IMCR 10-K & 10-Q changes, risk factors and insider trading
Immunocore Holdings plc · Nasdaq · Biological Products, (No Diagnostic Substances) · CIK 1671927 · All filings on SEC.gov
At a glance
What changed in the latest 10-K
Risk Factors
Removed heading “Health epidemics or pandemics could materially adversely impact our business, including the commercialization of KIMMTRAK, our supply chain, our pre-clinical studies and our clinical trials, our liquidity and access to capital markets and our business development activities, as well as the business or operations of our CROs or other third parties with whom we conduct business.”
Removed heading “Changes in U.S. patent law or the patent law of other countries or jurisdictions could diminish the value of patents in general, thereby impairing our ability to protect our product candidates.”
Removed heading “If a United States person is treated as owning at least 10% of our ordinary shares or ADSs, such holder may be subject to adverse U.S. federal income tax consequences.”
Largest changes
“The U.S. Department of Justice issued a rule entitled the Preventing Access to U.S. Sensitive Personal Data and Government-Related Data by Countries of Concern or Covered Persons, which places additional restriction on certain data transactions involving countries of concern (e.g., China, Russia, Iran) and covered persons (i.e., individuals and entities who are designated as such by the U.S. …”see in full comparison
“For example, in July 2025, the United States and the European Union announced a bilateral framework on tariffs and trade, which was further detailed in a joint statement on August 21, 2025. Under this framework, the United States committed to an all inclusive ceiling of 15% on most tariffs applied to goods originating from the European Union, including pharmaceuticals. These proposed tariffs under the framework are subject to ongoing negotiations, European Parliament and Member State approval, as well as further review and implementation by the U.S. government. …”see in full comparison
“Health epidemics or pandemics could materially adversely impact our business, including the commercialization of KIMMTRAK, our supply chain, our pre-clinical studies and our clinical trials, our liquidity and access to capital markets and our business development activities, as well as the business or operations of our CROs or other third parties with whom we conduct business.”see in full comparison
“In addition, on December 11, 2025, the European Commission, the Parliament and the European Council reached a political agreement on a comprehensive overhaul of EU pharmaceutical legislation (the “Pharma Package”). The reform has been under negotiation since the European Commission submitted its proposal in April 2023. This package - comprised of a new directive and regulation to replace existing legislation – aims to modernize the EU framework. The Pharma Package is still subject to formal approval by the European Parliament and Council. …”see in full comparison
“In addition, on April 26, 2023, the European Commission adopted a proposal for a new Directive and Regulation to revise the existing pharmaceutical legislation. The proposed revisions remain to be agreed and adopted by the European Council. Moreover, on December 1, 2024, a new European Commission took office. The proposal could, therefore, still be subject to revisions. …”see in full comparison
“The U.S. Supreme Court has ruled on several patent cases in recent years with potential impact on the scope of patent protection and patent eligibility, depending on the types of claims being pursued, as well as on the ability of patent owners to defend and challenge patents. This may result in greater uncertainty with respect to obtaining and ascribing value to patents. Depending on actions by the U.S. …”see in full comparison
Full comparison: every changed paragraph (112)
We have incurred significant losses in every year since our inception. We expect tomay continue to incur losses over the next several years and may never achieve or maintain profitability.
We are focusing a significant portion of our commercial activities and resources on KIMMTRAK, and we believe our ability to grow our long-term revenues, and a significant portion of the value of our company, relates to our ability to successfully commercialize KIMMTRAK in the United States and Europe. While we have established commercial teams, weWe expect to develop theseour commercial teams further and otherwiseto 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. For example, the mUM patient population could be lower than estimated, patient and physician acceptance and adoption of KIMMTRAK could change, and physicians’ willingness to prescribe or patients’ willingness to take KIMMTRAK could change, each of which could limit the commercial potential of KIMMTRAK. Thus, there is uncertainty regarding the full commercial potential of KIMMTRAK. If the continued commercialization of KIMMTRAK became less successful or was perceived as disappointing, the price of our ADSs could decline significantly and long-term success of the medicine and our company could be harmed.
As of December 31, 2024,2025, we had working capital (defined as total current assets less total current liabilities) of $717.7$750.0 million andmillion, cash and cash equivalents of $455.7$467.7 million, and marketable securities of $364.6$396.4 million. We expect that our existing cash and cash equivalents with the inclusion of expected revenue for KIMMTRAK will provide sufficient funds to continue to meet our liabilities as they fall due and for at least 12 months from the issuance of our Annual Report. However, it is possible that our revenue may be lower than our estimates, that our costs will be higher than expected, that our operating plan may change as a result of many factors currently unknown to us, and that we may need to seek additional funds sooner than planned, through public or private equity or debt financings or other sources, such as strategic collaborations or license and development agreements. In addition, we may seek additional capital due to favorable market conditions or strategic considerations, even if we believe we have sufficient funds for our current or future operating plans. Any additional fundraising efforts for us may divert our management from their day-to-day activities, which may adversely affect our ability to develop and commercialize product candidates that we may identify and pursue. Moreover, such financing may result in dilution to our shareholders, imposition of debt covenants and repayment obligations, or other restrictions that may affect our business. Our future funding requirements will depend on many factors, including, but not limited to:
Any additional fundraising efforts for us may divert our management from their day-to-day activities, which may adversely affect our ability to develop and commercialize product candidates that we may identify and pursue. Moreover, such financing may result in dilution to our shareholders, imposition of debt covenants and repayment obligations, or other restrictions that may affect our business. Our future funding requirements will depend on many factors, including, but not limited to:
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. The number of patients with cancers, solid tumors, HIV, and chronic HBV and test positive for HLA-A*02:01 may turn out to be lower than expected, patients may not be otherwise amenable to treatment with our products, or new patients may become increasingly difficult to identify or gain access to, all of which would adversely affect our results of operations and our business. We may not be successful in our efforts to identify additional product candidates. Due to our limited resources and access to capital, we must prioritize development of certain product candidates, which may prove to be the wrong choice and may adversely affect our business prospects. These and other factors may limit the estimated opportunities size of our products and product candidates. If the market opportunities for our product candidates are smaller than we estimate, our revenue and ability to achieve profitability will be adversely affected, possibly materially.
We are heavily dependent on the success of our ImmTAX platform technology, KIMMTRAK and the product candidates currently in our core programs. Our ImmTAC, ImmTAV and ImmTAAI platforms were developed from the foundation of our ImmTAX platform and are our primary platform technologies. Our commercial prospects will be heavily dependent on product candidates identified and developed using our ImmTAX platform. 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,trials and commercialization of KIMMTRAK that emerged from the ImmTAX platform and providing general and administrative support for these operations.
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.
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 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.KIMMTRAK and our product candidates. 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. There can be no assurance that the capabilities of the Syneos sales organization or other third parties will be more effective than an internally developed sales organization. In addition, Syneos can terminate our agreement under certain circumstances. If Syneos or other third parties fail to hire, train, and retain qualified sales personnel, market our product successfully or on a cost-effective basis or otherwise terminates our relationship, our ability to generate revenue will be limited and we will need to identify and retain an alternative organization or develop our own sales and marketing capability. This could involve significant delays and costs, including the diversion of our management’s attention from other activities. We may also need to retain additional consultants or external service providers to assist us in sales, marketing and distribution functions, and may be unsuccessful in retaining such services on acceptable financial terms or at all.
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. In addition, we may not be successful in entering into arrangements with third parties to sell and market our product candidates or may be unable to do so on terms that are favorable to us. We likely will have little control over such third parties and any of them may fail to devote the necessary resources and attention to sell and market our product candidates effectively. If we do not establish sales and marketing capabilities successfully, either on our own or in collaboration with third parties, we may not be successful in commercializing our product candidates.
Health epidemics or pandemics could materially adversely impact our business, including the commercialization of KIMMTRAK, our supply chain, our pre-clinical studies and our clinical trials, our liquidity and access to capital markets and our business development activities, as well as the business or operations of our CROs or other third parties with whom we conduct business.
Our business could be adversely affected by health epidemics or pandemics in regions where we have concentrations of clinical trial sites or other business operations, and could cause significant disruption in the operations of third-party manufacturers and CROs upon whom we rely.
Public health directives and executive orders in response to potential future health epidemics or pandemics may negatively impact productivity, disrupt our business and delay our clinical programs and timelines, the magnitude of which will depend, in part, on the length and severity of the restrictions and other limitations on our ability to conduct our business in the ordinary course. These and similar, and perhaps more severe, disruptions in our operations could negatively impact our business, operating results and financial condition.
