What changed in this filing

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Item 9A. Controls and Procedures

2024-03-28 compared with 2023-03-30 · 472 added, 356 removed, 756 unchanged (52% of the section changed)

Controls and Procedures.

of Disclosure Controls and Procedures

disclosure controls and procedures (as defined in Rules 13a-15(e) and 15d-15(e)) are designed to ensure that information required to

be disclosed by us in reports we file or submit under the Securities Exchange Act of 1934, as amended, is recorded, processed, summarized

and reported within the appropriate time periods, and that such information is accumulated and communicated to our Chief Executive Officer

and Chief Financial Officer, as appropriate, to allow timely discussions regarding required disclosure.

We, under the supervisions of

and with the participation of our management, including our Chief Executive Officer and Chief Financial Officer, have evaluated the effectiveness

of our disclosure controls and procedures.

Based on that evaluation, our Chief Executive Officer and Chief Financial Officer concluded

that the design and operation of our disclosure controls and procedures were not effective because of material weakness in our internal

control over financial reporting as of December 31, 2022.

Evaluation of Disclosure

Controls and Procedures

Our disclosure controls and procedures (as defined

in Rules 13a-15(e) and 15d-15(e)) are designed to ensure that information required to be disclosed by us in reports we file or submit

under the Securities Exchange Act of 1934, as amended, is recorded, processed, summarized and reported within the appropriate time periods,

and that such information is accumulated and communicated to our Chief Executive Officer and Chief Financial Officer, as appropriate,

to allow timely discussions regarding required disclosure.

We, under the supervisions of and with the participation of our management,

including our Chief Executive Officer and Chief Financial Officer, have evaluated the effectiveness of our disclosure controls and procedures.

Based on that evaluation, our Chief Executive Officer and Chief Financial Officer concluded that the design and operation of our disclosure

controls and procedures were not effective because of material weakness in our internal control over financial reporting as of December

The material weakness is further described below.

Weakness in Internal Control Over Financial Reporting

connection with the audit of our consolidated financial statements for the year ended December 31, 2022 and 2021, we and our independent

registered public accounting firm identified a material weakness in our internal control over financial reporting.

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.

year ended December 31, 2021, the material weakness related to the operating effectiveness of our review controls in that we did not

put the appropriate resources in place to be able to identify technical accounting issues and perform review functions appropriately.

Material errors were also identified in our analysis and review of our VIP contracts for applicable factors to meet the definition of

a contract under ASC 606 Contracts with Customers , step 1, and our evaluation of our note receivable with respect to our former

Orem dental clinic for impairment in accordance with ASC 310 Receivables.

in 2022 we did not put the appropriate resources in place to be able to identify technical accounting issues and perform review functions

appropriately related to revenue recognition.

Material errors were identified in our ability to determine that its existing revenue recognition

policy was consistent with the guidance in ASC 606.

After analyzing contracts using the five-step process in ASC 606, we have determined

that for both VIP enrollment contracts and Orofacial Myofunctional Therapy (MyoCorrect), modifications to our revenue recognition policies

were required in order to identify the performance obligations and recognize the revenue as the performance obligations are satisfied

or over the customer life as applicable.

Additionally, we

did not put the appropriate resources in place to be able to identify technical accounting issues and perform review functions appropriately.

Consequently, we did not effectively design, implement, and operate process-level control activities related to order-to-cash

(including revenue, trade receivables, allowance for doubtful accounts, deferred revenue, and bad debt expense), procure-to-pay (including

prepaid expenses), hire-to-pay (including compensation expense), and leases.

These control deficiencies resulted in immaterial misstatements,

some of which were corrected, in the consolidated financial statements as of and for the year ended December 31, 2022.

These control

deficiencies, aggregated, create a reasonable possibility that a material misstatement to the consolidated financial statements will

not be prevented or detected on a timely basis.

Nonetheless, we have concluded that this material weakness

does not require a restatement of or change in our consolidated financial statements for any prior interim period.

We also developed

a remediation plan for this material weakness which is described below.

of Material Weakness

are committed to maintaining a strong internal control environment and implementing measures designed to help ensure that significant

deficiencies contributing to the material weakness are remediated as soon as possible.

We believe we have made progress towards remediation

and continue to implement our remediation plan for the previously reported and current material weakness in internal control over financial

reporting, which includes steps to increase dedicated personnel, improve reporting processes, design, and implement new controls, and

enhance related supporting technology.

We will consider the material weakness remediated after the applicable controls operate for a

sufficient period of time, and management has concluded, through testing, that the controls are operating effectively.

However, we cannot provide assurance that these or other measures will

fully remediate our material weaknesses in a timely manner.

If our remediation of these material weaknesses is not effective, it may cause

our company to become subject to investigation or sanctions by the SEC.

It may also adversely affect investor confidence in our company

and, as a result, the value of our common stock.

There can be no assurance that all existing material weaknesses have been identified,

or that additional material weaknesses will not be identified in the future.

Auditor’s Attestation of Internal Control over Financial Reporting

Material Weakness in Internal Control Over Financial

In connection with the audit

of our consolidated financial statements for the year ended December 31, 2022 and 2021, we and our independent registered public accounting

firm identified a material weakness in our internal control over financial reporting.

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.

For the year ended December 31,

2021, the material weakness comprised of several deficiencies noted below related to the operating effectiveness of our review controls

in that we did not put the appropriate resources in place to be able to identify technical accounting issues and perform review functions

appropriately.

Material errors were also identified in our analysis and review of our VIP contracts for applicable factors to meet the

definition of a contract under ASC 606 Contracts with Customers , step 1, and our evaluation of our note receivable with respect

to our former Orem dental clinic for impairment in accordance with ASC 310 Receivables.

Furthermore, in 2022 we did not

put the appropriate resources in place to be able to identify technical accounting issues and perform review functions appropriately related

to revenue recognition.

Material errors were identified in our ability to determine that its existing revenue recognition policy was consistent

with the guidance in ASC 606.

After analyzing contracts using the five-step process in ASC 606, we have determined that for both VIP enrollment

contracts and Orofacial Myofunctional Therapy (MyoCorrect), modifications to our revenue recognition policies were required in order to

identify the performance obligations and recognize the revenue as the performance obligations are satisfied or over the customer life

as applicable.

Additionally, for 2022, we did not put the appropriate resources in place

to be able to identify technical accounting issues and perform review functions appropriately.

Consequently, we did not effectively design,

implement, and operate process-level control activities related to order-to-cash (including revenue, trade receivables, allowance for

doubtful accounts, deferred revenue, and bad debt expense), procure-to-pay (including prepaid expenses), hire-to-pay (including compensation

expense), and leases.

These control deficiencies resulted in immaterial misstatements, some of which were corrected, in the consolidated

financial statements as of and for the year ended December 31, 2022.

control deficiencies during 2022, when aggregated, created a reasonable possibility that a material misstatement to the consolidated

financial statements will not be prevented or detected on a timely basis.

Nonetheless, we concluded that the material weakness in 2022

did not require a restatement of or change in our consolidated financial statements for any prior interim period.

We also developed a

remediation plan for this material weakness which we began to implement in 2023 as described below.

For the year ended December 31, 2023, and as described further below, we began to implement a remediation plan to

address the material weakness derived from the deficiencies and errors noted above.

