What changed in this filing

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Item 9A. Controls and Procedures

2023-03-30 compared with 2022-03-16 · 237 added, 128 removed, 523 unchanged (41% of the section changed)

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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.

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, evaluated 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.

Due to the material weaknesses in internal control over financial reporting as described below, our Chief Executive Officer who also serves as its Chief Financial Officer concluded that, as of the end of the period covered by this report, our disclosure controls and procedures were not effective.

Management’s Annual Report on Internal Control Over Financial Reporting

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Management conducted an assessment of the Company’s internal control over financial reporting as of December 31, 2022 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, 2021, the Company’s internal control over financial reporting was effective at a reasonable assurance level 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 and procedures and its internal control processes will prevent all error and all fraud.

Based on the assessment, due to the material weaknesses in internal control over financial reporting as described below management concluded that, as of December 31, 2022, the Company’s internal control over financial reporting was not effective.

A control system, no matter how well conceived and operated, can provide only reasonable, not absolute, assurance that the objectives of the control system are met.

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Therefore, it is possible to design into the process safeguards to reduce, though not eliminate, this risk.

On March 10, 2022 we completed the acquisition of VCN Biosciences, S.L.

In conjunction with the acquisition of VCN, we are currently in the process of integrating VCN’s policies, processes, people, technology, and operations into the consolidated company, and integrating VCN’s operations into our system of internal control over financial reporting.

As permitted by the Securities and Exchange Commission, we have elected to exclude the internal controls of this acquisition that has not been integrated into our existing processes and controls from our assessment of the effectiveness of internal control over financial reporting as of December 31, 2022.

The excluded aggregate financial position of VCN represented less than 40% of our total assets as of December 31, 2022, and less than 31% of our total operating costs for the year then ended.

We will include the internal controls of VCN in our assessment of the effectiveness of our internal control over financial reporting as of December 31, 2023.

Material Weakness over Non-Routine Transactions

During the course of the preparation of our interim consolidated financial statements for 2022, we identified a material weakness in our controls relating to accounting and disclosure controls for non-routine transactions.

Specifically, the controls related to the review of internally and externally prepared reports and analysis used in the financial reporting process and the related income tax implication of non-routine transactions.

Additionally, during the preparation of our annual consolidated financial statements, we determined that our reported interim income tax provision for the interim periods ended June 30, 2022 and September 30, 2022 contained errors, which resulted in the restatement of our consolidated financial statements for the periods then ended.

Specifically, our controls over the review of the interim tax provisions did not properly identify the need to record a deferred tax asset and resulting deferred tax benefit for our VCN subsidiary’s indefinite-lived net operating loss carryforward created during those interim periods.

In addition, our controls related to the review of the business combination transaction in 2022 failed to identify the incorrect application of certain assumptions in calculating the valuation of certain intangibles, contingent consideration, and the related tax implications.

Remediation Plan

In order to remediate these material weaknesses, we plan to implement the following steps to improve the overall processes of identifying and reviewing non-routine transactions and preparing interim financial statements:

● Perform additional internal review processes to ensure the appropriate accounting and disclosure of non-routine transactions.

● Engage a third-party tax specialist to assist us in the preparation and review of interim tax provisions.

Should additional changes to the remediation plan be warranted, management will modify the planned measures accordingly.

Material Weakness over Information Technology General Controls

During the preparation of our annual consolidated financial statements for 2022, we identified a material weakness in our controls relating to general information technology controls over logical access and program change management for certain of our key information systems used to support the financial reporting process.

Specifically, management did not maintain effective controls to ensure proper segregation of duties related to implementing program changes in certain information systems.

Further, management did not have adequate controls over user administration and did not perform effective periodic user access reviews in a timely manner to ensure proper permissions were granted, resulting in segregation of duties conflicts within certain business processes.

Remediation Plan

Management will ensure proper segregation of duties over all IT functions ensuring IT personnel are properly trained as to the importance of and specifics over the internal controls for which they are responsible, including consistent, repeatable performance of such controls.

Management will also evaluate the responsibilities of its control owners to ensure that proper segregation of duties exists within the process level controls that are dependent upon information produced by IT systems affected by segregation of duties conflicts.

Further, management will ensure IT personnel do not have conflicting responsibilities with respect to program changes, administration and user access controls, or that additional controls are implemented to perform an effective review of program changes, administration and user access.

Material Weakness over Evidence of Control Performance

During the preparation of our annual consolidated financial statements for 2022, we identified a material weakness relating to the ineffective design and execution of management’s review of controls, particularly with regard to the precision of the review, evidence of review procedures performed, and the evaluation of the completeness and accuracy of information utilized in the performance of the control.

Remediation Plan

Management will ensure all personnel are properly trained as to the importance of properly documenting and evidencing the performance of controls.

When fully implemented, the Company believes that the measures described above will appropriately remediate the identified material weaknesses, although management may determine that taking additional measures to remediate the material weaknesses may be necessary.

Changes in 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 the net operating loss carry-forward and its tax impact through an Internal Revenue Code Section 382 analysis during our fiscal quarter ended December 31, 2021.

