Cabaletta Bio Inc.
03/23/2026 | Press release | Distributed by Public on 03/23/2026 05:33
No-preconditioning program enrolling in lupus and PV; anticipating initial RESET-SLE data in 1H26 and durability data from the RESET-SLE and RESET-PV® trials throughout 2026[...]
No-preconditioning program enrolling in lupus and PV; anticipating initial RESET-SLE™ data in 1H26 and durability data from the RESET-SLE and RESET-PV® trials throughout 2026
Automated manufacturing of rese-cel with Cellares' Cell Shuttle™ underway in the RESET™ clinical program, offering the potential to produce rese-cel for thousands of patients per year with minimal capital investment
Pivotal trial designs announced for SLE and LN single arm cohorts, each with ~25 patients; on track to announce SSc design in 1H26; FDA registrational design discussions and no preconditioning data will inform pivotal plans across the rese-cel program
Complete Phase 1/2 data to be presented in 1H26 from the RESET-SSc™, RESET-SLE and RESET-MG™ trials evaluating rese-cel with preconditioning
PHILADELPHIA, March 23, 2026 -- Cabaletta Bio, Inc. (Nasdaq: CABA), a late-stage clinical biotechnology company focused on developing and launching the first curative targeted cell therapies designed specifically for patients with autoimmune diseases, today reported financial results for the fourth quarter and full year ended December 31, 2025, and provided a business update.
"As we advance our core clinical programs for rese-cel with preconditioning and standard manufacturing, we have meaningfully advanced two potentially transformative innovations: rese-cel with no preconditioning and automated manufacturing using the Cellares Cell Shuttle. Clinical data on both innovations are on track to be shared in the first half of this year with durability data to follow later this year. Clinical data currently suggest that rese-cel offers a competitive profile that may reliably deliver an immune reset following a single, weight-based infusion with a safety profile that facilitates outpatient delivery with - or potentially without - preconditioning," said Steven Nichtberger, M.D., Chief Executive Officer of Cabaletta.
Recent Operational Highlights and Upcoming Anticipated Milestones
Rese-cel: Rese-cel (resecabtagene autoleucel) is an investigational, autologous CAR T cell therapy engineered with a fully human CD19 binder and a 4-1BB co-stimulatory domain, designed specifically for the treatment of autoimmune diseases. Administered as a single, weight-based infusion, rese-cel has demonstrated the ability to transiently, reliably and deeply deplete CD19-positive cells, with the goal of resetting the immune system and achieving durable clinical responses without the need for chronic therapy. Cabaletta is evaluating rese-cel in the RESET™ (REstoring SElf-Tolerance) clinical development program, which includes multiple
ongoing company-sponsored trials across a broad range of autoimmune diseases in rheumatology, neurology and dermatology.
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Registrational DM/ASyS cohort in RESET-Myositis® enrolling with outpatient dosing option: The registrational dermatomyositis (DM) and antisynthetase syndrome (ASyS) cohort is enrolling and is expected to evaluate 17 patients with a 16-week primary endpoint of moderate or major total improvement score response while off immunomodulators and on no or low-dose steroids. If successful, data from this cohort will support Cabaletta's first projected Biologics License Application (BLA) submission for rese-cel in myositis in 2027.
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First clinical experience using automated Cellares manufacturing platform expected in 1H26: Cabaletta anticipates reporting the initial clinical experience with rese-cel manufactured by Cellares in 1H26. The initial clinical experience is intended to confirm current Good Manufacturing Practice (GMP) readiness, including supply chain logistics, for Cellares-produced rese-cel implementation across the rese-cel portfolio. Longer-term clinical data from patients receiving rese-cel manufactured by Cellares are expected in 2H26. If successful, the Cellares Integrated Development and Manufacturing Organization (IDMO) Smart Factory has the potential to enable scalability to produce rese-cel for thousands of patients per year with minimal capital investment, lower manufacturing costs through decreased labor requirements with improved scheduling flexibility after commercialization and rapid expansion to global capacity. Cabaletta continues to work with its existing manufacturing partners to support the myositis registrational trial and launch-readiness efforts for rese-cel.
