Akari Therapeutics (AKTX) FY2025 10-K Risk Factors: 2 New, 22 Dropped

What the changes say

Akari Therapeutics increased its reported cash to $5.2 million as of December 31, 2025.

What changed since the prior 10-K

New

NewRisks Related to our Ordinary Shares and ADSs
Our business, operating results and growth rates may be adversely affected by current or future unfavorable economic and market conditions and adverse developments with respect to financial institutions and associated liquidity risk
Unfavorable macroeconomic conditions, inflation, and geopolitical conflicts could negatively affect our operating results and financial condition.
NewRisks Related to our Ordinary Shares and ADSs
We have in the past and may in the future fail to meet the requirements for continued listing on Nasdaq. If we fail to maintain compliance with the minimum listing requirements, our ADSs may be delisted, which could have a material adverse effect on the liquidity of our ADSs
We received a Nasdaq notice on November 24, 2025, regarding failure to meet minimum bid price requirements, risking delisting.

Dropped

DroppedRisks Related to Our Financial Position and Our Capital Requirements
the costs associated with being a public company
DroppedRisks Related to Discovery, Development and Regulatory Approval of Our Product Candidates
approval and ultimately commercialize them, or experience significant delays in doing so, our business will be materially harmed
DroppedRisks Related to Discovery, Development and Regulatory Approval of Our Product Candidates
the proprietary rights of others and their competing products and technologies that may prevent our product candidates from being commercialized
Costs of being a public company and funding uncertainties.
DroppedRisks Related to Discovery, Development and Regulatory Approval of Our Product Candidates
prevent our products from achieving market acceptance by the healthcare or patient communities
DroppedRisks Related to Discovery, Development and Regulatory Approval of Our Product Candidates
our ability to monitor patients adequately during and after treatment
DroppedRisks Related to Discovery, Development and Regulatory Approval of Our Product Candidates
we may not be able to produce sufficient quantities of the product candidate to complete the trials
Risks related to identifying, developing, and commercializing product candidates like AKTX-101.
DroppedRisks Related to Commercialization, Marketing and Competition
any restrictions on the use of the product together with other medications
DroppedRisks Related to Commercialization, Marketing and Competition
amount 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
Length of clinical trials and regulatory approval timelines.
DroppedRisks Related to Intellectual Property
patents will not be found invalid or unenforceable if challenged
Regulatory obligations post-approval and cGMP and GCP compliance.
DroppedRisks Related to Intellectual Property
our or our licensors’ inventions or technologies may be found to be not patentable; and we may not develop additional technologies that are patentable
Risks of clinical trial suspension or termination by regulatory authorities.
DroppedRisks Related to Our Reliance on Third Parties
If any collaborator fails to fulfill its responsibilities in a timely manner, or at all, our research, clinical
DroppedRisks Related to Our Reliance on Third Parties
delays associated with the lack of availability of staff at third-party manufacturers
DroppedRisks Related to Our Reliance on Third Parties
man-made or natural disasters and other environmental factors
DroppedRisks Related to our Business Operations
penalties or other sanctions
Lengthy and uncertain regulatory approval processes for new products.
DroppedRisks Related to our Business Operations
fluctuated 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
DroppedRisks Related to our Ordinary Shares and ADSs
Our business depends on the health of the global economies. If the conditions of the global economies
DroppedRisks Related to our Ordinary Shares and ADSs
the loss of any of our key scientific or management personnel; and
DroppedRisks Related to our Ordinary Shares and ADSs
The withdrawal of the United Kingdom from the EU (Brexit) could adversely affect our business, financial condition, results of operations and prospects
DroppedRisks Related to our Ordinary Shares and ADSs
We 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”)
Difficulties in educating the medical community and achieving market acceptance.
DroppedRisks Related to our Ordinary Shares and ADSs
As 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
Uncertainty related to insurance coverage and reimbursement.
DroppedRisks Related to our Ordinary Shares and ADSs
application 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
DroppedRisks Related to our Ordinary Shares and ADSs
The 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

