Rezolute — Fourth Quarter and Full Year Fiscal 2026 Earnings Summary

Financial Performance

• Cash, cash equivalents, and investments in marketable securities totaled $107.8 million as of June 30, 2026, a decrease from $167.9 million as of June 30, 2025.
• Research and development (R&D) expenses were $14.9 million for the fourth quarter of fiscal 2026, down from $20.9 million in the same period of fiscal 2025; full-year fiscal 2026 R&D expenses were $53.8 million, compared to $61.5 million in fiscal 2025.
• General and administrative (G&A) expenses were $6.7 million for the fourth quarter of fiscal 2026, up from $5.0 million in the same period of fiscal 2025; full-year fiscal 2026 G&A expenses were $29.2 million, compared to $18.4 million in fiscal 2025.
• Net loss was $20.5 million for the fourth quarter of fiscal 2026, compared to $24.4 million for the same period in fiscal 2025; full-year fiscal 2026 net loss was $77.6 million, compared to $74.4 million in fiscal 2025.
• Basic and diluted net loss per common share was $0.20 for the fourth quarter of fiscal 2026, compared to $0.26 in the prior year period; full-year fiscal 2026 net loss per share was $0.75, compared to $0.98 in fiscal 2025.
• Total operating expenses were $21.6 million for the fourth quarter of fiscal 2026 and $83.0 million for the full fiscal year 2026.
• Working capital was $99.1 million as of June 30, 2026, compared to $159.2 million as of June 30, 2025.
• Total assets were $112.8 million as of June 30, 2026, compared to $175.5 million as of June 30, 2025.
• Accumulated deficit was $(481.4) million as of June 30, 2026, compared to $(403.9) million as of June 30, 2025.
• Total stockholders' equity was $100.7 million as of June 30, 2026, compared to $162.1 million as of June 30, 2025.
• Share-based compensation expense was $6.5 million for R&D and $8.0 million for G&A in fiscal 2026, compared to $3.5 million and $3.6 million respectively in fiscal 2025.

Business Segments and Product Lines

• The upLIFT Phase 3 study for tumor HI is ongoing with enrollment in progress and top-line results expected before the end of 2026.
• Interim data from the upLIFT study showed that 6 of 8 enrolled participants met the primary endpoint responder criterion within the 8-week pivotal treatment phase, with all 6 achieving complete discontinuation of intravenous glucose requirements; a seventh participant subsequently met the criterion.
• One participant in the upLIFT study withdrew consent due to Stage 4 metastatic colon cancer and poor performance status (ECOG 4), resulting in death; this patient is counted as a non-responder.
• A case series of 9 patients with refractory hypoglycemia due to malignant insulin-secreting tumors and non-islet cell tumors presented at the ENDO meeting in June 2026 showed 75% achieved complete discontinuation of IV dextrose/TPN.
• Data from the case series was published in The Journal of Clinical Endocrinology & Metabolism.
• The Phase 3 sunRIZE study for congenital HI did not meet its primary endpoint, and data remains under review by the FDA.
• Additional study data, including source and analysis datasets and summary results from pre-specified, post-hoc, and sensitivity analyses focusing on continuous glucose monitoring (CGM) outcomes, were submitted to the FDA in June 2026.
• The open-label extension (OLE) phase of the sunRIZE study is ongoing with high participation rates and indicators of improved glycemic control, including reduced use of background standard of care therapies.
• Ersodetug is a fully human monoclonal antibody targeting hyperinsulinism (HI) and is currently investigational.

Market and Competitive Landscape

• Rezolute is a late-stage ultra-rare disease company focused on treating refractory hypoglycemia caused by any form of hyperinsulinism (HI).
• Ersodetug has the potential to be universally effective for refractory hypoglycemia due to congenital HI, tumor HI, or bariatric/non-bariatric gastrointestinal surgery hypoglycemia.

Risks and Challenges

• The FDA may determine that the only path forward for the congenital HI indication is a new randomized control trial similar to sunRIZE, which would adversely impact the Company's ability to pursue that indication and the commercial potential for ersodetug.
• Actual results may differ materially from anticipated results due to inherent uncertainties in predicting clinical results or plans.

Management Commentary and Tone

• Management noted that the decrease in R&D expenses was primarily due to decreased manufacturing costs for ersodetug, partially offset by increased stock-based compensation.
• Management attributed the increase in G&A expenses to increased stock-based compensation and higher professional fees in preparation for future commercial activities.
• The Company reserves the ability to request a formal meeting with the FDA under a regulatory timeline as needed regarding the sunRIZE study.

Other Key Points

• The Company provided an update on the sunRIZE study in September 2026 regarding its status with the FDA.
• Three data presentations focused on congenital HI were delivered at the ENDO meeting in June 2026, including an oral presentation by Principal Investigator Huseyin Demirbilek, M.D., and two poster presentations on natural history and health-economic outcomes.
• The Company has no revenue reported for the periods discussed, consistent with its status as a clinical-stage biopharmaceutical company.