PRODUCTAD109

AD109 is an oral, once-nightly, fixed-dose combination of atomoxetine and aroxybutynin designed to address neuromuscular dysfunction in patients with mild, moderate, and severe obstructive sleep apnea (OSA). By synergistically stimulating the hypoglossal motor nucleus, AD109 increases upper airway muscle tone across sleep stages, reducing the risk of airway collapse. Apnimed is currently preparing an NDA for AD109 and remains on track for submission in 2Q 2026. If approved, AD109 would become the first oral therapy targeting the underlying cause of airway collapse in OSA.

OSA is the most common sleep-related breathing disorder, characterized by repeated episodes of complete (apnea) or partial (hypopnea) upper airway collapse during sleep. Up to 80 million individuals in the U.S. are affected, yet existing non-surgical treatments – such as overnight devices – are often cumbersome and poorly adhered to. With an estimated 10 million patients underutilizing, discontinuing, or refusing therapy, AD109 represents a significant opportunity for a safe and effective pharmacological solution that addresses the root cause of sleep apnea.

Background

HealthCare Royalty provided Apnimed, Inc. with a credit facility of up to $150 million, including $50 million funded at closing, with a low single-digit synthetic royalty financing on net sales of AD109. This financing provides meaningful capital to extend Apnimed’s cash runway and support the NDA submission and future commercialization of AD109.