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 September 30, 2024 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) | --- | --- | --- | |------------------- ...

Exhibit 99.1 Rezolute Reports First Quarter Fiscal 2025 Financial Results and Provides Business Update Ersodetug, a novel, fully human monoclonal antibody for the treatment of hyperinsulinism (HI), advancing in two late-stage, registrational clinical trials in two indications Phase 3 sunRIZE study on track; U.S. enrollment expected to commence in the first part of 2025 Phase 3 tumor HI study expected to commence in the first half of 2025 REDWOOD CITY, Calif., November 07, 2024 – Rezolute, Inc. (Nasdaq: RZLT ...

Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-K (Mark One) ☑ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year ended June 30, 2024 ☐ 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 Company as Specified in its Charter) If an emerging growth company, indicate by check ...

Exhibit 99.1 Rezolute Reports Fourth Quarter and Full Year Fiscal 2024 Financial Results and Provides Business Update FDA lifts partial clinical holds on ersodetug for the treatment of congenital HI; Phase 3 sunRIZE study to proceed in the U.S. Phase 3 study for ersodetug for the treatment of tumor HI expected to commence in the first half of 2025 REDWOOD CITY, Calif., September 19, 2024 – Rezolute, Inc. (Nasdaq: RZLT) ("Rezolute" or the "Company"), a latestage biopharmaceutical company dedicated todevelopi ...

FDA lifts partial clinical holds on ersodetug for the treatment of congenital HI; Phase 3 sunRIZE study to proceed in the U.S. Phase 3 study for ersodetug for the treatment of tumor HI expected to commence in the first half of 2025 REDWOOD CITY, Calif., Sept. 19, 2024 (GLOBE NEWSWIRE) -- Rezolute, Inc. (Nasdaq: RZLT) ("Rezolute" or the "Company"), a late-stage biopharmaceutical company dedicated to developing transformative therapies for rare diseases with serious unmet needs, today reported financial resul ...

文章核心观点 - 美国食品药品监督管理局(FDA)已经解除了对Rezolute公司的RZ358(ersodetug)药物进行III期临床试验的部分临床禁令 [1] - RZ358是用于治疗先天性高胰岛素血症(HI)引起的低血糖的药物,这是一种罕见的儿童遗传性疾病 [1] - Rezolute公司正准备在美国启动RZ358的III期临床试验,预计2025年初开始患者入组,2025年下半年获得试验数据 [1] 公司情况 - 今年以来,Rezolute公司股价上涨435%,而同期行业下跌2.8% [2] - Rezolute公司目前没有上市产品,RZ358的成功开发及其他管线的进展是公司的关键重点 [5] - Rezolute公司目前被评为Zacks Rank 3(Hold),而Illumina、Krystal Biotech和Fulcrum Therapeutics等公司被评为Zacks Rank 1(Strong Buy) [6][7] RZ358临床试验进展 - Rezolute公司于2023年12月启动了RZ358的III期关键性临床试验sunRIZE,评估其在先天性HI患者中的安全性和有效性 [3] - 此前FDA曾因RZ358在Sprague Dawley大鼠中出现肝毒性而对该试验实施了部分临床禁令,但现已解除 [3] - FDA认为该肝毒性是Sprague Dawley大鼠特有的,与人类无关 [3] - II期RIZE试验显示RZ358可以显著改善先天性HI患者的低血糖水平 [3] - FDA还批准了RZ358用于治疗肿瘤性高胰岛素血症引起的低血糖的III期临床试验,预计2025年上半年开始患者入组 [5]

REDWOOD CITY, Calif., Sept. 09, 2024 (GLOBE NEWSWIRE) -- Rezolute, Inc. (Nasdaq: RZLT) ("Rezolute" or the "Company"), a late-stage rare disease company developing a novel therapy to treat hyperinsulinism (HI), today announced that the U.S. Food and Drug Administration (FDA) has removed the partial clinical holds on RZ358 (ersodetug), a potential treatment for hypoglycemia caused by congenital HI. Ersodetug is currently being studied in sunRIZE, a global Phase 3, multi-center, double-blind, randomized, place ...

Second rare disease program with RZ358 in Phase 3 development Follows successful treatment of multiple patients with tumor hyperinsulinism under the Company's Expanded Access Program REDWOOD CITY, Calif., Aug. 05, 2024 (GLOBE NEWSWIRE) -- Rezolute, Inc. (Nasdaq: RZLT) ("Rezolute" or the "Company"), a late-stage biopharmaceutical company committed to developing novel, transformative therapies for serious rare diseases, today announced that it received U.S. Food and Drug Administration (FDA) clearance for its ...

Second rare disease program with RZ358 in Phase 3 development Follows successful treatment of multiple patients with tumor hyperinsulinism under the Company's Expanded Access Program REDWOOD CITY, Calif., Aug. 05, 2024 (GLOBE NEWSWIRE) -- Rezolute, Inc. (Nasdaq: RZLT) ("Rezolute" or the "Company"), a late-stage biopharmaceutical company committed to developing novel, transformative therapies for serious rare diseases, today announced that it received U.S. Food and Drug Administration (FDA) clearance for its ...

NEW YORK, June 27, 2024 (GLOBE NEWSWIRE) -- Rezolute, Inc. (Nasdaq: RZLT) (“Rezolute” or the “Company”), a late-stage biopharmaceutical company committed to developing novel, transformative therapies for serious rare diseases, today announced that the underwriters of its previously announced public offering, which closed on June 24, 2024, have exercised an over-allotment option to purchase an additional 1,786,589 shares of the Company’s common stock at the public offering price of $4.00 per share, less unde ...