On November 13, 2023 Rezolute, Inc. (Nasdaq: RZLT), a clinical-stage biopharmaceutical company committed to developing novel, transformative therapies for serious metabolic and rare diseases, reported its financial results for the first quarter of fiscal 2024 ended September 30, 2023 (Press release, Rezolute, NOV 13, 2023, View Source [SID1234639828]).

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"We are on track to commence our Phase 3 study for RZ358 to treat congenital hyperinsulinism prior to year-end and are delighted to have recently obtained PRIME eligibility from the European Medicines Agency for this indication," said Nevan Charles Elam, Chief Executive Officer and Founder of Rezolute. "We also anticipate completing enrollment this quarter for our ongoing Phase 2 study of RZ402 for the treatment of diabetic macular edema and plan to provide an update on the study prior to year end."

Clinical Highlights

· RZ358, a monoclonal antibody for the treatment of hyperinsulinism
o Received EMA priority medicines (PRIME) designation for the treatment of congenital hyperinsulinism (cHI) from the European Medicines Agency
o Plan to initiate sunRIZE, a pivotal Phase 3 clinical study in patients with cHI, in Europe and other geographies outside the US in the fourth quarter 2023
o Continuing the administration of RZ358 in the US with FDA approval under a compassionate use program to treat patients with tumor associated hyperinsulinism, including for a patient with refractory hypoglycemia due to metastatic insulinoma who has remained on RZ358 for nearly a year

· RZ402, an oral plasma kallikrein inhibitor in Phase 2 to treat diabetic macular edema (DME)
o Multi-center, randomized, double-masked, placebo-controlled, parallel-arm study ongoing to evaluate the safety, efficacy, and pharmacokinetics of RZ402 administered as a monotherapy over a 12-week treatment period in participants with DME who are naïve to or have received limited anti-VEGF injections
o Study is in the latter stages of patient recruitment and an update on the study will be provided prior to year end

First Quarter Fiscal 2024 Financial Results

· Cash, cash equivalents and investments in marketable debt securities totaled $106.9 million as of September 30, 2023, compared to $118.4 million as of June 30, 2023

· Research and development expenses were $12.2 million for the first quarter of fiscal 2024, compared to $7.7 million for the same period in fiscal 2023, with the increase primarily attributable to increased expenditures in clinical trial activities, manufacturing costs and higher personnel-related expenses, which included employee compensation and stock-based compensation

· General and administrative expenses were $3.7 million for the first quarter of fiscal 2024, compared to $2.5 million for the same period in fiscal 2023, with the increase primarily attributable to higher personnel-related expenses, including employee compensation and stock-based compensation

· Net loss was $14.5 million for the first quarter of fiscal 2024, compared to $9.8 million for the same period in fiscal 2023