Immunocore(IMCR)

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Immunocore Holdings (IMCR) Investor Presentation - Slideshow
2022-11-15 19:20
| --- | --- | --- | --- | --- | --- | --- | --- | --- | |-------|-------|-------|-------|-------|-------|---------------|-----------------|-------| | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | Science to | | | | | | | | | | Transform Lives | | | | | | | | | | | | | | | | | | | NOVEMBER 2022 | | | Forward-looking statement 2 This presentation contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Words ...
Immunocore (IMCR) Presents at ESMO Congress 2022
2022-09-09 19:46
#728O Phase 1 dose escalation of IMC-F106C, the first PRAME × CD3 ImmTAC bispecific protein in solid tumors Omid Hamid, 1 Takami Sato,2 Diwakar Davar,3 Margaret Callahan,4 Fiona Thistlethwaite,5 Raid Aljumaily,6 Melissa Johnson,7 Hendrik-Tobias Arkenau,8 Ecaterina Dumbrava,9 Benjamin Izar,10 Hui Amy Chen,11 Shannon Marshall,12 Yuan Yuan,12 Mugdha Deo,12 Sarah Stanhope,12 Laura Collins,12 Renee Mundy,12 Shaad Abdullah,12 Juanita Lopez13 1The Angeles Clinic and Research Institute, A Cedars-Sinai Affiliate, Lo ...
Immunocore(IMCR) - 2022 Q2 - Earnings Call Presentation
2022-08-11 05:35
IMMUNOCORE Corporate Presentation August 2022 Forward-Looking Statements This presentation contains forward-looking statements within the meaning 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 pr ...
Immunocore(IMCR) - 2022 Q2 - Quarterly Report
2022-08-10 12:00
Revenue Performance - Product revenue for the three months ended June 30, 2022, was £23,992,000, compared to £0 in the same period of 2021[4] - Total revenue from the sale of therapies for the six months ended June 30, 2022, was £38,211,000, significantly up from £0 in 2021[4] - Total revenue for the six months ended June 30, 2022, was £54,476,000, a significant increase from £14,003,000 in the same period of 2021[44] - Revenue recognized during the three and six months ended June 30, 2022, included product revenue from KIMMTRAK and pre-product revenue from tebentafusp[43] - Collaboration revenue for the six months ended June 30, 2022, was £16,265,000, up from £14,003,000 in 2021, representing a 16% increase[4] - Collaboration revenue from Genentech for the three months ended June 30, 2022, was £4,302,000, slightly down from £4,447,000 in the same period of 2021[48] Financial Losses - Operating loss for the three months ended June 30, 2022, was £6,993,000, an improvement from a loss of £34,499,000 in the same period of 2021[4] - Loss for the period for the six months ended June 30, 2022, was £22,249,000, compared to £62,000,000 in 2021, indicating a reduction of 64%[4] - The operating loss for the six months ended June 30, 2022, was £23,453,000, with net cash used in operating activities of £40,017,000[24] - The company reported a basic and diluted loss per share of £0.14 for the three months ended June 30, 2022, compared to £0.75 for the same period in 2021[56] Cash and Assets - Cash and cash equivalents at the end of the period were £208,064,000, down from £278,870,000 at the end of June 30, 2021[12] - The Group reported cash and cash equivalents of £208,064,000 and net current assets of £192,548,000 as of June 30, 2022[24] - Total assets as of June 30, 2022, were £295,568,000, a decrease from £301,773,000 as of December 31, 2021[7] - As of June 30, 2022, trade receivables increased to £24,424,000 from £6,047,000 at the end of 2021[58] Research and Development - Research and development costs for the six months ended June 30, 2022, were £38,731,000, compared to £36,356,000 in 2021, reflecting a 6% increase[4] - The company is developing a pipeline of five clinical stage programs in oncology and infectious disease, leveraging its ImmTAX platform[17] Regulatory Approvals - KIMMTRAK received regulatory approval from the FDA and EC in January and April 2022, respectively, and is now approved in over 30 countries[18] - The Group expects to obtain further regulatory approvals for KIMMTRAK in additional territories in the second half of 2022[18] Funding and Future Outlook - The Group anticipates needing additional funding to support ongoing operations and further development of its pipeline[26] - The Group's estimated rebates and chargebacks are subject to significant judgment due to limited sales history in the U.S.[30] - The Board assessed downside risks, including the impact of COVID-19 and geopolitical tensions, concluding minimal future impact on clinical trials[25] Capital and Lease Activities - The company issued 2,000,000 American Depositary Shares (ADSs) generating proceeds of £116,700,000 in July 2022[16] - The company completed a capital reduction on April 28, 2022, creating distributable reserves of £261.4 million[59] - The company entered into a new lease for additional laboratory space in the UK, with potential total payments of up to £5,317,000[66]
Immunocore Holdings (IMCR) Investor Presentation - Slideshow
2022-06-09 19:38
IMMUNOCORE Corporate Presentation June 2022 Forward-Looking Statements This presentation contains forward-looking statements within the meaning 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 pres ...
