What changed in this filing

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Item 9A. Controls and Procedures

2021-03-04 compared with 2020-02-20 · 621 added, 759 removed, 419 unchanged (77% of the section changed)

4 unchanged sentences

filed under the Exchange Act, such as this Annual Report on Form 10-K, is collected, recorded, processed, summarized and reported

within the time periods specified in the rules of the SEC.

The Company’s disclosure controls and procedures are also designed

to ensure that such information is accumulated and communicated to management to allow timely decisions regarding required disclosure.

As required under Exchange Act Rule 13a-15, the Company’s management, including the Chief Executive Officer who also serves

as its Chief Financial Officer, after evaluating the effectiveness of disclosure controls and procedures (as defined in Exchange

Act Rules 13a-15(e) and 15d-15(e)) as of the end of the period covered by this Annual Report on Form 10-K, has concluded that based

on such evaluation, the Company’s disclosure controls and procedures were effective to ensure that information required to

be disclosed by the Company in the reports that the Company files or submits under the Exchange Act is recorded, processed, summarized

and reported, within the time periods specified in the SEC’s rules and forms, and that such information is accumulated and

communicated to the Company’s management, including the Company’s Chief Executive Officer who is also its Chief Financial

Officer, as appropriate, to allow timely decisions regarding required disclosure.

Management’s Annual Report on

within the time periods specified under the rules of the SEC.

The Company’s disclosure controls and procedures are also

designed to ensure that such information is accumulated and communicated to management to allow timely decisions regarding required

As required under Exchange Act Rule 13a-15, the Company’s management, including the Chief Executive Officer

who also serves as its Chief Financial Officer, after evaluating the effectiveness of disclosure controls and procedures (as defined

in Exchange Act Rules 13a-15(e) and 15d-15(e)) as of the end of the period covered by this Annual Report on Form 10-K,

has concluded that based on such evaluation, the Company’s disclosure controls and procedures were effective to ensure that

information required to be disclosed by the Company in the reports that the Company files or submits under the Exchange Act is

recorded, processed, summarized and reported, within the time periods specified in the SEC’s rules and forms, and that

such information is accumulated and communicated to the Company’s management, including the Company’s Chief Executive

Officer who is also its Chief Financial Officer, as appropriate, to allow timely decisions regarding required disclosure.

Management’s Annual Report on

Internal Control Over Financial Reporting

The Company’s management is responsible

for establishing and maintaining adequate internal control over financial reporting, as defined in Exchange Act Rule 13a-15.

control over financial reporting is defined in Rule 13a-15(f) and 15(d)-15(f) under the Exchange Act as a process designed to provide

reasonable assurance to the Company’s management and Board of Directors regarding the preparation and fair presentation of

published financial statements.

Management conducted an assessment of the Company’s internal control over financial reporting

as of December 31, 2019 based on the framework and criteria established by the Committee of Sponsoring Organizations of the Treadway

Commission in Internal Control-Integrated Framework (2013).

Based on the assessment, management concluded that, as of December

31, 2019, the Company’s internal control over financial reporting was effective based on those criteria.

The Company’s management, including

its Chief Executive Officer who is also its Chief Financial Officer, does not expect that the Company’s disclosure controls

The Company’s management is

responsible for establishing and maintaining adequate internal control over financial reporting, as defined in Exchange Act

Internal control over financial reporting is defined in Rule 13a-15(f) and 15(d)-15(f) under

the Exchange Act as a process designed to provide reasonable assurance to the Company’s management and Board of

Directors regarding the preparation and fair presentation of published financial statements.

Management conducted an

assessment of the Company’s internal control over financial reporting as of December 31, 2020 based on the

framework and criteria established by the Committee of Sponsoring Organizations of the Treadway Commission in Internal

Control-Integrated Framework (2013).

Based on the assessment, management concluded that, as of December 31, 2020, the

Company’s internal control over financial reporting was effective at a reasonable assurance level based on those

The Company’s management, including

its Chief Executive Officer who is also its Chief Financial Officer, does not expect that the Company’s disclosure controls

and procedures and its internal control processes will prevent all error and all fraud.

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Changes in Internal Control Over Financial

There has been no change in our internal

control over financial reporting (as defined in Rules 13a-15(f) and 15d-15(f) of the Exchange Act) that occurred during our fiscal

quarter ended December 31, 2019 that has materially affected, or is reasonably likely to materially affect, our internal control

over financial reporting.

The Company made changes in our internal control over financial

reporting (as defined in Rules 13a-15(f) and 15d-15(f) of the Exchange Act) to assess the limitation of net operating

loss carry-forward and its tax impact through an Internal Revenue Code Section 382 analysis during our fiscal quarter ended December 31,

There has been no other change in our internal control over financial reporting during our fiscal quarter ended December 31,

2020 that has materially affected, or is reasonably likely to materially affect, our internal control over financial reporting.

Other Information

4 unchanged sentences

Jeffrey Wolf, J.D.

Shallcross has been a member of our Board of Directors since December 6, 2018 and currently serves as our Chief Executive Officer,

a position he was appointed to on December 6, 2018, and our Chief Financial Officer.

Shallcross was appointed as our Interim

Chief Executive Officer on December 5, 2017 and has served as our Chief Financial Officer, Treasurer and Secretary since joining

us in June 2015.

Shallcross brings to our company operational, financial and international biotech industry experience, as

well as an established track record at leading the financial development and strategy for several publicly traded biotech companies.

Shallcross has been a member of our Board of Directors since December 6,

2018 and currently serves as our Chief Executive Officer, a position he was appointed to on December 6, 2018, and our Chief

Financial Officer.

Shallcross was appointed as our Interim Chief Executive Officer on December 5, 2017 and has served

as our Chief Financial Officer, Treasurer and Secretary since joining us in June 2015.

Shallcross brings to our company

operational, financial and international biotech industry experience, as well as an established track record at leading the financial

development and strategy for several publicly traded biotech companies.

From May 2013 through May 2015, Mr.

Shallcross served as Executive Vice President and Chief Financial Officer of Nuo Therapeutics,

served as Executive Vice President and Chief Financial Officer of Nuo Therapeutics, Inc.

(formerly Cytomedix, Inc.).

In January 2016, Nuo Therapeutics, Inc.

filed a voluntary petition for relief under Chapter 11

Bankruptcy Code in the United States Bankruptcy Court for the District of Delaware and on April 25, 2016, the Bankruptcy

Court entered an order granting approval of Nuo’s plan of reorganization.

filed a voluntary petition for relief under Chapter 11 of the U.S.

Code in the United States Bankruptcy Court for the District of Delaware and on April 25, 2016, the Bankruptcy Court entered

an order granting approval of Nuo’s plan of reorganization.

From July 2012 to May 2013, Mr.

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From July 2011 to March 2012, Mr.

Shallcross was Acting Chief Financial Officer of Senseonics, a privately-held

medical device company located in Germantown, MD.

From January 2009 to March 2011, he served as Executive Vice President and Chief

Financial Officer of Innocoll AG (formerly privately held Innocoll Holdings, Inc.), a global, commercial-stage biopharmaceutical

company specializing in the development and commercialization of collagen-based products.

He also served for four years as the

Chief Financial Officer and Treasurer of Vanda Pharmaceuticals, Inc., leading the company through its successful IPO and follow-on

offering and previously served as the Senior Vice President and Chief Financial Officer of Middlebrook Pharmaceuticals, Inc.

Advancis Pharmaceutical Corporation).

Shallcross was Acting Chief Financial Officer of Senseonics,

a privately-held medical device company located in Germantown, MD.

From January 2009 to March 2011, he served as Executive

Vice President and Chief Financial Officer of Innocoll AG (formerly privately held Innocoll Holdings, Inc.), a global, commercial-stage

biopharmaceutical company specializing in the development and commercialization of collagen-based products.

He also served for

four years as the Chief Financial Officer and Treasurer of Vanda Pharmaceuticals, Inc., leading the company through its successful

IPO and follow-on offering and previously served as the Senior Vice President and Chief Financial Officer of Middlebrook Pharmaceuticals, Inc.

(formerly Advancis Pharmaceutical Corporation).

In addition, Mr.

Shallcross also served as the Chief Financial Officer of Bering Truck Corporation.

Shallcross also served as the Chief Financial Officer of

Bering Truck Corporation.

Since June 2019, Mr.

Shallcross has served on the board of directors of Newgioco Group, Inc.

(Nasdaq:NWGI), an

international, vertically integrated commercial-stage company engaged in various aspects of the leisure gaming industry .

He holds an MBA from the University of Chicago’s Booth School of Business, a Bachelor of Science degree in Accounting from

the University of Illinois, Chicago, and is a Certified Public Accountant in the State of Illinois.

Shallcross brings to the Board significant

strategic, business and financial experience related to the business and financial issues facing biotechnology companies.

has a broad understanding of the financial markets, financial statements as well as generally accepted accounting principles.

his services as our Chief Executive Officer and Chief Financial Officer, he developed extensive knowledge of our business.

Kraws has been a member of the Company’s Board of Directors since January of 2006, and was appointed

independent, non-executive Chairman of the Board in May 2012.

Shallcross has served on the board of directors of Elys Game Technology, Corp.

(Nasdaq:ELYS), an international, vertically integrated commercial-stage company engaged in

various aspects of the leisure gaming industry .

He holds an MBA from the University of Chicago’s Booth School of Business,

a Bachelor of Science degree in Accounting from the University of Illinois, Chicago, and is a Certified Public Accountant in the

State of Illinois.

Shallcross brings to the Board

significant strategic, business and financial experience related to the business and financial issues facing biotechnology companies.

Shallcross has a broad understanding of the financial markets, financial statements as well as generally accepted accounting

Through his services as our Chief Executive Officer and Chief Financial Officer, he developed extensive knowledge of

our business.

Kraws has been a member of the Company’s Board of Directors since January of

2006, and was appointed independent, non-executive Chairman of the Board in May 2012.

Since 2003, Mr.

Kraws has served as Chief Executive Officer and

co-founder of Crystal Research Associates and CRA Advisors, and since February 2012, he has served as partner and co-founder

of TopHat Capital, LLC.

