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].

Financial Performance - Cash, cash equivalents, and investments in marketable securities were $127.1 million as of June 30, 2024, compared to $118.4 million as of June 30, 2023, representing a 6.1% increase[6] - Net loss for Q4 fiscal 2024 was $23.0 million, compared to a net loss of $12.7 million for the same period last year, an increase of 81.1%; full year fiscal 2024 net loss was $68.5 million, compared to a net loss of $51.8 million in fiscal year 2023, a 32.3% increase[7] - Total operating expenses for Q4 fiscal 2024 were $23.1 million, compared to $14.2 million for the same period last year, a 62.3% increase; full fiscal year 2024 total operating expenses were $70.4 million, compared to $56.0 million in fiscal year 2023, a 25.7% increase[12] Research and Development - Research and development (R&D) expenses for Q4 fiscal 2024 were $19.1 million, up from $10.9 million in the same period last year, marking a 75.7% increase; full fiscal year 2024 R&D expenses totaled $55.7 million, compared to $43.8 million in fiscal year 2023, a 27.5% increase[6] - Positive topline results from the Phase 2 proof-of-concept study of RZ402 for diabetic macular edema (DME) were announced, showing significant reduction in central subfield thickness (CST) of up to approximately 50 microns compared to placebo[5] - The company has engaged in discussions with potential partners for further development of RZ402[5] Regulatory Updates - The FDA lifted partial clinical holds on ersodetug for congenital hyperinsulinism (HI), allowing U.S. participant enrollment in the Phase 3 sunRIZE study to begin in early 2025[2] - The FDA cleared the IND application for the Phase 3 study of ersodetug for tumor HI, with patient enrollment anticipated to begin in the first half of 2025 and topline results expected in mid-2026[4] - Topline results from the sunRIZE study are expected in the second half of 2025[3] Administrative Expenses - General and administrative (G&A) expenses for Q4 fiscal 2024 were $4.0 million, compared to $3.3 million for the same period a year ago, a 21.2% increase; full fiscal year 2024 G&A expenses were $14.7 million, up from $12.2 million in fiscal year 2023, a 20.5% increase[7]

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 ...

Core Viewpoint - Rezolute, Inc. has received FDA approval to remove partial clinical holds on its phase III study for RZ358, a treatment for congenital hyperinsulinism, leading to a significant increase in its stock price by 22.1% on September 9 [1]. Company Developments - The phase III sunRIZE study will evaluate the safety and efficacy of RZ358 in patients aged three months to 45 years with congenital hyperinsulinism [2]. - Rezolute is preparing to initiate start-up activities for the study in the U.S., with participant enrollment expected to begin in early 2025 and top-line data anticipated in the second half of 2025 [3]. - The company has seen a remarkable 435% increase in its shares year-to-date, contrasting with a 2.8% decline in the industry [3]. - The pivotal phase III sunRIZE study was initiated in December 2023, following positive results from the phase IIb RIZE study, which demonstrated significant improvements in hypoglycemia levels [5]. Regulatory Background - The FDA had previously placed partial clinical holds due to liver toxicity observed in preclinical studies with Sprague Dawley rats, but has since determined that this toxicity is strain-specific and not relevant to humans [4]. Future Prospects - The FDA has also cleared Rezolute's investigational new drug application for RZ358 to treat hypoglycemia in patients with tumor-induced hyperinsulinism, with enrollment expected to begin in the first half of 2025 [6]. - The successful development of RZ358 and other pipeline candidates is crucial for the company's future, as it currently lacks a marketed product [6].

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 ...

In addition, the Company has entered into an agreement for a concurrent private placement exempt from the registration requirements of the Securities Act of 1933, as amended (the "Securities Act"), of 1,500,000 shares of its common stock, at a sale price of $4.00 per share. Contacts: Rezolute, Inc. 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 ...