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CSPC PHARMACEUTICAL(1093.HK):TWO MORE LARGE-SCALE BD DEALS ANTICIPATED IN 2H25
Ge Long Hui· 2025-08-26 19:16
EGFR ADC (SYS6010): a near-term BD catalyst. SYS6010 is currently in global Ph3 development. In China, two pivotal studies are ongoing: a Ph3 trial comparing SYS6010 to chemotherapy in 2L EGFR TKI-resistant NSCLC, and a Ph1b/3 trial evaluating SYS6010 + osimertinib vs osimertinib alone in 1L EGFR-mutant NSCLC, with the Ph3 portion to start by end-2025. The Company is also in discussion with CDE regarding the initiation of SYS6010 in 2L+ EGFR wild-type NSCLC, with additional Ph3 trials in ESCC and HNSCC in p ...
NuCana Reports Second Quarter 2025 Financial Results and Provides Business Update
Globenewswire· 2025-08-20 20:05
Core Insights - NuCana plc has initiated the dosing of the first patients in the expansion study of NUC-7738 in combination with pembrolizumab for patients with PD-1 inhibitor-resistant melanoma, with initial data expected in Q4 2025 and final data in 2026 [1][2] - The company reported a net loss of £24.1 million for Q2 2025, which includes a significant loss on revaluation of warrants, compared to a net loss of £7.0 million in Q2 2024 [7][11] - NuCana's cash and cash equivalents increased to £8.4 million as of June 30, 2025, up from £4.0 million at the end of Q1 2025, with additional funds raised through an ATM offering expected to extend the cash runway into 2029 [4][6] Clinical Development - NUC-7738 is designed to impact gene expression in cancer cells and has shown a favorable safety profile, meaningful tumor volume reduction, and prolonged progression-free survival in patients with PD-1 inhibitor refractory metastatic melanoma [2] - NUC-3373, another lead program, is a targeted thymidylate synthase inhibitor with immune-modulating properties, currently in a Phase 1b/2 study, showing notable tumor volume reductions and prolonged progression-free survival in patients with advanced solid tumors [2][5] Financial Position - As of June 30, 2025, NuCana's total assets were £16.2 million, with total equity attributable to equity holders amounting to £7.4 million [12][13] - The company has raised gross proceeds of £38.4 million in 2025 through various financing initiatives, positioning it well for upcoming clinical milestones [2][6] Anticipated Milestones - Initial data from the Phase 1/2 expansion study of NUC-7738 is expected in 2025, with regulatory guidance from the FDA anticipated in 2026 [5] - Additional data from the ongoing Phase 1b/2 study of NUC-3373 is also expected to be announced later in 2025 [5]
NuCana Reports First Quarter 2025 Financial Results and Provides Business Update
GlobeNewswire News Room· 2025-06-02 20:01
Core Insights - NuCana plc is advancing its clinical development programs for its lead anti-cancer medicines, NUC-7738 and NUC-3373, with a focus on key milestones towards commercialization [2][4][7] - The company has initiated an expansion study of NUC-7738 in combination with pembrolizumab for patients with PD-1 inhibitor-resistant melanoma, with initial data expected in Q4 2025 and final data in 2026 [1][2] - Financial results for Q1 2025 show a net loss of £2.5 million, a significant reduction from £6.8 million in Q1 2024, indicating improved financial performance [6][10] Clinical Development Updates - NUC-7738 has shown a favorable safety profile and meaningful tumor volume reduction in patients with PD-1 inhibitor refractory metastatic melanoma, leading to the initiation of an expansion trial [2][4] - NUC-3373 is being evaluated in a Phase 1b/2 study in combination with pembrolizumab for advanced solid tumors and with docetaxel for lung cancer, with notable tumor volume reductions reported [2][4] - The company plans to meet with the U.S. FDA to discuss the regulatory strategy for NUC-7738 based on the promising results from ongoing studies [2][4] Financial Position - As of March 31, 2025, NuCana had cash and cash equivalents of £4.0 million, down from £6.7 million at the end of 2024, but has since raised an additional £8.8 million to extend its cash runway into Q4 2026 [4][5][6] - The company reported a basic and diluted loss per ordinary share of £0.02 for Q1 2025, compared to £0.13 for the same period in 2024, reflecting improved financial health [6][10] - Total assets decreased from £14.774 million at the end of 2024 to £11.601 million as of March 31, 2025, primarily due to cash outflows [11][12]