On November 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 third quarter ended September 30, 2026, and provided a business update.
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"Nearly five years after launch, KIMMTRAK remains the proven standard of care in HLA-A*02:01+ metastatic uveal melanoma. With TEBE-AM fully enrolled and data expected in the second quarter of 2027, we are advancing our mission to bring this therapy to even more patients," said Bahija Jallal, CEO of Immunocore. "Recently, our platform delivered two significant firsts: what we believe is the first data demonstrating clinical activity and a manageable safety profile with the combination of two T cell engagers in a solid tumor, and the first patient dosed in our tissue-specific autoimmune program for type 1 diabetes."
Third Quarter Highlights (including post-period)
Financial Results
For the third quarter ended September 30, 2026, total net product revenue (or ‘net sales’) arising from the sales of KIMMTRAK was $102.2 million, compared to $103.7 million for the same period in 2025. Q3 2026 sales were $62.2 million in the United States, $34.9 million in Europe, and $5.1 million in international regions. Revenue from net product sales compared to Q3 of 2025 was impacted by (i) United States wholesaler stocking that occurred in Q2 of 2026 and (ii) one additional week of sales in the U.S. in Q3 2025. Normalizing for the two US-related items above, underlying revenue growth for this quarter was approximately 10%, as compared to Q3 2025.
For the nine months ended September 30, 2026, net sales of KIMMTRAK were $324.8 million, compared to $295.5 million for the same period in 2025. For the nine months ended September 30, 2026, sales were $204.6 million in the United States, $103.5 million in Europe and $16.7 million in international regions. The increase in net product sales was due to continued growth in the United States, Europe and international regions.
Research and development (R&D) expenses for Q3 2026 were $74.7 million, compared to $70.6 million for Q3 2025. This increase was primarily due to advancement of our clinical programs, including our three Phase 3 trials.
Selling, general and administrative (SG&A) expenses for Q3 2026 were $40.5 million, compared to $39.8 million for Q3 2025.
Net loss for Q3 2026 was $14.2 million ($0.28 loss per share) compared to $0.2 million ($0.00 loss per share) for Q3 2025. Net loss for the nine months ended September 30, 2026, was $2.1 million ($0.04 loss per share) compared to $5.5 million ($0.11 loss per share) for the nine months ended September 30, 2025.
Cash, cash equivalents and marketable securities were $901.3 million as of September 30, 2026, as compared to $864.2 million as of December 31, 2025. The Company expects to pay, in the fourth quarter of 2026, approximately $120 million in sales-related rebate accruals.
KIMMTRAK
The Company’s lead product, KIMMTRAK, 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 all major markets where it is launched.
The Company sees three key growth areas for KIMMTRAK as it plans to expand patient reach, 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
The five-year overall survival (OS) data from the Phase 3 trial of KIMMTRAK in patients with unresectable or mUM, which were presented at the AACR (Free AACR Whitepaper) 2026 meeting, have been accepted by the European Medicines Agency for inclusion in the European SmPC (Summary of Product Characteristics). This addition to the SmPC will allow the Company to engage more broadly with healthcare professionals in the region about the data.
The Company received the International Prix Galien 2026 for KIMMTRAK in the orphan/rare diseases category. This is the fifth Prix Galien awarded to KIMMTRAK.
2L+ advanced cutaneous melanoma
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 CM, has achieved its target enrollment of 540 patients. The trial is event-driven and topline overall survival data is expected in the second quarter of 2027.
There is great unmet need in second- and later-line CM, with no therapy, to date, having shown an OS improvement following progression on checkpoint inhibitors in a randomized clinical trial. The Company estimates there are up to 4,000 HLA-A*02:01 positive, previously treated, advanced CM patients in the US and Europe.
Adjuvant uveal (or ocular) melanoma
The European Organisation for Research and Treatment of Cancer (EORTC) is enrolling patients in the Phase 3 Adjuvant Trial in Ocular Melanoma (ATOM) in Europe and the United States.
The Company estimates the HLA-A*02:01 positive, high-risk adjuvant uveal melanoma patient population could represent 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 solid tumors, including ovarian cancer, uveal melanoma, 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 continues enrollment of HLA-A*02:01 positive, first-line, advanced or metastatic cutaneous melanoma patients with 1:1 randomization to brenetafusp 160 mcg + nivolumab or a control arm of either nivolumab or nivolumab + relatlimab.
