Nucana plc — FY 2022 Form 20-F
Reporting period: Fiscal year ended December 31, 2022; filed April 4, 2023. This is an annual report, not a quarterly filing. Financial statements are prepared under IFRS in pounds sterling. Nucana is a clinical-stage oncology biopharmaceutical company with no approved products and no product revenue.
Key financial results
| Metric | FY 2022 | FY 2021 |
|---|---|---|
| Revenue | None | None |
| Research and development expense | £36.4 million | £36.8 million |
| Administrative expense | £7.3 million | £8.5 million |
| Operating loss | £39.1 million | £47.9 million |
| Loss before tax | £38.5 million | £47.8 million |
| Income tax credit | £6.4 million | £7.3 million |
| Net loss | £32.0 million | £40.5 million |
| Basic and diluted loss per share | £0.61 | £0.78 |
| Net cash used in operating activities | £23.2 million | £23.8 million |
| Cash and cash equivalents at year-end | £41.9 million | £60.3 million |
Net loss narrowed year over year, principally alongside a £4.9 million foreign-exchange gain in 2022, compared with £0.3 million in 2021. Research and development spending was broadly stable; lower clinical-trial and manufacturing costs following Acelarin trial discontinuation were largely offset by increased patent-defense costs. A £4.1 million provision for Gilead-related legal cost reimbursements was recognized in 2022.
At December 31, 2022, total assets were £58.3 million, total liabilities £19.8 million and equity £38.5 million. Current assets were £54.9 million and current liabilities £19.3 million. The filing reports lease liabilities of £0.6 million; it does not disclose conventional borrowings. Cash fell by £18.4 million during the year. Management said available cash was expected to fund the current operating plan for at least 12 months.
No meaningful revenue or gross margin is reported because the company has no marketed products. The filing does not provide a meaningful operating-margin measure.
Business developments and comparison with prior period
- NUC-3373: The company continued combination studies in advanced colorectal cancer. Part 2 of the Phase 1b/2 NuTide:302 trial produced encouraging activity and safety signals in heavily pre-treated patients; Part 3 was enrolling and evaluating combinations with bevacizumab. A randomized Phase 2 second-line colorectal cancer trial, NuTide:323, and the modular NuTide:303 trial were initiated in 2022.
- NUC-7738: The Phase 1/2 NuTide:701 trial advanced to its Phase 2 part, evaluating monotherapy and combination treatment with pembrolizumab. The company reported preliminary activity and a favorable safety profile, including a melanoma case; these are not confirmatory results.
- Acelarin: The Phase 3 NuTide:121 trial in biliary tract cancer was discontinued in March 2022 after a planned futility analysis. Although response rate was higher than the comparator, median overall survival was 9.2 months versus 12.6 months, and more patients stopped Acelarin treatment because of adverse events. The company said it was assessing other doses, combinations and indications.
- Compared with 2021, 2022 R&D expense decreased slightly, administrative expense and impairment charges decreased, and operating cash outflow was similar. Acelarin-related spending remained the largest reported program allocation at £19.3 million, versus £22.8 million in 2021; NUC-3373 spending rose to £12.0 million from £7.3 million.
Outlook, risks and unusual items
Management expects continued losses and substantial development spending; profitability depends on successful development, regulatory approval and commercialization, none of which is assured. The company expects to report additional data from NuTide:302, NuTide:323, NuTide:303 and NuTide:701 during 2023. These are expectations, not guaranteed milestones. Nucana may need additional financing, which could dilute shareholders or require unfavorable terms; management’s stated cash runway is at least 12 months based on its operating plan.
Material risks include clinical-trial failure or delay, patient enrollment, safety and regulatory approval, reliance on contract research and manufacturing organizations, single-source supply for certain materials, competition, intellectual-property protection, foreign-exchange exposure and dependence on external capital. The company has no hedging arrangements for currency exposure. It also disclosed inflation, the Ukraine conflict, COVID-19-related disruption and financial-institution liquidity concerns as potential risks.
Unusual legal developments occurred after year-end: in March 2023, the EPO Technical Board of Appeal revoked patent EP 190, and the U.K. High Court ruled that EP 190 and EP 365 were invalid in the U.K. Nucana expects to abandon further German proceedings and recorded a £4.1 million provision for estimated Gilead legal-cost reimbursements. The final amounts remained subject to determination. Separately, the company reported that its SVB UK deposits remained accessible following HSBC’s acquisition of SVB UK.
Important facts for investors to verify
- Whether cash, financing access and actual spending support management’s stated minimum 12-month runway.
- Enrollment, safety, efficacy and timing of results for the NUC-3373 and NUC-7738 trials; distinguish preliminary findings from final, controlled data.
- Any revised development plans, costs or impairment implications for Acelarin after the NuTide:121 discontinuation.
- The final Gilead legal-cost reimbursement, payment timing and any further consequences of the patent decisions.
- Potential dilution from future equity issuance, including use of the company’s ATM facility, and the effect of share-based awards.
- Continuing eligibility for U.K. R&D tax credits and the effect of changes to tax-credit rules.