Quarantines, shelter-in-place and similar government orders, shutdowns or other restrictions on the conduct of business operations have occurred and could occur in the future, and could impact personnel at third-party manufacturing facilities, or the availability or cost of materials, which would disrupt our supply chain.
The effects of future health epidemics or pandemics may also negatively impact our clinical trials and the operations or our CROs or CMOs in the future, including:
•delays or difficulties in enrolling and retaining patients in our clinical trials, including patients that may not be able or willing to comply with clinical trial protocols such as weekly dosing regimens if quarantines impede patient movement or interrupt healthcare services;
•delays or difficulties in clinical site initiation, including difficulties in recruiting and retaining clinical site investigators and clinical site staff;
•increased rates of patients withdrawing from our clinical trials following enrollment, as a result of risks of exposure to disease, being forced to quarantine or being unable to visit clinical trial locations or otherwise comply with clinical trial protocols;
•diversion or prioritization of healthcare resources away from the conduct of clinical trials and towards the epidemic or pandemic, including the diversion of hospitals serving as our clinical trial sites and hospital staff supporting the conduct of our clinical trials, including because they, as healthcare providers, may have heightened exposure to disease, which would adversely impact our clinical trial operations;
•interruption of our clinical supply chain or key clinical trial activities, such as clinical trial site monitoring, due to limitations on travel imposed or recommended by federal, state/provincial or municipal governments, employers and others; and
•limitations in employee resources that would otherwise be focused on the conduct of our clinical trials, including because of sickness of employees or their families or the desire of employees to avoid contact with large groups of people.
For our clinical trials that we expect to conduct at sites outside the United States, particularly in countries which in the future could experience heightened impact future pandemics, in addition to the risks listed above, we may also experience the following adverse impacts:
•delays in receiving approval from local regulatory authorities to initiate our planned clinical trials;
•delays in clinical sites receiving the supplies and materials needed to conduct our clinical trials;
•interruption in global shipping that may affect the transport of clinical trial materials, such as investigational drug product and comparator drugs used in our clinical trials;
•changes in supranational, national, federal, state/provincial or municipal regulations as part of a response to outbreak of disease which may require us to change the ways in which our clinical trials are conducted, which may result in unexpected costs, or to discontinue the clinical trials altogether;
•delays in necessary interactions with local regulators, ethics committees and other important agencies and contractors due to limitations in employee resources or forced furlough of government employees; and
•the refusal of the FDA or comparable foreign regulatory authorities to accept data from clinical trials in these affected geographies.
Epidemics or pandemics may in the future, impact our business and clinical trials, and such impact will depend on future developments, which are highly uncertain and cannot be predicted with confidence, such as the duration of the outbreak, the emergence, infectiousness and severity of new variants, travel restrictions and social distancing, business closures or business disruptions and the effectiveness of actions taken in the United Kingdom, United States, and other countries to contain and treat the disease. The ultimate impact potential epidemics is highly uncertain and subject to change.
OurKIMMTRAK products,and our other product candidates, even if approved for commercial sale, may fail to achieve the degree of market acceptance by physicians, patients, third-party payors and others in the medical community necessary for continued commercial success.
OurKIMMTRAK products,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. 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 product candidatesmedicines are approved;
•physicians, hospitals, cancer treatment centers, and patients considering our product candidatesmedicines as a safe and effective treatment;
•hospitals and cancer treatment centers establishing the infrastructure required for the administration of the product candidatemedicine;
•the potential and perceived advantages of our product candidatesmedicines over alternative treatments;
•limitations or warnings contained in the labeling approved by the FDA or the European Commission ;
•the timing of market introduction of our product candidatesmedicines compared to competitive products;
•the amount of upfront costs or training required for physicians to administer our product candidatesmedicines;
Our efforts to educate physicians, patients, third-party payors and others in the medical community on the benefits of our products, if approved, may require significant resources and may never be successful. Such efforts may require more resources than are typically required due to the complexity and uniqueness of our product candidates. Even if our products achieve market acceptance, we may not be able to maintain that market acceptance over time, including if new products or technologies are introduced that are more favorably received than our products, are more cost effective or render our products obsolete. 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 candidatesmedicines to find or maintain market acceptance would harm our business and could require us to seek additional financing.
We may be unable to successfully complete additional large-scale, pivotal clinical trials for any product candidates we develop after KIMMTRAK in mUM.develop.
We may be unable to successfully complete additional large-scale, pivotal clinical trials for any product candidates we develop after KIMMTRAK in mUM.develop. We cannot be sure that issues will not arise that require us to suspend or terminate our clinical trials. Guidance we have received from the FDA or other regulatory authorities on clinical trial design is subject to change. These regulatory authorities could change their position, including, on the acceptability of our trial designs or the clinical endpoints selected, which may require us to complete additional clinical trials or impose stricter approval conditions than we currently expect. Successful completion of our clinical trials is a prerequisite to submitting a BLA to the FDA and a MAA to the EMA, for each product candidate and, consequently, the ultimate approval and commercial marketing of each product candidate. We do not know whether any of our future clinical trials will begin on time or ever be completed on schedule, if at all.
While we plan to pursue additional regulatory approvals, it is uncertain whether tebentafuspwe will receive further marketing approval for tebentafusp beyond the approval whichwe have received for KIMMTRAK hasfor receivedmUM in the United States, the EU, Canada and certain other territories. Furthermore,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-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. Before obtaining marketing approval from regulatory authorities for the sale of any product candidate, we must complete pre-clinical studies and then conduct extensive clinical trials to demonstrate the safety and efficacy of our product candidates in humans. Clinical testing is expensive, difficult to design and implement, can take many years to complete and is uncertain as to outcome. A failure of one or more clinical trials can occur at any stage of testing. The outcome of pre-clinical development testing and early clinical trials may not be predictive of the success of later clinical trials, and interim results of a clinical trial do not necessarily predict final results. Moreover, pre-clinical and clinical data are often susceptible to varying interpretations and analyses, and many companies that have believed their product candidates performed satisfactorily in pre-clinical studies and clinical trials have nonetheless failed to obtain marketing approval of their product candidates. Our pre-clinical studies and future clinical trials may not be successful. From time to time, we may publish interim top-line or preliminary data from our clinical trials. Interim data from clinical trials are subject to the risk that one or more of the clinical outcomes may materially change as patient enrollment continues and more patient data become available. Preliminary or top-line data also remain subject to audit and verification procedures that may result in the final data being materially different from the preliminary data we previously published. As a result, interim and preliminary data should be viewed with caution until the final data are available. Adverse differences between preliminary or interim data and final data could significantly harm our business prospects.
Our product candidates and the activities associated with their development and commercialization, including their design, testing, manufacture, safety, efficacy, recordkeeping, labeling, storage, approval, advertising, promotion, sale, distribution, import and export are subject to comprehensive regulation by the FDA and other regulatory authorities in the United States and by comparable authorities in the EU and other territories. 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.KIMMTRAK for mUM. It is possible that our product candidates, including any product candidates we may seek to develop in the future, will never obtain regulatory approval. We have only limited experience in filing and supporting the applications necessary to gain regulatory approvals and expect to rely on third-party CROs and/or regulatory consultants to assist us in this process. SecuringObtaining 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. SecuringObtaining regulatory approval also requires the submission of information about the product manufacturing process to, and inspection of manufacturing facilities by, the relevant regulatory authority. Our product candidates may not be effective, may be only moderately effective or may prove to have undesirable or unintended side effects, toxicities or other characteristics that may preclude our obtaining marketing approval or prevent or limit commercial use. In addition, regulatory authorities may find fault with our manufacturing process or facilities or that of third-party contract manufacturers. We may also face greater than expected difficulty in manufacturing our product candidates.
Because we have limited resources and access to capital to fund our operations, we must decide which product candidates to pursue and the amount of resources to allocate to each. Our decisions concerning the allocation of research, collaboration, management and financial resources toward particular proprietary molecules in our library, product candidates or therapeutic areas are subject to change over time, and these decisions may not lead to the development of viable commercial products and may divert resources away from better opportunities. For example, in 2025 we decided to pause our IMC-T119C (PRAME-A24) program. Similarly, our decisions to delay, terminate or collaborate with third parties in respect of certain product development programs may also prove not to be optimal and could cause us to miss valuable opportunities. 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.
