TCBP Provides Shareholder Update and Highlights Recent Milestone Achievements

Rhea-AI Summary

TC BioPharm (NASDAQ: TCBP) reported significant progress in 2024, highlighting achievements in its ACHIEVE UK trial for TCB008, where 8 patients have been dosed, including 2 completing all 4 doses. The company expanded trial sites, including Guy's and St. Thomas Hospital, with two more sites planned for Q1 2025. Key developments include signing two LOIs for acquisitions, initiating Mpox treatment research, and forming an AI partnership for donor screening. Financial highlights include a 50% reduction in Q1 cash burn and raising $8 million in Q3. Manufacturing improvements have increased treatment capacity from 52 to over 1,000 patients annually, with an 85% cost reduction per treatment.

Positive

• Manufacturing capacity increased from 52 to over 1,000 patient treatments annually
• 85% cost reduction per patient treatment
• Successfully raised $8.0 million in Q3 2024
• 50% reduction in Q1 cash burn
• Clinical trial expansion with new site additions
• MHRA approval for increased dosing size up to 230 million cells

Negative

• Clinical trial still in early stages with only 8 patients dosed
• Multiple acquisitions still in LOI phase, not finalized

Insights

Medical Research Analyst

This update from TC BioPharm demonstrates significant operational progress in their clinical trials and business development. The ACHIEVE UK trial has shown promising momentum with 8 patients dosed, including 2 completing all 4 doses. The expansion to Guy's and St. Thomas Hospital, a prestigious oncology center, validates the trial's credibility.

The company's manufacturing improvements are particularly noteworthy, with treatment capacity increasing from 52 to over 1,000 patients annually, alongside an 85% cost reduction per treatment. The $8 million capital raise strengthens their financial position for continued development.

The diversification into Mpox treatment and AI-driven donor screening shows strategic expansion beyond their core gamma-delta T cell platform. However, investors should note that the LOIs for acquisitions are non-binding and success in multiple programs will require significant resources for a company of this size.

Financial Analyst

The financial developments show improved operational efficiency with a 50% reduction in Q1 cash burn and an $8 million non-brokered capital raise. The manufacturing improvements represent significant value creation, potentially leading to better margins and scalability.

For a micro-cap biotech with a market cap under $1 million, the company is pursuing an ambitious strategy. The expansion into AI and potential acquisitions could create new revenue streams, but also increases execution risk. The non-dilutive funding is particularly positive given the company's size. The accelerated manufacturing timeline and cost reductions are important for long-term sustainability.

EDINBURGH, Scotland, Oct. 30, 2024 /PRNewswire/ -- TC BioPharm (Holdings) PLC ("TC BioPharm" or the "Company") (NASDAQ: TCBP), a clinical-stage biotechnology company developing platform allogeneic gamma-delta T cell therapies for cancer and other indications, today provides an update to its shareholders and highlighted the Company's operational achievements thus far in 2024.

"The Company has made tremendous strides during the current year and bolstered its standing as a leading clinical-stage biopharmaceutical company," said Bryan Kobel, CEO of TC BioPharm. "The ACHIEVE UK trial has progressed with alacrity since we received MHRA acceptance of the increased dosing regimen; 8 patients have been dosed to date, including 2 patients that have received their 4^th and final dose, all patients are in Cohort A bringing the total patients dosed to xx. We recently announced a new site opening, Guy's and St. Thomas Hospital which is one of the leading oncology clinics in the UK, this is expansion is related to increased scope and interest in the trial. Another site has opened since this announcement, and we are working towards opening two more sites in Q1 2025. Additionally, our compassionate use program has received physician attention in the UK and US, informing us of TCB008's potentially broad use case in patients suffering in various forms of cancer."

In addition to its existing therapeutic platform, TC BioPharm has signed two separate non-binding LOIs for acquisitions in cell therapy modalities outside the core of TCB008, announced its intention to begin proof of concept for preclinical trials for the treatment of Mpox with a leading infectious disease expert in the UK, and formed a strategic partnership with a leading University for AI initiative in the potentially multi-billion dollar field of donor screening for allogeneic cell therapies. In Q1 2024, cash burn was reduced by 50%, and TCBP aligned R&D efforts towards commercial applications. The benefits of these measures are now evident in Q4 2024, including Dr. Lauren Bor's team expects to implement manufacturing process improvements months ahead of the announced 24-month schedule.  Directly correlated to our achievements of our strategic initiatives and milestone successes, the Company added approximately $8 million in capital to the balance sheet in August in a non-brokered transaction with an investor group."

