KIMMTRAK (tebentafusp-tebn) Q4 net sales of
PRAME franchise Phase 1/2 data to be presented in 2H 2026: brenetafusp in ovarian and lung cancer, and initial data with half-life extended candidate (IMC-P115C)
Additional Phase 1 HIV data to be presented in 2H 2026
Cash, cash equivalents and marketable securities of
Conference call today,
(
The Company has demonstrated commercial momentum with 15 consecutive quarters of KIMMTRAK® (tebentafusp-tebn) revenue growth, driven by US community and global market penetration. In addition, the Company is preparing for potential new melanoma indications as it enrolls three Phase 3 trials:
The Company continued to advance its clinical pipeline beyond melanoma into other tumor types enrolling patients across multiple early-stage trials. In the second half of 2026, the Company expects to present data from the ongoing ovarian and NSCLC expansion cohorts of the Phase 1/2 trial of brenetafusp and the initial data from the half-life extended PRAME-A02 candidate (IMC-P115C).
The Company is progressing on its growth opportunities beyond oncology, as it continues to dose escalate in the HIV functional cure program and plans to enter the clinic with its first autoimmune candidate in the first half of this year. The Company’s strong balance sheet provides the financial flexibility to execute these programs.
“With
Full Year and Fourth Quarter Highlights (including post-period)
Financial Results
For the fourth quarter of 2025 (Q4 2025), total net product revenue (or ‘net sales’) arising from the sales of KIMMTRAK was
For the year ended
Research & development (R&D) expenses for Q4 2025 were
Selling, general and administrative (SG&A) expenses for Q4 2025 were
Net loss for Q4 2025 was
The Q4 2025 basic and diluted loss per share was
Cash, cash equivalents and marketable securities were
KIMMTRAK
The Company’s lead product, KIMMTRAK® (tebentafusp), is approved in 39 countries and has been launched in 30 countries globally to date for HLA-A*02:01 positive people with unresectable or metastatic uveal melanoma (mUM). KIMMTRAK continues to be the standard of care in most markets where it is launched.
The Company sees three key growth areas as it plans to expand patient reach for KIMMTRAK, including continued US community and global market penetration in mUM, the potential expansion into 2L+ advanced cutaneous melanoma (CM), and the potential expansion into adjuvant uveal melanoma.
Metastatic uveal melanoma
- KIMMTRAK net product sales were
$104.5 million and$400.0 million for the fourth quarter and year endedDecember 31, 2025 , respectively, representing increases of 24% and 29% respectively, as compared to the same periods in 2024. - 13% year-over-year sales growth in
the United States with mean duration of treatment increasing to 14 months. - 79% year-over-year sales growth in
Europe , driven by increased demand and launches in European markets.
2L+ advanced cutaneous melanoma
- The Company is currently enrolling patients in the
TEBE-AM registrational Phase 3 trial and expects to complete enrollment in the first half of 2026 with topline data expected as early as the second half of 2026. - The Phase 3 trial is enrolling three arms: tebentafusp monotherapy, tebentafusp in combination with pembrolizumab, and a control (investigator's choice of therapy including clinical trials, chemotherapy, or retreatment with anti-PD1 or BRAF therapy). The primary endpoint of the randomized Phase 3 trial is Overall Survival (OS).
- There is great unmet need in second- and later-line cutaneous melanoma, with no therapy having shown, to date, an OS improvement post checkpoint inhibitors in a randomized clinical trial. The Company estimates that there is a potential to address up to 4,000 previously treated advanced HLA-A*02:01 positive CM patients.
Adjuvant uveal (or ocular) melanoma
The European Organisation for Research and Treatment of Cancer (EORTC) continues to expand the site footprint of the Phase 3 Adjuvant Trial in Ocular Melanoma (ATOM).- The Company estimates that the HLA-A*02:01 positive, high-risk adjuvant uveal melanoma patient population could be up to 1,200 patients in the US and
Europe .