Kraws has served

as Chief Executive Officer and co-founder of Crystal Research Associates and CRA Advisors, and since February 2012, he has

served as partner and co-founder of TopHat Capital, LLC.

Since August 2016, Mr.

Kraws has served as the Co-President of Ra Medical Systems Inc.

(NYSE RMED), a

medical device company.

Kraws has served as the Co-President

of Ra Medical Systems Inc.

(NYSE RMED), a medical device company.

Kraws is a partner at Grannus Securities Pty Ltd.

(an Australian based private equity fund) since

November 2015.

Australian based private equity fund) since November 2015.

Well known and respected on Wall Street, Mr.

Kraws has received some of the most prestigious awards in the

Among other awards, he was given a “5-Star Rating” in 2001 by Zacks and was ranked the number one

analyst among all pharmaceutical analysts for stock performance in 2001 by Starmine.com.

Prior to founding Crystal Research

Associates, Mr.

Kraws served as co-president of The Investor Relations Group (IRG), a firm representing primarily

under-followed, small-capitalization companies.

Kraws has received

some of the most prestigious awards in the industry.

Among other awards, he was given a “5-Star Rating”

Zacks and was ranked the number one analyst among all pharmaceutical analysts for stock performance in 2001 by Starmine.com.

to founding Crystal Research Associates, Mr.

Kraws served as co-president of The Investor Relations Group (IRG), a firm representing

primarily under-followed, small-capitalization companies.

Previously, Mr.

Kraws served as a managing director of healthcare research

for Ryan Beck & Co.

and as director of research/senior pharmaceutical analyst and managing director at Gruntal & Co.,

LLC (prior to its merger with Ryan Beck & Company).

Kraws served as managing director of the healthcare research

group and senior pharmaceutical analyst at First Union Securities (formerly EVEREN Securities);

Kraws served as a managing director of healthcare

research for Ryan Beck & Co.

and as director of research/senior pharmaceutical analyst and managing director at Gruntal &

Co., LLC (prior to its merger with Ryan Beck & Company).

Kraws served as managing director of the healthcare

research group and senior pharmaceutical analyst at First Union Securities (formerly EVEREN Securities);

as senior U.S.

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analyst for the Swedish-Swiss conglomerate Asea Brown Boveri;

and as managing director and president of the

Brokerage/Investment Banking operation of ABB Aros Securities, Inc.

He also served as senior pharmaceutical analyst at

Nationsbanc Montgomery Securities, BT Alex Brown & Sons, and Buckingham Research.

Kraws also has industry experience,

having been responsible for competitive analysis within the treasury group at Bristol-Myers-Squibb Company.

through February of 2007, Mr.

Kraws served as our Vice President of Business Development, on a part-time basis.

December 2013, Mr.

Kraws serves on the board of directors of Avivagen Inc.

and as managing director and president of the Brokerage/Investment

Banking operation of ABB Aros Securities, Inc.

He also served as senior pharmaceutical analyst at Nationsbanc Montgomery Securities,

BT Alex Brown & Sons, and Buckingham Research.

Kraws also has industry experience, having been responsible for

competitive analysis within the treasury group at Bristol-Myers-Squibb Company.

During 2006 through February of 2007, Mr.

served as our Vice President of Business Development, on a part-time basis.

Since December 2013, Mr.

Kraws serves on

the board of directors of Avivagen Inc.

(TSX:VIV) and Saleen Automotive, Inc.

He holds an M.B.A.

from Cornell University and a B.S.

degree from State University of New

York — Buffalo.

Kraws brings a strong business background to us, having worked as a pharmaceutical

analyst for over 22 years.

University and a B.S.

degree from State University of New York —

Kraws brings a strong business

background to us, having worked as a pharmaceutical analyst for over 22 years.

Kraws brings to the Board significant

strategic, business and financial experience related to the business and financial issues facing pharmaceutical companies.

Kraws has a broad understanding of the operational, financial and strategic issues facing pharmaceutical companies.

His healthcare

experience, executive and leadership experience further qualify him as a member of the Board.

Tarriff has been a member of the Company’s Board of Directors since February 3, 2012.

Since January 2007 he has served as

a director and Chief Executive Officer of Eagle Pharmaceuticals, Inc., a publicly traded, hospital specialty company.

Eagle Pharmaceuticals,

EGRX) is focused on developing branded parenteral products through the application of various in-licensed drug delivery

technologies.

Prior to joining Eagle, Mr.

Tariff held various executive positions at Par Pharmaceutical Companies, Inc., a publicly-traded

developer, manufacturer and marketer of specialty pharmaceuticals, including as president and chief executive officer from September

2003 to September 2006, after joining Par in 1998.

Tarriff also served on Par’s board of directors from 2002 to September

Prior to that, Mr.

Tarriff held various positions with Bristol-Meyers Squibb, a publicly-traded biopharmaceutical company,

including senior director marketing.

Tarriff has served as a director of ZIOPHARM Oncology, Inc., a publicly traded company

biopharmaceutical company, since 2013 and previously served on the board of directors of Clinical Data, Inc., a publicly-traded

pharmaceutical company, from September 2009 to April 2011 when Clinical Data was acquired by Forest Laboratories, Inc.

in marketing from Pennsylvania State University and an M.B.A.

from Rider College.

Tarriff brings to our Board of Directors

significant knowledge of and experience in the pharmaceutical and medical industries.

He has extensive business, managerial, executive

and leadership experience that further qualify him to serve as a member of the Board and a valuable understanding of the role played

by the Board of Directors acquired through service on the boards of many companies.

He has had a long and successful career in

top executive leadership positions with leading, publicly traded pharmaceutical companies including Eagle Pharmaceuticals, Inc.,

Par Pharmaceuticals Companies, Inc.

and Bristol-Myers Squibb.

Jeffrey Wolf, J.D.

Wolf, who has been a member of the Company’s Board of Directors since 2006, has substantial experience in creating, financing,

nurturing and growing new ventures based upon breakthrough research and technology.

has a broad understanding of the operational, financial and strategic issues facing pharmaceutical companies.

His healthcare experience,

executive and leadership experience further qualify him as a member of the Board.

Monahan has been a member of the Company’s Board of Directors since November 11,

Monahan has served on the board of directors of Heat Biologics, Inc.

HTBX), a biopharmaceutical company

primarily engaged in the development of immune therapies and vaccines, since November 2009, and also served on the board of

directors of the biotech company Anixa Biosciences, Inc.

(formerly known as ITUS Corporation)(Nasdaq:

ANIX), a biotechnology

company focused on using the body’s immune system to diagnose, treat and prevent cancer, since 2016.

He is also a board member

of Cellix Ltd.

(Ireland) and has served on a number of other public and private boards over the years.

Monahan Co-Founded

AVGN) in 1992, a company which has become a leader in its sector for the development of novel pharmaceutical

products for the treatment of serious human diseases.

Over a 12 year period as Chief Executive Officer of Avigen he raised over

$235 million in several private and public financings including its initial public offering.

From 1989-1992, he was Vice President

of Research & Development at Somatix Therapy Corp., Alameda, CA and from 1985-1989 he was Director of Molecular &

Cell Biology at Triton Biosciences Inc., Alameda, CA.

Prior to that from 1982-1985, he was Research Group Chief, Department of

Molecular Genetics, Hoffmann-LaRoche, Inc.

Nutley, NJ, and from 1975 to 1977 he was an Instructor at Baylor College of Medicine,

Monahan served as a scientific advisory consultant to the Company from 2015 to November 10, 2020 and

from 2010 through 2015 he was the Company’s Senior Executive Vice President of Research & Development.

was also a Scientific Advisory Board member of Agilis Biotherapeutics (recently merged into PTC Therapeutics), from 2014 to 2019.

Monahan received his Ph.D.

in Biochemistry from McMaster University, Canada and his B.Sc.

from University College Dublin, Ireland.

Monahan brings to our Board of

Directors significant knowledge of and experience in the pharmaceutical and medical industries.

He has extensive business, managerial,

executive and leadership experience that further qualify him to serve as a member of the Board and a valuable understanding of

biochemistry and our product candidates.

Wolf, who has been a member of the Company’s Board of Directors since 2006,

has substantial experience in creating, financing, nurturing and growing new ventures based upon breakthrough research and technology.

In August 2008, Mr.

Wolf founded Heat Biologics,

HTBX), a publicly traded company engaged in research and development of drugs focused on combating cancer and other

Wolf founded Heat Biologics, Inc.

HTBX), a publicly traded company engaged in research

and development of drugs focused on combating cancer and other diseases.

Since April 2010, Mr.

Wolf has served as the Chief Executive Officer and Chairman of the Board of Heat Biologics, Inc.

Prior to founding Heat Biologics, Inc., from June 1997 to March 2011, Mr.

Wolf has served as managing director at Seed-One Ventures,

LLC a venture firm focused on launching and growing exceptional healthcare companies from the ground up.

Since founding Seed-One,

Wolf has founded and run several medical companies.

Wolf’s start-ups include Avigen, a San Francisco-based gene therapy

company where he was a co-founder and director;

TyRx Pharma, a Princeton-based company focused on the development of bio-compatible

polymers where he was a co-founder and Chairman;

EluSys Therapeutics, a New Jersey company focused on the development of novel

technology to remove blood-borne pathogens where he was a cofounder, Chairman and Chief Executive Officer;

and GenerationOne, a

Miami-based company focused on mobile-based collaborative care, where he was the founder, Chairman and Chief Executive Officer.

Wolf received his M.B.A.

Wolf has served as the

Chief Executive Officer and Chairman of the Board of Heat Biologics, Inc.

Prior to founding Heat Biologics, Inc., from

June 1997 to March 2011, Mr.

Wolf has served as managing director at Seed-One Ventures, LLC a venture firm focused

on launching and growing exceptional healthcare companies from the ground up.

Since founding Seed-One, Mr.

Wolf has founded

and run several medical companies.

Wolf’s start-ups include Avigen, a San Francisco-based gene therapy company where

he was a co-founder and director;

TyRx Pharma, a Princeton-based company focused on the development of bio-compatible polymers

where he was a co-founder and Chairman;

EluSys Therapeutics, a New Jersey company focused on the development of novel technology

to remove blood-borne pathogens where he was a cofounder, Chairman and Chief Executive Officer;

and GenerationOne, a Miami-based

company focused on mobile-based collaborative care, where he was the founder, Chairman and Chief Executive Officer.

received his M.B.A.

from Stanford Business School, his J.D.

from New York University School of Law and his B.A.

