6-K
Immunocore Holdings plc (IMCR)
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 6-K
REPORT OF FOREIGN PRIVATE ISSUER
PURSUANT TO RULE 13a-16 OR 15d-16
UNDER THE SECURITIES EXCHANGE ACT OF 1934
For the Month of January 2023
Commission File Number: 001-39992
Immunocore Holdings plc
(Translation of registrant’s name into English)
92 Park Drive
Milton Park
Abingdon, Oxfordshire OX14 4RY
United Kingdom
(Address of principal executive office)
Indicate by check mark whether the registrant files or will file annual reports under cover of Form 20-F or Form 40-F:
☒ Form 20-F ☐ Form 40-F
INCORPORATION BY REFERENCE
The information in this Report on Form 6-K (“Report”), other than Exhibit 99.3 hereto, is being furnished and shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934 (the “Exchange Act”) or otherwise subject to the liabilities of that section, nor shall it be deemed incorporated by reference in any filing under the Securities Act of 1933 or the Exchange Act.
Exhibit 99.3 to this Report shall be deemed to be incorporated by reference into the registration statements on Form S-8 (File Nos. 333-255182 and 333-265000) and the registration statement on Form F-3ASR (File No. 333-264105) of Immunocore Holdings plc (the “Company”) and to be a part thereof from the date on which this Report is furnished, to the extent not superseded by documents or reports subsequently filed or furnished.
INFORMATION CONTAINED IN THIS REPORT ON FORM 6-K
Preliminary Full Year and Fourth Quarter 2022 KIMMTRAK and tebentafusp Net Sales; Preliminary Year-End 2022 Cash and Cash Equivalents
On Monday, January 9, 2023, the Company announced preliminary estimates of (1) total net product and pre-product revenue arising from the sales of KIMMTRAK and tebentafusp (“net sales”) for the fourth quarter and twelve months ended December 31, 2022 and (2) the amount of cash and cash equivalents at December 31, 2022. While the Company has not finalized its financial results for the twelve months ended December 31, 2022, the Company preliminarily estimates that its total net sales were approximately $50 million for the fourth quarter ended December 31, 2022, an increase of approximately 25% compared to the third quarter ended September 30, 2022, and approximately $140 million for the fiscal year ended December 31, 2022. The Company preliminarily estimates that its cash and cash equivalents as of December 31, 2022 were approximately $400 million. The foregoing dollar amounts were converted using the December 31, 2022 convenience rate of 1 British pound sterling to 1.21 U.S. dollars.
The information in this subheading is preliminary, has not been audited and is subject to change pending completion of the Company’s audited financial statements for the year ended December 31, 2022. It is possible that the Company or its independent registered public accounting firm may identify items that require the Company to make adjustments to the amounts included in this subheading, and such changes could be material. Additional information and disclosures would also be required for a more complete understanding of the Company’s financial position and results of operations as of December 31, 2022.
Press Release Announcing Strategic Priorities for 2023; Updated Corporate Presentation and Pipeline Chart
On Monday, January 9, 2023, the Company announced its updated strategic priorities and pipeline expansion for 2023. A copy of the press release is furnished as Exhibit 99.1 to this Report on Form 6-K.
Also on January 9, 2023, the Company posted an updated corporate presentation reflecting these updates and the updated disclosure regarding the Company’s preliminary unaudited net sales for the fourth quarter and fiscal year ended December 31, 2022 and preliminary unaudited cash and cash equivalents as of December 31, 2022. The updated corporate presentation is available in the ‘Investors/Media’ section of the Company’s website at www.immunocore.com. The Company intends to use this presentation in meetings with analysts, investors and others from time to time, including its meetings at the 41st Annual J.P. Morgan Healthcare Conference. A copy of the presentation is being furnished hereto as Exhibit 99.2 and is incorporated herein by reference.
The Company published an updated pipeline chart of KIMMRAK and its therapeutic candidates in development, which is filed as Exhibit 99.3 to this Report and incorporated by reference herein.
Presentation at 41^st^ Annual J.P. Morgan Healthcare Conference
Bahija Jallal, the Company’s Chief Executive Officer, will present at the upcoming 41^st^ Annual J.P. Morgan Healthcare Conference on Wednesday, January 11, 2023 at 12:00 p.m. ET. The presentation will be webcast live and will be available in the “Investors/Media” section of the Company’s website, located at www.immunocore.com.
The Company’s website and any information contained on the Company’s website are not incorporated into this Report.
CAUTIONARY NOTE ON FORWARD-LOOKING STATEMENTS
This Report contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Words such as “may,” “will,” “expect,” “plan,” “anticipate,” “estimate,” “intend” and similar expressions (as well as other words or expressions referencing future events, conditions or circumstances) are intended to identify forward-looking statements. These statements include, but are not limited to, statements regarding the Company’s strategic priorities, pipeline and expansion thereof, and preliminary unaudited net sales and cash and cash equivalents. These forward-looking statements are based on the Company’s expectations and assumptions as of the date of this Report, and are subject to a number of risks and uncertainties that could cause actual results to differ materially and adversely from those set forth in or implied by such forward-looking statements, many of which are beyond the Company’s control. Actual results may differ materially from those expressed or implied by these forward-looking statements. For a discussion of risk factors that may cause the Company’s actual results to differ from those expressed or implied in the forward-looking statements in this Report, you should refer to the Company’s filings with the U.S. SEC, including the “Risk Factors” sections contained therein. Except as required by law, the Company undertakes no obligation to publicly update any forward-looking statements, whether as a result of new information, future events or otherwise. You should, therefore, not rely on these forward-looking statements as representing the Company’s views as of any date subsequent to the date of this Report.
EXHIBIT INDEX
| Exhibit<br><br> <br>No. | Description |
|---|---|
| 99.1 | Press Release dated January 9, 2023. |
| 99.2 | Corporate Presentation. |
| 99.3 | Pipeline Chart. |
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned, thereunto duly authorized.
| IMMUNOCORE HOLDINGS PLC | ||
|---|---|---|
| Date: January 9, 2023 | By: | /s/ Bahija Jallal, Ph.D. |
Exhibit 99.1
Immunocore announces strategic priorities including pipeline expansion for 2023 -2024
KIMMTRAK (tebentafusp-tebn) approved in over 30 countries with continued global expansion in 2023-2024; preliminary unaudited net sales of ~$50 million in Q4 and ~$140 million for full year 2022
Priority for IMC-F106C (PRAME HLA-A02) is enrollment in monotherapy and combination arms of Phase 1/2 clinical trial, with data planned by 1H 2024
Expanding PRAME franchise, including targeting PRAME HLA-A24 with a first-in-class ImmTAC to broaden the addressable patient population, and a PRAME HLA-A02 half-life extended ImmTAC for patient convenience
First-in-class ImmTAC targeting PIWIL1 for colorectal and other gastrointestinal cancers – IND planned for Q4 2023
Company to present at 41^st^ Annual J.P. Morgan Healthcare Conference on Wednesday, January 11, 2023 at 9:00 AM P.T.
