Rezolute Reports Fourth Quarter and Full Year Fiscal 2026 Financial Results and Provides Business Update

Clinical program updates

Rezolute said its Phase 3 upLIFT single-arm, open-label study in tumor hyperinsulinism (tumor HI) is ongoing with enrollment in progress and topline results expected before the end of 2026. The company reported interim results in June 2026 that among 8 enrolled participants, 6 had met the responder criterion for the study’s primary endpoint within the 8-week pivotal treatment phase; the seventh participant later met the responder criterion. The company also described one enrolled participant who withdrew consent and later died of cancer progression and is being counted as a non-responder for the primary endpoint. Separately, Rezolute stated that the Phase 3 sunRIZE study in congenital HI did not meet its primary endpoint and that sunRIZE data remain under review with the U.S. Food and Drug Administration; the company provided additional datasets and analyses to the Agency and continues an open-label extension with reported indicators of improved glycemic control and reduced use of background therapies. (Inference: positive interim tumor HI signals may support a completed single-arm pivotal package, but sunRIZE’s failed primary endpoint has created regulatory uncertainty for the congenital HI indication.)

Sources: S1

Financial results highlights for fiscal 2026

Rezolute reported cash, cash equivalents and investments in marketable securities of $107.8 million as of June 30, 2026. Research and development expense was $14.9 million for the fourth quarter of fiscal 2026 and $53.8 million for the full fiscal year 2026, down from $61.5 million in fiscal 2025; the company attributed the year-over-year R&D decrease primarily to decreased manufacturing costs for ersodetug, partially offset by increased employee-related stock-based compensation. General and administrative expense rose to $29.2 million for fiscal 2026 from $18.4 million in fiscal 2025, driven primarily by higher stock-based compensation and increased professional fees ahead of potential commercial activities. Net loss was $20.5 million for the fourth quarter of fiscal 2026 and $77.6 million for the full year fiscal 2026. (Inference: cash runway and expense mix will be central to operational planning as clinical programs proceed.)

Sources: S1

Product profile and regulatory posture

Rezolute described ersodetug as a fully human monoclonal antibody that binds allosterically to the insulin receptor to decrease receptor over-activation and potentially improve hypoglycemia across causes of hyperinsulinism; the company emphasized that ersodetug for the treatment of HI is investigational and that statements about safety and efficacy have not been approved by any health authority. The company noted it may request meetings with the FDA as needed and that the Agency could determine a new randomized control trial is required for the congenital HI indication. (Inference: the company positions ersodetug as a potentially broad mechanism for refractory hypoglycemia, but formal regulatory acceptance remains unresolved.)

Sources: S1

What remains uncertain

• All clinical efficacy and safety assertions in the release are company-reported and have not been independently verified; the reported upLIFT interim responder counts and sunRIZE outcomes are subject to final study data, FDA review, and potential further agency requests.
• Topline timing and regulatory pathways described are forward-looking company statements and may change; the company warns the FDA could require a new randomized control trial for congenital HI, which would affect development plans and commercial potential.