On this page of StockholderLetter.com we present the 5/24/2023 shareholder letter from ENDRA Life Sciences Inc. — ticker symbol NDRA. Reading current and past NDRA letters to shareholders can bring important insights into the investment thesis.

 •  5/24/2023 Letter Continued (Full PDF)
 •  6/25/2024 NDRA Stockholder Letter
 •  10/28/2025 NDRA Stockholder Letter
 •  More "Medical Instruments & Supplies" Category Stockholder Letters
 •  NDRA Benford's Law Stock Score = 66

NDRA 5/24/2023 Shareholder/Stockholder Letter Transcript:

UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
FORM 10   K
(Mark One)

ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
For the Fiscal Year Ended: December 31, 2022

TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
For the transition period from __________________ to __________________
Commission file number: 001-37969
ENDRA Life Sciences Inc.
(Exact Name of Registrant as Specified in Its Charter)
Delaware
(State or Other Jurisdiction of Incorporation or Organization)
26-0579295
(I.R.S. Employer Identification No.)
3600 Green Court, Suite 350, Ann Arbor, MI
(Address of Principal Executive Offices)
48105-1570
(Zip Code)
(734) 335-0468
(Registrant   s telephone number, including area code)
Securities registered pursuant to Section 12(b) of the Act:
Title of each class
Common Stock, par value $0.0001 per share
Trading Symbol
NDRA
Name of each exchange on which registered
The Nasdaq Stock Market LLC
Securities registered pursuant to Section 12(g) of the Act: None
Indicate by check mark if the registrant is a well-known seasoned issuer, as defined in Rule 405 of the Securities Act. Yes     No    
Indicate by check mark if the registrant is not required to file reports pursuant to Section 13 or Section 15(d) of the Act. Yes     No    
Indicate by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities
Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2)
has been subject to such filing requirements for the past 90 days. Yes     No    
If securities are registered pursuant to Section this 2(b) of the Act, indicate by check mark whether the financial statements of the
registrant included in the filing reflect the correction of an error to previously issued financial statements.    
Indicate by check mark whether any of those error corrections are restatements that required a recovery analysis of incentive-based
compensation received by any of the registrant   s executive officers during the relevant recovery period pursuant to    240.10D-1(b).    
Indicate by check mark whether the registrant has submitted electronically and posted on its corporate Web site, if any, every
Interactive Data File required to be submitted and posted pursuant to Rule 405 of Regulation S-T during the preceding 12 months (or for such
shorter period that the registrant was required to submit and post such files). Yes     No    
Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, a smaller
reporting company or an emerging growth company. See definitions of "large accelerated filer,       accelerated filer,       smaller reporting
company    and    emerging growth company    in Rule 12b-2 of the Exchange Act.
Large accelerated filer
Non-accelerated Filer


Accelerated filer
Smaller reporting company
Emerging growth company


If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for
complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act.    
Indicate by check mark whether the registrant has filed a report on and attestation to its management   s assessment of the effectiveness
of its internal control over financial reporting under Section 404(b) of the Sarbanes-Oxley Act (15 U.S.C. 7262(b)) by the registered public
accounting firm that prepared or issued its audit report.    
Indicate by check mark whether the registrant has filed a report on and attestation to its management   s assessment of the effectiveness
of its internal control over financial reporting under Section 404(b) of the Sarbanes-Oxley Act (15 U.S.C. 7262(b)) by the registered public
accounting firm that prepared or issued its audit report.    
Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Act): Yes     No    
The aggregate market value of voting and non-voting common equity held by non-affiliates of the registrant, as of June 30, 2022, was
approximately $15,628,360 based on the closing sales price of the common stock on such date as reported on the Nasdaq Capital Market.
As of March 16, 2023, there were 3,169,103 shares of the registrant   s common stock outstanding.
DOCUMENTS INCORPORATED BY REFERENCE
None.

