NCNA

Final Data from Phase 2 Expansion Study of NUC-7738 Expected in 2026 NUC-7738 Receives FDA IND Clearance: Planned Initial Studies to Focus on Melanoma Advancing Additional Indications and Combination Strategies Cash Runway Expected to Extend into 2029 EDINBURGH, United Kingdom, May 14, 2026 (GLOBE NEWSWIRE) -- NuCana plc (NASDAQ: NCNA) (“NuCana” or the “Company”) today announced financial results for the first quarter ended March 31, 2026 and provided an update on its clinical development program with its two lead anti-cancer medicines. "We are pleased to report continued progress in the first quarter of 2026 as NUC-7738 advances towards important clinical and regulatory milestones," said Hugh S. Griffith, NuCana's Founder and Chief Executive Officer. "During the quarter, we continued to advance enrollment for our Phase 2 NuTide:701 expansion study evaluating NUC-7738 in combination with Keytruda® (pembrolizumab) in patients with PD-1 inhibitor-resistant metastatic melanoma. The clinical activity and favorable safety profile previously reported, including confirmed objective responses and prolonged disease control, continue to support the therapeutic potential of NUC-7738 in this patient population, and we look forward to reporting final data from this study, which is expected later in 2026." "We are also delighted to announce that the U.S. Food and Drug Administration (the “FDA”) cleared our Investigational New Drug application (“IND”) for NUC-7738 in April 2026. This important milestone enables clinical investigation of NUC-7738 in the United States and we expect our initial focus will be in patients with melanoma. We look forward to advancing our dialogue with the FDA to determine the optimal pathway toward a potential registrational strategy for NUC-7738 in melanoma." Mr. Griffith continued, "Beyond our near-term, anticipated milestones in melanoma, we are actively exploring opportunities to broaden the clinical utility of NUC-7738 through additional indications and combination strategies. The mechanism of action of NUC-7738, disrupting RNA polyadenylation and targeting multiple aspects of the tumor microenvironment, positions it as a potentially versatile agent across a range of tumor types, and we are encouraged by the scientific rationale supporting its evaluation in new settings. We believe these efforts have the potential to significantly expand the...

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 (NASDAQ: 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 Comp...

Announced Encouraging Data on both NUC-7738 and NUC-3373 Initial Data from the Expansion Study of NUC-7738 Expected in Q4 2025 with Final Data Expected in 2026 Compliant with All Nasdaq Continued Listing Criteria Well Capitalized with Anticipated Cash Runway into 2029 EDINBURGH, United Kingdom, Nov. 13, 2025 (GLOBE NEWSWIRE) -- NuCana plc (NASDAQ: NCNA) (“NuCana” or the “Company”) announced 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. “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) 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 wit...

First Patients Dosed on Expansion Study of NUC-7738 in Combination with Pembrolizumab for Patients with PD-1 Inhibitor-Resistant Melanoma Initial Data from the Expansion Study of NUC-7738 Expected in Q4 2025 with Final Data in 2026 Additional Data from the Ongoing Phase 1b/2 Study of NUC-3373 in Combination with Pembrolizumab Remain on track for 2025 Strategic Execution of ATM Offering Extends Anticipated Cash Runway into 2029 EDINBURGH, United Kingdom, Aug. 20, 2025 (GLOBE NEWSWIRE) -- NuCana plc (NASDAQ: NCNA) (“NuCana” or the “Company”) announced financial results for the second quarter ended June 30, 2025 and provided an update on its clinical development program with its two lead anti-cancer medicines. “We are pleased to announce that the first patients have been dosed on the expansion of our ongoing Phase 1/2 NuTide:701 study in patients with PD-1 inhibitor-resistant melanoma,” said Andrew Kay, NuCana’s Executive Chairman. “Our lead program, NUC-7738 is a novel agent that profoundly impacts gene expression in cancer cells and targets multiple aspects of the tumor microenvironment. We remain encouraged by the clinical observations witnessed so far. We have observed a favorable safety profile, meaningful tumor volume reduction and prolonged progression free-survival in patients with PD-1 inhibitor refractory and resistant metastatic melanoma. The expansion study is expected to enroll an additional 28 patients, increasing the planned patient population treated in combination with pembrolizumab to 40 and further supporting our registrational path.” Mr. Kay continued, “Turning to our second program, NUC-3373 is a targeted thymidylate synthase inhibitor with immune modulating properties. We are encouraged by the data from the Phase 1b/2 NuTide:303 study, which is evaluating NUC-3373 in combination with pembrolizumab in patients with advanced solid tumors, and NUC-3373 with docetaxel in patients with lung cancer. Notable tumor volume reductions and prolonged progression free survival have been observed in these patients so far. We look forward to announcing additional data from this study later this year.” Mr. Kay concluded, “Lastly, we strengthened our balance sheet with a financing in May and the strategic execution of an at-the-market (“ATM”) offering, extending our cash runway into 2029 and through key value-driving milestones. To date in 2025, these init...