Immunocore(IMCR) - 2021 Q4 - Annual Report
2022-03-03 12:09
[PART I](index=9&type=section&id=PART%20I) [Item 3. Key Information](index=9&type=section&id=Item%203.%20Key%20Information.) This section details key investment risks, including financial losses, operational challenges, and dependence on KIMMTRAK's commercial success [Risk Factors](index=9&type=section&id=D.%20Risk%20factors.) This section details financial, clinical, commercial, and operational risks, emphasizing historical losses and reliance on the ImmTAX platform - The company has incurred significant net losses each year since inception, with a loss of **£131.5 million** in 2021 and an accumulated deficit of **£481.4 million** as of December 31, 2021, with losses expected to continue for the foreseeable future[34](index=34&type=chunk) - Future prospects are highly dependent on the successful commercialization of **KIMMTRAK**, approved by the FDA in January 2022 for metastatic uveal melanoma (mUM), with revenue generation subject to achieving significant market acceptance[32](index=32&type=chunk)[41](index=41&type=chunk) - The business is heavily reliant on the success of its **ImmTAX platform** to develop new product candidates, where any significant delays or failures could harm the business[35](index=35&type=chunk)[60](index=60&type=chunk) - The COVID-19 pandemic has adversely impacted and may continue to impact business operations, including the commercialization of KIMMTRAK, clinical trials, and the supply chain[32](index=32&type=chunk)[66](index=66&type=chunk) - The company will require substantial additional funding, with existing cash and cash equivalents expected to fund operations until at least Q3 2023, and with expected KIMMTRAK revenue, into the second half of 2024[32](index=32&type=chunk)[47](index=47&type=chunk) [Item 4. Information on the Company](index=88&type=section&id=Item%204.%20Information%20on%20the%20Company.) This section provides a comprehensive overview of Immunocore's history, structure, and business, highlighting its ImmTAX platform and KIMMTRAK product [History and Development of the Company](index=88&type=section&id=A.%20History%20and%20development%20of%20the%20company.) Immunocore Holdings plc was incorporated in January 2021, completed its IPO in February 2021, and focuses capital expenditures on UK assets - The company was incorporated as **Immunocore Holdings plc** on January 7, 2021, and completed its **IPO** on February 9, 2021, listing its ADSs on the Nasdaq under the symbol **IMCR**[398](index=398&type=chunk)[400](index=400&type=chunk) Capital Expenditures (£M) | Year | 2021 | 2020 | 2019 | | :--- | :--- | :--- | :--- | | Capital Expenditures | £1.0M | £3.1M | £4.3M | [Business Overview](index=89&type=section&id=B.%20Business%20overview.) Immunocore is a commercial-stage biotech company focused on ImmTAX immunotherapies, with FDA-approved KIMMTRAK and a pipeline in oncology and infectious diseases - On January 26, 2022, the FDA approved **KIMMTRAK** (tebentafusp-tebn) for unresectable or metastatic uveal melanoma (mUM), marking the first TCR therapeutic and first bispecific T cell engager for a solid tumor to receive FDA approval[404](index=404&type=chunk) - The company's proprietary **ImmTAX platform** engineers soluble, off-the-shelf, bispecific TCRs designed to target a wide range of intracellular proteins, expanding the therapeutic landscape beyond what is accessible to antibody-based therapies[403](index=403&type=chunk)[409](index=409&type=chunk) Clinical Pipeline Overview (as of Dec 31, 2021) | Candidate | Target | Indication | Phase 1 / 2 | Phase 3 | Approved | | :--- | :--- | :--- | :--- | :--- | :--- | | **Oncology** | | | | | | | KIMMTRAK® | gp100 | Uveal melanoma | | ✓ | ✓ | | | | Cutaneous melanoma | ✓ | | | | IMC-C103C | MAGE-A4 | NSCLC, gastric, head & neck, ovarian, etc. | ✓ | | | | IMC-F106C | PRAME | NSCLC, breast, endometrial, ovarian, etc. | ✓ | | | | **Infectious Diseases** | | | | | | | IMC-1109V | Envelope | Hepatitis B Virus (HBV) | ✓ | | | | IMC-M113V | Gag | Human Immunodeficiency Virus (HIV) | Pre-clinical | | | - The company has active strategic collaborations with **Genentech** for its MAGE-A4 program (IMC-C103C), and with **Eli Lilly** for other targets, while the collaboration with **GSK** was terminated in January 2022[462](index=462&type=chunk)[472](index=472&type=chunk)[473](index=473&type=chunk) [Organizational Structure](index=123&type=section&id=C.