On June 2, 2025 NuCana plc (NASDAQ: NCNA) reported 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 (Press release, Nucana, JUN 2, 2025, View Source [SID1234653616]).
Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:
Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing
Schedule Your 30 min Free Demo!
"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 balance sheet with a financing in May, extending our cash runway through key value-driving milestones. With multiple data readouts ahead, we are well-positioned to deliver on our mission of improving treatment outcomes for patients with cancer."
2025 Anticipated Milestones
NUC-7738
Initiate an expansion of the Phase 1/2 study (NuTide:701) of NUC-7738 in combination with pembrolizumab in patients with PD-1 inhibitor-resistant melanoma;
Announce data from the Phase 1/2 expansion study (NuTide:701) of NUC-7738 in combination with pembrolizumab; and
Obtain regulatory guidance from the U.S. Food and Drug Administration on pivotal study design for NUC-7738 in melanoma.
NUC-3373
Announce additional data from the Phase 1b/2 modular study (NuTide:303) of NUC-3373 in combination with pembrolizumab in patients with solid tumors.
First Quarter 2025 Financial Highlights and Cash Position
As of March 31, 2025, NuCana had cash and cash equivalents of £4.0 million compared to £6.7 million at December 31, 2024. Subsequent to March 31, 2025, NuCana completed a financing, raising an additional £8.8 million in gross proceeds before expenses and commission. NuCana expects that its cash and cash equivalents as of March 31, 2025, together with amounts raised through its financing, will be sufficient to fund its planned operations into Q4 2026.
NuCana continues to advance its numerous clinical programs and reported a net loss of £2.5 million for the quarter ended March 31, 2025, as compared to a net loss of £6.8 million for the quarter ended March 31, 2024. Basic and diluted loss per ordinary share was £0.02 for the quarter ended March 31, 2025, as compared to £0.13 per ordinary share for the comparable quarter ended March 31, 2024.