Rezolute Announces Q3 Fiscal 2024 Financial Results and Business Update

Rezolute, Inc., a clinical-stage biopharmaceutical company dedicated to developing innovative therapies for serious metabolic and rare diseases, has shared its financial results and provided a business update for the quarter ending March 31, 2024. The company is actively focusing on several key projects, particularly in the area of congenital hyperinsulinism (cHI) and diabetic macular edema (DME).

The company has made significant progress in its sunRIZE global Phase 3 clinical study of RZ358, aimed at treating patients with cHI. Patient enrollment is currently ongoing and is expected to be completed by the end of 2024, with topline results anticipated by mid-2025. Recently, an in-vivo toxicology study was conducted using brown Norway rats, revealing no abnormalities at the highest tested dose of 40 mg/kg. These findings support the notion that previous abnormalities observed in Sprague Dawley (SD) rats may not be relevant to other species, including humans.

In the United States, Rezolute is in discussions with the FDA to address partial clinical holds on the sunRIZE study. The company plans to submit additional data to the FDA this summer to support this effort.

In addition to cHI, Rezolute is exploring the potential of RZ358 for treating tumor hyperinsulinism (HI), including non-islet cell tumor hypoglycemia (NICTH) and insulinoma. To date, five metastatic insulinoma patients have been treated with RZ358 under the Expanded Access Program (EAP). The company is evaluating the initiation of a development program for this indication and expects to provide updates later in the year.

On the front of diabetic macular edema (DME), Rezolute has completed patient dosing for its Phase 2 multi-center clinical study in the U.S., involving 94 participants. The study aims to assess multiple primary endpoints, including stabilization of disease and changes in macular central subfield thickness and visual acuity, as well as the safety, tolerability, and pharmacokinetics of RZ402. The topline results of this study are expected in May 2024.

Financially, Rezolute reported cash, cash equivalents, and investments amounting to $81.6 million as of March 31, 2024, down from $118.4 million as of June 30, 2023. The company incurred research and development expenses of $12.4 million for the third quarter of fiscal 2024, a decrease from $14.2 million during the same period last year. This reduction is mainly due to a decrease in milestone expenses. General and administrative costs rose to $3.8 million from $2.9 million in the same quarter of the previous year, reflecting increased personnel-related expenses. The net loss for the third quarter of fiscal 2024 was $17.1 million, compared to $15.7 million for the same period a year ago.

Rezolute remains committed to developing transformative therapies for metabolic and rare diseases. By incorporating patient, clinician, and advocate voices into its drug development process, the company aims to improve outcomes and reduce the burden of treatment for patients and healthcare providers alike.