Item 9A. Controls and Procedures
Item 9A. Controls and Procedures.
Evaluation of Disclosure Controls and Procedures
As of the end of the period covered by this report, management performed, with the participation of our principal executive and principal financial officer, an evaluation of the effectiveness of our disclosure controls and procedures as defined in Rules 13a-15(e) and 15d-15(e) of the Exchange Act. Our disclosure controls and procedures are designed to ensure that information required to be disclosed in the reports we file or submit under the Exchange Act is recorded, processed, summarized, and reported within the time periods specified in the SEC’s forms, and that such information is accumulated and communicated to our management, including our principal executive officer and principal financial officer, to allow timely decisions regarding required disclosures. Based on the evaluation, our principal executive and principal financial officer concluded that, as of December 31, 2023, our disclosure controls and procedures were not effective due to a material weakness in internal control over financial reporting, as described below.
Management’s Report on Internal Control Over Financial Reporting
Our management is responsible for establishing and maintaining effective internal control over financial reporting as defined in Rules 13a-15(f) and 15d-15(f) of the Exchange Act. Internal control over financial reporting is a process designed to provide reasonable assurance to the Company’s management and board of directors regarding the reliability of our financial reporting for external purposes in accordance with accounting principles generally accepted in the United States of America.
Because of its inherent limitations, internal control over financial reporting is not intended to provide absolute assurance that a misstatement of our consolidated financial statements would be prevented or detected. Also, projections of any evaluation of effectiveness to future periods are subject to the risk that controls may become inadequate because of changes in conditions, or that the degree of compliance with the policies or procedures may deteriorate. Therefore, even those systems determined to be effective can only provide reasonable assurance with respect to financial statement preparation and presentation.
Management conducted an evaluation of the effectiveness of our internal control over financial reporting based on the framework in Internal Control - Integrated Framework (2013) issued by the Committee of Sponsoring Organizations of the Treadway Commission.
A material weakness is a deficiency, or a combination of deficiencies, in internal control over financial reporting, such that there is a reasonable possibility that a material misstatement of our annual or interim financial statements will not be prevented or detected on a timely basis. Management identified the following material weakness as of December 31, 2023: insufficient personnel resources within the accounting function to segregate the duties over financial transaction processing and reporting. Because of this material weakness, management concluded that the Company’s internal control over financial reporting was not effective as of December 31, 2023.
Continuing Remediation Efforts
To remediate its internal control weakness, management intends to implement the following measures, as the Company’s resources and financial means allow:
·
Add additional accounting personnel or outside consultants, such as a new controller, to properly segregate duties and to effect timely, accurate preparation of the financial statements; and
·
Complete the development of and maintain adequate written accounting policies and procedures.
As we are not an “accelerated filer” under SEC rules, we are not required to provide an auditor’s attestation of management’s assessment of internal control over financial reporting as of December 31, 2023.
Changes in Internal Control of Financial Reporting
During the quarter ended December 31, 2023, except as described above under “Continuing Remediation Efforts,” there were no changes that have materially affected, or are reasonably likely to materially affect, our internal control over financial reporting.
Item 9B. Other Information.
Not applicable.
Item 9C. Disclosure Regarding Foreign Jurisdictions that Prevent Inspections
Not applicable.
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PART III
Item 10. Directors, Executive Officers and Corporate Governance.
The following table sets forth the names and ages of all of our executive officers and directors. Our officers are appointed by, and serve at the pleasure of, the board of directors.
Name
Age
Position
Francois Michelon
58
Chief Executive Officer and Chairman
Michael Thornton
55
Chief Technology Officer
Irina Pestrikova
38
Senior Director, Finance
Louis J. Basenese
46
Director
Anthony DiGiandomenico
57
Director
Michael Harsh
69
Director
Alexander Tokman
62
Director
Biographical information with respect to our executive officers and directors is provided below. There are no family relationships between any of our executive officers or directors.
Francois Michelon joined ENDRA as Chief Executive Officer and Chairman of our board of directors in 2015. He has over 20 years of healthcare technology experience in general management, operations, strategy and marketing across the diagnostic imaging, surgical instrument and dental sectors.
From 2012 to 2014, Mr. Michelon served as Vice President of Global Marketing for the 3i division of Biomet, Inc. (now Zimmer Biomet Holdings, Inc.), a provider of oral reconstruction technologies, where he was responsible for the upstream and downstream development of the division’s global portfolio. From 2004 to 2011, Mr. Michelon served as Group Director of Global Services and Visualization for Smith & Nephew plc’s Advanced Surgical Devices division, where he led in the B2B service and capital equipment sectors and had responsibility over the financial performance of these as well. From 1997 to 2004, Mr. Michelon worked at GE Healthcare in a variety of global upstream and downstream marketing roles.
Mr. Michelon received an MBA from Carnegie-Mellon University and a BA in Economics from the University of Chicago. He has also earned his Six Sigma Black Belt certification.
Mr. Michelon’s extensive industry and executive experience and his intimate understanding of our business as our Chief Executive Officer position him well to serve as a member of our Board of Directors.
Michael Thornton joined ENDRA as Chief Operating Officer in 2007 and became our Chief Technology Officer in 2008 and has served in that role since. Prior to that, Mr. Thornton was a founder and President of Enhanced Vision Systems Corp., or EVS, a developer and supplier of medical imaging equipment to the pharmaceutical, biotech, and academic sectors.