There has been no other change in our internal control over financial reporting during our fiscal quarter ended December 31, 2021 that has materially affected, or is reasonably likely to materially affect, our internal control over financial reporting.

Except for the material weaknesses described above, there has been no change in the Company’s internal control over financial reporting during the Company’s most recent fiscal quarter that has materially affected, or is reasonably likely to materially affect, the Company’s internal control over financial reporting.

Other Information .

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Chief Executive Officer, Chief Financial Officer and Director

Chief Operating Officer

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

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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 and since April 2021, he has served on the board of directors of TwinVee Powercats, Co., a designer, manufacturer and marketer of recreational and commercial power catamaran boats.

a Nasdaq listed international, vertically

integrated commercial-stage company engaged in various aspects of the leisure gaming industry and from April 2021 until June 2022, he served on the board of directors of TwinVee Powercats, Co.

VEEE), a designer, manufacturer and marketer of recreational and commercial power catamaran boats.

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 brings to the Board of Directors 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 principles.

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

Frank Tufaro .

Tufaro served as President of Opa Therapeutics Inc.

from May 2020 until March 2022.

Opa Therapeutics is a privately held biologics company.

From January 2010 through December 2019, Dr.

Tufaro served as Chief Executive Officer of DNAtrix.DNAtrix is a privately held biotech company developing virus-driven immunotherapies to treat cancer.

Tufaro received a Ph.D.

in Molecular Biology and a Bachelor of Science in Biology from McGill University.

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.

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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 brings to the Board of Directors 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.

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Monahan has been a member of the Company's Board of Directors since November 11, 2020.

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 from August 2016 until May 2021 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.

Monahan has served on the board of directors of NightHawk Biosciences, Inc.

(formerly known as Heat Biologics, Inc.), a biopharmaceutical company primarily engaged in the development of immune therapies and vaccines, since November 2009, and from August 2016 until May 2021 also served on the board of directors of the biotech company Anixa Biosciences, Inc.

(formerly known as ITUS Corporation), a biotechnology company focused on using the body's immune system to diagnose, treat and prevent cancer.

He is also a board member of Cellix Ltd.

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Monahan co-founded Avigen Inc.

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.

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.

Prior to that from 1982-1985, he was Research Group Chief, Department of Molecular Genetics, Hoffmann-LaRoche,

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

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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.

Wolf, who has been a member of the Company’s Board of Directors since 2006, has substantial experience in creating, financing, nurturing and biomedical ventures based upon breakthrough research and technology.

In August 2008, Mr.

Wolf founded Heat Biologics, Inc.

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

Wolf founded NightHawk Biosciences, Inc.

NHWK), a publicly traded company engaged in research and development of drugs focused on modulating the immune system.

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 the Chief Executive Officer and Chairman of the Board of NightHawk Biosciences, Inc.

Prior to founding NightHawk, 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 has also founded and run several biomedical 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.

TyRx Pharma, a company focused on the development of bio-compatible polymers where he was a co-founder and Chairman;

and Elusys Therapeutics, a company focused on the development of ANTHIM, an FDA approved antitoxin against anthrax, which is currently a subsidiary of NightHawk.

Wolf received his MBA.

from Stanford Business School, his J.D.

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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.

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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 .

Our Audit Committee charter is located on our website www.therivabio.com .

Compensation Committee

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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 .

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

Nominations Committee

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Our Board has determined that all nominations committee members are independent under applicable SEC regulations and NYSE American rules.

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

Our Nominations Committee charter is located on our website www.therivabio.com .

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.

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 Theriva 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.

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In addition, we have adopted a Code of Ethics for Financial Management which applies to our Chief Executive Officer, Chief Financial Officer, Treasurer and Controller.

Each of these codes is posted on our website at www.syntheticbiologics.com .

Each of these codes is posted on our website at www.therivabio.com .

Executive Compensation .

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Accordingly, this section includes supplemental narratives that describe the 2022 executive compensation program for our Named Executive Officer.

The following table summarizes all compensation awarded to, earned by or paid to Steven A.

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

The following table summarizes all compensation awarded to, earned by or paid to our Named Executive Officers, Steven A.

Shallcross and Frank Tufaro, during the fiscal years presented below.

Name and Principal

Salary ($) (1)

Bonus ($) (2)

Awards ($) (3)

Steven Shallcross

1,190,663 (5)

Chief Executive Officer

and Chief Financial Officer

Chief Operating Officer (6)

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 $584,775 on December 5, 2019 and December 30, 2020, respectively.

Shallcross' annual salary was $550,000 commencing December 6, 2018, increased to $565,000 on December 5, 2019, and increased to $585,00 on December 30, 2020.

Tufaro was appointed our Chief Operating Officer on March 22, 2022.

Tufaro annual salary was $375,000 commencing March 22.

(2) Amounts represent annual cash bonuses earned for the applicable fiscal year.

The annual cash bonuses are paid in the first quarter of the calendar year following the year to which the cash bonus relates.

(3) Amount reflects the grant date fair value of the Named Executive Officer’s stock options, calculated in accordance with FASB ASC Topic 718.

