What changed in this filing

/stocks — the workspaceLOADING

Item 9A. Controls and Procedures

2022-03-28 compared with 2021-03-31 · 1625 added, 1847 removed, 346 unchanged (91% of the section changed)

1 unchanged sentence

of Controls and Procedures

management carried out an evaluation, under the supervision and with the participation of our Chief Executive Officer (who is

our Principal Executive Officer) and our Chief Financial Officer (who is our Principal Financial Officer and Principal Accounting

Officer), of the effectiveness of the design of our disclosure controls and procedures (as defined by Exchange Act Rules 13a-15(e)

or 15d-15(e)) as of December 31, 2020, pursuant to Exchange Act Rule 13a-15(b).

Based upon that evaluation, our Principal Executive

Officer and Principal Financial Officer concluded that our disclosure controls and procedures were not effective, due to the material

weakness in our internal controls over financial reporting described below.

management carried out an evaluation, under the supervision and with the participation of our Chief Executive Officer (who is our Principal

Executive Officer) and our Chief Financial Officer (who is our Principal Financial Officer and Principal Accounting Officer), of the

effectiveness of the design of our disclosure controls and procedures (as defined by Exchange Act Rules 13a-15(e) or 15d-15(e)) as of

December 31, 2021, pursuant to Exchange Act Rule 13a-15(b).

Based upon that evaluation, our Principal Executive Officer and

Principal Financial Officer concluded that our disclosure controls and procedures were effective as of December 31, 2021 to provide reasonable

assurance that information required to be disclosed by us in the reports that we file or submit under the Exchange Act is accumulated

and communicated to management, including our Chief Executive Officer and our Chief Financial Officer, as appropriate, to allow timely

decisions regarding required disclosure and are effective to provide reasonable assurance that such information is recorded, processed,

summarized and reported within the time periods specified by the Securities and Exchange Commission’s rules and forms.

Limitations on Effectiveness of Controls

should be noted that any system of controls, however well designed and operated, can provide only reasonable, and not absolute,

assurance that the objectives of the system will be met.

In addition, the design of any control system is based in part upon certain

assumptions about the likelihood of future events.

Because of these and other inherent limitations of control systems, there is

only reasonable assurance that our controls will succeed in achieving their goals under all potential future conditions.

Management’s

should be noted that any system of controls, however well designed and operated, can provide only reasonable, and not absolute, assurance

that the objectives of the system will be met.

In addition, the design of any control system is based in part upon certain assumptions

about the likelihood of future events.

Because of these and other inherent limitations of control systems, there is only reasonable assurance

that our controls will succeed in achieving their goals under all potential future conditions.

Report on Internal Control Over Financial Reporting

a result of ongoing remediation efforts, there was a material change

in our internal control over financial reporting identified in connection with the evaluation required by Exchange Act Rule 13a-15(d)

during the quarter ended December 31, 2020 that have materially affected, or are reasonably likely to materially affect, our internal

control over financial reporting.

Management, including the principal executive officer and principal financial officer, does

not expect that our disclosure controls and procedures or our internal control over financial reporting will prevent or detect

all error and all fraud.

Controls and procedures, no matter how well designed and operated, can provide only reasonable assurance

of achieving their objectives and management necessarily applies its judgment in evaluating the cost-benefit relationship of possible

controls and procedures.

Over time, controls may become inadequate because of changes in conditions, or deterioration in the degree

of compliance with the policies or procedures.

Because of the inherent limitations in a cost-effective control system, misstatements

due to error or fraud may occur and not be detected.

Our internal control over financial reporting is designed to provide reasonable

assurance regarding the reliability of financial reporting and the preparation of consolidated financial statements for external

purposes in accordance with generally accepted accounting principles.

the supervision and with the participation of our management, including the principal executive officer and principal financial

officer, we conducted an evaluation as to the effectiveness of our internal control over financial reporting as of December 31,

In making this assessment, our management used the criteria for effective internal control set forth by the Committee of

Sponsoring Organizations of the Treadway Commission in the 2013 Internal Control –

Integrated Framework.

Based on our assessment,

our management concluded that our internal control over financial reporting was not effective as of December 31, 2020 due to the

existence of a material weakness in our internal controls over complex equity transactions.

A material weakness in internal control

is a deficiency in internal control, or combination of control deficiencies, that adversely affects the Company’s ability

to initiate, authorize, record, process, or report external financial data reliably in accordance with GAAP such that there is

more than a remote likelihood that a material misstatement of the Company’s annual or interim financial statements will

not be prevented or detected.

The material weakness related to accounting for warrants issued in connection with our February

25, 2020 financing, in which we did not record an associated derivative liability on a timely basis.

At the time of issuance,

the Company sought and received technical accounting guidance on the accounting treatment for the derivative liability.

due to personnel changes, the existence of the guidance was not known to new finance personnel.

This deficiency did not result

in the revision of any of our previously issued financial statements.

However, if not addressed, the deficiency could have resulted

in material misstatement in the future.

Accordingly, our management has determined that this control deficiency constitutes a

material weakness.

remediate this weakness, we devoted resources, and will continue to devote resources to the remediation and improvement of our

internal control over financial reporting, in particular over handling of complex financial accounting issues.

As the Company

enters into transactions that involve complex accounting issues, it will consult with third party professionals with expertise

in these matters as necessary to ensure appropriate accounting treatment for such transactions.

Annual Report on Form 10-K does not include an attestation report of our independent registered public accounting firm regarding

were changes in our internal control over financial reporting identified in connection with the evaluation required by Exchange Act Rule

13a-15(d) during the quarter ended December 31, 2021 that have materially affected, or are reasonably likely to materially affect, our

internal control over financial reporting.

Management’s report was not subject to attestation by the Company’s independent

registered public accounting firm pursuant to a permanent exemption of the Commission that permits the Company to provide only

management’s report in this Annual Report on Form 10-K.

Accordingly, our management’s assessment of the effectiveness

of our internal control over financial reporting as of December 31, 2020 has not been audited by our auditors, Marcum LLP.

The change was to remediate and eliminate our previously disclosed material weakness over

reporting of complex financial transactions.

Management, including the principal executive officer and principal financial officer, does

not expect that our disclosure controls and procedures or our internal control over financial reporting will prevent or detect all error

and all fraud.

Controls and procedures, no matter how well designed and operated, can provide only reasonable assurance of achieving

their objectives and management necessarily applies its judgment in evaluating the cost-benefit relationship of possible controls and

Because of the inherent limitations in all control systems, no evaluation of controls can provide absolute assurance that

all control issues and instances of fraud, if any, within the Company have been detected.

These inherent limitations include the realities

that judgments in decision-making can be faulty, and that breakdowns can occur because of a simple error or mistake.

Additionally, controls

can be circumvented by the individual acts of some persons, by collusion of two or more people, or by management override of the controls.

The design of any system of controls also is based in part upon certain assumptions about the likelihood of future events, and there

can be no assurance that any design will succeed in achieving its stated goals under all potential future conditions.

Over time, controls

may become inadequate because of changes in conditions, or deterioration in the degree of compliance with the policies or procedures.

Because of the inherent limitations in a cost-effective control system, misstatements due to error or fraud may occur and not be detected.

Our internal control over financial reporting is designed to provide reasonable assurance regarding the reliability of financial reporting

and the preparation of consolidated financial statements for external purposes in accordance with generally accepted accounting principles.

Under the supervision and

with the participation of our management, including the principal executive officer and principal financial officer, we conducted an

evaluation as to the effectiveness of our internal control over financial reporting as of December 31, 2021.

In making this assessment,

our management used the criteria for effective internal control set forth by the Committee of Sponsoring Organizations of the Treadway

Commission in the 2013 Internal Control – Integrated Framework.

Based on this assessment, our management concluded that our internal

control over financial reporting was effective as of December 31, 2021.

Annual Report on Form 10-K does not include an attestation report of our independent registered public accounting firm regarding internal

control over financial reporting.

Management’s report was not subject to attestation by the Company’s independent registered

public accounting firm pursuant to a permanent exemption of the Commission that permits the Company to provide only management’s

report in this Annual Report on Form 10-K.

Accordingly, our management’s assessment of the effectiveness of our internal control

over financial reporting as of December 31, 2021 has not been audited by our auditors, Marcum LLP.

Disclosure Regarding Foreign Jurisdictions

That Prevent Inspections

Not Applicable.

Executive Officers and Corporate Governance

below are the names of the directors and executive officers of the Company, their ages as of the date of this Annual Report, their

positions held and the year they commenced service with the Company.

below are the names of the directors and executive officers of the Company, their ages as of the date of this Annual Report, their positions

held and the year they commenced service with the Company.

of Service Commencement

5 unchanged sentences

Vice President and Chief Medical Officer

Berman has served as our Chief Executive Officer and a member of our board of directors since April 2018.

From September

2017 to March 2018, Mr.

Berman worked as an independent strategic business consultant.

From September 2012 to July 2017, he served

as the President, Chief Executive Officer, and a member of the board of directors of ITUS Corporation (now called Anixa Biosciences),

a Nasdaq listed company, that develops a liquid biopsy technology for early cancer detection.

Prior to ITUS Corporation, from

March 2007 to September 2012, Mr.

Berman was the Chief Executive Officer of VIZ Technologies, a start-up company which developed

and licensed a beverage dispensing cap, and he was the founder of IP Dispute Resolution Corporation, a company focused on intellectual

property licensing.

From 2000 to March 2007, Mr.

Berman was the Chief Operating Officer and General Counsel of Acacia Research

Corporation, which was a publicly traded company engaged in the licensing and enforcement of patented technologies.

Prior thereto,

Berman was a Director of Business Development at QVC where he developed and selected products for on-air sales and distribution.

Berman started his career at the law firm of Blank Rome LLP.

He has a Bachelor of Science in Entrepreneurial Management from

the Wharton School of the University of Pennsylvania and holds a Juris Doctorate degree from the Northwestern University Pritzker

School of Law, where he serves as an adjunct faculty member.

We believe Mr.

Berman is qualified to serve as a member of our board

of directors because of his experience in broad variety of areas including healthcare, finance, acquisitions, marketing, compliance,

Berman Robert Berman has served as our Chief Executive Officer and a member of our Board of Directors since April of 2018.

Berman has over 25 years of experience in a broad variety of areas including healthcare, finance, acquisitions, marketing, compliance,

turnarounds, and the development and licensing of emerging technologies.

From September 2012 until July 2017, he served as the President,

Chief Executive Officer, and a member of the Board of Directors of ITUS Corporation (now called Anixa Biosciences), which at the time

he joined the company was a developer of flat panel display technologies, and under his leadership became a Nasdaq listed cancer therapeutics

From 2000 to March 2007, Mr.

Berman was the Chief Operating Officer and General Counsel of Acacia Research Corporation, where

he successfully transitioned the company from being an incubator of internet startups into a preeminent, publicly traded company for

licensing and enforcing patented technologies with a market cap exceeding $2 billion.

Berman started his career at the law firm of

Berman has a B.S.

in Entrepreneurial Management from the Wharton School of the University of Pennsylvania and holds a

from the Northwestern University School of Law, where he is an adjunct faculty member.

We believe that Mr.

Berman is qualified to

serve as a member of our board of directors because of his experience in a broad variety of areas including healthcare, finance, acquisitions,

marketing, compliance, turnarounds, and the development and licensing of emerging technologies.

Francis Duhay has served as member of our board of directors since October 2018.

A trained cardiac and thoracic surgeon,

A trained cardiac and thoracic surgeon, Dr.

Duhay has served the President and Chief Operating officer of Aegis Surgical Inc.

and Atrius Inc., makers of cardiac accessory

devices, since 2016, and as a Partner in K5_Ventures, an early stage venture fund since 2017.

Duhay is the former Chief Medical

Officer at Edwards Life Sciences, a world leader in heart valve products, where he led medical and clinical affairs for transcatheter

and surgical heart valves.

and Atrius Inc., makers of cardiac accessory devices,

since 2016, and as a Partner in K5_Ventures, an early stage venture fund since 2017.

Duhay is the former Chief Medical Officer at

Edwards Life Sciences, a world leader in heart valve products, where he led medical and clinical affairs for transcatheter and surgical

heart valves.

During his tenure at Edwards Life Sciences, from 2008 to 2016, Dr.

Duhay led the preparation and submission,

and ultimate regulatory approval, of two FDA Premarket Approval (PMA) applications for transcatheter and surgical heart valve

therapies and was responsible for the design and execution of the applicable clinical trials.

From April 2008 to October 2011,

Duhay was also the Vice President and General Manager of the Ascendra™

transcatheter heart valve business unit at Edwards,

where he grew the unit from sixteen to eighty employees and contributed to annual growth in sales from $3 million to $250 million.

Duhay led the preparation and submission, and ultimate

regulatory approval, of two FDA Premarket Approval (PMA) applications for transcatheter and surgical heart valve therapies and was responsible

for the design and execution of the applicable clinical trials.

From April 2008 to October 2011, Dr.

Duhay was also the Vice President

and General Manager of the Ascendra™ transcatheter heart valve business unit at Edwards, where he grew the unit from sixteen to

eighty employees and contributed to annual growth in sales from $3 million to $250 million.

From 1998 to 2003, Dr.

Duhay served as the Chief of the Department of Cardiothoracic Surgery and Cardiology at Kaiser Permanente.

Duhay has also served as an industry representative and clinical expert, and a member of the working group for ISO 5840, the

international quality standard for the design, development, and testing of heart valves.

Duhay received his MBA from the University

of Hawaii - Shidler College of Business and received his board certification for Cardiothoracic Surgery and General Surgery from

the Duke University School of Medicine and from the University of California, San Francisco, respectively.

Duhay served as the

Chief of the Department of Cardiothoracic Surgery and Cardiology at Kaiser Permanente.

Duhay has also served as an industry representative

and clinical expert, and a member of the working group for ISO 5840, the international quality standard for the design, development,

and testing of heart valves.

Duhay received his MBA from the University of Hawaii - Shidler College of Business and received his

board certification for Cardiothoracic Surgery and General Surgery from the Duke University School of Medicine and from the University

of California, San Francisco, respectively.

We believe that Dr.

Duhay is qualified to serve as a member of our board of directors because he is a trained cardiac and thoracic surgeon and former

Chief Medical Officer at Edwards Life Sciences.

Duhay is qualified to serve as a member of our board of directors because

he is a trained cardiac and thoracic surgeon and former Chief Medical Officer at Edwards Life Sciences.

Sanjay Shrivastava has served as a member of our board of directors since October 2018.

He has been involved in developing,

commercializing, evaluating, and acquiring medical devices for more than 18 years, including serving in Chief Executive Officer

and board of director positions at several medical device start-ups, and leadership positions in research and development, business

development, and marketing at BTG (from 2017 to 2018), Medtronic (2007 to 2017), Abbott Vascular (2003 to 2007), and Edwards Life

Sciences (2000 to 2003).

He is presently the Director of Business Development at Johnson & Johnson and a co-founder and board

member of BlackSwan Vascular, Inc.

While working as a vice president, upstream marketing and strategy at BTG, a medical device

and specialty pharmaceutical company with annual revenue of about $800 million, Dr.

Shrivastava worked on several acquisition

and investment deals.

He has been involved in developing, commercializing,

evaluating, and acquiring medical devices for more than 21 years, including serving in leadership positions in research and development,

business development, and marketing at J&J, BTG, plc, Medtronic, Abbott Vascular, and Edwards Life Sciences.

He is presently serving

as the chief executive officer at Innova Vascular, Inc., a medical device company funded largely via an investment from a publicly traded

medical device company.

Prior to this, he co-founded BlackSwan Vascular, Inc., which is a clinical stage medical device company and where

he serves on the board of directors.

He led the strategic alliance for BlackSwan with Sirtex Medical, which was announced in 2020.

Shrivastava worked on several acquisition and investment deals during his roles as a senior director, business development at J&J

and a vice president, upstream marketing and strategy at BTG, a medical device and specialty pharmaceutical company with annual revenue

of about $800 million.

At Medtronic, Dr.

Shrivastava was the Director of Global Marketing for the Cardiac and Vascular Group where

he helped build the embolization business, from its initiation to a substantial revenue with a very high CAGR over a period of

Shrivastava was a Manager of Research and Development for the peripheral vascular business at Abbott Vascular and

a Principal Research and Development Engineer for Trans-Catheter heart valves at Edwards Life Sciences.

Shrivastava received

his Bachelor of Science in engineering at the Indian Institute of Technology, and his Doctorate of Philosophy in materials science

and engineering from the University of Florida.

Shrivastava was the Director of Global Marketing for the Cardiac and Vascular Group where he

helped build the embolization business, from its initiation to a substantial revenue with a very high CAGR over a period of six years.

Shrivastava was a Manager of Research and Development for the peripheral vascular business at Abbott Vascular and a Principal Research

and Development Engineer for Trans-Catheter heart valves at Edwards Life Sciences.

Shrivastava received his Bachelor of Science in

engineering at the Indian Institute of Technology and a doctorate degree in materials science and engineering from the University of

We believe that Dr.

Shrivastava is qualified to serve as a member of our board

of directors because of having served in Chief Executive Officer and board of director positions at several medical device start-ups,

and leadership positions in research and development, business development, and marketing at BTG, Medtronic, Abbott Vascular,

and Edwards Life Sciences.

Shrivastava is qualified to serve as a member of our board of directors because of having served in Chief

Executive Officer and board of director positions at several medical device start-ups, and leadership positions in research and development,

business development, and marketing at Innova Vascular, Inc., BTG, Medtronic, Abbott Vascular, and Edwards Life Sciences.

Jenusaitis has served as a member of our board of directors since September 2019.

He has over 30 years of health care

experience with an emphasis on building and selling companies that develop medical devices to treat vascular diseases.

Jenusaitis has been the Chief of Staff and Chief of Innovation and Transformation

for the UC San Diego Health System.

He has over 30 years of health care experience

with an emphasis on building and selling companies that develop medical devices to treat vascular diseases.

Since March 2015, Mr.

has been a senior administrative executive at the UC San Diego Health System.

He currently serves as the Chief Administrative Officer

for UCSD’s Moore’s Cancer Center and UCSD Oncology.

From June 2009 to March 2015, Mr.

Jenusaitis was President and CEO of OCTANe Foundation for

Innovation, a non-profit focused on the development of innovation in Orange County, CA.

Over the course of his career, Mr.

has been on the board of directors of Pulsar Vascular (2008-2017), which was sold to Johnson and Johnson, Creagh Medical (2008-2015),

which was sold to SurModics, and Precision Wire Components (2009-2014), which was sold to Creganna Medical.

was also a Senior Vice President at ev3 (April 2006 to July 2008), which was sold to Covidian and later purchased by Medtronics.

Jenusaitis was President and CEO of

OCTANe Foundation for Innovation, a non-profit focused on the development of innovation in Orange County, CA.

Over the course of his

Jenusaitis has been on the board of directors of Pulsar Vascular (2008-2017), which was sold to Johnson and Johnson, Creagh

Medical (2008-2015), which was sold to SurModics, and Precision Wire Components (2009-2014), which was sold to Creganna Medical.

Jenusaitis was also a Senior Vice President at ev3 (April 2006 to July 2008), which was sold to Covidian and later purchased by Medtronics.

In addition, Mr.

Jenusaitis was the President of the Peripheral Division at Boston Scientific (July 2003 to August 2005) and was

an Executive in Residence at Warburg Pincus (September 2005 to March 2006).

Jenusaitis has an MBA from the University of California,

Irvine, a Masters Degree in Biomedical Engineering from Arizona State University, and a Bachelors Degree in Chemical Engineering

from Cornell University.

Jenusaitis was the President of the Peripheral Division at Boston Scientific (July 2003 to August 2005) and was an Executive

in Residence at Warburg Pincus (September 2005 to March 2006).

Jenusaitis has an MBA from the University of California, Irvine, a

Masters Degree in Biomedical Engineering from Arizona State University, and a Bachelors Degree in Chemical Engineering from Cornell University.

We believe that Mr.

Jenusaitis is qualified to serve as a member of our board of directors because of

over 30 years of health care experience with an emphasis on building and selling companies that develop medical devices to treat

vascular diseases and his prior board experiences.

Jenusaitis is qualified to serve as a member of our board of directors because of over 30 years of health care experience

with an emphasis on building and selling companies that develop medical devices to treat vascular diseases and his prior board experiences.

Gray has served as a member of our board of directors since September 2019.

He had a 20-year career at Highmark, Inc.,

one of America’s largest health insurance organizations, which serves over 20 million

subscribers, and includes Highmark Blue Cross Blue Shield Pennsylvania, Highmark Blue Cross Blue Shield Delaware, and Highmark

Blue Cross Blue Shield West Virginia, which he retired from in 2008.

He had a 20-year career at Highmark, Inc., one

of America’s largest health insurance organizations, which serves over 20 million subscribers, and includes Highmark Blue Cross

Blue Shield Pennsylvania, Highmark Blue Cross Blue Shield Delaware, and Highmark Blue Cross Blue Shield West Virginia, which he retired

from in 2008.

While at Highmark, Mr.

Gray helped increase revenues to $12.3

billion from $6.9 billion, and helped generate an operating gain of $375 million from an operating loss of $91 million.

to being the board chairman, Chief Executive Officer, and President of several of Highmark’s subsidiaries and affiliated

companies, Mr.

Gray was the Chief Financial Officer of Highmark’s parent company and was the primary contact to Highmark’s

board of directors for Highmark’s audit, investment and compensation (incentive plans) committees.

His many responsibilities

at Highmark included rate setting and reimbursement negotiations.

Gray helped increase revenues to $12.3 billion from $6.9 billion, and helped generate an operating

gain of $375 million from an operating loss of $91 million.

In addition to being the board chairman, Chief Executive Officer, and President

of several of Highmark’s subsidiaries and affiliated companies, Mr.

Gray was the Chief Financial Officer of Highmark’s parent

company and was the primary contact to Highmark’s board of directors for Highmark’s audit, investment and compensation (incentive

plans) committees.

His many responsibilities at Highmark included rate setting and reimbursement negotiations.

Following Highmark, Mr.

1 unchanged sentence

Holdings LLC (U.S.

Implants LLC.), a national distributor of orthopedic implants, and has served as Vice President since 2009.

Implants LLC.), a national distributor of orthopedic implants, and has served as Vice President

Since 2011, Mr.

has also been self-employed as a strategy and financial consultant.

Gray engaged in Postgraduate Studies at the University

of North Carolina–Chapel Hill and has an undergraduate degree from Bucknell University.

We believe that Mr.

is qualified to serve as a member of our board of directors because of his financial and medical reimbursement expertise having

served as the Chief Financial Officer at Highmark, Inc., one of America’s largest health insurance organization.

Gray has also been self-employed as a strategy and financial consultant.

Gray engaged in Postgraduate

Studies at the University of North Carolina–Chapel Hill and has an undergraduate degree from Bucknell University.

We believe that

Gray is qualified to serve as a member of our board of directors because of his financial and medical reimbursement expertise having

served as the Chief Financial Officer at Highmark, Inc., one of America’s largest health insurance organization.

Glickman, M.D.

has served as our Senior Vice President and Chief Medical Officer since May 2016 and served as member

of our board of directors from July 2016 to August 2017.

has served as our Senior Vice President and Chief Medical Officer since May 2016 and served as member of our

board of directors from July 2016 to August 2017.

Glickman started a vascular practice in Norfolk, Virginia.

He established the first Vein Center in Virginia and also created a dialysis access center.

He was employed by Sentara Health

Care as director of Vascular Services until he retired in 2014.

He established

the first Vein Center in Virginia and also created a dialysis access center.

He was employed by Sentara Health Care as director of Vascular

Services until he retired in 2014.

Glickman is a board certified vascular surgeon.

received his Doctor of Medicine from Case Western Reserve, in Cleveland, Ohio and completed his residency at the University of

Washington, Seattle.

He is board certified in Vascular Surgery and was the past president of the Vascular Society of the Americas.

He has served on the advisory boards of Possis Medical, Cohesion Technologies, Thoratec, GraftCath, Inc., TVA medical, Austin,

Glynn was hired as our interim Chief Financial Officer in April 2020 and has subsequently been elevated to our fulltime

Chief Financial Officer effective January 2021.

Glynn has more than thirty-five years of experience providing financial services

to a variety of public and private companies, including in the role as Chief Financial Officer.

Glynn founded Edward

Thomas Associates, a firm that provides public and private companies with accounting and finance services, including chief financial

officer services.

Glickman received his Doctor of Medicine from

Case Western Reserve, in Cleveland, Ohio and completed his residency at the University of Washington, Seattle.

He is board certified

in Vascular Surgery and was the past president of the Vascular Society of the Americas.

He has served on the advisory boards of Possis

Medical, Cohesion Technologies, Thoratec, GraftCath, Inc., TVA medical, Austin, Texas.

Glynn was hired as our interim Chief Financial Officer in April 2020 and has subsequently been elevated to our fulltime Chief

Financial Officer effective January 2021.

Glynn has more than thirty-five years of experience providing financial services to a variety

of public and private companies, including in the role as Chief Financial Officer.

Glynn founded Edward Thomas Associates,

a firm that provides public and private companies with accounting and finance services, including chief financial officer services.

Glynn has been a Managing Director of Edward Thomas Associates since 2012.

Glynn has a proven record

of success managing the financial aspects of dynamic organizations either as a member of the management team or in a consulting

He started his career as an auditor with Deloitte and went on to be the CFO and Controller of several technology, manufacturing,

and distribution companies.

Glynn earned his BS and MS degrees in Accounting from California State University Northridge.

Glynn has a proven record of success managing the financial

aspects of dynamic organizations either as a member of the management team or in a consulting capacity.

He started his career as an auditor

with Deloitte and went on to be the CFO and Controller of several technology, manufacturing, and distribution companies.

his BS and MS degrees in Accounting from California State University Northridge.

He is a member of the American Institute of CPAs.

Relationships

are no arrangements between our directors and any other person pursuant to which our directors were nominated or elected for their

are no arrangements between our directors and any other person pursuant to which our directors were nominated or elected for their positions.

There are no family relationships between any of our directors or executive officers.

4 unchanged sentences

are also required to furnish us with copies of all Section 16(a) forms that they file.

Based upon a review of these filings, we

believe that all required Section 16(a) reports were made on a timely basis during fiscal year 2020 other than as follows:

Jenusaitis filed late a Form 4 reporting the grant pursuant to Rule 16b-3(d) of (i) an option to purchase 4,000 shares

of common stock granted in July 2020 which fully vested during 2020 with an exercise price of $10.00 per share and (ii)

$40,000 of restricted stock granted in July 2020 which fully vested during 2020.

Based upon a review of these filings, we believe

that all required Section 16(a) reports were made on a timely basis during fiscal year 2021.

business and affairs are organized under the direction of our board of directors, which currently consists of five members.

directors hold office until the earlier of their death, incapacity, removal or resignation, or until their successors have been

elected and qualified.

Our board of directors does not have a formal policy on whether the roles of a Chief Executive Officer

and Chairman of our board of directors should be separate.

The primary responsibilities of our board of directors are to provide

oversight, strategic guidance, counseling and direction to our management.

Our directors

hold office until the earlier of their death, incapacity, removal or resignation, or until their successors have been elected and qualified.

Our board of directors does not have a formal policy on whether the roles of a Chief Executive Officer and Chairman of our board of directors

should be separate.

The primary responsibilities of our board of directors are to provide oversight, strategic guidance, counseling and

direction to our management.

Our board of directors meets on a regular basis.

bylaws provide that the authorized number of directors may be changed only by resolution of the board of directors.

Our bylaws provide that the authorized number of directors

may be changed only by resolution of the board of directors.

have no formal policy regarding board diversity.