In 2002, EVS was acquired by General Electric Company and was integrated into the Functional and Molecular Imaging business unit of GE Medical Systems (now GE Healthcare, a subsidiary of General Electric Company). Following the acquisition of EVS by GE Medical Systems, Mr. Thornton held a number of positions at GE Healthcare, including Sales Manager, Global Product Manager, and Site Leader. He was a member of the leadership team that expanded the pre-clinical imaging business to include: computed tomography, optical, and positron emission tomography imaging technologies, with global market reach. He is also a founder of Volumetrics Medical Corp., a developer and manufacturer of quality assurance devices for diagnostic imaging.
Prior to founding EVS, Mr. Thornton developed medical imaging related technologies at the Robarts Research Institute (London, Ontario, Canada) for which he obtained an MSc in Electrical Engineering from the University of Western Ontario. Mr. Thornton also holds a BASc in Electrical Engineering from the University of Toronto and is a member of the American Association of Physicists in Medicine.
Irina Pestrikova joined ENDRA as Senior Director, Finance in June 2021. From 2014 to 2021, Ms. Pestrikova was the Director of Operations of Wells Compliance Group. Wells Compliance Group is a technology-based services firm supporting the financial reporting needs of publicly traded companies and privately held firms whose investor or shareholder base requires timely GAAP-compliant financial reporting. In her role as Director of Operations, Ms. Pestrikova provided accounting and bookkeeping services to a number of public companies, including ENDRA. Ms. Pestrikova has also been the Director of Finance & Operations of Atlas Bookkeeping, Inc., a provider of financial reporting, modeling and analysis, since 2020. She holds an MBA in Finance from Pepperdine University.
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Louis J. Basenese , joined our Board of Directors in April 2020. Mr. Basenese is the President, Chief Market Strategist at Public Ventures, LLC, a registered broker-dealer, Member FINRA/SIPC. Previously, he was Founder and Chief Analyst of Disruptive Tech Research, LLC, an independent equity research and advisory firm focused exclusively on disruptive technology companies that has served the investment management community from June 2014 through September 2022. Since 2005, Mr. Basenese has also managed The Basenese Group, LLC, a consulting business focused on communications and business development for private and public small and microcap businesses.
Mr. Basenese holds an M.B.A. in Finance from the Crummer Graduate School of Business at Rollins College and a Bachelor of Arts from the University of Florida. He is also a former Series 7 and Series 66 license holder.
Mr. Basenese’s experience with investor relations and business development of technology-focused companies, as well as financing and strategic planning, provides him with the qualifications and skills necessary to serve as a member of our Board of Directors.
Anthony DiGiandomenico joined our Board of Directors in 2013. A co-founder of MDB Capital Group LLC, Mr. DiGiandomenico focuses on corporate finance and capital formation for growth-oriented companies. He has participated in all areas of corporate finance including private capital, public offerings, PIPEs, business consulting and strategic planning, and mergers and acquisitions.
Mr. DiGiandomenico has also worked on a wide range of transactions for growth-oriented companies in biotechnology, nutritional supplements, manufacturing and entertainment industries. Prior to forming MDB Capital Group LLC in 1997, Mr. DiGiandomenico served as President and CEO of the Digian Company, a real estate development company. Mr. DiGiandomenico has also served on the board of directors of Cue Biopharma, Inc., an immunotherapy company, and on the board of directors of Provention Bio, Inc., a clinical-stage biopharmaceutical company.
Mr. DiGiandomenico holds an MBA from the Haas School of Business at the University of California, Berkeley and a BS in Finance from the University of Colorado.
Mr. DiGiandomenico’s financial expertise, general business acumen and significant executive leadership experience position him well to make valuable contributions to our Board of Directors.
Michael Harsh joined our Board of Directors in 2015. He is a Portfolio Executive for the National Institutes of Health (NIH) Rapid Acceleration of Diagnostics (RADx) COVID-19 Response Program and a co-founder and Chief Product Officer of Terapede Systems, a digital Xray startup that focuses on developing an ultra-high resolution medical flat panel X-ray detector. He co-founded Terapede in 2015. Prior to Terapede, Mr. Harsh had a 36-year career with General Electric (“GE”). He held numerous positions within GE and served as Vice President and Chief Technology Officer of GE Healthcare, a multi-billion dollar division of GE, where he led its global science and technology organization and research and development teams in diagnostics, healthcare IT and life sciences. In 2004, Mr. Harsh was named Global Technology Leader - Imaging Technologies at the GE Global Research Center, where he led the research for imaging technologies across the company as well as the research associated with computer visualization and superconducting systems.
Additionally, Mr. Harsh is a member of the boards of directors of Magnetic Insights, Imagion Biosystems (ASX: IBX.AX), and EmOpti, Inc., as well as a member of the Radiological Society of North America (RSNA), Research & Education Foundation Board of Trustees. He had previously served as a director for Compute Health Acquisition Corp. until its merger with Allurion Technologies and as a director for FloDesign Sonics until its acquisition by MilliporeSigma, a division of the Merck Group. He is also a McKinsey Senior Advisor and a consultant in the medical device industry.
Mr. Harsh is a graduate of Marquette University, where he earned a bachelor’s degree in Electrical Engineering. He holds numerous U.S. patents in the field of medical imaging and instrumentation. In 2008, Mr. Harsh was elected to the American Institute for Medical and Biological Engineering College of Fellows for his significant contributions to the medical and biological engineering field.
Mr. Harsh’s extensive industry, executive and board experience position him well to serve on our Board of Directors.
Alexander Tokman joined our Board of Directors in 2008. He currently serves as a President of iUNU, a privately held AI/Computer Vision SaaS company and recently was a CEO-in-Residence at the Allen Institute for Artificial Intelligence (AI2), from 2019 to 2020. Mr. Tokman also serves as an independent board director for Izotropic Corporation (CSE: IZO), a company commercializing a dedicated breast CT imaging platform, and on the board of the American Academy of Thermography, a non-profit organization focused on bringing novel infrared imaging applications for disease diagnosis.
