NCNA NuCana plc

2.54
-0.03  -1%
Previous Close 2.57
Open 2.56
52 Week Low 1.88
52 Week High 7.83
Market Cap $132,491,592
Shares 52,162,044
Float 52,162,044
Enterprise Value $34,427,697
Volume 411,870
Av. Daily Volume 2,278,189
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Upcoming Catalysts

Drug Stage Catalyst Date
NUC-1031 (NuTide:121) + Cisplatin
Advanced biliary tract cancer
Phase 3
Phase 3
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NUC-7738 (NuTide:701)
Solid tumors
Phase 1
Phase 1
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Drug Pipeline

Drug Stage Notes
NUC-3373 (NuTide:302)
Colorectal Cancer
Phase 1/2
Phase 1/2
Phase 1b data showed several patients achieved a longer progression-free survival (PFS), tumor reductions in 3 patients: 1 who experienced a 40% reduction in their target lesion and 2 others with 28% and 15% reductions in overall tumor burden. Phase 1b trial now expanded into Phase 1b/2 trial, September 16, 2021.
NUC-3373 (NuTide:301)
Solid tumors
Phase 1
Phase 1
Phase 1 showed 3 patients achieved stable disease (SD), September 16, 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. EDINBURGH, United Kingdom, Sept. 29, 2021 (GLOBE NEWSWIRE) -- NuCana plc (NASDAQ:NCNA) announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to Acelarin (NUC-1031), currently being evaluated in a Phase III study (NuTide:121) for the first-line treatment of patients with advanced biliary tract cancer. Fast Track is a process designed to facilitate the development and expedite the review of drugs to treat serious conditions and address an unmet medical need.

    "We are very pleased that the FDA recognizes the potential of Acelarin to address the significant unmet need of patients with biliary tract cancer," said Hugh S. Griffith, NuCana's Founder and Chief Executive Officer. "We recently announced enrollment…

    EDINBURGH, United Kingdom, Sept. 29, 2021 (GLOBE NEWSWIRE) -- NuCana plc (NASDAQ:NCNA) announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to Acelarin (NUC-1031), currently being evaluated in a Phase III study (NuTide:121) for the first-line treatment of patients with advanced biliary tract cancer. Fast Track is a process designed to facilitate the development and expedite the review of drugs to treat serious conditions and address an unmet medical need.

    "We are very pleased that the FDA recognizes the potential of Acelarin to address the significant unmet need of patients with biliary tract cancer," said Hugh S. Griffith, NuCana's Founder and Chief Executive Officer. "We recently announced enrollment of 418 evaluable patients in our Phase III study, which is expected to enable the first interim analysis in the first half of 2022. This has the potential to allow for an accelerated approval of a new drug application (NDA) for Acelarin in the United States. 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."

    About Fast Track Designation

    Fast track is a process designed to facilitate the development, and expedite the review of drugs to treat serious conditions and fill an unmet medical need. The purpose is to get important new drugs to the patient earlier. Filling an unmet medical need is defined as providing a therapy where none exists or providing a therapy which may be potentially better than available therapy. Once a drug receives Fast Track designation, early and frequent communication between the FDA and a drug company is encouraged throughout the entire drug development and review process. The frequency of communication assures that questions and issues are resolved quickly, often leading to earlier drug approval and access by patients.

    About Biliary Tract Cancer

    Biliary tract cancer, including cholangiocarcinoma, gallbladder and ampullary carcinoma, are a group of cancers originating in the biliary tract. The biliary tract is comprised of the gallbladder and interconnecting ducts responsible for the transport of 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 first-line treatment of patients with advanced biliary tract cancer; however, the worldwide standard of care in these patients is the combination of gemcitabine and cisplatin. Patients receiving this regimen have a median overall survival of 11.7 months.

