What changed in this filing

/stocks — the workspaceLOADING

Item 9A. Controls and Procedures

2022-03-29 compared with 2021-03-29 · 117 added, 117 removed, 40 unchanged (85% of the section changed)

CONTROLS AND PROCEDURES

Disclosure Controls and Procedures

We maintain "disclosure controls and procedures," as defined in Rules 13a-15(e) and 15d-15(e) under the Securities Exchange Act of 1934, as amended, or the Exchange Act, that are designed to ensure that information required to be disclosed by a company in the reports that it 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 its chief executive officer and chief financial officer, as appropriate to allow timely decisions regarding required disclosure.

Management recognizes that any controls and procedures, no matter how well designed and operated, can provide only reasonable assurance of achieving their objectives and management necessarily applies its judgment in evaluating the cost-benefit relationship of possible controls and procedures.

Our management, with the participation of our chief executive officer and our chief financial officer, evaluated the effectiveness of our disclosure controls and procedures as of December 31, 2020.

Based on the evaluation of our disclosure controls and procedures as of December 31, 2020, our chief executive officer and chief financial officer concluded that, as of such date, our disclosure controls and procedures were effective at the reasonable assurance level.

Management’s Report on Internal Control over Financial Reporting

Our management is responsible for establishing and maintaining adequate internal control over financial reporting, as defined in Rules 13a-15(f) and 15d-15(f) of the Exchange Act.

Our management, under the supervision and with the participation of our chief executive officer and our chief financial officer, conducted an evaluation of the effectiveness of our internal control over financial reporting as of December 31, 2020 based on the framework in Internal Control-Integrated Framework (2013) issued by the Committee of Sponsoring Organizations of the Treadway Commission.

Based on the results of its evaluation, management concluded that our internal control over financial reporting was effective as of December 31, 2020.

Under SEC rules, because we are a non-accelerated filer, we are not required to provide an auditor attestation report on internal control over financial reporting, nor did we engage our independent registered public account firm to perform an audit of our internal control over financial reporting.

Evaluation of Disclosure Controls and Procedures

We maintain “disclosure controls and procedures,” as defined in Rules 13a-15(e) and 15d-15(e) under the Exchange Act, that are designed to ensure that information required to be disclosed in the reports that we file or submit under the Exchange Act is recorded, processed, summarized and reported within the time periods specified in the SEC’s rules and forms and accumulated and communicated to our management, including our principal executive and principal financial officers, or persons performing similar functions, as appropriate to allow timely decisions regarding required disclosure.

Our management, with the participation of our Chief Executive Officer (principal executive officer) and Vice-President, Strategy and Finance (principal financial officer), evaluated the effectiveness of our disclosure controls and procedures (as defined in the Securities Exchange Act of 1934 Rules 13a-15(e) or 15d-15(e)) as required by paragraph (b) of Exchange Act Rules 13a-15 or 15d-15, as of December 31, 2021.

Based on the evaluation of our disclosure controls and procedures as of December 31, 2021, our Chief Executive Officer and Vice-President, Strategy and Finance concluded that, as of such date, our disclosure controls and procedures were not effective at a reasonable assurance level because of the material weaknesses in internal control over financial reporting set forth below;

provided, however, that we have made improvements with respect to addressing such material weaknesses and will continue to execute on an existing plan to remedy them.

Internal Control Over Financial Reporting

Our management is responsible for establishing and maintaining adequate internal control over financial reporting (as defined in Rules 13a-15(f) and 15d (f) under the Exchange Act).

Internal control over financial reporting is a process designed to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external reporting purposes in accordance with GAAP.

Because of its inherent limitations, internal control over financial reporting may not prevent or detect misstatements.

Also, projections of any evaluation of effectiveness to future periods are subject to the risk that controls may become inadequate because of changes in conditions, or that the degree of compliance with the policies or procedures may deteriorate.

A company’s internal control over financial reporting is a process designed by, or under the supervision of, a company’s principal executive and principal financial officers, or persons performing similar functions, and effected by a company’s board of directors, management and other personnel to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements in accordance with generally accepted accounting principles.

A material weakness is a deficiency or combination of deficiencies in internal control over financial reporting, such that there is a reasonable possibility that a material misstatement of our annual or interim financial statements will not be prevented or detected and corrected on a timely basis.

In preparing the financial statements as of and for the year ended December 31, 2020, our management identified material weaknesses in its internal control over financial reporting.

