- Rezolute, Inc. reported a **net loss of $24.4 million** for the fourth quarter of fiscal 2025 and a **net loss of $74.4 million** for the full fiscal year 2025.  **[1509261_0001104659-25-090834_tm2526049d1_ex99-1.htm:1]** **[1509261_0001104659-25-090834_tm2526049d1_ex99-1.htm:3]** 
- As of June 30, 2025, cash, cash equivalents, and investments in marketable securities totaled **$167.9 million**, an increase from $127.1 million as of June 30, 2024.  **[1509261_0001104659-25-090834_tm2526049d1_ex99-1.htm:1]** **[1509261_0001104659-25-090834_tm2526049d1_ex99-1.htm:3]** 
- The company completed enrollment for its **Phase 3 sunRIZE trial** in congenital hyperinsulinism, with **62 participants**, and expects **topline results in December 2025**.  **[1509261_0001104659-25-090834_tm2526049d1_ex99-1.htm:0]** 
- FDA alignment was achieved for a **streamlined Phase 3 upLIFT study** in tumor hyperinsulinism, with topline results anticipated in the **second half of 2026**.  **[1509261_0001104659-25-090834_tm2526049d1_ex99-1.htm:1]** 
- **Dr. Sunil Karnawat** was appointed Chief Commercial Officer in August 2025 to lead commercialization strategy for ersodetug.  **[1509261_0001104659-25-090834_tm2526049d1_ex99-1.htm:1]**

Rezolute, Inc. Reports Q4 and Full Year Fiscal 2025 Financial Results and Provides Business Update

- Rezolute has achieved **FDA alignment** on a significantly streamlined clinical development path for its ongoing Phase 3 upLIFT study of ersodetug for the treatment of hypoglycemia caused by tumor hyperinsulinism (HI).  **[1509261_0001104659-25-085892_tm2524786d1_ex99-1.htm:0]** 
- The revised study design is now an **open-label trial** that will include as few as **16 participants**, removing the need for a double-blind randomized placebo-controlled trial.  **[1509261_0001104659-25-085892_tm2524786d1_ex99-1.htm:0]** 
- The FDA confirmed that Rezolute's pivotal sunRIZE trial in congenital HI, which is on track to report topline results in December 2025, would serve as **confirmatory clinical evidence**.  **[1509261_0001104659-25-085892_tm2524786d1_ex99-1.htm:0]** 
- **Topline data** from the upLIFT study is anticipated in the **second half of 2026**.  **[1509261_0001104659-25-085892_tm2524786d1_ex99-1.htm:0]** **[1509261_0001104659-25-085892_tm2524786d1_ex99-2.htm:1]** 
- The company reported having **$180 million in cash**, providing a financial runway until mid-2027.  **[1509261_0001104659-25-085892_tm2524786d1_ex99-2.htm:0]** **[1509261_0001104659-25-085892_tm2524786d1_ex99-2.htm:8]**

Rezolute (RZLT)