Company: NCNA
Filing Date: 2025-03-20
Form Type: 20-F
Source: 0000950170-25-042709
Chunk: 7

Company: NuCana plc
Filing Date: 2025-03-20
Form: 20-F
Item: Item 3
Chunk 7
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 applicable regulatory authorities may require development of a risk evaluation and mitigation strategy, or REMS, as a condition of approval;
 •the applicable regulatory authorities may change its approval policies or adopt new regulations;
 •the applicable regulatory authorities may identify deficiencies in our formulation and manufacturing processes or facilities of our third-party manufacturers;
 •we may face delays in our formulation and manufacturing process as a result of having not yet optimized formulations or due to lack of availability of starting materials;
 •we may be unable to scale up the manufacture process for some of our product candidates;
 

•we may face challenges on the safe and appropriate administration of our drugs in the clinic, including with respect to the conversion of our product candidates from a dry powder formulation to a liquid formulation prior to intravenous, or IV, administration, precipitation or other blockages in IV infusion lines, and the handling and storage of the IV infusion bags containing our product candidates, any of which may result in the need to carry out additional studies on the administration and compatibility of our product candidates with infusion sets and pumps;
 •we may be faced with challenges from third parties with respect to our right to use certain processes used in the formulation and process development of our product candidates;
 •we may have to defend our patents against infringement by third parties;
 •we may unknowingly infringe third-party patents;
 •we may face a “freedom to operate” issue;
 •we are dependent on the efforts of third parties in completing clinical trials of, receiving regulatory approval for and commercializing, any product candidate we license to such third parties;
 •through our clinical trials, we may discover factors that limit the commercial viability of the product candidate or make its commercialization unfeasible;
 •we may not be successful in completing preclinical studies and clinical trials of, receiving marketing approvals for, establishing commercial manufacturing capabilities for and commercializing, any product candidate to which we retain rights under a collaboration agreement; and
 •we may not be successful in gaining acceptance of any product candidate by patients, the medical community and third-party payors, effectively competing with other therapies, maintaining a continued acceptable safety profile following approval and qualifying for, maintaining, enforcing and defending our intellectual property rights and claims.
 With respect to each of NUC-7738 and NUC-3373, if we or our suppliers, as applicable, do not overcome one or more of these factors in a timely manner or at all, we could experience significant delays or an inability to successfully commercialize that product candidate.
 We cannot be certain that NUC-7738 or N