The material weaknesses identified were as follows:

(i) There was a material weakness in our internal control environment over financial reporting as a result of insufficient resources with appropriate knowledge and expertise to design, implement, document and operate effective internal controls over financial reporting.

(ii) There was a material weakness in our internal control activities due to a failure in design and implementation of controls to review clinical trial expenses, including the evaluation of the terms of clinical trial contracts.

Specifically, Tempest failed to properly review and evaluate progress of expense incurred in clinical trial contracts which resulted in the inaccurate actual of its clinical trial expenses.

Remediation of Material Weaknesses in Internal Control over Financial Reporting

Our management, under the supervision of its Chief Executive Officer, has undertaken a plan to remediate the material weaknesses identified above, including adjustment to the methodology used to reflect clinical trial expenses in our financial statements and leveraging additional accounting resources.

The additional efforts summarized below, which are in the process of being implemented, are intended to finalize the remediation, which our management expects to complete in the first half of 2022.

(i) We will seek to recruit and hire additional accounting personnel with appropriate experience, certification, education and training to help design, implement, document and operate effective internal controls over financial reporting;

(ii) We will finalize our internal control design, and implement management review controls to review clinical trial expenses and the completeness of our reserves based on the status of clinical development and the progress of expense incurred.

Our management cannot assure you that the material weaknesses identified will be remediated on the timelines currently anticipated by us, or at all, or that there will not be additional material weaknesses or significant deficiencies in the future.

Notwithstanding the existence of the material weaknesses as described above, we believe that the Consolidated Financial Statements in this Annual Report fairly present, in all material respects, our financial position, results of operations and cash flows as of the dates, and for the periods, presented, in conformity with GAAP.

Attestation Report of the Registered Public Accounting Firm.

We are a smaller reporting company, and therefore our independent registered public accounting firm has not issued a report on the effectiveness of internal control over financial reporting.

Changes in Internal Control over Financial Reporting

There were no changes in our internal control over financial reporting (as defined in Rules 13a-15(f) and 15d-15(f) under the Exchange Act) that occurred during the quarter ended December 31, 2020 which have materially affected, or are reasonably likely to materially affect, our internal control over financial reporting.

Inherent Limitations on Effectiveness of Controls

Our management, including our chief executive officer and our chief financial officer, believes that our disclosure controls and procedures and internal control over financial reporting are designed to provide reasonable assurance of achieving their objectives and are effective at the reasonable assurance level.

However, our management does not expect that our disclosure controls and procedures or our internal control over financial reporting will prevent all errors and all fraud.

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.

Further, the design of a control system must reflect the fact that there are resource constraints, and the benefits of controls must be considered relative to their costs.

Because of the inherent limitations in all control systems, no evaluation of controls can provide absolute assurance that all control issues and instances of fraud, if any, have been detected.

These inherent limitations include the realities that judgments in decision making can be faulty, and that breakdowns can occur because of a simple error or mistake.

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

The design of any system of controls also is based in part upon certain assumptions about the likelihood of future events, and there can be no assurance that any design will succeed in achieving its stated goals under all potential future conditions;

over time, controls may become inadequate because of changes in conditions, or the degree of compliance with policies or procedures may deteriorate.

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

There were no changes in internal control over financial reporting during the quarter ended December 31, 2021 that have materially affected, or are reasonably likely to materially affect, our internal control over financial reporting.

OTHER INFORMATION

Not applicable.

DISCLOSURE REGARDING FOREIGN JURISDICTIONS THAT PREVENT INSPECTIONS.

Not applicable.

DIRECTORS, EXECUTIVE OFFICERS AND CORPORATE GOVERNANCE

The information required by this item is incorporated by reference to our Proxy Statement for our 2022 Annual Meeting of Shareholders to be filed with the SEC within 120 days after the end of the fiscal year ended December 31, 2021.

As part of our system of corporate governance, our board of directors has adopted a code of business and ethics.

The code applies to all of our employees, officers (including our principal executive officer, principal financial officer, principal accounting officer or controller, or persons performing similar functions), agents and representatives, including our independent directors and consultants, who are not employees of ours, with regard to their Company-related activities.

Our code of business conduct and ethics is available on our website at www.millendo.com.

We intend to post on this section of our website any amendment to our code of business conduct and ethics, as well as any waivers of our code of business conduct and ethics, that are required to be disclosed by the rules of the SEC or the Nasdaq Stock Market.

EXECUTIVE COMPENSATION

14 unchanged sentences

(a)(3) Exhibits

Description of Exhibit

2.1 Agreement and Plan of Merger, dated as of March 29, 2021, by and among Millendo Therapeutics, Inc., Mars Merger Corp.

