million in the year ended December 31, 2024, due primarily to higher information technology and facilities costs.
SG&A Expenses For the year ended December 31, 2025 , our SG&A expenses were $165.4 million, compared to $155.8 million for the year ended December 31, 2024 , an increase of $9.6 million. The increase was primarily due to costs related to commercial and business support functions to support our growing pipeline and global commercial expansion.
This was primarily due to an increase of $5.5 million in salaries and other employee-related costs as our average number of employees and associated personnel costs increased with the growth of our clinical and preclinical programs, and an increase of $2.3 million in other internal R&D costs related to higher information technology and facilities costs.
For the year ended December 31, 2025 , our internal R&D expenses increased by $15.1 million primarily due to an increase in salaries and employee-related expenses and other internal R&D costs following the growth of our clinical and preclinical programs.
A deferred tax asset is, however, recognized in respect of the subsidiary in the United States, relating to unused tax credits on share-based compensation expense and other temporary differences on the basis that we expect to continue generating U.S. taxable income against which deductible temporary differences can unwind. 122 Table of Contents As we begin to generate significant net revenue from sale of therapies, we may benefit from the U.K.’s “patent box” regime, which allows profits attributable to revenues from patents or patented products to be taxed at a lower rate than other revenue.
As we generate significant net revenue from sale of therapies, we are able to benefit from the U.K.’s “patent box” regime, which allows profits attributable to revenues from patents or patented products to be taxed at a lower rate than other revenue.
Interest Income and Interest Expense For the year ended December 31, 2024 , interest income was $25.6 million compared to $18.0 million for the year ended December 31, 2023 .
Other Income (Expense), Net For the year ended December 31, 2025, other income, net was $19.7 million compared to other income, net of $14.2 million for the year ended December 31, 2024.
R&D tax credits (9,606) (6,289) (3,317) 53 % Total internal R&D expenses 70,199 64,434 5,765 9 % Total R&D expenses $ 222,151 $ 163,545 $ 58,606 36 % For the year ended December 31, 2024 , our R&D expenses were $222.2 million, as compared to $163.5 million for the year ended December 31, 2023 .
R&D tax credits (7,210) (9,606) 2,396 (25) % Total internal R&D expenses 85,285 70,199 15,086 21 % Total R&D expenses $ 274,869 $ 222,151 $ 52,718 24 % 121 Table of Contents For the year ended December 31, 2025 , our R&D expenses were $274.9 million, as compared to $222.2 million for the year ended December 31, 2024 .
Our net proceeds from the offering of the Notes were $389.1 million , after deducting the initial purchasers’ discounts and commissions and the offering expenses. The Notes are senior, unsecured obligations of the Company and will mature on February 1, 2030, unless earlier converted, redeemed or repurchased.
In February 2024, we completed a private offering of $402.5 million aggregate principal amount of the Notes. Our net proceeds from the offering of the Notes were $389.1 million , after deducting the initial purchasers’ discounts and commissions and the offering expenses.
Other Income (Expense), Net For the year ended December 31, 2024, other income, net was $14.2 million compared to other expense, net of $0.9 million for the year ended December 31, 2023. The change is primarily related to the unrealized gains resulting from the change in fair value of our marketable securities, which were purchased in 2024.
The increase was primarily related to income on our marketable securities purchased in the second quarter of 2024, including the unrealized gains resulting from the change in fair value, partially offset by lower unrealized gains due to less favorable interest rate movement in the year ended December 31, 2025.
Cost of revenue from sale of therapies may also include costs related to manufacturing losses and excess or obsolete inventory costs. Overheads and internal costs of revenue from sale of therapies are minimal under our manufacturing arrangements.
Cost of revenue from sale of therapies may also include costs related to manufacturing losses and excess or obsolete inventory costs. For example, in June 2025, we initiated a global recall for one batch of KIMMTRAK (tebentafusp) relating to an unexpected result in routine stability testing.
