Rezolute(RZLT) - 2025 Q4 - Annual Results

Executive Summary This section summarizes Rezolute, Inc.'s focus on hyperinsulinism, recent pipeline progress, CEO's strategic outlook, and key financial results for FY2025 Introduction and Company Focus Rezolute, Inc. is a late-stage rare disease company focused on treating hypoglycemia caused by hyperinsulinism, reporting financial results for the fourth quarter and full fiscal year ended June 30, 2025 - Rezolute, Inc. (Nasdaq: RZLT) is a late-stage rare disease company[1] - The company focuses on treating hypoglycemia caused by hyperinsulinism[1] - Financial results are reported for the fourth quarter and full fiscal year ended June 30, 2025[1] CEO's Strategic Outlook CEO Nevan Charles Elam highlighted substantial progress across both congenital and tumor hyperinsulinism indications for ersodetug, noting FDA alignment on a streamlined Phase 3 trial for tumor HI and anticipating topline results from the sunRIZE trial in December 2025 - Substantial progress has been made across two indications for ersodetug: congenital and tumor hyperinsulinism[2] - FDA alignment on a streamlined Phase 3 trial in tumor hyperinsulinism is seen as recognition of ersodetug's broad applicability and transformative potential[2] - Topline results from the sunRIZE trial are expected in December 2025[2] Recent Pipeline Progress and Anticipated Milestones This section details the latest advancements in ersodetug's clinical development for congenital and tumor hyperinsulinism, including enrollment completion and expected topline results Congenital Hyperinsulinism (HI) Program Rezolute completed enrollment for the sunRIZE Phase 3 study of ersodetug for congenital HI, exceeding targets with 62 participants, and expects topline results in December 2025 - Completed enrollment in sunRIZE, a Phase 3 study for congenital HI, exceeding enrollment with 62 participants (approximately 15% from U.S. sites)[5] - Topline results from the sunRIZE trial are expected in December 2025[5] - Preliminary Patient Demographics And Baseline Characteristics From A Phase 3 Study (sunRIZE): | Characteristic | Value | | :------------- | :---- | | Average Age | 3.4 years (35% <2 years old) | | Hypoglycemia Events | 15 (average) per week | | Daily Percent Time in Hypoglycemia | 19% | | Taking ≥1 SOC treatments | 95% | Tumor HI Program The Company achieved FDA alignment on a significantly streamlined clinical development path for its upLIFT Phase 3 study of ersodetug for tumor HI, reducing the study to as few as 16 participants in a single-arm open-label portion, with topline results expected in the second half of 2026 - Achieved FDA alignment on a significantly streamlined clinical development path for the ongoing Phase 3 study (upLIFT) of ersodetug for tumor HI[5] - The truncated upLIFT study will include as few as 16 participants and be limited to the single-arm open-label portion, removing the need for a double-blind randomized placebo-controlled trial[5] - Enrollment for upLIFT is underway, and topline results are expected in the second half of 2026[5] Corporate Updates This section highlights recent organizational changes, including key personnel appointments, to strengthen the company's commercialization efforts Key Personnel Appointment In August 2025, Dr. Sunil Karnawat was appointed as Chief Commercial Officer, bringing over 25 years of experience in global biopharmaceutical commercialization to spearhead the launch strategy for ersodetug - Dr. Sunil Karnawat was appointed as Chief Commercial Officer in August 2025[13] - Dr. Karnawat has over 25 years of experience in global commercialization of biopharmaceuticals and medical devices[13] - He will spearhead launch strategy and global market readiness for ersodetug, having previously led commercial functions for launching four ultra-rare disease products at Ultragenyx[13] Financial Results This section presents Rezolute's financial performance for Q4 and the full fiscal year 2025, detailing cash position, operating expenses, net loss, and key balance sheet data Cash, Cash Equivalents and Investments Rezolute's cash, cash equivalents, and investments in marketable securities increased to $167.9 million as of June 30, 2025, up from $127.1 million a year prior - Cash, Cash Equivalents and Investments in Marketable Securities: | Metric | June 30, 2025 (in millions) | June 30, 2024 (in millions) | YoY Change (in millions) | | :------------------------------------ | :-------------------------- | :-------------------------- | :----------- | | Cash, cash equivalents and investments | $167.9 | $127.1 | +$40.8 | Operating Expenses Total operating expenses increased year-over-year for both Q4 and the full fiscal year 2025, driven primarily by higher R&D expenditures related to clinical trials, manufacturing, and employee costs, as well as increased G&A expenses from professional fees and headcount - Total Operating Expenses: | Period | FY2025 (in thousands) | FY2024 (in thousands) | YoY Change (in thousands) | | :----- | :-------------------- | :-------------------- | :--------- | | Q4 | $25,850 | $23,102 | +$2,748 | | Full Year | $79,894 | $70,423 | +$9,471 | Research and Development (R&D) Expenses R&D expenses increased in both Q4 and the full fiscal year 2025, primarily due to higher clinical trial, manufacturing, and employee-related costs - Research and Development (R&D) Expenses: | Period | FY2025 (in thousands) | FY2024 (in thousands) | YoY Change (in thousands) | | :----- | :-------------------- | :-------------------- | :--------- | | Q4 | $20,863 | $19,089 | +$1,774 | | Full Year | $61,527 | $55,743 | +$5,784 | - The increase in R&D expenses was primarily due to increased expenditures in clinical trial activities, manufacturing costs for ersodetug, and higher employee-related expenses (including compensation and stock-based compensation)[8] General and Administrative (G&A) Expenses G&A