Expanded Access Policy

At Lisata Therapeutics (“Lisata” or the “Company”), we are dedicated to the development of innovative therapies based on clear differentiation and rigorous data applied in areas of high unmet medical need. We pledge to use our experience and knowledge to advance science, research and development.

Currently, Lisata’s product candidates are in clinical development, not yet approved by health authorities, such as the U.S. FDA, and therefore are “investigational drugs.” This phase of development means that more clinical studies are required and that health authorities have not yet found these products to be safe and effective for their specific use.

It is the FDA’s position that, whenever possible, an investigational drug should be used as part of a clinical trial. Therefore, Lisata’s clinical trial programs are the primary way to access our investigational drugs prior to regulatory approval and we encourage patients to speak with their doctors to determine potential benefits, risks, and eligibility to participate in clinical trials.

Where enrollment in a clinical trial is not an option, patients with serious or life-threatening diseases or conditions who have exhausted all other treatment options may receive investigational drug through another option commonly known as “Expanded Access” or “Compassionate Use”.

Per the FDA, Expanded Access may be appropriate when the below criteria are met:

1. Patient has a serious disease or condition, or whose life is immediately threatened.
2. There is no similar or satisfactory alternative therapy to diagnose, monitor or treat the disease or condition.
3. Enrollment in a clinical trial is not possible.
4. Possible patient benefit justifies the possible risks of treatment with investigational drugs.
5. Providing the investigational medical product will not affect the investigational trials.

Currently, Lisata does not generally make its unapproved drugs available on an expanded access basis. Lisata does, however, encourage interested individuals to contact the Company regarding potential participation in its clinical trials.

You can find additional information about Lisata’s ongoing clinical trials on our website and by accessing https://clinicaltrials.gov.

If you have any questions regarding potential participation in Lisata’s clinical trials or about this expanded access policy, please contact us.

As authorized by the 21st Century Cures Act, Lisata may revise this policy at any time.