Summary of Immunocore Holdings Conference Call Company Overview - **Company**: Immunocore Holdings (NasdaqGS:IMCR) - **Focus**: A commercial stage biotech company specializing in T-cell engager platform for oncology and infectious diseases, as well as autoimmune conditions. [4][6] Key Products and Pipeline - **KIMMTRAK**: - Approved for uveal melanoma in 38 markets, launched in 28 markets. [4] - Achieved over $100 million in sales for the first time in the last quarter. [10] - Currently has a duration of therapy of about 14 months, exceeding clinical trial results. [11] - 68% penetration in the US market, with higher penetration in European markets (80-90%). [14][15] - Two ongoing Phase 3 trials for cutaneous melanoma and adjuvant settings. [5][16] - **PRAME**: - In Phase 3 for first-line cutaneous melanoma, showing promising monotherapy activity. [22] - Ongoing trials in ovarian and lung cancers, with data expected next year. [24] Commercial Performance - **KIMMTRAK Sales**: - Growth driven by both US and international markets, with significant contributions from recent launches in the UK, Netherlands, and Poland. [10] - Safety profile has contributed to increased duration of therapy and penetration in community settings. [11] Clinical Trials and Data - **Cutaneous Melanoma**: - Phase 3 trial shows a one-year overall survival (OS) rate of 75% compared to 55% for comparators. [16] - Enrollment expected to finish in the first half of 2026, with data anticipated in the second half of 2026. [16] - **Adjuvant Setting**: - Focus on preventing metastasis in high-risk patients post-surgery. [18] - **PRAME BiSpecific**: - Ongoing Phase 3 trial in combination with Nivolumab, with data expected around the end of 2027 or early 2028. [26] Infectious Disease and Autoimmune Programs - **Infectious Disease**: - Programs in HIV and HBV, with promising single ascending dose data for HBV showing surface antigen reduction. [30] - Aim for a functional cure in HIV by targeting viral reservoirs. [31] - **Autoimmune**: - Focus on tissue-specific down modulation, with a Type 1 diabetes program targeting T-cell activity in the pancreas. [34] - Plans to initiate clinical trials next year. [35] Financial Position - **Cash Position**: - As of Q3, Immunocore holds $892 million in cash, indicating a strong financial position to support ongoing operations and R&D. [40] Upcoming Milestones - Key milestones for 2026 include: - Completion of the cutaneous melanoma trial with KIMMTRAK. - Data releases for HIV, PRAME, ovarian, and lung cancer programs. [38] Conclusion - Immunocore is positioned for significant growth with a robust pipeline and strong commercial performance of KIMMTRAK, alongside promising developments in PRAME and infectious disease programs. The company maintains a solid financial foundation to support its strategic initiatives. [41]

Core Insights - The article discusses the Phase 1 trial results of IMC-I109V, a bispecific T cell receptor designed to target HBV-infected hepatocytes, demonstrating a manageable safety profile and antiviral activity [1][2][3] Company Overview - Immunocore Holdings plc is a commercial-stage biotechnology company focused on developing immunomodulating medicines for cancer, infectious diseases, and autoimmune diseases [1][11] - The company is advancing clinical candidates aimed at achieving functional cures for HIV and hepatitis B virus (HBV) [10] Trial Details - The Phase 1 trial enrolled 20 participants, evaluating ascending doses of IMC-I109V (0.8 mcg, 2.4 mcg, 7 mcg, 20 mcg) administered as a single IV infusion [3][4] - Participants were assessed for safety, tolerability, pharmacokinetics, and pharmacodynamic activity up to week 4 [4] Efficacy Results - Dose-dependent decreases in serum HBsAg were observed, with reductions meeting the threshold of ≥ 0.2 log10 IU/ml in 4 individuals, indicating potential for resolving hepatitis B infection [5][6] - Consistent pharmacodynamic activity was noted at doses ≥ 7 mcg, with HBsAg levels typically reaching a nadir by day 8 [5] Safety Profile - Treatment-related adverse events were reported in 8 participants, primarily transient systemic symptoms, with ALT elevations resolving within 14 days [6][7] - One participant in the 20 mcg cohort experienced Grade 2 cytokine release syndrome, which resolved rapidly with treatment [7] Mechanism of Action - IMC-I109V is designed to recruit non-exhausted T cells to eliminate hepatocytes harboring HBV DNA, addressing HBV-specific T cell exhaustion [8] Future Directions - The company believes the initial evidence of HBsAg reduction supports further evaluation of IMC-I109V in multiple dose regimens [8]