    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 (NUC-1031) 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 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 potential benefits of Fast Track designation for Acelarin; Acelarin's clinical development program continuing to meet the criteria for Fast Track designation; the Company's ability to submit an NDA for Acelarin under the FDA's accelerated approval program or at all; the Company's 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 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, 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 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

    +44 131 357 1111

    info@nucana.com

    Westwicke, an ICR Company

    Chris Brinzey

    +1 339-970-2843

    chris.brinzey@westwicke.com

    RooneyPartners

    Marion Janic

    +1 212-223-4017

    mjanic@rooneyco.com



    View Full Article Hide Full Article
  2.       NUC-3373 Continues to Demonstrate Encouraging Efficacy Signals and a Favorable Safety Profile in Patients with Advanced Colorectal Cancer

          NUC-3373 Phase 1 Study Demonstrated Encouraging Efficacy Signals and a Favorable Safety Profile in Patients with Advanced Solid Tumors and Established the Recommended Monotherapy Phase 2 Dose

          NUC-7738 Continues to Show Anti-cancer Activity and Prolonged Disease Control with a Favorable Tolerability and Pharmacokinetic Profile in Patients with Advanced Solid Tumors

    EDINBURGH, United Kingdom, Sept. 16, 2021 (GLOBE NEWSWIRE) -- NuCana plc (NASDAQ:NCNA), announced the presentation of four posters at the European Society for Medical Oncology (ESMO) Congress 2021. The Company presented additional…

          NUC-3373 Continues to Demonstrate Encouraging Efficacy Signals and a Favorable Safety Profile in Patients with Advanced Colorectal Cancer

          NUC-3373 Phase 1 Study Demonstrated Encouraging Efficacy Signals and a Favorable Safety Profile in Patients with Advanced Solid Tumors and Established the Recommended Monotherapy Phase 2 Dose

          NUC-7738 Continues to Show Anti-cancer Activity and Prolonged Disease Control with a Favorable Tolerability and Pharmacokinetic Profile in Patients with Advanced Solid Tumors

    EDINBURGH, United Kingdom, Sept. 16, 2021 (GLOBE NEWSWIRE) -- NuCana plc (NASDAQ:NCNA), announced the presentation of four posters at the European Society for Medical Oncology (ESMO) Congress 2021. The Company presented additional data from the ongoing Phase 1b/2 study of NUC-3373 in combination with standard therapies in patients with advanced colorectal cancer (NuTide:302), final data from the Phase 1 study of NUC-3373 in patients with advanced solid tumors (NuTide:301), and additional interim data from the Phase 1 study of NUC-7738 in patients with advanced solid tumors. The Company also presented a trials-in-progress poster describing the ongoing Phase 3 study of Acelarin plus cisplatin in patients with advanced biliary tract cancer.

    "The posters being presented during ESMO continue to support the potential of our ProTide platform to transform both existing as well as novel nucleoside analogues into more effective and safer medicines for patients with cancer," said Hugh S. Griffith, NuCana's Founder and Chief Executive Officer. "Looking ahead to the remainder of 2021 and first half of 2022, we have multiple milestones that we plan to announce. These include announcing the outcome of the first interim analysis in the Phase 3 NuTide:121 study of Acelarin plus cisplatin in patients with biliary tract cancer, initiating a registrational study for NUC-3373 in patients with colorectal cancer, and initiating and announcing data from a Phase 2 study of NUC-7738 in patients with advanced solid tumors."

    Details of NuCana's e-poster presentations during the ESMO Congress 2021 being held September 16-21, 2021 are as follows:

    NUC-3373

    NuCana presented two posters on NUC-3373, its ProTide transformation of the active anti-cancer metabolite of 5-fluorouracil (5-FU), one of the most widely used anti-cancer medicines. NUC-3373 has been designed to overcome the main challenges associated with 5-FU, including cancer-resistance mechanisms, the generation of toxic metabolites and unfavorable pharmacokinetics.

    Poster Title: A Phase Ib study of NUC-3373, a targeted inhibitor of thymidylate synthase, in combination with standard therapies in patients with advanced colorectal cancer (NuTide:302)

    This poster describes encouraging interim data from 38 patients with metastatic colorectal cancer. In this difficult-to-treat group, with patients having received a median of four prior lines of therapy, NUC-3373, with or without leucovorin, demonstrated encouraging signs of efficacy. In addition to several patients achieving a longer progression-free survival on NUC-3373 than they had on their prior therapy, tumor reductions were observed in three patients: one who experienced a 40% reduction in their target lesion and two others with 28% and 15% reductions, respectively, in overall tumor burden. NUC-3373 also demonstrated a favorable safety profile in this patient population with no FBAL or FUTP-associated Grade 3 or 4 toxicities, such as hand-foot syndrome, diarrhea or neutropenia.