While we believe that at December 31, 2023, we had

taken great strides to complete the full remediation of all of our internal control deficiencies and associated material weakness by undertaking

the plan noted below, we believe that additional review and testing is required in the coming periods during 2024 before we can affirmatively

declare that the material weakness has been fully remediated.

Remediation of Material Weakness

We are committed to

maintaining a strong internal control environment and implementing measures designed to help ensure that significant deficiencies

contributing to the material weakness are remediated as soon as possible.

We believe we have made progress towards remediation and

continue to implement our remediation plan for the previously reported material weakness in internal control over financial

Our remediation plan, which we implemented in 2023, included:

(i) increasing dedicated personnel and the use of

third-party consultants with technical account expertise, (ii) improving our internal reporting processes, (iii) designing and

implementing new controls, and (iv) enhancing our supporting technology.

In particular, we believe we have significantly improved

our revenue recognition procedures, our technical accounting capabilities, including with respect to accounting for our outstanding

warrants, and process-level control activities.

In 2023 we began to implement a remediation plan to address the material

weakness derived from the deficiencies and errors noted above.

As of December 31, 2023, we had taken great strides to complete the full

remediation of all of our internal control deficiencies and associated material weakness by undertaking the plan noted above, we believe

that additional review and testing is required in the coming periods during 2024 before we can affirmatively declare that the material

weakness has been fully remediate.

We will consider the material

weakness remediated after the applicable controls operate for a sufficient period of time, and management has concluded, through testing,

that the controls are operating effectively.

We expect to engage in this testing during 2024.

However, we cannot provide assurance that

these or other measures will fully remediate our material weaknesses in a timely manner.

If our remediation of these material weaknesses

is not effective, it may cause our company to become subject to investigation or sanctions by the SEC.

It may also adversely affect investor

confidence in our company and, as a result, the value of our common stock.

There can be no assurance that all existing material weaknesses

have been identified, or that additional material weaknesses will not be identified in the future.

Auditor’s Attestation of Internal Control

over Financial Reporting

This Annual Report on Form 10-K

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reporting due to a transition period established by rules of the SEC for newly public companies.

in Internal Control over Financial Reporting

to the identification of the material weakness described above , we continue to seek to strengthen our internal control

structure by adding accounting staff, adding additional levels of review, adding accounting technical support, and we plan to engage

a consulting team to assist with the creation and implementation of processes.

Except as described herein, we made no other changes

in internal control over financial reporting, as defined in Rules 13a-15(f) and 15d-15(f) under the Exchange Act, during the year

ended December 31, 2022 that has materially affected, or is reasonably likely to materially affect, our internal control over

financial reporting.

Changes in Internal Control over Financial Reporting

Except as described above, we

made no other changes in internal control over financial reporting, as defined in Rules 13a-15(f) and 15d-15(f) under the Exchange Act,

during the year ended December 31, 2023 that has materially affected, or is reasonably likely to materially affect, our internal control

over financial reporting.

Other Information.

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following table and text set forth the names and ages of our directors and executive officers as of March 26, 2024.

Directors is comprised of only one class of directors.

Also provided herein are brief descriptions of the business experience of

each director and executive officer during the past five years (based on information supplied by them) and an indication of

directorships held by each director in other public companies subject to the reporting requirements under the Federal securities

During the past ten years, none of our directors or executive officers has been involved in any legal proceedings that are

material to an evaluation of the ability or integrity of such person:

The Board is comprised

of only one class of directors.

Also provided herein are brief descriptions of the business experience of each director and executive

officer during the past five years (based on information supplied by them) and an indication of directorships held by each director in

other public companies subject to the reporting requirements under the Federal securities laws.

During the past ten years, none of our

directors or executive officers has been involved in any legal proceedings that are material to an evaluation of the ability or integrity

of such person:

and Offices With the Company

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of Ortho Ventures, LLC, a U.S.

distributor of certain pediatric oral appliances with applications for pediatric sleep related breathing disorder.

distributor of certain pediatric oral appliances with applications for pediatric sleep disordered breathing.

Since November 2015, he has served as the Chief Executive Officer of First Vivos, Inc., which is now our wholly owned subsidiary.

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from the University of South Carolina and an International Trade Certificate from the University of Paris—Sorbonne.

Krammer currently

serves on the Board of Directors of Turn Biotechnologies and Pixium-Vision SA [EPA:

currently serves on the Board of Directors of Turn Biotechnologies and Pixium-Vision SA [EPA:

Lindsay joined our board of directors in June 2020.

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Sokolow joined our board of directors in June 2020.

Since 2015, Mr.

Sokolow has been Chief Executive Officer and President

of Newbridge Financial, Inc., a financial service holding company.

From 2015 through 2022 he served as Chairman of Newbridge Securities

Corporation, its full-service broker-dealer and from 2022 he has been its Chief Executive Officer as well as the Chief Executive Officer

of its affiliated SEC Registered Investment Adviser, Newbridge Financial Services Group, Inc., and the Chief Executive Officer and President

of its affiliate Bridge Line Advisors LLC, an SEC Exempt Reporting Adviser.

From 2008 through 2012, he served as President and Vice Chairman

of National Holdings Corporation, a publicly traded financial services company.

Since September 2023, Mr.

Sokolow has served as co-Chief Executive Officer

of SKYX Platforms Corp.

He had served as in independent director and board committee member of SKYX Platforms since 2015

and continues to serve as a board member of that company.

From 2015 to August 2023, Mr.

Sokolow served as Chief Executive Officer and

President of Newbridge Financial, Inc., a financial services holding company.

From 2015 to July 2022 Mr.

Sokolow served as Chairman of

Newbridge Securities Corporation, Newbridge Financial, Inc.’s full service broker-dealer.

From August 2022 to August 2023 Mr.

served as CEO of Newbridge Securities Corporation and Newbridge Financial Services Group, Inc., Newbridge Financial, Inc.’s, full

service registered investment adviser.

From 2008 through 2012, he served as President and Vice Chairman of National Holdings Corporation,

a publicly traded financial services company.

From November 1999 until January 2008, Mr.

Chief Executive Officer and President, and a member of the Board of Directors, of vFinance, Inc., a publicly traded financial services

company, which he cofounded.

Sokolow was the Chairman of the Board of Directors and Chief Executive Officer of vFinance, Inc.

January 2007 until July 2008, when it merged into National Holdings Corporation, a publicly traded financial services company.

was founder, chairman and chief executive officer of the Americas Growth Fund Inc., a closed-end 1940 Act management investment company,

from 1994 to 1998.

Sokolow was Chief Executive Officer and President,

and a member of the Board of Directors, of vFinance Inc., a publicly traded financial services company, which he cofounded.

was the Chairman of the Board of Directors and Chief Executive Officer of vFinance Inc.

from January 2007 until July 2008, when it merged

into National Holdings Corporation.

From 1994 to 1998, Mr.

Sokolow was founder, Chairman and Chief Executive Officer of the Americas

Growth Fund Inc., a closed-end registered investment company.

From 1988 until 1993, Mr.

Sokolow was an Executive Vice President and the General Counsel of Applica Inc.

Windmere Corporation), a publicly traded appliance marketing and distribution company.

Sokolow was an Executive Vice President and the

General Counsel of Applica Inc., a publicly traded appliance marketing and distribution company.

From 1982 until 1988, Mr.

