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Immunocore Holdings plc

Unaudited Condensed Consolidated Interim Financial Statements

Unaudited Condensed Consolidated Statements of Loss and Other Comprehensive Income

The accompanying notes form part of these unaudited condensed consolidated interim financial statements.

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Immunocore Holdings plc

Unaudited Condensed Consolidated Interim Financial Statements

Unaudited Condensed Consolidated Statements of Financial Position as at

The accompanying notes form part of these unaudited condensed consolidated interim financial statements.

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Immunocore Holdings plc

Unaudited Condensed Consolidated Interim Financial Statements

Unaudited Condensed Consolidated Statements of Changes in Equity

The accompanying notes form part of these unaudited condensed consolidated interim financial statements.

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Immunocore Holdings plc

Unaudited Condensed Consolidated Interim Financial Statements

Unaudited Condensed Consolidated Statements of Cash Flows

The accompanying notes form part of these unaudited condensed consolidated interim financial statements.

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Immunocore Holdings plc

Unaudited Condensed Consolidated Interim Financial Statements

Notes to the Financial Statements

1. Organization and nature of business

General information

Immunocore Holdings plc (the “Company”) is a public limited company incorporated in England and Wales and has the following wholly owned subsidiaries, Immunocore Limited, Immunocore LLC, Immunocore Commercial LLC, Immunocore Ireland Limited and Immunocore Nominees Limited (collectively referred to as the “Group”).

On February 9, 2021, the Company completed its initial public offering (“IPO”) of 11,426,280 American Depositary Shares (“ADSs”) representing 11,426,280 ordinary shares with nominal value of £0.002 per ordinary share for aggregate gross proceeds of $297,083,000.  The Company’s ADSs began trading on the Nasdaq Global Select Market under the ticker symbol “IMCR” on February 5, 2021.

In addition to the ADSs sold in the IPO, the Company completed the concurrent sale of an additional 576,923 ADSs at the initial offering price of $26.00 per ADS, for gross proceeds of approximately $15.0 million, in a private placement to the Bill & Melinda Gates Foundation (“Gates Foundation”).

Prior to completion of the IPO, Immunocore Holdings Limited was incorporated in England and Wales on January 7, 2021.  Following a subsequent corporate reorganization, Immunocore Holdings Limited became the ultimate parent company for the Group and was re-registered as a public limited company with the name Immunocore Holdings plc, the registrant. The corporate reorganization has been accounted for as a business combination under common control and therefore, Immunocore Holdings plc is a continuation of Immunocore Limited and its subsidiaries.  The corporate reorganization has been given retrospective effect in these financial statements and such financial statements represent the financial statements of Immunocore Holdings plc.

The principal activity of the Group is 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, infectious and autoimmune. Leveraging its proprietary, flexible, off-the-shelf ImmTAX platform, the Group is developing a deep pipeline in multiple therapeutic areas, including five clinical stage programs in oncology and infectious disease, advanced pre-clinical programs in autoimmune disease and multiple earlier pre-clinical programs.

2. Significant accounting policies

Basis of preparation

The unaudited condensed consolidated interim financial statements for the three and six months ended June 30, 2021 and 2020 have been prepared in accordance with International Accounting Standard 34, “Interim Financial Reporting” (“IAS 34”). The accounting policies and methods of computation applied in the preparation of the unaudited condensed consolidated interim financial statements are consistent with those applied in the Group’s annual financial statements for the year ended December 31, 2020.

The unaudited condensed consolidated interim financial statements do not include all of the information required for the full annual financial statements and should be read in conjunction with the annual consolidated financial statements of the Group for the year ended December 31, 2020 included in the Company’s Annual Report on Form 20-F for the year ended December 31, 2020, filed with the Securities and Exchange Commission on March 25, 2021 (the “Annual Report”).

The unaudited condensed and consolidated interim financial statements have been prepared under the historical cost basis, as modified by the recognition of certain financial instruments measured at fair value and are presented in pounds sterling which is the Company’s functional currency. All values are rounded to the nearest thousand, except where otherwise indicated.

