F-1: TC BioPharm Seeks $5 Million in New ADS and Warrant Offering

TC BioPharm is offering up to 6,297,230 American Depositary Shares (ADSs) and warrants in a bid to raise approximately $5 million for clinical trials and working capital.

Summary

• TC BioPharm (Holdings) PLC is offering 6,297,230 American Depositary Shares (ADSs) along with Series G warrants to purchase an equal number of ADSs.
• The offering also includes pre-funded warrants for certain purchasers who would otherwise exceed ownership limits.
• The assumed public offering price is $0.794 per ADS and accompanying warrant, based on the closing price on June 26, 2024.
• Series G warrants will have an exercise price translated to U.S. dollars at the rate of 1.00 to $[ ] as of July , 2024 and are immediately exercisable for five years.
• The company intends to use the net proceeds to advance its preclinical and clinical pipeline, and for continuing operating expenses and working capital.
• The offering will terminate on [], 2024, unless the company decides to terminate it earlier.
• The company is also registering the ADSs issuable upon exercise of the pre-funded warrants and the Warrants.

Sentiment

Score: 4

Explanation: The document is largely neutral, providing factual information about the offering. However, the inclusion of risk factors and the company's history of losses temper the overall sentiment.

Positives

• The company intends to use the net proceeds to support its upcoming clinical trial focusing on relapse/refractory Acute Myeloid Leukemia, and for continuing operating expenses and working capital.
• Pre-funded warrants are available for certain purchasers to avoid exceeding ownership limits, exercisable at $0.001 per ADS.

Negatives

• There is no established public trading market for the Warrants and pre-funded warrants, and the company does not expect a market to develop.
• The company may sell fewer than all of the securities offered hereby, which may significantly reduce the amount of proceeds received by us.