Sokolow practiced corporate,

securities and tax law and was one of the founding attorneys and a partner of an international boutique law firm.

From 1980 until 1982,

he worked as a Certified Public Accountant for Ernst & Young and KPMG Peat Marwick.

Sokolow practiced

corporate, securities and tax law and was one of the founding attorneys and a partner of an international boutique law firm.

until 1982, he worked as a Certified Public Accountant for Ernst & Young and KPMG Peat Marwick.

Since June 2006, Mr.

Sokolow has served on the

Board of Directors of Consolidated Water Company Ltd.

served on the Board of Directors of Consolidated Water Company Ltd.

CWCO) and as Chairman of its Audit Committee;

as well as a member of its

Nominations and Corporate Governance Committee since 2011.

Since January 2016 Mr.

Sokolow has served as a member of the Board of Directors

of SKYX Platforms Corp., d/b/a Sky Technologies (NASDAQ:

SKYX) and Chairman of its Audit Committee from January 2016 through February

2022 and, since September 2016, Chairman of its Corporate Development Committee.

a member of its Nominations and Corporate Governance Committee since 2011.

Since December 2021, Mr.

Sokolow has served as a member

of the Board of Directors of Agrify Corporation (NASDAQ:

AGFY), where he currently serves as a member of the Audit Committee and the

Compensation Committee.

The Audit Committee of Vivos has determined that Mr.

Sokolow meets the statutory requirements to be identified

as the audit committee financial expert.

Sokolow has served as a member of

the Board of Directors of Agrify Corporation (Nasdaq:

AGFY), where he currently serves as a member of the Audit Committee and the Compensation

Sokolow received his B.A.

degrees from the University of Florida and a Masters of Law in Taxation from New York

University Law School and remains a Certified Public Accountant.

Our Audit Committee has determined that Mr.

Sokolow meets the statutory

requirements to serve as an “audit committee financial expert” for Nasdaq purposes.

Thompson, M.D.

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sooner dies, resigns, is removed or becomes disqualified.

Officers serve at the discretion of our Board of Directors.

Officers serve at the discretion of the Board.

are no family relationships between any of our director nominees or executive officers and any other of our director nominees or executive

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interests of our stockholders.

nominating and corporate governance committee of our Board of Directors prepare policies regarding director qualification requirements

and the process for identifying and evaluating director candidates for adoption by our Board of Directors.

nominating and corporate governance committee of the Board of Directors prepare policies regarding director qualification requirements

and the process for identifying and evaluating director candidates for adoption by the Board of Directors.

The above-mentioned attributes,

along with the leadership skills and other experiences of our officers and directors described above, provide us with

along with the leadership skills and other experiences of our officers and Board of Directors members described above, provide us with

a diverse range of perspectives and judgment necessary to facilitate our goals of stockholder value appreciation through organic and

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Qualifications

Kirk Huntsman - Our Board of Directors believes that Mr.

Huntsman’s qualifications to serve on our Board include his extensive

experience in the dental industry, focusing on dental support organizations by integrating cutting-edge technology and better management

Green, DDS, MBA - Our Board of Directors believes that Dr.

Green’s qualifications to serve on our Board include his

extensive experience and relationships in the dental industry, his expertise with clinical trials and executive-level experience

with pharmaceutical and dental implant firms.

Krammer - Our Board of Directors believes that Ms.

Krammer’s qualifications to serve on our Board include her experience

as a director and chief executive officer, experience with startup enterprises, her successful leadership roles in securing capital

markets funding, and her experience in the pharmaceutical industry.

Lindsay - Our Board of Directors believes that Mr.

Lindsay’s qualifications to serve on our Board include his director

experience and his experience in legal, governmental, regulatory and business development within the healthcare industry.

Sokolow - Our Board of Directors believes Mr.

Sokolow’s qualifications include his experience as a director and

principal executive officer, his legal, accounting, auditing and consulting background, and that he meets the statutory requirements

to be identified as an “audit committee financial expert.”

Kirk Huntsman – Our Board believes that Mr.

Huntsman’s qualifications to serve on our Board include his extensive experience

in the dental industry, focusing on dental support organizations by integrating cutting-edge technology and better management practices.

Green, DDS, MBA – Our Board believes that Dr.

Green’s qualifications to serve on our Board include his extensive experience

and relationships in the dental industry, his expertise with clinical trials and executive-level experience with pharmaceutical and dental

implant firms.

Krammer – Our Board believes that Ms.

Krammer’s qualifications to serve on our Board include her experience as a director

and chief executive officer, experience with startup enterprises, her successful leadership roles in securing capital markets funding,

and her experience in the pharmaceutical industry.

Lindsay – Our Board believes that Mr.

Lindsay’s qualifications to serve on our Board include his director experience

and his experience in legal, governmental, regulatory and business development within the healthcare industry.

Sokolow – Our Board believes Mr.

Sokolow’s qualifications include his experience as a director and principal executive

officer, his legal, accounting, auditing and consulting background, and that he meets the statutory requirements to be identified as

an “audit committee financial expert.”

Thompson, M.D.

- Our Board of Directors believes that Dr.

Thompson’s qualifications to serve on our Board include his

executive-level experience with a publicly-traded medical technology firm and his extensive medical background.

Nasdaq standards, a director is not “independent” unless our Board of Directors affirmatively determines that he or she

does not have a direct or indirect material relationship with us or any of our subsidiaries.

In addition, the director must meet the

bright-line tests for independence set forth by the Nasdaq rules.

Board of Directors has undertaken a review of its composition, the composition of its committees and the independence of our

directors and considered whether any director has a material relationship with us that could compromise his or her ability to

exercise independent judgment in carrying out his or her responsibilities.

Based upon information requested from and provided by

each director concerning his or her background, employment and affiliations, including family relationships, our Board has

affirmatively determined that Ms.

– Our Board believes that Dr.

Thompson’s qualifications to serve on our Board include his executive-level

experience with a publicly-traded medical technology firm and his extensive medical background.

Nasdaq standards, a director is not “independent” unless the Board affirmatively determines that he or she does not have

a direct or indirect material relationship with us or any of our subsidiaries.

In addition, the director must meet the bright-line tests

for independence set forth by the Nasdaq rules.

Board has undertaken a review of its composition, the composition of its committees and the independence of our directors and considered

whether any director has a material relationship with us that could compromise his or her ability to exercise independent judgment in

carrying out his or her responsibilities.

Based upon information requested from and provided by each director concerning his or her background,

employment and affiliations, including family relationships, our Board has affirmatively determined that Ms.

Thompson, Dr.

Green and Mr.

Sokolow are “independent

directors,” and Mr.

Huntsman is a “non-independent director,” as defined by the applicable rules and regulations

of the Nasdaq.

In making these determinations, our Board of Directors considered the relationships that each non-employee director

has with us and all other facts and circumstances our Board of Directors deemed relevant in determining their independence,

including the director’s beneficial ownership of our Common Stock and the relationships of our non-employee directors with

certain of our significant stockholders.

Sokolow are “independent directors,” and Mr.

Huntsman is a “non-independent director,”

as defined by the applicable rules and regulations of the Nasdaq.

In making these determinations, our Board considered the relationships

that each non-employee director has with us and all other facts and circumstances our Board deemed relevant in determining their independence,

including the director’s beneficial ownership of our Common Stock and the relationships of our non-employee directors with certain

of our significant stockholders.