Incorporation by Reference

Exhibit Number Description of Exhibit Form File Number Exhibit Filing Date Filed or Furnished Herewith

2.1 Agreement and Plan of Merger, dated as of March 29, 2021, by and among Tempest Therapeutics, Inc., Mars Merger Corp.

and Tempest Therapeutics, Inc.

(incorporated by reference from Exhibit 2.1 to the Current Report on Form 8-K filed with the Securities and Exchange Commission on March 29, 2021, File No.

3.1 Restated Certificate of Incorporation of the Registrant, as amended (incorporated by reference from Exhibit 3.1 to the Quarterly Report on Form 10-Q filed with the Securities and Exchange Commission on May 15, 2019, File No.

3.2 Third Amended and Restated Bylaws, as Amended, of the Registrant (incorporated by reference from Exhibit 3.1 to the Current Report on Form 8-K filed with the Securities and Exchange Commission on August 9, 2018, File No.

4.1 Specimen Stock Certificate evidencing shares of Common Stock of the Registrant (incorporated by reference from Exhibit 4.1 to the Registration Statement on Form S-1 filed on August 29, 2012, File No.

8-K 001-35890 2.1 3/29/2021

3.1 Restated Certificate of Incorporation of the Registrant, as amended

10-Q 001-35890 3.1 5/15/2019

3.2 Certificate of Amendment to the Restated Certificate of Incorporation of the Company, as filed with the Secretary of State of the State of Delaware on June 24, 2021

8-K 001-35890 3.1 6/28/2021

3.3 Certificate of Amendment to the Restated Certificate of Incorporation of the Company, as filed with the Secretary of State of the State of Delaware on June 25, 2021

8-K 001-35890 3.2 6/28/2021

3.4 Amended and Restated Bylaws of the Registrant

8-K 001-35890 3.1 9/24/2021

4.1 Description of Securities Registered Pursuant to Section 12 of the Securities Exchange Act of 1934

10.1+ OvaScience, Inc.

2011 Stock Incentive Plan (incorporated by reference from Exhibit 10.1 to the Registration Statement on Form 10 filed on April 11, 2012, File No.

10.2+ Form of Incentive Stock Option Agreement under the OvaScience, Inc.

2011 Stock Incentive Plan (incorporated by reference from Exhibit 10.2 to the Registration Statement on Form 10 filed on May 17, 2012, File No.

10.3+ Form of Nonstatutory Stock Option Agreement under the OvaScience, Inc.

2011 Stock Incentive Plan (incorporated by reference from Exhibit 10.3 to the Registration Statement on Form 10 filed on May 17, 2012, File No.000-54647)

10.4+ Form of Restricted Stock Agreement under the OvaScience, Inc.

2011 Stock Incentive Plan (incorporated by reference from Exhibit 10.4 to the Registration Statement on Form 10 filed on April 11, 2012, File No.

10.5+ OvaScience, Inc.

2012 Stock Incentive Plan (incorporated by reference from Exhibit 10.5 to the Registration Statement on Form 10 filed on April 11, 2012, File No.

10.6+ Form of Incentive Stock Option Agreement under the OvaScience, Inc.

2012 Stock Incentive Plan (incorporated by reference from Exhibit 10.6 to the Annual Report on Form 10-K filed on March 16, 2015, File No.

10.7+ Form of Nonstatutory Stock Option Agreement under the OvaScience, Inc.

2012 Stock Incentive Plan (incorporated by reference from Exhibit 10.7 to the Annual Report on Form 10-K filed on March 16, 2015, File No.

10.8+ Form of Inducement Nonqualified Stock Option Agreement subject to the terms of the OvaScience 2012 Stock Incentive Plan

10.9+ Millendo Therapeutics, Inc.

2012 Stock Incentive Plan, as amended (incorporated by reference from Exhibit 10.8 to the Annual Report on Form 10-K filed on April 1, 2019, File No.

10.10+ Form of Stock Option Agreement under the Millendo Therapeutics, Inc.

2012 Stock Incentive Plan (incorporated by reference from Exhibit 10.9 to the Annual Report on Form 10-K filed on April 1, 2019, File No.

10.11+ Sub Plan for French Residents to the Millendo Therapeutics, Inc.

2012 Stock Plan, as amended (incorporated by reference from Exhibit 10.5 to the Current Report on Form 8-K, as filed with the Securities and Exchange Commission on December 13, 2018, File No.

