Impel NeuroPharma provided updates on Trudhesa™ (dihydroergotamine mesylate) nasal spray (0.725 mg per spray) launch progress and recent business highlights. In addition, during this first quarter of launch, the Company has secured contracts with several leading pharmacy benefit managers (PBMs) in the U.S. which cover approximately 80% of U.S. commercial lives. Impel is the first company to harness the benefits of delivery to the upper nasal space to improve the therapeutic potential of CNS therapies.

Using Impel's proprietary POD® technology, Trudhesa delivers dihydroergotamine mesylate (DHE) "a proven, well-established therapeutic for acute migraine for adults "quickly to the bloodstream through the vascular-rich upper nasal space. Trudhesa bypasses the gut and reduces potential absorption issues, offering rapid, sustained, and consistent symptom relief without injection or infusion, even when administered hours after the onset of a migraine attack. Impel continues to advance its combination product candidate, INP105, an intranasal olanzapine product (a widely used atypical, second-generation antipsychotic) being developed as an acute treatment for agitation in persons with autism spectrum disorder (ASD) via Impel's POD® technology.

Since filing the investigational new drug (IND) application in November of last year, the Company has been working with the U.S. Food and Drug Administration (FDA) to finalize the Phase 2a proof-of-concept clinical protocol and anticipates the study will start in first quarter 2022 with a data readout anticipated in fourth quarter 2022.