Cabaletta Bio reports Q3 EPS (62c), consensus (61c)

“Focused clinical execution has resulted in 40 U.S. clinical sites actively recruiting patients for the RESET clinical trial program for CABA-201. At the ACR Convergence conference this coming weekend, we are looking forward to sharing clinical safety and efficacy data from the first 8 myositis, lupus and scleroderma patients in the RESET clinical trial program evaluating whether a single dose of CABA-201 can provide compelling clinical responses without the need for immunosuppressants,” said Steven Nichtberger, M.D., Chief Executive Officer of Cabaletta. “We are encouraged by the accelerating pace of enrollment and, data permitting, anticipate meeting with the FDA next year regarding registrational program designs for CABA-201. As we expand our clinical trial network beyond the U.S., we are pleased to welcome Gerwin Winter as Head of International for Cabaletta. Gerwin was most recently head of Europe for Beigene from inception through commercialization leveraging his prior experiences at Portola, Celgene and BMS. His team is already well positioned to leverage the recent EMA CTA authorization for the RESET-SLE trial. We look forward to expanding the opportunity for CABA-201 globally as we seek to develop and launch the first targeted curative cell therapies for patients with autoimmune diseases.”