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NuCana Reports Third Quarter 2020 Financial Results and Provides


GlobeNewswire Inc | Nov 19, 2020 04:01PM EST

November 19, 2020

Completed Successful $80million Public Offering

Presented Encouraging Data for NUC-3373 and NUC-7738 at the ESMO Virtual Congress 2020

EDINBURGH, United Kingdom, Nov. 19, 2020 (GLOBE NEWSWIRE) -- NuCana plc (NASDAQ: NCNA) announced financial results for the third quarter ended September 30, 2020 and provided an update on its broad clinical program with its transformative ProTide therapeutics.

As of September 30, 2020, NuCana had cash and cash equivalents of 100.7 million compared to 47.8 million at June 30, 2020 and 52.0 million at December 31, 2019. This cash balance includes the net proceeds from NuCanas public offering in September 2020. NuCana continues to advance its various clinical programs and reported a net loss of 8.4 million for the quarter ended September 30, 2020, as compared to 3.9 million for the quarter ended September 30, 2019. Basic and diluted loss per share was 0.24 for the quarter as compared to 0.12 per share for the prior-year quarter.

We are very pleased with our achievements during the third quarter, said Hugh S. Griffith, NuCanas Founder and Chief Executive Officer. We significantly augmented our financial position with the successful completion of this public offering, supporting our progress towards several important milestones. These milestones include filing a New Drug Application (NDA) for Acelarin in biliary tract cancer, filing an NDA for NUC-3373 in colorectal cancer, and completing a Phase II clinical study for NUC-7738, in each case subject to regulatory feedback and clinical outcomes.

Mr. Griffith continued: We also presented encouraging data at the ESMO Virtual Congress 2020, including a poster highlighting interim data from the ongoing Phase Ib study of NUC-3373 in combination with other agents typically combined with 5-FU in patients with advanced colorectal cancer (NuTide:302) and a poster detailing the first-ever clinical data from the ongoing Phase I study of NUC-7738 in patients with advanced solid tumors (NuTide:701). We believe the data from the NuTide:302 study support the potential of NUC-3373 to improve progression-free survival in patients who had relapsed or were refractory to prior 5-FU-containing regimens. We also believe these data show NUC-3373s potential to offer enhanced efficacy, an improved safety profile and a more convenient dosing regimen as compared to 5-FU. With respect to NUC-7738, we believe the interim data from the NuTide:701 study demonstrate that NUC-7738 has a favorable pharmacokinetic and tolerability profile and is showing encouraging anti-cancer activity.

Mr. Griffith concluded, We continue to drive recruitment in all of our ongoing studies and remain focused on our mission of developing safer and more effective medicines for patients with cancer.

Anticipated2021Milestones

-- Acelarin is a ProTide transformation of gemcitabine. In 2021, NuCana expects to: Complete recruitment to enable the first interim analysis of the Phase III study of Acelarin combined with cisplatin as a first-line treatment for patients with advanced biliary tract cancer. -- NUC-3373 is a ProTide transformation of the active anti-cancer metabolite of 5-FU. In 2021, NuCana expects to: Report data from the Phase Ib study (NuTide:302) of NUC-3373 in combination with other agents with which 5-FU is typically combined, such as leucovorin, oxaliplatin and irinotecan in patients with advanced colorectal cancer.Initiate and report data from a Phase Ib expansion / Phase II study of NUC-3373 in combination with other agents for patients with colorectal cancer.Initiate a Phase III study of NUC-3373 in combination with other agents for patients with colorectal cancer.Report data from the ongoing Phase I study (NuTide:301) of NUC-3373 in patients with advanced solid tumors.

-- NUC-7738 is a ProTide transformation of a novel nucleoside analog, 3-deoxyadenosine. In 2021, NuCana expects to: Report data from the Phase I study (NuTide:701) of NUC-7738 in patients with advanced solid tumors.Initiate a Phase II study of NUC-7738 in patients with solid tumors.

About NuCana plc

NuCana is a clinical-stage biopharmaceutical company focused on significantly improving treatment outcomes for cancer patients 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 currently being evaluated in four clinical studies, including a Phase III study for patients with biliary tract cancer, a Phase Ib study for patients with biliary tract cancer, a Phase II study for patients with platinum-resistant ovarian cancer and a Phase III study for patients with metastatic pancreatic cancer for which enrollment has been suspended. NUC-3373 is currently in a Phase I study for the potential treatment of a wide range of advanced solid tumors and a Phase Ib study for patients with metastatic colorectal cancer. Our third ProTide, NUC-7738, is a transformation of a novel nucleoside analog (3-deoxyadenosine) and is in a Phase I study for patients with advanced solid tumors.

