Rezolute, Inc. (RZLT) Discusses Phase 3 sunRIZE Study Results and Challenges in Congenital Hyperinsulinism December 11, 2025 8:30 AM EST
Company Participants
Nevan Elam - Founder, CEO, Principal Financial Officer & Acting Chairman of the Board Brian Roberts - Chief Medical Officer
Conference Call Participants
Debjit Chattopadhyay - Guggenheim Securities, LLC, Research Division Maurice Raycroft - Jefferies LLC, Research Division Pete Stavropoulos - Cantor Fitzgerald & Co., Research Division Catherine Novack - JonesTrading Institutional Services, LLC, Research Division Julian Harrison - BTIG, LLC, Research Division Douglas Tsao - H.C. …
Rezolute, Inc. (RZLT) Discusses Phase 3 sunRIZE Study Results and Challenges in Congenital Hyperinsulinism December 11, 2025 8:30 AM EST
Company Participants
Nevan Elam - Founder, CEO, Principal Financial Officer & Acting Chairman of the Board Brian Roberts - Chief Medical Officer
Conference Call Participants
Debjit Chattopadhyay - Guggenheim Securities, LLC, Research Division Maurice Raycroft - Jefferies LLC, Research Division Pete Stavropoulos - Cantor Fitzgerald & Co., Research Division Catherine Novack - JonesTrading Institutional Services, LLC, Research Division Julian Harrison - BTIG, LLC, Research Division Douglas Tsao - H.C. Wainwright & Co, LLC, Research Division Gum-Ming Lowe - Craig-Hallum Capital Group LLC, Research Division Yun Zhong - Wedbush Securities Inc.
Presentation
Operator
Good morning, and welcome to the sunRIZE Topline Data Conference Call. [Operator Instructions] Please note, this event is being recorded.
I would now like to turn the conference over to Nevan. Please go ahead.
Nevan Elam Founder, CEO, Principal Financial Officer & Acting Chairman of the Board
Thank you, and good morning, everyone. We appreciate you joining us today to review the study results from our Phase III sunRIZE study for ersodetug in patients with congenital HI. I would like to start by thanking the patients, their families and the investigators for the tremendous effort in participating in the study. We are deeply grateful for the broad participation of the worldwide congenital HI community in working with us to explore the possibility of finally bringing a new therapy to this patient population, where there’s a massive unmet need.
As you’ve seen in our press release, the primary and secondary endpoints did not achieve statistical significance. Frankly, we are shocked and dismayed by the outcome of the study. With a drug that we believe has activity, we were unable to demonstrate a significant difference compared to placebo in an outpatient study, where glucose is both the endpoint and the vital sign