KIMMTRAK®
(tebentafusp-tebn) net revenues of $75.3 million in 2Q
2024 driven by US growth
Registrational Phase 3 TEBE-AM trial with
KIMMTRAK in previously treated cutaneous melanoma ongoing,
following conversion of Phase 2/3 trial – expect to complete
enrollment in 1H 2026
Registrational Phase 3 (PRISM-MEL-301)
evaluating brenetafusp + nivolumab in first-line
cutaneous melanoma started randomization
Presented Phase 1 data of brenetafusp in
late-line cutaneous melanoma patients at ASCO 2024; late-line
high-grade serous ovarian data to be presented at ESMO
2024
Conference call today, August 8, 2024 at
8:00 AM ET, 1:00 PM BST
(OXFORDSHIRE, England & CONSHOHOCKEN, Penn.
& ROCKVILLE, Md., US, 08 August 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 second quarter ended
June 30, 2024 and provided a business update.
“Over the next 18 months, we will present
multiple data read-outs including brenetafusp and the HIV MAD data,
while progressing three Phase 3 trials, with registrational data
expected in 2026, 2027 and 2028. We will also advance our new
autoimmune and oncology clinical and pre-clinical programs,” said
Bahija Jallal, Chief Executive Officer of
Immunocore.
“In the first half of 2024, we expanded
KIMMTRAK’s reach in the US community setting and globally with 9
new launches and 2 additional reimbursement agreements, in the
context of a challenging market access environment in Europe,”
said Ralph Torbay, Immunocore’s Chief Commercial
Officer. “We are exploring the potential of KIMMTRAK to
benefit more patients and deliver revenue growth beyond metastatic
uveal melanoma with our two ongoing Phase 3 registrational trials
in previously treated cutaneous melanoma and in adjuvant uveal
melanoma.”
Second Quarter 2024 Highlights
(including post-period)
KIMMTRAKThe Company’s lead
product, KIMMTRAK, is approved in 38 countries and has been
launched in 19 countries globally to date for HLA-A*02:01 positive
patients with unresectable or 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 2L+ advanced cutaneous
melanoma (CM) and adjuvant uveal melanoma.
Metastatic uveal melanoma
- In Q2 2024, KIMMTRAK net product
sales were $75 million and $146 million for the three and six
months ended June 30, respectively, representing increases of 32%
and 34% respectively, compared to the prior year periods.
- US growth driven by increased
penetration in community setting and duration of treatment.
- As of July 1, 2024, KIMMTRAK is
launched in 19 countries. Reimbursement agreements reached in
Sweden and Poland with expected launches in second half of
2024.
- Published data at ASCO 2024
demonstrating that KIMMTRAK-treated mUM patients with stable
disease and any confirmed tumor reduction have similar clinical
outcomes to patients with RECIST partial response.
- New T cell fitness insights from
the Phase 2 KIMMTRAK trial in previously treated uveal melanoma
will be an oral presentation during the “Basic Science &
Translational Research” proffered session at the 2024 ESMO
Congress.
2L + Previously treated cutaneous
melanoma
- Converted Phase 2/3 TEBE-AM trial
into registrational Phase 3 trial, which will continue three arms:
KIMMTRAK monotherapy, KIMMTRAK in combination with pembrolizumab,
and control.
- Over 120 patients already
randomized into the original Phase 2 portion will now be included
in the Phase 3 trial, which we expect will accelerate time to final
endpoint by up to 12 months.
- Expect enrollment to be completed in
the first half of 2026.
Adjuvant uveal (or ocular)
melanoma
- Randomization in the ATOM Phase 3
trial, led by the European Organisation for Research and Treatment
of Cancer (EORTC), expected to start in the second half of
2024.
PRAME franchiseBrenetafusp
(IMC-F106C) 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 (CM) and in a
Phase 1/2 clinical trial, as monotherapy and in combination, across
multiple tumor types, including platinum resistant ovarian,
non-small cell lung (NSCLC), and endometrial carcinoma.
PRISM-MEL-301 – First PRAME Phase 3
clinical trial with brenetafusp in first-line advanced or
metastatic HLA-A*02:01 positive cutaneous melanoma
- In 2Q, the Company randomized the
first patient in PRISM-MEL-301.
- Trial is evaluating brenetafusp +
nivolumab versus a control arm of either nivolumab or nivolumab +
relatlimab.