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Mr. Tokman served as President, Chief Executive Officer, and a director of Microvision, Inc., a publicly traded laser beam scanning display and imaging company, from January 2006 to December 2017.
Previously, Mr. Tokman completed a 10+ year tenure as an executive with GE Healthcare, where he led several global businesses, the latest being its Global Molecular Imaging and Radiopharmacy multi-technology business unit, of which he was General Manager from 2003 to 2005.
Between 1995 and 2003, Mr. Tokman served in various leadership roles at GE Healthcare, where he led the definition and successful commercialization of several product segments, including PET/CT.
Mr. Tokman is a certified Six Sigma and Design for Six Sigma (DFSS) Black Belt and Master Black Belt and as one of General Electric Company’s Six Sigma pioneers, he drove the quality culture change across GE Healthcare in the late 1990s. From 1989 to 1995, Mr. Tokman served as development programs lead and a head of Industry and Regional Development at Tracor Applied Sciences (BAE Systems). Mr. Tokman has both an MS and BS in Electrical Engineering from the University of Massachusetts, Dartmouth.
Mr. Tokman’s industry expertise and significant executive leadership and director experience position him well to make valuable contributions to our Board of Directors.
Board Independence
The Board of Directors has determined that each of Mr. Basenese, Mr. DiGiandomenico, Mr. Harsh and Mr. Tokman is an independent director within the meaning of the director independence standards of The Nasdaq Stock Market (“Nasdaq”). Furthermore, the Board has determined that all of the members of the Audit Committee, Compensation Committee and Corporate Governance and Nominating Committee are independent within the meaning of the director independence standards of Nasdaq and the rules of the SEC applicable to each such committee.
Committees
Audit Committee . Our Audit Committee consists of Mr. Basenese, Mr. DiGiandomenico, and Mr. Harsh. The Board of Directors has determined that each member of the Audit Committee is independent within the meaning of the Nasdaq director independence standards and applicable rules of the SEC for audit committee members. The Board of Directors has elected Mr. DiGiandomenico as Chairperson of the Audit Committee and has determined that he qualifies as an “audit committee financial expert” under the rules of the SEC. The Audit Committee is responsible for assisting the Board of Directors in fulfilling its oversight responsibilities with respect to financial reports and other financial information. The Audit Committee (1) reviews, monitors and reports to the Board of Directors on the adequacy of the Company’s financial reporting process and system of internal controls over financial reporting, (2) has the ultimate authority to select, evaluate and replace the independent auditor and is the ultimate authority to which the independent auditors are accountable, (3) in consultation with management, periodically reviews the adequacy of the Company’s disclosure controls and procedures and approves any significant changes thereto, (4) provides the audit committee report for inclusion in our proxy statement for our annual meeting of stockholders and (5) recommends, establishes and monitors procedures for the receipt, retention and treatment of complaints relating to accounting, internal accounting controls or auditing matters and the receipt of confidential, anonymous submissions by employees of concerns regarding questionable accounting or auditing matters. The Audit Committee met twice in 2023 as well as acted by written consent.
Compensation Committee . Our Compensation Committee presently consists of Mr. Basenese, Mr. DiGiandomenico, Mr. Harsh and Mr. Tokman, each of whom is a non-employee director as defined in Rule 16b-3 of the Exchange Act. The Board has also determined that each member of the Compensation Committee is also an independent director within the meaning of Nasdaq’s director independence standards. Mr. Tokman serves as Chairperson of the Compensation Committee. The Compensation Committee (1) discharges the responsibilities of the Board of Directors relating to the compensation of our directors and executive officers, (2) oversees the Company’s procedures for consideration and determination of executive and director compensation, and reviews and approves all executive compensation, and (3) administers and implements the Company’s incentive compensation plans and equity-based plans. The Compensation Committee [did not meet separately from the board of directors in 2023] but acted by unanimous written consent.
Corporate Governance and Nominating Committee . Our Corporate Governance and Nominating Committee consists of Mr. Harsh and Mr. Tokman. The Board of Directors has determined that each member of the Corporate Governance and Nominating Committee is an independent director within the meaning of the Nasdaq director independence standards and applicable rules of the SEC. Mr. Harsh serves as Chairperson of the Corporate Governance and Nominating Committee. The Corporate Governance and Nominating Committee (1) recommends to the Board of Directors persons to serve as members of the Board of Directors and as members of and chairpersons for the committees of the Board of Directors, (2) considers the recommendation of candidates to serve as directors submitted from the stockholders of the Company, (3) assists the Board of Directors in evaluating the performance of the Board of Directors and the Board committees, (4) advises the Board of Directors regarding the appropriate board leadership structure for the Company, (5) reviews and makes recommendations to the Board of Directors on corporate governance and (6) reviews the size and composition of the Board of Directors and recommends to the Board of Directors any changes it deems advisable. The Corporate Governance and Nominating Committee did not meet separately from the Board of Directors in 2023 but acted by written consent.
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Delinquent Section 16(a) Reports
Section 16(a) of the Exchange Act requires our directors, executive officers and persons who own more than ten percent of a registered class of our equity securities to file reports of ownership and changes in ownership with the SEC. Such persons are required by SEC regulations to furnish us with copies of all such filings. Based solely on our review of the copies of the reports that we received and written representations that no other reports were required, we believe that our executive officers, directors and greater than 10% stockholders complied with all applicable filing requirements on a timely basis during 2023.
