NCNA NuCana plc

6.33
-0.18  -3%
Previous Close 6.51
Open 6.49
52 Week Low 3.81
52 Week High 10.59
Market Cap $323,931,420
Shares 51,174,000
Float 51,174,000
Enterprise Value $196,772,655
Volume 401,320
Av. Daily Volume 528,684
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Upcoming Catalysts

Drug Stage Catalyst Date
NUC-7738 (NuTide:701)
Solid tumors
Phase 1
Phase 1
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NUC-3373 (NuTide:301)
Solid tumors
Phase 1
Phase 1
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Drug Pipeline

Drug Stage Notes
NUC-3373 (NuTide:302)
Colorectal Cancer
Phase 1b
Phase 1b
Phase 1b interim data released January 15, 2021. 62% disease control rate.
NUC-1031 (NuTide:121)
Front-Line Treatment of Advanced Biliary Tract Cancer
Phase 3
Phase 3
Phase 3 enrollment to be completed 2021.
NUC-1031 (Acelarin)
Platinum-sensitive ovarian cancer
Phase 2
Phase 2
Part 2 portion of trial will not be initiated.
NUC-1031 (Acelarin)
Pancreatic cancer
Phase 3
Phase 3
Phase 3 enrolment suspended due to futility - August 20, 2019.

Latest News

  1. Promising Efficacy Signals Including a 62% Disease Control Rate and a Partial Response in Patients who had Progressed on Prior Fluoropyrimidine Therapy

    Safety Profile Continues to be Favorable

    EDINBURGH, United Kingdom, Jan. 15, 2021 (GLOBE NEWSWIRE) -- NuCana plc (NASDAQ:NCNA) today announced interim data from the ongoing NuTide:302 study at the ASCO GI Conference, being held virtually January 15-17, 2021.

    NuTide:302 is a three-part study investigating NUC-3373, NuCana's targeted thymidylate synthase inhibitor, in heavily pre-treated patients with metastatic colorectal cancer. The study is evaluating NUC-3373's optimal dose and schedule in combination with agents commonly used to treat patients with colorectal cancer and is assessing safety…

    Promising Efficacy Signals Including a 62% Disease Control Rate and a Partial Response in Patients who had Progressed on Prior Fluoropyrimidine Therapy

    Safety Profile Continues to be Favorable

    EDINBURGH, United Kingdom, Jan. 15, 2021 (GLOBE NEWSWIRE) -- NuCana plc (NASDAQ:NCNA) today announced interim data from the ongoing NuTide:302 study at the ASCO GI Conference, being held virtually January 15-17, 2021.

    NuTide:302 is a three-part study investigating NUC-3373, NuCana's targeted thymidylate synthase inhibitor, in heavily pre-treated patients with metastatic colorectal cancer. The study is evaluating NUC-3373's optimal dose and schedule in combination with agents commonly used to treat patients with colorectal cancer and is assessing safety, pharmacokinetics and anti-cancer activity. NUC-3373 has been designed to overcome the main challenges associated with 5-FU and capecitabine, including cancer-resistance mechanisms which limit efficacy, off-target toxicity and administration burdens.

    The ASCO GI presentation highlighted data from 37 patients treated in Part I of the study who received NUC-3373 either as monotherapy or in combination with leucovorin. Ten patient case studies highlighted NUC-3373's ability to stabilize disease and achieve prolonged durations of progression-free survival. Many patients achieved longer progression-free survival on NUC-3373 than they had on their prior line of therapy and five patients experienced tumor shrinkage. These patients included:

    • A fourth-line patient who achieved a Partial Response with a 40% reduction in tumor volume;
    • A third-line patient who achieved a 28% reduction in tumor volume after their disease rapidly progressed through all prior fluoropyrimidine-containing regimens.

    Among the efficacy-evaluable population, a disease control rate of 62% was achieved.

    In addition to these encouraging efficacy signals, the presentation compared the safety profile of NUC-3373 in Part I of the study with historical data for 5-FU and capecitabine in the front-line treatment of patients with colorectal cancer. NUC-3373 was well tolerated with no hand-foot-syndrome or neutropenia as well as lower rates of diarrhea, mucositis and stomatitis.