%20Organizational%20structure.) Immunocore Holdings plc, a UK-incorporated parent, oversees wholly-owned subsidiaries in the UK, US, and Ireland - The parent company is **Immunocore Holdings Plc**, incorporated in the UK, with subsidiaries in the UK, US, and Ireland[576](index=576&type=chunk) [Property, Plant and Equipment](index=123&type=section&id=D.%20Property%2C%20plant%20and%20equipment.) The company leases corporate headquarters and R&D facilities in Oxfordshire, UK, and additional office space in the US and Ireland - The main corporate headquarters and R&D facilities are leased in **Oxfordshire, UK**, with leases expiring between 2037 and 2040[577](index=577&type=chunk) - The company maintains **U.S. headquarters** in Pennsylvania and Maryland through leased office space[577](index=577&type=chunk) [Item 5. Operating and Financial Review and Prospects](index=123&type=section&id=Item%205.%20Operating%20and%20Financial%20Review%20and%20Prospects.) This section analyzes financial performance, reporting a **£131.5 million** net loss in 2021, and discusses liquidity and critical accounting estimates [Operating Results](index=124&type=section&id=A.%20Operating%20Results) In 2021, Immunocore reported a **£131.5 million** net loss, with decreased revenue and significantly increased administrative expenses Consolidated Statement of Loss Summary (£'000) | | 2021 | 2020 | | :--- | :--- | :--- | | **Revenue** | **26,520** | **30,114** | | Research and development expenses | (73,226) | (74,809) | | Administrative expenses | (88,399) | (45,740) | | **Operating loss** | **(135,162)** | **(86,193)** | | Loss before taxes | (140,928) | (87,360) | | Income tax credit | 9,405 | 13,267 | | **Loss for the period** | **(131,523)** | **(74,093)** | - Collaboration revenue decreased from **£30.1 million** in 2020 to **£23.5 million** in 2021, mainly due to a pause in revenue recognition from the Lilly collaboration and reduced reimbursable costs from Genentech[630](index=630&type=chunk) - Administrative expenses increased by **£42.7 million**, primarily due to a **£23.8 million** increase in non-cash share-based payment charges related to the IPO and a **£17.4 million** increase in pre-commercial expenditure for tebentafusp[638](index=638&type=chunk) [Liquidity and Capital Resources](index=136&type=section&id=B.%20Liquidity%20and%20Capital%20Resources) As of December 2021, the company held **£237.9 million** in cash, funded by IPO proceeds, and expects to fund operations into 2024 - The company completed its IPO in February 2021, raising gross proceeds of **$297.1 million**, plus an additional **$15.0 million** from a concurrent private placement[648](index=648&type=chunk) Cash and Cash Flow Summary (£'000) | | 2021 | 2020 | | :--- | :--- | :--- | | Cash and cash equivalents at end of year | 237,886 | 129,716 | | Net cash used in operating activities | (96,110) | (61,250) | | Net cash from / (used in) investing activities | (367) | 1,143 | | Net cash from financing activities | 204,631 | 115,941 | - Management projects that existing cash and expected revenues will fund operations into 2024, however, future funding requirements are significant and depend on the progress of clinical trials and commercialization efforts[666](index=666&type=chunk) [Critical Accounting Estimates](index=142&type=section&id=E.%20Critical%20Accounting%20Estimates) Critical accounting estimates include revenue recognition for collaboration agreements and the valuation of share options, both requiring significant judgment - Revenue from collaboration agreements is recognized over time using a percentage of completion method, which requires management to estimate project timelines, where a six-month underestimation of project life would have increased deferred revenue by **£5.3 million** as of year-end 2021[678](index=678&type=chunk)[679](index=679&type=chunk) - The valuation of share options requires subjective assumptions, including expected life and share price volatility, with the fair value of ordinary shares prior to the IPO determined using third-party valuations and other factors, introducing significant judgment[680](index=680&type=chunk)[681](index=681&type=chunk)[682](index=682&type=chunk) [Item 6. Directors, Senior Management and Employees](index=143&type=section&id=Item%206.