Our priority in selection of board members is identification of members who will

further the interests of our stockholders through his or her established record of professional accomplishment, the ability to

contribute positively to the collaborative culture among board members, knowledge of our business and understanding of the competitive

amended and restated certificate of incorporation divides our board of directors into three classes, with staggered three-year

terms, as follows:

Our priority in selection of board members is identification of members who will further

the interests of our stockholders through his or her established record of professional accomplishment, the ability to contribute positively

to the collaborative culture among board members, knowledge of our business and understanding of the competitive landscape.

amended and restated certificate of incorporation divides our board of directors into three classes, with staggered three-year terms,

I Directors (serving until the 2024 Annual Meeting of Stockholders, or until their earlier death, disability, resignation or removal):

1 unchanged sentence

Sanjay Shrivastava*

II Directors (serving until the 2022 Annual Meeting of Stockholders, or until their earlier death, disability, resignation or

II Directors (serving until the 2022 Annual Meeting of Stockholders, or until their earlier death, disability, resignation or removal) :

Jenusaitis*, Robert A.

III Director (serving until the 2023 Annual Meeting of Stockholders, or until his earlier death, disability, resignation

or removal) :

III Director (serving until the 2023 Annual Meeting of Stockholders, or until his earlier death, disability, resignation or removal) :

Independent Director.

each annual meeting of stockholders to be held after the initial classification, the successors to directors whose terms then

expire will serve until the third annual meeting following their election and until their successors are duly elected and qualified.

The authorized size of our board of directors is currently five members.

The authorized number of directors may be changed only

by resolution of the board of directors.

Any additional directorships resulting from an increase in the number of directors will

be distributed between the three classes so that, as nearly as possible, each class will consist of one-third of the directors.

This classification of the board of directors may have the effect of delaying or preventing changes in our control or management.

Our directors may be removed for cause by the affirmative vote of the holders of at least 66 2/3% of our voting stock.

Nasdaq Marketplace Rules require a majority of a listed company’s board of directors to be comprised of independent directors

within one year of listing.

In addition, the Nasdaq Marketplace Rules require that, subject to specified exceptions, each member

of a listed company’s audit, compensation and nominating and corporate governance committees be independent and that audit

committee members also satisfy independence criteria set forth in Rule 10A-3 under the Exchange Act.

Rule 5605(a)(2) of the Nasdaq Marketplace Rules, a director will only qualify as an “independent director”

the opinion of our board of directors, that person does not have a relationship that would interfere with the exercise of independent

judgment in carrying out the responsibilities of a director.

In order to be considered independent for purposes of Rule 10A-3

of the Exchange Act, a member of an audit committee of a listed company may not, other than in his or her capacity as a member

of the audit committee, the board of directors, or any other board committee, accept, directly or indirectly, any consulting,

advisory, or other compensatory fee from the listed company or any of its subsidiaries or otherwise be an affiliated person of

the listed company or any of its subsidiaries.

each annual meeting of stockholders to be held after the initial classification, the successors to directors whose terms then expire

will serve until the third annual meeting following their election and until their successors are duly elected and qualified.

The authorized

size of our board of directors is currently five members.

The authorized number of directors may be changed only by resolution of the

board of directors.

Any additional directorships resulting from an increase in the number of directors will be distributed between the

three classes so that, as nearly as possible, each class will consist of one-third of the directors.

This classification of the board

of directors may have the effect of delaying or preventing changes in our control or management.

Our directors may be removed for cause

by the affirmative vote of the holders of at least 66 2/3% of our voting stock.

Nasdaq Marketplace Rules require a majority of a listed company’s board of directors to be comprised of independent directors within

one year of listing.

In addition, the Nasdaq Marketplace Rules require that, subject to specified exceptions, each member of a listed

company’s audit, compensation and nominating and corporate governance committees be independent and that audit committee members

also satisfy independence criteria set forth in Rule 10A-3 under the Exchange Act.

Rule 5605(a)(2) of the Nasdaq Marketplace Rules, a director will only qualify as an “independent director” if, in the opinion

of our board of directors, that person does not have a relationship that would interfere with the exercise of independent judgment in

carrying out the responsibilities of a director.

In order to be considered independent for purposes of Rule 10A-3 of the Exchange Act,

a member of an audit committee of a listed company may not, other than in his or her capacity as a member of the audit committee, the

board of directors, or any other board committee, accept, directly or indirectly, any consulting, advisory, or other compensatory fee

from the listed company or any of its subsidiaries or otherwise be an affiliated person of the listed company or any of its subsidiaries.

board of directors has reviewed the composition of our board of directors and its committees and the independence of each director.

Based upon information requested from and provided by each director concerning his background, employment and affiliations, including

family relationships, our board of directors has determined that each of Dr.

upon information requested from and provided by each director concerning his background, employment and affiliations, including family

relationships, our board of directors has determined that each of Dr.

Jenusaitis and Dr.

is an “independent director”

as defined under Rule 5605(a)(2) of the Nasdaq Marketplace Rules.

Our board of directors

also determined that Mr.

Shrivastava is an “independent

director” as defined under Rule 5605(a)(2) of the Nasdaq Marketplace Rules.

Our board of directors also determined that Mr.

Jenusaitis and Dr.

Shrivastava will serve on our audit committee, Mr.

Shrivastava will serve on our compensation committee, and Dr.

Jenusaitis and Dr.

Shrivastava will serve on

our nominating and corporate governance committee, and that each of the committees satisfy the independence standards for such

committees established by the SEC and the Nasdaq Marketplace Rules, as applicable.

In making such determinations, our board of

directors considered the relationships that each such non-employee director has with our company and all other facts and circumstances

our board of directors deemed relevant in determining independence, including the beneficial ownership of our capital stock by

each non-employee director.

Shrivastava will serve on our

compensation committee, and Dr.

Jenusaitis and Dr.

Shrivastava will serve on our nominating and corporate governance committee,

and that each of the committees satisfy the independence standards for such committees established by the SEC and the Nasdaq Marketplace

Rules, as applicable.

In making such determinations, our board of directors considered the relationships that each such non-employee

director has with our company and all other facts and circumstances our board of directors deemed relevant in determining independence,

including the beneficial ownership of our capital stock by each non-employee director.

of the Board and Stockholders

board of directors met in person and telephonically five times during 2020 and also acted by unanimous written consent.

were four Audit Committee meetings, one Compensation meeting and one Nominating and Corporate Governance meeting held in 2020.

Our board of directors had 100% attendance for the Annual Meeting that was held on December 17, 2020.

It is our policy that all

directors must attend all stockholder meetings, barring extenuating circumstances.

board of directors has established three standing committees—audit, compensation, and nominating and corporate governance—each

board of directors met in person and telephonically seven times during 2021 and also acted by unanimous written consent.

There were four

Audit Committee meetings, two Compensation meetings and one Nominating and Corporate Governance meeting held in 2021.

Our board of directors

had 100% attendance for the Annual Meeting that was held on November 30, 2021.

It is our policy that all directors must attend all stockholder

meetings, barring extenuating circumstances.

board of directors has established three standing committees—audit, compensation, and nominating and corporate governance—each

of which operates under a charter that has been approved by our board of directors.

Copies of each committee’s charter are

posted on the Investors section of our website, which is located at www.hancockjaffe.com.

Each committee has the composition and

responsibilities described below.

Copies of each committee’s charter are posted

on the Investors section of our website, which is located at www.envvenojaffe.com.

Each committee has the composition and responsibilities

described below.

Our board of directors may from time to time establish other committees.

2 unchanged sentences

Jenusaitis and Dr.

directors has determined that each of the members of our audit committee satisfies the Nasdaq Marketplace Rules and SEC independence

requirements.

Our board of directors

has determined that each of the members of our audit committee satisfies the Nasdaq Marketplace Rules and SEC independence requirements.

The functions of this committee include, among other things:

the performance, independence and qualifications of our independent auditors and determining whether to retain our existing

independent auditors or engage new independent auditors;

the performance, independence and qualifications of our independent auditors and determining whether to retain our existing independent

auditors or engage new independent auditors;

and approving the engagement of our independent auditors to perform audit services and any permissible non-audit services;

our annual and quarterly financial statements and reports, including the disclosures contained under the caption “Management’s

Discussion and Analysis of Financial Condition and Results of Operations,”

and discussing the statements and reports

with our independent auditors and management;

our annual and quarterly financial statements and reports, including the disclosures contained under the caption “Management’s

Discussion and Analysis of Financial Condition and Results of Operations,” and discussing the statements and reports with our

independent auditors and management;

with our independent auditors and management significant issues that arise regarding accounting principles and financial statement

presentation and matters concerning the scope, adequacy and effectiveness of our financial controls;

our major financial risk exposures, including the guidelines and policies to govern the process by which risk assessment and

risk management is implemented;

and evaluating on an annual basis the performance of the audit committee, including compliance of the audit committee with

our major financial risk exposures, including the guidelines and policies to govern the process by which risk assessment and risk

management is implemented;

and evaluating on an annual basis the performance of the audit committee, including compliance of the audit committee with its charter.

board of directors has determined that Mr.

Gray qualifies as an “audit committee financial expert”

within the meaning

of applicable SEC regulations and meets the financial sophistication requirements of the Nasdaq Marketplace Rules.

Gray qualifies as an “audit committee financial expert” within the meaning of

applicable SEC regulations and meets the financial sophistication requirements of the Nasdaq Marketplace Rules.

Both our independent

2 unchanged sentences

Shrivastava, who is the chair of the committee, Mr.

of directors has determined that each of the members of our compensation committee is an outside director, as defined pursuant

to Section 162(m) of the Internal Revenue Code of 1986, as amended, or the Code, and satisfies the Nasdaq Marketplace Rules independence

requirements.

The functions of this committee include, among other things:

modifying and approving (or if it deems appropriate, making recommendations to the full board of directors regarding) our

overall compensation strategy and policies;

Our board of directors

has determined that each of the members of our compensation committee is an outside director, as defined pursuant to Section 162(m) of

the Internal Revenue Code of 1986, as amended, or the Code, and satisfies the Nasdaq Marketplace Rules independence requirements.

functions of this committee include, among other things:

modifying and approving (or if it deems appropriate, making recommendations to the full board of directors regarding) our overall

compensation strategy and policies;

and approving the compensation, the performance goals and objectives relevant to the compensation, and other terms of employment

1 unchanged sentence

and approving (or if it deems appropriate, making recommendations to the full board of directors regarding) the equity incentive

plans, compensation plans and similar programs advisable for us, as well as modifying, amending or terminating existing plans

and programs;

and approving the terms of any employment agreements, severance arrangements, change in control protections and any other

compensatory arrangements for our executive officers;

with management and approving our disclosures under the caption “Compensation Discussion and Analysis”

periodic reports or proxy statements to be filed with the SEC;

plans, compensation plans and similar programs advisable for us, as well as modifying, amending or terminating existing plans and

and approving the terms of any employment agreements, severance arrangements, change in control protections and any other compensatory

arrangements for our executive officers;

with management and approving our disclosures under the caption “Compensation Discussion and Analysis” in our periodic

reports or proxy statements to be filed with the SEC;

the report that the SEC requires in our annual proxy statement.

3 unchanged sentences

Jenusaitis and Dr.

Our board of directors has determined that each of the members of this committee satisfies the Nasdaq Marketplace

Rules independence requirements.

Our board of directors has determined that each of the members of this committee satisfies the Nasdaq Marketplace Rules independence

requirements.

The functions of this committee include, among other things:

reviewing and evaluating candidates to serve on our board of directors consistent with criteria approved by our board of directors;

director performance on our board of directors and applicable committees of our board of directors and determining whether

continued service on our board of directors is appropriate;

director performance on our board of directors and applicable committees of our board of directors and determining whether continued

service on our board of directors is appropriate;

nominating and recommending individuals for membership on our board of directors;

nominations by stockholders of candidates for election to our board of directors.

board of directors has adopted a written code of conduct that applies to our directors, officers and employees, including our

principal executive officer, principal financial officer, principal accounting officer or controller, or persons performing similar

We have posted on our website a current copy of the code and all disclosures that are required by law or Nasdaq Marketplace

Rules concerning any amendments to, or waivers from, any provision of the code.

board of directors has adopted a written code of conduct that applies to our directors, officers and employees, including our principal

executive officer, principal financial officer, principal accounting officer or controller, or persons performing similar functions.

We have posted on our website a current copy of the code and all disclosures that are required by law or Nasdaq Marketplace Rules concerning

any amendments to, or waivers from, any provision of the code.

Leadership Structure

board of directors is free to select the Chairman of the board of directors and a Chief Executive Officer in a manner that it

considers to be in the best interests of our company at the time of selection.

Our board of directors is free

to select the Chairman of the board of directors and a Chief Executive Officer in a manner that it considers to be in the best interests

of our company at the time of selection.

Currently, Robert A.

Berman serves as our Chief

Executive Officer.

The office of the Chairman of the board of directors remains vacant since the voluntary resignation of Mr.

Yury Zhivilo in May 2019.

We currently believe that this leadership structure is in our best interests and strikes an appropriate

balance between our Chief Executive Officer’s responsibility for the day-to-day management of our company and the Chairman

of the board of directors’

responsibility to provide oversight, including setting the board of directors’

agendas and presiding at executive sessions of the independent directors.

Berman serves as our Chief Executive Officer.

The office of the Chairman

of the board of directors has been vacant since May 2019.

We currently believe that this leadership structure is in our best interests

and strikes an appropriate balance between our Chief Executive Officer’s responsibility for the day-to-day management of our company

and the Chairman of the board of directors’ responsibility to provide oversight, including setting the board of directors’

meeting agendas and presiding at executive sessions of the independent directors.

Additionally, four of our five members of our board

of directors have been deemed to be “independent”

by the board of directors, which we believe provides sufficient

independent oversight of our management.

of directors have been deemed to be “independent” by the board of directors, which we believe provides sufficient independent

oversight of our management.

Our board of directors has not designated a lead independent director.

board of directors, as a whole and also at the committee level, plays an active role overseeing the overall management of our

Our Audit Committee reviews risks related to financial and operational items with our management and our independent registered

public accounting firm.

Our board of directors is in regular contact with our Chief Executive Officer, who reports directly to

our board of directors and who supervises day-to-day risk management.

board of directors, as a whole and also at the committee level, plays an active role overseeing the overall management of our risks.

Our Audit Committee reviews risks related to financial and operational items with our management and our independent registered public

accounting firm.

Our board of directors is in regular contact with our Chief Executive Officer, who reports directly to our board of

directors and who supervises day-to-day risk management.

of Board in Risk Oversight Process

board of directors believes that risk management is an important part of establishing, updating and executing on our business

Our board of directors has oversight responsibility relating to risks that could affect the corporate strategy, business

objectives, compliance, operations, and the financial condition and performance of our company.

Our board of directors focuses

its oversight on the most significant risks facing us and on our processes to identify, prioritize, assess, manage and mitigate

Our board of directors receives regular reports from members of our senior management on areas of material risk to

us, including strategic, operational, financial, legal and regulatory risks.

While our board of directors has an oversight role,

management is principally tasked with direct responsibility for management and assessment of risks and the implementation of processes

and controls to mitigate their effects on us.

board of directors believes that risk management is an important part of establishing, updating and executing on our business strategy.

Our board of directors has oversight responsibility relating to risks that could affect the corporate strategy, business objectives,

compliance, operations, and the financial condition and performance of our company.

Our board of directors focuses its oversight on the

most significant risks facing us and on our processes to identify, prioritize, assess, manage and mitigate those risks.

directors receives regular reports from members of our senior management on areas of material risk to us, including strategic, operational,

financial, legal and regulatory risks.

While our board of directors has an oversight role, management is principally tasked with direct

responsibility for management and assessment of risks and the implementation of processes and controls to mitigate their effects on us.

Legal Proceedings

of the Company’s directors or executive officers have been involved, in the past ten years and in a manner material to an

evaluation of such director’s or officer’s ability or integrity to serve as a director or executive officer, in any

of those “Certain Legal Proceedings”

more fully detailed in Item 401(f) of Regulation S-K, which include but are not

limited to, bankruptcies, criminal convictions and an adjudication finding that an individual violated federal or state securities

of the Company’s directors or executive officers have been involved, in the past ten years and in a manner material to an evaluation

of such director’s or officer’s ability or integrity to serve as a director or executive officer, in any of those “Certain

Legal Proceedings” more fully detailed in Item 401(f) of Regulation S-K, which include but are not limited to, bankruptcies, criminal

convictions and an adjudication finding that an individual violated federal or state securities laws.

following table sets forth total compensation paid to our named executive officers for the years ended December 31, 2021 and 2020.

Individuals we refer to as our “named executive officers”

include our current Chief Executive Officer, our current

and previous Chief Financial Officer and our other most highly compensated executive officer whose salary and bonus for services

rendered in all capacities exceeded $100,000 during the fiscal year ended December 31, 2020.

Principal Position

Incentive Plan Compensation ($)

we refer to as our “named executive officers” include our current Chief Executive Officer, our current and previous Chief

Financial Officer and our other most highly compensated executive officer whose salary and bonus for services rendered in all capacities

exceeded $100,000 during the fiscal year ended December 31, 2021.

Equity Incentive Plan Compensation ($)

Deferred Compensation Earnings ($)

Other Compensation ($)

Executive Officer

Chief Financial Officer, Secretary and Treasurer

7,674,046 (3)

1,340,000 (9)

Chief Executive Officer

2,960,418 (5)

Chief Financial Officer

Glickman, M.D.

Medical Officer and Senior Vice President

Rankin’s annual base salary rate under his employment agreement was $250,000.

Rankin resigned as the Company’s

Chief Financial Officer, Secretary and Treasurer on March 30, 2020.

Amounts in this column for Mr.

Rankin reflect his base

salary earned for 2020.

4,247,442 (7)

Chief Medical Officer and Senior Vice President

Glynn served as our Chief Financial Officer on an interim basis during 2020.

Amounts in this column for Mr.

Glynn include

the amounts paid to him in that capacity during 2020.

Glynn include the amounts

paid to him in that capacity during 2020.

In January 2021, the board of directors elevated Mr.

Glynn to permanent

Chief Financial Officer.

Glynn to permanent Chief Financial

The company entered into an employment agreement with Mr.

1 unchanged sentence

July 26, 2019, Dr.

Glickman’s annual base salary rate under his employment agreement dated July 26, 2019, which superseded

his prior employment agreement, was $350,000.

1 unchanged sentence

Glickman reflect his base salary earned for 2019.

the grant date fair value of 40,000 stock options granted on July 18, 2020, computed in accordance with FASB ASC Topic 718.

The options vest monthly over a three-year period.

Also included is the fair value of his existing 43,209 options that were

repriced from $124.75 per share to $10.00 per share.

the grant date fair value of 838,000 stock options granted on February 18, 2021, and 349,781 stock options granted on November 30,

2021, computed in accordance with FASB ASC Topic 718.

The February options vest quarterly over a two-year period and the November

options vest quarterly over a three-year period.

the grant date fair value of 40,000 stock options granted on July 18, 2020, computed in accordance with FASB ASC Topic 718.

vest monthly over a three-year period.

Also included is the fair value of his existing 43,209 options that were repriced from $124.75

per share to $10.00 per share.

the grant date fair value of 324,000 stock options granted on February 18, 2021 and 125,925 stock options granted on November 30,

2021, computed in accordance with FASB ASC Topic 718.

The options vest quarterly over a three-year period.

the grant date fair value of 4,000 stock options granted on July 18, 2020, computed in accordance with FASB ASC Topic 718.

The options vest monthly over a three-year period.

vest quarterly over a three-year period.

the grant date fair value of 406,000 stock options granted on February 18, 2021 and 265,700 stock options granted on November 30,

2021, computed in accordance with FASB ASC Topic 718.

The February options vest quarterly over a two-year period and the November

options vest quarterly over a three-year period.

the grant date fair value of 40,000 stock options granted on July 18, 2020, computed in accordance with FASB ASC Topic 718.

The options vest quarterly over a three year period.

Also included is the fair value of his existing 7,380 options that were

repriced from $250.00 per share to $50.00 per share in connection with entering the July 26, 2019 employment agreement.

company paid healthcare of $1,404 and 401(k) match of $14,404.

company paid healthcare of $1,285 and 401(k) match of $14,000.

vest monthly over a three-year period.

the grant date fair value of 200,000 shares of restricted stock units granted on November 30, 2021, computed based on the

closing price of the Company’s stock on the grant date.

the grant date fair value of 50,000 shares of restricted stock units granted on November 30, 2021, computed based on the closing

price of the Company’s stock on the grant date.

the grant date fair value of 100,000 shares of restricted stock units granted on November 30, 2021, computed based on the

closing price of the Company’s stock on the grant date.

company paid healthcare of $1,155 and 401(k) match of $14,500.

company paid healthcare of $1,404 and 401(k) match of $14,404.

company paid healthcare of $651.

company paid healthcare of $42,447 and 401(k) match of $14,500.

1 unchanged sentence

have entered into various employment agreements with certain of our executive officers.

Set forth below is a summary of many of

the material provisions of such agreements, which summaries do not purport to contain all of the material terms and conditions

of each such agreement.

Set forth below is a summary of many of the material

provisions of such agreements, which summaries do not purport to contain all of the material terms and conditions of each such agreement.

For purposes of the following employment agreements:

“Cause”

generally means the executive’s (i) willful misconduct or gross negligence in the performance of his or her duties to

(ii) willful failure to perform his or her duties to us or to follow the lawful directives of the Chief Executive Officer

(other than as a result of death or disability);

(iii) indictment for, conviction of or pleading of guilty or nolo contendere

to, a felony or any crime involving moral turpitude:

(iv) repeated failure to cooperate in any audit or investigation of our

business or financial practices;

(v) performance of any material act of theft, embezzlement, fraud, malfeasance, dishonesty

or misappropriation of our property;

or (vi) material breach of his or her employment agreement or any other material agreement

with us or a material violation of our code of conduct or other written policy.

reason”

generally means, subject to certain notice requirements and cure rights, without the executive’s consent,

(i) material diminution in his or her base salary or annual bonus opportunity;

(ii) material diminution in his or her authority

or duties (although a change in title will not constitute “good reason”), other than temporarily while physically

or mentally incapacitated, as required by applicable law;

(iii) relocation of his or her primary work location by more than

25 miles from its then current location;

generally means the executive’s (i) willful misconduct or gross negligence in the performance of his or her duties to us;

willful failure to perform his or her duties to us or to follow the lawful directives of the Chief Executive Officer (other than

as a result of death or disability);

(iii) indictment for, conviction of or pleading of guilty or nolo contendere to, a felony or

any crime involving moral turpitude:

(iv) repeated failure to cooperate in any audit or investigation of our business or financial

(v) performance of any material act of theft, embezzlement, fraud, malfeasance, dishonesty or misappropriation of our

or (vi) material breach of his or her employment agreement or any other material agreement with us or a material violation

of our code of conduct or other written policy.

reason” generally means, subject to certain notice requirements and cure rights, without the executive’s consent, (i)

material diminution in his or her base salary or annual bonus opportunity;

(ii) material diminution in his or her authority or duties

(although a change in title will not constitute “good reason”), other than temporarily while physically or mentally incapacitated,

as required by applicable law;

(iii) relocation of his or her primary work location by more than 25 miles from its then current location;

or (iv) a material breach by us of a material term of the employment agreement.

“Change

of control”

generally means (i) the acquisition, other than from us, by any individual, entity or group (within the

meaning of Section 13(d)(3) or Section 14(d)(2) of the Exchange Act), other than us or any subsidiary, affiliate (within the

meaning of Rule 144 promulgated under the Securities Act) or employee benefit plan of ours, of beneficial ownership (within

the meaning of Rule 13d-3 promulgated under the Exchange Act) of more than 50% of the combined voting power of our then outstanding

voting securities entitled to vote generally in the election of directors;

(ii) a reorganization, merger, consolidation or

recapitalization of us, other than a transaction in which more than 50% of the combined voting power of the outstanding voting

securities of the surviving or resulting entity immediately following such transaction is held by the persons who, immediately

prior to the transaction, were the holders of our voting securities;

or (iii) a complete liquidation or dissolution of us,

or a sale of all or substantially all of our assets.

of control” generally means (i) the acquisition, other than from us, by any individual, entity or group (within the meaning

of Section 13(d)(3) or Section 14(d)(2) of the Exchange Act), other than us or any subsidiary, affiliate (within the meaning of Rule

144 promulgated under the Securities Act) or employee benefit plan of ours, of beneficial ownership (within the meaning of Rule 13d-3

promulgated under the Exchange Act) of more than 50% of the combined voting power of our then outstanding voting securities entitled

to vote generally in the election of directors;

(ii) a reorganization, merger, consolidation or recapitalization of us, other than

a transaction in which more than 50% of the combined voting power of the outstanding voting securities of the surviving or resulting

entity immediately following such transaction is held by the persons who, immediately prior to the transaction, were the holders

of our voting securities;

or (iii) a complete liquidation or dissolution of us, or a sale of all or substantially all of our assets.

March 30, 2018, we entered into an employment agreement with Robert A.

Berman, our current Chief Executive Officer and director.

Pursuant to the terms of his employment agreement, Mr.

Berman’s base salary is $400,000, subject to annual review and adjustment

at the discretion of our compensation committee, and he will be eligible for an annual year-end discretionary bonus of up to 50%

of his base salary, subject to the achievement of key performance indicators, as determined by our compensation committee.

initial term of Mr.

Berman’s employment agreement may be terminated at anytime with or without cause and with or without

notice or for good reason thereunder.

to the terms of his employment agreement, Mr.

Berman’s base salary is $400,000, subject to annual review and adjustment at the

discretion of our compensation committee, and he will be eligible for an annual year-end discretionary bonus of up to 50% of his base

salary, subject to the achievement of key performance indicators, as determined by our compensation committee.

The initial term of Mr.

Berman’s employment agreement may be terminated at anytime with or without cause and with or without notice or for good reason

In connection with his employment, Mr.

Berman received an initial equity grant of an option

to purchase 43,209 options with 8,642 vesting on the date of his Employment Agreement, March 30, 2018, and the remaining 80% vesting

ratably on a monthly basis over the following 24 months.

In February 2021, the board of directors approved an option grant to

Berman to purchase 838,000 shares of common stock at an exercise price of $8.20 per shares (the closing price of the Company’s

common stock on February 18, 2021).

The stock option vests in equal quarterly installments over a two year period, however the

stock options may only become exercisable following receipt by the Company of stockholder approval to increase the size of the

2016 Plan sufficiently to permit the exercise in full of such stock options under the 2016 Plan (if the Company’s stockholders

do not approve an increase in the size of the 2016 Plan, the options will be void).

Additionally, the board of directors paid

Berman a cash bonus of $200,000.

Berman is entitled to participate in our employee benefit, pension and/or profit sharing plans, and we will pay certain health

and dental premiums on his behalf.

Berman’s employment agreement prohibits him from inducing, soliciting or entertaining

any of our employees to leave our employ during the term of the agreement and for 12 months thereafter.

Berman received an initial equity grant of an option to purchase 43,209 options with

8,642 vesting on the date of his Employment Agreement, March 30, 2018, and the remaining 80% vesting ratably on a monthly basis over

the following 24 months.

In February 2021, the board of directors approved an option grant to Mr.

Berman to purchase 838,000 shares of

common stock at an exercise price of $8.20 per shares (the closing price of the Company’s common stock on February 18, 2021).

stock option vests in equal quarterly installments over a two year period.

Additionally, the board of directors paid Mr.

Berman a cash

bonus of $250,000 for 2021 and $200,000 for 2020.

Berman is entitled to participate in our employee benefit, pension and/or profit sharing plans, and we will pay certain health and dental

premiums on his behalf.

Berman’s employment agreement prohibits him from inducing, soliciting or entertaining any of our employees

to leave our employ during the term of the agreement and for 12 months thereafter.

to the terms of his employment agreement, Mr.

Berman is entitled to severance in the event of certain terminations of employment.

In the event Mr.

Berman’s employment is terminated by us without cause and other than by reason of disability or he resigns

for good reason, subject to his timely executing a release of claims in our favor and in addition to certain other accrued benefits,

he is entitled to receive 6 month of base salary if termination occurred prior to the second anniversary of his employment or

12 months of continued base salary on and after the second anniversary of his employment (or 24 months if such termination occurs

within 24 months following a change of control).

July 16, 2018, the Company entered into an employment agreement with Mr.

