**Cabaletta Bio Reports Financial Results and Strategic Progress in Autoimmune Disease Therapies**
Cabaletta Bio, Inc., a clinical-stage biotechnology company, has released its financial results, revealing a net loss of $167.9 million for the year ended December 31, 2025, compared to a net loss of $115.9 million in the previous year. The increased loss is primarily attributed to escalating research and development expenses as the company advances its engineered T cell therapies for autoimmune diseases. As of December 31, 2025, Cabaletta Bio held $133.6 million in cash, cash equivalents, and investments. The company anticipates that these funds will sustain operations into the fourth quarter of 2026, but acknowledges the need for substantial additional funding to complete ongoing and future clinical trials.
The company's research and development expenses for 2025 totaled $142.7 million, a significant increase from $97.2 million in 2024. This rise is primarily due to expanded cell processing capabilities, increased patient enrollment across multiple clinical studies for rese-cel, and higher personnel-related expenses. General and administrative expenses also saw a slight increase, reaching $29.6 million in 2025 compared to $27.9 million in 2024, driven by higher personnel-related expenses. The company's strategic focus remains on its CABA platform, which utilizes Chimeric Antigen Receptor T cells for Autoimmunity (CARTA) to potentially reset the immune system in patients with autoimmune diseases.
Operationally, Cabaletta Bio has made significant strides in its clinical programs. In December 2025, the company initiated a registrational trial for rese-cel in patients with dermatomyositis or anti-synthetase syndrome. Additionally, Phase 1/2 trials evaluating rese-cel in systemic lupus erythematosus (SLE), systemic sclerosis (SSc), and generalized myasthenia gravis (gMG) are ongoing. The company is also evaluating rese-cel without preconditioning in non-renal SLE and lupus nephritis (LN) patients, building on early data from a Phase 1/2 trial in pemphigus vulgaris patients. In January 2026, Cabaletta Bio announced IND clearance for rese-cel to be manufactured using an automated platform from Cellares Corporation, potentially enabling scalability for thousands of patients per year.
Looking ahead, Cabaletta Bio anticipates presenting initial clinical experience data from patients treated with rese-cel manufactured by the Cellares Cell Shuttle in the first half of 2026. Durability data from patients treated without preconditioning for SLE, LN, and PV, as well as those treated with rese-cel manufactured by the Cellares Cell Shuttle, is expected in the second half of 2026. The company has identified conditions that raise substantial doubt about its ability to continue as a going concern and will need to raise additional capital to fund its future operations and remain as a going concern. Cabaletta Bio is actively pursuing strategic collaborations and licensing arrangements to support its development and commercialization efforts.
About Cabaletta Bio, Inc.
Cabaletta Bio is a clinical-stage biotechnology company developing engineered T cell therapies targeting autoimmune diseases. Its proprietary CABA platform includes CARTA and CAART strategies to reset or eliminate disease-causing B cells. The company’s lead candidate, rese-cel, aims to provide durable, potentially curative responses across multiple autoimmune conditions. It collaborates with academic and manufacturing partners to advance innovative, scalable therapies with a focus on safety and broad patient impact.
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