    Based on these encouraging interim results, NuTide:302 has been expanded to a Phase 1b/2 study and now allows enrollment of less heavily pre-treated patients, including second-line colorectal cancer patients. A registrational study of NUC-3373 in second-line colorectal cancer patients is also planned.

    Poster Title: Final results of a first-in-human study of the ProTide thymidylate synthase inhibitor NUC-3373, in patients with advanced solid tumours (NuTide:301)

    This poster highlights final results from the NuTide:301 study in patients with advanced solid tumors. NUC-3373 showed a favorable safety profile and encouraging anti-cancer activity, including in patients previously treated with 5-FU. Additionally, three patients achieved stable disease lasting at least 9 months. NUC-3373 demonstrated an attractive pharmacokinetic profile with a long plasma half-life of between 6 and 14 hours compared to 8 to 14 minutes for 5-FU. Furthermore, NUC-3373 generated approximately 300 times higher levels of the active anti-cancer metabolite, FUDR-MP, than 5-FU. The recommended Phase 2 monotherapy dose of NUC-3373 was established at 2,500mg/m2.

    NUC-7738

    NUC-7738, a ProTide transformation of a novel anti-cancer nucleoside analog, 3'-deoxyadenosine, has multiple potential anti-cancer mechanisms of action and is being evaluated in a Phase 1 study in patients with advanced solid tumors who have exhausted all standard therapies.

    Poster Title: A first-in-human study of NUC-7738, a ProTide transformation of 3'-deoxyadenosine, in patients with advanced solid tumors (NuTide:701)

    This poster describes interim data from the ongoing Phase 1 study (NuTide:701) and the data demonstrate NUC-7738's encouraging anti-cancer activity in multiple tumor-types. NUC-7738 has been well tolerated with no Grade 3 or 4 treatment-related adverse events and no dose-limiting toxicities. The ProTide generated high levels of the key anti-cancer metabolite, 3'-dATP, which had a prolonged intracellular half-life and was still detectable after 50 hours.

    Three case studies were described detailing two patients with metastatic melanoma and one patient with metastatic lung adenocarcinoma who achieved reductions in the size of target lesions coupled with prolonged stable disease. Following treatment with NUC-7738, one patient with metastatic melanoma became eligible for surgery and their tumor was completely resected.

    Recruitment to the NuTide:701 study is ongoing and once the recommended Phase 2 dose has been established, NUC-7738 is expected to advance into the Phase 2 part of the study.

    Acelarin

    Poster Title: Phase III study of NUC-1031 + cisplatin vs gemcitabine + cisplatin for first-line treatment of patients with advanced biliary tract cancer (NuTide:121)

    This trial-in-progress poster highlights the Company's global multi-center, randomized Phase 3 study comparing Acelarin, a ProTide transformation of gemcitabine, in combination with cisplatin, to gemcitabine in combination with cisplatin in up to 828 patients with advanced biliary tract cancer who have not previously received treatment for advanced disease. Enrollment of 418 evaluable patients has been achieved and the first of three interim analyses is expected to occur in the first half of 2022. NuCana believes 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.

    Abstracts and full session details can be found at www.esmo.org

    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 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 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 Company's ability to submit an NDA for Acelarin under the FDA's accelerated approval program or at all; the Company's 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 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, 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 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

    info@nucana.com

    Westwicke, an ICR Company

    Chris Brinzey

    Tel: +1 339-970-2843

    chris.brinzey@westwicke.com

    RooneyPartners

    Marion Janic

    Tel: +1 212-223-4017

    mjanic@rooneyco.com

     



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  3. Enrollment of 418 Evaluable Patients Expected to Enable First Interim Analysis in the First Half of 2022

    Data from First Interim Analysis May Support an NDA Submission in the United States under the FDA's Accelerated Approval Program

