Full Press Release Details
Immunocore reports second quarter financial results and provides a business update
KIMMTRAK (tebentafusp-tebn) net revenues of $98.0 million in Q2 2025, growing by 30% year-over-year
Phase 3 TEBE-AM trial on track to complete enrollment in 1H 2026
Dose selection for PRISM-MEL-301 Phase 3 trial expected in 2H 2025
Phase 1 single ascending dose HBV data for IMC-I109V will be presented at the 2025 AASLD Liver Meeting
Cash, cash equivalents and marketable securities of $883 million as of June 30, 2025
Conference call today, August 7 at 8:00 AM ET, 1:00 PM BST
(OXFORDSHIRE, England & CONSHOHOCKEN, Penn. & GAITHERSBURG, Md., US, 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, today announced its financial results for the second quarter ended June 30, 2025, and provided a business update.
"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
Second Quarter 2025 Highlights (including post-period)
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
2L+ advanced cutaneous melanoma
Adjuvant uveal (or ocular) melanoma
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
PRISM-MEL-301 - First PRAME Phase 3 clinical trial with brenetafusp in first-line advanced cutaneous melanoma
Phase 1/2 clinical trial of brenetafusp in multiple solid tumors
IMC-P115C (PRAME-A02 Half-Life Extended) & IMC-T119C (PRAME-A24)
IMC-R117C (PIWIL1) for colorectal and other gastrointestinal cancers
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
Phase 1 trial of IMC-I109V (Envelope-A02) for people living with HBV or HBV-positive hepatocellular carcinoma
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
IMC-U120AI (CD1a) for atopic dermatitis as the initial indication - first universal program
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.
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
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.
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 mobilising monoclonal TCRs Against Virus) molecules are novel bispecifics that are designed to enable the immune system to recognize and eliminate virally
infected cells. Immunocore is advancing clinical candidates to cure patients with HIV and hepatitis B virus (HBV). The Company aims to achieve sustained control of HIV after patients stop anti-retroviral therapy (ART), without the risk of virological
relapse or onward transmission. This is known as functional cure'. For the treatment of HBV, the Company aims to achieve sustained loss of circulating viral antigens and markers of viral replication after stopping medication for people living with
About ImmTAAI 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 conditions, including Type 1 Diabetes and inflammatory
dermatological diseases.
About PRISM-MEL301 (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 melanoma to brenetafusp + nivolumab versus nivolumab or
nivolumab + relatlimab, depending on the country where the patient is enrolled. The trial will initially randomize to three arms: two brenetafusp dose regimens (40 mcg and 160 mcg) and control arm. One of the two brenetafusp dose regimens will be
discontinued after an initial review of the first 60 patients randomized to the two experimental arms (90 patients randomized total). 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 TEBE-AM - Phase 2/3 trial with tebentafusp (gp100xCD3) in second-line or later cutaneous melanoma
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, and 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 the United States and is randomizing HLA-A*02:01-positive patients with high-risk
primary uveal melanoma after definitive treatment, by surgery or radiotherapy, and no evidence of metastatic disease on imaging. The trial is expected to enroll a total of 290 patients who will be randomized 1:1 to one of two arms: tebentafusp as
monotherapy or observation. The primary endpoint of the trial is relapse-free survival (RFS), with secondary objectives of overall survival and safety and tolerability of tebentafusp. Exploratory objectives include the comparison of the
health-related quality of life between the treatment arms and the evaluation of the role of circulating tumor DNA (ctDNA) as a biomarker for the presence of residual disease.
About Uveal Melanoma
Uveal melanoma is a rare and aggressive form of melanoma, which affects the eye. Although it is the most common primary intraocular malignancy in adults, the diagnosis
is rare, 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.
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 the United States, European Union, Canada, Australia, and the United Kingdom.
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, 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