Rezolute(RZLT) - 2025 Q3 - Quarterly Results

Business and Pipeline Update Rezolute is advancing its HI clinical programs, including the sunRIZE study and a new registrational study for tumor HI, supported by a recent $97 million financing Pipeline Progress and Anticipated Milestones The company's clinical pipeline is progressing with key milestones for its hyperinsulinism drug, ersodetug, including Phase 3 study completion and Breakthrough Therapy Designation - The Phase 3 sunRIZE study for congenital HI is expected to complete enrollment in May 2025, with topline results anticipated in December 2025[1][5] - In May 2025, the FDA granted Breakthrough Therapy Designation (BTD) to ersodetug for treating hypoglycemia due to tumor HI, based on clinical data and real-world evidence from the Expanded Access Program[1][5] - A registrational study for tumor HI, named "upLIFT", is planned to start in mid-2025, with topline data expected in the second half of 2026[10] - An independent Data Monitoring Committee recommended the continuation of the sunRIZE study as planned without increasing the sample size following an interim analysis in April 2025[5] Corporate Updates Recent corporate developments include a successful financing round and a key board appointment to enhance commercialization expertise - In April 2025, the company closed an underwritten offering that raised approximately $97 million, extending its cash runway to the middle of 2027[10] - Appointed Erik Harris, Chief Commercial Officer at Ultragenyx, to its Board of Directors in March 2025 to provide commercialization expertise[10] Fiscal Third Quarter 2025 Financial Results Rezolute reported an increased net loss of $18.9 million for Q3 FY2025 due to higher operating expenses, with cash reserves at $88.4 million Financial Performance (Statement of Operations) The company's operating expenses and net loss increased in Q3 FY2025 compared to the prior year, driven by higher R&D and G&A costs Operating Metrics (Three Months Ended March 31) | Operating Metric | Three Months Ended Mar 31, 2025 ($ Millions) | Three Months Ended Mar 31, 2024 ($ Millions) | Change (YoY) (%) | | :--- | :--- | :--- | :--- | | Research and development | 15.3 | 12.4 | +23.4 | | General and administrative | 4.7 | 3.8 | +23.7 | | Total operating expenses | 20.0 | 16.2 | +23.5 | | Net loss | 18.9 | 17.1 | +10.5 | | Net loss per common share | 0.27 | 0.34 | N/A | Financial Position (Balance Sheet) The company's cash, cash equivalents, and investments decreased to $88.4 million as of March 31, 2025, impacting total assets and stockholders' equity Balance Sheet Highlights | Balance Sheet Item | As of March 31, 2025 ($ Millions) | As of June 30, 2024 ($ Millions) | | :--- | :--- | :--- | | Cash, cash equivalents and investments | 88.4 | 127.1 | | Total assets | 94.7 | 132.7 | | Total stockholders' equity | 82.6 | 121.0 | Company and Product Overview Rezolute is a late-stage rare disease company focused on developing treatments for hypoglycemia caused by hyperinsulinism (HI) with its primary drug candidate, ersodetug About Ersodetug Ersodetug is a fully human monoclonal antibody designed to treat hypoglycemia by reducing insulin receptor over-activation, making it potentially effective for all forms of hyperinsulinism - Ersodetug is a fully human monoclonal antibody that binds allosterically to the insulin receptor[11] - It is designed to decrease receptor over-activation by insulin and related substances (like IGF-2) to improve hypoglycemia[11] - Due to its mechanism of acting downstream from the pancreas, it has the potential to be universally effective for treating hypoglycemia from any congenital or acquired form of hyperinsulinism (HI)[11] About Rezolute, Inc. Rezolute, Inc. is a late-stage rare disease company specializing in developing treatments for hypoglycemia caused by hyperinsulinism - Rezolute is a late-stage rare disease company with a focus on treating hypoglycemia caused by hyperinsulinism (HI)[12]