Aethlon Medical (AEMD) FY2026 10-K Risk Factors: 18 New, 9 Dropped

What the changes say

Going-concern doubt is now explicit within 12 months, reflecting insufficient revenue and dependence on capital raising.
Intellectual-property risks broaden substantially, covering foreign protection, patent maintenance, challenges, inventorship and trade-secret loss.
Potential dilution increased: authorized shares rose to 100 million, with 96.47 million available for future issuance.
Clinical-trial, manufacturing-supply, reimbursement and Nasdaq-listing risks remain central to Hemopurifier commercialization.

What changed since the prior 10-K

New

NewRisks Relating to Our Financial Position and Need for Additional Capital
There is substantial doubt about our ability to continue as a going concern
Insufficient revenue and dependence on capital raising create substantial doubt about continuing operations within twelve months.
NewRisks Related to Our Business Operations
Our success depends in part on our ability to obtain, maintain, protect and enforce intellectual property protection for our proprietary technologies and products
Patent, trade-secret and licensing failures, including infringement of others’ patents, could force product changes, licensing or stopped sales.
NewRisks Related to Our Business Operations
different interpretations of our pre-clinical and clinical data, which could initially lead to inconclusive results; and
Different clinical-data interpretations and difficulty enrolling eligible patients could delay or expand Hemopurifier trials, increasing costs and jeopardizing approval.
NewRisks Related to Our Intellectual Property and Related Litigation
We may not be able to protect our intellectual property and proprietary rights throughout the world
Foreign patent protection is expensive and weaker in some jurisdictions, allowing competitors to use or export competing technology.
NewRisks Related to Our Intellectual Property and Related Litigation
Obtaining and maintaining our patent protection depends on compliance with various procedural, document submission, fee payment, and other requirements imposed by government patent agencies, and our patent protection could be reduced or eliminated for non-compliance with these requirements
Missed patent-agency filings, fees or procedural requirements by Aethlon or licensors could cause patent abandonment or loss of rights.
NewRisks Related to Our Intellectual Property and Related Litigation
Changes in U.S. patent law could diminish the value of patents in general, thereby impairing our ability to protect our products
Changes in U.S. patent law, including first-inventor-to-file rules, could increase uncertainty and reduce protection for Aethlon inventions.
NewRisks Related to Our Intellectual Property and Related Litigation
Issued patents covering our Hemopurifier devices and other proprietary technologies we may develop could be found invalid or unenforceable if challenged in court or before administrative bodies in the United States or abroad
Courts or administrative bodies could invalidate or render unenforceable patents covering Hemopurifier devices and other technologies.
NewRisks Related to Our Intellectual Property and Related Litigation
If we do not obtain a Patent Term Extension (PTE) for our products or product candidates, our business may be materially harmed
Failure to obtain available patent-term extensions could shorten protection for Hemopurifier products after FDA review.
NewRisks Related to Our Intellectual Property and Related Litigation
We may be subject to claims challenging the inventorship of our patents and other intellectual property
Former employees, collaborators or others could challenge inventorship or ownership of patents, trade secrets or other intellectual property.
NewRisks Related to Our Intellectual Property and Related Litigation
If we are unable to protect the confidentiality of our trade secrets, our business and competitive position would be harmed
Disclosure or independent development could expose Hemopurifier trade secrets and know-how despite confidentiality protections.
NewRisks Related to Our Intellectual Property and Related Litigation
We may be subject to claims that our employees have wrongfully used or disclosed alleged trade secrets of their former employers
Employees from biotechnology or pharmaceutical competitors could be accused of bringing former employers’ trade secrets to Aethlon.
NewRisks Related to Our Intellectual Property and Related Litigation
We may be at risk that our former employees may wrongfully use or disclose our trade secrets
Employees, consultants or other authorized parties could misappropriate Aethlon trade secrets for competitors, with costly and uncertain remedies.
NewRisks Related to Our Intellectual Property and Related Litigation
Third-party claims of intellectual property infringement, induced intellectual property infringement, misappropriation or other violation against us or our collaborators may prevent or delay the development and commercialization of our products, product candidates and other proprietary technologies we may develop
NewRisks Related to Our Intellectual Property and Related Litigation
In the ordinary course, we have been and again may become involved in lawsuits to protect or enforce our patents and other intellectual property rights, which could be expensive, time consuming, and unsuccessful
NewRisks Related to Our Intellectual Property and Related Litigation
If our trademarks and trade names are not adequately protected, then we may not be able to build name recognition in our markets of interest and our business may be adversely affected
NewRisks Related to Our Intellectual Property and Related Litigation
Intellectual property rights do not necessarily address all potential threats
NewRisks Relating to Our Common Stock and Our Corporate Governance
If Nasdaq adopts proposed continued listing standards requiring a minimum market value of listed securities of at least $5 million and we fail to satisfy such requirements, our common stock could become subject to delisting proceedings, which could materially harm our business
NewRisks Relating to Our Common Stock and Our Corporate Governance
The market price of our common stock is speculative and may be volatile, which could result in securities litigation

