1.     Introduction

NeuroGenesis Bio Inc. (“NeuroGenesis”) is developing NG01, an investigational autologous cell therapy, shown to have the potential to address unmet medical needs for Progressive Multiple Sclerosis (PMS). While clinical trial participation is the preferred pathway to access NG01, when a patient cannot enroll in a NeuroGenesis clinical trial, and has exhausted available treatment options, a healthcare Provider may submit a request for expanded access/compassionate use.

2.     Scope

This document outlines NeuroGenesis’ policy for providing NG01 for expanded access/compassionate use to individual patients or group of patients, who have no other treatment options and who are not eligible or cannot be enrolled in NeuroGenesis’ clinical studies

3.     Eligibility Criteria:

• The patient is diagnosed with PMS with no satisfactory alternative therapies.
• The patient is ineligible for participation in a clinical trial with NG01 or cannot otherwise enroll in such study.
• The patient cannot participate in a clinical study and/or be treated with another investigational product.
• Providing the NG01investigational cell therapy for the requested use will not interfere with the initiation, conduct, or completion of active clinical trials or the development of the product

4.     Process

• Submission of Expanded Access Request: The healthcare provider submits a written request to NeuroGenesis (see contact below) including patient diagnosis, medical history and justification for eligibility. Patient-identifiable information must not be included in initial communications.
• Evaluation: NeuroGenesis reviews the request and notifies the healthcare provider of its determination. NeuroGenesis does not commit to specific response timeframes and may request additional information at any point.
• Protocol and Consent: NeuroGenesis will prepare the Treatment Protocol and Master Informed Consent Form (ICF).
• Regulatory Submission: NeuroGenesis or the healthcare provider will submit the Treatment Protocol to the applicable Regulatory Authority. The treating healthcare provider is responsible for IRB/EC approval and patient informed consent. The patient must be informed that NG01 is investigational and has not been confirmed safe or effective.
• Written Agreement: NeuroGenesis’ obligation to provide NG01 arises only upon execution of a written agreement with the healthcare provider or institution.

5.     Roles and Responsibilities

• Healthcare provider: Submits the expanded access request to NeuroGenesis; provides patient-specific information; submits (or supports the submission of) the Treatment Protocol to the FDA; obtains IRB/EC approval; secures patient informed consent; adheres to the protocol; monitors the patient; reports adverse events to NeuroGenesis promptly and in accordance with the Treatment Protocol. The healthcare provider is responsible for all costs of treatment administration, monitoring, and protocol activities.
• NeuroGenesis: Reviews expanded access requests; verifies the healthcare provider qualifications; submits (or supports the submission of) the Treatment Protocol to the FDA; provides NG01 (the investigational cell therapy product) subject to a written agreement and all required authorizations; submits IND safety reports and annual reports to the FDA and maintains an effective IND and drug disposition records. NeuroGenesis shall not be responsible for any costs of treatment administration, monitoring, facility charges, or management of adverse events.

6.     Costs and Charging

NeuroGenesis reserves the right to charge for NG01 provided under Expanded Access. The patient, Healthcare provider, institution, and/or the patient’s insurer are responsible for all costs of treatment administration, monitoring, and other protocol activities. NeuroGenesis does not provide financial assistance for such costs.

7.     Safety Monitoring

The healthcare provider is responsible for submitting safety reports to NeuroGenesis. NeuroGenesis is responsible for submitting safety reports provided by the Healthcare Provider to Regulatory Authorities.

8.     Confidentiality

Both parties will maintain the confidentiality of patient personal data consistent with HIPAA and applicable law.

9.     Policy Review and Updates

This policy will be reviewed and updated regularly to align with new regulations and standards. NeuroGenesis reserves the right to amend and/or revoke this policy at any time.

NeuroGenesis Bio Inc. — Medical Affairs

Email: [email protected]  •  Website: https://neurogenesis-cell.com/

For Expanded Access inquiries, use subject line ‘Expanded Access Request’ and omit patient-identifiable information from initial communications.