Compassionate Use
Program

Expanded Access Policy

We recognize that some patients facing serious or life-threatening conditions may seek access to investigational therapies outside of a clinical trial setting. ECM Therapeutics may consider providing such access through our Compassionate Use (Expanded Access) Program in accordance with applicable laws and regulations.

Our investigational therapies are still in development and have not yet received regulatory approval. While clinical trials are the primary path to access our products, we understand that participation is not always possible. In limited cases, we may provide access to our investigational therapies for patients who meet specific criteria, including:

• No Alternatives: The patient has a serious or life-threatening condition with no comparable or satisfactory alternative treatment options.
• Ineligibility: The patient is not eligible for ongoing clinical trials.
• Clinical Data: There is sufficient clinical data to support that the potential benefits justify the potential risks.
• Non-Interference: Providing the investigational therapy will not interfere with or delay our ongoing clinical trials or regulatory submissions.
• Physician Request: The request is made by a qualified and licensed physician on behalf of the patient.