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Date of authorization

These unaudited condensed consolidated interim financial statements were prepared at the request of the Company’s Board of Directors (the “Board”) and were approved by the Board on August 11, 2021 and signed on its behalf by Dr. Bahija Jallal, Chief Executive Officer of the Group.

Adoption of New Accounting Standards

There have been no recent new accounting standards that have had an impact on these unaudited condensed consolidated interim financial statements. New accounting standards not listed below were assessed and determined to be either not applicable or did not have a material impact on the unaudited condensed consolidated interim financial statements or processes.

 

During the six-month period ended June 30, 2020, Interest Rate Benchmark Reform – Phase 1, issued by the International Accounting Standards Board (“IASB”), became effective. Phase 1 contained amendments to IFRS 9, IAS 39, and IFRS 7 related to the impact of interest rate benchmark reform on hedging relationships.  These amendments were not applicable to the Group, as the Group does not have any hedging arrangements. During the six month period ended June 30, 2021, the Group adopted the amendments to IFRS 9, IAS 39, IFRS 7, IFRS 4, and IFRS 16 related to Interest Rate Benchmark Reform – Phase 2, issued by the IASB, which addresses issues that might affect financial reporting during the reform on an interest rate benchmark.  The only financial instrument subject to interest rate reform is the Group’s loan and security agreement (“Loan Agreement”) with Oxford Finance Luxembourg S.A.R.L. (“Oxford Finance”), which has a carrying amount of £36,681,000 as of June 30, 2021 (£36,654,000 as of December 31, 2020).  Currently, borrowings under the Loan Agreement bear interest at an annual rate equal to LIBOR plus 8.85%, with a minimum rate of 9.01% and a maximum rate of 12.01%.  LIBOR is the subject of recent national, international, and other regulatory guidance and proposals for reform, which may cause LIBOR to cease to exist after 2021 or to perform differently than in the past. While the Group expects that alternatives to LIBOR will be implemented prior to the 2021 target date or that the 2021 cessation date may be extended, the consequences and timing of these developments cannot be predicted. There is currently no definitive information regarding the future utilization of LIBOR or of any particular replacement rate. A transition away from LIBOR as a benchmark for establishing the applicable interest rate may adversely affect the Group’s outstanding variable-rate indebtedness.

Going concern

The Group reported cash and cash equivalents of £278,870,000 and net current assets of £256,808,000 as at June 30, 2021, with an operating loss for the six months ended June 30, 2021 of £66,380,000.  The Group did not generate positive operational cash flow which was largely due to the continuing focus on the research, development, and clinical activities to advance the programs within the Group’s pipeline. During the six months ended June 30, 2021, the Company completed its IPO and the private placement to the Gates Foundation and received net proceeds of $286,887,000.

In assessing the going concern assumptions, the Board has undertaken an assessment of the forecasts, prepared through the end of 2022. As part of this assessment, the Board has considered the impact of the ongoing coronavirus 2019 (‘‘COVID-19’’) pandemic and have concluded that COVID-19 may have an impact, but the Board considers that any future impact will be minimal on clinical trials or other business activities over the period assessed for going concern purposes. As of the date of these financial statements, the Company is not aware of any specific event or circumstance that would require the Company to update its estimates, assumptions and judgments or revise the carrying value of its assets or liabilities. Actual results could differ from these estimates, and any such differences may be material to the Company’s financial statements.

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Given the current cash position and the assessment performed, the Board is confident that the Group will have sufficient funds to continue to meet its liabilities as they fall due until at least the end of 2022 and therefore, have prepared the financial statements on a going concern basis. As the Group continues to incur significant expenses in the pursuit of its business strategy, additional funding will be needed before the existing programs are expected to reach commercialization, which would potentially lead to operational cash inflows. Until the Group can generate significant revenue from product sales, if ever, it expects to finance its operations through a combination of public or private equity offerings and debt financings or other sources, such as potential collaboration agreements, strategic alliances and licensing arrangements.

Estimates and judgements

The preparation of the unaudited condensed consolidated interim financial statements in conformity with IAS 34 requires management to make judgments, estimates and assumptions. These judgments, estimates and assumptions affect the reported assets and liabilities as well as contingent liabilities and income and expenses in the financial period.

