GlobeNewswire Inc | Nov 18, 2021 04:01PM EST

November 18, 2021

Enrolled Required Number of Patients to Conduct First Interim Analysis in Phase 3 Biliary Tract Cancer Study in the First Half of 2022

Received Fast Track Designation from FDA for Acelarin for the Treatment of Patients with Biliary Tract Cancer

Announced Additional Encouraging Clinical Data for NUC-3373 and NUC-7738 at ESMO

Multiple Near-Term Study Initiations and Data Announcements Expected

EDINBURGH, United Kingdom, Nov. 18, 2021 (GLOBE NEWSWIRE) -- NuCana plc (NASDAQ: NCNA) announced financial results for the third quarter ended September 30, 2021 and provided an update on its broad clinical program with its transformative ProTide therapeutics.

As of September 30, 2021, NuCana had cash and cash equivalents of 71.0 million compared to 73.4 million at June 30, 2021 and 87.4 million as of December 31, 2020. NuCana continues to advance its various clinical programs and reported a net loss of 8.0 million for the quarter ended September 30, 2021, as compared to a loss of 8.4 million for the quarter ended September 30, 2020. Basic and diluted loss per share was 0.15 for the quarter ended September 30, 2021, as compared to 0.24 per share for quarter ended September 30, 2020.

NuCana had a very productive third quarter, said Hugh S. Griffith, NuCanas Founder and Chief Executive Officer. We completed enrollment of 418 evaluable patients required to conduct the first interim analysis in the Phase III study (NuTide:121) evaluating Acelarin combined with cisplatin compared to the global standard of care, gemcitabine plus cisplatin, as a first-line treatment for patients with advanced biliary tract cancer. We believe that a statistically significant improvement in the Objective Response Rate (ORR) at the first interim analysis, accompanied by positive trends in other endpoints, has the potential to allow for accelerated approval of a new drug application (NDA) for Acelarin in the United States. We look forward to announcing the outcome of the first interim analysis in the first half of 2022.

Mr. Griffith continued: Additionally, we announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation for Acelarin (NUC-1031) for the treatment of patients with biliary tract cancer. With both Fast Track and Orphan Drug designations in place, we look forward to working closely with the FDA in our efforts to gain approval for Acelarin as the first approved front-line treatment option for patients with biliary tract cancer.

We also announced positive data at the European Society for Medical Oncology (ESMO) Congress 2021 for three of our programs: NUC-3373 in patients with advanced colorectal cancer (NuTide:302); NUC-3373 in patients with advanced solid tumors (NuTide:301); and NUC-7738 in patients with advanced solid tumors (NuTide:701), said Mr. Griffith. Building on the exciting data presentations we made earlier in the year at AACR and ASCO GI, the data presented at ESMO continue to support the broad potential of our ProTide technology by demonstrating encouraging efficacy signals, durable anti-cancer activity and favorable safety and pharmacokinetic profiles.

Mr. Griffith added: We would like to express our sincere appreciation to Rafale Tordjman who retired as a director in September after ten years on the NuCana Board. We are also pleased to have welcomed Elliott Levy, who was most recently SVP of Global Development and R&D Strategy at Amgen, to the NuCana Board in November.

Mr. Griffith concluded: Throughout the remainder of 2021 and in the first half of 2022, we look forward to achieving multiple milestones, including: initiating a Phase III study of NUC-3373 in combination with other agents for patients with colorectal cancer, subject to anticipated regulatory feedback; reporting additional data from the Phase Ib / Phase II study of NUC-3373 in combination with other agents for patients with colorectal cancer; and initiating and reporting data from the Phase II study of NUC-7738 in patients with solid tumors.

