Item 9A. Controls and Procedures
ITEM 9A. CONTROLS AND PROCEDURES
Evaluation of Disclosure Controls and Procedures
Our management, with the participation of our Chief Executive Officer (our principal executive officer) and our Chief Financial Officer (our principal financial officer), evaluated the effectiveness of our disclosure controls and procedures as of the end of the period covered by this Annual Report. The term “disclosure controls and procedures,” as defined in Rules 13a-15(e) and 15d-15(e) under the Securities Exchange Act of 1934, as amended (the "Exchange Act"), means controls and other procedures of a company 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. Disclosure controls and procedures include, without limitation, controls and procedures 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 accumulated and communicated to the company’s management, including its principal executive and principal financial officers, or persons performing similar functions, as appropriate to allow timely decisions regarding required disclosure. Our management recognizes that any controls and procedures, no matter how well designed and operated, can provide only reasonable assurance of achieving their objectives and our management necessarily applies its judgment in evaluating the cost-benefit relationship of possible controls and procedures. Based on the evaluation of our disclosure controls and procedures as of the end of the period covered by this Annual Report, our Chief Executive Officer and our Chief Financial Officer concluded that, as of such date, our disclosure controls and procedures were effective at the reasonable assurance level.
Inherent Limitations Over Internal Controls
Our management is responsible for establishing and maintaining adequate internal control over financial reporting for the company. Internal control over financial reporting is defined in Rules 13a-15(f) and 15d-15(f) under the Exchange Act as a process designed by, or under the supervision of, a company’s principal executive officer and principal financial officer, 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 for external purposes in accordance with generally accepted accounting principles and includes those policies and procedures that:
• pertain to the maintenance of records that in reasonable detail accurately and fairly reflect the transactions and dispositions of a company’s assets;
• provide reasonable assurance that transactions are recorded as necessary to permit preparation of financial statements in accordance with generally accepted accounting principles, and that a company’s receipts and expenditures are being made only in accordance with authorizations of a company’s management and directors; and
• provide reasonable assurance regarding prevention or timely detection of unauthorized acquisition, use or disposition of a company’s assets that could have a material effect on the financial statements.
Because of its inherent limitations, internal control over financial reporting may not prevent or detect misstatements. Therefore, even those systems determined to be effective can provide only reasonable assurance with respect to financial statement preparation and presentation. 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.
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Management’s Annual Report on Internal Control over Financial Reporting
This Annual Report does not include a report of management's assessment regarding internal controls over financial reporting due to a transition period established by rules of the SEC for newly public companies.
Attestation Report of the Registered Public Accounting Firm
This Annual Report does not include an attestation report of our registered public accounting firm due to a transition period established by rules of the SEC for newly public companies. Additionally, our independent registered public accounting firm will not be required to opine on our internal controls over financial reporting due to an exemption established by the JOBS Act for "emerging growth companies".
Changes in Internal Control Over Financial Reporting
There was no change 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 year ended December 31, 2024, that has materially affected, or is reasonably likely to materially affect, our internal control over financial reporting.
ITEM 9B. OTHER INFORMATION
(a)
None.
(b)
Rule 10b5-1 Trading Plans
During the quarter ended December 31, 2024, none of our directors or executive officers adopted, modified, or terminated any contract, instruction or written plan for the purchase or sale of our securities that was intended to satisfy the affirmative defense conditions of Rule 10b5-1(c) or any "non-Rule 10b5-1 trading arrangements" as defined in Item 408(c) of Regulation S-K.
ITEM 9C. DISCLOSURE REGARDING FOREIGN JURISDICTIONS THAT PREVENT INSPECTIONS
Not applicable.
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PART III
ITEM 10. DIRECTORS, EXECUTIVE OFFICERS AND CORPORATE GOVERNANCE
The information required by this Item 10 will be included in our Definitive Proxy Statement to be filed with the SEC with respect to our 2025 Annual Meeting of Stockholders and is incorporated herein by reference.
There have been no material changes to the procedures by which security-holders may recommend nominees to our board of directors.
ITEM 11. EXECUTIVE COMPENSATION
The information required by this Item 11 will be included in our Definitive Proxy Statement to be filed with the SEC with respect to our 2025 Annual Meeting of Stockholders and is incorporated herein by reference.
ITEM 12. SECURITY OWNERSHIP OF CERTAIN BENEFICIAL OWNER AND MANAGEMENT AND RELATED STOCKHOLDER MATTERS
The information required by this Item 12 will be included in our Definitive Proxy Statement to be filed with the SEC with respect to our 2025 Annual Meeting of Stockholders and is incorporated herein by reference.
ITEM 13. CERTAIN RELATIONSHIPS AND RELATED TRANSACTIONS, AND DIRECTOR INDEPENDENCE
The information required by this Item 13 will be included in our Definitive Proxy Statement to be filed with the SEC with respect to our 2025 Annual Meeting of Stockholders and is incorporated herein by reference.