    EDINBURGH, United Kingdom, Sept. 15, 2021 (GLOBE NEWSWIRE) -- NuCana plc (NASDAQ:NCNA) announced it has completed enrollment of the number of patients in the ongoing Phase III NuTide:121 study required to conduct the first interim analysis. The study, which is comparing Acelarin combined with cisplatin to the global standard of care, gemcitabine plus cisplatin, as a first-line treatment for patients with advanced biliary tract cancer, has enrolled 418 patients with measurable disease. The first interim analysis…

    Enrollment of 418 Evaluable Patients Expected to Enable First Interim Analysis in the First Half of 2022

    Data from First Interim Analysis May Support an NDA Submission in the United States under the FDA's Accelerated Approval Program

    EDINBURGH, United Kingdom, Sept. 15, 2021 (GLOBE NEWSWIRE) -- NuCana plc (NASDAQ:NCNA) announced it has completed enrollment of the number of patients in the ongoing Phase III NuTide:121 study required to conduct the first interim analysis. The study, which is comparing Acelarin combined with cisplatin to the global standard of care, gemcitabine plus cisplatin, as a first-line treatment for patients with advanced biliary tract cancer, has enrolled 418 patients with measurable disease. The first interim analysis will be conducted after the 418th patient has completed 28 weeks of follow-up, which is expected to occur in the first half of 2022. NuCana believes 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. Recruitment in the NuTide:121 study, which is intended to enroll up to 828 patients, is ongoing and NuCana believes subsequent analyses could provide the confirmatory data to support full (regular) approval.

    "We are very pleased to achieve this important enrollment milestone which brings us closer to our goal of developing more effective and safer medicines for patients with cancer," said Hugh S. Griffith, NuCana's Founder and Chief Executive Officer. "Biliary tract cancer is a devastating disease and there is a significant need for more effective medicines. We are especially grateful to all of the patients, their families, the investigators and other health care professionals involved in the NuTide:121 study."

    Mr. Griffith continued: "The primary objective of the first interim analysis is to demonstrate at least a 14% improvement in the ORR in the Acelarin plus cisplatin arm compared to the gemcitabine plus cisplatin arm. In the ABC-08 study of Acelarin plus cisplatin as a first-line treatment for patients with biliary tract cancer, an ORR of 44% was achieved among the evaluable population. This compared favorably to the ORR of 26% achieved among evaluable patients treated with gemcitabine plus cisplatin in the ABC-02 study, which established this regimen as the global standard of care. We look forward to announcing the outcome of this first interim analysis in the first half of 2022."

    About NuTide:121

    NuTide:121 is a global, multi-center, 1:1 randomized Phase 3 study comparing Acelarin, a ProTide transformation of gemcitabine, in combination with cisplatin, to gemcitabine in combination with cisplatin in up to 828 patients with advanced biliary tract cancer who have not previously received treatment for advanced disease. The primary endpoints of NuTide:121 are Overall Survival (OS) and Objective Response Rate (ORR) and the FDA-approved protocol includes three interim analyses. Based on the statistical analysis plan, 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, accompanied by positive trends in other endpoints, has the potential to allow for an accelerated approval of a new drug application (NDA) for Acelarin in the United States. Under this scenario, the NuTide:121 study would continue and the Company believes it could use the data from subsequent analyses as the confirmatory data required to support full (regular) approval. There are currently no agents approved for the first-line treatment of patients with biliary tract cancer.

    About Biliary Tract Cancer

    Biliary tract cancer, including cholangiocarcinoma, gallbladder and ampullary carcinoma, are a group of cancers originating in the biliary tract. The biliary tract is comprised of the gallbladder and interconnecting ducts responsible for the transport of 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 first-line treatment of patients with advanced biliary tract cancer; however, the worldwide standard of care in these patients is the combination of gemcitabine and cisplatin. Patients receiving this regimen have a median overall survival of 11.7 months.

