NuCana(NCNA) - 2024 Q4 - Annual Report

Q4 and Full-Year 2024 Financial Results and Business Update This report details NuCana's Q4 and full-year 2024 financial performance, highlighting significant progress in its NUC-7738 and NUC-3373 clinical programs and its cash position Business Update & CEO Remarks NuCana reported encouraging 2024 data for its lead anti-cancer medicines, NUC-7738 and NUC-3373, alongside strengthening its intellectual property - NUC-7738, in combination with pembrolizumab, showed a 75% disease control rate (9/12 patients) in a study on PD-1 inhibitor-resistant metastatic melanoma, with plans to initiate an expansion study in 2025[3] - NUC-3373 demonstrated significant tumor volume reductions in the NuTide:303 study, including two Partial Responses. However, the NuTide:323 study in advanced colorectal cancer yielded a surprising and disappointing outcome[3] - The company's intellectual property was enhanced with a new granted patent from the USPTO covering NUC-7738's composition of matter[4] NUC-7738 Program Update NUC-7738 demonstrated significant potential in the NuTide:701 study for PD-1 inhibitor-resistant metastatic melanoma, with plans for an expansion study and FDA guidance NuTide:701 Study Highlights (NUC-7738 + Pembrolizumab) | Metric | Result | | :--- | :--- | | Patient Population | PD-1 inhibitor refractory/resistant metastatic melanoma | | Disease Control Rate | 75% (9 out of 12 patients) | | Tumor Reductions | 5 out of 12 patients | | Partial Responses | 2 patients | | Progression-Free Survival | > 5 months for 7 out of 12 patients | - NuCana plans to initiate an expansion of the NuTide:701 study and meet with the U.S. FDA to discuss the optimal registration strategy for NUC-7738[3] NUC-3373 Program Update NUC-3373 showed encouraging results in the NuTide:303 study for solid tumors, despite a disappointing outcome in the NuTide:323 colorectal cancer study - The NuTide:303 study is evaluating NUC-3373 in two modules: in combination with pembrolizumab for advanced solid tumors and with docetaxel for lung cancer[3] - Encouraging data from NuTide:303 includes significant tumor volume reductions, prolonged progression-free survival, and two Partial Responses[3] - The company acknowledged the surprising and unexpected disappointing outcome of the NuTide:323 study of NUC-3373 in patients with advanced colorectal cancer[3] 2025 Anticipated Milestones NuCana anticipates advancing its NUC-7738 program with an expansion study and FDA guidance, while also announcing further NUC-3373 data in 2025 - NUC-7738 Milestones: - Initiate an expansion of the Phase 1/2 study (NuTide:701) in combination with pembrolizumab for melanoma patients - Announce data from the NuTide:701 expansion study - Obtain regulatory guidance from the FDA on a pivotal study design for melanoma[7] - NUC-3373 Milestones: - Announce data from the Phase 1b/2 modular study (NuTide:303) in combination with pembrolizumab for solid tumor patients[7] Financial Highlights and Cash Position NuCana ended 2024 with £6.7 million in cash, significantly reducing its net loss and extending its cash runway into Q3 2025 Cash Position (in million GBP) | Date | Cash and Cash Equivalents (million GBP) | | :--- | :--- | | Dec 31, 2024 | 6.7 | | Sep 30, 2024 | 11.4 | | Dec 31, 2023 | 17.2 | - The company's cash runway is expected to fund planned operations into Q3 2025, supported by cash on hand and proceeds from its ATM offering[5] Net Loss and Loss Per Share Comparison | Period | Net Loss (million GBP) | Loss Per Share (GBP) | | :--- | :--- | :--- | | Q4 2024 | 0.7 | 0.01 | | Q4 2023 | 7.7 | 0.14 | | FY 2024 | 19.0 | 0.26 | | FY 2023 | 27.6 | 0.53 | Financial Statements This section presents the condensed consolidated financial statements for 2024 and 2023, including the Statement of Operations, Financial Position, and Cash Flows Condensed Consolidated Statements of Operations NuCana reported a net loss of £19.0 million in 2024, a significant improvement from 2023, primarily due to reduced research and development expenses Annual Statement of Operations Highlights (in thousand GBP) | Line Item | 2024 (thousand GBP) | 2023 (thousand GBP) | | :--- | :--- | :--- | | Research and development expenses | (18,017) | (25,062) | | Operating loss | (22,809) | (32,784) | | Loss for the period | (18,997) | (27,632) | | Basic and diluted loss per ordinary share | (0.26) | (0.53) | Condensed Consolidated Statements of Financial Position As of December 31, 2024, total assets decreased to £14.8 million, primarily due to reduced cash and cash equivalents, with total equity also declining Statement of Financial Position Highlights (in thousand GBP) | Line Item | As of Dec 31, 2024 (thousand GBP) | As of Dec 31, 2023 (thousand GBP) | | :--- | :--- | :--- | | Cash and cash equivalents | 6,749 | 17,225 | | Total assets | 14,774 | 27,811 | | Total liabilities | 8,820 | 12,924 | | Total equity | 5,954 | 14,887 | Condensed Consolidated Statements of Cash Flows Net cash used in operating activities improved to £19.1 million in 2024, with financing activities generating £8.2 million, resulting in a year-end cash balance of £6.7 million Annual Cash Flow Summary (in thousand GBP) | Cash Flow Activity | For the Year Ended Dec 31, 2024 (thousand GBP) | For the Year Ended Dec 31, 2023 (thousand GBP) | | :--- | :--- | :--- | | Net cash used in operating activities | (19,118) | (26,439) | | Net cash from investing activities | 79 | 2,888 | | Net cash from financing activities | 8,184 | (53) | | Net decrease in cash | (10,855) | (23,604) | | Cash at end of year | 6,749 | 17,225 | About NuCana NuCana is a clinical-stage biopharmaceutical company leveraging its ProTide technology to develop more effective and safer cancer treatments, with NUC-3373 and NUC-7738 as lead candidates - The company's core strategy is applying its ProTide technology to transform existing nucleoside analog chemotherapies into more effective and safer medicines[8] - The pipeline is led by NUC-3373, derived from 5-fluorouracil, and NUC-7738, a novel anti-cancer agent targeting RNA polyadenylation[8] Forward-Looking Statements This section provides a legal disclaimer, noting that statements about future events are forward-looking and subject to risks and uncertainties detailed in SEC filings - Statements concerning planned clinical studies, potential advantages of product candidates, timelines, and results are considered forward-looking[9] - The company's statement that its current cash is sufficient to fund operations into Q3 2025 is a forward-looking statement and subject to risk[9] - The company assumes no obligation to update forward-looking statements and directs investors to the "Risk Factors" section of its Annual Report on Form 20-F for more details[9]