Page 1

EX - 99.1 2 d869241dex991.htm EX - 99.1 Ⓡ Karuna Therapeutics Reports First Quarter 2021 Financial Results and Provides General Business Update - Three Phase 3 trials – EMERGENT - 2 , EMERGENT - 3 and EMERGENT - 4 – evaluating KarXT for the treatment of psychosis in adults with schizophrenia are currently enrolling Exhibit 99.1 On track to complete third cohort in Phase 1b trial evaluating KarXT in healthy elderly volunteers in the second quarter of 2021 Patents granted on co - formulation compositions of KarXT , extending exclusivity through 2039 $ 571.3 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 KARUNA THERAPEUTICS BOSTON- May 6 , 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 first quarter of 2021 and provided a general business update . " This year is off to a very productive start , with the advancement of our early- and late - stage clinical programs , most notably the initiation and ongoing enrollment of three Phase 3 trials in our EMERGENT program , the clinical program evaluating KarXT , our lead product candidate , in schizophrenia , ” said Steve Paul , M.D. , chief executive officer , president and chairman . " We believe KarXT represents a major advance in the treatment of neuropsychiatric conditions , such as schizophrenia and dementia - related psychosis , where symptoms of psychosis are prominent and disabling . We look forward to furthering our journey to improve the lives of those living with these conditions . " Pipeline Updates KarXT ( xanomeline - trospium ) is an oral investigational antipsychotic with a novel mechanism of action mediated via muscarinic cholinergic receptors . KarXT is currently being evaluated as a potential treatment for psychiatric disorders , including schizophrenia and dementia - related psychosis . KarXT for the treatment of psychosis in adults with schizophrenia . The U.S. Food & Drug Administration has indicated that the previously completed positive Phase 2 five - week , inpatient safety and efficacy trial ( EMERGENT - 1 ) , one successful Phase 3 efficacy and safety trial , and additional safety data would be acceptable to support a New Drug Application ( NDA ) filing in schizophrenia . The Phase 3 EMERGENT - 2 , EMERGENT - 3 and EMERGENT - 4 trials are currently enrolling . The Phase 3 EMERGENT - 5 trial remains on track to initiate in the second quarter of 2021 . ● The EMERGENT program includes the following Phase 3 trials : EMERGENT - 2 : A five - week inpatient trial evaluating the efficacy and safety of KarXT compared to placebo in 246 adults with schizophrenia in the U.S. 1 EMERGENT - 3 : A five - week inpatient trial evaluating the efficacy and safety of KarXT compared to placebo in 246 adults with schizophrenia in the U.S. and Ukraine .