Our TCR bispecific product candidates that have been produced and are stored for later use may degrade, become contaminated or suffer other quality defects, which may cause the affected product candidates to no longer be suitable for their intended use in clinical trials or other development activities. If the defective product candidates cannot be replaced in a timely fashion, we may incur significant delays in our development programs that could adversely affect the value of such product candidates. 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. As of the date of this Annual Report, based on all available data to date, we do not expect there will be a material impact on the supply of KIMMTRAK or our financial statements.
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, Adaptive, pure MHC, LLC, BioNTech SE, Genentech, Matterhorn Biosciences AG, Enara Bio Limited, and Boehringer Ingelheim International GmbH, and Regeneron, who are also seeking to identify peptide HLA targets and develop product candidates; Immatics, Anocca AB, T-Knife GmbH, Adaptive, 3T Biosciences, Inc., MediGene AG,Inc, Regeneron, Takara Bio Inc., BMS,AstraZeneca GSK plc, Kite Pharma , Inc.,PLC, Lion TCR Pte. Ltd., TCRCure Biopharma Ltd., Corregene Biotechnology Co. LTD, and TScan who are developing TCR-based cell therapies; and F. Hoffmann-La Roche Ltd, Amgen, Inc., Genmab, Inc.,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.
In August 2023, Delcath Systems, Inc. announced the approval and U.S. launch of HEPZATO KIT, a liver directed therapy that delivers a high dose of melphalan to the liver via percutaneous hepatic perfusion. This system is marketed in the European Union as a CE Marked medical device under the trade name Delcath Hepatic CHEMOSAT® Delivery System for Melphalan (CHEMOSAT). We are aware of several other companies with product candidates in clinical development, including an anticipated readout from Ideaya Biosciences’ first-line non-HLA-A2HLA-A*02:01 negative mUM registrational Phase 2/3 clinical trial in 2025.2026. We are also aware of various companies initiatingconducting registrational Phase 3 clinical trials in uveal melanoma ("UM"), including Ideaya Biosciences, Inc.’s initiation of a registrational Phase 3 clinical trial in high-risk neoadjuvant UM, and Replimune Group, Inc.’sInc. initiation of a registrationregistrational Phase 2/3 clinical trial in immune-checkpoint naïve UM, both anticipated in 2025.UM.
We anticipate that we will continue to face intense and increasing competition as new treatments enter the market and advanced technologies become available. There can be no assurance that our competitors are not currently developing, or will not in the future develop, products that are equally or more effective or are more economically attractive than any of our current or future product candidates. Competing products may gain faster or greater market acceptance than our products, if any, and medical advances or rapid technological development by competitorscompetitors, 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. If we or our product candidates do not compete effectively, it may have a material adverse effect on our business, financial condition and results of operations.
In addition, recently there has been heightened governmental scrutiny over the manner in which manufacturers set prices for their marketed products, which has resulted in several U.S. Congressional inquiries and proposed and enacted federal and state legislation designed to, among other things, bring more transparency to drug pricing, reduce the cost of prescription drugs under government payor programs, and review the relationship between pricing and manufacturer patient programs. For example, the Inflation Reduction Act (IRA) among other things, (1) requires the U.S. Department of Health and Human Services (HHS) to negotiate the price of certain single-source biologics that have been on the market for at least 11 years covered under Medicare as part of 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 on an annual basis. Each year up to twenty (20) products will be selected by HHS for the Medicare Drug Price Negotiation Program. Products subject to the Medicare Drug Price Negotiation Program are expected to experience a significant reduction in reimbursement from the Medicare program on a per unit basis.
On January 12, 2025, the HTA Regulation entered into application through a phased implementation. It is intended to increase cooperation among EU Member States in assessing health technologies, including new medicinal products, by establishing a framework for joint clinical assessments, joint scientific consultations, and the early identification of emerging health technologies. The Regulation permits Member States to use common tools, methodologies, and procedures and requires them to rely on EU‑level joint clinical assessment reports for the clinical components of their national HTA evaluations. Member States, however, remain responsible for assessing non‑clinical aspects, such as economic, ethical, and social considerations, and for making pricing and reimbursement decisions at the national level. As implementation of the HTA Regulation is phased in and key methodological and procedural guidance continues to evolve, there remains uncertainty regarding the evidence requirements, timing, and impact of joint clinical assessments on national reimbursement processes. The new framework may result in additional or differently structured evidentiary expectations, misalignment between assessment and regulatory timelines, or delays in national decisions. If we are unable to maintain favorable pricing and reimbursement status in Member States for product candidates that we may successfully develop and for which we may obtain regulatory approval, any anticipated revenue from and growth prospects for those products in the EU could be negatively affected.
In December 2021, Regulation No 2021/2282 on HTA amending Directive 2011/24/EU, was adopted in the European Union. This Regulation, which entered into force in January 2022 and applies as of January 12, 2025, is intended to boost cooperation among EU Member States in assessing health technologies, including new medicinal products, and providing the basis for cooperation at the level of the European Union for joint clinical assessments in these areas. The Regulation permits Member States to use common HTA tools, methodologies, and procedures across the European Union, working together in four main areas, including joint clinical assessment of the innovative health technologies with the most potential impact for patients, joint scientific consultations whereby developers can seek advice from HTA authorities, identification of emerging health technologies to identify promising technologies early, and continuing voluntary cooperation in other areas. Individual Member States continue to be responsible for assessing non-clinical (e.g., economic, social, ethical) aspects of health technologies, and making decisions on pricing and reimbursement. If we are unable to maintain favorable pricing and reimbursement status in Member States for product candidates that we may successfully develop and for which we may obtain regulatory approval, any anticipated revenue from and growth prospects for those products in the EU could be negatively affected. In light of the fact that the United Kingdom has left the European Union, Regulation No 2021/2282 on HTA does not apply in the United Kingdom. However, the MHRA is working with UK HTA bodies and other national organizations, such as the SMC, the NICE, and the All-Wales Medicines Strategy Group, to introduce new pathways supporting innovative approaches to the safe, timely and efficient development of medicinal products.
For example, we must enter into pricing agreements with individual Member States in order to be reimbursed for KIMMTRAK in such Member States. For Germany, we had entered into a pricing agreement,agreement whichwith isthe subjectGerman to certain conditions,government for KIMMTRAKKIMMTRAK. that was published in September 2023. BecauseAs the sales of KIMMTRAK exceeded the orphan drug threshold (€30 million) in Germany in 2023, German law requiresrequired a new benefit assessment and renegotiation of the price. The outcome of the benefit assessment remained unchanged; the Federal Joint Committee (G-BA) granted KIMMTRAK a Considerable Added BenefitBenefit, (publishedand Maywe 16,negotiated 2024).and Priceentered negotiationsinto a new pricing agreement with Germany in 2025. In 2025, we also entered into a pricing agreement with France regarding retrospective and future pricing of KIMMTRAK, however we are ongoingdisputing one element of the agreement related to certain prior periods. We are also negotiating pricing agreements with other Member States, and we cannot guarantee that the price of KIMMTRAK will not change in Germany.certain Simultaneouslycountries within the renegotiation of pricing agreements in Germany, we are negotiating pricing agreements with other Member States, including France.future. Limitations on our ability to price KIMMTRAK, or our future product candidates, if approved, may have a significant impact on our results of operations.
We have relatively limited capabilities for drug development and have limited experience of carrying out sales, marketing and distribution activities for KIMMTRAK. We have previously entered into collaborations with other companies that we believe can provide similar capabilities. These collaborations provided us with important funding for our development programs and technology platforms, and we could receive additional funding if we enter into further collaborations in the future. In addition, we have entered and may enter in the future into collaboration agreements whereby we investigate the therapeutic benefit of our own products or product candidates in combination with a product or product candidate of a third party. For example, in February 2024, we entered into a clinical trial collaboration and supply agreement with Bristol-Myers Squibb ("BMS"),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. Any future collaborations we enter into, may pose a number of risks, including the following:
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. If these CROs and other third parties do not successfully carry out their contractual duties, comply with regulatory requirements or meet expected deadlines, we may not be able to obtain regulatory approval for or commercialize our product candidates and our business could be substantially harmed.