The estimates and associated assumptions are based on information available when the unaudited condensed consolidated interim financial statements are prepared, historical experience and various other factors which are believed to be reasonable under the circumstances. Judgements and assumptions are primarily made in relation to revenue recognition, the valuation of ordinary shares prior to the IPO, the incremental borrowing rate for leases and valuation of derivatives.

Existing circumstances and assumptions about future developments may change due to market changes or circumstances arising that are beyond the Group’s control. Hence, estimates may vary from the actual results.

The estimates and underlying assumptions are reviewed on an ongoing basis. Revisions to accounting estimates are recognized in the period in which they become known and are applied prospectively.

Those judgements and estimates made, together with our significant accounting policies, are disclosed in the consolidated financial statements of the Group for the year ended December 31, 2020, included in the Annual Report. There have been no changes to these accounting policies for the six months ended June 30, 2021.

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3. Revenue

Revenue recognized during the three and six months ended June 30, 2021 and 2020 was from collaboration agreements with GlaxoSmithKline Intellectual Property Development Ltd (“GlaxoSmithKline”), Eli Lilly and Company (“Eli Lilly”) and Genentech, Inc. (“Genentech”).

Genentech Collaboration.

 

During the three and six months ended June 30, 2021, the Group recognized £4,447,000 and £9,347,000 of revenue, respectively, relating to the 2018 Genentech Agreement and Imm-C103C (for the three and six months ended June 30, 2020: £5,658,000 and £10,544,000, respectively). The revenue recognized represents both deductions from deferred revenue and research and development costs reimbursed, predominantly for clinical trial costs. Such reimbursements arise in order to ensure that research and development costs are shared equally in-line with the Genentech Agreement. Of the total revenue recognized during the three and six months ended June 30, 2021, £175,000 and £803,000, respectively, represented research and development cost reimbursements (for the three and six months ended June 30, 2020: £1,385,000 and £1,636,000 respectively).

GlaxoSmithKline Collaboration

 

During the three and six months ended June 30, 2021, the Group recognized £1,286,000 and £4,656,000 of revenue, respectively, relating to the GlaxoSmithKline Agreement (for the three and six months ended June 30, 2020: £1,705,000 and £2,400,000 respectively). Of the total revenue recognized during the three and six months ended June 30, 2021, £971,000 and £1,562,000 respectively, represented research and development cost reimbursement (for the three and six months ended June 30, 2020: £891,000 and £1,215,000 respectively). Such reimbursements arise where research and development costs in excess of a defined amount are incurred on one specified program.  Following an annual portfolio review, in March 2021, GlaxoSmithKline and the Group elected not to move forward with the expansion stage of the ongoing Phase 1 clinical trial for GSK-01 targeting NY-ESO. GlaxoSmithKline have forgone their option to acquire an exclusive license to this program and therefore, ownership of the program and NY-ESO target will remain with the Group. Accordingly, the balance of deferred revenue of £2,463,000 was released in full.

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Eli Lilly Collaboration

 

Deferred revenue

For the six months ended June 30, 2021 and the year ended December 31, 2020, deductions from deferred revenue represent revenue recognized during the period. During the six months ended June 30, 2021 and the year ended December 31, 2020 there were no additions to deferred revenue.

The total revenue recognized during the three and six months ended June 30, 2021 was £5,733,000 and £14,003,000, respectively, of which £4,587,000 and £11,638,000, respectively, was included in deferred revenue at January 1, 2021 and the balance of £1,146,000 and £2,365,000, respectively, relates to reimbursed research and development costs. The total revenue recognized during the three months and six months ended June 30, 2020 was £7,787,000 and £16,042,000 respectively, of which £5,511,000 and £13,191,000, respectively, was included in deferred revenue at January 1, 2020 and the balance of £2,276,000 and £2,851,000 respectively, relates to reimbursed research and development costs. Reimbursed research and development costs are recognized gross as revenue.  No revenue was recognized in the three or six months ended June 30, 2021 relating to performance obligations satisfied in previous years (for the three and six months ended June 30, 2020: £nil).

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The derivative liability represents a foreign exchange call option over certain series B shares which was settled in full in March 2020, resulting in a gain of £1,287,000 based on the fair value as at derecognition, and a credit to equity of £3,840,000.