(OXFORDSHIRE, England & CONSHOHOCKEN, Penn. & ROCKVILLE, Md., US, 09 January, 2023) Immunocore Holdings plc (Nasdaq: IMCR) (“Immunocore” or the “Company”), a commercial-stage biotechnology company pioneering the development of a novel class of T cell receptor (TCR) bispecific immunotherapies designed to treat a broad range of diseases, including cancer, autoimmune and infectious diseases, today announces the addition of three new ImmTAC product candidates (targeting PRAME-A24, PRAME-A02 half-life extended [HLE], and PIWIL1) to its pipeline and preliminary unaudited KIMMTRAK (tebentafusp-tebn) 2022 year-end net sales.
“We are so proud of what we have delivered for patients with metastatic uveal melanoma, thanks to the talent and hard work of our experienced team. With $140 million of preliminary net sales for KIMMTRAK for 2022, our solid financial position has enabled us to accelerate the development of our existing pipeline and expand our platform,” said Bahija Jallal, Chief Executive Office of Immunocore. “2023 is off to a great start with the continued execution of our ambitious development plan for IMC-F106C as well as today’s announcement of the expansion of our PRAME franchise and the nomination of a novel ImmTAC candidate for GI cancers.”
Preliminary Year-End 2022 KIMMTRAK and tebentafusp net sales
The preliminary unaudited total net product and net pre-product revenue (or “net sales”) arising from the sales of KIMMTRAK and tebentafusp was ~$50 million in Q4 2022, an increase of ~25% compared to the previous quarter, and ~$140 million for full year 2022. Preliminary unaudited cash and cash equivalents were ~$400 million USD year end 2022.^1^
^1^ These dollar amounts were converted using the Dec. 31, 2022 convenience rate of £1 to $1.21.
In 2023, the Company will continue to launch in additional countries and establish KIMMTRAK globally as first line treatment for metastatic uveal melanoma, while exploring how to enhance patient convenience. In addition, the Company is enrolling patients into a Phase 2/3 trial to investigate the potential of tebentafusp in advanced cutaneous melanoma.
Expansion of ImmTAC franchise targeting PRAME
IMC-F106C (PRAME-A02)
Initial Phase 1 data with IMC-F106C targeting PRAME, in the context of HLA-A02, presented in September 2022 at the ESMO Congress 2022, demonstrated multiple durable confirmed RECIST responses and a reduction in circulating tumor DNA (ctDNA) in multiple solid tumors.
As previously announced, and following the promising initial data, patient enrollment is ongoing in the four monotherapy expansion arms and multiple combination arms of the trial: cutaneous melanoma, ovarian, non-small cell lung cancer (NSCLC), and endometrial cancers. The IMC-F106C-101 trial is adaptive and enables combinations with standards-of-care including checkpoint inhibitors, chemotherapy, and tebentafusp. These combinations will position the Company to explore IMC-F106C in earlier lines of treatment.
In 2023, the Company plans to continue to expand the clinical trial footprint globally; enrolling additional patients in the expansion arms to understand the breadth of clinical activity across multiple tumor types. The Company expects to report initial data from the monotherapy and combination arms by the first half of 2024.
IMC-T119C (PRAME-A24) & IMC-P115C (PRAME-A02 Half-Life Extended)
IMC-F106C is an ImmTAC targeting PRAME for patients with HLA-A02, which is expressed in approximately 40% of Western populations (United States, Canada, EU). In order to expand the potential of TCR therapy targeting PRAME, the Company is developing IMC-T119C, a first-in-class ImmTAC product candidate targeting a PRAME peptide presented by HLA-A24. HLA-24 is an HLA-type that is estimated to be present in 60% of people in Japan and 15-20% in Western populations.
In addition, the Company is developing IMC-P115C, a half-life extended (HLE) ImmTAC product candidate targeting PRAME-A02, with the aim of improving patient convenience. IMC-P115C targets the same PRAME-A02 peptide and uses the same CD3 end and TCR specificity as IMC-F106C.
First-in-class ImmTAC candidate – IMC-R117C (PIWIL1) for colorectal and other gastrointestinal cancers
The Company has leveraged its proprietary peptidomic database to validate a novel target, PIWIL1. PIWIL1 is believed to play a role in tumor progression and is expressed across a range of tumors including colorectal, which is historically insensitive to immune checkpoints, as well as gastro-esophageal, and pancreatic cancer. PIWIL1 is also reported to be a negative prognostic marker. The Company believes IMC-R117C is the first PIWIL1 targeted immunotherapy and plans to submit an IND in Q4 2023.
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Enrolling ImmTAV candidates for a functional cure in HIV & HBV
The Company continues to enroll patients in the HIV and HBV global Phase 1 clinical trials. The Company plans to report data from the Single Ascending Dose portion of the Phase 1 HIV trial in 2023.
41^st^ Annual J.P. Morgan Healthcare Conference
The Company has updated its corporate presentation to reflect these updates. Additionally, the Immunocore management team will discuss these updates during a live and webcast presentation at the 41^st^ Annual J.P. Morgan Healthcare Conference, on Wednesday January 11, 2023, at 9:00AM P.T. The presentation and webcast will be available in the ‘Investors/Media’ section of Immunocore’s website at www.immunocore.com. A replay of the presentation will be made available for a limited time.
About ImmTAV molecules and infectious diseases
ImmTAV (Immune mobilising monoclonal TCRs Against Virus) molecules are novel bispecific molecules that, like ImmTAC (Immune mobilising monoclonal TCRs Against Cancer) molecules, are designed to enable the immune system to recognize and eliminate virally infected cells.
Immunocore is advancing clinical candidates to cure patients with HIV and hepatitis B virus (HBV). The Company aims to achieve sustained control of HIV after patients stop anti-retroviral therapy (ART), without the risk of virological relapse or onward transmission. This is known as ‘functional cure’. For the treatment of HBV, the Company aims to achieve sustained loss of circulating viral antigens and markers of viral replication after stopping medication for people living with chronic HBV.
About ImmTAC^®^ molecules for cancer
Immunocore’s proprietary T cell receptor (TCR) technology generates a novel class of bispecific biologics called ImmTAC (Immune mobilizing monoclonal TCRs Against Cancer) molecules that are designed to redirect the immune system to recognize and kill cancerous cells. ImmTAC molecules are soluble TCRs engineered to recognize intracellular cancer antigens with ultra-high affinity and selectively kill these cancer cells via an anti-CD3 immune-activating effector function. Based on the demonstrated mechanism of T cell infiltration into human tumors, the ImmTAC mechanism of action holds the potential to treat hematologic and solid tumors, regardless of mutational burden or immune infiltration, including immune “cold” low mutation rate tumors.
