Gadeta BV

The emerging pipeline of CAR-T in NHL includes late-stage, mid-stage, and early-stage drugs in different lines of therapies and different indications, mainly including B- cell Lymphoma such as DLBCL, FL, MCL, MZL, CLL/SLL, and others, with one of them being developed for a T-cell Lymphoma, PTCL. LAS VEGAS, April 15, 2024 /PRNewswire/ -- DelveInsight's CAR T-Cell Therapy for Non-Hodgkin's Lymphoma Market Insights report includes a comprehensive understanding of current treatment practices, CAR T-Cell Therapy for NHL emerging drugs, market share of individual therapies, and current and forecasted market size from 2019 to 2032, segmented into 7MM [the United States, the EU4 (Germany, France, Italy, and Spain), and the United Kingdom, and Japan]. Key Takeaways from the CAR T-Cell Therapy for Non-Hodgkin's Lymphoma Market Report According to DelveInsight's analysis, the market size for CAR T-Cell therapy for NHL reached USD 1,200 million in 2023 across the US. DelveInsight's analysis reveals that the total incident cases of selected indications for CAR-T in NHL in the 7MM comprised ~155,200 in 2023. Leading CAR T-Cell therapy for NHL companies such as Allogene Therapeutics, Novartis, Miltenyi Biomedicine, Mustang Bio, CRISPR Therapeutics, 2seventy Bio, Imugene, and others are developing novel CAR T-Cell therapies for NHL drugs that can be available in the CAR T-Cell therapy for NHL market in the coming years. Other promising CAR T-Cell therapies for NHL in the pipeline include Cemacabtagene Ansegedleucel, Rapcabtagene Autoleucel, Zamtocabtagene Autoleucel, MB-106, CTX110, BBT369, Azercabtagene Zapreleucel , and others. BREYANZI is poised to dominate the CAR-T market in NHL in the forthcoming years, with potential approvals anticipated across two indications: CLL/SLL, follicular lymphoma and MCL. Notably, it has already secured approval for DLBCL in 3L+, 2L+ TE, and NTE. Novartis is progressing with its additional CD-19 CAR-T therapy, Rapcabtagene autoleucel, with expectations of a significantly reduced turnaround time for availability compared to KYMRIAH. Companies are leveraging the strength of dual and triple targeting in CAR-T therapies. Miltenyi Biomedicine, ImmPACT Bio, 2seventy bio, and Novartis are developing CD19/20 Bispecific CAR-T, CD79a/CD20 Bispecific CAR-T, and CD2xCD3xCD19 CAR-T, enhancing treatment efficacy by targeting multiple antigens simultaneously. Discover which therapies are expected to grab the major CAR T-Cell therapy for NHL market share @ CAR T-Cell Therapy for NHL Market Report CAR T-Cell Therapy for Non-Hodgkin's Lymphoma Overview CAR-T cell therapy represents a groundbreaking advancement in cancer immunotherapy, especially for specific types of NHL that have shown resistance to traditional therapies. Through the manipulation of genetically modified T cells, this state-of-the-art treatment boosts the immune system's capacity to locate and eliminate cancerous cells. Essentially, CAR-T cell therapy modifies a patient's T cells genetically to carry chimeric antigen receptors (CARs) on their surface. These engineered CARs are tailored to identify and attach to particular proteins found on cancer cells' surfaces, thereby directing the immune system to effectively combat the malignancy. CAR T-Cell Therapy for Non-Hodgkin's Lymphoma Epidemiology Segmentation In 2023, DLBCL had the highest number of cases among all selected indications for CAR-T therapy, followed by Follicular lymphoma. The total incident cases of MZL in the 7MM were around 13,800 in 2023 and are projected to increase during the forecasted period. The CAR T-Cell therapy for NHL market report proffers epidemiological analysis for the study period 2019–2032 in the 7MM segmented into: Total Incident Cases of Selected Indications for CAR-T in NHL (Mantle cell lymphoma, DLBCL, Follicular lymphoma, Marginal Zone Lymphoma, Primary mediastinal large B-cell lymphoma, Chronic lymphocytic leukemia/small-cell lymphocytic lymphoma) and Total Indication-wise Eligible Cases of CAR-T in NHL. CAR T-Cell Therapy for Non-Hodgkin's Lymphoma Treatment Market The treatment landscape for NHL is complex, influenced by factors such as the type of NHL, the stage of the disease, the patient's overall health, and their preferences. CAR-T cell therapy has emerged as a promising option within this landscape, especially for aggressive B-cell NHLs that have not responded to standard treatments. Previously, such cases posed significant challenges, often resulting in poor outlooks despite attempts with salvage chemotherapy and autologous stem cell transplants. However, the introduction of CAR-T cell therapy has drastically changed this scenario, showing impressive response rates and the potential for long-lasting remissions even in patients with advanced disease after multiple prior treatments. The approval of various CAR-T therapies for NHL by the FDA highlights the importance of this