Cabaletta Bio

CABA

Market cap $248M

Cabaletta Bio, Inc. (CABA) Presents at Citi Annual Global Healthcare Conference 2025 Transcript

Rese-cel data presented at multiple medical meetings demonstrated potentially transformative, drug-free clinical responses with a favorable safety profile for autoimmune patients supporting outpatient use All myositis patients in the Phase 1/2 DM/ASyS cohort with sufficient follow-up who would have met key criteria for the registrational cohort met the registrational, 16-week primary endpoint Planned BLA submission for rese-cel in 2027 based on 14-patient, single-arm DM/ASyS registrational cohort initiating enrollment this quarter within the RESET-Myositis™ trial FDA alignment on additional registrational cohort designs for RESET-SSc™ and RESET-SLE™ anticipated by year-end 2025 PHILADELPHIA, Nov. 10, 2025 (GLOBE NEWSWIRE) -- Cabaletta Bio, Inc. (Nasdaq: CABA), a clinical-stage biotechnology company focused on developing and launching the first curative targeted cell therapies designed specifically for patients with autoimmune diseases, today reported financial results for the third quarter ended September 30, 2025, and provided a business update. “Our team continued to execute with discipline and precision to extend our leadership through the RESET™ clinical development program.

PHILADELPHIA, Nov. 04, 2025 (GLOBE NEWSWIRE) -- Cabaletta Bio, Inc. (Nasdaq: CABA), a clinical-stage biotechnology company focused on developing and launching the first curative targeted cell therapies designed specifically for patients with autoimmune diseases, today announced that the Company will participate in the following upcoming investor conferences in November and December:

– All myositis patients in the Phase 1/2 DM/ASyS cohort with sufficient follow-up who met key registrational inclusion criteria exceeded the registrational primary endpoint, demonstrating major TIS responses with no immunomodulators – – Myositis registrational trial being initiated this quarter with a planned cohort of 14 DM/ASyS patients and a 16-week primary endpoint – moderate or major TIS while off immunomodulators and on no or low-dose steroids – consistent with FDA alignment on key trial parameters – – All systemic sclerosis patients with sufficient follow-up demonstrated ongoing, transformative clinical responses off all immunomodulators and steroids – – Seven of 8 lupus patients with sufficient follow-up achieved DORIS or renal response; RESET-SLE™ trial expanding to include a no preconditioning cohort with initial clinical data expected in 2026 – – 76 patients enrolled at 77 clinical trial sites globally as of October 24, 2025 – PHILADELPHIA, Oct. 27, 2025 (GLOBE NEWSWIRE) -- Cabaletta Bio, Inc. (Nasdaq: CABA), a clinical-stage biotechnology company focused on developing and launching the first curative targeted cell therapies designed specifically for patients with autoimmune diseases, today announced positive clinical data and development updates across the RESET-Myositis™, RESET-SSc™ and RESET-SLE trials evaluating rese-cel (resecabtagene autoleucel, formerly known as CABA-201). These data are being presented in multiple oral and poster presentations at the ongoing American College of Rheumatology (ACR) Convergence 2025, which is being held at the McCormick Place Convention Center in Chicago, Illinois, from October 24-29, 2025.

– Gavel brings highly relevant CAR T experience from Legend Biotech where he led the launch and commercialization of CARVYKTI® from 2018 until 2025 – PHILADELPHIA, Oct. 14, 2025 (GLOBE NEWSWIRE) -- Cabaletta Bio, Inc. (Nasdaq: CABA), a clinical-stage biotechnology company focused on developing and launching the first curative targeted cell therapies designed specifically for patients with autoimmune diseases, today announced the appointment of Steve Gavel as Chief Commercial Officer, effective immediately. In his role, Mr.

– Complete B cell depletion, rapid reduction in autoantibodies and near-complete resolution of clinical symptoms in two of three refractory patients; all three patients remained off immunomodulators since infusion and are off or tapering steroids as of the data cut-off –

Cabaletta Bio (CABA) offers pioneering CAR T-cell therapy for autoimmune diseases, with recent data showing promising efficacy and manageable safety. CABA's lead candidate, rese-cel, has demonstrated meaningful responses in lupus and scleroderma, with additional pivotal data and FDA discussions expected in 2025-2027. Despite a recent stock rally and a strong pipeline, CABA faces significant cash runway concerns, making future dilution likely before regulatory milestones.

PHILADELPHIA, Aug. 27, 2025 (GLOBE NEWSWIRE) -- Cabaletta Bio, Inc. (Nasdaq: CABA), a clinical-stage biotechnology company focused on developing and launching the first curative targeted cell therapies designed specifically for patients with autoimmune diseases, today announced that the Company will participate in the following upcoming investor conferences in September: Cantor Global Healthcare Conference 2025: Webcasted fireside chat at 10:55 a.m. ET on Wednesday, September 3, 2025, in New York, NY.

Cabaletta Bio (CABA) might move higher on growing optimism about its earnings prospects, which is reflected by its upgrade to a Zacks Rank #2 (Buy).

Cabaletta Bio (CABA) Q2 Loss Widens 30%