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 clinical trial ofwith IMC-I109VIMC-R117C in peoplecolorectal who live with HBV.cancer. We may also rely on academic and private non-academic institutions to conduct and sponsor clinical trials relating to our product candidates. We will not control the design or conduct of the investigator-sponsored trials, and it is possible that the FDA or non-U.S. regulatory authorities will not view these investigator-sponsored trials as providing adequate support for future clinical trials, whether controlled by us or third parties, for any one or more reasons, including elements of the design or execution of the trials or safety concerns or other trial results.
In addition, any future collaborations that we enter into may not be successful. The success of our collaboration arrangements will depend heavily on the efforts and activities of our collaborators. Collaborators generally have significant discretion in determining the efforts and resources that they will apply to these collaborations. Disagreements between parties to a collaboration arrangement regarding clinical development and commercialization matters can lead to delays in the development process or commercializing the applicable product candidate and, in some cases, termination of the collaboration arrangement. These disagreements can be difficult to resolve if neither of the parties has final decision-making authority. Collaborations with pharmaceutical or biotechnology companies and other third parties often are terminated or allowed to expire by the other party. For example, our collaborations with GlaxoSmithKline Intellectual Property Development Ltd and with Eli Lilly were terminated in 2022, and in February 2023, we elected to withdraw from co-funding the MAGE-A4 HLA-A02 program, IMC-C103C with Genentech. Any such termination or expiration would adversely affect us financially and could harm our business reputation.
•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;
For example, in July 2025, the United States and the European Union announced a bilateral framework on tariffs and trade, which was further detailed in a joint statement on August 21, 2025. Under this framework, the United States committed to an all inclusive ceiling of 15% on most tariffs applied to goods originating from the European Union, including pharmaceuticals. These proposed tariffs under the framework are subject to ongoing negotiations, European Parliament and Member State approval, as well as further review and implementation by the U.S. government. On February 20, 2026, the Supreme Court of the United States invalidated certain tariffs imposed by the U.S. government under emergency statutory authority. In response to this ruling, President Trump signed an executive order implementing a new 10% global tariff pursuant to an alternative statutory authority, which may be raised up to 15%. As of the date of this Annual Report, it is unclear when and which level of alternative tariffs will be imposed, whether such tariffs would apply to our supply of drug, which is manufactured in the European Union and whether such alternative tariffs, if challenged in court, would be upheld. We are monitoring the developments and assessing the impact tariffs would have on our cost of importing clinical and commercial product into the United States, which is expected to increase the cost of revenue from sale of therapies and reduce our margins on the sale of our products. Unlike many industries, our ability to pass increased costs to customers is limited by the structure of pharmaceutical pricing and reimbursement systems. The complexity of announced or future tariffs may also increase the risk that we or our customers or suppliers may be subject to civil or criminal enforcement actions in the United States or non-U.S. jurisdictions related to compliance with trade regulations. In addition, the United States and other governments have imposed and may continue to impose additional sanctions, such as trade restrictions or trade barriers, which could restrict us from doing business directly or indirectly in or with certain countries or parties and may impose additional costs and complexity to our business. Trade disputes, tariffs, restrictions and other political tensions between the United States and other countries may also exacerbate unfavorable macroeconomic conditions including inflationary pressures, foreign exchange volatility, financial market instability, and economic recessions or downturns. The ultimate impact of current or future tariffs and trade restrictions remains uncertain and could materially and adversely affect our business, financial condition, and prospects.
Our commercial success will depend in part on our ability to obtain and maintain proprietary or intellectual property protection in the United States and other countries for our product candidates and our core technologies.technologies, including our novel target discovery technology, our proprietary compound library and other know-how. We seek to protect our proprietary and intellectual property position by, among other methods, filing patent applications in the United States and abroad related to our proprietary technology, inventions and improvements that are important to the development and implementation of our business. We also rely on trade secrets, know-how and continuing technological innovation to develop and maintain our proprietary and intellectual property position.
In addition, the patent prosecution process is expensive and time-consuming, and we may not be able to file and prosecute all necessary or desirable patent applications at a reasonable cost or in a timely manner. Further, with respect to most of the pending patent applications covering our product candidates, prosecution has yet to commence. Patent prosecution is a lengthy process, during which the scope of the claims initially submitted for examination by the U.S. 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 that our present or future pending patent applications (whether owned or licensed) will not lead to issued patents. It is also possible that we will fail to identify patentable aspects of our research and development output before it is too late to obtain patent protection or that we may not develop additional proprietary technologies that are patentable.
Management's Discussion & Analysis (MD&A)
New heading “Collaboration revenue”
Removed heading “Gadeta Collaboration”
Largest changes
“In December 2022, we entered into a collaboration, option and license agreement, (the “Gadeta Collaboration”), with Gadeta B.V., (“Gadeta”), which was acquired by Clade Therapeutics, (“Clade”), in October 2023. Under the Gadeta Collaboration, we collaborated on ‘201 γδ-TCR target discovery, and we had the option to develop ImmTAC therapies derived from the ‘201 TCR. Following the acquisition of Gadeta by Clade, the rights under the Gadeta Collaboration were transferred to a newly established entity called Ateda Therapeutics, (“Ateda”). …”see in full comparison
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. 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. As of the date of this Annual Report, based on all available data to date, we do not expect there will be a material impact on KIMMTRAK or our financial statements. Overheads and internal costs of revenue from sale of therapies are minimal under our manufacturing arrangements.see in full comparisonDue to the low costs involved in manufacturing KIMMTRAK, cost of revenue from sale of therapies is currently not material, and while these costs are expected to increase in future periods as inflationary pressures increase, we do not expect such costs to be material for the foreseeable future.
“Under the SME program, the trading losses that arise from our qualifying R&D activities can be surrendered for a cash rebate of up to 33.35% of qualifying expenditure incurred prior to April 1, 2023, and up to 18.6% of qualifying expenditure incurred thereafter. We exceeded the size limit thresholds to qualify as a “small or medium-sized enterprise” as defined for the purposes of the SME program in 2023, and may therefore, unless we once again fall within such thresholds, cease to be eligible to claim U.K. R&D tax credits under the SME program with effect from 2023.”see in full comparison
“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. Our collaboration agreement with Lilly was terminated in 2022 and in February 2023, we and Genentech agreed to wind down the co-funding arrangements and clinical trial for IMC-C103C. …”see in full comparison
Full comparison: every changed paragraph (76)
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. Leveraging our proprietary, flexible, off-the-shelf ImmTAX (Immune mobilizing monoclonal TCRs Against X disease) platform, we are developing a deep pipeline in multiple therapeutic areas, including clinical stage programs in oncology and infectious disease, advanced pre-clinicalpreclinical programs in autoimmune disease and earlier pre-clinicalpreclinical programs across three therapeutic areas.
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. We have commercially launched KIMMTRAK in 2430 countries globally including the United States, Germany and France through December 31, 2024,2025, with further commercial launches planned in additional territories where KIMMTRAK is approved.
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 commercializingcommercialization of KIMMTRAK. While we have successfully generated revenue from KIMMTRAK, which is our first marketed product, our ability to generate higher levels of revenue from other marketed products, which may never be fully developed or commercialized, depends on the successful development and regulatory approval of one or more of our product candidates and our ability to finance operations. Since inception, weWe 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. These funds have been and are being used to fund operations and invest in activities for technology creation, drug discovery and clinical development programs, infrastructure, creation of portfolio of intellectual property and commercial and administrative support.
We have incurred significant operating losses and expect to continue to incur significant expenses and operating losses for the near future. TheseWe had net losses wereof $51.1$35.5 million, $55.3$51.1 million and $52.5$55.3 million, for the years ended December 31, 2024,2025, 20232024 and 2022,2023, respectively. As of December 31, 2024,2025, our accumulated deficit was $795.8$831.3 million. We expect to continue to incur significant and increasing expenses and to incur operating losses for the foreseeable future, as we advance our product candidates through preclinical and clinical development and seek regulatory approvals, manufacture drug product and drug supply, maintain and expand our intellectual property portfolio, as well as hire additional personnel, pay for further accounting, audit, legal, regulatory and consulting services, and pay costs associated with maintaining compliance with Nasdaq listing rules and the requirements of the SEC, director and officer liability insurance, investor and public relations activities and other expenses associated with operating as a public company.
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. We have completed the SAD portion of the trial and will determine next steps in 2026.
In December 2025, we submitted the Clinical Trial Application for our first autoimmune candidate, IMC-S118AI (PPI x PD1), for the treatment of type 1 diabetes. We expect to dose the first patient in the Phase 1 dose escalation trial in the first half of 2026.