%20Directors%2C%20Senior%20Management%20and%20Employees.) This section details the company's leadership, including executive officers, directors, their compensation, board practices, and employee headcount [Directors and Senior Management](index=143&type=section&id=A.%20Directors%20and%20senior%20management.) The company's executive team is led by CEO Bahija Jallal, Ph.D., supported by a seven-member Board of Directors - The executive team is led by **CEO Bahija Jallal, Ph.D.**, formerly President of MedImmune at AstraZeneca[687](index=687&type=chunk) - The Board of Directors is composed of **seven members**, including distinguished scientists and industry veterans such as Chairman Professor Sir John Bell and Nobel laureate Professor Sir Peter Ratcliffe[686](index=686&type=chunk)[691](index=691&type=chunk)[696](index=696&type=chunk) [Compensation](index=146&type=section&id=B.%20Compensation.) In 2021, aggregate compensation for directors and executive officers totaled **£2.0 million**, including salaries, bonuses, and equity awards - Aggregate compensation for directors and executive officers in 2021 was **£2.0 million**, including salaries, benefits, and bonuses[701](index=701&type=chunk) 2021 Director and Executive Officer Compensation Summary | Name | Total Fixed Remuneration ($) | Annual Bonus ($) | Share-Based Awards ( options) | | :--- | :--- | :--- | :--- | | **Bahija Jallal, Ph.D. (CEO)** | 745,414 | 525,000 | 2,076,080 | | **Other Executive Officers (Group)** | 989,309 | 518,100 | 875,507 | | **Non-Executive Directors (Group)** | 222,477 | — | 58,383 | [Board Practices](index=149&type=section&id=C.%20Board%20Practices.) The Board of Directors comprises seven members, with six independent, and operates through three standing committees - The board is composed of **seven directors**, with **six** determined to be independent under Nasdaq rules[715](index=715&type=chunk) - The board has **three standing committees**: Audit, Remuneration, and Nominating and Corporate Governance[719](index=719&type=chunk) [Employees](index=153&type=section&id=D.%20Employees.) As of December 2021, Immunocore had **324** full-time employees, with **247** in R&D, primarily based in the UK Employee Headcount by Function and Geography | | 2021 | 2020 | 2019 | | :--- | :--- | :--- | :--- | | **Function** | | | | | Administrative | 77 | 55 | 67 | | Research and development | 247 | 236 | 392 | | **Total** | **324** | **291** | **459** | | **Geography** | | | | | United Kingdom | 264 | 242 | 409 | | United States | 58 | 47 | 47 | | European Union | 2 | 2 | 3 | [Item 7. Major Shareholders and Related Party Transactions](index=153&type=section&id=Item%207.%20Major%20Shareholders%20and%20Related%20Party%20Transactions.) This section details major shareholders as of December 2021 and outlines the company's policy for related party transactions [Major Shareholders](index=153&type=section&id=A.%20Major%20Shareholders.) As of December 2021, General Atlantic was the largest shareholder at **11.2%**, with other significant holders including Baker Brothers and Eli Lilly Principal Shareholders (as of December 31, 2021) | Name of Beneficial Owner | Percent of Ordinary Shares Beneficially Owned (%) | | :--- | :--- | | Entities affiliated with General Atlantic | 11.2% | | Entities affiliated with Baker Brothers | 7.6% | | Eli Lilly S.A. | 5.8% | | Entities affiliated with Rock Springs Capital | 5.6% | | Malin Life Sciences Holdings Limited | 5.4% | | Ian Laing | 5.4% | | All current directors and executive officers as a group | 5.7% | [Item 8. Financial Information](index=156&type=section&id=Item%208.%20Financial%20Information.) This section presents consolidated financial statements, dividend policy, and legal proceedings, including a concluded internal investigation - The company has not declared or paid any dividends since its incorporation and does not plan to in the foreseeable future, intending to retain earnings for business use[746](index=746&type=chunk) - The company is involved in a patent opposition proceeding at the European Patent Office and a trademark opposition for IMMTAX, but does not believe the outcomes will materially harm the business[748](index=748&type=chunk) - An internal investigation into a kickback scheme involving an employee and vendors between 2018-2020 was concluded, and the company recovered its estimated losses of **£1.8 million** in December 2020[749](index=749&type=chunk) [Item 9. The Offer and Listing](index=157&type=section&id=Item%209.