What Cabaletta Bio does

Cabaletta Bio is a clinical-stage biotechnology company developing engineered T cell therapies for B cell-mediated autoimmune diseases. The company's proprietary CABA (Cabaletta Approach to B cell Ablation) platform supports the CARTA (Chimeric Antigen Receptor T cells for Autoimmunity) strategy, with lead candidate rese-cel (resecabtagene autoleucel) — a fully human CD19-CAR T cell therapy with a 4-1BB co-stimulatory domain designed as a one-time infusion that transiently depletes B cells to enable durable, potentially curative drug-free remission. Rese-cel is being evaluated across five RESET Phase 1/2 clinical trials in systemic lupus erythematosus, myositis, systemic sclerosis, generalized myasthenia gravis, and pemphigus vulgaris, with 52+ evaluable patients dosed and an 83% immunomodulator-free response rate observed in dermatomyositis.

The company has no approved products and generates no product revenue. Its operating model centers on advancing clinical trials at major US academic medical centers, securing FDA designations (five Fast Track, four RMAT, one Rare Pediatric Disease), and building a commercial supply chain through a 10-year commercial agreement with Cellares for automated manufacturing on the Cell Shuttle platform — the first cell therapy manufacturing technology to receive FDA Advanced Manufacturing Technology designation. R&D spending reached $142.7M in FY2025 and the company reported a Q1 2026 net loss of $43.5M.

Cabaletta is preparing for its first BLA submission for rese-cel in myositis in the second half of 2027, with systemic sclerosis designated as the second pivotal indication (registrational study expected to begin Q4 2026). The company is publicly traded on NASDAQ (CABA), headquartered in Philadelphia, and was founded in 2017 emerging from the University of Pennsylvania. It has raised approximately $337M in public offerings since 2023, including a $150M registered direct offering in May 2026 with participation from Bain Capital Life Sciences, Eli Lilly, Cormorant Asset Management, and Adage Capital, extending cash runway into mid-2027.

Name

Cabaletta Bio

Legal name

Cabaletta Bio, Inc.

Website

https://cabalettabio.com

Company type

Public

Founded year

2017

Operating status

Operating

Headcount range

101–250 employees

Short description

Cabaletta Bio is a clinical-stage biotechnology company developing rese-cel, a fully human CD19-CAR T cell therapy, to treat B cell-mediated autoimmune diseases including lupus, myositis, systemic sclerosis, myasthenia gravis, and pemphigus vulgaris through five RESET Phase 1/2 trials.

Ownership category

akta.pro rank

Product category

Cell Therapy for Autoimmune Diseases

NAICS

Biological Product (except Diagnostic) Manufacturing (325414), Pharmaceutical and Medicine Manufacturing (3254)

SIC

Biological Products, (No Disgnostic Substances) (2836), Pharmaceutical Preparations (2834)

akta.pro primary industry

CAR-T & TCR-T Therapies (HLAAABAC)

akta.pro secondary industries

Cell Therapy Developers (Autologous) (HLAAABAA), Cell Therapy Manufacturing Services (GMP, autologous/allogeneic) (HLAAAKAC), Rare Immunology, Autoimmune & Autoinflammatory Therapies (HLAIAIAE), Immunology & Autoimmune Specialty Pharmaceuticals (HLAIACAB)

Keywords

• CAR T cell therapy
• Autoimmune disease therapy
• Engineered T cell therapies
• B cell ablation
• Cell therapy platform

Headquarters

HQ city

Philadelphia

HQ country

United States

HQ region

North America

Offices1 record

Markets served

GTM type

B2B

Offering type

Hardware or Manufacturing

Cost components

Technology or R&D, Personnel, Operations, Marketing or Sales, Infrastructure

Revenue model

1. Pre-Revenue / Clinical Stage: Cabaletta Bio is a clinical-stage biotechnology company with no commercialized products. The company has no reported product revenue. All revenue generation is expected upon FDA approval and commercial launch of rese-cel, anticipated beginning with a BLA submission in myositis in 2027.

