Product Development and Approval - KIMMTRAK has been approved in 39 countries for the treatment of unresectable or metastatic uveal melanoma, with launches in 24 countries as of December 31, 2024[610]. - The company has treated over 2,000 cancer patients with KIMMTRAK and other ImmTAX product candidates, representing a significant clinical data set in solid tumors[611]. - The company received regulatory approval for KIMMTRAK in Brazil in February 2025[618]. - The company plans to submit a CTA or IND for its second autoimmune candidate, IMC-U120AI, in 2026 for a Phase 1 trial in atopic dermatitis[616]. Financial Performance - Total revenue for the year ended December 31, 2024, was $310.2 million, a 24% increase from $249.4 million in 2023[638]. - Revenue from the sale of therapies, net, was $310.0 million, with $226.7 million from the United States, $73.2 million from Europe, and $10.1 million from International, reflecting a 30% increase year-over-year[639]. - Collaboration revenue decreased by 98% to $0.2 million in 2024, down from $10.7 million in 2023, due to the closure of a Phase 1 clinical trial[640]. Expenses and Losses - Net losses for the years ended December 31 were $51.1 million in 2024, $55.3 million in 2023, and $52.5 million in 2022, with an accumulated deficit of $795.8 million as of December 31, 2024[613]. - The company expects to continue incurring significant operating losses and expenses as it advances product candidates through clinical development and seeks regulatory approvals[614]. - Research and development expenses are anticipated to increase as the company advances existing and future product candidates into clinical studies[624]. - R&D expenses for the year ended December 31, 2024, totaled $222.2 million, a 36% increase from $163.5 million in 2023, driven by increased spending on PRAME and tebentafusp programs[642]. - SG&A expenses increased to $155.8 million in 2024, up 8% from $144.5 million in 2023, primarily due to the internalization of the U.S. sales force[646]. Cash Flow and Funding - Cash and cash equivalents increased to $455.7 million as of December 31, 2024, compared to $442.6 million in 2023, with marketable securities of $364.6 million[652]. - Net cash provided by operating activities was $26.1 million for the year ended December 31, 2024, significantly up from $2.9 million in 2023[658]. - Net cash used in investing activities increased to $355.1 million for the year ended December 31, 2024, from $5.4 million in 2023, primarily due to purchases of marketable securities of $350.0 million[659]. - Net cash provided by financing activities rose to $343.9 million in 2024, compared to $34.3 million in 2023, driven by net cash proceeds of $389.1 million from the offering of Notes after deducting issuance costs of $13.4 million[660]. - The company has raised funds through various means, including an initial public offering and private placements, to support operations and R&D activities[612]. - The company may need additional funding to support continued operations and pursue its clinical development and growth strategy[614]. - Future funding requirements may increase significantly due to various factors, including the progress and costs of clinical trials and the ability to commercialize product candidates[664]. - The company intends to explore additional financing opportunities to support long-term clinical development, depending on favorable market conditions[663]. Tax and Credit - The U.K. R&D tax credit regime allows the company to claim credits under the R&D Expenditure Credit program, with potential cash rebates increasing from 10.5% to 15% for qualifying R&D expenses incurred after April 1, 2023[627]. - Total accrued revenue deductions as of December 31, 2024, were $110.9 million, with $103.9 million subject to greater estimation uncertainty[681]. - A 20% increase or decrease in expected rebate and chargeback percentages could result in a $20.8 million reduction or increase in revenue from therapy sales for the year ended December 31, 2024[682]. Financial Position and Risks - The company reported an accumulated deficit of $795.8 million as of December 31, 2024[651]. - Cash and cash equivalents totaled $455.7 million, with marketable securities of $364.6 million as of December 31, 2024, expected to fund operating expenses for at least twelve months[663]. - The company has material contractual lease obligations potentially resulting in payments of up to $65.6 million, with lease terms extending to 2043[667]. - Existing manufacturing obligations could result in payments of up to $27.7 million, expected to increase as the company advances the development of its brenetafusp program in 2024 and beyond[668]. - Credit risk exposure is primarily from accounts receivable, cash and cash equivalents, and marketable securities held with high-quality financial institutions[692]. - The company continually monitors credit quality and does not anticipate non-performance from financial institutions and corporations[693].