advancement. YESCARTA, KYMRIAH, BREYANZI, and TECARTUS have all proven effective across different types of NHL, including DLBCL, follicular lymphoma, and mantle cell lymphoma. Ongoing research aims to improve CAR-T cell therapy for NHL further, seeking to increase effectiveness, decrease side effects, and expand the range of target antigens beyond CD19. Additionally, studies are looking into the combined use of CAR-T cell therapy with other treatments like checkpoint inhibitors or targeted therapies, with the ultimate goal of optimizing treatment outcomes for NHL patients. To know more about CAR T-Cell therapy for Non-Hodgkin's Lymphoma treatment guidelines, visit @ CAR T-Cell Therapy for Non-Hodgkin's Lymphoma Management Emerging CAR T-Cell Therapies for NHL and Key Companies Cemacabtagene Ansegedleucel: Allogene Therapeutics Rapcabtagene Autoleucel: Novartis Zamtocabtagene Autoleucel: Miltenyi Biomedicine MB-106: Mustang Bio CTX110: CRISPR Therapeutics BBT369: 2seventy Bio Azercabtagene Zapreleucel: Imugene Learn more about the FDA-approved CAR T-Cell therapy for NHL @ Drugs for CAR T-Cell Therapy for NHL Treatment CAR T-Cell Therapy for Non-Hodgkin's Lymphoma Market Dynamics The dynamics of the CAR T-Cell therapy for the NHL market are expected to change in the coming years. The market for CAR T-cell therapy in NHL is characterized by a surge in research and development activities, as pharmaceutical companies race to bring new therapies to the market. With several CAR T-cell therapies receiving FDA approval, competition among manufacturers is intense, driving innovation and investment in the field. As a result, we witness a dynamic landscape with ongoing clinical trials, collaborations, and strategic partnerships aiming to expand the reach and efficacy of CAR T-cell therapies for NHL. Moreover, the market dynamics of CAR T-cell therapy for NHL are influenced by patient accessibility and reimbursement challenges. Despite the remarkable efficacy of these therapies, their high cost poses a significant barrier to widespread adoption. Healthcare systems and insurers grapple with the economic implications of CAR T-cell therapy, leading to negotiations on pricing and reimbursement models. Efforts are underway to make these life-saving treatments more accessible to patients, including discussions on value-based pricing and outcome-based reimbursement. As the field continues to evolve, the CAR T-cell therapy for NHL market dynamics will be shaped by a delicate balance between the clinical benefits of CAR T-cell therapy and the economic considerations surrounding its widespread implementation in the treatment of Non-Hodgkin's lymphoma. Scope of the CAR T-Cell Therapy for Non-Hodgkin's Lymphoma Market Report Therapeutic Assessment: CAR T-Cell Therapy for Non-Hodgkin's Lymphoma current marketed and emerging therapies CAR T-Cell Therapy for Non-Hodgkin's Lymphoma Market Dynamics: Key Market Forecast Assumptions of Emerging CAR T-Cell Therapy for Non-Hodgkin's Lymphoma Drugs and Market Outlook Competitive Intelligence Analysis: SWOT analysis, Conjoint Analysis and Market entry strategies Unmet Needs, KOL's views, Analyst's views, CAR T-Cell Therapy for Non-Hodgkin's Lymphoma Market Access and Reimbursement Discover more about CAR T-Cell therapy for NHL drugs in development @ CAR T-Cell Therapy for Non-Hodgkin's Lymphoma Clinical Trials Table of Contents Related Reports CAR T-Cell Therapy for Non-Hodgkin's Lymphoma Pipeline CAR T-Cell Therapy for Non-Hodgkin's Lymphoma Pipeline Insight – 2024 report provides comprehensive insights about the pipeline landscape, pipeline drug profiles, including clinical and non-clinical stage products, and the key CAR T-Cell therapy for NHL companies, including Allogene Therapeutics, Novartis, Miltenyi Biomedicine, Mustang Bio, CRISPR Therapeutics, 2seventy Bio, Imugene, among others. CAR T-Cell Therapy Market CAR T-Cell Therapy Market Insights, Epidemiology, and Market Forecast – 2032 report delivers an in-depth understanding of the disease, historical and forecasted epidemiology, as well as the market trends, market drivers, market barriers, and key CAR T-cell therapy companies, including CytoAgents, Genentech, Incyte Corporation, Caribou Biosciences, Chimeric Therapeutics, Allogene Therapeutics, Kyverna Therapeutics, iCell Gene Therapeutics, Synthekine, Janssen Research & Development, SecuraBio, ImmPACT Bio, A2 Biotherapeutics, Gracell Biopharmaceuticals, Wugen, Sana Biotechnology, Oncternal Therapeutics, Vor Biopharma, CARsgen Therapeutics, Autolus Limited, Arcellx, Kite, Novartis, Lyell Immunopharma, ImmPACT Bio, Tmunity Therapeutics, Poseida Therapeutics, Precigen, AffyImmune Therapeutics, 2seventy bio, Takeda, Cartesian Therapeutics, Cabaletta Bio, Legend Biotech, Miltenyi Biomedicine, Beam Therapeutics, among others. CAR T-Cell Therapy Competitive Landscape CAR T-cell Therapy Competitive Landscape – 2024 report provides