Earnings release
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May 3 , 2021 Cabaletta BioⓇ Cabaletta Bio Reports First Quarter 2021 Financial Results and Provides New Pipeline Updates - Acute safety data from the first cohort in the DesCAARTes ™ trial announced today ; no dose limiting toxicities ( DLTs ) or clinically relevant adverse events observed in the first dose cohort as of April 30 , 2021 - -PLA2R - CAART announced as a new development program for patients with PLA2R- associated membranous nephropathy ; pre - IND meeting with FDA planned in the second half of 2021- - MUSK - CAART Investigational New Drug ( IND ) application submission planned for the second half of 2021 - PHILADELPHIA , May 03 , 2021 ( GLOBE NEWSWIRE ) -- Cabaletta Bio , Inc. ( Nasdaq : CABA ) , a clinical - stage biotechnology company focused on the discovery and development of engineered T cell therapies for patients with B cell - mediated autoimmune diseases , today reported financial results for the first quarter ended March 31 , 2021 , and provided new pipeline updates . " The initial safety data from the first low dose cohort of three patients in the DesCAARTes ™ clinical trial for DSG3 - CAART , our lead clinical candidate , support the acute safety profile of DSG3 - CAART at the administered dose in mucosal - dominant pemphigus vulgaris patients , and are an encouraging indicator for the safety of the CAAR T platform overall . We look forward to reporting additional topline data on safety and potential target engagement on completed dose cohorts throughout the second half of 2021 , ” said Steven Nichtberger , M.D. , Chief Executive Officer and Co - founder of Cabaletta . " On the heels of this important milestone , which we believe begins to de - risk our CABAT platform , we are pleased to announce a new development program , PLA2R - CAART , for the treatment of patients with PLA2R - associated membranous nephropathy with a pre - IND meeting planned for the second half of 2021. In addition , we look forward to submitting our second IND application for MUSK - CAART , our lead preclinical candidate , in the second half of 2021. " Acute Safety Data from First Dose Cohort of DesCAARTes ™ Trial Today , the Company reported results from the first cohort of three patients dosed with DSG3 - CAART . There were no clinically relevant adverse events , including cytokine release syndrome or neurotoxicity , during the 8 - day acute safety window , which the Company expects is the period with highest probability of observing treatment - related toxicities . In addition , no dose - limiting toxicities ( DLTs ) were observed in the first two subjects who have completed the 28 - day DLT monitoring period post - infusion . The third patient has completed the 8 - day acute safety window , and is in the DLT follow - up period . These safety data were observed with an administered dose of 20 million DSG3 - CAART cells , without