Code of Business Conduct and Ethics
We have in place a Code of Business Conduct and Ethics (the “Code of Ethics”) that applies to all of our directors, officers and employees. The Code of Ethics is designed to deter wrongdoing and to promote:
·
honest and ethical conduct, including the ethical handling of actual or apparent conflicts of interest between personal and professional relationships;
·
full, fair, accurate, timely and understandable disclosure in reports and documents that we file with, or submit to, the SEC and in other public communications that we make;
·
compliance with applicable governmental laws, rules and regulations;
·
the prompt internal reporting of violations of the Code of Ethics to an appropriate person identified in the Code of Ethics; and
·
accountability for adherence to the Code of Ethics.
A current copy of the Code of Ethics is available at www.endrainc.com. A copy may also be obtained, free of charge, from us upon a request directed to ENDRA Life Sciences, Inc., 3600 Green Court, Suite 350, Ann Arbor, Michigan 48105, attention: Investor Relations. We intend to disclose any amendments to or waivers of a provision of the Code of Ethics required to be disclosed by applicable SEC rules by posting such information on our website available at www.endrainc.com and/or in our public filings with the SEC.
Nasdaq Rule 5608 Clawback Policy
The Company has adopted an incentive-based compensation recovery policy as required by the rules of the Nasdaq Stock Market, which is filed as Exhibit 97 to this report.
Item 11. Executive Compensation
Our compensation philosophy is to offer our executive officers compensation and benefits that are competitive and meet our goals of attracting, retaining and motivating highly skilled management, which is necessary to achieve our financial and strategic objectives and create long-term value for our stockholders. We believe the levels of compensation we provide should be competitive, reasonable and appropriate for our business needs and circumstances. Our board of directors uses benchmark compensation studies in determining compensation elements and levels. The principal elements of our executive compensation program have to date included base salary, annual bonus opportunity and long-term equity compensation in the form of stock options. We believe successful long-term Company performance is more critical to enhancing stockholder value than short-term results. For this reason and to conserve cash and better align the interests of management and our stockholders, we emphasize long-term performance-based equity compensation over base annual salaries.
The following table sets forth information concerning the compensation earned by the individual that served as our principal executive officer during 2023 and our two most highly compensated executive officers other than the individual who served as our principal executive officer during 2023 (collectively, the “named executive officers”):
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2023 Summary Compensation Table
Name and
Principal
Position
Year
Salary ($)
Option
Awards ($) (1)
Non-equity
Incentive Plan Compensation ($)
All Other Compensation ($)(2)
Total ($)
Francois Michelon (3)
2023
387,859
258,341
-
587
646,787
Chief Executive Officer
2022
423,000
212,609
-
587
636,196
Michael Thornton (3)
2023
278,851
252,734
-
392
531,977
Chief Technology Officer
2022
301,278
208,128
-
392
509,798
Irina Pestrikova
2023
185,000
29,724
-
-
214,724
Senior Director, Finance
2022
174,952
12,373
-
-
187,325
______________
(1)
The amounts shown in this column indicate the grant date fair value of option awards granted in the subject year computed in accordance with FASB ASC Topic 718. For additional information regarding the assumptions made in calculating these amounts, see notes 2 and 8 to the financial statements included in Part II, Item 8 of this Annual Report. The shares underlying these option awards vest and become exercisable in three equal annual installments beginning on the first anniversary of their respective grant dates.
(2)
Represents insurance premiums paid by the Company with respect to life insurance for the benefit of the named executive officer.
(3)
In consideration of the Company’s limited resources, in September 2023, Mr. Michelon and Mr. Thornton each agreed to a 30% reduction in each of their base salaries received for the remainder of 2023 in order to preserve cash for the Company’s operations.
Employment Agreements and Change of Control Arrangements
The following is a summary of the employment arrangements with our named executive officers.
Francois Michelon . Effective May 12, 2017, the Company entered into an amended and restated employment agreement with Francois Michelon, our Chief Executive Officer and Chairman of the Board of Directors, which agreement was amended on December 27, 2019. Mr. Michelon’s employment with the Company is “at will” and may be terminated by him or the Company at any time and for any reason. Pursuant to the employment agreement, Mr. Michelon receives an annual base salary that is subject to adjustment at the Board of Directors’ discretion. Effective January 1, 2022, the Compensation Committee increased Mr. Michelon’s annual salary to $423,000. In September 2023, Mr. Michelon agreed to a 30% reduction of his base salary received for the remainder of 2023 in order to preserve cash for the Company’s operations. Mr. Michelon is also eligible for an annual cash bonus based upon the achievement of performance-based objectives established by the Board of Directors.
If Mr. Michelon’s employment is terminated by the Company without cause (as defined in the 2016 Plan) or if Mr. Michelon resigns for good reason (as defined in the employment agreement), Mr. Michelon will be entitled to receive, subject to his execution of a standard release agreement, 12 months’ continuation of his current base salary and a lump sum payment equal to 12 months of continued healthcare coverage (or 24 months’ continuation of his current base salary and a lump sum payment equal to 24 months of continued healthcare coverage if such termination occurs within one year following a change in control).
Under his employment agreement, Mr. Michelon is eligible to receive benefits that are substantially similar to those of the Company’s other senior executive officers.
Michael Thornton . Effective May 12, 2017, the Company entered into an amended and restated employment agreement with Michael Thornton, our Chief Technology Officer, which agreement was amended on December 27, 2019. The employment agreement provides that Mr. Thornton’s employment with the Company is “at will” and may be terminated by him or the Company at any time and for any reason. Pursuant to the employment agreement, Mr. Thornton receives an annual base salary that is subject to adjustment at the Board of Directors’ discretion. Effective January 1, 2022, the Compensation Committee increased Mr. Thornton’s annual salary to $324,000. In September 2023, Mr. Thornton agreed to a 30% reduction of his base salary received for the remainder of 2023 in order to preserve cash for the Company’s operations.