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In December 2021 and December 2022, Mr.

Shallcross was issued an option to purchase 450,000 and 650,000 shares of common stock, respectively;

Shallcross was issued an option to purchase 65,000 (as adjusted to reflect the stock split effected in 2022) and 475,000 shares of common stock, respectively;

the awards vest monthly over 36 months.

(4) 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.

(4) This bonus was earned in 2021 and paid in 2022.

These benefits are offered to all Theriva Biologics’ employees who work at least 17.5 hours per week.

(5) Amount excludes compensation paid to the wife of Mr.

Shallcross disclosed under the "Related Party Transactions"

Tufaro was appointed as our Chief Operating officer on March 22, 2022.

Narrative Disclosure to Summary Compensation Table

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Philosophy and Objectives

The Compensation Committee seeks to attract 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.

The Compensation Committee seeks to attract and retain superior executive talent by offering competitive base salaries, bonuses and long-term incentives.

The Compensation Committee’s philosophy is to deliver 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 that of our stockholders.

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● 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.

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.

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

Executive bonuses are tied directly to the achievement of performance goals that the Compensation Committee believes will ultimately drive stockholder value creation.

To accomplish this objective, executive compensation is reviewed annually to ensure that compensation levels are competitive and reasonable relative to our level of performance and to the compensation opportunities provided by 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.

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

Oversight of Executive Compensation

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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, 2021 was Steven Shallcross, our Chief Executive Officer who also serves as our Chief Financial Officer.

Our Named Executive Officers for the year ended December 31, 2022 were Steven Shallcross, our Chief Executive Officer who also serves as our Chief Financial Officer and Frank Tufaro, who serves as our Chief Operating 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 performance at least annually in light of those goals and objectives, and based upon these evaluations setting the compensation level for those officers.

● Evaluating the Chief Executive Officer’s and other senior executive officers’ 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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● Reviewing the financial performance and operations of our major benefit plans.

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

Additional information regarding the Compensation Committee’s responsibilities is set forth in its charter, which is posted on our website at www.therivabio.com .

Role of the Chief Executive Officer

Our Chief Executive Officer makes recommendations to the Compensation Committee regarding the compensation of our other Named Executive Officers, if any.

Our Chief Executive Officer makes recommendations to the Compensation Committee regarding the compensation of our other Named Executive Officers.

The Chief Executive Officer does not participate in any discussions or processes concerning his own compensation and participates in a non-voting capacity in discussions or processes concerning the compensation of our other members of management.

In addition to our Chief Executive Officer, as well as members of our management and consultants also attend Compensation Committee meetings from time to time and may take part in discussions of executive compensation.

In addition to our Chief Executive Officer, other members of our management and consultants also attend Compensation Committee meetings from time to time and may take part in discussions of executive compensation.

Program Design

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Of the performance based variable compensation 60% was equity-based compensation and 40% was his target cash bonus.

During 2022, the salary for our Chief Operating Officer was 66% of his annualized target compensation package and performance based variable compensation comprised 34% of his target compensation.

Of the performance based variable compensation 21% was equity-based compensation and 79% was his target cash bonus.

Compensation Review Process

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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.

Consequently, our Compensation Committee reviewed an executive compensation benchmarking report prepared by Meridian Compensation Partners, LLC (“Meridian”) at the Compensation Committee’s request.

With respect 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.

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Our Compensation Committee values the opinion of our stockholders.

At our 2019 Annual Meeting of Stockholders approximately 59% of the votes that were cast (excluding broker non-votes) were cast in favor of our say-on-pay proposal adopting a resolution approving the compensation paid to our Named Executive Officers as disclosed in our proxy statement for our 2019 Annual Meeting of Stockholders.

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.

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.

At our 2022 Annual Meeting of Stockholders approximately 97% of the shares voted (excluding broker non-votes) were cast in support of our fiscal 2021 executive compensation and related disclosures.

At that time, our Compensation Committee viewed those voting results as broad stockholder support for our executive compensation program and consequently made no material changes to the program or to our compensation policies.

Our Compensation Committee will continue to consider input from stockholders, including through advisory votes on executive compensation, in making compensation decisions and reviewing executive compensation programs and policies.

We currently hold our advisory vote to approve the compensation of our named executive officers (“Say-on-Pay vote”) every three years.

Stockholders have an opportunity to cast an advisory vote on the frequency of the Say-on-Pay vote at least every six years, and the next advisory vote on the frequency of the Say-on-Pay vote will be at our 2025 Annual Meeting of Stockholders.

Components of Compensation

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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.

Based on the analysis of the executive compensation benchmarking report provided by Meridian 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.

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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 $584,775.

Pursuant to his current employment agreement, which was entered into on January 3, 2022, after expiration of the prior agreement, Mr.

Shallcross’ base salary is $585,000.

The 2020 and current base salary for our Chief Executive Officer who also serves as our Chief Financial Officer is:

Shallcross’ base salary, increasing his annual base salary to $585,000 and further amended on December 15, 2022 to increase his base salary to $614,250.

On December 15, 2022, the Company entered into an Amendment to Dr.

