Tiziana Life Sciences Ltd — FY2022 Form 20-F
Reporting period: Year ended December 31, 2022; this is an annual report, not a standalone Q4 report. Financial statements are audited and prepared under IFRS in U.S. dollars. Tiziana is a clinical-stage biotechnology company with no approved products and no product-sales revenue.
Financial performance and position
| Metric | FY2022 | FY2021 |
|---|---|---|
| Product-sales revenue | None | None |
| Research and development expense | $12.955m | $13.208m |
| General and administrative expense | $1.631m | $13.311m |
| Operating loss | $14.586m | $27.374m |
| Net loss | $15.397m | $23.417m |
| Basic and diluted loss per share | $0.15 | $0.24 |
| Net cash used in operating activities | $19.615m | $21.762m |
| Cash and cash equivalents at year-end | $18.122m | $42.186m |
| Working capital | $17.619m | $41.133m |
| Total assets / shareholders’ equity | $26.477m / $19.571m | $48.826m / $41.280m |
Margins are not meaningful because the company had no product revenue. It reported no borrowings at year-end; lease liabilities totaled $0.365m. Current assets were $24.282m and current liabilities $6.663m.
Changes versus FY2021
- Net loss narrowed by $8.020m. Lower G&A expense—principally from reduced share-option charges, lower labor and legal costs—was the main driver. R&D expense decreased modestly by $0.253m.
- FY2021 included a $3.240m tax credit; no credit was recognized in 2022 while the prior claim was under HMRC review.
- Cash fell by $24.064m during 2022. Operating cash use was partly offset by lower operating cash outflow than in 2021, but there was little financing inflow.
- Other comprehensive loss included a $3.582m foreign-currency translation loss. A $0.869m fair-value loss was recorded on the Accustem investment.
Outlook, risks and unusual items
- Management’s near-term priority shifted to intranasal Foralumab for CNS diseases, particularly non-active secondary progressive multiple sclerosis (SPMS). Foralumab, Milciclib and TZLS-501 programs for other indications were temporarily paused or deprioritized. A multisite Phase 2 SPMS trial was planned for Q3 2023; Alzheimer’s Phase 1 plans were subject to toxicology work and an IND filing.
- Management stated that cash-flow projections supported the going-concern basis through at least April 2024, with approximately $1m of cash projected at that point. The company also said available cash would fund the “immediate future.” It expects continued losses and may need additional capital; financing may dilute shareholders or require unfavorable terms.
- Reported Foralumab SPMS expanded-access results included clinical and PET-imaging improvements in a very small number of patients. These are early, uncontrolled observations, not evidence of efficacy from a controlled trial. The company’s clinical programs remain exposed to trial, regulatory, safety, enrollment, manufacturing and funding risks.
- In 2022, the company invested $2.676m in related-party Accustem shares, which were valued at $1.806m at year-end, and spent $1.320m buying back its own shares. It also extended a related-party credit facility to OKYO Pharma; $1.056m had been drawn at year-end, with further drawdown reported by January 2023.
- Management concluded that disclosure controls and internal control over financial reporting were ineffective at December 31, 2022 because the company lacked a timely employee handbook. Management said the weakness did not cause a material misstatement and planned remediation. The auditor gave an unqualified opinion on the financial statements, but did not audit internal-control effectiveness.
- After the reporting period, Nasdaq notified the company on April 21, 2023 that it had regained compliance with the minimum bid-price requirement. The filing also states the company believed it was a PFIC for 2022, which may have adverse U.S. tax consequences for U.S. holders.
Most important facts for investors to verify
- Cash runway assumptions, spending plans and the timing and terms of any additional financing.
- Progress, trial design and controlled clinical evidence for Foralumab; distinguish expanded-access observations from trial results.
- The reconciliation of the filing’s inconsistent loss disclosures: audited statements report a $15.397m FY2022 net loss, while one narrative passage states $12.1m.
- Related-party balances and transactions, including the OKYO loan, Accustem investment and treasury-share purchases.
- Remediation of the disclosed material weakness and whether internal controls improve in subsequent filings.
- Share-count presentation: the filing reports 102,272,614 shares outstanding while also reporting 1,683,544 shares held in treasury; confirm the current voting and outstanding share count.