Phase 1/2 clinical trial of brenetafusp
(PRAME-A02) in multiple solid tumors
- Presented data at ASCO 2024 from
the Phase 1/2 trial with brenetafusp in patients with late-line CM
showing promising brenetafusp monotherapy disease control (partial
response and stable disease), progression free survival (PFS), and
circulating tumor DNA (ctDNA) molecular response. In PRAME positive
patients, the disease control rate was 58% and median PFS was 4.2
months. Brenetafusp was well tolerated as monotherapy and in
combination with anti-PD1.
- Clinical data from monotherapy and
chemotherapy combinations in heavily pre-treated platinum-resistant
high grade serous ovarian cancer will be presented as a poster at
ESMO 2024 (Phase 1 safety and efficacy of brenetafusp, a PRAME ×
CD3 ImmTAC T cell engager, in platinum resistant ovarian cancer
(PROC), Poster 750P). The next step is to further evaluate
brenetafusp in combination with non-platinum chemotherapies in
platinum resistant disease and to test the combination with
platinum chemotherapy and with bevacizumab in platinum sensitive
disease.
- The Company plans to present
clinical data for brenetafusp in late-line non-small cell lung
cancer (NSCLC) in the fourth quarter of 2024. The next step is to
evaluate brenetafusp in combinations with docetaxel and with
osimertinib in earlier-line NSCLC.
IMC-P115C (PRAME-A02 Half-Life Extended)
& IMC-T119C (PRAME-A24)
- Submitted Clinical Trial Application
(CTA) for IMC-P115C in the second quarter of 2024, which is
currently under review.
- Remain on track for regulatory
submission of Investigational New Drug (IND) or Clinical Trial
Application (CTA) for IMC-T119C in the fourth quarter of 2024.
Additional Oncology Candidates
IMC-R117C (first PIWIL1-A02 targeted
immunotherapy) for colorectal and other gastrointestinal
cancersThe Company has leveraged its proprietary
peptidomic database to validate a novel target, PIWIL1. PIWIL1 is a
negative prognostic marker and is expressed across a range of
tumors including colorectal, which is historically insensitive to
immune checkpoints, as well as gastro-esophageal, and pancreatic
cancer.
- The CTA for IMC-R117C was accepted in
April 2024 by the EMA, and the Phase 1 clinical trial is expected
to start in the second half of 2024.
ImmTAV Candidates for a Functional Cure in
Infectious DiseasesThe 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
- The objective of the clinical trial
is to identify a safe and tolerable dose and evaluate whether
IMC-M113V could lead to reduction in the viral reservoir and, after
stopping antiretroviral therapies (ART) and IMC-M113V, delay or
prevent HIV rebound.
- Historically, viral rebound occurs
rapidly after ART interruption at a median of 2 weeks, and
approximately 98% of people will have >200 viral copies/ml (the
threshold for transmission) by week 8 (Feher C et. al, 2019).
- In the MAD portion, the Company has
enrolled 3 cohorts with 5 people living with HIV (PLWH) per cohort.
The highest tested dose is 300 mcg.
- A biologically active dose has been
reached and the Company plans to enroll more PLWH to characterize
anti-viral activity and to explore higher doses. This will move the
planned data release from fourth quarter of 2024 into first quarter
of 2025.
Phase 1 trial of IMC-I109V (Envelope-A02)
for people living with HBV or HBV-positive hepatocellular
carcinoma
- Patient enrollment continues into
the single ascending dose portion of the clinical trial.
Tissue-specific Down Modulation of the
Immune System for Autoimmune DiseasesThe 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
- IMC-S118AI recognizes a peptide
from pre-proinsulin presented by HLA-A02 on beta cells, coupled
with a PD1 agonist effector arm.
- IMC-S118AI is advancing towards GMP
manufacturing in 2024.
Undisclosed non-HLA restricted (universal)
candidate for inflammatory dermatological diseases
- The candidate is an antigen presenting
cell (APC) tethered ImmTAAI and is not HLA restricted (i.e.
universal for all populations).