Anticipated Milestones: Q4 2021 & H1 2022

? Acelarin (a ProTide transformation of gemcitabine) In the first half of 2022, NuCana expects to: Announce whether the overall response rate objective for the first interim data from the Phase III study of Acelarin combined with cisplatin ? as a first-line treatment for patients with advanced biliary tract cancer has been met, which may allow for accelerated approval of an NDA submission in the United States. ? NUC-3373 (a ProTide transformation of 5-FU) In Q4 2021, NuCana expects to: Initiate a Phase III study of NUC-3373 in combination with other agents ? for patients with colorectal cancer, subject to anticipated regulatory feedback. In the first half of 2022, NuCana expects to: ? Initiate a Phase Ib / Phase II basket study of NUC-3373 in combination with other agents in a variety of solid tumors; and Expand the Phase Ib / Phase II study of NUC-3373 in combination with ? other agents for patients with colorectal cancer to include second-line colorectal cancer patients, as well as evaluate NUC-3373 in combination with monoclonal antibodies such as bevacizumab (Avastin^). ? NUC-7738 (a ProTide transformation of 3?-deoxyadenosine) In Q4 2021, NuCana expects to: ? Initiate the Phase II study of NUC-7738 in patients with solid tumors. In the first half of 2022, NuCana expects to: ? Report data from the Phase II study of NUC-7738 in patients with solid tumors.

About NuCana

NuCana is a clinical-stage biopharmaceutical company focused on significantly improving treatment outcomes for patients with cancer by applying our ProTide technology to transform some of the most widely prescribed chemotherapy agents, nucleoside analogs, into more effective and safer medicines. While these conventional agents remain part of the standard of care for the treatment of many solid and hematological tumors, their efficacy is limited by cancer cell resistance mechanisms and they are often poorly tolerated. Utilizing our proprietary technology, we are developing new medicines, ProTides, designed to overcome key cancer resistance mechanisms and generate much higher concentrations of anti-cancer metabolites in cancer cells. NuCanas robust pipeline includes three ProTides in clinical development. Acelarin and NUC-3373, are new chemical entities derived from the nucleoside analogs gemcitabine and 5-fluorouracil, respectively, two widely used chemotherapy agents. Acelarin is in a Phase 3 study for patients with advanced biliary tract cancer. NUC-3373 is in a Phase 1b/2 study in patients with metastatic colorectal cancer. Our third ProTide, NUC-7738, is a transformation of a novel anti-cancer nucleoside analog (3-deoxyadenosine) and is in a Phase 1 study for patients with advanced solid tumors.

Forward-Looking Statements

This press release may contain forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 that are based on the beliefs and assumptions and on information currently available to management of NuCana plc (the Company). All statements other than statements of historical fact contained in this press release are forward-looking statements, including statements concerning the Companys planned and ongoing clinical studies for the Companys product candidates and the potential advantages of those product candidates, including Acelarin, NUC-3373 and NUC-7738; the initiation, enrollment, timing, progress, release of data from and results of those planned and ongoing clinical studies; the potential benefits of Fast Track designation for Acelarin and the Companys ability to submit an NDA for Acelarin under the FDAs accelerated approval program or at all; the Companys goals with respect to the development, regulatory pathway and potential use, if approved, of each of its product candidates; and the utility of prior non-clinical and clinical data in determining future clinical results. In some cases, you can identify forward-looking statements by terminology such as may, will, should, expects, plans, anticipates, believes, estimates, predicts, potential or continue or the negative of these terms or other comparable terminology. Forward-looking statements involve known and unknown risks, uncertainties and other factors that may cause the Companys actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements. These risks and uncertainties include, but are not limited to, the risks and uncertainties set forth in the Risk Factors section of the Companys Annual Report on Form 20-F for the year ended December 31, 2020 filed with the Securities and Exchange Commission (SEC) on March 4, 2021, and subsequent reports that the Company files with the SEC. Forward-looking statements represent the Companys beliefs and assumptions only as of the date of this press release. Although the Company believes that the expectations reflected in the forward-looking statements are reasonable, it cannot guarantee future results, levels of activity, performance or achievements. Except as required by law, the Company assumes no obligation to publicly update any forward-looking statements for any reason after the date of this press release to conform any of the forward-looking statements to actual results or to changes in its expectations.

