On August 7, 2025 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 second quarter ended June 30, 2025, and provided a business update (Press release, Immunocore, AUG 7, 2025, View Source [SID1234654980]).

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"We are delighted to announce robust revenue for the first half of 2025, a 32% year-over-year increase. This is testament to our steadfast dedication to expanding access to KIMMTRAK in the US and across the globe," said Bahija Jallal, Chief Executive Officer of Immunocore. "Our Phase 3 TEBE-AM trial remains on schedule to complete enrollment in the first half of 2026, and we are making good progress with our other two Phase 3 trials: PRISM-MEL-301 and ATOM. We are also advancing our Phase 1/2 trials in oncology and infectious diseases and preparing for the clinical trial applications for our autoimmune candidates, further underscoring the depth and diversity of our platform."

Second Quarter 2025 Highlights (including post-period)

KIMMTRAK
The Company’s lead product, KIMMTRAK (tebentafusp), is approved in 39 countries and has been launched in 28 countries globally to date for HLA-A*02:01 positive people with 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 global expansion 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 $98.0 million and $191.8 million for the three and six months ended June 30, 2025, respectively, representing increases of 30% and 32% respectively, as compared to the same periods in 2024.
15% year-over-year quarterly growth in the United States, with demand continuing to grow, duration of treatment extending, and the majority of patients treated in the community setting (70%).
71% year-over-year quarterly growth in Europe and in international regions combined, driven by increased demand, new country launches, and completion of price negotiations in France and Germany.
The Company signed a distribution and commercialization agreement with Er-Kim Pharmaceuticals for KIMMTRAK, for the treatment of HLA-A*02:01-positive adults with unresectable or metastatic uveal melanoma, in Turkey, the Middle East, North Africa, Caucasus and the Commonwealth of Independent States regions.
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.
The Phase 3 trial is enrolling three arms: tebentafusp monotherapy, tebentafusp in combination with pembrolizumab, and a control (investigator’s choice of therapy including options such as investigator’s choice of 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 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 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 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 has now activated over 150 clinical trial sites around the world, enrolling patients in the registrational Phase 3 clinical trial evaluating brenetafusp + nivolumab versus a control arm of either nivolumab or nivolumab + relatlimab for HLA-A*02:01 positive patients with first-line, advanced or metastatic cutaneous melanoma.
The trial is currently randomizing to three arms: two brenetafusp dose regimens (40 mcg and 160 mcg) and a control arm.
In a pre-planned analysis, the Independent Data Monitoring Committee (IDMC) reviewed the safety of the first 30 patients randomized and recommended to continue the study with no changes. The trial is on track for selection of the go-forward brenetafusp dose in the second half of 2025; this analysis will be conducted by an IDMC.
Despite approved therapies, there remains a need for improved progression-free survival and overall survival, 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 trial of brenetafusp in multiple solid tumors

The Company continues to evaluate brenetafusp in a Phase 1/2 trial in combination with non-platinum chemotherapies in platinum-resistant ovarian cancer (PROC) and with bevacizumab or with platinum chemotherapy 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 brenetafusp in combination with docetaxel and with osimertinib in earlier-line NSCLC.
The Company estimates that, across all solid tumors, the annual number of eligible patients worldwide who test positive for HLA-A*02:01 is up to 150,000.
IMC-P115C (PRAME-A02 Half-Life Extended) & IMC-T119C (PRAME-A24)

The Company is enrolling patients in the Phase 1 dose escalation trial, in multiple solid tumors, with IMC-P115C.

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.

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’. Two investigational candidates are in Phase 1 or Phase 1/2 trials for people living with human immunodeficiency virus (HIV) and people with chronic hepatitis B infection (HBV).

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.

Phase 1 trial of IMC-I109V (Envelope-A02) for people living with HBV or HBV-positive hepatocellular carcinoma

The Company will report data from the single ascending dose portion of the trial at the 2025 American Association for the Study of Liver Diseases’ Meeting in November 2025.

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.

IMC-S118AI (PPI-A02) for type 1 diabetes

The Company is on track to file a clinical trial application (CTA) or investigational new drug application (IND) for IMC-S118AI (PPI x PD1) in the second half of 2025.

IMC-U120AI (CD1a) for atopic dermatitis as the initial indication – first universal program

The Company plans to file a CTA/IND for IMC-U120AI (CD1a x PD1) in 2026.

Corporate update
On August 5, 2025, Rob Perez resigned as director of the Company, effective September 16, 2025. The Company expresses its appreciation to Mr. Perez for his dedication and service to Immunocore for the last 6 years.

Financial Results
For the second quarter ended June 30, 2025, the Company generated net product sales of $98.0 million compared to $75.3 million for the same period in 2024. Sales of KIMMTRAK were $64.1 million in the United States, $33.0 million in Europe, and $0.8 million in the 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.

For the quarter ended June 30, 2025, research and development (R&D) expenses were $69.0 million compared to $51.1 million for the same period in 2024. The increase was due to preclinical expenses related to the advancement of the Company’s autoimmune programs, including clinical material manufacturing for anticipated Phase 1 initiations, and clinical expenses related to the progression of the Company’s Phase 3 trials, primarily TEBE-AM and PRISM-MEL-301.

For the quarter ended June 30, 2025, SG&A expenses were $42.8 million compared to $38.6 million for the same period in 2024. The increase was primarily due to costs related to business support functions to support the Company’s growing pipeline and global commercial expansion.

Net loss for the quarter ended June 30, 2025, was $10.3 million, as compared to a net loss of $11.6 million for the same period in 2024. Basic and diluted loss per share was $0.20 for the quarter ended June 30, 2025, as compared to a basic and diluted loss per share of $0.23 for the same period in 2024.

Cash, cash equivalents and marketable securities were $882.8 million as of June 30, 2025, as compared to $820.4 million as of December 31, 2024. The Company expects to pay, in the second half of 2025, approximately $65 million in sales-related rebate accruals.