The fair value of this derivative liability at the time of derecognition was determined using an option pricing model using a range of inputs both quoted, observable and unobservable in nature. The unobservable input was the expected final closing of the series B preferred share financing. The resulting derivative liability was not sensitive to changes in the expected close date nor in changes to other underlying input assumptions.

5. Finance costs

Interest expense for the three and six months ended June 30, 2021 is related to the $50.0 million of borrowings under the debt facility with Oxford Finance entered into on November 6, 2020 and includes £546,000, representing a fee of $750,000, that became payable to Oxford Finance on completion of the IPO on February 9, 2021, (see Note 10).

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Interest expense for the three and six months ended June 30, 2020 related to the convertible loan with the Gates Foundation, which was partially converted into series B preferred shares in March 2020.

The convertible loan received from the Gates Foundation contains conversion features which were accounted for as an embedded derivative and separated from the convertible loan. During the three and six months ended June 30, 2020, the loss from the change in fair value of the embedded derivative asset represented the movement in fair value of this embedded derivative asset on derecognition arising from the conversion of the loan into series B preferred shares in March 2020.

The fair value of this embedded derivative asset at the time of derecognition was determined using an option pricing model, discounted and probability weighted for the conversion features within the underlying convertible loan, which included unobservable (Level 3) inputs supported by little or no market activity. Significant unobservable inputs used in the fair value measurement of the embedded derivative asset were predominantly regarding the probability of each of the conversion features occurring.

6. Income tax

 

Income tax credit is recognized at an amount determined by multiplying the loss before taxation for the interim reporting period by the Group’s best estimate of the weighted-average annual income tax credit rate expected for the full financial year, adjusted for the tax effect of certain items recognized in full in the interim period. As such, the effective tax credit rate in the interim financial statements may differ from the Group’s estimate of the effective tax credit rate for the annual financial statements.

The Group’s consolidated effective tax credit rate for the three months ended June 20, 2021 was 7.9% (for the three months ended June 30, 2020: 17.7%), for the six months ended June 20, 2021 was 10.8% (for the six months ended June 30, 2020: 16.0%).

A deferred tax asset of £2,192,000 has been recognized as of June 30, 2021 (December 31, 2020: £2,230,000) representing unused tax credits carried forward for Immunocore LLC following an annual assessment, or periodically as required, of all available and applicable information, including its forecasts of costs and future profitability and the resulting ability to reverse the recognized deferred tax assets over a short period of time.

7. Basic and diluted loss per share

(1) The basic and diluted loss per share are adjusted for the (i) the exchange of shares of Immunocore Limited for shares of Immunocore Holdings Limited on a 1 for 100 basis, and (ii) the reorganization of the share capital of Immunocore Holdings plc, resulting in a consolidation with the effect of a 20 to 1 reverse stock split on the Company’s ordinary shares and non-voting ordinary shares, all of which took place in connection with the IPO which closed on February 9, 2021. Refer to Note 11 for further information.

Basic loss per share is calculated by dividing the loss for the period attributable to the equity holders of the Group by the weighted average number of ordinary shares outstanding during the period, including ordinary shares represented by ADSs. The dilutive effect of potential shares through equity settled transactions are considered to be anti-dilutive as they would decrease the loss per share and are, therefore, excluded from the calculation of diluted loss per share.

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8. Property, plant and equipment

During the six months ended June 30, 2021, the Group acquired assets at a cost of £355,000, of which £282,000 were additions to plant and equipment, primarily laboratory equipment, and wrote-off leasehold improvements totaling £231,000.

9. Trade and other receivables

Included within prepayments and accrued income are amounts paid in advance for clinical trials that are expected to be expensed within 12 months.

10. Interest-bearing loans and borrowings

11. Capital and reserves

IPO and Impact of Corporate Reorganization

On January 7, 2021 Immunocore Holdings Limited was incorporated as a private limited company under the laws of England and Wales with nominal assets and liabilities for the purpose of becoming the holding company of Immunocore Limited.

