Immunocore (IMCR) announces strategic priorities

Reaching more mUM patients globally with KIMMTRAK (tebentafusp) in 2025 through additional launches and increased community penetration

Enrolling three Phase 3 trials across multiple melanoma indications – potential data readouts beginning with TEBE-AM in 2026

Enrolling Phase 1/2 trial with brenetafusp combinations in ovarian and lung cancer; ongoing dose escalation with IMC-R117C (PIWIL1) and IMC-P115C (PRAME-A02-HLE)

Presenting initial HIV Phase 1 MAD data in the first quarter 2025

Progressing first-in-class, tissue-tethered autoimmune platform – Type 1 diabetes candidate on track for CTA submission in 2025; first universal candidate targeting CD1a initially for atopic dermatitis announced today

Company to present at 43^rd Annual J.P. Morgan Healthcare Conference on Wednesday, January 15, 2025, at 8:15 AM PST / 4:15 PM GMT

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, today set out its strategic priorities for 2025 including its plans for reaching more patients with melanoma and other diseases with high unmet needs.

The Company also highlights the potential of its melanoma franchise building on KIMMTRAK’s performance and reveals details of IMC-U120AI (CD1a x PD1), its first non-HLA restricted candidate. This second autoimmune therapy adds to the Company’s pipeline of ImmTAX candidates across three therapeutic areas. The updates will be shared during a presentation at the 43rd Annual J.P. Morgan Healthcare Conference in San Francisco.

“Since launching the world’s first bispecific TCR therapy, we have made KIMMTRAK available to patients in 23 countries. We are now building a melanoma franchise through life cycle management with two Phase 3 KIMMTRAK trials, and with the brenetafusp Phase 3 trial in first-line melanoma. We anticipate topline results for the first of these three pivotal trials in 2026,” said Bahija Jallal, Immunocore’s Chief Executive Officer. “In 2025, we plan to report initial multiple ascending dose data for our HIV TCR therapy, expand enrollment in multiple oncology Phase 1/2 trials, including our PRAME and PIWIL1 programs, and advance our autoimmune candidates toward the clinic.”

Key Strategic Priorities 2025

Immunocore’s mission is to bring transformative medicines to patients with cancer, infectious diseases, and autoimmune diseases. In 2025, the Company’s priorities will be:

• Building a melanoma franchise – reaching more metastatic uveal melanoma (mUM) patients and delivering KIMMTRAK’s lifecycle management program through two ongoing registrational Phase 3 trials (TEBE-AM and ATOM). The Company is also enrolling a third registrational trial, PRISM-MEL-301, evaluating brenetafusp in first-line melanoma.

• Advancing the clinical portfolio – enrolling patients in multiple Phase 1 oncology trials with brenetafusp (PRAME-A02), IMC-P115C (PRAME-A02-HLE), IMC-R117C (PIWIL1-A02), and IMC-M113V in HIV.

• Innovating for sustainable growth – planning to submit a clinical trial application (CTA) for the Company’s two autoimmune disease candidates: IMC-S118AI (PPI x PD1) by year end 2025 and IMC-U120AI (CD1a x PD1) in 2026.

Building a melanoma franchise

In 2025, Immunocore will continue expanding access to KIMMTRAK to more patients with mUM globally, through additional launches and approvals, building on the 38 country approvals and 23 launches as of year-end 2024.

In countries where KIMMTRAK has been launched, the Company will continue to focus on reaching more patients in the community and highlighting the three-year overall survival data.

The Company is enrolling patients in three registrational Phase 3 trials, with the first topline results anticipated in 2026 and a potential to reach up to 15,000 additional patients across three new melanoma indications:

• TEBE-AM – trial evaluating KIMMTRAK for HLA-A*02:01 in second-line and later cutaneous melanoma – with a potential to address up to 4,000 previously treated advanced cutaneous melanoma patients. This is an area of great unmet need where no therapy has shown an Overall Survival (OS) improvement in a randomized clinical trial.

• PRISM-MEL-301 – trial evaluating brenetafusp + nivolumab versus a control arm of either nivolumab or nivolumab + relatlimab for HLA-A*02:01 patients with first-line, advanced or metastatic cutaneous melanoma. Despite approved therapies, there remains an unmet need, and there is the potential to address an estimated 10,000 patients.

• ATOM – led by the European Organisation for Research and Treatment of Cancer (EORTC) to evaluate KIMMTRAK as adjuvant therapy for uveal (or ocular) melanoma for HLA-A*02:01 patients. The Company estimates that the HLA-A*02:01 high risk adjuvant uveal melanoma patient population could be up to 1,200 patients.

