Financial Data and Key Metrics Changes - The company has seen significant progress in the development of CABA-201, with multiple diseases fully enrolled in the RESET clinical development program, indicating a strong pipeline and potential for future revenue growth [6][11][70] - The safety profile of CABA-201 is notably better than traditional CAR-T therapies, with approximately one-third of patients experiencing CRS, mostly grade 1, which is significantly lower than oncology counterparts [14][29] Business Line Data and Key Metrics Changes - The myositis pivotal trial is set to initiate enrollment imminently, with the company expecting to generate data in 2026, which could lead to a strong market position in this therapeutic area [11][12] - The lupus program is also progressing, with early data showing promising results, indicating a robust pipeline across multiple autoimmune diseases [8][9] Market Data and Key Metrics Changes - The company is preparing to launch CABA-201 in a market that is increasingly recognizing the value of outpatient CAR-T therapies, which could lead to a more sustainable financial model compared to traditional inpatient therapies [12][38] - The competitive landscape includes other CAR-T therapies, but the company believes its safety profile and outpatient potential will differentiate it from competitors [10][50] Company Strategy and Development Direction - The company aims to leverage its outpatient therapy model to create a financially sustainable CAR-T infusion center, contrasting with the traditional inpatient model that has been financially burdensome [37][62] - The partnership with Cellares for fully automated manufacturing is expected to enhance scalability and cost-effectiveness, positioning the company favorably in the market [63][64] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the future, highlighting the potential for CABA-201 to transform treatment for autoimmune diseases and the company's readiness to file for BLA in 2027 [70] - The management emphasized the importance of educating both patients and physicians about the benefits of CABA-201, particularly regarding the safety and efficacy compared to traditional therapies [42][49] Other Important Information - The company has established a large clinical footprint with 77 sites across the U.S., which is expected to facilitate a successful launch and broad patient access [35][61] - The company is focused on ensuring that the product is available at all sites, aiming to avoid supply constraints that have plagued other CAR-T therapies [34][39] Q&A Session Summary Question: How does the safety profile of CABA-201 compare to other CAR-T therapies? - The safety profile of CABA-201 shows a lower incidence of CRS, with most cases being grade 1, which is a significant differentiator from other autologous CAR-T therapies [14][29] Question: What are the company's plans for outpatient therapy? - The company intends to implement outpatient therapy for the myositis pivotal study, which has been reviewed and aligned with the FDA [28][30] Question: How does the company plan to address potential manufacturing bottlenecks? - The company is working with CDMOs to ensure sufficient supply at launch and is focused on avoiding the common manufacturing issues seen in other CAR-T therapies [33][34] Question: What is the company's strategy regarding pricing and reimbursement? - The company believes it can price CABA-201 competitively based on the value it delivers, especially when compared to annual therapies that cost between $250,000 and $500,000 [58][59] Question: How does the company view competition from other modalities like bispecifics? - The company remains confident in the efficacy of CAR-T therapies and believes it can outperform bispecifics in terms of patient outcomes [50][51]