REDWOOD CITY, Calif., June 04, 2026 (GLOBE NEWSWIRE) -- Rezolute, Inc. (Nasdaq: RZLT) (“Rezolute” or the “Company”), a late-stage ultra-rare disease company focused on treating refractory hypoglycemia caused by a congenital or any acquired form of hyperinsulinism (HI), today announced four presentations at the upcoming Annual Meeting of the Endocrine Society (ENDO) being held June 13-16, 2026, in Chicago, IL.
The Company’s presentations at the meeting will include one oral presentation to be made by Huseyin Demirbilek, M.D., Professor, Department of Pediatric Endocrinology, Hacettepe University Faculty of Medicine, Ankara, Turkey, and Principal Investigator of the Phase 3 sunRIZE study in congenital HI. The oral presentation will highlight previously reported results from sunRIZE. Additionally, three poster presentations will cover the natural history and adverse outcomes associated with congenital HI, as well as results from the Company’s ersodetug clinical development program, including a case series report on compassionate use of ersodetug in a cohort of patients with tumor HI.
Presentation Details:
Presentation Title: Ersodetug (RZ358) in Congenital Hyperinsulinism: Top-Line Results from a Global, Multicenter, Randomized, Double-Blind, Placebo-Controlled Phase 3 Study (sunRIZE)
Format: Oral presentation
Presenter: Huseyin Demirbilek, M.D.
Poster Number: SAT-10-06
Session Date and Time: Saturday, June 13, 2026, from 2:30 - 2:45 p.m. CDT
Session Title: Pediatric and Adolescent Endocrinology: Diabetes and Insulin
Presentation Title: A Case Series on the Compassionate Use of Ersodetug, an Insulin Receptor Modulating Antibody, in Patients with Refractory Hypoglycemia Due to Malignant Insulin-Secreting Tumors
Format: Poster presentation
Presenter: Gopal Saha, M.B.B.S.
Poster Number: SAT-087
Session Date and Time: Saturday, June 13, 2026, from 12:15 - 1:45 p.m. CDT
Session Title: Neuroendocrinology and Pituitary: Neuroendocrine Tumors I
Presentation Title: Association of Early-Life Hypoglycemia with Later Neurological Outcomes in Congenital Hyperinsulinism: A US Claims-Based Study
Format: Poster presentation
Presenter: Cody Akana
Poster Number: SAT-221
Session Date and Time: Saturday, June 13, 2026, from 12:15 - 1:45 p.m. CDT
Session Title: Pediatric and Adolescent Endocrinology: Pediatric Diabetes, Metabolic and Cardiovascular Disorders I
Presentation Title: Outcomes in Congenital Hyperinsulinism: A Systematic Review
Format: Poster presentation
Presenter: Davelyn Eaves Hood, M.D., M.B.A.
Poster Number: MON-215
Session Date and Time: Monday, June 15, 2026, from 12:00 - 1:30 p.m. CDT
Session Title: Pediatric and Adolescent Endocrinology: Pediatric Diabetes, Metabolic and Cardiovascular Disorders III
For more information on the conference presentation schedule, please visit the ENDO 2026 website.
About sunRIZE
The Phase 3 sunRIZE study (RZ358-301) was a multi-center, randomized, double-blind, placebo-controlled, parallel arm study designed to evaluate the efficacy and safety of ersodetug in patients with congenital hyperinsulinism (HI), ages 3 months to 45 years old, who were experiencing continued hypoglycemia on currently available standard of care (SOC). Eligible participants were randomized to one of three treatment arms to receive either ersodetug (5 or 10 mg/kg) or matched placebo-control as add on to existing SOC. Study drug was administered every other week during an initial loading phase, and then every 4 weeks during the 6-month controlled pivotal treatment period. Following the pivotal treatment phase of the study, participants could roll-over into an optional open-label extension phase to continue to receive ersodetug.
The study enrolled 63 participants in more than a dozen countries around the world, inclusive of U.S. patients. The primary and key secondary efficacy endpoints in the study were the change from baseline in the average number of hypoglycemia events per week and the average percent time in hypoglycemia, respectively, over six months of treatment.
In December 2025, the Company announced that the sunRIZE study did not meet its primary or key secondary endpoints. Although statistical significance for the secondary endpoint (% time in hypoglycemia by continuous glucose monitoring [“CGM”]) was not achieved at the Week 24/End of Treatment evaluation window, larger and often nominally statistically significant glycemic improvements compared to placebo were consistently observed throughout the maintenance dosing phase of the study, across time and numerous pre-specified and post-hoc CGM-based endpoints. As a next step for the program, the U.S. Food and Drug Administration (FDA) encouraged Rezolute to submit comprehensive analysis datasets and summary outcomes for the agency’s independent evaluation.
About Ersodetug
Ersodetug is a fully human monoclonal antibody that binds allosterically to the insulin receptor to decrease receptor over-activation by insulin and related substances (such as IGF-2) in the setting of hyperinsulinism (HI), thereby improving hypoglycemia. Because ersodetug acts downstream from glucose absorption, gastrointestinal incretin hormones, and pancreatic insulin secretion, it has the potential to be universally effective at treating refractory hypoglycemia due to a congenital or any acquired form of HI, including tumor HI (insulinoma, NICTH) or hypoglycemia as a complication of a variety of bariatric or non-bariatric gastrointestinal surgeries.
About Rezolute, Inc.
Rezolute is a late-stage ultra-rare disease company focused on treating refractory hypoglycemia caused by a congenital or any acquired form of hyperinsulinism (HI). The Company’s antibody therapy, ersodetug, has been studied in clinical trials and used in real-world cases for the treatment of refractory hypoglycemia due to a variety of causes of HI. For more information, visit www.rezolutebio.com.
Forward-Looking Statements
This release, like many written and oral communications presented by Rezolute and our authorized officers, may contain certain forward-looking statements regarding our prospective performance and strategies within the meaning of Section 27A of the Securities Act and Section 21E of the Securities Exchange Act of 1934, as amended. We intend such forward-looking statements to be covered by the safe harbor provisions for forward-looking statements contained in the Private Securities Litigation Reform Act of 1995 and are including this statement for purposes of said safe harbor provisions. Forward-looking statements, which are based on certain assumptions and describe future plans, strategies, and expectations of Rezolute, are generally identified by use of words such as "anticipate," "believe," "estimate," "expect," "intend," "plan," "project," "seek," "strive," "try," or future or conditional verbs such as "could," "may," "should," "will," "would," or similar expressions. These forward-looking statements include, but are not limited to, the potential efficacy of ersodetug in treating hypoglycemia. Our ability to predict results or the actual effects of our plans or strategies is inherently uncertain. Accordingly, actual results may differ materially from anticipated results. Readers are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date of this release. Except as required by applicable law or regulation, Rezolute undertakes no obligation to update these forward-looking statements to reflect events or circumstances that occur after the date on which such statements were made. Important factors that may cause such a difference include any other factors discussed in our filings with the SEC, including the Risk Factors contained in Rezolute’s Annual Report on Form 10-K and Quarterly Reports on Form 10-Q, which are available at the U.S. Securities and Exchange Commission’s website at www.sec.gov. You are urged to consider these factors carefully in evaluating the forward-looking statements in this release and are cautioned not to place undue reliance on such forward-looking statements, which are qualified in their entirety by this cautionary statement.
Rezolute Contacts:
Christen Baglaneas
cbaglaneas@rezolutebio.com
508-272-6717
Carrie McKim
cmckim@rezolutebio.com
336-608-9706
