Item 9A. Controls and Procedures
Item 9A. Controls and Procedures
Evaluation of Disclosure Controls and Procedures
Our management, with the participation of our principal executive officer and our principal financial officer, evaluated the effectiveness of our disclosure controls and procedures as defined in Rules 13a-15(e) and 15d-15(e) under the Exchange Act as of December 31, 2024. The term “disclosure controls and procedures,” as defined in Rules 13a-15(e) and 15d-15(e) under the Exchange Act, means controls and other procedures of a company that are designed to ensure that information required to be disclosed by us in the reports that we file 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. 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. Based on the evaluation of our disclosure controls and procedures as of December 31, 2024, our principal executive officer and principal financial officer concluded that, as of such date, our disclosure controls and procedures were effective at the reasonable assurance level.
Management's Annual Report on Internal Control Over Financial Reporting
This Annual Report on Form 10-K does not include a report of management’s assessment regarding internal control over financial reporting or an attestation report of our independent registered public accounting firm due to a transition period established by rules of the SEC for newly public companies.
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) during the quarter ended December 31, 2024 that have materially affected, or are reasonably likely to materially affect, our internal control over financial reporting.
Item 9B. Other Information
During our fiscal quarter ended December 31, 2024, no “Rule 10b5-1 plans” or “non-Rule 10b5-1 trading arrangements ”, as each term is defined in Item 408(a) of Regulation S-K, were adopted , modified , or terminated by officers or directors of the Company.
Item 9C. Disclosure Regarding Foreign Jurisdiction 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 will be included in our proxy statement with respect to our 2025 Annual Meeting of Stockholders, which we intend to file with the SEC within 120 days after the end of our 2024 fiscal year and is incorporated herein by reference.
Insider Trading Policies and Procedures
We have adopted an insider trading policy that governs the purchase, sale, and other dispositions of our securities by our
directors, officers and employees, and other covered persons. The insider trading policy also applies to transactions by
the Company in its securities. We believe that the insider trading policy is reasonably designed to promote compliance
with insider trading laws, rules and regulations and the listing standards of Nasdaq. A copy of our Insider Trading Policy
is filed with this Annual Report on Form 10-K as Exhibit 19.1.
Item 11. Executive Compensation
The information required by this item will be included in our proxy statement with respect to our 2025 Annual Meeting of Stockholders, which we intend to file with the SEC within 120 days after the end of our 2024 fiscal year and is incorporated herein by reference.
Item 12. Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters
The information required by this item will be included in our proxy statement with respect to our 2025 Annual Meeting of Stockholders, which we intend to file with the SEC within 120 days after the end of our 2024 fiscal year and is incorporated herein by reference.
Item 13. Certain Relationships and Related Transactions, and Director Independence
The information required by this item will be included in our proxy statement with respect to our 2025 Annual Meeting of Stockholders, which we intend to file with the SEC within 120 days after the end of our 2024 fiscal year and is incorporated herein by reference.
Item 14. Principal Accountant Fees and Services
The information required by this item will be included in our proxy statement with respect to our 2025 Annual Meeting of Stockholders, which we intend to file with the SEC within 120 days after the end of our 2024 fiscal year and is incorporated herein by reference.
PART IV
Item 15. Exhibits and Financial Statements.
(1) For a list of the financial statements included herein, see the Index to the Consolidated Financial Statements on page 134 of this Annual Report on Form 10-K, incorporated into this item by reference.
(2) Financial statement schedules have been omitted because they are either not required, not appliable or the information is included in the consolidated financial statements or the notes thereto.
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(3) Exhibits:
Exhibit No.
Description
3.1
Second Restated Certificate of Incorporation of Zenas BioPharma, Inc. (incorporated by reference to Exhibit 3.1 to the Form 8-K filed on September 16, 2024, File No. 001-42270)
3.2
Amended and Restated Bylaws of Zenas BioPharma, Inc. (incorporated by reference to Exhibit 3.2 to the Form 8-K filed on September 16, 2024, File No. 001-42270)
4.1
Specimen stock certificate evidencing shares of common stock (incorporated by reference to Exhibit 4.1 to the Registration Statement on Form S-1 filed on September 6, 2024, File No. 333-281713).
4.2
Fourth Amended and Restated Shareholders Agreement, among the Registrant and certain of its stockholders, dated May 3, 2024 (incorporated by reference to Exhibit 4.2 to the Registration Statement on Form S-1 filed on September 6, 2024, File No. 333-281713).
4.3†
Description of Securities
10.1+
License Agreement by and between Zenas BioPharma (Cayman) Limited and Xencor, Inc., dated September 23, 2020 (incorporated by reference to Exhibit 10.1 to the Registration Statement on Form S-1 filed on August 22, 2024, File No. 333-281713).
