TC BioPharm (NASDAQ:TCBPW) is a clinical-stage biotechnology company at the forefront of developing innovative allogeneic gamma-delta T cell therapies to treat a wide range of diseases, including cancer and infectious disorders. With a robust pipeline and a state-of-the-art manufacturing facility, TC BioPharm is poised to revolutionize the field of cell-based immunotherapies.
Business Overview and History
TC BioPharm was incorporated in October 2021 as a public limited company in Scotland, with the ambitious goal of pioneering the commercialization of allogeneic, off-the-shelf gamma-delta T cell (GD-T) therapies. The company's core technology platform is centered around the development of allogeneic gamma-delta T cells, a unique subtype of T cells that possess potent anti-tumor and anti-viral properties.
TC BioPharm's principal activity is the development of a pipeline of unmodified allogeneic GD-T therapies and next generation GD CAR-T treatments. In 2021, prior to the company's IPO, TC BioPharm reorganized its share capital, redesignating all outstanding series A ordinary shares as ordinary shares on a one-for-one basis. Immediately prior to the IPO completion, the company issued an additional 493,860 ordinary shares to certain pre-IPO shareholders who held A ordinary shares with the right to subscribe for additional shares based on the IPO pre-money valuation.
In January 2023, TC BioPharm issued over 1.3 million ordinary shares upon the exercise of pre-funded warrants that had been issued in prior financing rounds. As the pre-funded warrants contained a nominal exercise price, the exercise resulted in nominal proceeds to the company. Later that year in March 2023, TC BioPharm entered into a securities purchase agreement to issue and sell American Depositary Shares (ADSs), pre-funded warrants, and Series C purchase warrants. This offering resulted in net proceeds of approximately $4 million. As part of this transaction, the company also agreed to amend certain existing warrants to purchase ADSs by reducing the exercise price.
TC BioPharm faced a legal challenge in 2023 when a holder of a convertible loan note filed a claim asserting the company should have paid the note holder in cash rather than settling through the issuance of ordinary shares and warrants. The litigation process was in its early stages and not expected to conclude until late 2024 or later. The company contested the claim, believing it acted correctly under the terms of the note.
Financial Performance and Ratios
TC BioPharm's financial performance has been marked by significant investments in research and development, as is typical for a clinical-stage biotechnology company. The company's annual net income for the past three years has been N/A, N/A, and N/A, respectively, reflecting the company's focus on advancing its pipeline rather than generating immediate profits.
The company's annual revenue for the same period has been N/A, N/A, and N/A, respectively, as it has not yet commercialized any of its product candidates. However, TC BioPharm has maintained a strong focus on managing its cash flow, with annual operating cash flow of N/A, N/A, and N/A, and annual free cash flow of N/A, N/A, and N/A.
Financials
TC BioPharm's financial performance reflects its status as a clinical-stage biotechnology company, with significant investments in research and development. The company has not yet generated substantial revenue or profits, as it focuses on advancing its pipeline of innovative therapies.
For the most recent fiscal year (2023), TC BioPharm reported no revenue, and its annual net income, operating cash flow, and free cash flow figures were not available. However, in the most recent quarter (Q1 2024), the company reported zero revenue and a net loss of approximately $2 million. Quarterly operating cash flow and free cash flow figures were not provided.
For the three months ended March 31, 2024, TC BioPharm reported total operating expenses of $3.44 million, consisting of $1.30 million in research and development expenses and $2.14 million in administrative expenses. The company's net loss for the quarter was $3.32 million.
TC BioPharm operates primarily in the United States, but specific performance metrics by geographic market were not provided.
Liquidity
As of March 31, 2024, TC BioPharm had cash and cash equivalents of $980,960. The company has stated that this amount will not be sufficient to enable it to conduct its business for the next 12 months, and additional funding will be required to complete the development and research of its products.
The company's current ratio, a measure of its ability to meet short-term obligations, stands at 1.12 as of the most recent quarter, indicating a relatively healthy liquidity position. The quick ratio is also 1.12, suggesting that the company can cover its short-term liabilities with its most liquid assets.
The debt-to-equity ratio, a metric that assesses the company's financial leverage, is 0.83, suggesting a moderate level of debt in the capital structure.
No information was provided regarding available credit lines.