At the JP Morgan Healthcare Conference in January 2026, we announced our strategic priorities for the company. In the first half of 2026, we expect to complete enrollment in the registrational, advanced melanoma trial, TEBE-AM, with topline data expected as early as the second half of 2026. We are advancing multiple Phase 1/2 trials, with readouts expected from brenetafusp combinations in ovarian and lung cancer, from our PRAME half-life extended candidate (IMC-P115C), and from our HIV candidate, IMC-M113V, in the second half of 2026.
Tina St. Leger notified Immunocore of her resignation as its Chief Human Resources Officer, with her departure effective May 26, 2026. The Company is conducting a formal search process to identify a successor.
On January 30, 2026, the Company announced that Dr. David Berman, its EVP, Research and Development, will depart the Company effective February 27, 2026, to pursue another opportunity. The Company will not seek a direct replacement for Dr. Berman but will leverage its existing R&D leadership.
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.
At the JP Morgan Healthcare Conference in January 2025, we announced that our second autoimmune candidate is IMC-U120AI (CD1a x PD1), a CD1a-tethered PD1 agonist ImmTAAI therapy, and that we are planning to submit a CTA or IND in 2026 initially for a Phase 1 trial in atopic dermatitis.
We appointed Travis Coy as Executive Vice President, Chief Financial Officer and Head of Corporate Development, effective January 1, 2025.
In February 2025, we appointed Dr. William Pao as a non-executive member of our Board of Directors.
In February 2025, we received regulatory approval for KIMMTRAK in Brazil for the treatment of unresectable or mUM.
Revenue from sale of therapies, net relates to the sale of KIMMTRAK following marketing approval and the sale of tebentafusp under compassionate use and early access programs in France through September 2022.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. 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. 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,and in certain countries including France,countries, pricing negotiations. 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. We have no continuing performance obligations under our historical collaboration agreements.
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. Our collaboration agreement with Lilly was terminated in 2022 and in February 2023, we and Genentech agreed to wind down the co-funding arrangements and clinical trial for IMC-C103C. We could be eligible to receive development and commercial milestone payments and royalties from Genentech on any sales of MAGE-A4 HLA-A02 targeted products arising under the Genentech collaboration. As of December 31, 2023, we determined our performance obligation under the collaboration with Genentech was complete.
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. 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. As of the date of this Annual Report, based on all available data to date, we do not expect there will be a material impact on KIMMTRAK or our financial statements. Overheads and internal costs of revenue from sale of therapies are minimal under our manufacturing arrangements. Due to the low costs involved in manufacturing KIMMTRAK, cost of revenue from sale of therapies is currently not material, and while these costs are expected to increase in future periods as inflationary pressures increase, we do not expect such costs to be material for the foreseeable future.
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 understandingunderstanding. andR&D expenses consist primarily of personnel-relatedemployee-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 are expensed as incurred, although the timing of expense recognition can vary with contractual and payment terms in order to determine when services are received.
R&D expenses incurred with external organizations to undertake R&D activities on our behalf typically relate to clinical programs and are assigned to the individual programs in tables further below. 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-relatedemployee-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.
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, 2024,2025, 20232024 and 20222023, we claimed credits under the Research and Development Expenditure Credit ("RDEC") program and these credits are presented as a reduction to R&D expenses. For the period ending December 31, 2022, we also benefited from the Small and Medium-sized Enterprise, ("SME") R&D tax relief program.
Under the SME program, the trading losses that arise from our qualifying R&D activities can be surrendered for a cash rebate of up to 33.35% of qualifying expenditure incurred prior to April 1, 2023, and up to 18.6% of qualifying expenditure incurred thereafter. We exceeded the size limit thresholds to qualify as a “small or medium-sized enterprise” as defined for the purposes of the SME program in 2023, and may therefore, unless we once again fall within such thresholds, cease to be eligible to claim U.K. R&D tax credits under the SME program with effect from 2023.
Selling, general and administrative ("SG&A") expenses consist primarily of personnel-relatedemployee-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.
In order to support our continued commercialization and global expansion of KIMMTRAKKIMMTRAK, R&D activities and our substantial increase in planned R&D expenses, and operatingoperations 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. Additionally, if and as we receive further regulatory approvals of product candidates, we anticipate an increase in personnel-relatedemployee-related costs and expenses in connection with our commercial operations. We have experienced, and may continue to experience, increased personnel-relatedemployee-related costs attributable to offering and maintaining competitive salaries and other impacts due to global inflation.
Interest expense represents costs under our interest-bearing loans and borrowings under the effective interest method and the loss on extinguishment of loans we have repaid in the period.method.
TheForeign 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.
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. Our income tax benefit (expense) represents the sum of income taxes payable in the United States, Ireland and Switzerland, offset by deferredmovements taxin credits arising onour deferred tax assets generated.assets.
Unsurrendered tax losses are carried forward to be offset against future taxable profits. After accounting for tax credits receivable, there were accumulated tax losses available for carry forward in the United Kingdom of $277.4$525.5 million as of December 31, 2024.2025. 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. AThere deferredwere tax assetlosses is,in however,the United States that were generated in 2025 available for carry forward in the amount of $73.6 million. A full valuation allowance is recognized in respect of the subsidiary in the United States, relating to unusedthese tax credits on share-based compensation expenselosses and other temporary differences onin the basisUnited thatStates webecause expectfuture toprofits continueare generatingnot U.S.sufficiently taxable income against which deductible temporary differences can unwind.certain.
As we begin to generate significant net revenue from sale of therapies, we mayare 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. We have filed the patent box election for the 2023 and 2024 tax years and intend to file the patent box election for 2025 and subsequent tax years. The effective rate of tax for relevant streams of revenue for companies receiving this relief is 10%.
Revenue from sale of therapies, net is presented by country / region based on location of the end customer in the table below (in thousands):
For the year ended December 31, 2024,2025, we generated net revenue from sale of therapies of $310.0$400.0 million due to the sale of KIMMTRAK, of which $226.7$257.0 million was in the United States, $73.2$131.4 million in EuropeEurope, (including the impact of a net increasedecrease in estimated reserves related to prior periods of $18.1$6.0 million)million, and $10.1$11.6 million in International. Revenue from the sale of therapies, net increased in the year ended December 31, 20242025 as compared to December 31, 2023,2024 due primarily to increased volume in the United States and Europe as well as global country expansion, as we continued our commercialization efforts.expansion.
Revenue from collaboration agreements decreased by $10.5 million to $0.2 million in the year ended December 31, 2024, compared to $10.7 million for the year ended December 31, 2023. This 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.
For the year ended December 31, 2025, our external R&D expenses increased by $37.6 million due to an increase in all other external clinical and preclinical costs of $36.0 million related to continued progress in the pipeline, primarily for our autoimmune programs, including clinical material manufacturing for anticipated Phase 1 initiation. 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. There was a decrease of $7.8 million in expenses incurred for our PRAME programs primarily resulting from higher costs in the year ended December 31, 2024, due to timing of manufacturing batches and purchases of drug consumables for our clinical trials, partially offset by higher costs in the year ended December 31, 2025 due to enrollment in our PRISM-MEL-301 Phase 3 clinical trial.
For the year ended December 31, 2024, our external R&D expenses increased by $52.8 million. This was driven by an increase of $35.6 million in expenses incurred for our PRAME programs as a result of the initiation of our registrational Phase 3 PRISM-MEL-301 clinical trial, scale-up of manufacturing and increase in the number of patients in combination expansions in our brenetafusp Phase 1/2 clinical trial. 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, 2024,2025, our internal R&D expenses increased by $5.8$15.1 million. This wasmillion primarily due to an increase of $5.5 million in salaries and employee-related expenses and other employee-relatedinternal R&D costs as our average number of employees and associated personnel costs increased withfollowing 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. These cost increases were partially offset by an increase in the U.K. R&D tax credits of $3.3 million in 2024, primarily due to an increase in eligible U.K. R&D expenses.programs.
We expect our R&D expenses to increase in future periods as we advance our trials and further develop our clinical and preclinical pipeline.
The following table summarizes our SG&A expenses (in thousands):
For the year ended December 31, 2024,2025, our SG&A expenses were $155.8$165.4 million, compared to $144.5$155.8 million for the year ended December 31, 2023,2024, an increase of $11.3$9.6 million. SalariesThe andincrease otherwas employee-related costs increased by $12.5 million during the year ended December 31, 2024,primarily due to thecosts internalization of our U.S. sales force in the fourth quarter of 2023. Priorrelated to this, these costs were outsourcedcommercial and included in selling and commercial costs. 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.