10.2
First Amendment to License Agreement by and between Zenas BioPharma, Inc. and Xencor, Inc., dated June 24, 2024 (incorporated by reference to Exhibit 10.2 to the Registration Statement on Form S-1 filed on August 22, 2024, File No. 333-281713).
10.3+
License Agreement by and between Zenas BioPharma (Cayman) Limited and Xencor, Inc., dated May 27, 2021(incorporated by reference to Exhibit 10.3 to the Registration Statement on Form S-1 filed on August 22,2024, File No. 333-281713).
10.4+
First Amendment to License Agreement by and between Zenas BioPharma (Cayman) Limited and Xencor, Inc., dated May 27, 2021 (incorporated by reference to Exhibit 10.4 to the Registration Statement on Form S-1 filed on August 22, 2024, File No. 333-281713).
10.5+
Second Amendment to License Agreement by and between Zenas BioPharma, Inc. and Xencor, Inc., dated May 27, 2021 (incorporated by reference to Exhibit 10.5 to the Registration Statement on Form S-1 filed on August 22, 2024, File No. 333-281713).
10.6+
License Agreement by and between the Registrant and Bristol-Myers Squibb Company, dated as of August 30, 2023 (incorporated by reference to Exhibit 10.6 to the Registration Statement on Form S-1 filed on August 22, 2024, File No. 333-281713).
10.7#
Zenas BioPharma, Inc. 2020 Equity Incentive Plan (incorporated by reference to Exhibit 10.7 to the Registration Statement on Form S-1 filed on August 22, 2024, File No. 333-281713).
10.8#
Amendment to Zenas BioPharma, Inc. 2020 Equity Incentive Plan (incorporated by reference to Exhibit 10.8 to the Registration Statement on Form S-1 filed on August 22, 2024, File No. 333-281713).
10.9#
Amendment to Zenas BioPharma, Inc. 2020 Equity Incentive Plan (incorporated by reference to Exhibit 10.9 to the Registration Statement on Form S-1 filed on August 22, 2024, File No. 333-281713).
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10.10#
Form of Restricted Share Agreement under the Zenas BioPharma, Inc. 2020 Equity Incentive Plan (incorporated by reference to Exhibit 10.10 to the Registration Statement on Form S-1 filed on August 22, 2024, File No. 333-281713).
10.11#
Form of Non-Qualified Stock Option Agreement (Non-Employee Directors) under the Zenas BioPharma, Inc. 2020 Equity Incentive Plan (incorporated by reference to Exhibit 10.11 to the Registration Statement on Form S-1 filed on August 22, 2024, File No. 333-281713).
10.12#
Form of Non-Qualified Stock Option Agreement (Employees) under the Zenas BioPharma, Inc. 2020 Equity Incentive Plan (incorporated by reference to Exhibit 10.12 to the Registration Statement on Form S-1 filed on August 22, 2024, File No. 333-281713).
10.13#
Form of Incentive Stock Option Agreement under the Zenas BioPharma, Inc. 2020 Equity Incentive Plan (incorporated by reference to Exhibit 10.13 to the Registration Statement on Form S-1 filed on August 22, 2024, File No. 333-281713).
10.14#
Zenas BioPharma, Inc. Short-Term Incentive Plan (incorporated by reference to Exhibit 10.14 to the Registration Statement on Form S-1 filed on September 6, 2024, File No. 333-281713).
10.15#
Zenas BioPharma, Inc. 2024 Equity Incentive Plan (incorporated by reference to Exhibit 4.6 the Form S-8 filed on September 16, 2024, File No. 333-282151)
10.16#
Form of U.S. Non-Qualified Stock Option Agreement under the Zenas BioPharma, Inc. 2024 Equity Incentive Plan (incorporated by reference to Exhibit 10.16 to the Registration Statement on Form S-1 filed on September 6, 2024, File No. 333-281713).
10.17#
Form of Global Non-Qualified Stock Option Agreement under the Zenas BioPharma, Inc. 2024 Equity Incentive Plan (incorporated by reference to Exhibit 10.17 to the Registration Statement on Form S-1 filed on September 6, 2024, File No. 333-281713).
10.18#†
Zenas BioPharma, Inc. 2024 Employee Stock Purchase Plan (amended and restated).
10.19#†
Zenas BioPharma, Inc. Non-Employee Director Compensation Policy (as amended) .
10.20#
Amended and Restated Employment Agreement between the Registrant and Leon O. Moulder, Jr., dated September 4, 2024 (incorporated by reference to Exhibit 10.20 to the Registration Statement on Form S-1 filed on September 6, 2024, File No. 333-281713).