Pricing tiers

Go-to-market motion1 record

Distribution channels2 records

Marketing channels6 records

Core offering

Cabaletta Bio is developing engineered T cell therapies for B cell-mediated autoimmune diseases. Its lead product, rese-cel (resecabtagene autoleucel), is a fully human CD19-CAR T cell therapy with a 4-1BB co-stimulatory domain designed as a one-time infusion to transiently deplete B cells and potentially reset the immune system. The therapy is being evaluated across multiple Phase 1/2 RESET clinical trials in lupus, myositis, systemic sclerosis, myasthenia gravis, and pemphigus vulgaris, with automated manufacturing via Cellares Cell Shuttle under a 10-year commercial supply agreement.

Product overview

Cabaletta Bio is a clinical-stage biotechnology company developing engineered T cell therapies for autoimmune diseases. The company's core offering centers on rese-cel (resecabtagene autoleucel), a fully human CD19-CAR T cell therapy with 4-1BB co-stimulatory domain, built on the proprietary CABA platform. Rese-cel is being evaluated across five RESET Phase 1/2 clinical trials in multiple autoimmune indications: myositis (RESET-Myositis), systemic lupus erythematosus (RESET-SLE), systemic sclerosis (RESET-SSc), generalized myasthenia gravis (RESET-MG), and pemphigus vulgaris (RESET-PV). Manufacturing is supported by a 10-year commercial supply agreement with Cellares using their automated Cell Shuttle platform. The company is planning its first BLA submission for rese-cel in myositis in 2027.

Differentiator

Problem solved

Functional benefit

Products and services

• Rese-cel (resecabtagene autoleucel) Investigational fully human CD19 chimeric antigen receptor (CAR) T cell therapy with a 4-1BB co-stimulatory domain designed to transiently eliminate B cells, potentially enabling an immune system reset for patients with autoimmune diseases. Administered as a one-time infusion.
• RESET-Myositis Phase 1/2 Trial Phase 1/2 clinical trial evaluating rese-cel in patients with idiopathic inflammatory myopathies, including dermatomyositis, antisynthetase syndrome, and immune-mediated necrotizing myopathy. Includes juvenile myositis cohort. 83% of DM patients achieved immunomodulator-free TIS response.
• RESET-SLE Phase 1/2 Trial Phase 1/2 clinical trial evaluating rese-cel in patients with systemic lupus erythematosus and lupus nephritis. 75% of patients with 12 months follow-up achieved DORIS remission while remaining off immunomodulators.
• RESET-SSc Phase 1/2 Trial Phase 1/2 clinical trial evaluating rese-cel in patients with systemic sclerosis, including those with interstitial lung disease. 83% (5/6) achieved rCRISS-25 and 67% (4/6) achieved rCRISS-50 at 36 weeks while off immunomodulators.
• RESET-MG Phase 1/2 Trial Phase 1/2 clinical trial evaluating rese-cel in patients with generalized myasthenia gravis, including both AChR-positive and AChR-negative patients. 5 AChR-positive and 5 AChR-negative patients experienced clinically meaningful improvement on MG-ADL score.
• RESET-PV Phase 1/2 Trial Phase 1/2 clinical trial evaluating rese-cel without lymphodepleting preconditioning in patients with pemphigus vulgaris. Preliminary data shows complete B cell depletion and early clinical responses without standard preconditioning regimen.
• Cellares Cell Shuttle Manufacturing Platform (for rese-cel production) Automated cell therapy manufacturing platform used for commercial-scale production of rese-cel under a 10-year commercial supply agreement, enabling scalable, low-cost manufacturing with reduced manual touchpoints. First FDA Advanced Manufacturing Technology designation for cell therapy.

