Hopstem Biotechnology, Inc. (hereinafter “Hopstem”) is committed to developing innovative therapies for patients with serious and life-threatening conditions. Hopstem recognizes that some patients with serious or immediately life-threatening conditions who are unable to participate in a clinical trial may seek access to investigational therapies outside of a clinical study. This policy describes the circumstances under which Hopstem may consider providing hNPC01 through an Expanded Access (also known as compassionate use) program, consistent with applicable laws and regulations.

1. Conditions for Considering Expanded Access
Expanded access, also known as compassionate use, may be considered when all of the following criteria are met:
· Patient Condition: The patient has chronic motor dysfunction resulting from a serious neurological disease or condition, including:

 ■ Ischemic stroke

 ■ Hemorrhagic stroke

 ■ Traumatic brain injury

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

· Benefit-Risk Profile: Available clinical and nonclinical evidence reasonably supports that the potential benefit outweighs the foreseeable risks for the individual patient.

· Non-interference with Development: Providing the investigational product will not interfere with the initiation, conduct, or completion of clinical investigations that could support marketing approval of the expanded access use or otherwise compromise the potential development of the expanded access use.

2. Request Submission 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 and medical history.

■ Summary of prior therapy and response.

■ Rationale for ineligibility for clinical trials.

■ A commitment to obtain necessary regulatory and ethics approvals.

3. Internal Review and Response

Upon receipt of a complete request from a qualified physician:

· Review Committee: An interdisciplinary Expanded Access Review Committee composed of representatives from Medical Affairs, Clinical Development, Regulatory Affairs will review the request on a case-by-case basis.

· Key Factors for Review: The review will consider the criteria listed in Section 1, along with drug supply availability and the physician’s capability to manage treatment and monitor the patient.

· Response Timeframe: Hopstem will provide a preliminary response acknowledging receipt of the request within 5-7 business days of receiving all necessary information. A final decision will be communicated as soon as possible thereafter.

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

4. Requirements for Implementation

If a request is granted by Hopstem, the following must be obtained before the drug can be shipped:

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

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

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

·  Execution of Any Required Agreements between Hopstem and the treating institution

5. Cost and Drug Supply

· Patient 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).

· Drug Cost: Hopstem currently intends to provide hNPC01 without charging for the investigational product in the United States. However, Hopstem reserves the right to modify this approach as permitted under applicable laws and regulations.

6. Policy Availability and Updates

This policy is publicly available on our website at www.hopstem.com in accordance with applicable U.S. requirements. This policy may be revised as the development program for hNPC01 evolves. Updates will be posted to the company website.

7. Circumstances Under Which Requests May Be Declined

Hopstem may be unable to provide Expanded Access if:

·  drug supply is insufficient;

·  clinical development could be adversely affected;

·  adequate safety information is unavailable;

·  required regulatory approvals cannot be obtained;

·  the treating institution lacks appropriate expertise;

·  the request does not meet the criteria described above.

8. Contact for Physicians

For expanded access inquiries, treating physicians should contact:

·  Email: info@hopstem.com

·  Phone: +1 (571) 881-9777