Full Press Release Details
Immunocore reports first quarter financial results and provides a business update
KIMMTRAK (tebentafusp-tebn) net revenues of $70.3 million in Q1 2024; continuing to expand global access with 7 additional
launches since January 2024
Phase 1/2 brenetafusp (IMC-F106C; PRAME-A02) clinical data in post-checkpoint late-line cutaneous melanoma selected for oral presentation
(OXFORDSHIRE, England & CONSHOHOCKEN, Penn. & ROCKVILLE, Md., US, May 8, 2024) 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 first quarter ended March 31, 2024 and provided a business update.
"With our differentiated pipeline, we continue to work with a sense of urgency to bring KIMMTRAK to more patients; start the first registrational trial for
brenetafusp, our PRAME ImmTAC therapy; and explore innovative new TCR treatments across oncology, infectious diseases, and autoimmune diseases," said Bahija Jallal, Chief
Executive Officer of Immunocore.
"We continue to gain insights into our ImmTAC platform, drawing on data from over 1,000 patients treated in our clinical programs. I am particularly pleased
that the brenetafusp melanoma data has been selected for an oral presentation at ASCO," said Mohammed Dar, Head of Clinical Development and Chief Medical Officer.
"In addition, our KIMMTRAK registrational trial in late-line cutaneous melanoma, TEBE-AM, is recruiting ahead of schedule."
First Quarter 2024 Highlights (including post-period)
Total net product revenue (or "net sales") arising from the sales of KIMMTRAK (tebentafusp) was $70.3 million in the first quarter of 2024, an
increase of 36% over first quarter of 2023, of which $50.0 million was generated in the United States, $19.0 million in Europe (net of an increase in estimated reserves of $5.4 million) and $1.4 million in international regions.
Research & development expenses for the three months ended March 31, 2024 were $57.5 million, compared to $36.6 million for the same period in 2023.
Selling, general and administrative (SG&A) expenses for the three months ended March 31, 2024 were $39.3 million, compared to $32.6 million for the same period in 2023.
Net loss for the first quarter of 2024 was $24.4 million compared to a net loss of $19.4 million in the same period in 2023.
The first quarter basic and diluted loss per share was $0.49, compared to $0.40 for the first quarter of 2023.
Cash and cash equivalents at March 31, 2024 were $832.8 million. This includes net cash proceeds of $390.2 million from the Company's offering of convertible
notes in February 2024. The Company plans to use $50 million from the net proceeds to repay its existing loan by the end of 2024.
The Company's lead product, KIMMTRAK (tebentafusp-tebn), is approved in 38 countries and has been launched in 17 countries
globally to date for people with HLA-A02+ 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 for the KIMMTRAK opportunity, including:
continued global expansion in mUM, as well as the potential expansion into adjuvant uveal melanoma and 2L+ advanced cutaneous melanoma (CM).
Metastatic uveal melanoma
2L + advanced cutaneous melanoma
Adjuvant uveal (or ocular) melanoma
Brenetafusp (IMC-F106C) is the Company's lead PRAME-A02 ImmTAC bispecific protein being investigated in solid tumors. The Company is
evaluating brenetafusp, in combination with nivolumab, in a Phase 3 registrational trial (PRISM-MEL-301) in patients with first-line advanced cutaneous melanoma (CM). Brenetafusp is also being tested in monotherapy and combination in a Phase 1/2
clinical trial across multiple tumor types, including platinum resistant ovarian, non-small cell lung, and endometrial carcinoma. The Company's PRAME franchise also includes two new PRAME ImmTAC candidates: IMC-P115C (PRAME-A02 HLE), a half-life
extended version of brenetafusp for improved dosing convenience, and IMC-T119C (PRAME-A24), which is suitable for people with HLA-A24 allele.
PRISM-MEL-301 - First PRAME Phase 3 clinical trial with brenetafusp in first-line advanced cutaneous melanoma
Phase 1/2 clinical trial of brenetafusp (PRAME-A02) in multiple solid tumors
IMC-P115C (PRAME-A02 Half-Life Extended) & IMC-T119C (PRAME-A24)
Additional Oncology Candidates
IMC-R117C (first PIWIL1-A02 targeted immunotherapy) for colorectal and other gastrointestinal cancers
ImmTAV candidates for a functional cure in infectious diseases
The Company's bispecific TCR technology platform has potential to offer a new approach for the treatment of 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 clinical trials for people living with human immunodeficiency virus
(HIV) and people with chronic Hepatitis B infection (HBV).
Phase 1 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 Company is expanding its platform into autoimmune diseases with two new, first-in-class bispecific candidates recently entering its
pipeline. The key differentiator of the Company's ImmTAAI (Immune Modulating Monoclonal TCRs Against AutoImmune disease) platform is tissue-specific down modulation of the immune system whereby, when tethered to the tissue of interest, the new
candidates suppress pathogenic T cells via PD1 receptor agonism.
