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Immunocore presents initial multiple ascending dose data for HIV functional cure candidate in an oral presentation at CROI 2025
Newsfilter· 2025-03-10 19:00
Core Insights - Immunocore presented initial data from the multiple ascending dose (MAD) portion of its Phase 1/2 STRIVE trial for IMC-M113V, a functional cure candidate for HIV, at CROI 2025, indicating the treatment is well tolerated and shows potential for viral control after antiretroviral treatment interruption [1][2][3] Group 1: Trial Data and Results - The MAD trial included 16 participants living with HIV who were stable on antiretroviral therapy (ART), with doses evaluated at 60 mcg, 120 mcg, and 300 mcg over 12 weeks, followed by a treatment interruption for up to 12 weeks [4][10] - No serious adverse events or dose-limiting toxicities were reported, with mild cytokine release syndrome observed in five participants at the highest dose [5][6] - Among 15 evaluable participants, delayed viral rebound was noted in 0 of 5 at 60 mcg, 1 of 5 at 120 mcg, and 2 of 5 at 300 mcg, with the historical rate for such observations being 5% [7][8] Group 2: Mechanism and Objectives - IMC-M113V employs a T cell receptor that targets HIV-infected immune cells, aiming to eliminate CD4+ cells containing integrated HIV DNA [10] - The STRIVE trial's objectives include establishing safe dosing regimens alongside ART and quantifying antiviral activity, specifically post-treatment viral control [11][13] Group 3: Future Directions - The company is advancing its clinical candidates to achieve a functional cure for HIV and aims for sustained control of the virus after ART cessation without virological relapse [13][14] - Further data from the trial at higher doses is anticipated, contributing to broader efforts to enable individuals with HIV to maintain health without lifelong ART [3][12]
Immunocore: A Commercial Biotech Nearing Its Pivotal Break-Even Point
Seeking Alpha· 2025-02-27 13:11
Core Insights - Immunocore Holdings is a biotech company focused on immunotherapy in oncology, gaining attention for its novel treatment approach to rare skin cancers approved in 2022 [1] Company Overview - Immunocore Holdings operates in the oncology space, specifically targeting immunotherapy solutions [1] Recent Developments - The company made a significant impact with the approval of a new treatment for rare skin cancers, marking a pivotal moment in its development [1]
Immunocore(IMCR) - 2024 Q4 - Earnings Call Transcript
2025-02-26 18:24
Financial Data and Key Metrics Changes - For the full year 2024, Immunocore reported total revenues of $310 million, representing a 30% year-on-year growth [8][51] - In Q4 2024, net revenues reached $84.1 million, a 5% increase from Q3 2024 [16][51] - The United States accounted for $206 million of the total revenue, growing at an impressive 34% year-on-year [17] Business Line Data and Key Metrics Changes - KymTrak achieved 30% year-on-year revenue growth, with $310 million in net revenues for 2024 [8][16] - KymTrak's Q4 revenues were $84.1 million, reflecting a 5% increase from the previous quarter [16][51] - The company launched KymTrak in 14 new countries in 2024, bringing the total to 39 countries [15] Market Data and Key Metrics Changes - The US market penetration for KymTrak is estimated at around 65%, with nearly half of new patients starting treatment in community settings [17][104] - The reimbursement environment in Europe remains challenging, impacting revenue recognition [52][67] Company Strategy and Development Direction - The company is focused on expanding KymTrak's market presence and exploring new therapeutic areas, including autoimmune diseases and infectious diseases [11][12] - Immunocore is advancing its clinical pipeline with three ongoing phase three trials and two phase one trials [9][26] - The company aims to leverage its modular technology to tackle autoimmune diseases and expand its therapeutic offerings [11][38] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in KymTrak's potential for incremental growth in 2025, driven by community expansion and new launches [18][54] - The company anticipates increased R&D expenses as it advances its clinical pipeline [52][55] - Management highlighted a strong financial position with $820 million in cash and marketable securities at the end of 2024 [56] Other Important Information - The company initiated two phase one trials in 2024 and completed a single ascending dose trial for HBV [11][26] - Management emphasized the importance of data-driven investments and disciplined spending to support growth [56] Q&A Session Summary Question: Upcoming HIV results and patient follow-up - All patients will be off therapy for twelve weeks to assess antiviral activity and viral reservoir reduction [63] - A good rate of success would be suppression of viral copies to less than 200 copies per ml for 20-30% of patients [65] Question: European sales adjustments - The reimbursement environment in Europe is challenging, with ongoing price negotiations affecting sales [67] Question: Factors for determining go-forward dose in HIV - Factors include tolerability, evidence of antiviral activity, and potential need for dose optimization [71] Question: Duration of patient follow-up in HIV trials - Patients will be followed for twelve weeks to assess antiviral control, with potential for longer follow-up [78] Question: Updates on branetafus and patient follow-up - Patients in the dose selection analysis will be followed for eight to twelve weeks to assess safety and initial response [84] Question: Safety and tolerability profile in non-oncology settings - Mild cytokine release syndrome is expected in infectious disease settings, while autoimmune treatments should avoid systemic immune suppression [90] Question: Business development opportunities for 2025 - The company is continuously looking for strategic partnerships to enhance portfolio value [100] Question: KymTrak market penetration and treatment duration - KymTrak has achieved 65% market penetration in the US, with ongoing efforts to expand community prescriptions [104] Question: HIV data and potential for combination strategies - The platform is combinable with other therapies, and the goal is to achieve a finite dosing regimen [127] Question: Atopic dermatitis program benchmarks - Initial entry will focus on patients refractory to all therapy to find a signal for efficacy [132] Question: Preclinical data supporting HIV program - Preclinical studies show the ability to redirect T cells to kill HIV-infected cells, providing confidence for the trial [141]
Immunocore(IMCR) - 2024 Q4 - Annual Report
2025-02-26 12:00
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].