Leadership Structure and Board’s Role in Risk Oversight

Kirk Huntsman is our Chairman of the Board as well as our Chief Executive Officer.

The Chairman has authority, among other things,

to preside over Board meetings and set the agenda for Board meetings.

Accordingly, the Chairman has substantial ability to shape the

work of our Board.

We believe that the presence of five independent members of our Board ensures appropriate oversight by our Board

of Directors of our business and affairs.

The Chairman has authority, among other things, to

preside over Board meetings and set the agenda for Board meetings.

Accordingly, the Chairman has substantial ability to shape the work

of our Board.

We believe that the presence of five independent members of our Board ensures appropriate oversight by the Board of our

business and affairs.

However, no single leadership model is right for all companies and at all times.

of Directors recognizes that depending on the circumstances, other leadership models, such as the appointment of a lead independent

director, might be appropriate.

Accordingly, our Board of Directors may periodically review its leadership structure.

our Board of Directors holds executive sessions in which only independent directors are present.

Board of Directors is generally responsible for the oversight of corporate risk in its review and deliberations relating to our

Our principal source of risk falls into two categories:

The Board recognizes that depending

on the circumstances, other leadership models, such as the appointment of a lead independent director, might be appropriate.

the Board may periodically review its leadership structure.

In addition, the Board holds executive sessions in which only independent

directors are present.

Board is generally responsible for the oversight of corporate risk in its review and deliberations relating to our activities.

Our principal

source of risk falls into two categories:

financial and product commercialization.

Our Audit Committee

oversees management of financial risks;

our Board of Directors regularly reviews information regarding our cash position, liquidity

and operations, as well as the risks associated with each.

Our Board of Directors regularly reviews plans, results and potential

risks related to our product offerings, growth, and strategies.

Our Compensation Committee oversees risk management as it relates to

our compensation plans, policies and practices for all employees including executives and directors, particularly whether our

compensation programs may create incentives for our employees to take excessive or inappropriate risks which could have a material

adverse effect on our company.

Our Audit Committee oversees management of financial

our Board regularly reviews information regarding our cash position, liquidity and operations, as well as the risks associated

The Board regularly reviews plans, results and potential risks related to our product offerings, growth, and strategies.

Compensation Committee oversees risk management as it relates to our compensation plans, policies and practices for all employees including

executives and directors, particularly whether our compensation programs may create incentives for our employees to take excessive or

inappropriate risks which could have a material adverse effect on our company.

of Directors Overview

Bylaws provide that the size of our Board is to be determined from time to time by resolution of our Board of Directors but shall

consist of at least three members.

Our Board of Directors presently consists of six members.

Our Board of Directors has determined

five of our directors - Ms.

Bylaws provide that the size of our Board is to be determined from time to time by resolution of the Board but shall consist of at least

three members.

Our Board presently consists of six members.

Our Board has determined five of our directors – Ms.

Thompson, Dr.

Green, and Mr.

Sokolow - to be independent under the rules of

the Nasdaq Stock Market, after taking into consideration, among other things, those transactions described under “Certain

Transactions”.

Huntsman serves as Chairman of the Board and is Chief Executive Officer and is a “non-independent

director,” as defined by the applicable rules and regulations of the Nasdaq Stock Market.

Our Board of Directors does not have

a lead director;

however, recognizing that our Board of Directors is composed almost entirely of outside directors, in addition to

its strong committee system (as described more fully below), our Board of Directors believes this leadership structure is

appropriate for our company and allows our Board of Directors to maintain effective oversight of management.

At each annual meeting

of stockholders, members of our Board of Directors are elected to serve until the next annual meeting and until their successors are

duly elected and qualified.

Sokolow – to be independent under the rules of the Nasdaq Stock Market, after taking into consideration,

among other things, those transactions described under “Certain Transactions”.

Huntsman serves as Chairman of the Board

and is Chief Executive Officer and is a “non-independent director,” as defined by the applicable rules and regulations of

the Nasdaq Stock Market.

The Board does not have a lead director;

however, recognizing that the Board is composed almost entirely of

outside directors, in addition to the Board’s strong committee system (as described more fully below), we believe this leadership

structure is appropriate for the Company and allows the Board to maintain effective oversight of management.

At each annual meeting of

stockholders, members of our Board are elected to serve until the next annual meeting and until their successors are duly elected and

of the Board of Directors

Board of Directors has established three standing committees:

an Audit Committee, a Compensation Committee, and a Nominating and

Corporate Governance Committee.

Board has established an Audit Committee, a Compensation Committee, and a Nominating and Corporate Governance Committee.

following table sets forth the current composition of the three standing committees of our Board:

Nominating and

Sokolow (audit committee financial expert)

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and determine our stock incentive and purchase plans;

the evaluation of our Board of Directors and management;

the evaluation of the Board of Directors and management;

the independence of any compensation advisers;

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members of our Nominating and Corporate Governance Committee are independent under the listing standards of the Nasdaq Stock Market.

the fiscal year ended December 31, 2022, our Board of Directors met nine times, the audit committee met six times, the compensation

committee met two times and the nominating and corporate governance committee met one time.

the fiscal year ended December 31, 2023, our Board of Directors met eight times, the audit committee met six times, the compensation

committee met four times and the nominating and corporate governance committee met one time.

In the fiscal year ended December 31, 2023,

2022, each of our directors attended 100% of the meetings of our Board of Directors and committees on which he or she served as a

sessions, which are meetings of the non-management members of our Board of Directors, are regularly scheduled throughout the year.

our directors attended 99% of the meetings of the Board and committees on which he or she served as a member.

sessions, which are meetings of the non-management members of the Board of Directors, are regularly scheduled throughout the year.

addition, at least once a year, the independent directors meet in a private session that excludes management and any non-independent

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annual meetings.

All of our directors attended the last annual meeting of stockholders held on August 25, 2022.

All of our directors attended our 2023 virtual annual meeting of stockholders held on September 22, 2023.

Committee Interlocks and Insider Participation

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officers on our Board of Directors or Compensation Committee.

of Business Conduct and Ethics and Insider Trading Policy

of Business Conduct and Ethics

have adopted a code of business conduct and ethics that applies to all of our employees, officers and directors, including those officers

4 unchanged sentences

disclosed on our website.

Insider Trading Policy

In March 2023, our Board of Directors

adopted a revised Insider Trading Policy for our company principally to reflect changes to SEC Rule 10b5-1 which went into effect in

February 2023.

Among other customary provisions, our Insider Trading Policy provides for pre-clearance by our Chief Financial Officer

of any purchases or sales of our securities by officers, directors or employees of our company and specifies “trading windows”

in which purchases and sales of our securities by such persons are permitted (provided such persons are not then in possession of material

non-public information regarding or relating to our company).

Our revised Insider Trading Policy and related compliance manual is filed

as Exhibit 99.1 to this Report.

adopted a revised Insider Trading Policy for our company principally to reflect changes to SEC Rule 10b5-1 which went into effect in February

Among other customary provisions, our Insider Trading Policy provides for pre-clearance by our Chief Financial Officer of any purchases

or sales of our securities by officers, directors or employees of our company and specifies “trading windows” in which purchases

and sales of our securities by such persons are permitted (provided such persons are not then in possession of material non-public information

regarding or relating to our company).

