On September 17, 2025 Rezolute, Inc. (Nasdaq: RZLT) ("Rezolute" or the "Company"), a late-stage rare disease company focused on treating hypoglycemia caused by hyperinsulinism, reported financial results and provided a business update for the fourth quarter and full fiscal year ended June 30, 2025 (Press release, Rezolute, SEP 17, 2025, View Source [SID1234656036]).
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"We have made substantial progress this year across our two indications for ersodetug in both congenital and tumor hyperinsulinism," said Nevan Charles Elam, Chief Executive Officer and Founder of Rezolute. "We believe that FDA alignment on a streamlined Phase 3 trial in tumor hyperinsulinism is further recognition of ersodetug’s broad applicability across multiple forms of hyperinsulinism and highlights both the urgent need and the transformative potential of our therapy for patients and families living with this condition. We remain on track to report topline results from the sunRIZE trial in December and look forward to progressing towards potential commercialization."
Recent Pipeline Progress and Anticipated Milestones
Congenital Hyperinsulinism (HI)
· Completed enrollment in sunRIZE, a Phase 3, multicenter, double-blind, randomized, controlled safety and efficacy registrational study of ersodetug for the treatment of congenital HI.
○ Exceeded enrollment with 62 participants enrolled, including approximately 15 percent from U.S. sites.
○ Topline results expected in December 2025.
· Presented "Preliminary Patient Demographics And Baseline Characteristics From A Phase 3 Study (sunRIZE) Of Ersodetug For Hypoglycemia Due To Congenital Hyperinsulinism: Trial In Progress" at the Annual Meeting of the Endocrine Society (ENDO 2025). The enrolled population is comparable to the Phase 2 RIZE study and include:
○ 3.4y average age: 35% <2 years old
○ 15 (average) hypoglycemia events/week
○ 19% daily percent time in hypoglycemia
○ 95% taking ≥1 SOC treatments
Tumor HI
· In August 2025, the Company achieved alignment with FDA on a significantly streamlined clinical development path for its ongoing Phase 3 study (upLIFT) of ersodetug for the treatment tumor HI.
o The truncated study will include as few as 16 participants and will be limited to the single-arm open-label portion of the upLIFT study, removing the need to conduct a double-blind randomized placebo-controlled trial.
o Enrollment is underway and topline results are expected in the second half of 2026.
Corporate Updates
· In August 2025 the Company appointed Dr. Sunil Karnawat as Chief Commercial Officer.
o Dr. Karnawat has over 25 years of experience in global commercialization of biopharmaceuticals and medical devices and will spearhead launch strategy and global market readiness for ersodetug.
o Before joining Rezolute, Dr. Karnawat served as a Vice President at Cytokinetics and Ultragenyx. At Ultragenyx, he was responsible for leading key commercial functions in launching four ultra-rare disease products, including Crysvita.
Fourth Quarter and Full Year Fiscal 2025 Financial Results
Cash, cash equivalents and investments in marketable securities were $167.9 million as of June 30, 2025, compared with $127.1 million as of June 30, 2024.
Research and development (R&D) expenses were $20.9 million for the fourth quarter of fiscal 2025, compared with $19.1 million for the same period a year ago. Full fiscal year 2025 R&D expenses were $61.5 million, compared to $55.7 million in fiscal year 2024. The increase from fiscal year 2024 to fiscal year 2025 was primarily due to (i) increased expenditures in clinical trial activities, (ii) manufacturing costs for ersodetug, and (iii) higher employee-related expenses, which included employee compensation and stock-based compensation.
General and administrative (G&A) expenses were $5.0 million for the fourth quarter of fiscal 2025, compared with $4.0 million for the same period a year ago. Full fiscal year 2025 G&A expenses were $18.4 million, compared to $14.7 million in fiscal year 2024. The increase was primarily attributable to professional fees and employee-related expenses due to increased headcount.
Net loss was $24.4 million for the fourth quarter of fiscal 2025 compared with a net loss of $23.0 million for the same period a year ago. Full year fiscal 2025 net loss was $74.4 million compared to net loss of $68.5 million for the fiscal year 2024.
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.