On February 12, 2026 Rezolute, Inc. (Nasdaq: RZLT) ("Rezolute" or the "Company"), a late-stage rare disease company focused on treating hypoglycemia caused by all forms of hyperinsulinism (HI), reported financial results and provided a business update for the three months ended December 31, 2025.

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Congenital Hyperinsulinism (HI)

· In December 2025, Rezolute reported topline results from sunRIZE, a Phase 3, multicenter, double-blind, randomized, placebo-controlled safety and efficacy study of ersodetug for the treatment of congenital HI. The study did not meet its primary or key secondary endpoints.

· The study demonstrated reductions from baseline in hypoglycemia events by self-monitored blood glucose at both ersodetug dose levels, but reductions were not statistically significant compared to placebo, due to a pronounced study effect.

· A reduction in hypoglycemia time by continuous glucose monitoring (CGM) was also demonstrated with both dose levels of ersodetug, which was statistically significant compared to placebo at the Week 16 timepoint, but did not meet significance at the Week 24 end of pivotal timepoint.

· In sunRIZE, pharmacologic activity was observed, with target therapeutic drug concentrations achieved in both treatment groups, along with highly sensitive biomarker responses of decreased insulin cell signaling in the active treatment groups, indicating drug activity.

· Notably, all 59 participants who completed the study continued into the ongoing open-label extension portion, including the roll-over of placebo participants onto ersodetug, and the vast majority remain on therapy. Some of the children have been able to stop taking their standard congenital HI therapies and are now receiving ersodetug as monotherapy.

· Subsequent to the announcement of the topline results of the primary and key secondary endpoints, the Company is undertaking extensive analysis of the results and other endpoints, in preparation for its upcoming FDA meeting.

· The Company will be meeting with FDA prior to the end of the first quarter under Breakthrough Therapy Designation to determine next steps for the program.

Tumor HI

· upLIFT, a Phase 3, single-arm, open label study in up to 16 hospitalized participants for the treatment of tumor HI, is ongoing.

§ Enrollment is underway and topline results are expected in the second half of 2026.

· In January 2026, the Company shared aggregate data from the initial 9 tumor HI patients treated under the historical Expanded Access Program (EAP).

§ The data show that 75% of the patients receiving IV dextrose/total parenteral nutrition (TPN) in the EAP achieved a complete discontinuation of IV dextrose/TPN, providing additional evidence of the activity and potential efficacy of ersodetug across various forms of HI.

§ This cohort was the basis for FDA to grant Breakthrough Designation and agree to a single-arm, open-label registrational study design.

§ The glucose infusion rate (GIR) assessment in the EAP is the primary endpoint in upLIFT, which measures the number of participants (out of approximately 16) who achieve at least a 50% reduction in GIR.

§ The full EAP data table, filed on Form 8-K with the U.S. Securities and Exchange Commission, can be found here.

Corporate Updates

· In November 2025, the Company hosted a virtual Investor Event during which Rezolute Chief Commercial Officer, Sunil Karnawat, discussed the anticipated commercial opportunities for ersodetug as a potential treatment for congenital and tumor HI. The event also featured presentations from two leading physician experts who provided perspectives on disease background and the significant unmet clinical need in HI.

§ A replay of the virtual event is available on the Investor Relations section of the Company’s website here.

Second Quarter Fiscal 2026 Financial Results

Cash, cash equivalents and investments in marketable securities were $132.9 million as of December 31, 2025, compared with $167.9 million as of June 30, 2025.

Research and development (R&D) expenses were $14.3 million for the second quarter of fiscal 2026, compared with $12.6 million for the same period a year ago. The increase from fiscal year 2025 to fiscal year 2026 was primarily due to (i) increased expenditures in clinical trial activities and (ii) higher employee-related expenses, which included one-time severance benefits related to the December 2025 reduction in force, partially offset by a decrease in manufacturing costs for ersodetug.

General and administrative (G&A) expenses were $9.9 million for the second quarter of fiscal 2026, compared with $4.5 million for the same period a year ago. The increase was primarily attributable to increased professional fees and employee-related expenses, which included one-time severance benefits related to the December 2025 reduction in force.

Net loss was $22.8 million for the second quarter of fiscal 2026 compared with a net loss of $15.7 million for the same period a year ago.

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 the pancreas, it has the potential to be universally effective at treating hypoglycemia due to any congenital or acquired form of HI.

(Press release, Rezolute, FEB 12, 2026, View Source [SID1234662644])