For the year ended December 31, 2024,2025, interest income was $25.6$16.5 million compared to $18.0$25.6 million for the year ended December 31, 2023.2024. This increasedecrease of $7.6$9.1 million reflectswas higherprimarily levels of cash and cash equivalents held in 2024 relativedue to 2023 due primarily to the net cash proceeds from the Notes issued in February 2024 and increases inlower interest rates earned on our cashmoney andmarket cashfunds equivalentsin balances.the year ended December 31, 2025. For the year ended December 31, 2024,2025, interest expense was $18.8$12.2 million compared to $5.2$18.8 million for the year ended December 31, 20232024 and the increasedecrease was primarily related to interest arising on the Notes and the loss on extinguishment of our Pharmakon Loan Agreementwhich ofwas $3.9 millionrepaid in November 2024.
For the year ended December 31, 2024,2025, foreign currency lossgain was $3.4$2.2 million compared to a loss of $13.2$3.4 million for the year ended December 31, 2023.2024. This change of $9.8$5.6 million reflects favorable exchange rate movements mainly relateddue to the company holding a greater portionweakening of its cash and cash equivalents and marketable securities within athe U.S. dollar denominatedagainst entity.the pound sterling and the euro in the year ended December 31, 2025.
For the year ended December 31, 2024,2025, other income, net was $14.2$19.7 million compared to other expense,income, net of $0.9$14.2 million for the year ended December 31, 2023.2024. The changeincrease iswas 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 valuevalue, ofpartially ouroffset marketableby securities,lower whichunrealized weregains purchaseddue to less favorable interest rate movement in 2024.the year ended December 31, 2025.
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. This change of $18.3 million primarily relates to a $14.7 million deferred tax expense in 2025 for a valuation allowance on our U.S. deferred tax assets as we no longer expect to be profitable in the United States jurisdiction in the short term, due to a change in intercompany pricing arrangements implemented in the year consistent with our evolution as a company and associated reallocation of income and expenses between geographic jurisdictions that aligns with global tax authority standards.
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. This change of $3.7 million relates to an increase in the tax charge in the US, offset by a valuation allowance release in 2023 related to US stock compensation.
Although we have recorded revenue from the sale of therapies in the year ended December 31, 2024,therapies, we have continued to incur operating losses and cumulative negative cash flows from our operations since our inception. We have an accumulated deficit of $795.8$831.3 million as of December 31, 2024.2025.
Since our inception, we have funded our operations primarily with proceeds from sales of equity securities, productrevenue sales,from sale of therapies, debt financing,financings, and historical payments from collaboration partners. As of December 31, 20242025 and 2023,2024, we had cash and cash equivalents of $455.7$467.7 million and $442.6$455.7 million, respectively, and marketable securities of $364.6$396.4 million and $0,$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.
In September 2022, we entered into an Open Market Sale Agreement (the "Sales Agreement") with Jefferies LLC ("Jefferies"), pursuant to which we may issue and sell ADSs, each representing one ordinary share, having an aggregate offering price of up to $250 million, from time to time, in one or more at-the-market offerings, for which Jefferies will act as sales agent and/or principal. 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, 2024,2025, no issuances or sales hadhave 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. 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. 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 previous loan agreement with Pharmakon (the “Pharmakon Loan Agreement”).Pharmakon.
In November 2024, we paid $52.1 million to prepay in full the loans outstanding under the Pharmakon Loan Agreement with a maturity of November 8, 2028, consisting of $50.0 million principal, $0.5 million accrued interest and $1.6 million attributable to a prepayment premium and other expenses payable pursuant to the Pharmakon Loan Agreement.
WeOther 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.
As of December 31, 2024, we had cash and cash equivalents of $455.7 million, as compared to $442.6 million as of December 31, 2023 and we also have marketable securities of $364.6 million as of December 31, 2024 as compared to $0 as of December 31, 2023. Our working capital was $717.7 million as of December 31, 2024 as compared to $389.8 million as of December 31, 2023.
The following table summarizes the primary sources and uses of cash and cash equivalents for each period presented (in thousands):
Net cash used in operating activities was $10.7 million for the year ended December 31, 2025, compared to net cash provided by our operating activities wasof $26.1 million for the year ended December 31, 2024, compared to $2.9 million for the year ended December 31, 2023.2024. The increasedecrease of $23.1$36.8 million was due to increased revenue related to KIMMTRAK and favorable working capital movementsprimarily driven by highera reduction in accrued expenses relatingand toother liabilities, reflecting the timing of rebate payments, partlypartially offset by increasesan increase in R&Dnet expensesrevenue primarilyfrom relatedsale toof clinicaltherapies trialand costscash in the year ended December 31, 2024 as compared to the year ended December 31, 2023.collections.
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, 2024,2024. comparedThe decrease is predominantly due to $5.4higher millionpurchases forof marketable securities in the year ended December 31, 2023. 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.2024.
Net cash provided by our financing activities during the year ended December 31, 20242025 was $343.9$12.4 million as compared to $34.3$343.9 million for the year ended December 31, 2023.2024. The increase of $309.5 milliondecrease was theprimarily resultdue ofto the net cash proceeds of $389.1 million from the offering of the Notes after deducting issuance costs of $13.4 million,Notes, partially offset by the $52.1 million Pharmakon loan repayment.repayment in 2024.
Since our inception, we have incurred significant losses due to our substantial R&D and SG&A expenses. We have an accumulated deficit of $795.8 million as of December 31, 2024. 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 amounts and timing of our actual expenditure may vary significantly depending on numerous factors. Our expenses will continue to increase if, and as, we:
What changed in the latest 10-Q
Risk Factors
Our business has significant risks. In addition to the other information set forth in this Quarterly Report on Form 10-Q, you should carefully consider the risks described in Part I, Item 1A. “Risk Factors” in our Annual Report. These are not the only risks facing our business. Other risks and uncertainties that we are not currently aware of or that we currently consider immaterial also may materially adversely affect our business, financial condition and future results if our assumptions about those risks are incorrect or if circumstances change.
There were no material changes during the period covered in this Quarterly Report to the risk factors previously disclosed in Item 1A. Risk Factors in our Annual Report.
No wording changes found in this section.
Full comparison: every changed paragraph (0)
Management's Discussion & Analysis (MD&A)
New heading “Comparison of the Six Months Ended June 30, 2026 and 2025”
New heading “Interest Income and Interest Expense”
New heading “Foreign Currency Gain”
New heading “Other Income, Net”
New heading “Income Tax (Expense) Benefit”
Removed heading “Collaboration revenue”
Largest changes
“1) "Phase 1 evaluation of the PRAME‑targeted ImmTAC brenetafusp in advanced melanoma": The data showed improved clinical activity of brenetafusp monotherapy, in heavily-pretreated advanced melanoma, with an overall response rate (ORR) of 17% and a disease control rate (DCR) of 67%, in the 160 mcg vs 40 mcg cohort, despite patients on the 160 mcg dose having less favorable prognostic factors. These data support the selected dose for the ongoing Phase 3 PRISM-MEL-301 trial in first-line advanced melanoma. …”see in full comparison
Full comparison: every changed paragraph (68)
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. Leveraging our proprietary, flexible, off-the-shelf ImmTAX (Immune mobilizing monoclonal TCRs Against 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.
In 2022, we received approval for our lead product, KIMMTRAK,KIMMTRAK (tebentafusp), 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 we have commercially launched KIMMTRAK in over 30 countries, including the United States, Germany and France, among other territories.
KIMMTRAK is the lead product from our ImmTAX platform and was the first approved therapy in mUM. To date, we have treated over 2,0005,000 cancer patients with KIMMTRAK (tebentafusp),KIMMTRAK, 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 TCR therapeutic. Our clinical programs are being conducted with patients with a broad range of cancers including melanoma, ovarian, lung, and colorectal, among others. We believe that these tumor types have large addressable patient populations and significant unmet need. We are progressing three late-stage clinical programs within our ImmTAC® (Immune mobilizing monoclonal TCRs Against Cancer) portfolio, including KIMMTRAK and PRAME-targeted brenetafusp.