    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 3 study for patients with advanced biliary tract cancer. NUC-3373 is in a Phase 1 study for the potential treatment of a wide range of patients with advanced solid tumors and a Phase 1b/2 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 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 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 Company's ability to submit an NDA for Acelarin under the FDA's accelerated approval program, or at all; the Company's 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 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, 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 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

    +44 131 357 1111

    info@nucana.com

    Westwicke, an ICR Company

    Chris Brinzey

    +1 339-970-2843

    chris.brinzey@westwicke.com

    RooneyPartners

    Marion Janic

    +1 212-223-4017

    mjanic@rooneyco.com

     



    View Full Article Hide Full Article
  4. EDINBURGH, United Kingdom, Sept. 01, 2021 (GLOBE NEWSWIRE) -- NuCana plc (NASDAQ:NCNA) announced today that Hugh Griffith, Chief Executive Officer, and Don Munoz, Chief Financial Officer, will participate in three upcoming virtual investor conferences.

    Event: Citi's 16th Annual BioPharma Virtual Conference
    Dates: September 8-10, 2021

    Event: H.C. Wainwright 23rd Annual Global Investment Conference
    Dates: September 13-15, 2021

    Event: Oppenheimer's Virtual Fall Healthcare Life Sciences & MedTech Summit
    Presentation Date: Wednesday, September 22, 2021
    Presentation Time: 9:05 AM ET

    A pre-recorded webcast of the presentation at the H.C. Wainwright 23rd Annual Global Investment Conference will be made available on the Company's website starting…

    EDINBURGH, United Kingdom, Sept. 01, 2021 (GLOBE NEWSWIRE) -- NuCana plc (NASDAQ:NCNA) announced today that Hugh Griffith, Chief Executive Officer, and Don Munoz, Chief Financial Officer, will participate in three upcoming virtual investor conferences.

    Event: Citi's 16th Annual BioPharma Virtual Conference

    Dates: September 8-10, 2021

    Event: H.C. Wainwright 23rd Annual Global Investment Conference

    Dates: September 13-15, 2021

    Event: Oppenheimer's Virtual Fall Healthcare Life Sciences & MedTech Summit

    Presentation Date: Wednesday, September 22, 2021

    Presentation Time: 9:05 AM ET

    A pre-recorded webcast of the presentation at the H.C. Wainwright 23rd Annual Global Investment Conference will be made available on the Company's website starting on Monday, September 13, 2021, at 7:00 AM ET. The presentation at the Oppenheimer Virtual Fall Healthcare Life Sciences & MedTech Summit will be webcast live. Both presentations will be available for replay under "Events & Presentations" in the Investors section of the Company's website at www.nucana.com.

    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. 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; the Company's 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 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, 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 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

    +44 131 357 1111

    info@nucana.com

    Westwicke, an ICR Company

    Chris Brinzey

    +1 339-970-2843

    chris.brinzey@westwicke.com

    RooneyPartners

    Marion Janic

    +1 212-223-4017

    mjanic@rooneyco.com



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  5. EDINBURGH, United Kingdom, Aug. 19, 2021 (GLOBE NEWSWIRE) -- NuCana plc (NASDAQ:NCNA) announced financial results for the second quarter ended June 30, 2021 and provided an update on its broad clinical program with its transformative ProTide therapeutics.

    As of June 30, 2021, NuCana had cash and cash equivalents of £73.4 million compared to £78.6 million at March 31, 2021 and £87.4 million as of December 31, 2020. NuCana continues to advance its various clinical programs and reported a net loss of £9.1 million for the quarter ended June 30, 2021, as compared to a net loss of £6.1 million for the quarter ended June 30, 2020. Basic and diluted loss per share was £0.17 for the quarter ended June 30, 2021, as compared to £0.19 per share…

    EDINBURGH, United Kingdom, Aug. 19, 2021 (GLOBE NEWSWIRE) -- NuCana plc (NASDAQ:NCNA) announced financial results for the second quarter ended June 30, 2021 and provided an update on its broad clinical program with its transformative ProTide therapeutics.

    As of June 30, 2021, NuCana had cash and cash equivalents of £73.4 million compared to £78.6 million at March 31, 2021 and £87.4 million as of December 31, 2020. NuCana continues to advance its various clinical programs and reported a net loss of £9.1 million for the quarter ended June 30, 2021, as compared to a net loss of £6.1 million for the quarter ended June 30, 2020. Basic and diluted loss per share was £0.17 for the quarter ended June 30, 2021, as compared to £0.19 per share for quarter ended June 30, 2020.