10.12+ Form of Stock Option Agreement under the Sub Plan for French Residents to the Millendo Therapeutics, Inc.

2012 Stock Plan, as amended (incorporated by reference from Exhibit 10.11 to the Annual Report on Form 10-K filed on April 1, 2019, File No.

10.13+ 2019 Equity Incentive Plan (incorporated by reference from Exhibit 10.1 to the Current Report on Form 8-K filed with the Securities and Exchange Commission on June 13, 2019, File No.

10.14+ Form of Option Grant Package under 2019 Equity Incentive Plan (incorporated by reference from Exhibit 10.7 to the Quarterly Report on Form 10-Q filed with the Securities and Exchange Commission on August 12, 2019, File No.

10.15+ Form of RSU Grant Package under 2019 Equity Incentive Plan (incorporated by reference from Exhibit 10.8 to the Quarterly Report on Form 10-Q filed with the Securities and Exchange Commission on August 12, 2019, File No.

10.16+ Form of Stock Option Agreement under the Sub Plan for French Residents under 2019 Equity Incentive Plan (incorporated by reference from Exhibit 10.16 to the Annual Report on Form 10-K filed on Mar ch 11, 2020, File No.

10.17+ Form of Inducement Nonqualified Stock Option Agreement subject to the terms of the 2019 Equity Incentive Plan (incorporated by reference from Exhibit 10.17 to the Annual Report on Form 10-K filed on March 11, 2020, File No.

10.18+ 2019 Employee Stock Purchase Plan (incorporated by reference from Exhibit 10.2 to the Current Report on Form 8-K filed with the Securities and Exchange Commission on June 13, 2019, File No.

10.19+ Form of Indemnity Agreement between Millendo Therapeutics, Inc.

and each of its directors and executive officers (incorporated by reference from Exhibit 10.1 to the Current Report on Form 8-K, as filed with the Securities and Exchange Commission on December 13, 2018, File No.

10.20 Stock Purchase Agreement, by and among OvaScience, Inc., the purchasers set forth on Schedule I thereto and Millendo Therapeutics, Inc., dated November 1, 2018 (incorporated by reference from Exhibit 10.45 to the Registration Statement on Form S-4 filed on November 2, 2018, File No.

10.21 First Amendment to Shareholders and Option Agreement, dated September 28, 2018 (incorporated by reference from Exhibit 4.9 to the Registration Statement on Form S-3, as filed with the Securities and Exchange Commission on November 6, 2018, File No.

10.22 Registration Rights Agreement, by and among OvaScience, Inc.

and the persons listed on Schedule A thereto, dated November 1, 2018 (incorporated by reference from Exhibit 10.46 to the Registration Statement on Form S-4 filed on November 2, 2018, File No.

10.23 Second Amended and Restated Investor Rights Agreement by and among Millendo Therapeutics, Inc.

and certain of its stockholders, dated December 19, 2017 (incorporated by reference from Exhibit 4.6 to the Registration Statement on Form S-3, as filed with the Securities and Exchange Commission on November 6, 2018, File No.

10.24 First Amendment to Second Amended and Restated Investor Rights Agreement, dated October 24, 2018 (incorporated by reference from Exhibit 4.7 to the Registration Statement on Form S-3, as filed with the Securities and Exchange Commission on November 6, 2018, File No.

10.25 Shareholders and Option Agreement, by and between Millendo Therapeutics, Inc.

and Otonnale SAS, dated December 19, 2017 (incorporated by reference from Exhibit 4.8 to the Registration Statement on Form S-3, as filed with the Securities and Exchange Commission on November 6, 2018, File No.

10.26 Amended and Restated Equity Distribution Agreement dated March 4, 2020, between Millendo Therapeutics, Inc., Citigroup Global Markets Inc.

and SVB Leerink LLC (incorporated by reference from Exhibit 1.1 to the Current Report on Form 8-K filed with the Securities and Exchange Commission on March 4, 2020, File No.

10.27 Lease Agreement, by and between Millendo Therapeutics, Inc.

and Ann Arbor Real Estate Group, L.L.C., dated October 22, 2018 (incorporated by reference from Exhibit 10.29 to the Annual Report on Form 10-K, Filed on March 11, 2020, File No.

10.28 Lease Agreement by and between Millendo Therapeutics, Inc.

and Ann Arbor Real Estate Group, L.L.C., dated February 1, 2019 (incorporated by reference from Exhibit 10.1 to the Current Report on Form 8-K, as filed with the Securities and Exchange Commission on February 7, 2019, File No.

