Executive Summary / Key Takeaways

• Immunocore reported net income of $5.0 million in Q1 2025, a significant turnaround from a net loss of $24.4 million in Q1 2024, driven by robust KIMMTRAK sales growth and disciplined expense management.
• KIMMTRAK, the company's lead product for metastatic uveal melanoma (mUM), continues its strong commercial trajectory, with Q1 2025 net revenue reaching $93.9 million (up 33.5% year-over-year), fueled by expansion in the U.S. community setting, increasing duration of therapy, and new international launches.
• The company is aggressively advancing a deep pipeline leveraging its ImmTAX platform across three therapeutic areas – oncology, infectious diseases, and autoimmune diseases – with three Phase 3 trials underway in melanoma and promising early data emerging from novel programs like the HIV functional cure candidate.
• Immunocore maintains a strong liquidity position with $837.0 million in cash and marketable securities as of March 31, 2025, expected to fund operations for at least twelve months, supporting significant planned R&D investments despite anticipated increases in expenses.
• Key catalysts include upcoming data readouts from the HIV program (initial MAD data presented Q1 2025, further data expected), dose selection for the PRAME Phase 3 trial (2H 2025), and potential data from the TEBE-AM Phase 3 trial (2H 2026), alongside continued global KIMMTRAK launches and progress in autoimmune candidates.

Immunocore's Platform Potential: Profitable Quarter Signals Pipeline Acceleration

Immunocore Holdings plc is a commercial-stage biotechnology company dedicated to pioneering transformative immunomodulating medicines. At its core lies the proprietary ImmTAX (Immune mobilizing monoclonal TCRs Against X disease) platform, a differentiated technology designed to redirect the immune system to target diseased cells with high precision. Unlike traditional antibody-based therapies that primarily target proteins on the cell surface, ImmTAX molecules are soluble T-cell receptor (TCR) bispecifics capable of recognizing intracellular antigens presented on the cell surface by HLA molecules. This capability unlocks a vast universe of potential targets previously inaccessible to conventional biologics, including cancer-specific proteins, viral antigens, and autoantigens.

The ImmTAX platform offers tangible benefits rooted in its unique mechanism. Preclinical data and clinical observations suggest the technology can target cells expressing very low levels of the target peptide-HLA complex, potentially down to 5-10 copies per cell, enabling efficacy against targets with limited surface expression. This ultra-high affinity and specificity are designed to minimize off-target effects while maximizing potency. The platform's ability to recruit and activate T cells, even in "cold" or poorly infiltrated tumors like uveal melanoma, represents a significant technological advantage. While precise, directly comparable quantitative metrics across all potential applications are still emerging, the strategic intent is clear: leverage this targeting precision for potentially higher efficacy and reduced systemic toxicity compared to less targeted approaches.

Immunocore's journey has evolved from a research-intensive organization, building its foundational technology and pipeline, to a commercial entity following the landmark approval of its lead product, KIMMTRAK (tebentafusp-tebn), for unresectable or metastatic uveal melanoma (mUM) in 2022. This success validated the ImmTAX platform and provided the crucial revenue stream necessary to fuel the company's ambitious pipeline expansion across multiple therapeutic areas.

KIMMTRAK: The Commercial Engine Driving Growth

KIMMTRAK's approval marked a turning point, establishing it as the first and only approved therapy for mUM and rapidly becoming the standard of care in launched territories. The commercial performance of KIMMTRAK has been robust, demonstrating consistent growth since launch. In the first quarter of 2025, net revenue from KIMMTRAK sales reached $93.9 million, a substantial 33.5% increase compared to $70.3 million in the same period of 2024. This growth was broadly distributed across key regions: U.S. revenue grew 13.2% to $56.6 million, Europe saw a significant 73.1% increase to $32.8 million, and International markets surged 227.7% to $4.5 million. The European growth in Q1 2025 included a $6.0 million net decrease in estimated reserves related to prior period sales, reflecting changes in estimates primarily due to European pricing negotiations. Partnered revenue, including sales through Medison Pharma Ltd., contributed $7.3 million in Q1 2025, up from $2.2 million in Q1 2024.

Management attributes this continued momentum to several key drivers. In the United States, growth is fueled by increasing penetration into the community setting, supported by initiatives like the AI-enabled patient finding tool designed to identify eligible patients in less dense areas. Furthermore, the duration of therapy is trending longer than observed in clinical trials, highlighting the sustained clinical benefit experienced by patients. New country launches outside the U.S., including recent additions like the UK and Poland, also contribute incrementally to global sales. While the cost of revenue from KIMMTRAK sales is currently minimal, it is expected to increase with volume and inflationary pressures, though not materially in the near term.

