NuCana Reports Third Quarter 2020 Financial Results and Provides Business Update

Rhea-AI Summary

NuCana plc (NASDAQ: NCNA) reported a successful $80 million public offering and shared third-quarter 2020 financial results. As of September 30, 2020, cash and equivalents reached £100.7 million, up from £47.8 million in June 2020. The company posted a net loss of £8.4 million, compared to £3.9 million in Q3 2019. NuCana highlighted promising interim data for NUC-3373 and NUC-7738 presented at ESMO Virtual Congress 2020, with expectations for upcoming milestones, including new drug applications and clinical trial updates in 2021.

Positive

• Successful completion of $80 million public offering, enhancing financial position.
• Encouraging interim data for NUC-3373 improving progression-free survival in colorectal cancer patients.
• Positive early data for NUC-7738 showing favorable pharmacokinetics and anti-cancer activity.

Negative

• Net loss of £8.4 million in Q3 2020, an increase from £3.9 million in Q3 2019.
• Basic and diluted loss per share at £0.24, up from £0.12 year-over-year.

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<

FAQ

What were the financial results for NuCana (NCNA) in Q3 2020?

NuCana reported a net loss of £8.4 million for Q3 2020, compared to £3.9 million in the same period last year.

What is the cash position of NuCana (NCNA) as of September 30, 2020?

As of September 30, 2020, NuCana had cash and cash equivalents of £100.7 million.

What clinical data did NuCana present at ESMO Virtual Congress 2020?

NuCana presented interim data for NUC-3373 and first-ever clinical data for NUC-7738, showing promising results.

What milestones does NuCana (NCNA) expect in 2021?

NuCana anticipates filing NDAs for Acelarin and NUC-3373 and reporting data from ongoing studies in 2021.