On November 16, 2023 NuCana plc (NASDAQ: NCNA) reported financial results for the third quarter ended September 30, 2023 and provided an update on its broad clinical development program with its transformative ProTide therapeutics (Press release, Nucana BioPharmaceuticals, NOV 16, 2023, View Source [SID1234637739]).

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As of September 30, 2023, NuCana had cash and cash equivalents of £17.8 million compared to £24.6 million at June 30, 2023 and £41.9 million at December 31, 2022. NuCana continues to advance its various clinical programs and reported a net loss of £6.7 million for the quarter ended September 30, 2023, as compared to a net loss of £4.5 million for the quarter ended September 30, 2022. Basic and diluted loss per share was £0.13 for the quarter ended September 30, 2023, as compared to £0.09 per share for the comparable quarter ended September 30, 2022.

"We were excited to have recently presented promising clinical data for both NUC-3373 and NUC-7738 that continue to support the potential of our ProTides to transform the treatment of patients with cancer." said Hugh S. Griffith, NuCana’s Founder and Chief Executive Officer. "For NUC-3373, we presented the first data in second-line patients with colorectal cancer from Part 3 of the NuTide:302 study. These data supported NUC-3373’s favorable safety profile and demonstrated encouraging signs of efficacy, including tumor volume reductions in patients who have failed prior fluoropyrimidine treatment. The data also showed that most patients dosed with NUC-3373 in combination with irinotecan, leucovorin and bevacizumab (NUFIRI-bev) achieved a longer progression free survival compared to their first-line treatment with a 5-FU-based therapy. We were also pleased to report that NuTide:323, our randomized Phase 2 study of NUFIRI-bev compared to the standard of care FOLFIRI-bev in second-line patients with colorectal cancer remains on track to reach full enrollment in the coming months and that no new safety signals have been observed."

Mr. Griffith continued: "We also presented data from the Phase 2 part of the NuTide:701 study evaluating NUC-7738 both as a monotherapy in patients with solid tumors and in combination with the anti-PD-1 therapy pembrolizumab in patients with metastatic melanoma who had exhausted standard therapies. The data showed NUC-7738 to be well tolerated with promising signs of efficacy, including tumor volume reductions and prolonged time on treatment. Importantly, these data indicated that NUC-7738 may potentiate the activity of anti-PD-1 agents in patients who were refractory to or progressed on prior immunotherapy, including anti-PD-1 therapy. We look forward to sharing additional updates as these data continue to mature."

Mr. Griffith concluded, "We have executed on all of our goals this year and we look forward to providing numerous data updates throughout 2024, including additional data from the NuTide:323 study. With a cash runway that is expected to extend into 2025, we are excited as we continue towards our goal of improving treatment outcomes for patients with cancer."

2024 Anticipated Milestones

NUC-3373 (a ProTide transformation of 5-FU)
In 2024, NuCana expects to:
Announce data from the randomized Phase 2 (NuTide:323) study of NUFIRI-bev compared to the standard of care FOLFIRI-bev for the second-line treatment of patients with colorectal cancer;
Announce data from the Phase 2 (NuTide:302) study of NUC-3373 in combination with irinotecan, leucovorin and bevacizumab (NUFIRI-bev) and in combination with oxaliplatin, leucovorin and bevacizumab (NUFOX-bev) for the second-line treatment of patients with colorectal cancer; and
Announce data from the Phase 1b (NuTide:303) modular study of NUC-3373 in combination with pembrolizumab in patients with solid tumors and in combination with docetaxel in patients with lung cancer to identify additional indications for development.
NUC-7738 (a ProTide transformation of 3’-deoxyadenosine)
In 2024, NuCana expects to:
Announce data from the Phase 2 part of the NuTide:701 study of NUC-7738 in combination with pembrolizumab in patients with melanoma.