Despite approved therapies, there remains an unmet need for improved progression-free survival and OS in the first-line setting, where there is the potential to address an estimated 10,000 HLA-A*02:01 positive patients across the US and Europe.
Phase 1/2 clinical trials of brenetafusp and IMC-P115C (PRAME-A02 Half-Life Extended) in multiple solid tumors
Combination of KIMMTRAK and brenetafusp in metastatic uveal melanoma
As of June 2026, 22 HLA-A*02:01 positive adult patients with mUM received brenetafusp monotherapy at clinically active doses and 26 received the combination of KIMMTRAK and brenetafusp.
Among the 16 evaluable patients who received brenetafusp monotherapy in the second-line or later setting, overall response rate (ORR) was 19%, median duration of response (mDoR) was 14.5 months, median progression-free survival (mPFS) was 4.2 months, and median OS was 20.3 months.
Across the 17 evaluable first-line patients who received the combination, ORR was 29%, mDoR was 24.1 months, mPFS was 8.1 months, and median OS was not yet reached with 29 months of follow-up and 10 patients still on study. The two-year OS rate was 70%.
The most common brenetafusp monotherapy treatment-related adverse events (TRAEs) were reversible and manageable cytokine release syndrome (CRS) (73%) and rash (50%) consistent with the molecule’s mechanism of action. Grade 3/4 TRAEs were primarily transient lymphocyte decrease which resolved without intervention.
Combination regimens were generally well-tolerated. The most common TRAEs were Grade 1/2 CRS and rash (77% each). These attenuated over time with no Grade ≥3 CRS reported. No TRAE led to discontinuation or death.
The Company will present these data in a poster today at 10:00 a.m. MST / 12:00 p.m. ET and in an oral session, Saturday, November 7 at 1:45 p.m. MST / 3:45 p.m. ET, at the 2026 Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) Annual Meeting.
The Company believes these are the first data showing clinical activity and a manageable safety profile for a combination of two T cell engagers in a solid tumor.
Based on these data, the Company is planning to start DUET-UVEAL, a randomized Phase 2/3 trial, to evaluate the combination for the treatment of HLA-A*02:01-positive patients with mUM.
Brenetafusp in other tumors and IMC-P115C
After observing an initial brenetafusp monotherapy signal in platinum-resistant ovarian cancer (PROC), the Company is evaluating, as part of an ongoing Phase 1/2 trial, combination therapy with bevacizumab in earlier lines, including platinum-sensitive ovarian cancer (PSOC). In the same trial, the Company continues signal detection across multiple metastatic non-small cell lung cancer (NSCLC) cohorts, including combinations with standards of care in earlier-line NSCLC.
The Company expects to present clinical data for brenetafusp from the ovarian and lung cohorts in the Phase 1/2 trial at a medical conference later this year.
In parallel, the Company is continuing to enroll patients in the Phase 1 dose escalation trial evaluating IMC-P115C in patients with multiple solid tumors.
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 by eliminating the remaining virus in circulation after the patients stop taking their antiviral 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
In July 2026, at the International AIDS Society meeting in Rio de Janeiro, the Company presented translational data, from the first three cohorts of the multiple ascending dose (MAD) part of 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-treatment viral control.
The Company completed enrollment of additional patients at higher dose cohorts, up to 1200 mcg, as part of the MAD portion of the Phase 1/2 trial. Analysis of the new data is ongoing with results planned to be shared early next year.
Tissue-specific down modulation of the immune system for autoimmune diseases
The key differentiator of the ImmTAAI platform is down modulation of the immune system in a tissue-specific manner. The candidates achieve this by suppressing pathogenic T cells via PD1 receptor agonism only when tethered to the target tissue.
The Company recently announced that the first person with type 1 diabetes has been dosed in the Phase 1 trial of IMC-S118AI, its first tissue-specific autoimmune candidate.
IMC-S118AI is designed to bind preproinsulin on beta cells of the pancreas and deliver a PD-1 agonist signal to nearby auto-reactive T cells, thereby protecting the pancreatic beta cells from T cell attack, preserving beta cell mass, and avoiding systemic immune suppression.
The Company plans to file a clinical trial application (CTA) or investigational new drug (IND) application before the end of the year for its second autoimmune program, IMC-U120AI (CD1a x PD1), which is designed to target a variety of dermatological diseases including atopic dermatitis.
(Press release, Immunocore, NOV 6, 2026, View Source [SID1234674391])