We have incurred significant operating losses and expect to continue to incur significant expenses and operating losses for the near future. We had net income of $13.0$12.2 million and a net loss of $5.0$5.3 million for the threesix months ended MarchJune 31,30, 2026 and 2025, respectively. As of MarchJune 31,30, 2026, our accumulated deficit was $818.3$819.1 million. Despite the net income result for the threesix months ended MarchJune 31,30, 2026, we expect to continue to incur significant and increasing expenses and to incur operating losses for the foreseeable future, as we advance our product candidates through preclinical and clinical development and seek regulatory approvals, manufacture drug product and drug supply, maintain and expand our intellectual property portfolio, as well as hire additional personnel, pay for further accounting, audit, legal, regulatory and consulting services, and pay costs associated with director and officer liability insurance, investor and public relations activities and other expenses associated with operating as a public company.
Enrollment in the registrational Phase 3 TEBE-AM trial, evaluating tebentafusp as monotherapy and in combination with pembrolizumab, versus a control arm in patients with previously treated advanced cutaneous melanoma, is nearing the target of 540 patients, with topline data that could come as early as the end of 2026.
During the 2026 American Society of Clinical Oncology Meeting in May, we presented two posters:
1) "Phase 1 evaluation of the PRAME‑targeted ImmTAC brenetafusp in advanced melanoma": The data showed improved clinical activity of brenetafusp monotherapy, in heavily-pretreated advanced melanoma, with an overall response rate (ORR) of 17% and a disease control rate (DCR) of 67%, in the 160 mcg vs 40 mcg cohort, despite patients on the 160 mcg dose having less favorable prognostic factors. These data support the selected dose for the ongoing Phase 3 PRISM-MEL-301 trial in first-line advanced melanoma. Median OS for brenetafusp monotherapy of 14.3 months is similar to other Ph1/2 trials of combination therapies in heavily pre-treated patients with advanced melanoma, including studies with autologous cell therapies. Brenetafusp in combination with pembrolizumab (n=6) demonstrated promising clinical activity with ORR of 33% and DCR 67% in patients with PD1 primary resistance (defined as progressive disease within 6 months of starting first PD1-based regimen). Brenetafusp was generally well tolerated as monotherapy and in combination with pembrolizumab.
2) "Effect of IL7 on ImmTAC-mediated killing by T cells in vitro and T-cell fitness in patients": Building on previously disclosed data regarding the importance of T cell fitness for the efficacy of ImmTAC molecules, the new data demonstrated the anti-tumor activity of these therapies may increase when combined with IL7 in vitro.
The European Organisation for Research and Treatment of Cancer (EORTC) is now enrolling patients in the United States for the Phase 3 Adjuvant Trial in Ocular Melanoma (ATOM).
In July 2026, we presented translational data, at the International AIDS Society meeting in Rio de Janeiro, from the Phase 1/2 trial demonstrating that IMC-M113V induces robust type I and II interferon-associated immune programs, with stronger induction in participants who maintained viral control after treatment interruption. The data also showed that, in addition to previously demonstrated direct killing of HIV-infected cells, IMC-M113V redirection of T cells results in induction of a robust interferon-associated immune program that may contribute to post-rebound viral control. The Company completed enrollment of additional patients at higher dose cohorts, up to 1200 mcg, as part of the multiple ascending dose (MAD) part of the Phase 1/2 trial. Analysis of the new data is ongoing with results planned to be shared early next year.
Clinical trial sites for the Phase 1 trial with IMC-S118AI are open and the Company expects the first type 1 diabetes patient to be dosed in the coming weeks.
We presented the five-year overall survival (OS) from our pivotal Phase 3 trial with KIMMTRAK in unresectable or mUM, in an oral session at the American Association for Cancer Research (AACR) 2026 meeting. This is the longest, prospective Phase 3 randomized trial in patients with unresectable or mUM – a disease with a very poor prognosis and a historical survival rate of <5% at five years. These results also represent the longest follow-up reported for any T cell engager in a solid tumor.
In the Phase 3 trial, KIMMTRAK doubled the likelihood of being alive at five years, with an OS for KIMMTRAK of 16% versus 8% in the control arm (hazard ratio of 0.67 [95% CI: 0.54-0.85]).
In the trial, 378 patients were randomized to tebentafusp (252) or investigator’s choice (126; 82% pembrolizumab). The median OS was 21.6 months on KIMMTRAK, versus 16.9 months on investigator’s choice (IC). The Kaplan–Meier survival curves separated early and remained separated over time, confirming the durability of the benefit with extended follow-up.
The OS benefit with KIMMTRAK was observed regardless of known poor prognostic factors at baseline (high tumor burden [≥10cm]; elevated lactate dehydrogenase) or tumor location (hepatic only; hepatic and extra-hepatic). OS benefit was also observed in patients with a best response of progressive disease, including those with >20% tumor growth as best change on treatment.
More patients continued treatment beyond progression in the KIMMTRAK arm than in the control arm (57% vs 25%) – with the trial allowing this option in both arms. Patients on KIMMTRAK achieved nearly a 7-fold higher rate of tumor reduction with treatment beyond initial progression compared to IC patients (27% vs 4%). In fact, patients who continued tebentafusp treatment beyond tumor progression experienced longer post-progression survival compared to those who stopped treatment, even after accounting for variations in patient characteristics.
During the 2026 American Society of Clinical Oncology Meeting in May, we will present two posters titled "Phase 1 evaluation of the PRAME‑targeted ImmTAC brenetafusp in advanced melanoma" (Abstract number: 9527) and "Effect of IL7 on ImmTAC-mediated killing by T cells in vitro and T-cell fitness in patients" (Abstract number: 2662).
Revenue
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. We have no continuing performance obligations under our historical collaboration agreements.
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. 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. As of the date of this Quarterly Report, based on all available data to date, we do not expect there will be a material impact on KIMMTRAK or our financial statements. Overheads and internal costs of revenue from sale of therapies are minimal under our manufacturing arrangements.
As a company that carries out extensive R&D activities, we benefit from the U.K. R&D tax regime. For the periods ended MarchJune 31,30, 2026 and 2025, we claimed credits under the Research and Development Expenditure Credit ("RDEC") program and these credits are presented as a reduction to R&D expenses.
Foreign currency (losses) gains arisesarise 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 cash and cash equivalents.
Unsurrendered tax losses are carried forward to be offset against future taxable profits. After accounting for tax credits receivable, there were accumulated tax losses available for carry forward in the United Kingdom and United States of $596.7$600.5 million and $103.1$90.1 million, respectively, as of MarchJune 31,30, 2026. A full valuation allowance is recognized in respect of accumulated tax losses and other temporary differences in the United Kingdom and United States because future profits are not sufficiently certain.
Comparison of the Three Months Ended MarchJune 31,30, 2026 and 2025
Revenue
For the three months ended MarchJune 31,30, 2026, we generated net revenue from sale of therapies of $106.7$115.9 million due to the sale of KIMMTRAK, of which $67.4$74.9 million was in the United States, $34.4$34.1 million in Europe and $4.8$6.9 million in International. Revenue from sale of therapies, net increased in the three months ended MarchJune 31,30, 2026 compared to the three months ended MarchJune 31,30, 2025, primarily due primarily to increased sales volumevolumes in the United States and EuropeInternational as well as global country expansion.regions.
For the three months ended MarchJune 31,30, 2026, our R&D expenses were $61.1$73.9 million, compared to $56.5$69.0 million for the three months ended MarchJune 31,30, 2025.
For the three months ended June 30, 2026, our external R&D expenses increased by $1.2 million primarily due to an increase of $1.4 million in expenses incurred for our tebentafusp programs and driven by progress of our TEBE-AM and ATOM clinical trials. These increases were partially offset by a net decrease of $0.6 million in expenses incurred for our PRAME programs, primarily driven by lower costs due to decreased patient enrollment on PRAME-101 and the timing of manufacturing activities, partially offset by higher costs associated with enrollment in our PRISM-MEL-301 Phase 3 clinical trial.
For the three months ended March 31, 2026, our external R&D expenses increased by $0.9 million primarily due to an increase of $3.9 million in expenses incurred for our PRAME programs, primarily driven by higher costs associated with enrollment in the PRISM-MEL-301 Phase 3 clinical trial, partially offset by lower costs following decreased patient enrollment in the PRAME-101 Phase 1/2 clinical trial. This net increase is partially offset by a decrease in all other external clinical and preclinical costs of $2.7 million due to timing of manufacturing activities in the pipeline, primarily for our autoimmune programs.
