Throne Biotechnologies Inc

Expanded Access to Investigational Drugs Policy:
1. Purpose and philosophy behind the policy
Throne Biotechnologies (Throne) is a clinical-stage therapeutic company with a disruptive stem cell technology that can fundamentally reverse type 1 diabetes (T1D), alopecia areata (AA) and other autoimmune diseases through immune education of Stem Cell Educator therapy (Gleukocellä) at the root causes. Over last 12 years, international multicenter clinical trials in the United States, China, and Spain have demonstrated the clinical safety and efficacy of Stem Cell Educator therapy. Throne is committed to bring this innovative therapy to help patients with serious and life-threatening diseases in medical need before it is fully approved by FDA for clinical use on prescription.
2. Approach to requests for access to Stem Cell Educator therapy
It is the first and most preferable route for patients to participate Throne’s ongoing clinical trials by using Stem Cell Educator therapy to treat type 1 diabetes and alopecia areata. If patients do not meet the criteria of clinical trials, their treating physician, who is able to comply with the requirements that are stated in this document, may request information about how to apply for access to Throne's investigational products by contacting the Company.

3. Policy
3.1. Patient Eligibility Criteria: To be eligible for accessing to the investigational product, patients must meet following criteria:
• The patient has a serious or life-threatening condition with no satisfactory alternative.
• Assessment that benefits outweigh the risks to the patient.
• Adequate venous access for blood cell separation (apheresis).
• Ability to provide informed consent.
• Must agree to comply with all study requirements and be willing to complete all study visits.

3.2. Investigational Product Criteria:

• The product is under clinical investigation in one or more clinical trials, with high safety profiles.
• Assessment that the company has an adequate supply of the investigational product.
• A determination that expanded access will not interfere with the company's ability to complete clinical trials in a timely fashion or which might otherwise delay marketing approval and ultimately availability to all patients.

3.3. Treating Physician Criteria and Responsibility: The physician must agree in writing to comply with:
• Physician(s) is (are) properly licensed.
• Physician(s) meet the applicable country-specific legal and regulatory requirements related to providing the investigational products under the Expanded Access.
• Any Throne’s requirements in terms of safety reporting and protection of intellectual properties.
• A treating physician may submit questions and requests regarding to the Expanded Access to email: connect@thronebio.com. We will do our best efforts to acknowledge each submitted request within 5 business days.