ESMO Congress 2024 - Presentation and
poster details
Title:
Phase 1 safety and efficacy of brenetafusp, a PRAME × CD3 ImmTAC T
cell engager, in platinum resistant ovarian cancer
(PROC) (Poster 750P)Presenting author: Claire
F. FriedmanSession: Poster Session –
Gynaecological cancers, Saturday 14 September 2024; 09:00 a.m. -
5:00 p.m. CEST / 04:00 a.m. - 12:00 p.m. ET
Title:
Chemotherapy and hypomethylating agents enhance anti-tumor activity
of PRAME ImmTAC Presenting author: Adel
BenlahrechSession: Poster Session –
Investigational immunotherapy, Saturday 14 September 2024; 09:00
a.m. - 5:00 p.m. CEST / 04:00 a.m. - 12:00 p.m. ET (Poster
1021P)
Title:
Association of a blood T cell fitness gene signature with clinical
benefit from ImmTAC bispecific T cell engagers (Oral
66O) Presenting
author: Joseph SaccoSession:
Proffered paper session 2 – Basic Science
and Translational Research, Monday 16 September 2024;
02:45-04:15 p.m. CEST / 09:45-11:15 a.m. ET
Financial ResultsFor the second
quarter ended June 30, 2024, the Company generated net product
sales of $75.3 million compared to $56.9 million for the same
period in 2023. This increase was due to revenue from KIMMTRAK, of
which $55.6 million was in the United States, $15.4 million (net of
an increase in estimated reserves related to prior periods of $6.7
million) in Europe, and $4.3 million in international regions. The
increase in net product sales was due primarily to increased volume
in the United States and global country expansion, as the Company
continued its commercialization efforts.
For the second quarter ended June 30, 2024,
research and development (R&D) expenses were $51.1 million,
compared to $38.2 million for the same period in 2023. This
increase was primarily driven by expenses incurred for the PRAME
programs, including the initiation of the Company’s Phase 3
clinical trial.
For the quarter ended June 30, 2024, SG&A
expenses were $38.6 million, compared to $35.0 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.
Basic and diluted loss per share was $0.23 for the
quarter ended June 30, 2024, as compared to a basic and diluted
loss per share of $0.35 for the same period in 2023. Net loss for
the quarter ended June 30, 2024 was $11.6 million, as compared to
$17.0 million for the same period in 2023.
Cash, cash equivalents, and marketable securities
at June 30, 2024 were $859.6 million. The Company plans to use $50
million to repay its existing loan by the end of 2024, and also
expects to pay approximately $40 million in sales-related rebate
accruals in the second half of 2024.
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 are designed to
enable the immune system to recognize and eliminate virally
infected cells. Immunocore is advancing clinical candidates to
achieve functional cure for 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
ImmTAAITM 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 diseases,
including type 1 diabetes and inflammatory dermatological
diseases.
About PRISM-MEL-301 (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 a 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 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 is enrolling patients into three
expansion arms in NSCLC, as well as ovarian 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 3 registrational
trial with tebentafusp in previously treated advanced 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 – or a control arm.
The primary endpoint is overall survival.
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 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 comparison of health-related quality of life between the
treatment arms and 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 affecting 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.
About
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 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
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
Elevations in liver enzymes occurred in 65% of
patients treated with KIMMTRAK. Monitor alanine aminotransferase
(ALT), aspartate aminotransferase (AST), and total blood bilirubin
prior to the start of and during treatment with KIMMTRAK. Withhold
KIMMTRAK according to severity.
Embryo-Fetal Toxicity
KIMMTRAK may cause fetal harm. Advise pregnant
patients of potential risk to the fetus and patients of
reproductive potential to use effective contraception during
treatment with KIMMTRAK and 1 week after the last dose.
The most common adverse reactions (≥30%) in
patients who received KIMMTRAK were cytokine release syndrome,
rash, pyrexia, pruritus, fatigue, nausea, chills, abdominal pain,
edema, hypotension, dry skin, headache, and vomiting. The most
common (≥50%) laboratory abnormalities were decreased lymphocyte
count, increased creatinine, increased glucose, increased AST,
increased ALT, decreased hemoglobin, and decreased phosphate.
For more information, please see full Summary of
Product Characteristics (SmPC) or full U.S. Prescribing Information
(including BOXED WARNING for CRS).
About KIMMTRAKConnect
Immunocore is committed to helping patients who
need KIMMTRAK obtain access via our KIMMTRAKConnect program. The
program provides services with dedicated nurse case managers who
provide personalized support, including educational resources,
financial assistance, and site of care coordination. To learn more,
visit KIMMTRAKConnect.com or call 844-775-2273.
About Immunocore
Immunocore is a commercial-stage biotechnology
company pioneering the development of a novel class of TCR
bispecific immunotherapies called ImmTAX – Immune mobilizing
monoclonal TCRs Against X disease – designed to treat a broad range
of diseases, including cancer, autoimmune diseases and infectious
diseases. Leveraging its proprietary, flexible, off-the-shelf
ImmTAX platform, Immunocore is developing a deep pipeline in
multiple therapeutic areas, including nine active clinical and
pre-clinical programs in oncology, infectious diseases, and
autoimmune diseases. The Company’s most advanced oncology TCR
therapeutic, 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.