expenses rose in both Q4 and the full fiscal year 2025, mainly driven by increased professional fees and employee-related costs due to higher headcount - General and Administrative (G&A) Expenses: | Period | FY2025 (in thousands) | FY2024 (in thousands) | YoY Change (in thousands) | | :----- | :-------------------- | :-------------------- | :--------- | | Q4 | $4,987 | $4,013 | +$974 | | Full Year | $18,367 | $14,680 | +$3,687 | - The increase in G&A expenses was primarily attributable to professional fees and employee-related expenses due to increased headcount[9] Net Loss and EPS Rezolute reported an increased net loss for both Q4 and the full fiscal year 2025, with basic and diluted net loss per common share also increasing year-over-year - Net Loss and Basic/Diluted Net Loss Per Common Share: | Metric | Period | FY2025 (in thousands) | FY2024 (in thousands) | YoY Change (in thousands) | | :----- | :----- | :-------------------- | :-------------------- | :--------- | | Net Loss | Q4 | $(24,390) | $(22,976) | $(1,414) | | Net Loss | Full Year | $(74,412) | $(68,459) | $(5,953) | | Basic and diluted net loss per common share | Q4 | $(0.26) | $(0.44) | +$0.18 | | Basic and diluted net loss per common share | Full Year | $(0.98) | $(1.33) | +$0.35 | Condensed Consolidated Financial Statements Data The condensed consolidated financial statements provide detailed data for the statements of operations and balance sheets, showing increases in total assets, working capital, and total stockholders' equity, alongside the reported losses and increased accumulated deficit - Condensed Consolidated Statements of Operations Data (Selected): | Metric | Three Months Ended June 30, 2025 (in thousands) | Three Months Ended June 30, 2024 (in thousands) | Year Ended June 30, 2025 (in thousands) | Year Ended June 30, 2024 (in thousands) | | :-------------------------- | :-------------------------------------- | :-------------------------------------- | :------------------------------------ | :------------------------------------ | | Research and development | $20,863 | $19,089 | $61,527 | $55,743 | | General and administrative | $4,987 | $4,013 | $18,367 | $14,680 | | Total operating expenses | $25,850 | $23,102 | $79,894 | $70,423 | | Loss from operations | $(25,850) | $(23,102) | $(79,894) | $(70,423) | | Non-operating income (expenses), net | $1,460 | $126 | $5,482 | $1,964 | | Net loss | $(24,390) | $(22,976) | $(74,412) | $(68,459) | | Basic and diluted net loss per common share | $(0.26) | $(0.44) | $(0.98) | $(1.33) | | Shares used to compute basic and diluted net loss per common share | 94,340 | 52,235 | 75,999 | 51,466 | - Condensed Consolidated Balance Sheets Data: | Metric | June 30, 2025 (in thousands) | June 30, 2024 (in thousands) | | :-------------------------------- | :--------------------------- | :--------------------------- | | Cash and cash equivalents | $94,107 | $70,396 | | Investments in marketable debt securities | $73,751 | $56,741 | | Working capital | $159,233 | $119,047 | | Total assets | $175,490 | $132,737 | | Accumulated deficit | $(403,856) | $(329,444) | | Total stockholders' equity | $162,127 | $121,003 | Product Information This section provides an overview of ersodetug, a fully human monoclonal antibody designed to treat hypoglycemia caused by hyperinsulinism About Ersodetug Ersodetug is a fully human monoclonal antibody designed to treat hypoglycemia caused by hyperinsulinism by allosterically binding to the insulin receptor, thereby decreasing over-activation and offering potential universal effectiveness across all forms of HI - Ersodetug is a fully human monoclonal antibody[11] - It binds allosterically to the insulin receptor to decrease receptor over-activation by insulin and related substances (such as IGF-2) in hyperinsulinism (HI), thereby improving hypoglycemia[11] - Ersodetug has the potential to be universally effective at treating hypoglycemia due to any congenital or acquired form of HI, as it acts downstream from the pancreas[11] Company Information This section offers a brief profile of Rezolute, Inc., emphasizing its mission as a late-stage rare disease company developing ersodetug for hyperinsulinism About Rezolute, Inc. Rezolute, Inc. is a late-stage rare disease company focused on hyperinsulinism-induced hypoglycemia, developing ersodetug, an antibody therapy that has demonstrated meaningful clinical benefit for both congenital and tumor HI - Rezolute is a late-stage rare disease company focused on treating hypoglycemia caused by hyperinsulinism (HI)[12] - The Company's antibody therapy, ersodetug, is designed to treat all forms of HI[12] - Ersodetug has shown meaningful benefit in clinical trials and real-world use for the treatment of both congenital and tumor HI[12] Legal and Investor Information This section includes important disclosures regarding forward-looking statements and provides contact details for investor relations inquiries Forward-Looking Statements This section contains standard forward-looking statements regarding prospective performance, strategies, and anticipated milestones, including trial results and ersodetug's effectiveness, and advises caution due to inherent uncertainties and risks detailed in SEC filings - The release contains forward-looking statements regarding prospective performance and strategies, covered by safe harbor provisions[14] - These statements include the timing of topline results from sunRIZE and upLIFT trials, ersodetug's applicability and effectiveness for hyperinsulinism, and clinical trial timelines[14] - Readers are cautioned that actual results may differ materially from anticipated results due to inherent uncertainties and factors discussed in SEC filings (e.g., Risk Factors in 10-K and 10-Q)[14] Contacts This section provides contact information for investor relations inquiries - Contact information for Rezolute, Inc. is provided for inquiries[15]