Company: IMCR
Filing Date: 2025-02-26
Form Type: 10-K
Source: 0001671927-25-000006
Chunk: 112

Company: Immunocore Holdings plc
Filing Date: 2025-02-26
Form: 10-K
Item: Item 1A
Chunk 112
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 safety, efficacy, manufacturing, or supply issues arise with, the drugs we choose to evaluate in combination with our or any product candidate we develop, the approval of our product candidates may be delayed and their value may be reduced, which may harm our business, financial condition and prospects.

If we do not achieve our projected development and commercialization goals within the timeframes we announce and expect, the commercialization of our product candidates or any future product candidates may be delayed, and our business will be harmed.

For planning purposes, we estimate the timing of achieving various scientific, clinical, regulatory, and other product development objectives. These milestones may include our expectations regarding the commencement or completion of scientific studies and clinical trials, regulatory submissions or commercialization objectives. From time to time, we may publicly announce the expected timing of some of these milestones, such as the submission of a CTA or IND application, completion of an ongoing clinical trial, the initiation of clinical trials, announcement of trial data, receipt of regulatory approval, or the commercial launch of a product. The achievement of many of these milestones may be affected by factors outside of our control. All of these milestones are based on a variety of assumptions, which may cause the timing of achieving the milestones to vary considerably from our estimates, including:

•our available capital resources or capital constraints we experience;

•the rate of progress, costs, and results of our clinical trials and research and development activities, including the extent of scheduling conflicts with participating clinicians and collaborators;

•our ability to identify and enroll patients who meet clinical trial eligibility criteria;

•our receipt of approvals by the FDA, European Commission and comparable foreign regulatory authorities, and the timing thereof;

•other actions, decisions, or rules issued by regulators;

•our ability to access sufficient, reliable, and affordable supplies of materials used in the manufacture of our product candidates;

•our ability to manufacture and supply clinical trial materials to our clinical sites on a timely basis;

•the efforts of our collaborators with respect to the commercialization of our approved products, if any; and

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•the securing of, costs related to, and timing issues associated with, commercial product manufacturing, as well as sales and marketing activities.

If we fail to achieve announced milestones in the timeframes we expect, the commercialization of our lead product candidate and any other current or future product candidates may be delayed, and our business, results of operations, financial condition, and prospects may be adversely affected.