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No-preconditioning program advancing in RESET-SLE and RESET-PV: Clinical data from patients treated with a single weight-based dose of rese-cel with no preconditioning are expected from the RESET-SLE trial in 1H26 (initial data) and 2H26 (durability data). Additionally, dose-ranging durability data from the RESET-PV trial are anticipated throughout 2026, supplementing the initial low dose PV data without preconditioning that were previously presented.
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Recent Nature Biotechnology publication and company presentation at the 2025 ASH Annual Meeting highlight rese-cel safety data across autoimmune portfolio: A recent Nature Biotechnology review, which included rese-cel clinical data, highlighted that CAR T administration in autoimmune diseases has shown a more favorable safety profile when compared to its use in the oncology setting. In addition, Cabaletta's presentation at the 2025 ASH Annual Meeting expanded on these data, showing that in the first 40 patients treated with rese-cel with preconditioning, 95% of patients had either no cytokine release syndrome (CRS) or Grade 1 CRS and 95% of patients experienced no immune effector cell-associated neurotoxicity syndrome.
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Complete Phase 1/2 data anticipated from three RESET trials to be presented in 1H26: Complete Phase 1/2 clinical data from cohorts in RESET-SLE, RESET-SSc and RESET-MG are expected to be presented in 1H26. In RESET-MG, data will be presented in an oral presentation at 1:24 p.m. CDT on Monday, April 20, 2026, at the American Academy of Neurology (AAN) Annual Meeting in Chicago, IL. Complete Phase 1/2 clinical data from cohorts in RESET-SLE and RESET-SSc are also expected in 1H26. These clinical data are expected to support Cabaletta's discussions with the FDA on potential registrational pathways specifically in RESET-SSc and RESET-MG.
Cabaletta anticipates providing an update regarding registrational designs for RESET-SSc in 1H26 and for RESET-MG in mid-2026.
Fourth Quarter and Full Year 2025 Financial Results
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Research and development expenses were $36.2 million and $142.7 million for the three months and full year ended December 31, 2025, respectively, compared to $25.5 million and $97.2 million for the three months and full year ended December 31, 2024, respectively.
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General and administrative expenses were $6.4 million and $29.6 million for the three months and full year ended December 31, 2025, respectively, compared to $8.3 million and $27.9 million for the three months and full year ended December 31, 2024, respectively.
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As of December 31, 2025, Cabaletta had cash, cash equivalents and short-term investments of $133.6 million, compared to $164.0 million as of December 31, 2024. Since December 31, 2025, the Company has raised an additional $30.0 million from a combination of ATM sales and exercise of certain common stock warrants set to expire in September 2026. The Company expects that its cash position as of December 31, 2025, along with cash raised during the first quarter of 2026, will enable it to fund its operating plan into the fourth quarter of 2026.
About Cabaletta Bio
Cabaletta Bio (Nasdaq: CABA) is a late-stage clinical biotechnology company focused on developing and launching the first curative targeted cell therapies designed specifically for patients with autoimmune diseases. The CABA™ platform encompasses two complementary strategies which aim to advance the discovery and development of engineered T cell therapies with the potential to become deep and durable, perhaps curative, treatments for a broad range of autoimmune diseases. The lead CARTA (Chimeric Antigen Receptor T cells for Autoimmunity) strategy is prioritizing the development of rese-cel, a 4-1BB-containing fully human CD19-CAR T cell investigational therapy. Rese-cel is currently being evaluated in the RESET™ (REstoring SElf-Tolerance) clinical development program spanning multiple therapeutic areas, including rheumatology, neurology and dermatology. Cabaletta Bio's headquarters and labs are located in Philadelphia, PA. For more information, please visit www.cabalettabio.com and connect with us on LinkedIn.
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