Company Overview - Rezolute, Inc. is a late-stage rare disease company focused on treating hypoglycemia caused by hyperinsulinism (HI) [3] - The company's antibody therapy, ersodetug, is designed to treat all forms of HI and has been studied in clinical trials and real-world cases for both congenital and tumor HI [3] Upcoming Events - Management will participate in the Guggenheim Emerging Outlook: Biotech Summit 2026, taking place on February 11-12, 2026, in New York [1] - One-on-one investor meetings will be held throughout the conference, and interested investors can contact their Guggenheim representative to schedule a meeting with the management team [2]

Group 1 - Rezolute, Inc. shares experienced a significant decline on December 11, 2025, due to disappointing topline results from its Phase 3 sunRIZE clinical trial for the drug candidate ersodetug, which is intended for treating congenital hyperinsulinism [5] - The clinical trial failed to meet both its primary and key secondary endpoints, with the highest dose showing reductions in hypoglycemia events that were not statistically significant compared to placebo [5] - Faruqi & Faruqi, LLP is investigating potential claims against Rezolute, Inc. for investors who suffered significant losses [2][4]

Core Viewpoint - Rezolute, Inc. is under investigation for potential violations of federal securities laws following disappointing results from its Phase 3 sunRIZE study evaluating ersodetug for congenital hyperinsulinism [1][2]. Group 1: Study Results - The Phase 3 sunRIZE study did not meet its primary endpoint, as results were "not statistically significant" compared to the placebo group, which showed a 40% improvement [2]. - The study also failed to meet its key secondary endpoint, which was similarly "not statistically significant" compared to the placebo [2]. - Management expressed disappointment and stated they are conducting a thorough evaluation to understand the study outcomes better [2]. Group 2: Stock Market Reaction - Following the announcement of the study results, Rezolute's stock price plummeted over 89%, opening at $1.21 per share [2].

Group 1 - The law firm Faruqi & Faruqi, LLP is investigating potential claims against Rezolute, Inc. following significant losses in its stock [2][4] - Rezolute's shares experienced a sharp decline on December 11, 2025, due to disappointing topline results from its Phase 3 sunRIZE clinical trial for the drug candidate ersodetug [5] - The clinical trial failed to meet both primary and key secondary endpoints, with the highest dose showing reductions in hypoglycemia events that were not statistically significant compared to placebo [5] Group 2 - Faruqi & Faruqi has a history of recovering hundreds of millions of dollars for investors since its establishment in 1995 [4] - The firm encourages investors who suffered losses in Rezolute stock or options to discuss their legal rights directly with their attorneys [1]

Core Viewpoint - Rezolute, Inc. is under investigation for potential violations of federal securities laws following the announcement of disappointing results from its Phase 3 sunRIZE study evaluating ersodetug for congenital hyperinsulinism [1][2]. Group 1: Study Results - The Phase 3 sunRIZE study did not meet its primary endpoint, as results were "not statistically significant" compared to the placebo group, which showed a 40% improvement [2]. - The study also failed to meet its key secondary endpoint, which was similarly "not statistically significant" compared to the placebo [2]. - Management expressed disappointment and stated they are conducting a thorough evaluation to understand the study outcomes better [2]. Group 2: Stock Performance - Following the announcement of the study results, Rezolute's stock price plummeted over 89%, opening at $1.21 per share [2].

Core Viewpoint - Rezolute, Inc. is facing potential legal claims following a significant drop in its stock price due to disappointing results from its Phase 3 clinical trial for its lead drug candidate, ersodetug [5]. Group 1: Company Overview - Rezolute, Inc. is publicly traded on NASDAQ under the ticker symbol RZLT [2]. - The company is focused on developing treatments for congenital hyperinsulinism [5]. Group 2: Clinical Trial Results - The Phase 3 sunRIZE clinical trial for ersodetug did not meet its primary and key secondary endpoints [5]. - The highest dose in the trial showed reductions in hypoglycemia events that were not statistically significant compared to placebo [5]. Group 3: Legal Implications - Faruqi & Faruqi, LLP is investigating potential claims against Rezolute for investors who suffered significant losses [2][4]. - The law firm has a history of recovering hundreds of millions of dollars for investors since its founding in 1995 [4].