    Dr. Andrew Coveler, Associate Professor at the University of Washington School of Medicine and Fred Hutchinson Cancer Research Center and an investigator in the NuTide:302 study, remarked: "I am encouraged by both the clinical activity and safety of NUC-3373. To observe this anti-cancer activity, including a Partial Response, in such a heavily pre-treated patient population is very promising. In addition, NUC-3373 has been well tolerated and its safety appears favorable when compared to 5-FU and capecitabine. As such, I look forward to advancing NUC-3373's development in patients with colorectal cancer."

    "We are very pleased with these additional data from Part I of the NuTide:302 study," said Hugh S. Griffith, NuCana's Founder and CEO. "It was particularly encouraging to observe tumor shrinkages, prolonged disease stabilization and a favorable safety profile in a patient population that had received at least two prior fluoropyrimidine-containing regimens. We look forward to continuing Part II of the study in which NUC-3373 is being combined with leucovorin and either oxaliplatin or irinotecan. Our objective is to replace 5-FU and capecitabine with NUC-3373 as the backbone of treatment for patients with colorectal cancer."

    Details of the poster presentation are as follows:

     Title: A phase Ib study of NUC-3373 in combination with standard therapies in

    advanced/metastatic colorectal cancer (NuTide:302) 

    Session: Colorectal Cancer

    Abstract Number: 93

    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. NuCana's 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 III study for patients with advanced biliary tract cancer and a Phase III study for patients with metastatic pancreatic cancer for which enrollment has been suspended. NUC-3373 is in a Phase I study for the potential treatment of a wide range of patients with 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 "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 Company's planned and ongoing clinical studies for the Company's 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, including NuTide:121; the Company's 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 Company's 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 Company's 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 Company's 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.

    For more information, please contact:

    NuCana plc

    Hugh S. Griffith

    Chief Executive Officer

    T: +44 131 357 1111

    E:

    Westwicke, an ICR Company

    Chris Brinzey

    T: +1 339-970-2843

    E:

    RooneyPartners

    Marion Janic

    T: +1 212-223-4017

    E:



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  2. Pharmaceutical Executive Brings a Wealth of Experience to NuCana's Board of Directors

    Previously Served as CEO of Algeta, Chairman of Wilson Therapeutics and Chairman of KaNDy Therapeutics

    EDINBURGH, United Kingdom, Dec. 21, 2020 (GLOBE NEWSWIRE) -- NuCana plc, a clinical-stage biopharmaceutical company focused on significantly improving treatment outcomes for patients with cancer, announced the appointment of Andrew Kay as Chairman of its Board of Directors.

    "We are delighted to welcome Andrew as NuCana's Board Chairman," said Hugh S. Griffith, NuCana's Founder and Chief Executive Officer. "Andrew is an internationally recognized executive and brings a wealth of leadership experience at several successful biotechnology and pharmaceutical…

    Pharmaceutical Executive Brings a Wealth of Experience to NuCana's Board of Directors

    Previously Served as CEO of Algeta, Chairman of Wilson Therapeutics and Chairman of KaNDy Therapeutics

    EDINBURGH, United Kingdom, Dec. 21, 2020 (GLOBE NEWSWIRE) -- NuCana plc, a clinical-stage biopharmaceutical company focused on significantly improving treatment outcomes for patients with cancer, announced the appointment of Andrew Kay as Chairman of its Board of Directors.

    "We are delighted to welcome Andrew as NuCana's Board Chairman," said Hugh S. Griffith, NuCana's Founder and Chief Executive Officer. "Andrew is an internationally recognized executive and brings a wealth of leadership experience at several successful biotechnology and pharmaceutical companies. His track record of building shareholder value throughout his career, along with his experience taking compounds through development and commercialization will bring significant value to NuCana. We look forward to working with Andrew as we advance our ProTide pipeline."

    Andrew Kay said, "I look forward to serving as Chairman of NuCana's Board as we leverage our ProTide technology platform with the aim of developing more efficacious and better tolerated medicines for patients with cancer. With several important ongoing clinical studies and numerous upcoming data announcements, I believe this is an exciting time to be joining NuCana's Board."