On January 22, 2021, each holder of series A preferred shares, series B preferred shares, series C preferred shares, Growth Shares and ordinary shares in Immunocore Limited, sold and transferred their shares to Immunocore Holdings Limited in exchange for 100 shares of the same class at par value of 0.01 pence in Immunocore Holdings Limited.  Following this share exchange, Immunocore Limited became a wholly owned subsidiary of Immunocore Holdings Limited.

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All Immunocore Limited share options granted to directors and employees under share option plans that were in existence immediately prior to the reorganization were exchanged for share options in Immunocore Holdings Limited on a one-for-100 basis.

Following the share exchange, Immunocore Limited undertook a reorganization of its share capital to re-designate its series A preferred shares, series B preferred shares, series C preferred shares and Growth shares into a single class of ordinary shares and subsequently undertook a share capital reduction, cancelling all amounts standing to the credit of its share premium account and cancelling 6,414,412 ordinary shares.

On February 1, 2021, Immunocore Holdings Limited was re-registered as a public limited company (“plc”) with the name Immunocore Holdings plc. The Company’s consolidated assets and liabilities immediately following the reorganization were the same as Immunocore Limited immediately before the reorganization.

Effective immediately prior to completion of the IPO, the Company re-organized its share capital whereby all of the outstanding series A preferred shares, series B preferred shares and series C preferred shares were re-designated as ordinary shares of the Company on a one for one basis.  A total of 16,632,540 of the ordinary shares, following the re-designation of the series C preferred shares, were converted to a separate class of non-voting ordinary shares. A total of 6,250,000 Growth Shares were re-designated of which 4,324,000 of the Growth Shares were re-designated as deferred shares of the Company. The remaining 1,926,000 Growth Shares were re-designated in the ratio of one ordinary share, issued for non-cash consideration and three deferred shares.

Immediately following these re-designations referred to above every 20 ordinary shares of £0.0001 and every 20 non-voting ordinary shares of £0.0001 in the Company were consolidated into one ordinary share and one non-voting ordinary share of £0.002.

On February 9, 2021, the Company completed an IPO of 11,426,280 ADSs representing 11,426,280 ordinary shares with nominal value of £0.002 per ordinary share, for gross proceeds of $297,083,000.  In addition to the ADSs sold in the IPO, the Company completed the concurrent sale of an additional 576,923 ADSs, representing 576,923 ordinary shares with a nominal value of £0.002 per ordinary share, at the initial offering price of $26.00 per ADS, for gross proceeds of approximately $15.0 million, in a private placement to the Gates Foundation.  The total aggregate gross proceeds were $312,083,000 (£226,528,000).  A total of £15,543,000 representing underwriting discounts and commissions and other offering expenses incurred incrementally and directly attributable to the offering of securities and have been deducted from the gross proceeds of the IPO.

Under the terms of the Company’s agreement with the Gates Foundation, the Group is required to develop, manufacture and commercialize soluble TCR bispecific therapeutic candidates targeted to mutually agreed neglected diseases, currently HIV, with the potential to treat people at an affordable price in developing countries. In the event of certain defaults by the Group under the agreement, the Gates Foundation has the right to sell, or require the Group to buy-back, any of the shareholdings in the Group held by the Gates Foundation. In such an event, if within 12 months after such redemption or sale, the Group experiences a change in control at a valuation of more than 150% of the valuation used for the redemption or the sale of the shares, the Group has agreed to pay the Gates Foundation compensation equal to the excess of what it would have received in such transaction if it still held its shares at the time of such change of control over what it received in the sale or redemption of its shares.

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Share premium

The £325,000 of share premium is attributable to ordinary shares issued for non-cash consideration arising from the redesignation of 1,926,000 Growth Shares in the ratio of one ordinary share, issued for non-cash consideration and three deferred shares.

Nature and purpose of reserves

The share-based payments reserve is used to recognize the value of equity-settled share-based payments provided to employees. All other reserves are as stated in the consolidated statement of changes in equity.

The other reserve arose as a result of the corporate reorganization described above.

No dividends were paid or declared in the six months ended June 30, 2021 (for the six months ended June 30, 2020: £nil).