If Mr. Thornton’s employment is terminated by the Company without cause (as defined in the 2016 Plan) or if Mr. Thornton resigns for good reason (as defined in the employment agreement), Mr. Thornton will be entitled to receive, subject to his execution of a standard release agreement, 12 months’ continuation of his current base salary and a lump sum payment equal to 12 months of continued healthcare coverage (or 24 months’ continuation of his current base salary and a lump sum payment equal to 24 months of continued healthcare coverage if such termination occurs within one year following a change in control).
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Under his employment agreement, Mr. Thornton is eligible to receive benefits that are substantially similar to those of the Company’s other senior executive officers.
Irina Pestrikova . Ms. Pestrikova is employed by the Company pursuant to an Offer Letter by and between the Company and Ms. Pestrikova, dated as of June 9, 2021. Ms. Pestrikova’s employment is “at will” and may be terminated by the Company at any time and for any reason. Effective as of December 31, 2023, Ms. Pestrikova’s annual salary was set by the Board at $185,000. Per the terms of her offer letter, Ms. Pestrikova is eligible to receive employee benefits plans including medical, dental, vision, and 401(k) plans.
Additionally, our named executive officers are eligible to participate in our health and welfare programs and 401(k) plan, and other benefit programs on the same basis as other employees.
Outstanding Equity Awards at 2023 Fiscal Year End
The following table provides information regarding equity awards held by the named executive officers as of December 31, 2023.
Option Awards
Number of
Securities
Underlying
Unexercised
Options (#)
Exercisable
Number of
Securities
Underlying
Unexercised
Options (#)
Unexercisable
Option
Exercise
Price ($)
Option
Expiration
Date
Francois Michelon
15,366
-
100.00
5/12/25
Chief Executive Officer
1,598
-
91.00
5/12/25
6,250
-
45.00
12/13/26
30,600
-
18.00
12/11/29
1,667
833 (1)
52.80
4/5/31
-
15,000 (2)
52.80
4/5/31
11,886
23,771 (3)
7.60
3/28/32
-
69,531 (4)
4.02
1/30/33
Michael Thornton
1,598
-
91.00
5/12/25
Chief Technology Officer
15,667
-
100.00
5/12/25
6,250
-
45.00
12/13/26
28,796
-
18.00
12/11/29
1,667
833 (1)
52.80
4/5/31
-
15,000 (2)
52.80
4/5/31
11,635
23,271 (3)
7.60
3/28/32
-
68,022 (4)
4.02
1/30/33
Irina Pestrikova
133
67 (5)
44.60
2/5/31
Senior Director, Finance
2,500
1,250 (6)
42.20
6/18/31
200
-
14.00
10/27/30
692
1,383 (3)
7.60
3/28/32
-
8,000 (4)
4.02
1/30/33
(1)
Represents unvested portion of stock option award which vests in three equal annual installments beginning on April 5, 2022.
(2)
Represents unvested portion of stock option award which vests as follows: (i) 25% vests upon the Company’s earning $5 million or more of revenue with a gross margin of 10% or greater, (ii) 25% vests upon the Company’s earning $10 million or more of revenue with a gross margin of 35% or greater, (iii) 25% vests upon the Company’s earning $15 million or more of revenue with a gross margin of 40% or greater, and (iv) 25% vests upon the Company’s earning $20 million or more of revenue with a gross margin of 50% or greater.
(3)
Represents unvested portion of stock option award which vests in three equal annual installments beginning on March 28, 2023.
(4)
Represents unvested portion of stock option award which vests in three equal annual installments beginning on January 30, 2024.
(5)
Represents unvested portion of stock option award which vests in three equal annual installments beginning on February 5, 2022.
(6)
Represents unvested portion of stock option award which vests in three equal annual installments beginning on June 18, 2022.
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Equity Compensation Plan Table
The following table presents information on the Company’s equity compensation plans as of December 31, 2023. All outstanding awards relate to our common stock.
Plan Category
Number of Securities
to Be Issued upon
Exercise of Outstanding
Options, Warrants
and Rights
(a)
Weighted-Average
Exercise Price of
Outstanding Options,
Warrants and Rights
(b)
Number of Securities
Remaining Available
for Future Issuance
under Equity
Compensation Plans
(Excluding Securities
Reflected in Column (a))
(c)
Equity compensation plans approved by security holders
624,240
(1)
$
19.25
663,633
(2)
Equity compensation plans not approved by security holders
-
-
-
Total
624,240
$
19.25
663,633
_________________
(1)
Consists of outstanding stock options exercisable for shares of common stock issued under the 2016 Plan.
(2)
As of January 1, 2024, as a result of an automatic increase to the pool of shares available for issuance under the 2016 Plan on such date, the number of shares available for future issuance under the 2016 Plan was 2,381,416 shares.
Director Compensation
Effective January 30, 2023, the Company adopted a non-employee director compensation policy (the “ Compensation Policy ”) pursuant to which each of our non-employee directors receives, upon his or her initial election to the Board of Directors, a stock option exercisable for 2,500 shares of common stock with a per share exercise price equal to the closing price of the common stock on the Nasdaq on the grant date. All such stock options vest in three equal annual installments beginning on the one-year anniversary of the grant date. Under the Compensation Policy, on the first trading day of each calendar year, each non-employee director is awarded a stock option exercisable for 600 shares of common stock, with a per share exercise price equal to the closing price of the common stock on the Nasdaq on the grant date, which becomes exercisable in three equal annual installments beginning on the first anniversary of the grant date. Additionally, pursuant to the Compensation Policy, each non-employee director is paid an annual cash retainer of $40,000, prorated for partial years of service and paid quarterly in arrears.
