Biodexa Pharmaceuticals Plc — FY2023 Form 20-F
Reporting period: Year ended December 31, 2023. This is an annual report, not a standalone Q4 filing. Financial statements are prepared under IFRS as issued by the IASB and presented in pounds sterling; amounts below are in £ millions unless stated otherwise.
Business context and reporting period
Biodexa is a clinical-stage biopharmaceutical company developing treatments for Type 1 diabetes and rare brain cancers. Its lead programs are tolimidone, licensed in December 2023 for development in Type 1 diabetes, and MTX110, studied in glioblastoma, diffuse midline glioma and medulloblastoma. The company shifted its strategy toward developing therapeutics to proof of concept and then seeking licensees; its proprietary drug-delivery platforms are no longer a key priority.
Biodexa had no approved products and relied on research-and-development service revenue. Revenue in 2023 came from one customer and prior R&D collaboration work; the company said those services had ceased. Its ADSs trade on Nasdaq under BDRX.
Financial performance and position
| Metric (£m, except where noted) | FY2023 | FY2022 | Change / context |
|---|---|---|---|
| Revenue | 0.381 | 0.699 | Down 45%; all revenue was service revenue from one customer. |
| Research and development costs | 4.067 | 5.111 | Down 20%, mainly following reprioritization and lower preclinical and personnel costs; MTX110 clinical spending increased. |
| Administrative costs | 4.342 | 4.542 | Down 4%; included £1.31m of legal and professional fees related to financing, the tolimidone license and aborted acquisitions. |
| Operating loss | (8.014) | (8.932) | Improved by £0.918m. |
| Loss before tax | (7.485) | (8.488) | Improved by £1.003m. |
| Net loss | (7.079) | (7.656) | Improved by £0.577m; the company remained loss-making. |
| Finance income | 0.570 | 0.497 | Included a £0.487m fair-value gain on warrant-related derivative liabilities. |
| Cash used in operating activities | (6.826) | (7.048) | Outflow narrowed by £0.222m. |
| Cash and cash equivalents at year-end | 5.971 | 2.836 | Increased following financing, partly offset by operating cash burn. |
| Total assets | 10.542 | 5.525 | Included £2.941m of intangible assets, principally the acquired tolimidone program. |
| Total liabilities / equity | 5.864 / 4.678 | 2.363 / 3.162 | Year-end current liabilities included a £4.160m warrant-related derivative liability. |
The filing does not present a clear gross-profit or operating-margin measure. Lease liabilities were £0.464m in total (£0.169m current and £0.295m non-current); the company reported no other borrowing balance in the borrowings note. Trade and other payables were £1.240m. The warrant-related derivative liability is separately reported and should not be confused with cash debt.
Net proceeds from share issues, including warrants, were £10.427m in 2023; the cash-flow note reports £12.084m gross proceeds and £1.657m transaction costs. The December U.S. offering raised approximately $6.0m gross, and included warrants and pre-funded warrants. Ordinary shares outstanding at December 31, 2023 were 1,189,577,722.
Material changes versus the prior comparable period
- Revenue declined as R&D service activity decreased; the report says the related collaborations had ceased.
- Research and development spending fell following the strategic shift away from expanding internal drug-delivery platforms and a 2023 cost-reduction program. Eight employees were made redundant at a one-time cost of approximately £0.10m.
- Operating and net losses narrowed, while operating cash outflow remained substantial.
- Cash increased from £2.836m to £5.971m, mainly because of equity financings. The financing brought significant share and warrant issuance and potential dilution.
- The company acquired tolimidone rights in December 2023 and recognized £2.938m of acquired in-process R&D intangible assets. The transaction also involved cash, shares, pre-funded warrants, deferred consideration and future royalties.
Outlook, commentary, risks and unusual items
- Going concern and funding: Management forecast that further financing would be needed before Q4 2024, assuming planned programs and operations continued. The company said failure to secure funding before then could mean it would no longer be a going concern and would likely enter Administration. The auditor’s report highlighted substantial doubt about the company’s ability to continue as a going concern. Management stated it was evaluating financing and other options, but gave no assurance of success. Funding may be dilutive or impose additional obligations.
- Development outlook: The company expected recruitment for a small, open-label Phase IIa tolimidone study in Type 1 diabetes later in 2024. After an inconclusive in-vitro experiment reported in February 2024, it planned further preclinical work while continuing preparations. MTX110 remained in early clinical development; the report cited planned interim recurrent-GBM progression-free-survival results in Q2 2024.
- Clinical uncertainty: Tolimidone and MTX110 remained investigational. Early clinical or preclinical findings may not predict later results, approval or commercial success. Biodexa said it expected partners to undertake later-stage trials and commercialization, but securing partners is uncertain.
- MTX110 rights: Biodexa disclosed that the panobinostat license was terminated by Secura Bio in 2020. The company believes related patents could delay a potential MTX110 launch for DMG, though it did not expect the same impact for GBM. Disputes or patent constraints could affect development and commercialization.
- Unusual accounting and items: The £0.487m warrant-liability remeasurement gain contributed to finance income; the related liability rose to £4.160m after new warrant issuance. Biodexa also wrote off a loan to Adhera on completion of the tolimidone transaction and previously impaired and wrote off loans to Bioasis, whose proposed acquisition did not proceed.
- Other key risks: The filing identifies financing dependence, potential dilution, early-stage clinical and regulatory risk, reliance on external trial and manufacturing providers, intellectual-property and licensing risks, foreign-exchange exposure, and Nasdaq listing compliance. The company reported that its ADSs regained compliance with Nasdaq’s minimum bid-price rule in July 2023 but remained subject to a one-year panel monitor.
- Controls and other disclosures: Management concluded that disclosure controls and internal control over financial reporting were effective as of December 31, 2023; the auditor did not provide an internal-control attestation because Biodexa was a non-accelerated filer. The report also describes material weaknesses in prior years and the need to sustain remediation. No material cybersecurity incidents were reported for the previous three fiscal years. No dividends were intended in the foreseeable future.
Important facts an investor should verify
- Latest cash balance, actual cash burn and whether financing secured after the filing extended the runway beyond the forecast need before Q4 2024.
- Current share count and fully diluted capitalization, including pre-funded warrants, Series E/F and other warrants, exercise terms and potential resale supply.
- Progress, enrollment, safety and data timing for the tolimidone Phase IIa study and MTX110 trials; distinguish reported observations from controlled evidence of efficacy.
- Status of the tolimidone license conditions, including the Bukwang arrangements, deferred consideration, royalty obligations and any required financing threshold.
- Secura Bio patent and license dispute status, and its implications for MTX110 indications and potential launch timing.
- Financial statement and note disclosures contain inconsistent accumulated-deficit figures: narrative sections cite £142.82m, while the year-end statement of financial position reports £144.767m. Confirm the correct figure and reconciliation in the filed statements.
- Nasdaq listing compliance, the warrant-related derivative valuation and classification, and any subsequent financing or material post-balance-sheet developments.