Rankin which provides for an annual base salary of $250,000

as well as standard employee insurance and other benefits.

Pursuant to this agreement, Mr.

Rankin is eligible for annual salary

increases at the discretion of our board of directors as well as an annual year-end discretionary bonus of up to 30% of his base

salary, subject to the achievement of key performance indicators, as determined by the board and the Chief Executive Officer of

the Company in their sole discretion.

In connection with his employment, Mr.

Rankin received an initial equity grant of an option

to purchase 6,000 options with 2,000 options vesting on July 16, 2019 and the remaining 4,000 vesting on a quarterly basis over

the following two-year period.

Rankin’s options were forfeit as a result of his resignation.

Rankin’s employment agreement provides for severance payments in the event of termination without Cause or he resigns for

Good Reason (as defined in the agreement), equal to three months of base salary for each year that he has been employed by the

Company at the time of termination, up to a total of one year of his base salary, provided, that if such termination results from

a Change of Control (as defined in the agreement), Mr.

Rankin’s severance will not be less than six months of his base salary

Rankin’s employment with the Company is “at-will”

and may be terminated at any time, with or without cause and

with or without notice by either Mr.

Rankin or the Company.

March 30, 2020, Mr.

Rankin resigned from the Company.

the event Mr.

Berman’s employment is terminated by us without cause and other than by reason of disability or he resigns for good

reason, subject to his timely executing a release of claims in our favor and in addition to certain other accrued benefits, he is entitled

to receive 6 month of base salary if termination occurred prior to the second anniversary of his employment or 12 months of continued

base salary on and after the second anniversary of his employment (or 24 months if such termination occurs within 24 months following

a change of control).

February 19, 2021, the Company entered into an employment agreement with Mr.

Glynn, in connection with Mr.

Glynn’s elevation

to full time Chief Financial Officer in addition to treasurer and secretary of the Company.

Pursuant to the employment agreement,

Glynn will earn $225,000 per year.

Glynn’s elevation to

full time Chief Financial Officer in addition to treasurer and secretary of the Company.

Pursuant to the employment agreement, Mr.

will earn $225,000 per year.

In addition, Mr.

Glynn will receive stock options to purchase 324,000 shares of common

stock of the Company at an exercise price of $8.20 per shares (the closing price of the Company’s common stock on February

The stock options vest in equal quarterly installments over a three year period with a six month cliff, however the

stock options may only become exercisable following receipt by the Company of stockholder approval to increase the size of the

2016 Plan, sufficiently to permit the exercise in full of such stock options under the Plan (if the Company’s stockholders

do not approve an increase in the size of the 2016 Plan, the options will be void).

The employment agreement further provides

Glynn will receive stock options to purchase 324,000 shares of common stock of the Company

at an exercise price of $8.20 per shares (the closing price of the Company’s common stock on February 18, 2021).

The stock options

vest in equal quarterly installments over a three year period with a six month cliff.

The employment agreement further provides that

Glynn is entitled to participate in any employee benefit plans that the Company has adopted or may adopt.

to the terms of the employment agreement, Mr.

Glynn’s employment agreement is terminable due to Mr.

Glynn’s disability

or death, for “Cause”

(as defined in the employment agreement) or without “Cause”

by the Company, and

for “Good Reason”

(as defined in the employment agreement) or voluntarily by Mr.

Glynn’s employment agreement is terminable due to Mr.

Glynn’s disability or

death, for “Cause” (as defined in the employment agreement) or without “Cause” by the Company, and for “Good

Reason” (as defined in the employment agreement) or voluntarily by Mr.

In the event of Mr.

Glynn’s

death or disability, or termination for “Cause”

by the Company or without “Good Reason”

Glynn (or his estate) is entitled to receive any unpaid base salary through the termination date, reimbursement for unreimbursed

business expenses, accrued but unused vacation time in accordance with the Company’s policy and any other payments or benefits

Glynn as entitled to in accordance with any Company benefit plans (collectively, the “Accrued Benefits”).

Upon termination without “Cause”

(other than by reason of death or disability) or resignation for “Good Reason,”

Glynn will be entitled to three months of severance for each year Mr.

Glynn is employed up to one year of severance, in addition

to all Accrued Benefits.

Any outstanding unvested securities owned by Mr.

Glynn on the termination date will vest (or terminate)

in accordance with the terms of such grant.

to his full time role as Chief Financial Officer, on April 6, 2020 he was appointed as Interim Chief Financial Officer and Interim

Glynn’s death or disability,

or termination for “Cause” by the Company or without “Good Reason” by Mr.

Glynn (or his estate) is

entitled to receive any unpaid base salary through the termination date, reimbursement for unreimbursed business expenses, accrued but

unused vacation time in accordance with the Company’s policy and any other payments or benefits that Mr.

Glynn as entitled to in

accordance with any Company benefit plans (collectively, the “Accrued Benefits”).

Upon termination without “Cause”

(other than by reason of death or disability) or resignation for “Good Reason,” Mr.

Glynn will be entitled to three months

of severance for each year Mr.

Glynn is employed up to one year of severance, in addition to all Accrued Benefits.

Any outstanding unvested

securities owned by Mr.

Glynn on the termination date will vest (or terminate) in accordance with the terms of such grant.

to his full time role as Chief Financial Officer, on April 6, 2020 he was appointed as Interim Chief Financial Officer and Interim Treasurer.

For his services as Interim Chief Financial Officer and Interim Treasurer, Mr.

2 unchanged sentences

July 22, 2016, we entered into an employment agreement with Marc H.

Glickman, M.D., our Senior Vice President and Chief Medical

Officer (the “Pre-existing Employment Agreement”).

Pursuant to the terms of his Pre-existing Employment Agreement,

Glickman’s base salary is $300,000, subject to annual review and adjustment at the discretion of our board of directors,

and he will be eligible for an annual year-end discretionary bonus of up to 50% of his base salary, subject to the achievement

of key performance indicators, as determined by our board of directors.

In connection with his Pre-existing Employment Agreement,

Glickman received an initial equity grant of an option to purchase up to 7,380 shares of our common stock with 20% of the

shares vesting immediately and 80% vesting on a monthly basis over 24 months thereafter.

Glickman, M.D., our Senior Vice President and Chief Medical Officer

(the “Pre-existing Employment Agreement”).

Pursuant to the terms of his Pre-existing Employment Agreement, Dr.

base salary is $300,000, subject to annual review and adjustment at the discretion of our board of directors, and he will be eligible

for an annual year-end discretionary bonus of up to 50% of his base salary, subject to the achievement of key performance indicators,

as determined by our board of directors.

In connection with his Pre-existing Employment Agreement, Dr.

Glickman received an initial equity

grant of an option to purchase up to 7,380 shares of our common stock with 20% of the shares vesting immediately and 80% vesting on a

monthly basis over 24 months thereafter.

The initial term of Dr.

Glickman’s

Pre-existing Employment Agreement ended on December 31, 2018 and was automatically extended for additional three-year terms.

Glickman’s Pre-existing Employment Agreement ended on December

31, 2018 and was automatically extended for additional three-year terms.

July 26, 2019, we entered into an employment agreement with Dr.

Glickman (the “New Employment Agreement”) that supersedes

the terms of the Pre-existing Employment Agreement.

Pursuant to the terms of the New Employment Agreement, Dr.

Glickman’s

base salary is $350,000 per year, subject to annual review and adjustment at the discretion of the Board.

In connection with entering

into the New Employment Agreement, Dr.

Glickman’s existing seven thousand three hundred and eighty (7,380) options (“Existing

Options”) to purchase Company common stock at two hundred and fifty dollars ($250.00) per share until October 1, 2026, were

repriced to fifty dollars ($50.00) per share.

Glickman’s base

salary is $350,000 per year, subject to annual review and adjustment at the discretion of the Board.

In connection with entering into

the New Employment Agreement, Dr.

Glickman’s existing seven thousand three hundred and eighty (7,380) options (“Existing

Options”) to purchase Company common stock at two hundred and fifty dollars ($250.00) per share until October 1, 2026, were repriced

to fifty dollars ($50.00) per share.

Additionally, Dr.

Glickman, in connection to the New Employment Agreement, was granted

stock options for the right to purchase seven thousand two hundred (7,200) common stock at a price equal to two dollars ($50.00)

per share exercisable until July 26, 2029, which shall vest quarterly over a three (3) year period.

In February 2021, the board

of directors approved an option grant to Dr.

Glickman to purchase 406,000 shares of common stock at an exercise price of $8.20

per shares (the closing price of the Company’s common stock on February 18, 2021).

The stock option vests in equal quarterly

installments over a two year period, however the stock options may only become exercisable following receipt by the Company of

stockholder approval to increase the size of the 2016 Plan sufficiently to permit the exercise in full of such stock options under

the 2016 Plan (if the Company’s stockholders do not approve an increase in the size of the 2016 Plan, the options will be

Additionally, the board of directors paid Mr.

Glickman, in connection to the New Employment Agreement, was granted stock options

for the right to purchase seven thousand two hundred (7,200) common stock at a price equal to two dollars ($50.00) per share exercisable

until July 26, 2029, which shall vest quarterly over a three (3) year period.

In February 2021, the board of directors approved an option

Glickman to purchase 406,000 shares of common stock at an exercise price of $8.20 per shares (the closing price of the Company’s

common stock on February 18, 2021).

The stock option vests in equal quarterly installments over a two year period.

Additionally, the

board of directors paid Mr.

Berman a cash bonus of $50,000.

to the terms of the New Employment Agreement, Dr.

Glickman is an at-will employee and is entitled to severance in the event of

certain terminations of his employment.

Glickman is an at-will employee and is entitled to severance in the event of certain

terminations of his employment.

In the event that Dr.

Glickman’s employment is terminated by the Company without

Cause (as defined in the New Employment Agreement), other than by reason of Disability (as defined in the New Employment Agreement),

or he resigns for Good Reason (as defined in the New Employment Agreement), subject to his timely executing a release of claims

in favor of the Company and in addition to certain other accrued benefits, Dr.

Glickman is entitled to receive three months of

his base salary for each year that he has been employed by the Company at the time of termination, up to a total of one year of

his base salary.

Glickman’s employment is terminated by the Company without Cause (as defined

in the New Employment Agreement), other than by reason of Disability (as defined in the New Employment Agreement), or he resigns for

Good Reason (as defined in the New Employment Agreement), subject to his timely executing a release of claims in favor of the Company

and in addition to certain other accrued benefits, Dr.

Glickman is entitled to receive three months of his base salary for each year

that he has been employed by the Company at the time of termination, up to a total of one year of his base salary.

Payments Upon Termination or Change-in-Control

to the terms of the employment agreements discussed above, we will pay severance in the event of certain terminations of employment.

In the event employment is terminated by us without cause and other than by reason of disability or if the executive resigns for

good reason, subject to his or her timely executing a release of claims in our favor and in addition to certain other accrued

benefits, he or she is entitled to receive severance pursuant to the terms of his or her employment agreements discussed above.

In the event employment is terminated by us without cause and other than by reason of disability or if the executive resigns for good

reason, subject to his or her timely executing a release of claims in our favor and in addition to certain other accrued benefits, he

or she is entitled to receive severance pursuant to the terms of his or her employment agreements discussed above.

Equity Awards at Fiscal Year-End

following table sets forth information regarding equity awards held by our named executive officers as of December 31, 2021.

of securities underlying unexercised options (#) exercisable

of securities underlying unexercised options (#) unexercisable

incentive plan awards:

Number of securities underlying unexercised options (#) exercisable

Number of securities underlying unexercised options (#) unexercisable

Equity incentive plan awards:

Number of securities underlying unexercised unearned options (#)

exercise price ($)

Executive Officer

Option exercise price ($)

expiration date

September 23, 2028

Chief Executive Officer

July 18, 2030

February 18, 2031

November 30, 2031

Glickman, M.D.

Medical Officer and Senior Vice President

Glynn, Chief Financial Officer (5)

July 25, 2029

Chief Medical Officer and Senior Vice President

October 1, 2026

July 18, 2030

February 18, 2031

November 30, 2031

Craig Glynn, Chief Financial Officer (6)

July 18, 2030

February 18, 2031

November 30, 2031

were granted on September 24, 2018, and vested 20% on the date of his Employment Agreement, March 30, 2018, and the remaining 80%

1 unchanged sentence

were granted on July 18, 2020 and vest ratably on a monthly basis over 36 months.

were granted on February 18, 2021 and vest ratably on a quarterly basis over two years.

were granted on November 30, 2021 and vest ratably on a quarterly basis over three years.

July 26, 2019, the Company entered a new employment agreement with Dr.

Glickman that superseded the terms of his existing

employment agreement.

Glickman that superseded the terms of his existing employment

In connection with entering into the new employment agreement, Dr.

Glickman’s existing 7,380 options

that were granted on October 1, 2016 were repriced from $250.00 to $50.00 per share.

Glickman’s existing 7,380 options that were granted

on October 1, 2016 were repriced from $250.00 to $50.00 per share.

Additionally, on July 26, 2019, Dr.

was granted 7,200 options at $50.00 per share vesting quarterly over a three-year period.

were granted on July 18, 2020 and vest ratably on a quarterly basis over three years.

Glickman was granted 7,200

options at $50.00 per share vesting quarterly over a three-year period.

Glynn was elevated to permanent Chief Financial Officer in January 2021.

were granted on July 18, 2020 and vest ratably on a quarterly basis over three years.

were granted on February 18, 2021 and vest ratably on a quarterly basis over three years.

Number of unearned restricted stock units that

have not vested

value of unearned restricted stock units that have not vested (a)

Berman, Chief Executive Officer

Glickman, M.D., Chief Medical Officer and Senior Vice President

Craig Glynn, Chief Financial Officer

by multiplying the number of restricted stock units that have not vested by $6.59, the closing price of NVNO’s common stock on December 31,

November 30, 2021, Mr.

Berman was granted 200,000 restricted stock units, Dr.

Glickman was granted 100,000 restricted stock units,

Glynn was granted 50,000 restricted stock units.

The restricted stock units are subject to milestone-based vesting as follows:

(i) 50% upon SAVVE (Surgical Anti-reflux Venous Valve Endoprosthesis) endpoints being achieved, and (ii) 50% upon the Pre-Market

Approval of the VenoValve.

Benefit Plans

and Restated 2016 Omnibus Incentive Plan

October 1, 2016, our board of directors and our stockholders adopted and approved the Hancock Jaffe Laboratories, Inc.

Incentive Plan, and, subsequently, on April 26, 2018, our board of directors and our stockholders adopted and approved the Amended

and Restated 2016 Omnibus Incentive Plan which was subsequently amended by Amendment No.

1 to the Amended and Restated 2016 Omnibus

Incentive Plan following receipt of stockholder approval on December 17, 2020 (as amended, the “2016 Plan”).

The principal

features of the 2016 Plan are summarized below.

This summary is qualified in its entirety by reference to the text of the 2016

Plan, which is filed as an exhibit to the registration statement of which this prospectus is a part.

have reserved 600,000 shares of our common stock for issuance under the 2016 Plan, plus an annual increase on each January 1 st

by an amount equal to 3% of the total issued and outstanding shares of our common stock as of such date (or

such lesser number of shares as may be determined by our board of directors), all of which may be granted as incentive stock options

under Code Section 422.

The shares of common stock issuable under the 2016 Plan will consist of authorized and unissued shares,

treasury shares or shares purchased on the open market or otherwise, all as determined by our company from time to time.

any award is canceled, terminates, expires or lapses for any reason prior to the issuance of shares or if shares are issued under

the 2016 Plan and thereafter are forfeited to us, the shares subject to such awards and the forfeited shares will not count against

the aggregate number of shares of common stock available for grant under the 2016 Plan.

In addition, the following items will

not count against the aggregate number of shares of common stock available for grant under the 2016 Plan:

(1) shares issued under

the 2016 Plan repurchased or surrendered at no more than cost or pursuant to an option exchange program, (2) any award that is

settled in cash rather than by issuance of shares of common stock, (3) shares surrendered or tendered in payment of the option

price or purchase price of an award or any taxes required to be withheld in respect of an award or (4) awards granted in assumption

of or in substitution for awards previously granted by an acquired company.

October 1, 2016, our board of directors and our stockholders adopted and approved the enVVeno Medical Corporation 2016 Omnibus

Incentive Plan, and, subsequently, on April 26, 2018, our board of directors and our stockholders adopted and approved the Amended and

Restated 2016 Omnibus Incentive Plan which was subsequently amended by Amendment No.

1 to the Amended and Restated 2016 Omnibus Incentive

Plan following receipt of stockholder approval on December 17, 2020 and by Amendment No.

2 to the Amended and Restated 2016 Omnibus Incentive

Plan following receipt of stockholder approval on November 30, 2021 (as amended, the “2016 Plan”).

The principal features

of the 2016 Plan are summarized below.

This summary is qualified in its entirety by reference to the text of the 2016 Plan, which is

filed as an exhibit to the registration statement of which this prospectus is a part.

We currently have reserved 4,500,000

shares of our common stock for issuance under the 2016 Plan, provided, however, if at any time the Company issues additional shares

of Common Stock or securities that are convertible or exercisable into shares of Common Stock (other than pursuant to the Plan) then

the number of shares authorized to be awarded under the Plan shall increase to an amount equal to no less than 20% of the issued and

outstanding shares of common stock of the Company on a fully diluted basis.

Such increase, if any, shall occur automatically upon each

applicable issuance of securities by the Company.

All shares available for issuance under the Plan may be granted as incentive

stock options under Code Section 422.

The shares of common stock issuable under the 2016 Plan will consist of authorized and unissued

shares, treasury shares or shares purchased on the open market or otherwise, all as determined by our company from time to time.

any award is canceled, terminates, expires or lapses for any reason prior to the issuance of shares or if shares are issued under the

2016 Plan and thereafter are forfeited to us, the shares subject to such awards and the forfeited shares will not count against the aggregate

number of shares of common stock available for grant under the 2016 Plan.

In addition, the following items will not count against the

aggregate number of shares of common stock available for grant under the 2016 Plan:

(1) shares issued under the 2016 Plan repurchased

or surrendered at no more than cost or pursuant to an option exchange program, (2) any award that is settled in cash rather than by issuance

of shares of common stock, (3) shares surrendered or tendered in payment of the option price or purchase price of an award or any taxes

required to be withheld in respect of an award or (4) awards granted in assumption of or in substitution for awards previously granted

by an acquired company.

Administration

3 unchanged sentences

of such awards.

Our board of directors also has the authority, subject to the terms of the 2016 Plan, to amend existing options

(including to reduce the option’s exercise price), to institute an exchange program by which outstanding options may be

surrendered in exchange for options that may have different exercise prices and terms, restricted stock, and/or cash or other

Our board of directors also has the authority, subject to the terms of the 2016 Plan, to amend existing options (including

to reduce the option’s exercise price), to institute an exchange program by which outstanding options may be surrendered in exchange

for options that may have different exercise prices and terms, restricted stock, and/or cash or other property.

may be granted under the 2016 Plan to officers, employees, directors, consultants and advisors of us and our affiliates.

stock options may be granted only to employees of us or our subsidiaries.

Incentive stock

options may be granted only to employees of us or our subsidiaries.

2016 Plan permits the granting of any or all of the following types of awards:

Stock options entitle the holder to purchase a specified number of shares of common stock at a specified price

(the exercise price), subject to the terms and conditions of the stock option grant.

Our compensation committee may grant

either incentive stock options, which must comply with Code Section 422, or nonqualified stock options.

Our compensation committee

sets exercise prices and terms and conditions, except that stock options must be granted with an exercise price not less than

100% of the fair market value of our common stock on the date of grant (excluding stock options granted in connection with

assuming or substituting stock options in acquisition transactions).

Unless our compensation committee determines otherwise,

fair market value means, as of a given date, the closing price of our common stock.

At the time of grant, our compensation

committee determines the terms and conditions of stock options, including the quantity, exercise price, vesting periods, term

(which cannot exceed 10 years) and other conditions on exercise.

Stock options entitle the holder to purchase a specified number of shares of common stock at a specified price (the

exercise price), subject to the terms and conditions of the stock option grant.

Our compensation committee may grant either incentive

stock options, which must comply with Code Section 422, or nonqualified stock options.

Our compensation committee sets exercise prices

and terms and conditions, except that stock options must be granted with an exercise price not less than 100% of the fair market

value of our common stock on the date of grant (excluding stock options granted in connection with assuming or substituting stock

options in acquisition transactions).

Unless our compensation committee determines otherwise, fair market value means, as of a given

date, the closing price of our common stock.

At the time of grant, our compensation committee determines the terms and conditions

of stock options, including the quantity, exercise price, vesting periods, term (which cannot exceed 10 years) and other conditions

Appreciation Rights .

Our compensation committee may grant SARs, as a right in tandem with the number of shares underlying

stock options granted under the 2016 Plan or as a freestanding award.

Upon exercise, SARs entitle the holder to receive payment

per share in stock or cash, or in a combination of stock and cash, equal to the excess of the share’s fair market value

on the date of exercise over the grant price of the SAR.

The grant price of a tandem SAR is equal to the exercise price of

the related stock option and the grant price for a freestanding SAR is determined by our compensation committee in accordance

with the procedures described above for stock options.

Exercise of a SAR issued in tandem with a stock option will reduce

the number of shares underlying the related stock option to the extent of the SAR exercised.

The term of a freestanding SAR

cannot exceed 10 years, and the term of a tandem SAR cannot exceed the term of the related stock option.

Our compensation committee may grant SARs, as a right in tandem with the number of shares underlying stock

options granted under the 2016 Plan or as a freestanding award.

Upon exercise, SARs entitle the holder to receive payment per share

in stock or cash, or in a combination of stock and cash, equal to the excess of the share’s fair market value on the date of

exercise over the grant price of the SAR.

The grant price of a tandem SAR is equal to the exercise price of the related stock option

and the grant price for a freestanding SAR is determined by our compensation committee in accordance with the procedures described

above for stock options.

Exercise of a SAR issued in tandem with a stock option will reduce the number of shares underlying the related

stock option to the extent of the SAR exercised.

The term of a freestanding SAR cannot exceed 10 years, and the term of a tandem

SAR cannot exceed the term of the related stock option.

Stock, Restricted Stock Units and Other Stock-Based Awards .

Our compensation committee may grant awards of restricted

stock, which are shares of common stock subject to specified restrictions, and restricted stock units, or RSUs, which represent

the right to receive shares of our common stock in the future.

These awards may be made subject to repurchase, forfeiture

or vesting restrictions at our compensation committee’s discretion.

The restrictions may be based on continuous service

with us or the attainment of specified performance goals, as determined by our compensation committee.

Stock units may be

paid in stock or cash or a combination of stock and cash, as determined by our compensation committee.

Our compensation committee

may also grant other types of equity or equity-based awards subject to the terms and conditions of the 2016 Plan and any other

terms and conditions determined by our compensation committee.

Our compensation committee may grant performance awards, which entitle participants to receive a payment from

us, the amount of which is based on the attainment of performance goals established by our compensation committee over a specified

award period.

Performance awards may be denominated in shares of common stock or in cash, and may be paid in stock or cash

or a combination of stock and cash, as determined by our compensation committee.

Cash-based performance awards include annual

incentive awards.

cash and equity awards granted under the 2016 plan will be subject to all applicable laws regarding the recovery of erroneously

awarded compensation, any implementing rules and regulations under such laws, any policies we adopted to implement such requirements

and any other compensation recovery policies as we may adopt from time to time.

the 2016 Plan, in the event of a change in control (as defined in the 2016 Plan), outstanding awards will be treated in accordance

with the applicable transaction agreement.

If no treatment is provided for in the transaction agreement, each award holder will

be entitled to receive the same consideration that stockholders receive in the change in control for each share of stock subject

to the award holder’s awards, upon the exercise, payment or transfer of the awards, but the awards will remain subject to

the same terms, conditions and performance criteria applicable to the awards before the change in control, unless otherwise determined

by our compensation committee.

In connection with a change in control, outstanding stock options and SARs can be cancelled in

exchange for the excess of the per share consideration paid to stockholders in the transaction, minus the option or SARs exercise

to the terms and conditions of the applicable award agreements, awards granted to non-employee directors will fully vest on an

accelerated basis, and any performance goals will be deemed to be satisfied at target.

For awards granted to all other service

providers, vesting of awards will depend on whether the awards are assumed, converted or replaced by the resulting entity.

Our compensation committee may grant awards of restricted stock,

which are shares of common stock subject to specified restrictions, and restricted stock units, or RSUs, which represent the right

to receive shares of our common stock in the future.

These awards may be made subject to repurchase, forfeiture or vesting restrictions

at our compensation committee’s discretion.

The restrictions may be based on continuous service with us or the attainment of

specified performance goals, as determined by our compensation committee.

Stock units may be paid in stock or cash or a combination

of stock and cash, as determined by our compensation committee.

Our compensation committee may also grant other types of equity or

equity-based awards subject to the terms and conditions of the 2016 Plan and any other terms and conditions determined by our compensation

Our compensation committee may grant performance awards, which entitle participants to receive a payment from us, the

amount of which is based on the attainment of performance goals established by our compensation committee over a specified award

Performance awards may be denominated in shares of common stock or in cash, and may be paid in stock or cash or a combination

of stock and cash, as determined by our compensation committee.

Cash-based performance awards include annual incentive awards.

cash and equity awards granted under the 2016 plan will be subject to all applicable laws regarding the recovery of erroneously awarded

compensation, any implementing rules and regulations under such laws, any policies we adopted to implement such requirements and any

other compensation recovery policies as we may adopt from time to time.

the 2016 Plan, in the event of a change in control (as defined in the 2016 Plan), outstanding awards will be treated in accordance with

the applicable transaction agreement.

If no treatment is provided for in the transaction agreement, each award holder will be entitled

to receive the same consideration that stockholders receive in the change in control for each share of stock subject to the award holder’s

awards, upon the exercise, payment or transfer of the awards, but the awards will remain subject to the same terms, conditions and performance

criteria applicable to the awards before the change in control, unless otherwise determined by our compensation committee.

In connection

with a change in control, outstanding stock options and SARs can be cancelled in exchange for the excess of the per share consideration

paid to stockholders in the transaction, minus the option or SARs exercise price.

to the terms and conditions of the applicable award agreements, awards granted to non-employee directors will fully vest on an accelerated

basis, and any performance goals will be deemed to be satisfied at target.

For awards granted to all other service providers, vesting

of awards will depend on whether the awards are assumed, converted or replaced by the resulting entity.

awards that are not assumed, converted or replaced, the awards will vest upon the change in control.

For performance awards,

the amount vesting will be based on the greater of (1) achievement of all performance goals at the “target”

or (2) the actual level of achievement of performance goals as of our fiscal quarter end preceding the change in control,

and will be prorated based on the portion of the performance period that had been completed through the date of the change

awards that are assumed, converted or replaced by the resulting entity, no automatic vesting will occur upon the change in

Instead, the awards, as adjusted in connection with the transaction, will continue to vest in accordance with their

terms and conditions.

In addition, the awards will vest if the award recipient has a separation from service within two years

after a change in control by us other than for “cause”

or by the award recipient for “good reason”

(each as defined in the applicable award agreement).

For performance awards, the amount vesting will be based on the greater

of (1) achievement of all performance goals at the “target”

level or (2) the actual level of achievement of performance

goals as of our fiscal quarter end preceding the change in control, and will be prorated based on the portion of the performance

period that had been completed through the date of the separation from service.

For performance awards, the

amount vesting will be based on the greater of (1) achievement of all performance goals at the “target” level or (2)

the actual level of achievement of performance goals as of our fiscal quarter end preceding the change in control, and will be prorated

based on the portion of the performance period that had been completed through the date of the change in control.

awards that are assumed, converted or replaced by the resulting entity, no automatic vesting will occur upon the change in control.

Instead, the awards, as adjusted in connection with the transaction, will continue to vest in accordance with their terms and conditions.

In addition, the awards will vest if the award recipient has a separation from service within two years after a change in control

by us other than for “cause” or by the award recipient for “good reason” (each as defined in the applicable

award agreement).