comprehensive insights about the pipeline and current landscape, pipeline and marketed drug profiles, and the key CAR T-cell therapy companies, including Alnylam Pharmaceuticals, JW Therapeutics, Gilead Sciences, Janssen Pharmaceuticals, Innovent Biologics, Sorrento Therapeutics, Cartesian Therapeutics, CASI Pharmaceuticals, Juventas Cell Therapy, Novartis, Poseida Therapeutics,Shanghai Unicar-Therapy Bio-medicine Technology, Sinobioway Cell Therapy, Tessa Therapeutics, Wuhan Bio-Raid Biotechnology, Miltenyi Biomedicine, Bristol-Myers Squibb, Autolus Limited, Beijing Immunochina Medical Science and Technology, Carsgen Therapeutics, Cellular Biomedicine Group, Chongqing Precision Biotech, Eureka Therapeutics, Formula Pharmaceuticals, Guangzhou Bio-gene Technology, Hebei Senlang Biotechnology, Mustang Bio, MolMed, Aurora BioPharma, Atara Biotherapeutics, Autolus, Bellicum Pharmaceuticals, Kecellitics Biotech Company, Yake Biotechnology, Minerva Biotechnologies, Allogene Therapeutics, PersonGen BioTherapeutics (Suzhou), Precision BioSciences, Pregene (ShenZhen) Biotechnology Company, Shanghai GeneChem, Shanghai Longyao Biotechnology, Shenzhen BinDeBio, among others. CAR T-Cell Therapy for Multiple Myeloma Market CAR T-Cell Therapy for Multiple Myeloma Market Insights, Epidemiology, and Market Forecast – 2032 report delivers an in-depth understanding of the disease, historical and forecasted epidemiology, as well as the market trends, market drivers, market barriers, and key CAR T-cell therapy for multiple myeloma companies, including Cartesian Therapeutics, Arcellx, Novartis, Bristol-Myers Squibb, CARsgen Therapeutics, Poseida Therapeutics, Juno Therapeutics, CRISPR Therapeutics, bluebird bio, Cellectis SA, Caribou Biosciences, Luminary Therapeutics, Celyad Oncology, Allogene Therapeutics, Gadeta, Nanjing IASO Biotherapeutics, among others. About DelveInsight DelveInsight is a leading Business Consultant and Market Research firm focused exclusively on life sciences. It supports pharma companies by providing comprehensive end-to-end solutions to improve their performance. Get hassle-free access to all the healthcare and pharma market research reports through our subscription-based platform PharmDelve . Contact Us Shruti Thakur [email protected] +14699457679 Logo: SOURCE DelveInsight Business Research, LLP

Expands Clade’s pipeline and broadens its platform with: - proprietary gamma/delta (g/d) TCR universal targeting platform technology, -g/d TCR candidate integrated into Clade’s solid tumor pipeline BOSTON, Oct. 02, 2023 (GLOBE NEWSWIRE) -- Clade Therapeutics (“Clade”), a biopharmaceutical company focused on discovering and delivering engineerable, off-the-shelf, scalable, and consistent stem cell-based medicines, today announced that it has completed the acquisition of Gadeta B.V. (“Gadeta”), a cell therapy company developing innovative gamma/delta (g/d) T-cell receptor (TCR)-based immunotherapies for cancer patients. Gadeta is an international R&D company, focused on innovative immunotherapies for cancer. The company developed a proprietary platform to engineer novel g/d TCRs that possess broad tumor targeting capabilities. These g/d TCRs recognize unique patterns or targets on the surface of cancer cells that signal that they are diseased, thereby specifically targeting cancer cells and sparing healthy cells. The acquisition will provide Clade with preclinical cell therapy programs, g/d TCR discovery engine and a suite of cell enhancement to improve anti-tumor activity of cell therapies. The integration of Gadeta’s g/d TCR targeting technology is complementary to Clade’s cellular platform technology and will enhance the development of engineerable, off-the-shelf, scalable, and consistent stem-cell based medicines. Under the terms of the acquisition agreement, Clade has acquired all outstanding shares of Gadeta, making it a wholly owned subsidiary of Clade. Gadeta shareholders will receive upfront and downstream economics. “Clade is at the forefront of broadening the impact of cell therapy by establishing a more robust cellular platform with stem-cell derived immune cells,” said Chad Cowan, Ph.D., Chief Executive Officer of Clade Therapeutics. “Our technology platform consists of both a ‘Cell Foundry’ that enables the generation of adult immune cells including both CD8+ and CD4+ T Cells, as well as a ‘Cloaking Engine’ that ensures best-in-class and tuned protection from both the cellular and humoral wings of a host’s immune system. The acquisition of Gadeta represents a strategic move to integrate a third element to our platform: ‘Universal Targeting’. This integration seamlessly complements Clade's existing platform and commitment to developing engineerable, off-the-shelf, scalable, and consistent cell medicines.” Jim Glasheen, Ph.D., President and Chief Business Offer of Clade Therapeutics added, “Gadeta has generated compelling in-vitro and in-vivo