F-1/A: TC BioPharm Announces Public Offering of ADSs and Warrants to Fuel Clinical Pipeline

TC BioPharm is launching a public offering of American Depositary Shares (ADSs) and warrants to raise capital for its clinical development programs.

Summary

• TC BioPharm (Holdings) PLC is offering 1,162,790 American Depositary Shares (ADSs) along with Series H warrants to purchase an equal number of ADSs.
• The offering also includes pre-funded warrants for certain purchasers who would exceed ownership limits with direct ADS purchases.
• The assumed public offering price is $4.30 per ADS and warrant, with the Series H warrants having an exercise price of 3.28 per ADS and expiring in one year.
• The pre-funded warrants are priced at the ADS price less $0.001, with an exercise price of $0.001 per ADS.
• The offering is set to terminate on September 15, 2024, and the company intends to use the net proceeds to advance its preclinical and clinical pipeline, and for continuing operating expenses, including market awareness and working capital.
• The company's ADSs are listed on the Nasdaq Capital Market under the symbol TCBP.

Sentiment

Score: 6

Explanation: The sentiment is neutral. The document primarily describes the terms of a public offering, which is a common financial transaction. While the offering provides capital for the company, it also carries risks for investors, such as potential dilution and market volatility.

Positives

• The offering will provide capital to advance TC BioPharm's clinical pipeline.
• The company has flexibility in allocating the net proceeds.
• The company's ADSs are already listed on the Nasdaq Capital Market.

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 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 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.

Risks

• Investment in the company's securities involves a high degree of risk.
• 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 its 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 its business to date and to assess its 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 its 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 its 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 its 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, it 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 its ability to be able to commercialize its products and generate revenues and investment return for its stockholders.
• The company may not be able to obtain the intellectual property protection it seeks due to its cost, requirement to pursue it in many jurisdictions, challenges by others and patent office rejection.
• Obtaining and maintaining the company's patent protection depends on compliance with various procedural, document submission, fee payment and other requirements imposed by governmental patent agencies acting in multiple jurisdictions, and its patent protection could be reduced or eliminated for non-compliance with these requirements.
• As part of product development, the company may need to license aspects of its research and products from third parties or if its IP is challenged, it may have to seek license accommodation, any of which may be expensive, limited in scope, or unavailable.
• The company currently has a limited number of employees, and its future success depends on its 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 its organization, and it 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 expects to expand its development and regulatory capabilities and potentially implement sales, marketing and distribution capabilities, and as a result, it may encounter difficulties in achieving and managing its growth, which could disrupt its operations.
• The company expects to require further funding for these expansions of activity.
• The company incurs substantial costs as a result of operating as a public company in the United States, and its 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, its ability to produce accurate financial statements on a timely basis could be impaired, which would adversely affect its business and its stock price.
• Certain of the company's existing stockholders, members of its board of directors and senior management maintain the ability to exercise significant control over it.
• The interests of investors may conflict with the interests of these other stockholders.
• The company's ADSs provide rights that are different from directly holding its ordinary shares.
• The outstanding Warrants do not have the rights of shareholders until exercised.
• The company's Warrants form a substantial part of its capitalization, and they have substantial protective provisions, which may limit its ability to raise capital.
• 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 its Warrants, could adversely affect the price of its ADSs or Warrants in the market.
• As a foreign private issuer, the company, and its stockholders, have certain exceptions to disclosure regulation under United States federal securities regulation, and it 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.
• Half of the company's directors and officers are not resident in the United States.
• Most of the company's assets are located in the United Kingdom.
• If the company fails to meet the requirements for continued listing on the Nasdaq Capital Market or Nasdaq, its ADSs could be delisted from trading, which would decrease the liquidity of its ADSs and its 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.
• 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 it believes is required for its business plans, including its 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.
• If the company fails to maintain proper and effective internal controls, its ability to produce accurate financial statements on a timely basis could be impaired, which would adversely affect its business and its stock price.
• 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 advance its preclinical and clinical pipeline, and for continuing operating expenses, including market awareness and working capital.

Industry Context

The document relates to a public offering in the biopharmaceutical industry, where companies often raise capital to fund research, clinical trials, and commercialization efforts. The use of ADSs and warrants is a common structure for such offerings, particularly for foreign companies listed on U.S. exchanges.

Comparison to Industry Standards

• It is difficult to compare the results to industry standards without knowing the specific terms of the offering (e.g., the discount to market price, the warrant coverage, etc.). However, the use of ADSs and warrants is a common structure for small-cap biopharmaceutical companies seeking to raise capital. Some comparable companies that have used similar structures include:
• * **Atossa Therapeutics (ATOS):** Has conducted multiple public offerings of common stock and warrants to fund its clinical trials.
• * **Citius Pharmaceuticals (CTXR):** Has also used a combination of common stock and warrant offerings to raise capital.
• * **Cyclacel Pharmaceuticals (CYCC):** Has utilized similar financing strategies to advance its drug development programs.
• These companies, like TC BioPharm, are focused on developing novel therapies and require significant capital to fund their operations. The success of these offerings depends on various factors, including market conditions, investor sentiment, and the company's progress in its clinical development programs.

Stakeholder Impact

• Shareholders may experience dilution due to the issuance of new ADSs and warrants.
• The company's employees and management will benefit from the capital infusion, which will support the company's operations and growth.
• Customers may benefit from the advancement of the company's clinical pipeline, which could lead to new therapies.
• Creditors may be affected by the company's use of proceeds, which will not be used for debt repayment.
• Suppliers may benefit from the company's increased spending on research and development.

Next Steps

• The company and purchasers will execute the agreement.
• The company will file a Current Report on Form 6-K with the Commission.
• The company will apply to list the ADSs and Warrant ADSs on the Trading Market.
• The company will use the net proceeds to advance its preclinical and clinical pipeline, and for continuing operating expenses, including market awareness and working capital.
• The closing will occur on the Closing Date, upon satisfaction of the conditions set forth in Sections 2.2 and 2.3.

Key Dates

Keywords

ADSs, Warrants, Public Offering, TC BioPharm, Clinical Pipeline, Securities, Pre-funded Warrants