On November 16, 2022 NuCana plc (NASDAQ: NCNA) reported that financial results for the third quarter ended September 30, 2022 and provided an update on its broad clinical program with its transformative ProTide therapeutics (Press release, Nucana BioPharmaceuticals, NOV 16, 2022, View Source [SID1234624156]).
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As of September 30, 2022, NuCana had cash and cash equivalents of £50.8 million compared to £46.5 million as of June 30, 2022 and £60.3 million at December 31, 2021. NuCana continues to advance its various clinical programs and reported a net loss of £4.5 million for the quarter ended September 30, 2022, as compared to a net loss of £8.0 million for the quarter ended September 30, 2021. Basic and diluted loss per share was £0.09 for the quarter ended September 30, 2022, as compared to £0.15 per share for the quarter ended September 30, 2021.
"This year we have focused on advancing our transformative ProTides through the clinic and evaluating additional indications and combinations to expand our development program," said Hugh S. Griffith, NuCana’s Founder and Chief Executive Officer. "Based on NUC-3373’s promising efficacy and favorable safety profile, we initiated two clinical studies: NuTide:323, a randomized Phase 2 trial of NUC-3373 in combination with irinotecan (NUFIRI) and bevacizumab for the second-line treatment of patients with colorectal cancer; and NuTide:303 a Phase 1b/2 study of NUC-3373 in combination with either pembrolizumab in patients with solid tumors or in combination with docetaxel in patients with non-small cell lung cancer (NSCLC). Furthermore, we entered the Phase 2 part of the NuTide:701 study which is investigating NUC-7738 as a monotherapy and in combination with pembrolizumab in patients with solid tumors."
Mr. Griffith continued: "We recently presented data at the European Society of Medical Oncology (ESMO) (Free ESMO Whitepaper) Annual Meeting that showed the promising anti-tumor activity and favorable safety profiles of both NUC-3373 and NUC-7738. We presented encouraging data for NUC-3373 in combination with irinotecan (NUFIRI) or oxaliplatin (NUFOX) from the NuTide:302 Phase 1b/2 study in patients with advanced colorectal cancer. We also presented positive data on NUC-7738 in patients with solid tumors, including melanoma, from the Phase 1 part of the Phase 1/2 NuTide:701 study. At the 34th EORTC-NCI-AACR (Free EORTC-NCI-AACR Whitepaper) Annual Meeting in October, we presented data demonstrating that NUC-3373 is a more potent inhibitor of thymidylate synthase than pemetrexed in both adenocarcinoma and squamous subtypes of NSCLC. In addition, we presented data that demonstrate NUC-3373’s ability to increase the immunogenic cell death of lung cancer cells in combination with pembrolizumab."
Mr. Griffith concluded: "We are pleased with the progress we have made this year with NUC-3373 and NUC-7738. Based on these positive data updates, we have expanded our development programs and are rapidly advancing them as we progress towards our goal of providing more effective and safer treatment options for patients with cancer. With a cash runway that is expected to fund operations into 2025, we look forward to achieving numerous value-driving catalysts in the near future."
Anticipated Milestones: Q4 2022 and H1 2023
• NUC-3373 (a ProTide transformation of 5-FU)
In Q4 2022, NuCana expects to:
Commence enrollment in the randomized, controlled Phase 2 (NuTide:323) study of NUC-3373 in combination with other agents for the second-line treatment of patients with colorectal cancer;
Commence enrollment in the Phase 1b/2 (NuTide:303) modular study of NUC-3373 in combination with either pembrolizumab in patients with various solid tumors or in combination with docetaxel in patients with non-small cell lung cancer (NSCLC) to identify additional indications for development; and
Expand the Phase 1b/2 (NuTide:302) study of NUC-3373 in colorectal cancer patients, and evaluate NUC-3373-based regimens in combination with bevacizumab in second-line patients with colorectal cancer.
In the first half of 2023, NuCana expects to:
Announce data from the Phase 1b/2 (NuTide:302) study of NUC-3373 combined with leucovorin, bevacizumab and either irinotecan or oxaliplatin in second-line patients with colorectal cancer; and
Announce data from the Phase 1b/2 (NuTide:303) modular study of NUC-3373 in combination with either pembrolizumab in patients with various solid tumors or docetaxel in patients with non-small cell lung cancer (NSCLC) to identify additional indications for development.
• NUC-7738 (a ProTide transformation of 3’-deoxyadenosine)
In Q4 2022, NuCana expects to:
Commence enrollment in the Phase 2 part of the NuTide:701 study of NUC-7738 in combination with the PD-1 inhibitor pembrolizumab, in patients with solid tumors; and
Announce data from the Phase 2 part of the NuTide:701 study in patients with solid tumors treated with NUC-7738 monotherapy.
In the first half of 2023, NuCana expects to:
Announce data from the Phase 1 part of the NuTide:701 study of NUC-7738 in patients with solid tumors; and
Announce data from the Phase 2 part of the NuTide:701 study in patients with solid tumors treated with NUC-7738 monotherapy and NUC-7738 in combination with pembrolizumab.