Initiation of Expansion Study of NUC-7738 in Combination with Pembrolizumab for Patients with PD-1 Inhibitor-Resistant Melanoma Initial Data from the Expansion Study of NUC-7738 Expected in Q4 2025 with Final Data in 2026 Additional Data from the Ongoing Phase 1b/2 Study of NUC-3373 in Combination with Pembrolizumab Remain on track for 2025 Anticipated Cash Runway Extended into Q4 2026 to Support Key Value-Driving Milestones and Complete the Expansion Study of NUC-7738 EDINBURGH, United Kingdom, June 02, 2025 (GLOBE NEWSWIRE) -- NuCana plc (NASDAQ: NCNA) announced financial results for the first quarter ended March 31, 2025 and provided an update on its clinical development program with its two lead anti-cancer medicines. “We have entered 2025 with a clear focus on the advancement of our pipeline through key milestones, into late-stage development, and towards commercialization,” said Hugh S. Griffith, NuCana’s Founder and Chief Executive Officer. “Our lead program, NUC-7738, continues to show significant promise. NUC-7738 is a novel agent that profoundly impacts gene expression in cancer cells and targets multiple aspects of the tumor microenvironment. In our ongoing Phase 1/2 NuTide:701 study, we have observed a favorable safety profile, meaningful tumor volume reduction and prolonged progression free-survival in patients with PD-1 inhibitor refractory and resistant metastatic melanoma. Based on these compelling results, we have recently initiated an expansion trial of NUC-7738 in an additional 28 patients with PD-1 inhibitor-resistant melanoma, that supports our registrational path. Based on this, we plan to meet with the U.S. Food and Drug Administration to determine the optimal regulatory strategy forward towards commercialization.” Mr. Griffith continued, “Turning to our second program, NUC-3373 is a targeted thymidylate synthase inhibitor with immune modulating properties. We are encouraged by the data from the ongoing Phase 1b/2 NuTide:303 study. This study is evaluating NUC-3373 in combination with pembrolizumab in patients with advanced solid tumors, and NUC-3373 with docetaxel in patients with lung cancer. To date, we have seen notable tumor volume reductions and prolonged progression free survival in these patients. We look forward to sharing additional data from this trial later this year.” Mr. Griffith concluded, “Lastly, we strengthened our ba...

