Material Event (Form 8-K)

Item 8.01 Other Events.

Regulatory Update

In connection with the approval of the Biologics License Application ("BLA") for Afrezza in June 2014, the U.S. Food and Drug Administration ("FDA") required us to conduct a five-year, randomized, controlled trial in 8,000-10,000 patients with type 2 diabetes to assess the risk of pulmonary malignancy observed with Afrezza to that observed in a standard of care control group.

On May 27, 2026, the FDA informed us that we were released from this postmarketing requirement.

The only remaining postmarketing requirement for Afrezza is an assessment of its efficacy and safety in pediatric patients. In October 2025, the FDA accepted for review a supplemental BLA for Afrezza in children and adolescents between the ages of 4-17 who are living with type 1 or type 2 diabetes, with a PDUFA target action date of May 29, 2026.

Clinical Update

INHALE-1st: An additional eight sites have been activated to enroll participants into INHALE-1st, a study to evaluate the efficacy and safety of Afrezza plus basal insulin for youth aged 10-17 with newly-diagnosed type 1 diabetes. Up to 100 participants are expected to be enrolled in this study across 10 clinical sites. This single-arm, multi-center, clinical study will follow participants for 13 weeks during the main phase followed by an optional extension phase for participants continuing to use Afrezza in combination with basal insulin for up to 26 weeks. The primary endpoint is the percentage of participants with a continuous glucose meter who measured time in range of 70-180 mg/dL ≥70% during 14 days prior to the 13-week visit. Data from this study is expected to be available in late 2027.