University of Chicago, where he graduated with honors in Economics.

Wolf serves as a director of several Seed-One portfolio

Wolf has extensive knowledge of the

industry and in particular research and development.

His legal and business background provide him with a broad understanding of

the legal, operational, financial and strategic issues facing our company.

from the University

of Chicago, where he graduated with honors in Economics.

Wolf serves as a director of several Seed-One portfolio companies.

Wolf has extensive knowledge of

the industry and in particular research and development.

His legal and business background provide him with a broad understanding

of the legal, operational, financial and strategic issues facing our company.

Having served as a board member on other public company

Wolf has an extensive understanding of the operational, financial and strategic issues facing public companies.

Directors’ Term of Office

Directors’

Term of Office

Directors will hold office until the next

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Audit Committee

The Audit Committee is comprised of Mr.

The Audit Committee is comprised of

Wolf (Chairman), Mr.

Kraws and Mr.

The Audit Committee is responsible for recommending our independent public accounting

firm and reviewing management’s actions in matters relating to audit functions.

The Committee reviews with our independent

public accountants the scope and results of the audit engagement and the system of internal controls and procedures.

The Committee

also reviews the effectiveness of procedures intended to prevent violations of laws.

The Committee also reviews, prior to publication,

our reports on Form 10-K and Form 10-Q.

Our Board has determined that all audit committee members are independent under applicable

SEC regulations and NYSE American rules.

Our Board of Directors has determined that each of Mr.

Kraws and Mr.

qualify as “audit committee financial experts” as that term is used in Section 407 of Regulation S-K.

Our Audit Committee

charter is located on our website www.syntheticbiologics.com .

Kraws and Dr.

The Audit Committee is responsible for recommending our

independent public accounting firm and reviewing management’s actions in matters relating to audit functions.

Committee reviews with our independent public accountants the scope and results of the audit engagement and the system of

internal controls and procedures.

The Committee also reviews the effectiveness of procedures intended to prevent violations

The Committee also reviews, prior to publication, our reports on Form 10-K and Form 10-Q.

Our Board has

determined that all audit committee members are independent under applicable SEC regulations and NYSE American rules.

Board of Directors has determined that each of Mr.

Kraws qualify as “audit

committee financial experts”

as that term is used in Section 407 of Regulation S-K.

Our Audit Committee charter is

located on our website www.syntheticbiologics.com .

Compensation Committee

Our Compensation Committee consists of

Kraws (Chairman), Mr.

Tarriff and Mr.

This committee performs several functions, including reviewing all forms of compensation

provided to our executive officers, directors, consultants and employees, including stock compensation.

Our Board has determined

that all compensation committee members are independent under applicable SEC regulations and NYSE American rules.

Our Compensation

Committee charter is located on our website www.syntheticbiologics.com .

Kraws (Chairman), Dr.

Monahan and Mr.

This committee performs several functions, including reviewing all

forms of compensation provided to our executive officers, directors, consultants and employees, including stock compensation.

Board has determined that all compensation committee members are independent under applicable SEC regulations and NYSE American

Our Compensation Committee charter is located on our website www.syntheticbiologics.com .

Nominations Committee

Our Nominations Committee consists of Mr.

Tarriff (Chairman), Mr.

Our Nominations Committee consists of Dr.

(Chairman), Mr.

Kraws and Mr.

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Delinquent Section 16(a) Reports

Section 16(a) of the Exchange Act requires

our executive officers, directors and persons who beneficially own more than 10 percent of a registered class of the Synthetic

Biologics’ equity securities to file with the SEC initial reports of ownership and reports of changes in ownership of our

common stock.

Such officers, directors and persons are required by SEC regulation to furnish us with copies of all Section 16(a)

forms that they file with the SEC.

Section 16(a) of the Exchange

Act requires our executive officers, directors and persons who beneficially own more than 10 percent of a registered class of the

Synthetic Biologics’

equity securities to file with the SEC initial reports of ownership and reports of changes in ownership

of our common stock.

Such officers, directors and persons are required by SEC regulation to furnish us with copies of all Section 16(a) forms

that they file with the SEC.

Based solely on a review of the copies

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and the following compensation disclosure is intended to comply with the requirements applicable to smaller reporting companies.

Although the rules allow us to provide less detail about its executive compensation program, the Compensation Committee is committed

to providing the information necessary to help stockholders understand its executive compensation-related decisions.

this section includes supplemental narratives that describe the 2019 executive compensation program for our Named Executive Officers.

Although the rules allow us to provide less detail about its executive compensation program, the Compensation Committee is

committed to providing the information necessary to help stockholders understand its executive compensation-related decisions.

Accordingly, this section includes supplemental narratives that describe the 2020 executive compensation program for our Named

Executive Officer.

The following table summarizes all compensation

awarded to, earned by or paid to Steven A.

Shallcross and Joseph Sliman, our Named Executive Officers, during the fiscal years

presented below.

Shallcross, our Named Executive Officer, during the fiscal years presented below.

Name and Principal Position

Salary ($) (1)

Awards ($) (2)

Steven Shallcross

$ 412,500 (4)

Chief Executive Officer

and Chief Financial Officer

Joseph Sliman (5)

Chief Medical Officer

Amount reflects the grant date

fair value of the Named Executive Officer’s stock options, calculated in accordance with FASB ASC Topic 718.

a discussion of the assumptions used in calculating these values, see Note 5 to our consolidated financial statements.

Shallcross was appointed as our Chief Executive Officer on December 6, 2018.

Shallcross’

annual salary was $550,000 commencing

December 6, 2018 and increased to $565,000 and $585,000 on December 5, 2019 and December 30, 2020, respectively.

Amount reflects the grant date fair value

of the Named Executive Officer’s stock options, calculated in accordance with FASB ASC Topic 718.

For a discussion of the

assumptions used in calculating these values, see Note 5 to our consolidated financial statements.

In December 2020, Mr.

Shallcross was issued an option to purchase 200,000 shares of common stock;

the awards vest monthly

over 36 months.

The all other compensation column

is comprised of vacation accrual paid, and the portion of medical, dental and vision premiums paid by us on behalf of

our Named Executive Officers.

was issued an option to purchase 450,000 shares of common stock;

the awards vest monthly over 36 months.

The all other compensation column is comprised

of vacation accrual paid, and the portion of medical, dental and vision premiums paid by us on behalf of our Named Executive Officers.

These benefits are offered to all Synthetic Biologics’

employees who work at least

17.5 hours per week.

Shallcross was appointed as our Chief Executive Officer

on December 6, 2018.

Shallcross’

annual salary is $550,000 commencing December 6, 2018 and increased to $565,000

on December 5, 2019.

These bonuses were earned in 2019 and paid in 2020.

Sliman was appointed our Chief Medical Officer effective

January 17, 2017.

His agreement expired January 16, 2019 and was not renewed.

employees who work at least 17.5 hours per week.

This bonus was earned in 2020 and paid in 2021.

Narrative Disclosure to Summary Compensation

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and retain executive talent by offering competitive base salaries, bonuses and long-term incentives.

The Compensation Committee’s

philosophy is to provide a compensation package that attracts and retains superior executive talent and delivers higher rewards

for superior performance and consequences for underperformance.

It is also the Compensation Committee’s practice to provide

a balanced mix of cash and equity-based compensation that aligns both the short and long-term interests of our executives with

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Our executive compensation program is based on the following philosophies and objectives:

Compensation Should Align with Stockholders’ Interests — The Compensation Committee believes that executives’ interests should be aligned with those of the stockholders.

Compensation Should Align with Stockholders’

Interests —

The Compensation Committee believes that executives’

interests should be aligned with those of the stockholders.

Executives are granted stock options so that their total compensation is tied directly to the same value realized by our stockholders.

Executive bonuses are tied directly to the value that we gain from an executive’s contribution to our success as a whole.

Compensation is Competitive — The Compensation Committee seeks to provide a total compensation package that attracts, motivates and retains the executive talent that we need in order to maximize its return to stockholders.

Executive bonuses are tied directly to the value that we gain from an executive’s contribution to our success as a whole.

Compensation is Competitive —

The Compensation Committee seeks to provide a total compensation package that attracts, motivates and retains the executive talent that we need in order to maximize its return to stockholders.

To accomplish this objective, executive compensation is reviewed annually to ensure that compensation levels are competitive and reasonable given our level of performance and other comparable companies with which we compete for talent.

Compensation Motivates and Rewards the Achievement of Goals — Our executive compensation program is designed to appropriately reward both individual and collective performance that meets and exceeds our annual, long-term and strategic goals.

To accomplish this objective, a substantial percentage of total compensation is variable, “at risk”, both through annual incentive compensation and the granting of long-term incentive awards.

Compensation Motivates and Rewards the Achievement of Goals —

Our executive compensation program is designed to appropriately reward both individual and collective performance that meets and exceeds our annual, long-term and strategic goals.

To accomplish this objective, a substantial percentage of total compensation is variable, “at risk”, both through annual incentive compensation and the granting of long-term incentive awards.

Oversight of Executive Compensation

Role of the Compensation Committee

Pursuant to the terms of its charter, the

Compensation Committee is responsible for the review of all aspects of our executive compensation program and makes decisions regarding

the compensation of the Named Executive Officers.

Our Named Executive Officers for the year ended December 31, 2019 were as follows:

Steven Shallcross, our Chief Executive Officer and Joseph Sliman, our former Chief Medical Officer.

The Compensation Committee’s responsibilities

Pursuant to the terms of its charter, the Compensation Committee is responsible for the review of all aspects of our executive compensation

program and makes decisions regarding the compensation of the Named Executive Officers.

Our sole Named Executive Officer for the year

ended December 31, 2020 was Steven Shallcross, our Chief Executive Officer.

The Compensation Committee’s responsibilities

include but are not limited to the following:

Establishing on an annual basis the performance goals and objectives for purposes of determining the compensation of our Chief Executive Officer and other senior executive officers.

Evaluating the Chief Executive Officer’s and other Named Executive Officer’s performance at least annually in light of those goals and objectives, and based upon these evaluations setting the compensation level for those officers.

