Financial Performance - Net loss for Q2 FY2025 was $15.7 million, compared to a net loss of $13.9 million for the same period last year[5]. - The company reported a basic and diluted net loss per common share of $0.22 for Q2 FY2025, compared to $0.27 for the same period last year[12]. - Total operating expenses for Q2 FY2025 were $17.1 million, compared to $15.2 million for the same period last year[12]. Cash and Equity - Cash, cash equivalents, and investments in marketable securities totaled $105.3 million as of December 31, 2024, down from $127.1 million as of June 30, 2024[3]. - Total stockholders' equity decreased to $99.6 million as of December 31, 2024, down from $121.0 million as of June 30, 2024[12]. Research and Development - Research and development expenses increased to $12.6 million for Q2 FY2025, compared to $12.0 million for the same period last year, primarily due to higher clinical trial activities and personnel-related expenses[4]. - The company anticipates beginning a Phase 3 registrational study for ersodetug in patients with tumor HI in the first half of 2025, with topline results expected in the second half of 2026[8]. - An interim analysis of the sunRIZE study is planned for this quarter, with topline results expected in Q4 2025[8]. Regulatory Developments - The FDA granted Breakthrough Therapy Designation to ersodetug for congenital hyperinsulinism, with enrollment of U.S. participants expected in Q2 2025[2]. Administrative Expenses - General and administrative expenses rose to $4.5 million for Q2 FY2025, up from $3.2 million in the same period last year, driven by increased professional fees and headcount[5].

Core Insights - Rezolute, Inc. has received Breakthrough Therapy Designation and Orphan Drug Designation from the FDA for its novel monoclonal antibody, ersodetug, aimed at treating hyperinsulinism (HI) [1][3] - The company reported a net loss of $15.7 million for the second quarter of fiscal 2025, compared to a net loss of $13.9 million for the same period in the previous year [5][10] - The ongoing Phase 3 sunRIZE study is designed to evaluate the safety and efficacy of ersodetug in patients with congenital HI, with topline results expected in the fourth quarter of 2025 [3][7] Regulatory Progress - The FDA granted Breakthrough Therapy Designation to ersodetug for treating hypoglycemia due to congenital HI [3] - The company anticipates starting a Phase 3 registrational study for ersodetug in patients with tumor HI in the first half of 2025, with topline results expected in the second half of 2026 [3][6] Financial Performance - As of December 31, 2024, the company had cash, cash equivalents, and investments totaling $105.3 million, down from $127.1 million as of June 30, 2024 [3][10] - Research and development expenses increased to $12.6 million for the second quarter of fiscal 2025, compared to $12.0 million for the same period a year ago [3][4] - General and administrative expenses rose to $4.5 million for the second quarter of fiscal 2025, up from $3.2 million in the same period last year [4][10] Clinical Trial Updates - The Data Monitoring Committee (DMC) reviewed the open-label arm of the sunRIZE study, confirming that target drug concentrations were safely reached in infant participants [1][3] - An interim analysis of the primary study endpoint is planned for the current quarter, with three possible outcomes regarding the continuation of the study [3][4] Company Overview - Rezolute, Inc. focuses on developing therapies for rare diseases, particularly those related to hypoglycemia caused by hyperinsulinism [8] - Ersodetug is designed to treat all forms of HI and has shown substantial benefits in clinical trials [6][8]

Core Viewpoint - Rezolute (RZLT) shares have increased by 30.8% over the past six months, contrasting with a 4.1% decline in the industry, primarily due to positive investor sentiment regarding the development of its lead candidate, ersodetug (RZ358) [1] Group 1: Company Overview - Rezolute is a late-stage clinical biotech company focused on improving outcomes for individuals suffering from hypoglycemia caused by hyperinsulinism (HI) [1] - The company is currently evaluating ersodetug in the phase III sunRIZE study for treating patients with congenital HI, an ultra-rare pediatric genetic disorder [2] Group 2: Study Progress and Results - Recent outcomes from the open label arm (OLA) of the phase III sunRIZE study indicated that treatment with ersodetug was generally safe and well-tolerated among eight infants aged three months to one year [4][5] - The Data Monitoring Committee (DMC) approved the enrollment of additional infants into the double-blind portion of the study [5] - Enrollment in the sunRIZE study is expected to be completed by the second quarter of 2025, with top-line data anticipated in the fourth quarter of 2025 [6] Group 3: Regulatory Designations - The FDA granted Breakthrough Therapy designation to ersodetug for treating hypoglycemia due to congenital HI in January 2025 [6] - The FDA removed the partial clinical hold on the phase III sunRIZE study in September 2024 [6] - Rezolute is also developing ersodetug for treating hypoglycemia caused by tumor HI, with enrollment expected to begin in the first half of 2025 [9] Group 4: Future Expectations - Top-line data from the study evaluating ersodetug in patients with tumor HI is expected in the second half of 2026 [9] - The successful development of ersodetug, along with upcoming clinical milestones, is anticipated to sustain the stock's upward momentum in 2025 [10]