The following table sets forth information with respect to compensation earned by or awarded to each of our non-employee directors who served on the Board of Directors during the fiscal year ended December 31, 2023:
Name
Fees Earned or Paid in Cash ($)
Option
Awards ($)
(1) (2)
All Other Compensation ($)
Total ($)
Anthony DiGiandomenico
40,000
35,747
75,747
Michael Harsh
40,000
33,566
73,566
Alexander Tokman
40,000
35,747
27,600
103,347
Louis Basenese
40,000
25,065
65,065
(1)
The amounts shown in this column indicate the grant date fair value of option awards granted in the subject year computed in accordance with FASB ASC Topic 718. For additional information regarding the assumptions made in calculating these amounts, see Notes 2 and 8 to the audited financial statements included in our Annual Report on Form 10-K for the fiscal year ended December 31, 2023. The following table shows the number of shares subject to outstanding option awards held by each non-employee director as of December 31, 2023:
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Name
Shares
Subject to Outstanding
Option
Awards (#)
Louis Basenese
17,921
Anthony DiGiandomenico
26,022
Michael Harsh
25,460
Alexander Tokman
26,022
(2)
In addition to annual awards granted pursuant to the Compensation Policy, in 2023 the Company awarded each director additional stock options in order to realign the incentive nature of the Company’s equity compensation with the price of the Company’s common stock.
(3)
Represent fees paid for consulting services pursuant to that certain Consulting Agreement, dated October 17, 2023, between the
Company and Mr. Tokman.
Item 12. Security Ownership of Certain Beneficial Owners and Management and Related Stockholders Matters.
The following tables set forth certain information regarding beneficial ownership of our voting stock as of March 24, 2024 by:
·
each person or group of affiliated persons known by us to be the beneficial owner of more than 5% of any class of our voting stock;
·
each named executive officer included in the Summary Compensation Table above;
·
each of our directors;
·
each person nominated to become director; and
·
all executive officers, directors and nominees as a group.
Unless otherwise noted below, the address of each person listed in the tables is c/o ENDRA Life Sciences Inc. at 3600 Green Court, Suite 350, Ann Arbor, Michigan 48105. To our knowledge, each person listed below has sole voting and investment power over the shares shown as beneficially owned except to the extent jointly owned with spouses or otherwise noted below.
Beneficial ownership is determined in accordance with the rules of the SEC. The information does not necessarily indicate ownership for any other purpose. Under these rules, shares of stock which a person has the right to acquire ( i.e. , by the exercise of any option or warrant) within 60 days after March 24, 2024 are deemed to be beneficially owned and outstanding for purposes of calculating the number of shares and the percentage beneficially owned by that person. However, these shares are not deemed to be beneficially owned and outstanding for purposes of computing the percentage beneficially owned by any other person. The applicable percentages of stock outstanding as of March 24, 2024 is based upon 11,035,659 shares of common stock and 34.976 shares of Series A Preferred Stock outstanding on that date.
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Table of Contents
Beneficial Ownership
Name of
Beneficial
Owner
Shares of
Common
Stock
Beneficially
Owned
Percentage
of Common
Stock
Beneficially
Owned
Shares of
Series A
Preferred
Stock
Beneficially
Owned
Percentage
of Series A
Preferred
Stock
Beneficially
Owned
Francois Michelon
108,229
(1)
*
-
-
Michael Thornton
136,122
(2)
1.2
%
-
-
Irina Pestrikova
6,950
(3)
*
Louis Basenese
14,636
(4)
*
-
-
Anthony DiGiandomenico
161,887
(5)
1.5
%
-
-
Michael Harsh
21,570
(6)
*
-
-
Alexander Tokman
25,929
(7)
*
-
-
All directors and executive officers as a group (7 persons)
475,323
4.2
%
-
-
5% Stockholders
-
-
Mark R. Busch (8)
17.488
50.0
%
Juan R. Rivero (9)
17.488
50.0
%
* Less than one percent.
(1)
Consists of 4,860 shares of common stock, 103,262 shares of common stock issuable upon the exercise of options that are presently exercisable or becoming exercisable within 60 days of March 24, 2024 and 107 shares of common stock issuable upon the exercise of restricted warrants.
(2)
Consists of 34,139 shares of common stock, 100,770 shares of common stock issuable upon the exercise of options that are presently exercisable or becoming exercisable within 60 days of March 24, 2024 and 1,213 shares of common stock issuable upon the exercise of restricted warrants.
(3)
Consists of 6,950 shares of common stock issuable upon the exercise of options that are presently exercisable or becoming exercisable within 60 days of March 24, 2024.
(4)
Consists of 2,454 shares of common stock and 12,182 shares of common stock issuable upon the exercise of options that are presently exercisable or becoming exercisable within 60 days of March 24, 2024.
(5)
Consists of 102,434 shares of common stock, 17,786 shares of common stock issuable upon the exercise of options that are presently exercisable or becoming exercisable within 60 days of March 24, 2024 and 41,667 shares of common stock issuable upon the exercise of restricted warrants.
(6)
Consists of 3,457 shares of common stock, 17,810 shares of common stock issuable upon the exercise of options that are presently exercisable or becoming exercisable within 60 days of March 24, 2024 and 303 shares of common stock issuable upon the exercise of restricted warrants.
(7)
Consists of 8,143 shares of common stock and 17,786 shares of common stock issuable upon the exercise of options that are presently exercisable or becoming exercisable within 60 days of March 24, 2024.