R&D expenses incurred for our tebentafusp programs increased by $15.1 million primarily due to the progression of the advanced cutaneous melanoma ("TEBE-AM") and ATOM Phase 3 clinical trials. For the year ended December 31, 2024 , our internal R&D expenses increased by $5.8 million.
In addition, R&D expenses incurred for our tebentafusp programs increased by $9.7 million as a result of continued advancement of the TEBE-AM and ATOM Phase 3 trials, and purchases of drug consumables.
Removed
If we fail to become profitable or are unable to sustain profitability on a continuing basis, then we may be unable to continue our operations at planned levels and may be forced to reduce our operations. 119 Table of Contents Recent Developments In December 2024 we: • randomized the first patient in the ATOM Phase 3 clinical trial – led by the EORTC to evaluate KIMMTRAK as adjuvant therapy for uveal (or ocular) melanoma for HLA-A*02:01 patients; • started enrolling patients in the Phase 1/2 dose escalation trial with IMC-P115C (PRAME-A02-HLE) in multiple solid tumors; • started enrolling patients in the Phase 1/2 trial with IMC-R117C (targeting PIWIL1) in HLA-A*02:01-positive patients with advanced solid tumors, including colorectal cancer.
Added
If we fail to become profitable or are unable to sustain profitability on a continuing basis, then we may be unable to continue our operations at planned levels and may be forced to reduce our operations. 117 Table of Contents Recent Developments In November 2025, we presented data at The Liver Meeting 2025, organized by the American Association for the Study of Liver Diseases, showing that IMC-I109V is generally well tolerated in all evaluated doses and exhibits pharmacodynamic effects consistent with its mechanism of action, including reduction in HBsAg levels, clearance of which is indicative of resolved hepatitis B infection.

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Item 7A. Quantitative and Qualitative Disclosures About Market Risk

Market Risk — interest-rate, FX, commodity exposure

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Biggest changeOur exposure to credit losses is low, however, owing largely to the credit quality of our distributors, collaboration partners, and other customers, the significant majority of which are considerably larger than us. We continually monitor our positions with, and the credit quality of, the financial institutions and corporations, which are counterparts to our financial instruments and do not anticipate non-performance.
Biggest changeWe are also potentially subject to concentrations of credit risk in our accounts receivable with respect to amounts owed by a limited number of entities comprising our customer base. Our exposure to credit losses is low, however, owing largely to the credit quality of our distributors, and other customers, the significant majority of which are considerably larger than us.
A five percentage point increase in exchange rates would reduce the carrying value of net financial assets and liabilities held in foreign currencies as of December 31, 2024 by $6.5 million and as of December 31, 2023 by $6.0 million.
A five percentage point increase in exchange rates would reduce the carrying value of net financial assets and liabilities held in foreign currencies as of December 31, 2025 by $6.5 million and as of December 31, 2024 by $6.0 million.
Changes in exchange rates had an impact on U.S. dollar balances held by our main operating subsidiary in the U.K., which resulted in foreign exchange gains and losses in the Consolidated Statements of Operations and Comprehensive Loss due to the appreciation and depreciation of the subsidiary’s U.S. dollars in pounds sterling terms.
Changes in exchange rates had an impact on U.S. dollar cash and cash equivalents balances held by our main operating subsidiary in the United Kingdom, which resulted in foreign exchange gains and losses in the Consolidated Statements of Operations and Comprehensive Loss due to the appreciation and depreciation of the subsidiary’s U.S. dollars in pounds sterling terms.
We minimize foreign currency risk by maintaining cash and cash equivalents of each currency at levels sufficient to meet foreseeable expenditure to the extent practical. Our cash and cash equivalents were $455.7 million and $442.6 million as of December 31, 2024 and 2023, respectively.
We minimize foreign currency risk by maintaining cash and cash equivalents of each currency at levels sufficient to meet foreseeable expenditure to the extent practical. Our cash and cash equivalents were $467.7 million and $455.7 million as of December 31, 2025 and 2024, respectively.