Immunocore reports fourth quarter and full year 2024 financial results and provides a business update
Globenewswire· 2025-02-26 12:00
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]
Immunocore to report fourth quarter and full year 2024 financial results and host call on February 26, 2025
Globenewswire· 2025-02-19 12:00
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].
Immunocore Gears Up to Report Q4 Earnings: Is a Beat in Store?
ZACKS· 2025-02-17 16:26
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].
Wall Street Analysts Believe Immunocore (IMCR) Could Rally 113.13%: Here's is How to Trade
ZACKS· 2025-01-13 15:55
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]
Immunocore(IMCR) - 2024 Q4 - Annual Results
2025-02-26 12:22
KIMMTRAK Performance and Market Potential - KIMMTRAK Q1-Q3 2024 net sales reached $226M, with potential to help up to 6K patients per year in the US and Europe[11] - KIMMTRAK has been launched in 45 countries as of December 31, 2024, with Q1-Q3 2024 net revenue from these launches[13] - KIMMTRAK active in cutaneous melanoma (CM) with Phase 1/2 study showing durable disease control in patients who progressed on prior anti-PD1 therapy[15] - KIMMTRAK's dosing frequency in CM patients shows durable response regardless of time since last dose of anti-PD1 therapy[15] - KIMMTRAK (tebentafusp) is being evaluated in a Phase 3 trial for adjuvant uveal melanoma, targeting ~1,200 patients[47] - The company's preliminary, unaudited year-end cash position is $820M, with $226M in commercial revenues from KIMMTRAK[43] Clinical Trials and Pipeline Development - TEBE-AM Phase 3 trial in 2L+ cutaneous melanoma targets a market opportunity of up to 4,000 patients, with expected enrollment completion in 1H 2026[18][19] - ATOM Phase 3 trial for KIMMTRAK in adjuvant uveal melanoma shows 88% ctDNA reduction in 1st line treatment and 71% in 2nd+ line treatment[21] - HIV STRIVE Phase 1 trial for IMC-M113V has enrolled 15 people living with HIV (PLWH) as of June 2024, with biologically active dose reached and Phase 1 MAD data planned for 1Q 2025[30] - Immunocore's pipeline includes candidates across oncology, autoimmune diseases, and infectious diseases, with multiple Phase 1/2 and Phase 3 trials ongoing[6][7] - PRISM-MEL-301, a Phase 3 trial for first-line advanced cutaneous melanoma, is enrolling ~10,000 HLA-A02+ patients annually in the US and Europe[72] - The company is evaluating brenetafusp in combination with standard-of-care therapies for ovarian and NSCLC, with enrollment expected in 2025[54] - PRAME franchise expansion opportunities include HLE and A24 programs, with IND/Phase 1 trials planned[54] Therapeutic Potential and Innovation - Immunocore's TCR therapeutics can target >90% of the human proteome, offering a broad therapeutic potential[5] - Immunocore's vision for autoimmunity includes tissue-specific downmodulation of the immune system, aiming to suppress activation only in inflamed tissues[33] - IMC-S118AI for type 1 diabetes (T1D) is expected to submit CTN for Phase 1 trial by end of 2025, targeting 160,000 newly diagnosed T1D patients annually in the US and EU5[35] - IMC-U120AI is a non-HLA restricted bispecific candidate for dermatology, addressing a broader patient population beyond HLA-A02[43] - PRAME-A02-HLE targets 20,000 PIWIL+ CRC patients, expanding the addressable patient population[43] Brenetafusp Clinical Data - Brenetafusp monotherapy in cutaneous melanoma showed a median H-score of 215 for PRAME expression, with 89% of patients being PRAME positive[58] - Brenetafusp monotherapy demonstrated a durable disease control rate (DCR) of 58% in PRAME+ patients, with a median progression-free survival (mPFS) of 3.7 months[69] - Median age of patients in monotherapy group is 63 years (range 40-80) and in chemo combo group is 65 years (range 47-72)[75] - 51% of monotherapy patients had ECOG PS 0, compared to 25% in chemo combo group[75] - 94% of monotherapy patients were PRAME positive, while 81% in chemo combo group were PRAME positive[75][77] - Disease Control Rate (DCR) for monotherapy was 58% with a median Progression-Free Survival (mPFS) of 3.3 months[82] - 6-month Overall Survival (OS) rate for monotherapy was 73%[82] - Treatment-related adverse events (TRAE) occurred in 97% of monotherapy patients and 100% of chemo combo patients[78] - Grade 3/4 TRAE were reported in 19% of monotherapy patients and 50% of chemo combo patients[78] - Cytokine Release Syndrome (CRS) was observed in 57% of monotherapy patients and 75% of chemo combo patients[78] - ALT increased in 11% of monotherapy patients and 50% of chemo combo patients[78] - AST increased in 5% of monotherapy patients and 50% of chemo combo patients[78]
Immunocore announces strategic priorities at 43rd Annual J.P. Morgan Healthcare Conference
Globenewswire· 2025-01-10 12:00
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]