Reviewing the competitive position of, and making recommendations to, the Board of Directors with respect to the cash-based and equity-based compensation plans and our programs relating to compensation and benefits.

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Additional information regarding the Compensation

Committee’s responsibilities is set forth in its charter, which is posted on our website at www.syntheticbiologics.com .

Role of the Chief Executive Officer

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In designing and implementing our executive

compensation program, our Compensation Committee considers our company’s operating and financial objectives, including our

risk profile, and the effect that its executive compensation decisions will have on encouraging our executive officers to take

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risk-taking to achieve short-term results that may not be sustainable in the long-term.

As an executive’s level of

responsibility increases, the Compensation Committee generally targets a greater portion of the executive’s

compensation to be contingent upon performance.

For example, historically our Named Executive Officers have a higher

percentage of compensation at risk (and thus greater upside and downside potential) relative to our other employees.

Compensation Committee believes this is appropriate because our Named Executive Officers have the greatest influence on our

During 2019, the salary for our Chief Executive Officer who also serves as our Chief Financial Officer was 49.6%

of his compensation package and performance based variable compensation comprised 48% of the compensation packages.

performance based variable compensation 22% was equity incentive performance-based compensation and 78% was cash

Target compensation comprises base salary and performance based variable compensation, including targeted cash bonus amounts and equity-based

compensation.

As an executive’s level of responsibility increases, the Compensation Committee generally targets a greater portion

of the executive’s compensation to be contingent upon performance in the form of variable compensation.

For example, historically

our Named Executive Officers have a higher percentage of compensation at risk (and thus greater upside and downside potential) relative

to our other employees.

The Compensation Committee believes this is appropriate because our Named Executive Officers have the greatest

influence on our performance.

During 2020, the salary for our Chief Executive Officer who also serves as our Chief Financial Officer was

51% of his target compensation package and performance based variable compensation comprised 49% of his target compensation.

Of the performance

based variable compensation 22% was equity-based compensation and 78% was his target cash bonus.

Compensation Review Process

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compensation for our Named Executive Officers.

The Compensation Committee considers the executive’s role and responsibilities,

corporate and individual performance, and industry-wide compensation practices and trends for other companies of similar size.

This approach is used to set base salaries, bonuses, stock option award levels and the mix of compensation elements.

We strive to attract and retain the most

highly qualified executive officers in an extremely competitive market.

Our Compensation Committee believes that it is important

when making its compensation decisions to be informed as to the competitive market for executive talent, including the current

practices of comparable public companies with which we compete for such talent.

Consequently, our Compensation Committee primarily

reviewed survey data which it had used in the prior year to aid in assessment of our Named Executive Officers pay program, a review

of the KornFerry November 2017 report that had been provided to the Compensation Committee and their own analysis of companies

that they considered to be similarly situated in terms of industry, number of employees and financial position.

With respect to

its analysis of the compensation of the Chief Executive Officer, although the Compensation Committee took into account the data

from the survey and report which included compensation for chief executive officers and chief financial officers separately, due

to the fact that our Chief Executive Officer also serves as our Chief financial Officer, which is not typical for most companies,

the Compensation Committee analysis included a blended analysis of the compensation for the two roles .

We strive to attract and retain the most highly qualified executive officers in an extremely competitive market.

Our Compensation Committee

believes that it is important when making its compensation decisions to be informed as to the competitive market for executive talent,

including the current practices of comparable public companies with which we compete for such talent.

Consequently, our Compensation Committee

primarily reviewed a report from Meridian Compensation Partners, LLC that had been provided to the Compensation Committee.

to its analysis of the compensation of the Chief Executive Officer, the Compensation Committee took into account that our Chief Executive

Officer also serves as our Chief Financial Officer, which is not typical for most companies.

While the Compensation Committee does take

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role of Chief Financial Officer.

The Compensation Committee’s general aim is for our compensation to remain competitive with

the market, falling above or below the median of the market data as appropriate based on corporate and individual executive performance,

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In addition, at our 2019 Annual Meeting

of Stockholders approximately the greatest number of votes were cast in favor of a three (3) year frequency for holding an advisory

vote on executive compensation.

Accordingly, our Compensation Committee decided not to make any significant changes to the executive

compensation policies;

however, our Compensation Committee continues to monitor and evaluate our compensation program in light

of our stockholders’ views and our transforming business needs.

of Stockholders approximately the greatest number of votes were cast in favor of a three (3) year frequency for holding an

advisory vote on executive compensation.

Our Compensation Committee decided not to make any significant changes to

the executive compensation policies;

however, our Compensation Committee continues to monitor and evaluate our compensation program

in light of our stockholders’

views and our transforming business needs.

Components of Compensation

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Base Salaries

We provide our Named Executive Officers

a base salary commensurate with their position, responsibilities and experience.

In setting the base salary, the Compensation Committee

considers the scope and accountability associated with each Named Executive Officer’s position and such factors as performance

and experience of each Named Executive Officer.

We design base pay to provide the essential reward for an employee’s work

and are required to be competitive in attracting talent.

Once base pay levels are initially determined, increases in base pay may

be provided to recognize an employee’s specific performance achievements.

The base salaries are targeted to be competitive

with other similar biotechnology companies.

Base salaries for the Named Executive Officers are set by their respective employment

contracts and are reviewed annually by the Compensation Committee.

Our Chief Executive Officer typically makes performance assessments

of our other employees throughout the year, and provides ongoing feedback to employees, provide resources and maximize individual

and team performance levels.

Based on the analysis of the peer group and other comparative research performed by the Committee,

the Committee was able to compare the base salary for the Chief Executive Officer who also serves as our Chief Financial Officer,

including base salary, long-term incentives and bonuses.

Upon the appointment of Mr.

Shallcross to serve as our Chief Executive

Officer in December 2018 and in light of the fact that he also serves as our Chief Financial Officer, it was determined that

his overall compensation levels were not competitive with the peer group and therefore his annual base salary was increased to

$550,000, which was the same annual base salary as that of our prior Chief Executive Officer.

Prior to his appointment as Chief

Executive Officer, from December 2017 until December 2018 Mr.

Shallcross served as the Interim Chief Executive Officer in

addition to serving as our Chief Financial Officer and his annual base salary for serving as Chief Financial Officer was $381,150

and he received an additional $8,000 per month for his service as Interim Chief Executive Officer.

Shallcross’ current

employment agreement, dated December 6, 2018, was amended (the “Amended Employment Agreement”) on December 5, 2019

to reflect a 3% cost of living adjustment to Mr.

Shallcross’ base salary, increasing his annual base salary to $565,000.

Our former Chief Medical Officer, Dr.

received an annual base salary of $385,000 for the two years that he served as our Chief Medical Officer.

The current base salary for our Chief Executive

Officer who also serves as our Chief Financial Officer is:

We provide our Named Executive Officers a base salary commensurate with their position, responsibilities and experience.

In setting the

base salary, the Compensation Committee considers the scope and accountability associated with each Named Executive Officer’s position

and such factors as performance and experience of each Named Executive Officer.

We design base pay to provide the essential reward for

an employee’s work that is required to be competitive in attracting talent.

Once base pay levels are initially determined, increases

in base pay may be provided to recognize an employee’s specific performance achievements or expansion of responsibilities.

salaries are targeted to be competitive with other similar biotechnology companies.

Base salaries for the Named Executive Officers are

set by their respective employment contracts and are reviewed annually by the Compensation Committee.

Based on the analysis of the peer

group and other comparative research performed by the Committee, the Committee was able to compare the base salary for the Chief Executive

Officer who also serves as our Chief Financial Officer, including base salary, long-term incentives and bonuses.

Upon the appointment

Shallcross to serve as our Chief Executive Officer in December 2018 and in light of the fact that he also serves as our Chief Financial

Officer, it was determined that his overall compensation levels were not competitive with the peer group and therefore his annual base

salary was increased to $550,000, which was the same annual base salary as that of our prior Chief Executive Officer.

Shallcross’

current employment agreement, dated December 6, 2018, was amended (the “Amended Employment Agreement”) on December 5, 2019

to reflect a 3% merit adjustment to Mr.

Shallcross’

base salary, increasing his annual base salary to $565,000 and further amended

on December 31, 2020 to reflect a 3.5% merit adjustment to Mr.

Shallcross’

base salary, increasing his annual base salary to $585,000.

The 2020 and current base salary for our

Chief Executive Officer who also serves as our Chief Financial Officer is:

Named Executive Officer

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The Compensation Committee also used information from the report and analysis

discussed above in determining bonuses as well as its own research of peer company compensation.

discussed above in determining bonus as well as its own research of peer company compensation.

For the year ended December 31,

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The employment agreement with Mr.

Shallcross that was in effect during 2019 provided that he was eligible for a bonus of up to seventy five percent (75%) of

his base salary (a “Target Bonus”) in cash or equity and Mr.

Shallcross received a cash bonuses with a value

equal to approximately seventy five percent (75%) of his Target Bonus.

The bonuses are to be rewarded based on whether, in

the discretion of the Compensation Committee and the Board of Directors, our company and the Named Executive Officer met

certain objectives established by the Compensation Committee or the Board of Directors.

The Compensation Committee believes

that the granting of a bonus is appropriate to motivate the Named Executive Officers.

The Compensation Committee focuses on

individual performance, which enables the Compensation Committee to differentiate among executives and emphasize the link

between personal performance and compensation.

Although the Compensation Committee does not use any fixed formula in

determining bonuses, it does link them to financial objectives of importance to it.

The following factors, in addition, to

the market data from the survey, were among those reviewed in determining the bonus for Mr.

successful filings of

all SEC reports in a timely manner;

commencement of enrollment in the Phase 2b investigator sponsored study for SYN-010,

engagement of AutoCruitment to aid with study enrollment, completion of toxicology studies, manufacturing and assay

development work for SYN-020, successful pre-IND meeting with FDA for Syn-020, entering into the clinical trial agreement

with Washington University for an investigator initiated study of SYN-004(Ribaxamase) in aGVHD program, completion of

Phase 1/2 study protocol and successful Type C meeting with FDA and successful management of our cash position during a

challenging environment.

