Target enrollment exceeded with 62 participants enrolled, including approximately 15 percent from U.S. sites Topline data is anticipated in December of 2025 REDWOOD CITY, Calif., May 28, 2025 (GLOBE NEWSWIRE) -- Rezolute, Inc. (Nasdaq: RZLT) ("Rezolute" or the "Company"), a late-stage rare disease company focused on treating hypoglycemia caused by hyperinsulinism (HI), today announced that enrollment is complete in the sunRIZE study, a global, Phase 3 multicenter, double-blind, randomized, placebo-controlle ...

Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended March 31, 2025 or ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to Commission File Number: 001-39683 REZOLUTE, INC. (Exact Name of Registrant as Specified in its Charter) Nevada 27-3440894 (State or other jurisdicti ...

U.S. Food and Drug Administration (FDA) grants Breakthrough Therapy Designation to ersodetug for hypoglycemia due to tumor hyperinsulinism Exhibit 99.1 REDWOOD CITY, Calif., May 13, 2025 -- Rezolute, Inc. (Nasdaq: RZLT) ("Rezolute" or the "Company"), a late-stage rare disease company focused on treating hypoglycemia caused by hyperinsulinism (HI), today reported financial results and provided a business update for the three months ended March 31, 2025. Rezolute Reports Third Quarter Fiscal 2025 Financial Re ...

sunRIZE enrollment on track including U.S. sites and expected to be completed in May 2025; topline data anticipated in December 2025 U.S. Food and Drug Administration (FDA) grants Breakthrough Therapy Designation to ersodetug for hypoglycemia due to tumor hyperinsulinism REDWOOD CITY, Calif., May 13, 2025 (GLOBE NEWSWIRE) -- Rezolute, Inc. (Nasdaq: RZLT) (“Rezolute” or the “Company”), a late-stage rare disease company focused on treating hypoglycemia caused by hyperinsulinism (HI), today reported financial ...

REDWOOD CITY, Calif., May 01, 2025 (GLOBE NEWSWIRE) -- Rezolute, Inc. (Nasdaq: RZLT) (“Rezolute” or the “Company”), a late-stage rare disease company focused on significantly improving outcomes for individuals with hypoglycemia caused by hyperinsulinism, today announced that management will participate in the following investor conferences: Event: The Citizens JMP Life Sciences Conference Date: May 7-8, 2025 Event: H.C. Wainwright BioConnect Investor Conference Date: May 20, 2025 Event: Craig-Hallum Institu ...

This article is published by Terry Chrisomalis, who runs the Biotech Analysis Central pharmaceutical service on Seeking Alpha Marketplace. If you like what you read here and would like to subscribe to, I'm currently offering a two-week free trial period for subscribers to take advantage of. My service offers a deep-dive analysis of many pharmaceutical companies. The Biotech Analysis Central SA marketplace is $49 per month, but for those who sign up for the yearly plan will be able to take advantage of a 33. ...

Core Viewpoint - Rezolute, Inc. has successfully closed an underwritten offering of 24,940,769 shares of common stock at a price of $3.25 per share, raising approximately $96.9 million for research and development, corporate expenses, and working capital needs [1][2]. Group 1: Offering Details - The offering included 4,153,846 shares from the underwriters' option and pre-funded warrants for up to 6,905,385 shares at an offering price of $3.2490 per warrant [1]. - The offering attracted participation from both new and existing investors, including notable firms such as Federated Hermes Kaufmann Funds and Blackstone Multi-Asset Investing [2]. - Guggenheim Securities served as the sole book-running manager, with BTIG, H.C. Wainwright & Co., and Jones as lead managers [3]. Group 2: Private Placement - In addition to the offering, existing investors have committed to purchase up to $4.2 million in shares in a private placement at the same offering price, expected to close around May 7, 2025 [4]. Group 3: Company Overview - Rezolute, Inc. is a late-stage biopharmaceutical company focused on developing therapies for rare diseases, particularly targeting hypoglycemia caused by hyperinsulinism [7]. - The company's antibody therapy, ersodetug, has demonstrated significant benefits in clinical trials for treating congenital and tumor-related hypoglycemia [7].

Core Viewpoint - Rezolute, Inc. has announced an underwritten offering of common stock and pre-funded warrants, aiming to raise approximately $90 million for research and development, general corporate expenses, and working capital needs [1][4]. Group 1: Offering Details - The offering consists of 20,786,923 shares of common stock priced at $3.25 per share and pre-funded warrants to purchase up to 6,905,385 shares at $3.2490 each [1]. - Gross proceeds from the offering are expected to be around $90 million before deducting underwriting discounts and commissions [1]. - The underwriters have a 30-day option to purchase an additional 4,153,846 shares at the offering price [1]. Group 2: Investor Participation - The offering includes participation from both new and existing investors, such as Federated Hermes Kaufmann Funds, Blackstone Multi-Asset Investing, and others [3]. Group 3: Management and Advisors - Guggenheim Securities is the sole book-running manager for the offering, with BTIG, H.C. Wainwright & Co., and Jones acting as lead managers [4]. - Craig-Hallum and Maxim Group LLC are co-managers, while WG Partners LLP serves as the financial advisor [4]. Group 4: Company Overview - Rezolute, Inc. is a late-stage biopharmaceutical company focused on developing therapies for serious rare diseases, particularly targeting hypoglycemia caused by hyperinsulinism [7]. - The company's antibody therapy, ersodetug, has shown significant benefits in clinical trials for treating congenital and tumor-related hyperinsulinism [7].

Core Viewpoint - Rezolute, Inc. (RZLT) has been upgraded to a Zacks Rank 2 (Buy), indicating a positive outlook on its earnings estimates, which significantly influence stock prices [1][3]. Earnings Estimates and Stock Price Impact - The Zacks rating system emphasizes the correlation between changes in earnings estimates and stock price movements, driven by institutional investors adjusting their valuations based on these estimates [4][6]. - Rezolute is projected to earn -$0.93 per share for the fiscal year ending June 2025, reflecting a year-over-year change of 30.1% [8]. Analyst Sentiment and Market Position - Analysts have raised their earnings estimates for Rezolute, with the Zacks Consensus Estimate increasing by 6.1% over the past three months [8]. - The upgrade to Zacks Rank 2 places Rezolute in the top 20% of Zacks-covered stocks, suggesting potential for market-beating returns in the near term [10].

Company Overview - Rezolute, Inc. is a late-stage biopharmaceutical company focused on developing transformative therapies for rare diseases with significant unmet needs [1] - The company is particularly dedicated to improving outcomes for individuals suffering from hypoglycemia caused by hyperinsulinism (HI) [3] Leadership Appointment - Erik Harris has been appointed to the Board of Directors of Rezolute, effective immediately [1] - Mr. Harris is currently the Chief Commercial Officer and Executive Vice President at Ultragenyx, bringing over 20 years of biopharmaceutical expertise [1][2] - The CEO of Rezolute, Nevan Charles Elam, expressed enthusiasm about Mr. Harris's appointment, highlighting his experience in rare disease commercialization and strategic vision [2] Product Development - Rezolute's lead product, ersodetug, is an antibody therapy designed to treat all forms of hyperinsulinism and has shown substantial benefits in clinical trials [3] - The company aims to advance ersodetug through clinical development and prepare for potential commercialization [2][3]