Expanded Access Policy

Precision BioSciences is currently investigating multiple gene therapy candidates as potential treatment options for patients with diseases with high unmet need.

Expanded Access refers to the use of an investigational therapy outside of a clinical trial for potential treatment of a serious condition in a patient. The US Food and Drug Administration has established guidelines for considering expanded access.

Guidelines include:

• Disease or condition must be serious or immediately life-threatening
• No comparable or satisfactory alternative therapy is available
• Potential benefit justifies the potential risks of the treatment, and those risks are not unreasonable in the context of the disease or condition being treated
• Providing access to the investigational therapy will not interfere or compromise clinical development

Precision does not currently offer patients Expanded Access to these investigational therapies outside of clinical trials. We believe that facilitating patients’ participation in our ongoing clinical trials is the best way to speed investigation and subsequent approval of these candidate therapies for broad access by providing a rigorous assessment of the products’ benefits, risks, and appropriate uses for patients.

Treating physicians may request information about Precision BioSciences’ Expanded Access policy by contacting our team at clinical@precisionbiosciences.com. We anticipate acknowledging receipt of requests sent to this email within five business days.

Eligibility requirements and more information about Precision BioSciences’ clinical trials is available at https://www.clinicaltrials.gov.

Precision BioSciences conducts regular reviews of its policies to ensure conformity with applicable laws and regulations. We reserve the right to revise this policy at any time.