- 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)