About the IMC-F106C-101 Phase 1/2 Trial
IMC-F106C-101 is a first-in-human, Phase 1/2 dose escalation trial in patients with multiple solid tumor cancers including non-small cell lung cancer (NSCLC), small-cell lung cancer (SCLC), endometrial, ovarian, cutaneous melanoma, and breast cancers. The Phase 1 dose escalation trial was designed to determine the maximum tolerated dose (MTD), as well as to evaluate the safety, preliminary anti-tumor activity and pharmacokinetics of IMC-F106C, a bispecific protein built on Immunocore’s ImmTAC^®^ technology, and the Company’s first molecule to target the PRAME antigen. The Company has initiated patient enrollment into four expansion arms in cutaneous melanoma, ovarian, NSCLC, and endometrial cancers. The IMC-F106C-101 trial is adaptive and includes the option for Phase 2 expansion, allowing for approximately 100 patients treated per tumor type in the Phase 1 and 2 expansion arms. Dose escalation continues in additional solid tumors as well as plans for combination arms with standards-of-care, including checkpoint inhibitors, chemotherapy, and tebentafusp.
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About Uveal Melanoma
Uveal melanoma is a rare and aggressive form of melanoma, which affects the eye. Although it is the most common primary intraocular malignancy in adults, the diagnosis is rare, and up to 50% of people with uveal melanoma will eventually develop metastatic disease. Unresectable or metastatic uveal melanoma typically has a poor prognosis and had no approved treatment until KIMMTRAK.
About KIMMTRAK^®^
KIMMTRAK is a novel bispecific protein comprised of a soluble T cell receptor fused to an anti-CD3 immune-effector function. KIMMTRAK specifically targets gp100, a lineage antigen expressed in melanocytes and melanoma. This is the first molecule developed using Immunocore’s ImmTAC technology platform designed to redirect and activate T cells to recognise and kill tumour cells. KIMMTRAK has been approved for the treatment of HLA-A*02:01-positive adult patients with unresectable or metastatic uveal melanoma in the United States, European Union, Canada, Australia, and the United Kingdom.
About Phase 3 IMCgp100-202 Trial
IMCgp100-202 (NCT03070392) is a randomized pivotal trial that evaluated overall survival (OS) of KIMMTRAK compared to investigator’s choice (either pembrolizumab, ipilimumab, or dacarbazine) in HLA-A*02:01-positive adult patients with previously untreated mUM. KIMMTRAK demonstrated an unprecedented OS benefit with a Hazard Ratio (HR) in the intent-to-treat population favoring KIMMTRAK, HR=0.51 (95% CI: 0.37, 0.71); p< 0.0001, over investigator’s choice (82% pembrolizumab; 13% ipilimumab; 6% dacarbazine).
IMPORTANT SAFETY INFORMATION
Cytokine Release Syndrome (CRS), which may be serious or life-threatening, occurred in patients receiving KIMMTRAK. Monitor for at least 16 hours following first three infusions and then as clinically indicated. Manifestations of CRS may include fever, hypotension, hypoxia, chills, nausea, vomiting, rash, elevated transaminases, fatigue, and headache. CRS occurred in 89% of patients who received KIMMTRAK with 0.8% being grade 3 or 4. Ensure immediate access to medications and resuscitative equipment to manage CRS. Ensure patients are euvolemic prior to initiating the infusions. Closely monitor patients for signs or symptoms of CRS following infusions of KIMMTRAK. Monitor fluid status, vital signs, and oxygenation level and provide appropriate therapy. Withhold or discontinue KIMMTRAK depending on persistence and severity of CRS.
Skin Reactions
Skin reactions, including rash, pruritus, and cutaneous edema occurred in 91% of patients treated with KIMMTRAK. Monitor patients for skin reactions. If skin reactions occur, treat with antihistamine and topical or systemic steroids based on persistence and severity of symptoms. Withhold or permanently discontinue KIMMTRAK depending on the severity of skin reactions.
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Elevated Liver Enzymes
Elevations in liver enzymes occurred in 65% of patients treated with KIMMTRAK. Monitor alanine aminotransferase (ALT), aspartate aminotransferase (AST), and total blood bilirubin prior to the start of and during treatment with KIMMTRAK. Withhold KIMMTRAK according to severity.
Embryo-Fetal Toxicity
KIMMTRAK may cause fetal harm. Advise pregnant patients of potential risk to the fetus and patients of reproductive potential to use effective contraception during treatment with KIMMTRAK and 1 week after the last dose.
The most common adverse reactions (≥30%) in patients who received KIMMTRAK were cytokine release syndrome, rash, pyrexia, pruritus, fatigue, nausea, chills, abdominal pain, edema, hypotension, dry skin, headache, and vomiting. The most common (≥50%) laboratory abnormalities were decreased lymphocyte count, increased creatinine, increased glucose, increased AST, increased ALT, decreased hemoglobin, and decreased phosphate.
For more information, please see full Summary of Product Characteristics (SmPC) or full U.S. Prescribing Information (including BOXED WARNING for CRS).
About KIMMTRAKConnect
Immunocore is committed to helping patients who need KIMMTRAK obtain access via our KIMMTRAKConnect program. The program provides services with dedicated nurse case managers who provide personalized support, including educational resources, financial assistance, and site of care coordination. To learn more, visit KIMMTRAKConnect.com or call 844-775-2273.
About Immunocore
Immunocore is a commercial-stage biotechnology company pioneering the development of a novel class of TCR bispecific immunotherapies called ImmTAX – Immune mobilizing monoclonal TCRs Against X disease – designed to treat a broad range of diseases, including cancer, autoimmune, and infectious disease. Leveraging its proprietary, flexible, off-the-shelf ImmTAX platform, Immunocore 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. The Company’s most advanced oncology TCR therapeutic, KIMMTRAK has been approved for the treatment of HLA-A*02:01-positive adult patients with unresectable or metastatic uveal melanoma in the United States, European Union, Canada, Australia, and the United Kingdom.
