Rare Daily Staff

Rezolute raised $55 million to fund development of a pipeline focused on metabolic diseases related to chronic glucose imbalance.

The company priced an underwritten public offering of 6 million shares of its common stock at a public offering price of $6.50 per share and of pre-funded warrants to purchase 1.7 million shares of its common stock at $6.49 per pre-funded warrant. In addition, Rezolute priced a concurrent registered direct offering to certain institutional investors that are current shareholders of 769,231 shares of its common stock at a public offering price of $6.50 per share.

Rezolute has granted the underwriters a 30-day option to purchase up to an aggregate of 1.2 million additional shares of its common stock in the underwritten public offering at $6.50 per share, before underwriting discounts and commissions.

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.

Congenital HI is caused by at least 10 known genetic mutations. It 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.

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