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Item 9A. Controls and Procedures

2026-03-16 compared with 2025-03-11 · 66 added, 22 removed, 128 unchanged (41% of the section changed)

7 unchanged sentences

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.

Our management is responsible for establishing and maintaining adequate internal control over financial reporting, as such term is defined in Rules 13a-15(f) and 15d-15(f) promulgated under the Exchange Act as a process designed by, or under the supervision of, the company’s principal executive and principal financial officers 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.

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 that 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.

Our management assessed the effectiveness of our internal control over financial reporting as of December 31, 2025.

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, 2025, our internal control over financial reporting was effective.

Attestation Report of the Registered Public Accounting Firm

This Annual Report on Form 10-K does not include an attestation report of our registered public accounting firm due to an exemption established by the JOBS Act for “emerging growth companies.”

Changes in Internal Control Over Financial Reporting

1 unchanged sentence

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.

Loan Agreement

On March 14, 2026, the Company entered into the Loan Agreement with Credit PLC (the “Collateral Agent”), BPCR Limited Partnership and BioPharma Credit Investments V (Master) LP, which are funds managed by Pharmakon and the guarantors party thereto.

The Loan Agreement provides for up to a $250.0 million Term Loan that matures on March 27, 2031 and consists of five tranches including (1) a Tranche A Loan of $75.0 million drawn ten business days following the execution of the Loan Agreement, (2) a Tranche B Loan of $50.0 million which will be required to be drawn (and up to an additional $25.0 million that the Company may elect to draw) by no later than November 1, 2027, subject to the occurrence of the Tranche B/C Approval Condition, (3) a Tranche C Loan of $25.0 million (less any amounts elected to be (and actually) drawn under the Tranche B Loan in excess of $50.0 million) which will be available at the Company’s election, subject to the occurrence of the Tranche B/C Approval Condition, no later than April 28, 2028, (4) a Tranche D Loan of $50.0 million which will be available at the Company’s election no later than October 30, 2028, subject to the occurrence of the Tranche B/C Approval Condition and achievement of certain milestones in respect of certain net sales levels and (5) a Tranche E Loan of $50.0 million which will be available at the Company’s election no later than April 30, 2029, subject to the occurrence of the Tranche B/C Approval Condition and achievement of certain milestones in respect of net sales levels.

The Term Loan bears interest at a rate based upon an annual interest rate of 3-month secured overnight financing rate (subject to a 3.25% floor) plus 5.75% payable quarterly in arrears;

provided that the Company may elect for 100% of the interest for the first 24 months following the Tranche A Loan funding date may be paid-in-kind without an increase in the interest rate.

The Company is required pay a funding fee equal to (i) 2.00% of the funding amount of the Tranche A Loan on the funding date of such loan, (ii) 2.00% of $50,000,000 of the funding amount of the Tranche B Loan on the funding date for such loan, (iii) 1.00% of any amounts in excess of $50,000,000 of the funding amount for the Tranche B Loan on the funding date for such loan, and (iv) 1.00% of each of the funding amount of the Tranche C Loan, Tranche D Loan, and Tranche E Loan on each respective funding date.

The Company may elect to prepay the Term Loans in whole or, subject to certain conditions, in part prior to the Term Loan Maturity Date with such prepayments being subject to certain prepayment, make-whole and exit fees.

The Term Loans are subject to certain mandatory prepayments, including a repayment in full of all term loans in four equal payments commencing on September 30, 2028 to the extent the Tranche B/C Approval Condition is not met on or prior to June 30, 2028.

The Loan Agreement contains customary affirmative and restrictive covenants and representations and warranties.

We and our subsidiaries are bound by certain affirmative covenants setting forth actions that are required during the term of the Loan Agreement, including, without limitation, certain information delivery requirements (including that consolidated financial statements delivered for and after the fiscal year ending December 31, 2026 are not subject to any qualification as to “going concern” or “scope of audit”), obligations to maintain certain insurance, and certain notice requirements.

