On May 6, 2026 Immunocore Holdings plc (Nasdaq: IMCR) ("Immunocore" or the "Company"), a commercial-stage biotechnology company pioneering and delivering transformative immunomodulating medicines to radically improve outcomes for patients with cancer, infectious diseases and autoimmune diseases, reported its financial results for the first quarter ended March 31, 2026, and provided a business update.
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"We are proud to report another quarter of strong commercial performance, with KIMMTRAK generating $107 million in net revenues in Q1 2026," said Bahija Jallal, CEO of Immunocore. "The five-year overall survival (OS) data from our Phase 3 trial presented at AACR (Free AACR Whitepaper) is a landmark moment. It is the longest OS follow-up ever reported in a randomized trial in metastatic uveal melanoma and underscores the long-term benefit KIMMTRAK delivers to patients. In parallel, we are executing with discipline across our pipeline."
First Quarter Highlights (including post-period)
Financial Results
For the first quarter of 2026 (Q1 2026), total net product revenue (or ‘net sales’) arising from the sales of KIMMTRAK was $106.7 million, compared to $93.9 million for the same period in 2025. Q1 2026 sales were $67.4 million in the United States, $34.4 million in Europe, and $4.8 million in international regions. The increase in net product sales was due to increased volumes in the United States and Europe as well as global country expansion.
Research & development (R&D) expenses for Q1 2026 were $61.1 million, compared to $56.5 million for Q1 2025. This increase was primarily due to clinical expenses related to the progression of our Phase 3 trials, primarily PRISM-MEL-301.
Selling, general and administrative (SG&A) expenses for Q1 2026 were $37.9 million, compared to $40.2 million for Q1 2025. This decrease was primarily due to increases in forfeitures of share-based compensation.
Net income for Q1 2026 was $13.0 million compared to $5.0 million for Q1 2025.
The Q1 2026 diluted income per share was $0.25 compared to $0.10 for Q1 2025.
Cash, cash equivalents and marketable securities were $844.9 million as of March 31, 2026.
KIMMTRAK
The Company’s lead product, KIMMTRAK (tebentafusp), is approved in 39 countries and has been launched in over 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 $106.7 million for the first quarter ended March 31, 2026, representing an increase of 13.6%, as compared to the same period in 2025.
19.1% year-over-year sales growth in the United States with mean duration of treatment of 14 months.
4.9% year-over-year sales growth in Europe, driven by increased demand and launches in European markets.
Five-year overall survival (OS) data from the landmark Phase 3 trial of KIMMTRAK in patients with unresectable or mUM were presented in an oral session at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) 2026 meeting, representing the longest follow-up reported for any T cell engager in a solid tumor. In this study of 378 patients, KIMMTRAK doubled the likelihood of being alive at five years with an OS rate of 16% versus 8% in the control arm (HR 0.67), while demonstrating a median OS of 21.6 months compared to 16.9 months for investigator’s choice.
The OS benefit with KIMMTRAK was observed regardless of known poor prognostic factors at baseline (high tumor burden [≥10cm]; elevated lactate dehydrogenase [LDH]) 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.
The data also confirmed that the OS benefit was primarily driven by KIMMTRAK rather than subsequent therapies. Among patients treated with KIMMTRAK who were alive at five years, nearly half (44%) received only KIMMTRAK, while among patients in the control arm alive at the same time point, 86% subsequently received KIMMTRAK.
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
The Company is enrolling 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 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).
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 (MAD) part of the Phase 1/2 clinical trial to identify a safe and tolerable dose.
Additional Phase 1 MAD data is expected 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.
Corporate update
The Company will present the following two posters at the 2026 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Meeting:
Title: Phase 1 evaluation of the PRAME-targeted ImmTAC brenetafusp in advanced melanoma (Mel). (Abstract number: 9527)
Session: Melanoma/Skin Cancers (Poster Board: 243)
Date and Time: May 31, 2026, 9:00 AM-12:00 PM CDT
Title: Effect of IL7 on ImmTAC-mediated killing by T cells in vitro and T-cell fitness in patients. (Abstract number: 2662)
Session: Developmental Therapeutics – Immunotherapy (Poster Board: 452)
Date and Time: May 30, 2026, 1:30 PM-4:30 PM CDT
(Press release, Immunocore, MAY 6, 2026, View Source [SID1234665188])