data over the last few years with its lead gamma/delta (g/d) TCRs in solid tumor indications and we’re excited to integrate this novel targeting into Clade’s solid tumor programs. Clade’s pipeline programs are focused on replicating the benefits of the autologous cell therapy products, while addressing their profound limitations - inconsistent quality, challenging patient logistics, and lack of scalability. This acquisition reaffirms our belief that Clade’s engineerable platform provides the right ‘chassis’ for integrating compelling innovations coming out of the autologous cell therapy ecosystem.” Marcel Zwaal, Chief Executive Officer of Gadeta said, “Today, we are pleased to announce a significant milestone in the journey of Gadeta. Our pipeline of novel, distinctive g/d TCRs has the potential to make a significant impact to the lives of patients with solid tumors, and this strategic transaction with Clade Therapeutics represents a major step towards bringing our novel g/d TCRs to the clinic in an off-the-shelf platform.” About Clade Therapeutics Clade Therapeutics’ mission is to discover and deliver next generation cell medicines to improve the lives of patients in need. Clade Therapeutics is shifting the paradigm of cell medicine by establishing a robust cellular platform with stem-cell derived immune cells for treatment of cancer and autoimmune diseases. Clade has unparalleled expertise in generating adult human T cells, Treg cells and B cells derived from induced pluripotent stem cells (iPSCs). Clade is combining this expertise with its proprietary immune “cloaking” of human iPSCs and their adult derivatives, novel universal targeting, and cellular enhancements to enable the development of true “off-the-shelf” cell therapies. The Company is supported by a premier investor syndicate including: Syncona, LifeSci Venture Partners, Emerson Collective and Bristol-Myers Squibb. Clade promises to become a leading innovator in developing engineerable, off-the-shelf, scalable, and consistent cell medicines. For further information, please visit the company’s website at . About Gadeta B.V. Gadeta is a cell therapy company developing innovative treatments based on g/d T cell receptors for targeting solid tumors. Gadeta’s platform is focused on discovering and developing novel g/d T cell receptors (TCRs) that can specifically recognize novel cancer specific surface targets. It can eliminate the cancer cells, while sparing healthy tissue. The g/d TCR is an immune receptor expressed by a special type of immune cell with an important role in patrolling the body for any sign of cancer. The g/d T cell receptors (TCRs) provide the unique combination of virtues of tumor specific targeting, natural signaling and universal targeting in a HLA-independent manner. Gadeta was founded in 2015 and has had collaborations with Kite Pharma, a Gilead Company and has an ongoing collaboration with Immunocore. Gadeta’s investor syndicate includes Kite Pharma, Medicxi and Utrecht Holdings. For further information, please visit the company website at . Contact: Mari Purpura LifeSci Advisors mpurpura@lifesciadvisors.com

Immunocore Reports 2022 Financial Results and Provides Business Update KIMMTRAK / tebentafusp net revenues of £42 million ($51 million) in Q4 2022 and £117 million ($141 million) in 2022; approved in over 30 countries and nearly 200 patients on global early access program Enrolling IMC-F106C (PRAME-HLA-A02) in monotherapy and combination arms of Phase 1/2 clinical trial and expanding PRAME franchise, including first-in-class PRAME-HLA-A24 target and a PRAME HLA-A02 half-life extension IND planned for first-in-class ImmTAC targeting PIWIL1 for colorectal and other gastrointestinal cancers in Q4 2023 Completed single ascending dose escalation part of IMC-M113V Phase 1 trial in people living with HIV and presented data at CROI 2023; multiple ascending dose portion of trial is enrolling Cash and cash equivalents of $401.6 million as of December 31, 2022; cash runway into 2026 with projected KIMMTRAK revenues Conference call today, March 1st at 8:00 AM ET, 1:00 PM GMT (OXFORDSHIRE, England & CONSHOHOCKEN, Penn. & ROCKVILLE, Md., US, 1 March, 2023) Immunocore Holdings plc (Nasdaq: IMCR), 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, infectious diseases and autoimmune conditions, today announced its financial results for the fourth quarter and year ended December 31, 2022, and provided a business update. “We are proud that KIMMTRAK, the world’s first commercialized TCR therapy, has been approved in over 30 countries for patients with metastatic uveal melanoma. In 2023, we will make it available to even more patients with launches planned in additional countries and through enrollment of cutaneous melanoma patients into our registrational tebentafusp trial,” said Bahija Jallal, Chief Executive Officer of Immunocore. “We are also focused on progressing our PRAME