NuCana(NCNA) - 2023 Q4 - Annual Report

Executive Summary NuCana plc reported its fourth quarter and full-year 2023 financial results, highlighting a reduced net loss and a cash runway extending into 2025. The company also provided encouraging updates on its transformative ProTide therapeutics, NUC-3373 and NUC-7738, with key data readouts anticipated for all programs in 2024 Financial Highlights (Q4 & FY 2023) NuCana ended 2023 with £17.2 million in cash and cash equivalents, a decrease from £41.9 million at the end of 2022. The company significantly reduced its net loss for both the fourth quarter and the full year 2023 compared to the previous year | Metric | Q4 2023 (£M) | Q4 2022 (£M) | FY 2023 (£M) | FY 2022 (£M) | | :------------------------- | :----------- | :----------- | :----------- | :----------- | | Net Loss | (7.7) | (15.2) | (27.6) | (32.0) | | Basic & Diluted Loss per Share | (0.14) | (0.29) | (0.53) | (0.61) | - Cash and cash equivalents as of December 31, 2023, were £17.2 million, compared to £17.8 million as of September 30, 2023, and £41.9 million as of December 31, 2022[3] - Anticipated cash runway is expected to extend into 2025[1][4] Business & Pipeline Update Overview NuCana announced encouraging efficacy signals and favorable safety profiles for its ProTides, NUC-3373 and NUC-7738, in 2023. The development programs are progressing well, with a randomized Phase 2 study for NUC-3373 fully recruited and key data readouts expected across the pipeline in 2024 - Encouraging signals of efficacy and favorable safety profiles demonstrated for ProTides NUC-3373 and NUC-7738 in 2023[1][4] - The randomized Phase 2 study of NUC-3373 in 171 second-line colorectal cancer patients is fully recruited, with data expected in 2024[1][4] - Key data readouts are expected for all pipeline programs in 2024[1][4] Company Profile NuCana is a clinical-stage biopharmaceutical company dedicated to significantly improving cancer treatment outcomes by applying its proprietary ProTide technology to transform conventional chemotherapy agents into more effective and safer medicines Mission and Technology NuCana's mission is to develop more effective and safer medicines for cancer patients by utilizing its proprietary ProTide technology. This technology aims to overcome the key limitations of widely prescribed nucleoside analog chemotherapy agents by generating much higher concentrations of anti-cancer metabolites directly in cancer cells - NuCana is a clinical-stage biopharmaceutical company focused on significantly improving treatment outcomes for patients with cancer[7] - The company applies its ProTide technology to transform nucleoside analogs, widely prescribed chemotherapy agents, into more effective and safer medicines[7] - ProTides are designed to overcome limitations of conventional agents and generate much higher concentrations of anti-cancer metabolites in cancer cells[7] Clinical Development Programs NuCana's pipeline includes two main ProTide candidates, NUC-3373 and NUC-7738, both advancing through multiple clinical studies for various solid and hematological tumors, with promising early efficacy and safety data reported NUC-3373 Program NUC-3373, a ProTide transformation of 5-FU, is being evaluated in three ongoing clinical studies for colorectal cancer and solid tumors/lung cancer. Recent data from a Phase 1b/2 study demonstrated a favorable safety profile and encouraging efficacy, including tumor volume reductions and prolonged progression-free survival in some patients - NUC-3373 is a new chemical entity derived from the nucleoside analog 5-fluorouracil, currently being evaluated in three ongoing clinical studies[4][7] - The randomized Phase 2 study (NuTide:323) comparing NUC-3373-based regimen (NUFIRI + bev) with standard of care (FOLFIRI + bev) for second-line advanced colorectal cancer has fully recruited all 171 patients[4][7] - Phase 1b/2 study (NuTide:302) in metastatic colorectal cancer showed a favorable safety profile and encouraging signs of efficacy, including tumor volume reductions and longer progression-free survival in some patients[4][7] NUC-7738 Program NUC-7738, a transformation of 3'-deoxyadenosine, is in the Phase 2 part of a Phase 1/2 study for advanced solid tumors, including melanoma. Recent data from the melanoma cohort showed tumor volume reductions and prolonged time on treatment, indicating NUC-7738 may potentiate the activity of anti-PD-1 agents in patients refractory to prior immunotherapy - NUC-7738 is a ProTide transformation of 3'-deoxyadenosine, currently in the Phase 2 part of a Phase 1/2 study in patients with advanced solid tumors[4][7] - Data from the Phase 2 part of the study of NUC-7738 in combination with pembrolizumab in melanoma patients showed tumor volume reductions and prolonged time on treatment[4][7] - The 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[4] 2024 Anticipated Milestones NuCana expects to announce significant clinical data readouts across its NUC-3373 and NUC-7738 programs throughout 2024, advancing its pipeline of transformative ProTide therapeutics NUC-3373 Milestones In 