Pfizer's PFE non-COVID operational revenues improved in 2024, driven by its key in-line products like Vyndaqel, Padcev and Eliquis, new launches and newly acquired products from Seagen. The trend is expected to have continued in the first quarter of 2025. Vyndaqel/Vyndamax sales are likely to have been strong, driven by continued demand growth due to increases in diagnosis and treatment rates. However, the unfavorable impact of the IRA and new competition in the United States can hurt Vyndaqel’s growth. Sales of key vaccine, Prevnar, are likely to have declined due to competitive pressure for the adult indication. The Zacks Consensus Estimate for sales of Vyndaqel/Vyndamax is $1.42 billion while our model estimates the same to be $1.37 billion. The Zacks Consensus Estimate for sales of Prevnar family of vaccines is $1.7 billion while our model estimates Prevnar family vaccine sales to be $1.73 billion. In addition, alliance revenues and direct sales from Eliquis are likely to have provided top-line support, driven by continued share gains in the oral anti-coagulant market and recent launches in international markets. However, sales could be hurt by lower pricing in the United States. The Zacks Consensus Estimate for alliance revenues from Eliquis is $2.0 billion, while our model estimate is $2.28 billion. So far this year, Pfizer’s stock has declined 12.7% compared with a decrease of 1.9% for the industry. Image Source: Zacks Investment Research We expect Pfizer’s several newly launched drugs, like the Velsipity pill for ulcerative colitis, the pentavalent meningococcal vaccine Penbraya, and new gene therapies for hemophilia, Hympavzi (marstacimab), and Beqvez/Durveqtix, to have contributed to top-line growth. As far as new RSV vaccine, Abrysvo, is concerned, its sales are likely to have benefited from international market expansion. Its sales in the United States are expected to have been hurt by revised recommendations for RSV vaccinations issued in June 2024 by the US Advisory Committee on Immunization Practices. The Zacks Consensus Estimate for Abrysvo is $158 million, while our model estimate is $183.9 million. The antibody-drug conjugates or ADCs — Adcetris, Padcev, Tukysa and Tivdak — added to Pfizer’s portfolio with the Seagen acquisition in December 2023, boosted Pfizer’s oncology sales in 2024. Pfizer is particularly witnessing strong demand for Pa...

Remains on Track to Initiate an Expansion Study of NUC-7738 in Combination with Pembrolizumab for Patients with PD-1 Inhibitor-Resistant Melanoma in 2025 Data from the Expansion Study to Support Interaction with FDA and Define Regulatory Strategy for NUC-7738 Data from the Ongoing Phase 1b/2 Study of NUC-3373 in Combination with Pembrolizumab Anticipated Cash Runway Extended into Q3 2025 EDINBURGH, United Kingdom, March 20, 2025 (GLOBE NEWSWIRE) -- NuCana plc (NASDAQ: NCNA) announced financial results for the fourth quarter and year ended December 31, 2024 and provided an update on its clinical development program with its two lead anti-cancer medicines. “Throughout 2024, we shared multiple data updates from our two lead anti-cancer medicines, NUC-7738 and NUC-3373,” said Hugh S. Griffith, NuCana’s Founder and Chief Executive Officer. “Our lead program, NUC-7738, is a novel agent that profoundly impacts gene expression in cancer cells and targets multiple aspects of the tumor microenvironment. Over the past year, we presented data highlighting NUC-7738’s potential, when used in combination with pembrolizumab, to reduce tumor volume and prolong progression free survival in PD-1 inhibitor refractory and resistant patients with metastatic melanoma in the NuTide:701 study. Notably, disease control was observed in 75% (9/12) of the patients, five of whom had tumor reductions, with two patients achieving Partial Responses. Seven of the 12 patients had a progression free survival time of greater than five months, which is highly atypical in this patient population. Equally important, the combination has shown a favorable safety profile.” Mr. Griffith added, “Encouraged by these findings, we are excited to further evaluate NUC-7738’s potential in an expansion of the NuTide:701 study for patients with PD-1 inhibitor-resistant melanoma. We plan to initiate this expansion study and provide data updates later this year. In addition, we plan to meet with the U.S. Food and Drug Administration to seek guidance on the optimal registration strategy for NUC-7738 as we look to advance it towards approval.” Mr. Griffith continued, “Turning to NUC-3373, our second anti-cancer program is a targeted thymidylate synthase inhibitor with immune modulating properties. It is currently being evaluated in a Phase 1b/2 study known as NuTide:303, which has two separate modules. One module...