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Forward Looking Statements
This press release contains “forward-looking statements” within the meaning of the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Words such as “may,” “can,” “will,” “believe,” “expect,” “plan,” “anticipate,” and similar expressions (as well as other words or expressions referencing future events or circumstances) are intended to identify forward-looking statements. All statements, other than statements of historical facts, included in this press release are forward-looking statements. These statements include, but are not limited to, statements regarding the therapeutic potential and expected clinical benefits, including overall survival benefit, of Immunocore’s products and product candidates, including KIMMTRAK, IMC-F106C, IMC-T119C, IMC-P115C, IMC-R117C, and IMC-M113V ; statements that IMC-T119C is first-in-class ImmTAC and that IMC-R117C is first in class and first PIWIL targeted immunotherapy for colorectal and other gastrointestinal cancers; expectations regarding the development and expansion of Immunocore’s pipeline and the design, progress, timing, enrollment, scope, expansion and results of Immunocore’s existing and planned clinical trials, including statements regarding the ongoing enrollment of patients in the Phase 2/3 trial to investigate the potential of tebentafusp in advanced cutaneous melanoma, the continued expansion of, enrollment of additional patients in, and timing for reporting data from the monotherapy and combination arms of the IMC-F106C-101 trial, the planned IND timing for IMC-R117C, and the timing for reporting data from the single ascending dose portion of the IMC-M113V Phase 1 HIV clinical trial; Immunocore’s ability to obtain and maintain regulatory approval for its products and product candidates; expectations regarding the potential market opportunity and potential commercial performance of KIMMTRAK and Immunocore’s other product candidates, if approved; statements regarding the continued launch of KIMMTRAK in additional countries; statements regarding the establishment of KIMMTRAK globally as a first line treatment for metastatic uveal melanoma; statements regarding the planned exploration of patient convenience; preliminary unaudited net sales of KIMMTRAK and tebentafusp; and preliminary unaudited cash and cash equivalents. Any forward-looking statements are based on management’s current expectations of future events and are subject to a number of risks and uncertainties that could cause actual results to differ materially and adversely from those set forth in or implied by such forward-looking statements, many of which are beyond Immunocore’s control.
These risks and uncertainties include, but are not limited to, the impact of worsening macroeconomic conditions and the ongoing and evolving COVID-19 pandemic on Immunocore’s business, strategy, clinical trials, financial position and anticipated milestones, including Immunocore’s ability to conduct ongoing and planned clinical trials; Immunocore’s ability to obtain a clinical supply of current or future product candidates, or commercial supply of KIMMTRAK or any future approved products, including as a result of supply chain disruptions, the COVID-19 pandemic, the war in Ukraine or global geopolitical tension; Immunocore’s ability to obtain and maintain regulatory approvals for its product candidates; Immunocore’s ability to develop, manufacture and commercialize its product candidates; Immunocore’s ability and plans in continuing to establish and expand a commercial infrastructure and to successfully launch, market and sell KIMMTRAK and any future approved products; Immunocore’s ability to successfully expand the approved indications for KIMMTRAK or obtain marketing approval for KIMMTRAK in additional geographies in the future; the delay of any current or planned clinical trials, whether due to the COVID-19 pandemic, patient enrollment delays or otherwise; Immunocore’s ability to successfully demonstrate the safety and efficacy of its product candidates and gain approval of its product candidates on a timely basis, if at all; competition with respect to market opportunities; unexpected safety or efficacy data observed during pre-clinical studies or clinical trials; actions of regulatory agencies, which may affect the initiation, timing and progress of Immunocore’s clinical trials or future regulatory approval; Immunocore’s need for and ability to obtain additional funding, on favorable terms or at all, including as a result of worsening macroeconomic conditions such as rising inflation and interest rates, volatility in the capital markets and related market uncertainty, the COVID-19 pandemic, the war in Ukraine and global geopolitical tension; Immunocore’s ability to obtain, maintain and enforce intellectual property protection for KIMMTRAK or any product candidates it is developing; clinical trial site activation or enrollment rates that are lower than expected; and the success of Immunocore’s current and future collaborations, partnerships or licensing arrangements. These and other risks and uncertainties are described in greater detail in the section titled "Risk Factors" in Immunocore’s filings with the Securities and Exchange Commission, including Immunocore’s most recent Annual Report on Form 20-F for the year ended December 31, 2021 filed with the Securities and Exchange Commission on March 3, 2022, as well as discussions of potential risks, uncertainties, and other important factors in the Company’s subsequent filings with the Securities and Exchange Commission. All information in this press release is as of the date of the release, and the Company undertakes no duty to update this information, except as required by law. In addition, as the reported net sales and cash and cash equivalents in this press release are preliminary, have not been audited and are subject to change pending completion of the Company’s audited financial statements for the year ended December 31, 2022, it is possible that the Company or its independent registered public accounting firm may identify items that require the Company to make adjustments to the amount included in this release, and such changes could be material. Additional information and disclosures would also be required for a more complete understanding of the Company’s financial position and results of operations as of December 31, 2022.
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CONTACT:
Immunocore
Sébastien Desprez, Head of Communications
T: +44 \(0\) 7458030732
E: mailto:sebastien.desprez@immunocore.com
Follow on Twitter: @Immunocore
Consilium Strategic Communications (corporate and financial)
Mary-Jane Elliott/ Chris Welsh/Jessica Hodgson
T: +44 (0)203 709 5700
E: Immunocore@consilium-comms.com
Investor Relations
Clayton Robertson, Head of Investor Relations
T: +1 215-384-4781
E: ir@immunocore.com
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Exhibit 99.2
Transformative Medicines for Patients January 2023
This presentation contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Words such as “may,” “can,” “will,” “believe,” “expect,” “plan,” “anticipate,” “potential” 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 presentation are forward-looking statements. These statements include, but are not limited to, statements regarding the marketing, therapeutic potential, and expected clinical benefits, including extended overall survival benefit and reduction in circulating tumor DNA, of Immunocore’s products and product candidates; expectations regarding the development of Immunocore’s pipeline and the design, progress, timing, enrollment, scope, expansion and results of Immunocore’s existing, planned and other future clinical trials and IND enabling studies, including the targeted delivery of IND for three new product candidates, the expansion of, and timing for reporting data from the monotherapy and combination arms of, the PRAME-A02 trial and the timing for reporting data from the single ascending dose portion of the IMC-M113V Phase 1 HIV clinical trial; the ability of TCR therapeutics to target 90% of the human proteome; statements regarding the durability, efficacy and toleration of Immunocore’s product candidates; expectations regarding the commercialization of KIMMTRAK including potential growth opportunities and trends and increasing access to KIMMTRAK; expectations regarding the value proposition of KIMMTRAK in metastatic uveal melanoma (mUM) and advanced melanoma; expectations regarding the potential market size and opportunity for Immunocore’s products and product candidates, including statements with respect to potential patient population; expectations regarding the potential of PRAME-A02 to benefit a large number of patients; the Company’s belief that IMC-R117C is potentially the first-in-class PIWIL1-targeted immunotherapy for colorectal and other gastrointestinal cancers; statements regarding the planned IND timing for IMC-R117C; expectations