For performance awards, the amount vesting will be based on the greater of (1) achievement of all performance goals

at the “target” level or (2) the actual level of achievement of performance goals as of our fiscal quarter end preceding

the change in control, and will be prorated based on the portion of the performance period that had been completed through the date

of the separation from service.

and Termination of the 2016 Plan

earlier terminated by our board of directors, the 2016 Plan will terminate, and no further awards may be granted, 10 years after

October 1, 2016, the date on which it was approved by our stockholders.

Our board of directors may amend, suspend or terminate

the 2016 Plan at any time, except that, if required by applicable law, regulation or stock exchange rule, stockholder approval

will be required for any amendment.

The amendment, suspension or termination of the 2016 Plan or the amendment of an outstanding

award generally may not, without a participant’s consent, materially impair the participant’s rights under an outstanding

earlier terminated by our board of directors, the 2016 Plan will terminate, and no further awards may be granted, 10 years after October

1, 2016, the date on which it was approved by our stockholders.

Our board of directors may amend, suspend or terminate the 2016 Plan

at any time, except that, if required by applicable law, regulation or stock exchange rule, stockholder approval will be required for

any amendment.

The amendment, suspension or termination of the 2016 Plan or the amendment of an outstanding award generally may not,

without a participant’s consent, materially impair the participant’s rights under an outstanding award.

of Liability and Indemnification Matters

amended and restated certificate of incorporation limits the liability of our directors for monetary damages for breach of their

fiduciary duties, except for liability that cannot be eliminated under the DGCL.

Consequently, our directors will not be personally

liable for monetary damages for breach of their fiduciary duties as directors, except liability for any of the following:

amended and restated certificate of incorporation limits the liability of our directors for monetary damages for breach of their fiduciary

duties, except for liability that cannot be eliminated under the DGCL.

Consequently, our directors will not be personally liable for

monetary damages for breach of their fiduciary duties as directors, except liability for any of the following:

breach of their duty of loyalty to us or our stockholders;

2 unchanged sentences

transaction from which the director derived an improper personal benefit.

amended and restated bylaws also provide that we will indemnify our directors and executive officers and may indemnify our other

officers and employees and other agents to the fullest extent permitted by law.

Our amended and restated bylaws also permit us

to secure insurance on behalf of any officer, director, employee or other agent for any liability arising out of his or her actions

in this capacity, regardless of whether our amended and restated bylaws would permit indemnification.

We have obtained directors’

and officers’

liability insurance.

have entered into separate indemnification agreements with our directors and executive officers, in addition to indemnification

provided for in our amended and restated bylaws.

These agreements, among other things, provide for indemnification of our directors

and executive officers for expenses, judgments, fines and settlement amounts incurred by this person in any action or proceeding

arising out of this person’s services as a director or executive officer or at our request.

We believe that these provisions

and agreements are necessary to attract and retain qualified persons as directors and executive officers.

above description of the indemnification provisions of our amended and restated bylaws and our indemnification agreements is not

complete and is qualified in its entirety by reference to these documents, each of which is incorporated by reference as an exhibit

to the registration statement to which this prospectus forms a part.

limitation of liability and indemnification provisions in our amended and restated certificate of incorporation and amended and

restated bylaws may discourage stockholders from bringing a lawsuit against directors for breach of their fiduciary duties.

may also reduce the likelihood of derivative litigation against directors and officers, even though an action, if successful,

might benefit us and our stockholders.

A stockholder’s investment may be harmed to the extent we pay the costs of settlement

and damage awards against directors and officers pursuant to these indemnification provisions.

Insofar as indemnification for

liabilities under the Securities Act may be permitted to directors, officers or persons controlling us pursuant to the foregoing

provisions, we have been informed that in the opinion of the SEC such indemnification is against public policy as expressed in

the Securities Act and may be unenforceable.

There is no pending litigation or proceeding naming any of our directors or officers

as to which indemnification is being sought, nor are we aware of any pending or threatened litigation that may result in claims

for indemnification by any director or officer.

Board determines the form and amount of director compensation after its review of recommendations made by the Compensation Committee.

A substantial portion of each director’s annual retainer is in the form of equity.

Under the Company’s nonemployee

director compensation program members of the Board who are not also Company employees (“Non-Employee

Directors”) are granted eight hundred (800) options and restricted stock units (“RSUs”) worth up to twenty-five

thousand dollars ($25,000) per annum (the “Annual Award”).

A Non-Employee Director who is newly appointed to the Board

other than in connection with an annual meeting of stockholders will generally receive a grant of two thousand four hundred (2,400)

options and RSUs worth up to seventy-five thousand dollars ($75,000) upon appointment (an “Initial Award”), which

covers their compensation for their first three years of service.

The Initial Award and Annual Award to Non-Employee Directors

will vest as long as they remain directors in equal annual portions over three years

following the date in which the award is granted.

On February 18, 2021, the board agreed to change 2021 director compensation

to eliminate the RSU component of its annual director compensation and increase the stock option component from options for stock

worth up to $25,000, to options for stock worth up to $37,500.

amended and restated bylaws also provide that we will indemnify our directors and executive officers and may indemnify our other officers

and employees and other agents to the fullest extent permitted by law.

Our amended and restated bylaws also permit us to secure insurance

on behalf of any officer, director, employee or other agent for any liability arising out of his or her actions in this capacity, regardless

of whether our amended and restated bylaws would permit indemnification.

We have obtained directors’ and officers’ liability

have entered into separate indemnification agreements with our directors and executive officers, in addition to indemnification provided

for in our amended and restated bylaws.

These agreements, among other things, provide for indemnification of our directors and executive

officers for expenses, judgments, fines and settlement amounts incurred by this person in any action or proceeding arising out of this

person’s services as a director or executive officer or at our request.

We believe that these provisions and agreements are necessary

to attract and retain qualified persons as directors and executive officers.

above description of the indemnification provisions of our amended and restated bylaws and our indemnification agreements is not complete

and is qualified in its entirety by reference to these documents, each of which is incorporated by reference as an exhibit to the registration

statement to which this prospectus forms a part.

limitation of liability and indemnification provisions in our amended and restated certificate of incorporation and amended and restated

bylaws may discourage stockholders from bringing a lawsuit against directors for breach of their fiduciary duties.

They may also reduce

the likelihood of derivative litigation against directors and officers, even though an action, if successful, might benefit us and our

stockholders.

A stockholder’s investment may be harmed to the extent we pay the costs of settlement and damage awards against directors

and officers pursuant to these indemnification provisions.

Insofar as indemnification for liabilities under the Securities Act may be

permitted to directors, officers or persons controlling us pursuant to the foregoing provisions, we have been informed that in the opinion

of the SEC such indemnification is against public policy as expressed in the Securities Act and may be unenforceable.

There is no pending

litigation or proceeding naming any of our directors or officers as to which indemnification is being sought, nor are we aware of any

pending or threatened litigation that may result in claims for indemnification by any director or officer.

The Board determines

the form and amount of director compensation after its review of recommendations made by the Compensation Committee.

A substantial portion

of each director’s annual retainer is in the form of equity.

Under the Company’s nonemployee director compensation program

members of the Board who are not also Company employees (“Non-Employee Directors”) are granted options worth up to thirty-seven

thousand five hundred dollars ($37,500) per annum (the “Annual Award”).

Prior to February 18, 2021, the equity

portion of director compensation included eight hundred options and restricted stock units (“RSU’s” worth up to twenty-five

thousand dollars ($25,000) per annum.

A Non-Employee Director who is newly appointed to the Board other than in connection with an

annual meeting of stockholders will generally receive a grant of two thousand four hundred (2,400) options and RSUs worth up to seventy-five

thousand dollars ($75,000) upon appointment (an “Initial Award”), which covers their compensation for their first three years

The Initial Award and Annual Award to Non-Employee Directors will vest as long as they remain directors in equal annual portions

over three years following the date in which the award is granted.

table below shows the compensation paid to our non-employee directors during 2021 and 2020.

earned or paid in cash

incentive plan compensation ($)

deferred compensation earnings ($)

other compensation($)

Under the Company’s nonemployee director compensation program, Dr.

Fees earned or paid in cash

Stock awards ($)

Option awards

Non-equity incentive plan compensation ($)

Nonqualified deferred compensation earnings

All other compensation($)

Francis Duhay,

Under the Company’s nonemployee director compensation program, Dr.

Shrivastava, Mr.

Jenusaitis were

each granted 2,500 Restricted Stock Grants on July 17, 2020, which based on the Company’s closing stock price on the grant

date were valued at $10.00 per share.

Jenusaitis were each

granted 2,500 Restricted Stock Grants on July 17, 2020, which based on the Company’s closing stock price on the grant date were

valued at $10.00 per share.

These Restricted Stock Grants fully vested on December 31, 2020.

Under the Company’s nonemployee director compensation program, Dr.

Shrivastava, Mr.

Jenusaitis were

each granted 4,000 options to purchase shares of our common stock on July 17, 2020 at an exercise price of $10.00 per share.

options were valued at $7.80 per share as of the date of the grant.

All of these options vest in equal quarterly portions from

the grant date through December 31, 2020, such that they are fully vested at December 31, 2020, and valued in accordance with

FASB ASC Topic 718.

Under the Company’s nonemployee director compensation program, Messrs.

Gray and Jenusaitis in connection with their appointment

to the BOD on September 13, 2019 were each granted 3,125 Restricted Stock units, which based on the Company’s closing stock

price on the grant date were valued at $24 per unit.

These units vest in equal annual portions on the 9/13/2020, 9/13/2021 and

Under the Company’s nonemployee director compensation program, Messrs.

Gray and Jenusaitis in connection with their appointment

to the BOD on September 13, 2019 were each granted 2,400 options to purchase shares of our common stock at an exercise price of

Jenusaitis were each

granted 5,673 options to purchase shares of our common stock on February 18, 2021 at an exercise price of $8.20 per share.

were valued at $6.61 per share as of the date of the grant.

All of these options vest in equal quarterly portions from the grant date

through December 31, 2021, such that they are fully vested at December 31, 2021, and valued in accordance with FASB ASC Topic 718.

Under the Company’s nonemployee director compensation program, Dr.

Shrivastava, Mr.

Jenusaitis were each

granted 4,000 options to purchase shares of our common stock on July 17, 2020 at an exercise price of $10.00 per share.

The options were

valued at $7.80 per share as of the date of the grant.

All of these options vest in equal quarterly portions from the grant date through

December 31, 2020, such that they are fully vested at December 31, 2020, and valued in accordance with FASB ASC Topic 718.

(4) Under the Company’s nonemployee

director compensation program, Dr.

Shrivastava, Mr.

Jenusaitis were each granted 7,211 options to purchase shares

of our common stock on November 30, 2021, as part of their compensation for the year ending December 31, 2022, at an exercise price of

$6.70 per share.

The options were valued at $3.25 per share as of the date of the grant.

All of these options vest in equal quarterly

portions over a 3 year period starting from September 13, 2019 and valued in accordance with FASB ASC Topic 718.

The options were valued at $5.20 per share as of the date of the grant and will vest in equal quarterly portions starting

on March 31, 2022 and through December 31, 2022, such that they are fully vested at December 31, 2022.

The grant date value of each grant

determined in accordance with FASB ASC Topic 718 was $37,500.

Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters

following table lists, as of March 22, 2021, the number of shares of common stock of our Company that are beneficially

owned by (i) each person or entity known to our Company to be the beneficial owner of more than 5% of the outstanding common stock;

(ii) each officer and director of our Company;

following table lists, as of March 24, 2022, the number of shares of common stock of our Company that are beneficially owned

by (i) each person or entity known to our Company to be the beneficial owner of more than 5% of the outstanding common stock;

officer and director of our Company;

and (iii) all officers and directors as a group.

percentage ownership is based on 9,469,850 shares of common stock outstanding as the date of this Form 10-K.

We have determined

beneficial ownership in accordance with the rules of the SEC.

These rules generally attribute beneficial ownership of securities

to persons who possess sole or shared voting or dispositive power with respect to such securities.

In addition, pursuant to such

rules, we deemed outstanding shares of common stock subject to options or warrants held by that person that are currently exercisable

or exercisable within 60 days of March 22, 2021.

We did not deem such shares outstanding, however, for the purpose of computing

the percentage ownership of any other person.

Except as indicated by the footnotes below, we believe, based on the information

furnished to us, that the beneficial owners named in the table below have sole voting and dispositive power with respect to all

shares of our common stock that they beneficially own, subject to applicable community property laws.

and Address of Beneficial Owner (1)

Ventures, Inc.

Asset Management LLC (3)

Investments, Inc.

Executive Officers and Directors

Glickman, M.D.

We have determined beneficial

ownership in accordance with the rules of the SEC.

These rules generally attribute beneficial ownership of securities to persons who

possess sole or shared voting or dispositive power with respect to such securities.

In addition, pursuant to such rules, we deemed outstanding

shares of common stock subject to options or warrants held by that person that are currently exercisable or exercisable within 60 days

of March 24, 2022.

We did not deem such shares outstanding, however, for the purpose of computing the percentage ownership

of any other person.

Except as indicated by the footnotes below, we believe, based on the information furnished to us, that the beneficial

owners named in the table below have sole voting and dispositive power with respect to all shares of our common stock that they beneficially

own, subject to applicable community property laws.

Beneficial Ownership

Name and Address of Beneficial Owner (1)

5% Stockholders

Perceptive Life Sciences Master Fund Ltd.

Named Executive Officers and Directors

Marc Glickman, M.D.

Craig Glynn (5)

Francis Duhay, M.D.

Sanjay Shrivastava (7)

Jenusaitis (11)

directors and executive officers as a group (7 persons)

Robert Gray (8)

Matthew Jenusaitis (9)

All directors and executive officers as a group (7 persons)

Represents beneficial ownership of less than 1%.

as otherwise noted below, the address for each person or entity listed in the table is c/o Hancock Jaffe Laboratories, Inc.,

as otherwise noted below, the address for each person or entity listed in the table is c/o enVVeno Medical Corporation, 70

Doppler, Irvine, California 92618.

Ventures, Inc.

has voting control and investment discretion over the securities it holds.

As General Partners of Analytica Ventures,

Andrew Schacter and Mr.

Charles Wachsberg may be deemed to have beneficial ownership (as determined under Section 13(d)

of the Securities Exchange Act of 1934, as amended) of the securities held by Analytica Ventures, Inc.

The address for Analytica

Ventures, Inc.

is 1 Apollo Place, Toronto, ON M3J 0H2 Canada.

Asset Management, L.P.

is the investment manager to the Empery Funds, has voting control and investment discretion over securities

held by the Empery Funds.

As Managing Members of Empery AM GP, LLC, the General Partner of the Empery Funds, Mr.

Hoe may be deemed to have beneficial ownership (as determined under Section 13(d) of the Securities Exchange

Act of 1934, as amended) of the securities held by Empery Asset Management, L.P.

The address for Empery Asset Management,

is 1 Rockefeller Plaza, Suite 1205, New York, New York 10020.

Capital Management, Inc., which serves as the investment manager to CVI Investments, Inc., may be deemed to be the beneficial

owner of all Shares owned by CVI Investments, Inc.

The address for CVI Investments, Inc.

Box 309GT, Ugland House,

South Church Street, George Town, Grand Cayman, KY1-1104, Cayman Islands.

53,208 shares of common stock issuable upon exercise of options that are currently exercisable or exercisable within

60 days of March 22, 2021.

on a Schedule 13G filed by the Perceptive Live Sciences Master Fund Ltd.

(the “Master Fund”).

The Master Fund directly

holds 781,615 shares of common stock and 1,759,035 pre-funded warrants.

The pre-funded warrants may not be exercised if the Master

Fund would beneficially own more than 9.9% of the Company’s outstanding shares of common stock after giving effect to such

Perceptive Advisors serves as the investment manager to the Master Fund and may be deemed to beneficially own such shares.

Edelman is the managing member of Perceptive Advisors and may be deemed to beneficially own such shares.

588,071 shares of common stock issuable upon exercise of options that are currently exercisable or exercisable within 60 days of

March 24, 2022.

278,836 shares of common stock that are issuable upon exercise of options that are currently exercisable or exercisable within 60

11 unchanged sentences

Relationships and Related Transactions, and Director Independence

following is a description of transactions since January 1, 2019 to which we were a party in which (i) the amount involved exceeded

or will exceed the lesser of (A) $120,000 or (B) one percent of our average total assets at year end for the last two completed

fiscal years and (ii) any of our directors, executive officers or holders of more than 5% of our capital stock, or any member

of the immediate family of, or person sharing the household with, any of the foregoing persons, who had or will have a direct

or indirect material interest, other than equity and other compensation, termination, change in control and other similar arrangements,

which are described under “Executive Compensation.”

of March 24, 2021, Analytica Ventures owned 954,142 shares of our common stock representing an ownership interest of approximately

Analytica Ventures is affiliated through ownership with Axiom Real Time Metrics (Axiom) a vendor to the Company

involved in our pivotal trial and first-in-human studies.

In connection with those studies, we incurred costs payable to

Axiom of approximately $210,000 in 2019 and $820,000 in 2020, respectively.

following is a description of transactions since January 1, 2021 to which we were a party in which (i) the amount involved exceeded or

will exceed the lesser of (A) $120,000 or (B) one percent of our average total assets at year end for the last two completed fiscal years

and (ii) any of our directors, executive officers or holders of more than 5% of our capital stock, or any member of the immediate family

of, or person sharing the household with, any of the foregoing persons, who had or will have a direct or indirect material interest,

other than equity and other compensation, termination, change in control and other similar arrangements, which are described under “Executive

Compensation.”

Indemnification

2 unchanged sentences

and officers to the fullest extent permitted by the DGCL.

Further, we intend to enter into indemnification agreements with each

of our directors and officers, and we intend to purchase a policy of directors’

and officers’

liability insurance

that insures our directors and officers against the cost of defense, settlement or payment of a judgment under certain circumstances.

For further information, see “Executive Compensation—Limitations of Liability and Indemnification Matters.”

the best of our knowledge, during the past two fiscal years, other than as set forth above, there were no material transactions,

or series of similar transactions, or any currently proposed transactions, or series of similar transactions, to which we were

or are to be a party, in which the amount involved exceeds the lesser of (A) $120,000 or (B) one percent of our average total

assets at year end for the last two completed fiscal years, and in which any director or executive officer, or any security holder

who is known by us to own of record or beneficially more than 5% of any class of our common stock, or any member of the immediate

family of any of the foregoing persons, has an interest (other than compensation to our officers and directors in the ordinary

course of business).

Further, we intend to enter into indemnification agreements with each of our

directors and officers, and we intend to purchase a policy of directors’ and officers’ liability insurance that insures our

directors and officers against the cost of defense, settlement or payment of a judgment under certain circumstances.

For further information,

see “Executive Compensation—Limitations of Liability and Indemnification Matters.”

the best of our knowledge, during the past two fiscal years, other than as set forth above, there were no material transactions, or series

of similar transactions, or any currently proposed transactions, or series of similar transactions, to which we were or are to be a party,

in which the amount involved exceeds the lesser of (A) $120,000 or (B) one percent of our average total assets at year end for the last

two completed fiscal years, and in which any director or executive officer, or any security holder who is known by us to own of record

or beneficially more than 5% of any class of our common stock, or any member of the immediate family of any of the foregoing persons,

has an interest (other than compensation to our officers and directors in the ordinary course of business).

and Procedures for Related Party Transactions

future transactions between us and our officers, directors or five percent stockholders, and respective affiliates will be on

terms no less favorable than could be obtained from unaffiliated third parties and will be approved by a majority of our independent

directors who do not have an interest in the transactions and who had access, at our expense, to our legal counsel or independent

legal counsel.

information provided in Item 10, under the subheading “Director Independence”

is incorporated herein.

future transactions between us and our officers, directors or five percent stockholders, and respective affiliates will be on terms no

less favorable than could be obtained from unaffiliated third parties and will be approved by a majority of our independent directors

who do not have an interest in the transactions and who had access, at our expense, to our legal counsel or independent legal counsel.

information provided in Item 10, under the subheading “Director Independence” is incorporated herein.

Accounting Fees and Services

The aggregate fees billed by Marcum LLP (“

Marcum ”) for professional services rendered for the audit

of our annual financial statements, review of the financial information included in our Forms 10-Q for the respective periods

and other required filings with the SEC for the years ended December 31, 2020 and 2019 totaled $243,750 and $175,407, respectively.

The above amounts include interim procedures, audit fees, fees related to registration statements filed during those years, and

attendance at audit committee meetings.

The aggregate fees billed by Marcum LLP (“ Marcum ”) for professional services rendered for the audit of our

annual financial statements, review of the financial information included in our Forms 10-Q for the respective periods and other required

filings with the SEC for the years ended December 31, 2021 and 2020 totaled $126,000 and $244,000, respectively.

amounts include interim procedures, audit fees, fees related to registration statements filed during those years, and attendance at audit

committee meetings.

For Board of Directors Pre-Approval of Audit and Permissible Non-Audit Services of Independent Auditor

1 unchanged sentence

or relationship between us and our independent registered public accounting firm.

Our engagement of Marcum to conduct all audit

and permissible non-audit related activities incurred during fiscal years 2020 and 2019 were approved by our audit committee in

accordance with these procedures.

Our engagement of Marcum to conduct all audit and permissible

non-audit related activities incurred during fiscal years 2021 and 2020 were approved by our audit committee in accordance with these

and Financial Statements Schedules

Financial Statements

financial statements and the notes thereto, together with the report of our independent registered public accounting firm on those

financial statements, are hereby filed as part of this report beginning on page F-1.

financial statements and the notes thereto, together with the report of our independent registered public accounting firm on those financial

statements, are hereby filed as part of this report beginning on page F-1.

Statement Schedules

financial statement schedules have been omitted since the required information is not applicable or is not present in amounts

sufficient to require submission of the schedule, or because the information required is included in the consolidated financial

statements and notes thereto.

financial statement schedules have been omitted since the required information is not applicable or is not present in amounts sufficient

to require submission of the schedule, or because the information required is included in the consolidated financial statements and notes

following is a complete list of exhibits filed as part of this Form 10-K.

Exhibit numbers correspond to the numbers in the Exhibit

Table of Item 601 of Regulation S-K.

Amended and Restated Certificate of Incorporation (incorporated by reference to Exhibit 3.1 of the Registrant’s Current

Report on Form 8-K filed on September 16, 2020).

and Restated Bylaws (incorporated by reference to Exhibit 3.2 to the Registrant’s Current Report on Form 8-K filed on

June 6, 2018).

of Amendment to the Fifth Amended and Restated Certificate of Incorporation (incorporated by reference to Exhibit 3.1to the

Registrant’s Current Report on Form 8-K filed on December 2, 2020).

common stock certificate (incorporated by reference to Exhibit 4.1 to the Registrant’s Registration Statement on Form

Exhibit numbers correspond to the numbers in the Exhibit Table

of Item 601 of Regulation S-K.

Fifth Amended and Restated Certificate of Incorporation (incorporated by reference to Exhibit 3.1 of the Registrant’s Current Report on Form 8-K filed on September 16, 2020).

Amended and Restated Bylaws (incorporated by reference to Exhibit 3.2 to the Registrant’s Current Report on Form 8-K filed on June 6, 2018).

Certificate of Amendment to the Fifth Amended and Restated Certificate of Incorporation (incorporated by reference to Exhibit 3.1to the Registrant’s Current Report on Form 8-K filed on December 2, 2020).

Certificate of Amendment to the Fifth Amended and Restated Certificate of Incorporation (incorporated by reference to Exhibit 3.1 to the Registrant’s Current Report on Form 8-K filed on October 1, 2021).

Specimen common stock certificate (incorporated by reference to Exhibit 4.1 to the Registrant’s Registration Statement on Form S-1 (No.

333-220372) filed on September 7, 2017).

of Series A Preferred Stock Placement Agents’

Warrant (incorporated by reference to Exhibit 4.4 to the Registrant’s

Registration Statement on Form S-1/A (No.

Form of Series A Preferred Stock Placement Agents’ Warrant (incorporated by reference to Exhibit 4.4 to the Registrant’s Registration Statement on Form S-1/A (No.

333-220372) filed on December 14, 2017).

of Series B Preferred Stock Placement Agents’

Warrant (incorporated by reference to Exhibit 4.5 to the Registrant’s

Registration Statement on Form S-1/A (No.

Form of Series B Preferred Stock Placement Agents’ Warrant (incorporated by reference to Exhibit 4.5 to the Registrant’s Registration Statement on Form S-1/A (No.

333-220372) filed on December 14, 2017).

of Common Stock Purchase Warrant (issued in connection with the 2017 Notes) (incorporated by reference to Exhibit 4.6 to the

Registrant’s Registration Statement on Form S-1/A (No.

Form of Common Stock Purchase Warrant (issued in connection with the 2017 Notes) (incorporated by reference to Exhibit 4.6 to the Registrant’s Registration Statement on Form S-1/A (No.

333-220372) filed on December 14, 2017).

of Underwriters’

Warrant (incorporated by reference to Exhibit 4.7 to the Registrant’s Registration Statement

on Form S-1/A (No.

Form of Underwriters’ Warrant (incorporated by reference to Exhibit 4.7 to the Registrant’s Registration Statement on Form S-1/A (No.

333-220372) filed on January 26, 2018).

of Warrant to Purchase Shares of Common Stock (issued to Mr.

Cantor) (incorporated by reference to Exhibit 4.8 to the Registrant’s

Registration Statement on Form S-1/A (No.

Form of Warrant to Purchase Shares of Common Stock (issued to Mr.

Cantor) (incorporated by reference to Exhibit 4.8 to the Registrant’s Registration Statement on Form S-1/A (No.

333-220372) filed on December 14, 2017).

of Amended and Restated Common Stock Purchase Warrant (issued in connection with the 2017 Notes) (incorporated by reference

to Exhibit 4.9 to the Registrant’s Registration Statement on Form S-1/A (No.

Form of Amended and Restated Common Stock Purchase Warrant (issued in connection with the 2017 Notes) (incorporated by reference to Exhibit 4.9 to the Registrant’s Registration Statement on Form S-1/A (No.

333-220372) filed on January 26, 2018).

of Common Stock Purchase Warrant (issued in connection with the 2018 Notes) (incorporated by reference to Exhibit 4.10 to

the Registrant’s Registration Statement on Form S-1/A (No.

Form of Common Stock Purchase Warrant (issued in connection with the 2018 Notes) (incorporated by reference to Exhibit 4.10 to the Registrant’s Registration Statement on Form S-1/A (No.

333-220372) filed on January 26, 2018).

of Second Amended and Restated Common Stock Purchase Warrant (issued in connection with the 2017 Notes) (incorporated by reference

to Exhibit 4.11 to the Registrant’s Registration Statement on Form S-1/A (No.

Form of Second Amended and Restated Common Stock Purchase Warrant (issued in connection with the 2017 Notes) (incorporated by reference to Exhibit 4.11 to the Registrant’s Registration Statement on Form S-1/A (No.

333-220372) filed on April 16, 2018).

of Amended and Restated Common Stock Purchase Warrant (issued in connection with the 2018 Notes) (incorporated by reference

to Exhibit 4.12 to the Registrant’s Registration Statement on Form S-1/A (No.

Form of Amended and Restated Common Stock Purchase Warrant (issued in connection with the 2018 Notes) (incorporated by reference to Exhibit 4.12 to the Registrant’s Registration Statement on Form S-1/A (No.

333-220372) filed on April 16, 2018).

of Warrant Agreement (incorporated by reference to Exhibit 4.13 to the Registrant’s Registration Statement on Form S-1/A

Form of Warrant Agreement (incorporated by reference to Exhibit 4.13 to the Registrant’s Registration Statement on Form S-1/A (No.

333-220372) filed on May 14, 2018).

to Warrant to Purchase Shares (incorporated by reference to Exhibit 4.14 to the Registrant’s Registration Statement

on Form S-1/A (No.

Amendment to Warrant to Purchase Shares (incorporated by reference to Exhibit 4.14 to the Registrant’s Registration Statement on Form S-1/A (No.