    Andrew Kay brings more than 30 years of experience in building and leading biotechnology and pharmaceutical companies. Andrew currently serves as Chairman of the Board of NeRRe Therapeutics and Blueberry Therapeutics. He also recently held the same role for KaNDy Therapeutics, a biotechnology company that was acquired by Bayer for a deal value of up to $875 million in 2020, and for Wilson Therapeutics, a biopharmaceutical company acquired by Alexion Pharmaceuticals for $855 million in 2018. Prior to that, Andrew served as the President and Chief Executive Officer for Algeta. During Andrew's leadership, Algeta's lead product, Xofigo, was approved by the FDA and EMA for the treatment of bone metastases in castration-resistant prostate cancer patients, followed by a strong commercial launch. In February 2014, Algeta was acquired by Bayer AG for $2.9 billion. Prior to Algeta, Andrew was the Global Head of Marketing and Sales and a Member of the Healthcare Committee and Pharmaceutical Executive Committee at Novartis, and held several other senior commercial positions in Europe and the US having worked at AstraZeneca, Eli Lilly, Sandoz and Boots.

    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. NuCana's 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 three clinical studies, including a Phase III study for patients with advanced 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 patients with 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 "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 Company's planned and ongoing clinical studies for the Company's 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, including NuTide:121; the Company's 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 Company's 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 Company's 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 Company's 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.

    For more information, please contact:

    NuCana plc

    Hugh S. Griffith

    Chief Executive Officer

    T: +44 131 357 1111

    E:

    Westwicke, an ICR Company

    Chris Brinzey

    T: +1 339-970-2843

    E:

    RooneyPartners

    Marion Janic

    T: +1 212-223-4017

    E:



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  3. Acelarin plus Cisplatin's High Objective Response Rate and Favorable Safety Profile Confirmed

    NuTide:121 Global Phase III Study Recruitment Ongoing

    EDINBURGH, United Kingdom, Nov. 30, 2020 (GLOBE NEWSWIRE) -- NuCana plc (NASDAQ:NCNA) announced that the final results of the Phase Ib study of Acelarin plus cisplatin for patients with advanced biliary tract cancer (ABC-08) have been published online ahead of print in The Oncologist. Encouraging interim data had previously been reported and the final data confirm the high objective response rate and favorable safety profile of Acelarin plus cisplatin in this patient population.

    In the efficacy-evaluable patient population, the Objective Response Rate was 44%. By comparison, in the ABC-02 study…

    Acelarin plus Cisplatin's High Objective Response Rate and Favorable Safety Profile Confirmed

    NuTide:121 Global Phase III Study Recruitment Ongoing

    EDINBURGH, United Kingdom, Nov. 30, 2020 (GLOBE NEWSWIRE) -- NuCana plc (NASDAQ:NCNA) announced that the final results of the Phase Ib study of Acelarin plus cisplatin for patients with advanced biliary tract cancer (ABC-08) have been published online ahead of print in The Oncologist. Encouraging interim data had previously been reported and the final data confirm the high objective response rate and favorable safety profile of Acelarin plus cisplatin in this patient population.

    In the efficacy-evaluable patient population, the Objective Response Rate was 44%. By comparison, in the ABC-02 study, which led to gemcitabine plus cisplatin becoming the current standard of care for the first-line treatment of patients with advanced biliary tract cancer, an Objective Response Rate of 26% was achieved in the efficacy-evaluable population.

    Dr. Mairéad McNamara, Co-Chief Investigator of the ABC-08 study and Senior Lecturer and Honorary Consultant in Medical Oncology at the University of Manchester and The Christie NHS Foundation Trust remarked: "Acelarin combined with cisplatin demonstrated a favorable safety profile and achieved good tumor control. Responses were seen across all five biliary tract cancer sub-types, including a Complete Response in one patient, a very rare occurrence in this patient population. In ABC-02, only one out of 161 efficacy-evaluable patients who received gemcitabine plus cisplatin achieved a Complete Response. Additionally, one patient with Stable Disease, whose tumor had initially been considered unsuitable for surgical resection, was able to have complete surgical removal of the tumor following treatment with Acelarin plus cisplatin. Four patients were still alive at the end of follow-up, having survived between 16 and 36 months."

    "We are very encouraged by the final efficacy and safety data from ABC-08", said Hugh S. Griffith, NuCana's founder and CEO. "We are committed to developing Acelarin plus cisplatin as the first approved front-line treatment for patients with advanced biliary tract cancer. We continue to drive recruitment in the ongoing Phase III NuTide:121 Study where we believe we have the potential opportunity to apply for accelerated approval based on Objective Response Rate. We remain on track to enroll the required number of patients in NuTide:121 by the end of 2021 in order to conduct the first interim analysis in 2022."