regarding future milestones; future development plans of tebentafusp and Immunocore’s other product candidates; the ability to obtain and maintain regulatory approval for its products and product candidates; expectations regarding the sustained or potential commercial performance and uptake of KIMMTRAK and Immunocore’s other product candidates, if approved; expectations regarding Immunocore’s management of resources and expected cash runway; and preliminary unaudited net sales and cash and cash equivalents of KIMMTRAK and tebentafusp; and the validation of the ImmTAC platform. These forward-looking statements are based on management’s current expectations and beliefs and are subject to a number of risks, uncertainties and important factors that may cause actual events or results to differ materially and adversely from those expressed or implied by any forward-looking statements, many of which are beyond Immunocore’s control. These include, without limitation, risks and uncertainties related to the impact of worsening macroeconomic conditions and the ongoing and evolving COVID-19 pandemic, the war in Ukraine or global geopolitical tension on Immunocore’s business, strategy, clinical trials, financial position and anticipated milestones, including Immunocore’s ability to conduct ongoing and planned clinical trials; Immunocore’s ability to obtain and maintain regulatory approval of its product candidates; Immunocore’s ability to obtain clinical supply of current or future product candidates or commercial supply of KIMMTRAK or any future approved products, including as a result of supply chain disruptions; Immunocore’s ability to develop, manufacture and commercialize its product candidates; Immunocore’s ability and plans to launch, market and sell KIMMTRAK or any future approved products, to continue to establish and expand a commercial infrastructure; Immunocore’s ability to successfully expand the approved indications for KIMMTRAK, or obtain marketing approval for KIMMTRAK in additional geographies in the future; the delay of any current or planned clinical trials, whether due to the COVID-19 pandemic, patient enrollment delays or otherwise; unexpected safety or efficacy data observed during preclinical studies or clinical trials and Immunocore’s ability to successfully demonstrate the safety and efficacy of its product candidates and gain approval of its product candidates on a timely basis, if at all; competition with respect to market opportunities; actions of regulatory agencies, which may affect the initiation, timing and progress of clinical trials or future regulatory approval; Immunocore’s ability to obtain, maintain and enforce intellectual property protection for KIMMTRAK or any product candidates it is developing; clinical trial site activation or enrollment rates that are lower than expected; Immunocore’s need for and ability to obtain additional funding on favorable terms or at all, including as a result of worsening macroeconomic conditions such as rising inflation and interest rates, volatility in the capital markets and related market uncertainty; and the success of Immunocore’s current and future collaborations, partnerships or licensing arrangements. These and other risks and uncertainties are described in greater detail in the section titled ‘Risk Factors’; in Immunocore’s filings with the Securities and Exchange Commission, including Immunocore’s most recent Annual Report on Form 20-F, as supplemented by its most recent filings that Immunocore has made or may make with the SEC in the future. Such risks may be amplified by the COVID-19 pandemic and its potential impact on Immunocore’s business and the overall global economy. Any forward-looking statements represent Immunocore’s views only as of the date of this presentation and should not be relied upon as representing its views as of any subsequent date. Immunocore does not assume any obligation to update any forward-looking statements, except as may be required by law. In addition, as the reported net sales and cash and cash equivalents in this presentation are preliminary, have not been audited and are subject to change pending completion of our audited financial statements for the year ended December 31, 2022, it is possible that Immunocore or its independent registered public accounting firm may identify items that require Immunocore to make adjustments to the amount included in this presentation, and such changes could be material. Additional information and disclosures would also be required for a more complete understanding of Immunocore’s financial position and results of operations as of December 31, 2022. Certain information contained in this presentation relates to or is based on studies, publications, surveys, and other data obtained from third-party sources and Immunocore’s own internal estimates and research. While Immunocore believes these third-party sources to be reliable as of the date of this presentation, it has not independently verified, and makes no representation as to the adequacy, fairness, accuracy, or completeness of, any information obtained from third-party sources. KIMMTRAK™ is a trademark owned or licensed to Immunocore. Forward-looking statement 2
We have written the next chapter in cancer treatment 3 T Cell Receptor (TCR) Therapy Off-the-shelf bispecific T cell engagers Chemotherapy 1949 Targeted Therapy 1997 Immunotherapy 2011 Antibody-DrugConjugate 2013 Cell Therapy 2017 2022
4 Harnessing the immune system to fight disease with targeted, off-the-shelf, bispecific, soluble T cell receptors (TCRs)
5 Multiple candidates in oncology and infectious diseases Delivering leading bispecific TCR pipeline Candidate Target Indication IND-enabling Phase 1 Phase 2 Phase 3 Approved gp100 Uveal melanoma Tebentafusp Advanced melanoma IMC-F106C PRAME-A02 Multiple solid tumors Multiple solid tumors 2L+ cutaneous melanoma PRR Ovarian* Advanced endometrial 2L+ NSCLC IMC-P115C PRAME-A02-HLE Multiple solid tumors IMC-T119C PRAME-A24 Multiple solid tumors IMC-R117C PIWIL1 Colorectal, gastric, pancreatic IMC-C103C1 MAGE-A4 Multiple solid tumors IMC-I109V Envelope Hepatitis B Virus (HBV) IMC-M113V2 Gag Human Immunodeficiency Virus (HIV) ONCOLOGY INFECTIOUS DISEASES Monotherapy dose exploration Combinations w/ standards of care New ImmTAC candidate 1. Developed under a co-development/co-promotion collaboration with Genentech; 2. Program is wholly owned, development costs being provided by the Bill & Melinda Gates Foundation (BMGF), Immunocore retains all development and commercialization rights in the developed world. * Platinum refractory or resistant serous ovarian carcinoma
Technology platform
7 …into soluble, off-the-shelf, bispecific therapeutics (ImmTAX) We pioneered converting membrane-bound T cell receptors… Natural TCR ImmTAX
8 TCR therapeutics target >90% of the human proteome
Our platform is modular Applicable across 3 therapeutic areas 9 Oncology Infectious Diseases Autoimmune Conditions UPREGULATION OF THE IMMUNE SYSTEM DOWNREGULATION OF THE IMMUNE SYSTEM
KIMMTRAK® in metastatic melanoma
11 We are using our TCR technology to target gp100 protein in melanoma Metastatic Uveal Melanoma (mUM): is an ultra-rare and aggressive tumor ~1,000 Until KIMMTRAK, no approved treatment3 Originates from melanocytes within the uveal tract of the eye Median age at diagnosis is 62 years1 HLA-02 mUM pts per year in the US/EU2 Up to 50% may develop metastatic disease; liver primary site of metastasis1 Historic median survival with metastatic disease2 ~12 months 1. Yang J et al. Ther Adv Med Oncol. 2018 ; 2. Carvajal RD et al. Br J Ophthalmol. 2017; 3. Rantala ES et al. Melanoma Res. Published online. 2019
Nathan, P. et. al. New England Journal of Medicine 2021; 385:1196-1206 12 KIMMTRAK®: First-in-class, off-the-shelf, bispecific TCR Primary endpoint: Overall Survival (OS) statistically significant Overall Survival benefit in patients treated with KIMMTRAK or investigator’s choice in first-line KIMMTRAK was proven to extend median OS by 6 months months median OS hazard ratio 21.7 0.51
Safety profile of KIMMTRAK was predictable and manageable 13 Key KIMMTRAK findings No treatment related deaths 378 previously untreated mUM patients randomized 2:1 KIMMTRAK vs. Investigator’s Choice (pembrolizumab 82%, ipilimumab 13%, dacarbazine 6%) Majority of ARs in first 3 weeks Low discontinuation rate: KIMMTRAK 2% vs. Investigator’s Choice of 4.5% Adverse Reactions (AR) Any Grade, % Grade 3 or 4, % Any 244 (99.6) 110 (45) Cytokine release syndromea 89 0.8 Rashb 83 18.4 Pyrexia 76 3.7 Pruritus 69 4.5 Fatigueb 64 5.7 Nausea 49 2 Chills 48 0.4 Hypo-/hyperpigmentationb 47 0.4 Abdominal painb 45 2.9 Edemab 45 0 Adverse Reactions (ARs) consistent with mechanism of action KIMMTRAK (n = 245)* * KIMMTRAK. US Package insert. Immunocore Ltd.; 2021. Adverse reactions listed are those with any grade >45%; a. Represents algorithmic identification of CRS cases based on ASTCT grading criteria (Lee et al. 2019). b. Represents a composite of multiple related terms.