333-220372) filed on April 16, 2018).

of Warrant Certificate (incorporated by reference to Exhibit 4.15 to the Registrant’s Registration Statement on Form

Form of Warrant Certificate (incorporated by reference to Exhibit 4.15 to the Registrant’s Registration Statement on Form S-1/A (No.

333-220372) filed on May 14, 2018).

of Warrant (incorporated by reference to Exhibit 4.1 to the Registrant’s Current Report on Form 8-K filed on March 2,

of Warrant (incorporated by reference to Exhibit 4.1 to the Registrant’s Current Report on Form 8-K filed on April 28,

of Warrant (incorporated by reference to Exhibit 4.1 to the Registrant’s Current Report on Form 8-K filed on June 3,

of Warrant Agent Agreement, inclusive of Form of Warrant (incorporated by reference to Exhibit 4.1 to the Registrant’s

Current Report on Form 8-K filed on July 21, 2020).

of Private Placement Warrant (incorporated by reference to Exhibit 4.18 to the Registrant’s Registration Statement on

Form S-1/A (No.

Form of Warrant (incorporated by reference to Exhibit 4.1 to the Registrant’s Current Report on Form 8-K filed on March 2, 2020).

Form of Warrant (incorporated by reference to Exhibit 4.1 to the Registrant’s Current Report on Form 8-K filed on April 28, 2020).

Form of Warrant (incorporated by reference to Exhibit 4.1 to the Registrant’s Current Report on Form 8-K filed on June 3, 2020).

Form of Warrant Agent Agreement, inclusive of Form of Warrant (incorporated by reference to Exhibit 4.1 to the Registrant’s Current Report on Form 8-K filed on July 21, 2020).

Form of Private Placement Warrant (incorporated by reference to Exhibit 4.18 to the Registrant’s Registration Statement on Form S-1/A (No.

333-239658) filed on July 16, 2020).

of Warrant (incorporated by reference to Exhibit 4.1 to the Registrant’s Current Report on Form 8-K filed on October

of Warrant Agent Agreement (including Form of Warrant Certificate) (incorporated by reference to Exhibit 4.20 to the Registrant’s

Registration Statement on Form S-1/A (No.

Form of Warrant (incorporated by reference to Exhibit 4.1 to the Registrant’s Current Report on Form 8-K filed on October 8, 2020).

Form of Warrant Agent Agreement (including Form of Warrant Certificate) (incorporated by reference to Exhibit 4.20 to the Registrant’s Registration Statement on Form S-1/A (No.

333 -251528) filed on February 5, 2021).

of the Company’s Securities Registered under Section 12 of the Exchange Act*

of Indemnification Agreement (incorporated by reference to Exhibit 10.30 to the Registrant’s Registration Statement

on Form S-1/A (No.

Form of Pre-Funded Warrant (Form of Placement Agency Agreement, dated September 3, 2021 (incorporated by reference to Exhibit 4.1 to the Registrant’s Current Report on Form 8-K filed on September 8, 2021).

Form of Warrant (Form of Placement Agency Agreement, dated September 3, 2021 (incorporated by reference to Exhibit 4.2 to the Registrant’s Current Report on Form 8-K filed on September 8, 2021).

Description of the Company’s Securities Registered under Section 12 of the Exchange Act (incorporated by reference to Exhibit 4.21 to the Registrant’s Annual Report on Form 10-K for the year ended December 31, 2020)

Form of Indemnification Agreement (incorporated by reference to Exhibit 10.30 to the Registrant’s Registration Statement on Form S-1/A (No.

333-220372) filed on December 14, 2017).

Agreement, dated as of March 30, 2018, by and between the Registrant and Robert A.

(incorporated by reference to Exhibit

10.47 to the Registrant’s Registration Statement on Form S-1/A (No.

Employment Agreement, dated as of March 30, 2018, by and between the Registrant and Robert A.

(incorporated by reference to Exhibit 10.47 to the Registrant’s Registration Statement on Form S-1/A (No.

333-220372) filed on April 16, 2018).

and Restated 2016 Omnibus Incentive Plan (incorporated by reference to Exhibit 10.50 to the Registrant’s Registration

Statement on Form S-1/A (No.

Amended and Restated 2016 Omnibus Incentive Plan (incorporated by reference to Exhibit 10.50 to the Registrant’s Registration Statement on Form S-1/A (No.

333-220372) filed on May 14, 2018).

Amendment No.

1 to Amended and Restated 2016 Omnibus Incentive Plan.

of Stock Option Grant under Amended and Restated 2016 Omnibus Incentive Plan (incorporated by reference to Exhibit 10.44 to

the Registrant’s Annual Report on Form 10-K for the year ended December 31, 2018).

of Restricted Stock Unit under Amended and Restated 2016 Omnibus Incentive Plan (incorporated by reference to Exhibit 10.45

to the Registrant’s Annual Report on Form 10-K for the year ended December 31, 2018).

Purchase Agreement, dated as March 12, 2019, by and among the Company and the investors signatory thereto (incorporated by

reference to Exhibit 10.46 to the Registrant’s Annual Report on Form 10-K for the year ended December 31, 2018).

of Placement Agency Agreement, between the Company and the placement agent signatory thereto (incorporated by reference to

Exhibit 1.1 to the Registrant’s Registration Statement on Form S-1 filed on June 7, 2019).

Agreement, dated as of July 26, 2019, by and between Hancock Jaffe Laboratories, Inc.

and Marc Glickman, M.D.

(incorporated

by reference to Exhibit 10.1 to the Registrant’s Current Report on Form 8-K filed on August 1, 2019).

of Securities Purchase Agreement dated as of February 25, 2020 (incorporated by reference to Exhibit 10.1 to the Registrant’s

Current Report on Form 8-K filed on March 2, 2020).

of Securities Purchase Agreement, dated as of April 24, 2020 (incorporated by reference to Exhibit 10.1 to the Registrant’s

Current Report on Form 8-K filed on April 28, 2020).

of Placement Agency Agreement, dated as of April 24, 2020, by and between Hancock Jaffe Laboratories, Inc.

and Spartan Capital

Securities, LLC (incorporated by reference to Exhibit 10.2 to the Registrant’s Current Report on Form 8-K filed on April

of Securities Purchase Agreement dated as of June 1, 2020 (incorporated by reference to Exhibit 10.1 to the Registrant’s

Current Report on Form 8-K filed on June 3, 2020).

of Securities Purchase Agreement (incorporated by reference to Exhibit 10.53 to the Registrant’s Registration Statement

on Form S-1/A (No.

(incorporated by reference to Exhibit 10.4 to the Registrant’s Annual Report on Form 10-K for the year ended December 31, 2020).

Amendment No.

2 to Amended and

Restated 2016 Omnibus Incentive Plan.*

Form of Stock Option Grant under Amended and Restated 2016 Omnibus Incentive Plan (incorporated by reference to Exhibit 10.44 to the Registrant’s Annual Report on Form 10-K for the year ended December 31, 2018).

Form of Restricted Stock Unit under Amended and Restated 2016 Omnibus Incentive Plan (incorporated by reference to Exhibit 10.45 to the Registrant’s Annual Report on Form 10-K for the year ended December 31, 2018).

Agreement, dated as of July 26, 2019, by and between enVVeno Medical Corporation and Marc Glickman, M.D.

(incorporated by

reference to Exhibit 10.1 to the Registrant’s Current Report on Form 8-K filed on August 1, 2019).

Form of Securities Purchase Agreement dated as of February 25, 2020 (incorporated by reference to Exhibit 10.1 to the Registrant’s Current Report on Form 8-K filed on March 2, 2020).

Form of Securities Purchase Agreement, dated as of April 24, 2020 (incorporated by reference to Exhibit 10.1 to the Registrant’s Current Report on Form 8-K filed on April 28, 2020).

of Placement Agency Agreement, dated as of April 24, 2020, by and between enVVeno Medical Corporation and Spartan Capital

Securities, LLC (incorporated by reference to Exhibit 10.2 to the Registrant’s Current Report on Form 8-K filed on April 28,

Form of Securities Purchase Agreement dated as of June 1, 2020 (incorporated by reference to Exhibit 10.1 to the Registrant’s Current Report on Form 8-K filed on June 3, 2020).

Form of Securities Purchase Agreement (incorporated by reference to Exhibit 10.53 to the Registrant’s Registration Statement on Form S-1/A (No.

333-239658) filed on July 16, 2020).

of Registration Rights Agreement (incorporated by reference to Exhibit 10.54 to the Registrant’s Registration Statement

on Form S-1/A (No.

Form of Registration Rights Agreement (incorporated by reference to Exhibit 10.54 to the Registrant’s Registration Statement on Form S-1/A (No.

333-239658) filed on July 16, 2020).

of Securities Purchase Agreement, dated as of October 7, 2020 (incorporated by reference to Exhibit 10.1 to the Registrant’s

Current Report on Form 8-K filed on October 8, 2020).

of Placement Agency Agreement, dated as of October 7, 2020 (incorporated by reference to Exhibit 10.2 to the Registrant’s

Current Report on Form 8-K filed on October 8, 2020).

Agreement, dated as of February 19, 2021, by and between Hancock Jaffe Laboratories, Inc.

and Craig Glynn.*

of the registrant*

Form of Securities Purchase Agreement, dated as of October 7, 2020 (incorporated by reference to Exhibit 10.1 to the Registrant’s Current Report on Form 8-K filed on October 8, 2020).

Form of Placement Agency Agreement, dated as of October 7, 2020 (incorporated by reference to Exhibit 10.2 to the Registrant’s Current Report on Form 8-K filed on October 8, 2020).

Employment Agreement, dated as of February 19, 2021, by and between enVVeno Medical Corporation and Craig Glynn (incorporated by reference to Exhibit 10.18 to the Registrant’s Annual Report on Form 10-K for the year ended December 31, 2020).

At-the-Market Offering Agreement, dated August 12, 2021, by and between enVVeno Medical Corporation and Ladenburg Thalmann & Co.

(incorporated by reference to Exhibit 10.1 to the Registrant’s Current Report on Form 8-K filed on August 12, 2021).

Form of Securities Purchase Agreement, dated September 3, 2021 (incorporated by reference to Exhibit 10.1 to the Registrant’s Current Report on Form 8-K filed on September 8, 2021).

Form of Placement Agency Agreement, dated September 3, 2021 (incorporated by reference to Exhibit 10.2 to the Registrant’s Current Report on Form 8-K filed on September 8, 2021).

Code of Conduct (incorporated by reference to Exhibit 14.1 to the Registrant’s Annual Report on Form 10-K for the year ended December 31, 2020).

Subsidiaries of the registrant incorporated by reference to Exhibit 21.1 to the Registrant’s Annual Report on Form 10-K for the year ended December 31, 2020).

Consent of Marcum LLP, independent registered public accounting firm*

Certification

of Chief Executive Officer pursuant to Rule 13a-14(a) or Rule 15d-14(a) of the Exchange Act.

Certification

of Chief Financial Officer pursuant to Rule 13a-14(a) or Rule 15d-14(a) of the Sarbanes-Oxley Act.

Certification

of Chief Executive Officer and Chief Financial Officer pursuant to Rule 13a-14(a) or Rule 15d-14(a) of the Exchange Act**

Instance Document*

Taxonomy Extension Schema Document*

Certification of Chief Executive Officer pursuant to Rule 13a-14(a) or Rule 15d-14(a) of the Exchange Act.

Certification of Chief Financial Officer pursuant to Rule 13a-14(a) or Rule 15d-14(a) of the Sarbanes-Oxley Act.

Certification of Chief Executive Officer and Chief Financial Officer pursuant to Rule 13a-14(a) or Rule 15d-14(a) of the Exchange Act**

XBRL Instance Document*

XBRL Taxonomy Extension Schema Document*

Taxonomy Extension Calculation Linkbase Document*

4 unchanged sentences

Form 10-K Summary

to the requirements of Section 12 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.

to the requirements of Section 12 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.

March 28, 2022

JAFFE LABORATORIES, INC.

MEDICAL CORPORATION

Robert Berman

2 unchanged sentences

Financial Officer

Financing and Accounting Officer)

JAFFE LABORATORIES, INC.

Financial and Accounting Officer)

MEDICAL CORPORATION

REPORT ON FORM 10-K

INDEX TO AUDITED FINANCIAL STATEMENTS

of Independent Registered Public Accounting Firm

Sheets as of December 31, 2020 and 2019

of Operations for the Years Ended December 31, 2020 and 2019

of Stockholders’

Equity for the Years Ended December 31, 2020 and 2019

of Cash Flows for the Years Ended December 31, 2020 and 2019

TO AUDITED FINANCIAL STATEMENTS

Report of Independent Registered Public Accounting Firm (PCAOB:

Balance Sheets as of December 31, 2021 and 2020

Statements of Operations for the Years Ended December 31, 2021 and 2020

Statements of Stockholders’ Equity for the Years Ended December 31, 2021 and 2020

Statements of Cash Flows for the Years Ended December 31, 2021 and 2020

to Financial Statements

1 unchanged sentence

the Shareholders and Board of Directors of

Jaffe Laboratories, Inc.

Medical Corporation

on the Financial Statements

have audited the accompanying balance sheets of Hancock Jaffe Laboratories, Inc.

(the “Company”) as of December 31,

2020 and 2019, the related statements of operations, changes in stockholders’

equity and cash flows for each of the two

years in the period ended December 31, 2020, and the related notes (collectively referred to as the “financial statements”).

In our opinion, the financial statements present fairly, in all material respects, the financial position of the Company as of

December 31, 2020 and 2019, and the results of its operations and its cash flows for each of the two years in the period ended

December 31, 2020, in conformity with accounting principles generally accepted in the United States of America .

have audited the accompanying balance sheets of enVVeno Medical Corporation (the “Company”) as of December 31, 2021

and 2020, the related statements of operations, changes in stockholders’ equity and cash flows for each of the two years in the

period ended December 31, 2021, and the related notes (collectively referred to as the “financial statements”).

In our opinion,

the financial statements present fairly, in all material respects, the financial position of the Company as of December 31, 2021 and

2020, and the results of its operations and its cash flows for each of the two years in the period ended December 31, 2021, in conformity

with accounting principles generally accepted in the United States of America .

financial statements are the responsibility of the Company’s management.

1 unchanged sentence

financial statements based on our audits.

We are a public accounting firm registered with the Public Company Accounting Oversight

Board (United States) ("PCAOB") and are required to be independent with respect to the Company in accordance with the

federal securities laws and the applicable rules and regulations of the Securities and Exchange Commission and the PCAOB.

We are a public accounting firm registered with the Public Company Accounting Oversight Board

(United States) (“PCAOB”) and are required to be independent with respect to the Company in accordance with the U.S.

securities laws and the applicable rules and regulations of the Securities and Exchange Commission and the PCAOB.

conducted our audits in accordance with the standards of the PCAOB.

Those standards require that we plan and perform the audits

to obtain reasonable assurance about whether the financial statements are free of material misstatement, whether due to error

The Company is not required to have, nor were we engaged to perform, an audit of its internal control over financial

As part of our audits we are required to obtain an understanding of internal control over financial reporting but not

for the purpose of expressing an opinion on the effectiveness of the Company's internal control over financial reporting.

we express no such opinion.

audits included performing procedures to assess the risks of material misstatement of the financial statements, whether due to

error or fraud, and performing procedures that respond to those risks.

Such procedures included examining, on a test basis, evidence

regarding the amounts and disclosures in the financial statements.

Our audits also included evaluating the accounting principles

used and significant estimates made by management, as well as evaluating the overall presentation of the financial statements.

We believe that our audits provide a reasonable basis for our opinion.

have served as the Company’s auditor since 2015.

JAFFE LABORATORIES, INC.

and cash equivalents

expenses and other current assets

Those standards require that we plan and perform the audits to obtain

reasonable assurance about whether the financial statements are free of material misstatement, whether due to error or fraud.

is not required to have, nor were we engaged to perform, an audit of its internal control over financial reporting.

As part of our audits

we are required to obtain an understanding of internal control over financial reporting but not for the purpose of expressing an opinion

on the effectiveness of the Company’s internal control over financial reporting.

Accordingly, we express no such opinion.

audits included performing procedures to assess the risks of material misstatement of the financial statements, whether due to error

or fraud, and performing procedures that respond to those risks.

Such procedures included examining, on a test basis, evidence regarding

the amounts and disclosures in the financial statements.

Our audits also included evaluating the accounting principles used and significant

estimates made by management, as well as evaluating the overall presentation of the financial statements.

We believe that our audits

provide a reasonable basis for our opinion.

have served as the Company’s auditor since 2015.

MEDICAL CORPORATION

HANCOCK JAFFE LABORATORIES, INC.

Current Assets:

and equipment, net

lease right-of-use assets, net

deposits and other assets

and Stockholders’

expenses and other current liabilities

revenue - related party

portion of operating lease liabilities

Cash and cash equivalents

Prepaid expenses and other current assets

Total Current Assets

Property and equipment, net

Operating lease right-of-use assets, net

Security deposits and other assets

Liabilities and Stockholders’ Equity

Current Liabilities:

operating lease liabilities

and Contingencies (Note 11)

Stockholders’

stock, par value $0.00001, 10,000,000 shares authorized:

Accounts payable

Accrued expenses and other current liabilities

Current portion of operating lease liabilities

Total Current Liabilities

Long-term operating lease liabilities

Total Liabilities

Commitments and Contingencies (Note 9)

Stockholders’ Equity:

Preferred stock, par value $ 0.00001 , 10,000,000 shares authorized:

no shares issued or outstanding

stock, par value $0.00001, 250,000,000 shares authorized, 2,541,529 and 717,274 shares issued and outstanding as of December

31, 2020 and December 31, 2019, respectively

paid-in capital

Common stock, par value $ 0.00001 , 250,000,000 shares authorized, 9,469,850 and 2,541,529 shares issued and outstanding as of December 31, 2021 and December 31, 2020, respectively

Additional paid-in capital

Accumulated deficit

( 81,851,233 )

( 65,323,411 )

Stockholders’

Liabilities and Stockholders’

Total Stockholders’ Equity

Total Liabilities and Stockholders’ Equity

accompanying notes are an integral part of these financial statements.

JAFFE LABORATORIES, INC.

MEDICAL CORPORATION

HANCOCK JAFFE LABORATORIES, INC.

OF OPERATIONS

the Years Ended

general and administrative expenses

and development expenses

on impairment of intangible asset

from Operations

(Income) Expense:

(income) expense, net

in fair value of derivative liabilities

For the Years Ended

Operating Expenses:

Selling, general and administrative expenses

Research and development expenses

Loss from Operations

( 16,892,503 )

( 9,135,126 )

Other (Income) Expense:

dividend to Series C Preferred Stockholders

Loss Attributable to Common Stockholders

Gain on extinguishment of note payable

Interest (income) expense, net

Change in fair value of derivative liabilities

Other (income) expense

Total Other (Income) Expense

( 16,527,822 )

( 9,135,486 )

Loss Per Basic and Diluted Common Share:

Average Number of Common Shares Outstanding:

Deemed dividend to Series C Preferred Stockholders

Net Loss Attributable to Common Stockholders

$ ( 16,527,822 )

$ ( 9,742,706 )

Net Loss Per Basic and Diluted Common Share:

Weighted Average Number of Common Shares Outstanding:

Basic and Diluted

accompanying notes are an integral part of these financial statements.

JAFFE LABORATORIES, INC.

OF CHANGES IN STOCKHOLDERS’

Stockholders’

at January 1, 2019

stock issued in private

placement offering [1]

stock issued in public

compensation [3]

at December 31, 2019

net of offering costs of $387,000.

net of offering costs of $549,000.

net of forfeiture of 246 shares.

C Convertible Preferred Stock

Stockholders’

at January 1, 2020

stock issued in private placement offering [5]

stock issued in public offerings [6]

stock issued in private placement [7]

stock exchange to common stock

stock issued for exercise of warrants

Reclassification

of Warrant Derivatives to Equity

at December 31, 2020

of offering costs of $80,000.

of offering costs of $2,185,000.

of offering costs of $198,000.

MEDICAL CORPORATION

HANCOCK JAFFE LABORATORIES, INC.

OF CHANGES IN STOCKHOLDERS’ EQUITY

Preferred Stock

Additional Paid-in

Total Stockholders’

Balance at January 1, 2020

$ ( 56,187,925 )

Common stock issued in private placement offering [1]

Common stock issued in public offerings [2]

Preferred stock issued in private placement [3]

Preferred stock exchange to common stock

( 4,205,406 )

Common stock issued for exercise of warrants

Fair Value of Warrants Issued

Shares issued in satisfaction of trade payable

Shares issued in satisfaction of trade payable, shares

Common stock issued in At the Market Transactions (ATM)

Common stock issued in At the Market Transactions (ATM), shares

Common stock issued in registered direct offering

Common stock issued in registered direct offering, shares

Reclassification of Warrant Derivatives to Equity

Share-Based Compensation

( 9,135,486 )

Balance at December 31, 2020

$ ( 65,323,411 )

net of offering

costs of $ 0.1 million.

net of offering costs of $ 2.2 million.

net of offering costs of $ 0.2 million.

Stockholders’

Balance at January 1, 2021

$ ( 65,323,411 )

Common stock issued in public offering

Common stock issued for exercise of warrants

Fair Value of Warrants Issued

Shares issued in satisfaction of trade payable

Common stock issued in At The Market Transactions (ATM)

Common stock issued in registered direct offering

Shared-Based Compensation

( 16,527,822 )

Balance at December 31, 2021

( 81,851,233 )

accompanying notes are an integral part of these financial statements.

JAFFE LABORATORIES, INC.

MEDICAL CORPORATION

HANCOCK JAFFE LABORATORIES, INC.

OF CASH FLOWS

the Years Ended

Flows from Operating Activities

For the Years Ended

Cash Flows from Operating Activities

$ ( 16,527,822 )

$ ( 9,135,486 )

to reconcile net loss to net cash used in operating

and amortization

of right-of-use assets

in fair value of derivatives

on impairment

on disposition of fixed assets

in operating assets and liabilities:

expenses and other current assets

on lease liabilities

Cash Used in Operating Activities

Flows from Investing Activities

of property and equipment

Cash Used in Investing Activities

Flows from Financing Activities

from private placement, net [1]

from public offerings, net [2]

from preferred stock issued in private placement, net [3]

from issuance of note payable

from warrant exercises

Cash Provided by Financing Activities

Increase (Decrease) in Cash, Cash Equivalent, and Restricted Cash

cash equivalents and restricted cash - Beginning of year

cash equivalents and restricted cash - End of year

Adjustments to reconcile net loss to net cash used in operating

Share-based compensation

Depreciation and amortization

Amortization of right-of-use assets

Change in fair value of derivatives

Gain on extinguishment of note payable

Loss on disposition of fixed assets

Changes in operating assets and liabilities:

Prepaid expenses and other current assets

Security deposit and other assets

Accounts payable

Accrued expenses

Payments on lease liabilities

Total adjustments

Net Cash Used in Operating Activities

( 11,845,846 )

( 7,677,210 )

Cash Flows from Investing Activities

Purchase of property and equipment

Net Cash Used in Investing Activities

Cash Flows from Financing Activities

Proceeds from private placement, net

Proceeds from shares issued under ATM

Proceeds from registered direct offering

Proceeds from public offerings, net

Proceeds from preferred stock issued in private placement, net

Proceeds from issuance of note payable

Proceeds from warrant exercises

Net Cash Provided by Financing Activities

Net Increase (Decrease) in Cash, Cash Equivalent, and Restricted Cash

Cash, cash equivalents and restricted cash - Beginning of year

Cash, cash equivalents and restricted cash - End of year

accompanying notes are an integral part of these financial statements.

JAFFE LABORATORIES, INC.

MEDICAL CORPORATION

HANCOCK JAFFE LABORATORIES, INC.

OF CASH FLOWS - continued

Disclosures of Cash Flow Information:

Paid During the Period For:

Investing and Financing Activities

liabilities reclassified to equity

of preferred stock for common stock

Supplemental Disclosures of Cash Flow Information:

Cash Paid During the Period For:

Interest paid

Income taxes paid

Non-Cash Investing and Financing Activities

Gain on extinguishment of note payable

$ ( 312,700 )

Fair value of common stock issued in satisfaction of trade payable

Fair value of warrants issued to Preferred Exchange Participants, SABR and re-priced placement agent warrant

Derivative liabilities reclassified to equity

accompanying notes are an integral part of these financial statements.

JAFFE LABORATORIES, INC.

MEDICAL CORPORATION

HANCOCK JAFFE LABORATORIES, INC.

TO FINANCIAL STATEMENTS

1 – Business Organization and Nature of Operations

Jaffe Laboratories, Inc.

is a medical device company developing tissue-based solutions that are designed to be life sustaining

or life enhancing for patients with cardiovascular disease, and peripheral arterial and venous disease.

The Company’s products

Medical Corporation is a med-tech company focused on improving the standard of care in the treatment of venous disease.

We are developing

tissue-based solutions that are designed to be life sustaining or life enhancing for patients with deep venous Chronic Venous Insufficiency

CVI occurs when valves inside of the veins of the leg fail, resulting in insufficient blood being returned to the heart.

are being developed to address large unmet medical needs by either offering treatments where none currently exist or by substantially

increasing the current standards of care.

Our products which we are developing include:

the VenoValve®, a porcine

based device to be surgically implanted in the deep venous system of the leg to treat a debilitating condition called chronic

venous deficiency (“CVI”);

and the CoreoGraft®, a bovine based conduit to be used to revascularize the heart

during coronary artery bypass graft (“CABG”) surgeries.

Both of these products are currently being

developed for approval by the U.S.

Food and Drug Administration (“FDA”).

Our current senior management team

has been affiliated with more than 50 products that have received FDA approval or CE marking.

Our lead product is a porcine based device to be surgically implanted in our deep venous

system of the leg, and is called the VenoValve®.

The VenoValve is currently being evaluated in the SAVVE U.S.

pivotal trial for the

purpose of obtaining approval to market and sell the device from the U.S.

Food and Drug Administration (“FDA”).

of officers and directors has been affiliated with numerous medical devices that have received FDA approval or CE marking and have been

commercially successful.

We currently lease a 14,507 sq.

manufacturing facility in Irvine, California, where we manufacture products for our clinical trials and which has previously

been FDA certified for commercial manufacturing of product.

of our products will be required to successfully complete clinical trials to demonstrate the safety and efficacy of the product

before it will able to be approved by the FDA.

Going Concern and Management’s Liquidity Plan

accompanying financial statements have been prepared on a going concern basis, which contemplates the realization of assets and

the satisfaction of liabilities in the normal course of business.

of December 31, 2020, the Company had a cash balance of $9,334,584 and working capital of $6,382,818.

On February 11, 2021, the

Company closed a public offering resulting in net proceeds to the Company of approximately $38,100,000 (see Note 14, Subsequent

the Company expects to continue incurring losses for the foreseeable future and may need to raise additional capital to sustain

its operations, pursue its product development initiatives and penetrate markets for the sale of its products, Management believes

that its capital resources at December 31, 2020, together with the proceeds from the February 11, 2021 offering, are sufficient

to meet our obligations as they become due within one year after the date of this Annual Report, and sustain operations.

JAFFE LABORATORIES, INC.

TO FINANCIAL STATEMENTS

manufacturing facility in Irvine, California, where we manufacture medical

devices for our clinical trials, and which has capacity for commercial manufacturing.

September 21, 2021, we announced that we were changing our name from Hancock Jaffe to enVVeno Medical Corporation and that our development

strategy is to focus on the treatment of venous disease.

In addition to the VenoValve, we announced that we have begun development of

a second device for the treatment of venous disease which we are calling enVVe.

In connection with this change in strategy, we indicated

that we are not pursuing further development of the CoreoGraft, which is now outside of our primary focus area.

2 – Management’s Liquidity Plan

of December 31, 2021, the Company had a cash balance of $ 54.7

million and working capital of $ 53.5

Although the Company expects to continue

incurring losses for the foreseeable future and may need to raise additional capital to sustain its operations, pursue its product development

initiatives and penetrate markets for the sale of its products, Management believes that our capital resources at December 31, 2021,

are sufficient to meet our obligations as they become due within one year after the date of this Annual Report, and sustain operations.

