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EX - 99.1 2 d212727dex991.htm EX - 99.1 Exhibit 99.1 Karuna Therapeutics Reports Second Quarter 2021 Financial Results and Provides General Business Update All Phase 3 trials in the EMERGENT clinical program evaluating KarXT for the treatment of psychosis in adults with schizophrenia are enrolling Topline data from the Phase 3 EMERGENT - 2 trial expected mid - 2022 On track to initiate the Phase 3 ARISE trial evaluating KarXT in adults with schizophrenia who inadequately respond to current standard of care in the second half of 2021 Plan to initiate a Phase 2 trial evaluating KarXT in dementia - related psychosis in the first half of 2022 $ 543.6 million in cash expected to fund operations , including multiple milestones , for at least 12 months following the potential New Drug Application ( NDA ) submission of KarXT in schizophrenia BOSTON- August 5 , 2021— Karuna Therapeutics , Inc. ( NASDAQ : KRTX ) , a clinical - stage biopharmaceutical company driven to create and deliver transformative medicines for people living with psychiatric and neurological conditions , today announced financial results for the second quarter of 2021 and provided a general business update . " The second quarter was an exciting one for Karuna as we've made important progress in advancing our mid- and late - stage clinical trials studying our lead asset , KarXT , across multiple indications to drive innovation in the treatment of schizophrenia and dementia - related psychosis , " said Steve Paul , M.D. , chief executive officer , president and chairman . “ All four Phase 3 trials in the EMERGENT program evaluating KarXT in schizophrenia are now enrolling , with completion of the first trial , EMERGENT - 2 , expected mid - 2022 . We also plan to evaluate KarXT in adults with schizophrenia who inadequately respond to atypical antipsychotics in a Phase 3 trial initiating later this year . " " We plan to advance KarXT into a Phase 2 clinical trial for the treatment of dementia - related psychosis in the first half of 2022 following encouraging results from our completed Phase 1b healthy elderly volunteer trial which suggest that potentially therapeutic doses of KarXT can be administered to elderly adults while maintaining a favorable tolerability profile , " Dr. Paul commented further . " We are pleased with the breadth of milestones we've achieved in the first half of 2021 , including significant growth across our organization , all of which we believe contribute to laying a strong foundation for the company as we seek to push the boundaries of neuroscience to transform mental illness . " 1