Time since last dose of prior anti-PD(L)1 does not impact OS 14 OS by whether prior anti-PD(L)1 therapy was remote or most recent therapy Tebentafusp active in cutaneous melanoma Time from prior anti-PD(L)1 1-yr OS 2-yr OS Remote 75% 22% Immediately prior 75% 23% Benchmark 55% N/A Median time from last anti-PD(L)1 to tebentafusp 2-yr OS Remote anti-PD(L)1 9 months Anti-PD(L)1 immediately prior 2 months Remote = Patients received prior anti-PD1 but it was not most recent therapy prior to enrolment Immediately prior = anti-PD1 was most recent therapy prior to enrolment Middleton et al., ASCO 2022
15 Randomization to ‘real world’ treatment as a control arm Phase 2/3 trial for previously treated, advanced melanoma patients Phase Primary endpoint Per arm size 2 ctDNA and OS 40 3 OS 170 Optionality to review Phase 2 data to inform changes to Phase 3, including line of prior therapy, dropping an Arm and optimize powering of study Investigator discretion on subsequent therapy: local standard, supportive care or other clinical trials. Collect data on subsequent therapy, survival and ctDNA sample. HLA*A2:01 Advanced melanoma Uveal melanoma excluded Prior anti-PD(L)1 Progression within 6 months last dose Prior ipilimumab Prior TKI (BRAFm) 1:1:1 Randomization Treatment phase OS follow-up Tebentafusp Tebentafusp + anti-PD-1 R Straight to follow-up
PRAME Franchise:A02, A24, A02-HLE
PRAME heavily expressed in multiple solid tumor types LOW HIGH Tumor gp100 expression PRAME expression MAGE-A4 expression Cutaneous melanoma Renal Cell Carcinoma (RCC) Bladder Non-Small Cell Lung Cancer (NSCLC) Hepatocellular carcinoma (HCC) Gastric Esophageal SCCHN1 Small Cell Lung Cancer (SCLC) Triple Negative Breast Cancer (TNBC) Endometrial Cervical Ovarian Uveal melanoma Relative Checkpoint Inhibitor sensitivity 17 Epidemiology data from cancer registries and Decision Resources, Annual incidence of metastatic patients; 1. Squamous cell carcinoma of head and neck cancer
18 Most broadly expressed cancer-testis antigen in several tumor types but with minimal normal tissue expression IMC-F106C: ImmTAC targeting HLA-A2-presented peptide from PRAME Squamous NSCLC Adeno NSCLC Ovarian serous carcinoma Cutaneous melanoma Endometrial adenocarcinoma
IMC-F106C-101 PRAME Phase 1 study design 19 Screening Treatment Follow-up Weekly IV infusion with intra-patient dose escalation (over 3 weeks) Tumor assessment every 9 weeks HLA-A*02:01 (central testing) Select advanced solid tumors Tumor PRAME by immunohistochemistry High PRAME prevalence: enroll all comers; test retrospectively All other indications: prospective confirmation of PRAME Key eligibility criteria Primary endpoint Determine MTD/expansion dose Secondary endpoint Preliminary antitumor activity Pharmacokinetics Pharmacodynamic markers Key objectives Dose Escalation Target Dose, Starting Day 15 0.3-10 mcg 20 mcg 40 mcg 80 mcg 160 mcg 320 mcg Total safety population N = 55 Cohorts 1-5 Cohorts 6 and above Efficacy population n=31* Strong and consistent pharmacodynamic activity * Of 36 patients treated at target escalation dose of ≥20 mcg, 5 patients were excluded from efficacy analyses as they were PRAME-negative (n=2) or not yet had tumor assessment (n=3)
20 T cell activation and re-direction into tumor seen across ImmTAC platform Strong and consistent pharmacodynamic activity at ≥20 mcg IMC-F106C Interferon induction T cell trafficking Hamid, O., et. al, Annals of Oncology (ESMO 2022) 33 (suppl_7): S331-S355.
Baseline patient characteristics 21 Characteristic Safety Population N=55 Efficacy Population N=31† Age – Mean (range) 60 (26, 79) 61 (36, 79) ECOG status 0 – n (%) 30 (55%) 19 (61%) PRAME status (IHC) Positive 49 (89%) 28 (90%) Negative 2 (4%) 0 Not evaluable 4 (7%) 3 (10%) Median H-score 195 188 Tumor type Melanoma 34 (62%) 17 (55%) Uveal (UM) 26 (47%) 11 (35%) Cutaneous (CM)* 8 (15%) 6 (19%) Ovarian Carcinoma 10 (18%) 5 (16%) Serous (SOC)* 7 (13%) 4 (13%) Non-serous 3 (5%) 1 (3%) NSCLC 4 (7%) 4 (13%) TNBC* 3 (5%) 3 (10%) Endometrial* 4 (7%) 2 (6%) Median PRAME H-score (188) in efficacy population was high Efficacy population heavily pretreated Ovarian: all platinum resistant CM: all received prior anti-PD1 and anti-CTLA4 NSCLC: all received prior anti-PD1 TNBC and endometrial: 2-5 prior lines of therapy * In efficacy population, these tumors enrolled regardless of PRAME immunohistochemistry (IHC) testing, which was evaluated retrospectively. NSCLC squamous also enrolled regardless of PRAME testing † Of 36 patients treated at target escalation dose of ≥20 mcg, 5 patients were excluded from efficacy analyses as they were PRAME-negative (n=2) or not yet had tumor assessment (n=3) Hamid, O., et. al, Annals of Oncology (ESMO 2022) 33 (suppl_7): S331-S355.