Tufaro’s Employment Agreement to increase his base salary to $393,750.

The table below shows the 2022 base salary level for each of our Named Executive Officers, including a comparison with our 2021 for our Chief Executive Officer who also serves as our Chief Financial Officer.

Our Chief Operating Officer was hired in 2022.

Named Executive Officer

Shallcross, Chief Executive Officer and Chief Financial Officer

The Compensation Committee also makes recommendations to the full Board of Directors for determining bonuses.

The Compensation Committee also used information from the report and analysis discussed above in determining bonus as well as its own research of peer company compensation.

For the year ended December 31, 2021, the Compensation Committee approved a $365,000 cash bonus and an option grant to purchase 650,000 shares of our common stock for Mr.

The employment agreement with Mr.

Shallcross that was in effect during 2021 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.

Frank Tufaro, Chief Operating Officer

The Compensation Committee believes that the granting of a bonus is appropriate to motivate the Named Executive Officers.

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 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.

The Compensation Committee also used information from the Meridian executive compensation benchmarking report in determining bonus amounts.

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 for 2022, effective M&A strategy and implementation, financings, and achievement of clinical milestones.

Shallcross’ employment agreement provided that he was eligible for a target bonus of up to fifty percent (50%) of his base salary in cash.

After considering Mr.

Shallcross’ achievement relative to performance goals in 2022, the Compensation Committee approved a $385,000 cash bonus, or 132% of target.

Tufaro’s employment agreement provided that he was eligible for a target bonus of up to forty percent (40%) of his base salary in cash.

After considering Dr.

Tufaro’s achievement relative to performance goals in 2022, the Compensation Committee approved a $85,000 cash bonus, or 72% of his target, pro-rated for the number of days he provided service to us in 2022.

● The Comepnsation Committee also approved and an option grant to purchase 475,000 shares of our common stock for Mr.

Shallcross and $85,000 cash bonus and an option grant to purchase 100,000 shares of our common stock for Dr.

Long-Term Incentives

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● provide competitive levels of total compensation.

Shallcross’ 2020 and 2021 bonuses included a grant of options exercisable for 450,000 and 650,000 shares of common stock, respectively.

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.

In 2022, the Compensation Committee approved grants of options exercisable for 475,000 and 100,000 shares to Mr.

Shallcross and Dr.

Tufaro in 2022, respectively.

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

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Steven Shallcross

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

(1) Options will vest pro rata, on a monthly basis, over 36 months.

Employment Agreements

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Pursuant to the Amended Shallcross Employment Agreement, as amended, Mr.

Shallcross is entitled to an annual base salary of $584,775 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 $614,250 and an annual performance bonus targeted at fifty percent (50%) of his annual base salary.

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

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Pursuant to the 2022 Employment Agreement, Mr.

Shallcross is entitled to an annual base salary of $585,000 and an annual cash performance bonus of up to fifty percent (50%) of his annual base salary as well as discretionary annual equity awards pursuant to the Company’s incentive plans.

Shallcross is entitled to an annual base salary of $585,000 and an annual cash performance bonus targeted at fifty percent (50%) of his annual base salary as well as discretionary annual equity awards pursuant to the Company’s incentive plans.

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

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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.

Frank Tufaro, Chief Operating Officer,

On March 22, 2022, we entered into an employment agreement with Frank Tufaro, as amended on December 15, 2022 (the “Employment Agreement”) to serve as the Chief Operating Officer of the Company.

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

Pursuant to the Employment Agreement, as amended Dr.

Tufaro will receive an annual base salary of $393,750 and is eligible to earn an annual performance bonus targeted at forty percent (40%) of his annual base salary.

The annual bonus will be based upon the assessment of the Company’s Board of Dr.

Tufaro’s performance and the Company’s attainment of targeted goals set by the Board.

In addition, Dr.

Tufaro will also be eligible to receive annual equity awards pursuant to the Company’s incentive equity plans, such awards (including the number and type of awards), if any, will be in the sole discretion of the Board.

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

Tufaro and non-solicitation and non-competition provisions.

The Employment Agreement has a stated term of three (3) years but may be terminated earlier pursuant to its terms.

Tufaro’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, any unpaid annual bonus earned with respect to any calendar year ending on or preceding the date of termination, 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 the Company without Cause or by Dr.

Tufaro for Good Reason (as each is defined in the Employment Agreement) then in addition to paying the Accrued Obligations, (a) the Company 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 six (6) months and (b) all unvested stock options and other equity awards will immediately vest and he will be entitled 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 Employment Agreement), then in addition to paying the Accrued Obligations, Dr.

Tufaro, or his estate as the case may be, 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.

Tufaro 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 the Company as described herein would terminate.

The Employment Agreement provides that upon the closing of a “Change in Control” (as defined in the Employment Agreement), all unvested stock options and other equity awards will immediately vest and the time period that Dr.

Tufaro will have to exercise all vested stock options and other awards that Dr.

Tufaro may have will be equal to the shorter of:

(i) eighteen (18) 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, Dr.

Tufaro terminates his employment for “Good Reason” or the Company terminates Dr.