ITEM 14. PRINCIPAL ACCOUNTING FEES AND SERVICES
Our independent public accounting firm is Deloitte & Touche LLP, Boston, Massachusetts, PCAOB Auditor ID 34.
The information required by this Item 14 will be included in our Definitive Proxy Statement to be filed with the SEC with respect to our 2025 Annual Meeting of Stockholders and is incorporated herein by reference.
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PART IV
ITEM 15. EXHIBITS AND FINANCIAL STATEMENT SCHEDULES
(a) Financial Statements
For a list of the consolidated financial statements included herein, see Index to the Consolidated Financial Statements on page F-1 of this Annual Report, which is incorporated into this Item by reference.
(b) Exhibits
Exhibit
Number Description
3.1 Fifth Amended and Restated Certificate of Incorporation of Sionna Therapeutics, Inc. (Incorporated by r eference to Exhibit 3.1 of the Registrant’s Current Report on Form 8-K (File No. 001-42504) filed on February 10, 2025) .
3.2 Amended and Restated Bylaws of Sionna Therapeutics, Inc. (Incorporated by r eference to Exhibit 3.2 of the Registrant’s Current Report on Form 8-K (File No. 001-42504) filed on February 10, 2025) .
4.1 Specimen Common Stock Certificate (Incorporated by r eference to Exhibit 4.1 of the Registrant’s Registration Statement on Form S-1/A (File No. 333-284352) filed on February 3, 2025).
4.2+
Third Amended and Restated Investors’ Rights Agreement, by and between the Registrant and certain of its stockholders, dated as of March 4, 2024 (Incorporated by r eference to Exhibit 4.2 of the Registrant’s Registration Statement on Form S-1/A (File No. 333-284352) filed on February 3, 2025) .
4.3*
Description of Securities of the Regist rant .
10.1#
2020 Stock Option and Grant Plan and form of award agreements thereunder (Incorporated by r eference to Exhibit 10.1 of the Registrant’s Registration Statement on Form S-1/A (File No. 333-284352) filed on February 3, 2025) .
10.2#
Sionna Therapeutics, Inc. 2025 Stock Option and Incentive Plan and form of award agreements thereunder (Incorporated by r eference to Exhibit 10.2 of the Registrant’s Registration Statement on Form S-1/A (File No. 333-284352) filed on February 3, 2025) .
10.3#
Sionna Therapeutics, Inc. 2025 Employee Stock Purchase Plan (Incorporated by r eference to Exhibit 10.3 of the Registrant’s Registration Statement on Form S-1/A (File No. 333-284352) filed on February 3, 2025) .
10.4#
Form of Indemnification Agreement by and between the Registrant and its director and executive officers (Incorporated by r eference to Exhibit 10.4 of the Registrant’s Registration Statement on Form S-1/A (File No. 333-284352) filed on February 3, 2025) .
10.5#
Senior Executive Cash Incentive Bonus Plan (Incorporated by r eference to Exhibit 10.5 of the Registrant’s Registration Statement on Form S-1/A (File No. 333-284352) filed on February 3, 2025) .
10.6#
Severance and Change in Control Plan (Incorporated by r eference to Exhibit 10.6 of the Registrant’s Registration Statement on Form S-1/A (File No. 333-284352) filed on February 3, 2025).
10.7#
Non-Employee Director Compensation Policy (Incorporated by r eference to Exhibit 10.7 of the Registrant’s Registration Statement on Form S-1/A (File No. 333-284352) filed on February 3, 2025) .
10.8†+
License Agreement by and between the Registrant and Sanofi Genzyme, dated as of December 20, 2019, as amended (Incorporated by r eference to Exhibit 10.9 of the Registrant’s Registration Statement on Form S-1/A (File No. 333-284352) filed on February 3, 2025) .
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Exhibit
Number Description
10.9†+
License Agreement by and between the Registrant and AbbVie Global Enterprises Ltd., dated as of July 11, 2024 (Incorporated by r eference to Exhibit 10.10 of the Registrant’s Registration Statement on Form S-1/A (File No. 333-284352) filed on February 3, 2025) .
10.10†+
Payment Agreement by and between the Registrant and Cystic Fibrosis Foundation, dated as of December 20, 2019 (Incorporated by r eference to Exhibit 10.11 of the Registrant’s Registration Statement on Form S-1/A (File No. 333-284352) filed on February 3, 2025) .
10.11#+
Offer Letter by and between the Registrant and Michael Cloonan, dated as of March 8, 2021 (Incorporated by r eference to Exhibit 10.12 of the Registrant’s Registration Statement on Form S-1/A (File No. 333-284352) filed on February 3, 2025) .
10.12#+
Offer Letter by and between the Registrant and Charlotte McKee, dated as of May 7, 2021 (Incorporated by r eference to Exhibit 10.13 of the Registrant’s Registration Statement on Form S-1/A (File No. 333-284352) filed on February 3, 2025) .
10.13#+
Offer Letter by and between the Registrant and Elena Ridloff, dated as of August 20, 2021 (Incorporated by r eference to Exhibit 10.14 of the Registrant’s Registration Statement on Form S-1/A (File No. 333-284352) filed on February 3, 2025) .
