Cabaletta Bio, Inc. develops engineered T cell therapies for autoimmune diseases as a late-stage clinical biotechnology company. Its CABA platform includes the CARTA strategy, and its lead investigational therapy, rese-cel (resecabtagene autoleucel), is a fully human CD19-CAR T cell therapy evaluated through the RESET clinical development program across rheumatology, neurology and dermatology.
Recurring company updates cover rese-cel clinical and translational data, trial-program presentations, manufacturing scale-up, and supply arrangements using automated cell-therapy production platforms. News also includes financial results, business updates, conference participation, shareholder voting matters, capital-structure disclosures, and regulatory disclosures tied to Cabaletta Bio’s autoimmune cell-therapy pipeline.
Cabaletta Bio (Nasdaq: CABA) will present multiple manufacturing, translational and clinical updates on resecabtagene autoleucel (rese-cel) at the ASGCT 2026 Annual Meeting in Boston, May 11–15, 2026. Sessions include data on rese-cel without preconditioning, automated Cellares Cell Shuttle manufacturing, donor vs patient product comparability, and single-cell profiling across RESET Phase 1/2 cohorts.
Selected poster dates: May 12 and May 14; presentation materials and accepted abstracts will be posted after presentation.
Cabaletta Bio (Nasdaq: CABA) and Cellares announced that the first two GMP doses of rese-cel manufactured on Cellares' automated Cell Shuttle platform met all release specifications, were delivered on time, and have been infused into patients in Cabaletta’s RESET clinical trial.
The FDA cleared an Investigational New Drug amendment to use the Cell Shuttle after three years of process adaptation and comparability testing; collaboration began in 2023 to benchmark the automated process against Cabaletta’s established method.
Cabaletta Bio (NASDAQ: CABA) reported Q4 and full‑year 2025 results and a program update. Key items: a projected BLA submission in 2027 for rese‑cel in myositis based on a 17‑patient registrational cohort, no‑preconditioning data due in 1H26, and automated Cellares manufacturing expected in 1H26.
Financials: R&D was $142.7M for 2025, cash and short‑term investments were $133.6M at year‑end, and $30M was raised post‑year end, supporting operations into Q4 2026.
Cabaletta Bio (Nasdaq: CABA) will participate in a fireside chat at the TD Cowen 46th Annual Health Care Conference on March 3, 2026 at 11:10 a.m. ET in Boston. A live webcast will be available on the company website and replays will be available for 30 days.
Cabaletta Bio (Nasdaq: CABA) will participate in a fireside chat at the Guggenheim Emerging Outlook: Biotech Summit 2026 on Thursday, February 12, 2026 at 9:30 a.m. ET in New York. A live webcast will be available on the company website and replays will be posted for 30 days.
Cabaletta Bio (Nasdaq: CABA) outlined 2026 priorities to advance rese-cel development, regulatory alignment, and scalable automated manufacturing.
Key plans: an FDA-aligned 17-patient myositis registrational cohort supporting a planned 2027 BLA submission; RMAT designation for systemic sclerosis; registrational cohort designs in SLE and LN (~25 patients each); IND amendment cleared to manufacture rese-cel using the Cellares automated platform with clinical manufacturing data expected in 1H26; and multiple Phase 1/2 data readouts across RESET trials expected in 1H26, including durability and no-preconditioning dose-ranging results.
Cabaletta Bio (Nasdaq: CABA) received FDA clearance of an IND Amendment to manufacture its investigational CAR T therapy rese-cel using Cellares' automated Cell Shuttle™ and Cell Q™ platforms. The clearance enables clinical manufacturing and QC release on Cellares' end-to-end automated systems, marking the platforms' first use supporting an active clinical program. First patient dosing is anticipated in the first half of 2026. Cabaletta and Cellares presented split apheresis comparability data and completed multi-batch engineering runs to support the transition to automated GMP production.
Cabaletta Bio (Nasdaq: CABA) reported Q3 2025 results and a business update on Nov 10, 2025. Key operational points: rese-cel clinical data from 32 patients across four autoimmune trials showed drug-free responses and a favorable safety profile supporting outpatient use. All myositis Phase 1/2 patients with sufficient follow-up who met registrational criteria achieved the 16-week primary endpoint. A 14-patient DM/ASyS registrational cohort will begin enrolling this quarter, supporting a planned BLA submission in 2027. Regulatory progress includes EMA PRIME and FDA RMAT and Fast Track designations. Financials: R&D expense rose to $39.8M in Q3; cash and investments were $159.9M, funding operations into H2 2026.
Cabaletta Bio (Nasdaq: CABA) announced participation in five investor conferences in November–December 2025 with scheduled webcasted fireside chats and investor meetings.
Key dates and times: Guggenheim fireside chat on Nov 11, 2025 at 10:30 a.m. ET; TD Cowen on Nov 13, 2025 at 11:00 a.m. ET; Jefferies (London) on Nov 17, 2025 at 1:30 p.m. GMT (meetings Nov 17–18); Evercore on Dec 2, 2025 at 8:20 a.m. ET; and Citi on Dec 3, 2025 at 1:45 p.m. ET.
All webcasted fireside chats will be available on the company's News and Events website page and replays will be posted for 30 days. The company will be available for in-person and virtual investor meetings as noted per event.
Cabaletta Bio (Nasdaq: CABA) reported positive clinical and development updates for rese-cel across RESET-Myositis, RESET-SSc and RESET-SLE at ACR Convergence 2025 (data cut-off Sept 11, 2025).
Key points: all 4 DM/ASyS patients meeting registrational criteria achieved moderate/major TIS at week 16; Cabaletta plans a 14-patient DM/ASyS registrational cohort with a 16-week primary endpoint; 76 patients enrolled at 77 sites as of Oct 24, 2025; SSc and SLE cohorts showed clinical responses off immunomodulators; a no-preconditioning dose-escalation cohort for SLE is being added with initial data expected in 2026.