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

Company: NuCana plc
Filing Date: 2025-03-20
Form: 20-F
Item: Item 3
Chunk 25
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 NUC-7738 is currently being evaluated in the Phase 2 part of a Phase 1/2 clinical trial (NuTide:701) which is evaluating NUC-7738 as a monotherapy in patients with advanced solid tumors and in combination with the PD-1 inhibitor pembrolizumab in patients with melanoma. While favorable results were obtained from the Phase 1 part of the Phase 1/2 clinical trial (NuTide:701), they may not be replicated in any ongoing or future clinical trials. NUC-3373 is currently being evaluated in a Phase 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. While favorable results were obtained from our Phase 1 clinical trial of NUC-3373 in patients with advanced solid tumors, our ongoing Phase 1b/2 modular clinical trial of NUC-3373 may not be replicated in any future clinical trials. As an example, our Phase 1b/2 clinical trial of NUC-3373 in patients with metastatic colorectal cancer and our Phase 2 randomized NuTide:323 clinical trial investigating NUFIRI + bevacizumab versus the global standard of care, 5-FU in combination with leucovorin, irinotecan and bevacizumab, or FOLFIRI + bevacizumab, were discontinued despite the favorable Phase 1 results of NUC-3373. In addition, data generated in early-stage trials in particular are not the basis on which marketing approval by the FDA or a comparable foreign regulatory authority would be sought. Furthermore, the results of our clinical trials may not meet the level of statistical significance required by the FDA or comparable foreign regulatory authorities for marketing approval. Statistical significance means that an effect is unlikely to have occurred by chance. Clinical trial results are considered statistically significant when the probability of the results occurring by chance, rather than from the efficacy of the product candidate, is sufficiently low. There can be no assurance that any of our clinical trials will ultimately be successful or support further clinical development of any of our product candidates. There is a high failure rate for drugs proceeding through clinical trials. A number of companies in the pharmaceutical and biotechnology industries have suffered significant setbacks in clinical development even after achieving promising results in earlier studies.
 Preliminary