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| Name | Symbol | Market | Type |
|---|---|---|---|
| Immunocore Holdings PLC | NASDAQ:IMCR | NASDAQ | Depository Receipt |
| Price Change | % Change | Price | Bid Price | Offer Price | High Price | Low Price | Open Price | Traded | Last Trade | |
|---|---|---|---|---|---|---|---|---|---|---|
| 0.00 | 0.00% | 28.56 | 26.00 | 35.00 | 7 | 09:25:13 |
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(State or other jurisdiction of incorporation)
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(Commission File Number)
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(IRS Employer Identification No.)
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(Address of principal executive offices)
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(Zip Code)
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Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
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Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)
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Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))
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Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))
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Title of each class
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Trading
Symbol(s)
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Name of each exchange on which registered
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Ordinary share, nominal value £0.002 per share*
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*
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The Nasdaq Stock Market LLC
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| Item 2.02. |
Results of Operations and Financial Condition.
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| Item 9.01. |
Financial Statements and Exhibits
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Exhibit No.
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Description
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Press Release dated August 8, 2024.
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104
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Cover Page Interactive Data File (embedded within the Inline XBRL document).
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IMMUNOCORE HOLDINGS PLC
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Dated: August 8, 2024
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By:
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/s/ Bahija Jallal, Ph.D.
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Name:
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Bahija Jallal, Ph.D.
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Title:
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Chief Executive Officer
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Page 1 of 14
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| • |
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.
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| • |
US growth driven by increased penetration in community setting and duration of treatment.
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| • |
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.
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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.
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| • |
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.
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| • |
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.
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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.
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Expect enrollment to be completed in the first half of 2026.
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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.
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Page 2 of 14
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In 2Q, the Company randomized the first patient in PRISM-MEL-301.
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Trial is evaluating brenetafusp + nivolumab versus a control arm of either nivolumab or nivolumab + relatlimab.
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| • |
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.
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| • |
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.
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| • |
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.
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| • |
Submitted Clinical Trial Application (CTA) for IMC-P115C in the second quarter of 2024, which is currently under review.
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| • |
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.
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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.
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Page 3 of 14
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| • |
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.
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| • |
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).
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| • |
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.
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| • |
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.
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| • |
Patient enrollment continues into the single ascending dose portion of the clinical trial.
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Page 4 of 14
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| • |
IMC-S118AI recognizes a peptide from pre-proinsulin presented by HLA-A02 on beta cells, coupled with a PD1 agonist effector arm.
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| • |
IMC-S118AI is advancing towards GMP manufacturing in 2024.
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| • |
The candidate is an antigen presenting cell (APC) tethered ImmTAAI and is not HLA restricted (i.e. universal for all populations).
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Page 5 of 14
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Page 6 of 14
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Page 7 of 14
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Page 8 of 14
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Page 9 of 14
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Page 10 of 14
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Page 11 of 14
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Quarter Ended
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Year to Date
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|||||||||||||||
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June 30, 2024
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June 30, 2023
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June 30, 2024
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June 30, 2023
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|||||||||||||
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Product revenue, net
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$
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75,347
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$
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56,932
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$
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145,689
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$
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108,513
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||||||||
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Collaboration revenue
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53
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2,825
|
213
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5,903
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||||||||||||
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Total revenue
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75,400
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59,757
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145,902
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114,416
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||||||||||||
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Cost of product revenue
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(1,707
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)
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(346
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)
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(1,953
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)
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(562
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)
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||||||||
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Research and development expense
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(51,072
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)
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(38,158
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)
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(108,531
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)
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(74,730
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)
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||||||||
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Selling, general, & administrative expense
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(38,638
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)
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(35,010
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)
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(77,925
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)
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(67,577
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)
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Loss from operations
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(16,017
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)
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(13,757
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)
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(42,507
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)
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(28,453
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)
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Interest income
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6,239
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4,278
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14,485
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7,406
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||||||||||||
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Interest expense
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(4,277
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)
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(1,274
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)
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(7,516
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)
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(2,524
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)
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||||||||
