Cabaletta Bio (CABA) Q1 2026 earnings summary

Executive summary

• Developing engineered T cell therapies for autoimmune diseases, with lead candidate rese-cel in late-stage clinical trials across multiple indications, including myositis, SLE, SSc, gMG, and PV.

• Presented 6- to 9-month clinical data for lowest dose rese-cel in RESET-PV, showing drug-free clinical responses in half of pemphigus vulgaris patients without preconditioning.

• Initiated a registrational trial for dermatomyositis/anti-synthetase syndrome and expanded manufacturing partnerships for commercial readiness.

• Secured multiple FDA designations (Fast Track, Orphan Drug, RMAT, Rare Pediatric Disease) for rese-cel in various indications.

• Entered a 10-year commercial supply agreement with Cellares for automated, scalable, low-cost manufacturing of rese-cel.

Financial highlights

• Net loss of $43.5 million for Q1 2026, compared to $35.9 million in Q1 2025, driven by increased R&D and manufacturing costs.

• Cash and cash equivalents of $116.6 million as of March 31, 2026; raised an additional $141 million and $150 million in May 2026.

• Research and development expenses rose to $37.4 million (Q1 2026), up from $29.0 million (Q1 2025), mainly due to expanded clinical activities and manufacturing.

• General and administrative expenses decreased to $6.9 million from $8.1 million year-over-year.

• Net proceeds of $22.6 million from ATM sales and $6.9 million from warrant exercises in Q1 2026.

Outlook and guidance

• Current cash runway, including May 2026 financing, expected to fund operations into mid-2027.

• Anticipates continued increase in R&D and G&A expenses as clinical programs advance and manufacturing scales.

• Pivotal RESET-Myositis cohort progressing, with BLA submission planned for 2027; updates on RESET-SSC and RESET-MG trial designs anticipated in 2026.

• Initial data from lowest dose RESET-SLE cohort without preconditioning expected in 1H26; longer-term and higher dose data anticipated in 2H26.

• Complete Phase 1/2 data from RESET-SLE and RESET-SSC to be presented at EULAR Congress in June 2026.