Company: IMCR
Filing Date: 2025-02-26
Form Type: 10-K
Source: 0001671927-25-000006
Chunk: 96

Company: Immunocore Holdings plc
Filing Date: 2025-02-26
Form: 10-K
Item: Item 1A
Chunk 96
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 product candidates are approved;

•physicians, hospitals, cancer treatment centers, and patients considering our product candidates as a safe and effective treatment;

•hospitals and cancer treatment centers establishing the infrastructure required for the administration of the product candidate;

•the potential and perceived advantages of our product candidates over alternative treatments;

•the prevalence and severity of any side effects, including cytokine release syndrome ("CRS"), for which KIMMTRAK has a boxed warning recommending at least 16 hours of patient monitoring after each of the first three infusions, and as clinically indicated thereafter;

•product labeling or product insert requirements of the FDA, the European Commission or other regulatory authorities;

•limitations or warnings contained in the labeling approved by the FDA or the European Commission ;

•the timing of market introduction of our product candidates compared to competitive products;

•the cost of treatment in relation to alternative treatments;

•the amount of upfront costs or training required for physicians to administer our product candidates;

•the pricing of our products and the availability of coverage and adequate reimbursement by third-party payors and government authorities;

•the willingness of patients to pay out-of-pocket in the absence of comprehensive coverage and adequate reimbursement by third-party payors and government authorities;

•relative convenience and ease of administration, including as compared to alternative treatments and competitive therapies; and

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•the effectiveness of our sales and marketing efforts and distribution support.

Our efforts to educate physicians, patients, third-party payors and others in the medical community on the benefits of our products, if approved, may require significant resources and may never be successful. Such efforts may require more resources than are typically required due to the complexity and uniqueness of our product candidates. Even if our products achieve market acceptance, we may not be able to maintain that market acceptance over time, including if new products or technologies are introduced that are more favorably received than our products, are more cost effective or render our products obsolete. Because we expect sales of KIMMTRAK and our other product candidates, if approved, to generate substantially all of our revenue for the foreseeable future, the failure of our product candidates to find or maintain market acceptance would harm our business and could require us to seek additional financing.

We may be unable to successfully complete additional large-scale, pivotal clinical trials for any product candidates we develop after KIMMTRAK in mUM.

We may be unable to successfully complete