Core Viewpoint - Faruqi & Faruqi, LLP is investigating potential claims against Rezolute, Inc. following a significant decline in its stock price due to disappointing results from a clinical trial for its lead drug candidate, ersodetug [4][5]. Group 1: Company Overview - Rezolute, Inc. is a publicly traded company listed on NASDAQ under the ticker symbol RZLT [4]. - The company is focused on developing treatments for congenital hyperinsulinism, with ersodetug being its lead drug candidate [5]. Group 2: Clinical Trial Results - The Phase 3 sunRIZE clinical trial for ersodetug did not meet its primary and key secondary endpoints, leading to a sharp decline in the company's stock on December 11, 2025 [5]. - The highest dose of ersodetug showed reductions in hypoglycemia events, but these results were not statistically significant compared to the placebo [5]. Group 3: Legal Investigation - Faruqi & Faruqi, LLP is encouraging investors who suffered significant losses in Rezolute stock or options to discuss their legal rights [1]. - The law firm has a history of recovering hundreds of millions of dollars for investors since its establishment in 1995 [4].

Core Insights - The company believes that data from the sunRIZE study and the Expanded Access Program (EAP) provide evidence of the activity of ersodetug in treating hypoglycemia caused by hyperinsulinism (HI) [1][2] - The company plans to meet with the FDA to discuss the path forward for congenital HI treatment [1][8] Summary by Sections Congenital HI - The sunRIZE study did not meet its primary or key secondary endpoints, but the company believes the overall data supports the pharmacologic activity of ersodetug against hypoglycemia [2][4] - Target therapeutic drug concentrations were achieved in both treatment groups (5 mg/kg and 10 mg/kg), with significant biomarker responses indicating reduced insulin activity [2][4] - The study showed reductions in hypoglycemia events and time in hypoglycemia, but these were not statistically significant compared to the placebo group [4][5] - The company is exploring how to characterize the study dynamics, including patient-reported quality of life outcomes [5] Ongoing Studies - All 59 participants who completed the sunRIZE study chose to continue receiving ersodetug in the open-label extension (OLE) phase, with 57 participants remaining [7] - Some children in the OLE have stopped all other therapies and are now on ersodetug monotherapy, which the company views as a potential indicator of efficacy [7] Tumor HI - Over the past two years, the company has provided ersodetug to over a dozen patients with severe hypoglycemia due to tumor HI, reporting substantial improvements and well-tolerated therapy [9][10] - In the EAP, 75% of patients receiving IV dextrose/total parenteral nutrition (TPN) achieved complete discontinuation of these treatments [10] - The ongoing upLIFT study will assess the primary endpoint of the glucose infusion rate (GIR), with topline results expected in the second half of 2026 [11] About Ersodetug - Ersodetug is a fully human monoclonal antibody designed to decrease insulin receptor over-activation, potentially effective for all forms of HI [15] About Rezolute, Inc. - Rezolute is focused on treating hypoglycemia caused by HI, with ersodetug being studied for both congenital and tumor HI [16]

Core Viewpoint - Faruqi & Faruqi, LLP is investigating potential claims against Rezolute, Inc. following a significant drop in its stock price due to disappointing clinical trial results for its lead drug candidate, ersodetug [4][5]. Group 1: Company Overview - Rezolute, Inc. is a biopharmaceutical company listed on NASDAQ under the ticker RZLT [4]. - The company focuses on developing treatments for congenital hyperinsulinism, with ersodetug being its lead drug candidate [5]. Group 2: Recent Developments - On December 11, 2025, Rezolute's shares fell sharply after the Phase 3 sunRIZE clinical trial results for ersodetug failed to meet primary and key secondary endpoints [5]. - The highest dose in the trial showed reductions in hypoglycemia events that were not statistically significant compared to placebo [5]. Group 3: Stock Performance - During intraday trading on December 11, 2025, Rezolute's stock price plummeted from approximately $10.94 to an intraday low of around $0.90, marking an approximate 85-90% decline [6].

Core Viewpoint - Pomerantz LLP is investigating potential securities fraud or unlawful business practices by Rezolute, Inc. and its officers or directors following disappointing clinical trial results that led to a significant drop in the company's stock price [1][3]. Group 1: Company Overview - Rezolute, Inc. is a publicly traded company on NASDAQ under the ticker RZLT [1]. - The company recently announced topline results from its Phase 3 sunRIZE study evaluating ersodetug for congenital hyperinsulinism [3]. Group 2: Clinical Trial Results - The Phase 3 study did not meet its primary endpoint, which was to assess the change in average weekly hypoglycemia events, showing only a 45% reduction in events at the highest dose of ersodetug (10 mg/kg), which was not statistically significant compared to a 40% improvement in the placebo group [3]. - The study also failed to meet its key secondary endpoint, with a 25% reduction in average daily percent time in hypoglycemia at the 10 mg/kg dose, again not statistically significant compared to a 5% increase in the placebo group [3]. Group 3: Stock Market Reaction - Following the announcement of the clinical trial results, Rezolute's stock price fell by $9.44 per share, or 87.2%, closing at $1.77 per share on December 19, 2025 [3].