Unaudited Condensed Consolidated Statements of Operations

For the three months For the nine months ended ended September 30, September 30, 2021 2020 2021 2020 (in thousands, except per share data) Research and development (8,971 ) (6,117 ) (26,200 ) (17,918 )expensesAdministrative expenses (2,277 ) (1,906 ) (6,456 ) (5,144 )Net foreign exchange gains 1,274 (1,601 ) 488 610 (losses)Operating loss (9,974 ) (9,624 ) (32,168 ) (22,452 )Finance income 22 26 81 234 Loss before tax (9,952 ) (9,598 ) (32,087 ) (22,218 )Income tax credit 1,911 1,204 5,198 3,797 Loss for the period (8,041 ) (8,394 ) (26,889 ) (18,421 ) Basic and diluted loss per (0.15 ) (0.24 ) (0.52 ) (0.55 )share

Unaudited Condensed Consolidated Statements of Financial Position

September December31, 30, 2020 2021 (in thousands) Assets Non-current assets Intangible assets 4,896 4,753 Property, plant and equipment 952 1,189 Deferred tax asset 34 44 Other non-current assets 2,600 - 8,482 5,986 Current Assets Prepayments, accrued income and other 5,133 4,628 receivablesCurrent income tax receivable 5,143 9,822 Cash and cash equivalents 71,027 87,356 81,303 101,806 Total assets 89,785 107,792 Equity and liabilities Capital and reserves Share capital and share premium 143,136 142,937 Other reserves 70,395 66,887 Accumulated deficit (136,084 ) (110,594 ) Total equity attributable to equity holders 77,447 99,230 of the Company Non-current liabilities Provisions 46 46 Lease liabilities 195 367 241 413 Current Liabilities Trade payables 3,891 2,257 Payroll taxes and social security 152 177 Accrued expenditure 7,811 5,437 Lease liabilities 243 278 12,097 8,149 Total liabilities 12,338 8,562 Total equity and liabilities 89,785 107,792

Unaudited Condensed Consolidated Statements of Cash Flows

For the nine months ended September 30, 2021 2020 (in thousands) Cash flows from operating activities Loss for the period (26,889 ) (18,421 )Adjustments for: Income tax credit (5,198 ) (3,797 )Amortization and depreciation 673 667 Finance income (81 ) (234 )Interest expense on lease liabilities 15 20 Share-based payments 4,919 3,069 Net foreign exchange gains (533 ) (619 ) (27,094 ) (19,315 )Movements in working capital: Increase in prepayments, accrued income and other (497 ) (408 )receivablesIncrease in trade payables 1,634 1,778 Increase in payroll taxes, social security and accrued 2,333 1,153 expenditureMovements in working capital 3,470 2,523 Cash used in operations (23,624 ) (16,792 )Net income tax received 9,888 4,152 Net cash used in operating activities (13,736 ) (12,640 )Cash flows from investing activities Interest received 79 300 Payments for property, plant and equipment (43 ) (350 )Payments for intangible assets (537 ) (1,079 )Payments for other non-current assets (2,597 ) - Net cash used in investing activities (3,098 ) (1,129 )Cash flows from financing activities Payments of lease liabilities (222 ) (223 )Proceeds from issue of share capital ? exercise of share 198 15 optionsProceeds from issue of share capital - 66,581 Share issue expenses - (4,499 )Net cash (used in) from financing activities (24 ) 61,874 Net (decrease) increase in cash and cash equivalents (16,858 ) 48,105 Cash and cash equivalents at beginning of period 87,356 51,962 Effect of exchange rate changes on cash and cash 529 611 equivalentsCash and cash equivalents at end of period 71,027 100,678

For more information, please contact:

NuCana plcHugh S. GriffithChief Executive Officer+44 131 357 1111info@nucana.com

ICRWestwickeChris Brinzey+1 339-970-2843chris.brinzey@westwicke.com

RooneyPartnersMarion Janic+1 212-223-4017mjanic@rooneyco.com