Dropped

DroppedRisks Relating to Our Financial Position and Need for Additional Capital
We may not currently or in the future be able to continue as a going concern
DroppedRisks Related to Our Business Operations
As of March 31, 2025, management has concluded that the previously identified material weakness has been remediated. While we are committed to maintaining a robust control environment, there can be no assurance that future material weaknesses will not be identified
DroppedRisks Related to Our Intellectual Property and Related Litigation
If we are unable to protect our proprietary technology and preserve our trade secrets, we will increase our vulnerability to competitors which could materially adversely impact our ability to remain in business
General inability to continue as a going concern through revenue generation and capital raising.
DroppedRisks Related to Our Intellectual Property and Related Litigation
If we are required to engage in expensive and lengthy litigation to enforce our intellectual property rights, such litigation could be very costly and the results of such litigation may not be satisfactory
DroppedRisks Related to Our Intellectual Property and Related Litigation
Other companies may claim that our technology infringes on their intellectual property or proprietary rights and commence legal proceedings against us which could be time-consuming and expensive and could result in our being prohibited from developing, marketing, selling or distributing our products
DroppedRisks Relating to Our Common Stock and Our Corporate Governance
On June 24, 2025, the Company received notification that they had regained compliance with the Minimum Bid Price Requirement
DroppedRisks Relating to Our Common Stock and Our Corporate Governance
Our stock price is speculative, and there is a risk of litigation
DroppedRisks Relating to Our Common Stock and Our Corporate Governance
As a result of the Holder exercising the Existing Warrants, the Company issued an aggregate of 6,200,000 shares of its common stock. The shares underlying the Existing Warrants have all been registered on Form S-1 registration statement (Registration Number 333-278188)
DroppedRisks Relating to Our Common Stock and Our Corporate Governance
Subject to the terms of the Agreement, the Company will be required to pay certain liquidated damages if the shares underlying the New Warrants are not filed within the ninety (90) period, as more fully described in the Agreement
Future material weaknesses in internal controls could cause reporting errors, reputational harm and stock-price declines.