Advancing the clinical portfolio

In 2025, beyond executing the three ongoing registrational trials in three additional melanoma indications, Immunocore will continue to enroll patients in the multiple ongoing Phase 1 trials in oncology and infectious diseases, to evaluate safety and efficacy across several cohorts. The Company will also use its translational medicine (i.e. ctDNA, T cell fitness) dataset from more than a thousand patients treated in the clinic with KIMMTRAK and its investigational therapies to inform clinical development.

PRAME portfolio

The Company is evaluating 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 has recently started enrolling patients in the Phase 1 dose escalation trial with IMC-P115C (PRAME-A02-HLE) in multiple solid tumors. IMC-P115C is the Company’s half-life extended ImmTAC therapy – targeting the same PRAME peptide and with the same CD3 effector and TCR specificity as brenetafusp – and is designed to improve patient convenience by reducing the frequency of treatment administration.

PIWIL1-A02

The third ongoing Phase 1 clinical trial in oncology is evaluating the safety and clinical activity of IMC-R117C (targeting PIWIL1) 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.

Infectious diseases

The Company continues to enroll people living with HIV (PLWH) in the multiple ascending dose (MAD) part of the Phase 1 clinical trial with IMC-M113V and will present initial data during the first quarter of 2025. The trial aims to identify a safe and tolerable dosing schedule, test whether IMC-M113V could lead to reduction in the viral reservoir and, after stopping all therapies (antiretroviral therapies and IMC-M113V), delay or prevent HIV rebound (known as functional cure). A biologically active dose has been reached, and the Company is enrolling more PLWH to characterize anti-viral activity and to explore higher doses.

The Company plans to present data from the single ascending dose (SAD) portion of the Phase 1 trial with IMC-I109V for people living with hepatitis B virus (HBV) in 2025.

Innovating for sustainable growth

Immunocore will continue pioneering immunotherapy and unlocking the full potential of its platform to generate transformative treatments for patients, by using different targeting mechanisms and immune effectors for next-generation bispecific therapies.

This approach is most recently illustrated by the Company’s second candidate in autoimmune diseases, IMC-U120AI, which is also its first non-HLA restricted (i.e. universal for all populations) program.

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.

In the second half of 2025, the Company plans to file a CTA for its first candidate – IMC-S118AI (PPI x PD1) – targeted specifically to the pancreatic beta-cell and intended as a disease-modifying treatment in type 1 diabetes. IMC-S118AI recognizes a peptide from pre-pro-insulin presented by HLA-A02 on beta cells, coupled with a PD1 agonist effector arm.

The Company announced today its second autoimmune candidate. IMC-U120AI (CD1a x PD1) is a CD1a-tethered PD1 agonist ImmTAAI therapy. CD1a is an HLA-like protein that is expressed on skin and mucosal antigen presenting cells, such as Langerhans cells. It plays an important role in triggering allergic inflammation in atopic dermatitis and potentially other immune diseases. The Company plans to file a CTA in 2026 for a Phase 1 trial in atopic dermatitis for this candidate.

Corporate updates

In January 2025, Travis Coy was appointed Executive Vice President, Chief Financial Officer and Head of Corporate Development. Travis brings with him over 20 years of experience working at Eli Lilly and Company, where his most recent role was Vice President, Head of Transactions and M&A, Corporate Business Development.

Preliminary Year-End 2024 cash position

Preliminary unaudited cash, cash equivalents and marketable securities were approximately $820 million as of December 31, 2024. In the fourth quarter of 2024, the Company prepaid in full the loan outstanding under the Pharmakon Loan Agreement and also paid sales-related rebate accruals. These preliminary unaudited results are subject to adjustment. Immunocore will report its final and complete fourth-quarter and full-year 2024 financial results in late February 2025, and the actual results could be different from these preliminary unaudited financial results.

43^rd Annual J.P. Morgan Healthcare Conference

The Company has updated its corporate presentation to reflect its business and strategic updates. The Immunocore management team will discuss these updates during a live and webcast presentation at the 43rd Annual J.P. Morgan Healthcare Conference, on Wednesday, January 15, 2025, at 8:15 a.m. Pacific Standard Time (PST). The presentation and webcast will be available in the ‘Investors/Media’ section of Immunocore’s website at www.immunocore.com. A replay of the presentation will be made available for a limited time.

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