ENDRA LIFE SCIENCES INC.
TABLE OF CONTENTS
Page
PART I
Item 1.
Item 1A.
Item 1B.
Item 2.
Item 3.
Item 4.
PART II
Item 5.
Business. ..................................................................................................................................................
Risk Factors. ............................................................................................................................................
Unresolved Staff Comments. ...................................................................................................................
Properties. ................................................................................................................................................
Legal Proceedings. ..................................................................................................................................
Mine Safety Disclosures. .........................................................................................................................
Market for Registrant   s Common Equity, Related Stockholder Matters and Issuer Purchases of Equity
Securities. ................................................................................................................................................
[Reserved] ...............................................................................................................................................
Management's Discussion and Analysis of Financial Condition and Results of Operations. ..................
Quantitative and Qualitative Disclosures About Market Risk. ................................................................
Financial Statements and Supplementary Data. ......................................................................................
Changes in and Disagreements with Accountants on Accounting and Financial Disclosure. .................
Controls and Procedures. .........................................................................................................................
Other Information. ...................................................................................................................................
Disclosure Regarding Foreign Jurisdictions that Prevent Inspections. ....................................................
Item 6.
Item 7.
Item 7A.
Item 8.
Item 9.
Item 9A.
Item 9B.
Item 9C.
PART III
Item 10.
Directors, Executive Officers and Corporate Governance. .....................................................................
Item 11.
Executive Compensation. ........................................................................................................................
Item 12.
Security Ownership of Certain Beneficial Owners and Management and Related Stockholders
Matters. ....................................................................................................................................................
Item 13.
Certain Relationships and Related Transactions, and Director Independence. .......................................
Item 14.
Principal Accountant Fees and Services. .................................................................................................
PART IV
Item 15.
Exhibits, Financial Statements and Schedules.........................................................................................
Item 16.
Form 10-K Summary. ..............................................................................................................................
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CAUTIONARY NOTE REGARDING FORWARD-LOOKING STATEMENTS
This Annual Report on Form 10-K (this    Annual Report   ) contains    forward-looking statements    within the meaning of
Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as
amended, that are intended to be covered by the    safe harbor    created by those sections. Forward-looking statements, which
are based on certain assumptions and describe our future plans, strategies and expectations, can generally be identified by the
use of forward-looking terms such as    believe,       expect,       may,       will,       should,       would,       could,       seek,       intend,   
   plan,       goal,       project,       estimate,       anticipate,       strategy   ,    future   ,    likely    or other comparable terms and references to
future periods. All statements other than statements of historical facts included in this Annual Report regarding our strategies,
prospects, financial condition, operations, costs, plans and objectives are forward-looking statements. Examples of forwardlooking statements include, among others, statements we make regarding expectations for revenues, cash flows and financial
performance, the anticipated results of our development efforts and the timing for receipt of required regulatory approvals
and product launches.
Forward-looking statements are neither historical facts nor assurances of future performance. Instead, they are based only on
our current beliefs, expectations and assumptions regarding the future of our business, future plans and strategies, projections,
anticipated events and trends, the economy and other future conditions. Because forward-looking statements relate to the
future, they are subject to inherent uncertainties, risks and changes in circumstances that are difficult to predict and many of
which are outside of our control. Our actual results and financial condition may differ materially from those indicated in the
forward-looking statements. Therefore, you should not rely on any of these forward-looking statements. Important factors
that could cause our actual results and financial condition to differ materially from those indicated in the forward-looking
statements include, among others, the following:

our limited commercial experience, limited cash and history of losses;

our ability to obtain adequate financing to fund our business operations in the future;

our ability to achieve profitability;

our ability to develop a commercially feasible application based on our Thermo-Acoustic Enhanced
Ultrasound (   TAEUS   ) technology;

market acceptance of our technology;

uncertainties associated with COVID-19 or future pandemics, including possible effects on our operations;

the effect of macroeconomic conditions on our business;

results of our human studies, which may be negative or inconclusive;

our ability to find and maintain development partners;

our reliance on third parties, collaborations, strategic alliances and licensing arrangements to complete our
business strategy;

the amount and nature of competition in our industry;

our ability to protect our intellectual property;

potential changes in the healthcare industry or third-party reimbursement practices;

delays and changes in regulatory requirements, policy and guidelines, including potential delays in
submitting required regulatory applications or other submissions with respect to U.S. Food and Drug
Administration (   FDA   ) or other regulatory agency approval;

our ability to maintain CE mark certification, and secure required FDA and other governmental approvals,
for our TAEUS applications;

our ability to comply with regulation by various federal, state, local and foreign governmental agencies and
to maintain necessary regulatory clearances or approvals;

our ability to maintain compliance with Nasdaq listing standards;

our dependence on our senior management team; and

the other risks and uncertainties described in the Risk Factors and in Management   s Discussion and Analysis
of Financial Condition and Results of Operations sections of this Annual Report.
Any forward-looking statement made by us in this report is based only on information currently available to us and speaks
only as of the date on which it is made. We undertake no obligation to publicly update any forward-looking statement,
whether written or oral, that may be made from time to time, whether as a result of new information, future developments or
otherwise.
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RISK FACTOR SUMMARY
Below is a bulleted summary of our principal risk factors, however this list does not fully represent all of our known risk
factors. We encourage you to carefully review the full risk factors contained in this Annual Report in their entirety for
additional information regarding the material factors that make an investment in our securities speculative or risky. These
risks and uncertainties include, but are not limited to, the following:
Risks Related to our Business

We have a history of operating losses, we may never achieve or maintain profitability, and we will need to
raise significant additional capital if we are going to continue as a going concern.

