Reveals Fourth Quarter and Overall Fiscal 2025 Financial Statements, Along with a Business Overview from Rezolute
Rezolute, Inc., a late-stage rare disease company focused on treating hypoglycemia caused by hyperinsulinism, has made significant strides in its research this year. The company's antibody therapy, ersodetug, is showing promising results in clinical trials and real-world use for the treatment of both congenital and tumor hyperinsulinism.
Enrollment for the upLIFT study is currently underway, and topline results are expected in the second half of 2026. In a significant development, the truncated upLIFT study will include as few as 16 participants and will be limited to the single-arm open-label portion of the study, bypassing the need for a double-blind randomized placebo-controlled trial. This decision was made following alignment with the FDA on a streamlined clinical development path for the study.
In another major milestone, Rezolute has completed enrollment in sunRIZE, a Phase 3 study of ersodetug for the treatment of congenital hyperinsulinism. A total of 62 participants were enrolled, including approximately 15% from U.S. sites. Topline results from the sunRIZE trial are expected in December 2025.
Financial updates also highlight the company's progress. As of June 30, 2025, Rezolute had cash, cash equivalents, and investments in marketable securities of $167.9 million. Despite increased expenses, the company reported a net loss for the fourth quarter of fiscal 2025 of $24.4 million, compared with a net loss of $23.0 million for the same period a year ago. Full fiscal year 2025 G&A expenses were $18.4 million, an increase from $14.7 million in fiscal year 2024. G&A expenses for the fourth quarter of fiscal 2025 were $5.0 million, an increase from $4.0 million for the same period a year ago. The full year fiscal 2025 net loss was $74.4 million, compared to net loss of $68.5 million for the fiscal year 2024.
To bolster its commercial efforts, Rezolute appointed Dr. Sunil Karnawat as Chief Commercial Officer in August 2025. Dr. Karnawat, who has over 25 years of experience in global commercialization of biopharmaceuticals and medical devices, was previously employed at Rezolute. His extensive experience will be instrumental in driving the company's growth and commercial success.
ersodetug is a fully human monoclonal antibody that binds allosterically to the insulin receptor, decreasing receptor over-activation by insulin and related substances in the setting of hyperinsulinism. 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 hyperinsulinism.
Rezolute, Inc. (Nasdaq: RZLT) continues to focus on its mission to improve the lives of patients with rare metabolic disorders. With the progress made this year and the anticipated results from the upLIFT and sunRIZE trials, the company is well-positioned to make a significant impact in the treatment of hyperinsulinism.
Read also:
- Money allocated, approximately 1.17 million euros, for local nursing conferences
- Leeds set for a healthier future through new collaborative endeavor
- Eight strategies for promoting restful slumber in individuals with hypertrophic cardiomyopathy
- Exploring the Strength of Minimally Digestible Diets: A Roadmap to Gastrointestinal Healing