Tufaro’s employment for any reason other than death, Disability or Cause, Dr.

Tufaro will be entitled to receive:

(a) the portion of his base salary for periods prior to the effective date of termination accrued but unpaid (if any);

(b) all unreimbursed expenses (if any);

and (c) 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).

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

Tufaro terminates his employment for “Good Reason” or the Company terminates Dr.

Tufaro’s employment for any reason other than death, Disability or Cause, Dr.

Tufaro 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 the Company for him.

Compensation of Directors

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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, 2021.

(2) As of December 31, 2022, the following are the outstanding aggregate number of option awards held by each of our directors who were not also Named Executive Officers:

During 2021, 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.

During 2022, our independent, non-executive Chairman of the Board of Directors received an annual cash retainer of $150,000, each other non-employee member of the Board of Directors received an annual cash retainer of $43,000, all non-employee directors receive an annual cash fee of $7,500, $5,000 and $3,750 for service as a member of the Audit, Compensation and Nominations Committees, respectively, or an additional annual cash fee of $15,000, $10,000 and $7,500 for service as Chairman of the Audit, Compensation and Nominations Committees, respectively.

In addition, each non-employee member of the Board of Directors was issued an option exercisable for 100,000 shares of our common stock, for a term of seven years, vesting monthly over one year of the date of grant.

In setting 2021 and 2020 compensation for directors, the Compensation Committee relied on a report form Meridian Compensation Partners, LLC.

In setting 2022 and 2021 compensation for directors, the Compensation Committee relied on a report from Meridian Compensation Partners, LLC.

Based on an analysis of director compensation set forth in the report, our financial performance, general market conditions 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 2023 the same as they were in 2022 and 2021.

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

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

Compensation Committee Interlocks

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John Monahan (7)

Frank Tufaro (8)

All current officers and directors as a group (5 persons)

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(2) Beneficial ownership is determined in accordance with SEC rules and generally includes voting or investment power with respect to securities.

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.

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, prefrred 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 March 30, 2023.

We currently have outstanding 275,000 shares of Series C Preferred Stock and 100,000 shares of Series D Preferred Stock convertible, at a conversion price (the “Conversion Price”) of $1.22 per share (subject in certain circumstances to adjustments and to a 4.99% limit on beneficial ownership), into an aggregate of 2,459,016 shares of the common stock.

The shares of Series C Preferred Stock and Series D Preferred Stock had voting rights exclusively with respect to certain corporate actions (name change, increase in authorized shares and adjournment with respect to such proposals), which corporate actions were approved by our stockholders and therefore the Series C Preferred Stock and Series D Preferred Stock no longer have voting rights with respect to such corporate matters and only have voting rights with certain limited actions directly impacting the Series C Preferred Stock and Series D Preferred Stock.

All of the shares of Series C Preferred Stock and Series D Preferred Stock are owned by MSD Credit Opportunity Master Fund, L.P.

MSD Partners, L.P.

(“MSD Partners”) is the investment manager of MSD Credit Opportunity Master Fund, L.P.

MSD Partners (GP), LLC (“MSD GP”), a Delaware limited liability company, is the general partner of MSD Partners.

Each of Gregg R.

Lemkau, Marc R.

Lisker and Brendan Rogers is a manager of, and may be deemed to beneficially own securities beneficially owned by, MSD GP.

The business address of MSD Credit Opportunity Master Fund, L.P.

is One Vanderbilt Avenue, 26 th Floor, New York, New York 10017.

(3) As of March 30, 2023, the Company had 15,124,061 shares of common stock outstanding.

2 unchanged sentences

Does not include an additional 58,334 shares issuable upon exercise of options held by Mr.

Kraws that are not exercisable within the 60-day period following March 16, 2022.

Kraws that are not exercisable within the 60-day period following May 26, 2023.

(5) Includes 202,244 shares issuable upon exercise of options held by Mr.

Shallcross that are exercisable within the 60-day period following March 16, 2022.

Shallcross a nd 8,028 shares of Common Stock issuable upon exercise of options held by Mrs.

Shallcross (Mr.

Shallcross’s wife) that are exercisable within the 60-day period following March 30, 2023.

Does not include an additional 453,334 shares issuable upon exercise of options held by Mr.

Shallcross and 44,972 issuable upon exercise of options held by Mrs.

Shallcross that are not exercisable within the 60-day period following March 30, 2023.

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Monahan that are not exercisable within the 60-day period following March 30 , 2023.

(8) Includes 13,888 shares issuable upon exercise of options held by Dr.

Tufaro that are exercisable within the 60-day period following March 30 , 2023.

Does not include an additional 86,112 shares issuable upon exercise of options held by Dr.

Tufaro that are not exercisable within the 60-day period following March 30 , 2023.

Equity Compensation Plan Information

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Wolf are independent directors.

Except as disclosed under “Executive Compensation,” there were no related party transactions during the two year’s ended December 31, 2021 or the current year.

Except as disclosed under “Executive Compensation,” and below there were no related party transactions during the two years ended December 31, 2022 or the current year.