Summary of Immunocore Holdings FY Conference Call Company Overview - **Company**: Immunocore Holdings (NasdaqGS:IMCR) - **Date of Conference**: September 10, 2025 Key Industry Insights - **Biotech Innovation in China**: China has made significant advancements in biotech, particularly in immunology and cell therapy. Immunocore views China as both a competitive threat and an opportunity for collaboration and innovation [2][2]. - **AI Integration**: Immunocore is leveraging AI to enhance business operations and R&D, particularly in T-cell receptor (TCR) target identification and clinical data analysis. AI is seen as essential for improving efficiency and accelerating drug discovery [3][4]. Regulatory Environment - **Regulatory Interactions**: The FDA's guidance is crucial for Immunocore's investment strategies and clinical trial developments. The company has not faced significant regulatory impacts recently but emphasizes the importance of clear regulatory guidance [5][6]. T-Cell Receptor (TCR) Platform - **Oncology and Autoimmune Applications**: Immunocore's TCR platform is designed to engage T-cells to target tumors and downregulate the immune system for autoimmune diseases. The platform allows for tissue-specific therapies, minimizing systemic immunosuppression [7][8]. - **KIMMTRAK**: The first approved TCR therapy, KIMMTRAK, has shown success in oncology, generating $192 million in the first half of the year with a 32% growth rate year-over-year. However, growth is expected to moderate as the product matures [11][12]. Market Penetration and Growth - **U.S. Market Penetration**: KIMMTRAK is approaching 70% penetration in the U.S., with potential for further growth, especially in community settings. Comparatively, European markets have achieved over 80% penetration [16][17]. - **International Expansion**: Immunocore is expanding KIMMTRAK's global access, having launched in 28 countries and entered distribution agreements in regions like MENA and Turkey [17][18]. Clinical Trials and Future Indications - **Advanced Melanoma Trials**: Immunocore is pursuing phase 3 trials for KIMMTRAK in advanced cutaneous melanoma, leveraging similarities with uveal melanoma. The company anticipates a significant commercial opportunity due to the larger patient population [20][30]. - **PRAME-targeted Portfolio**: The company is conducting a phase 3 study for a PRAME-targeted agent in combination with nivolumab, based on promising phase 1 results showing better disease control rates than existing therapies [34][35]. Financial Health and Strategy - **Robust Financial Position**: Immunocore has nearly $900 million in cash, allowing for continued investment in R&D and clinical trials without immediate concerns about cash flow [50][53]. - **Operational Discipline**: The company maintains a disciplined approach to operational expenses, with SG&A costs remaining stable while planning for incremental increases related to new product launches [50][51]. Pipeline and Future Outlook - **Autoimmune and Infectious Disease Programs**: Immunocore is advancing programs in autoimmune diseases, including type 1 diabetes and atopic dermatitis, with expected clinical trials starting in 2026 [45][46]. - **Long-term Growth Strategy**: The company aims to maximize KIMMTRAK's potential while continuing to innovate its platform for sustainable growth, focusing on both oncology and emerging therapeutic areas [54][55].

Summary of Immunocore Holdings plc Conference Call Company Overview - **Company**: Immunocore Holdings plc - **Key Product**: KIMMTRAK, the first approved T-cell receptor therapy demonstrating a survival benefit in solid tumors, specifically uveal melanoma [2][4] - **Market Position**: The company has a total enterprise value of approximately $1 billion, with KIMMTRAK achieving a $400 million run rate [4] Core Points and Arguments Product Development and Pipeline - **KIMMTRAK**: - Demonstrated a survival benefit in uveal melanoma, a type of melanoma where checkpoint inhibitors are ineffective [2] - Currently undergoing lifecycle management with two phase 3 trials [2] - Mean duration of therapy is reported at 13 months, exceeding clinical trial results [7] - The company is exploring further applications of its technology in oncology, HIV, HPV, and autoimmune diseases [3] - **Tevyam**: - A phase 3 trial for cutaneous melanoma is expected to enroll 2,000 to 4,000 patients, with data anticipated in 2026 [5][15] - The trial design includes patients who have progressed on PD-1 and other therapies, with overall survival as the primary endpoint [15][16] - **Brunetafusp PRAME**: - Aiming to combine with nivolumab in first-line cutaneous melanoma, with a focus on demonstrating superior efficacy compared to existing treatments [44][49] - The trial is designed to assess the combination's effectiveness against nivolumab monotherapy and nivolumab plus LAG3 [49] Commercial Strategy - **Market Opportunity**: - There is a high unmet need in the second-line cutaneous melanoma market, with KIMMTRAK positioned as a potentially first-line treatment option [27] - Approximately 50% of physicians treating cutaneous melanoma have experience with KIMMTRAK, which may facilitate its adoption [29] - **Exclusivity and Competition**: - The composition of matter patent for KIMMTRAK extends to 2030, with a filed extension to 2035 [10] - Anticipation of competition from newer therapies, but KIMMTRAK's established efficacy may provide a competitive edge [11] Financial Outlook - **Valuation Concerns**: - The company is perceived as undervalued despite strong performance metrics, with a focus on improving investor perception leading up to 2026 [4][5] - **Operational Goals**: - The company aims to maintain operations near break-even while advancing its pipeline and investing in growth [68] Additional Important Insights - **Real-World Evidence**: - The company plans to publish real-world evidence linking treatment beyond progression to overall survival, which may strengthen its market position [14] - **Patient Experience**: - Reports of patients remaining on KIMMTRAK for extended periods (up to seven years) suggest significant therapeutic benefits [7][12] - **Regulatory Considerations**: - The company is focused on obtaining NCCN listing and reimbursement strategies to ensure market access for new therapies [31] Conclusion Immunocore Holdings plc is positioned for significant growth with its innovative T-cell receptor therapies, particularly KIMMTRAK and upcoming products like Tevyam and brunetafusp PRAME. The company is navigating a competitive landscape while focusing on data-driven strategies to enhance its market presence and investor confidence leading into 2026.