PRAME portfolio
Brenetafusp is the Company’s lead PRAME-A02 ImmTAC bispecific candidate. Brenetafusp is being evaluated in combination with nivolumab in a Phase 3 registrational trial (PRISM-MEL-301) in patients with first-line, advanced cutaneous melanoma, and in a Phase 1/2 clinical trial as monotherapy and in combination across multiple tumor types, including ovarian cancer and non-small cell lung cancer (NSCLC).
PRISM-MEL-301 – First PRAME Phase 3 clinical trial with brenetafusp in first-line advanced cutaneous melanoma
- In
November 2025 , the Independent Data Monitoring Committee (IDMC) recommended the dose of 160 mcg as the go-forward dose in PRISM-MEL-301, the Company’s registrational Phase 3 trial in first-line, advanced cutaneous melanoma. - The Company continues with a 1:1 randomization of HLA-A*02:01 positive patients with first-line, advanced or metastatic cutaneous melanoma to brenetafusp 160 mcg + nivolumab or a control arm of either nivolumab or nivolumab + relatlimab.
- Despite approved therapies, there remains a need for improved progression-free survival and OS, and there is the potential to address an estimated 10,000 HLA-A*02:01 positive patients in the US and
Europe .
Phase 1/2 clinical trials of brenetafusp and IMC-P115C (PRAME-A02 Half-Life Extended) in multiple solid tumors
- The Company continues to evaluate brenetafusp in a Phase 1/2 trial in combination in platinum-resistant ovarian cancer (PROC) and in earlier lines of platinum-sensitive ovarian cancer (PSOC). In the same trial, the Company continues signal detection in metastatic non-small cell lung cancer (NSCLC) cohorts, including combination in earlier-line NSCLC.
- The Company is enrolling patients in the Phase 1 dose escalation trial evaluating IMC-P115C in patients with multiple solid tumors.
- The Company expects to present Phase 1/2 data from both trials in the second half of 2026.
IMC-R117C (PIWIL1) for colorectal and other gastrointestinal cancers
- The Company is enrolling patients in the Phase 1/2 dose escalation trial evaluating IMC-R117C in HLA-A*02:01 positive patients with advanced solid tumors, including colorectal cancer, as a single agent and in combination with standards of care.
- The Company expects to present initial data in 2027.
ImmTAV candidates for a functional cure in infectious diseases
The Company’s bispecific TCR technology platform has the potential to offer a new approach for the treatment of certain chronic infections and aims to eliminate evidence of remaining virus in circulation after the patient stops taking medication – known as a ‘functional cure’. The Company is studying an investigational candidate for people living with human immunodeficiency virus (HIV). The Company has completed the single ascending dosing in the Phase 1 study for its chronic hepatitis B infection (HBV) program and is evaluating next steps.
Phase 1/2 trial of IMC-M113V (Gag-A02) for people living with HIV
- Patient enrollment continues at higher doses in the multiple ascending dose part of the Phase 1/2 clinical trial to identify a safe and tolerable dose.
- The Company published the single ascending dose data in a manuscript in
Nature Communications . - Additional Phase 1 data to be presented in the second half of 2026
Tissue-specific down modulation of the immune system for autoimmune diseases
The key differentiator of the ImmTAAI platform is tissue-specific, down modulation of the immune system, as the candidates suppress pathogenic T cells via PD1 receptor agonism only when tethered to the target tissue.
- The Company filed a clinical trial application (CTA) for IMC-S118AI (PPI x PD1) in
December 2025 and expects to begin the Phase 1 trial in the first half of 2026. - The Company plans to file a CTA or investigational new drug (IND) application for IMC-U120AI (CD1a x PD1) in the second half of 2026.
###
About ImmTAC® molecules for cancer
Immunocore’s proprietary T cell receptor (TCR) technology generates a novel class of bispecific biologics called ImmTAC (Immune mobilizing monoclonal TCRs Against Cancer) molecules that are designed to redirect the immune system to recognize and kill cancerous cells. ImmTAC molecules are soluble TCRs engineered to recognize intracellular cancer antigens with ultra-high affinity and selectively kill these cancer cells via an anti-CD3 immune-activating effector function. Based on the demonstrated mechanism of T cell infiltration into human tumors, the ImmTAC mechanism of action holds the potential to treat hematologic and solid tumors, regardless of mutational burden or immune infiltration, including immune “cold” low mutation rate tumors.