    "It has been a productive first half of 2021 with our release of important non-clinical and clinical data announcements. These include data from the NuTide:302 Phase Ib study of NUC-3373 in patients with advanced colorectal cancer as well as from the NuTide:701 Phase I study of NUC-7738 in patients with advanced solid tumors," said Hugh S. Griffith, NuCana's Founder and Chief Executive Officer. "These data presentations, made at several medical conferences, continue to support the favorable clinical profile we have observed to date and the broad potential of our ProTide technology."

    Mr. Griffith continued: "As we look ahead to the second half of the year, we anticipate presenting additional clinical data from NUC-3373 and NUC-7738. Despite the COVID-19 pandemic, we remain on track to recruit sufficient patients in 2021 in the ongoing NuTide:121 Phase III clinical study of Acelarin combined with cisplatin as a first-line treatment for patients with advanced biliary tract cancer to enable the first interim analysis in 2022. We are hopeful that this could enable us to submit an NDA in the United States under the FDA's accelerated approval program. We are also on track with other key milestones, including the initiation this year of a Phase III study of NUC-3373 in combination with other agents for patients with colorectal cancer."

    Mr. Griffith also noted that NuCana has established preliminary objectives for the first half of 2022: "We are looking forward to 2022, which will be an important and active year for NuCana. With Acelarin, we anticipate announcing whether the NuTide:121 study has achieved the overall response rate objective at the first interim analysis in the first half of 2022. Additionally, based on the encouraging data seen to date with NUC-3373 and 5-FU's broad usage in oncology, we anticipate initiating in 2022 a Phase Ib basket study of NUC-3373 in combination with other agents in a variety of solid tumors to identify further indications to target. We also expect to announce in 2022 data from the Phase II study of NUC-7738, which is anticipated to start later in 2021."

    Mr. Griffith concluded: "Lastly, it is my pleasure to welcome Dr. Jeffrey Bloss to NuCana as our new Chief Medical Officer. Jeff brings more than two decades of relevant oncology experience leading clinical development and medical affairs at a number of companies. Over his career, he has been a key member of the teams responsible for the development, approval and commercialization of over ten successful oncology drugs including Gemzar®, Tarceva®, Sorafenib®, Tykerb® and Xtandi®. His experience and contributions will be invaluable to NuCana as we continue to advance our pipeline of novel ProTides through the clinic and towards commercialization."

    Anticipated Milestones: H2 2021 & H1 2022

     
    Acelarin (a ProTide transformation of gemcitabine)

        
      ºIn 2021, NuCana expects to reach enrollment of at least 418 evaluable patients to enable the first interim analysis in 2022 of the Phase III study of Acelarin combined with cisplatin as a first-line treatment for patients with advanced biliary tract cancer; and
      ºIn the first half of 2022, NuCana expects to announce whether the overall response rate objective for the first interim data from this Phase III study has been met, which may enable an NDA submission in the United States under the FDA's accelerated approval program.
        
    NUC-3373 (a ProTide transformation of 5-FU)

        
      In 2021, NuCana expects to: 
        
      ºReport 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;
      ºInitiate and report data from the Phase Ib expansion / Phase II study of NUC-3373 in combination with other agents for patients with colorectal cancer;
      ºInitiate a Phase III study of NUC-3373 in combination with other agents for patients with colorectal cancer; and
      ºReport data from the Phase I study (NuTide:301) of NUC-3373 in patients with advanced solid tumors.
        
      In the first half of 2022, NuCana expects to:
        
      ºInitiate a Phase Ib basket study of NUC-3373 in combination with other agents in a variety of solid tumors; and
      ºExpand the Phase Ib / Phase II study 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 2021, NuCana expects to:
       
      ºReport data from the Phase I study (NuTide:701) of NUC-7738 in patients with advanced solid tumors; and
      ºInitiate a Phase II study of NUC-7738 in patients with solid tumors.
        