2024, NuCana plans to release data from three key NUC-3373 studies, including the randomized Phase 2 study in colorectal cancer and two Phase 1b/2 studies in metastatic colorectal cancer and solid tumors/lung cancer - Announce data from the randomized Phase 2 (NuTide:323) study of NUFIRI + bev compared to FOLFIRI + bev for second-line advanced colorectal cancer[8] - Announce data from the Phase 1b/2 (NuTide:302) study of NUFIRI + bev and NUFOX + bev for second-line advanced colorectal cancer[8] - Announce data from the Phase 1b/2 (NuTide:303) modular study of NUC-3373 in combination with pembrolizumab in solid tumors and with docetaxel in lung cancer[8] NUC-7738 Milestones NuCana anticipates announcing data from the Phase 2 part of the Phase 1/2 study of NUC-7738 in combination with pembrolizumab in melanoma patients in 2024 - Announce data from the Phase 2 part of the Phase 1/2 study (NuTide:701) of NUC-7738 in combination with pembrolizumab in patients with melanoma[6] Condensed Consolidated Financial Statements The report includes the condensed consolidated statements of operations, financial position, and cash flows, providing a detailed view of NuCana's financial performance and health for the fourth quarter and full year ended December 31, 2023, compared to the prior year Condensed Consolidated Statements of Operations For the year ended December 31, 2023, NuCana reported a net loss of £27.6 million, an improvement from £32.0 million in 2022, primarily driven by a significant reduction in research and development expenses | Metric | Q4 2023 (£'000) | Q4 2022 (£'000) | FY 2023 (£'000) | FY 2022 (£'000) | | :--------------------------------- | :---------- | :---------- | :---------- | :---------- | | Research and development expenses | (6,859) | (13,188) | (25,062) | (36,426) | | Administrative expenses | (1,286) | (1,535) | (6,063) | (7,291) | | Operating loss | (9,107) | (17,248) | (32,784) | (39,122) | | Loss for the period | (7,655) | (15,199) | (27,632) | (32,021) | | Basic and diluted loss per share | (0.14) | (0.29) | (0.53) | (0.61) | - Research and development expenses decreased by approximately 31.2% from £36.4 million in FY 2022 to £25.1 million in FY 2023[10] Condensed Consolidated Statements of Financial Position As of December 31, 2023, NuCana's total assets decreased to £27.8 million from £58.3 million in 2022, primarily driven by a significant reduction in cash and cash equivalents. Total equity attributable to equity holders also decreased from £38.5 million to £14.9 million | Metric | Dec 31, 2023 (£'000) | Dec 31, 2022 (£'000) | | :---------------------------------------- | :--------------- | :--------------- | | Total assets | 27,811 | 58,254 | | Cash and cash equivalents | 17,225 | 41,912 | | Total equity attributable to equity holders | 14,887 | 38,502 | | Total liabilities | 12,924 | 19,752 | - Cash and cash equivalents decreased by approximately 58.9% year-over-year, from £41.9 million in 2022 to £17.2 million in 2023[11] Condensed Consolidated Statements of Cash Flows For the year ended December 31, 2023, net cash used in operating activities increased to £26.4 million from £23.2 million in 2022. Net cash from investing activities was positive at £2.9 million, a significant increase from the prior year, primarily due to the repayment of other assets | Metric | FY 2023 (£'000) | FY 2022 (£'000) | | :-------------------------------- | :---------- | :---------- | | Net cash used in operating activities | (26,439) | (23,158) | | Net cash from investing activities | 2,888 | 120 | | Net cash used in financing activities | (53) | (161) | | Net decrease in cash and cash equivalents | (23,604) | (23,199) | | Cash and cash equivalents at end of year | 17,225 | 41,912 | - Net cash from investing activities significantly increased from £120 thousand in FY 2022 to £2,888 thousand in FY 2023, largely driven by the repayment of other assets[12] Forward-Looking Statements This section contains forward-looking statements based on current beliefs and assumptions, which involve known and unknown risks and uncertainties that could cause actual results to differ materially. The company explicitly states it assumes no obligation to publicly update these statements after the date of the press release - This press release contains "forward-looking" statements based on the beliefs and assumptions of NuCana plc's management[9] - Forward-looking statements involve known and unknown risks, uncertainties, and other factors that may cause actual results to be materially different from those expressed or implied[9] - The company assumes no obligation to publicly update any forward-looking statements for any reason after the date of this press release[9] Contact Information This section provides contact details for NuCana plc's Chief Executive Officer and investor relations through ICR Westwicke for further inquiries - For more information, contact Hugh S. Griffith, Chief Executive Officer of NuCana plc, at +44 131-357-1111 or info@nucana.com[13] - For investor relations, contact Chris Brinzey of ICR Westwicke at +1 339-970-2843 or chris.brinzey@westwicke.com[13]