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Item 9A. Controls and Procedures

2026-03-05 compared with 2025-03-03 · 28 added, 28 removed, 139 unchanged (29% of the section changed)

13 unchanged sentences

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.

Remediation of Previously Reported Material Weakness in Internal Control over Financial Reporting

During the year ended December 31, 2024, we completed the control enhancements and testing necessary to conclude that the previously noted material weaknesses were remediated.

Remediation of Material Weakness in Internal Control over Financial Reporting – Manual Journal Entries

We have remediated the material weakness identified in our Annual Report on Form 10-K for the year ended December 31, 2023 concerning the review and approval of manual journal entries.

In addressing this material weakness, we have undertaken actions in each of the steps identified below:

● Hiring, developing, and retaining additional personnel with appropriate accounting and internal controls expertise;

● Reviewing and updating (as appropriate) our methodologies, policies, and procedures designed to ensure adequate internal control over financial reporting, including underlying information technology and business process controls;

● Implementing systems-level controls requiring the automated routing of manual journal entries for review by someone independent of the preparer before they are finalized in the Company’s books and records.

Remediation of Material Weakness in Internal Control over Financial Reporting – Nonroutine Transactions

We have remediated the material weakness identified in our Annual Report on Form 10-K for the year ended December 31, 2023 concerning the accounting for certain nonroutine transactions.

To remediate the material weakness described above, we:

● Engaged temporary third-party resources with the appropriate level of technical knowledge and experience in accounting related to complex non-routine transactions and the related internal control activities to complement the existing corporate accounting resources;

● Continued to hire, develop and retain incremental full-time personnel with appropriate accounting and internal controls expertise;

● Reviewed and updated (as appropriate) our methodologies, policies and procedures designed to ensure we are able to more timely address our evaluation of complex non-routine transactions, including the related evidence of management’s review of the significant assumptions used in those evaluations

Internal controls are a high priority for us.

These remediation activities have strengthened our internal control over financial reporting and remediated these two material weaknesses.

We believe the consolidated financial statements included in the periods covered by this Annual Report on Form 10-K fairly present, in all material respects, our financial condition, results of operations and cash flows for the periods presented in conformity with U.S.

Management’s Report on Internal Control Over Financial Reporting

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) under the Exchange Act.

Our internal control over financial reporting is designed to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with accounting principles generally accepted in the United States.

Our internal control over financial reporting is

designed to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with accounting principles generally accepted in the United States.

Our management assessed the effectiveness of the Company's internal control over financial reporting as of December 31, 2025, using the criteria set forth by the Committee of Sponsoring Organizations of the Treadway Commission in Internal Control - Integrated Framework (2013).

6 unchanged sentences

An evaluation was also performed under the supervision and with the participation of our management, including our Chief Executive Officer and Chief Financial Officer, of any changes in our internal control over financial reporting that occurred during our last fiscal quarter and that has materially affected, or is reasonably likely to materially affect, our internal control over financial reporting.

Other than the items discussed above, there were no changes in our internal control over financial reporting during the fourth quarter of the year ended December 31, 2024 that have materially affected, or are reasonably likely to materially affect, our internal control over financial reporting.

T here were no changes in our internal control over financial reporting during the quarter ended December 31, 2025 that have materially affected, or are reasonably likely to materially affect, our internal control over financial reporting.

Other Information

Rule 10b5-1 Trading Plans

During the fiscal 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 arrangement” as defined in Item 408(c) of Regulation S-K.

During the fiscal year ended December 31, 2025, 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 arrangement” as defined in Item 408(c) of Regulation S-K.

Disclosure Regarding Foreign Jurisdictions that Prevent Inspections

Directors, Executive Officers and Corporate Governance

The response to this item is incorporated by reference from the discussion responsive thereto under the captions “Management and Corporate Governance,” “Corporate Code of Conduct” and “Insider Trading Policies” in our Proxy Statement for the 2025 Annual Meeting of Stockholders expected to be held on June 18, 2025.

The response to this item is incorporated by reference from the discussion responsive thereto under the captions “Management and Corporate Governance,” “Delinquent Section 16(a) Reports,” “Corporate Code of Conduct” and “ Insider Trading Policies ” in our Proxy Statement for the 2026 Annual Meeting of Stockholders expected to be held on June 18, 2026.

Executive Compensation

7 unchanged sentences

Exhibits and Financial Statement Schedules

(a) The financial statements filed as part of this Annual Report are listed in the Index to Financial Statements.

