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Apnimed Reports Second Quarter 2026 Financial Results and Provides Corporate Update • EX - 99.1 U.S. Food and Drug Administration ( " FDA " ) Accepted the NDA for AD109 , with a proposed proprietary name Oxnimbi ™ , and assigned a PDUFA target action date of February 28 , 2027 If approved , Oxnimbi has the potential to become the first oral pharmacologic therapy designed to address the neuromuscular root cause of upper airway collapse for the millions of people living with OSA Strengthened the Company's leadership team with several key appointments Completed its upsized initial public offering for gross proceeds of $ 220.8 million and its common stock began trading on the Nasdaq Global Select Market CAMBRIDGE , Mass . , September 8 , 2026 - Apnimed , Inc. ( Nasdaq : APMD ) ( " Apnimed " ) , a late stage clinical pharmaceutical company dedicated to the discovery , development and commercialization of novel oral therapies that address the neurobiology of sleep - related breathing diseases , today announced its financial results for the second quarter ended June 30 , 2026 , and provided a corporate update . " This was a highly productive quarter for Apnimed as we continued to execute against our strategy , highlighted by the FDA's acceptance of our NDA for AD109 ( proposed proprietary name Oxnimbi ) , with a PDUFA target action date of February 28 , 2027 , " said Kevin Lind , Chief Executive Officer of Apnimed . " Over the past several months , we have significantly strengthened our financial position , including through the successful completion of our IPO , providing us with additional resources as we prepare for the potential commercialization of Oxnimbi , pending approval . With this strengthened financial position , we are advancing our commercial readiness activities and building the capabilities needed to support a potential U.S. launch . With an estimated 80 million people in the U.S. living with OSA , many of whom remain untreated , we believe Oxnimbi has the potential to address the scale of unmet need in OSA and , if approved , represents a significant commercial opportunity for Apnimed . " Recent Highlights and Upcoming Milestones Announced the FDA accepted for review the New Drug Application ( " NDA ” ) for AD109 ( proposed proprietary name Oxnimbi ) for the treatment of adults with obstructive sleep apnea ( " OSA " ) . The FDA has assigned a Prescription Drug User Fee Act ( " PDUFA ” ) target action date of February 28 , 2027 . Presented a broad body of data and research at both ATS 2026 and SLEEP 2026 , including pooled analyses of the SynAIRgy and LunAIRO Phase 3 trials of Oxnimbi , reflecting one of the largest clinical development programs conducted for an OSA pharmacotherapy , as well as research highlighting the significant unmet need in OSA . Simultaneously published two peer - reviewed articles on Oxnimbi , including results from the Phase 3 SynAIRgy trial in the American Journal of Respiratory and Critical Care Medicine and a companion mechanistic review article in the American Journal of Respiratory Cell and Molecular Biology . Strengthened the Company's leadership team with the appointments of Kevin Lind as Chief Executive Officer , Michael Kelly as Chief Financial Officer and Steven Spector as Chief Legal Officer and Head of Corporate Affairs as part of a planned leadership transition . Completed two financing transactions to support commercial readiness and the potential U.S. launch of Oxnimbi , if approved by the FDA , including an upsized initial public offering for gross proceeds of $ 220.8 million and a senior secured credit facility for up to $ 150 million with funds managed by HealthCare Royalty Partners .