PHILADELPHIA, PA — Cabaletta Bio Inc. (Nasdaq: CABA) extended its operating cash runway into early 2028 after receiving approximately $115 million from warrant exercises during the third quarter of 2026, giving the Philadelphia biotechnology company additional time to advance its experimental autoimmune disease therapy toward a planned FDA submission.
The company ended Sept. 30 with $299.4 million in cash and cash equivalents, including proceeds from warrants exercised between July 1 and their expiration on Sept. 12.
Cabaletta expects the funding to support operations into the first quarter of 2028, when it plans to submit a Biologics License Application to the U.S. Food and Drug Administration for resecabtagene autoleucel, or rese-cel, in patients with myositis.
The investigational CAR T-cell therapy is designed to reset immune activity in patients with autoimmune diseases, potentially producing sustained clinical responses without continued use of immunomodulatory medications.
The company’s lead registrational study, RESET-Myositis, is evaluating rese-cel in 17 adults with dermatomyositis or antisynthetase syndrome, two inflammatory conditions that can affect muscles and other organs.
Top-line results are expected in the second half of 2027, supporting the planned regulatory filing in the first quarter of 2028.
Enrollment and screening activity have recently increased after a slower third quarter, according to Chief Executive Officer Steven Nichtberger.
Nichtberger attributed the earlier slowdown partly to caution among physicians and patients following safety events reported by other companies developing therapies in the field.
“We are now seeing increased enrollment and screening activity, with multiple patients enrolled in the past few weeks in the registrational adult myositis study,” Nichtberger stated.
The trial includes an outpatient dosing option, a feature also incorporated into other parts of Cabaletta’s clinical development program.
Following a recent regulatory interaction with the FDA, Cabaletta plans to include longer-term clinical data from its Phase 1/2 myositis studies in its application.
The company expects some previously treated patients to have three years of follow-up data by the time of a potential commercial launch.
Cabaletta is also enrolling children with juvenile dermatomyositis in a Phase 1/2 study, with plans to include pediatric results in its myositis application.
Those data could support a pediatric indication and potential eligibility for a Priority Review Voucher, which may have financial value because such vouchers can be transferred to other drug developers.
The company has initiated a second registrational study, RESET-SSc, targeting systemic sclerosis patients with interstitial lung disease.
The approximately 25-patient cohort will evaluate whether rese-cel can improve lung function and overall disease activity in patients with a condition associated with substantial mortality risk.
The primary endpoint measures changes in percent-predicted forced vital capacity, a standard assessment of lung function, without immunomodulatory or antifibrotic medications and with no steroids or low-dose steroid treatment.
Earlier Phase 1/2 findings provide the clinical basis for the larger study.
Among five systemic sclerosis patients with interstitial lung disease who reached one year of follow-up, mean percent-predicted forced vital capacity improved approximately 9% while patients remained off immunomodulators.
Six of seven systemic sclerosis patients with at least one year of follow-up achieved a clinically meaningful response on the revised Combined Response Index in Systemic Sclerosis, known as rCRISS-25.
Those findings were presented at the European Society of Gene and Cell Therapy’s 2026 annual meeting.
Cabaletta is also investigating whether rese-cel can be administered without the preconditioning chemotherapy typically used before CAR T-cell treatment.
The company’s preconditioning-free program includes ongoing dose exploration in lupus, myasthenia gravis and pemphigus vulgaris.
Higher-dose treatment is being evaluated in the RESET-SLE lupus and RESET-PV pemphigus vulgaris studies, while RESET-MG has begun preconditioning-free dose exploration in myasthenia gravis.
Cabaletta expects accumulating clinical data to guide dose selection and its next development decisions during the first half of 2027.
Separately, its lupus program has expanded enrollment to include adolescents in Phase 1/2 cohorts receiving preconditioning.
The company presented additional myasthenia gravis findings from 14 patients treated with rese-cel following preconditioning at the American Association of Neuromuscular & Electrodiagnostic Medicine’s 2026 annual meeting.
At 24 weeks, 10 patients who remained off immunomodulators had mean improvements of 7.9 points on the Myasthenia Gravis Activities of Daily Living scale and 7.8 points on the Quantitative Myasthenia Gravis score.
Ten of the 14 patients achieved a clinically meaningful improvement on the daily living scale during their latest follow-up, with a median follow-up period of 38 weeks.
The company reported no cytokine release syndrome in 12 of the 14 patients and no cases of immune effector cell-associated neurotoxicity syndrome or immune effector cell-associated hemophagocytic lymphohistiocytosis-like syndrome.
Cabaletta has also examined how inflammatory responses may differ among autoimmune diseases, presenting research on macrophage activation and its potential relationship to treatment-related safety events.
Additional clinical findings are being presented at the American College of Rheumatology’s ACR Convergence 2026 meeting.
The presentations include one-year clinical outcomes from the complete Phase 1/2 dermatomyositis cohort, longer-term results from lupus nephritis patients followed for as long as two years, and updated safety information from the company’s preconditioned treatment program.
Cabaletta’s expanding clinical activities have increased operating expenses.
Research and development spending rose to $47.1 million in the third quarter of 2026 from $39.8 million a year earlier, an increase of approximately 18%.
General and administrative expenses increased to $7.6 million from $6.8 million, or approximately 12%.
The company’s near-term development schedule centers on completing enrollment and follow-up in its registrational myositis trial, generating additional evidence of treatment durability and establishing a dosing strategy for its preconditioning-free programs.
The planned 2028 regulatory filing would represent a significant milestone for rese-cel, although its potential commercialization remains dependent on clinical results and FDA review.
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