About ImmTAV® molecules and infectious diseases
ImmTAV (Immune mobilizing monoclonal TCRs Against Virus) molecules are novel bispecifics that are designed to enable the immune system to recognize and eliminate virally infected cells.
About ImmTAAITM molecules and autoimmune diseases
ImmTAAI (Immune mobilizing monoclonal TCRs Against AutoImmune disease) molecules are novel bispecifics that are designed for tissue-specific down modulation of the immune system. When tethered to the tissue of interest, ImmTAAI candidates suppress pathogenic T cells via PD1 receptor agonism. The Company is currently advancing two candidates for autoimmune diseases, including type 1 diabetes and inflammatory dermatological diseases.
About PRISM-MEL-301 (NCT06112314) – Phase 3 trial with brenetafusp (IMC-F106C, PRAME-A02) in 1L advanced cutaneous melanoma
The Phase 3 registrational trial is randomizing HLA-A*02:01-positive patients with previously untreated, advanced or metastatic cutaneous melanoma, to brenetafusp 160 mcg + nivolumab or a control arm of either nivolumab or nivolumab + relatlimab. The brenetafusp dose of 160 mcg was recommended by the Independent Data Monitoring Committee, following a pre-planned review of safety for all three arms and of efficacy for the two brenetafusp regimens (40 mcg and 160 mcg) in the first 90 patients randomized in the Phase 3 trial. The primary endpoint of the trial is progression free survival (PFS) by blinded independent central review (BICR), with secondary endpoints of overall survival (OS) and overall response rate (ORR).
About the IMC-F106C-101 Phase 1/2 trial
IMC-F106C-101 is a first-in-human, Phase 1/2 dose escalation trial in patients with multiple solid tumors, including non-small cell lung and ovarian cancers. The Phase 1 dose escalation trial was designed to determine the maximum tolerated dose (MTD), as well as to evaluate the safety, preliminary anti-tumor activity and pharmacokinetics of IMC-F106C (brenetafusp), a bispecific protein built on Immunocore’s ImmTAC technology, and the Company’s first molecule to target the PRAME antigen. The Company is currently focusing on enrolling patients in combination arms with standards-of-care across multiple tumor types.
About
The trial is randomizing patients with second-line or later advanced cutaneous melanoma who have progressed on an anti-PD1, received prior ipilimumab and, if applicable, received a BRAF kinase inhibitor. Patients are randomized to one of three arms, including tebentafusp – as monotherapy or in combination with an anti-PD1 – or a control arm. The primary endpoint is overall survival.
About the ATOM Phase 3 trial
The EORTC-sponsored Phase 3 clinical trial will include sites in 10 EU countries and
About Uveal Melanoma
Uveal melanoma is a rare and aggressive form of melanoma, which affects the eye. This is the most common primary intraocular malignancy in adults and up to 50% of people with uveal melanoma will eventually develop metastatic disease. Unresectable or metastatic uveal melanoma typically has a poor prognosis and had no approved treatment until KIMMTRAK.
About Cutaneous Melanoma
Cutaneous melanoma (CM) is the most common form of melanoma. It is the most aggressive skin carcinoma and is associated with the vast majority of skin cancer-related mortality. The majority of patients with CM are diagnosed before metastasis but survival remains poor for the large proportion of patients with metastatic disease. Despite recent progress in advanced melanoma therapy, there is still an unmet need for new therapies that improve first-line response rates and duration of response as well as for patients who are refractory to first-line treatments.