Expanding the Melanoma Franchise and Diversifying the Pipeline

Building on KIMMTRAK's success, Immunocore is strategically expanding its melanoma franchise and diversifying its pipeline across therapeutic areas, leveraging the versatility of the ImmTAX platform and its related technologies.

In melanoma, three Phase 3 trials are underway, aiming to significantly broaden the addressable patient population:

• TEBE-AM: A Phase 3 trial evaluating KIMMTRAK in second-line or later advanced cutaneous melanoma (CM) patients who have progressed on prior therapies. Enrollment is on track to finish in the first half of 2026, with data anticipated in the second half of 2026. This addresses a setting with significant unmet need post-checkpoint inhibitors, where patient survival is historically poor.
• ATOM: An EORTC-led Phase 3 trial assessing KIMMTRAK in the adjuvant setting for high-risk uveal melanoma patients after definitive local treatment. The first patient was enrolled in Q4 2024. This is the only ongoing registrational trial in this setting, aiming to delay or prevent metastatic recurrence.
• PRISM-MEL-301: A Phase 3 study of brenetafusp (IMC-F106C), the company's PRAME-targeted ImmTAC, in combination with nivolumab in previously untreated, HLA-A*02:01-positive metastatic CM. The first patient was randomized in Q1 2024. This trial is notable as the first Phase 3 evaluating a PRAME-targeted therapy and includes a control arm with a checkpoint doublet (nivolumab + relatlimab), positioning brenetafusp to potentially demonstrate superiority in this large first-line setting. Dose selection between the 40 mcg and 160 mcg regimens is expected in the second half of 2025 based on an interim review of the first 90 randomized patients.

Beyond melanoma, the PRAME franchise is being explored in other tumor types. Phase 1/2 combination cohorts are ongoing in ovarian carcinoma (platinum-resistant and platinum-sensitive settings) and lung cancer (signal detection in various subsets), with data expected over the next 12-18 months. The company also initiated a Phase 1 trial for IMC-P115C (PRAME-HLE-A02) in December 2024, a half-life extended version of the PRAME ImmTAC designed for less frequent dosing to improve patient convenience.

Further pipeline expansion includes IMC-R117C (PIWIL1), a first-in-class ImmTAC targeting PIWIL1, a novel antigen expressed in colorectal carcinoma (CRC) and other solid tumors. CRC has historically been insensitive to checkpoints, and PIWIL1's expression profile makes it an attractive target for the ImmTAX platform's ability to target immune-cold tumors. A Phase 1 dose escalation trial is underway.

Immunocore is also applying its technology to infectious diseases with the ImmTAV platform, aiming for functional cures. IMC-M113V is being evaluated in the Phase 1/2 STRIVE trial for HIV. Initial multiple ascending dose (MAD) data presented at CROI 2025 showed IMC-M113V was well tolerated with signals of dose-dependent viral control after ART interruption in some patients, alongside trends of reduction in the viral reservoir. Dose escalation is ongoing. A Phase 1 trial for IMC-I109V in Hepatitis B virus (HBV) is also progressing.

A third platform, ImmTAAI, is being developed for autoimmune diseases, focusing on tissue-specific immune down-modulation via tethered PD-1 agonists. The first candidate, IMC-S118AI (PPI x PD1), targeting pancreatic beta cells for Type 1 diabetes, is on track for CTA submission in 2025. The second, IMC-U120AI (CD1a x PD1), targeting CD1a on skin antigen-presenting cells for inflammatory dermatological diseases like atopic dermatitis, is universal (not HLA-restricted) and showed promising in vitro data compared to untethered PD-1 agonists. A CTA for IMC-U120AI is planned for 2026.

Financial Health and Outlook

Immunocore's financial position has strengthened, enabling significant investment in its expanding pipeline. The company reported net income of $5.0 million for the three months ended March 31, 2025, a marked improvement from a net loss of $24.4 million in the prior-year period. This turnaround was driven by the substantial increase in KIMMTRAK revenue, coupled with a smaller decrease in operating expenses (loss from operations was $3.6 million in Q1 2025 vs $26.5 million in Q1 2024).

As of March 31, 2025, Immunocore held $476.8 million in cash and cash equivalents and $360.2 million in marketable securities, totaling $837.0 million in liquid assets. This robust liquidity position is supported by prior financings, including the $402.5 million convertible senior notes offering completed in February 2024 (net proceeds $389.1 million), which also facilitated the repayment of the higher-interest Pharmakon loan in November 2024. Net cash provided by operating activities was positive at $0.4 million in Q1 2025, compared to cash used of $4.6 million in Q1 2024, reflecting improved revenue and cash collections.