Financial Performance - 1H 2025 KIMMTRAK net sales reached $192 million, a 32% year-over-year increase[10] - Q2 2025 KIMMTRAK net revenue was $98 million, including $641 million from the US and $33 million from Europe[19] - The company's cash position as of June 30, 2025, was $883 million[11] KIMMTRAK Market Expansion - KIMMTRAK is approved in 39 countries and launched in 28 countries[17] - US revenue for KIMMTRAK showed a 15% year-on-year quarterly growth[21] - European revenue for KIMMTRAK showed a 115% year-on-year quarterly growth[25] Pipeline Development - The company is advancing autoimmune candidates towards CTA/IND[10] - Phase 3 trials are ongoing for TEBE-AM, ATOM, and PRISM-MEL[10] - Phase 1/2 trials are ongoing for HIV and HBV infectious diseases trials[10] Clinical Trials - TEBE-AM Phase 3 trial in 2L+ cutaneous melanoma is expected to complete randomization in 1H 2026[35] - PRISM-MEL-301 Phase 3 trial for 1L advanced cutaneous melanoma is ongoing, with dose selection expected in 2H 2025[32] - ATOM Phase 3 trial is ongoing in adjuvant uveal melanoma[32]

Core Viewpoint - Immunocore Holdings plc is set to report its second quarter financial results on August 7, 2025, and will host a teleconference to discuss these results and provide a business update [1][2]. Company Overview - Immunocore is a commercial-stage biotechnology company focused on developing TCR bispecific immunotherapies, known as ImmTAX, aimed at treating various diseases including cancer, autoimmune diseases, and infectious diseases [4]. - The company's leading oncology product, KIMMTRAK, is approved for treating HLA-A*02:01-positive adult patients with unresectable or metastatic uveal melanoma in multiple regions including the US, EU, Canada, Australia, and the UK [4]. Upcoming Events - A live teleconference and webcast will occur on August 7, 2025, at 8:00 a.m. EDT to discuss the financial results and provide updates on the business and portfolio [2][3]. Contact Information - For inquiries, Immunocore's VP 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].

KIMMTRAK® - KIMMTRAK® is the global standard of care for HLA-A*02:01-positive patients with 1L mUM, expecting continued moderate growth in 2025[19, 23] - Q1 2025 net sales for KIMMTRAK® reached $94 million, including $6 million of one-time favorable adjustments[20, 23] - A Phase 3 trial (TEBE-AM) is underway for 2L+ advanced cutaneous melanoma, targeting an enrollment completion in 1H 2026, addressing a market opportunity of up to 4,000 patients[16, 27, 29] - The ATOM Phase 3 trial is designed for adjuvant uveal melanoma, targeting ~1,200 patients, with the first patient randomized in Q4 2024[16, 34, 35] - KIMMTRAK® has the potential to help up to 6,000 patients per year across various melanoma indications[36] PRAME Portfolio - Brenetafusp, targeting PRAME-A02, is in Phase 1/2 development for NSCLC and additional solid tumors[16] - Phase 3 PRISM-MEL-301 trial is randomizing for Cutaneous Melanoma[44] - In a Phase 1 ovarian cancer trial, 94% of monotherapy patients and 81% of chemo combination patients were PRAME positive[70, 72] Infectious Diseases - IMC-M113V3, targeting Gag-A02, is in Phase 1/2 development for Human Immunodeficiency Virus (HIV)[16] - There are 40 million people living with HIV (PLWH)[103] - Initial cohorts (n=16) of dose escalation presented at CROI 2025 showed IMC-M113V is well tolerated, with only low grade cytokine release syndrome[113, 114] Autoimmune Diseases - IMC-S118AI (PPI-A02 x PD1) for Type 1 Diabetes is expected to submit CTA/IND in 2H 2025[16, 133] - IMC-U120AI (CD1a x PD1) for Atopic Dermatitis is expected to submit CTA/IND in 2026[16] Financial Position - The company's Q1 2025 cash position is $837 million[150]

Core Insights - Immunocore Holdings plc is a commercial-stage biotechnology company focused on developing immunomodulating medicines for cancer, infectious diseases, and autoimmune diseases [1][3] - The company will participate in the 2025 Jefferies Global Healthcare Conference, indicating its ongoing engagement with investors and the healthcare community [1][2] Company Overview - Immunocore is pioneering a novel class of TCR bispecific immunotherapies known as ImmTAX, aimed at treating a wide range of diseases [3] - The company has a robust pipeline with multiple active clinical and pre-clinical programs across oncology, infectious diseases, and autoimmune diseases [3] - KIMMTRAK, Immunocore's leading oncology TCR therapeutic, is 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 [3]

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]