Shallcross that was in effect during 2020 provided that he was eligible for a bonus of up to seventy

five percent (75%) of his base salary (a “Target Bonus”) in cash or equity and Mr.

Shallcross received a cash bonuses with

a value equal to approximately eighty-three (83%) of his Target Bonus.

The bonuses are to be rewarded in the discretion of the Compensation

Committee and the Board of Directors, based on a review of achievements for the year.

The Compensation Committee believes that the granting

of a bonus is appropriate to motivate the Named Executive Officers.

The Compensation Committee focuses on individual performance, which

enables the Compensation Committee to differentiate among executives and emphasize the link between personal performance and compensation.

Although the Compensation Committee does not use any fixed formula in determining bonuses, it does link bonuses to objectives the Compensation

Committee deems important such as financings, reduction in burn rate and achievement of clinical milestones.

Long-Term Incentives

The Compensation Committee believes that

a substantial portion of the Named Executive Officer’s compensation should be awarded in equity-based compensation since

equity-based compensation is directly linked to the interests of stockholders.

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provide competitive levels of total compensation.

Shallcross’ 2018 and 2019

bonus included a grant of options exercisable for 200,000, and 450,000 shares of common stock.

The stock options granted vest

in equal monthly installments over a three-year term and are subject to the recipient’s continued employment, therefore

acting as a significant retention incentive.

The Compensation Committee reviews the

performance, potential burn rates and dilution levels to create an option pool that may be awarded to employee participants.

to the Named Executive Officers were determined by the Compensation Committee after reviewing market data, including the reports

and analysis discussed above and after considering each executive’s performance, role and responsibilities.

Shallcross’

2019 and 2020 bonuses included a grant of options exercisable for 450,000 shares of common stock.

The stock options granted vest in equal monthly installments over a three-year term and are subject to the recipient’s

continued employment, therefore acting as a significant retention incentive.

The Compensation Committee reviews

the performance, potential burn rates and dilution levels to create an option pool that may be awarded to employee

participants.

Grants to the Named Executive Officers are determined by the Compensation Committee after reviewing market

data, including the reports and analysis discussed above and after considering each executive’s performance, role and

responsibilities.

The Compensation Committee does not seek

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eligible to participate in our 401(k) contributory defined contribution plan.

Pursuant to our 401(k) plan, all eligible employees,

including our Named Executive Officers, are provided with a means of saving for their retirement.

We currently match all participating

employee contributions up to maximum of 4 percent of compensation which vest immediately.

Pursuant to our 401(k) plan, all eligible

employees, including our Named Executive Officers, are provided with a means of saving for their retirement.

We currently match

all participating employee contributions up to maximum of 4 percent of compensation which vest immediately.

Nonqualified Deferred Compensation

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compensation plans to our employees, although we may consider such benefits in the future.

Former Chief Medical Officer Compensation

Joseph Sliman, served as our Chief Medical

Officer from February 3, 2012 until the expiration of his employment agreement on January 16, 2019.

Prior to the expiration date,

he was compensated in accordance with his employment agreement and other benefits consistent with those provided to members of

On October 9, 2018, we received a letter from Dr.

Sliman, our Chief Medical Officer purporting to provide notice of

a right to terminate his employment agreement, dated January 17, 2017, with us for “good reason”, alleging a material

reduction in his duties, authorities, and responsibilities as an executive of our company.

We are reviewing with legal counsel

our rights and remedies and we dispute certain aspects regarding Dr.

Sliman’s attempt to terminate his employment agreement.

The details of the agreement relating to Mr.

Sliman’s employment can be found under “—Employment Agreements—Joseph

Sliman, Former Chief Medical Officer.” Dr.

Sliman’s base salary for 2018 was $385,000, which was the same as his

base salary for 2017, and he was eligible for a target bonus of 75% of his base salary.

Sliman did not receive any performance

based variable compensation in 2018.

Sliman received a prorated salary of $18,716.

Attracting and retaining talented and motivated

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Risk Analysis of Our Compensation Program

Our Compensation Committee has reviewed

our compensation policies as generally applicable to our employees and believes that our policies do not encourage excessive or

inappropriate risk taking and that the level of risk that they do encourage is not reasonably likely to have a material adverse

effect on us.

As part of its assessment, the Compensation Committee considered, among other factors, the allocation of compensation

among base salary and short- and long-term compensation, our approach to establishing company-wide and individual financial, operational

and other performance goals.

Our Compensation Committee has

reviewed our compensation policies as generally applicable to our employees and believes that our policies do not encourage

excessive or inappropriate risk taking and that the level of risk that they do encourage is not reasonably likely to have a

material adverse effect on us.

As part of its assessment, the Compensation Committee considered, among other factors, the

allocation of compensation among base salary and short- and long-term compensation, and our approach to establishing

company-wide and individual financial, operational and other performance goals.

Outstanding Equity Awards at Fiscal

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We currently grant stock-based

awards pursuant to our 2010 Stock Incentive Plan (the “2010 Stock Plan”) and have outstanding awards under our 2001

Stock Incentive Plan (the “2001 Stock Plan”) and 2007 Stock Incentive Plan (the “2007 Stock Plan”).

awards pursuant to our 2020 Stock Incentive Plan (the “2020 Stock Plan”) and have outstanding awards under our 2001

Stock Incentive Plan (the “2001 Stock Plan”), 2007 Stock Incentive Plan (the “2007 Stock Plan”) and 2010

Stock Incentive Plan (the “2010 Stock Plan”).

Grant Date (1)

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Shallcross Options will vest pro rata, on a monthly basis, over 36 months.

Employment Agreements and Separation

Employment Agreements

Shallcross, Chief Executive

Officer, Chief Financial Officer

On December 6, 2018, we entered into

a three-year employment agreement with Mr.

Shallcross (the “Shallcross Employment Agreement”), to serve as the

Chief Executive Officer and to continue to serve as our Chief Financial Officer.

Shallcross has served as our Chief

Financial Officer since June 1, 2015, initially pursuant to the terms of a two year employment agreement that we entered with

him on April 28, 2015 (the “Initial Shallcross Employment Agreement”) that provided for an annual base salary of

$315,000, which was increased to $346,500 in 2016 and $381,150 in 2017.

Shallcross also served as our Interim Chief

Executive Officer from December 5, 2017 until his appointment as Chief Executive Officer in December 2018.

Effective December

20, 2017, we entered into an amendment to the Initial Shallcross Employment Agreement dated April 28, 2015, as amended on

December 1, 2016 and May 31, 2017, that increased Mr.

Shallcross’ annual base salary to $381,150 and for the period

Shallcross served as Interim Chief Executive Officer, it provided that he receive a cash payment of $8,000 per

calendar month;

pro-rated for any partial months that Mr.

Shallcross serves as Interim Chief Executive Officer.

Shallcross Employment Agreement replaced the Initial Shallcross Employment Agreement.

In addition, Mr.

Shallcross was

appointed as a director of the Company.

Shallcross does not receive additional compensation for service as our director.

On December 6, 2018, we entered

into a three-year employment agreement with Mr.

Shallcross (the “Shallcross Employment Agreement”), to serve

as the Chief Executive Officer and to continue to serve as our Chief Financial Officer.

Shallcross has served as our

Chief Financial Officer since June 1, 2015, initially pursuant to the terms of a two year employment agreement that we

entered with him on April 28, 2015 (the “Initial Shallcross Employment Agreement”).

The Shallcross

Employment Agreement replaced the Initial Shallcross Employment Agreement.

In addition, on December 6, 2018

Shallcross was appointed as a director of the Company.

Shallcross does not receive additional compensation

for service as our director.

The material terms of the Shallcross Employment Agreement are set forth below.

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as amended, Mr.

Shallcross is entitled to an annual base salary of $565,000 and an annual performance bonus of up to seventy five

percent (75%) of his annual base salary.

Shallcross is entitled to an annual base salary of $585,000 and an annual performance bonus of up to seventy

five percent (75%) of his annual base salary.

The annual bonus will be based upon the assessment of the Board of Mr.

Shallcross’s

The Shallcross Employment Agreement also includes confidentiality obligations and inventions assignments by Mr.

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a stated term of three years but may be terminated earlier pursuant to its terms.

Shallcross’s employment is terminated

for any reason, he or his estate as the case may be, will be entitled to receive the accrued base salary, vacation pay, expense

reimbursement and any other entitlements accrued by him to the extent not previously paid (the “Accrued Obligations”);

Shallcross’s employment is

terminated for any reason, he or his estate as the case may be, will be entitled to receive the accrued base salary, vacation pay,

expense reimbursement and any other entitlements accrued by him to the extent not previously paid (the “Accrued Obligations”);

provided, however, that if his employment is terminated (i) by us without Cause or by Mr.

Shallcross for Good Reason (as each is

defined in the Shallcross Employment Agreement) then in addition to paying the Accrued Obligations, (a) we will continue to pay

his then current base salary and continue to provide benefits at least equal to those that were provided at the time of termination

for a period of twelve (12) months and (b) he shall have the right to exercise any vested equity awards until the earlier of six

(6) months after termination or the remaining term of the awards;

or (ii) by reason of his death or Disability (as defined in the

Shallcross Employment Agreement), then in addition to paying the Accrued Obligations, Mr.

Shallcross would have the right to exercise

any vested options until the earlier of six (6) months after termination or the remaining term of the awards.

In such event, if

Shallcross commenced employment with another employer and becomes eligible to receive medical or other welfare benefits under

another employer-provided plan, the medical and other welfare benefits to be provided by us as described herein would terminate.

Shallcross for Good Reason

(as each is defined in the Shallcross Employment Agreement) then in addition to paying the Accrued Obligations, (a) we will

continue to pay his then current base salary and continue to provide benefits at least equal to those that were provided at the

time of termination for a period of twelve (12) months and (b) he shall have the right to exercise any vested equity awards

until the earlier of six (6) months after termination or the remaining term of the awards;

or (ii) by reason of his death

or Disability (as defined in the Shallcross Employment Agreement), then in addition to paying the Accrued Obligations, Mr.

would have the right to exercise any vested options until the earlier of six (6) months after termination or the remaining

term of the awards.

In such event, if Mr.

Shallcross commenced employment with another employer and becomes eligible to receive

medical or other welfare benefits under another employer-provided plan, the medical and other welfare benefits to be provided by

us as described herein would terminate.

