On November 25, 2024 NuCana plc (NASDAQ: NCNA) reported financial results for the third quarter ended September 30, 2024 and provided an update on its clinical development program with its two lead anti-cancer medicines (Press release, Nucana, NOV 25, 2024, View Source [SID1234648615]).
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"We announced encouraging data from our ongoing clinical studies of both NUC-7738 and NUC-3373, underscoring the potential of our pipeline," said Hugh S. Griffith, NuCana’s Founder and Chief Executive Officer. "At the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Congress 2024 in September, we presented promising data on NUC-7738, a novel agent that profoundly impacts gene expression in cancer cells and targets multiple aspects of the tumor microenvironment. The data from the Phase 2 part of the NuTide:701 study in PD-1 inhibitor-resistant melanoma showed that 9 of the 12 patients achieved disease control when treated with NUC-7738 in combination with pembrolizumab. One of these patients, who had received two prior lines of PD-1 inhibitor-based therapy and had progressed on their latest treatment of ipilimumab plus nivolumab within two months, achieved a 55% reduction in tumor volume. Given the typically poor outcomes in this patient population, with a median progression-free survival of just two to three months under current standard care, we are highly encouraged by the results showing a median progression-free survival of over five months for patients receiving NUC-7738 plus pembrolizumab."
Mr. Griffith added, "We also announced the issuance of a new patent by the United States Patent and Trademark Office covering NUC-7738’s composition of matter. This patent (US12,054,510) is expected to serve as a key component of the intellectual property protection for NUC-7738, which currently consists of over 80 issued patents worldwide."
Mr. Griffith continued, "We recently announced initial data from the ongoing Phase 1b/2 NuTide:303 study of NUC-3373, a targeted thymidylate synthase inhibitor with immune modulating properties, in a manuscript authored by the study’s lead investigators. In this study, NUC-3373 is being combined with pembrolizumab in patients with advanced solid tumors and with docetaxel in patients with lung cancer. Results from the study indicate that NUC-3373 may promote an anti-tumor immune response and potentiate the activity of immune checkpoint inhibitors. We were particularly encouraged to see significant tumor volume reductions and prolonged progression free survival, including a patient with urothelial bladder cancer who achieved 100% reduction in their target lesions. While we were disappointed with the previously announced discontinuation of the NuTide:323 study in patients with metastatic colorectal cancer, we remain optimistic about the potential of NUC-3373."
Mr. Griffith concluded, "Our unwavering commitment to improving treatment outcomes for patients with cancer drives our relentless pursuit of the development of new anti-cancer agents. We look forward to progressing these exciting new medicines and sharing future development plans for NUC-7738 and NUC-3373."
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 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
Initiate an expansion of the Phase 1b/2 modular study (NuTide:303) of NUC-3373 in combination with pembrolizumab in patients with solid tumors; and
Announce data from the Phase 1b/2 modular study (NuTide:303) of NUC-3373 in combination with pembrolizumab in patients with solid tumors.
Third Quarter 2024 Financial Highlights and Cash Position
As of September 30, 2024, NuCana had cash and cash equivalents of £11.4 million compared to £11.6 million as of June 30, 2024 and £17.2 million at December 31, 2023. The reduction in cash and cash equivalents during the third quarter was primarily the result of cash used in operating activities, partially offset by £4.7 million in net proceeds raised through its at-the-market (ATM) offering. Subsequent to September 30, 2024, NuCana has raised an additional £1.8 million in net proceeds through its ATM offering. NuCana expects that its cash and cash equivalents as of September 30, 2024, together with amounts raised through its ATM offering subsequent to that date, will be sufficient to fund its planned operations into Q2 2025.
NuCana continues to advance its clinical programs and reported a net loss of £4.5 million for the quarter ended September 30, 2024, as compared to a net loss of £6.7 million for the quarter ended September 30, 2023. Basic and diluted loss per ordinary share was £0.07 for the quarter ended September 30, 2024, as compared to £0.13 per ordinary share for the comparable quarter ended September 30, 2023.