Core Insights - Immunocore Holdings plc reported Q4 net sales of $84.1 million and full-year sales of $310.0 million for 2024, with continued growth expected in 2025 [1][9][28] - The company has achieved 11 consecutive quarters of revenue growth for KIMMTRAK (tebentafusp), with significant expansion in the U.S. and launches in 14 new territories outside the U.S. [4][7] - Immunocore is advancing its clinical pipeline with multiple Phase 3 trials and new candidates targeting various cancers and autoimmune diseases [5][6][12] Financial Performance - Q4 2024 net sales of KIMMTRAK were $84.1 million, with $63.8 million from the U.S., $17.8 million from Europe, and $2.5 million from international regions [9][28] - Full-year 2024 net sales totaled $310.0 million, an increase from $238.7 million in 2023, reflecting a 30% year-on-year growth [9][28] - R&D expenses for 2024 were $222.2 million, up from $163.5 million in 2023, driven by the advancement of clinical trials [10][30] - SG&A expenses increased to $155.8 million in 2024 from $144.5 million in 2023, primarily due to growth in business support functions [31] Clinical Development - The company is executing on KIMMTRAK lifecycle management with two Phase 3 trials (TEBE-AM and ATOM) for additional melanoma indications [1][4] - The first patient was randomized in the Phase 3 PRISM-MEL-301 trial for brenetafusp in advanced cutaneous melanoma, with ongoing enrollment in other trials for ovarian cancer and NSCLC [5][15] - Immunocore plans to file clinical trial applications for new candidates targeting type 1 diabetes and atopic dermatitis in the coming years [29] Cash Position - As of December 31, 2024, the company had cash, cash equivalents, and marketable securities totaling $820.4 million [11][32] - The company repaid its existing Pharmakon loan of $50.0 million in November 2024, strengthening its financial position [11][32]

Core Viewpoint - Immunocore Holdings plc, a biotechnology company focused on immunomodulating medicines, will report its financial results for Q4 and the year ended December 31, 2024, on February 26, 2025 [1]. Company Overview - Immunocore is pioneering a novel class of TCR bispecific immunotherapies known as ImmTAX, aimed at treating various diseases including cancer, autoimmune diseases, and infectious diseases [4]. - The company has developed a deep pipeline across multiple therapeutic areas, with its leading oncology TCR therapeutic, KIMMTRAK, already approved for treating HLA-A*02:01-positive adult patients with unresectable or metastatic uveal melanoma in several regions including the US, EU, Canada, Australia, and the UK [4]. Upcoming Events - Following the financial results announcement, the company will host a live teleconference and webcast on February 26, 2025, at 8:00 a.m. EST to discuss the results and provide a business update [2]. - The webcast will be accessible through the company's website, and a replay will be available for a limited time after the event [3]. Contact Information - For inquiries, Immunocore's Head of Communications is Sébastien Desprez, reachable at +44 (0) 7458030732 or via email at sebastien.desprez@immunocore.com [7]. - Investor relations can be contacted through Clayton Robertson or Morgan Warenius at +1 (215) 384-4781 or ir@immunocore.com [7].