Quantifiable outcome

• 83% (5/6) of dermatomyositis patients achieved immunomodulator-free moderate-to-major TIS response at 16 weeks vs. 50% registrational threshold requirement
• +5 more outcomes

Named customers5 records

Segments1 record

Ideal customer profiles2 records

Technology focussed Yes

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

Feature4 records

Partnerships

16 partnerships are on record, tiered core / flagship, foundational / core, core and supporting.

• Cellarescore / flagshipTechnology or Integration · 28 April 2026Cabaletta Bio signed a 10-year commercial supply agreement with Cellares in April 2026 for the automated manufacture of rese-cel using Cellares' Cell Shuttle™ and Cell Q™ platforms. This partnership enables flexible, low-cost scaling of commercial production to thousands of batches per year at among the lowest cost per batch in the industry. The collaboration builds on prior work since 2023, including successful first patient dosing with GMP-grade rese-cel manufactured on the automated platform in April 2026.
• Cellares (Manufacturing Technology)core / flagshipTechnology or Integration · 1 January 2023Ongoing manufacturing partnership with Cellares, the first Integrated Development and Manufacturing Organization (IDMO). Cellares received FDA Advanced Manufacturing Technology designation for its Cell Shuttle platform — the first cell therapy manufacturing technology to achieve this. The companies have collaborated since 2023 to adapt the rese-cel manufacturing process to the automated platform, with FDA clearance obtained for clinical manufacturing use.
• University of Pennsylvaniafoundational / coreStrategic or Co-development PartnerCabaletta Bio originated from the University of Pennsylvania in 2017. The company was founded by leading Penn experts in autoimmune diseases and CAR T technology (including Dr. Aimee Payne and Dr. Michael Milone, co-inventors of CTL019/tisagenlecleucel). The company continues to collaborate with Penn on clinical trials and research. Dr. Carl June (Penn) serves on Cabaletta's Scientific Advisory Board.
• Children's Hospital of Philadelphia (CHOP)coreStrategic or Co-development PartnerCHOP is listed as a clinical collaborator. Dr. Catherine Bollard (Children's National Health System / George Washington University) serves on Cabaletta's Board of Directors.
• UC DavissupportingStrategic or Co-development PartnerUC Davis is listed as both a scientific and clinical collaborator for Cabaletta Bio's programs.
• Yale UniversitysupportingStrategic or Co-development PartnerYale University is listed as a scientific collaborator for Cabaletta Bio's research programs.
• Stanford MedicinesupportingStrategic or Co-development PartnerStanford Medicine is listed as a clinical collaborator for Cabaletta Bio's autoimmune disease programs.
• The University of IowasupportingStrategic or Co-development PartnerThe University of Iowa is listed as a clinical collaborator for Cabaletta Bio's autoimmune disease programs.
• Artisan BiosupportingTechnology or IntegrationArtisan Bio is listed as an industry partner for Cabaletta Bio's cell therapy development programs.
• B-MoGen BiotechnologiessupportingTechnology or IntegrationB-MoGen Biotechnologies is listed as an industry partner for Cabaletta Bio's cell therapy development programs.
• WuXi AppTecsupportingTechnology or IntegrationWuXi AppTec is listed as an industry partner providing contract manufacturing and development services for Cabaletta Bio's cell therapy programs.
• Oxford BioMedicasupportingTechnology or IntegrationOxford BioMedica is listed as an industry partner for Cabaletta Bio's cell therapy development programs.
• Lupus Foundation of AmericasupportingOthersThe Lupus Foundation of America is listed as an advocacy partner helping connect Cabaletta Bio with the lupus patient community.
• International Pemphigus and Pemphigoid Foundation (IPPF)supportingOthersThe International Pemphigus and Pemphigoid Foundation is listed as an advocacy partner helping connect Cabaletta Bio with the pemphigus vulgaris patient community.
• Myasthenia Gravis Foundation of America (MGFA)supportingOthersThe Myasthenia Gravis Foundation of America is listed as an advocacy partner helping connect Cabaletta Bio with the myasthenia gravis patient community.
• Cure JM FoundationsupportingOthersCure JM Foundation is listed as an advocacy partner helping connect Cabaletta Bio with the juvenile myositis patient community.