Pipeline and Clinical Development
TC BioPharm's pipeline is anchored by its lead product candidate, TCB008 (also referred to as TCB-8), an allogeneic gamma-delta T cell therapy targeting acute myeloid leukemia (AML) and myelodysplastic syndrome (MDS). TCB-8 is currently in phase 2b-into-pivotal phase 3 clinical studies for the treatment of AML. The ACHIEVE clinical trial, an adaptive, open-label, phase II study, is currently evaluating the efficacy and effectiveness of TCB008 in patients with relapsed or refractory AML or MDS.
TC BioPharm's in-house clinical studies have demonstrated that its unmodified allogeneic GD-T products are well-tolerated and show preliminary evidence of disease modification in late-stage AML patients. Based on the clinical data generated, TC BioPharm has obtained FDA orphan drug status for the treatment of AML with TCB-8.
In addition to its work in oncology, TC BioPharm has recently announced its intention to explore the potential of TCB008 in the treatment of H5N1, commonly known as "Bird Flu." The company is currently engaging with potential university partners to expedite the necessary preclinical studies required for a phase I clinical trial in this indication.
Beyond its unmodified GD-T pipeline, TC BioPharm is also developing an expanded platform for TCB-8 in anti-fungal, anti-viral, and anti-microbial applications. The company believes TCB-8 can be impactful in treating and acting as a prophylactic for immune-suppressed and immune-compromised patient populations, including cancer patients.
The company's robust pipeline also includes other gamma-delta T cell-based therapies targeting a variety of cancer and infectious disease indications. These programs are in various stages of preclinical and early-stage clinical development, demonstrating TC BioPharm's commitment to diversifying its product portfolio and addressing unmet medical needs.
Manufacturing Capabilities
To manufacture its portfolio of allogeneic GD-T products, TC BioPharm selects high-quality GD-T cells from healthy donors, activates the cells, and grows them in large numbers at its in-house GMP-compliant manufacturing facility before administration to patients. The company has implemented a freeze-thaw process that it believes will allow its products to be shipped from the cleanroom to the clinic without any shelf-life issues, making them more cost-effective and straightforward to distribute.
Competitive Landscape and Risks
TC BioPharm operates in a highly competitive industry, with numerous biotechnology and pharmaceutical companies vying for a share of the cell therapy market. The company faces competition from both established players and emerging rivals, each with their own proprietary technologies and approaches to cell-based treatments.
One of the key risks facing TC BioPharm is the inherent uncertainty associated with the development and regulatory approval of novel therapeutic modalities. The company's ability to successfully navigate the complex clinical trial process and secure regulatory approvals for its product candidates is crucial to its long-term success.
Additionally, the company is subject to the challenges inherent in the biopharmaceutical industry, such as managing manufacturing complexities, securing adequate funding for ongoing operations, and mitigating the potential impact of adverse events or safety concerns during clinical trials.
Outlook and Guidance
TC BioPharm has provided guidance on the continued advancement of its clinical programs. The company expects to complete the enrollment of Cohort A in the ACHIEVE trial for AML and MDS by the end of 2024, with data readouts anticipated in the first half of 2025.
Furthermore, the company has announced plans to initiate preclinical studies for the evaluation of TCB008 in the treatment of H5N1 virus, commonly known as "Bird Flu." This strategic expansion into infectious disease indications showcases TC BioPharm's commitment to diversifying its pipeline and addressing unmet medical needs.
In terms of financial guidance, TC BioPharm has not provided any specific revenue or earnings projections, as it remains in the clinical development stage and has not yet generated significant commercial revenue. However, the company has stated its intention to continue pursuing strategic partnerships and funding opportunities to support the ongoing development of its pipeline.
Conclusion
TC BioPharm is a pioneering clinical-stage biotechnology company at the forefront of the allogeneic gamma-delta T cell therapy space. With a robust pipeline, a state-of-the-art manufacturing facility, and a seasoned management team, the company is well-positioned to advance its innovative therapies and address the significant unmet medical needs in cancer and infectious disease.
As TC BioPharm continues to navigate the challenges of the biopharmaceutical industry, its ability to secure regulatory approvals, establish strategic partnerships, and efficiently manage its financial resources will be crucial to its long-term success. The company's focus on unmodified GD-T and GD-T CAR-T therapies, along with its manufacturing capabilities and intellectual property position, are key differentiators. However, its financial position and the need for additional funding remain significant challenges going forward.
Investors interested in the promising field of cell-based immunotherapies may find TC BioPharm's story and growth potential compelling, but should carefully consider the risks associated with early-stage biotechnology companies and the need for substantial additional funding to support ongoing research and development efforts.