What changed in this filing

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Item 9A. Controls and Procedures

2024-03-19 compared with 2023-03-22 · 34 added, 55 removed, 129 unchanged (41% of the section changed)

1 unchanged sentence

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.

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, 2023.

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Our management assessed the effectiveness of our internal control over financial reporting as of December 31, 2023.

In making this assessment, management used the criteria set forth by the Committee of Sponsoring organizations of the Treadway Commission (COSO) in Internal Control –

Integrated Framework (2013).

In making this assessment, management used the criteria set forth by the Committee of Sponsoring organizations of the Treadway Commission (COSO) in Internal Control – Integrated Framework (2013).

Based on that assessment, our management concluded that, as of December 31, 2023, our internal control over financial reporting was effective.

Previously Reported Material Weakness and Remediation

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, we 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.

Management completed the remediation of the previously identified material weaknesses described above during the year ended December 31, 2022.

Remedial actions include adjustments to the methodology used to reflect clinical trial expenses in our financial statements.

In addition, management also (i) hired additional accounting personnel with appropriate experience, certification, education and training to help design, implement, document and operate effective internal controls over financial reporting;

and (ii) with the assistance of such personnel, finalized our internal control design and implemented 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.

Attestation Report of the Registered Public Accounting Firm.

1 unchanged sentence

Changes in Internal Control over Financial Reporting

Other than remediation measures discussed above, there were no changes in internal control over financial reporting during the quarter ended December 31, 2022 that have materially affected, or are reasonably likely to materially affect, our internal control over financial reporting.

There were no changes in internal control over financial reporting during the quarter ended December 31, 2023 that have materially affected, or are reasonably likely to materially affect, our internal control over financial reporting.

OTHER INFORMATION

Not applicable.

During the three months ended December 31, 2023, no director or officer of the Company adopted or terminated a “Rule 10b5-1 trading arrangement” or “non-Rule 10b5-1 trading arrangement,” as each term is defined in Item 408(a) of Regulation S-K.

DISCLOSURE REGARDING FOREIGN JURISDICTIONS THAT PREVENT INSPECTIONS .

2 unchanged sentences

Information About Our Directors

Information regarding our Directors required by this item will be contained in our 2023 Proxy Statement under the caption “Information Regarding Director Nominees and Continuing Directors,”

and is hereby incorporated by reference.

Information regarding our Directors required by this item will be contained in our 2024 Proxy Statement under the caption “Information Regarding Director Nominees and Continuing Directors,” and is hereby incorporated by reference.

Information About Our Executive Officers

Information regarding our Executive Officers required by this item will be contained in our 2023 Proxy Statement under the caption “Executive Officers,”

and is hereby incorporated by reference.

Information regarding our Executive Officers required by this item will be contained in our 2024 Proxy Statement under the caption “Executive Officers,” and is hereby incorporated by reference.

Identification of Audit Committee and Financial Experts

Information regarding our Audit Committee and Financial Experts required by this item will be contained in our 2023 Proxy Statement under the caption “Information Regarding the Board of Directors and Corporate Governance—Audit Committee,”

and is hereby incorporated by reference.

Information regarding our Audit Committee and Financial Experts required by this item will be contained in our 2024 Proxy Statement under the caption “Information Regarding the Board of Directors and Corporate Governance—Audit Committee,” and is hereby incorporated by reference.

Material Changes to Procedures for Recommending Directors

Information regarding our Procedures for Recommending Directors required by this item will be contained in our 2023 Proxy Statement under the caption “Information Regarding the Board of Directors and Corporate Governance—Nominating and Corporate Governance Committee,”

and is hereby incorporated by reference.

Information regarding our Procedures for Recommending Directors required by this item will be contained in our 2024 Proxy Statement under the caption “Information Regarding the Board of Directors and Corporate Governance—Nominating and Corporate Governance Committee,” and is hereby incorporated by reference.

Code of Business Conduct and Ethics

Information regarding our Code of Business Conduct and Ethics (the “Code of Conduct”) required by this item will be contained in our 2023 Proxy Statement under the caption “Information Regarding the Board of Directors and Corporate Governance—Code of Ethics,”

and is hereby incorporated by reference.

Information regarding our Code of Business Conduct and Ethics (the “Code of Conduct”) required by this item will be contained in our 2024 Proxy Statement under the caption “Information Regarding the Board of Directors and Corporate Governance—Code of Ethics,” and is hereby incorporated by reference.

If we make any substantive amendments to the Code of Conduct or grant any waiver from a provision of the Code of Conduct to any executive officer or director, we will promptly disclose the nature of the amendment or waiver on its website.

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Delinquent Section 16(a) Reports

Information regarding compliance with Section 16(a) of the Exchange Act required by this item will be contained in our 2023 Proxy Statement under the caption “Security Ownership of Certain Beneficial Owners and Management—Delinquent Section 16(A) Reports,”

if any, and is hereby incorporated by reference.

Information regarding compliance with Section 16(a) of the Exchange Act required by this item will be contained in our 2024 Proxy Statement under the caption “Security Ownership of Certain Beneficial Owners and Management—Delinquent Section 16(A) Reports,” if any, and is hereby incorporated by reference.

EXECUTIVE COMPENSATION

Information regarding our Executive Compensation required by this item will be contained in our 2023 Proxy Statement under the caption “Executive and Director Compensation,”

and is hereby incorporated by reference.

Information regarding our Executive Compensation required by this item will be contained in our 2024 Proxy Statement under the caption “Executive and Director Compensation,” and is hereby incorporated by reference.

