Key Data Readouts on Track for All Programs in 2024 Randomized Phase 2 Study of 182 Second-Line Colorectal Cancer Patients Fully Enrolled NUC-7738 plus Pembrolizumab Demonstrated Encouraging Anti-Cancer Activity in Several Patients who were Resistant to PD-1 Inhibitors Anticipated Cash Runway into Q1 2025 EDINBURGH, United Kingdom, May 16, 2024 (GLOBE NEWSWIRE) -- NuCana plc (NASDAQ: NCNA) announced financial results for the first quarter ended March 31, 2024 and provided an update on its broad clinical dev ...

Key Data Readouts on Track for All Programs in 2024 Randomized Phase 2 Study of 182 Second-Line Colorectal Cancer Patients Fully Enrolled "Our focus remains on advancing our innovative ProTide pipeline to develop more efficacious and safer medicines for patients with cancer," said Hugh S. Griffith, NuCana's Founder and Chief Executive Officer. "NUC-3373, a transformation of 5-FU, is currently being investigated in three ongoing clinical studies. Our randomized Phase 2 study (NuTide:323) is now fully enrolle ...

EDINBURGH, United Kingdom, May 01, 2024 (GLOBE NEWSWIRE) -- NuCana plc (NASDAQ:NCNA), ("NuCana" or the "Company"), announced that it has received a written notification (the "Notification Letter") from the Listing Qualifications Department of the Nasdaq Stock Market, LLC ("Nasdaq") informing the Company that it has regained compliance with the minimum bid price requirement for continued listing set forth in Nasdaq Listing Rule 5450(a)(1) (the "Minimum Bid Price Requirement") and the matter is closed. As ann ...

As filed with the Securities and Exchange Commission on March 20, 2024 UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 20-F ☐ REGISTRATION STATEMENT PURSUANT TO SECTION 12(b) OR (g) OF THE SECURITIES EXCHANGE ACT OF 1934 OR ☒ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year ended December 31, 2023 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 OR ☐ SHELL COMPANY REPORT PURSUANT ...

[Executive Summary](index=1&type=section&id=Executive%20Summary) 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)](index=1&type=section&id=Financial%20Highlights%20%28Q4%20%26%20FY%202023%29) 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](index=3&type=chunk) - Anticipated cash runway is expected to extend **into 2025**[1](index=1&type=chunk)[4](index=4&type=chunk) [Business & Pipeline Update Overview](index=1&type=section&id=Business%20%26%20Pipeline%20Update%20Overview) 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](index=1&type=chunk)[4](index=4&type=chunk) - The randomized Phase 2 study of NUC-3373 in 171 second-line colorectal cancer patients is **fully recruited**, with data expected in 2024[1](index=1&type=chunk)[4](index=4&type=chunk) - Key data readouts are expected for **all pipeline programs in 2024**[1](index=1&type=chunk)[4](index=4&type=chunk) [Company Profile](index=2&type=section&id=Company%20Profile) 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](index=2&type=section&id=Mission%20and%20Technology) 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](index=7&type=chunk) - The company applies its **ProTide technology** to transform nucleoside analogs, widely prescribed chemotherapy agents, into **more effective and safer medicines**[7](index=7&type=chunk) - ProTides are designed to overcome limitations of conventional agents and generate **much higher concentrations of anti-cancer metabolites** in cancer cells[7](index=7&type=chunk) [Clinical Development Programs](index=1&type=section&id=Clinical%20Development%20Programs) 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](index=1&type=section&id=NUC-3373%20Program) 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](index=4&type=chunk)[7](index=7&type=chunk) - 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](index=4&type=chunk)[7](index=7&type=chunk) - 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](index=4&type=chunk)[7](index=7&type=chunk) [NUC-7738 Program](index=1&type=section&id=NUC-7738%20Program) 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](index=4&type=chunk)[7](index=7&type=chunk) - 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](index=4&type=chunk)[7](index=7&type=chunk) - 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](index=4&type=chunk) [2024 Anticipated Milestones](index=2&type=section&id=2024%20Anticipated%20Milestones) 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](index=2&type=section&id=NUC-3373%20Milestones) 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](index=8&type=chunk) - Announce data from the **Phase 1b/2 (NuTide:302) study** of NUFIRI + bev and NUFOX + bev for second-line advanced colorectal cancer[8](index=8&type=chunk) - 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](index=8&type=chunk) [NUC-7738 Milestones](index=2&type=section&id=NUC-7738%20Milestones) 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](index=6&type=chunk) [Condensed Consolidated Financial Statements](index=4&type=section&id=Condensed%20Consolidated%20Financial%20Statements) 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](index=4&type=section&id=Condensed%20Consolidated%20Statements%20of%20Operations) 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](index=10&type=chunk) [Condensed Consolidated Statements of Financial Position](index=5&type=section&id=Condensed%20Consolidated%20Statements%20of%20Financial%20Position) 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](index=11&type=chunk) [Condensed Consolidated Statements of Cash Flows](index=6&type=section&id=Condensed%20Consolidated%20Statements%20of%20Cash%20Flows) 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](index=12&type=chunk) [Forward-Looking Statements](index=3&type=section&id=Forward-Looking%20Statements) 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](index=9&type=chunk) - 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](index=9&type=chunk) - The company assumes **no obligation to publicly update** any forward-looking statements for any reason after the date of this press release[9](index=9&type=chunk) [Contact Information](index=7&type=section&id=Contact%20Information) 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](index=13&type=chunk) - For investor relations, contact **Chris Brinzey of ICR Westwicke** at +1 339-970-2843 or chris.brinzey@westwicke.com[13](index=13&type=chunk)

