Material Event (Form 8-K)

Item 8.01 Other Events.

On May 29, 2026, we announced that the U.S. Food and Drug Administration (FDA) approved Afrezza®(insulin human) Inhalation Powder for use in children and adolescents aged 6 and older living with type 1 and type 2 diabetes. In the United States, more than 350,000 children and adolescents are living with diabetes, the majority of whom have type 1 diabetes and require lifelong insulin therapy.

The FDA also stated that the supplemental biologics license application for the pediatric indication has fulfilled the last remaining postmarketing requirement for Afrezza as set forth in the original June 27, 2014 approval letter.