Most frequent related AE was Grade 1/2 CRS, consistent with proposed mechanism IMC-F106C was well tolerated MTD not reached CRS events were all manageable Majority (77%) within first 3 doses 71% Grade 1 29% Grade 2 No Grade ≥ 3 CRS No treatment-related discontinuation or Grade 5 related AEs Adverse events attenuate over time Preferred Term (MedDRA v23.1) 0.3 – 10 mcg†N=18 20 – 320 mcg†N=37 Total N=55 All grades (events in ≥ 25% of patients), n (%) At least one event 18 (100) 34 (92) 52 (95) Pyrexia* 10 (56) 21 (57) 31 (56) Cytokine release syndrome 5 (28) 22 (59) 27 (49) Fatigue 6 (33) 13 (35) 19 (35) Hypotension* 3 (17) 15 (41) 18 (33) Chills 9 (50) 8 (22) 17 (31) Nausea 7 (39) 10 (27) 17 (31) Rash 3 (17) 12 (32) 15 (27) Grade ≥ 3 (Events in > 1 patient), n (%) At least one event 6 (33) 13 (35) 19 (35) Lymphopenia 1 (6) 7 (19) 8 (15) Aspartate aminotransferase increased 3 (17) 1 (3) 4 (7) Anemia 1 (6) 2 (5) 3 (5) Alanine aminotransferase increased 2 (11) 0 2 (4) Arthralgia 1 (6) 1 (3) 2 (4) Pyrexia* 0 2 (5) 2 (4) 22 * Includes events reported as a sign/symptom of CRS † Safety presented by intended target escalation dose on Day 15. 1/37 patients received only a single dose of 2 mcg and did not reach target dose of ≥ 20 mcg Hamid, O., et. al, Annals of Oncology (ESMO 2022) 33 (suppl_7): S331-S355.
* Two patients (1 with NSCLC, 1 serous ovarian) discontinued treatment due to PD with scan data not available at DCO ; † This serous ovarian patient (H-score 39) had an unconfirmed partial response (uPR) at the time of the ESMO Congress September 2022 presentation, that was subsequently confirmed.; ‡ PRAME expression assessed by IHC H-score; Two PRAME-negative patients both had PD (not shown); Endo, endometrial carcinoma; NSCLC, non small cell lung carcinoma; TNBC, triple-negative breast cancer. Hamid, O., et. al, Annals of Oncology (ESMO 2022) 33 (suppl_7): S331-S355. 23 IMC-F106C ESMO 2022 Responses observed in multiple tumor types Positive Not evaluable PRAME expression‡
NSCLC, non small cell lung carcinoma Hamid, O., et. al, Annals of Oncology (ESMO 2022) 33 (suppl_7): S331-S355. 24 IMC-F106C ESMO 2022 Majority of patients have durable tumor response or stabilization
25 IMC-F106C ESMO 2022 | Two PRs ongoing for 7+ months Responses are durable, 6 of 7 PRs still ongoing * PRAME expression assessed by IHC H-score Endo, endometrial carcinoma; NSCLC, non small cell lung carcinoma; TNBC, triple-negative breast cancer; UM, uveal melanoma; ctDNA, circulating tumor DNA; ND, not yet determined (9 patients pending); NE, not evaluable; PR, partial response; Hamid, O., et. al, Annals of Oncology (ESMO 2022) 33 (suppl_7): S331-S355.
† 20 of 31 efficacy evaluable patients had paired ctDNA. Data not yet available for 9 patients, including 3 PRs. Two patients did not have baseline detectable ctDNA. B, triple-negative breast cancer; C, cutaneous melanoma; ctDNA, circulating tumor DNA; E, endometrial carcinoma; LA, non small cell lung adenocarcinoma; LS, non small cell lung squamous cell carcinoma; O, ovarian; U, uveal melanoma; CPI, checkpoint inhibitor; tebe, tebentafusp.; Hamid, O., et. al, Annals of Oncology (ESMO 2022) 33 (suppl_7): S331-S355. 26 IMC-F106C ESMO 2022 Reduction in circulating tumor DNA observed across tumor types 4 PR patients evaluated for ctDNA had > 50% reduction, including 3 with clearance Two patients had ctDNA clearance despite best response of PD ctDNA reduction correlated with OS in KIMMTRAK mUM study
Monotherapy activity provides optionality to develop in single arm and randomized trials 27 Expanding clinical trial footprint |
Aim to understand breadth of clinical activity in solid tumors Enrolling patients globally in adaptive trial with multiple arms P Endometrial Monotherapy expansion Monotherapy IV dose escalation Checkpoint inhibitor combinations ImmTAC
combinations Chemotherapy combinations Monotherapy Combinations NSCLC Monotherapy expansion Ovarian Monotherapy expansion Cutaneous melanoma Monotherapy expansion Enables future randomized trials into earlier lines of therapy
Adaptive design enables flexible expansion size
Total ~150,000 PRAME+, HLA-A2 patients/year PRAME-A02 has the potential to benefit a large number of patients Tumor type Prevalence of PRAME expression1 HLA*02:01+, PRAME+ metastatic patients (G7)2 70-100% Endometrial >10K Melanoma >10K Ovarian >15K NSCLC-squamous >30K 50-70% NSCLC-adeno >40K SCLC >15K TNBC >5K 20-50% SCCHN >30K Gastric RCC Esophageal Cholangiocarcinoma Cervical 28 1. PRAME prevalence derived from immunohistochemistry and RTqPCR of patient samples and analysis of TCGA 2. Epidemiology data from cancer registries and Decision Resources, Annual incidence of metastatic patients
Consistency of RECIST responses enriched at higher H scoresKIMMTRAK demonstrated ctDNA reduction and OS benefit at high and low H score 29 PRAME MAGE-A4 KIMMTRAK Phase 1/2 Study IMCgp100-1021 Phase 1 Study IMC-C103C-1012,5,6 Phase 1 Study IMC-F106C-1013,4 Non-PR PR Best overall response 1. Carvajal RD, et al. Nat Med 2022 28:2364-2373; 2. Davar D, et al. Ann Oncol 2021 32:S1411-S1413; 3. Hamid, O., et. al, Annals of Oncology (ESMO 2022) 33 (suppl_7): S331-S355; Sweis, R. et. al., Ann Oncol 2022 (ESMO I-O 2022); 4. Includes H score negative and positive patients who received ≥ 20 mcg target dose and were efficacy evaluable. Excluded are patients with unevaluable H score and 5 mUM IMC-F106C patients who progressed on prior KIMMTRAK; 5. includes H score negative and positive patients who received ≥ 90 mcg target dose and were efficacy evaluable. 6. One patient (MAGE-A4 H score 265) had an SD convert to an uPR after the data cutoff for the presentation and remains on study as of 05Dec2022. Medians represent all patients.