10.21#
Amended and Restated Employment Agreement between the Registrant and Joseph Farmer, dated September 4, 2024 (incorporated by reference to Exhibit 10.21 to the Registration Statement on Form S-1 filed on September 6, 2024, File No. 333-281713).
10.22#
Amended and Restated Employment Agreement between the Registrant and Jennifer Fox, dated September 4, 2024 (incorporated by reference to Exhibit 10.22 to the Registration Statement on Form S-1 filed on September 6, 2024, File No. 333-281713).
10.23#
Amended and Restated Employment Agreement between the Registrant and Orlando Oliveira, dated September 4, 2024 (incorporated by reference to Exhibit 10.23 to the Registration Statement on Form S-1 filed on September 6, 2024, File No. 333-281713).
10.24#
Employment Agreement between the Registrant and Tanya Fischer, dated September 22, 2023 (incorporated by reference to Exhibit 10.23 to the Registration Statement on Form S-1 filed on August 22, 2024, File No. 333-281713).
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10.25#
Transition and Separation Agreement between the Registrant and Hua Mu, dated June 29, 2023 (incorporated by reference to Exhibit 10.24 to the Registration Statement on Form S-1 filed on August 22, 2024, File No. 333-281713).
10.26#
Transition and Separation Agreement between the Registrant and Tanya Fischer, dated August 29, 2024 (incorporated by reference to Exhibit 10.26 to the Registration Statement on Form S-1 filed on September 6, 2024, File No. 333-281713).
10.27
Form of Indemnification Agreement between the Registrant and each of its directors and executive officers (incorporated by reference to Exhibit 10.27 to the Registration Statement on Form S-1 filed on September 6, 2024, File No. 333-281713).
19.1†
Insider Trading Policy
21.1
Subsidiaries of the Registrant (incorporated by reference to Exhibit 21.1 to the Registration Statement on Form S-1 filed on September 6, 2024, File No. 333-281713).
23.1†
Consent of Ernst & Young LLP, independent registered public accounting firm.
31.1†
Certification of Chief Executive Officer Pursuant to Section 302 of the Sarbanes-Oxley Act of 2002
31.2†
Certification of Chief Financial Officer Pursuant to Section 302 of the Sarbanes-Oxley Act of 2002
32.1*
Certification of Chief Executive Officer Pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002
32.2*
Certification of Chief 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†
Policy for Recoupment of Incentive Compensation (Clawback) Policy
101.INS†
XBRL Instance Document – the instance document does not appear in the Interactive Data File because its XBRL tags are embedded within the Inline XBRL 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
104†
Cover Page Interactive Data File (formatted in Inline XBRL and contained in Exhibit 101)
†
Filed herewith.
#
Indicates management contract or compensatory plan.
+
Portions of this exhibit (indicated by asterisks) have been redacted pursuant to Item 601 S-K because they are both not material and the registrant customarily and actually treats such information as private of confidential.
*
This certification will not be deemed “filed” for purposes of Section 18 of the Exchange Act, or otherwise subject to the liability of that section. Such certification will not be deemed to be incorporated by reference into any filing under
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the Securities Act of 1933, as amended, or the Exchange Act, except to the extent specifically incorporated by reference into such filing.
Item 16. Form 10-K Summary
Not applicable.
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SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the Registrant has duly caused this report to be signed on its behalf by the undersigned, duly authorized.
Date: March 11, 2025
ZENAS BIOPHARMA, INC.
By:
/s/ Leon O. Moulder, Jr.
Name:
Leon O. Moulder, Jr.
Title:
Chief Executive Officer
(Principal Executive Officer)
By:
/s/ Jennifer Fox
Name:
Jennifer Fox
Title:
Chief Business Officer and Chief Financial Officer
(Principal Financial and Accounting Officer)
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.
Signature
Title
Date
/s/ Leon O. Moulder, Jr.
Leon O. Moulder, Jr.
Chief Executive Officer and Director
(Principal Executive Officer)
March 11, 2025
/s/ Jennifer Fox
Jennifer Fox
Chief Business Officer and Chief
Financial Officer
(Principal Financial and Accounting Officer)
March 11, 2025
/s/ Patricia Allen
Patricia Allen
Director
March 11, 2025
/s/ James Boylan
James Boylan
Director
March 11, 2025
/s/ Patrick Enright
Patrick Enright
Director
March 11, 2025
/s/ Tomas Kiselak
Tomas Kiselak
Director
March 11, 2025
/s/ Hongbo Lu, Ph.D.
Hongbo Lu, Ph.D.
Director
March 11, 2025
/s/ Jake Num
Jake Nunn
Director
March 11, 2025
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/s/ John Orloff, M.D.
John Orloff, M.D.
Director
March 11, 2025
/s/ Ting Xiao
Ting Xiao
Director
March 11, 2025
176