clinical programs with ongoing expansion arms in multiple tumor types. Our platform continues to deliver first-in-class oncology programs, like PIWIL1, and several infectious disease candidates.” Full Year and Fourth Quarter 2022 Highlights (including post-period) Financial Results Total net product and net pre-product revenue (or “net sales”) arising from the sales of KIMMTRAK (tebentafusp) were £42.3 million (or $51.1 million) in the fourth quarter of 2022, of which £32.1 million (or $38.8 million) was in the United States, £10.1 million (or $12.2 million) in Europe and £0.1 million (or $0.1 million) in international regions. For the year ended December 31, 2022, the Company generated total revenue from the sale of KIMMTRAK and tebentafusp in the amount of £116.8 million (or $141.1 million), of which £80.4 million (or $97.2 million) was in the United States, £35.5 million (or $42.9 million) in Europe and £0.9 million (or $1.1 million) in international regions. R&D expenses for the year 2022 were £89.2 million (or $107.9 million), compared to £73.2 million for the year 2021. Selling and Administrative expenses for the year 2022 were £93.7 million (or $113.2 million), compared to £88.4 million for the year 2021. Net loss for the fourth quarter of 2022 was £25.2 million (or $30.4 million) compared to a net loss of £39.4 million in the same period in 2021, and full year net loss for 2022 was £41.24 million (or $49.8 million) compared to a full year net loss of £131.5 million in 2021. The fourth quarter basic and diluted loss per share for was $0.63, compared to $1.21 on December 31, 2021. Basic and diluted loss per share for the year ended December 31, 2022 was $1.09, compared to $4.19 for 2021. Cash and cash equivalents for the year ended December 31, 2022 were £332.5 million (or $401.6 million). The Company’s current cash position and projected KIMMTRAK revenue provides a projected cash runway into 2026. KIMMTRAK® (tebentafusp-tebn) for metastatic uveal melanoma During the fourth quarter of 2022, the Company continued to add new accounts prescribing KIMMTRAK in the United States, Germany, and France. As of December 31, 2022 there were 240 new accounts prescribing KIMMTRAK in the United States, which brings the capture rate of these accounts, according to the Company’s internal estimates, to 50% of potentially eligible patients. There were 100 new accounts prescribing KIMMTRAK in Germany and France, which brings the capture rate to approximately 80% of the eligible patient population. In the United States, Germany, and France the commercial team is focused on treating patients closer to home. In the three countries where KIMMTRAK is commercially available the real-world mean duration of treatment for KIMMTRAK continues increasing to the 9 months observed in the Phase 2 and 3 clinical trials. During the fourth quarter of 2022, the Company received numerous awards and positive recognitions for KIMMTRAK’s clinical benefit. In November, the Company was awarded the SCRIP award in the UK in the ‘Best New Drug’ category, and in December, the prestigious Prix Galien France 2022 award in the ‘Medicine in Innovative Therapeutics’ category, for KIMMTRAK. KIMMTRAK's clinical benefit to patients was recognized with Germany’s G-BA (Gemeinsamer Bundesausschuss) granting the therapy a considerable added benefit rating, as well as in France, where the HAS transparency committee granted an ASMR III and a SMR rating of important. These recommendations build upon the positive recommendations by American Society of Clinical Oncology (ASCO) and National Comprehensive Cancer Network (NCCN) in the second quarter of 2022. KIMMTRAK was approved by the U.S. Food and Drug Administration; the European Commission; and health authorities in the United Kingdom, Australia and Canada in the first half of 2022. The Company is undergoing reimbursement discussions in a number of countries, including Germany and France where the Company is currently receiving revenues. The Company expects reimbursement decisions in one additional major European country by mid-2023 and up to five smaller countries by end of 2023. In November 2022, the Company and Medison Pharma Ltd. (“Medison”) amended and restated their exclusive distribution agreement for KIMMTRAK originally entered into in September 2021. Medison is the exclusive distribution partner for KIMMTRAK in Canada, Australia, New Zealand, Israel, Central and Eastern Europe, and following this amendment South and Central America, and the Caribbean. Tebentafusp Phase 2/3 trial in advanced melanoma The Company is screening patients in its Phase 2/3 clinical trial of tebentafusp in patients with previously treated advanced melanoma. The trial will enroll patients with advanced melanoma, excluding uveal melanoma, who have progressed on an anti-PD1, received prior ipilimumab and, if applicable, received a tyrosine kinase inhibitor (TKI). Patients