Company: IMCR
Filing Date: 2025-11-06
Form Type: 10-Q
Source: 0001671927-25-000018
Chunk: 108

Company: Immunocore Holdings plc
Filing Date: 2025-11-06
Form: 10-Q
Item: Part I, Item 8
Chunk 108
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 worsening macroeconomic conditions, such as supply chain disruptions, fluctuations in interest rates and volatility in the capital markets. If we fail to raise capital or enter into such arrangements as, and when, needed, we may have to significantly delay, scale back or discontinue the development and commercialization of one or more of our programs.

Because of the numerous risks and uncertainties associated with pharmaceutical development, we are unable to predict the timing or amount of future revenues, increased expenses or when or if we will be able to achieve or maintain profitability. If we fail to become profitable or are unable to sustain profitability on a continuing basis, then we may be unable to continue our operations at planned levels and may be forced to reduce our operations.

Recent Developments

The Independent Data Monitoring Committee ("IDMC") has recommended the dose of 160 mcg as the go-forward dose in PRISM-MEL-301, our registrational Phase 3 trial in first-line, advanced cutaneous melanoma. The IDMC made the decision following a pre-planned review of safety for all three arms and of efficacy for the two brenetafusp regimens (40 mcg and 160 mcg) in the first 90 patients randomized in the Phase 3 trial. Patients treated with the dose of 160 mcg will be included in the intent-to-treat analysis for the primary endpoint. Patients who are receiving 40 mcg have the option to dose-escalate to 160 mcg, but will not be included in the intent-to-treat analysis for the primary endpoint. We will now continue with a 1:1 randomization of HLA-A*02:01 positive, first-line, advanced or metastatic cutaneous melanoma patients to brenetafusp 160 mcg + nivolumab or a control arm of either nivolumab or nivolumab + relatlimab.

We will present a poster, entitled "IMC-I109V, a soluble T cell receptor (TCR) bispecific targeting HBsAg (ENVxCD3), is tolerable and active against hepatitis B in a first-in-human (FIH) single ascending dose (SAD) study" (Poster 1185), at the 2025 American Association for the Study of Liver Diseases’ Meeting on November 7, 2025.

Components of Results of Operations

Revenue

Revenue from sale of therapies, net

Revenue from sale of therapies, net relates to the sale of KIMMTRAK following marketing approval. We