The Loan Agreement contains customary financial covenants, including (i) at all times prior to the satisfaction of the Tranche B/C Approval Condition, a minimum liquidity requirement and (ii) subject to the outstanding aggregate principal amount of Term Loans advanced under the Loan Agreement being equal to or greater than $200.0 million, a minimum trailing

twelve months consolidated net revenue covenant.

Additionally, we and our subsidiaries are bound by certain restrictive covenants setting forth actions that are not permitted to be taken during the term of the Loan Agreement, including, without limitation, (i) selling or disposing of assets, (ii) amending, modifying or waiving our rights under material agreements, (iii) consummating change in control transactions unless all amounts becoming due under the Loan Agreement are paid in full immediately upon (and concurrent with) the consummation of any such change in control transaction, (iv) incurring additional indebtedness, (v) incurring non-permitted liens or encumbrances on our or our subsidiaries’ assets, (vi) paying dividends or making any distribution or payment on or redeeming, retiring or purchasing any equity interests, (vii) making payments on subordinated indebtedness and (viii) making investments other than permitted acquisitions and permitted investments, in each case, subject to specified exceptions including, in the case of restrictions on incurrence of additional indebtedness, the ability to incur certain convertible indebtedness and enter into certain permitted royalty financing agreements.

The Loan Agreement also contains certain events of default, including the following:

(i) failure to pay principal, interest and other amounts when due, (ii) the breach of the covenants under the Loan Agreement, (iii) the occurrence of a material adverse change or a withdrawal event in respect of obexelimab or orelabrutinib, (iv) certain attachments of the credit parties assets and restraints on their business, (v) certain insolvency, liquidation, bankruptcy or similar events, (vi) certain cross-default of third-party indebtedness and royalty revenue contracts, (vii) the failure to pay certain judgements, (viii) material misrepresentations, (ix) the loan documents ceasing to create a valid security interest in a material portion of the collateral, (x) the occurrence of certain ERISA events and (xi) the occurrence of a default under any intercreditor agreement, in each case subject to the grace periods, cure period and thresholds as specified in the Loan Agreement.

Upon the occurrence of an event of default, the Lenders may, among other things, accelerate our obligations under the Loan Agreement (including all obligations for principal, interest and any applicable make-whole and prepayment premiums); provided that upon an event of default relating to certain insolvency, liquidation, bankruptcy or similar events, all outstanding obligations will be automatically accelerated.

Our obligations under the Loan Agreement are secured by substantially all of our assets, including our intellectual property.

Certain of our subsidiaries may, from time to time after the Tranche A Closing Date, be required to guarantee our obligations under the Loan Agreement and, in connection with such guarantee, pledge substantially all of their assets, including intellectual property, to secure such guarantee.

The foregoing summary of the Loan Agreement is not complete and is qualified in its entirety by reference to the complete text of the Loan Agreement, a copy of which the Company intends to file as an exhibit to its Quarterly Report on Form 10-Q for the quarter ending March 31, 2026.

During our fiscal quarter ended December 31, 2025, no director or “officer” (as defined in Rule 16a-1(f) under the Exchange Act) of the Company entered into , modified or terminated contracts , instructions or written plans for the purchase or sale of our common stock that are intended to satisfy the affirmative defense conditions specified in Rule 10b5-1(c) under the Exchange Act.

Disclosure Regarding Foreign Jurisdiction that Prevent Inspections

3 unchanged sentences

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.

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.

Executive Compensation

16 unchanged sentences

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.

Description of Securities

Description of Securities (incorporated by reference to Exhibit 4.3 to the Annual Report on Form 10-K filed on March 11, 2025, File No.

Registration Rights Agreement, by and between Zenas BioPharma, Inc.

and InnoCare Pharma Inc., dated October 7, 2025 (incorporated by reference to Exhibit 10.2 to the Current Report on Form 8-K filed on October 8, 2025, File No.

Form of Registration Rights Agreement, by and among Zenas BioPharma, Inc.

and the investors party thereto (incorporated by reference to Exhibit 10.4 to the Current Report on Form 8-K filed on October 8, 2025, File No.

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.

21 unchanged sentences

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.

Short-Term Incentive Plan (as amended).