30 Consistency of ImmTAC platform beyond gp100 T cell activation Durable tumor shrinkage Activity even in low target expression ctDNA reduction Overall survival benefit KIMMTRAK® gp100 IMC-F106C PRAME IMC-C103C MAGE-A4
HLE, Half-life extension Building on enthusiasm for IMC-F106C targeting PRAME HLA-A02 Expansion of ImmTAC franchise targeting PRAME IMC-F106C PRAME HLA-A02 TCRxCD3 Clinically validated Focus on expanding clinical program IMC-T119C PRAME HLA-A24 TCRxCD3 Expands potential addressable population by ~30% (G7) High prevalence in Japan IMC-P115C PRAME HLA-A02 TCRxCD3 HLE Half-life extended (HLE) for less frequent dosing Target HLA subtype Format 31
32 IND enabling studies ongoing IMC-P115C: Half-Life Extended (HLE) ImmTAC targeting PRAME-A02 * Half-life estimated using a research tool version of IMC-P115C Same PRAME peptide Same CD3 end Less frequent dosing Same TCR specificity Half-life ~ 7 days in mouse PK study* Highly potent in vitro
Prevalence of individual HLA subtypes 2. 5EU: France, Germany, Italy, Spain, and the United Kingdom 33 IND enabling studies ongoing IMC-T119C: ImmTAC targeting PRAME-A24 Patient diversity, including Japan Expands beyond PRAME-A02 by ~30% in non-overlapping patients PRAME-A02 development as a blueprint US 15-20% ~40% 5EU2 ~20% ~45% Japan ~30% ~60% HLA-A*24:02 HLA-A*02:01 S. Korea ~30% ~40% Expands & diversifies patient population1
Novel ImmTAC Candidate for GI cancers from our discovery engine
PIWIL1, piwi-like protein1, MSS, ^ including mutant & wildtype RAS and BRAF; microsatellite stable (MSS) and Microsatellite instability (MSI)-high 35 CRC is historically insensitive to immune checkpoints PIWIL1: promising target in colorectal cancer (CRC) PIWIL1 RNA in situ hybridization Colon adenocarcinoma Normal colon PIWIL1 detected Negative prognostic marker in multiple cancers, involved in tumor progression 25% CRC patients have broad PIWIL1 expression (e.g., > 75% of tumor cells positive) Expressed in CRC, historically insensitive to IO, and across major subgroups^
ImmTAC, Immune mobilizing T cell receptor Against Cancer; PIWIL, piwi-like protein 1 36 IND planned Q4 2023 IMC-R117C: First-in-class immunotherapy targeting PIWIL1 (PIWIL1 x CD3) Tumor type Prevalence of PIWIL1 expression HLA*02:01+, PIWIL1+ metastatic patients (G7) 20-30% Colorectal >20K Esophageal >xK 15-20% Ovarian ~10K Gastric >xK ~10-15% Endometroid ~6K Pancreatic >xK Total >35,000 PIWIL1+, HLA-A2 patients/year Relative PIWIL1 expression PIWIL RNA expression Individual patient tumor n = mRNA sample size
Pursuing a functional cure in infectious diseases
Our unique approach for functional cure of chronic Hepatitis B Key advantages of redirecting non-exhausted T cells Same CD3 MoA validated in oncology Independent of natural T cell reactivity to Hep B Goal is functional cure with finite treatment Mass-spectrometry antigen discovery engine for HBV Pipeline funnel (e.g., conserved sequences, pHLA presentation/stability, mimetic risk) Seven optimal targets identified from envelope, core capsid, and polymerase 38
IMC-I109V: Encouraging signs of activity observed in HBV 39 Induction of IL-6 in all 3 patients1 Transient decrease in HBsAg transiently coincided with transient increase in ALT 1 Patient #1 Patient #2 Patient #3 1. Bourgeois, et al. EASL 2022 Initial results from single 0.8 mcg dose presented at EASL 2022
40 Functional cure program for HIV with goal of eliminating HIV reservoirs Same MoA as tebentafusp, but optimized for low target viral peptide presentation Bypasses exhausted T cells Targets highly conserved & functionally constrained viral epitopes Active in ex vivo assays of infected CD4+ T cells from ART-treated HIV patients Soluble format access to tissue reservoirs Initial IMC-M113V Phase 1 data in 2023
KIMMTRAK commercial performance
~$400M *Preliminary financial results are approximated and unaudited. 1. “Net sales” refers to total net product and net pre-product revenue of KIMMTRAK and tebentafusp. 2. Dollar amounts based on conversion rate of approximately 1.21. 42 ~$50M Q4 preliminary net sales of KIMMTRAK / tebentafusp1,2 Preliminary cash and cash equivalents as of December 31, 20222 YE preliminary net sales of KIMMTRAK / tebentafusp1,2 Cash runway projected into 2026 with anticipated KIMMTRAK revenues ~$140M Preliminary 2022 Financial Results
Delivering on our promise – Consistent execution
41st Annual J.P. Morgan Healthcare Conference 44 Continuing to write the next chapter of cancer and infectious diseases treatment Looking ahead Continue responsible management of resources Sustain and grow Deliver IND for 3 new ImmTAC candidates Global site expansion for PRAME-A02 trial (data by 1H 2024) HIV Phase 1 SAD data expected 2023
THANK YOU
Exhibit 99.3
1 Multiple candidates in oncology and infectious diseases Delivering leading bispecific TCR pipeline Candidate Target Indication IND-enabling Phase 1 Phase 2 Phase 3 Approved gp100 Uveal melanoma Tebentafusp Advanced melanoma IMC-F106C PRAME-A02 Multiple solid tumors Multiple solid tumors 2L+ cutaneous melanoma PRR Ovarian* Advanced endometrial 2L+ NSCLC IMC-P115C PRAME-A02-HLE Multiple solid tumors IMC-T119C PRAME-A24 Multiple solid tumors IMC-R117C PIWIL1 Colorectal, gastric, pancreatic IMC-C103C1 MAGE-A4 Multiple solid tumors IMC-I109V Envelope Hepatitis B Virus (HBV) IMC-M113V2 Gag Human Immunodeficiency Virus (HIV) ONCOLOGY INFECTIOUS DISEASES Monotherapy dose exploration Combinations w/ standards of care New ImmTAC candidate 1. Developed under a co-development/co-promotion collaboration with Genentech; 2. Program is wholly owned, development costs being provided by the Bill & Melinda Gates Foundation (BMGF), Immunocore retains all development and commercialization rights in the developed world. * Platinum refractory or resistant serous ovarian carcinoma