Core Viewpoint - Investors are expected to focus on the sales performance of Immunocore Holdings plc's sole marketed drug, Kimmtrak, during the upcoming fourth-quarter 2024 results, with a consensus estimate of $83.5 million in revenue and a loss of 40 cents per share [1]. Group 1: Sales Performance and Market Presence - Kimmtrak is approved in 38 countries and has been launched in 21 countries, serving as the standard of care for metastatic uveal melanoma (mUM) in most markets where it is available [3]. - Revenue for the upcoming quarter is anticipated to be driven by increased sales of Kimmtrak in the U.S. and other markets due to strong demand [4]. - The company aims to expand its reach to more mUM patients globally by 2025 through additional launches and increased community penetration [5]. Group 2: Pipeline and Development - Immunocore is developing brenetafusp in combination with Bristol Myers' Opdivo for treating first-line advanced cutaneous melanoma, with studies also targeting other cancer indications [5]. - The company has a robust pipeline with nine active clinical and pre-clinical programs across oncology, infectious diseases, and autoimmune diseases, with updates expected in the upcoming earnings call [8]. Group 3: Earnings Performance and Predictions - Immunocore has a mixed history of earnings surprises, having beaten earnings estimates in two of the last four quarters, with an average surprise of 25.57% [9]. - The company's Earnings ESP is +20.57%, indicating a potential earnings beat, with the most accurate estimate at a loss of 32 cents compared to the consensus estimate of a loss of 40 cents [11].

Core Viewpoint - Immunocore Holdings PLC (IMCR) shows significant upside potential with a mean price target of $64.79, indicating an 113.1% increase from the current price of $30.40 [1] Price Target Analysis - The average of 14 short-term price targets ranges from a low of $24 to a high of $100, with a standard deviation of $23.28, suggesting variability in analyst estimates [2] - The lowest estimate indicates a potential decline of 21.1%, while the most optimistic estimate suggests a 229% upside [2] - A low standard deviation indicates a high degree of agreement among analysts regarding price movement direction [7] Analyst Sentiment - Analysts have shown increasing optimism about IMCR's earnings prospects, with a strong consensus in revising EPS estimates higher, which correlates with potential stock price increases [9] - The Zacks Consensus Estimate for the current year has increased by 0.2% over the past month, with no negative revisions [10] - IMCR holds a Zacks Rank 1 (Strong Buy), placing it in the top 5% of over 4,000 ranked stocks based on earnings estimates [11] Caution on Price Targets - While price targets are often sought after, they can mislead investors, as empirical research shows they rarely indicate actual stock price movements [5] - Analysts may set overly optimistic price targets due to business incentives, which can inflate expectations [6] - Investors should treat price targets with skepticism and not rely solely on them for investment decisions [8]

Strategic Priorities for 2025 - The company aims to expand access to KIMMTRAK for metastatic uveal melanoma (mUM) patients globally through additional launches and increased community penetration, building on 38 country approvals and 23 launches as of year-end 2024 [1][7] - Three Phase 3 trials are enrolling across multiple melanoma indications, with the first topline results expected in 2026, potentially addressing up to 15,000 additional patients across three new melanoma indications [1][8] - The company plans to present initial HIV Phase 1 MAD data in Q1 2025 and advance autoimmune candidates, including a CTA submission for a Type 1 diabetes candidate in 2025 [1][6][15] Melanoma Franchise Expansion - KIMMTRAK, the world's first bispecific TCR therapy, is available in 23 countries, with ongoing Phase 3 trials in melanoma and a brenetafusp Phase 3 trial in first-line melanoma [4][7] - The company is enrolling patients in three registrational Phase 3 trials: TEBE-AM, PRISM-MEL-301, and ATOM, targeting up to 4,000, 10,000, and 1,200 patients respectively [12] - The company will continue to highlight three-year overall survival data for KIMMTRAK in launched countries [7] Clinical Portfolio Advancements - The company is enrolling patients in multiple Phase 1/2 trials, including brenetafusp combinations in ovarian and lung cancer, and dose escalation trials with IMC-R117C (PIWIL1) and IMC-P115C (PRAME-A02-HLE) [1][9][10] - A Phase 1/2 trial is evaluating brenetafusp in platinum-resistant ovarian cancer (PROC) and platinum-sensitive ovarian cancer (PSOC), as well as in metastatic non-small cell lung cancer (NSCLC) cohorts [9] - The company is also enrolling patients in a Phase 1 trial with IMC-P115C (PRAME-A02-HLE) in multiple solid tumors, designed to reduce treatment administration frequency [10] Infectious Diseases Pipeline - The company is enrolling people living with HIV (PLWH) in the Phase 1 MAD trial with IMC-M113V, aiming to identify a safe dosing schedule and explore higher doses for a potential functional cure [5][12] - Initial data from the Phase 1 trial with IMC-I109V for hepatitis B virus (HBV) will be presented in 2025 [5] Autoimmune Diseases Innovation - The company is advancing two autoimmune candidates: IMC-S118AI (PPI x PD1) for Type 1 diabetes, with a CTA submission planned for 2025, and IMC-U120AI (CD1a x PD1) for atopic dermatitis, with a CTA submission planned for 2026 [6][15][16] - IMC-U120AI is the company's first non-HLA restricted candidate, targeting CD1a for atopic dermatitis and potentially other immune diseases [16] Corporate Updates - Travis Coy was appointed Executive Vice President, Chief Financial Officer, and Head of Corporate Development in January 2025, bringing over 20 years of experience from Eli Lilly and Company [17] - The company's preliminary unaudited cash position as of December 31, 2024, was approximately $820 million, with final financial results to be reported in late February 2025 [18] Technology and Platform Overview - The company's ImmTAC platform generates bispecific biologics designed to redirect the immune system to recognize and kill cancerous cells, with potential applications in hematologic and solid tumors [20] - ImmTAV molecules target virally infected cells, aiming for functional cures in HIV and HBV [21][22] - ImmTAAI molecules are designed for tissue-specific immune modulation, with candidates in development for Type 1 diabetes and inflammatory dermatological diseases [23]

