On November 13, 2025 NuCana plc (NASDAQ: NCNA) ("NuCana" or the "Company") reported financial results for the third quarter ended September 30, 2025 and provided an update on its clinical development program with its two lead anti-cancer medicines.

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"We recently announced promising data for both NUC-7738 and NUC-3373 that continue to support the potential of our ProTides to deliver significantly improved treatment outcomes for patients with cancer," said Hugh S. Griffith, NuCana’s Chief Executive Officer. "For NUC-7738, we presented new data at the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Congress 2025 on NUC-7738 in combination with PD-1 inhibitors in a real-time organoid model system, which revealed that NUC-7738 enhances the effectiveness of PD-1 inhibitors, resulting in increased tumor cell killing. These data demonstrate the benefit of combining PD-1 inhibitors with NUC-7738, similar to that seen in patients on the ongoing NuTide:701 study. Based on the exciting initial data from this study, we are currently recruiting an additional 28 patients with PD-1 inhibitor-resistant melanoma and plan to meet with the U.S. Food and Drug Administration to discuss the data from this study to determine the optimal registration strategy to support potential marketing approval."

Mr. Griffith continued, "We also presented new clinical data from the NuTide:303 study, where encouraging signals of durable activity were observed in patients treated with NUC-3373 plus pembrolizumab who had exhausted all standard treatment options, including prior PD-1 inhibitors. Notably, one patient with melanoma remains progression-free at 23 months and continues to exhibit a partial response with an 81% reduction in target lesions. Another patient with urothelial carcinoma of the bladder achieved a 100% reduction in their target lesions and remained on treatment for over 15 months. These clinical findings are further supported by nonclinical data published in September 2025, which corroborate the immunogenic effects of NUC-3373 observed in patients, particularly in combination with a PD-1 inhibitor. We are currently evaluating optimal combinations and indications for further clinical studies of NUC-3373, while continuing to maintain our anticipated cash runway into 2029."

Mr. Griffith concluded, "Lastly, we have significantly strengthened our balance sheet via the strategic utilization of our at-the-market ("ATM") program in July, extending our cash runway into 2029 and through key value-driving milestones. This initiative, together with the financing in May, raised gross proceeds of $38.4 million, and with multiple data readouts ahead, we are well-positioned to deliver on our mission of improving treatment outcomes for patients with cancer."

Anticipated Milestones

NUC-7738

Announce initial data from the Phase 1/2 expansion study (NuTide:701) of NUC-7738 in combination with pembrolizumab in Q4 2025

Obtain regulatory guidance from the U.S. Food and Drug Administration on pivotal study design for NUC-7738 in melanoma in 2026; and

Announce final data from the Phase 1/2 expansion study (NuTide:701) of NUC-7738 in combination with pembrolizumab in 2026.

NUC-3373

Announce nonclinical data on further characterization of mode of action and target indications in 2026.

Third Quarter 2025 Financial Highlights and Cash Position

As of September 30, 2025, NuCana had cash and cash equivalents of £25.2 million compared to £8.4 million at June 30, 2025 and £6.7 million at December 31, 2024.

In July 2025, NuCana raised, through the ATM program, £19.0 million in gross proceeds before expenses and commission. On July 21, 2025, having raised the full amount of capital required, NuCana announced it had successfully canceled all remaining Series A Warrants issued in the May 2025 financing, in exchange for payments totaling $3.6 million. This initiative fully eliminated all overhanging rights from the May 2025 financing.

NuCana anticipates its cash and cash equivalents at September 30, 2025 will be sufficient to fund its planned operations into 2029.

NuCana reported a net loss of £0.3 million for the quarter ended September 30, 2025, which includes other income of £2.7 million, as compared to a net loss of £4.5 million for the quarter ended September 30, 2024. Basic and diluted loss per ordinary share was £0.00 for the quarter ended September 30, 2025, as compared to a loss per ordinary share of £0.07 for the comparable quarter ended September 30, 2024.

NuCana reported a net loss of £26.9 million for the nine months ended September 30, 2025, as compared to a net loss of £18.3 million for the nine months ended September 30, 2024. The net loss for the nine months ended September 30, 2025 included the following non-cash or non-recurring items:

Finance expense of £12.6 million (2024: £nil) relating to the non-cash loss on fair value revaluation of the warrants issued in the May 2025 financing;

Professional fees of £1.4 million (2024: £nil) related to the issue of warrants; and

Share-based payment expenses of £9.1 million (2024: £1.7 million); partly offset by

Other income of £2.7 million (2024: £nil).

Basic and diluted loss per ordinary share was £0.00 for the nine months ended September 30, 2025, as compared to a loss per ordinary share of £0.32 for the comparable nine months ended September 30, 2024.

(Press release, Nucana, NOV 13, 2025, View Source [SID1234659909])