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Rezolute (RZLT) investor relations material
Rezolute Q4 2025 earnings summary
Complete event summary combining all related documents: earnings call transcript, report, and slide presentation.Q4 2025 earnings summary17 Sep, 2025
Executive summary
Achieved significant progress in clinical development for ersodetug in both congenital and tumor hyperinsulinism, including FDA alignment on a streamlined Phase 3 trial for tumor HI.
Completed enrollment in the sunRIZE Phase 3 trial for congenital HI, with topline results expected in December 2025.
Appointed Dr. Sunil Karnawat as Chief Commercial Officer to lead commercialization efforts for ersodetug.
Financial highlights
Cash, cash equivalents, and investments totaled $167.9 million as of June 30, 2025, up from $127.1 million a year earlier.
R&D expenses were $20.9 million for Q4 2025 (up from $19.1 million YoY) and $61.5 million for FY 2025 (up from $55.7 million YoY), driven by increased clinical and manufacturing costs.
G&A expenses were $5.0 million for Q4 2025 (up from $4.0 million YoY) and $18.4 million for FY 2025 (up from $14.7 million YoY), mainly due to higher professional fees and headcount.
Net loss was $24.4 million for Q4 2025 (vs. $23.0 million YoY) and $74.4 million for FY 2025 (vs. $68.5 million YoY).
Outlook and guidance
Topline results from the sunRIZE Phase 3 trial in congenital HI expected in December 2025.
Topline results from the upLIFT Phase 3 trial in tumor HI anticipated in the second half of 2026.
What does the streamlined upLIFT trial imply?
How will CCO's experience impact ersodetug launch?
What caused the significant share count increase?
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Q1 20265 Nov, 2025
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Frequently asked questions
Rezolute, Inc. is a clinical-stage biopharmaceutical company focused on developing therapies for metabolic diseases, particularly those related to chronic glucose imbalances. The company's lead product, RZ358, is a human monoclonal antibody currently in clinical trials aimed at treating congenital hyperinsulinism, a rare pediatric disorder. Additionally, Rezolute is working on RZ402, an oral plasma kallikrein inhibitor, intended for the treatment of diabetic macular edema. The company is headquartered in Redwood City, California, and its shares are listed on the NASDAQ.
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