(8)
Shares jointly owned with spouse. Mr. Busch’s address is 300 S. Tryon St., Suite 1000, Charlotte, NC 28202.
(9)
Mr. Rivero’s address is 14521 Jockey Circle, N. Davie, FL 33330.
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Item 13. Certain Relationships and Related Transactions, and Director Independence
Policy for Review of Related Person Transactions
The Board of Directors has adopted a written policy with regard to related person transactions, which sets forth our procedures and standards for the review, approval or ratification of any transaction required to be reported in our filings with the SEC or in which one of our executive officers or directors has a direct or indirect material financial interest, with limited exceptions. Our policy is that the Corporate Governance and Nominating Committee shall review the material facts of all related person transactions (as defined in the related person transaction approval policy) and either approve or disapprove of the entry into any related person transaction. In the event that obtaining the advance approval of the Corporate Governance and Nominating Committee is not feasible, the Corporate Governance and Nominating Committee shall consider the related person transaction and, if the Corporate Governance and Nominating Committee determines it to be appropriate, may ratify the related person transaction. In determining whether to approve or ratify a related person transaction, the Corporate Governance and Nominating Committee will take into account, among other factors it deems appropriate, whether the related person transaction is on terms comparable to those available from an unaffiliated third-party under the same or similar circumstances and the extent of the related person's interest in the transaction.
Related Person Transactions
SEC regulations define the related person transactions that require disclosure to include any transaction, arrangement or relationship in which the amount involved exceeds the lesser of (a) $120,000 or (b) one percent of the average of the Company’s total assets at year-end for the last two completed fiscal years in which it was or is to be a participant and in which a related person had or will have a direct or indirect material interest. A related person is: (i) an executive officer, director or director nominee of the Company, (ii) a beneficial owner of more than 5% of any class of the Company’s voting securities, (iii) an immediate family member of an executive officer, director or director nominee or beneficial owner of more than 5% of any class of the Company’s voting securities, or (iv) any entity that is owned or controlled by any of the foregoing persons or in which any of the foregoing persons has a substantial ownership interest or control.
Other than as set forth below, since January 1, 2022, the Company has not participated in any such related party transaction.
On May 2, 2023, the Company conducted a public offering in which Anthony DiGiandomenico, a director of the Company, purchased 83,333 shares of the Company’s common stock and 41,667 warrants at the public offering price, for an aggregate purchase price of approximately $100,000.
Item 14. Principal Accountant Fees and Services
RBSM LLP (“RBSM”) audited our financial statements for the year ended December 31, 2023. The following table sets forth the aggregate fees billed or expected to be billed by RBSM for audit and non-audit services in 2023 and 2022, including “out-of-pocket” expenses incurred in rendering these services. The nature of the services provided for each category is described following the table.
Fee Category
2023
2022
Audit Fees (1)
$ 161,448
$ 146,000
Audit-Related Fees
‒
‒
Tax Fees (2)
$ 60,000
$ 30,000
Total
$ 221,448
$ 176,000
_________________
(1)
Audit fees include fees for professional services rendered for the audit of our annual statements, quarterly reviews, consents and assistance with and review of documents filed with the SEC.
(2)
Tax fees include fees (or, for 2023, estimated fees) for professional services rendered for tax compliance, tax advice and tax planning.
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Table of Contents
PART IV
Item 15. Exhibits, Financial Statements and Schedules
(a) List of documents filed as part of this report:
1. Financial Statements (see “Financial Statements and Supplementary Data” at Item 8 and incorporated herein by reference)
2. Financial Statement Schedules (Schedules to the Financial Statements have been omitted because the information required to be set forth therein is not applicable or is shown in the accompanying Financial Statements or notes thereto)
3. Exhibits
The following is a list of exhibits filed as part of this Annual Report:
Exhibit
Incorporated by Reference
Number
Exhibit Description
Filed Herewith
Form
Exhibit
Filing Date
3.1
Fourth Amended and Restated Certificate of Incorporation of the Company
8-K
3.2
05/12/17
3.2
Certificate of Amendment to the Fourth Amended and Restated Certificate of Incorporation
8-K
3.1
12/08/22
3.3
Amended and Restated Bylaws of the Company
S-1
3.4
12/06/16
4.1
Specimen Certificate representing shares of common stock of the Company
S-1
4.1
11/21/16
4.2
Certificate of Designations of Series A Convertible Preferred Stock
8-K
4.1
12/11/19
4.3
Form of Warrant issued in December 2019 Series A Convertible Preferred Stock Offering
8-K
4.2
12/11/19
4.4
Certificate of Designations of Series B Convertible Preferred Stock
8-K
4.1
12/26/19
4.5
Form of Warrant issued in December 2019 Series B Convertible Preferred Stock Offering
8-K
4.2
12/26/19
4.6
Certificate of Designations of Series C Preferred Stock
8-K
3.1
09/27/22
4.7
Form of Warrant issued in April 2023 Underwritten Public Offering
S-1
4.2
03/30/2023
4.8