First Half 2024 Highlights

• Announced that the MHRA has officially accepted its proposed amendment to the Company's clinical trial authorization (CTA).
  • The amendment allows for an increase in dosing size of TCB008 (unmodified expanded gamma delta T cell Lymphocytes), up to 230 million gamma delta T-cells per dose.
• Completed the dosing of 5 new patients in the ACHIEVE Phase 2b trial ongoing in the UK.
  • To date, the trial has successfully dosed 8 patients with their first and second doses, of a possible 4 doses at the higher dose level.
• TCBP Announced the Launch of the Compassionate Use Program for TCB008.
• TC BioPharm Announced Execution of Two Non-Binding Letter of Intent for Acquisition, Targeting Innovative CAR-T Therapies and NK Platform Technologies.
• Developed a streamlined and scaled-up manufacturing process
  • increases treatment capacity from 52 patient treatments per year to more than 1,000
  • Cost reduction of 85% per patient treatment.

Second Half 2024 Highlights

• Announced new site opening of Guys and St. Thomas Hospital in the ACHIEVE UK Trial;
  • Guys and St. Thomas is a London-based leading oncology clinic and cell therapy clinical team.
  • This new site was opened in September 2024, facilitating the expedited progression of the ACHIEVE clinical trial timelines.
• TCBP intends to begin Proof of Concept preclinical studies for its lead therapeutic TCB008, for the treatment of Mpox;
  • Research studies are being planned in collaboration with Dr. Carlos Maluquer de Motes, a Reader and Principal Investigator at the University of Surrey, who works closely with a leading center of excellence in research of viral diseases, the Pirbright Institute.
• TC BioPharm is partnering with Dr. Wei Wu of Carnegie Mellon University to create an artificial intelligence solution to optimize the donor screening and matching process.
  • Potentially multi-billion-dollar market of screening capabilities for all allogeneic cell therapy companies utilizing donor material
• Successfully raised $8.0 Million in capital during the Third Quarter 2024.

Kobel concluded, "TCBP's objectives for 2024 were ambitious, yet our team has executed plans to achieve and exceed the requirements of each milestone by a significant margin. We expect to continue executing our strategic initiatives and operational plans for 2025, including driving Cohort B to a data readout, amending our Phase 1b FDA trial to a shortened timeline, and executing our acquisition strategy to expand our cell therapy offerings at TCB. The Company will continue this trend through the remainder of 2024 and beyond as we approach the collation of clinical data in H1 2025 for Cohort A."

Forward-Looking Statements

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. All statements contained in this Current Report on Form 8-K that do not relate to matters of historical fact should be considered forward-looking statements, including statements regarding the Company's intent or ability to affect any budget savings or execute any M&A or capital raising strategy. These statements are based on management's current assumptions and are neither promises nor guarantees but involve known and unknown risks, uncertainties, and other important factors that may cause the Company's actual results, performance, or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements. For other important factors that could cause actual results to differ materially from the forward-looking statements in this Current Report on Form 8-K, please see the risks and uncertainties identified under the heading "Risk Factors" in our Annual Report on Form 10-K for the year ended December 31, 2023, and our other reports filed with the SEC, all of which is available on the Company's Investor Relations website at www.tcbiopharm.com and on the SEC website at www.sec.gov. All forward-looking statements reflect the Company's beliefs and assumptions only as of the date of this Current Report on Form 8-K. The Company undertakes no obligation to update forward-looking statements to reflect future events or circumstances.

About TC BioPharm (Holdings) PLC

TC BioPharm is a clinical-stage biopharmaceutical company focused on discovering, developing, and commercializing gamma-delta T-cell therapies for cancer treatment with human efficacy data in acute myeloid leukemia. Gamma-delta T cells are naturally occurring immune cells that embody properties of both the innate and adaptive immune systems and can intrinsically differentiate between healthy and diseased tissue.

TC BioPharm is the leader in developing gamma-delta T cell therapies and the first company to conduct phase II/pivotal clinical studies in oncology. The Company is conducting two investigator-initiated clinical trials for its unmodified gamma-delta T cell product line - Phase 2b/3 pivotal trial in treating acute myeloid leukemia using the Company's proprietary allogeneic CryoTC technology to provide frozen product to clinics worldwide.

 

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SOURCE TC BioPharm

FAQ

How many patients have been dosed in TCBP's ACHIEVE UK trial as of October 2024?

8 patients have been dosed in the ACHIEVE UK trial, with 2 patients completing all 4 doses in Cohort A.

What is the new manufacturing capacity for TCBP's treatment in 2024?

The manufacturing capacity has increased from 52 to over 1,000 patient treatments per year, with an 85% cost reduction per treatment.

How much capital did TCBP raise in Q3 2024?

TCBP raised $8.0 million in capital during the Third Quarter of 2024 through a non-brokered transaction with an investor group.

What is the maximum approved dose size for TCB008 in TCBP's clinical trials?

The MHRA approved an increased dosing size of up to 230 million gamma delta T-cells per dose for TCB008.