    Professor Juan Valle, Co-Chief Investigator of the ABC-02, ABC-08 and NuTide:121 studies and Professor and Honorary Consultant in Medical Oncology at the University of Manchester and The Christie NHS Foundation Trust said: "Biliary tract cancer is a devastating disease for which more effective treatments are desperately needed. While targeted therapies and immunotherapies may play a role in the treatment of biliary tract cancer in the future, chemotherapy will remain the backbone of treatment. Medicines like Acelarin, with the potential for improved efficacy and safety, would be welcome additions to the treatment options for patients with biliary tract cancer."

    About NuTide:121

    NuTide:121 is a global, multi-center, randomized Phase III study that is enrolling up to 828 patients in approximately 130 sites across North America, Europe, Asia and Australia. Patients are being randomized 1:1 and treated with either a combination of Acelarin (725 mg/m2) plus cisplatin (25 mg/m2) or the current standard of care regimen, gemcitabine (1,000 mg/m2) plus cisplatin (25 mg/m2). The primary objectives of NuTide:121 are Overall Survival (OS) and Objective Response Rate (ORR). Three interim analyses, including two designed to support accelerated approval, are planned as part of the Phase III study protocol, in addition to the final analysis. Based on discussions with the FDA and subject to any further regulatory guidance, the Company believes that a statistically significant improvement in ORR at either of the first two interim analyses, supported by positive trends in other endpoints, could potentially allow for an accelerated approval of a new drug application (NDA) for Acelarin. Accelerated approval requires a confirmatory clinical study to verify the drug's clinical benefit. If accelerated approval were to occur, NuTide:121 would continue and the Company anticipates that data from subsequent analyses could provide the confirmatory data to support full (regular) approval.

    About Biliary Tract Cancer

    Biliary tract cancer, including cholangiocarcinoma, gallbladder and ampullary carcinoma, is cancer originating in the bile duct, a vessel that transports bile from the liver to the gallbladder and small intestine. Approximately 178,000 new cases of biliary tract cancer are diagnosed each year worldwide, with more than 18,000 of those diagnoses in the United States. There are currently no agents approved for the treatment of biliary tract cancer; however, the worldwide standard of care in the first-line setting for patients with advanced biliary tract cancer is the combination of gemcitabine and cisplatin.

    About NuCana plc

    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. NuCana's 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 three clinical studies, including a Phase III study for patients with advanced 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 patients with 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 "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 Company's planned and ongoing clinical studies for the Company's 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, including NuTide:121; the potential for accelerated approval of Acelarin; the Company's 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 Company's 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 Company's 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 Company's 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.

     For more information, please contact:

    Hugh S. Griffith

    Chief Executive Officer

    NuCana plc

    Tel: +44 131 357 1111

    Westwicke, an ICR Company

    Chris Brinzey

    Tel: +1 339-970-2843

    RooneyPartners

    Marion Janic

    Tel: +1 212-223-4017



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  4. Completed Successful $80 million 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 NuCana's public offering in September 2020. NuCana continues to advance its various clinical programs and reported a net loss of £8.4 million…

    Completed Successful $80 million 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 NuCana's 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, NuCana's 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-3373's 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."

    Anticipated 2021 Milestones

    • 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. NuCana's 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 "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 sufficiency of the Company's current cash and cash equivalents; the Company's planned and ongoing clinical studies for the Company's 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 Company's 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 Company's 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 Company's expectations as to the sufficiency of the Company's 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 Company's 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 Company's 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 ended

    September 30,

     For the nine months ended

    September 30,
     
     2020 2019  2020 2019 
     (in thousands, except per share data)
     £ £  £ £ 
              
    Research and development expenses(6,117)(4,845) (17,918)(14,551)
    Administrative expenses(1,906)(1,423) (5,144)(4,231)
    Net foreign exchange (losses) gains(1,601)1,227  610 1,191 
    Operating loss(9,624)(5,041) (22,452)(17,591)
    Finance income26 252  234 867 
    Loss before tax (9,598)(4,789) (22,218)(16,724)
    Income tax credit1,204 912  3,797 3,020 
    Loss for the period(8,394)(3,877) (18,421)(13,704)
              
              
    Basic and diluted loss per share(0.24)(0.12) (0.55)(0.42)
          





