On November 5, 2026 Rezolute, Inc. (Nasdaq: RZLT) (Rezolute or the Company), a late-stage ultra-rare, metabolic disease company focused on treating refractory hypoglycemia caused by any form of hyperinsulinism (HI), reported financial results and provided a business update for the first quarter ended September 30, 2026.

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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 complete and topline results are expected by mid-December 2026.
· Earlier this year, the Company announced that 7 of the 8 participants enrolled in the first half of the study met the responder criterion for the study’s primary endpoint.
· Each of these participants also achieved complete discontinuation of intravenous glucose with the administration of ersodetug.
· Ersodetug has been well-tolerated in the study thus far, with no drug-related safety findings reported.
· The eighth participant in the first half of the study discontinued study drug shortly after enrollment in favor of pursuing hospice care at home, where they died one week later due to cancer progression. The Company considers this participant as a non-responder, for purposes of the primary endpoint.

Congenital HI

· In October 2026, the Company provided an update that the U.S. Food and Drug Administration (FDA or the Agency) has reviewed additional study data provided by the Company at the Agency’s request.
· The Agency recommended the Company file for review under a Biologics License Agreement (BLA) for congenital HI after holding a pre-BLA meeting.
· As previously reported, sunRIZE, a Phase 3, multicenter, double-blind, randomized, placebo-controlled safety and efficacy study of ersodetug for the treatment of congenital HI, demonstrated glycemic improvements, but did not meet the primary endpoint because the reductions in hypoglycemia events by finger-stick self-monitored blood glucose (SMBG) were not statistically significant compared to placebo. However, consistent and clinically relevant improvements in hypoglycemia were observed across multiple CGM-based hypoglycemia endpoints in both treatment arms.
· The open-label extension (OLE) phase of the sunRIZE study is ongoing, with a high participation rate and several indicators of improved glycemic control, including a notable reduction in the use of background standard of care therapies.

Business Update

· On October 29, 2026, the Company participated in a virtual Q&A as part of Guggenheim’s Healthcare Spotlight Series. The discussion focused on commercial outlook and launch strategy for ersodetug. Key highlights include:

· Potential $5 billion combined market opportunity.
· Plan to submit a BLA for ersodetug for one or potentially both indications in 2027.

First Quarter Fiscal 2027 Financial Results

Cash, cash equivalents and investments in marketable securities were $90.0 million as of September 30, 2026, compared with $107.8 million as of June 30, 2026.

Research and development (R&D) expenses were $12.8 million for the first quarter of fiscal 2027, compared with $13.1 million for the same period a year ago. The decrease was primarily due to decreased manufacturing costs for ersodetug and patient affairs costs, partially offset by increased employee-related stock-based compensation expense. R&D expenses include $1.5 million of share-based compensation expense for the first quarter of fiscal 2027, compared with $1.2 million for the same period a year ago.

General and administrative (G&A) expenses were $6.6 million for the first quarter of fiscal 2027, compared with $6.7 million for the same period a year ago. The decrease was primarily attributable to a decrease in professional fees, partially offset by increased employee-related stock-based compensation expense. G&A expenses include $1.8 million of share-based compensation expense for the first quarter of fiscal 2027, compared with $1.4 million for the same period a year ago.

Net loss was $18.5 million for the first quarter of fiscal 2027 compared with a net loss of $18.2 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 pancreatic insulin or paraneoplastic IGF-2 secretion, and from entero-incretin pathways, it has the potential to be universally effective at treating refractory hypoglycemia due to any form of hyperinsulinism (HI), including congenital HI, tumor HI (insulinoma, non-islet cell tumors) or bariatric/non-bariatric gastrointestinal surgery hypoglycemia. Ersodetug for the treatment of HI is investigational. Statements about safety and efficacy have not been approved by any health authority.

(Press release, Rezolute, NOV 5, 2026, View Source [SID1234674325])