Zenas BioPharma, Inc.

5 unchanged sentences

Zenas BioPharma, Inc.

2024 Employee Stock Purchase Plan (amended and restated).

2024 Employee Stock Purchase Plan (amended and restated) (incorporated by reference to Exhibit 10.18 to the Annual Report on Form 10-K filed on March 11, 2025, File No.

Zenas BioPharma, Inc.

Non-Employee Director Compensation Policy (as amended) .

Non-Employee Director Compensation Policy (as amended January 1, 2026) .

Zenas BioPharma, Inc.

Non-Employee Director Compensation Policy (as amended July 7, 2025) (incorporated by reference to Exhibit 10.1 to the Quarterly Report on Form 10-Q filed on August 12, 2025, File No.

Amended and Restated Employment Agreement between the Registrant and Leon O.

3 unchanged sentences

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.

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.

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.

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.

Employment Agreement between the Registrant and Lisa von Moltke, dated February 17, 2025

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.

Consulting Agreement between the Registrant and Ting Xiao, dated June 10, 2025 (incorporated by reference to Exhibit 10.2 to the Quarterly Report on Form 10-Q filed on August 12, 2025, File No.

Revenue Participation Right Purchase and Sale Agreement, by and between Zenas BioPharma, Inc.

and Royalty Pharma Investments 2019 ICAV, dated September 2, 2025 (incorporated by reference to Exhibit 10.1 to the Quarterly Report on Form 10-Q filed on November 12, 2025, File No.

Form of Securities Purchase Agreement, by and among Zenas BioPhama, Inc.

and the investors party thereto, dated October 7, 2025 (incorporated by reference to Exhibit 10.3 to the Current Report on Form 8-K filed on October 8, 2025, File No.

Subscription Agreement, by and between Zenas BioPharma, Inc.

and InnoCare Pharma Inc., dated October 7, 2025 (incorporated by reference to Exhibit 10.1 to the Current Report on Form 8-K filed on October 8, 2025, File No.

License Agreement by and between Zenas BioPharma, Inc.

and InnoCare Pharma Inc., dated October 7, 2025.

Zenas BioPharma, Inc.

2026 Inducement Plan (incorporated by reference to Exhibit 10.1 to the Current Report on Form 8-K filed on December 15, 2025, File No.

Form of Non-Statutory Stock Option Agreement under the Zenas BioPharma, Inc.

2026 Inducement Plan (incorporated by reference to Exhibit 10.2 to the Current Report on Form 8-K filed on December 15, 2025, File No.

Form of Restricted Stock Unit Agreement under the Zenas BioPharma, Inc.

2026 Inducement Plan (incorporated by reference to Exhibit 10.3 to the Current Report on Form 8-K filed on December 15, 2025, File No.

Form of Global Non-Statutory Stock Option Agreement under the Zenas BioPharma, Inc.

2026 Inducement Plan (incorporated by reference to Exhibit 10.4 to the Current Report on Form 8-K filed on December 15, 2025, File No.

Form of Global Restricted Stock Unit Agreement under the Zenas BioPharma, Inc.

2026 Inducement Plan (incorporated by reference to Exhibit 10.5 to the Current Report on Form 8-K filed on December 15, 2025, File No.

Insider Trading Policy.

7 unchanged sentences

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

Policy for Recoupment of Incentive Compensation (Clawback) Policy

Policy for Recoupment of Incentive Compensation (Clawback) Policy (incorporated by reference to Exhibit 97.1 to the Annual Report on Form 10-K filed on March 11, 2025, File No.

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

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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

the Securities Act of 1933, as amended, or the Exchange Act, except to the extent specifically incorporated by reference into such filing.

Such certification will not be deemed to be incorporated by reference into any filing under the Securities Act of 1933, as amended, or the Exchange Act, except to the extent specifically incorporated by reference into such filing.

Form 10-K Summary

31 unchanged sentences

March 16, 2026

/s/ Jake Nunn

March 16, 2026

2 unchanged sentences

March 16, 2026

/s/ Ting Xiao

March 11, 2025

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