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12. Share-based payments

The total charge, to the consolidated statement of loss and other comprehensive loss, for such share-based payment plans during the three and six months ended June 30, 2021 was £9,342,000 and £17,938,000 respectively (three and six months ended June 30, 2020 £3,187,000 and £3,392,000, respectively).

Immediately prior to completion of the IPO, the Group undertook a corporate reorganization (see Note 11), the following changes were undertaken in respect to share options and growth share awards in existence immediately prior to the reorganization.

All Immunocore Limited share options and Growth Shares granted to directors and employees under share incentive arrangements that were in existence immediately prior to the reorganization were exchanged for share options and Growth Shares in the Company on a one-for-100 basis with no change in any of the vesting terms and exercise prices.

Immediately prior to completion of the IPO, the Company reorganized its share capital which included the re-designation of 6,250,000 Growth Shares, or 312,500 Growth Shares reflecting the consolidation of every 20 ordinary shares into one ordinary share of £0.002, as both ordinary shares and deferred shares (see Note 11).  Previously awarded Growth Shares were replaced with an award of share options in the Company on a one-for-one basis.  For 216,200 of these replacement share option awards, the vesting terms and exercise prices were substantially unchanged.  For the remaining 96,300 replacement share option awards the vesting terms and exercise prices and revised to an extent that these Growth Shares are considered cancelled, for the purpose of determining the share-based payment charge, prior to the replacement share options being awarded. In addition, the replacement ordinary shares that arose from the re-designation of Growth Shares resulted in an incremental fair value of £325,000, attributed to share premium.

Immediately following these re-designations referred to above every 20 share options over ordinary shares of £0.0001 in the Company was consolidated into one share option over an ordinary share of £0.002.  At the same time, the exercise price for each of the outstanding share options was adjusted to reflect the reorganization, subject to a minimum exercise price equal to the nominal value of a share and was re-designated into U.S. Dollars.  The adjustment to exercise price did not impact the fair value of the underlying share options, with the exception of the 96,300 replacement share options re-designated from Growth Shares where the exercise price was increased.

During the six months ended June 30, 2021, options over a total of 4,534,527 shares were awarded (for the six months ended June 30, 2020: 721,850) which will vest over a four-year period from the date of grant, with 25% of the award vesting at the end of the first year and the remaining award vesting quarterly over the following three years.  The awards are not entitled to dividends prior to exercise. There were no grants during the three months ended June 30, 2021 or during the three and six months ended June 30, 2020.

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The number and weighted average exercise prices of share options are as follows:

The weighted average fair value of options granted in the six months ended June 30, 2021 was $16.23.

The number and weighted average hurdle rate of Growth Shares are as follows:

For share options outstanding at June 30, 2021, the range of exercise prices and weighted average remaining contractual life are as follows:

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Awards granted in the six months ended June 30, 2021, have been valued using the Black-Scholes option pricing model. The assumptions used in the models for share options granted during the six months ended June 30, 2021, are as follows:

13. Trade and other payables

14. Commitments and contingencies

The following table summarizes the Group’s contractual obligations as of June 30, 2021:

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The following table summarizes the Group’s contractual obligations as of December 31, 2020:

The Group has contractual obligations for two leasehold properties under which it is obligated to take on the leases should the properties become vacant at specified dates in the future.  For both properties, the Group has reassessed these contingent events as at June 30, 2021, and has continued to recognize a contingent commitment totaling £6,566,000 (December 31, 2020: £6,566,000).

Exhibit 99.2

 

MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS

Unless otherwise indicated or the context otherwise requires, all references to “Immunocore,” the “Company,” “we,” “our,” “us” or similar terms refer to Immunocore Holdings plc.

 

 

 

Our ImmTAV Platform (Infectious Diseases)

 

 

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IMC-M113V, our ImmTAV molecule targeting a human immunosuppression virus, or HIV, gag antigen bispecific TCR molecule, is currently in pre-clinical development. We anticipate regulatory submission during the second half of 2021 in support of our Phase 1 trial.