IMC-S118AI (pre-pro insulin A02 x PD1), intended for disease-modifying treatment in type 1 diabetes
Undisclosed non-HLA restricted (universal) candidate for inflammatory dermatological diseases
Basic and diluted loss per share was $0.49 for the quarter ended March 31, 2024, as compared to a basic and diluted loss per share of $0.40 for the same
period in 2023. Net loss for the quarter ended March 31, 2024 was $24.4 million, as compared to $19.4 million for the same period in 2023.
For the first quarter ended March 31, 2024, the Company generated net sales of $70.3 million compared to $51.6 million for the same period in 2023, due to
revenue from KIMMTRAK, of which $50.0 million was in the United States, $19.0 million (net of an increase in estimated reserves of $5.4 million) was in Europe, and $1.4 million was in the international regions. The increase in net sales was due
primarily to increased volume in the United States and global country expansion, as the Company continued its commercialization efforts.
For the first quarter ended March 31, 2024, research and development (R&D) expenses were $57.5 million, compared to $36.6 million for the same period in
2023. These increases were primarily driven by expenses incurred for the PRAME programs, including the initiation of the Company's Phase 3 clinical trial.
For the quarter ended March 31, 2024, SG&A expenses were $39.3 million, compared to $32.6 million for the same period in 2023. This increase was
primarily related to additional employees engaged in business support functions, including medical and regulatory activities, to support our growing pipeline and commercial activities.
Cash and cash equivalents were $832.8 million as of March 31, 2024, as compared to $442.6 million as of December 31, 2023. In February 2024, the Company
raised net cash proceeds of $390.2 million from a convertible notes offering with a six-year term and 2.50% interest rate. The Company plans to use $50 million from the net proceeds to repay its existing Pharmakon loan by the end of 2024.
As of December 31, 2023, the Company no longer qualified as a foreign private issuer for U.S. public company reporting purposes. Effective January 1, 2024,
it now files periodic reports on U.S. domestic filer forms with the Securities and Exchange Commission (SEC) and complies with other rules as required, including but not limited to presenting its financial results in press releases and Annual
Report on Form 10-K in accordance with U.S. GAAP, with such change being applied retrospectively including for the quarter ended March 31, 2023. See the Company's Annual Report on Form 10-K, and its Form 10-Q filed today with the SEC, for more
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 mobilizing monoclonal TCRs Against Virus) molecules are novel bispecifics that, like ImmTAC (Immune mobilizing monoclonal TCRs Against Cancer)
molecules, 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 chronic HBV.
About ImmTAAI molecules and autoimmune diseases
ImmTAAI (Immune mobilizing monoclonal TCRs Against Autoimmune) 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-MEL-301 - Phase 3 trial with brenetafusp (IMC-F106C, PRAME-A02) in 1L advanced cutaneous melanoma
The Phase 3 registrational trial will randomize patients with previously untreated, HLA-A*02:01-positive, 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 and will discontinue one of the
brenetafusp dose regimens 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 clinical trial in patients with multiple solid tumor cancers including non-small cell lung
cancer (NSCLC), small-cell lung cancer (SCLC), endometrial, ovarian, cutaneous melanoma, and breast 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 has initiated patient
enrollment into four expansion arms in cutaneous melanoma, ovarian, NSCLC, and endometrial carcinomas. The IMC-F106C-101 trial is adaptive and includes the option for Phase 2 expansion, allowing for approximately 100 patients treated per tumor type
in the Phase 1 and 2 expansion arms. Dose escalation continues in additional solid tumors as well as plans for combination arms with standards-of-care, including checkpoint inhibitors, chemotherapy, and tebentafusp.
About TEBE-AM - Phase 2/3 trial with tebentafusp (gp100xCD3) in second-line or later cutaneous melanoma
The clinical trial is randomizing patients with second-line or later cutaneous melanoma who have progressed on an anti-PD1, received prior ipilimumab and, if
applicable, received a BRAF kinase inhibitor. Patients will be randomized to one of three arms including tebentafusp, as monotherapy or in combination with an anti-PD1, and a control arm. The Phase 2 portion of the trial will include 40 patients
About the ATOM Phase 3 trial
The EORTC-led Phase 3 clinical trial will include sites in 10 EU countries and the United States and will randomize patients with HLA-A*02:01-positive
high-risk primary uveal melanoma after definitive treatment, by surgery or radiotherapy, and no evidence of metastatic disease on imaging. The clinical trial is expected to enroll a total of 290 patients who will be randomized 1:1 to one of two
arms: KIMMTRAK 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 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.
KIMMTRAK is a novel bispecific protein comprised of a soluble T cell receptor fused to an anti-CD3 immune-effector function. KIMMTRAK specifically targets