Exhibit 99.1 NUCANA PLC UNAUDITED CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS | | | For the Three Months Ended | | For the Nine Months Ended | | | --- | --- | --- | --- | --- | --- | | | | September 30, | | September 30, | | | | Notes | 2023 | 2022 | 2023 | 2022 | | | | | (in thousands, except per share data) | | | | | | ਣ | | キ | ਦੇ | | Research and development expenses | | (7,439) | (7,386) | (18,203) | (23,238) | | Administrative expenses | | (1,375) | (1,715) | (4,777) | (5,756) | | Net foreign exch ...

Exhibit 99.1 NUCANA PLC UNAUDITED CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS | | | For the Three Months Ended March 31, | | | --- | --- | --- | --- | | | Notes | 2023 | 2022 | | | | (in thousands, except per share data) | | | | | £ | £ | | Research and development expenses | | (6,805) | (9,446) | | Administrative expenses | | (1,648) | (2,152) | | Net foreign exchange (losses) gains | | (695) | 1,131 | | Operating loss | | (9,148) | (10,467) | | Finance income | | 287 | 31 | | Loss before tax | | (8,86 ...

A New Era in Oncology Limitations of Nucleoside Analogs Peak Year Sales 16 FDA Approved Anti-Cancer Nucleoside Drugs Activation Inefficient generation of anti-cancer metabolites 4 HIV Genvoya® 150 mg / 150 mg 200 mg / 10 mg film-coated tablets Elvitegravir/cobicistat/ Genvoya® emtricitabine/ tenofovir alafenamide 50 mg / 150 mg 30 film-coated tablets ericitabin Grail use (I GILEAD ¹ Sovaldi + Harvoni + Epclusa + Vosevi cumulative sales through 31 December 2022 2 Genvoya + Descovy + Odefsey + Biktarvy + Symt ...

As filed with the Securities and Exchange Commission on April 4, 2023 UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 20-F ☐ REGISTRATION STATEMENT PURSUANT TO SECTION 12(b) OR (g) OF THE SECURITIES EXCHANGE ACT OF 1934 OR ☒ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year ended December 31, 2022 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 OR ☐ SHELL COMPANY REPORT PURSUANT ...

