Company: IMCR
Filing Date: 2025-02-26
Form Type: 10-K
Source: 0001671927-25-000006
Chunk: 84

Company: Immunocore Holdings plc
Filing Date: 2025-02-26
Form: 10-K
Item: Item 1A
Chunk 84
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 to quarter and year to year. We anticipate that our expenses will increase substantially if, and as, we:

•further commercialize KIMMTRAK and any future product candidate for which we may obtain marketing approval in the United States and expanded territories and countries;

•continue our ongoing and planned development of our clinical stage programs and our preclinical pipeline assets;

•initiate pre-clinical studies and clinical trials for any additional product candidates that we may pursue in the future;

•seek regulatory approvals for our existing and potential future product candidates that successfully complete clinical trials;

•build a portfolio of product candidates through the discovery, development, or acquisition or in-license of drugs, product candidates or technologies;

•maintain, protect, enforce and expand our intellectual property portfolio;

•acquire or in-license other product candidates, intellectual property and technologies;

•hire additional clinical, regulatory, scientific and sales and marketing personnel;

•add operational, financial and management information systems and personnel, including personnel to support commercial development of KIMMTRAK, our product development and planned future commercialization efforts of existing and future product candidates; and

•incur additional legal, accounting and other expenses associated with operating as a public company.

To become and remain profitable, we must succeed in developing and commercializing KIMMTRAK in additional countries and indications, and other products that generate significant revenue. This will require us to be successful in a range of challenging activities, including continuing to market and sell KIMMTRAK and any future products for which we may obtain regulatory approval, our global regulatory submissions for any existing or future product candidates that we may pursue, obtaining regulatory approval, procuring commercial-scale manufacturing, as well as discovering or acquiring and then developing additional product candidates. We may never succeed in these activities and, even if we do, may never generate revenues that are significant enough to achieve profitability.

Because of the numerous risks and uncertainties associated with drug development, we are unable to accurately predict the timing or amount of expenses or when, or if, we will be able to achieve profitability. Our expenses could increase beyond our expectations if we are required by the FDA, the EMA, or other regulatory authorities to perform studies in addition to those we currently expect, if issues associated with KIMMTRAK arise following regulatory approval, or if there are any delays in the initiation and completion of our clinical trials or the development of tebentafusp or any future product candidates