Forward-Looking Statements

This press release may contain forwardlooking 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 sufficiency of the Companys current cash and cash equivalents;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 impact of COVID-19 on its preclinical studies, clinical studies, business, financial condition and results of operations; the Companys goals with respect to the development 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 fact that the Companys expectations as to the sufficiency of the Companys current cash and cash equivalents to fund its planned operations excludes any potential costs related to pre-commercial activities or, if approved, commercialization costs, as well as 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, 2019 filed with the Securities and Exchange Commission (SEC) on March 10, 2020, 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 forwardlooking 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,

2020 2019 2020 2019 (in thousands, except per share data) Research and development (6,117 ) (4,845 ) (17,918 ) (14,551 )expensesAdministrative expenses (1,906 ) (1,423 ) (5,144 ) (4,231 )Net foreign exchange (losses) (1,601 ) 1,227 610 1,191 gainsOperating loss (9,624 ) (5,041 ) (22,452 ) (17,591 )Finance income 26 252 234 867 Loss before tax (9,598 ) (4,789 ) (22,218 ) (16,724 )Income tax credit 1,204 912 3,797 3,020 Loss for the period (8,394 ) (3,877 ) (18,421 ) (13,704 ) Basic and diluted loss per (0.24 ) (0.12 ) (0.55 ) (0.42 )share

Unaudited Condensed Consolidated Statements of Financial Position

September December 30, 31, 2020 2019 (in thousands) Assets Non-current assets Intangible assets 4,686 3,960 Property, plant and equipment 1,281 1,109 Deferred tax asset 34 46 6,001 5,115 Current assets Prepayments, accrued income and other receivables 5,065 4,710 Current income tax receivable 8,140 8,481 Cash and cash equivalents 100,678 51,962 113,883 65,153 Total assets 119,884 70,268 Equity and liabilities Capital and reserves Share capital and share premium 142,937 80,840 Other reserves 65,740 62,737 Accumulated deficit (98,403 ) (80,055 )Total equity attributable to equity holders of the 110,274 63,522 Company Non-current liabilities Provisions 46 26 Lease liabilities 441 538 487 564 Current liabilities Trade payables 4,190 2,412 Payroll taxes and social security 138 160 Lease liabilities 278 268 Accrued expenditure 4,517 3,342 9,123 6,182 Total liabilities 9,610 6,746 Total equity and liabilities 119,884 70,268

Unaudited Condensed Consolidated Statements of Cash Flows

For the nine months ended September 30, 2020 2019 (in thousands) Cash flows from operating activities Loss for the period (18,421 ) (13,704 )Adjustments for: Income tax credit (3,797 ) (3,020 )Amortization and depreciation 667 522 Finance income (234 ) (867 )Interest expense on lease liabilities 20 - Share-based payments 3,069 2,191 Net foreign exchange gains (619 ) (1,228 ) (19,315 ) (16,106 )Movements in working capital: Increase in prepayments, accrued income and other (408 ) (3,593 )receivablesIncrease (decrease) in trade payables 1,778 (300 )Increase in payroll taxes, social security and accrued 1,153 8 expenditureMovements in working capital 2,523 (3,885 )Cash used in operations (16,792 ) (19,991 )Net income tax received 4,152 20 Net cash used in operating activities (12,640 ) (19,971 )Cash flows from investing activities Interest received 300 915 Payments for property, plant and equipment (350 ) (29 )Payments for intangible assets (1,079 ) (988 )Net cash used in investing activities (1,129 ) (102 )Cash flows from financing activities Payments of lease liabilities (223 ) (146 )Proceeds from issue of share capital ? exercise of share 15 117 optionsProceeds from issue of share capital 66,581 - Share issue expenses (4,499 ) - Net cash from (used in) financing activities 61,874 (29 )Net increase (decrease) in cash and cash equivalents 48,105 (20,102 )Cash and cash equivalents at beginning of period 51,962 76,972 Effect of exchange rate changes on cash and cash 611 1,221 equivalentsCash and cash equivalents at end of period 100,678 58,091



For more information, please contact:

NuCana plcHugh S. GriffithChief Executive OfficerT: +44 131 357 1111E: info@nucana.com

Westwicke, an ICR CompanyChris BrinzeyT: +1 339-970-2843E: chris.brinzey@westwicke.com

RooneyPartnersMarion JanicT: +1 212-223-4017E: mjanic@rooneyco.com









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