%20The%20Offer%20and%20Listing.) The company's ADSs have been listed and traded on the Nasdaq Global Select Market under "IMCR" since February 5, 2021 - The company's ADSs are listed on the **Nasdaq Global Select Market** under the ticker symbol "**IMCR**" since February 5, 2021[752](index=752&type=chunk)[754](index=754&type=chunk) [Item 10. Additional Information](index=159&type=section&id=Item%2010.%20Additional%20Information.) This section provides supplementary information on material contracts, exchange controls, and U.K. and U.S. tax considerations for ADS holders [Taxation](index=159&type=section&id=E.%20Taxation) This subsection details U.S. and U.K. tax implications for ADS holders, including PFIC risk for U.S. holders and U.K. dividend tax - For U.S. tax purposes, there is a risk the company could be classified as a **Passive Foreign Investment Company (PFIC)**, and while the company believes it was not a PFIC for the 2021 taxable year, this is an annual determination and its status could change[377](index=377&type=chunk)[771](index=771&type=chunk) - Because the company has U.S. subsidiaries, its non-U.S. subsidiaries are treated as **controlled foreign corporations (CFCs)**, and U.S. holders owning 10% or more of the company's shares may be subject to specific anti-deferral tax rules[373](index=373&type=chunk) - For U.K. tax purposes, dividends paid by the company are not expected to be subject to **U.K. withholding tax**[799](index=799&type=chunk) - Transfers of ADSs are generally not subject to **U.K. stamp duty** or **Stamp Duty Reserve Tax (SDRT)**, however, the issuance or transfer of ordinary shares to a depositary may be subject to a 1.5% SDRT charge[811](index=811&type=chunk)[814](index=814&type=chunk) [Item 11. Quantitative and Qualitative Disclosures About Market Risk](index=168&type=section&id=Item%2011.%20Quantitative%20and%20Qualitative%20Disclosures%20About%20Market%20Risk.) The company faces market risks including interest rate, currency, and credit risk, with currency risk being significant due to global operations - The company is exposed to **interest rate risk** through its variable-rate loan from Oxford Finance, which has an interest rate of LIBOR plus 8.85% within a defined cap and collar[824](index=824&type=chunk) - **Currency risk** is significant due to global operations, where as of December 31, 2021, 54% of cash held in the UK was denominated in U.S. dollars and 2% in euros, and a 5 percentage point change in exchange rates would impact the carrying value of net financial assets by **£2.6 million**[827](index=827&type=chunk)[828](index=828&type=chunk) - **Credit risk** is considered low, as cash is held with high-quality financial institutions and trade receivables are primarily from large, reputable pharmaceutical collaboration partners[829](index=829&type=chunk) [PART II](index=170&type=section&id=PART%20II) [Item 15. Controls and Procedures](index=170&type=section&id=Item%2015.%20Controls%20and%20Procedures.) This section confirms the effectiveness of the company's disclosure controls and internal control over financial reporting as of December 31, 2021 - Management concluded that as of December 31, 2021, the company's disclosure controls and procedures were **effective**[845](index=845&type=chunk) - Based on an assessment using the COSO 2013 framework, management concluded that the company's internal control over financial reporting was **effective** as of December 31, 2021[848](index=848&type=chunk) - A material weakness related to procurement processes, identified in 2020, was **remediated** as of December 31, 2020[670](index=670&type=chunk) [Item 16. Corporate Governance and Other Matters](index=171&type=section&id=Item%2016.