Reworded

90% rewrittenRisks Related to Discovery, Development and Regulatory Approval of Our Product Candidates
Our 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
Minor grammatical and punctuation adjustments made to the risk text.
73% rewrittenRisks Related to Our Reliance on Third Parties
Use 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
Minor grammatical and punctuation adjustments made to the risk text.
63% rewrittenRisks Related to Our Financial Position and Our Capital Requirements
We 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
Updated cash figure from approximately $2.6 million as of December 31, 2024 to approximately $5.2 million as of December 31, 2025.
60% rewrittenRisks Related to Commercialization, Marketing and Competition
If 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
Minor grammatical and punctuation adjustments made to the risk text.
59% rewrittenRisks Related to our Ordinary Shares and ADSs
Provisions 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
Added parentheses around the defined term 'the Takeover Panel'.
44% rewrittenRisks Related to Intellectual Property
Our success depends in part on our ability to protect our intellectual property and proprietary technologies
Minor grammatical and punctuation adjustments made to the risk text.
34% rewrittenRisks Related to Discovery, Development and Regulatory Approval of Our Product Candidates
We 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
Minor grammatical and punctuation adjustments made to the risk text.
32% rewrittenRisks Related to our Business Operations
Any 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
Removed specific past clinical trial enrollment delay examples related to the COVID-19 pandemic and discontinued BP clinical program.
30% rewrittenRisks Related to our Ordinary Shares and ADSs
Provisions 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
28% rewrittenRisks Related to our Ordinary Shares and ADSs
The market price of our ADSs may be volatile and may fluctuate in a way that is disproportionate to our operating performance
26% rewrittenRisks Related to our Business Operations
If 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
24% rewrittenRisks Related to our Ordinary Shares and ADSs
Insiders 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
21% rewrittenRisks Related to Intellectual Property
Our intellectual property rights may not adequately protect our technologies and product candidates and may not necessarily address all potential threats to our competitive advantage

All 46 risk factors

Headings as the filing states them, in filing order.

Risks Related to Our Financial Position and Our Capital Requirements

01We have a history of operating losses and cannot give assurance of future revenues or operating profits
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 candidates63% rewritten
03Raising additional capital may cause significant dilution to our shareholders or restrict our operations
04Our 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

05Our 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 prospects90% rewritten
06Any 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
07Interim, 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
08We 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 designed34% rewritten
09Our 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
10The 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

11Our industry is highly competitive, and our product candidates may become obsolete
12If 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 drugs60% rewritten
13Our 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
14EU drug marketing and reimbursement regulations may materially affect our ability to market and receive coverage for our products in the EU Member States
15Obtaining 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
16If 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
17If 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

18Our success depends in part on our ability to protect our intellectual property and proprietary technologies44% rewritten
19With 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
20As 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
21In 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
22If 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
23Our intellectual property rights may not adequately protect our technologies and product candidates and may not necessarily address all potential threats to our competitive advantage21% rewritten
24Others 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

25We 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
26If 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
27Use 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 cost73% rewritten

Risks Related to our Business Operations

28We 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
29As of March 1, 2026, we had 6 employees, 5 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
30If 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 business26% rewritten
31Any 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 candidates32% rewritten
32Our business and operations could suffer in the event of computer system failures or security breaches
33Our business is subject to risks associated with conducting business internationally

Risks Related to our Ordinary Shares and ADSs

34Our business, operating results and growth rates may be adversely affected by current or future unfavorable economic and market conditions and adverse developments with respect to financial institutions and associated liquidity riskNew
35The market price of our ADSs may be volatile and may fluctuate in a way that is disproportionate to our operating performance28% rewritten
36Insiders 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 directors24% rewritten
37Future 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
38Provisions 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 management30% rewritten
39We have in the past and may in the future fail to meet the requirements for continued listing on Nasdaq. If we fail to maintain compliance with the minimum listing requirements, our ADSs may be delisted, which could have a material adverse effect on the liquidity of our ADSsNew
40We do not anticipate paying cash dividends, and accordingly, shareholders must rely on appreciation in our ADSs for any return on their investment
41We 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
42U.S. investors may not be able to enforce their civil liabilities against our Company or certain of our directors, controlling persons and officers
43The rights of our shareholders may differ from the rights typically offered to shareholders of a U.S. corporation
44Provisions 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 shareholders59% rewritten
45Holders of ADSs must act through the depositary to exercise their rights as shareholders of our Company
46Holders of our ADSs may be subject to limitations on transfers of ADSs

Other Akari Therapeutics 10-Ks

FY2024 10-K risk factors
66 risks
Akari Therapeutics faces substantial operating losses and negative cash flows, with only $2.6 million in cash as of December 31, 2024. The company is heavily dependent on third-party contractors for clinical trials and manufacturing. Regulatory hurdles, complex intellectual property protection, and foreign market requirements dominate the risk profile.
Filed Apr 15, 2025

About this page

The headings are the filing's own. The one-line readings and the overview are automated and can be wrong: read Item 1A of the 10-K for the exact wording.