Biodexa Pharmaceuticals PLC (formerly Midatech Pharma PLC) — FY2022 Form 20-F
Reporting period: Year ended December 31, 2022; 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 (£), unless otherwise noted. Biodexa’s business is an early-stage biopharmaceutical company focused on developing therapeutics and drug-delivery technologies. Its lead clinical asset is MTX110, in Phase I development for rare brain cancers.
Financial results and liquidity
| Metric | FY2022 | FY2021 |
|---|---|---|
| Revenue | £0.699 million | £0.578 million |
| Research and development costs | £5.111 million | £4.654 million |
| Administrative costs | £4.542 million | £2.946 million |
| Operating loss | £8.932 million | £6.998 million |
| Net loss | £7.656 million | £5.460 million |
| Operating cash outflow | £7.048 million | £6.008 million |
| Cash and cash equivalents at year-end | £2.836 million | £10.057 million |
| Total assets | £5.525 million | £12.913 million |
| Total liabilities | £2.363 million | £2.461 million |
| Borrowings, including lease liabilities | £0.624 million | £0.766 million |
Revenue came from research and development collaboration services, not product sales. All FY2022 revenue was from one customer, located in Belgium. The filing does not provide a clear gross profit or gross margin figure; product-margin measures are not meaningful for the company’s current development-stage business.
The net loss widened by £2.196 million year over year. R&D spending rose 10%, principally from higher staff costs and MTX110 clinical costs, partly offset by lower preclinical and patent costs. Administrative costs increased mainly due to £1.36 million in fees related to the proposed Bioasis acquisition and a provision associated with the Bioasis loan. Finance income fell to £0.497 million from £0.936 million, including a £0.468 million non-cash gain from remeasurement of warrant-related derivative liabilities.
Cash declined by £7.221 million during 2022; operating activities used £7.048 million. The company reported £3.162 million of equity at year-end and £1.900 million of current liabilities. Cash runway was a central concern: management estimated year-end cash would fund planned operations into Q4 2023, but forecast further financing would be needed. A February 2023 private placement subsequently raised approximately $6.0 million gross and $5.2 million net (about £4.3 million), according to the financial statement notes. Management still expected further funding to be required within 12 months of the financial statements’ approval.
Material changes and significant developments
- Revenue increased £0.121 million, while operating cash outflow increased £1.040 million compared with 2021.
- Cash and cash equivalents fell £7.221 million to £2.836 million. Financing proceeds were only £0.243 million net in 2022, compared with £9.035 million in 2021.
- The company’s proposed Bioasis acquisition and related planned $9.6 million financing did not proceed after shareholders rejected the required resolutions in January 2023. Biodexa had advanced Bioasis $500,000 in two tranches by the filing date; the company recorded a £0.207 million impairment against the 2022 advance and disclosed a $225,000 expense-reimbursement demand. Bioasis defaulted, and recovery was uncertain.
- After year-end, the company completed the private placement, changed its name to Biodexa, effected a 1-for-20 ordinary-share consolidation and changed the depositary-share ratio from 25 ordinary shares to five. The ordinary shares’ AIM admission was cancelled on April 26, 2023; the depositary shares continued to trade on Nasdaq under BDRX.
Outlook, risks and unusual items
Management repositioned the company toward therapeutics, with MTX110 and generation of clinical proof-of-concept data as priorities. It does not expect to initiate new internal drug-delivery-platform development programs, though it intends to pursue existing and new collaborations. The longer-term model is to seek licensing partners, with potential milestone and royalty income; the filing cautions that such revenue is not expected in the foreseeable future and is not assured.
- Going concern: The auditor’s report includes an emphasis concerning material uncertainty over going concern. The filing states that additional financing was required and that failure to secure it before cash resources ran out could lead to administration. Management continued to use the going-concern basis, citing financing and asset-disposal options, but gave no assurance they would succeed. Financing may be dilutive.
- MTX110 and intellectual property: The panobinostat license was purportedly terminated by Secura Bio in 2020, followed by a further termination notice in 2021. Biodexa disputes the requested rights and says the related patents may delay a DIPG launch; it did not expect the issue to affect a potential GBM launch. The dispute and its outcome remain uncertain.
- Clinical and regulatory risk: MTX110 trials are early-stage; trial delays, safety or efficacy results, enrollment, manufacturing, regulatory approvals and reliance on collaborators could materially affect development. The FDA granted Fast Track designation for recurrent glioblastoma in 2022. In January 2023, after the first patient completed a month of treatment without treatment-associated adverse events noted, the study’s monitoring board recommended dose escalation; this is a post-year-end development, not a FY2022 result.
- Nasdaq listing: Nasdaq notified the company in January 2023 that its depositary-share bid price had remained below $1 for 30 consecutive business days. The stated initial compliance deadline was July 31, 2023; the reverse split and depositary-share ratio change were intended in part to address this issue, with no assurance of compliance.
- Other risks: The company has no recurring product revenue, expects continuing losses, relies on third parties for clinical work and manufacturing, and faces potential dilution, customer concentration, currency exposure, intellectual-property risks and changes in healthcare pricing and reimbursement. The filing says management assessed disclosure controls and internal control over financial reporting as effective at December 31, 2022; the auditor did not provide an internal-control attestation.
Important facts for investors to verify
- Current cash, operating burn and committed funding needs against the stated runway and the requirement for additional financing.
- Terms, net proceeds, warrant conditions and dilution from the February 2023 private placement and subsequent share and depositary-share changes.
- Bioasis loan recovery, the $225,000 expense claim and any related legal or contingent liabilities.
- MTX110 trial progress, safety and efficacy evidence, timelines, and the status and potential impact of the Secura Bio license dispute.
- Nasdaq continued-listing compliance and any subsequent change in trading status or liquidity.
- Reliance on a single customer for FY2022 revenue and the terms, duration and renewal prospects of collaboration agreements.