Company Overview - Immunocore is a commercial-stage biotechnology company pioneering the development of a novel class of TCR bispecific immunotherapies called ImmTAX, designed to treat a broad range of diseases including cancer, autoimmune, and infectious diseases [4] - The company leverages its proprietary ImmTAX platform to develop 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 [4] - Immunocore'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 [4] Upcoming Event - Immunocore management will participate in a presentation at the 43rd Annual J P Morgan Healthcare Conference in San Francisco, California, scheduled for Wednesday, January 15, 2025, at 8:15 a m Pacific Standard Time (PST) [2][3] - The presentation will be webcast live and accessible via the "Events & Presentations" section under "Investors" on Immunocore's website, with a replay available for a limited time following the event [3]

Immunocore's IMC-P115C Phase 1 Trial - Immunocore has dosed the first patient in the Phase 1 trial of IMC-P115C, a half-life extended (HLE) ImmTAC candidate targeting PRAME-expressing tumors [6] - IMC-P115C is designed with the same CD3 effector and TCR specificity as brenetafusp, but with an extended half-life [6] - The Phase 1 trial will evaluate safety, pharmacokinetics, and clinical activity in HLA-A*02:01-positive patients with advanced solid tumors expressing PRAME [6][7] IMC-P115C Development and Mechanism - IMC-P115C is Immunocore's first half-life extended candidate and the sixth ImmTAC candidate to enter clinical trials [2] - It is a PRAME x CD3 ImmTAC bispecific protein targeting the same HLA-A*02:01 PRAME peptide as brenetafusp [2] - The trial aims to assess preliminary anti-tumor activity and pharmacokinetics of IMC-P115C [8] ImmTAC Technology Overview - Immunocore's ImmTAC molecules are bispecific biologics designed to redirect the immune system to recognize and kill cancerous cells [3] - These molecules use engineered soluble TCRs to recognize intracellular cancer antigens with ultra-high affinity and selectively kill cancer cells via an anti-CD3 immune-activating effector function [3] - The ImmTAC mechanism has potential to treat both hematologic and solid tumors, including immune "cold" low mutation rate tumors [3] Immunocore's Pipeline and Focus - Immunocore is a commercial-stage biotechnology company developing TCR bispecific immunotherapies called ImmTAX for cancer, autoimmune diseases, and infectious diseases [4] - The company has a deep pipeline with nine active clinical and pre-clinical programs across multiple therapeutic areas [9] - Its most advanced oncology TCR therapeutic, KIMMTRAK, is approved for unresectable or metastatic uveal melanoma in several regions [9] Clinical Development and Future Prospects - The Phase 1 trial of IMC-P115C builds on the largest Phase 1/2 PRAME dataset from brenetafusp, which served as the basis for the first Phase 3 trial with a PRAME therapy [7] - Immunocore aims to expand the understanding of PRAME candidates through this trial [7] - The company continues to pioneer transformative immunomodulating medicines for cancer, infectious diseases, and autoimmune diseases [6]