About KIMMTRAK®
KIMMTRAK is a novel bispecific protein comprised of a soluble T cell receptor fused to an anti-CD3 immune-effector function. KIMMTRAK specifically targets gp100, a lineage antigen expressed in melanocytes and melanoma. This is the first molecule developed using Immunocore’s ImmTAC technology platform, designed to redirect and activate T cells to recognize and kill tumor cells. KIMMTRAK has been approved for the treatment of HLA-A*02:01-positive adult patients with unresectable or metastatic uveal melanoma in
IMPORTANT SAFETY INFORMATION
Cytokine Release Syndrome (CRS), which may be serious or life-threatening, occurred in patients receiving KIMMTRAK. Monitor for at least 16 hours following first three infusions and then as clinically indicated. Manifestations of CRS may include fever, hypotension, hypoxia, chills, nausea, vomiting, rash, elevated transaminases, fatigue, and headache. CRS occurred in 89% of patients who received KIMMTRAK, with 0.8% being grade 3 or 4. Ensure immediate access to medications and resuscitative equipment to manage CRS. Ensure patients are euvolemic prior to initiating the infusions. Closely monitor patients for signs or symptoms of CRS following infusions of KIMMTRAK. Monitor fluid status, vital signs, and oxygenation level and provide appropriate therapy. Withhold or discontinue KIMMTRAK depending on persistence and severity of CRS.
Skin Reactions
Skin reactions, including rash, pruritus, and cutaneous edema occurred in 91% of patients treated with KIMMTRAK. Monitor patients for skin reactions. If skin reactions occur, treat with antihistamine and topical or systemic steroids based on persistence and severity of symptoms. Withhold or permanently discontinue KIMMTRAK depending on the severity of skin reactions.
Elevated Liver Enzymes
Elevations in liver enzymes occurred in 65% of patients treated with KIMMTRAK. Monitor alanine aminotransferase (ALT), aspartate aminotransferase (AST), and total blood bilirubin prior to the start of and during treatment with KIMMTRAK. Withhold KIMMTRAK according to severity.
Embryo-Fetal Toxicity
KIMMTRAK may cause fetal harm. Advise pregnant patients of potential risk to the fetus and patients of reproductive potential to use effective contraception during treatment with KIMMTRAK and 1 week after the last dose.
The most common adverse reactions (=30%) in patients who received KIMMTRAK were cytokine release syndrome, rash, pyrexia, pruritus, fatigue, nausea, chills, abdominal pain, edema, hypotension, dry skin, headache, and vomiting. The most common (=50%) laboratory abnormalities were decreased lymphocyte count, increased creatinine, increased glucose, increased AST, increased ALT, decreased hemoglobin, and decreased phosphate.
For more information, please see full Summary of Product Characteristics (SmPC) or full
About KIMMTRAKConnect
About
Forward Looking Statements
This press release contains “forward-looking statements” within the meaning of the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Words such as “may”, “will”, “believe”, “expect”, “plan”, “anticipate”, “aim”, “continue”, “target” and similar expressions (as well as other words or expressions referencing future events or circumstances) are intended to identify forward-looking statements. All statements, other than statements of historical facts, included in this press release are forward-looking statements. These statements include, but are not limited to, statements regarding the Company’s ability to reach more patients for KIMMTRAK, including continued
Contact Information
T: +44 (0) 7458030732
E: sebastien.desprez@immunocore.com
Follow on LinkedIn: @Immunocore
Investor Relations
T: +1 (215) 384-4781
E: ir@immunocore.com
Condensed Consolidated Statement of Operations
Fourth Quarter and Year Ended
(In thousands, except share and per share data)