3 – Significant Accounting Policies

preparation of financial statements in conformity with accounting principles generally accepted in the United States of America

requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities and disclosures

of contingent liabilities at the dates of the financial statements and the reported amounts of revenues and expenses during the

reporting periods.

preparation of financial statements in conformity with accounting principles generally accepted in the United States of America requires

management to make estimates and assumptions that affect the reported amounts of assets and liabilities and disclosures of contingent

liabilities at the dates of the financial statements and the reported amounts of revenues and expenses during the reporting periods.

Actual results could differ from these estimates.

Significant estimates and assumptions include the valuation

allowance related to the Company’s deferred tax assets, and the valuation of warrants and derivative liabilities.

investments over which the Company exercises significant influence, but does not control, are accounted for using the equity method,

whereby investment accounts are increased (decreased) for the Company’s proportionate share of income (losses), but investment

accounts are not reduced below zero.

Company holds a 28.0% ownership investment, consisting of founders’

shares acquired at nominal cost, in HJLA.

To date, HJLA

has recorded cumulative losses.

Since the Company’s investment is recorded at $0, the Company has not recorded its proportionate

share of HJLA’s losses.

If HJLA reports net income in future years, the Company will apply the equity method only after

its share of HJLA’s net income equals its share of net losses previously incurred.

Significant estimates and assumptions include the valuation allowance related to the

Company’s deferred tax assets, and the valuation of warrants and derivative liabilities.

and Equipment, Net

and equipment are stated at cost, net of accumulated depreciation using the straight-line method over their estimated useful lives,

which range from 5 to 7 years.

and equipment are stated at cost, net of accumulated depreciation using the straight-line method over their estimated useful lives, which

range from 5 to 7 years.

Leasehold improvements are amortized over the lesser of (a) the useful life of the asset;

the remaining lease term.

Expenditures for maintenance and repairs, which do not extend the economic useful life of the related

assets, are charged to operations as incurred, and expenditures, which extend the economic life are capitalized.

When assets are

retired, or otherwise disposed of, the costs and related accumulated depreciation or amortization are removed from the accounts

and any gain or loss on disposal is recognized.

or (b) the remaining

Expenditures for maintenance and repairs, which do not extend the economic useful life of the related assets, are charged

to operations as incurred, and expenditures, which extend the economic life are capitalized.

When assets are retired, or otherwise disposed

of, the costs and related accumulated depreciation or amortization are removed from the accounts and any gain or loss on disposal is

of Long-lived Assets

Company reviews for the impairment of long-lived assets whenever events or changes in circumstances indicate that the carrying

amount of an asset may not be recoverable.

An impairment loss would be recognized when estimated future cash flows expected to

result from the use of the asset and its eventual disposition are less than its carrying amount.

JAFFE LABORATORIES, INC.

Company reviews for the impairment of long-lived assets whenever events or changes in circumstances indicate that the carrying amount

of an asset may not be recoverable.

An impairment loss would be recognized when estimated future cash flows expected to result from the

use of the asset and its eventual disposition are less than its carrying amount.

MEDICAL CORPORATION

HANCOCK JAFFE LABORATORIES, INC.

TO FINANCIAL STATEMENTS

The Company follows the asset and liability

method of accounting for income taxes under ASC 740, “Income Taxes.”

Deferred tax assets and liabilities are recognized

for the estimated future tax consequences attributable to differences between the financial statement carrying amounts of existing

assets and liabilities and their respective tax bases.

Deferred tax assets and liabilities are measured using enacted tax rates

expected to apply to taxable income in the years in which those temporary differences are expected to be recovered or settled.

Company follows the asset and liability method of accounting for income taxes under ASC 740, “Income Taxes.” Deferred tax

assets and liabilities are recognized for the estimated future tax consequences attributable to differences between the financial statement

carrying amounts of existing assets and liabilities and their respective tax bases.

Deferred tax assets and liabilities are measured

using enacted tax rates expected to apply to taxable income in the years in which those temporary differences are expected to be recovered

The effect on deferred tax assets and liabilities of a change in tax rates is recognized in income in the period that included

the enactment date.

Valuation allowances are established, when necessary, to reduce deferred tax assets to the amount expected

to be realized.

ASC 740 prescribes a recognition threshold

and a measurement attribute for the financial statement recognition and measurement of tax positions taken or expected to be taken

in a tax return.

For those benefits to be recognized, a tax position must be more likely than not to be sustained upon examination

by taxing authorities.

The Company recognizes accrued interest and penalties related to unrecognized tax benefits as income tax

There were no unrecognized tax benefits and no amounts accrued for interest and penalties as of December 31, 2020 and

December 31, 2019.

Valuation allowances are established, when necessary, to reduce deferred tax assets to the amount expected to be

740 prescribes a recognition threshold and a measurement attribute for the financial statement recognition and measurement of tax positions

taken or expected to be taken in a tax return.

For those benefits to be recognized, a tax position must be more likely than not to be

sustained upon examination by taxing authorities.

The Company recognizes accrued interest and penalties related to unrecognized tax benefits

as income tax expense.

There were no unrecognized tax benefits and no amounts accrued for interest and penalties as of December 31, 2021

and December 31, 2020.

The Company is currently not aware of any issues under review that could result in significant payments, accruals

1 unchanged sentence

Value of Financial Instruments

Company measures the fair value of financial assets and liabilities based on the guidance of Financial Accounting Standards Board

(“FASB”) Accounting Standards Codification (“ASC”) ASC 820 “Fair Value Measurements and Disclosures”

(“ASC 820”) which defines fair value, establishes a framework for measuring fair value, and expands disclosures about

fair value measurements.

ASC 820 defines fair value as the exchange price that would be received for an asset or paid to transfer a liability (an exit

price) in the principal or most advantageous market for the asset or liability in an orderly transaction between market participants

on the measurement date.

ASC 820 also establishes a fair value hierarchy, which requires an entity to maximize the use of observable

inputs and minimize the use of unobservable inputs when measuring fair value.

ASC 820 describes three levels of inputs that may

be used to measure fair value:

prices available in active markets for identical assets or liabilities trading in active markets.

inputs other than quoted prices included in Level 1, such as quotable prices for similar assets and liabilities in active

quoted prices for identical or similar assets and liabilities in markets that are not active;

or other inputs that

are observable or can be corroborated by observable market data.

inputs that are supported by little or no market activity and that are significant to the fair value of the assets or liabilities.

This includes certain pricing models, discounted cash flow methodologies and similar valuation techniques that use significant

unobservable inputs.

instruments, including accounts receivable and accounts payable are carried at cost, which management believes approximates fair

value due to the short-term nature of these instruments.

The Company’s other financial instruments include notes payable,

the carrying value of which approximates fair value, as the notes bear terms and conditions comparable to market for obligations

with similar terms and maturities.

Derivative liabilities are accounted for at fair value on a recurring basis.

JAFFE LABORATORIES, INC.

Company measures the fair value of financial assets and liabilities based on the guidance of Financial Accounting Standards Board (“FASB”)

Accounting Standards Codification (“ASC”) ASC 820 “Fair Value Measurements and Disclosures” (“ASC 820”)

which defines fair value, establishes a framework for measuring fair value, and expands disclosures about fair value measurements.

ASC 820 defines fair value as the exchange price that would be received for an asset or paid to transfer a liability (an exit price)

in the principal or most advantageous market for the asset or liability in an orderly transaction between market participants on the

measurement date.

ASC 820 also establishes a fair value hierarchy, which requires an entity to maximize the use of observable inputs

and minimize the use of unobservable inputs when measuring fair value.

ASC 820 describes three levels of inputs that may be used to measure

Quoted prices available

in active markets for identical assets or liabilities trading in active markets.

Observable inputs other

than quoted prices included in Level 1, such as quotable prices for similar assets and liabilities in active markets;

quoted prices

for identical or similar assets and liabilities in markets that are not active;

or other inputs that are observable or can be corroborated

by observable market data.

Unobservable inputs that

are supported by little or no market activity and that are significant to the fair value of the assets or liabilities.

This includes

certain pricing models, discounted cash flow methodologies and similar valuation techniques that use significant unobservable inputs.

Financial instruments, including accounts payable

are carried at cost, which management believes approximates fair value due to the short-term nature of these instruments.

Derivative liabilities

are accounted for at fair value on a recurring basis.

MEDICAL CORPORATION

HANCOCK JAFFE LABORATORIES, INC.

TO FINANCIAL STATEMENTS

financial instruments are recorded as a liability at fair value and are marked-to-market as of each balance sheet date.

in fair value at each balance sheet date is recorded as a change in the fair value of derivative liabilities on the statement

of operations for each reporting period.

The fair value of the derivative liabilities was determined using a Monte Carlo simulation,

incorporating observable market data and requiring judgment and estimates.

The Company reassesses the classification of the financial

instruments at each balance sheet date.

If the classification changes as a result of events during the period, the financial instrument

is marked to market and reclassified as of the date of the event that caused the reclassification.

February 25, 2020 in connection with the Bridge Offering (Note 11 –Stockholders’

Equity - Equity Issuances ),

the Company issued warrants to purchase 57,200 shares of its common stock.

The Company determined these warrants were derivative

financial instruments when issued.

Company recorded a gain on the change in fair value of derivative liabilities of $211,807 and $0 during the years ended December

31, 2020 and 2019, respectively.

July 15, 2020, the Company adopted a sequencing policy, whereby, in the event that reclassification of contracts from equity to

assets or liabilities is necessary pursuant to ASC 815 due to the Company’s inability to demonstrate it has sufficient authorized

shares, shares will be allocated on the basis of the earliest issuance date of potentially dilutive instruments, with the earliest

grants receiving the first allocation of shares.

Pursuant to ASC 815, issuances of securities to the Company’s employees

and directors, or to compensate grantees in a share-based payment arrangement, are not subject to the sequencing policy.

JAFFE LABORATORIES, INC.

TO FINANCIAL STATEMENTS

The change in

fair value at each balance sheet date is recorded as a change in the fair value of derivative liabilities on the statement of operations

for each reporting period.

The fair value of the derivative liabilities was determined using a Monte Carlo simulation, incorporating

observable market data and requiring judgment and estimates.

The Company reassesses the classification of the financial instruments at

each balance sheet date.

If the classification changes as a result of events during the period, the financial instrument is marked to

market and reclassified as of the date of the event that caused the reclassification.

Loss per Share

Company computes basic and diluted loss per share by dividing net loss attributable to common stockholders by the weighted average

number of common stock outstanding during the period.

Net loss attributable to common stockholders consists of net loss, adjusted

for the convertible preferred stock deemed dividend resulting from the 8% cumulative dividend on the Preferred Stock (see Note

10 - Stockholders Equity Series C Convertible Preferred Stock ).

Basic and diluted net loss per common share are the same

since the inclusion of common stock issuable pursuant to the exercise of warrants and options, would have been anti-dilutive.

following table summarizes the number of potentially dilutive common stock equivalents excluded from the calculation of diluted

net loss per common share as of December 31, 2020 and 2019:

of common stock issuable upon exercise of warrants

of common stock issuable upon exercise of options and restricted stock units

dilutive common stock equivalents excluded from diluted net loss per share

JAFFE LABORATORIES, INC.

TO FINANCIAL STATEMENTS

March 2016, the Financial Accounting Standards Board (“FASB”) issued Accounting Standard Update (“ASU”)

2016-08, “Revenue from Contracts with Customers - Principal versus Agent Considerations”, in April 2016, the FASB

issued ASU No.

2016-10, “Revenue from Contracts with Customers (Topic 606) - Identifying Performance Obligations and Licensing”

and in May 9, 2016, the FASB issued ASU No.

2016-12, “Revenue from Contracts with Customers (Topic 606)”, or ASU 2016-12.

This update provides clarifying guidance regarding the application of ASU No.

2014-09 - Revenue From Contracts with Customers

which is not yet effective.

These new standards provide for a single, principles-based model for revenue recognition that replaces

the existing revenue recognition guidance.

In July 2015, the FASB deferred the effective date of ASU 2014-09 until annual and

interim periods beginning on or after December 15, 2017.

It has replaced most existing revenue recognition guidance under U.S.

The ASU may be applied retrospectively to historical periods presented or as a cumulative-effect adjustment as of the date

The Company adopted Topic 606 using a modified retrospective approach and was applied prospectively in the Company’s

financial statements from January 1, 2018 forward.

Revenues under Topic 606 are required to be recognized either at a “point

in time”

or “over time”, depending on the facts and circumstances of the arrangement, and are evaluated using

a five-step model.

The adoption of Topic 606 did not have a material impact on the Company’s financial statements, at initial

implementation nor will it have a material impact on an ongoing basis.

Company recognizes revenue when goods or services are transferred to customers in an amount that reflects the consideration which

it expects to receive in exchange for those goods or services.

In determining when and how revenue is recognized from contracts

with customers, the Company performs the following five-step analysis:

(i) identification of contract with customer; (ii)

determination of performance obligations; (iii) measurement of the transaction price; (iv) allocation of the transaction

price to the performance obligations; and (v) recognition of revenue when (or as) the Company satisfies each performance

following table summarizes the Company’s revenue recognized in the accompanying statements of operations:

the Years Ended

from sales of products is recognized at the point where the customer obtains control of the goods and the Company satisfies its

performance obligation, which generally is at the time the product is shipped to the customer.

Royalty revenue, which is based

on resales of ProCol Vascular Bioprosthesis to third-parties, will be recorded when the third-party sale occurs and the performance

obligation has been satisfied.

Contract research and development revenue is recognized over time using an input model, based on

labor hours incurred to perform the research services, since labor hours incurred over time is thought to best reflect the transfer

JAFFE LABORATORIES, INC.

Company computes basic and diluted loss per share by dividing net loss attributable to common stockholders by the weighted average number

of common shares outstanding during the period including warrants exercisable for little or no cash consideration.

Net loss attributable

to common stockholders in 2020 consists of net loss adjusted for the convertible preferred stock deemed dividend resulting from the 8%

cumulative dividend on the Preferred Stock (see Note 10 - Stockholders Equity Series C Convertible Preferred Stock ).

diluted net loss per common share are the same since the inclusion of common stock issuable pursuant to the exercise of warrants and

options, would have been anti-dilutive.

MEDICAL CORPORATION

HANCOCK JAFFE LABORATORIES, INC.

TO FINANCIAL STATEMENTS

on Remaining Performance Obligations and Revenue Recognized from Past Performance

about remaining performance obligations pertaining to contracts that have an original expected duration of one year or less is

not disclosed.

The transaction price allocated to remaining unsatisfied or partially unsatisfied performance obligations with

an original expected duration exceeding one year was not material at December 31, 2020.

timing of our revenue recognition may differ from the timing of payment by our customers.

A receivable is recorded when revenue

is recognized prior to payment and the Company has an unconditional right to payment.

Alternatively, when payment precedes the

provision of the related services, deferred revenue is recorded until the performance obligations are satisfied.

The Company had

deferred revenue of $33,000 and $33,000 as of December 31, 2020 and 2019, respectively, related to cash received in advance for

contract research and development services.

Company measures the cost of services received in exchange for an award of equity instruments based on the fair value of the award.

The fair value of the award is measured on the grant date and recognized over the period services are required to be provided

in exchange for the award, usually the vesting period.

Forfeitures of unvested stock options are recorded when they occur.

Company has an Equity Incentive Plan under which the Board of Directors may grant restricted stock or stock options to employees and

nonemployees.

The accounting treatment for share-based payments to employees and non-employees is substantially equivalent.

compensation cost is recorded for all option grants and awards of non-vested stock based on the grant date fair value of the award, and

is recognized over the service period required for the award.

fair value of the Company’s stock options is estimated at the date of grant using the Black-Scholes based option valuation model.

For the expected term, the Company uses SEC Staff Accounting Bulletin No.

107 simplified method for “plain vanilla” options

with following characteristics:

(i) the share options are granted at the market price on the grant date;

(ii) exercisability is conditional

on performing service through the vesting date on most options;

(iii) if an employee terminates service prior to vesting, the employee

would forfeit the share options;

(iv) if an employee terminates service after vesting, the employee would have 30 to 90 days to exercise

the share options;

and (v) the share options are nontransferable and nonhedgeable.

volatility assumption is based on the historical volatility of the Company’s common stock with an equivalent remaining expected

The dividend yield assumption is based on the Company’s history and expectation of future dividend payouts on the common

The risk-free interest rate is based on the implied yield available on U.S.

treasury zero-coupon issues with an equivalent remaining

expected term.

option grants without performance conditions, the Company recognizes compensation expense over the requisite service period ratably,

recognizing expense for each tranche of each grant starting on the grant date.

For grants that have both service and performance conditions,

the Company recognizes compensation expense using the graded attribution method.

Compensation expense for grants with performance conditions

is recognized only for those awards expected to vest.

Forfeitures of unvested stock options are recorded

when they occur.

Concentrations

Company maintains cash with major financial institutions.

Cash held in United States bank institutions is currently insured by

the Federal Deposit Insurance Corporation (“FDIC”) up to $250,000 at each institution.

There were aggregate uninsured

cash balances of $9,084,584 and $1,867,286 as of December 31, 2020 and 2019, respectively.

the year ended December 31, 2019, 100% of the Company’s revenues were from royalties earned from the sale of product by

The three-year Post-Acquisition Supply Agreement from which the Company earned royalty from the sale of product by LeMaitre

ended on March 18, 2019.

The Company did not have any similar revenue in the year ended December 31, 2020.

Company evaluated events that have occurred after the balance sheet date through the date the financial statements were issued.

Based upon the evaluation and transactions, the Company did not identify any subsequent events that would have required adjustment

or disclosure in the financial statements, except as disclosed in Note 14 to the Financial Statements - Subsequent Events.

JAFFE LABORATORIES, INC.

TO FINANCIAL STATEMENTS

Cash held in United States bank institutions is currently insured by the Federal

Deposit Insurance Corporation (“FDIC”) up to $ 250,000 at each institution.

There were aggregate uninsured cash balances of

$ 54.5 million and $ 9.1 million as of December 31, 2021 and 2020, respectively.

Adopted Accounting Standards

February 2016, the FASB issued ASU No.

2016-02, “Leases (Topic 842),”

(“ASU 2016-02”).

ASU 2016-02 requires

an entity to recognize assets and liabilities arising from a lease for both financing and operating leases.

ASU 2016-02 will also

require new qualitative and quantitative disclosures to help investors and other financial statement users better understand the

amount, timing, and uncertainty of cash flows arising from leases.

ASU 2016-02 is effective for fiscal years beginning after December

As a result of the new standard, all of our leases greater than one year in duration were recognized in our Balance

Sheets as both operating lease liabilities and right-of-use assets upon adoption of the standard.

We adopted the standard using

the prospective approach.

Upon adoption on January 1, 2019, we recorded approximately $1.1 million in right-of-use assets and

operating lease liabilities in our Balance Sheets.

Accounting Standards

December 2019, the FASB issued ASU No.

2019-12, Simplifying the Accounting for Income Taxes, which is intended to simplify

various aspects of the income tax accounting guidance, including requirements such as tax basis step-up in goodwill obtained in

a transaction that is not a business combination, ownership changes in investments, and interim-period accounting for enacted

changes in tax law.

ASU 2019-12 is effective for public business entities for fiscal years beginning after December 15, 2020,

including interim periods within those fiscal years, and early adoption is permitted.

are currently evaluating the impact that this guidance will have on our consolidated financial statements.

Restricted Cash

of December 31, 2020, the Company did not have any restricted cash.

Previously, the Company had maintained a restricted cash balance

in connection with a vendor litigation matter with ATSCO, Inc.

(see Note 10 - Commitments and Contingencies - Litigations Claims

and Assessments ).

The matter was resolved on July 20, 2020, and on August 28, 2020 ATSCO took possession of the restricted

cash as full settlement of the dispute.

following table provides a reconciliation of cash, cash equivalents and restricted cash reported in the balance sheet as of December

31, 2020 and that sum to the total of the same amounts shown in the statement of cash flows for the year ended December 31, 2019

with the comparative cash balance without restricted cash as of December 31, 2020.

of December 31,

and cash equivalents

cash, cash equivalents, and restricted cash in the balance sheets

JAFFE LABORATORIES, INC.

2019-12, Simplifying the Accounting for Income Taxes, which is intended to simplify various

aspects of the income tax accounting guidance, including requirements such as tax basis step-up in goodwill obtained in a transaction

that is not a business combination, ownership changes in investments, and interim-period accounting for enacted changes in tax law.

2019-12 is effective for public business entities for fiscal years beginning after December 15, 2020, including interim periods within

those fiscal years, and early adoption is permitted.

adoption of this standard did not have a material impact on our financial statements.

Accounting Standards

January 2020, the FASB issued Accounting Standards Update 2020-01 (“ASU 2020-01”) Investments-Equity Securities (Topic 321),

Investments-Equity Method and Joint Ventures (Topic 323), and Derivatives and Hedging (Topic 815).

The amendments in ASU 2020-01 clarify

certain interactions between the guidance to account for certain equity securities under Topic 321, the guidance to account for investments

under the equity method of accounting in Topic 323, and the guidance in Topic 815, which could change how an entity accounts for an equity

security under the measurement alternative or a forward contract or purchased option to purchase securities that, upon settlement of

the forward contract or exercise of the purchased option, would be accounted for under the equity method of accounting or the fair value

option in accordance with Topic 825, Financial Instruments.

These amendments improve current GAAP by reducing diversity in practice and

increasing comparability of the accounting for these interactions.

The amendments in this update are effective for fiscal years beginning

after December 15, 2020, and interim periods within those fiscal years.

The adoption of this standard will not have a material impact

on our financial statements and related disclosures.

August 2020, the FASB issued Accounting Standards Update 2020-06 (“ASU 2020-06”), Accounting for Convertible Instruments

and Contracts in an Entity’s Own Equity.

The amendments in ASU 2020-06 include guidance on convertible instruments and the derivative

scope exception for contracts in an entity’s own equity and simplifies the accounting for convertible instruments which include

beneficial conversion features or cash conversion features by removing certain separation models in Subtopic 470-20.

Additionally, ASU

2020-06 will require entities to use the “if-converted” method when calculating diluted earnings per share for convertible

The amendments in this update are effective for fiscal years beginning after December 15, 2021, including interim periods

within those fiscal years.

We do not expect the adoption of this standard to have a material impact on our financial statements and related

May 2021, the FASB issued Accounting Standards Update 2021-04 (“ASU No.

2021-04”), Issuer’s Accounting for Certain

Modifications or Exchanges of Freestanding Equity-Classified Written Call Options.

The guidance in ASU 2021-04 requires the issuer to

treat a modification of an equity-classified written call option (the “option”) that does not cause the option to become

liability-classified as an exchange of the original option for a new option.

This guidance applies whether the modification is structured

as an amendment to the terms and conditions of the option or as termination of the original option and issuance of a new option.

amendments in this update are effective for fiscal years beginning after December 15, 2021, including interim periods within those fiscal

We do not expect the adoption of this standard to have a material impact on our financial statements and related disclosures.

October 2021, the FASB issued Accounting Standards Update 2021-08 (“ASU No.

2021-08”), Business Combinations (Topic 805):

Accounting for Contract Assets and Contract Liabilities from Contracts with Customers, to require that an acquirer recognize and measure

contract assets and contract liabilities acquired in a business combination in accordance with Topic 606, Revenue from Contracts with

At the acquisition date, an acquirer should account for the related revenue contracts in accordance with Topic 606 as if it

had originated the contracts.

The amendments in this update should be applied prospectively and are effective for fiscal years beginning

after December 15, 2022, including interim periods within those fiscal years.

We do not expect the adoption of this standard to have

a material impact on our financial statements and related disclosures.

MEDICAL CORPORATION

HANCOCK JAFFE LABORATORIES, INC.

TO FINANCIAL STATEMENTS

1 unchanged sentence

of December 31, 2021, and 2020, property and equipment consist of the following:

property and equipment

of Property and Equipment

Laboratory equipment

Furniture and fixtures

Computer equipment

Leasehold improvements

Total property and equipment

accumulated depreciation

and equipment, net

expense was $97,549 and $46,017 for the years ended December 31, 2020 and 2019, respectively.

Depreciation expense is reflected

in general and administrative expenses in the accompanying statements of operations.

Property and equipment, net

expense was $ 0.1 million for the years ended December 31, 2021 and 2020.

Depreciation expense is reflected in general and administrative

expenses in the accompanying statements of operations.

5 – Right-of-Use Assets and Lease Liabilities

September 20, 2017, the Company renewed its operating lease for its manufacturing facility in Irvine, California, effective October

1, 2017, for five years with an option to extend the lease for an additional 60-month term at the end of lease term.

lease rate was $26,838 per month with escalating payments.

In connection with the lease, the Company is obligated to pay $7,254

monthly for operating expenses for building repairs and maintenance.

The Company has no other operating or financing leases with

terms greater than 12 months.

Company determined the lease liabilities using the Company’s estimated incremental borrowing rate of 8.5% to estimate the

present value of the remaining monthly lease payments.

November 17, 2021, the Company amended its operating lease for its manufacturing facility in Irvine, California, to extend the term an

additional 60 months from its September 30, 2022 expiration date to a new expiration date of September 30, 2027.

The initial lease rate

at the date of the amendment was $ 30,206 per month with escalating payments.

In connection with the lease, the Company is obligated to

pay $ 7,254 monthly for operating expenses for building repairs and maintenance.

The Company has no other operating or financing leases

with terms greater than 12 months .

Company determined the lease liabilities using the Company’s estimated incremental borrowing rate of 3.95 % to estimate the present

value of the remaining monthly lease payments.

operating lease cost is as follows:

the Year Ended

JAFFE LABORATORIES, INC.

TO FINANCIAL STATEMENTS

of Operating Lease Cost

For the Year Ended

December 31, 2021

Operating lease cost

cash flow information related to our operating lease is as follows:

the Year Ended

cash flow information:

paid for amounts included in the measurement of lease

of Supplemental Cash Flow Information Related to Operating Lease

For the Year Ended

December 31, 2021

Operating cash flow information:

Cash paid for amounts included in the measurement of lease

lease term and discount rate for our operating lease is as follows:

of our lease liabilities by fiscal year for our operating lease is as follows:

ended December 31, 2021

of Operating Remaining Lease Term and Discount Rate

December 31, 2021

Remaining lease term

Discount rate

of our lease liabilities by fiscal year for our operating lease is as follows:

of Maturity of Lease Liabilities

Year ended December 31, 2022

Year ended December 31, 2023

Year ended December 31, 2024

Year ended December 31, 2025

Year ended December 31, 2026

Year ended December 31, 2027

Imputed interest

value of our lease liability

JAFFE LABORATORIES, INC.

Present value of our lease liability

MEDICAL CORPORATION

HANCOCK JAFFE LABORATORIES, INC.

TO FINANCIAL STATEMENTS

1 unchanged sentence

of December 31, 2021 and 2020, accrued expenses consist of the following:

compensation costs

professional fees

franchise taxes

research and development

of Accrued Expenses

Accrued compensation costs

Accrued professional fees

Accrued research and development

Accrued warrants

Accrued expenses

April 12, 2020, the Company obtained a loan (the “Loan”) in the amount of $312,700, pursuant to the Paycheck Protection

Program (the “PPP”) under Division A, Title I of the CARES Act, which was enacted March 27, 2020.

Loan, which was in the form of a Note dated April 12, 2020, matures on April 12, 2022, and bears interest at a rate of 1% per

annum, payable monthly commencing on November 12, 2020.

The Note may be prepaid at any time before maturity with no prepayment

Funds from the Loan may only be used for payroll costs, costs used to continue group health care benefits, mortgage

payments, rent, utilities, and interest on other debt obligations incurred before February 15, 2020.

The Company believes it has

used the entire Loan amount for qualifying expenses.

Under the terms of the PPP, certain amounts of the Loan may be forgiven if

they are used for qualifying expenses as described in the CARES Act.

