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 ...

Rezolute, Inc. (RZLT) announced that the FDA has granted an Orphan Drug Designation (“ODD”) to its lead pipeline candidate, ersodetug (RZ358), for the treatment of hypoglycemia caused by tumor hyperinsulinism (HI), a rare disease.Shares of the company were up almost 5% on Dec. 3 following the announcement of the news.The FDA grants ODD to support the development of medicines for rare disorders that affect a few patients in the United States. The Orphan Drug Designation makes the sponsor eligible to receive ...

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

Financial Performance - Net loss for Q1 fiscal 2025 was $15.4 million, compared to a net loss of $14.5 million for the same period last year[5]. - Basic and diluted net loss per common share for Q1 fiscal 2025 was $0.22, an improvement from $0.28 for the same period last year[10]. - Total operating expenses for Q1 fiscal 2025 were $16.9 million, compared to $15.9 million for the same period last year[10]. Cash and Investments - Cash, cash equivalents, and investments in marketable securities totaled $117.8 million as of September 30, 2024, down from $127.1 million as of June 30, 2024[3]. - Working capital increased to $102.2 million as of September 30, 2024, compared to $95.5 million a year ago[10]. - Total stockholders' equity rose to $113.4 million as of September 30, 2024, up from $103.6 million a year earlier[10]. Research and Development - Research and development expenses increased to $12.8 million for Q1 fiscal 2025, compared to $12.2 million for the same period last year, primarily due to higher clinical trial activities and personnel-related expenses[4]. - The Phase 3 sunRIZE study for ersodetug in congenital hyperinsulinism is on track, with U.S. enrollment expected to commence in early 2025 and topline results anticipated in the second half of 2025[2]. - Start-up activities for the Phase 3 registrational study for tumor hyperinsulinism are progressing, with patient enrollment expected to begin in the first half of 2025 and topline results expected in the second half of 2026[3]. General and Administrative Expenses - General and administrative expenses rose to $4.2 million for Q1 fiscal 2025, up from $3.7 million year-over-year, driven by increased professional fees and employee-related expenses[5].

Market Opportunity - The addressable market for congenital hyperinsulinism (HI) in the U.S. is estimated to be more than 1,500 individuals[11]. - The total addressable market for tumor HI is estimated to be approximately 1,500 patients in the U.S., including around 500 with islet cell tumor hypoglycemia and approximately 1,000 with non-islet cell tumor hypoglycemia[20]. Clinical Trials - The Phase 3 sunRIZE study of ersodetug aims to enroll approximately 56 participants aged 3 months to 45 years, with topline results expected in the second half of calendar 2025[15]. - FDA clearance for the Phase 3 registrational study of ersodetug for tumor HI was announced on August 5, 2024, with patient enrollment planned to commence in the first half of calendar 2025[20]. - The primary endpoint of the Phase 3 registrational study for tumor HI is the change in Level 2 and Level 3 hypoglycemia events as measured by self-monitored blood glucose[21]. - The company is actively enrolling participants in the pivotal Phase 3 clinical study for congenital HI, which is a randomized, double-blind, placebo-controlled trial[14]. - The Phase 3 study for tumor HI will include a randomized 1:1 allocation to receive ersodetug 9 mg/kg per week or matched placebo[21]. Drug Designation and Development - Ersodetug has received Orphan Drug Designation in the U.S. and European Union for the treatment of congenital HI, and Rare Pediatric Disease Designation in the U.S.[12]. - The company has received and approved several requests for the use of ersodetug in patients with tumor HI caused by metastatic insulinomas, indicating a growing interest in the treatment[24]. - The company is actively engaged in conversations with potential partners to further develop RZ402[27]. Financial Performance - The company incurred approximately $55.7 million and $43.8 million in research and development expenses for the fiscal years ended June 30, 2024, and 2023, respectively, representing a year-over-year increase of 27.5%[34]. - Operating expenses rose to $70,423,000 in 2024, up from $55,990,000 in 2023, marking a 25.8% increase[187]. - Net loss for the fiscal year 2024 was $68,459,000, compared to a net loss of $51,787,000 in 2023, reflecting a 32.2% increase in losses[187]. - Cash and cash equivalents significantly increased to $70,396,000 in 2024 from $16,036,000 in 2023, a growth of 338.5%[185]. - Total current assets increased to $128,653,000 in 2024 from $104,910,000 in 2023, representing a 22.6% growth[185]. - Total liabilities increased to $11,734,000 in 2024 from $7,549,000 in 2023, indicating a 55.0% rise[185]. - The company reported a basic and diluted net loss per common share of $1.33 in 2024, compared to $1.01 in 2023[187]. - The company experienced a net unrealized gain on marketable debt securities of $272,000 in 2024, compared to a loss of $351,000 in 2023[187]. Cash Flow and Investments - Cash used in operating activities for 2024 was $57,368,000, an increase from $44,481,000 in 2023, indicating a 29% rise in cash outflow[192]. - Total cash provided by investing activities was $48,699,000 in 2024, a significant improvement compared to cash used of $101,464,000 in 2023[192]. - As of June 30, 2024, investments in marketable debt securities totaled $56.7 million, with short-term investments of $56.5 million scheduled to mature during the 12-month period ending June 30, 2025[223]. - During the fiscal year ended June 30, 2024, marketable debt securities for $115.1 million matured, with approximately $66.4 million of the proceeds reinvested[224]. Shareholder and Stock Information - The weighted average number of common shares outstanding increased to 51,465,000 in 2024 from 51,187,000 in 2023[187]. - The Company completed a 2024 Underwritten Offering in June 2024, resulting in the issuance of approximately 13.0 million shares of common stock and 3.8 million pre-funded warrants for net proceeds of $62.6 million[220]. - The Company is obligated to make milestone payments totaling up to $30 million under the XOMA License Agreement, with $5 million due upon dosing of the last patient in the ongoing Phase 3 clinical trial for ersodetug[233]. - As of June 30, 2024, the total number of authorized shares under the stock option plans is 11.233 million, with 10.891 million outstanding and 342,000 available for future grants[248]. Regulatory and Compliance - The company is subject to rigorous regulatory approval processes for its pharmaceutical products, which is a significant factor in their development and marketing[32]. - The company identified a material weakness in internal control related to pre-funded warrant accounting, which was remediated by June 30, 2024[305]. Patent and Licensing - The company holds a worldwide, exclusive license from XOMA for the ersodetug molecule, which includes 37 issued patents worldwide, expiring between 2030 and 2036[29]. - The company has a worldwide, exclusive license from ActiveSite for RZ402, which includes 9 issued international patents and 7 issued U.S. patents, expected to expire between 2040 and 2043[30]. - Under the ActiveSite License Agreement, the Company has milestone payments up to $46.5 million, with $5 million due upon the first dosing of a patient in a Phase 3 clinical trial for RZ402[234]. Employee and Compensation - As of June 30, 2024, the company had 59 full-time employees, with 42 engaged in research and development and clinical operations[35]. - The company reported an annual base salary of $460,000 for its Chief Financial Officer, with a target bonus of 40%[297]. - The total share-based compensation expense for the fiscal year ended June 30, 2024, is $7.36 million, compared to $7.27 million for the previous year[257].