On June 4, 2021 the Company presented a subset analysis from the Phase 3 study exploring the overall survival benefit from tebentafusp in patients with best RECIST* response of progressive disease (PD) at the American Society of Clinical Oncology (ASCO) Annual Meeting. In patients with a best response of PD in the phase 3 trial, the overall survival (OS) was superior for the tebentafusp arm versus the investigator’s choice arm with a hazard ratio (HR) of 0.43 (95% CI 0.27-0.68). More than half of tebentafusp patients with best response of PD were treated beyond initial progression and no new safety signals were observed. In addition, analysis from the phase 2 tebentafusp trial suggests that at least one-third of patients on tebentafusp with a best response of PD have a reduction in circulating tumor DNA and that this may be associated with longer OS.

On May 18, 2021, we announced the dosing of the first patient in the first-in-human clinical trial of IMC-I109V, a new class of bispecific protein immunotherapy that is being developed for the treatment of patients with chronic hepatitis B (HBV) infection (CHB). Wholly-owned IMC-I109V is the first candidate in development using Immunocore’s immune‐mobilizing monoclonal T cell receptors against virus (ImmTAV®) platform to enter clinical trials. The trial is an open label study evaluating the safety, antiviral activity, and pharmacokinetics of IMC-I190V in HLA-A*02:01 positive patients with Chronic HBV who are non-cirrhotic, hepatitis B antigen-negative, and virally suppressed.

In April 2021, we launched a global early access program for tebentafusp in metastatic uveal melanoma.

On April 10, 2021, we presented Phase 3 clinical trial data from IMCgp100-202 clinical trial in an oral presentation in the Phase 3 clinical trials plenary session at the American Association for Cancer Research (AACR) Annual Meeting 2021. Tebentafusp demonstrated a statistically significant and clinically meaningful improvement in overall survival (OS) as a first-line treatment in mUM.  In the intent-to-treat population, tebentafusp demonstrated a median overall survival of 21.7 months compared to 16.0 months for investigator’s choice and with 73% of patients alive at 1 year for tebentafusp vs. 58% for investigator’s choice. The OS Hazard Ratio (HR) favored tebentafusp, HR=0.51 (95% CI: 0.37, 0.71); p< 0.0001, over investigator’s choice (82% pembrolizumab; 12% ipilimumab; 6% dacarbazine). In addition, tebentafusp resulted in a statistically significant longer PFS. Treatment-related adverse events were manageable and consistent with the proposed mechanism.

 In July, the European Medicines Agency (EMA) granted tebentafusp accelerated assessment procedure for its Marketing Authorization Application (MAA). Accelerated assessment potentially reduces the time frame for the EMA Committee for Medicinal Products for Human Use (CHMP) and Committee for Advanced Therapies (CAT) to review a MAA for an Advanced Therapy Medicinal Product (ATMP). The U.S. Food and Drug Administration (FDA) will review the Biologics License application (BLA) for tebentafusp (IMCgp100) under the Real-Time Oncology Review (RTOR) pilot program, an initiative of the FDA’s Oncology Center of Excellence designed to expedite the delivery of safe and effective cancer treatments to patients.  Tebentafusp is also being reviewed under the FDA’s Project Orbis initiative, which enables concurrent review by the health authorities in partner countries that have requested participation.

Basic and diluted loss per share was £0.75 or $1.04 for the three months ended June 30, 2021 compared to an adjusted £0.63 for the three months ended June 30, 2020.  Basic and diluted loss per share was £1.51 or $2.08 for the six months ended June 30, 2021 compared to an adjusted £1.39 for the six months ended June 30, 2020. Total operating loss for the three months ended June 30, 2021 was £34.5 million or $47.6 million compared to £20.5 million for the same period last year, largely due to an increase in employee costs associated with non-cash share-based payment charge. Total operating loss for the six months ended June 30, 2021 was £66.4 million or $91.6 million compared to £42.6 million for the same period last year, largely due to an increase in employee costs associated with non-cash share-based payment charge.

