Core Insights - Cabaletta Bio is focused on advancing its investigational CAR T cell therapy, rese-cel, for autoimmune diseases, with a pivotal myositis trial actively enrolling and a planned Biologics License Application (BLA) submission in 2027 [1][2] Group 1: Strategic Priorities and Clinical Development - The company aims to translate registrational pathways for rese-cel into a product pipeline across various autoimmune diseases, with a specific focus on enrolling a 17-patient cohort for the myositis trial [3] - The FDA has aligned with Cabaletta on the design of registrational cohorts for systemic lupus erythematosus (SLE) and lupus nephritis (LN), evaluating a weight-based dose of 1 million cells/kg [3][4] - Cabaletta has received Regenerative Medicine Advanced Therapy (RMAT) designation for rese-cel in systemic sclerosis and is working on aligning registrational cohort designs for additional conditions [4] Group 2: Manufacturing and Scalability - The company has obtained clearance for an Investigational New Drug (IND) amendment to manufacture rese-cel using the Cellares platform, which is expected to enhance scalability and reduce costs [5] - Clinical manufacturing data is anticipated in the first half of 2026 to confirm Good Manufacturing Practice (GMP) readiness and supply chain logistics for Cellares-produced rese-cel [5] Group 3: Clinical Data and Innovations - New durability data from ongoing trials without preconditioning and higher dose initial clinical data from RESET-PV™ are expected in the first half of 2026 [1][8] - Complete Phase 1/2 data from trials in lupus, scleroderma, and myasthenia gravis are anticipated in the first half of 2026, which will provide insights into the therapy's efficacy [1][8] Group 4: Company Overview - Cabaletta Bio is a late-stage clinical biotechnology company dedicated to developing targeted cell therapies for autoimmune diseases, with its lead therapy, rese-cel, being evaluated in multiple ongoing trials [9]

Financial Performance - Company reported record first quarter revenue of $222.3 million, up 15.4% year-over-year, driven by double-digit organic growth in both residential and multi-family/commercial projects [1][6] - Single-family residential revenue increased to a first quarter record of $88.9 million, up 21.6% year-over-year [1][6] - Gross margin improved to 43.9%, up 510 basis points year-over-year [1][7] - Net income was $42.2 million, or $0.90 per diluted share, compared to $29.7 million, or $0.63 per diluted share, in the prior year quarter [1][9] - Adjusted net income was $43.1 million, or $0.92 per diluted share, compared to $30.9 million, or $0.66 per diluted share, in the prior year quarter [1][10] - Adjusted EBITDA was $70.2 million, up 37.5% year-over-year, representing 31.6% of total revenues [1][11] Cash Position and Capital Allocation - Company ended the first quarter with an all-time high cash position of $157.3 million and total liquidity of approximately $330 million [2][14] - Strong free cash flow of $28.8 million was generated during the quarter [1] - Company returned $7.0 million in cash dividends to shareholders [12][13] Strategic Developments - Company expanded its backlog by 24.9% year-over-year to a record $1.14 billion [2] - In April 2025, the company acquired Continental Glass Systems for approximately $30 million, enhancing its U.S. manufacturing capabilities [2][15] - Company is launching a feasibility analysis to develop automated manufacturing capabilities in the U.S. over the coming years [2] Market Outlook - Company updated its full year 2025 revenue guidance to a range of $960 million to $1.02 billion, representing growth of approximately 11% at the midpoint [2][17] - Adjusted EBITDA outlook narrowed to a range of $305 million to $330 million, representing growth of approximately 15% at the midpoint [2][17] - Company anticipates a full year 2025 impact of approximately $25 million associated with higher input costs and tariffs, which it expects to mitigate through pricing strategies and supply chain adjustments [2][17]