Reworded

93% rewrittenRisks Relating to Our Common Stock and Our Corporate Governance
Our issuance of additional shares of common stock or convertible securities could be dilutive
Authorized shares increased from 60 million to 100 million; reserved shares rose to 1,958,149 and future issuance capacity to 96,471,402, including ATM offerings.
92% rewrittenRisks Related to Our Intellectual Property and Related Litigation
If the combination of patents, trade secrets and contractual provisions upon which we rely to protect our intellectual property is inadequate, our ability to commercialize our products successfully will be harmed
The supplied prior-year and current-year wording is unchanged, including three U.S. patents, 14 foreign patents and expirations from 2027 through 2031.
83% rewrittenRisks Relating to Our Common Stock and Our Corporate Governance
If we are unable to maintain compliance with the listing requirements of the Nasdaq Capital Market, our common stock may be delisted from the Nasdaq Capital Market, which could have a material adverse effect on our financial condition and could make it more difficult for you to sell your shares
The specific June 2024 $1.00 bid-price deficiency was removed and replaced with broader uncertainty about maintaining Nasdaq compliance.
66% rewrittenRisks Related to Our Business Operations
Should our Hemopurifier or any future products, be approved for commercialization, certain health reform measures and adverse changes in reimbursement policies and procedures may impact our ability to market and sell our products
The risk now emphasizes coverage and reimbursement reductions, adding that Medicare payments are reduced 2% through fiscal 2032.
61% rewrittenRisks Related to Our Business Operations
We have limited experience in identifying and working with large-scale contracts with medical device manufacturers; manufacture of our devices must comply with good manufacturing practices in the United States
Only wording changed from “large-scale” to “large scale”; the manufacturing, supplier-compliance and financing risk is otherwise unchanged.
59% rewrittenRisks Related to Our Business Operations
Delays in successfully commencing or completing our planned clinical trials could jeopardize our ability to obtain regulatory approval and sustain our operations
The description now specifically identifies the ongoing Hemopurifier solid-tumor trial rather than referring generally to planned solid-tumor studies.
54% rewrittenRisks Related to Our Business Operations
Our products are manufactured with raw materials that are sourced from specialty suppliers with limited competitors and we may therefore be unable to access the materials we need to manufacture our products
The prior reference to FDA approval for Sigma Aldrich as a backup supplier was removed; any alternate supplier now requires regulatory review and approval.
53% rewrittenRisks Relating to Our Financial Position and Need for Additional Capital
We have incurred significant losses and expect to continue to incur losses for the foreseeable future
The no-revenue periods shifted to fiscal 2026 and 2025 from fiscal 2025 and 2024; the continuing-loss and commercialization risk remains.
48% rewrittenRisks Related to U.S. Government Contracts
We may not obtain U.S. Government contracts to further develop our technology
43% rewrittenRisks Related to Our Business Operations
Our Hemopurifier technology may become obsolete
30% rewrittenRisks Relating to Our Common Stock and Our Corporate Governance
If at any time our common stock is subject to the SEC’s penny stock rules, broker-dealers may experience difficulty in completing customer transactions and trading activity in our securities may be adversely affected
27% rewrittenRisks Relating to Our Common Stock and Our Corporate Governance
If securities or industry analysts do not publish research or reports about our business, or if they change their recommendations regarding our stock adversely, our stock price and trading volume could decline
26% rewrittenRisks Related to Our Intellectual Property and Related Litigation
We rely upon licenses and patent rights from third parties which are subject to termination or expiration
25% rewrittenRisks Related to Our Business Operations
U.S. legislative or FDA or TGA regulatory reforms may make it more difficult and costly for us to obtain regulatory approval of our product candidates and to manufacture, market and distribute our products after approval is obtained
Was: U.S. legislative or FDA regulatory reforms may make it more difficult and costly for us to obtain regulatory approval of our product candidates and to manufacture, market and distribute our products after approval is obtained

All 70 risk factors

Headings as the filing states them, in filing order.

Risks Relating to Our Financial Position and Need for Additional Capital

01We have incurred significant losses and expect to continue to incur losses for the foreseeable future53% rewritten
02We will require additional financing to sustain our operations, achieve our business objectives and satisfy our cash obligations, which may dilute the ownership of our existing stockholders
03There is substantial doubt about our ability to continue as a going concernNew