will be randomized to one of three arms including tebentafusp, as monotherapy or in combination with an anti-PD1, and a control arm. The Phase 2 portion of the trial will include 40 patients per arm and has a dual primary endpoint of overall survival (OS) and circulating tumor DNA (ctDNA) reduction. IMC-F106C targeting PRAME-A02 in multiple solid tumors The Company’s planned global expansion of the clinical trial footprint for PRAME-A02 studies is underway, with additional patients now being recruited into the Phase 1/2 monotherapy and combination expansion arms in order to characterize the breadth of clinical activity across multiple tumor types. Initial Phase 1 data with IMC-F106C targeting PRAME (PRAME-A02) was presented at the European Society for Medical Oncology (ESMO) Congress 2022, and the Company initiated four expansion arms—cutaneous melanoma, ovarian, non-small cell lung cancer (NSCLC), and endometrial cancers. The combinations with standards-of-care (checkpoint inhibitors, chemotherapy, and tebentafusp) will position the Company to explore IMC-F106C in earlier lines of treatment. The Company expects to report data from the monotherapy and combination arms by the first half of 2024. Expansion of PRAME franchise: IMC-T119C (PRAME-A24) & IMC-P115C (PRAME-A02 HLE) In January 2023, the Company revealed the addition of two new PRAME ImmTAC candidates for solid tumors to the pipeline. Building on enthusiasm for IMC-F106C targeting PRAME HLA-A02, the Company has expanded its franchise targeting PRAME. 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. The Company plans to submit investigational new drug applications (INDs) for these two ImmTAC candidates in 2024. First-in-class ImmTAC candidate – IMC-R117C (PIWIL1) In January 2023, the Company announced an ImmTAC targeting a novel protein 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 the fourth quarter of 2023. IMC-C103C targeting MAGE-A4 In December 2022, the Company presented Phase 1 data for IMC-C103C in a poster presentation at the ESMO Immuno-Oncology 2022 Congress. In February 2023, Genentech accepted Immunocore’s proposal to cease co-funding the development of MAGE-A4 HLA-A02 targeted programs, except for Immunocore’s equal share of the wind-down costs of the IMC-C103C Phase 1 clinical trial. The clinical trial with IMC-C103C is nearing completion and Immunocore does not plan to enroll additional patients. Immunocore is eligible to receive development and commercial milestone payments plus royalties from Genentech on any sales of MAGE-A4 HLA-A02 targeted products arising under the Genentech agreement. ImmTAV® clinical programs In February 2023, the Company presented initial safety and pharmacodynamic activity data with IMC-C113V, the first soluble TCR therapy for people living with Human Immunodeficiency Virus (HIV), at the Conference on Retroviruses and Opportunistic Infections (CROI) 2023. IMC-M113V is an immunotherapeutic approach designed to specifically eliminate CD4+ cells that are persistently infected with HIV (‘reservoirs’). All doses (1.6 mcg, 5 mcg, and 15 mcg) of IMC-M113V were well tolerated and not associated with cytokine release syndrome or neurotoxicity of any grade. There were no serious adverse events, nor significant changes in hematology or chemistry. Plasma viral load remained suppressed throughout dosing and follow-up. In addition, transient, dose-dependent increases in serum IL6 occurred 8-24 hours post-infusion. Five out of the ten participants who received the 15-mcg dose showed a >4-fold rise in IL6, which had been prespecified as indicative of pharmacodynamic activity based on prior experience from clinical trials with KIMMTRAK. The Company has started enrolling people living with HIV in the multiple ascending dose (MAD) part of the trial, to identify a safe and tolerable dosing schedule that could lead to reduction in the viral reservoir and control of HIV after stopping antiretroviral therapies (ART), or functional cure. The MAD trial will enroll up to 28 participants. In the second quarter of 2022, the Company presented data from the first three patients in the first-in-human clinical trial of IMC-I109V for chronic hepatitis B at the EASL International Liver Congress. In this first cohort, the three patients received a single dose of 0.8 mcg, based on the minimum anticipated biological effect level (MABEL). The dose in this initial cohort was well tolerated and was not associated with adverse events and resulted in a transient, small decrease in serum HBsAg with concomitant minor increase in alanine transaminase (ALT). The Company is enrolling patients in the single ascending dose portion of the trial. Corporate and financial updates In December 2022, the Company entered into an agreement with Gadeta B.V., to develop the first gamma delta (γδ) TCR ImmTAC for solid tumors, including colorectal cancer. Immunocore will collaborate with Gadeta on ‘201 γδ-TCR target discovery and has an option to develop ImmTAC therapies derived from the ‘201 TCR as part of the research collaboration. Financial Results Basic and diluted loss per share was £0.54 (or $0.63) and £0.90 (or $1.09) for the quarter and year ended December 31, 2022, respectively, as compared to a basic and diluted loss per share of £0.90 and £3.10, respectively, for the same periods in 2021. Total operating loss for the quarter and year ended December 31, 2022, was £22.3 million (or $27.0 million) and £39.6 million (or $47.8 million), respectively, as compared to £37.8 million and £135.2 million respectively for the same periods in 2021. For the fourth quarter and year ended December 31, 2022, we generated total revenue from the sale of therapies of £42.3 million ($51.1 million) and £116.8 million ($141.1 million), respectively, due to the sale of KIMMTRAK and tebentafusp, of which £32.1 million ($38.8 million) and £80.4 million ($97.2 million), respectively was in the United States, £10.1 million ($12.2 million) and £35.5 million ($42.9 million), respectively, was in Europe, and £0.1 million ($0.1 million) and £0.9 million ($1.1 million), respectively, was in the rest of the world. We received marketing approval for KIMMTRAK in the United States, Europe and other territories in the year ended December 31, 2022, and did not have marketing approval for, and thus no product revenue from, KIMMTRAK in the year ended December 31, 2021. For the fourth quarter and year ended December 31, 2022, our research and development (“R&D”) expenses were £27.1 ($32.8 million) and £89.2 million (or $107.9 million), respectively as compared to £20.1 million and £73.2 million for the quarter and year ended December 31, 2021. These increases were due to increased expenses in connection with our IMC-F106C program and increased headcount and laboratory costs. The Company expects R&D expenses to increase in future periods as the Company advances its trials and further develops clinical and preclinical pipeline candidates. For the quarter and year ended December 31, 2022, our selling and administrative expenses were £43.1 million ($52.1 million) and £93.7 million (or $113.2 million), respectively, compared to £24.4 million and £88.4 million for the quarter and year ended December 31, 2021. These increases were related to higher selling and distribution costs following regulatory approval of KIMMTRAK and an increase in headcount costs (excluding share-based payment charges, which reduced in 2022). Our administrative expenses also increased in the fourth quarter of 2022 due to approximately $15 million of non-cash foreign exchange losses, primarily on U.S. dollar balances. Cash and cash equivalents were £332.5 million (or $401.6 million) as of December 31, 2022, as compared to £237.9 million (or $321.1 million) as of December 31, 2021. We expect that our existing cash, along with anticipated revenue from KIMMTRAK, will be sufficient to fund our planned operating expenses, financial commitments and other cash requirements into 2026. We maintain our books and records in pounds sterling. For the convenience of the reader, we have translated pound sterling amounts as of and for the period ended December 31, 2022 into U.S. dollars at a rate of £1.00 to $1.2077. Audio Webcast Immunocore will host a conference call today, March 1, 2023 at 8:00 A.M. ET/ 1:00 PM GMT, to discuss the fourth quarter and full year 2022 financial results and provide a business update. The call will also be available via webcast by visiting the Events & Presentations section on Immunocore’s website. A replay of this webcast will be available for 30 days. Conference Call Details:U.S. (toll-free): 877-405-1239International (toll): +1 201-389-0851 ### About KIMMTRAK®KIMMTRAK is a novel bispecific protein comprised of a soluble T cell receptor fused to an anti-CD3 immune-effector function. KIMMTRAK specifically targets gp100, a lineage antigen expressed in melanocytes and melanoma. This is the first molecule developed using Immunocore’s ImmTAC technology platform designed to redirect and activate T cells to recognize and kill tumor cells. KIMMTRAK has been approved for the treatment of HLA-A*02:01-positive adult patients with unresectable or metastatic uveal melanoma in the United States, European Union, Canada, Australia, and the United Kingdom. About Phase 3 IMCgp100-202 TrialIMCgp100-202 (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. 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 ToxicityKIMMTRAK 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 KIMMTRAKConnectImmunocore 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 ImmunocoreImmunocore 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. 