%20Corporate%20Governance%20and%20Other%20Matters) This section covers corporate governance, including the audit committee expert, code of conduct, accountant fees, and foreign private issuer exemptions - The Board has identified Mr. Coy as an "**audit committee financial expert**"[852](index=852&type=chunk) Principal Accountant Fees (£'000) | | 2021 | 2020 | | :--- | :--- | :--- | | Audit fees | 650 | 470 | | Audit-related fees | 125 | 237 | | **Total** | **775** | **707** | - As a **foreign private issuer**, the company follows **U.K. corporate governance practices** and is exempt from certain Nasdaq rules, including those related to shareholder approval for certain security issuances and the composition of the compensation committee[861](index=861&type=chunk)[863](index=863&type=chunk) [PART III](index=175&type=section&id=PART%20III) [Item 17. Financial Statements](index=175&type=section&id=Item%2017.%20Financial%20Statements.) This section presents the audited consolidated financial statements for 2019-2021, prepared under IFRS, including statements of loss, position, equity, and cash flows Key Financial Metrics (£'000) | Metric | 2021 | 2020 | 2019 | | :--- | :--- | :--- | :--- | | **Revenue** | 26,520 | 30,114 | 25,669 | | **Operating Loss** | (135,162) | (86,193) | (118,320) | | **Loss for the year** | (131,523) | (74,093) | (103,931) | | **Total Assets** | 301,773 | 197,194 | N/A | | **Total Equity** | 171,547 | 55,346 | 14,771 | | **Cash at Year End** | 237,886 | 129,716 | 73,966 |
Immunocore(IMCR) - 2022 Q1 - Quarterly Report
2022-03-03 12:01
[Overview and Key Highlights](index=1&type=section&id=Overview%20and%20Key%20Highlights) Immunocore achieved FDA approval and launched KIMMTRAK for mUM, advanced its clinical pipeline, and ended 2021 with $321 million cash - KIMMTRAK® (tebentafusp-tebn) received **FDA approval** for unresectable or metastatic uveal melanoma (mUM) and the US **commercial launch** has been initiated[2](index=2&type=chunk)[5](index=5&type=chunk) - The European Medicines Agency's CHMP issued a **positive opinion** for KIMMTRAK, with regulatory submissions also under review in the UK, Canada, and Australia[2](index=2&type=chunk)[10](index=10&type=chunk) - The company plans to report **Phase 1 data** from its clinical candidates targeting PRAME in **Q3 2022** and MAGE-A4 in **Q4 2022**[2](index=2&type=chunk)[6](index=6&type=chunk) - Cash position was approximately **$321 million** as of December 31, 2021[3](index=3&type=chunk) [Management Commentary](index=2&type=section&id=Management%20Commentary) Management highlighted KIMMTRAK's approval as platform validation, prioritizing its commercial rollout and accelerating pipeline programs with upcoming data - The CEO stated that KIMMTRAK's approval provides an important validation of the **ImmTAX platform** and opens doors for further discoveries in cancer and other diseases[8](index=8&type=chunk) - Priorities for the new year include the **commercial roll-out** of KIMMTRAK and **accelerating the clinical programs**, with updates from PRAME and MAGE-A4 programs planned for later in the year[9](index=9&type=chunk) [Clinical Pipeline and Program Updates](index=2&type=section&id=Clinical%20Pipeline%20and%20Program%20Updates) Immunocore advances its multi-program clinical pipeline, with KIMMTRAK achieving regulatory milestones and key oncology and infectious disease programs progressing [KIMMTRAK® (tebentafusp-tebn)](index=2&type=section&id=KIMMTRAK%C2%AE%20%28tebentafusp-tebn%29) KIMMTRAK received FDA approval for mUM, a positive CHMP opinion, and is being explored for mCM with a new commercialization agreement - Received **FDA approval** in **January 2022** for HLA-A*02:01-positive adult patients with unresectable or metastatic uveal melanoma (mUM)[11](index=11&type=chunk) - Received a **positive CHMP opinion** in Europe in **February 2022**, with an anticipated launch in **Q2 2022** upon final EMA decision[10](index=10&type=chunk) - A Phase 1b trial in metastatic cutaneous melanoma (mCM) showed preliminary evidence of clinical activity in patients who had prior anti-PD(L)1 therapy, with a **1-year overall survival rate of 76%**[12](index=12&type=chunk) - An **exclusive multi-regional agreement** was signed with Medison Pharma to commercialize tebentafusp in Canada, Central Eastern Europe, and Israel[15](index=15&type=chunk) [IMC-C103C targeting MAGE-A4](index=3&type=section&id=IMC-C103C%20targeting%20MAGE-A4) IMC-C103C's Phase 1 trial showed manageable