Elicio Therapeutics
Expanded Access Policy

This document reflects Elicio’s position and corporate policy on a potential pathway to gain access to an investigational medical product when no comparable or alternative therapy options are available for seriously ill patients who are not eligible for our clinical trials. Such access is sometimes referred to as “expanded access” or “compassionate use.” In these circumstances, Elicio will consider providing a requesting physician with pre-approval access to a specific Elicio investigational product, for the treatment of an individual patient outside of a clinical trial, when certain conditions are met. These conditions include the following:

• Patient has a serious or immediately life-threatening disease or condition, and there is no comparable or satisfactory alternative therapy to diagnose, monitor, or treat the disease or condition.
• Potential patient benefit justifies the potential risks of treatment, and the potential risks of treatment are not greater than the risk of the disease or condition to be treated.
• Patient is ineligible for, or otherwise unable to, participate in a clinical trial for the investigational product.
• Providing the investigational medical product will not negatively impact broader patient access by delaying or interfering with the conduct of clinical trials that could support the development, regulatory review, or marketing approval of the investigational product.
• A licensed physician is responsible for treating the patient with the investigational product.
• FDA and all other legal and regulatory requirements have been met.

We continually evaluate the benefit-risk profile of each of our investigational products based on evolving clinical data. Each compound under development is different and the fact that one investigational product is made available for the treatment of a particular patient does not mean it will be made available in response to other requests on behalf of other patients whose circumstances and medical histories may be different, or that a different investigational medical product will be made available under our policy. Requests will be considered on a case-by-case basis. Elicio is committed to evaluating all requests in a fair and equitable manner. All requests must be submitted by the patient’s treating physician; we may require more detailed information in order to fully evaluate a request. The requesting physician must agree to obtain appropriate regulatory and institutional review board or ethics committee approvals and comply with regulatory obligations, including obtaining patient consent, patient monitoring and safety reporting. Each request will be given careful consideration by Elicio whose decisions are final. Any instance of pre-approval access granted by Elicio will be terminated upon marketing approval of the investigational medical product or Elicio’s decision to discontinue development of the investigational medical product. Physicians seeking pre-approval access for patients with no alternative treatment options should submit their requests to clinicaltrialinquiries@elicio.com. We regularly monitor this mailbox and will use our best efforts to acknowledge each submitted request within 10 business days after receipt. We will re-evaluate this policy periodically and upon emerging clinical trial data for our investigational therapies or other business considerations, may revise it at any time. Elicio reserves the right to grant or deny a request or to change its overall policy on expanded access in its full discretion. Additional information regarding Elicio’s investigational medical products is available here:  AMPLIFY clinical program