Our efforts may never result in the successful development of commercial applications based on our TAEUS
technology, on which our success is substantially dependent.

Our TAEUS platform applications may not achieve adequate market acceptance by the physicians, patients,
third-party payors and others in the medical community.

The outbreak of COVID-19, or future pandemics, could adversely impact our business, including our presales activities, clinical trials and ability to obtain regulatory approvals.

We may not remain 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.

We have limited resources and depend on third parties to design and manufacture, and seek regulatory
approval of, our TAEUS applications.

We 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.

Competition in the medical imaging market is intense and we may be unable to successfully compete.

We intend to market our TAEUS applications, if approved, globally, in which case we will be subject to the
risks of doing business outside of the United States.

We depend on our senior management team and the loss of one or more key employees or an inability to
attract and retain highly skilled employees could harm our business.

Misdiagnosis, 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.
Risks Related to Intellectual Property and Other Legal Matters

If 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.

Policing 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.

Intellectual property rights may not provide adequate protection, which may permit third parties to compete
against us more effectively.
Risks Related to Government Regulation

If 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.

Healthcare reform measures could hinder or prevent our planned products' commercial success.

If we fail to comply with healthcare regulations, we could face substantial penalties and our business,
operations and financial condition could be adversely affected.
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Risks Related to Owning Our Securities, Our Financial Results and Our Need for Financing

Our 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.

Our stock price has fluctuated in the past, has recently been volatile and may be volatile in the future for
reasons unrelated to our operating performance or prospects, and as a result, investors in our common stock
could incur substantial losses.

We may be subject to securities litigation, which is expensive and could divert management attention.

If we are unable to implement and maintain effective internal control over financial reporting, including by
remediating current material weaknesses in our internal control over financial reporting, investors may lose
confidence in the accuracy and completeness of our financial reports and the market price of our securities
may decrease.

Our disclosure controls and procedures may not prevent or detect all errors or acts of fraud.

Future sales and issuances of our common stock or rights to purchase common stock, including pursuant to
our equity incentive plan, could result in dilution of the percentage ownership of our stockholders and could
cause the price of our securities to fall.

Our charter documents and Delaware law may inhibit a takeover that stockholders consider favorable.
General Risk Factors

Our business is affected by macroeconomic conditions.

Our cash and cash equivalents could be adversely affected if the financial institutions in which we hold our
cash and cash equivalents fail.

The ongoing military action by Russia in Ukraine could have negative impact on the global economy, which
could materially adversely affect our business, operations, operating results and financial condition.

Our business and operations are subject to risks related to climate change.

Our business could be negatively impacted by corporate social responsibility and sustainability matters.
PART I
As used in this Annual Report, unless the context otherwise requires, the terms    ENDRA,       we,       us,       our,    and the
   Company    refer to ENDRA Life Sciences Inc., a Delaware corporation, and its subsidiaries.
Item 1. Business
Overview
We were incorporated as a Delaware corporation in 2007. We are leveraging experience with pre-clinical enhanced
ultrasound devices to develop technology for increasing the capabilities of clinical diagnostic ultrasound in order to broaden
patient access to the safe diagnosis and treatment of a number of significant medical conditions in circumstances where
expensive X-ray computed tomography (   CT   ) and magnetic resonance imaging (   MRI   ) technology, or other diagnostic
technologies such as surgical biopsy, are unavailable or impractical.
In 2010, we began marketing and selling our Nexus 128 system, which combined light-based thermoacoustics and ultrasound
to address the imaging needs of researchers studying disease models in pre-clinical applications. Building on this expertise in
thermoacoustics, we have developed a next-generation technology platform   Thermo Acoustic Enhanced Ultrasound, or
TAEUS       which is intended to enhance the capability of clinical ultrasound technology and support the diagnosis and
treatment of a number of significant medical conditions that currently require the use of expensive CT or MRI imaging or
where imaging is not practical using existing technology. We ceased production, service support and parts for our Nexus 128
system in 2019 in order to focus our resources exclusively on the development of our TAEUS technology.
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 5/24/2023 Letter Continued (Full PDF)