Immunocore Q2 Financial Results and Business Update

Immunocore Holdings plc, a biotechnology firm specializing in immunomodulating medicines for cancer, infectious diseases, and autoimmune conditions, has reported its financial results for the second quarter ending June 30, 2024, alongside a comprehensive business update.

CEO Bahija Jallal highlighted the company’s ambitious plans for the next 18 months, including multiple data releases for brenetafusp and HIV MAD data, while progressing three Phase 3 trials with expected registrational data in 2026, 2027, and 2028. Additionally, Immunocore aims to advance its newly initiated autoimmune and oncology clinical and pre-clinical programs.

In the first half of 2024, Immunocore significantly expanded the reach of KIMMTRAK in the US and globally, achieving nine new launches and securing two additional reimbursement agreements in Europe. Chief Commercial Officer Ralph Torbay emphasized the potential of KIMMTRAK to benefit more patients beyond metastatic uveal melanoma (mUM) through ongoing Phase 3 registrational trials in previously treated cutaneous melanoma and adjuvant uveal melanoma.

Second Quarter 2024 Highlights

KIMMTRAK®:
KIMMTRAK, approved in 38 countries and launched in 19, remains the standard of care in mUM across most markets. The company has identified three key growth areas: continued global expansion in mUM, potential expansion into second-line (2L+) advanced cutaneous melanoma (CM), and adjuvant uveal melanoma.

In Q2 2024, KIMMTRAK’s net sales reached $75 million, with a six-month total of $146 million, marking increases of 32% and 34% compared to the same periods in the previous year. The growth was driven by increased penetration in the US community setting and extended treatment durations. Notably, reimbursement agreements were reached in Sweden and Poland, with expected launches in the second half of 2024.

Clinical Trials:
The Phase 2/3 TEBE-AM trial for previously treated cutaneous melanoma has transitioned into a registrational Phase 3 trial, comprising three arms: KIMMTRAK monotherapy, KIMMTRAK in combination with pembrolizumab, and a control. Enrollment is expected to complete in the first half of 2026.

The ATOM Phase 3 trial for adjuvant uveal melanoma, led by the European Organisation for Research and Treatment of Cancer (EORTC), is set to begin randomization in the latter half of 2024.

PRAME Franchise:
Brenetafusp (IMC-F106C) is undergoing evaluation in combination with nivolumab in a Phase 3 registrational trial (PRISM-MEL-301) for first-line advanced cutaneous melanoma (CM). The first patient was randomized in Q2 2024, with the trial comparing brenetafusp + nivolumab against control groups involving nivolumab with or without relatlimab.

Phase 1 data presented at ASCO 2024 indicated promising outcomes for brenetafusp monotherapy in late-line CM patients, with a disease control rate of 58% and median progression-free survival (PFS) of 4.2 months. Brenetafusp showed good tolerability both as monotherapy and in combination with anti-PD1 agents. Further data on high-grade serous ovarian cancer will be presented at ESMO 2024.

Oncology and Infectious Disease Candidates:
IMC-R117C, targeting colorectal and other gastrointestinal cancers, is set to begin a Phase 1 clinical trial in the second half of 2024. The trial application for IMC-P115C, a PRAME-A02 half-life extended candidate, was submitted in Q2 2024.

Two investigational candidates, IMC-M113V and IMC-I109V, are in Phase 1 trials for HIV and chronic Hepatitis B infection (HBV), respectively. These trials aim to achieve a "functional cure," defined as sustained control of HIV or HBV without ongoing medication.

Autoimmune Diseases:
Immunocore is extending its platform into autoimmune diseases with two new candidates. IMC-S118AI is advancing towards GMP manufacturing in 2024, targeting type 1 diabetes, while an undisclosed candidate addresses inflammatory dermatological diseases.

Financial Performance:
For the quarter ending June 30, 2024, Immunocore reported net product sales of $75.3 million, compared to $56.9 million in Q2 2023, driven by increased US sales and global expansion efforts. Research and development expenses rose to $51.1 million from $38.2 million the previous year, primarily due to the PRAME program. Selling, general, and administrative expenses also increased slightly.

The company reported a net loss of $11.6 million for Q2 2024, an improvement from the $17 million loss in Q2 2023. Cash, cash equivalents, and marketable securities totaled $859.6 million as of June 30, 2024, with plans to repay a $50 million loan by year-end and to address $40 million in sales-related rebate accruals in the latter half of the year.

Immunocore remains dedicated to leveraging its proprietary TCR technology to develop innovative treatments for cancer, infectious, and autoimmune diseases, with a robust pipeline of clinical and pre-clinical programs underway.

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