On November 7, 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 three months ended September 30, 2024 (Press release, Rezolute, NOV 7, 2024, View Source [SID1234647969]).
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"Execution across our two Phase 3 programs in patients with congenital HI and tumor HI will be the focus going into 2025," said Nevan Elam, Chief Executive Officer and Founder of Rezolute. "We are pleased with the progress we’ve made in sunRIZE enrollment and look forward to advancing our Phase 3 study in tumor HI patients based on the success demonstrated in our Expanded Access Program. As a rare disease company with two late-stage clinical trials, we recognize how critical 2025 will be in progressing our programs in order to provide a potentially meaningful therapy for patients where limited options currently exist."
Recent Pipeline Progress and Anticipated Milestones
Congenital HI
· Ex-U.S. patient enrollment in sunRIZE, a global, pivotal Phase 3 clinical study for ersodetug in patients with congenital HI, is on track.
· Study start-up activities are underway for enrollment of U.S. participants in early 2025.
· Topline results from sunRIZE expected in the second half of 2025.
Tumor HI
· Start-up activities are progressing for the Phase 3 registrational study for ersodetug in patients with tumor HI.
· Patient enrollment anticipated to begin in the first half of 2025.
· Topline results expected in the second half of 2026.
Fiscal First Quarter Financial Results
Cash, cash equivalents and investments in marketable securities were $117.8 million as of September 30, 2024, compared to $127.1 million as of June 30, 2024.
Research and development expenses were $12.8 million for the first quarter of fiscal 2025, compared with $12.2 million for the same period a year ago, with the increase primarily attributable to increased expenditures in clinical trial activities, manufacturing costs and higher personnel-related expenses, which include employee compensation.
General and administrative expenses were $4.2 million for the first quarter of fiscal 2025, compared with $3.7 million for the same period a year ago, with the increase primarily attributable to professional fees and employee-related expenses as a result of increased headcount.
Net loss was $15.4 million for the first quarter of fiscal 2025 compared with a net loss of $14.5 million for the same period a year ago.
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.