Akari Therapeutics (AKTX) risk factors, FY2024 10-K

Risks Related to Our Financial Position and Our Capital Requirements

1. 01We have a history of operating losses and cannot give assurance of future revenues or operating profits
2. 02We will require substantial additional capital to fund our operations, and if we are unable to obtain such capital, we will be unable to successfully develop and commercialize any product candidates
3. 03the costs associated with being a public company
4. 04Raising additional capital may cause significant dilution to our shareholders or restrict our operations
5. 05Our ability to use net operating losses to offset future income may be subject to certain limitations

Risks Related to Discovery, Development and Regulatory Approval of Our Product Candidates

1. 06approval and ultimately commercialize them, or experience significant delays in doing so, our business will be materially harmed
2. 07Our inability to complete development of, or commercialize, our product candidates, or significant delays in doing so due to one or more of these factors, or other factors, could have a material and adverse effect on our business, financial condition, results of operations and prospects
3. 08the proprietary rights of others and their competing products and technologies that may prevent our product candidates from being commercialized
4. 09prevent our products from achieving market acceptance by the healthcare or patient communities
5. 10our ability to monitor patients adequately during and after treatment
6. 11Any of these events could prevent us from achieving or maintaining market acceptance of our product candidates or could substantially increase commercialization costs and expenses, which in turn could delay or prevent us from generating significant revenue from the sale of our product candidates
7. 12Interim, initial, or preliminary results from our preclinical testing or clinical trials that we announce or publish from time to time may change as more patient data become available and are subject to additional audit, validation and verification procedures that could result in material changes in the final data
8. 13We or a future strategic partner may choose to, or may be required to, suspend, repeat, or terminate clinical trials of our assets if they are not conducted in accordance with regulatory requirements, the results are negative or inconclusive or the trials are not well designed
9. 14we may not be able to produce sufficient quantities of the product candidate to complete the trials
10. 15Our employees, independent contractors, principal investigators, contract research organizations, consultants, vendors and collaboration partners may engage in misconduct or other improper activities, including non-compliance with regulatory standards
11. 16The UK government has confirmed that the EEA is adequate, and so all transfers of personal data from the UK to the EEA will continue to be unrestricted after July 1, 2021

Risks Related to Commercialization, Marketing and Competition

1. 17Our industry is highly competitive, and our product candidates may become obsolete
2. 18If we are unable to establish sales, marketing and distribution capabilities on our own or through collaborations with partners, we may not be successful in commercializing any approved drugs
3. 19any restrictions on the use of the product together with other medications
4. 20amount we will be able to charge for such product. If reimbursement is not available or is available only at limited levels, we may not be able to successfully commercialize our products or product candidates, and may not be able to obtain a satisfactory financial return on products that we may develop
5. 21Our future growth may depend, in part, on our ability to commercialize products in foreign markets, where we would be subject to additional regulatory burdens and other risks and uncertainties
6. 22EU drug marketing and reimbursement regulations may materially affect our ability to market and receive coverage for our products in the EU Member States
7. 23Obtaining and maintaining marketing approval of our product candidates in one jurisdiction does not mean that we will be successful in obtaining marketing approval of our product candidates in other jurisdictions
8. 24If the market opportunities for any of our product candidates are smaller than we estimate, even assuming approval of a product candidate, our revenue may be adversely affected, and our business may suffer
9. 25If we or our partners market products in a manner that violates fraud and abuse and other healthcare laws, or if we or they violate government price reporting laws, we or our partners may be subject to administrative civil and/or criminal penalties

Risks Related to Intellectual Property

1. 26Our success depends in part on our ability to protect our intellectual property and proprietary technologies
2. 27patents will not be found invalid or unenforceable if challenged
3. 28With respect to certain patents, we enjoy only limited geographical protection, and as a consequence we may not be able to protect our intellectual property rights throughout the world
4. 29As a result, these product candidates may compete with our product candidates, and our and our licensors’ patents or other intellectual property rights may not be effective or sufficient to prevent them from competing
5. 30In addition, the laws of some jurisdictions do not protect intellectual property rights to the same extent as the laws or rules and regulations in the United States, The UK and Europe, and many companies have encountered significant difficulties in protecting and defending such rights in such jurisdictions
6. 31If we or our licensors encounter difficulties in protecting, or are otherwise precluded from effectively protecting, the intellectual property rights important for our business in such jurisdictions, the value of these rights may be diminished, and we may face additional competition from others in those jurisdictions
7. 32Our intellectual property rights may not adequately protect our technologies and product candidates and may not necessarily address all potential threats to our competitive advantage
8. 33our or our licensors’ inventions or technologies may be found to be not patentable; and we may not develop additional technologies that are patentable
9. 34Others may claim an ownership interest in our intellectual property, which could expose us to litigation and have a significant adverse effect on our prospects