For the three and six months ended June 30, 2021, revenue from collaboration agreements was £5.7 million or $7.9 million and £14.0 million or $19.3 million, respectively, as compared to £7.8 million and £16.0 million, respectively, for the three and six months ended June 30, 2020. For the three and six months ended June 30, 2021, our research and development expenses were £16.5 million or $22.7 million and £36.4 million or $50.2 million, respectively, as compared to £16.4 million and £37.2 million, respectively, for the three and six months ended June 30, 2020. For the three and six months ended June 30, 2021, our administrative expenses were £23.8 million or $32.9 million and £44.0 million or $60.7 million, respectively, compared to £12.3 million and £21.9 million respectively, for the three and six months ended June 30, 2020 including a £5.1 million and £13.0 million increase, respectively, in the non-cash share-based payment charge.

Cash and cash equivalents are £278.9 million or approximately $385 million as of June 30, 2021 compared to £129.7 million as of December 31, 2020.

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after reviewing trial results, our collaboration partners may abandon projects that might previously have been believed to be promising;

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we, our collaboration partners, or regulators may suspend or terminate clinical trials if the participating subjects or patients are being exposed to unacceptable health risks;

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our potential products may not have the desired effects or may include undesirable side effects or other characteristics that preclude regulatory approval or limit their commercial use if approved;

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manufacturers may not meet the necessary standards for the production of the product candidates or may not be able to supply the product candidates in a sufficient quantity;

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regulatory authorities may find that our clinical trial design or conduct does not meet the applicable approval requirements; and

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safety and efficacy results in various human clinical trials reported in scientific and medical literature may not be indicative of results we obtain in our clinical trials.

For the three months ended June 30, 2021, our research and development expenses were £16.5 million, as compared to £16.4 million for the three months ended June 30, 2020. This increase of £0.1 million was primarily attributable to an increase in internal research and development expenses of £1.4 million partially offset by a decrease in external research and development expenses of £1.3 million.

For the three months ended June 30, 2021, administrative expenses were £23.8 million, compared to £12.3 million for the three months ended June 30, 2020, an increase of £11.6 million.  The administrative expenses for the three months ended June 30, 2021, of £23.8 million  comprises the following:  a share based payment charge of £8.3 million which has increased by £5.1 million compared to the comparative period; other staff related expenses of £3.6 million, a decrease of £0.4 million;  pre-commercial expenditure related to tebentafusp of £4.7 million, an increase of £4.2 million; legal and professional fees of £2.5 million, an increase of £1.8 million primarily attributable to additional costs incurred as a result of being a public company; depreciation of property, plant and equipment of £1.8 million, a decrease of £0.5 million and unfavourable foreign exchange movements of £1.4 million, increased from £nil.

For the six months ended June 30, 2021, administrative expenses were £44.0 million, compared to £21.9 million for the six months ended June 30, 2020, an increase of £22.1 million.  The administrative expenses for the six months ended June 30, 2021, of £44.0 million, comprises the following:  a share based payment charge of £16.4 million which has increased by £13.0 million compared to the comparative period; other staff related expenses of £6.9 million, a decrease of £2.7 million;  pre-commercial expenditure related to tebentafusp of £6.1 million, an increase of £5.6 million; legal and professional fees of £5.7 million, an increase of £4.3 million primarily attributable to the IPO and additional costs incurred as a result of being a public company; depreciation of property, plant and equipment of £3.6 million, a decrease of £1.0 million and unfavourable foreign exchange movements of £2.3 million, compared to favourable foreign exchange movements of £1.3 million in the comparative period.

Gates Foundation convertible loan into series B preferred shares.

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continue to advance our clinical trials and the development of our pre-clinical programs;

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continue to invest in our soluble TCR platforms to conduct research to identify novel technologies;

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change or add additional suppliers;

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add additional infrastructure to our quality control, quality assurance, legal, compliance and other groups to support our operations as we progress product candidates toward commercialization;

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seek to attract and retain skilled personnel;

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create additional infrastructure to support our operations as a public company listed in the United States and our product development and planned future commercialization efforts;

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seek marketing approvals and reimbursement for our product candidates;

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establish a sales, marketing and distribution infrastructure to commercialize any products for which we may obtain marketing approval;

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seek to identify and validate additional product candidates;

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acquire or in-license other product candidates and technologies;

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maintain, protect, defend, enforce and expand our intellectual property portfolio; and

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experience any delays, interruptions or encounter issues with any of the above, including any delays or other impacts as a result of the COVID-19 pandemic.