ENDRA Life Sciences (NDRA) risk factors, FY2025 10-K

Risks Related to Our Business

1. 01Our activities to evaluate and pursue potential strategic alternatives may not result in any transaction or enhance stockholder value
2. 02We may not be able to successfully execute our TAEUS business model
3. 03Our TAEUS platform applications may not achieve adequate market acceptance by physicians, patients, third-party payors and others in the medical community
4. 04Our revenues will be adversely affected if, due to these or other factors, the products we are able to commercialize do not gain significant market acceptance
5. 05We may not become commercially viable if there is an inadequate level of reimbursement by governmental programs and other third-party payors for our planned products or associated procedures
6. 06We have limited data regarding the efficacy of our TAEUS platform applications. If any of our applications that receive regulatory approval do not perform in accordance with our expectations, we are unlikely to successfully commercialize our applications
7. 07We cannot be certain that results from limited human studies of our TAEUS liver device will be indicative of future studies or that any of our TAEUS applications will be successfully commercialized
8. 08Our limited commercial experience makes it difficult to evaluate our business, predict our future results or forecast our financial performance and growth
9. 09We intend in the future to form or seek additional strategic alliances, create joint ventures or collaborations or enter into licensing arrangements with third parties that we believe will complement or augment our development and commercialization efforts with respect to our technologies and applications
10. 10We have limited resources and depend on third parties to design and manufacture, and seek regulatory approval of, our TAEUS applications
11. 11We will need to develop marketing and distribution capabilities both internally and through our relationships with third parties in order to sell any of our TAEUS products receiving regulatory approval
12. 12We intend to partner with others to assist us with some or all of these functions. However, we may be unable to find appropriate third parties with which to enter into these arrangements and any such third parties may not perform as expected
13. 13If we are unable to manage the growth of our business, our future revenues and operating results may be harmed
14. 14Competition in the medical imaging market is intense and we may be unable to successfully compete
15. 15The medical device market is characterized by rapid innovation
16. 16Changes in the healthcare industry could result in a reduction in the size of the market for our products or may require us to decrease the selling price for our products, either of which could have a negative impact on our financial performance
17. 17We intend to market our approved TAEUS applications globally, and currently market our TAEUS liver probe in the EU, and are therefore subject to the risks of doing business outside of the United States
18. 18There is no assurance that, if approved, the Company’s TAEUS applications will be widely adopted by customers or their patients
19. 19If we are unable to attract and retain qualified personnel, we may not be able to successfully manage our business and achieve our objectives
20. 20Our employees, independent contractors, consultants, commercial partners and vendors may engage in misconduct or other improper activities, including noncompliance with regulatory standards and requirements
21. 21Misdiagnosis, warranty and other claims, as well as product field actions and regulatory proceedings, initiated against us could increase our costs, delay or reduce our sales and damage our reputation, adversely affecting our financial condition
22. 22Our internal computer systems, or those used by third-party manufacturers or other contractors or consultants, may fail or suffer security breaches
23. 23Public health crises can adversely impact our business, including our pre-sales activities, clinical trials and ability to obtain regulatory approvals

Risks Related to Intellectual Property and Other Legal Matters

1. 24If we are unable to protect our intellectual property, which entails significant expense and resources, then our financial condition, results of operations and the value of our technology and products could be adversely affected
2. 25Policing unauthorized use of our proprietary rights can be difficult, expensive and time-consuming, and we might be unable to determine the extent of this unauthorized use
3. 26If we are unable to protect the confidentiality of our proprietary information and know-how, the value of our technology and products could be adversely affected
4. 27We may in the future be a party to intellectual property litigation or administrative proceedings that could be costly and could interfere with our ability to sell our TAEUS applications