Compensation Recovery Policy

On December 1, 2023, our Board

of Directors adopted a policy (commonly known as a “clawback” policy) which provides for the recovery of erroneously awarded

incentive compensation to certain of our officers in the event that we are required to prepare an accounting restatement due to material

noncompliance by us with any financial reporting requirements under the federal securities laws.

This policy is designed to comply with

Section 10D of the Securities Exchange Act of 1934, as amended, related rules and the listing standards of Nasdaq Stock Market or any

other securities exchange on which our shares are listed in the future.

The policy is administered by our Board of Directors or, if so

designated by the Board of Directors, the Compensation Committee.

Any determinations made by the Board shall be final and binding on all

affected individuals.

The individuals covered by this

policy (the “Covered Executives”) are any current or former employee who is or was identified as our president, principal

financial officer, principal accounting officer (or if there is no such accounting officer, the controller), any vice-president in charge

of a principal business unit, division, or function (such as sales, administration, or finance), any other officer who performs a policy-making

function, or any other person (including any executive officer of our subsidiaries or affiliates) who performs similar policy-making functions

The policy covers our recoupment

of “Incentive Compensation” (as defined in the policy) received by a person after beginning service as a Covered Executive

and who served as a Covered Executive at any time during the performance period for that Incentive Compensation.

In the event we are required

to prepare an accounting restatement, the policy requires us to recover, reasonably promptly, any excess incentive compensation (as determined

by our Board of Directors or Compensation Committee) received by any Covered Executive during the three completed fiscal years immediately

preceding the date on which we are required to prepare such accounting restatement.

The foregoing description of our Compensation Recovery Policy does not

purport to be complete and is qualified in its entirety by the terms and conditions of such policy, a copy of which is filed as an exhibit

to this Report and is incorporated herein by reference.

Communications

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Diversity Matrix

Diversity Matrix as of December 31, 2022

Diversity Matrix as of January 31, 2024

Number of Directors

Not Disclose Gender

Gender Identity

5 unchanged sentences

Not Disclose Demographic Background

Section 16(a) Reports

16(a) of the Exchange Act requires that our executive officers and directors, and persons who own more than ten percent of our common

stock, file reports of ownership and changes in ownership with the SEC.

Executive officers, directors and greater-than-ten percent stockholders

are required by SEC regulations to furnish us with all Section 16(a) forms they file.

Based solely on our review of the copies of the

forms received by us and written representations from certain reporting persons that they have complied with the relevant filing requirements,

we believe that, during the year ended December 31, 2022, all of our executive officers, directors and greater-than-ten percent stockholders

complied with all Section 16(a) filing requirements, except that, due to administrative errors, the following form was filed late:

Kirk Huntsman filed a Form 4 on June 3, 2022 to report a transaction that occurred on March 31, 2022.

Executive Compensation.

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We refer to these individuals as our “named executive officers”,

Non-Qualified

Name and Position

Non-Equity Incentive

Non-Qualified Deferred

All Other Compensation

Kirk Huntsman

1 unchanged sentence

Chief Executive Officer

$ 570,300 (4)

$ 144,318 (5)

Former Chief Medical Officer

Chief Medical Officer

Bradford Amman

$ 195,691 (4)

Chief Financial Officer

$ 805,560 (4)

Huntsman has served as Chief Executive Officer of our company since September 2016.

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annual incentive compensation in accordance with terms of individual employment agreement.

deferred compensation for salary and bonuses in accordance with terms of individual employment agreement.

contributions towards health insurance premiums in 2023 and 2022.

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officer as of December 31, 2023.

Number of Securities

Unexercised Options

of Securities Underlying

Unexercisable

Kirk Huntsman:

Total for Mr.

Bradford Amman:

Total for Mr.

option grant is fully vested on the grant date.

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to our initial public offering in late 2020, our directors did not received compensation for their service except for option grants.

Following our initial public offering, we adopted a new director compensation program recommended by our nominating and corporate

governance committee pursuant to which we make equity-plan based awards to the directors and (i) each of our non-employee directors

receive $48,000 cash compensation annually;

Following our initial public offering, we adopted a new director compensation program recommended by our nominating and corporate governance

committee pursuant to which we make equity-plan based awards to the directors and (i) each of our non-employee directors receive $48,000

cash compensation annually;

(ii) chairs of our committees receive $10,000 cash compensation annually;

members of our committees receive $5,000 cash compensation annually.

No additional compensation will be provided for attending

and (iii) members of our committees

receive $5,000 cash compensation annually.

No additional compensation will be provided for attending committee meetings.

Our nominating

and corporate governance committee will continue to review and make recommendations to the Board regarding compensation of directors,

including equity-based plans.

We reimburse our non-employee directors for reasonable travel expenses incurred in attending Board and

committee meetings.

Our nominating and corporate governance committee will continue to review and make recommendations to our Board

of Directors regarding compensation of directors, including equity-based plans.

We reimburse our non-employee directors for

reasonable travel expenses incurred in attending Board and committee meetings.

Compensation Table

following table sets forth information concerning the compensation of our non-employee directors for the fiscal year ended December 31,

Earned or Paid In Cash

Matthew Thompson, M.D.

Anja Krammer (4)

Green, DDS, MBA

Sokolow commenced service as a member of our Board of Directors on June 19, 2020.

Thompson commenced service as a member of our Board of Directors on June 19, 2020.

Lindsay commenced service as a member of our Board of Directors on June 19, 2020.

Krammer commenced service as a member of our Board of Directors on June 19, 2020.

Green commenced service as a member of our Board of Directors on June 19, 2020.

Sokolow commenced service as a member of the Board on June 19, 2020.

Thompson commenced service as a member of the Board on June 19, 2020.

Lindsay commenced service as a member of the Board on June 19, 2020.

Krammer commenced service as a member of the Board on June 19, 2020.

Green commenced service as a member of the Board on June 19, 2020.

option award value was based upon a Black-Scholes valuation calculation at the date of the stock option grant.

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Plan category:

Number of Securities to be issued Upon Exercise of Outstanding Options, Warrants, and Rights (a)

Weighted Average Exercise Price of Outstanding Options (b)

Number of Securities Remaining Available for Future Issuance Under Equity Compensation Plans (Excluding Securities Reflected in column (a)) (c)

of Securities to be issued Upon Exercise of Outstanding Options, Warrants, and Rights (a)

Average Exercise Price of Outstanding Options (b)

of Securities Remaining Available for Future Issuance Under Equity Compensation Plans (Excluding Securities Reflected in column (a))

Equity compensation plans approved by stockholders

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the 2019 Plan.

options granted to officers and employees prior to the approval by our stockholders of the 2017 Plan.

Stock Option and Stock Issuance Plan

2017 Stock Option and Stock Issuance Plan (or the “2017 Plan”) is intended to promote the interests of our company by providing eligible

persons in our employ or service with the opportunity to acquire a proprietary interest, or otherwise increase their proprietary interest,

in our company as an incentive for them to continue in such employ or service.

persons in our employment or service with the opportunity to acquire a proprietary interest, or otherwise increase their proprietary

interest, in our company as an incentive for them to continue in such employment or service.

eligible to participate in the 2017 Plan are as follows:

(3 eligible employees),

members of our Board of Directors or the non-employee members of our Board of Directors of any parent or subsidiary (5 eligible non-employee

members of the Board of Directors or the non-employee members of the Board of Directors of any parent or subsidiary (5 eligible non-employee

directors), and

and other independent contractors who provide services to us (or any parent or subsidiary).

