Cabaletta Bio reported third-quarter 2026 results alongside updates to its clinical plans for rese-cel, its investigational CAR T-cell therapy for autoimmune diseases. The company is targeting a U.S. application for myositis in early 2028, while expanding its work into systemic sclerosis and continuing to develop an approach that would avoid preconditioning treatment.
The company ended September with $299.4 million in cash and expects its operating runway to extend into the first quarter of 2028.
Key details
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Myositis study remains on a path toward a 2028 application. Cabaletta expects topline results in the second half of 2027 from its 17-patient registrational study in adults with dermatomyositis and antisynthetase syndrome. The study includes an outpatient dosing option. The company plans to use the results to support a biologics license application in the first quarter of 2028.
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The planned application may include longer-term and pediatric data. Following a recent discussion with the FDA, Cabaletta says it can include multi-year durability data from earlier myositis studies. It expects to present one-year data from the complete Phase 1/2 dermatomyositis cohort at the 2026 American College of Rheumatology meeting, and expects some patients to have three years of follow-up by a potential launch.
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A juvenile study is continuing. The Phase 1/2 cohort is enrolling children with juvenile dermatomyositis and also includes an outpatient dosing option. Cabaletta plans to include data from the study in its myositis application to support a potential pediatric indication. The company says this could make it eligible for a Priority Review Voucher; eligibility is not assured.
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A second registrational study has begun. Cabaletta opened an approximately 25-patient study of rese-cel in systemic sclerosis, focusing on patients with interstitial lung disease. The study will assess lung function and overall disease.
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Additional clinical data are due at the 2026 rheumatology meeting. Cabaletta plans to present one-year, immunomodulator-free durability data from the complete Phase 1/2 dermatomyositis cohort, follow-up of up to two years from the complete lupus nephritis cohort, and updated safety data from the RESET program, which uses preconditioning.
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Enrollment activity has picked up after a slower quarter. The company said adult myositis enrollment and screening were slower in the third quarter, which it believes reflected caution among patients and physicians after safety events reported by other companies in the field. Cabaletta said multiple patients had enrolled in the study in recent weeks.
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A preconditioning-free program is advancing. Cabaletta expects maturing data from this program to help determine its dose and future clinical-development plans, which it intends to share in the first half of 2027.
Rese-cel is an investigational therapy given as a single, weight-based infusion after patients stop immunomodulators. Cabaletta is studying it as a way to reset the immune system in autoimmune diseases; it is not an approved treatment. The company described its safety and benefit-risk profile to date as favorable. Its stated cash runway extends into the quarter in which it plans to submit the myositis application.