Forward Looking Statements
This press release contains “forward-looking
statements” within the meaning of the safe harbor provisions of the
Private Securities Litigation Reform Act of 1995. Words such as
“may”, “will”, “believe”, “expect”, “plan”, “anticipate” and
similar expressions (as well as other words or expressions
referencing future events or circumstances) are intended to
identify forward-looking statements. All statements, other than
statements of historical facts, included in this press release are
forward-looking statements. These statements include, but are not
limited to, statements regarding the commercial performance of
KIMMTRAK; the potential benefits and advantages that KIMMTRAK will
provide for patients, including its potential for expansion into
other indications such as cutaneous and adjuvant uveal melanoma;
expectations regarding the design, progress, timing, enrollment,
randomization, scope, expansion, funding, and results of the
Company’s existing and planned clinical trials; the timing and
sufficiency of clinical trial outcomes to support potential
approval of any of the Company’s product candidates or those of, or
combined with, its collaboration partners; the Company’s goals to
develop and commercialize product candidates based on its KIMMTRAK
platform alone or with collaboration partners; the expected
submission of investigational new drug applications or clinical
trial applications; the potential regulatory approval, expected
clinical benefits and availability of the Company’s product
candidates; and the use of the Company’s cash, cash equivalents and
maketable securities. Any forward-looking statements are based on
management’s current expectations and beliefs of future events and
are subject to a number of risks and uncertainties that could cause
actual events or results to differ materially and adversely from
those set forth in or implied by such forward-looking statements,
many of which are beyond the Company’s control. These risks and
uncertainties include, but are not limited to, the impact of
worsening macroeconomic conditions on the Company’s business,
financial position, strategy and anticipated milestones, including
Immunocore’s ability to conduct ongoing and planned clinical
trials; Immunocore’s ability to obtain a clinical supply of current
or future product candidates or commercial supply of KIMMTRAK or
any future approved products; Immunocore’s ability to obtain and
maintain regulatory approval of its product candidates, including
KIMMTRAK; Immunocore’s ability and plans in continuing to establish
and expand a commercial infrastructure and to successfully launch,
market and sell KIMMTRAK and any future approved products;
Immunocore’s ability to successfully expand the approved
indications for KIMMTRAK or obtain marketing approval for KIMMTRAK
in additional geographies in the future; the delay of any current
or planned clinical trials, whether due to patient enrollment
delays or otherwise; Immunocore’s ability to successfully
demonstrate the safety and efficacy of its product candidates and
gain approval of its product candidates on a timely basis, if at
all; competition with respect to market opportunities; unexpected
safety or efficacy data observed during preclinical studies or
clinical trials; actions of regulatory agencies, which may affect
the initiation, timing and progress of clinical trials or future
regulatory approval; Immunocore’s need for and ability to obtain
additional funding, on favorable terms or at all, including as a
result of worsening macroeconomic conditions, including changes in
inflation and interest rates and unfavorable general market
conditions, and the impacts thereon of the war in Ukraine, the
conflict between Hamas and Israel, and global geopolitical tension;
Immunocore’s ability to obtain, maintain and enforce intellectual
property protection for KIMMTRAK or any of its product candidates
it or its collaborators are developing; and the success of
Immunocore’s current and future collaborations, partnerships or
licensing arrangements. These and other risks and uncertainties are
described in greater detail in the section titled "Risk Factors" in
Immunocore’s filings with the Securities and Exchange Commission,
including Immunocore’s most recent Annual Report on Form 10-K for
the year ended December 31, 2023 filed with the Securities and
Exchange Commission on February 28, 2024, as well as discussions of
potential risks, uncertainties, and other important factors in the
Company’s subsequent filings with the SEC. All information in this
press release is as of the date of the release, and the Company
undertakes no duty to update this information, except as required
by law.
