Rezolute Enters $30 Million Debt Agreement to Advance Rare and Metabolic Disease Pipeline

Rare Daily Staff

Rezolute said it has entered into a $30 million debt financing agreement with investment affiliates managed by SLR Capital Partners.

Fifteen million of the $30 million loan was funded upon closing with an interest only period of 24 months. The remaining $15 million may be funded upon Rezolute achieving certain predetermined milestones and conditions.

“The access to capital provided by this facility gives Rezolute non-dilutive operational flexibility as we continue advancing our pipeline,” said Nevan Elam, chief executive officer of Rezolute.

Rezolute will use the funds to advance its pipeline of targeted therapies for rare, metabolic, and life-threatening diseases. Its lead product candidate, RZ358, is in phase 2b development as a potential treatment for congenital hyperinsulinism (HI), an ultra-rare, genetic, endocrine disorder in which the pancreas secretes excess insulin.

Caused by at least 10 known genetic mutations, congenital HI appears in 1 in 25,000 to 1 in 50,000 live births, with a greater prevalence in certain populations such as among Ashkenazi Jews. Congenital HI is characterized by excess insulin secretion, which causes repeated episodes of low blood sugar, or hypoglycemia. The condition often goes unnoticed in infants, putting them at risk of complications of recurring hypoglycemic events, including developmental delays, seizures, coma and even death.

There are currently no approved therapies specifically for congenital HI and existing medical options are often sub-optimal, ineffective in some groups, or associated with substantial side effects that discourage compliance.

RZ358, a human monoclonal antibody, is designed to restore healthy levels of insulin action. The drug binds to an allosteric site on the insulin receptor to counteract the effects of elevated insulin at its target tissues by diminishing the binding and downstream signaling of insulin at its receptor. This unique mechanism of action gives properties of reversibility and graded activity, which are dependent on the extent of insulin elevation.

RZ358 has received both Orphan Drug and Rare Pediatric Disease designations from the U.S. Food and Drug Administration.

Rezolute’s pipeline also includes RZ402, an orally available plasma kallikrein inhibitor in phase 1 development as a potential treatment for diabetic macular edema.

Photo: Nevan Elam, chief executive officer of Rezolute