| Quarter Ended | Year Ended | ||||||||||||
| Revenue from sale of therapies, net | $ | 104,478 | $ | 84,052 | $ | 400,016 | $ | 309,989 | |||||
| Collaboration revenue | — | — | — | 213 | |||||||||
| Total revenue | 104,478 | 84,052 | 400,016 | 310,202 | |||||||||
| Cost of revenue from sale of therapies | (2,703 | ) | (330 | ) | (5,087 | ) | (2,731 | ) | |||||
| Research and development expense | (78,821 | ) | (60,850 | ) | (274,869 | ) | (222,151 | ) | |||||
| Selling, general, & administrative expense | (42,645 | ) | (42,324 | ) | (165,413 | ) | (155,781 | ) | |||||
| Loss from operations | (19,691 | ) | (19,452 | ) | (45,353 | ) | (70,461 | ) | |||||
Interest income | 3,906 | 5,173 | 16,476 | 25,618 | |||||||||
| Interest expense | (3,053 | ) | (7,038 | ) | (12,166 | ) | (18,844 | ) | |||||
| Foreign currency (loss) gain | (1,460 | ) | (4,497 | ) | 2,215 | (3,448 | ) | ||||||
| Other income, net | 4,504 | 993 | 19,728 | 14,198 | |||||||||
| Net income (loss) before income taxes | (15,794 | ) | (24,821 | ) | (19,100 | ) | (52,937 | ) | |||||
| Income tax (expense) benefit | (14,266 | ) | 1,050 | (16,414 | ) | 1,850 | |||||||
| Net loss | $ | (30,060 | ) | $ | (23,771 | ) | $ | (35,514 | ) | $ | (51,087 | ) | |
| Basic and diluted net loss per share | $ | (0.60 | ) | $ | (0.47 | ) | $ | (0.71 | ) | $ | (1.02 | ) | |
| Basic and diluted weighted-average number of shares outstanding | 50,465,586 | 50,046,748 | 50,345,666 | 49,991,064 | |||||||||
Condensed Consolidated Balance Sheets
As of
(In thousands)
| ASSETS | ||||||
| Current assets | ||||||
| Cash and cash equivalents | $ | 467,709 | $ | 455,731 | ||
| Marketable securities | 396,444 | 364,645 | ||||
| Accounts receivable, net | 73,977 | 63,009 | ||||
| Prepaid expenses and other current assets | 50,055 | 41,033 | ||||
| Tax receivable | 1,815 | — | ||||
| Inventory, net | 6,742 | 5,446 | ||||
| Total current assets | 996,742 | 929,864 | ||||
| Property and equipment, net | 11,462 | 10,092 | ||||
| Operating lease right of use assets, net | 38,783 | 37,643 | ||||
| Deferred tax assets, net | — | 14,790 | ||||
| Other non-current assets | 20,282 | 17,117 | ||||
| Total assets | $ | 1,067,269 | $ | 1,009,506 | ||
| Liabilities and shareholders’ equity | ||||||
| Current liabilities | ||||||
| Accounts payable | $ | 24,364 | $ | 25,100 | ||
| Accrued expenses and other current liabilities | 219,744 | 185,534 | ||||
| Deferred revenue, current | 583 | — | ||||
| Operating lease liabilities, current | 2,006 | 1,547 | ||||
| Total current liabilities | 246,697 | 212,181 | ||||
| Deferred revenue, non-current | 4,858 | 5,434 | ||||
| Operating lease liabilities, non-current | 41,556 | 40,162 | ||||
| Interest-bearing loans and borrowings | 393,125 | 391,013 | ||||
| Total liabilities | $ | 686,236 | $ | 648,790 | ||
| Shareholders' equity | ||||||
| Ordinary shares | 136 | 135 | ||||
| Deferred shares | 1 | 1 | ||||
| Additional paid-in capital | 1,240,255 | 1,190,104 | ||||
| Accumulated deficit | (831,275 | ) | (795,761 | ) | ||
| Accumulated other comprehensive loss | (28,084 | ) | (33,763 | ) | ||
| Total shareholders' equity | 381,033 | 360,716 | ||||
| Total liabilities and shareholders' equity | $ | 1,067,269 | $ | 1,009,506 | ||
Summary Condensed Consolidated Statements of Cash Flows
For the Years Ended
(In thousands)
| 2025 | 2024 | |||||
| Cash and cash equivalents at beginning of the year | $ | 455,731 | $ | 442,626 | ||
| Net cash (used in) provided by operating activities | (10,712 | ) | 26,061 | |||
| Net cash used in investing activities | (16,340 | ) | (355,129 | ) | ||
| Net cash provided by financing activities | 12,371 | 343,881 | ||||
| Net foreign exchange difference on cash held | 26,659 | (1,708 | ) | |||
| Cash and cash equivalents at end of the year | $ | 467,709 | $ | 455,731 | ||