Board of Directors, as plan administrator, or a committee solely of two or more directors, has broad authority to administer the 2017 Plan,

including the authority to determine which eligible persons are to receive any grants of options or direct issuances of stock, the

time or times when such grants or issuances are to be made, the number of shares to be covered by each such grant or issuance, the

time or times when each option is to become exercisable, the vesting schedule (if any) applicable to the option shares or issued

shares and the maximum term for which the option is to remain outstanding or the consideration to paid by the participant for such

shares, as applicable.

Our Board of Directors has granted the power to administer the 2017 Plan to the Compensation

Board, as plan administrator, or a committee solely of two or more directors, has broad authority to administer the 2017 Plan, including

the authority to determine which eligible persons are to receive any grants of options or direct issuances of stock, the time or times

when such grants or issuances are to be made, the number of shares to be covered by each such grant or issuance, the time or times when

each option is to become exercisable, the vesting schedule (if any) applicable to the option shares or issued shares and the maximum

term for which the option is to remain outstanding or the consideration to paid by the participant for such shares, as applicable.

Board of Directors has granted the power to administer the 2017 Plan to the Board’s Compensation Committee.

Common Stock issuable under the 2017 Plan shall be shares of authorized but unissued or reacquired Common Stock.

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underlying the 2017 Plan options have been registered on our registration statement on Form S-8 (File No.

under the 2017 Plan may be in the form of incentive or non-statutory stock options or stock directly at the discretion of our Board of

under the 2017 Plan may be in the form of incentive or non-statutory stock options or stock directly at the discretion of the Board of

Awards under the 2017 Plan generally will not be transferable other than by will or inheritance laws.

Our Board of Directors

The Board of Directors

has the discretion to grant options which are exercisable for unvested shares of Common Stock.

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all of those unvested shares.

exercise price per share of any options granted under the 2017 Plan is fixed by our Board of Directors or its designated committee in

exercise price per share of any options granted under the 2017 Plan is fixed by the Board of Directors or its designated committee in

accordance with the following provisions:

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The exercise price shall become immediately due and payable upon exercise of the option.

purchase price per share of any Common Stock issued under the 2017 Plan shall be fixed by our Board of Directors or its designated committee

purchase price per share of any common stock issued under the 2017 Plan shall be fixed by the Board of Directors or its designated committee

in accordance with the following provisions:

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option shares at the time of the Corporate Transaction and provides for subsequent payout in accordance with the same vesting schedule

applicable to those unvested option shares or the acceleration of such option is subject to other limitations imposed by our Board of

applicable to those unvested option shares or the acceleration of such option is subject to other limitations imposed by the Board of

Directors at the time of the option grant.

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eligible to participate in the 2019 Plan are as follows:

members of our Board of Directors or the non-employee members of our Board of Directors of any parent or subsidiary (5 eligible non-employee

members of the Board of Directors or the non-employee members of the Board of Directors of any parent or subsidiary (5 eligible non-employee

directors), and

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as applicable.

Our Board of Directors has granted the power to administer the 2019 Plan to the Compensation Committee.

The Board of Directors has granted the power to administer the 2019 Plan to the Board’s Compensation Committee.

Common Stock issuable under the 2019 Plan shall be shares of authorized but unissued or reacquired Common Stock.

The maximum number of

shares of Common Stock which may be issued over the term of the 2019 Plan shall not exceed 1,166,667 shares, although we are seeking

approval at the Annual Meeting to increase the number of shares such to the 2019 Plan to an aggregate of 2,366,667 shares.

of Common Stock underlying the 2019 Plan options have been registered on our registration statement on Form S-8 (File No.

under the 2019 Plan may be in the form of incentive or non-statutory stock options or stock directly at the discretion of our Board of

shares of Common Stock which may be issued over the term of the 2019 Plan shall not exceed 174,667 shares.

The shares of Common Stock

underlying the 2019 Plan options have been registered on our registration statement on Form S-8 (File No.

under the 2019 Plan may be in the form of incentive or non-statutory stock options or stock directly at the discretion of the Board of

Awards under the 2019 Plan generally will not be transferable other than by will or inheritance laws.

Our Board of Directors

The Board of Directors

has the discretion to grant options which are exercisable for unvested shares of common stock.

2 unchanged sentences

all of those unvested shares.

exercise price per share shall of any options granted under the 2019 Plan be fixed by our Board of Directors or its designated committee

exercise price per share shall of any options granted under the 2019 Plan be fixed by the Board of Directors or its designated committee

in accordance with the following provisions:

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The exercise price shall become immediately due and payable upon exercise of the option.

purchase price per share of any Common Stock issued under the 2019 Plan shall be fixed by our Board of Directors or its designated committee

purchase price per share of any Common Stock issued under the 2019 Plan shall be fixed by the Board of Directors or its designated committee

in accordance with the following provisions:

21 unchanged sentences

option shares at the time of the Corporate Transaction and provides for subsequent payout in accordance with the same vesting schedule

applicable to those unvested option shares or the acceleration of such option is subject to other limitations imposed by our Board of

applicable to those unvested option shares or the acceleration of such option is subject to other limitations imposed by the Board of

Directors at the time of the option grant.

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Shares of Common Stock Owned

Name Director and Officer Beneficial Owners

Name of Director and Officer Beneficial Owners

Kirk Huntsman

5 unchanged sentences

Name of 5% Stockholder Beneficial Owners

Armistice Capital, LLC

Kirk Huntsman

11 unchanged sentences

Kirk Huntsman, all of which are exercisable within 60 days.

Excludes 270,000 shares

of Common Stock underlying unvested options.

Excludes 7,600 shares of

common stock underlying unvested options.

Kirk Huntsman and his wife are the members and managers of Coronado V Partners, LLC.

2 unchanged sentences

Amman is our Chief Financial Officer, Treasurer and Secretary.

Includes 218,667 shares of Common Stock issuable upon exercise of

options, all of which are exercisable within 60 days, and 2,000 shares of Common Stock purchased in the open market.

Excludes 281,334

shares of Common Stock underlying unvested options.

Includes 14,027 shares of common stock issuable upon exercise of options,

all of which are exercisable within 60 days, and 80 shares of common stock purchased in the open market.

Excludes 8,453 shares of

common stock underlying unvested options.

3,067 shares of common stock issuable upon exercise of options held by Mark F.

Lindsay, all of which are exercisable within 60 days.

Excludes 7,500 shares of Common Stock underlying unvested options.

3,067 shares of common stock issuable upon exercise of options held by Anja Krammer, all of which are exercisable within 60 days.

Excludes 7,500 shares of Common Stock underlying unvested options.

3,067 shares of common stock issuable upon exercise of options held by Ralph E.

Green, DDS, MBA, all of which are exercisable within

Excludes 7,500 shares of Common Stock underlying unvested options.

3,467 shares of common stock issuable upon exercise of options held by Leonard J.

Sokolow, all of which are exercisable within 60

Excludes 10,000 shares of Common Stock underlying unvested options.

