NUC-7738 Demonstrates Clinical Activity and Favorable Safety in Patients with PD-1 Inhibitor-Resistant Melanoma
Final Data from Phase 2 Expansion Study of NUC-7738 Expected in 2026
Advancing Additional Indications and Combination Strategies
Cash Runway Expected to Extend into 2029
EDINBURGH, United Kingdom, March 19, 2026 (GLOBE NEWSWIRE) -- NuCana plc $(NCNA)$ ("NuCana" or the "Company") today announced financial results for the fourth quarter and year ended December 31, 2025 and provided an update on its clinical development program with its two lead anti-cancer medicines.
"We are excited to enter 2026 with significant momentum as we continue to advance the development of our ProTide pipeline with the aim to deliver significantly improved treatment outcomes for patients with cancer," said Hugh S. Griffith, NuCana's Chief Executive Officer. "In late 2025, we presented compelling data from our Phase 2 NuTide:701 study at the annual European Society for Medical Oncology Immuno-Oncology Congress, evaluating NUC-7738 in combination with pembrolizumab in patients with PD-1 inhibitor-resistant metastatic melanoma. These data demonstrated a favorable safety profile and evidence of clinical activity, including two partial responses, one of which was confirmed, and multiple cases of stable disease, including one patient whose disease converted to a complete metabolic response with no detectable active disease."
Mr. Griffith continued, "We expect to complete enrollment in the Phase 2 NuTide:701 expansion study in the first half of 2026, with final data expected later this year. We also plan to obtain regulatory guidance from the U.S. Food and Drug Administration regarding a potential registrational pathway for NUC-7738 in melanoma. In parallel, we are evaluating additional indications and combination strategies to further explore the therapeutic potential of NUC-7738."
Mr. Griffith concluded, "Earlier this year we appointed Theresa Bruce as our Chief Operating Officer. Ms. Bruce brings over 25 years of oncology research and development experience, and her operational leadership will support the continued advancement of our pipeline. Based on our current operating plan, we expect our existing cash resources to fund operations into 2029, positioning us to execute on our key anticipated clinical and regulatory objectives."
2026 Anticipated Milestones
-- NUC-7738
-- Complete patient recruitment in the Phase 2 expansion study
(NuTide:701) evaluating NUC-7738 in combination with pembrolizumab
in patients with PD-1 resistant melanoma;
-- Announce final data from the Phase 2 expansion study (NuTide:701)
of NUC-7738 in combination with pembrolizumab in patients with
PD-1 resistant melanoma;
-- Obtain regulatory guidance from the U.S. Food and Drug
Administration regarding a potential registrational strategy for
NUC-7738 in melanoma; and
-- Advance evaluation of additional indications and combination
strategies.
-- NUC-3373
-- Evaluate optimal combinations and indications to inform potential
future clinical studies of NUC-3373.
Fourth Quarter and Year-End 2025 Financial Highlights and Cash Position
As at December 31, 2025, NuCana had cash and cash equivalents of GBP24.3 million compared to GBP25.2 million at September 30, 2025 and GBP6.7 million at December 31, 2024.
In May 2025, NuCana completed a financing, raising GBP9.6 million in gross proceeds, GBP5.2 million upfront and GBP4.4 million from the exercise of warrants, before expenses and commissions.
Subsequently, in July 2025, NuCana raised, through the at-the-market program, GBP19.0 million in gross proceeds before expenses and commissions. 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 December 31, 2025 will be sufficient to fund its planned operations into 2029.
NuCana reported a net loss of GBP2.5 million for the quarter ended December 31, 2025, as compared to a net loss of GBP0.7 million for the quarter ended December 31, 2024. Basic and diluted loss per ordinary share was GBP0.00 for the quarter ended December 31, 2025, as compared to a loss per ordinary share of GBP0.01 for the comparable quarter ended December 31, 2024.