safety and durable responses, with an expansion arm initiated and further data expected in Q4 2022 - Initial Phase 1 data showed a **manageable safety profile** and clinical activity with confirmed **durable responses** in ovarian cancer and head and neck squamous cell carcinoma (HNSCC)[16](index=16&type=chunk) - An **expansion arm initiated** in high-grade serous ovarian carcinoma at 140 micrograms/weekly in **Q4 2021**[16](index=16&type=chunk) - The company plans to report data from the MAGE-A4 program in the **fourth quarter of 2022**[16](index=16&type=chunk) [IMC-F106C targeting PRAME](index=3&type=section&id=IMC-F106C%20targeting%20PRAME) IMC-F106C's Phase 1/2 trial enrolled 39 patients, showing early biological activity, with initial Phase 1 data expected in Q3 2022 - As of December 16, 2021, **39 patients** have been enrolled in the Phase 1 study for multiple solid tumor cancers[17](index=17&type=chunk) - Early pharmacodynamic data indicate that IMC-F106C monotherapy is demonstrating **biological activity**[17](index=17&type=chunk) - The company plans to report the initial Phase 1 data in the **third quarter of 2022**[17](index=17&type=chunk) [Infectious Disease Programs (ImmTAV®)](index=3&type=section&id=Infectious%20Disease%20Programs%20%28ImmTAV%C2%AE%29) Immunocore advances its ImmTAV® platform for infectious diseases, with ongoing Phase 1 enrollment for HBV and a CTA accepted for HIV with Q2 2022 dosing - **HBV (IMC-I109V):** The global Phase 1 single ascending dose trial continues to enroll patients[18](index=18&type=chunk) - **HIV (IMC-M113V):** A clinical trial application (CTA) was accepted in the UK, with plans to dose the first patient in **Q2 2022**[19](index=19&type=chunk) [Financial Results](index=4&type=section&id=Financial%20Results) Immunocore's FY2021 operating loss increased to £135.2 million, revenue decreased to £26.5 million, but cash and equivalents significantly increased to £237.9 million Financial Performance Summary | Metric | Q4 2021 | Q4 2020 | FY 2021 | FY 2020 | | :--- | :--- | :--- | :--- | :--- | | **Revenue** | £6.6M | £7.4M | £26.5M | £30.1M | | **R&D Expenses** | £20.1M | £17.2M | £73.2M | £74.8M | | **Admin Expenses** | £24.4M | £14.2M | £88.4M | £45.7M | | **Operating Loss** | £37.8M | £20.2M | £135.2M | £86.2M | | **Loss per Share** | £0.90 | £0.69 | £3.10 | £2.79 | - The increase in operating loss was primarily driven by higher employee costs from a non-cash share-based payment charge and pre-commercial expenditure for tebentafusp[21](index=21&type=chunk)[24](index=24&type=chunk) - Cash and cash equivalents increased to **£237.9 million** (approx. **$321.1 million**) as of December 31, 2021, compared to **£129.7 million** as of December 31, 2020[25](index=25&type=chunk) [About KIMMTRAK® and Important Safety Information](index=4&type=section&id=About%20KIMMTRAK%C2%AE%20and%20Important%20Safety%20Information) KIMMTRAK is a first-in-class bispecific T cell receptor therapeutic, approved based on Phase 3 data showing overall survival benefit, with a boxed warning for Cytokine Release Syndrome - KIMMTRAK is a novel bispecific protein comprised of a soluble T cell receptor fused to an anti-CD3 immune-effector function, targeting the gp100 antigen[26](index=26&type=chunk) - The pivotal Phase 3 trial demonstrated an unprecedented **overall survival benefit** with a **Hazard Ratio (HR) of 0.51** (95% CI: 0.37, 0.71; p< 0.0001) favoring KIMMTRAK over investigator's choice[28](index=28&type=chunk) - **BOXED WARNING:** KIMMTRAK can cause **Cytokine Release Syndrome (CRS)**, which may be serious or life-threatening. CRS occurred in **89%** of patients, with **0.8%** being grade 3 or 4[29](index=29&type=chunk) - The **most common adverse reactions (≥30%)** were cytokine release syndrome, rash, pyrexia, pruritus, fatigue, nausea, chills, abdominal pain, edema, hypotension, dry skin, headache, and vomiting[33](index=33&type=chunk) [About Immunocore and its Technology](index=6&type=section&id=About%20Immunocore%20and%20its%20Technology) Immunocore is a commercial-stage biotech company pioneering ImmTAX TCR bispecific immunotherapies, utilizing its ImmTAC platform for oncology, autoimmune, and infectious diseases, with five clinical-stage programs - Immunocore is a **commercial-stage biotech