Management expects existing cash, cash equivalents, and marketable securities, along with anticipated KIMMTRAK revenue, to fund operations and capital expenditures for at least twelve months from the filing date of the Q1 2025 report (May 7, 2025). However, R&D expenses are anticipated to increase relative to 2024 as the clinical and preclinical pipeline advances, particularly with the acceleration of Phase 3 trials and expansion cohorts. SG&A expenses are expected to remain largely consistent with Q4 2024 levels in 2025. The need for additional funding for long-term clinical development remains.

Competitive Landscape and Strategic Positioning

Immunocore operates within highly competitive landscapes in oncology, infectious diseases, and autoimmune disorders, facing established players with significant resources and market share. In oncology, major competitors like Merck (MRK), Bristol-Myers Squibb (BMY), and AstraZeneca (AZN) dominate the immunotherapy space, particularly with checkpoint inhibitors like Keytruda (MRK) and Opdivo (BMY). These companies benefit from vast scale, established global commercial infrastructures, and broad pipelines. For instance, MRK's 2023 revenue of $60.1 billion dwarfs IMCR's $310 million in 2024, reflecting a significant difference in operational scale and financial capacity.

Immunocore's competitive edge lies primarily in its differentiated ImmTAX platform. While competitors offer therapies targeting surface antigens, ImmTAX's ability to target intracellular antigens via TCRs provides access to a unique target space and potentially higher specificity. This technological advantage is crucial in niche markets like mUM, where KIMMTRAK is the first approved therapy, and in targeting antigens like PRAME or PIWIL1, which may be expressed in tumors historically less responsive to checkpoint inhibition, such as CRC. The company's strategy to pursue indications like 1L CM (PRISM-MEL-301 vs. checkpoint doublet) and 2L+ CM post-checkpoint (TEBE-AM) directly challenges established treatment paradigms, leveraging the potential for superior efficacy in specific patient populations.

In infectious diseases, Immunocore's pursuit of functional cures for HIV and HBV places it in competition with companies like Gilead Sciences (GILD), a leader in antiviral therapies. GILD's established drugs offer effective viral suppression but do not eliminate the viral reservoir or provide a functional cure. IMCR's ImmTAV platform, aiming to directly eliminate infected cells, represents a distinct approach, though it is still in early clinical stages compared to GILD's commercialized portfolio.

In autoimmune diseases, the ImmTAAI platform's focus on tissue-specific immune down-modulation contrasts with the systemic immunosuppression offered by many current standards of care. This targeted approach could offer a significant safety and tolerability advantage, representing a unique competitive angle if validated clinically.

Despite its technological differentiation, Immunocore faces vulnerabilities inherent to a smaller biotech, including higher per-unit R&D costs compared to large-scale manufacturing of established therapies and the need for significant future funding to advance its broad pipeline. The challenging European reimbursement environment also poses a commercial hurdle, requiring country-by-country negotiations that can impact revenue recognition and market access.

Risks and Challenges

Immunocore faces several key risks. The success of its pipeline hinges on positive clinical trial outcomes, which are inherently uncertain. Delays in trial enrollment, execution, or unexpected safety findings could significantly impact timelines and potential approvals. The company's ability to successfully commercialize KIMMTRAK globally depends on navigating complex reimbursement landscapes, particularly in Europe, where pricing negotiations can be protracted and outcomes uncertain, potentially impacting revenue forecasts. While liquidity is currently strong, the significant anticipated increase in R&D expenses means the company will require additional funding in the future, and the ability to raise capital on favorable terms may be influenced by macroeconomic conditions and market volatility. Manufacturing commitments and lease obligations also represent ongoing financial outlays. Competition from larger, more established companies with extensive resources and pipelines remains a constant factor, potentially impacting market share and pricing power for both existing and future products.

Conclusion

Immunocore's first quarter 2025 results, demonstrating a shift to net income driven by robust KIMMTRAK sales, underscore the company's successful transition to a commercial-stage entity. This financial strength, coupled with a solid liquidity position, provides a foundation to aggressively pursue the potential of its differentiated ImmTAX platform. With three Phase 3 trials underway in melanoma, promising early signals in infectious diseases, and the expansion into autoimmune disorders, Immunocore is building a broad and diversified pipeline targeting significant unmet needs. The company's technological edge in targeting intracellular antigens offers a unique competitive angle against larger players focused on traditional surface targets. While challenges remain, particularly in navigating complex reimbursement environments and the inherent risks of clinical development, upcoming data readouts and continued commercial execution position Immunocore as a compelling story centered on platform-driven value creation and pipeline acceleration.