Rezolute’s ersodetug advances in pediatric study

REDWOOD CITY, Calif. - Rezolute , Inc. (NASDAQ:RZLT), a biopharmaceutical company with a market capitalization of $303.62 million and impressive recent momentum (up 13.91% in the past week), announced that its Phase 3 study of ersodetug has reached a critical milestone with the independent Data Monitoring Committee (DMC) approving the enrollment of infants into the double-blind portion of the sunRIZE study. According to InvestingPro data, the company maintains a strong financial health score, particularly noteworthy for a clinical-stage biotech company. Ersodetug is being evaluated for the treatment of hypoglycemia due to congenital hyperinsulinism (HI).

The open label arm of the study, involving infants aged 3 months to 1 year, has been completed with the DMC confirming that the target drug concentrations were safely achieved at the tested doses. The review did not encompass glycemic efficacy, and the company remains blinded to these results.

The DMC found that ersodetug was generally safe and well-tolerated in the young participants, with drug levels comparable to those in older children from a previous Phase 2b study. The safety profile and drug exposures support the dose regimen of 5 and 10 mg/kg administered bi-weekly and monthly. InvestingPro analysis reveals that Rezolute maintains a healthy balance sheet with more cash than debt and a strong current ratio of 13.79, providing sufficient runway for its clinical development programs.

Chief Medical (TASE:PMCN) Officer at Rezolute, Dr. Brian Roberts, expressed optimism about the preliminary outcomes and the potential of ersodetug, especially following the recent FDA Breakthrough Therapy Designation. The company anticipates completing enrollment for the sunRIZE study in the second quarter of 2025, with topline results expected in the fourth quarter of 2025, depending on the upcoming interim analysis (IA) by the DMC.

The IA, scheduled for the end of this quarter, will evaluate the sample size for the primary endpoint and may suggest adjustments. The DMC will consider three possible outcomes: stopping the study for futility, continuing as planned, or increasing the sample size by 33% to enhance statistical confidence. An increase in sample size would delay study completion to the fourth quarter of 2025, with results by mid-2026.

Congenital HI is a leading cause of persistent hypoglycemia in children, which can lead to severe brain injury or death if not managed properly. Ersodetug, a fully human monoclonal antibody, is designed to treat all forms of HI by normalizing insulin receptor signaling.

Rezolute is focused on advancing treatments for rare diseases with significant unmet needs. The sunRIZE Phase 3 study is a randomized, double-blind, placebo-controlled trial, enrolling participants across multiple countries to assess the efficacy and safety of ersodetug. Wall Street appears optimistic about the company’s prospects, with analyst price targets ranging from $8 to $16 per share. For deeper insights into Rezolute’s financial health and growth potential, investors can access comprehensive analysis through InvestingPro, which offers exclusive ProTips and detailed research reports covering over 1,400 US stocks.

This article is based on a press release statement from Rezolute, Inc. and does not contain any promotional content.

In other recent news, Rezolute, Inc. has made significant strides in their ongoing clinical trials, including the release of a patient’s testimonial from their Phase 2 clinical study, which is available on the company’s website. Additionally, the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation to Rezolute’s ersodetug (RZ358) for the treatment of hypoglycemia due to congenital hyperinsulinism. This decision was influenced by positive outcomes from the Phase 2b (RIZE) study and the company plans to announce top-line results from the ongoing global Phase 3 sunRIZE study later this year.

Investment firms including BTIG, Craig-Hallum, Jones Trading, and H.C. Wainwright have all maintained a Buy rating on Rezolute, influenced by the FDA’s recent decisions and the positive results from a Phase 2 trial of RZ402, a potential treatment for diabetic macular edema.

Rezolute has also announced a significant change to its capital structure, following shareholder approval to increase its authorized common stock from 100 million to 165 million shares. Furthermore, the FDA has lifted the partial clinical holds on Rezolute’s pivotal trial for ersodetug, allowing the company to proceed with clinical trials for patients older than 3 months.

Finally, Rezolute’s fiscal fourth quarter of 2024 concluded with $127.1 million in cash and equivalents, and the company recently raised approximately $67 million in gross proceeds from an additional stock offering. These funds are anticipated to support its operations into the second quarter of 2026.

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