The financial statements filed as part of this Annual Report are listed in the Index to Financial Statements.

Certain schedules are omitted because they are not applicable, or not required, or because the required information is included in the financial statements or notes thereto.

12 unchanged sentences

001-41929) filed on March 28, 2024).

Form of Pre-Funded Warrant (incorporated by reference to Exhibit 4.1 of the Registrant’s Current Report on Form 8-K (File No.

001-41929) filed on July 2, 2025).

Form of Indemnification Agreement (incorporated by reference to Exhibit 10.1 of the Registrant’s Registration Statement on Form S-1 (File No.

7 unchanged sentences

333-276397) filed on January 5, 2024).

Non-Employee Director Compensation Policy (incorporated by reference to Exhibit 10.5 of the Registrant’s Registration Statement on Form S-1 (File No.

333-276397) filed on January 5, 2024).

Description of Exhibit

Amended and Restated Non-Employee Director Compensation Policy (incorporated by reference to Exhibit 10.1 of the Registrant’s Quarterly Report on Form 10-Q (File No.

001-41929) filed on November 10, 2025) .

Offer Letter Agreement, by and between the Registrant and Zhengbin (Bing) Yao, Ph.D., dated May 5, 2021 (incorporated by reference to Exhibit 10.7 of the Registrant’s Registration Statement on Form S-1 (File No.

2 unchanged sentences

333-276397) filed on January 5, 2024).

Description of Exhibit

Offer Letter Agreement, by and between the Registrant and Robin LaChapelle, dated May 21, 2021 (incorporated by reference to Exhibit 10.9 of the Registrant’s Registration Statement on Form S-1 (File No.

11 unchanged sentences

001-41929) filed on November 14, 2024).

Amendment No.

1 to the Amended and Restated Research Collaboration Agreement, by and between the Registrant and Aarvik Therapeutics, Inc., dated July 2, 2025 (incorporated by reference to Exhibit 10.2 of the Registrant’s Quarterly Report on Form 10-Q (File No.

001-41929) filed on November 10, 2025).

Clinical Collaboration Agreement, by and between the Registrant and Beijing InnoCare Pharma Tech Co., Ltd., dated June 23, 2023 (incorporated by reference to Exhibit 10.15 of the Registrant’s Registration Statement on Form S-1 (File No.

2 unchanged sentences

001-41929) filed on August 14, 2024).

Open Market Sale AgreementSM, by and between Jefferies LLC and the Registrant, dated February 3, 2025 (incorporated by reference to Exhibit 1.2 of the Registrant’s Registration Statement on Form S-3 (File No.

333-284661) filed with the SEC on February 3, 2025).

Exclusive License Agreement, dated January 21, 2025, by and between Lepu Biopharma Co., Ltd and the Registrant (incorporated by reference to Exhibit 10.1 of the Registrant’s Quarterly Report on Form 10-Q (File No.

001-41929) filed on May 12, 2025).

Loan and Security Agreement, dated May 8, 2025, by and between Silicon Valley Bank, a Division of First-Citizens Bank & Trust Company, and the Registrant (incorporated by reference to Exhibit 10.2 of the Registrant’s Quarterly Report on Form 10-Q (File No.

001-41929) filed on August 11, 2025).

Letter from KPMG LLP, dated March 13, 2025 (incorporated by reference to Exhibit 16.1 of the Registrant’s Current Report on Form 8-K (File No.

001-41929) filed on March 13, 2025.

Insider Trading Policy.

(incorporated by reference to Exhibit 19 of the Registrant’s Annual Report on Form 10-K (File No.

001-41929) filed on March 3, 2025.

Description of Exhibit

Subsidiaries of the Registrant (incorporated by reference to Exhibit 21.1 of the Registrant’s Registration Statement on Form S-1 (File No.

333-276397) filed on January 5, 2024).

Consent of PricewaterhouseCoopers LLP.

Consent of KPMG LLP.

9 unchanged sentences

Inline XBRL Taxonomy Extension Schema Document

Description of Exhibit

Cover Page Interactive Data File (formatted as inline XBRL with applicable taxonomy extension information contained in Exhibits 101)

27 unchanged sentences

Principal Financial Officer)

Gordon, Ph.D., CFA

/s/ Merdad Parsey, M.D., Ph.D.

March 5, 2026

Gordon, Ph.D., CFA

Merdad Parsey, M.D., Ph.D.

/s/ James Healy, M.D., Ph.D.

13 unchanged sentences

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