10.29+ Executive Chair Agreement, by and between Millendo Therapeutics US, Inc.

Owens, Ph.D., dated January 27, 2021.

10.30+ Separation from Employment, by and between Millendo Therapeutics US, Inc.

Owens, Ph.D., dated January 27, 2021.

10.31+ Amended and Restated Employment Agreement between Louis Arcudi III and Millendo Therapeutics US, Inc., dated as of January 27, 2021.

10.32+ Amended and Restated Employment Agreement between Jennifer Minai-Azary and Millendo Therapeutics US, Inc., dated of January 27, 2021.

21.1 Subsidiaries of the Registrant.

4.2† Form of Tempest Therapeutics, Inc.

Warrant to Purchase Stock

S-4/A 333-255198 4.2 5/4/2021

10.1+ 2 011 Equity Incentive Plan

S-8 333-257727 10.2 7/7/2021

10.2+ 2017 Equity Incentive Plan

S-8 333-257727 10.1 7/7/2021

10.3+ Form of Stock Option Agreement under the 2017 Equity Incentive Plan

2019 Equity Incentive Plan

8-K 001-35890 10.1 6/13/2019

Form of Option Grant Package under 2019 Equity Incentive Plan

10-Q 001-35890 10.7 8/12/2019

Form of RSU Grant Package under 2019 Equity Incentive Plan

10-Q 001-35890 10.8 8/12/2019

Form of Stock Option Agreement under the Sub Plan for French Residents under 2019 Equity Incentive Plan

10-K 001-35890 10.16 3/11/2020

Form of Inducement Nonqualified Stock Option Agreement subject to the terms of the 2019 Equity Incentive Plan

10-K 001-35890 10.17 3/11/2020

2019 Employee Stock Purchase Plan

8-K 001-35890 10.2 6/13/2019

10.19 Loan and Security Agreement, dated January 15, 2021, by and among Oxford Finance LLC, the Lenders party thereto, and Tempest

S-4/A 333-255198 10.3 5/4/2021

Form of Indemnification Agreement

8-K 001-35890 10.1 7/07/2021

Employment Agreement, dated July 7, 2021, by and between the Company and Stephen Brady

8-K 001-35890 10.2 7/07/2021

Employment Agreement, dated July 7, 2021, by and between the Company and Thomas Dubensky, Ph.D.

8-K 001-35890 10.3 7/07/2021

Employment Agreement, dated July 7, 2021, by and between the Company and Samuel Whiting, M.D., Ph.D.

8-K 001-35890 10.4 7/07/2021

10.24† Lease Agreement, dated February 22, 2019, by and between ARE-San Francisco No.

17, LLC and Tempest Therapeutics, Inc.

S-4/A 333-255198 10.1 5/4/2021

10.25† First Amendment to Lease, dated June 28, 2019, by and between ARE-San Francisco No.

17, LLC and Tempest Therapeutics, Inc.

S-4/A 333-255198 10.2 5/4/2021

21.1 Subsidiaries of the Registrant X

23.1 Consent of Ernst & Young LLP, independent registered public accounting firm

24.1 Power of Attorney (included on signature page)

23.2 Consent of Deloitte & Touche LLP, independent registered public accounting firm

24.1 Power of Attorney (included on signature page) X

31.1 Certification of Principal Executive Officer pursuant to Rules 13a-14(a) and 15d-14(a) promulgated under the Securities Exchange Act of 1934, as adopted pursuant to Section 302 of the Sarbanes-Oxley Act of 2002

2 unchanged sentences

Section 1350, as adopted pursuant to section 906 of The Sarbanes-Oxley Act of 2002

101.INS XBRL Instance Document

101.SCH XBRL Taxonomy Extension Schema Document

101.CAL XBRL Taxonomy Extension Calculation Linkbase Document

101.DEF XBRL Taxonomy Extension Definition Linkbase Document

101.LAB XBRL Taxonomy Extension Label Linkbase Document

101.PRE XBRL Taxonomy Extension Presentation Linkbase Document

101.INS Inline XBRL Instance Document X

101.SCH Inline XBRL Taxonomy Extension Schema Document X

101.CAL Inline XBRL Taxonomy Extension Calculation Linkbase Document X

101.DEF Inline XBRL Taxonomy Extension Definition Linkbase Document X

101.LAB Inline XBRL Taxonomy Extension Label Linkbase Document X

101.PRE Inline XBRL Taxonomy Extension Presentation Linkbase Document X

_______________________________________

+ Indicates management contract or compensatory plan.

