Rezolute to Initiate a Pivotal Phase 3 Study of RZ358 in Participants 3 Months of Age and Older with Congenital Hyperinsulinism - Seite 2

Nevan Charles Elam, Rezolute’s Founder and Chief Executive Officer, stated, “We believe that RZ358 has tremendous potential to fulfill a significant unmet need for patients and families living with congenital HI around the world and we are delighted to have alignment for sunRIZE with regulators outside of the US. We believe that there may be a path forward to address FDA’s nonclinical concerns and ensure that patients in the US have access to RZ358 should the therapy continue to demonstrate good safety and efficacy and be eligible for regulatory approval.”

More information on sunRIZE and related regulatory interactions can be found in a filing made today on Form 8-K filed with the US Securities and Exchange Commission.

Conference Call Information
Rezolute will host a conference call today, June 27, 2023, at 4:30 p.m. EDT. To access the conference call, dial 1-877-270-2148 from the U.S. and Canada or 1-412-902-6510 internationally and ask to be joined into the Rezolute call. The live audio webcast of the call will be available under "Events" in the Investor section of the Company's website at https://ir.rezolutebio.com/news-events/ir-calendar.

About Congenital Hyperinsulinism (HI)
Congenital HI is the most common cause of recurrent and persistent hypoglycemia in children. Patients with congenital HI typically present with signs or symptoms of hypoglycemia within the first month of life. These episodes can result in significant brain injury and death if not recognized and managed appropriately. Additionally, recurrent, or cumulative, hypoglycemia can lead to progressive and irreversible damage over time, including serious and devastating brain injury, seizures, neuro-developmental problems, feeding difficulties, and significant impact on patient and family quality of life. The two most-commonly used long-term medications, diazoxide and somatostatin analogs, are not Food and Drug Administration (FDA) approved for all forms of this condition and often are ineffective or have intolerable side effects. In cases of congenital HI that are unresponsive to medical management, surgical removal of the pancreas may be required. In those with diffuse congenital HI where the whole pancreas is affected, a near-total pancreatectomy can be undertaken, although about half of these children will continue to have hypoglycemia and require medical treatment for congenital HI.