Summary of Climb Bio Conference Call Company Overview - **Company**: Climb Bio - **Focus**: Development of monoclonal antibodies for autoimmune diseases, specifically targeting CD19 and APRIL Key Milestones and Upcoming Data - **2026**: Significant year for Climb Bio with multiple data readouts expected - **Budoprutug (CD19 monoclonal antibody)**: - Data from subcutaneous (subQ) formulation in healthy volunteers expected in the first half of 2026 - Data for ITP (Immune Thrombocytopenic Purpura) and SLE (Systemic Lupus Erythematosus) in the second half of 2026 - **Climb 116 (anti-APRIL for IgA nephropathy)**: - Healthy volunteer data anticipated mid-2026 - Focus on potential best-in-class assets for rare autoimmune diseases [2][10][27] Differentiation and Market Opportunity - **CD19 Antibody**: - High affinity for CD19, allowing for broader patient access - Only two monoclonal antibodies targeting CD19 in clinical development: Oplinza and Budoprutug - Oplinza has been successful but focuses on rare neurological diseases, leaving a gap in B-cell mediated diseases [4][5][6] - **IgA Nephropathy**: - Approximately 70,000 patients with no approved therapies, presenting a significant commercial opportunity - Current off-label use of Rituximab shows low efficacy (12%-14% complete renal response at 12 months) [10][11][37] Clinical Development Strategy - **Phase Two Study**: Initiated for PMN (Primary Membranous Nephropathy) with guidance on additional milestones forthcoming - **Indication Strategy**: Focus on high unmet needs in ITP and SLE, with a cautious approach to moving forward based on data [7][8][12] - **SLE Program**: Requires significant investment for late-phase development, with a focus on safety and potential immune reset in patients [16][17] Dosing and Formulation - **Dosing Strategy**: Careful selection of doses based on recent learnings from other CD19 programs, aiming for deep B-cell depletion rather than just peripheral suppression [19][21] - **SubQ Formulation**: Expected to be ready for phase three studies across all indications, optimizing patient access and market potential [22][23] Financial Overview - **Cash Position**: $176 million at the end of Q3, providing a runway through 2027, covering all data releases in 2026 [36] Regulatory Path and Study Size - **Regulatory Clarity**: Established path for PMN with a focus on complete renal response as a registrational endpoint - **Study Size**: Approximately 150 patients for PMN, manageable for a company of Climb Bio's size [37][38] Investor Interest - Growing interest in both Budoprutug and Climb 116, with investors recognizing the competitive profiles of both drugs in their respective markets [35]