On December 15, 2022, we approved the retention of MaryAnn Shallcross, the wife of Steven Shallcross, as director of Clinical Operations, for compensation of $145,000 and the grant of an option to purchase 50,000 shares of common stock having a value of $20,000.

Shallcross had been performing services for us during 2022 for total compensation of less than $120,000.

See Part III–Item 10 under the heading “Directors, Executive Officers and Corporate Governance” of this Annual Report for information related to director independence.

Principal Accountant Fees and Services .

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The following table sets forth the aggregate fees including expenses billed to us for the years ended December 31, 2022 and 2021 by BDO USA, LLP.

Audit Fees and Expenses (1)

Audit-Related fees

Total Fees (1)

(1) Audit fees and expenses were for professional services rendered for the audit and reviews of the consolidated financial statements of the Company, professional services rendered for issuance of consents and assistance with review of documents filed with the SEC.

19 unchanged sentences

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

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

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

Riley Securities, Inc.

1 unchanged sentence

Amendment No.

1, dated May 3, 2021, to the Amended and Restated At Market Issuance Sales Agreement by and among Synthetic Biologics, Inc., B.

1, dated May 3, 2021, to the Amended and Restated At Market Issuance Sales Agreement by and among Theriva 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 May 3, 2021)

Share Purchase Agreement by and among Synthetic Biologics, Inc., VCN Biosciences, S.L.

Share Purchase Agreement by and among Theriva Biologics, Inc., VCN Biosciences, S.L.

and the shareholders of VCN Biosciences, S.L.

dated December 14, 2021(Incorporated by reference to Exhibit 2.1 of the Registrant’s Current Report on Form 8-K filed December 14, 2021, File No.

Amendment, dated March 9, 2022, to the Share Purchase Agreement, by and among Synthetic Biologics, Inc., VCN Biosciences, S.L.

Amendment, dated March 9, 2022, to the Share Purchase Agreement, by and among Theriva Biologics, Inc., VCN Biosciences, S.L.

and the shareholders of VCN Biosciences, S.L., dated December 14, 2021 (Incorporated by reference to Exhibit 2.1 of the Registrant’s Current Report on Form 8-K filed March 11, 2022, File No.

5 unchanged sentences

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.

10 unchanged sentences

Certificate of Amendment to the Certificate of Designation for the Series A Convertible Preferred Stock (Incorporated by reference to Exhibit 3.1 of the Registrant’s Current Report on Form 8-K/A filed on February 1, 2021 File No.

Certificate of Change filed with the Secretary of State of the State of Nevada on July 21, 2022 (effective as of July 25, 2022) (Incorporated by reference to Exhibit 3.1 of the Registrant’s Current Report on Form 8-K filed on July 25, 2022 (File No.

Form of Certificate of Designation of Series C Convertible Preferred Stock (Incorporated by reference to Exhibit 3.1 of the Registrant’s Current Report on Form 8-K filed on July 29, 2022 (File No.

Form of Certificate of Designation of Series D Convertible Preferred Stock (Incorporated by reference to Exhibit 3.2 of the Registrant’s Current Report on Form 8-K filed on July 29, 2022 (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 on October 12, 2022 (File No.

Certificate of Change to Articles of Incorporation (Incorporated by reference to Exhibit 3.2 of the Registrant’s Current Report on Form 8-K filed on October 12, 2022 (File No.

Amended and Restated By-Laws Synthetic Biologics, Inc.

Adopted and Effective October 12, 2022 (Incorporated by reference to Exhibit 3.3 of the Registrant’s Current Report on Form 8-K filed on October 12, 2022 (File No.

Specimen Stock Certificate (Incorporated by reference to Exhibit 4.1 to the Registrant’s Registration Statement on Form S-3 filed on July 3, 2013, File No.

Form of Warrant issued December 26, 2017 to InSite Communications (Incorporated by reference to Exhibit 4.1 of the Registrant’s Current Report on Form 10-Q filed May 5, 2018, File No.

Warrant Agency Agreement, dated October 15, 2018, by and between Synthetic Biologics, Inc.

Warrant Agency Agreement, dated October 15, 2018, by and between Theriva Biologics, Inc.

and Corporate Stock Transfer, Inc.

(including the form of warrant certificate) (Incorporated by reference to Exhibit 4.1 of the Registrant’s Current Report on Form 8-K filed October 15, 2018, File No.

Description of Securities of Synthetic Biologics, Inc.

Description of Securities of Theriva Biologics, Inc.

2007 Stock Incentive Plan (Incorporated by reference to Exhibit 4.2 of the Registrant’s Registration Statement on Form S-8 filed January 18, 2008, File No.

1 unchanged sentence

2010 Stock Incentive Plan (Incorporated by reference to Exhibit 4.1 of the Registrant’s Registration Statement on Form S-8 filed November 29, 2010, File No.

Asset Purchase Agreement dated November 8, 2012 between Synthetic Biologics, Inc.

and Prev ABR LLC (1)

Patent License Agreement dated December 19, 2012 between Synthetic Biologics, Inc.