As of December 31, 2024, 86% of our cash and cash equivalents were held by our U.K. subsidiary, of which 52% were denominated in U.S. dollars, 34% were denominated in pounds sterling and 14% were denominated in euros. All of our marketable securities were held in our U.K. parent company and were denominated in U.S. dollars.
As of December 31, 2025, 81% of our cash and cash equivalents were held by our U.K. operating subsidiary, of which 46% were denominated in U.S. dollars, 41% were denominated in pounds sterling and 13% were denominated in euros. All of our marketable securities were held by our U.K. parent company and were denominated in U.S. dollars.
Issuance costs and lender fees totaling $13.4 million are being amortized as interest expense at an effective rate of 3.06% over the life of the Notes. Given the fixed interest rate, the Company is not subject to interest rate risk with respect to these Notes.
The Notes accrue interest payable semiannually at a fixed rate of 2.50% per annum, commencing August 1, 2024. Issuance costs totaling $13.4 million are being amortized as interest expense at an effective rate of 3.06% over the life of the Notes. Given the fixed interest rate, the Company is not subject to interest rate risk with respect to these Notes.
A five percentage point decrease in exchange rates would increase the carrying value of net financial assets and liabilities held in foreign currencies at December 31, 2024 by $6.5 million and as of December 31, 2023 by $6.0 million. 132 Table of Contents Credit Risk We are exposed to credit risk from our operating activities, primarily accounts receivable, cash and cash equivalents, and marketable securities held with banks and financial institutions.
A five percentage point decrease in exchange rates would increase the carrying value of net financial assets and liabilities held in foreign currencies at December 31, 2025 by $6.5 million and as of December 31, 2024 by $6.0 million.
Interest Rate Risk Our exposure to changes in interest rates relates to investments in deposits and to changes in the interest for overnight deposits. Changes in the general level of interest rates may lead to an increase or decrease in the fair value of these investments.
Interest Rate Risk Our exposure to changes in interest rates relates to investments in deposits and to changes in the interest for overnight deposits and marketable securities.
The maximum default risk corresponds to the carrying amount of the financial assets shown in the Consolidated Balance Sheets. We monitor the risk of a liquidity shortage. The main factors we consider are the maturities of financial assets as well as expected cash flows from equity measures.
The main factors we consider are the maturities of financial assets as well as expected cash flows from equity measures.
Cash and cash equivalents and marketable securities are maintained with high-quality financial institutions in the United Kingdom and United States. We are also potentially subject to concentrations of credit risk in our accounts receivable with respect to amounts owed by a limited number of entities comprising our customer base.
Credit Risk We are exposed to credit risk from our operating activities, primarily accounts receivable, cash and cash equivalents, and marketable securities held with banks and financial institutions. Cash and cash equivalents and marketable securities are maintained with high-quality financial institutions in the United Kingdom and United States.
In February 2024, we completed a private offering of $402.5 million aggregate principal amount of convertible senior notes (the "Notes"), which mature on February 1, 2030, unless earlier converted, redeemed, or repurchased. The Notes accrue interest payable semiannually at a fixed rate of 2.50% per annum, commencing August 1, 2024.
Changes in the general level of interest rates may lead to an increase or decrease in the fair value of these investments. 128 Table of Contents In February 2024, we completed a private offering of $402.5 million aggregate principal amount of the Notes, which mature on February 1, 2030, unless earlier converted, redeemed, or repurchased.
The significant remainder of our cash and cash equivalents are held in the United States and denominated in U.S. dollars.
The remainder of our cash and cash equivalents are held across our other subsidiaries and denominated in a mix of operating currencies.
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We continually monitor our positions with, and the credit quality of, the financial institutions and corporations, which are counterparts to our financial instruments and do not anticipate non-performance. The maximum default risk corresponds to the carrying amount of the financial assets shown in the Consolidated Balance Sheets. We monitor the risk of a liquidity shortage.