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EX - 99.1 2 krtx - ex99_1.htm EX - 99.1 Exhibit 99.1 Karuna Therapeutics Reports Third Quarter 2021 Financial Results and Provides General Business Update Topline data from the Phase 3 EMERGENT - 2 and EMERGENT - 3 trials expected in mid - 2022 and in the second half of 2022 , respectively 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 fourth quarter of 2021 Company plans to initiate a Phase 3 program evaluating KarXT for the treatment of psychosis in elderly patients with Alzheimer's disease in mid - 2022 $ 498.9 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 - Nov . 4 , 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 third quarter of 2021 and provided a general business update . " We continue to progress our late - stage clinical programs evaluating KarXT in schizophrenia , including the ongoing enrollment in our EMERGENT program , comprised of four Phase 3 trials , with topline data from the first trial expected in mid - 2022 , and the Phase 3 ARISE trial , which is on track to initiate by the end of the year , " said Steve Paul , M.D. , chief executive officer , president and chairman . “ This robust development program is a testament to our confidence in the novel mechanism of action of KarXT , as demonstrated by the compelling clinical data to date , and the promise it has to treat the multiple symptom domains of schizophrenia as both a monotherapy and an adjunctive therapy in adults who do not respond adequately to current standard of care . " " We have also advanced our efforts in dementia - related psychosis , with an initial focus on developing KarXT for Alzheimer's disease , the leading form of dementia in the U.S. Nearly half of those living with Alzheimer's disease experience symptoms of psychosis and related behavioral disturbances , such as agitation and aggression , which can negatively impact and disrupt day - to - day functioning of patients and caregivers alike . There is a dire need for an effective therapy that can alleviate these disabling symptoms , " added Dr. Paul . " We look forward to building on the encouraging data seen in an earlier Phase 2 study of xanomeline in treating and preventing symptoms of psychosis in Alzheimer's disease as we progress KarXT into late - stage clinical studies in mid - 2022 . " Pipeline Updates Karuna is advancing a pipeline of novel drug candidates for the treatment of various psychiatric and neurological conditions . The clinical pipeline is led by KarXT ( xanomeline - trospium ) , an oral investigational antipsychotic with a novel mechanism of action mediated via muscarinic cholinergic receptors , which is currently being evaluated in late - stage clinical trials as a potential treatment for schizophrenia and Alzheimer's disease psychosis . 0 KarXT for the treatment of psychosis in adults with schizophrenia . The EMERGENT program , the clinical program evaluating KarXT for the treatment of schizophrenia , is underway . The EMERGENT program includes the completed positive Phase 2 EMERGENT - 1 trial and four ongoing Phase 3 trials , including : 0 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. Enrollment for this trial began in December 2020 , with topline data expected mid - 2022 . 0