Asset Purchase Agreement dated November 8, 2012 between Theriva Biologics, Inc.

and Prev ABR LLC (Incorporated by reference to Exhibit 10.33 of the Registrant's Annual Report on Form 10-K filed on March 16, 2022, File No.

Patent License Agreement dated December 19, 2012 between Theriva Biologics, Inc.

and The University of Texas at Austin (Incorporated by reference to Exhibit 10.1 of the Registrant’s Current Report on Form 8-K filed December 21, 2012, File No.

Sponsored Research Agreement dated December 19, 2012 between Synthetic Biologics, Inc.

Sponsored Research Agreement dated December 19, 2012 between Theriva Biologics, Inc.

and The University of Texas at Austin (Incorporated by reference to Exhibit 10.2 of the Registrant’s Current Report on Form 8-K filed December 21, 2012, File No.

Amended and Restated 2010 Stock Incentive Plan (Incorporated by reference to Exhibit 4.1 to the Registrant’s Registration Statement on Form S-8 filed on November 15, 2013, File No.

Exclusive License Agreement between Synthetic Biologics, Inc., Synthetic Biomics, Inc.

and Cedars-Sinai Medical Center dated December 5, 2013 (Incorporated by reference to Exhibit 10.1 to the Registrant’s Current Report on Form 8-K filed on December 10, 2013, File No.

Stock Purchase Agreement between Synthetic Biologics, Inc., Synthetic Biomics, Inc.

and Cedars-Sinai Medical Center dated December 5, 2013(Incorporated by reference to Exhibit 10.3 to the Registrant’s Current Report on Form 8-K filed on December 10, 2013, File No.

Stock Purchase Agreement between Synthetic Biologics, Inc., Synthetic Biomics, Inc.

and Cedars-Sinai Medical Center dated December 5, 2013 (Incorporated by reference to Exhibit 10.5 to the Registrant’s Current Report on Form 8-K filed on December 10, 2013, File No.

Amended and Restated 2010 Stock Incentive Plan.

(Incorporated by reference to Exhibit B to the Definitive Proxy Statement filed on April 13, 2015, File No.

Synthetic Biologics, Inc.

Theriva Biologics, Inc.

2010 Stock Incentive Plan, as amended and restated on May 15, 2015.

(Incorporated by reference to Exhibit 4.1 to the Registrant’s Registration Statement on Form S-8 filed on August 10, 2015, File No.

Third Amendment to the License Agreement between Synthetic Biologics, Inc., Synthetic Biomics, Inc.

and Cedar-Sinai Medical Center, dated September 4, 2015.

(Incorporated by reference to Exhibit 10.1 of the Registrant’s Quarterly Report on Form 10-Q for the quarter ended September 30, 2015 filed November 5, 2015, File No.

Form of Stock Option Agreement.

(Incorporated by reference to Exhibit 10.2 of the Registrant’s Current Report on Form 8-K filed December 10, 2015, File No.

Synthetic Biologics, Inc.

Theriva Biologics, Inc.

2010 Stock Incentive Plan, as amended and restated on May 31, 2016.

1 unchanged sentence

Amended and Restated 2010 Stock Incentive Plan (Incorporated by reference to Exhibit 4.1 to the Registrant’s Registration Statement on Form S-8 filed on September 8, 2017, File No.

Share Purchase Agreement dated as of September 11, 2017 between Synthetic Biologics, Inc.

and MSD Credit Opportunity Master Fund, L.P.

(Incorporated by reference to Exhibit 10.1 of the Registrant’s Current Report on Form 8-K filed September 12, 2017, File No.

Registration Rights Agreement dated as of September 11, 2017 between Synthetic Biologics, Inc.

and MSD Credit Opportunity Master Fund, L.P.

(Incorporated by reference to Exhibit 4.1 of the Registrant’s Current Report on Form 8-K filed on September 12, 2017, File No.

Fourth Amendment to Exclusive License Agreement entered into February 16, 2017 between Synthetic Biologics, Inc.

and Cedars-Sinai Medical Center.

(Incorporated by reference to Exhibit 10.53 of the Registrant’s Annual Report on Form 10-K filed on February 22, 2018, File No.

Fifth Amendment dated August 22, 2017 to Sponsored Research Agreement dated December 19, 2012 between Synthetic Biologics, Inc.

Fifth Amendment dated August 22, 2017 to Sponsored Research Agreement dated December 19, 2012 between Theriva Biologics, Inc.

and The University of Texas at Austin (Incorporated by reference to Exhibit 10.54 of the Registrant’s Annual Report on Form 10-K filed on February 22, 2018, File No.

Stock Purchase Agreement entered into as of September 5, 2018 by and among Synthetic Biologics, Inc., Synthetic Biomics, Inc., and Cedars-Sinai Medical Center(Incorporated by reference to Exhibit 10.1 of the Registrant’s Current Report on Form 8-K filed on September 6, 2018, File No.

Employment Agreement between Synthetic Biologics, Inc.

and Steven A.

Shallcross dated as of December 6, 2018 (Incorporated by reference to Exhibit 10.1 of the Registrant’s Current Report on Form 8-K filed on December 6, 2018), File No.

Synthetic Biologics, Inc.

