Company: NCNA
Filing Date: 2025-03-20
Form Type: 20-F
Source: 0000950170-25-042709
Chunk: 27

Company: NuCana plc
Filing Date: 2025-03-20
Form: 20-F
Item: Item 3
Chunk 27
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 1b/2 modular clinical trial (NuTide:303) of NUC-3373 in combination with the PD-1 inhibitor pembrolizumab for patients with advanced solid tumors and in combination with

docetaxel for patients with lung cancer is ongoing. We currently do not generate any revenues from sales of any products, and we may never be able to develop or commercialize a marketable drug. Each of our product candidates will require development, management of development and manufacturing activities, marketing approval in multiple jurisdictions, obtaining manufacturing supply, building of a commercial organization, substantial investment and significant marketing efforts before we generate any revenues from drug sales.
 We have not yet demonstrated an ability to successfully overcome many of the risks and uncertainties frequently encountered by companies in new and rapidly evolving fields, particularly in the biopharmaceutical area. For example, to execute our business plan, we will need to successfully:
 •execute development activities for our product candidates, including successful enrollment in and completion of clinical trials;
 •manage our spending as costs and expenses increase due to preclinical development, clinical trials, marketing approvals and commercialization;
 •obtain required marketing approvals for the development and commercialization of our product candidates;
 •obtain and maintain patent and trade secret protection and regulatory exclusivity for our product candidates and ensure that we do not infringe the valid patent rights of third parties;
 •protect, leverage and expand our intellectual property portfolio;
 •establish and maintain clinical and commercial manufacturing capabilities or make arrangements with third-party manufacturers for clinical and commercial manufacturing;
 •build and maintain robust sales, distribution and marketing capabilities, either on our own or in collaboration with strategic partners, if our product candidates are approved;
 •gain acceptance for our product candidates, if approved, by patients, the medical community and third-party payors;
 •compete effectively with other therapies;
 •obtain and maintain healthcare coverage and adequate reimbursement;
 •maintain a continued acceptable safety profile for our product candidates following approval, if approved; and
 •develop and maintain any strategic relationships we elect to enter into, if any.
 If we do not achieve one or more of these factors in a timely manner or at all, we could experience significant delays or an inability to successfully commercialize our product candidates, which would harm our business. If we do not receive marketing approvals for our product candidates, we may not be able to continue our operations.
 If we experience delays or difficulties in the enrollment of patients in clinical trials, development of our product candidates may be delayed or prevented.
 Identifying and qualifying