Hopstem Biotechnology, Inc. (hereinafter “Hopstem”) is committed to developing innovative therapies for patients with serious and life-threatening conditions. We understand that some patients who are ineligible for our ongoing clinical trials may seek access to our investigational product, hNPC01, outside of a clinical trial setting. This policy outlines the conditions under which Hopstem may consider providing hNPC01 for expanded access use.

1. General Conditions for Consideration
Expanded access, also known as compassionate use, may be considered when all of the following criteria are met:

· The patient has a serious or immediately life-threatening form of chronic motor dysfunction due to ischemic stroke with no comparable or satisfactory alternative treatment options available.

· The patient is ineligible for participation in any ongoing clinical trial of hNPC01 (due to geographic constraints, enrollment closure, or specific trial exclusion criteria).

· The potential benefit to the patient justifies the potential risks of treatment, and the potential risks are not unreasonable in the context of the disease.

· Providing the investigational product will not interfere with the conduct of clinical trials that could support regulatory approval, thereby potentially delaying the availability of the therapy to a broader patient population.

2. Request Process
All requests for expanded access must be initiated by the patient's treating physician. Hopstem will not accept requests directly from patients or family members.

· Point of Contact: Treating physicians should submit a formal request for expanded access to the company's designated medical contact at: [info@hopstem.com].

· Required Information: The request must include comprehensive medical information justifying the need, including diagnosis, treatment history, rationale for ineligibility for clinical trials, and a commitment to obtain necessary regulatory and ethics approvals.

3. Sponsor Evaluation & Decision
Upon receipt of a complete request from a qualified physician:

· Hopstem will acknowledge receipt promptly.

· Our internal expanded access committee, comprising medical, regulatory, and supply chain experts, will review the request on a case-by-case basis.

· Key factors for review include the criteria listed in Section 1, along with drug supply availability and the physician’s capability to manage treatment and monitor the patient.

· The company strives to provide a preliminary response within a reasonable timeframe, typically within e.g., 5-7 business days of receiving all necessary information.

· Hopstem reserves the sole right to grant or deny requests based on the above assessment.

4. Regulatory and Ethical Requirements
If a request is granted by Hopstem, the following must be obtained before the drug can be shipped:

· Approval from the treating institution’s Institutional Review Board (IRB) or an independent ethics committee.

· Authorization from the relevant regulatory authority (e.g., the U.S. Food and Drug Administration via an Expanded Access IND application).

· Written informed consent from the patient or legal guardian, which must detail the investigational nature, potential risks, and alternative options.

5. Costs
The patient or their insurer will be responsible for costs associated with the medical care related to the expanded access use (e.g., hospitalization, monitoring). Hopstem will provide the investigational drug at no cost for the duration of the approved expanded access period. The company will not charge for the drug itself in the United States.

6. Policy Availability & Updates
This policy is publicly available on our website at www.hopstem.com and has been submitted to the National Institutes of Health (NIH) ClinicalTrials.gov registry. This policy may be revised as the development program for hNPC01 evolves.

Contact for Physicians:
For expanded access inquiries, treating physicians should contact:
Email:  info@hopstem.com
Phone: +1 (571) 88197776