The Company has included this loan as current liability on

the accompanying balance sheet as of December 31, 2020, because it intends to repay it within the next twelve months.

of December 31, 2020, the note payable balance was $312,700.

JAFFE LABORATORIES, INC.

TO FINANCIAL STATEMENTS

following summarizes the Company’s income tax provision (benefit):

the Years Ended December 31,

in valuation allowance

tax provision (benefit)

7 – Note Payable

April 12, 2020, the Company obtained a loan (the “Loan”) in the amount of $ 312,700 , pursuant to the Paycheck Protection Program

(the “PPP”) under Division A, Title I of the CARES Act, which was enacted March 27, 2020.

Loan, which was in the form of a Note dated April 12, 2020, was to mature on April 12, 2022 , and bore interest at a rate of 1 % per annum,

payable monthly commencing on November 12, 2020.

On September 8, 2021, the Company was notified the Loan and any accrued interest had

been forgiven.

In connection with this, the Company recorded a gain on extinguishment of debt of $ 312,700 .

8 – Income Taxes

following summarizes the Company’s income tax provision (benefit):

of Income Tax Provision (Benefit)

For the Years Ended December 31,

( 2,700,372 )

( 1,828,584 )

State and local:

Current and Deferred Federal, State and Local, Tax Expense

( 3,600,496 )

( 2,438,112 )

Change in valuation allowance

Income tax provision (benefit)

reconciliation between the U.S.

statutory federal income tax rate and the Company’s effective tax rate for the year’s

ended December 31, 2020 and 2019 is as follows:

the Years Ended

benefit at federal statutory rate

taxes, net of federal benefit

up adjustments

in valuation allowance

income tax rate

JAFFE LABORATORIES, INC.

statutory federal income tax rate and the Company’s effective tax rate for the year’s ended

December 31, 2021 and 2020 is as follows:

of Effective Income Tax Rate Reconciliation

the Years Ended December 31,

Tax benefit at federal statutory rate

State taxes, net of federal benefit

Nondeductible compensation

Permanent differences

True up adjustments

Change in valuation allowance

Effective income tax rate

MEDICAL CORPORATION

HANCOCK JAFFE LABORATORIES, INC.

TO FINANCIAL STATEMENTS

components of the Company’s deferred tax assets at December 31, 2020 and 2019 are as follows:

operating loss carryforwards

and development credit carryforwards

lease liability

gross deferred tax assets

tax liabilities

and equipment

net deferred tax assets

components of the Company’s deferred tax assets at December 31, 2021 and 2020 are as follows:

of Deferred Tax Assets and Liabilities

Deferred tax assets:

Net operating loss carryforwards

Research and development credit carryforwards

Intangible assets

Operating lease liability

Stock-based compensation

Impairment loss

Total gross deferred tax assets

Deferred tax liabilities

Operating lease asset

Property and equipment

Total net deferred tax assets

valuation allowance

ASC 740 requires that the tax benefit of

net operating losses, temporary differences and credit carryforwards be recorded as an asset to the extent that management assesses

that realization is "more likely than not."

Realization of the future tax benefits is dependent on the Company's ability

to generate sufficient taxable income within the carryforward period.

Because of the Company's history of operating losses, management

believes that recognition of the deferred tax assets arising from the above listed future tax benefits is currently not likely

to be realized and, accordingly, has provided a full valuation allowance.

The valuation allowance increased by $2.4 million and

$1.9 million during the years ended December 31, 2020 and 2019, respectively.

Section 382 of the Internal Revenue Code of 1986, as amended, if a corporation undergoes an “ownership change”

defined as a greater than 50% change (by value) in its equity ownership over a three-year period), the corporation’s ability

to use its pre-change net operating loss, or NOL, carryforwards and other pre-change tax attributes to offset its post-change

income taxes may be limited.

In accordance with Section 382 of the Internal Revenue Code, the usage of the Company’s NOL

carry forwards are subject to annual limitations due to a greater than 50% ownership change in 2018.

( 14,308,838 )

( 10,708,342 )

740 requires that the tax benefit of net operating losses, temporary differences and credit carryforwards be recorded as an asset to

the extent that management assesses that realization is “more likely than not.” Realization of the future tax benefits is

dependent on the Company’s ability to generate sufficient taxable income within the carryforward period.

Because of the Company’s

history of operating losses, management believes that recognition of the deferred tax assets arising from the above listed future tax

benefits is currently not more likely than not to be realized and, accordingly, has provided a full valuation allowance.

The valuation

allowance increased by $ 3.6

million and $ 2.4

million during the years ended December 31, 2021

and 2020, respectively.

Section 382 of the Internal Revenue Code of 1986, as amended, if a corporation undergoes an “ownership change” (generally

defined as a greater than 50% change (by value) in its equity ownership over a three-year period), the corporation’s ability to

use its pre-change net operating loss, or NOL, carryforwards and other pre-change tax attributes to offset its post-change income taxes

may be limited.

In accordance with Section 382 of the Internal Revenue Code, the usage of the Company’s NOL carry forwards are

subject to annual limitations due to a greater than 50 % ownership change in 2021.

December 31, 2021 and 2020, the Company had post-ownership change net operating loss carryforwards for federal income tax purposes

of approximately $35.0 million and $26.1 million, respectively.

Pre-2018 federal NOLs of approximately $12.0 million

of approximately $ 45.7

million and $ 35.0

million, respectively.

Pre-2018 federal NOLs

of approximately $ 12.0 million

may be carried forward for twenty years and begin to expire in 2029.

Under the Tax Act, post-2017 federal NOLs in

the aggregate amount of $23.0 million can be carried forward indefinitely and the annual limit of deduction equals 80% of

taxable income.

Based on the 2021 ownership change, the Company expects $ 7.6

million of its pre-2018 federal NOLs to expire unused.

Under the Tax Act, post-2017 federal NOLs in the aggregate amount of $ 33.0

million can be carried forward indefinitely and

the annual limit of deduction equals 80 %

of taxable income.

However, to the extent the Company utilizes its NOL carryforwards in the future, the tax years in which the attribute

was generated may still be adjusted upon examination by the Internal Revenue Service or state tax authorities of the future period

tax return in which the attribute is utilized.

The Company also has federal research and development tax credit carryforwards

of approximately $0.2 million which begin to expire in 2027.

was generated may still be adjusted upon examination by the Internal Revenue Service or state tax authorities of the future period tax

return in which the attribute is utilized.

The Company also has federal research and development tax credit carryforwards of approximately

million which begin to expire in 2027.

of December 31, 2021 and 2020, the Company had net operating loss carryforwards for state income tax purposes of approximately

$35.0 million and $26.1 million, respectively, which can be carried forward for twenty years and begin to expire in 2028.

million and $ 35.0

million, respectively, which can be carried forward for twenty years and begin to expire in 2028.

Company files income tax returns in the U.S.

federal jurisdiction as well as California and local jurisdictions and is subject

to examination by those taxing authorities.

The Company’s federal income taxes for the years beginning in 2016 remain subject

to examination.

The Company’s state and local income tax returns for the years beginning in 2016 remain subject to examination.

No tax audits were initiated during 2020 or 2019.

has evaluated and concluded that there were no material uncertain tax positions requiring recognition in the Company’s financial

federal jurisdiction as well as California and local jurisdictions and is subject to examination

by those taxing authorities.

The Company’s federal income taxes for the years beginning in 2018 remain subject to examination.

The Company’s state and local income tax returns for the years beginning in 2017 remain subject to examination.

No tax audits were

initiated during 2021 or 2020.

has evaluated and concluded that there were no material uncertain tax positions requiring recognition in the Company’s financial

statements as of December 31, 2021 and 2020.

The Company does not expect any significant changes in its unrecognized tax benefits

within twelve months of the reporting date.

The Company’s policy is to classify assessments, if any, for tax related interest

as interest expense and penalties as general and administrative expenses in the statements of operations.

On March 27, 2020, the CARES Act was enacted

in response to COVID-19 pandemic.

Under ASC 740, the effects of changes in tax rates and laws are recognized in the period which

the new legislation is enacted.

The CARES Act made various tax law changes including among other things (i) increasing the limitation

under Section 163(j) of the Internal Revenue Code of 1986, as amended (the “IRC”) for 2019 and 2020 to permit additional

expensing of interest (ii) enacting a technical correction so that qualified improvement property can be immediately expensed

under IRC Section 168(k), (iii) making modifications to the federal net operating loss rules including permitting federal net

operating losses incurred in 2018, 2019, and 2020 to be carried back to the five preceding taxable years in order to generate

The Company does not expect any significant changes in its unrecognized tax benefits within

twelve months of the reporting date.

The Company’s policy is to classify assessments, if any, for tax related interest as interest

expense and penalties as general and administrative expenses in the statements of operations.

March 27, 2020, the CARES Act was enacted in response to COVID-19 pandemic.

Under ASC 740, the effects of changes in tax rates and laws

are recognized in the period which the new legislation is enacted.

The CARES Act made various tax law changes including among other things

(i) increasing the limitation under Section 163(j) of the Internal Revenue Code of 1986, as amended (the “IRC”) for 2019

and 2020 to permit additional expensing of interest (ii) enacting a technical correction so that qualified improvement property can be

immediately expensed under IRC Section 168(k), (iii) making modifications to the federal net operating loss rules including permitting

federal net operating losses incurred in 2018, 2019, and 2020 to be carried back to the five preceding taxable years in order to generate

a refund of previously paid income taxes and (iv) enhancing the recoverability of alternative minimum tax credits.

is evaluating the impact but does not believe there is any significant impact to income taxes.

On June 29, 2020, California’s Governor

Newsom signed AB85 suspending California net operating loss (“NOL”) utilization and imposing a cap on the amount of

business incentives tax credits (R&D credit) for tax years 2020-2022.

Given an expected tax loss for 2020, the suspension

will not have an impact on the company’s NOL in California.

JAFFE LABORATORIES, INC.

The Company has evaluated

the impact CARES Act on its provision for income taxes and determined there is not a significant impact to income taxes because of the

On June 29, 2020, California’s Governor Newsom

signed AB85 suspending California net operating loss (“NOL”) utilization and imposing a cap on the amount of business incentives

tax credits (R&D credit) for tax years 2020-2022.

Given the tax loss in 2020 and an expected tax loss for 2021, the

suspension will not have an impact on the Company’s NOL in California.

On February 9, 2022, Mr.

Newsom signed SB113 which removes

the restrictions in AB85 effective for the 2022 tax year.

MEDICAL CORPORATION

HANCOCK JAFFE LABORATORIES, INC.

TO FINANCIAL STATEMENTS

1 unchanged sentence

Claims and Assessments

the normal course of business, the Company may be involved in legal proceedings, claims and assessments arising in the ordinary

course of business.

The Company records legal costs associated with loss contingencies as incurred and accrues for all probable

and estimable settlements.

September 21, 2018, ATSCO, Inc., a vendor, filed a lawsuit with the Superior Court seeking payment of $809,520 plus legal costs

for disputed invoices to the Company dated from 2015 to June 30, 2018.

The Company had entered into a Services and Material Supply

Agreement (“Agreement”), dated March 4, 2016 for ATSCO to supply porcine and bovine tissue to the Company.

18, 2019, the Orange County Superior Court granted a Right to Attach Order and Order for Issuance of Writ of Attachment in the

amount of $810,055 (the “Disputed Amount”) and on March 21, 2019, the Santa Clara, CA sheriff department served the

Writ of Attachment and took custody of and was holding the Disputed Amount (see Note 4 –

Restricted Cash).

On July 20, 2020,

the Company and ATSCO agreed to settle the dispute.

Pursuant to the terms of the settlement, the Company agreed to release the

Disputed Amount of restricted cash in exchange for a full release from all claims made by ATSCO related to this matter.

28, 2020, ATSCO took possession of the Restricted Cash.

Accordingly, as of August 28, 2020, the Company removed the restricted

cash and related accounts payable from its financial statements.

Company has replaced ATSCO and has entered into new supply relationships with two domestic and one international company to supply

porcine and bovine tissues.

Kaplan Nusbaum Complaint

October 8, 2018, Gusrae Kaplan Nusbaum PLLC (“Gusrae”) filed a complaint with the Supreme Court of the State of New

York seeking payment of $178,926 plus interest and legal costs for invoices to the Company dated from November 2016 to December

On November 30, 2020, the Company paid Gusrae $120,000 as full settlement of the complaint.

Settlement Agreement

May 31, 2019, the Company entered into an agreement (“Boxer Settlement Agreement”) with Allen Boxer and Donna Mason

(collectively, the “Boxer Parties”) for the purposes of settling a previously disclosed dispute in which the Boxer

Parties claimed to be owed fees for introducing the Company to Alexander Capital and Network 1 Securities who assisted the Company

for the capital raise of the convertible notes issued in 2017 and 2018, which raised over $5.6 million in gross proceeds.

to the Boxer Settlement Agreement, the Boxer Parties agreed to a complete release of claims of fees relating to past and future

capital raises and the Company agreed to issue 6,280 restricted shares of common stock and a five-year warrant to purchase 6,000

shares of common stock that vested immediately with an exercise price of $150.00 per share.

the normal course of business, the Company may be involved in legal proceedings, claims and assessments arising in the ordinary course

The Company records legal costs associated with loss contingencies as incurred and accrues for all probable and estimable

Rankin Complaints

July 9, 2020, the Company was served with a civil complaint filed in the Superior Court for the State of California, County of

Orange by a former employee, Robert Rankin, who resigned his employment on or about March 30, 2020.

The case is entitled Rankin

Hancock Jaffe Laboratories, Inc.

July 9, 2020, the Company was served with a civil complaint filed in the Superior Court for the State of California, County of Orange

by a former employee, Robert Rankin, who resigned his employment on or about March 30, 2020.

The case is entitled Rankin v.

Jaffe Laboratories, Inc.

et al., Case No.

30-2020-01146555-CU-WR-CJC and was filed on May 27, 2020.

On September 3,

2020 the Company and its Chief Executive Officer were served with a second complaint filed in the Superior Court for the State

of California, County of Orange by Mr.

On September 3, 2020 the Company

and its Chief Executive Officer were served with a second complaint filed in the Superior Court for the State of California, County of

Orange by Mr.

The case is entitled Rankin v.

1 unchanged sentence

et al., Case No.

30-2020-01157857 and was filed on August 31, 2020.

The complaints assert several causes of action including a cause of action

for failure to timely pay Mr.

Rankin’s accrued and unused vacation and three months’

severance under his July 16,

2018 employment agreement, defamation, unlawful labor code violations, sex-based discrimination, and unfair competition, and seeks

damages for lost wages, emotional and mental distress, consequential damages, punitive damages and attorney’s fees and costs.

The Company intends to vigorously defend the claims, investigate the allegations, and assert counterclaims.

As of the date of

these financial statements, the amount of loss associated with these complaints, if any, cannot be reasonably estimated.

no amounts related to these complaints are accrued as of December 31, 2020.

JAFFE LABORATORIES, INC.

NOTES TO FINANCIAL STATEMENTS

11 –Stockholders’

September 15, 2020, the Company completed a special meeting of stockholders (the “Special Meeting”).

At the Special

Meeting, the Company’s stockholders, among other things, (i) approved an amendment to the Company’s Amended and Restated

Certificate of Incorporation (the “A&R Certificate of Incorporation”) to increase the aggregate number of authorized

shares of common stock by 200,000,000 shares from 50,000,000 to 250,000,000 shares;

(ii) approved an amendment to the A&R

Certificate of Incorporation to reduce the vote required to amend, repeal, or adopt any provisions of the A&R Certificate

of Incorporation from the approval of 66 2/3% of the voting power of the shares of the then outstanding voting stock of the Company

entitled to vote to a majority of such shares;

and (iii) approved a reverse stock split of the Company’s common stock at

a ratio of between one-for-five and one-for-twenty-five, with such ratio to be determined at the sole discretion of the Company’s

Board of Directors (the “Board”) and with such reverse stock split to be effected at such time and date, if at all,

as determined by the Board in its sole discretion.

November 30, 2020, the Company”) effected a one-for-twenty five (1:25) reverse stock split (the “Reverse Stock Split”)

of the shares of the Company’s common stock, par value $0.00001 per share (the “Common Stock”).

of the Reverse Stock Split, every twenty five shares of issued and outstanding Common Stock was automatically combined into one

issued and outstanding share of Common Stock, without any change in the par value per share.

No fractional shares were issued

as a result of the Reverse Stock Split and any fractional shares resulting from the Reverse Stock Split were rounded up to the

nearest whole share.

2020 and 2019 the Company has completed various separate equity transactions to raise capital through the placement of its common

and preferred stock.

The following discussion provides an overview of the key elements of these transactions.

February 25, 2020, the Company raised $570,341 in net proceeds through a private placement bridge offering of its common stock

and warrants to purchase its common stock to certain accredited investors (the “Bridge Offering”).

The Company sold

an aggregate of 52,000 shares of common stock and warrants to purchase 52,000 shares of common stock in the Bridge Offering pursuant

to a securities purchase agreement between the Company and each of the investors in the Bridge Offering (the “Purchase Agreement”).

The placement was intended to bridge into a larger financing which did not occur.

Pursuant to the terms of the Purchase Agreement,

the Company agreed to hold a meeting of its stockholders on or prior to May 25, 2020 for the purpose of seeking approval of either

an increase in the number of shares of common stock the Company is authorized to issue or a reverse split of the Company’s

common stock (a “Capital Event”).

Company held a meeting of its stockholders on September 15, 2020 where the Company’s stockholders approved resolutions comprising

a Capital Event.

The warrants became exercisable upon the Capital Event, expire on February 25, 2025, and have an exercise price

of $19.75 per share.

April 28, 2020, the Company raised $ $1,000,000 in gross proceeds, with cash offering costs of $188,359 in a registered direct

offering of 75,472 shares of its common stock and concurrent private placement of warrants to purchase 75,472 shares of its common

stock for a combined issuance price of $13.25 per share.

The exercise price of the warrants is $10.125 per share and they expire

30-2020-01157857 and was

filed on August 31, 2020.

The complaints assert several causes of action including a cause of action for failure to timely pay Mr.

accrued and unused vacation and three months’ severance under his July 16, 2018 employment agreement, defamation, unlawful labor

code violations, sex-based discrimination, and unfair competition, and seeks damages for lost wages, emotional and mental distress, consequential

damages, punitive damages and attorney’s fees and costs.

The Company has denied all claims in both matters (which have now been

consolidated) and has filed a counterclaim asserting that Rankin has breached his employment agreement with the Company to the Company’s

The Company continues to believe it has meritorious defenses to both matters.

As of the date of these financial statements,

the amount of loss associated with these complaints, if any, cannot be reasonably estimated.

Accordingly, no amounts related to these

complaints are accrued as of December 31, 2021.

10 – Stockholders’ Equity

November 30, 2020, the Company”) effected a one-for-twenty-five (1:25) reverse stock split (the “Reverse Stock Split”)

of the shares of the Company’s common stock, par value $ 0.00001 per share (the “Common Stock”).

As a result of the

Reverse Stock Split, every twenty-five shares of issued and outstanding Common Stock was automatically combined into one issued and outstanding

share of Common Stock, without any change in the par value per share.

No fractional shares were issued as a result of the Reverse Stock

Split and any fractional shares resulting from the Reverse Stock Split were rounded up to the nearest whole share.

2021 and 2020 the Company has completed various equity transactions to raise capital through the placement of its common and preferred

The following table provides an overview of these transactions.

of Equity Transactions to Raise Capital Through the Placement

Number of shares

February 25, 2020

Private placement

April 28, 2020

June 3, 2020, the Company raised $1,333,000 in gross proceeds, with cash offering costs of $171,666 in a registered direct offering

of 117,216 shares of its common stock and concurrent private placement of warrants to purchase 117,216 shares of its common stock

for a combined issuance price of $11.38 per share.

The exercise price of the warrants is $8.25 per share and they expire June

JAFFE LABORATORIES, INC.

NOTES TO CONDENSED FINANCIAL STATEMENTS

July 17, 2020, the Company raised $4,600,000 in gross proceeds, with cash offering costs of $718,093, in a public offering of

575,000 shares of its common stock for a purchase price of $8.00 per share and warrants to purchase 575,000 shares of its common

The exercise price of the warrants is $8.00 per share, subject to customary adjustments and they expire on July 17, 2025.

investors in the July 17, 2020 public offering agreed with the underwriter to enter into a lock-up and voting agreement (the “Lock-Up

and Voting Agreements”) whereby each such investor was subject to a lock-up period through July 21, 2020 and agreed to vote

all shares of common stock each beneficially owned on the closing date of the Public Offering with respect to any proposals presented

to the stockholders of the Company.

Additionally, certain investors that agreed to enter into the Lock-Up and Voting Agreements,

as consideration for their waiver of certain rights described in the April 2020 Purchase Agreement and June 2020 Purchase Agreement,

were issued unregistered warrants (the “Waiver Warrants”) to purchase an aggregate of 139,800 shares of common stock.

These warrants were substantially similar to the warrants issued in the concurrent private placement, except that the warrants

have a term of five (5) years, an exercise price equal to $9.25 per share and carry piggy-back registration rights.

July 17, 2020, the Company raised $1,556,000 in gross proceeds, with cash offering costs of $197,901, in a private placement offering

of 4,205,406 shares of its Series C Convertible Preferred Stock (the “Preferred Stock”) to certain investors for a

purchase price of $0.37 per share of Preferred Stock, and warrants to purchase 243,125 shares of its common stock.

price of the warrants is $8.00 per share, subject to customary adjustments.

The warrants expire on July 17, 2025.

October 9, 2020, the Company raised $5,100,000 in gross proceeds, with cash offering costs of $649,500 in a registered direct

offering of 381,308 shares of its common stock and concurrent private placement of warrants to purchase 381,308 shares of its

common stock for a combined issuance price of $13.38 per share.

The exercise price of the warrants is $10.25 per share.

expire on October 7, 2025.

February 7, 2019, the Company entered into an Agreement (“MZ Agreement”) with MZHCI, LLC a MZ Group Company (“MZ”)

for MZ to provide investor relations advisory services.

The MZ Agreement was for an initial term of twelve (12) months with six-month

automatic extension periods.

MZ received cash compensation of $8,000 per month and eighty-five thousand (85,000) restricted shares

which vested quarterly over the initial twelve-month term.

Effective on July 24, 2020, the Company and MZ terminated the agreement.

March 12, 2019, the Company raised $2,704,000 in gross proceeds, with cash offering costs of $386,724 in a private placement offering

of its common stock to certain accredited investors (the “Offering”).

The Company sold an aggregate of 93,185 shares

of common stock in the Offering for a purchase price of $28.75 per share pursuant to a share purchase agreement between the Company

and each of the investors in the Offering.

Our CEO also participated in the Offering purchasing 736 shares at a price of $34 per

share, the final bid price of our common stock as reported on The Nasdaq Capital Market on the date of the Offering.

April 18, 2019, 246 unvested shares were returned to the Company by a consultant as a result of the December 26, 2018 termination

of such consultant’s consulting agreement.

May 31, 2019, the Company issued 6,280 restricted shares of common stock to the Boxer Parties pursuant to the Boxer Settlement

Agreement valued at $298,300 or $47.50 per share, the closing price of the Company’s common stock on the date the shares

JAFFE LABORATORIES, INC.

NOTES TO CONDENSED FINANCIAL STATEMENTS

June 14, 2019, the Company completed a public offering of 144,625 shares of its common stock at a price to the public of $26.75

per share, for total gross proceeds of $3,868,716 (the “Public Offering”), with cash offering costs of $549,060.

shares were offered pursuant to a registration statement that was declared effective on June 11, 2019.

2020 and 2019, the Company issued restricted shares of its common stock to its directors under the nonemployee directors compensation

program for shares vesting during the respective years.

In 2020 the Company issued 3,542 shares valued at $36,213 to Mr.

Matthew Jenusaitis, 2,890 shares valued at $24,842 to Mr.

Francis Duhay, and 2,500 shares valued at $21,625 to Mr.

In 2019, the Company issued 390 restricted shares of common stock to Dr.

Francis Duhay at a fair value of $19,164.

Registered Direct Offering

July 17, 2020

Public Offering

July 17, 2020

Private Placement

Preferred Stock

October 9, 2020

Registered Direct Offering

February 11, 2021

Public Offering

At-the-Market Equity Program

September 9, 2021

Registered Direct Offering

MEDICAL CORPORATION

HANCOCK JAFFE LABORATORIES, INC.

TO CONDENSED FINANCIAL STATEMENTS

C Convertible Preferred Stock

July 17, 2020, the Company issued 4,205,406 shares of Preferred Stock in a private placement.

On November 17, 2020 the Company

entered exchange agreements with the holders of the Preferred Stock pursuant to which all of the preferred shares were exchanged

for common shares.

the Preferred Stock was outstanding, the holders of the Company’s Preferred Stock could vote with holders of the Common

Stock, and with any other shares of preferred stock that vote with the Common Stock, with each holder of Preferred Stock being

entitled to one vote per share of Preferred Stock, and were entitled to receive 8% non-compounding cumulative dividends, payable

when, as and if declared by the Board of Directors.

The Series C Preferred Stock ranked senior to the common stock as to dividends

and the distribution of assets in the event of any liquidation, dissolution, or winding up of the Company, either voluntary or

involuntary, or any sale of the Company.

On November 17, 2020, the holders of the

Preferred Stock purchased in the July 17, 2020 private placement entered exchange agreements with the Company whereby the holders agreed

to exchange all of their 4,205,406 shares of Preferred Stock for 243,125 shares of common stock.

This was the original conversion rate

of the Preferred Stock after giving effect to the 25:1 reverse split of the Company’s common stock.

the Preferred Stock was outstanding, the holders of the Company’s Preferred Stock could vote with holders of the Common Stock,

and with any other shares of preferred stock that vote with the Common Stock, with each holder of Preferred Stock being entitled to one

vote per share of Preferred Stock, and were entitled to receive 8 % non-compounding cumulative dividends, payable when, as and if declared

by the Board of Directors.

The Series C Preferred Stock ranked senior to the common stock as to dividends and the distribution of assets

in the event of any liquidation, dissolution, or winding up of the Company, either voluntary or involuntary, or any sale of the Company.

the event of any liquidation, dissolution, or winding up of the Company, either voluntary or involuntary, or any sale of the Company,

the holders of Preferred Stock were entitled to receive, before and in preference to any distribution of any of the assets to

the holders of the common stock, or any other series of the Company’s preferred stock that would then be junior to

the Preferred Stock, an amount per share equal to $0.37 for each outstanding share of Preferred Stock (the “Original Series

C Issue Price”), plus all accrued but unpaid dividends thereon through the date of such event.

certain circumstances, the holders of Preferred Stock were entitled to receive a liquidation preference payment of $0.37 per share

of Preferred Stock, plus accrued and unpaid dividends.

Those accrued and unpaid dividends were $23,859 in the aggregate as of

September 30, 2020 and were reflected as a deemed dividend in determining net loss available to common stockholders during that

As a result of the exchange of the Preferred Stock for common stock, it is no longer outstanding (see

the holders of Preferred Stock were entitled to receive, before and in preference to any distribution of any of the assets to the holders

of the common stock, or any other series of the Company’s preferred stock that would then be junior to the Preferred Stock, an

amount per share equal to $0.37 for each outstanding share of Preferred Stock (the “Original Series C Issue Price”), plus

all accrued but unpaid dividends thereon through the date of such event.

certain circumstances, the holders of Preferred Stock were entitled to receive a liquidation preference payment of $ 0.37 per share of

Preferred Stock, plus accrued and unpaid dividends.

Those accrued and unpaid dividends were $ 23,859 in the aggregate as of September

30, 2020 and were reflected as a deemed dividend in determining net loss available to common stockholders during that period.

of the exchange of the Preferred Stock for common stock, it is no longer outstanding (see below).

liquidation preference of the Preferred Stock was subordinate and ranks junior to all indebtedness of the Company.

