Cabaletta Bio (CABA) Q4 2025 earnings summary

Executive summary

• Advanced two innovations: rese-cel with no preconditioning and automated manufacturing using Cellares Cell Shuttle, with clinical data expected in 1H26 and durability data throughout 2026.

• Registrational cohort for myositis enrolling, targeting a 2027 BLA submission; pivotal trial designs for SLE and LN announced, with SSc design update expected in 1H26.

• RESET clinical program spans multiple autoimmune diseases in rheumatology, neurology, and dermatology.

Financial highlights

• Research and development expenses rose to $36.2M for Q4 2025 and $142.7M for FY 2025, up from $25.5M and $97.2M in 2024.

• General and administrative expenses were $6.4M for Q4 2025 and $29.6M for FY 2025, compared to $8.3M and $27.9M in 2024.

• Net loss for Q4 2025 was $41.9M and $167.9M for FY 2025, compared to $32.6M and $115.9M in 2024.

• Cash, cash equivalents, and short-term investments totaled $133.6M as of December 31, 2025, with an additional $30M raised in Q1 2026.

• Cash position expected to fund operations into Q4 2026.

Outlook and guidance

• Initial RESET-SLE data (no preconditioning) expected in 1H26, with durability data from RESET-SLE and RESET-PV throughout 2026.

• Complete Phase 1/2 data from RESET-SSc, RESET-SLE, and RESET-MG trials to be presented in 1H26.

• Update on registrational designs for RESET-SSC in 1H26 and RESET-MG in mid-2026.

• BLA submission for rese-cel in myositis planned for 2027.