      In the first half of 2022, NuCana expects to:
        
      ºAnnounce 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. 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. 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; the Company's ability to submit an NDA under the FDA's accelerated approval program; the Company's 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 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, 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 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

    June 30,

     For the six months ended

    June 30,

     2021 2020  2021 2020 
     (in thousands, except per share data)
     £ £  £ £ 
              
    Research and development expenses(8,523) (5,863)  (17,229) (11,801) 
    Administrative expenses(2,075) (1,629)  (4,179) (3,238) 
    Net foreign exchange (losses) gains(109) 84  (786) 2,211 
    Operating loss(10,707) (7,408)  (22,194) (12,828) 
    Finance income35 64  59 208 
    Loss before tax (10,672) (7,344)  (22,135) (12,620) 
    Income tax credit1,585 1,283  3,287 2,593 
    Loss for the period(9,087) (6,061)  (18,848) (10,027) 
          
    Basic and diluted loss per share(0.17) (0.19)  (0.36) (0.31) 
          





    Unaudited Condensed Consolidated Statements of Financial Position

     
      June 30,

    2021
     December 31,

    2020


     (in thousands)
      £ £
    Assets    
    Non-current assets    
    Intangible assets 4,814 4,753
    Property, plant and equipment 1,038 1,189
    Deferred tax asset 37 44
      5,889 5,986
    Current assets    
    Prepayments, accrued income and other receivables 4,198 4,628
    Current income tax receivable 8,815 9,822
    Cash and cash equivalents 73,421 87,356
      86,434 101,806
         
    Total assets 92,323 107,792
         
    Equity and liabilities    
    Capital and reserves    
    Share capital and share premium 143,135 142,937
    Other reserves 69,214 66,887
    Accumulated deficit (128,158) (110,594)
    Total equity attributable to equity holders of the Company 84,191 99,230
         
    Non-current liabilities    
    Provisions 46 46
    Lease liabilities 231 367
      277 413
         
    Current liabilities    
    Trade payables 1,697 2,257
    Payroll taxes and social security 166 177
    Accrued expenditure 5,717 5,437
    Lease liabilities 275 278
      7,855 8,149
    Total liabilities 8,132 8,562
         
    Total equity and liabilities 92,323 107,792
         





    Unaudited Condensed Consolidated Statements of Cash Flows

     
     For the six months ended

     June 30,


     
     2021 2020 
     (in thousands)
     £ £ 
    Cash flows from operating activities   
    Loss for the period(18,848) (10,027) 
    Adjustments for:   
    Income tax credit(3,287) (2,593) 
    Amortization and depreciation444 440 
    Finance income(59) (208) 
    Interest expense on lease liabilities10 14 
    Share-based payments3,615 1,669 
    Net foreign exchange losses (gains)759 (2,252) 
     (17,366) (12,957) 
    Movements in working capital:   
    Decrease in prepayments, accrued income and other receivables424 802 
    Decrease in trade payables(560) (484) 
    Increase in payroll taxes, social security and accrued expenditure269 840 
    Movements in working capital133 1,158 
    Cash used in operations(17,233) (11,799) 
    Net income tax received4,302 4,152 
    Net cash used in operating activities(12,931) (7,647) 
    Cash flows from investing activities   
    Interest received58 279 
    Payments for property, plant and equipment(37) (14) 
    Payments for intangible assets(319) (804) 
    Net cash used in investing activities(298) (539) 
    Cash flows from financing activities   
    Payments of lease liabilities(148) (148) 
    Proceeds from issue of share capital – exercise of share options198 15 
    Proceeds from issue of share capital- 2,033 
    Share issue expenses- (105) 
    Net cash from financing activities 50 1,795 
    Net decrease in cash and cash equivalents(13,179) (6,391) 
    Cash and cash equivalents at beginning of period87,356 51,962 
    Effect of exchange rate changes on cash and cash equivalents(756) 2,229 
    Cash and cash equivalents at end of period73,421 47,800 

    For more information, please contact:

    NuCana plc

    Hugh S. Griffith

    Chief Executive Officer

    +44 131 357 1111

    info@nucana.com

    Westwicke, an ICR Company

    Chris Brinzey

    +1 339-970-2843

    chris.brinzey@westwicke.com

    RooneyPartners

    Marion Janic

    +1 212-223-4017

    mjanic@rooneyco.com



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