The Shallcross Employment Agreement provides

that upon the closing of a “Change in Control” (as defined in the Shallcross Employment Agreement), all unvested options

that upon the closing of a “Change in Control”

(as defined in the Shallcross Employment Agreement), all unvested options

shall immediately vest and the time period that Mr.

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Shallcross may have will be equal to the shorter of:

(i) six (6) months after termination, or (ii) the remaining term

of the award(s).

(i) six (6) months after termination, or (ii) the

remaining term of the award(s).

If within one (1) year after the occurrence of a Change in Control, Mr.

Shallcross terminates his employment for

“Good Reason” or we terminate Mr.

Shallcross’s employment for any reason other than death, disability or Cause,

Shallcross terminates

his employment for “Good Reason”

or we terminate Mr.

Shallcross’s employment for any reason other than death,

disability or Cause, Mr.

Shallcross will be entitled to receive:

(i) the portion of his base salary for periods prior to the effective date of termination

accrued but unpaid (if any);

(i) the portion of his base salary for periods prior

to the effective date of termination accrued but unpaid (if any);

(ii) all unreimbursed expenses (if any);

(iii) an aggregate amount (the “Change in Control Severance

Amount”) equal to two (2) times the sum of his base salary plus an amount equal to the bonus that would be payable if the

“target” level performance were achieved under the Company’s annual bonus plan (if any) in respect of the fiscal

year during which the termination occurs (or the prior fiscal year if bonus levels have not yet been established for the year of

termination);

(iii) an aggregate

amount (the “Change in Control Severance Amount”) equal to two (2) times the sum of his base salary plus an amount

equal to the bonus that would be payable if the “target”

level performance were achieved under the Company’s

annual bonus plan (if any) in respect of the fiscal year during which the termination occurs (or the prior fiscal year if bonus

levels have not yet been established for the year of termination);

and (iv) the payment or provision of any other benefits.

If within two (2) years after the occurrence of a Change

in Control, Mr.

Shallcross terminates his employment for “Good Reason” or we terminate Mr.

Shallcross’s employment

for any reason other than death, disability or Cause, Mr.

Shallcross will be entitled to also receive for the period of two (2)

consecutive years commencing on the date of such termination of his employment, medical, dental, life and disability insurance

coverage for him and the members of his family that are not less favorable to him than the group medical, dental, life and disability

insurance coverage carried by us for him.

If within two (2) years after the occurrence of a Change in Control, Mr.

Shallcross terminates his employment for “Good

Reason”

or we terminate Mr.

Shallcross’s employment for any reason other than death, disability or Cause, Mr.

will be entitled to also receive for the period of two (2) consecutive years commencing on the date of such termination of

his employment, medical, dental, life and disability insurance coverage for him and the members of his family that are not less

favorable to him than the group medical, dental, life and disability insurance coverage carried by us for him.

The Change in Control Severance Amount

is to be paid in a lump sum if the Change in Control event constitutes a “change in the ownership” or a “change

in the effective control” of the Company or a “change in the ownership of a substantial portion of a corporation’s

assets” (each within the meaning of Section 409A of the Internal Revenue Code (“Rule 409A”)), or in 48 substantially

equal payments, if the Change in Control event does not so comply with Section 409A.

On December 4, 2019, the Board

awarded Steven A.

Shallcross, the Company’s Chief Executive Officer and Chief Financial Officer, (i) a cash bonus equal

to his full target bonus of 75% of his prior base salary and (ii) an option to purchase 450,000 shares of our common stock.

The stock option granted to Mr.

Shallcross has an exercise price of $0.418 per share, which is the closing price of the

Common Stock on the date of the grant (December 4, 2019), vests pro rata, on a monthly basis, over 36 consecutive months and

expires in seven (7) years from the date of the grant, unless terminated earlier.

The stock option was granted pursuant to

our 2010 Stock Incentive Plan, as amended, and our effective registration statement on Form S-8 for the 2010 Stock Incentive

In addition, the Shallcross Employment Agreement was amended on December 5, 2019 to reflect a 3% cost of living

adjustment to Mr.

Shallcross’ base salary, increasing his annual base salary to $565,000.

Joseph Sliman, Former Chief Medical

On January 17, 2017, we entered into a

two-year employment agreement with Dr.

Joseph Sliman (the “Sliman Employment Agreement”), who was promoted from the

position of Senior Vice President–Clinical & Regulatory Affairs to the position of Chief Medical Officer, which agreement

expired in January 2019 and was not renewed.

On October 9, 2018, we received a letter from Dr.

Sliman, purporting to provide notice

of a right to terminate the Sliman Employment Agreement for “good reason”, alleging a material reduction in his duties,

authorities, and responsibilities as an executive of the Company.

We are reviewing with legal counsel our rights and remedies and

dispute certain aspects regarding Mr.

Sliman’s attempt to terminate the Sliman Employment Agreement.

Pursuant to the terms of the Sliman Employment

Agreement, Dr.

Sliman was entitled to an annual base salary of $385,000 and an annual performance bonus of up to seventy five percent

(75%) of his annual base salary.

The annual bonus was to be based upon the assessment of the Board of Dr.

Sliman’s performance.

Sliman was also granted a seven year incentive stock option to purchase one hundred and eighty-eight thousand nine hundred

and twenty-seven (5,398) shares of our common stock, vesting pro rata on a monthly basis over a three year period.

signed a standard agreement that also includes confidentiality obligations and inventions assignments by Dr.

Sliman and non-solicitation

and non-competition provisions.

The Sliman Employment Agreement had a stated

term of two years but provided that it could be terminated earlier pursuant to its term.

The Sliman Agreement provided that if

Sliman’s employment was terminated for any reason, he or his estate as the case may be, would be entitled to receive

the accrued base salary, vacation pay, expense reimbursement and any other entitlements accrued by him to the extent not previously

paid (the “Accrued Obligations”);

provided , however , that if his employment were terminated (1) by us

without Cause or by the Executive for Good Reason (as each is defined below) then in addition to paying the Accrued Obligations,

(x) we would be obligated to continue to pay his then current base salary and continue to provide benefits at least equal to those

which were provided at the time of termination for a period of 12 months and (y) he would have the right to exercise any vested

equity awards until the earlier of six months after termination or the remaining term of the awards, or (2) by reason of his death

or Disability (as defined in each of the Sliman Employment Agreement), then in addition to paying the Accrued Obligations, he would

have the right to exercise any vested options until the earlier of six months after termination or the remaining term of the awards.

In such event, if Dr.

Sliman commenced employment with another employer and became eligible to receive medical or other welfare

benefits under another employer-provided plan, the medical and other welfare benefits to be provided by us as described herein

The Sliman Employment Agreement provided

for similar provisions upon a “Change in Control” (as defined in the Sliman Employment Agreement, as in the Shallcross

Employment Agreement

For purpose of the Sliman Employment Agreement,

“Good Reason” was defined as the occurrence of any of the following events without the respective Dr.

(i) a material reduction in the Dr.

Sliman’s base salary (other than an across-the-board decrease in base salary

applicable to all of our executive officers);

(ii) a material breach of the employment agreement by us;

(iii) a material reduction

Sliman’s duties, authority and responsibilities relative to Dr.

Sliman’s duties, authority, and responsibilities

in effect immediately prior to such reduction;

or (iv) the relocation of Dr.

Sliman’s principal place of employment, without

Sliman’s consent, in a manner that lengthens his one-way commute distance by fifty (50) or more miles from his then-current

principal place of employment immediately prior to such relocation.

For purposes of the Sliman Employment

Agreement, “Cause” was defined as that Dr.

Sliman shall have engaged in any of the following acts or that any of

the following events shall have occurred, all as determined by the Board of Directors in its sole and absolute discretion:

(i) gross insubordination, acts of embezzlement or misappropriation of funds, fraud, dereliction of fiduciary obligations;

(ii) conviction of a felony or other crime involving moral turpitude, dishonesty or theft (including entry of a nolo

contendere plea);

(iii) willful unauthorized disclosure of confidential information belonging to the us or entrusted

to us by a client;

(iv) material violation of any provision of the employment agreement, of any of our policies, and/or of a

confidentiality agreement, which, to the extent it is curable by Dr.

Sliman, is not cured by Dr.

Sliman within 30 days of

receiving written notice of such violation by us;

(v) being under the influence of drugs (other than prescription medicine or

other medically related drugs to the extent that they are taken in accordance with their directions) during the performance

Sliman’s duties;

(vi) engaging in certain behavior;

or (vii) willful failure to perform his written assigned

tasks, where such failure is attributable to the fault of Dr.

Sliman which, to the extent it is curable by Dr.

Sliman, is not

Sliman within 30 days of receiving written notice of such violation by us.

is to be paid in a lump sum if the Change in Control event constitutes a “change in the ownership”

or a “change

in the effective control”

of the Company or a “change in the ownership of a substantial portion of a corporation’s

assets”

(each within the meaning of Section 409A of the Internal Revenue Code (“Rule 409A”)), or in

48 substantially equal payments, if the Change in Control event does not so comply with Section 409A.

On December 30, 2020, the Board awarded

Shallcross, the Company’s Chief Executive Officer and Chief Financial Officer, (i) a cash bonus equal to 62% of his prior base salary and (ii) an option to purchase 450,000 shares of our common stock.

The stock option granted to

Shallcross has an exercise price of $0.42 per share, which is the closing price of the Common Stock on the date of the

grant (December 30, 2020), vests pro rata, on a monthly basis, over 36 consecutive months and expires in seven (7) years

from the date of the grant, unless terminated earlier.

The stock option was granted pursuant to our 2020 Stock Incentive Plan,

as amended, and our effective registration statement on Form S-8 for the 2020 Stock Incentive Plan.

In addition, the Shallcross

Employment Agreement was amended on December 5, 20120 to reflect a 3.5% merit adjustment to Mr.

Shallcross’

base salary, increasing his annual base salary to $585,000.

Former Chief Medical Officer Compensation

Joseph Sliman, served as our Chief Medical Officer from February 3,

2012 until the expiration of his employment agreement on January 16, 2019.

Prior to the expiration date, he was compensated

in accordance with his employment agreement and other benefits consistent with those provided to members of management.

