Our purpose at Actio Biosciences, Inc. is to develop new therapies that have a positive impact on patient health, and to serve patients, patient families and patient communities through education, empathy, and awareness.

We are united by a shared commitment to advancing science with purpose, aiming to turn new insights into therapies that can genuinely improve patients’ lives. We move with both urgency and care, recognizing the responsibility we carry to deliver progress. Every step forward matters, especially as patients continue to wait for safer, more effective treatment options.

Expanded Access Policy for ABS-1230

Actio Biosciences is committed to making investigational drug ABS-1230 available to seriously ill patients with a life-threatening condition who will not be eligible for our clinical trials and do not have options for alternative therapies. In these unique circumstances, Actio Biosciences may consider expanded access requests, also knowActio Biosciences is committed to making investigational drug ABS-1230 available to seriously ill patients with a life-threatening condition who will not be eligible for our clinical trials and do not have options for alternative therapies. In these unique circumstances, Actio Biosciences may consider expanded access requests, also known as compassionate use, from a treating healthcare provider (HCP) for an individual patient. Requests will be considered on a case-by-case basis. For a request to be considered, both the patient eligibility criteria and HCP responsibilities described below must be met. All requests must be submitted by the patient’s treating HCP and cannot be accepted from patients or family members.

Criteria Evaluated by Actio Biosciences

Actio Biosciences will evaluate whether:

• The patient is 1 year of age or younger, in or recently in an intensive care unit for KCNT1-related epilepsy with an identified pathogenic or likely pathogenic mutation, having a high seizure burden, and whose condition is refractory to available treatment options;
• The patient is located in a region where ABS-1230 clinical trial activities are not ongoing or planned; but an expanded access patient could be supported
• Based on the available clinical and nonclinical data, the potential benefits of treatment with ABS-1230 outweigh the potential risks for the individual patient; and
• Providing access to investigational drug ABS-1230 will not negatively impact or delay the ongoing clinical trials or regulatory review or approval of ABS-1230

Responsibilities of the Treating Healthcare Provider

The treating healthcare provider must:

• Confirm the patient is 1 year of age or younger, in or recently in an intensive care unit for KCNT1-related epilepsy with an identified pathogenic or likely pathogenic mutation, having a high seizure burden, and whose condition is refractory to available treatment options.
• Provide sufficient clinical information to allow Actio Biosciences to evaluate the request, including the patient’s medical history, pathogenic mutation, prior treatment experience, and current condition, weight, and medications, and if the patient has a feeding tube and/or is on a ketogenic diet.
• Adhere to, and agree to oversee the proper administration of ABS-1230 and provide appropriate patient care, monitoring, and follow-up.
• Obtain all required regulatory, ethics committee, and institutional approvals before treatment is initiated.
• Obtain informed consent from the patient’s parent(s) or legal guardian(s), as applicable.
• Comply with all applicable safety reporting, monitoring, drug accountability, and regulatory requirements associated with Expanded Access treatment.
• Identify and provide the address for a suitable Importer of Record, if not in the United States.

Actio Biosciences continually evaluates the benefit-risk profile of each of our investigational drugs as new clinical data becomes available. Because each patient’s circumstances are unique, the availability of ABS-1230 for one patient does not guarantee the availability for another patient whose circumstances and medical histories may be different.

Actio Biosciences is committed to evaluating all requests in a fair and equitable manner. We may require more detailed information in order to fully evaluate a request. Each request will be given careful consideration by Actio Biosciences whose decisions are final.

Expanded Access Policy for ABS-0871 and Other Programs

HCPs seeking expanded access for patients with no alternative treatment options should submit their requests to ea@actiobio.com. We regularly monitor this mailbox and will use our best efforts to acknowledge each submitted request as soon as possible.

Investigational drug ABS-0871 and other programs are in the early stages of clinical development, where we are carefully evaluating their safety and potential effectiveness in the conditions being studied.

We recognize the urgency many patients and families feel in seeking new treatment options outside of clinical trials or prior to regulatory approval, especially in serious or life-threatening diseases. At this time, however, we are not able to offer Expanded Access Programs for ABS-0871 or our other early-stage programs.

Our priority is to advance these therapies through well-designed clinical trials as efficiently and safely as possible, so that we can generate the evidence needed to bring them to patients more broadly. We encourage patients and caregivers who are interested in our investigational therapies to explore participation in our ongoing or planned clinical trials, where appropriate.

Actio Biosciences will re-evaluate the status of our expanded access policy based on data from ongoing and future clinical trials.

Expanded Access Policy dated:  June 30, 2026