Contact Information
Immunocore Sébastien Desprez,
Head of CommunicationsT: +44 (0) 7458030732E:
sebastien.desprez@immunocore.comFollow on Twitter: @Immunocore
Investor RelationsClayton
Robertson, Head of Investor RelationsT: +1 (215) 384-4781E:
ir@immunocore.com
Immunocore Holdings plc |
|
|
|
|
Condensed Consolidated Statement of
Operations |
|
|
|
|
Comparison of the Quarters and Year to Date Ended June 30,
2024 and 2023 |
|
|
|
|
(In thousands, except share and per share
data)(Unaudited) |
|
|
|
|
|
|
|
|
|
|
Quarter Ended |
|
Year to Date |
|
June 30, 2024 |
June 30, 2023 |
|
June 30, 2024 |
June 30, 2023 |
Product revenue, net |
$75,347 |
$56,932 |
|
$145,689 |
$108,513 |
Collaboration revenue |
53 |
2,825 |
|
213 |
5,903 |
Total revenue |
75,400 |
59,757 |
|
145,902 |
114,416 |
Cost of product revenue |
(1,707) |
(346) |
|
(1,953) |
(562) |
Research and development expense |
(51,072) |
(38,158) |
|
(108,531) |
(74,730) |
Selling, general, & administrative expense |
(38,638) |
(35,010) |
|
(77,925) |
(67,577) |
Loss from operations |
(16,017) |
(13,757) |
|
(42,507) |
(28,453) |
Interest income |
6,239 |
4,278 |
|
14,485 |
7,406 |
Interest expense |
(4,277) |
(1,274) |
|
(7,516) |
(2,524) |
Foreign currency loss |
(508) |
(5,880) |
|
(2,914) |
(11,893) |
Other income (expense), net |
4,433 |
(190) |
|
4,243 |
(515) |
Net loss before income taxes |
(10,130) |
(16,823) |
|
(34,209) |
(35,979) |
Income tax expense |
(1,486) |
(191) |
|
(1,843) |
(484) |
Net loss |
$(11,616) |
$(17,014) |
|
$(36,052) |
$(36,463) |
|
|
|
|
|
|
|
|
|
|
|
Basic and diluted net loss per share |
$(0.23) |
$(0.35) |
|
$(0.72) |
$(0.75) |
|
|
|
|
|
Basic and diluted weighted average number of shares |
50,014,086 |
48,694,047 |
|
49,944,767 |
48,440,318 |
|
|
|
|
|
|
|
|
|
|
|
Immunocore Holdings plc |
|
|
Condensed Consolidated Balance Sheets |
|
|
As of June 30, 2024 |
|
|
(In thousands)(Unaudited) |
|
|
|
|
|
|
Jun '24 |
Dec '23 |
ASSETS |
|
|
Current assets |
|
|
Cash and cash equivalents |
$504,985 |
$442,626 |
Marketable securities |
354,612 |
- |
Accounts receivable, net |
60,245 |
52,093 |
Prepaid expenses and other current assets |
33,555 |
29,600 |
Inventory, net |
3,462 |
4,501 |
Total current assets |
956,859 |
528,820 |
Property and equipment, net |
7,684 |
9,215 |
Operating lease right of use assets, net |
32,435 |
33,520 |
Deferred tax assets, net |
10,111 |
10,973 |
Other non-current assets |
16,276 |
14,473 |
Total assets |
$1,023,365 |
$597,001 |
|
|
|
Liabilities and shareholders’ equity |
|
|
Current liabilities |
|
|
Accounts payable |
$19,947 |
$17,798 |
Accrued expenses and other current liabilities |
163,762 |
119,835 |
Operating lease liabilities, current |
1,387 |
1,388 |
Total current liabilities |
185,096 |
139,021 |
Accrued expenses, non-current |
2,089 |
978 |
Deferred revenue, non-current |
5,477 |
5,515 |
Operating lease liabilities, non-current |
33,445 |
34,633 |
Interest-bearing loans and borrowings |
438,121 |
48,011 |
Total liabilities |
664,228 |
228,158 |
|
|
|
Shareholders' equity |
|
|
Ordinary shares |
135 |
134 |
Deferred shares |
1 |
1 |
Additional paid-in capital |
1,174,147 |
1,149,643 |
Accumulated deficit |
(780,726) |
(744,674) |
Accumulated other comprehensive loss |
(34,420) |
(36,261) |
Total shareholders' equity |
359,137 |
368,843 |
Total liabilities and shareholders' equity |
$1,023,365 |
$597,001 |
Immunocore Holdings plc |
|
|
Summary Condensed Consolidated Statements of Cash
Flows |
|
|
For the Year to Date Period Ended June 30, |
|
|
(In thousands)(Unaudited) |
|
|
|
|
|
|
June '24 |
June '23 |
|
|
|
Cash and cash equivalents at beginning of period |
$442,626 |
$402,472 |
Net cash provided by operating activities |
18,885 |
10,584 |
Net cash used in investing activities |
(350,761) |
(4,396) |
Net cash provided by financing activities |
395,194 |
17,716 |
Net foreign exchange difference on cash held |
(959) |
5,619 |
Cash and cash equivalents at end of period |
$504,985 |
$431,995 |
Grafico Azioni Immunocore (NASDAQ:IMCR)
Storico
Da Nov 2024 a Dic 2024
Grafico Azioni Immunocore (NASDAQ:IMCR)
Storico
Da Dic 2023 a Dic 2024