Galvanize Therapeutics, Inc.
California Comprehensive Compliance Declaration

Galvanize Therapeutics, Inc. (“Galvanize”) is committed to maintaining an effective and visible compliance program in accordance with the Compliance Program Guidance issued by the U.S. Department of Health and Human Services Office of Inspector General and the requirements of California Health and Safety Code Section 119402.

This commitment reflects Galvanize’s dedication to preventing and detecting misconduct, promoting ethical business practices, and continuously enhancing its compliance program to ensure adherence to all applicable federal and state laws and industry standards.

Annual Dollar Limit

In accordance with California law, Galvanize has established an annual dollar limit of $2,500 per covered healthcare professional in California for promotional expenditures, including gifts, promotional materials, and other items of value, as defined under applicable law.

Galvanize conducted an audit for fiscal year 2025 and confirmed that no covered healthcare professional exceeded this annual limit during the reporting period.

A printed copy of this declaration may be obtained by calling 1-800-214-7236.

This declaration is effective as of January 1, 2026, and will be reviewed and updated annually.

Galvanize Therapeutics, Inc. Compliance Program

Introduction

The U.S. Department of Health and Human Services Office of the Inspector General (“U.S. DHHS OIG”) outlines seven key elements of an effective compliance program. Galvanize is committed to upholding these elements while fostering a culture of integrity and ensuring the adherence to ethical standards of a medical device company.

Overview of the Compliance Program

1. Written Policies and ProceduresGalvanize maintains and reviews policies and procedures that govern interactions with healthcare professionals (HCPs) and employee conduct. Each year, the policies are reviewed to ensure that they are in accordance with new laws and guidelines from the U.S. DHHS OIG. Galvanize’s document, “Interactions with Healthcare Professionals” acts as a Code of Conduct for employee behavior, setting clear expectations for ethical engagement, compliance, and professional integrity in the workplace.
2. Compliance OfficerGalvanize has appointed a Vice President as its official Compliance Officer. Galvanize is committed to ensuring that this individual has the proper tools and resources to act as an independent investigator when conducting monitoring and auditing activities. This individual will act in good faith and report regularly to the Board of Directors regarding compliance updates and unlawful conduct. The Compliance Officer will ensure that a culture of integrity and the development of a visible compliance program is ongoing.
3. Effective Training and EducationAll employees and third-party vendors receive training upon hiring. Training and educational materials review company policies and procedures, the Code of Conduct, as well as the employee handbook to ensure that new hires are compliant with Galvanize’s company standards and that the workplace fosters a culture of integrity and ethical conduct.
4. Effective Lines of CommunicationGalvanize Therapeutics, Inc. uses an anonymous hotline to facilitate reporting, promote open communication, and ensure concerns can be raised without fear of retaliation. The hotline is publicized throughout the office as well as in the employee handbook and new hire training documents.
5. Internal Monitoring and AuditingAs part of the compliance program, Galvanize conducts yearly audits and periodic monitoring activities to ensure that interactions with healthcare professionals, sales, marketing, and billing practices are operated in an ethical and professional manner.
6. Well-Publicized Disciplinary GuidelinesGalvanize enforces policies and procedures and enacts disciplinary action when violations occur. These disciplinary actions are outlined and in the employee handbook and communicated to each employee upon hiring. Depending on the violation, disciplinary action can range from additional training to termination.
7. Prompt ResponseWhen potential issues arise and are brought to the attention of the company, compliance professionals are to be prompt with their investigative manners. If corrective action is to be taken, this will be done in a consistent and efficient manner. Corrective action may include additional educational training, policy revisions, or disciplinary action.

Declaration of Compliance – Galvanize Therapeutics, Inc. 2026

Galvanize Therapeutics, Inc. declares that it has adopted a Comprehensive Compliance Program in accordance with the US Department of Health and Human Services Office of Inspector General Compliance Guidance and the requirements of California Health C Safety Code §§ 119400-119402.

Galvanize believes in conducting business in an ethical manner and fosters integrity in the everyday work of its employees. This declaration reflects the company’s dedication to continuously developing its compliance program and ensuring that all interactions between both employees and healthcare professionals are conducted with transparency and are in full compliance with applicable laws, regulations, and industry standards.