Form of Underwriter’s Warrant issued in April 2023 Underwritten Public Offering
S-1/A
4.3
04/18/2023
4.9
Form of Warrant Agency Agreement
S-1
4.4
03/30/2023
4.13
Description of Securities
10-K
4.12
03/30/22
10.1
ENDRA Life Sciences Inc. 2016 Omnibus Incentive Plan *
S-1
10.4
12/06/16
10.2
First Amendment to ENDRA Life Sciences Inc. 2016 Omnibus Incentive Plan*
DEF 14A
Appx. A
05/10/18
10.3
Form of Stock Option Award under 2016 Omnibus Incentive Plan*
S-1
10.5
12/06/16
10.4
Form of Restricted Stock Unit Award under 2016 Omnibus Incentive Plan*
S-1
10.6
12/06/16
10.5
Non-Employee Director Compensation Policy, effective January 30, 2023*
10-K
10.6
03/16/23
10.6
Form of Indemnification Agreement by and between the Company and each of its directors and executive officers*
S-1
10.8
11/21/16
10.7
Amended and Restated Employment Agreement, dated May 12, 2017, by and between the Company and Francois Michelon*
8-K
10.1
05/12/17
10.8
First Amendment to Employment Agreement, dated December 27, 2019, by and between the Company and Francois Michelon*
8-K
10.1
12/27/19
10.9
Amended and Restated Employment Agreement, dated May 12, 2017, by and between the Company and Michael Thornton*
8-K
10.2
05/12/17
10.10
First Amendment to Employment Agreement, dated December 27, 2019, by and between the Company and Michael Thornton*
8-K
10.2
12/27/19
10.11
Collaborative Research Agreement, dated April 22, 2016, by and between the Company and General Electric Company
S-1
10.17
11/21/16
10.12
Amendment to Collaborative Research Agreement, dated April 21, 2017, by and between the Company and General Electric Company
S-1
10.21
05/03/17
10.13
Amendment 2 to Collaborative Research Agreement, dated January 30, 2018, by and between the Company and General Electric Company
8-K
10.1
01/30/18
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Table of Contents
10.14
Amendment 3 to Collaborative Research Agreement, dated January 13, 2020, by and between the Company and General Electric Company
8-K
10.1
01/15/20
10.15
Amendment 4 to Collaborative Research Agreement, dated December 16, 2020, by and between the Company and General Electric Company
8-K
10.1
12/21/20
10.16
Amendment 5 to Collaborative Research Agreement, dated December 16, 2022, by and between the Company and General Electric Company
8-K
10,1
12/19/22
10.17
Gross Lease, dated January 1, 2015, between the Company and Green Court LLC
S-1
10.18
11/21/16
10.18
Amendment to Gross Lease, dated October 10, 2017, by and between the Company and Green Court LLC
10-Q
10.2
05/15/18
10.19
Second Amendment to Lease, dated March 15, 2021, by and between the Company and Green Court LLC
10-K
10.18
03/25/21
10.20
Consulting Agreement, dated October 31, 2017, by and between the Company and StarFish Product Engineering, Inc.
10-K
10.16
03/20/18
10.21
Consulting Agreement, dated October 17, 2023, by and between the Company and Alexander Tokman*
x
10.22
Offer Letter, dated June 9, 2021, by and between the Company and Irina Pestrikova.*
x
21.1
Subsidiaries of the Company
10-K
21.1
03/30/22
23.1
Consent of RBSM LLP, Independent Registered Public Accounting Firm (with respect to Forms S-3)
x
23.2
Consent of RBSM LLP, Independent Registered Public Accounting Firm (with respect to Forms S-8)
x
24.1
Power of Attorney (included on signature page)
31.1
Certification Pursuant to Rule 13a-14(a) or Rule 15d-14(a) of the Securities Exchange Act of 1934
x
31.2
Certification Pursuant to Rule 13a-14(a) or Rule 15d-14(a) of the Securities Exchange Act of 1934
x
32.1
Certification Pursuant to 18 U.S.C Section 1350, as Adopted Pursuant to Section 906 of the Sarbanes-Oxley Act of 2002
x
97
Incentive-Based Compensation Recovery Policy
x
101.INS
XBRL Instance Document
101.SCH
XBRL Taxonomy Schema
101.CAL
XBRL Taxonomy Extension Calculation Linkbase
101.DEF
XBRL Taxonomy Extension Definition Linkbase
101.LAB
XBRL Taxonomy Extension Label Linkbase
101.PRE
XBRL Taxonomy Extension Presentation Linkbase
________________
* Indicates management compensatory plan, contract or arrangement.
Item 16. Form 10-K Summary
None.
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Table of Contents
SIGNATURES
Pursuant to the requirements of Section 13 or 15(d) of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned, thereunto duly authorized.
ENDRA Life Sciences Inc.
Dated: March 28, 2024
By:
/s/ Francois Michelon
Francois Michelon
Chief Executive Officer and Director
(Principal Executive Officer)
POWER OF ATTORNEY AND SIGNATURES
We, the undersigned officers and directors of ENDRA Life Sciences Inc., hereby severally constitute and appoint Francois Michelon our true and lawful attorney, with full power to him to sign for us and in our names in the capacities indicated below, any amendments to this Annual Report on Form 10-K, and generally to do all things in our names and on our behalf in such capacities to enable ENDRA Life Sciences Inc. to comply with the provisions of the Securities Exchange Act of 1934, as amended, and all the requirements of the Securities Exchange Commission.
Pursuant to the requirements of the Securities Exchange Act of 1934, this report has been signed below by the following persons on behalf of the registrant and in the capacities and on the dates indicated.
Signatures
Title
Date
/s/ Francois Michelon
Chief Executive Officer and Director (Principal Executive Officer)
March 28, 2024
Francois Michelon
/s/ Irina Pestrikova
Senior Director, Finance (Principal Financial and Accounting Officer)
March 28, 2024
Irina Pestrikova
/s/ Louis J. Basenese
Director
March 28, 2024
Louis J. Basenese
/s/ Anthony DiGiandomenico
Director
March 28, 2024
Anthony DiGiandomenico
/s/ Michael Harsh
Director
March 28, 2024
Michael Harsh
/s/ Alexander Tokman
Director
March 28, 2024
Alexander Tokman
56