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 (CABA) reported new Phase 1/2 rese-cel data showing sustained improvements across three autoimmune diseases at ACR Convergence 2026.
The open-label, single-arm studies evaluated one infusion after preconditioning, with a September 4, 2026 cutoff. All six dermatomyositis patients maintained moderate-to-major Total Improvement Score responses without immunomodulators through one year. All five lupus nephritis patients with repeat biopsies achieved remission without immunomodulators and biopsy-based response or remission. In systemic sclerosis, 71% (5/7) achieved the rCRISS-50 disease-improvement threshold at one year. Among 71 patients, 94% had no or mild cytokine release syndrome, an inflammatory reaction; 6% had Grade 2 cases.
Cabaletta expects registrational adult dermatomyositis/antisynthetase syndrome results in second-half 2027 and a myositis biologics application in first-quarter 2028.
Cabaletta Bio (Nasdaq: CABA) reported third-quarter financial results and advanced rese-cel clinical programs, with myositis topline results expected in 2H27. The company plans a 1Q28 biologics license application in myositis, including juvenile dermatomyositis data for a potential pediatric indication and Priority Review Voucher eligibility. An approximately 25-patient registrational systemic sclerosis cohort has opened.
Third-quarter net loss widened to $53.053 million from $44.866 million a year earlier, while loss per share narrowed to $0.28 from $0.44. Cash, cash equivalents and short-term investments totaled $299.383 million at September 30, including approximately $115.0 million from warrant exercises. Cabaletta expects funding to support operations into 1Q28. Development plans for rese-cel without preconditioning treatment are expected in 1H27, informed by maturing dose-exploration data.
Cabaletta Bio (CABA) granted inducement stock options covering 240,200 shares to four newly hired non-executive employees to begin their employment.
The options have an exercise price of $1.43 per share, equal to the Nasdaq closing price on November 2, 2026, and a 10-year term. They vest over four years: 25% on the first anniversary of each employee’s start date, followed by 12 equal quarterly installments over the next three years. The awards were approved under Nasdaq Listing Rule 5635(c)(4) and are subject to the 2025 Inducement Plan and the option agreements.
Cabaletta Bio (Nasdaq: CABA) will participate in Guggenheim’s healthcare investor conference on November 10, 2026, with investor meetings and a webcasted fireside chat. The Boston chat begins at 9:00 a.m. ET. The company will also hold investor meetings and a webcasted fireside chat at the Jefferies Global Healthcare Conference in London on November 18 at 5:00 p.m. GMT (12:00 p.m. ET). Webcasts will be available on its website, with replays available for 30 days.
Cabaletta Bio (Nasdaq: CABA) granted inducement stock options to four newly hired non-executive employees as an incentive to begin employment. The awards cover 200,000 shares at $2.46, 100,000 shares at $2.00 and 85,000 shares at $2.00. Each exercise price matches the Nasdaq closing share price on September 21, September 28 and October 2, 2026, respectively.
Each option has a 10-year term and vests over four years: 25% on the first grant anniversary, followed by 12 equal quarterly installments. The awards were approved under Nasdaq Listing Rule 5635(c)(4) and are subject to the 2025 Inducement Plan and their option agreements.
Cabaletta Bio (Nasdaq: CABA) will participate in four September 2026 healthcare and investment conferences, including events hosted by Wells Fargo, Cantor, Morgan Stanley, and H.C. Wainwright. The company will hold investor meetings and several webcasted fireside chats, which will be accessible via the News and Events section of its website with replays available for 30 days.
Cabaletta Bio (Nasdaq: CABA) reported second quarter 2026 results and detailed progress of rese-cel, its CD19 CAR T therapy for autoimmune diseases. Registrational RESET-Myositis data from a 17-patient adult dermatomyositis/antisynthetase cohort remain on track for mid-2027 to support a planned 2H27 BLA submission, including juvenile Phase 1/2 data that may support a Priority Review Voucher.
At EULAR 2026, 80% (8/10) of evaluable adult patients would have met the registrational primary endpoint, with durable responses and a favorable safety profile (no ICANS; only Grade 0–1 CRS). Cabaletta plans a single-arm registrational RESET-SSc study in ~25 SSc-associated ILD patients starting 4Q26 and is incorporating a PC-free approach in RESET-MG, with higher-dose cohorts in RESET-PV and RESET-SLE.
Manufacturing resilience was strengthened via ElevateBio as a second CDMO and a 10-year automated commercial supply agreement with Cellares. Cabaletta reported Q2 2026 R&D expenses of $44.4 million, net loss of $51.0 million, and cash of $225.1 million, expected to fund operations into mid-2027.
Cabaletta Bio (Nasdaq:CABA) reported new rese-cel data and development updates across myositis, systemic sclerosis (SSc) and lupus at EULAR 2026.
Key findings include high immunomodulator-free response rates in dermatomyositis and antisynthetase syndrome, improved lung function in SSc-ILD, early PC-free lupus activity, a favorable safety profile, and plans for pivotal studies starting 4Q26 with a BLA targeted for 2H27.
Cabaletta Bio (Nasdaq:CABA) reported Q1 2026 results and advanced its rese-cel RESET program across multiple autoimmune indications.
Key updates include 6–9 month preconditioning-free RESET-PV data, a 10-year Cellares commercial supply agreement, complete Phase 1/2 RESET-MG data, a $150M registered direct offering, and cash runway into mid-2027.
Cabaletta Bio (Nasdaq:CABA) reported preconditioning-free clinical and automated manufacturing data for rese-cel at the ASGCT 2026 meeting. In the lowest-dose RESET-PV cohort, 2 of 4 pemphigus vulgaris patients achieved 6-month, drug-free responses without preconditioning. Initial Cell Shuttle automated manufacturing runs met release specs and showed translational profiles consistent with prior RESET experience. Additional RESET-PV and RESET-SLE data are expected in 1H26 and 2H26.