Earnings release
Page 1
cerevel Cerevel Therapeutics Reports First Quarter 2021 Financial Results and Business Updates May 17 , 2021 Announced strategic $ 125 million non - dilutive financing for tavapadon Welcomed Abraham Ceesay as President Appointed Scott Akamine as Chief Legal Officer Phase 1b trial for CVL - 231 in schizophrenia on track for data mid - year 2021 Phase 1 acute anxiety data for darigabat now expected in the fourth quarter of 2021 Conference call and webcast scheduled for today at 8:00 a.m. EDT CAMBRIDGE , Mass . , May 17 , 2021 ( GLOBE NEWSWIRE ) -- Cerevel Therapeutics , ( Nasdaq : CERE ) , a company dedicated to unraveling the mysteries of the brain to treat neuroscience diseases , today reported financial results for the quarter ended March 31 , 2021 and provided key pipeline and business highlights . " Cerevel has made great progress in our quest to become the premier neuroscience company . We completed a $ 125 million non - dilutive financing to fund tavapadon , our most advanced asset , added key talent to our executive team , and advanced our extensive clinical and pre - clinical pipeline , " said Tony Coles , M.D. , chairperson and chief executive officer of Cerevel Therapeutics . " As we continue execution of our ongoing clinical trials , we are also building the additional capabilities needed for our long - term success . We look forward to key data readouts from two of our near - term trials . " Pipeline Highlights Leveraging its deep understanding of neurocircuitry and receptor subtype selectivity , Cerevel continues to execute on its broad pipeline of novel neuroscience drug candidates . CVL - 231 : Cerevel's CVL - 231 is an M4 - selective positive allosteric modulator ( PAM ) currently in a Phase 1b trial in schizophrenia . • Cerevel presented data from the Phase 1 single ascending dose trial of CVL - 231 in healthy volunteers at the Schizophrenia International Research Society ( SIRS ) Conference on April 18 . • Cerevel's ongoing Phase 1b trial for CVL - 231 includes a placebo - controlled pharmacodynamic assessment of change in the Positive and Negative Syndrome Scale ( PANSS ) total score . • Data from this trial are expected mid - year 2021 . Darigabat ( formerly CVL - 865 ) : Cerevel's darigabat is an a2 / 3 / 5 - selective GABAA receptor PAM currently under development for anxiety and epilepsy . • Cerevel is conducting a Phase 1 proof - of - principle trial in acute anxiety using a well - established CO2 inhalation challenge model in healthy volunteers . • Data for the acute anxiety trial are expected in the fourth quarter of 2021 . • Cerevel is also conducting the REALIZE trial , a Phase 2 proof - of - concept trial in focal epilepsy . This trial remains ongoing and multiple patients have completed the 8 - week maintenance portion of the trial and have opted to participate in the accompanying open - label extension trial ( REALIZE OLE ) . • Data from the REALIZE trial are expected in the second half of 2022 . Tavapadon : Cerevel's tavapadon is a D1 / D5 partial agonist currently in Phase 3 trials for the treatment of Parkinson's disease . • In April 2021 , Cerevel announced a $ 125 million non - dilutive financing that will fully fund the tavapadon Phase 3 program through New Drug Application ( NDA ) submission . • All three of Cerevel's Phase 3 trials in early- and late - stage Parkinson's disease ( TEMPO - 1 , -2 , and -3 ) are ongoing . Cerevel has also begun dosing rollover and de novo patients in the corresponding open - label extension trial , known as TEMPO - 4 . • Data readouts from the Phase 3 program are expected beginning in the first half of 2023 . CVL - 871 : Cerevel's CVL - 871 is a D1 / D5 partial agonist in development for treatment of dementia - related apathy .