Presentations included analyses of natural history and adverse outcomes in congenital hyperinsulinism (HI), as well as previously reported results from the Company’s Phase 3 sunRIZE study in congenital HI and a case series from its Expanded Access Program (EAP) in tumor HI
REDWOOD CITY, Calif., June 17, 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 highlighted four data presentations delivered at the Annual Meeting of the Endocrine Society (ENDO).
Two poster presentations highlighted results from systematic analyses of the natural history and adverse neurologic and health-economic outcomes resulting from congenital HI, using a meta-analysis of the literature as well as a claims-based approach to quantifying congenital HI complications, respectively. This is an important step toward consolidating and quantifying the disease-impact and informing future health economics and outcomes research that will facilitate the development and potential future launch of the Company’s therapy, ersodetug, in this indication. A third poster presentation highlighted favorable outcomes from a case series report of 9 patients with refractory hypoglycemia due to malignant insulinoma and non-islet cell tumors (tumor HI), demonstrating that 75% of the patients receiving IV dextrose/total parenteral nutrition (TPN) in the EAP achieved a complete discontinuation of IV dextrose/TPN.
In an oral presentation, 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 of ersodetug in congenital HI, reviewed previously reported sunRIZE results.
“We were pleased to have the opportunity to present at ENDO and to continue showcasing progress across our two late-stage programs in congenital and tumor HI,” said Brian Roberts, M.D., Chief Medical Officer of Rezolute. “Deeper analyses of the sunRIZE data demonstrate the meaningful therapeutic benefit of ersodetug, further supported by the positive outcomes observed in both our EAP and recently announced interim and preliminary Phase 3 upLIFT study observations in tumor HI patients. Additionally, the natural history outcomes studies further underscore the significant clinical outcomes impacts of this disease, and the urgent need for improved treatment options.”
Each of the Company’s full data presentations from ENDO can be found on the Publications and Presentations page of the Rezolute website here.
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
508-272-6717
Carrie McKim
336-608-9706