Risks Related to Our Business Operations

04Delays, interruptions or the cessation of production by our third-party suppliers of important materials or delays in qualifying new materials, have and may continue to prevent or delay our ability to manufacture our Hemopurifier
05Difficulties in manufacturing our Hemopurifier could have an adverse effect upon our expenses, our product revenues and our ability to complete our clinical trials
06Our products are manufactured with raw materials that are sourced from specialty suppliers with limited competitors and we may therefore be unable to access the materials we need to manufacture our products54% rewritten
07We face intense competition in the medical device industry
08Our success depends in part on our ability to obtain, maintain, protect and enforce intellectual property protection for our proprietary technologies and productsNew
09We have limited experience in identifying and working with large-scale contracts with medical device manufacturers; manufacture of our devices must comply with good manufacturing practices in the United States61% rewritten
10Our Hemopurifier technology may become obsolete43% rewritten
11We are highly dependent on our key personnel, and if we are not successful in attracting and retaining highly qualified personnel, we may not be able to successfully implement our business strategy
12Our inability to attract and retain qualified personnel could impede our ability to achieve our business objectives
13We plan to expand our operations, which may strain our resources; our inability to manage our growth could delay or derail implementation of our business objectives
14We have limited experience in the organ transplant market and face competition from entities more familiar with this business and our efforts may not succeed
15As a public company with limited financial resources undertaking the launch of new medical technologies, we may have difficulty attracting and retaining executive management and directors
16If we fail to comply with extensive regulations of U.S. and foreign regulatory agencies, the commercialization of our products could be delayed or prevented entirely
17Delays in successfully commencing or completing our planned clinical trials could jeopardize our ability to obtain regulatory approval and sustain our operations59% rewritten
18different interpretations of our pre-clinical and clinical data, which could initially lead to inconclusive results; andNew
19If we or our suppliers fail to comply with ongoing FDA or foreign regulatory authority requirements, or if we experience unanticipated problems with our products, these products could be subject to restrictions or withdrawal from the market
20If our products, or malfunction of our products, cause or contribute to a death or a serious injury, we will be subject to medical device reporting regulations, which can result in voluntary corrective actions or agency enforcement actions
21We will need to outsource and rely on third parties for the clinical development, sales and marketing of our Hemopurifier or any future product candidates that we may develop, and our future success will be dependent on the timeliness and effectiveness of the efforts of these third parties
22We are and will be exposed to product liability risks, and clinical and preclinical liability risks, which could place a substantial financial burden upon us should we be sued
23We have not received, and may never receive, regulatory approval to market the Hemopurifier in the United States, Australia or other jurisdictions
24The approval requirements for medical products used to fight bioterrorism and pandemics are still evolving, and any products we develop for such uses may not meet these requirements
25The results of our clinical trials may not support our product candidate claims or may result in the discovery of adverse side effects
26U.S. legislative or FDA or TGA regulatory reforms may make it more difficult and costly for us to obtain regulatory approval of our product candidates and to manufacture, market and distribute our products after approval is obtained25% rewritten
27Our current and future business activities are subject to applicable anti-kickback, fraud and abuse, false claims, physician payment transparency, health information privacy and security and other healthcare laws and regulations, which could expose us to significant penalties
28Any of the previously identified or similar threats could cause a Security Breach or other interruption and disrupt our ability and that of third parties with whom we work to provide our services
29Our contracts may not contain limitations of liability, and even where they do, any such limitations or exclusions of liability in our contracts may not be adequate to protect us from liabilities or damages if we fail to comply with Data Protection Obligations related to information security or Security Breaches
30Should our products be approved for commercialization, lack of third-party coverage and reimbursement for our devices could delay or limit their adoption
31Should our Hemopurifier or any future products, be approved for commercialization, certain health reform measures and adverse changes in reimbursement policies and procedures may impact our ability to market and sell our products66% rewritten
32Our ability to use net operating loss carryforwards and certain other tax attributes to offset future taxable income or taxes may be limited
33Uncertainties in the interpretation and application of existing, new and proposed tax laws and regulations could materially affect our tax obligations and effective tax rate
34Our use of hazardous materials, chemicals and viruses exposes us to potential liabilities for which we may not have adequate insurance
35Our products may in the future be subject to product recalls. A recall of our products, either voluntarily or at the direction of the FDA or another governmental authority, including a third-country authority, or the discovery of serious safety issues with our products, could have a significant adverse impact on us
36Even though we have received breakthrough device designation for the Hemopurifier for two independent indications, this designation may not expedite the development or review of the Hemopurifier and does not provide assurance ultimately of PMA submission or approval by the FDA