Scale indicators15 records

Recent moves6 records

Expansion highlights5 records

Direct peers

• Kyverna Therapeutics: Clinical-stage biotech developing KYV-101, an autologous CD19 CAR-T cell therapy for autoimmune diseases including lupus, myositis, and other B cell-mediated conditions — the most directly competitive program to Cabaletta's rese-cel with overlapping indications and trial designs.

Broad incumbents

• Bristol Myers Squibb: Major pharmaceutical company with Breyanzi (lisocabtagene maraleucel), an approved CD19 CAR-T therapy originally for lymphoma that is now being investigated in autoimmune diseases; also sells approved lupus therapies (Saphnelo) that compete for the same autoimmune patients Cabaletta is targeting.
• Gilead Sciences (Kite): Owns Kite Pharma, a leading cell therapy franchise with approved CD19 CAR-T therapies (Yescarta, Tecartus). Has the largest commercial CAR-T infrastructure and is positioned to extend into autoimmune indications where rese-cel will compete for patients and treatment center capacity.
• Novartis: Developed and commercializes Kymriah (tisagenlecleucel), the first FDA-approved CAR-T therapy, originally partnered with the University of Pennsylvania where Cabaletta's founders trained. Novartis has the deepest CAR-T commercial experience globally and could enter autoimmune indications through label expansion.
• Johnson & Johnson / Legend Biotech: Co-develop and commercialize Carvykti (ciltacabtagene autoleucel), a BCMA-directed CAR-T for multiple myeloma. Legend Biotech's commercial leadership previously included Steve Gavel (now Cabaletta's CCO), and J&J's pharma scale makes them a natural competitor if they pursue autoimmune CAR-T indications.

Emerging players

• Adicet Bio: Clinical-stage biotech developing allogeneic gamma delta CAR-T cell therapies for autoimmune diseases and oncology. Its off-the-shelf approach, if successful, would compete directly with Cabaletta's autologous rese-cel on convenience, cost, and scalability.
• Caribou Biosciences: Clinical-stage company developing allogeneic CAR-T cell therapies using CRISPR-based genome editing for both oncology and autoimmune indications. Its allogeneic platform is a direct alternative approach to rese-cel's autologous model in overlapping autoimmune diseases.
• Allogene Therapeutics: Clinical-stage biotech pioneering allogeneic CAR-T cell therapies for oncology and autoimmune diseases, with CD19 and CD70 programs in development. Its allogeneic manufacturing model would compete with rese-cel on cost and time-to-treatment.
• Fate Therapeutics: Clinical-stage biotech developing off-the-shelf iPSC-derived cell therapies, including NK and T cell products for autoimmune and oncology indications. Its multiplexed-engineering, off-the-shelf approach is an alternative platform paradigm to Cabaletta's autologous CAR-T model.

Others

• 2seventy bio: Cell therapy company that helped bring three cell therapy products to approval (Abecma, and others via bluebird bio heritage). Cabaletta's CTO Sarah Yuan previously led process and analytical development at 2seventy bio, making it a comparable technical and CMC organization.

Market position

Strengths5 records

Weaknesses5 records

Competitive moat5 records

Key risks1 record

Key highlights6 records

Customer concentration

• Xx.com/cabalettabio
• LinkedInlinkedin.com/company/cabalettabio

Revenue estimate

Valuation estimate

Number of profiles

Profiles11 records

Funding overview

Funding rounds7 records

Investors11 records

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M&A

Investments

M&A and investment is available on the Subscription and Enterprise plan.Contact sales →

Frequently asked questions about Cabaletta Bio