Risks Related to Our Reliance on Third Parties

1. 35We rely on third parties to conduct, supervise and monitor our preclinical studies and clinical trials, and if those third parties perform in an unsatisfactory manner it may harm our business
2. 36If any collaborator fails to fulfill its responsibilities in a timely manner, or at all, our research, clinical
3. 37If the third parties on which we intend to rely for our clinical trials and results do not perform our clinical trial activities in accordance with good clinical practices and related regulatory requirements, we may be unable to obtain marketing authorization for or commercialize our product candidates
4. 38Use of third parties to manufacture our product candidates may increase the risk that we will not have sufficient quantities of our product candidates, products, or necessary quantities at an acceptable cost
5. 39delays associated with the lack of availability of staff at third-party manufacturers
6. 40man-made or natural disasters and other environmental factors

Risks Related to our Business Operations

1. 41We only have a limited number of employees to manage and operate our business. Our business could suffer if we are unable to attract and retain key employees
2. 42As of March 31, 2025, we had 9 employees, 8 of which are full-time. Our limited financial resources have led us to focus on the development of our ADC Platform and to manage and operate our business in a highly efficient manner
3. 43If we or any third-party manufacturers we engage fail to comply with environmental, health and safety laws and regulations, we could become subject to fines or penalties or incur costs or liabilities that could harm our business
4. 44penalties or other sanctions
5. 45Any pandemic, epidemic, or outbreak of an infectious disease, may materially and adversely affect our business and our financial results and could cause a disruption to the development of our product candidates
6. 46fluctuated in the past as a result of these factors, and government funding of the SEC, and other government agencies on which our operations may rely, is subject to the impacts of political events, which are inherently fluid and unpredictable
7. 47Our business and operations could suffer in the event of computer system failures or security breaches
8. 48Our business is subject to risks associated with conducting business internationally

Risks Related to our Ordinary Shares and ADSs

1. 49Our business depends on the health of the global economies. If the conditions of the global economies
2. 50The market price of our ADSs may be volatile and may fluctuate in a way that is disproportionate to our operating performance
3. 51the loss of any of our key scientific or management personnel; and
4. 52Insiders own a significant amount of our outstanding shares which could delay or prevent a change in corporate control or result in the entrenchment of management and/or the board of directors
5. 53Future sales and issuances of our ordinary shares or ADSs or rights to purchase ordinary shares or ADSs pursuant to our equity incentive plans could result in additional dilution of the percentage ownership of our shareholders and could cause our share price to fall
6. 54The withdrawal of the United Kingdom from the EU (Brexit) could adversely affect our business, financial condition, results of operations and prospects
7. 55Provisions in our Articles of Association and under English law could make an acquisition of our Company more difficult and may prevent attempts by our shareholders to replace or remove our organization management
8. 56We have in the past received notices from The Nasdaq Stock Market relating to a failure to comply with the minimum $2,500,000 stockholders’ equity requirement for continued listing set forth in Listing Rule 5550(b) (the “Stockholders’ Equity Requirement”)
9. 57We do not anticipate paying cash dividends, and accordingly, shareholders must rely on appreciation in our ADSs for any return on their investment
10. 58As of January 1, 2024, we were no longer a foreign private issuer and we are required to comply with the provisions of the Exchange Act, and the rules of Nasdaq, applicable to U.S. domestic issuers, which will continue to require us to incur significant expenses and expend time and resources
11. 59We incur significant costs and demands upon management as a result of complying with the laws and regulations affecting public companies, which could harm our operating results
12. 60U.S. investors may not be able to enforce their civil liabilities against our Company or certain of our directors, controlling persons and officers
13. 61The rights of our shareholders may differ from the rights typically offered to shareholders of a U.S. corporation
14. 62Provisions in the UK City Code on Takeovers and Mergers may have anti-takeover effects that could discourage an acquisition of us by others, even if an acquisition would be beneficial to our shareholders
15. 63application of the Takeover Code by the Takeover Panel, changes (including changes to the way in which the Takeover Panel assesses the application of the Takeover Code to English companies whose shares are listed outside of the UK), the Takeover Code may apply to us in the future
16. 64Holders of ADSs must act through the depositary to exercise their rights as shareholders of our Company
17. 65Holders of our ADSs may be subject to limitations on transfers of ADSs
18. 66The rights of holders of our ADSs to participate in any future rights offerings may be limited, which may cause dilution to their holdings, and they may not receive cash dividends if it is impractical to make them available to them