    Unaudited Condensed
    Consolidated Statements of Financial Position

     September 30,

    2020
     December 31,

    201
    9
     
     (in thousands)
     £ £ 
    Assets  
    Non-current assets  
    Intangible assets4,686 3,960 
    Property, plant and equipment1,281 1,109 
    Deferred tax asset34 46 
     6,001 5,115 
    Current assets  
    Prepayments, accrued income and other receivables5,065 4,710 
    Current income tax receivable8,140 8,481 
    Cash and cash equivalents100,678 51,962 
     113,883 65,153 
    Total assets119,884 70,268 
    Equity and liabilities  
    Capital and reserves  
    Share capital and share premium142,937 80,840 
    Other reserves65,740 62,737 
    Accumulated deficit(98,403)(80,055)
    Total equity attributable to equity holders of the Company110,274 63,522 
       
    Non-current liabilities  
    Provisions46 26 
    Lease liabilities441 538 
     487 564 
       
    Current liabilities  
    Trade payables4,190 2,412 
    Payroll taxes and social security138 160 
    Lease liabilities278 268 
    Accrued expenditure4,517 3,342 
     9,123 6,182 
       
    Total liabilities9,610 6,746 
       
    Total equity and liabilities119,884 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 depreciation667 522 
    Finance income(234)(867)
    Interest expense on lease liabilities20 - 
    Share-based payments3,069 2,191 
    Net foreign exchange gains(619)(1,228)
     (19,315)(16,106)
    Movements in working capital:  
    Increase in prepayments, accrued income and other receivables(408)(3,593)
    Increase (decrease) in trade payables1,778 (300)
    Increase in payroll taxes, social security and accrued expenditure1,153 8 
    Movements in working capital2,523 (3,885)
    Cash used in operations(16,792)(19,991)
    Net income tax received4,152 20 
    Net cash used in operating activities(12,640)(19,971)
    Cash flows from investing activities  
    Interest received300 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 options15 117 
    Proceeds from issue of share capital66,581 - 
    Share issue expenses(4,499)- 
    Net cash from (used in) financing activities 61,874 (29)
    Net increase (decrease) in cash and cash equivalents48,105 (20,102)
    Cash and cash equivalents at beginning of period51,962 76,972 
    Effect of exchange rate changes on cash and cash equivalents611 1,221 
    Cash and cash equivalents at end of period100,678 58,091 
         





    For more information, please contact:

    NuCana plc

    Hugh S. Griffith

    Chief Executive Officer

    T: +44 131 357 1111

    E:

    Westwicke, an ICR Company

    Chris Brinzey

    T: +1 339-970-2843

    E:

    RooneyPartners

    Marion Janic

    T: +1 212-223-4017

    E:

     



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  5. EDINBURGH, United Kingdom, Nov. 17, 2020 (GLOBE NEWSWIRE) -- NuCana plc (NASDAQ:NCNA) announced today that Hugh Griffith, Chief Executive Officer, and Don Munoz, Chief Financial Officer, will present and host one-on-one meetings at the Piper Sandler 32nd Annual Healthcare Conference being held virtually from December 1 to December 3, 2020.

    Event: Piper Sandler 32nd Annual Healthcare Conference
    Pre-Recorded Presentation Replay: November 23, 2020 – December 3, 2020

    The presentation will be pre-recorded and available for replay starting Monday, November 23, 2020 at 10:00 AM ET under "Events & Presentations" in the Investors section of the Company's website at www.nucana.com.

    About NuCana plc

    NuCana is a clinical-stage biopharmaceutical company…

    EDINBURGH, United Kingdom, Nov. 17, 2020 (GLOBE NEWSWIRE) -- NuCana plc (NASDAQ:NCNA) announced today that Hugh Griffith, Chief Executive Officer, and Don Munoz, Chief Financial Officer, will present and host one-on-one meetings at the Piper Sandler 32nd Annual Healthcare Conference being held virtually from December 1 to December 3, 2020.

    Event: Piper Sandler 32nd Annual Healthcare Conference

    Pre-Recorded Presentation Replay: November 23, 2020 – December 3, 2020

    The presentation will be pre-recorded and available for replay starting Monday, November 23, 2020 at 10:00 AM ET under "Events & Presentations" in the Investors section of the Company's website at www.nucana.com.

    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. NuCana's 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 "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 Company's planned and ongoing clinical studies for the Company's 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 Company's 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 Company's 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 Company's 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 Company's 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.

    For more information, please contact:

    Hugh S. Griffith

    Chief Executive Officer

    NuCana plc

    Tel: +44 131 357 1111

    Westwicke, an ICR Company

    Chris Brinzey

    Tel: +1 339-970-2843

    RooneyPartners

    Marion Janic

    Tel: +1 212-223-4017



    View Full Article Hide Full Article
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