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Foreign currency loss
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(508
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)
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(5,880
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)
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(2,914
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)
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(11,893
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)
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Other income (expense), net
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4,433
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(190
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)
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4,243
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(515
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)
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Net loss before income taxes
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(10,130
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)
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(16,823
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)
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(34,209
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)
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(35,979
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)
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Income tax expense
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(1,486
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)
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(191
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)
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(1,843
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)
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(484
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)
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Net loss
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$
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(11,616
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)
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$
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(17,014
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)
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$
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(36,052
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)
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$
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(36,463
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)
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Basic and diluted net loss per share
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$
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(0.23
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)
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$
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(0.35
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)
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$
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(0.72
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)
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$
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(0.75
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)
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||||
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Basic and diluted weighted average number of shares
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50,014,086
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48,694,047
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49,944,767
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48,440,318
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||||||||||||
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Page 12 of 14
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Jun '24
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Dec '23
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|||||||
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ASSETS
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Current assets
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||||||||
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Cash and cash equivalents
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$
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504,985
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$
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442,626
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||||
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Marketable securities
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354,612
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-
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||||||
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Accounts receivable, net
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60,245
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52,093
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||||||
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Prepaid expenses and other current assets
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33,555
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29,600
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||||||
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Inventory, net
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3,462
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4,501
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||||||
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Total current assets
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956,859
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528,820
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||||||
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Property and equipment, net
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7,684
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9,215
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||||||
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Operating lease right of use assets, net
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32,435
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33,520
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||||||
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Deferred tax assets, net
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10,111
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10,973
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||||||
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Other non-current assets
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16,276
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14,473
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||||||
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Total assets
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$
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1,023,365
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$
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597,001
|
||||
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Liabilities and shareholders’ equity
|
||||||||
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Current liabilities
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||||||||
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Accounts payable
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$
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19,947
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$
|
17,798
|
||||
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Accrued expenses and other current liabilities
|
163,762
|
119,835
|
||||||
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Operating lease liabilities, current
|
1,387
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1,388
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||||||
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Total current liabilities
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185,096
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139,021
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||||||
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Accrued expenses, non-current
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2,089
|
978
|
||||||
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Deferred revenue, non-current
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5,477
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5,515
|
||||||
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Operating lease liabilities, non-current
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33,445
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34,633
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||||||
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Interest-bearing loans and borrowings
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438,121
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48,011
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||||||
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Total liabilities
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664,228
|
228,158
|
||||||
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Shareholders' equity
|
||||||||
|
Ordinary shares
|
135
|
134
|
||||||
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Deferred shares
|
1
|
1
|
||||||
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Additional paid-in capital
|
1,174,147
|
1,149,643
|
||||||
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Accumulated deficit
|
(780,726
|
)
|
(744,674
|
)
|
||||
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Accumulated other comprehensive loss
|
(34,420
|
)
|
(36,261
|
)
|
||||
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Total shareholders' equity
|
359,137
|
368,843
|
||||||
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Total liabilities and shareholders' equity
|
$
|
1,023,365
|
$
|
597,001
|
||||
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Page 13 of 14
|
|
June '24
|
June '23
|
|||||||
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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
|
||||
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Page 14 of 14
|
Document and Entity Information |
Aug. 08, 2024 |
|---|---|
| Cover [Abstract] | |
| Document Type | 8-K |
| Amendment Flag | false |
| Document Period End Date | Aug. 08, 2024 |
| Entity File Number | 001-39992 |
| Entity Registrant Name | Immunocore Holdings plc |
| Entity Central Index Key | 0001671927 |
| Entity Incorporation, State or Country Code | X0 |
| Entity Tax Identification Number | 00-0000000 |
| Entity Address, Address Line One | 92 Park Drive |
| Entity Address, Address Line Two | Milton Park |
| Entity Address, Address Line Three | Abingdon |
| Entity Address, City or Town | Oxfordshire |
| Entity Address, Country | GB |
| Entity Address, Postal Zip Code | OX14 4RY |
| City Area Code | 44 |
| Local Phone Number | 1235 438600 |
| Title of 12(b) Security | American Depositary Shares, each representing one ordinary share, nominal value £0.002 per share |
| Trading Symbol | IMCR |
| Security Exchange Name | NASDAQ |
| Entity Emerging Growth Company | false |
| Written Communications | false |
| Soliciting Material | false |
| Pre-commencement Tender Offer | false |
| Pre-commencement Issuer Tender Offer | false |
1 Year Immunocore Chart |
1 Month Immunocore Chart |
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