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 Company’s 2023 financial outlook, milestone expectations, future expenses and revenue and financial performance; 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; expected capture rate for KIMMTRAK; expected expansion plans for KIMMTRAK; the Company’s belief that IMC-T119C is first-in-class ImmTAC; the Company’s belief that IMC-R117C is first in class and first PIWIL targeted immunotherapy for colorectal and other gastrointestinal cancers; 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, IMC-T119C and IMC-P115C; 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; the ability of and timing to obtain reimbursement decisions; statements regarding partnerships, including the amended partnership with Medison and the partnership with Genentech, and potential milestone payments under such partnerships; the continued launch of KIMMTRAK in additional countries and the potential to secure majority market share of patients with metastatic uveal melanoma; the establishment of KIMMTRAK globally as a first line treatment for metastatic uveal melanoma; the planned exploration of patient convenience; and Immunocore’s anticipated cash runway. 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. CONTACT: ImmunocoreSébastien Desprez, Head of CommunicationsT: +44 (0) 7458030732E: mailto:sebastien.desprez@immunocore.com Follow on Twitter: @Immunocore Consilium Strategic Communications (corporate and financial)Mary-Jane Elliott/ Chris Welsh/Jessica HodgsonT: +44 (0)203 709 5700E: Immunocore@consilium-comms.com Investor Relations Clayton Robertson, Head of Investor RelationsT: +1 215-384-4781E: ir@immunocore.com Consolidated Statement of Loss Comparison of the Years Ended December 31, 2022 and 2021: Year ended December 31,​2022 2021 $’000 £’000 £’000Product revenue 130,610 108,148 —Pre-product revenue 10,460 8,661 3,010Total revenue from sale of therapies 141,070 116,809 3,010Collaboration revenue 32,521 26,928 23,510Total revenue 173,591 143,737 26,520Cost of product revenue (548) (454) —Net other operating income / (loss) 4 3 (57)Research and development costs (107,691) (89,170) (73,226)Selling and administrative expenses (113,189) (93,723) (88,399)Operating loss (47,833) (39,607) (135,162)Finance income 3,809 3,154 47Finance costs (9,290) (7,692) (5,813)Non-operating expense (5,481) (4,538) (5,766)Loss before taxes (53,314) (44,145) (140,928)Income tax credit 3,528 2,921 9,405Loss for the period (49,786) (41,224) (131,523)Basic and diluted loss per share (1.09) (0.90) (3.10) Consolidated Statement of Loss Comparison of the Quarters Ended December 31, 2022 and 2021: Quarter ended December 31,​2022 2021 $’000 £’000 £’000Product revenue 52,197 43,220 —Pre-product revenue (1,117) (925) 3,010Total revenue from sale of therapies 51,080 42,295 3,010Collaboration revenue 6,964 5,767 3,583Total revenue 58,044 48,062 6,593Cost of product revenue (132) (109) —Net other operating income 2 2 13Research and development costs (32,774) (27,138) (20,072)Selling and administrative expenses (52,103) (43,143) (24,366)Operating loss (26,963) (22,326) (37,832)Finance income 2,934 2,429 5Finance costs (3,837) (3,177) (1,348)Non-operating expense (903) (748) (1,343)Loss before taxes (27,866) (23,074) (39,175)Income tax expense (2,571) (2,129) (214)Loss for the period (30,437) (25,203) (39,389)Basic and diluted loss per share (0.63) (0.54) (0.90) Cash Flows Year ended December 31,​2022 2021 $’000 £’000 £’000Cash and cash equivalents at beginning of the year 287,295 237,886 129,716Net cash flows used in operating activities (31,269) (25,891) (96,110)Net cash flows from / (used in) investing activities 233 193 (367)Net cash flows from financing activities 138,226 114,454 204,631Net foreign exchange difference on cash held 7,122 5,897 16Cash and cash equivalents at end of the year 401,607 332,539 237,886 Consolidated Statements of Financial Position as at December 31, 2022 2021 £’000 £’000Non-current assets Property, plant and equipment 6,472 8,944Intangible assets 410 —Right of use assets 25,173 22,593Other non-current assets 7,342 4,935Deferred tax asset 4,240 2,575Total non-current assets 43,637 39,047Current assets Inventory 943 —Trade and other receivables 46,711 15,208Tax receivable 11,688 9,632Cash and cash equivalents 332,539 237,886Total current assets 391,881 262,726Total assets 435,518 301,773Equity Share capital 97 88Share premium 123,751 212,238Foreign currency translation reserve (3,097) 89Other reserves 337,847 386,167Share-based payment reserve 81,411 54,357Accumulated deficit (261,253) (481,392)Total equity 278,756 171,547Non-current liabilities Non-current accruals 1,479 —Interest-bearing loans and borrowings 39,500 37,226Deferred revenue 4,331 6,408Lease liabilities 28,248 25,355Provisions 114 57Total non-current liabilities 73,672 69,046Current liabilities Trade and other payables 75,076 35,436Deferred revenue 6,408 24,450Lease liabilities 1,555 1,255Provisions 51 39Total current liabilities 83,090 61,180Total liabilities 156,762 130,226Total equity and liabilities 435,518 301,773