On October 9,

2018, we received a letter from Dr.

Sliman, our Chief Medical Officer purporting to provide notice of a right to terminate

his employment agreement, dated January 17, 2017, with us for “good reason”, alleging a material reduction in

his duties, authorities, and responsibilities as an executive of our company.

Pursuant to the terms of his two year employment

agreement that we entered into on January 17, 2017, Dr.

Sliman served as our Chief Medical Officer and was entitled a

base salary of $385,000, and he was eligible for a target bonus of 75% of his base salary.

Sliman did not receive any

performance based variable compensation in 2018.

Sliman received a prorated salary of $18,716.

The agreement

also provided that if Dr.

Sliman ‘s employment was terminated for any reason, he or his estate as the case may be, would

be entitled to receive the accrued base salary, vacation pay, expense reimbursement and any other entitlements accrued by him to

the extent not previously paid (the “Accrued Obligations”):

provided, however that if his employment were terminated

(1) by us without Cause (as defined in the agreement) or by him for Good Reason (as defined in the agreement) then in addition

to paying the Accrued Obligations, (x) we would be obligated to continue to pay his then current base salary and continue

to provide benefits at least equal to those which were provided at the time of termination for a period of 12 months and (y) he

would have the right to exercise any vested equity options until the earlier of six months after termination or the remaining term

of the awards.

In 2020, we paid Dr.

Sliman a settlement payment of $385,000.

Compensation of Directors

The following table sets forth information

for the fiscal year ended December 31, 2019 regarding the compensation of our directors who at December 31, 2019 were not also

our Named Executive Officers.

for the fiscal year ended December 31, 2020 regarding the compensation of our directors who at December 31, 2020 were

not also our Named Executive Officers.

Fees Earned or

1 unchanged sentence

Scott Tarriff (4)

The amounts in the “Option Awards” column reflect the dollar amounts of the grant date fair value for the financial statement reporting purposes for stock options for the fiscal year ended December 31, 2019 in accordance with ASC 718.

John Monahan (5)

The amounts in the “Option Awards”

column reflect the dollar amounts of the grant date fair value for the financial statement reporting purposes for stock options for the fiscal year ended December 31, 2020 in accordance with ASC 718.

The fair value of the options was determined using the Black-Scholes model.

For a discussion of the assumptions used in computing this valuation, see “Management’s Discussion and Analysis of Financial Conditions and Results of Operations” and Note 5 of the Notes to Consolidated Financial Statements in our Annual Report on Form 10-K for the fiscal year ended December 31, 2019.

Kraws was appointed as our independent, non-executive Chairman of the Board of Directors in May 2012.

Pursuant to his agreement Mr.

Kraws receives an annual retainer of $150,000 for serving as our Chairman.

As of December 31, 2019, the following are the outstanding aggregate number of option awards held by each of our directors who were not also Named Executive Officers:

For a discussion of the assumptions used in computing this valuation, see “Management’s Discussion and Analysis of Financial Conditions and Results of Operations”

and Note 5 of the Notes to Consolidated Financial Statements in our Annual Report on Form 10-K for the fiscal year ended December 31, 2020.

As of December 31, 2020, the following are the outstanding aggregate number of option awards held by each of our directors who were not

also Named Executive Officers:

Option Awards

Scott Tarriff

During 2019, each non-employee member

of the Board of Directors received an annual cash retainer of $43,000, our independent, non-executive Chairman of the Board

of Directors receives an annual cash retainer of $150,000, all non-employee directors receive an annual cash fee of $7,500,

$5,000 and $3,750 for service on the Audit, Compensation and Nominations Committees, respectively, and the Chairman of the

Audit, Compensation and Nominations Committees receive an additional annual cash fee of $15,000, $10,000 and $7,500,

respectively.

In addition, each non-employee member of the Board of Directors was issued an option exercisable for 250,000

shares of our common stock, for a term of seven years, vesting one third on each of one year, two year and three year

anniversary of the date of grant .

In setting 2019 compensation for directors, the Compensation Committee relied upon the

report that was provided by Korn Ferry Hay Group in November 2017 to provide an assessment of our director compensation.

During 2020, each non-employee member of

the Board of Directors received an annual cash retainer of $43,000, our independent, non-executive Chairman of the Board of Directors

receives an annual cash retainer of $150,000, all non-employee directors receive an annual cash fee of $7,500, $5,000 and $3,750

for service on the Audit, Compensation and Nominations Committees, respectively, and the Chairman of the Audit, Compensation and

Nominations Committees receive an additional annual cash fee of $15,000, $10,000 and $7,500, respectively.

In addition, each non-employee

member of the Board of Directors was issued an option exercisable for 250,000 shares of our common stock, for a term of seven years,

vesting monthly over one year of the date of grant.

In setting 2020 compensation for directors, the Compensation Committee relied

upon the report that was provided by Korn Ferry Hay Group in November 2017 to provide an assessment of our director compensation.

In setting 2021 compensation for directors, the Compensation Committee relied on a report form Meridian Compensation Partners,

Based on an analysis of director compensation set forth in the report, our financial performance, general market conditions

and the interests of shareholders, it was determined that the annual cash retainer for serving on the board and the committee

retainers would remain for 2020 the same as they were in 2019.

and the interests of stockholders, it was determined that the annual cash retainer for serving on the board and the committee retainers

would remain for 2021 the same as they were in 2020 and 2019.

Kraws was appointed as our independent, non-executive Chairman of the Board of Directors in May 2012.

Pursuant to his agreement Mr.

Kraws receives an annual retainer of $150,000 for serving as our Chairman.

Tarriff resigned as a director on November 11, 2020.

Upon his resignation, the Board of Directors accelerated vesting of his unvested options and extended the period for which he has the right to exercise vested options from three months to the earlier of December 31, 2022 and the original option exercise expiration date.

Monahan was appointed as a director on November 11, 2020.

Fees in the director compensation chart do not include $11,250 for consulting fees earned for services provided during 2020 prior to his appointment as a director.

Compensation Committee Interlocks

3 unchanged sentences

Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters

The following table sets forth information,

as of February 20, 2020, or as otherwise set forth below, with respect to the beneficial ownership of our common stock (i) all

persons known to us to be the beneficial owners of more than 5% of the outstanding shares of our common stock;

(ii) each of our

directors and our named executive officers named in the Summary Compensation Table;

and (iii) all of our directors and our executive

officer as a group.

The following table sets forth

information, as of March 3, 2021, or as otherwise set forth below, with respect to the beneficial ownership of our common

stock (i) all persons known to us to be the beneficial owners of more than 5% of the outstanding shares of our common

(ii) each of our directors and our named executive officers named in the Summary Compensation Table;

(iii) all of our directors and our executive officer as a group.

Shares Owned (1)

3 unchanged sentences

Jeffrey Wolf (6)

John Monahan (7)

All current officers and directors as a group (4 persons)

Hudson Bay Capital Management LP and affiliates (8)

Iroquois Capital Management, L.L.C.

and affiliates (9)

represents less than 1% of our common stock

2 unchanged sentences

Except as indicated in the footnotes to the table, to the knowledge of the Company, the persons named in the table have sole voting and investment power with respect to all shares of common stock, options and/or warrants shown as beneficially owned by them, subject to community property laws, where applicable.

Pursuant to the rules of the SEC, the number of shares of our common stock deemed outstanding includes shares issuable pursuant to options held by the respective person or group that are currently exercisable or may be exercised within 60 days of February 20, 2020.

As of February 20, 2020, the Company had 16,956,865 shares of common stock outstanding.

Includes 53,396 shares issuable upon exercise of options held by Mr.

Kraws that are exercisable within the 60-day period following February 20, 2020.

Does not include an additional 294,167 shares issuable upon exercise of options held by Mr.

Kraws that are not exercisable within the 60-day period following February 20, 2020.

As of March 3, 2021, the Company had 129,654,575 shares of common stock outstanding.

Includes 212,990 shares issuable upon exercise of options held by Mr.

Shallcross that are exercisable within the 60-day period following February 20, 2020.

Does not include an additional 514,604 shares issuable upon exercise of options held by Mr.

Shallcross that are not exercisable within the 60-day period following February 20, 2020.

Includes (i) 8,572 shares purchased from us in our November 2016 offering, (ii ) 53,872 shares issuable upon exercise of options held by Mr.

Tarriff that are exercisable within the 60-day period following February 20, 2020, and (iii) warrants to purchase 8,572 shares of our common stock, which warrants were acquired in our November 2016 offering.

Kraws that are exercisable within the 60-day period following March 3, 2021.

Does not include an additional 284,334 shares issuable upon exercise of options held by Mr.

Tarriff that are not exercisable within the 60-day period following February 20, 2019.

Kraws that are not exercisable within the 60-day period following March 3, 2021.

Includes 464,130

shares issuable upon exercise of options held by Mr.

Shallcross that are exercisable within the 60-day period following

March 3, 2021.

Does not include an additional 694,445 shares i ssuable upon exercise of options held by

Shallcross that are not exercisable within the 60-day period following March 3, 2021.

Includes 212,990 shares issuable upon exercise of options held by Mr.

Wolf that are exercisable within the 60-day period following February 20, 2020.

Wolf that are exercisable within the 60-day period following March 3, 2021.

Does not include an additional 284,334 shares issuable upon exercise of options held by Mr.

Wolf that are not exercisable within the 60-day period following February 20, 2020.

Includes warrants to purchase 1,882,002 shares of our common stock owned by Hudson Bay Master Fund Ltd.

Share ownership information is based on information contained in a Schedule 13G filed by Hudson Bay Master Fund Ltd and Sander Gerber with the SEC on February 5, 2019 by Hudson Bay Capital Management LP, as the investment manager to Hudson Bay Master Fund Ltd, in whose name the securities are held and Sander Gerber, the managing member of Hudson Bay Capital GP LLC, which is the general partner of Hudson Bay Capital Management LP.

Gerber disclaims beneficial ownership of the warrants.

The business address of each of such entities and Mr.

Gerber is 777 Third Avenue, 30 th floor, New York, New York 10017.

Pursuant to the terms of the warrant, the holder cannot exercise the warrant if the holder would beneficially own, after such exercise, in excess of 9.99% of the outstanding shares of our common Stock.

