Filing summary
Issuer and period: The supplied filing is Midatech Pharma plc’s Form 20-F for the fiscal year ended December 31, 2021, not a quarterly report. Although the request identifies Biodexa Pharmaceuticals plc, the filing itself names Midatech Pharma plc; verify whether this is the intended issuer or a later company name.
The company is an early-stage biopharmaceutical developer using Q-Sphera, MidaSolve and MidaCore drug-delivery platforms. Its strategy is to advance programs toward proof of concept and seek partners to fund later development and commercialization. Financial statements are prepared under IFRS in pounds sterling.
Financial performance and position
| Metric | 2021 | 2020 |
|---|---|---|
| Revenue | £578,000 | £180,000 |
| Grant revenue | — | £163,000 |
| Loss from operations | £6.998 million | £23.040 million |
| Loss for the year | £5.460 million | £22.189 million |
| Net cash used in operating activities | £6.008 million | £9.301 million |
| Cash and cash equivalents at year-end | £10.057 million | £7.546 million |
| Total assets | £12.913 million | £9.817 million |
| Total liabilities | £2.461 million | £3.099 million |
Revenue was predominantly service income from R&D collaborations; 2021 revenue came from one customer. The filing reports no meaningful operating margin for this loss-making development-stage business. R&D costs fell 23% to £4.654 million, while administrative costs declined to £2.946 million. The 2020 operating loss included £12.369 million of impairment charges; there were no impairment charges in 2021. 2021 finance income included a £936,000 non-cash gain on remeasurement of warrant-related derivative liabilities.
Operating cash outflow before working-capital changes was £6.548 million; net operating cash outflow was £6.008 million after tax-credit receipts. Investing activities used £278,000 and financing activities provided £8.805 million, mainly from share issuance and warrant exercises. The July 2021 placing generated £10.0 million gross proceeds and approximately £9.0 million net proceeds. Shares outstanding rose from 63.074 million at year-end 2020 to 98.468 million at year-end 2021.
Year-end borrowings of £766,000 comprised lease liabilities; the Spanish government and research loans were repaid by February 2021. Cash exceeded current liabilities at year-end, but management stated that additional financing would be needed to continue planned operations. The company had an accumulated deficit of £127.803 million.
Changes, outlook and material risks
- Strategy and portfolio: Following its 2020 strategic review, Midatech ended further in-house development of MTD201, closed its Bilbao manufacturing site and shifted toward earlier-stage programs and partnering. The company reported eight pipeline projects, including two collaborations with Janssen, and a 2021 expansion of research collaboration work following protein-formulation results.
- Development plans: Management planned a Phase II MTX110 study in DIPG in the second half of 2022, targeting approximately 20 patients. Following FDA clearance of an IND, preparations were underway for a recurrent glioblastoma Phase I study in the first half of 2022. A University of Texas Phase I medulloblastoma study was also underway. These are plans stated in the filing, not reported outcomes.
- Going concern and financing: Management estimated year-end cash would fund planned operations into the first quarter of 2023, but forecasts indicated further financing would be required within the next 12 months from approval of the financial statements. The auditor highlighted a material uncertainty that raises substantial doubt about the company’s ability to continue as a going concern. Funding alternatives included equity or debt financing and partnering or disposing of assets; none was assured.
- MTX110 license dispute: Secura Bio purported to terminate the panobinostat license in 2020 and issued a further termination and license demand in 2021, which Midatech rejected. Management said relevant patents could delay a DIPG launch, but did not anticipate the same impact for glioblastoma. The dispute’s resolution and commercial consequences remain uncertain.
- Other contingencies and risks: The company was appealing a €149,835 Spanish tax-authority fine related to repayment of a government loan. COVID-19 had delayed clinical-trial recruitment and execution and could affect suppliers, timelines and financing. Other key risks include clinical failure, dependence on third-party manufacturers and collaborators, dilution from future financing, foreign-exchange exposure, and the ability to retain NASDAQ listing. After year-end, NASDAQ notified the company of a bid-price deficiency and gave it until October 10, 2022 to regain compliance.
- Unusual items and controls: A £936,000 derivative remeasurement gain contributed to 2021 results and is not recurring operating revenue. Management concluded disclosure controls and internal control over financial reporting were effective at December 31, 2021; the auditor did not provide an internal-control attestation because the company was a non-accelerated filer.
Most important facts to verify
- Confirm that Midatech Pharma plc’s 2021 Form 20-F is the intended filing for Biodexa Pharmaceuticals plc.
- Check the company’s subsequent financing, cash runway and going-concern status against the stated Q1 2023 cash estimate.
- Verify actual progress and results for the planned MTX110 trials, including the DIPG Phase II and recurrent glioblastoma Phase I programs.
- Review the current status and potential impact of the Secura Bio license and patent dispute, and the Spanish tax fine appeal.
- Confirm the outcome of the NASDAQ bid-price compliance period and assess dilution from subsequent financings, warrants and options.