company** developing a novel class of TCR bispecific immunotherapies called **ImmTAX**[37](index=37&type=chunk) - The proprietary **ImmTAC® technology** generates bispecific biologics designed to redirect T cells to recognize and kill cancerous cells by targeting intracellular cancer antigens[36](index=36&type=chunk) - The company has a deep pipeline with **five clinical-stage programs** in oncology and infectious disease[37](index=37&type=chunk) [Consolidated Financial Statements](index=8&type=section&id=Consolidated%20Financial%20Statements) Immunocore's 2021 consolidated financial statements show a net loss of £131.5 million, year-end cash of £237.9 million, total assets of £301.8 million, and total equity of £171.5 million [Consolidated Statement of Loss](index=8&type=section&id=Consolidated%20Statement%20of%20Loss) Immunocore's FY2021 loss increased to £131.5 million from £74.1 million, with Q4 loss widening to £39.4 million, primarily due to increased expenses Full Year Consolidated Statement of Loss | (in thousands £) | Year Ended Dec 31, 2021 | Year Ended Dec 31, 2020 | | :--- | :--- | :--- | | Revenue | 26,520 | 30,114 | | Operating loss | (135,162) | (86,193) | | Loss for the period | (131,523) | (74,093) | Quarter Ended Consolidated Statement of Loss | (in thousands £) | Quarter Ended Dec 31, 2021 | Quarter Ended Dec 31, 2020 | | :--- | :--- | :--- | | Revenue | 6,593 | 7,420 | | Operating loss | (37,832) | (20,160) | | Loss for the period | (39,389) | (18,880) | [Consolidated Statement of Cash Flows](index=10&type=section&id=Consolidated%20Statement%20of%20Cash%20Flows) Net cash used in operating activities was £96.1 million, offset by £204.6 million from financing, resulting in year-end cash of £237.9 million Consolidated Statement of Cash Flows Summary | (in thousands £) | Year Ended Dec 31, 2021 | Year Ended Dec 31, 2020 | | :--- | :--- | :--- | | Net cash flows used in operating activities | (96,110) | (61,250) | | Net cash flows from financing activities | 204,631 | 115,941 | | **Cash and cash equivalents at end of period** | **237,886** | **129,716** | [Consolidated Statements of Financial Position](index=11&type=section&id=Consolidated%20Statements%20of%20Financial%20Position) As of December 31, 2021, Immunocore reported total assets of £301.8 million, total liabilities of £130.2 million, and total equity of £171.5 million Consolidated Statements of Financial Position Summary | (in thousands £) | Dec 31, 2021 | Dec 31, 2020 | | :--- | :--- | :--- | | Total non-current assets | 39,047 | 44,263 | | Total current assets | 262,726 | 152,931 | | **Total assets** | **301,773** | **197,194** | | **Total equity** | **171,547** | **55,346** | | Total non-current liabilities | 69,046 | 86,850 | | Total current liabilities | 61,180 | 54,998 | | **Total liabilities** | **130,226** | **141,848** |
Immunocore (IMCR) presents at JP Morgan 40th Annual Virtual Healthcare Conference (Slideshow)
2022-01-14 17:46
IMMUNOCORE | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | |-------|--------------|-----------------------------------------------------------------|-------|-------|-------|-------|-------|-------|-------| | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | 40th | | Corporate Presentation Annual J.P. Morgan Healthcare Conference | | | | | | | | | | January 2022 | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | Forward-Looking Statements This presentation contains fo ...
Immunocore (IMCR) Investor Presentation - Slideshow
2021-06-11 18:32
IMMUNOCORE Corporate Presentation June 2021 Forward-Looking Statements This presentation contains forward-looking statements within the meaning 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. Forward-looking statements contained in this presentation may include statements ...
Immunocore(IMCR) - 2020 Q4 - Annual Report
2021-03-25 11:01
UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 20-F (Mark One) ☐ REGISTRATION STATEMENT PURSUANT TO SECTION 12(b) OR (g) OF THE SECURITIES EXCHANGE ACT OF 1934 OR ☒ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year ended December 31, 2020 OR Date of event requiring this shell company report Commission File Number 001-39992 Immunocore Holdings plc (Exact name of Registrant as specified in its charter and translation of Regis ...