For the three months ended MarchJune 31,30, 2026, our internal R&D expenses increased by $3.8 million primarily due to increases in all other internal R&D costs and salaries and other employee-related costs followingin accordance with the growthadvancement of our clinical and preclinical programs and associated headcount increases.programs.
For the three months ended MarchJune 31,30, 2026, our SG&A expenses were $37.9$43.9 million, compared to $40.2$42.8 million for the three months ended MarchJune 31,30, 2025, reflecting aan decreaseincrease of $2.3$1.1 million. TheThis decreasenet increase was primarily due to lower internal costs following increases in share-based compensation forfeitures, partially offset by increased costs related to business support functions to support our growing pipeline and global commercial expansion.
For the three months ended MarchJune 31,30, 2026, interest income was $3.4$3.6 million, compared to $4.2$4.3 million for the three months ended MarchJune 31,30, 2025. This decrease of $0.8$0.7 million was due to lower interest rates earned on our money market funds. For the three months ended MarchJune 31,30, 2026, interest expense on our convertible loansenior notes was $3.1 million, compared to $3.0 million for the three months ended MarchJune 31,30, 2025.
Foreign Currency Gains(Loss) Gain
For the three months ended MarchJune 31,30, 2026, foreign currency gainloss was $3.8$1.1 millionmillion, compared to $3.1$0.7 million,million for the three months ended MarchJune 31,30, 2025. This increaseincreased loss of $0.7$0.4 million reflects more favorableadverse exchange rate movements mainly due to the weakening of the U.S. dollar against the pound sterling and the euro when comparing the three months ended MarchJune 31,30, 2026 with the three months ended MarchJune 31,30, 2025.
For the three months ended MarchJune 31,30, 2026, other income, net was $1.8$3.1 millionmillion, compared to $5.5$4.7 million for the three months ended MarchJune 31,30, 2025. This decrease was due to lower unrealized gains due to less favorable interest rates impacting our marketable securities in the three months ended MarchJune 31,30, 2026 compared to the three months ended MarchJune 31,30, 2025.
For the three months ended MarchJune 31,30, 2026, the income tax expense was $0.3 millionmillion, compared to $1.1$0.6 million for the three months ended MarchJune 31,30, 2025. This change was primarily the result of lower forecasted taxable income in the United States jurisdiction.jurisdiction for 2026 compared to 2025.
Comparison of the Six Months Ended June 30, 2026 and 2025
The following table summarizes our total revenue (in thousands):
Revenue from sale of therapies, net is presented by country / region based on location of the end customer below (in thousands).
For the six months ended June 30, 2026, we generated revenue from sale of therapies, net of $222.6 million, due to the sale of KIMMTRAK, of which $142.4 million was in the United States, $68.5 million in Europe and $11.7 million in International. Revenue from sale of therapies, net increased in the six months ended June 30, 2026 compared to the six months ended June 30, 2025, primarily due to increased volumes in the United States and International regions.
R&D Expenses
The following table summarizes our R&D expenses (in thousands):
For the six months ended June 30, 2026, our R&D expenses were $135.1 million, compared to $125.5 million for the six months ended June 30, 2025.
For the six months ended June 30, 2026, our external R&D expenses increased by $2.0 million primarily due to an increase of $3.3 million in expenses incurred for our PRAME programs associated with continued enrollment in our PRISM-MEL-301 Phase 3 clinical trial partially offset by lower costs following decreased patient enrollment in the PRAME-101 Phase 1/2 clinical trial. This increase was partially offset by a net decrease of $1.6 million in all other external clinical and preclinical costs primarily due to the timing of third-party costs associated with our earlier stage programs, including our autoimmune programs.
For the six months ended June 30, 2026, our internal R&D expenses increased by $7.6 million primarily due to an increase in salaries and other employee-related costs and all other internal R&D costs in accordance with the advancement of our clinical and preclinical programs.
SG&A Expenses
For the six months ended June 30, 2026, our SG&A expenses were $81.7 million, compared to $83.0 million for the six months ended June 30, 2025, reflecting a decrease of $1.3 million. The decrease was primarily due to lower internal costs following increases in share-based compensation forfeitures, partially offset by increased costs related to business support functions to support our growing pipeline and global commercial expansion.
Interest Income and Interest Expense
For the six months ended June 30, 2026, interest income was $7.0 million compared to $8.4 million for the six months ended June 30, 2025. This decrease of $1.4 million was due to lower interest rates earned on our money market funds in the six months ended June 30, 2026. For the six months ended June 30, 2026, interest expense on our convertible senior notes was $6.1 million compared to $6.1 million for the six months ended June 30, 2025.
Foreign Currency Gain
For the six months ended June 30, 2026, foreign currency gain was $2.7 million compared to $2.3 million for the six months ended June 30, 2025. This increase of $0.4 million reflects more favorable exchange rate movements mainly of the U.S. dollar against the pound sterling and the euro in the six months ended June 30, 2026 compared to the six months ended June 30, 2025.
Other Income, Net
For the six months ended June 30, 2026, other income, net was $4.8 million compared to $10.2 million for the six months ended June 30, 2025. This decrease was due to lower unrealized gains due to less favorable interest rates impacting our marketable securities in the six months ended June 30, 2026 compared to the six months ended June 30, 2025.
Income Tax (Expense) Benefit
For the six months ended June 30, 2026, the income tax expense was $0.6 million compared to $1.7 million for the six months ended June 30, 2025. This change was primarily the result of lower forecasted taxable income in the United States jurisdiction for 2026 compared to 2025.
Although we have recorded revenue from the sale of therapies,therapies and a net income result for the six months ended June 30, 2026, we haveexpect continuedto continue to incur operating lossessignificant and increasing expenses, cumulative negative cash flows from our operations sinceand ouroperating inception.losses for the foreseeable future. We have an accumulated deficit of $818.3$819.1 million as of MarchJune 31,30, 2026.
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. As of MarchJune 31,30, 2026 and December 31, 2025, we had cash and cash equivalents of $452.7$484.9 million and $467.7 million, respectively, and marketable securities of $392.2$395.3 million and $396.4 million, respectively. Our working capital was $763.7$815.8 million as of MarchJune 31,30, 2026, compared to $750.0 million as of December 31, 2025.
In September 2022, we entered into an Open Market Sale Agreement (the "Sales Agreement") with Jefferies LLC ("Jefferies"), pursuant to which we may issue and sell ADSs, each representing one ordinary share, having an aggregate offering price of up to $250 million, from time to time, in one or more at-the-market offerings, for which Jefferies will act as sales agent and/or principal. 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 MarchJune 31,30, 2026, no issuances or sales have been made pursuant to the Sales Agreement.
Other than the above mentioned indebtedness, our lease obligations and supplier purchase commitments in the normal course of business, we currently have no other 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.years.
IMCR insider buying and selling (Form 4)
Since 2026-04-11, insiders reported open-market purchases in 0 Form 4 filings and open-market sales in 0 filings. Totals add up every open-market (code P and S) line in those filings, using the prices reported in the filings. Awards, option exercises, tax withholding and gifts are listed below but not counted.
No Form 4 stock transactions in this period.
Well-known investors holding IMCR (13F)
| Investor | Quarter | Shares | Reported value | % of their 13F | Change vs prior quarter |
|---|---|---|---|---|---|
| PRIMECAP Management | 2026-06-30 | 3,638,241 | $115.5M | 0.07% | Reduced 1% |
| Two Sigma Investments | 2026-06-30 | 1,648,983 | $52.4M | 0.04% | Added 61% |
| Millennium Management (Israel Englander) | 2026-06-30 | 1,597,037 | $50.7M | 0.03% | Added 29% |
| Point72 Asset Management (Steve Cohen) | 2026-06-30 | 990,280 | $31.4M | 0.05% | Reduced 10% |
| Citadel Advisors (Ken Griffin) | 2026-06-30 | 566,761 | $18.0M | 0.01% | Added 146% |
| D. E. Shaw & Co. | 2026-06-30 | 405,116 | $12.9M | 0.01% | Added 21% |
| Renaissance Technologies | 2026-06-30 | 102,400 | $3.3M | 0.0% | Reduced 38% |
| Bridgewater Associates | 2026-06-30 | 36,707 | $1.2M | 0.0% | Added 94% |
| Oaktree Capital Management (Howard Marks) | 2026-06-30 | 0 | $766.4K | 0.01% | No change |