Cabaletta Bio

Today, we reported our financial results for 4Q and the full year 2025. We also provided a business update highlighting progress with rese-cel as a potential treatment for autoimmune diseases, including: ➡️ Registrational DM/ASyS cohort in RESET-Myositis® enrolling with outpatient dosing option ➡️ First clinical experience using automated Cellares manufacturing platform expected in 1H26 ➡️ No-preconditioning program advancing in RESET-SLE™ and RESET-PV® ➡️ Recent Nature Biotechnology publication and company presentation at the 2025 ASH Annual Meeting highlight rese-cel safety data across autoimmune portfolio ➡️ Complete Phase 1/2 data anticipated from three RESET™ trials to be presented in 1H26 Read our full press release here: https://lnkd.in/eYPJ-jT2 #CART #CellTherapy #RESET #Autoimmune

Our team will participate in a fireside chat at the TD Cowen 46th Annual Health Care Conference today, March 3rd. Join the live webcast at 11:10am ET at the following link: https://lnkd.in/emdaZq4f #tdcowen #celltherapy #reset #autoimmune

It was an honor to have David J. Chang, MD, MPH, FACR, Cabaletta Bio's Chief Medical Officer, speak at Rare Disease Day at NIH on Friday, where he shared his perspective on the value of public-private partnerships to bring therapies like rese-cel closer to patients living with rare diseases.   During the session, Rare Research: How Collaboration Becomes Cures – A Juvenile Myositis and CAR T Story, Cure JM Foundation and David highlighted how early industry partnerships with the NIH, academic institutions, clinical researchers, and patient organizations can meaningfully accelerate drug development progress.   In addition, we are grateful for the opportunity to review how Cabaletta Bio is advancing therapeutic breakthroughs for rare diseases with rese-cel, a potentially curative treatment for patients living with autoimmune diseases like juvenile myositis.   Thank you to the organizers of Rare Disease Day at NIH and Cure JM Foundation for the opportunity to contribute to this important day of recognition in support of patients living with rare diseases. #RDDNIH #raredisease #autoimmune #CART

We are pleased to see the rese-cel clinical experience contribute to ongoing scientific and medical dialogue that supports CAR T therapy as a safe and compelling treatment option for patients living with autoimmune diseases. As recently featured in Nature Biotechnology, “Clinical progress of engineered cellular immunotherapies for autoimmunity”, the article reflects on meaningful progress made across the field in establishing the safety of CAR T therapy for autoimmune diseases relative to its experience from the oncology setting. The latest data from rese-cel, reported at ASH 2025 and spanning 40 patients living with multiple autoimmune diseases, illustrated that 95% of patients experienced either no CRS or Grade 1 CRS (transient fever) and 95% of patients experienced no ICANS. We believe this emerging safety profile supports potential outpatient administration in the ongoing registration-enabling RESET-Myositis® trial. To read the Nature Biotechnology publication, visit https://lnkd.in/eP7fDKut. For the latest rese-cel safety data, visit https://lnkd.in/eYuCeXRy. #CART #CellTherapy #RESET #Autoimmune

2026 is about coming closer to turning our vision into reality – delivering curative targeted cell therapies designed specifically for patients living with autoimmune diseases.   In this spirit, our ambitions for rese-cel this year are guided by three core priorities:   ➡ Translate clinical breakthroughs into patient-centric medicines: Our FDA-aligned registrational cohort in myositis is now enrolling to support our planned rese-cel BLA submission in 2027.   ➡ Unlock significant value from innovative manufacturing: Our partnership with Cellares has the potential to automate, lower costs and increase scale of manufacturing, all of which are critical steps toward broader patient access to rese-cel.   ➡ Expand the clinical experience with process innovations: Multiple rese-cel clinical datasets across autoimmune diseases, with and without preconditioning, are anticipated throughout the year.   Learn more about how we’re redefining what’s possible in autoimmune disease care by reading our full press release here: https://lnkd.in/ekE-Hq5M   #CART #CellTherapy #RESET #Autoimmune

This past weekend at #ASH25, our team presented updated insights reinforcing the generally well-tolerated and consistent safety profile of rese-cel.   In the poster presentation, we featured favorable safety and biologic activity data from 40 patients living with myositis, lupus, systemic sclerosis and myasthenia gravis who were treated with rese-cel and completed at least one month of follow-up. Collectively, these data continue to highlight rese-cel’s favorable patient and physician treatment experience.   We are grateful to ASH platform for the opportunity to share these findings as we move to bring rese-cel closer to patients living with autoimmune diseases. Read the poster presented at the conference here: https://lnkd.in/evMvwmGr   #CART #CellTherapy #RESET #Autoimmune

Cabaletta Bio will participate in a fireside chat at the Jefferies Global Healthcare Conference in London today, November 17th. Join the live webcast at 1:30pm GMT / 8:30am ET at the following link: https://lnkd.in/eMhnzX6F #jefferies #celltherapy #reset #autoimmune

Cabaletta Bio reported our third quarter 2025 earnings and provided a business update.   With recent clinical data presentations last month at multiple major scientific meetings demonstrating potentially transformative, drug-free responses in patients following rese-cel infusion, we look forward to initiating our first registrational cohort this quarter evaluating rese-cel in myositis and moving with urgency to bring rese-cel closer to patients living with autoimmune diseases.   Read our full press release here: https://lnkd.in/eBYMR72X   #CART #CellTherapy #RESET #Autoimmune

In multiple oral and poster presentations at American College of Rheumatology (ACR) Convergence 2025, we are proud to share clinical and translational insights highlighting the transformative impact of rese-cel on patients across the RESET-Myositis™, RESET-SSc™, and RESET-SLE™ trials.   In myositis, all DM/ASyS patients with sufficient follow-up who would meet the key inclusion criteria for the registrational cohort exceeded the primary endpoint of the registrational cohort, which is initiating this quarter.   In lupus, we are accelerating our no preconditioning strategy by initiating a cohort within the RESET-SLE study with initial clinical data anticipated next year. Read our press release https://lnkd.in/eV3AspD7   #celltherapy #reset #autoimmune #myositis #systemicsclerosis #lupus #ACR2025

Hundreds of attendees packed today's Basic & Clinical Research Conference at #ACRConvergence for a full day focused on CAR T therapy for patients with autoimmune disease. Engaging talks from Georg Schett, Meghan Sise and Marcela Maus highlight the scientific advances and the operational learnings shaping this transformative modality for autoimmune disease. The momentum is building! #CART #Autoimmune #ACRConvergence #CabalettaBio