Financial Performance - The net loss for Q4 2022 was £15.2 million, compared to a net loss of £13.6 million for Q4 2021; the net loss for the year 2022 was £32.0 million, an improvement from £40.5 million in 2021[3]. - Basic and diluted loss per share for Q4 2022 was £0.29, compared to £0.26 for Q4 2021; for the year 2022, it was £0.61, down from £0.78 in 2021[3]. - The operating loss for the year was £17,248,000, compared to £15,737,000 in 2021, indicating an increase in losses of 10%[10]. - The loss for the period was £15,199,000, compared to £13,644,000 in 2021, which is an increase of 11%[10]. - Basic and diluted loss per share for the year was £0.29, compared to £0.26 in the previous year, indicating a worsening of 12%[10]. - The company reported a net loss for the period of £40.5 million, compared to £33.3 million in the previous year, indicating a year-over-year increase of approximately 21.6% in losses[12]. Cash and Liquidity - As of December 31, 2022, NuCana reported cash and cash equivalents of £41.9 million, down from £50.8 million as of September 30, 2022, and £60.3 million at December 31, 2021[3]. - NuCana's cash runway is anticipated to fund operations into 2025, supporting ongoing clinical programs[4][9]. - Cash used in operations was £30.4 million, a decrease from £33.7 million in the prior year, reflecting an improvement in operational efficiency[12]. - The company experienced a net cash used in investing activities of £120,000, compared to £3.5 million in the previous year, showing a significant reduction in investment outflows[12]. - Interest received was £6.3 million, a notable increase from £1.2 million year-over-year, indicating improved cash management strategies[12]. - The company reported a decrease in prepayments and accrued income of £30.7 million, reflecting tighter cash flow management[12]. - The net cash from financing activities was £66.2 million, indicating strong capital raising efforts through share issuance[12]. - Cash and cash equivalents at the beginning of the year were $60.26 million, with an effect of exchange rate changes on cash and cash equivalents amounting to $4.84 million[9]. - Cash and cash equivalents at the end of the year were $41.91 million, reflecting a decrease of $23.19 million[9]. Assets and Liabilities - Total assets as of December 31, 2022, amounted to £58,254,774, which is an increase from £57,474,000 in 2021[11]. - Non-current assets, including intangible assets, were valued at £23,652,410, compared to £24,100,000 in the previous year[11]. - Current assets totaled £39,574,161, showing a growth from £41,616,000 in 2021[11]. - Total equity attributable to equity holders of the company was £38,502,265, up from £35,548,000 in 2021[11]. - Current liabilities, including trade payables, were £48,031,829, reflecting an increase from £48,290,000 in the previous year[11]. - Total liabilities amounted to £19,752,121, which is an increase from £19,926,000 in 2021[11]. - The company reported accumulated deficit of £180,573, compared to £149,726 in the previous year[11]. - Provisions for liabilities were recorded at £4,100,000, consistent with the previous year[11]. - The company’s total equity and liabilities were £58,254,774, indicating a stable financial position[11]. Research and Development - NuCana plans to announce data from three clinical studies of NUC-3373 in 2023, including a Phase 2 study with 171 patients comparing NUFIRI plus bevacizumab to standard care[4][7]. - The company expects to provide updates on the Phase 2 part of the NuTide:701 study for NUC-7738, investigating its use as a monotherapy and in combination with pembrolizumab[4][7]. - The company achieved significant development milestones for NUC-3373 and NUC-7738 in 2022, progressing both to Phase 2 development[4]. - NUC-3373 is being evaluated for its potential to replace 5-FU across multiple tumor types, with ongoing studies aimed at optimizing treatment combinations[4][6]. - The NuTide:323 study aims to provide meaningful data for second-line colorectal cancer patients, potentially influencing future Phase 3 study designs[4][7]. Expenses - Research and development expenses for the year ended December 31, 2022, were £13,188,000, compared to £10,634,000 for the previous year, representing a 24% increase[10]. - Administrative expenses increased to £1,535,000 in 2022 from £2,073,000 in 2021, showing a decrease of 26%[10].