NuCana reported a net loss of GBP29.4 million for the year ended December 31, 2025, as compared to a net loss of GBP19.0 million for the year ended December 31, 2024. The net loss for the year ended December 31, 2025 included the following non-cash or non-recurring items:
-- Finance expense of GBP12.6 million (2024: GBPnil) relating to the
non-cash loss on fair value revaluation of the warrants issued in the May
2025 financing;
-- Professional fees of GBP1.4 million (2024: GBPnil) related to the issue
of warrants; and
-- Share-based payment expenses of GBP10.0 million (2024: GBP1.6 million);
partly offset by
-- Total other income of GBP2.7 million (2024: GBPnil).
Basic and diluted loss per ordinary share was GBP0.00 for the year ended December 31, 2025, as compared to a loss per ordinary share of GBP0.26 for the year ended December 31, 2024.
About NuCana
NuCana is a clinical-stage biopharmaceutical company focused on significantly improving treatment outcomes for patients with cancer by applying our ProTide technology to transform some of the most widely prescribed chemotherapy agents, nucleoside analogs, into more effective and safer medicines. While these conventional agents remain part of the standard of care for the treatment of many solid and hematological tumors, they have significant shortcomings that limit their efficacy and they are often poorly tolerated. Utilizing our proprietary technology, we are developing new medicines, ProTides, designed to overcome the key limitations of nucleoside analogs and generate much higher concentrations of anti-cancer metabolites in cancer cells. NuCana's pipeline includes NUC-7738 and NUC-3373. NUC-7738 is a novel anti-cancer agent that disrupts RNA polyadenylation, profoundly impacts gene expression in cancer cells and targets multiple aspects of the tumor microenvironment. NUC-7738 is in the Phase 2 part of a Phase 1/2 study which is evaluating NUC-7738 as a monotherapy in patients with advanced solid tumors and in combination with pembrolizumab in patients with melanoma. NUC-3373 is a targeted thymidylate synthase ("TS") inhibitor designed to overcome key pharmacological limitations associated with other TS inhibitors. NUC-3373 has recently been evaluated in a Phase 1b/2 modular study (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, and NuCana is currently evaluating further characterization of mode of action and target indications for further clinical studies of NUC-3373.
Forward-Looking Statements
This press release may contain "forward-looking" statements within the meaning of the Private Securities Litigation Reform Act of 1995 that are based on the beliefs and assumptions and on information currently available to management of the Company. All statements other than statements of historical fact contained in this press release are forward-looking statements, including statements concerning the Company's planned and ongoing clinical studies for the Company's product candidates and the potential advantages of those product candidates, including NUC-7738 and NUC-3373; the initiation, enrollment, timing, progress, release of data from and results of those planned and ongoing clinical studies; the Company's goals with respect to the development, regulatory pathway and potential use, if approved, of each of its product candidates; the utility of prior non-clinical and clinical data in determining future clinical results; and the sufficiency of the Company's current cash and cash equivalents to fund its planned operations into 2029. In some cases, you can identify forward-looking statements by terminology such as "may," "will," "should," "expects," "plans," "anticipates," "believes," "estimates," "predicts," "potential" or "continue" or the negative of these terms or other comparable terminology. Forward-looking statements involve known and unknown risks, uncertainties and other factors that may cause the Company's actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements. These risks and uncertainties include, but are not limited to, our ability to raise additional capital sufficient to fund our planned operations and the risks and uncertainties set forth in the "Risk Factors" section of the Company's Annual Report on Form 20-F for the year ended December 31, 2025 filed with the Securities and Exchange Commission ("SEC") on March 19, 2026, and subsequent reports that the Company files with the SEC. Forward-looking statements represent the Company's beliefs and assumptions only as of the date of this press release. Although the Company believes that the expectations reflected in the forward-looking statements are reasonable, it cannot guarantee future results, levels of activity, performance or achievements. Except as required by law, the Company assumes no obligation to publicly update any forward-looking statements for any reason after the date of this press release to conform any of the forward-looking statements to actual results or to changes in its expectations.
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