Company: IMCR
Filing Date: 2025-02-26
Form Type: 10-K
Source: 0001671927-25-000006
Chunk: 237

Company: Immunocore Holdings plc
Filing Date: 2025-02-26
Form: 10-K
Item: Item 7
Chunk 237
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 of many factors, including:

•the progress, timing, scope and costs of our clinical trials, including the ability to timely initiate clinical sites, enroll subjects and manufacture soluble bispecific TCR product candidates for our ongoing, planned and potential future clinical trials;

•the time and costs required to perform R&D to identify and characterize new product candidates from our research programs;

•the time and cost necessary to obtain regulatory authorizations and approvals that may be required by regulatory authorities to execute clinical trials or commercialize our products;

•the amount of sales and other revenues from KIMMTRAK in the United States, Europe, and other regions, if approved;

•our ability to successfully commercialize our other product candidates;

•our ability to have clinical and commercial products successfully manufactured consistent with FDA, regulations of the EU and other authorities’ regulations;

•the amount of sales and other revenues from product candidates that we may commercialize, if any, including the selling prices for such potential products and the availability of adequate third-party coverage and reimbursement for patients;

•the sales and marketing costs associated with commercializing our products, if approved, including the cost and timing of building our marketing and sales capabilities;

•the cost of building, staffing and validating our manufacturing processes, which may include capital expenditure;

•the continued costs of operating as a public company;

•the time and cost necessary to respond to technological, regulatory, political and market developments;

•the costs of filing, prosecuting, defending and enforcing any patent claims and other intellectual property rights;

•the costs, associated with, and terms and timing of, any future any potential acquisitions, strategic collaborations, licensing agreements or other arrangements that we may establish; and

•the inability of clinical sites to enroll patients as healthcare capacities are required to cope with natural disasters, epidemics or other health system emergencies.

A change in the outcome of any of these or other variables with respect to the development of any of our current and future product candidates could significantly change the costs and timing associated with the development and commercialization of that product candidate. Furthermore, our operating plans may change in the future, and we may need additional funds to meet operational needs and capital requirements associated with such operating plans.

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Until we can generate sufficient revenue to finance our cash requirements, which we may never do, we expect to finance our future cash needs through a combination of public or private equity offerings, debt financ