Risks Related to Government Regulation

1. 28Failure to comply with laws and regulations could harm our business
2. 29Disruptions at the FDA, including due to a reduction in the FDA’s workforce and/or inadequate funding for the FDA, could prevent the FDA from performing normal functions on which our business relies, which could negatively impact our business
3. 30If we fail to obtain and maintain necessary regulatory clearances or approvals for our TAEUS applications, or if clearances or approvals for future applications and indications are delayed or not issued, our commercial operations will be harmed
4. 31We are also required to comply with the regulations of each other country where we commercialize products, such as the requirement that we obtain approval from the FDA before we can launch new products in the United States
5. 32Even if we obtain regulatory approval for our TAEUS device, our product will remain subject to regulatory oversight
6. 33We have experienced and may in the future experience delays and other difficulties in enrolling a sufficient number of patients in our clinical trials which could delay or prevent the receipt of necessary regulatory approvals
7. 34We may have other delays in completing our clinical trials and we may not complete them at all
8. 35Our TAEUS applications may require recertification or new regulatory clearances or premarket approvals and we may be required to recall or cease marketing our TAEUS applications until such recertification or clearances are obtained
9. 36If any OEMs fail to comply with the FDA’s Quality System Regulations or other regulatory bodies’ equivalent regulations, manufacturing operations could be delayed or shut down and the development of our TAEUS platform could suffer
10. 37Our TAEUS applications may in the future be subject to product recalls that could harm our reputation
11. 38Healthcare reform measures could hinder or prevent our planned products’ commercial success
12. 39If we fail to comply with healthcare regulations, we could face substantial penalties and our business, operations and financial condition could be adversely affected
13. 40Compliance with environmental laws and regulations could be expensive. Failure to comply with environmental laws and regulations could subject us to significant liability

Risks Related to Owning Our Securities, Our Financial Results and Our Need for Financing

1. 41Our stock is subject to minimum requirements to remain listed on the Nasdaq Capital Market, including a minimum bid price requirement and stockholders’ equity requirement, and may be delisted if it does not maintain compliance with those requirements
2. 42Nasdaq has proposed enhanced listing standards, which could adversely affect our ability to maintain our Nasdaq listing and access to capital markets
3. 43Our quarterly and annual results may fluctuate significantly, may not fully reflect the underlying performance of our business and may result in volatility in the price of our securities
4. 44Our stock price has fluctuated in the past, has recently been volatile and may be volatile in the future
5. 45We may be subject to securities litigation, which is expensive and could divert management attention
6. 46There is a limited market for our common stock
7. 47If securities or industry analysts do not publish research reports about our business, or if they issue an adverse opinion about our business, the price of our securities and trading volume could decline
8. 48We have not paid dividends in the past and have no plans to pay dividends for the foreseeable future
9. 49We incur significant costs as a result of being a public company that reports to the SEC and our management is required to devote substantial time to meet compliance obligations
10. 50Future sales and issuances of our common stock or rights to purchase common stock, including pursuant to our equity incentive plan and our at-the-market equity offering program, could result in dilution of the percentage ownership of our stockholders and could cause the price of our securities to fall
11. 51Our charter documents and Delaware law may inhibit a takeover that stockholders consider favorable

Risks Related to Our Digital Asset Treasury Strategy

1. 52The emergence or growth of other digital assets, including those with significant private or public sector backing, could have a negative impact on the price of cryptocurrencies we hold and adversely affect our business
2. 53The accounting treatment of cryptocurrency holdings could have significant accounting impacts, including increasing the volatility of our results
3. 54We have engaged an asset manager to manage our cryptocurrency holdings. Our management, Digital Asset Advisory Board and asset manager will have broad discretion in the management of our digital asset treasury and their decisions on the execution of such strategy may not be successful
4. 55Cryptocurrency holdings are less liquid than our existing cash and cash equivalents and may not be able to serve as a source of liquidity for us to the same extent as cash and cash equivalents
5. 56Cryptocurrencies do not pay interest or dividends
6. 57We face significant risks relating to disruptions, forks, 51% attacks, hacks, network disruptions, or other adverse events or other compromises to the cryptocurrency blockchains, which could materially and adversely impact our business, financial condition and results of operations
7. 58We plan to hold substantially all of our cryptocurrency in custody accounts at a U.S.-based, institutional-grade custodian that has demonstrated a record of regulatory compliance and information security. As we further execute on our strategy, we intend to expand our holdings to multiple similar custodians
8. 59Absent of federal regulations, there is a possibility that certain cryptocurrencies may be classified as “securities.” Any classification of a cryptocurrency as a “security” would subject us to additional regulation and could materially impact the operation of our business
9. 60We, in connection with our DAT strategy, are not subject to legal and regulatory obligations that apply to investment companies such as mutual funds and exchange-traded funds, or to obligations applicable to investment advisers
10. 61We may be subject to regulatory developments related to crypto assets and crypto asset markets, which could adversely affect our business, financial condition, and results of operations

General Risk Factors

1. 62Unfavorable national or global economic conditions or political developments could adversely affect our business, financial condition or results of operations
2. 63Our cash and cash equivalents could be adversely affected if the financial institutions in which we hold our cash and cash equivalents fail
3. 64Our business and operations are subject to risks related to climate change and natural disasters