Company had the ability to elect to convert the Preferred Stock to common stock in the event the Company either (i) consummated

a merger, or (ii) raised an aggregate of at least $8,000,000 in gross proceeds in a transaction or series of transactions within

any twelve (12) month period.

In the event the Company elected to affect such a conversion, each share of Series C Preferred Stock

would have been convertible into 0.05781 shares of common stock.

JAFFE LABORATORIES, INC.

Company had the ability to elect to convert the Preferred Stock to common stock in the event the Company either (i) consummated a merger,

or (ii) raised an aggregate of at least $8,000,000 in gross proceeds in a transaction or series of transactions within any twelve (12)

month period.

In the event the Company elected to affect such a conversion, each share of Series C Preferred Stock would have been convertible

into 0.05781 shares of common stock.

MEDICAL CORPORATION

HANCOCK JAFFE LABORATORIES, INC.

NOTES TO CONDENSED FINANCIAL STATEMENTS

Company determined that the Preferred Stock represented permanent equity due to the absence of a redemption feature and that the

embedded conversion option was clearly and closely related to the equity host and did not require bifurcation.

The $2,431,250

fair value of the warrants was calculated using the Black-Scholes option pricing model, using the $11.00 stock price, an expected

term of 7.0 years, volatility of 118.7%, a risk-free rate of 0.47% and expected dividends of 0.00%.

The $1,556,000 of gross proceeds

were allocated on a relative fair value basis of $607,220 to the Preferred Stock and $948,781 to the warrants.

The Preferred Stock

includes a contingent beneficial conversion feature (“BCF”) which was valued at its $2,067,155 intrinsic value using

the commitment date stock price of $11.00 per share and the effective conversion price of $2.50 per share, but was limited to

the $607,220 of proceeds that were allocated to the Preferred Stock.

November 17, 2020, the Company entered exchange agreements with the holders of the Preferred Stock whereby the holders agreed

to exchange all of their 4,205,406 shares of Preferred Stock for 243,125 shares of common stock.

This was the original conversion

rate of the Preferred Stock after giving effect to the 25:1 reverse split of the Company’s common stock.

This resolved the

contingency related to the BCF and, accordingly, the contingent BCF was recognized as a deemed dividend for the purposes of determining

the net loss attributable to common stockholders for calculating net loss per share.

In addition, since the Company does not have

retained earnings, the dividend has been recorded against additional paid-in capital.

addition to the warrants issued to investors in the equity issuances during 2020 discussed above, the Company issued warrants

to the placement agents and underwriters in those transactions.

The placement agent in the February 25, 2020 transaction received

warrants to purchase 5,200 shares of common stock with an exercise price of $19.75 per share and expiring on February 25, 2025.

The placement agent in the April 28, 2020 transaction received warrants to purchase 6,038 shares of common stock with an exercise

price of $10.13 per share and expiring on April 28, 2025.

The placement agent in the June 3, 2020 transaction received warrants

to purchase 9,378 shares of common stock at an exercise price of $8.25 per share and expiring on June 3, 2025.

The placement agent

in the October 9, 2020 transaction received warrants to purchase 22,875 shares of common stock at an exercise price of $12.81

and expiring on October 7, 2025.

underwriter in the July 17, 2020 transactions received warrants to purchase 39,713 shares of common stock at an exercise price

of $10 per share and expiring on July 16, 2025.

These underwriter warrants were cancelled in connection with the Company’s

public offering completed on February 11, 2021 (see Note 14, Subsequent Events).

November 10, 2020 the Company agreed to pay Spartan Capital Securities LLC $355,000 in cash, warrants to purchase 17,618 shares

of common stock at a purchase price of $8.00 per share, and warrants to purchase 18,056 shares of common stock at a purchase price

of $10.25 per share.

These amounts were in dispute and were paid pursuant to an investment banking agreement dated February 12,

2020 in connection with financings which occurred in July and October 2020.

The fair value of these warrants on the settlement

date was $92,492 and $85,766, respectively, bringing the total amount of the payment to $533,261, of which $20,000 was

for reimbursement of legal fees and expensed, and $513,261 was included in the cost of the July and October financings.

JAFFE LABORATORIES, INC.

Company determined that the Preferred Stock represented permanent equity due to the absence of a redemption feature and that the embedded

conversion option was clearly and closely related to the equity host and did not require bifurcation.

The $ 2,431,250 fair value of the

warrants was calculated using the Black-Scholes option pricing model, using the $ 11.00 stock price, an expected term of 7.0 years, volatility

of 118.7 %, a risk-free rate of 0.47 % and expected dividends of 0.00 %.

The $ 1,556,000 of gross proceeds were allocated on a relative fair

value basis of $ 607,220 to the Preferred Stock and $ 948,781 to the warrants.

The Preferred Stock includes a contingent beneficial conversion

feature (“BCF”) which was valued at its $ 2,067,155 intrinsic value using the commitment date stock price of $ 11.00 per share

and the effective conversion price of $2.50 per share, but was limited to the $607,220 of proceeds that were allocated to the Preferred

November 17, 2020 exchange agreements resolved the contingency related to the BCF and, accordingly, the contingent BCF was recognized

as a deemed dividend for the purposes of determining the net loss attributable to common stockholders for calculating net loss per share.

In addition, since the Company does not have retained earnings, the dividend has been recorded against additional paid-in capital.

MEDICAL CORPORATION

HANCOCK JAFFE LABORATORIES, INC.

TO FINANCIAL STATEMENTS

fair value of the warrants was determined using the Black-Scholes method with the following assumptions:

summary of warrant activity during the years ended December 31, 2021 and 2020 is presented below:

Schedule of Stock Warrant Activity

Outstanding, January 1, 2020

Outstanding, January 1, 2021

Outstanding and exercisable, December 31, 2021

November 2020 as part of resolving a dispute,

the Company agreed to issue warrants to purchase 17,618

shares of common stock at a purchase price of

per share, and warrants to purchase 18,056

shares of common stock at a purchase price of

These amounts were in dispute and

were paid pursuant to an investment banking agreement dated February 12, 2020 in connection with financings which occurred in July and

October 2020.

The fair value of these warrants on the settlement date was $ 0.1

million and $ 0.1

million , respectively.

total amount of the payment to settle the dispute was $ 0.5

million, including the value of the warrants.

was included in the cost of the July and October financings.

The fair value of the warrants was determined using the Black-Scholes method

with the following assumptions:

stock price of $ 8.00

and $10.35, risk-free interest rate of 0.46%, volatility of 112.7%, annual rate of quarterly dividends of 0%, and an expected

term of 2.5 years.

and $ 10.35 ,

risk-free interest rate of 0.46 %,

volatility of 112.7 %,

annual rate of quarterly dividends of 0 %,

and an expected term of 2.5

The investment banking agreement has now been terminated with no further obligations.

November 2020 the Company’s Board of Directors approved the issuance of warrants to purchase 6,400 shares of common stock

to an advisor and warrants to purchase 20,000 shares of common stock to certain participants in the preferred share exchange (see

Note 11, Stockholders Equity –

Series C Convertible Preferred Stock ).

Separately the Company agreed to re-price warrants

issued to the placement agent for the Company’s February 25, 2020 private placement.

These warrants and the re-priced warrant

were issued in February 2021.

The value of these warrants at December 31, 2020 was $188,804 and is included in accrued expenses.

The Company determined their value using the Black-Scholes method with the following assumptions:

stock price of $8.65, risk-free

interest rate of 0.36%, volatility of 114.3%, annual rate of quarterly dividends of 0%, and an expected term of 2.5 to 3.5 years.

January 3, 2019, the Company entered into an Agreement (“Alere Agreement”) with Alere Financial Partners, a division

of Cova Capital Partners LLC (“Alere”), for Alere to provide capital markets advisory services.

The Alere Agreement

was on a month to month basis that could be cancelled by either party with thirty (30) days advance notice.

The Company paid a

monthly fee of $7,500 and issued to Alere five-year warrants to purchase 1,400 shares of the Company’s common stock at an

exercise price of $39.75, equal to the closing price of the Company’s common stock on February 7, 2019, the date of approval

by the Company’s board of directors (the “Board”).

The warrants had a grant date fair value of $14,000 using

the Black-Scholes pricing model, with the following assumptions used:

stock price of $39.75, risk free interest rate of 2.46%,

expected term of 2.8 years, volatility of 34.4% and an annual rate of quarterly dividends of 0%.

The warrants vested monthly equally

over a 12 month period provided that the Alere Agreement remained in effect.

On June 11, 2019, both parties agreed to terminate

the Alere Agreement as of June 30, 2019 and the unvested warrants as of June 30, 2019 totalling 700 were forfeited with a fair

value of $7,000.

The net charge to the statement of operations for the year ended 2019 was $7,000.

placement agent for the Offering on March 12, 2019 received a warrant to purchase such number of shares of the Company’s

common stock equal to 8% of the total shares of common stock sold in the Offering or 7,525 shares.

Such warrant is exercisable

for a period of five years from the date of issuance and has an exercise price of $37.50 per share.

May 31, 2019, the Company issued a five-year warrant to purchase 6,000 shares of common stock pursuant to the Boxer Settlement

Agreement that vested immediately with an exercise price of $150 per share to the Boxer Parties.

The warrants had a grant date

fair value of $3,000 using the Black-Scholes pricing model, with the following assumptions used:

stock price of $47.50, risk free

interest rate of 1.93%, expected term of 2.5 years, volatility of 35.1% and an annual rate of quarterly dividends of 0%.

May 31, 2019, the Company issued a five-year warrant to purchase 2,000 shares of common stock that vested immediately with an

exercise price of $50 to DFC Advisory Services LLC, D.B.A.

Tailwinds Research Group, LLC (“Tailwinds”) to provide

digital marketing services.

The warrants had a grant date fair value of $20,500 using the Black-Scholes pricing model, with the

following assumptions used:

stock price of $47.50, risk free interest rate of 1.93%, expected term of 2.5 years, volatility of

35.1% and an annual rate of quarterly dividends of 0%.

placement agent for the Public Offering on June 14, 2019 received a warrant to purchase such number of shares of the Company’s

common stock equal to 5% of the total shares of common stock sold in the Public Offering or 7,232 shares.

Such warrant is exercisable

for a period from December 8, 2019 through June 11, 2024 and has an exercise price of $32.10 per share.

JAFFE LABORATORIES, INC.

NOTES TO FINANCIAL STATEMENTS

November 2020 the Company’s Board of Directors approved the issuance of warrants to purchase 6,400

shares of common stock to an advisor and warrants

to purchase 20,000

shares of common stock to certain participants

in the preferred share exchange (see Note 10, Stockholders Equity – Series C Convertible Preferred Stock ).

the Company agreed to re-price warrants issued to the placement agent for the Company’s February 25, 2020 private placement.

warrants and the re-priced warrant were issued in February 2021.

The value of these warrants at December 31, 2020 was $ 188,804

and is included in accrued expenses.

determined their value using the Black-Scholes method with the following assumptions:

stock price of $ 8.65 ,

risk-free interest rate of 0.36 %,

volatility of 114.3 %,

annual rate of quarterly dividends of 0 %,

and an expected term of 2.5

MEDICAL CORPORATION

HANCOCK JAFFE LABORATORIES, INC.

TO FINANCIAL STATEMENTS

– Derivative Liabilities

warrants issued in connection with the February 25, 2020 Bridge Offering were determined to be derivative financial instruments

when issued because the Company did not have control of the obligation to obtain shareholder approval by May 25, 2020 to increase

the number of authorized shares or to approve a reverse stock split.

The accounting treatment of derivative financial instruments

required that the Company record the warrants as a liability at fair value and marked-to-market the instruments at fair

values as of each subsequent balance sheet date.

Any change in fair value is recorded as a change in the fair value of derivative

liabilities for each reporting period at each balance sheet date.

warrants issued in connection with our February 25, 2020 Bridge Offering were determined to be derivative financial instruments when

issued because the Company did not have control of the obligation to obtain shareholder approval by May 25, 2020 to increase the number

of authorized shares or to approve a reverse stock split.

The accounting treatment of derivative financial instruments required that

the Company record the warrants as a liability at fair value and marked-to-market the instruments at fair values as of each subsequent

balance sheet date.

Any change in fair value is recorded as a change in the fair value of derivative liabilities for each reporting period

at each balance sheet date.

warrant derivatives were valued as of the February 25, 2020 issuance date, as of the quarter ended March 31, 2020, as of June 30, 2020,

30, 2020, and as of September 15, 2020 when the Company’s stockholders approved an increase in authorized shares in an amount

sufficient to allow full exercise of these warrants.

and as of September 15, 2020 when the Company’s stockholders approved an increase in authorized shares in an amount sufficient

to allow full exercise of these warrants.

The value at issuance was $ 546,036 and was recorded as a derivative liability.

The value of the derivative liability was $199,907 at March 31, 2020, $281,183 at June 30, 2020, and $334,229 at September 15,

the derivative liability was $ 199,907 at March 31, 2020, $ 281,183 at June 30, 2020, and $ 334,229 at September 15, 2020.

derivative liability increased $ 53,046 and decreased $ 211,807 during the three and nine months ended September 30, 2020, respectively.

The changes in derivative liability is reflected in Other Income on the accompanying Statement of Operations.

Company reassessed the classification at each balance sheet date to determine if it should be changed as a result of events during

On September 15, 2020, the fair value of derivative

liabilities was reclassified to equity when the Company’s stockholders approved items comprising a Capital Event.

there is no fair value of derivative liabilities as of December 31, 2020.

Company reassessed the classification at each balance sheet date to determine if it should be changed as a result of events during the

On September 15, 2020, the fair value of derivative liabilities was reclassified to equity when the Company’s stockholders

approved items comprising a Capital Event.

Accordingly, there is no fair value of derivative liabilities as of December 31, 2020.

fair value of the warrants was determined using a Monte Carlo simulation, incorporating observable market data and requiring judgment

and estimates.

The following inputs and assumptions were used

for the valuation of the derivative liability:

was assumed the stock price would fluctuate with the Company’s projected volatility.

projected volatility was based on the historical volatility of the Company.

the Company was required to pay the fair value of the warrant in cash as of May 25, 2020, the obligation was discounted at

the Company’s estimated cost of debt based on short-term C-CCC bond ratings of 19.5% and 28.5%.

likelihood of the Company calling a shareholder meeting and achieving shareholder approval was 90% as of February 25, 2020.

June 30, 2020, the Company projected shareholder approval would not be obtained until approximately 8/31/20.

exercise was allowed prior to that date.

the Company obtained shareholder approval to increase the authorized shares on September 15, 2020, we assumed the warrant

holders have an option to require the Company to pay the fair value of the warrants.

The following inputs and assumptions were used for the valuation of the derivative liability:

Schedule of Assumption Used for Valuation of Derivative Liability

September 15,

Projected Volatility

Risk-Free Rate

Contractual Term (Years)

It was assumed the stock

price would fluctuate with the Company’s projected volatility.

The projected volatility

was based on the historical volatility of the Company.

If the Company was required

to pay the fair value of the warrant in cash as of May 25, 2020, the obligation was discounted at the Company’s estimated cost

of debt based on short-term C-CCC bond ratings of 19.5% and 28.5% .

The likelihood of the Company

calling a shareholder meeting and achieving shareholder approval was 90% as of February 25, 2020 .

As June 30, 2020, the Company

projected shareholder approval would not be obtained until approximately 8/31/20.

No mandatory exercise was allowed prior to that

Until the Company obtained

shareholder approval to increase the authorized shares on September 15, 2020, we assumed the warrant holders have an option to require

the Company to pay the fair value of the warrants.

The derivative value at that date was $ 334,229 .

following table sets forth a summary of the changes in the fair value of Level 3 derivative liabilities that are measured at fair

value on a recurring basis:

January 1, 2020

liabilities associated with the issuance of common stock warrants

liabilities associated with the issuance of placement agent warrants

in fair value of derivative liabilities

Reclassification

of warrant derivatives to equity

December 31, 2020

summary of warrant activity during the years ended December 31, 2020 and 2019 is presented below:

January 1, 2019

January 1, 2020

and exercisable, December 31, 2020

JAFFE LABORATORIES, INC.

NOTES TO FINANCIAL STATEMENTS

summary of outstanding and exercisable warrants as of December 31, 2020 is presented below:

Life in Years

JAFFE LABORATORIES, INC.

NOTES TO FINANCIAL STATEMENTS

MEDICAL CORPORATION

HANCOCK JAFFE LABORATORIES, INC.

TO FINANCIAL STATEMENTS

following table sets forth a summary of the changes in the fair value of Level 3 derivative liabilities that are measured at fair value

on a recurring basis:

Schedule of Fair Value of Level 3 Derivative Liabilities on Fair Value of Recurring Basis

Balance – January 1, 2020

Derivative liabilities associated with the issuance of common stock warrants

Derivative liabilities associated with the issuance of placement agent warrants

Change in fair value of derivative liabilities

Reclassification of warrant derivatives to equity

Balance – December 31, 2020

11 – Share Based Compensation

Incentive Plan

November 21, 2016, the board of directors approved the Company’s 2016 Omnibus Incentive Plan, which enables the Company

to grant stock options, stock appreciation rights, restricted stock, restricted stock units, unrestricted stock, other share based

awards and cash awards to associates, directors, consultants, and advisors of the Company and its affiliates, and to improve the

ability of the Company to attract, retain, and motivate individuals upon whom the Company’s sustained growth and financial

success depend, by providing such persons with an opportunity to acquire or increase their proprietary interest in the Company.

Stock options granted under the 2016 Plan may be non-qualified stock options or incentive stock options, within the meaning of

Section 422(b) of the Internal Revenue Code of 1986, except that stock options granted to outside directors and any consultants

or advisers providing services to the Company or an affiliate shall in all cases be non-qualified stock options.

The option price

must be at least 100% of the fair market value on the date of grant and if issued to a 10% or greater shareholder must be 110%

of the fair market value on the date of the grant.

2016 Plan is to be administered by the Board, which shall have discretion over the awards and grants thereunder.

No awards may

be issued after November 21, 2026.

On December 11, 2017 the board of directors approved an amendment to the 2016 Omnibus Incentive

Plan, whereby the number of common shares reserved for issuance under the plan was increased from 66,000 to 100,000.

26, 2018, our board of directors and our stockholders adopted and approved the Amended and Restated 2016 Omnibus Incentive Plan

(the “2016 Plan”), whereby the number of common shares reserved for issuance under the plan was increased from 100,000

to 180,000, plus an annual increase on each anniversary of April 26, 2018 equal to 3% of the total issued and outstanding shares

of our common stock as of such anniversary (or such lesser number of shares as may be determined by our board of directors).

December 17, 2020 our shareholders approved an amendment to the 2016 Plan to increase the number of shares authorized to be awarded

under the plan to 600,000 shares and to change the date of the annual 3% automatic increase of shares available under the plan

from April 26 to January 1.

exercise price of each option is determined based on the market price of the Company’s common stock at the grant date.

Company issues share-based awards under its Company’s 2016 Omnibus Incentive Plan, which enables the Company to grant stock options,

stock appreciation rights, restricted stock, restricted stock units, unrestricted stock, other share based awards and cash awards to

associates, directors, consultants, and advisors of the Company and its affiliates, and to improve the ability of the Company to attract,

retain, and motivate individuals upon whom the Company’s sustained growth and financial success depend, by providing such persons

with an opportunity to acquire or increase their proprietary interest in the Company.

Stock options granted under the 2016 Plan may be

non-qualified stock options or incentive stock options, within the meaning of Section 422(b) of the Internal Revenue Code of 1986, except

that stock options granted to outside directors and any consultants or advisers providing services to the Company or an affiliate shall

in all cases be non-qualified stock options.

The option price must be at least 100% of the fair market value on the date of grant and

if issued to a 10% or greater shareholder must be 110% of the fair market value on the date of the grant .

2016 Plan is to be administered by the Board, which has discretion over the awards and grants thereunder.

No awards may be issued

after November 21, 2026.

Plan was adopted in 2016 and amended in 2018, 2020 and 2021 to increase the number of shares authorized to be awarded under

As of December 31, 2021 there are 4,500,000 shares

authorized under the Plan as a result of the increase authorized by our shareholders in 2021.

The number of shares subject to

the Plan is automatically adjusted from time to time such that shares authorized under the plan shall at all times be equal

to at least 20 %

of the issued and outstanding shares of the Company on a fully diluted basis.

The current number of shares authorized is greater

than the 20 % minimum.

fair value of each option grant is estimated at the grant date using the Black Scholes method.

The following assumptions were

used in estimating fair value:

free interest rate

The following assumptions were used in

estimating fair value:

Schedule of Stock Options Assumptions in Estimated Fair Value

Expected term

5.44 – 6.5 years

5.16 – 5.76 years

112.94 – 103.6 %

Risk free interest rate

0.08 – 1.20 %

0..30 – 0.36 %

Dividend yield

Company estimated the expected term of the options using the simplified method.

In 2019, the Company used the volatility indices

of a selected group of peer companies from the primary industry sector in which the Company operates because its stock did not

have enough historical market information to calculate volatility with its own stock.

In 2020, the Company had enough stock price

history and therefor used that in estimating fair value of the options granted.

JAFFE LABORATORIES, INC.

NOTES TO FINANCIAL STATEMENTS

September 13, 2019, u nder the Company’s nonemployee director compensation program,

Robert Gray and Matthew Jenusaitis in connection with their appointment to the Board were each granted 2,400 options to purchase

shares of our common stock at an exercise price of $50.00 per share in accordance with the Option Plan.

All of these options vest

in equal quarterly portions over a three-year period starting from the September 13, 2019 grant date.

The Options had grant date

fair value of $3.25 per share for an aggregate grant date fair value of $15,600 using the Black-Scholes method with the following

assumptions used:

stock price of $24.00, risk-free interest rate of 1.75%, volatility of 35.7%, annual rate of quarterly dividends

of 0%, and a contractual term of 5.3 years.

July 18, 2020, u nder the Company’s nonemployee director compensation program,

the Company granted 4,000 options to purchase shares of common stock to each of its four independent directors at an exercise

price of $10 per share.

These options vested through the rest of 2020 such that they were fully vested as of December 31, 2020.

The options had a grant date fair value of $7.80 per share for an aggregate grant date fair value of $124,720 using the Black-Scholes

method with the following assumptions:

stock price of $10.00, risk-free interest rate of 0.3%, volatility of 107.5%, annual rate

of quarterly dividends of 0%, and an expected term of 5.2 years.

The Company uses its stock’s historical market

information to calculate volatility used in estimating fair value of options granted.

MEDICAL CORPORATION

HANCOCK JAFFE LABORATORIES, INC.

TO FINANCIAL STATEMENTS

summary of the option activity during the years ended December 31, 2021 and 2020 is presented below:

January 1, 2019

December 31, 2019

December 31, 2020

JAFFE LABORATORIES, INC.

NOTES TO FINANCIAL STATEMENTS

Number of Options

Remaining Life In

Company includes share-based compensation expense in selling, general and administrative expenses, and recognized $679,039 and

$492,084 during the years ended December 31, 2020 and 2019, respectively.

of December 31, 2020, there was $777,552 of unrecognized share-based compensation expense related to outstanding stock

options and restricted stock units that will be recognized over the weighted average remaining vesting period of 2.4 years.

JAFFE LABORATORIES, INC.

NOTES TO FINANCIAL STATEMENTS

April 2019, Mr.

Marcus Robins, a Director on the Board passed away.

Per his restricted stock unit Award Agreement, upon his death,

1,167 units representing the non-vested portion of his restricted stock units were forfeited.

September 13, 2019, u nder the Company’s nonemployee director compensation program,

Robert Gray and Matthew Jenusaitis in connection with their appointment to the Board were each granted 3,125 restricted stock

units in accordance with the Option Plan, which based on the Company’s closing stock price on the grant date were valued

at $24.00 per unit for an aggregate grant date value of $150,000.

These units vest in equal annual portions on the September 13,

2020, September 13, 2021 and September 13, 2022.

July 18, 2021, under the Company’s nonemployee director compensation program Robert Gray, Matthew Jenusaitis, Sanjay Shrivastava

and Francis Duhay each received a restricted stock grant for 4,000 shares, which, based on the Company’s closing stock price

on the grant date were valued at $10.00 per unit for an aggregate value of $160,000.

The grants fully vested on December 31, 2020

and each director received 4,000 shares of common stock.

Schedule of Stock Option Activity

Outstanding, January 1, 2020

Outstanding, December 31, 2020

Outstanding, December 31, 2021

Exercisable, December 31, 2021

Company includes share-based compensation expense in selling, general and administrative expenses, and recognized $ 6.0 million and $ 0.7

million during the years ended December 31, 2021 and 2020, respectively.

of December 31, 2021, there was $ 15.2 million of unrecognized share-based compensation expense related to outstanding stock options and

restricted stock units that will be recognized over the weighted average remaining vesting period of 2 years.

MEDICAL CORPORATION

HANCOCK JAFFE LABORATORIES, INC.

TO FINANCIAL STATEMENTS

Company also issues restricted shares and restricted stock units under the 2016 Plan.

A summary of the restricted share and restricted

stock units activity during the years ended December 31, 2021 and 2020 is presented below:

of Stock Option Activity Restricted Shares

Restricted Shares

Outstanding, January 1, 2020

Shares vested

Outstanding, December 31, 2020

Shares Vested

Outstanding, December 31, 2021

summary of outstanding restricted stock units as of December 31, 2021 is presented below:

Stock Units Exercisable

Number of Units

Remaining Life In

Related Party Transactions

February 11, 2021 the Company closed a public offering of its common stock (see Note 14 –

Subsequent Events).

investors in that transaction who, after the close of the transaction, holds approximately 10% of the Company’s outstanding

common stock is affiliated through common ownership with the vendor used by the Company to collect and assemble the data related

to its products’

clinical trials.

Expenditures to that vendor during the year ending December 31, 2020 were approximately

$820,000 and are included in Research and Development expenses in the accompanying statement of operations.

Expenditures to that

vendor were approximately $210,000, during the year ending December 31, 2019, and were included as software in property and equipment.

Subsequent Events

February 11, 2021, the Company raised $41,400,000 in gross proceeds, with cash offering costs of approximately $3,300,000, in

a public offering of 5,914,284 shares of its common stock for a purchase price of $7.00 per share and warrants to purchase 2,957,142

shares of its common stock.

The exercise price of the warrants is $7.00 per share, subject to customary adjustments and they expire

on February 11, 2026.

connection with this transaction, the underwriter agreed to cancel warrants to purchase 39,713 shares of the Company’s common

stock for $10.00 per share that it had received in connection with the July 21, 2020 public and private offerings (see Note 12

–Stockholders’

February 18, 2021, the Board approved option grants for the purchase of 1,917,492 shares of the Company’s common stock at

an exercise price of $8.20 per share (the closing price of the Company’s common stock on February 18, 2021).

The stock options

vest in equal quarterly or monthly installments over terms of two to three years.

These include grants for the purchase of 1,888,000

shares that may only become exercisable following receipt by the company of stockholder approval to increase the size of the Plan

sufficiently to permit the exercise in full of such stock options under the Plan.

Robert Berman, Marc H.

Glickman and Craig Glynn

received options to purchase 838,000 shares of common stock, 406,000 shares of common stock, and 324,000 shares of common stock,

respectively, that are subject to stockholder approval.

If the Company’s stockholders do not approve an increase in the

size of the Plan, these options will be void.

Schedule of Outstanding and Exercisable Restricted Stock Units

Restricted Stock Units

Restricted Stock Unit for

Note 12 – Net Loss Per Share

following table summarizes the number of potentially dilutive common stock equivalents excluded from the calculation of diluted net loss

per common share as of December 31, 2021 and 2020:

of Dilutive Net Loss Per Common Share

Shares of common stock issuable upon exercise of warrants

Shares of common stock issuable upon exercise of options and restricted stock

Potentially dilutive common stock equivalents excluded from diluted net loss

Compared sentence by sentence after normalising whitespace, quotation marks, case and digits, so re-formatting and restated figures do not read as changed language. Wording changes appear as one removal and one addition. The current filing and the prior one are authoritative.

What changed 10-K

Item 9A. Controls and Procedures