Summary of Kyverna Therapeutics FY Conference Call Company Overview - **Company**: Kyverna Therapeutics (NasdaqGS:KYTX) - **Focus**: Development of CAR T therapies for autoimmune diseases, specifically targeting Stiff Person Syndrome (SPS) and Myasthenia Gravis (MG) [2][3] Key Points and Arguments Clinical Progress - **Transformative Year**: 2025 was described as a transformative year for Kyverna, with significant advancements in clinical data for SPS and MG [2][3] - **Patient Outcomes**: - In SPS trials, patients showed dramatic improvements in mobility, with one patient reducing their 25-foot walk test time from 17.3 seconds to 4.5 seconds (74% reduction) [4][5] - Over 80% of patients experienced clinically meaningful responses to therapy [12] - Patients previously reliant on walking aids were able to walk normally post-treatment [12] - **Regulatory Pathway**: A clear regulatory pathway has been established with the FDA for both SPS and MG, with plans to file a Biologics License Application (BLA) for SPS in the first half of 2026 [20][21] Market Opportunity - **SPS Market Size**: Approximately 6,000 diagnosed patients in the U.S., with 2,000 to 2,500 being particularly in need of new therapies [25][26] - **Economic Burden**: Current off-label treatments like IVIG cost hundreds of thousands of dollars annually without effective results, highlighting the economic value of Kyverna's therapy [26][40] - **Patient Demographics**: The majority of SPS patients are of working age, emphasizing the urgency for effective treatment to improve their quality of life [26] Commercialization Strategy - **First Mover Advantage**: Kyverna aims to leverage its first mover advantage in the CAR T space for autoimmune diseases, with plans to activate new treatment centers and engage with patient advocacy groups [22][23][27] - **Manufacturing Preparedness**: The company has validated manufacturing processes with a 95% success rate, ensuring readiness for commercial demand [50] Future Developments - **Pipeline Expansion**: Kyverna is exploring additional indications such as Multiple Sclerosis (MS), Rheumatoid Arthritis (RA), and Lupus Nephritis, with promising early data [28][29] - **Next-Generation Therapy**: KYV-102, a second-generation CAR T therapy, has been filed for IND, aiming to simplify patient access and reduce costs [51][52] Competitive Landscape - **Differentiation**: Kyverna's approach focuses on deep B-cell depletion and resetting the immune system, which distinguishes it from other therapies, including T-cell engagers [45][46] - **Long-Term Vision**: The company is positioned to address high unmet needs in autoimmune diseases, with a focus on executing its strategy effectively [48][49] Additional Important Insights - **Physician Feedback**: Physicians treating SPS patients expressed surprise and excitement over the significant improvements seen in clinical trials, indicating a strong unmet need in the market [34][35] - **Pricing Strategy**: The company anticipates a premium pricing model for its CAR T therapy, justified by the substantial cost savings and benefits it offers compared to existing treatments [40][41] This summary encapsulates the key points discussed during the conference call, highlighting Kyverna Therapeutics' advancements, market opportunities, and strategic plans for the future.

As filed with the Securities and Exchange Commission on April 29, 2024. Registration Statement No. 333-275997 UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 Amendment No. 1 to Form S-1 REGISTRATION STATEMENT UNDER THE SECURITIES ACT OF 1933 Mustang Bio, Inc. (Exact name of registrant as specified in its charter) (State or Other Jurisdiction of Incorporation or Organization) Delaware 2834 47-3828760 (Primary Standard Industrial Classification Code Number) Identification Number) 377 P ...