10.14+
Lease by and between the Registrant and BP3-BOS6 21 Hickory LLC, dated as of May 18, 2022, as amended (Incorporated by r eference to Exhibit 10.15 of the Registrant’s Registration Statement on Form S-1/A (File No. 333-284352) filed on February 3, 2025) .
19.1*
S ionna Therapeutics , Inc. Ins ider Trading Policy .
21.1 Subsidiaries of Registrant (Incorporated by r eference to Exhibit 21.1 of the Registrant’s Registration Statement on Form S-1/A (File No. 333-284352) filed on February 3, 2025) .
23.1*
Consent of Deloitte & Touche LLP, independent registered public accounting firm.
31.1*
Certification of Principal Executive Officer Pursuant to Rules 13a-14(a) and 15d-14(a) under the Securities Exchange Act of 1934, as Adopted Pursuant to Section 302 of the Sarbanes-Oxley Act of 2002 .
31.2*
Certification of Principal Financial Officer Pursuant to Rules 13a-14(a) and 15d-14(a) under the Securities Exchange Act of 1934, as Adopted Pursuant to Section 302 of the Sarbanes-Oxley Act of 2002 .
32.1*
Certification of Principal Executive Officer and Principal Financial Officer Pursuant to 18 U.S.C. Section 1350, as Adopted Pursuant to Section 906 of the Sarbanes-Oxley Act of 2002.
97.1 Compensation R eco very P olicy ( Incorporated by r eference to Exhibit 10.8 of the Registrant’s Registration Statement on Form S-1/A (File No. 333-284352) filed on February 3, 2025 ) .
____________
* Filed herewith.
** The certification furnished in Exhibit 32.1 hereto is deemed to be furnished with this Annual Report and will not be deemed to be “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended, except to the extent that the Registrant specifically incorporates it by reference.
# Indicates a management contract or any compensatory plan, contract or arrangement.
† Certain portions of this document that constitute confidential information have been redacted pursuant to Item 601(b)(10) of Regulation S-K.
+ Certain exhibits and schedules to these agreements have been omitted pursuant to Item 601(a)(5) and (6) of Regulation S-K. The registrant will furnish copies of any of the exhibits and schedules to the Securities and Exchange Commission upon request.
(c) Financial Statement Schedules
No financial statements have been submitted because they are not required or are not applicable or because the information required is included in the consolidated financial statements or the notes thereto.
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ITEM 16. FORM 10-K SUMMARY
None.
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SIGNATURES
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.
SIONNA THERAPEUTICS, INC.
By: /s/
Michael Cloonan
Name: Michael Cloonan, M.B.A.
Title: President and Chief Executive Officer
POWER OF ATTORNEY AND SIGNATURES
Each individual whose signature appears below hereby constitutes and appoints Michael Cloonan, M.B.A., and Elena Ridloff, C.F.A., as such person’s true and lawful attorney-in-fact and agent with full power of substitution and resubstitution, for such person in such person’s name, place and stead, in any and all capacities, to sign any and all amendments (including post-effective amendments) to this Annual Report on Form 10-K, and to file the same, with all exhibits thereto, and all documents in connection therewith, with the Securities and Exchange Commission granting unto each said attorney-in-fact and agent full power and authority to do and perform each and every act and thing requisite and necessary to be done in and about the premises, as fully to all intents and purposes as such person might or could do in person, hereby ratifying and confirming all that any said attorney-in-fact and agent, or any substitute or substitutes of any of them, 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 and Power of Attorney has been signed by the following person in the capacities and on the date indicated.
Signature Title Date
/s/ Michael Cloonan
President, Chief Executive Officer and Director ( Principal Executive Officer )
March 20, 2025
Michael Cloonan, M.B.A.
/s/ Elena Ridloff
Chief Financial Officer and Head of Corporate Development ( Principal Financial Officer and Principal Accounting Officer )
March 20, 2025
Elena Ridloff, C.F.A.
/s/ Paul Clancy
Chair of the Board of Directors March 20, 2025
Paul Clancy, M.B.A.
/s/ Bruce Booth
Director March 20, 2025
Bruce Booth, D.Phil.
/s/ H. Edward Fleming
Director March 20, 2025
H. Edward Fleming, Jr., M.D.
/s/ Lucian Iancovici
Director March 20, 2025
Lucian Iancovici, M.D.
/s/ Joshua Resnick
Director March 20, 2025
Joshua Resnick, M.D., M.B.A.
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Signature Title Date
/s/ Laurie Stelzer
Director March 20, 2025
Laurie Stelzer, M.B.A.
/s/ Peter A. Thompson
Director March 20, 2025
Peter A. Thompson, M.D.
/s/ Marcella K. Ruddy
Director March 20, 2025
Marcella K. Ruddy, M.D.
/s/ Joanne Viney
Director March 20, 2025
Joanne Viney, Ph.D.
127