# Confidential treatment has been granted with respect to portions of this exhibit (indicated by asterisks) and those portions have been separately filed with the Securities and Exchange Commission.

† Filed previously.

^ These certifications are being furnished solely to accompany this Annual Report pursuant to 18 U.S.C.

3 unchanged sentences

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

MILLENDO THERAPEUTICS, INC.

/s/ Louis Arcudi III

March 29, 2021 Louis Arcudi III

President and Chief Executive Officer

KNOW ALL PERSONS BY THESE PRESENTS, that each person whose signature appears below constitutes and appoints Louis Arcudi III and Jennifer Minai-Azary , jointly and severally, as his or her true and lawful attorneys-in-fact and agents, with full power of substitution and resubstitution, for him or her and in his or her name, place and stead, in any and all capacities, to sign this Annual Report on Form 10-K of Millendo Therapeutics, Inc., and any or all amendments thereto, and to file the same, with all exhibits thereto, and other documents in connection therewith, with the Securities and Exchange Commission, granting unto said attorneys-in-fact and agents full power and authority to do and perform each and every act and thing requisite or necessary to be done in and about the premises hereby ratifying and confirming all that said attorneys-in-fact and agents, or his, her or their substitute or substitutes, may lawfully do or cause to be done by virtue hereof.

TEMPEST THERAPEUTICS, INC.

/s/ Stephen Brady

Stephen Brady

Chief Executive Officer (Principal Executive Officer)

/s/ Nicholas Maestas

Nicholas Maestas

Vice-President, Strategy and Finance (Principal

Financial Officer)

March 29, 2022

KNOW ALL PERSONS BY THESE PRESENTS, that each person whose signature appears below constitutes and appoints Stephen Brady and Nicolas Maestas , jointly and severally, as his or her true and lawful attorneys-in-fact and agents, with full power of substitution and resubstitution, for him or her and in his or her name, place and stead, in any and all capacities, to sign this Annual Report on Form 10-K of Tempest Therapeutics, Inc., and any or all amendments thereto, and to file the same, with all exhibits thereto, and other documents in connection therewith, with the Securities and Exchange Commission, granting unto said attorneys-in-fact and agents full power and authority to do and perform each and every act and thing requisite or necessary to be done in and about the premises hereby ratifying and confirming all that said attorneys-in-fact and agents, or his, her or their substitute or substitutes, may lawfully do or cause to be done by virtue hereof.

Pursuant to the requirements of the Securities Exchange Act of 1934, as amended, this report has been signed below by the following persons on behalf of the registrant and in the capacities and on the dates indicated.

/s/ Louis Arcudi III President, Chief Executive Officer and Director (Principal Executive Officer)

Signature Title Date

/s/ Stephen Brady President, Chief Executive Officer and Director (Principal Executive Officer)

March 29, 2022

Louis Arcudi III

/s/ Jennifer Minai-Azary Chief Financial Officer

(Principal Financial Officer and Principal Accounting Officer)

Stephen Brady

/s/ Nicholas Maestas Vice President, Strategy and Finance

(Principal Financial Officer)

March 29, 2022

Jennifer Minai-Azary

Chairperson of the Board of Directors March 29, 2021

/s/ Carol Gallagher, Pharm.D.

Director March 29, 2021

Carol Gallagher, Pharm.D.

/s/ James Hindman Director March 29, 2021

James Hindman

Howe, III, M.D.

Director March 29, 2021

Howe, III, M.D.

/s/ Geoff Nichol, M.B., Ch.B., M.B.A.

Director March 29, 2021

Nicholas Maestas

/s/ Pierre Lorenzo Corporate Controller, Treasurer and Secretary

(Principal Accounting Officer)

March 29, 2022

Pierre Lorenzo

/s/ Michael Rabb Chairman of the Board of Directors March 29, 2022

/s/ Thomas Dubensky President and Director March 29, 2022

Thomas Dubensky, Ph.D.

/s/ Geoff Nichol Director March 29, 2022

Geoff Nichol, M.B., Ch.B., M.B.A.

/s/ Carole Nuechterlein, J.D.

Director March 29, 2021

Carole Nuechterlein, J.D.

/s/ Christine Pellizzari Director March 29, 2022

Christine Pellizzari

/s/ Ronit Simantov Director March 29, 2022

Ronit Simantov, M.D.

/s/ Thomas Woiwode Director March 29, 2022

Thomas Woiwode, Ph.D.

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