On September 19, 2024 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, reported financial results and provided a business update for the fourth quarter and full fiscal year ended June 30, 2024 (Press release, Rezolute, SEP 19, 2024, View Source [SID1234646750]).
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"We are thrilled to close out the year with FDA alignment to advance ersodetug in two Phase 3 rare disease programs for the treatment of hypoglycemia resulting from congenital and acquired forms of hyperinsulinism," said Nevan Elam, Chief Executive Officer and Founder of Rezolute. "The Phase 3 sunRIZE study remains on track for ex-U.S. participant enrollment and we expect U.S. enrollment to begin in the first part of 2025. We look forward to progressing both Phase 3 studies and remain excited at the prospect of ersodetug as a best-in-class treatment for hyperinsulinism based on the success we’ve seen to date."
Recent Pipeline Progress and Anticipated Milestones
Congenital HI
U.S. Food and Drug Administration (FDA) removal of partial clinical holds on ersodetug, a potential treatment for hypoglycemia caused by congenital HI, and authorization of U.S. inclusion in the ongoing Phase 3 sunRIZE study.
Commencing study start-up activities in the U.S. with the goal of including U.S. participants in early 2025.
Ex-U.S. patient enrollment in sunRIZE is on track.
Topline results from sunRIZE expected in the second half of 2025.
Tumor HI
FDA clearance of Investigational New Drug (IND) application for Phase 3 registrational study for ersodetug for the treatment of hypoglycemia caused by tumor HI.
Start-up activities are ongoing for the study, which will be primarily conducted in the U.S., with patient enrollment anticipated to begin in the first half of 2025.
Topline results expected in the second half of 2026.
Several insulinoma patients have been treated with ersodetug in the Expanded Access Program (EAP).
Diabetic Macular Edema (DME)
Announced positive topline results in May of 2024 from the Phase 2 proof-of-concept study of RZ402 in patients with DME.
The study met primary endpoints, demonstrating good safety and tolerability, and a significant reduction in central subfield thickness (CST) in the Study Eye at all RZ402 dose levels compared to placebo (up to approximately 50 micron improvement).
We are actively engaged in conversations with potential partners to take RZ402 into further development.
Fourth Quarter and Full Year Fiscal 2024 Financial Results
Cash, cash equivalents and investments in marketable securities were $127.1 million as of June 30, 2024, compared with $118.4 million as of June 30, 2023.
Research and development (R&D) expenses were $19.1 million for the fourth quarter of fiscal 2024, compared with $10.9 million for the same period a year ago. Full fiscal year 2024 R&D expenses were $55.7 million, compared to $43.8 million in fiscal year 2023. The increase from fiscal year 2023 to fiscal year 2024 was primarily due to (i) increased expenditures in clinical trial activities, (ii) manufacturing costs for ersodetug, (iii) milestone payments due to license agreement partners, and (iv) higher employee-related expenses, which included employee compensation and stock-based compensation.
General and administrative (G&A) expenses were $4.0 million for the fourth quarter of fiscal 2024, compared with $3.3 million for the same period a year ago. Full fiscal year 2023 G&A expenses were $14.7 million, compared to $12.2 million in fiscal year 2023. The increase was primarily attributable to employee-related expenses due to increased headcount and professional fees.
Net loss was $23.0 million for the fourth quarter of fiscal 2024 compared with a net loss of $12.7 million for the same period a year ago. Full year fiscal 2024 net loss was $68.5 million compared to net loss of $51.8 million for the fiscal year 2023.
About Ersodetug
Ersodetug is a fully human monoclonal antibody that binds to a unique allosteric site on insulin receptors to counteract the effects of insulin receptor over-activation by insulin and related substances (such as IGF-2), thereby improving hypoglycemia in the setting of hyperinsulinism (HI). Because ersodetug acts downstream from the pancreas, it has the potential to be universally effective at treating hypoglycemia due to any form of HI.
About sunRIZE
The Phase 3 sunRIZE study is a multi-center, randomized, double-blind, placebo-controlled, parallel arm study designed to evaluate the efficacy and safety of ersodetug in patients with congenital HI who are experiencing poorly controlled hypoglycemia. Participants between the ages of 3 months to 45 years old are eligible to participate. The study is enrolling up to 56 participants in more than a dozen countries around the world.