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TC BioPharm (Holdings) PLC (NASDAQ: TCBP) is a clinical-stage biopharmaceutical company dedicated to the discovery, development, and commercialization of innovative immunotherapy products. The company leverages its proprietary allogeneic gamma-delta T (GD-T) cell platform to create novel therapies aimed at treating cancer and viral infections.
Gamma-delta T cells are unique immune cells that possess characteristics of both the innate and adaptive immune systems, enabling them to distinguish between healthy and diseased tissues. TC BioPharm's approach uses these cells to develop effective treatments for various cancers, including both liquid and solid tumors.
Notable achievements include the initiation of phase 2b/3 pivotal trials for OmnImmune® in the treatment of acute myeloid leukemia (AML) using their proprietary allogeneic CryoTC technology, which allows for the distribution of frozen cell products to clinics worldwide. The company also maintains a robust pipeline targeting solid tumors and has built a significant intellectual property portfolio.
Recent developments highlight TC BioPharm's dynamic progress:
- March 1, 2024: CEO Bryan Kobel featured on 'The Big Biz Show,' discussing the company's ongoing advancements.
- March 18, 2024: An institutional investor exercised warrants resulting in a net cash infusion of $1.17M, strengthening the company’s financial position.
- March 19, 2024: The company adjourned its General Meeting to gather additional information for a shareholder vote.
- April 2, 2024: Announcement of a new streamlined manufacturing process to increase patient treatment capacity and reduce costs by 85%.
- April 4, 2024: Execution of a non-binding letter of intent to acquire assets focused on CAR-NK cell therapies, enhancing their cancer treatment capabilities.
- May 6, 2024: Agreement for the immediate exercise of certain warrants, raising approximately £3.1M for clinical trials and operations.
- May 6, 2024: Announcement of a second letter of intent to acquire a company developing CAR-T therapies for solid tumors and autoimmune diseases.
- May 15, 2024: Launch of a compassionate use program in the UK for TCB-008, providing new treatment options for patients ineligible for clinical trials.
TC BioPharm continues to focus on expanding its therapeutic platform, leveraging strategic partnerships, and advancing its clinical trials, all while upholding its commitment to improving patient outcomes.
TC BioPharm (NASDAQ: TCBP), a clinical stage biotechnology company developing allogeneic gamma-delta T cell therapies, has announced its participation in the H.C. Wainwright 26th Annual Global Investment Conference. The event will take place from September 9-11, 2024 in New York City, with both in-person and virtual options available. Bryan Kobel, CEO of TC BioPharm, will present an overview of the company's business during the conference. The event will feature over 550 corporate presentations and panels, providing investors with opportunities to learn about various companies and schedule individual meetings with management teams.
TC BioPharm (NASDAQ: TCBP) has announced significant progress in its ACHIEVE Phase 2b trial for TCB008, a potential monotherapy for blood cancers. The company has dosed 6 patients at a higher dose level, with 5 patients receiving their second dose and 2 patients receiving their third dose. Each 5mL dose contains up to 230 million gamma delta T cells, with patients expected to receive approximately 1 billion cells over four doses.
The trial's rapid progression and strong enrollment reflect clinician interest in TCB008. TCBP has implemented process improvements and protocol amendments, resulting in improved patient recruitment and retention. The company is prepared to continue executing its clinical trial plans for ACHIEVE and ACHIEVE2 through 2024 and into 2025, alongside expanded manufacturing capabilities.
TC BioPharm (NASDAQ: TCBP) has successfully closed its upsized $6.0 million public offering. The offering included 6,000,000 American Depository Shares (ADSs) or pre-funded warrants, along with Series H warrants to purchase up to 6,000,000 ADSs at a combined price of $1 per ADS. The Series H Warrants have an exercise price of £0.76 per ADS and will expire in one year. Each ADS represents 200 ordinary shares of the company.
The net proceeds will be used to support TC BioPharm's upcoming clinical trial on relapse/refractory Acute Myeloid Leukemia, increase market awareness, and cover operating expenses and working capital. This offering was made through a registration statement on Form F-1 declared effective by the SEC on August 28, 2024.
TC BioPharm (NASDAQ: TCBP) has been granted a European patent for the use of modified gamma delta cells in treating cancer and viral indications. This patent expands TCBP's portfolio and aligns with their commercial strategy. CEO Bryan Kobel emphasized the company's focus on TCB008 applications while developing future high-value gamma delta assets for indications like solid tumors.