3,067 shares of common stock issuable upon exercise of options held by Matthew Thompson M.D., all of which are exercisable within

Excludes 7,500 shares of Common Stock underlying unvested options.

(i) 65,067 shares of common stock issuable upon exercise of options held by this group, of which 49,013 are exercisable within 60

2 unchanged sentences

Excludes 7,600 shares of common stock underlying unvested options.

shares of common stock reported herein are held by the Armistice Capital Master Fund Ltd.

(the “Master Fund”) and may

be deemed to be indirectly beneficially owned by (i) Armistice Capital, LLC (“Armistice Capital”), as the investment

manager of the Master Fund, and (ii) Steven Boyd, as the Managing Member of Armistice Capital.

Armistice Capital and Steven Boyd

disclaim beneficial ownership of the securities except to the extent of their respective pecuniary interests therein.

850,393 shares of common stock underlying a pre-funded warrant held by the Master Fund, (ii) 980,393 shares of common stock underlying

a Series A warrant held by the Master Fund, and (iii) 980,393 shares of common stock underlying a Series B warrant held by the Master

Fund, each of which are subject to beneficial ownership limitations that prohibit the Master Fund from exercising any portion of

those warrants if such exercise would result in the Master Fund owning a percentage of our outstanding common stock exceeding 9.99%

(in the case of the pre-funded warrant) and 4.99% (in the case of the Series A and Series B warrants) after giving effect to the

issuance of common stock in connection with the Master Fund’s exercise of any portion of such warrant.

The address of the Master

Fund is c/o Armistice Capital, LLC, 510 Madison Avenue, 7th Floor, New York, NY 10022.

Certain Relationships and Related Transactions and Directors Independence.

33 unchanged sentences

proposals could result in an improvement of their terms.

Newly created directorships resulting from any increase in the number of directors and any vacancies on our Board of Directors resulting

Newly created directorships resulting from any increase in the number of directors and any vacancies on the board of directors resulting

from death, resignation, disqualification, removal or other cause shall be filled by a majority of the remaining directors on the board.

Our certificate of incorporation and bylaws authorizes our Board of Directors to adopt, repeal, rescind, alter or amend our bylaws

Our certificate of incorporation and bylaws authorizes the board of directors to adopt, repeal, rescind, alter or amend our bylaws

without shareholder approval.

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Our bylaws provide that special meetings of stockholders for any purpose or purposes may be

called at any time only by our Board of Directors or by our Secretary following receipt of one or more written demands from

stockholders of record who own, in the aggregate, at least 15% the voting power of our outstanding stock then entitled to vote on

the matter or matters to be brought before the proposed special meeting.

called at any time only by the board of directors or by our Secretary following receipt of one or more written demands from stockholders

of record who own, in the aggregate, at least 15% the voting power of our outstanding stock then entitled to vote on the matter or matters

to be brought before the proposed special meeting.

of authorized but unissued common stock and blank check preferred stock.

71 unchanged sentences

and Non-Audit Fees

& Moran, PPLC (“Plante Moran”), Denver, Colorado (PCAOB ID No.

166 ) served as the independent registered public accounting

firm to audit our books and accounts for the fiscal years ending December 31, 2022 and 2021.

table below presents the aggregate fees billed for professional services rendered by Plante Moran for the years ended December 31, 2022

Audit -related fees

All other fees

the above table, “audit fees” are fees billed for services related to the audit of our annual financial statements,

quarterly reviews of our interim financial statements, and services normally provided by the independent accountant in connection

with regulatory filings or engagements for those fiscal periods.

“Audit-related fees” are fees not included in audit

fees that are billed by the independent accountant for assurance and related services that are reasonably related to the performance

of the audit or review of our financial statements.

These audit-related fees also consist of the review of our registration

statements filed with the SEC and related services normally provided in connection with regulatory filings or engagements.

“Tax fees” are comprised of tax compliance, preparation and consultation fees.

“All other fees” are fees

billed by the independent accountant for products and services not included in the foregoing categories.

Adams, LLP (“Moss Adams”), Denver, Colorado (PCAOB ID No.

659) served as the independent registered public accounting firm

to audit our books and accounts for the fiscal years ending December 31, 2023.

Plante & Moran, PLLC (“Plante Moran”), Denver, Colorado (PCAOB ID No.

166) served as our independent

registered public accounting firm for the fiscal year ended December 31, 2022.

table below presents the aggregate fees billed for professional services rendered by Moss Adams and Plante Moran for the years ended

December 31, 2023 and 2022.

$ 563,625 (1)

-related fees

These fees include $333,425 paid to Moss Adams and $230,200 paid to Plante Moran.

These fees were all paid to Plante Moran.

the above table, “audit fees” are fees billed for services related to the audit of our annual financial statements, quarterly

reviews of our interim financial statements, and services normally provided by the independent accountant in connection with regulatory

filings or engagements for those fiscal periods.

“Audit-related fees” are fees not included in audit fees that are billed

by the independent accountant for assurance and related services that are reasonably related to the performance of the audit or review

of our financial statements.

These audit-related fees also consist of the review of our registration statements filed with the SEC and

related services normally provided in connection with regulatory filings or engagements.

“Tax fees” are comprised of tax

compliance, preparation and consultation fees.

“All other fees” are fees billed by the independent accountant for products

and services not included in the foregoing categories.

Change in Accounting Firm

On May 3, 2023, as approved by

our Audit Committee, the Company dismissed Plante Moran as the Company’s independent registered public accounting firm, effective

fiscal years ended December 31, 2022 and 2021, Plante Moran’s audit reports on the Company’s financial statements did not

contain an adverse opinion or disclaimer of opinion, nor were they qualified or modified as to uncertainty, audit scope or accounting

principles, except that Plante Moran’s report for the year ended December 31, 2022 included an explanatory paragraph indicating

that there was substantial doubt about the Company’s ability to continue as a going concern.

During the fiscal years ended December

31, 2022 and 2021, and through the date of Plante Moran’s dismissal, (i) there were no disagreements between the Company and Plante

Moran on any matter of accounting principles or practices, financial statement disclosure or auditing scope or procedures, which disagreements,

if not resolved to Plante Moran’s satisfaction, would have caused Plante Moran to make reference in connection with Plante Moran’s

report to the subject matter of the disagreement;

and (ii) there were no “reportable events” as the term is described in Item

304(a)(1)(v) of Regulation S-K, except for the disclosure of material weaknesses in the Company’s internal controls over financial

reporting as disclosed in Part II, Item 9A of the Company’s Form 10-K for the years ended December 31, 2022 and 2021.

The Audit Committee approved the engagement of Moss Adams as the Company’s

new independent registered public accounting firm, which engagement was effective as of May 3, 2023.

During the fiscal years ended December

31, 2022 and 2021 and through the date of their engagement, neither the Company nor anyone acting on its behalf consulted Moss Adams with

respect to (i) the application of accounting principles to a specified transaction, either completed or proposed, nor the type of audit

opinion that might be rendered on the Company’s financial statements, and neither a written report was provided to the Company nor

oral advice provided that Moss Adams concluded was an important factor considered by the Company in reaching a decision as to any accounting,

auditing or financial reporting issue;

or (ii) any matter that was the subject of a disagreement or a “reportable event” as

described in Items 304(a)(1)(iv) and (v), respectively, of Regulation S-K.

is the Audit Committee’s policy to approve in advance the types and amounts of audit, audit-related, tax, and any other services

5 unchanged sentences

at its next scheduled meeting.

