20-F: NuCana PLC Files 2023 Annual Report, Continues Clinical Trials Amid Financial Losses

Biopharmaceutical company NuCana PLC reported continued losses for 2023 as it advances clinical trials for its cancer treatment candidates, NUC-3373 and NUC-7738.

Summary

• NuCana PLC, a clinical-stage biopharmaceutical company, is focused on improving cancer treatment outcomes using its ProTide technology.
• The company's lead product candidates, NUC-3373 and NUC-7738, are designed to overcome limitations of existing chemotherapy agents.
• NUC-3373 is currently in Phase 1b/2 and Phase 2 trials for colorectal cancer and a Phase 1b/2 trial for advanced solid tumors and lung cancer.
• NUC-7738 is in Phase 2 of a Phase 1/2 trial for advanced solid tumors.
• The company reported a net loss of 27.6 million for 2023, compared to a 32.0 million loss in 2022.
• Research and development expenses decreased to 25.1 million in 2023 from 36.4 million in 2022.
• As of December 31, 2023, NuCana had 17.2 million in cash and cash equivalents.
• The company's cash and cash equivalents on hand will not be sufficient to fund its anticipated operations for at least the next twelve months.
• The company will need to obtain substantial additional funding in connection with our continuing operations.

Sentiment

Score: 3

Explanation: The company is facing significant financial challenges and uncertainty regarding its ability to continue as a going concern, despite some promising clinical data.

Positives

• NUC-3373 has shown promising anti-tumor activity and a favorable safety profile in clinical trials.
• NUC-7738 has demonstrated encouraging signs of efficacy in early clinical trials.
• The company's ProTide technology has the potential to overcome key limitations of existing nucleoside analog chemotherapies.

Negatives

• NuCana has incurred significant operating losses since its inception and expects to continue incurring losses.
• The company's cash and cash equivalents on hand will not be sufficient to fund its anticipated operations for at least the next twelve months.
• The company will need to obtain substantial additional funding, which may not be available on acceptable terms.
• The company's ability to generate revenue depends heavily on the successful development and commercialization of its product candidates, which may never occur.

Risks

• There is substantial doubt about NuCana's ability to continue as a going concern.
• Clinical trials may be delayed or fail to demonstrate the safety and efficacy of product candidates.
• Regulatory approval for product candidates may not be obtained or may be delayed.
• The company relies on third parties for clinical trials and manufacturing, which introduces risks.
• Even if approved, product candidates may not achieve market acceptance.
• The company faces substantial competition from other pharmaceutical and biotechnology companies.
• The company may be unable to obtain and maintain intellectual property protection for its technology and products.

Future Outlook

NuCana expects to continue incurring significant expenses and operating losses for the foreseeable future as it continues clinical trials and seeks marketing approval for its product candidates. The company anticipates needing substantial additional funding.

Industry Context

NuCana operates in the highly competitive biopharmaceutical industry, specifically in the oncology sector. Its ProTide technology aims to improve upon existing nucleoside analog chemotherapies, a widely used class of cancer treatments.

Comparison to Industry Standards

• NuCanas ProTides are designed to overcome the limitations of existing nucleoside analogs like 5-FU and gemcitabine, which are widely used but have efficacy and safety issues.
• If approved, NUC-3373 would compete with existing chemotherapies, including 5-FU, and other targeted therapies or immunotherapies.
• NUC-7738, if approved, would compete with existing chemotherapies and other drugs in development for similar indications.

Legal Proceedings

• In 2018, we were granted a European patent from the European Patent Office, or EPO, EP 2955190, or EP 190, that covered the composition of matter of a genus of phosphoramidate nucleotide compounds that includes sofosbuvir, sold under the brand name Sovaldi , a leading drug for the treatment of hepatitis C sold by Gilead Sciences, Inc. Sofosbuvir is also a key component of Harvoni , Vosevi and Epclusa . In September 2022, we were granted a further European patent from the EPO, EP 3904365, or EP 365, that covered the composition of matter of a smaller genus of phosphoramidate nucleotide compounds that includes sofosbuvir. In connection with these patents, we and Gilead engaged in patent infringement litigation at the EPO, in the United Kingdom, and later in Germany over a several year period between 2018 and 2023. This litigation resulted in the revocation of EP 190 by the EPO and the determination of the invalidity of EP 190 and EP 365 in the United Kingdom. As a result of these decisions, we reached settlements with Gilead in relation to their legals fees for the proceedings in each of the United Kingdom and Germany. All obligations arising from the patent infringement litigation in the United Kingdom and Germany have been settled as at December 31, 2023.

Related Party Transactions

• The company has entered into agreements with Cardiff University, University College Cardiff Consultants Ltd., and Cardiff ProTides Ltd., entities related to the development of its ProTide technology.

Stakeholder Impact

• Shareholders: Potential dilution from future capital raises, risk of investment loss due to ongoing losses and uncertainty.
• Employees: Potential impact on job security if the company fails to secure additional funding.
• Patients: Potential benefit from improved cancer treatments if the company's product candidates are successful.

Next Steps

• Continue ongoing clinical trials for NUC-3373 and NUC-7738.
• Report additional data from clinical trials in 2024.
• Seek additional funding to support operations and development programs.

Key Dates

Keywords

NuCana, ProTide, NUC-3373, NUC-7738, Acelarin, cancer, chemotherapy, clinical trials, colorectal cancer, solid tumors, biopharmaceutical, oncology, drug development, FDA, EMA, financial results, investment