Key Takeaways:
Cabaletta Bio Inc. (Nasdaq: CABA) reported that a single infusion of its lowest dose of rese-cel, administered without preconditioning chemotherapy, produced a durable 6-month response in 50% of patients in a study for the autoimmune disease pemphigus vulgaris.
"It is encouraging that at the lowest PC-free dose... 50% of the patients demonstrated compelling and drug-free responses through 6 months of follow-up," David J. Chang, Chief Medical Officer of Cabaletta, said in a statement. "PC-free rese-cel has the potential to substantially expand access for patients in current CAR T centers on an outpatient basis as well as in community-based infusion centers.”
The data, presented at the American Society of Gene & Cell Therapy (ASGCT) 2026 Annual Meeting, showed that two of four refractory patients achieved the 6-month drug-free response. The three patients who exhibited full peripheral B cell depletion showed the most robust clinical improvements, with the therapy demonstrating a generally well-tolerated safety profile. Rese-cel is an autologous CAR T-cell therapy designed to target CD19-positive B cells, a key driver of many autoimmune diseases.
The results are significant as forgoing preconditioning chemotherapy, which is standard for cancer-related CAR-T treatments, could lower risks and costs, broadening the potential use of the therapy in outpatient and community settings. Cabaletta expects to report initial data from a similar preconditioning-free study in lupus patients later this quarter and data from a higher dose cohort in the second half of 2026.
The company also reported first-quarter 2026 financial results, posting a net loss of $43.5 million, or $0.39 per share, compared to a net loss of $35.9 million, or $0.71 per share, for the same period in 2025. Research and development expenses grew to $37.4 million from $29.0 million year-over-year.
Cabaletta ended the quarter with $116.6 million in cash, cash equivalents, and short-term investments, which it stated is sufficient to fund operations into mid-2027.
Alongside the clinical data, the company presented the first results for rese-cel manufactured on the automated Cellares Cell Shuttle platform. The first two doses met all quality and release specifications, supporting a path toward more scalable and cost-effective production, a critical factor for meeting potential demand from what the company estimates to be thousands of patients.
This article is for informational purposes only and does not constitute investment advice.