Clinical Trial and Drug Development - Immunocore has initiated a Phase 1/2 trial for IMC-R117C, targeting PIWIL1 in advanced cancers, including colorectal cancer, marking the first immunotherapy program to target this cancer-testis antigen [1][2] - IMC-R117C is the fifth ImmTAC candidate from Immunocore to enter clinical trials, with PIWIL1 being overexpressed in multiple malignancies, including colorectal cancer, and associated with aggressive tumor growth and poor patient survival [2] - The trial will evaluate IMC-R117C as a monotherapy and in combination with standard therapies, focusing on HLA-A*02:01-positive patients with advanced solid tumors [4][6] Market and Patient Population - Immunocore estimates that up to 20,000 colorectal cancer patients globally are positive for both PIWIL1 and HLA-A*02:01, highlighting a significant unmet medical need in this patient population [3] - Colorectal cancer remains one of the most prevalent cancers, with low survival rates for advanced or metastatic cases, despite advancements in treatment [7] Technology and Mechanism of Action - Immunocore's ImmTAC molecules are a novel class of bispecific biologics designed to redirect the immune system to recognize and kill cancerous cells, leveraging ultra-high affinity TCRs to target intracellular cancer antigens [5] - The ImmTAC platform has the potential to treat both hematologic and solid tumors, including immune "cold" tumors with low mutation rates, due to its mechanism of T cell infiltration into tumors [5] Company Overview - Immunocore is a commercial-stage biotechnology company focused on developing TCR bispecific immunotherapies, with a pipeline that includes nine active clinical and pre-clinical programs across oncology, infectious diseases, and autoimmune diseases [9] - The company's most advanced oncology therapeutic, KIMMTRAK, has been approved for the treatment of uveal melanoma in multiple regions, including the United States and the European Union [9]

Morgan Stanley Analyst Actions - Morgan Stanley downgraded Amicus Therapeutics Inc FOLD to Equal-weight from Overweight and lowered the price target from $17 to $12 [2] - The analyst noted that Amicus is well-positioned but expectations are largely priced into shares [1] - Investors are shifting focus to the company's next leg of growth, with potential updates to the pipeline in 2025 and beyond [2] Immunocore Holdings plc IMCR Analysis - Morgan Stanley lowered the price target for Immunocore Holdings plc IMCR from $74 to $35 due to disappointing data for brenetafusp in cutaneous melanoma and ovarian cancer [3] - The analyst continues to give full credit for Kimmtrak (tebentafusp), which was approved for unresectable or metastatic uveal melanoma [3] - Limited upside potential is seen from additional brenetafusp updates as the company detects signals in metastatic NSCLC and combination in earlier-line NSCLC [4] Immuneering Corp IMRX Analysis - Morgan Stanley downgraded Immuneering Corp IMRX shares to Underweight from Equal-weight and set a base case range of $1 to $5 versus the previous target of $4 [5] - The analyst supports Immuneering's strategy of targeting the MAPK pathway but notes stronger investment opportunities in the coverage on a relative basis [5] - Early clinical results are promising but more robust data with a larger patient pool is needed to confirm outcomes [6] Stock Price Movements - IMRX stock is down 18% at $1 615 [6] - IMCR stock is down 5 89% at $28 53 [6] - FOLD stock is down 6 70% at $9 47 [6]