Risks

• Investing in the company's securities involves a high degree of risk, as detailed in the Risk Factors section.
• The company has generated operating losses since inception and expects to continue to generate losses.
• The company may never achieve or maintain profitability.
• The company will continue to require financing to continue to implement its business plan and sustain operations.
• The company, as well as its independent registered public accounting firm, in relation to its financial position, have expressed substantial doubt about the company's ability to continue as a going concern.
• The company's lack of any approved products and its limited operating history may make it difficult for an investor to evaluate the success of the company's business to date and to assess the company's future viability.
• GD-T cell therapies are a novel approach to treating cancers and infectious diseases, which have development risks and will require the company to obtain regulatory approvals for development, testing, commercialization, manufacturing and distribution.
• The company may not achieve all the required regulatory approvals or approvals may not be obtained as timely as needed.
• Because GD-T cell therapies are a novel approach, potential side effects, and long-term efficacy, regulatory approval will require considerable time for trials, data collection, regulatory submissions and funding for the process.
• Enrolling patients in clinical trials may be difficult for many reasons, including high screen failure, GD-T cell proliferation capacity, timing, proximity and availability of clinical sites, perceived risks, and publicity about the success or lack of success in the methods of treatment.
• Because GD-T cell therapies are novel, the company's research and development and clinical trial results may not support the company's products intended purposes and regulatory approval.
• The company is heavily dependent on the success of its lead product candidate (OmnImmune), and intend to seek breakthrough therapy designation for some or all of the company's other therapeutic candidates in due course.
• Market opportunities for certain of the company's product candidates may be limited to those patients who are ineligible for or have failed prior treatments.
• The company relies on many third parties for aspects of the company's product development and commercialization, such as raw material supply, clinical trials, obtaining approvals, aspects of manufacturing, development of additional product candidates and distribution.
• The company faces substantial competition: others may discover, develop and/or commercialize competing products before or more successfully than TCB.
• Even if the company is able to commercialize any product candidates, such drugs may become subject to unfavorable pricing regulations or third-party coverage and reimbursement policies.
• Commercialized products may not be adopted by the medical profession.
• Because the company operates internationally, the company is subject to a wide array of regulation of the United Kingdom, European Union and United States.
• Product liability claims are frequent in drug development of novel therapies and insurance is mandatory and expensive.
• Protecting the company's intellectual property is paramount in the company's ability to be able to commercialize the company's products and generate revenues and investment return for the company's stockholders.
• The company currently has a limited number of employees, and the company's future success depends on the company's ability to retain key executives and to attract, retain and motivate qualified personnel at all levels.
• The company will need to grow the size and capabilities of the company's organization, and the company may experience difficulties in managing this growth including, but not limited to, operating as a public company and taking a therapeutic through to market approval and acceptance.
• The company incurs substantial costs as a result of operating as a public company in the United States, and the company's management is required to devote substantial time to required SEC compliance and corporate governance practices.
• If the company fails to maintain proper and effective internal controls, the company's ability to produce accurate financial statements on a timely basis could be impaired, which would adversely affect the company's business and the company's stock price.
• Certain of the company's existing stockholders, members of the company's board of directors and senior management maintain the ability to exercise significant control over the company.
• The company's ADSs provide rights that are different from directly holding the company's ordinary shares.
• Future sales, or the possibility of future sales, of a substantial number of the company's ordinary shares, through the additional deposit of ordinary shares for ADSs and exercises of the company's Warrants, could adversely affect the price of the company's ADSs or Warrants in the market.
• As a foreign private issuer, the company, and the company's stockholders, have certain exceptions to disclosure regulation under United States federal securities regulation, and the company will take certain NASDAQ governance exceptions.
• Shareholder rights and recourse will be governed by and ultimately determined by Scottish and United Kingdom law and judicial process, which in many ways are more limited than United States law and practice.
• If the company fails to meet the requirements for continued listing on the Nasdaq Capital Market or Nasdaq, the company's ADSs could be delisted from trading, which would decrease the liquidity of the company's ADSs and the company's ability to raise additional capital.
• The price of the ADSs has been, and is likely to continue to be, highly volatile, which could result in substantial losses for purchases of ADSs in this offering.
• The company has broad discretion in the use of the net proceeds from this offering and any exercise of the Warrants and consequently may not use them effectively.
• The exercise of outstanding ADS purchase warrants and share options will have a dilutive effect on the percentage ownership of the company's capital stock by existing stockholders.
• There is no public market for Warrants or pre-funded warrants being offered by the company in this offering.
• This is a best efforts offering, no minimum amount of securities is required to be sold, and the company may not raise the amount of capital the company believes is required for the company's business plans, including the company's near-term business plans.
• You will experience immediate dilution in the book value per ADS purchased in the offering.
• If you purchase the company's securities in this offering you may experience future dilution as a result of future equity offerings or other equity issuances.
• The company faces risks and uncertainties related to litigation, regulatory actions and government investigations and inquiries.
• Unstable market and economic factors could adversely affect the company's business, financial condition or results of operations.

Future Outlook

The company intends to use the net proceeds of this offering to support its upcoming clinical trial focusing on relapse/refractory Acute Myeloid Leukemia, and for continuing operating expenses and working capital.

Industry Context

TC BioPharm is operating in the competitive biopharmaceutical industry, focusing on novel immunotherapy products based on allogeneic gamma delta T (GD-T) cell platform.

Comparison to Industry Standards

• The document does not contain enough information to make a detailed comparison to industry standards.
• A full comparison would require a detailed analysis of the company's financial performance, clinical trial results, and competitive landscape relative to other companies in the cell therapy space, such as bluebird bio, Inc (now 2seventybio) and Nipro Corporation.

Stakeholder Impact

• Shareholders will be impacted by potential dilution from the offering and warrant exercises.
• The company's ability to fund its clinical trials and operations will impact employees and patients.

Next Steps

• The company will proceed with the offering, subject to market conditions and regulatory approvals.
• The company will use the net proceeds to advance its clinical trials and for working capital.

Key Dates

Keywords

ADS, warrants, offering, TC BioPharm, capital raise, clinical trials, securities, biopharmaceutical, AML, financing