Nucana plc — FY2023 Form 20-F summary
Reporting period: Fiscal year ended December 31, 2023; filed March 20, 2024. This is an annual report, not a standalone fourth-quarter report. Financial statements are prepared under IFRS in pounds sterling (£), with amounts below shown in millions unless noted. NuCana is a clinical-stage oncology biotechnology company with no approved products or product-sales revenue.
Financial performance and liquidity
| Metric | FY2023 | FY2022 |
|---|---|---|
| Revenue from product sales | None | None |
| Research and development expense | £25.1m | £36.4m |
| Administrative expense | £6.1m | £7.3m |
| Operating loss | £32.8m | £39.1m |
| Net loss | £27.6m | £32.0m |
| Basic and diluted loss per share | £0.53 | £0.61 |
| Net cash used in operating activities | £26.4m | £23.2m |
| Cash and cash equivalents at year-end | £17.2m | £41.9m |
| Total assets / total liabilities | £27.8m / £12.9m | £58.3m / £19.8m |
| Total equity | £14.9m | £38.5m |
Gross margin is not applicable because the company had no product revenue. The filing reports no conventional borrowings; lease liabilities were £0.4m at year-end. Operating lease commitments totaled £0.4m. Operating cash use exceeded the prior year despite lower operating expenses, reflecting working-capital outflows and lower R&D tax refunds. Cash fell by £24.7m during 2023. The company raised £0.2m gross under its ATM program and received £5.6m in tax refunds.
Material changes versus FY2022
- Net loss narrowed by £4.4m, while operating loss narrowed by £6.3m. R&D expense fell £11.4m, partly offset by a £6.0m less favorable foreign-exchange result: a £1.2m loss in 2023 versus a £4.9m gain in 2022.
- R&D spending shifted substantially by program: NUC-3373 increased to £17.8m from £12.0m; NUC-7738 was £3.6m versus £3.7m; Acelarin fell to £2.2m from £19.3m, following discontinuation of its Phase 3 NuTide:121 trial.
- Cash and cash equivalents declined 59% to £17.2m. Operating cash outflow increased £3.3m to £26.4m.
- The £4.1m year-end 2022 provision for Gilead-related legal costs was settled in 2023; the related litigation obligations in the U.K. and Germany were reported settled by year-end.
Outlook, commentary and key risks
- Funding and going concern: Management says year-end cash will not fund anticipated operations for the full 12-month going-concern assessment period. The auditor’s report includes an explanatory paragraph noting substantial doubt about the company’s ability to continue as a going concern. Additional capital is required; unavailable or delayed funding could force program reductions, delays or discontinuation. Management expects cash spending to decrease over the next 12 months, partly because 2023 included payments for prior Acelarin trial accruals and legal settlements.
- Clinical outlook: Management expected additional data in 2024 from NUC-3373 trials NuTide:302, NuTide:323 and NuTide:303, and NUC-7738 trial NuTide:701. These are expectations, not assured milestones or financial guidance.
- Clinical evidence: Management reported encouraging interim activity and generally favorable tolerability for NUC-3373 and NUC-7738, but emphasized that early or interim results may change and may not predict pivotal-trial outcomes or approval. NuTide:323 was recruiting; no new safety signals were reported in aggregated data from its first 40 patients.
- Acelarin: NuTide:121 was discontinued after a planned futility analysis. Although response rate was higher with Acelarin plus cisplatin, this did not translate into overall-survival benefit: median survival was 9.2 months versus 12.6 months for gemcitabine plus cisplatin. Treatment-emergent-adverse-event discontinuations were 30% versus 16%, with liver-related events noted.
- Other risks: The business depends on successful development of NUC-3373 and NUC-7738, additional financing, third-party clinical and manufacturing providers, regulatory approval, and continued intellectual-property protection. Other cited risks include clinical-trial failure or delay, competition, currency movements, U.K. R&D tax-credit eligibility, cybersecurity/privacy, and Nasdaq listing compliance. The company received a minimum-bid-price deficiency notice in 2023 and had until May 6, 2024 to regain compliance after transfer to the Nasdaq Capital Market.
- Unusual items and controls: A £0.5m impairment charge was recorded for patents, mainly related to preclinical candidates. Management concluded disclosure controls and internal control over financial reporting were effective at year-end; the auditor did not provide an internal-control attestation because the company was a non-accelerated filer.
Important facts for investors to verify
- Current cash, actual cash runway, and whether financing has been secured since year-end; the filing states existing cash was insufficient for the full going-concern period.
- Subsequent clinical-trial enrollment, complete and updated efficacy and safety data, and whether the expected 2024 data disclosures occurred.
- Development plans and funding priorities for NUC-3373 and NUC-7738, and whether Acelarin remains in development.
- Nasdaq bid-price compliance and any resulting reverse split, ADS ratio change or delisting risk.
- Future R&D tax-credit receipts and eligibility under changing U.K. tax-credit rules; the filing says cash-runway assumptions depend partly on continued eligibility.
- Potential dilution from future equity financing, ATM or other securities issuance; 52,860,335 ordinary shares were outstanding at December 31, 2023.