Cabaletta Bio, Inc.

Good morning. At this time, I would like to welcome everyone to Caballero Bio's conference call and webcast. Currently, all participants are in a listen-only mode. After the speaker's remarks, there will be a question and answer session. Please note that this call is being recorded and is the property of Caballero Bio. Unauthorized recording, reproduction, or transmission of this call without the express written consent of Caballero Bio is strictly prohibited. I would now like to turn the call over to Will Gramick,

of precision aq please go ahead thank you michelle good morning everyone and thank you for joining cabaletta bios conference call and webcast to discuss clinical and translational data from the first eight patients in the phase one two reset program in myositis lupus and systemic sclerosis that were presented at acr convergence 2024 in oral and poster presentations over the weekend Before we begin, I encourage everyone to go to the Investors section of our website at cabalettabaya.com, where you can find the press release and slides related to today's call. I would like to remind everyone that we will be making forward-looking statements, which are based on our current expectations and beliefs. These statements are subject to certain risks and uncertainties, and your actual results may differ materially. Please review the risk factors in our SEC filings for additional details. We will begin the call with prepared remarks by Stephen Knicksberger, our CEO, Carl June, the director of the Center for Cellular Immunotherapies at Penn Medicine, pioneer of the first CAR-T cell therapy approved in oncology, and member of CAB11's Scientific Advisory Board, will provide an overview of the lessons from CAR-T cell therapy in oncology. as it relates to the expansion into autoimmunity. Then David Chang, our CMO, will review the results of the updated clinical data presented at ACR in more detail. In addition to the previously mentioned speakers, Gwen Bender, our President of Science and Technology, and Denise Marta, our CFO, will join for the question and answer portion of the call. With that, I'll now turn the call over to Dr. Nick Wilkerson.

Thanks, Will, and thank you everyone for joining us today. We're excited that we had the opportunity to share updated clinical and translational data from our Reset Clinical Program, evaluating Kappa-201 in myositis, lupus, and systemic sclerosis this weekend at ACR. We're evaluating whether a single dose of Kappa-201 can safely deliver through telling clinical responses after discontinuation of all immunosuppressants. By way of background, Kappa-201 was specifically designed for patients with autoimmune diseases. It was engineered to be similar to the academic 4-1-BB co-stim domain containing BB-19 CAR-T that's been evaluated in multiple academic studies. Kappa-201 contains the identical signaling and 4-1-BB co-stim domains as the academic construct. with a fully human CD19 targeting domain that binds to the same epitopes on the CD19 antigen as the urine FMC53 binder utilized in the academic studies with the same biologic activity as published earlier this year. Next slide, please. Kappa-201 is being studied across a broad range of autoimmune diseases within four specific company-sponsored INDs in lupus, myositis, systemic sclerosis, and myasthenia gravis, each with distinct disease-specific cohorts. In addition, Kappa-201 is being evaluated a fifth indication without any preconditioning regimen in the RESET-PV trial with seven clinical sites already actively enrolling. Today's presentation focuses on clinical and translational data from the RESET myositis and the RESET SLE trials, as well as initial clinical data from the RESET SSE trial, which we believe support a favorable risk-benefit profile and the use of the selected dose of Kava-201 at one times 10 to the sixth cells per kilogram. The data we will present supports the potential of Kava-201 to deliver compelling immunosuppressant-free clinical responses for patients with active refractory disease while tapering steroid doses to complete elimination. Next slide, please. The recent clinical trial program currently has 40 clinical sites open for enrollment, with 16 patients enrolled and 10 patients already dosed across the program as of November 12th. We recently announced that clinical development expanding into Europe with EMA CTA authorization for Capital One receives for a reset SLE and the appointment of Gavin Winter as our new head of international. With an expanding clinical site footprint and efficient clinical development strategy, data permitting, we anticipate meeting with the FDA as early in 2025 as data will allow regarding potential registrational design for CAHPS 201. Next slide, please. With that, I'll turn the call over to Carl June, pioneer of the first CAR T-cell therapy approved in oncology and director of the Center of Cellular Immunotherapies and Medicine, to provide his perspective on the lessons from CAR T-cell therapy in oncology as it relates to the expansion into autoimmunity. Carl.