Kobel highlighted the potential of modified gamma delta t-cells to outperform current CAR and modified t-cells in terms of safety and efficacy. The patent protection is seen as creating a competitive advantage and adding value in potential acquisition scenarios.
TC BioPharm (NASDAQ: TCBP) has regained compliance with Nasdaq's Minimum Stockholders' Equity Requirement, maintaining its listing on the Nasdaq Global Select Market. The company, which develops allogeneic gamma-delta T cell therapies, had received a non-compliance notification on May 24, 2024, based on its March 31, 2024 financial position. Despite Nasdaq's concerns about potential future non-compliance due to historical burn rate, TC BioPharm was granted a hearing and subsequently given until August 15, 2024, to meet the requirement. The company believes it has achieved compliance through the closing of transactions outlined in a Purchase Agreement.
TC BioPharm (NASDAQ: TCBP), a clinical stage biotechnology company, has closed a $2.0 million public offering of 2,000,000 American Depository Shares (ADSs) or pre-funded warrants, along with Series G Warrants. The offering was priced at $1 per ADS with associated warrants. Series G Warrants have an exercise price of £0.78 per ADS and will expire in one year. The company plans to use the net proceeds to support its upcoming clinical trial on relapse/refractory Acute Myeloid Leukemia, as well as for continuing operating expenses and working capital. This offering was made through a registration statement on Form F-1 declared effective by the SEC on August 12, 2024.
TC BioPharm (NASDAQ: TCBP) has announced pricing for a $2.0 million registered direct offering. The biotechnology company, focused on developing allogeneic gamma-delta T cell therapies for cancer, will sell 2,000,000 American Depository Shares and Pre-Funded Warrants at $1 per share. Additionally, 2,000,000 cash exercise only Series G warrants with an exercise price of £0.78 will be offered to a single investor.
The company plans to use the net proceeds to support its upcoming clinical trial for relapse/refractory Acute Myeloid Leukemia, as well as for continuing operating expenses and working capital. A final prospectus supplement with additional offering details will be filed with the SEC.
TC BioPharm (NASDAQ: TCBP) has announced a significant change in its American Depositary Shares (ADS) ratio. Effective August 5th, 2024, the company will adjust its ADS to ordinary shares ratio from 1:20 to 1:200. This change will function similarly to a 1-for-10 reverse ADS split for ADS holders. Key points:
- No impact on underlying ordinary shares
- ADS holders must exchange every 10 ADSs for 1 new ADS
- Fractional new ADSs will be sold, with proceeds distributed to holders
- Trading continues on Nasdaq under 'TCBP' symbol
- ADS trading price expected to increase proportionally, though not guaranteed
This strategic move aims to adjust TCBP's market presence, potentially affecting its stock valuation and investor perception.
TC BioPharm (NASDAQ: TCBP) has announced the dosing of the sixth patient in its ACHIEVE UK clinical trial for acute myeloid leukemia (AML) on July 16, 2024. This marks the first patient treated with a higher dose of TCB-008 following an amendment approved by the MHRA in February 2024. The trial, now in Phase II, aims to evaluate the efficacy of TCB-008 in patients with AML or MDS/AML who have relapsed or refractory disease.
The study consists of two cohorts: Cohort A for relapsed/refractory patients and Cohort B for patients with detectable residual disease after remission. The new dosage contains up to 230 million cells per dose, increased from the previous 35 million. Eligible patients may receive up to four doses, totaling approximately 1 billion cells. TC BioPharm expects to dose up to 10 more patients in 2024 and plans to open an additional clinical trial site in Q3.
TC BioPharm (NASDAQ: TCBP) announced the launch of a compassionate use program for its lead therapeutic, TCB008. This program allows access to TCB008 for patients in the UK who cannot be treated with available licensed treatments. Compassionate use involves prescribing unlicensed medicinal products in specific clinical scenarios. Patients must meet entry criteria to ensure safety and data integrity. Regulatory approval is required for any market use of these products. The program provides treatment options for patients not eligible for experimental treatments in clinical trials. CEO Bryan Kobel emphasized the importance of patient needs, quality of life, and the potential to expand data and use cases for TCB008.
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