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Impel NEUROPHARMA Impel NeuroPharma Announces Second Quarter 2021 Financial Results and Provides Corporate Update August 16 , 2021 TRUDHESA TMNew Drug Application ( NDA ) Under Review by U.S. Food & Drug Administration ( FDA ) with PDUFA Target Action Date of September 6 , 2021 Preparations On Track for Potential TRUDHESA Launch in the Fourth Quarter of 2021 Increased Cash Position and Extended Runway through 2022 Following $ 50 Million Debt Facility Agreement with Oxford Finance LLC and Silicon Valley Bank Impel to Host Investor Conference Call Today at 8:30 a.m. ET SEATTLE , Aug. 16 , 2021 ( GLOBE NEWSWIRE ) -- Impel NeuroPharma ( NASDAQ : IMPL ) , a late - stage pharmaceutical company focused on utilizing its proprietary technology to develop and commercialize transformative therapies for people suffering from diseases with high unmet needs , with an initial focus on diseases of the CNS , today reported financial results for the second quarter ended June 30 , 2021 and provided a corporate update . " The first half of 2021 has been marked by significant milestones , which we believe have positioned Impel well for a successful commercial launch of TRUDHESA ™ in the fourth quarter , subject to regulatory approval . In addition , our pre - launch activities together with ongoing interactions with patients and healthcare providers continue to reinforce our view that significant unmet needs remain in the treatment of acute migraine , " said Adrian Adams , chairman and chief executive officer of Impel NeuroPharma . " Following the recent closing of our debt financing agreement , we are confident that Impel's strengthened balance sheet will provide us not only with the resources for a successful launch of TRUDHESA , but also the continued development of INP105 for the potential treatment of agitation and aggression in autism . " Recent Corporate Highlights : • On August 6 , the Company hosted a virtual key opinion leader ( KOL ) event to review the evolving role of DHE in the treatment of acute migraine . The event featured presentations from guest speakers Dr. Nada Hindiyeh , Assistant Professor of neurology and neurological systems at Stanford Medical School , Dr. Wade Cooper , Director of Headache and Neuropathic Pain at the University of Michigan School of Medicine , Dr. Stewart Tepper , Director of Dartmouth Headache Center at the Geisel School of Medicine and Impel NeuroPharma management . The event presentation and webcast recording can be accessed here . • In July , the Company announced the closing of a $ 50 million debt facility with Oxford Finance LLC and Silicon Valley Bank , of which the first $ 20 million was funded at closing . The initial $ 20 million tranche extends Impel's expected cash runway through 2022 . • The Company's 505 ( b ) ( 2 ) New Drug Application ( NDA ) for TRUDHESA for the treatment of acute migraine headaches with or without aura in adults is under review by the FDA with a PDUFA target action date of September 6 , 2021 . • Results from the pivotal Phase 3 STOP 301 study , which met its primary objectives , with no new safety signals or concerning trends in nasal safety findings observed for TRUDHESA , were presented at the 63RD American Headache Society Annual Scientific Meeting ( AHS ) and published in Headache : The Journal of Head and Face Pain . Second Quarter 2021 Financial Results : • Research and Development ( R & D ) Expenses : Research and development expenses for the second quarter of 2021 were $ 6.1 million , which compares with $ 6.8 million for the second quarter of 2020. The decrease in R & D spending was due primarily to a decrease in clinical costs post the completion of the TRUDHESA Phase 3 trial . • General and Administrative ( G & A ) Expenses : General and administrative expenses for the second quarter of 2021 were $ 8.9 million , which compares with $ 6.1 million for the second quarter of 2020. The increase in G & A was due primarily to the ramp up in commercial expenses related to pre - launch activities ahead of the TRUDHESA launch . • Net Loss : For the second quarter of 2021 , Impel reported a net loss of $ 15.5 million , compared to a net loss of $ 13.1