Core Viewpoint - Rezolute, Inc. has announced positive outcomes from the Data Monitoring Committee (DMC) review of the open-label arm of the sunRIZE Phase 3 study for ersodetug, indicating safety and allowing enrollment of infants into the double-blind portion of the study [1][3] Group 1: Study Updates - The open-label arm included 8 infant participants aged 3 months to 1 year, who received doses of 5 or 10 mg/kg of ersodetug [2] - The DMC confirmed the safety and pharmacokinetics of ersodetug, validating the chosen dose regimen and allowing for the continuation of the study [7] - Enrollment completion for the sunRIZE study is expected in Q2 2025, with topline results anticipated in Q4 2025, pending the outcomes of an upcoming interim analysis [1][3] Group 2: Interim Analysis - An interim analysis will assess the adequacy of the sample size for the primary endpoint and may recommend adjustments, including a potential increase in sample size by 33% [4][5] - The DMC will announce the conclusions of the interim analysis early in Q2 2025, with three possible outcomes: stop the study for futility, continue as is, or increase the sample size [4] Group 3: Company Background and Product Information - Rezolute is focused on developing therapies for rare diseases, particularly congenital hyperinsulinism, which causes recurrent hypoglycemia in children [8][11] - Ersodetug is a fully human monoclonal antibody designed to counteract insulin receptor over-activation, potentially effective for various forms of hyperinsulinism [9][11] - The sunRIZE study is a multi-center, randomized, double-blind, placebo-controlled trial evaluating the efficacy and safety of ersodetug in patients aged 3 months to 45 years [10]

REDWOOD CITY, Calif., Jan. 31, 2025 (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 announced that management will participate in the Guggenheim SMID Cap Biotech Conference, taking place February 5-6, 2025, in New York City. Management will be participating in one-on-one investor meetings throughout the conference. Investors interested in ...

When it comes to short-term investing or trading, they say "the trend is your friend." And there's no denying that this is the most profitable strategy. But making sure of the sustainability of a trend to profit from it is easier said than done.Often, the direction of a stock's price movement reverses quickly after taking a position in it, making investors incur a short-term capital loss. So, it's important to ensure that there are enough factors -- such as sound fundamentals, positive earnings estimate rev ...

Breakthrough Therapy Designation granted based on key positive data from the Phase 2b (RIZE) study and current unmet medical need in congenital hyperinsulinism (HI) Ersodetug continues to advance in clinical development as a potential treatment for hypoglycemia caused by all forms of hyperinsulinism; topline sunRIZE data expected second half of this year REDWOOD CITY, Calif., Jan. 07, 2025 (GLOBE NEWSWIRE) -- Rezolute, Inc. (Nasdaq: RZLT) (“Rezolute” or the “Company”), a late-stage biopharmaceutical company ...

REDWOOD CITY, Calif., Dec. 05, 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 announced that its compensation committee has approved the issuance of One Hundred and Fifty Thousand (150,000) shares of its common stock as an inducement award (the “Inducement Award”) permitted under Nasdaq Rule 5635(c)(4) to its new Senior Vice Presiden ...

Core Viewpoint - Rezolute, Inc. has received Orphan Drug Designation from the FDA for its lead candidate, ersodetug, aimed at treating hypoglycemia caused by tumor hyperinsulinism, a rare disease [1][2]. Company Developments - Following the FDA announcement, shares of Rezolute increased by nearly 5% on December 3 [2]. - Year-to-date, Rezolute's shares have surged by 439.1%, contrasting with a 7% decline in the industry [3]. - The FDA previously cleared Rezolute's investigational new drug application for ersodetug in August, and the company is preparing for a phase III registrational study [4]. - Patient enrollment for the phase III study is expected to start in the first half of 2025, with top-line data anticipated in the second half of 2026 [5]. Additional Research and Studies - Rezolute is also developing ersodetug for congenital hyperinsulinism, an ultra-rare pediatric genetic disorder, with the FDA lifting partial clinical holds on the phase III sunRIZE study in September [6]. - Enrollment for the sunRIZE study is expected to begin in early 2025, with topline data expected in the second half of 2025 [7]. - The sunRIZE study was initiated in December 2023 [8].

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) | --- | --- | --- | |------------------- ...