Expanded Access Policy

89bio is dedicated to developing new potential treatments for serious and life-threatening diseases. We are committed to efficiently advancing our investigational products through the clinical development process. It is our mission to bring innovative medicines that, if approved, would have a positive impact on patient health, and to serve patients, patient families, and patient communities through education, empathy, and awareness.

We are currently focused on enrolling and conducting the clinical trials necessary to apply for, and potentially gain, regulatory approvals to make our medicines available to patients. We are privileged to collaborate with clinical investigators and patients who participate in our studies. We believe this approach is best suited to help us develop products that could help patients, if approved.

We recognize that there are seriously ill patients who are not and will not be eligible for 89bio-sponsored clinical trials and do not and may not have options for alternative therapies, including investigational therapies in trials being conducted by other sponsors. However, at this time, 89bio does not provide any of its investigational product candidates, including pegozafermin, via expanded access (also referred to as compassionate use). We have considered many factors in arriving at this determination, including making reasonable assessments of potential risk versus benefit for patients outside the clinical trial setting, and our ability to maintain supply for clinical trials, from enrollment to completion. In the event that 89bio decides to consider expanded access use for any of its investigational product candidates, including pegozafermin, in the future, we will evaluate and respond to each expanded access request on a case-by-case basis using criteria that ensure such requests are considered in a fair and consistent manner.

1. Contact Information. If you have any questions about 89bio’s expanded access policy or wish to make an expanded access request, please contact info@89bio.com.

2. Request Procedures. A licensed physician or healthcare provider (HCP) must initiate the expanded access request and include sufficient supporting detail to enable us to evaluate the request. The request must include the physician’s or other HCP’s contact information so that we may respond or follow up for further information.

3. General Criteria. While 89bio retains sole discretion in determining whether to grant an expanded access request, the following criteria will guide 89bio’s evaluation of expanded access requests:

• The patient has a serious or life-threatening illness or condition and there are no comparable or satisfactory available alternative treatments, such as when the patient is either no longer responsive to or no longer able to tolerate any available treatment option;
• The investigational drug is in active clinical development with sufficient data available to determine an appropriate dose and schedule for the patient’s specific condition;
• The patient has failed to meet eligibility criteria for any applicable ongoing clinical trials, or is otherwise ineligible to participate in any ongoing clinical trials;
• A benefit-risk analysis, based on both the available clinical data as well as the requesting physician’s assessment of the individual patient’s condition and history, supports making the investigational drug available based on the probable risk from the investigational drug the probable risk from the disease or condition at issue;
• Making the investigational drug available will not negatively impact or delay the conduct of clinical trials or regulatory review or approval of the investigational drug for broader patient access;
• Adequate supply of the investigational drug is available to meet the needs of the expanded access request without impairing ongoing clinical trials;
• The requesting physician or HCP must be appropriately licensed, experienced with the disease and drug class, have investigational new drug (IND) trial experience, and be willing and able to work with the local regulatory authorities for single patient use, comply with all applicable laws and regulations, including applicable requirements for an IND sponsor, comply with 89bio requirements, and provide regular reports to 89bio;
• The patient must be a resident of the United States, or there must be a plan by 89bio to market the product in the country or region from which the expanded access was requested;
• If the patient is located outside of the United States, there must be a regulatory mechanism in the country or region to support expanded access;
• Provision of the investigational product in response to the expanded access request must be compliant with all applicable laws and regulations; and
• Additional criteria regarding the investigational product, its development program, the patient or other circumstances that may, in 89bio’s sole discretion, may impact eligibility.

4. Anticipated Timing. We anticipate acknowledging receipt of any expanded access request within ten (10) business days from its receipt. Further information about 89bio’s clinical trials is available at www.clinicaltrials.gov.

As authorized by the 21^st Century Cures Act, 89bio may revise or cancel this expanded access program at any time. Additionally, the posting of this program and its criteria in no way serves as a guarantee of access to any investigational product by any individual patient, physician, or HCP. Finally, 89bio reserves the right to discontinue the provision of investigational product to a patient at any time.