The Audit Committee approved 100% of all services provided by Plante Moran during 2022 and 2021.

The Audit Committee approved 100% of all services provided by Moss Adams during 2023 and 2022.

Exhibits and Financial Statement Schedules.

1 unchanged sentence

Financial Statements

financial statements included in Part II, Item 8 of this document are filed as part of this Annual Report on Form 10-K.

consolidated financial statements, together with the reports thereon of Moss Adams, LLP and Plante & Moran, PLLC dated March 28,

2024, respectively, are included in Part II, Item 8 of this document are filed as part of this Annual Report on Form

Financial Statement Schedules

6 unchanged sentences

of Conversion filed with Delaware Secretary of State on August 12, 2020.

of Amendment to the Certificate of Incorporation of Vivos Therapeutics, Inc., dated October 25, 2023.

of Stock Certificate.

1 unchanged sentence

of Representative’s Warrant in connection with the Company’s May 2021 follow-on offering.

of Registered Securities.

Form of Common Stock Warrant, dated January 9, 2023, issued to the investor in the January 2023 private placement (6)

Form of Pre-Funded Warrant, dated January 9, 2023, issued to the investor in the January 2023 private placement (6)

of Common Stock Warrant, dated January 9, 2023, issued to the investor in the January 2023 private placement (7)

of Pre-Funded Warrant, dated January 9, 2023, issued to the investor in the January 2023 private placement (7)

of Series A Common Stock Purchase Warrant, dated November 2, 2023, issued to the investor in the November 2023 private placement.

of Series B Common Stock Purchase Warrant, dated November 2, 2023, issued to the investor in the November 2023 private placement.

2023 Warrant Amendment, dated November 2, 2023, issued to the investor in the November 2023 private placement.

of Pre-Funded Warrant, dated November 2, 2023, issued to the investor in the November 2023 private placement.

Form of Series B-1 Common Stock Purchase Warrant, issued to the investor in the February 2024 Inducement Transaction (11)

Form of Series B-2 Common Stock Purchase Warrant, issued to the investor in the February 2024 Inducement Transaction (11)

Amended and Restated Executive Employment Agreement, dated October 8, 2020, between R.

1 unchanged sentence

Amended and Restated Executive Employment Agreement, dated October 8, 2020, between Bradford Amman and Vivos Therapeutics, Inc.

Vivos Therapeutics, Inc.

Therapeutics, Inc.

2017 Stock Option and Stock Issuance Plan.

Vivos Therapeutics, Inc.

Therapeutics, Inc.

2019 Stock Option and Stock Issuance Plan.

Distribution, and Marketing Agreement dated February 12, 2021 between the Company and MyCardio, LLC.

Agreement dated February 7, 2022, between the Company and Roth Capital Partners, LLC.

Form of Securities Purchase Agreement, dated January 5, 2023, between the Company and the investor in the January 2023 private placement (6)

Form of Registration Rights Agreement, dated January 5, 2023, between the Company and the investor in the January 2023 private placement (6)

Placement Agency Agreement, dated January 5, 2023, between the Company and Roth Capital Partners, LLC and A.G.P./Alliance Global Partners (6)

List of Subsidiaries.

Consent of Plante & Moran PLLC.*

Certification of the Chief Executive Officer pursuant to Rule 13a-14(a) under the Securities Exchange Act of 1934, as adopted pursuant to Section 302 of the Sarbanes-Oxley Act of 2002.

Certification of the Chief Financial Officer pursuant to Rule 13a-14(a) under the Securities Exchange Act of 1934, as adopted pursuant to Section 302 of the Sarbanes-Oxley Act of 2002.

Certification of the Chief Executive Officer pursuant to Section 13(a) or 15(d) of the Securities Exchange Act of 1934, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002.

Certification of the Chief Financial Officer pursuant to Section 13(a) or 15(d) of the Securities Exchange Act of 1934, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002.

Insider Trading Compliance Manual.*

XBRL Instance Document

XBRL Taxonomy Extension Schema Document

XBRL Taxonomy Extension Calculation Linkbase Document

XBRL Taxonomy Extension Definition Linkbase Document

XBRL Taxonomy Extension Label Linkbase Document

XBRL Taxonomy Extension Presentation Linkbase Document

Page Interactive Data File (formatted as Inline XBRL and contained in Exhibit 101).

by reference to the Company’s Registration Statement on Form S-1, filed with the SEC on October 9, 2020.

by reference to the Company’s Registration Statement on Form S-1/A, filed with the SEC on November 19, 2020.

by reference to the Company’s Annual Report on Form 10-K, filed with the SEC on March 25, 2021.

by reference to the Company’s Current Report on Form 8-K, filed with the SEC on May 12, 2021.

by refence to the Company’s Registration Statement on Form S-3, filed with the SEC on February 7, 2022.

Incorporated by refence to the Company’s Current Report on Form 8-K, filed with the SEC on January 9, 2023.

management contracts and compensation plans and arrangements

portions of this exhibit have been omitted pursuant to Item 601(b)(10)(iv) of Regulation S-K.

The Company will furnish supplementally

an unredacted copy of such exhibit to the U.S.

Licensing, Distribution, and Marketing Agreement dated February 12, 2021 between the Company and MyCardio, LLC.

Sales Agreement dated February 7, 2022, between the Company and Roth Capital Partners, LLC.

of Securities Purchase Agreement, dated January 5, 2023, between the Company and the investor in the January 2023 private placement

of Registration Rights Agreement, dated January 5, 2023, between the Company and the investor in the January 2023 private placement

Agency Agreement, dated January 5, 2023, between the Company and Roth Capital Partners, LLC and A.G.P./Alliance Global Partners (7)

of Securities Purchase Agreement, dated November 2, 2023, between the Company and the investor in the November 2023 private placement

of Registration Rights Agreement, dated November 2, 2023, between the Company and the investor in the November 2023 private placement

Agency Agreement, dated November 2, 2023, between the Company and A.G.P./Alliance Global Partners (9)

Inducement Agreement, dated February 14, 2024, between the Company and the investor in the February 2024 Inducement Transaction (11)

Insider Trading Policy and Compliance Manual (10)

of Subsidiaries.

of Moss Adams, LLP.*

of Plante & Moran PLLC.*

Certification

of the Chief Executive Officer pursuant to Rule 13a-14(a) under the Securities Exchange Act of 1934, as adopted pursuant to Section

302 of the Sarbanes-Oxley Act of 2002.

Certification

of the Chief Financial Officer pursuant to Rule 13a-14(a) under the Securities Exchange Act of 1934, as adopted pursuant to Section

302 of the Sarbanes-Oxley Act of 2002.

Certification

of the Chief Executive Officer pursuant to Section 13(a) or 15(d) of the Securities Exchange Act of 1934, as adopted pursuant to

Section 906 of the Sarbanes-Oxley Act of 2002.

Certification

of the Chief Financial Officer pursuant to Section 13(a) or 15(d) of the Securities Exchange Act of 1934, as adopted pursuant to

Section 906 of the Sarbanes-Oxley Act of 2002.

Policy Relating to Recovery of Erroneously Awarded Compensation., adopted as of December 1, 2023

Inline XBRL Instance Document