20-F: TC BioPharm Faces Financial Uncertainty Despite Ongoing Clinical Trials

TC BioPharm reports recurring losses and expresses substantial doubt about its ability to continue as a going concern, despite advancing its GD-T cell therapies.

Summary

• TC BioPharm (Holdings) plc reports recurring losses and expresses substantial doubt about its ability to continue as a going concern.
• The company has incurred net losses of £12.2 million in 2024 and £5.9 million in 2023, with an accumulated deficit of £51.0 million as of December 31, 2024.
• TCB is focused on developing novel immunotherapy products based on its proprietary allogeneic gamma delta T (GD-T) cell platform.
• The company's lead product candidate, OmnImmune, is in clinical development for acute myeloid leukemia (AML) and other blood cancers.
• TCB is also developing genetically-modified CAR-T products for solid tumors.
• The company's ADSs were delisted from the Nasdaq Capital Market and are now quoted on the OTC Pink marketplace.
• TCB is appealing the Nasdaq delisting determination.
• TCB's cash on hand as of May 7, 2025, was $2.7 million, which is insufficient to fund operations through the going concern period (May 9, 2026).
• The company expects to fund current operations to June 2025.
• TCB is seeking additional financing through various sources, including private and public sales of equity and debt securities, licensing fees, joint ventures, and government grants.
• The company's independent registered public accounting firm has expressed substantial doubt about its ability to continue as a going concern.
• TCB is involved in ongoing litigation regarding a convertible loan note, with the holder demanding approximately $860,000.
• The company is subject to various risks and uncertainties, including those related to product development, clinical testing, regulatory approvals, manufacturing, commercialization, competition, and intellectual property.

Sentiment

Score: 3

Explanation: The document presents a concerning financial situation with significant risks and uncertainties. While the company is pursuing promising research and development, its ability to continue as a going concern is in doubt.

Positives

• TCB is focused on developing novel immunotherapy products based on its proprietary allogeneic gamma delta T (GD-T) cell platform.
• The company's lead product candidate, OmnImmune, is in clinical development for acute myeloid leukemia (AML) and other blood cancers.
• TCB is also developing genetically-modified CAR-T products for solid tumors.
• TCB is appealing the Nasdaq delisting determination.

Negatives

• TC BioPharm faces significant financial challenges, with recurring losses and substantial doubt about its ability to continue as a going concern.
• The company has incurred net losses of £12.2 million in 2024 and £5.9 million in 2023, with an accumulated deficit of £51.0 million as of December 31, 2024.
• The company's ADSs were delisted from the Nasdaq Capital Market and are now quoted on the OTC Pink marketplace.
• TCB's cash on hand as of May 7, 2025, was $2.7 million, which is insufficient to fund operations through the going concern period (May 9, 2026).
• TCB is involved in ongoing litigation regarding a convertible loan note, with the holder demanding approximately $860,000.

Risks

• The company's ability to continue as a going concern is dependent on generating cash flow from sales or finding adequate financing.
• The delisting from Nasdaq and continued declines in stock price could impair the ability to raise additional capital.
• The company faces substantial competition and may not be able to commercialize its product candidates successfully.
• Clinical trials may fail to demonstrate the safety and efficacy of T cell therapeutic candidates.
• Manufacturing and administering GD-T cell-based therapeutic candidates is complex and may encounter difficulties.
• Product liability claims could cause substantial liabilities and limit commercialization of products.
• The company may not be able to obtain and maintain patent protection for its GD-T cell technologies and product candidates.
• The company depends on key personnel and its ability to attract and retain employees.
• The company may have difficulty managing growth in its business.
• The company faces risks and uncertainties related to litigation, regulatory actions and government investigations and inquiries.

Future Outlook

The company expects to continue incurring significant losses as it continues with its research and development and clinical programs. The company believes it will require additional capital, likely in significant amounts, for the further development and commercialization of its GD-T cell-based therapeutic candidates.

Industry Context

The document provides insight into the challenges faced by small biopharmaceutical companies in a competitive and highly regulated industry. It highlights the difficulties in securing funding, navigating regulatory hurdles, and achieving commercial success with novel therapies.

Comparison to Industry Standards

• The document does not provide enough information to make a detailed comparison to industry standards.
• However, it is noted that many other companies in the biopharmaceutical industry have suffered significant setbacks in advanced clinical trials due to lack of efficacy or adverse safety profiles.
• The document mentions several competitors in the cell therapy space, including Adicet Bio, Allogene, Autolus, Gamma Delta Therapeutics, and In8Bio.
• These companies are developing similar cell-based products for various indications, including blood cancers and solid tumors.
• The document also mentions Novartis and Gilead as commercial leaders in the CAR-T space, marketing autologous CD19-targeted AB CAR-T products.

Legal Proceedings

• The company is involved in ongoing litigation regarding a convertible loan note, with the holder demanding approximately $860,000.

Related Party Transactions

• During August of 2024, the Company entered into a consulting agreement for investor relation services with an expected term of twelve months with MavDB Consulting LLC (the Vendor) for services with a total value of $3 million.
• The vendor is wholly owned by David Joshua Bartch, a principal owner of the Company during the period.
• The Company incurred $1 million of expense related to the agreement during its year ended December 31, 2024 and had accounts payable related to the agreement of $Nil as of December 31, 2024.
• The agreement provides compensation for the services at fair market value.

Stakeholder Impact

• Shareholders face the risk of dilution and potential loss of investment.
• Employees face uncertainty regarding job security.
• Patients may benefit from successful development of new therapies, but face risks associated with clinical trials.
• Suppliers and creditors face the risk of non-payment.
• The company's ability to continue as a going concern affects all stakeholders.

Next Steps

• Continue clinical development of OmnImmune and CAR-T product candidates.
• Seek regulatory approvals for product candidates.
• Secure additional financing to fund operations.
• Manage costs and improve operational efficiency.
• Monitor and respond to competitive landscape and industry trends.

Key Dates

Keywords

TC BioPharm, GD-T cell therapy, OmnImmune, Financial Results, Going Concern, Clinical Trials, Capital Raise, Delisting, OTC Markets, Warrants, ADSs, AML, CAR-T, Biopharmaceutical