SECURITY OWNERSHIP OF CERTAIN BENEFICIAL OWNERS AND MANAGEMENT AND RELATED STOCKHOLDER MATTERS

Ownership of Securities

Information regarding our Ownership of Securities required by this item will be contained in our 2023 Proxy Statement under the caption “Security Ownership of Certain Beneficial Owners and Management,”

and is hereby incorporated by reference.

Information regarding our Ownership of Securities required by this item will be contained in our 2024 Proxy Statement under the caption “Security Ownership of Certain Beneficial Owners and Management,” and is hereby incorporated by reference.

Equity Compensation Plan Information

Information regarding our Equity Compensation Plan required by this item will be contained in our 2023 Proxy Statement under the caption “Equity Compensation Plan Information,”

and is hereby incorporated by reference.

Information regarding our Equity Compensation Plan required by this item will be contained in our 2024 Proxy Statement under the caption “Equity Compensation Plan Information,” and is hereby incorporated by reference.

CERTAIN RELATIONSHIPS AND RELATED TRANSACTIONS, AND DIRECTOR INDEPENDENCE

Information regarding Related Transactions and Director Independence required by this item will be contained in our 2023 Proxy Statement under the caption “Transactions with Related Persons and Indemnification,”

and “Information Regarding the Board of Directors and Corporate Governance –

Independence of the Board of Directors,”

and is hereby incorporated by reference.

Information regarding Related Transactions and Director Independence required by this item will be contained in our 2024 Proxy Statement under the caption “Transactions with Related Persons and Indemnification,” and “Information Regarding the Board of Directors and Corporate Governance – Independence of the Board of Directors,” and is hereby incorporated by reference.

PRINCIPAL ACCOUNTING FEES AND SERVICES

Information regarding Accounting Fees and Services required by this item will be contained in our 2023 Proxy Statement in Proposal 3 under the captions “—Principal Accountant Fees and Services”

and “—Pre-Approval Policies and Procedures,”

and is hereby incorporated by reference.

Information regarding Accounting Fees and Services required by this item will be contained in our 2024 Proxy Statement in Proposal 3 under the captions “—Principal Accountant Fees and Services” and “—Pre-Approval Policies and Procedures,” and is hereby incorporated by reference.

EXHIBITS AND FINANCIAL STATEMENT SCHEDULES

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The financial statements are included in Item 8.

“Financial Statements and Supplementary Data.”

(a)(2) Financial Statement Schedules

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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

Certificate of Designation of Series A Junior Participating Preferred Stock filed with the Secretary of State of the State of Delaware on October 10, 2023

Amended and Restated Bylaws of the Registrant

3 unchanged sentences

Form of Pre-Funded Warrant

Registration Rights Agreement, dated April 26, 2022, by and among Tempest Therapeutics, Inc.

and the persons party thereto

Rights Agreement, dated as of October 10, 2023, between Tempest Therapeutics, Inc.

and Computershare Trust Company, N.A., which includes the form of Certificate of Designation as Exhibit A, the form of Right Certificate as Exhibit B and the Summary of Rights to Purchase Preferred Shares as Exhibit C

2011 Equity Incentive Plan

14 unchanged sentences

and Tempest Therapeutics, Inc.

Securities Purchase Agreement, dated April 26, 22, by and among Tempest Therapeutics, Inc.

and the persons party thereto

Registration Rights Agreement, dated April 26, 22, by and among Tempest Therapeutics, Inc.

and the persons party thereto

First Amendment to Loan and Security Agreement, dated December 23, 2022, by and among Oxford Finance LLC, Tempest Therapeutics, Inc., Tempest TX, Inc.

and Millendo Therapeutics US, Inc.

Second Amendment to Loan and Security Agreement, dated November 3, 2023, by and among Oxford Finance LLC, Tempest Therapeutics, Inc., Tempest TX, Inc.

and Millendo Therapeutics US, Inc

Tempest Therapeutics, Inc.

Amended and Restated 2023 Equity Incentive Plan

Form of Option Grant Package under the Amended and Restated 2023 Equity Incentive Plan

Tempest Therapeutics, Inc.

2023 Inducement Plan

Form of Option Grant Package under the 2023 Inducement Plan

Separation and Consulting Agreement by and between the Registrant and Thomas Dubensky, Ph.D., dated September 15, 2023

Subsidiaries of the Registrant

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

Incentive Compensation Recoupment Policy

Inline XBRL Instance Document

11 unchanged sentences

Section 1350, and are not being filed for purposes of Section 18 of the Securities Exchange Act of 1934, as amended, and are not to be incorporated by reference into any filing of the Registrant, whether made before or after the date hereof, regardless of any general incorporation language in such filing.

# Pursuant to Item 601(b)(10)(iv) of Regulation S-K, certain portions of this exhibit (indicated by ***) have been omitted because the identified information is not material and is the type that the Registrant treats as private or confidential.

FORM 10-K SUMMARY

4 unchanged sentences

Stephen Brady

Chief Executive Officer (Principal Executive Officer)

Chief Executive Officer & President (Principal Executive Officer)

/s/ Nicholas Maestas

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/s/ Stephen Brady

Chief Executive Officer and Director (Principal Executive Officer)

Chief Executive Officer, President and Director (Principal Executive Officer)

March 19, 2024

13 unchanged sentences

March 19, 2024

/s/ Thomas Dubensky

President and Director

March 22, 2023

Thomas Dubensky, Ph.D.

/s/ Geoff Nichol

7 unchanged sentences

Ronit Simantov, M.D.

/s/ Thomas Woiwode

March 22, 2023

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