Theriva Biologics, Inc.

2010 Stock Incentive Plan, as amended (incorporated by reference to Appendix A to the Definitive Proxy Statement filed with the Securities and Exchange Commission on July 15, 2019, File No.

Clinical Trial Agreement between Washington University School of Medicine in St.

Louis and Synthetic Biologics, Inc.

Louis and Theriva Biologics, Inc.

dated August 7, 2019 (Incorporated by reference to Exhibit 10.1 of the Registrant’s Current Report on Form 8-K filed on August 8, 2019, File No.

Amendment to Employment Agreement with Steven A.

Shallcross dated December 5, 2019 (Incorporated by reference to Exhibit 10.1 of the Registrant’s Current Report on Form 8-K filed on December 5, 2019, File No.

Synthetic Biologics, Inc.

Theriva Biologics, Inc.

2020 Stock Incentive Plan (Incorporated by reference to Appendix A to the Registrant’s Definitive Proxy Statement on Schedule 14A filed on August 4, 2020, File No.

2 unchanged sentences

Form of Restricted Stock Unit Award Agreement (Incorporated by reference to Exhibit 4.13 to the Registration Statement on Form S-8 filed on October 28, 2020, File No.

Termination of Exclusive License Agreement, effective November 9, 2020, by and among Cedars- Sinai Medical Center, Synthetic Biologics, Inc.

Termination of Exclusive License Agreement, effective November 9, 2020, by and among Cedars- Sinai Medical Center, Theriva Biologics, Inc.

and Synthetic Biomics, Inc.

2 unchanged sentences

Contract to Grant Marketing License for Catalan Institute of Oncology Patent Ownership Application to VCN Biosciences S.L.

(Incorporated by reference to Exhibit 10.32 of the Registrant's Annual Report on Form 10-K filed on March 16, 2022, File No.

License Agreement between Bellvitge Biomedical Research Institute Foundation (Idibell) and VCN Biosciences S.L.

dated May 4, 2016 (1)

dated May 4, 2016 (Incorporated by reference to Exhibit 10.33 of the Registrant's Annual Report on Form 10-K filed on March 16, 2022, File No.

Technology Transfer Agreement between Bellvitge Biomedical Research Institute and VCN Biosciences S.L.

dated August 31, 2010 (1)

Collaboration Agreement to Conduct a Clinical Trial and Grant Operating License Agreement between Hospital Sant Joan Dee Deu and VCN Biosciences, S.L dated February 15, 2016 (1)

dated August 31, 2010 (Incorporated by reference to Exhibit 10.34 of the Registrant's Annual Report on Form 10-K filed on March 16, 2022, File No.

Collaboration Agreement to Conduct a Clinical Trial and Grant Operating License Agreement between Hospital Sant Joan Dee Deu and VCN Biosciences, S.L dated February 15, 2016 (Incorporated by reference to Exhibit 10.35 of the Registrant's Annual Report on Form 10-K filed on March 16, 2022, File No.

Employment Agreement with Frank Tufaro dated March 22, 2022 (Incorporated by reference to Exhibit 10.1 of the Registrant’s Current Report on Form 8-K filed on March 23, 2022, File No.

Securities Purchase Agreement between Synthetic Biologics Inc.

and MSD Credit Opportunity Master Fund, L.P., dated as of July 28, 2022 (Incorporated by reference to Exhibit 10.1 of the Registrant’s Current Report on Form 8-K filed on July 29, 2022, File No.

Amendment No.

1 dated as of August 9, 2022 to Securities Purchase Agreement between Synthetic Biologics Inc.

and MSD Credit Opportunity Master Fund, L.P., dated as of July 28, 2022 (Incorporated by reference to Exhibit 10.2 of the Registrant’s Quarterly Report on Form 10-Q filed on August 11, 2022, File No.

Amendment No.

1 to Employment Agreement between Theriva Biologics, Inc.

and Steven A.

Shallcross, dated as of December 15, 2022 (Incorporated by reference to Exhibit 10.1 of the Registrant’s Current Report on Form 8-K filed on December 20, 2022, File No.

Amendment No.

1 to Employment Agreement between Theriva Biologics, Inc.

and Francis Tufaro, dated as of December 15, 2022 (Incorporated by reference to Exhibit 10.1 of the Registrant’s Current Report on Form 8-K filed on December 20, 2022, File No.

Form of Share Repurchase Agreement between Theriva Biologics, Inc.

and certain selling stockholders (Incorporated by reference to Exhibit 10.1 of the Registrant’s Current Report on Form 8-K filed on December 23, 2022, File No.

List of Subsidiaries (1)

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Pursuant to the requirements of Section 13 or 15(d) of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned.

SYNTHETIC BIOLOGICS, INC.

THERIVA BIOLOGICS, INC.

/s/ Steven A.

16 unchanged sentences

Compared sentence by sentence after normalising whitespace, quotation marks, case and digits, so re-formatting and restated figures do not read as changed language. Wording changes appear as one removal and one addition. The current filing and the prior one are authoritative.

What changed 10-K

Item 9A. Controls and Procedures