Information obtained from a Schedule 13G filed by Iroquois

Capital Management L.L.C.

(“Iroquois Capital”), Mr.

Page with the SEC on February 14, 2020.

to the Schedule 13G.

Iroquois Master Fund held 6,198 shares of our common stock, 841 shares of our Series B Preferred Stock

convertible into 731,304 shares of our common stock and warrants to purchase 1,130,195 shares of our common stock and

Iroquois Capital Investment Group LLC (“ICIG”) held 9,073 shares of our common stock, 1,099 shares of our Series

B Preferred Stock convertible into 955,625 shares of our common stock and warrants to purchase 1,478,501 shares of our common

stock, a Delaware limited liability company (“Iroquois”) Mr.

Page share authority and responsibility

for the investments made on behalf of Iroquois Master Fund with Ms.

Kimberly Page, each of whom is a director of the Iroquois

Master Fund, and as such, each of Richard Abbe and Kimberly Page may be deemed to beneficially own the securities held by

Iroquois Master Fund (“Mr.

and “Ms.

together with Iroquois, the “Reporting

Persons”).

Iroquois Capital is the investment advisor for Iroquois Master Fund and Mr.

Abbe is the President of

Iroquois Capital.

Abbe has the sole authority and responsibility for the investments made on behalf of ICIG.

Abbe may be deemed to be the beneficial owner of all shares of Common Stock held by, and underlying the Series B Preferred

Stock and warrants (each subject to the blockers) held by, Iroquois Master Fund and ICIG.

The business address of each of

such entities and Mr.

Page is 205 East 42nd Street, 20th Floor, New York, NY 10017.

Pursuant to the terms of the

warrant and the Series B Preferred Stock, the holder cannot exercise the warrant or Series B Preferred Stock if the holder

would beneficially own, after such exercise, in excess of 9.99% of the outstanding shares of our common Stock.

Wolf that are not exercisable within the 60-day period following March 3, 2021.

Includes 63,469 shares issuable upon exercise of options held by Dr.

Monahan that are exercisable within the 60-day period following March 3, 2021.

Does not include an additional 113,889 shares issuable upon exercise of options held by Dr.

Monahan that are not exercisable within the 60-day period following March 3, 2021.

Equity Compensation Plan Information

16 unchanged sentences

2010 Stock Incentive Plan

2020 Stock Incentive Plan

Equity compensation plans not approved by stockholders

1 unchanged sentence

Pursuant to our charter, our Audit Committee

shall review on an on-going basis for potential conflicts of interest, and approve if appropriate, all our “Related Party

Transactions” as required by Section 120 of the NYSE American Company Guide.

shall review on an on-going basis for potential conflicts of interest, and approve if appropriate, all our “Related Party

Transactions”

as required by Section 120 of the NYSE American Company Guide.

For purposes of the Audit Committee Charter,

“Related Party Transactions” shall mean those transactions required to be disclosed pursuant to SEC Regulation S-K,

The Board of Directors has determined that

Tarriff and Mr.

“Related Party Transactions”

shall mean those transactions required to be disclosed pursuant to SEC Regulation S-K, Item

Board of Directors has determined that Mr.

Monahan and Mr.

Wolf are independent directors.

Except as disclosed under “Executive

Compensation,” there were no related party transactions during the two year’s ended December 31, 2019 or the current

Except as disclosed under “Executive

Compensation,”

there were no related party transactions during the two year’s ended December 31, 2020 or the current

Principal Accountant Fees and Services

6 unchanged sentences

Audit Committee Pre-Approval Policy

The Audit Committee has adopted

procedures for pre-approving all audit and non-audit services provided by the independent registered public accounting firm,

including the fees and terms of such services.

These procedures include reviewing detailed back-up documentation for audit

and permitted non-audit services.

The documentation includes a description of, and a budgeted amount for, particular

categories of non-audit services that are recurring in nature and therefore anticipated at the time that the budget is

Audit Committee approval is required to exceed the pre-approved amount for a particular category of non-audit

services and to engage the independent registered public accounting firm for any non-audit services not included in those

pre-approved amounts.

For both types of pre-approval, the Audit Committee considers whether such services are consistent with

the rules on auditor independence promulgated by the SEC and the Public Company Accounting Oversight Board (PCAOB).

Committee also considers whether the independent registered public accounting firm is best positioned to provide the most

effective and efficient service, based on such reasons as the auditor’s familiarity with our business, people, culture,

accounting systems, risk profile, and whether the services enhance our ability to manage or control risks and improve audit

The Audit Committee may form and delegate pre-approval authority to subcommittees consisting of one or more members

of the Audit Committee, and such subcommittees must report any pre-approval decisions to the Audit Committee at its next

scheduled meeting.

All of the services provided by the independent registered public accounting firm were pre-approved by the

Audit Committee.

The Audit Committee has adopted procedures

for pre-approving all audit and non-audit services provided by the independent registered public accounting firm, including the

fees and terms of such services.

These procedures include reviewing detailed back-up documentation for audit and permitted non-audit

The documentation includes a description of, and a budgeted amount for, particular categories of non-audit services that

are recurring in nature and therefore anticipated at the time that the budget is submitted.

Audit Committee approval is required

to exceed the pre-approved amount for a particular category of non-audit services and to engage the independent registered public

accounting firm for any non-audit services not included in those pre-approved amounts.

For both types of pre-approval, the Audit

Committee considers whether such services are consistent with the rules on auditor independence promulgated by the SEC and

the Public Company Accounting Oversight Board (PCAOB).

The Audit Committee also considers whether the independent registered public

accounting firm is best positioned to provide the most effective and efficient service, based on such reasons as the auditor’s

familiarity with our business, people, culture, accounting systems, risk profile, and whether the services enhance our ability

to manage or control risks and improve audit quality.

The Audit Committee may form and delegate pre-approval authority to subcommittees

consisting of one or more members of the Audit Committee, and such subcommittees must report any pre-approval decisions to the

Audit Committee at its next scheduled meeting.

All of the services provided by the independent registered public accounting firm

were pre-approved by the Audit Committee.

Exhibits and Financial Statement Schedules

The following financial statements are included in this Annual Report on Form 10-K for the fiscal years ended December 31, 2019 and 2018.

Independent Registered Public Accounting Firm

Consolidated Balance Sheets as of December 31, 2019 and 2018

Consolidated Statements of Operations for the years ended December 31, 2019 and 2018

Consolidated Statements of (Deficit) Equity for the years ended December 31, 2019 and 2018

Consolidated Statements of Cash Flows for the years ended December 31, 2019 and 2018

Notes to Consolidated Financial Statements

All financial statement schedules have been omitted as the required information is either inapplicable or included in the Consolidated Financial Statements or related notes.

Reference is made to the Exhibit Index on the following

Form 10-K Summary

Not applicable.

The following financial

statements are included in this Annual Report on Form 10-K for the fiscal years ended December 31, 2020 and 2019.

Registered Public Accounting Firm

Balance Sheets as of December 31, 2020 and 201 9

Statements of Operations for the years ended December 31, 2020 and 201 9

Statements of (Deficit) Equity for the years ended December 31, 2020 and 2019

Statements of Cash Flows for the years ended December 31, 2020 and 201 9

to Consolidated Financial Statements

All financial statement

schedules have been omitted as the required information is either inapplicable or included in the Consolidated Financial Statements

or related notes.

EXHIBIT INDEX

The following

exhibits are either filed as part of this report or are incorporated herein by reference:

The following exhibits are either filed as part of this report or are incorporated herein by reference:

At Market Issuance Agreement dated August 5, 2016 between Synthetic Biologics, Inc.

and FBR Capital Markets & Co.

(Incorporated by reference to Exhibit 1.1 of the Registrant’s Current Report on Form 8-K filed August 5, 2016, File No.

Amendment No.

1 to At The Market Issuance Sales Agreement(Incorporated by reference to Exhibit 1.1 of the Registrant’s Current Report on Form 8-K filed May 7, 2016, File No.

Underwriting Agreement, dated October 10, 2018, by and between Synthetic Biologics, Inc.

and A.G.P./Alliance Global Partners, as representative of the underwriters (Incorporated by reference to Exhibit 1.1 of the Registrant’s Current Report on Form 8-K filed October 51, 2018), File No.

Certificate of Incorporation, as amended (Incorporated by reference to (i) Exhibit 3.1 of the Registrant’s Current Report on Form 8-K filed October 16, 2008, File No.

001-12584, (ii) Exhibit 3.1 of the Registrant’s Quarterly Report on Form 10-Q for the quarterly period ended June 30, 2001 filed August 14, 2001, File No.

and (iii) Exhibits 3.1, 4.1 and 4.2 of the Registrant’s Quarterly Report on Form 10-Q for the quarterly period ended June 30, 1998 filed August 14, 1998, File No.

Articles of Merger (Incorporated by reference to Exhibit 3.1 of the Registrant’s Current Report on Form 8-K filed October 19, 2009, File No.

Certificate of Merger filed with the Secretary of State of Delaware (Incorporated by reference to Exhibit 3.2 of the Registrant’s Current Report on Form 8-K filed October 19, 2009, File No.

Articles of Incorporation filed with the Nevada Secretary of State (Incorporated by reference to Exhibit 3.3 of the Registrant’s Current Report on Form 8-K filed October 19, 2009, File No.

Amended and Restated Bylaws Adopted and Effective October 31, 2011 (Incorporated by reference to Exhibit 3.1 of the Registrant’s Current Report on Form 8-K filed November 2, 2011, File No.

Certificate of Amendment to Articles of Incorporation (Incorporated by reference to Exhibit 3.1 of the Registrant’s Current Report on Form 8-K filed February 16, 2012, File No.

1 to At The Market Issuance Sales Agreement(Incorporated by reference to Exhibit 1.1 of the Registrant’s Current Report on Form 8-K filed May 7, 2016, File No.

Amended and Restated At Market Issuance Sales Agreement by and among Synthetic Biologics, Inc., B.

Riley Securities, Inc.

and A.G.P./Alliance Global Partners, dated February 9, 2021 (Incorporated by reference to Exhibit 1.1 of the Registrant’s Current Report on Form 8-K filed February 10, 2021), File No.