Risks Related to Our Intellectual Property and Related Litigation

37We rely upon licenses and patent rights from third parties which are subject to termination or expiration26% rewritten
38We could become subject to intellectual property litigation that could be costly, result in the diversion of management’s time and efforts, require us to pay damages, prevent us from selling our commercially available products and/or reduce the margins we may realize from our products
39If the combination of patents, trade secrets and contractual provisions upon which we rely to protect our intellectual property is inadequate, our ability to commercialize our products successfully will be harmed92% rewritten
40We may not be able to protect our intellectual property and proprietary rights throughout the worldNew
41Obtaining and maintaining our patent protection depends on compliance with various procedural, document submission, fee payment, and other requirements imposed by government patent agencies, and our patent protection could be reduced or eliminated for non-compliance with these requirementsNew
42Changes in U.S. patent law could diminish the value of patents in general, thereby impairing our ability to protect our productsNew
43Issued patents covering our Hemopurifier devices and other proprietary technologies we may develop could be found invalid or unenforceable if challenged in court or before administrative bodies in the United States or abroadNew
44If we do not obtain a Patent Term Extension (PTE) for our products or product candidates, our business may be materially harmedNew
45We may be subject to claims challenging the inventorship of our patents and other intellectual propertyNew
46If we are unable to protect the confidentiality of our trade secrets, our business and competitive position would be harmedNew
47We may be subject to claims that our employees have wrongfully used or disclosed alleged trade secrets of their former employersNew
48We may be at risk that our former employees may wrongfully use or disclose our trade secretsNew
49We may rely on licenses for new technology, which may affect our continued operations with respect thereto
50New technology may lead to our competitors developing superior products which would reduce demand for our products
51Third-party claims of intellectual property infringement, induced intellectual property infringement, misappropriation or other violation against us or our collaborators may prevent or delay the development and commercialization of our products, product candidates and other proprietary technologies we may developNew
52In the ordinary course, we have been and again may become involved in lawsuits to protect or enforce our patents and other intellectual property rights, which could be expensive, time consuming, and unsuccessfulNew
53If our trademarks and trade names are not adequately protected, then we may not be able to build name recognition in our markets of interest and our business may be adversely affectedNew
54Intellectual property rights do not necessarily address all potential threatsNew

Risks Related to U.S. Government Contracts

55We may not obtain U.S. Government contracts to further develop our technology48% rewritten
56U.S. Government agencies have special contracting requirements, including a right to audit us, which create additional risks ; a negative audit would be detrimental to us
57As a potential future U.S. Government contractor, we would be subject to a number of procurement rules and regulations

Risks Relating to Our Common Stock and Our Corporate Governance

58If we are unable to maintain compliance with the listing requirements of the Nasdaq Capital Market, our common stock may be delisted from the Nasdaq Capital Market, which could have a material adverse effect on our financial condition and could make it more difficult for you to sell your shares83% rewritten
59If Nasdaq adopts proposed continued listing standards requiring a minimum market value of listed securities of at least $5 million and we fail to satisfy such requirements, our common stock could become subject to delisting proceedings, which could materially harm our businessNew
60Historically we have not paid dividends on our common stock, and we do not anticipate paying any cash dividends in the foreseeable future
61The market price of our common stock is speculative and may be volatile, which could result in securities litigationNew
62If at any time our common stock is subject to the SEC’s penny stock rules, broker-dealers may experience difficulty in completing customer transactions and trading activity in our securities may be adversely affected30% rewritten
63Generally, brokers may be less willing to execute transactions in securities subject to the “penny stock” rules. This may make it more difficult for investors to dispose of our common stock and cause a decline in the market value of our stock
64Our common stock has had an unpredictable trading volume which means you may not be able to sell our shares at or near trading prices or at all
65The market price for our common stock is volatile; you may not be able to sell our common stock at or above the price you have paid for it, which may result in losses to you
66Our issuance of additional shares of common stock or convertible securities could be dilutive93% rewritten
67Our officers and directors are entitled to indemnification from us for liabilities under our articles of incorporation, which could be costly to us and may discourage the exercise of stockholder rights
68Certain anti-takeover provisions of Nevada law could have the effect of delaying or preventing a third-party from acquiring us, even if the acquisition arguably could benefit our stockholders
69We incur substantial costs as a result of being a public company and our management expects to devote substantial time to public company compliance programs
70If securities or industry analysts do not publish research or reports about our business, or if they change their recommendations regarding our stock adversely, our stock price and trading volume could decline27% rewritten

Other Aethlon Medical 10-Ks

FY2025 10-K risk factors
61 risks
Aethlon Medical has never been profitable, generated zero revenue for fiscal years 2025 and 2024, and depends heavily on financing and the clinical development of its Hemopurifier.
Filed Jun 26, 2025

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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.