Rezolute 'Thrilled' With Positive Review Of Genetic Disorder Trial, Expects Topline Results In December -

Rezolute, Inc. (NASDAQ:RZLT) on Wednesday announced the Independent Data Monitoring Committee’s (DMC) recommendation to continue the Phase 3 sunRIZE study as planned in patients with congenital hyperinsulinism (HI) without increasing the study sample size.

HI is a genetic disorder in which the insulin cells of the pancreas, called beta cells, secrete too much insulin.

“We are thrilled with the DMC’s favorable recommendation, which appears to validate our initial assumptions for the design and powering of the Phase 3 sunRIZE study,” Rezolute Chief Medical Officer Brian Roberts said. “While we remain blinded to the partial study data and are not privy to any of the statistical outputs from the DMC, we are nevertheless encouraged by this recommendation considering past outcomes from the Phase 2 RIZE study with the same objectively measured glycemic primary endpoint, real-world observations from our Expanded Access Program, and previously announced pharmacokinetic data from the open-label arm of the sunRIZE study.”

Also Read: FDA Gives Green Signal To Rezolute’s Genetic Disorder Treatment

The company says it is on track to complete enrollment in May, with topline results anticipated in December 2025.

An unblinded DMC performed the interim analysis of the Phase 3 sunRIZE study. It was based on a pre-specified analysis of the primary study endpoint (hypoglycemia events) after approximately half of the enrolled patients completed the primary assessments.

The analysis was intended to evaluate for study futility or otherwise to inform a potential sample size increase, optimizing the study power and statistical confidence in the final analysis outcomes.

On Wednesday, Rezolute priced an underwritten offering of 20.8 million at $3.25 per share and pre-funded warrants to purchase up to 6.91 million at $3.2490 per pre-funded warrant, with approximately $90 million gross proceeds.

Rezolute will use the net proceeds from the offering for research and development, general corporate expenses, and working capital needs.

Price Action: RZLT stock is up 25.7% at $3.91 at the last check Wednesday.

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