Cabaletta Bio reports Q4 EPS (46c), consensus (39c)

“Throughout the past year, we set the foundation to enable an efficient development strategy for CABA-201 across a broad range of autoimmune diseases. Clinical sites across the United States are actively recruiting for our myositis and SLE trials, and the first patient has been dosed with no CRS or ICANS of any grade observed as of 21 days following CABA-201 infusion. We look forward to building on this momentum with expansion into additional clinical sites and to delivering data across the RESET program in 2024,” said Steven Nichtberger, M.D., Chief Executive Officer and Co-founder of Cabaletta. “By advancing individual, company-sponsored trials for each autoimmune disease without the need for an initial dose escalation study, we believe we have an accelerated path to initiate discussions with the FDA on registrational cohorts and/or studies following treatment of six patients in any one of the nine cohorts in our current RESET clinical trial program. Our commitment to exploring the broad potential of CABA-201 for patients is further demonstrated by the recently granted Rare Pediatric Disease designation in juvenile dermatomyositis, an indication in which there are no FDA approved therapies. Based on our strong balance sheet and a differentiated CABA-201 development strategy, we believe we are well positioned to develop and launch the first targeted, and perhaps curative, cell therapy specifically designed for patients with autoimmune diseases.”