Summary of Cullinan Therapeutics 2026 Conference Call Company Overview - **Company**: Cullinan Therapeutics (NasdaqGS: CGEM) - **Focus**: Development of T cell engager programs for autoimmune diseases and oncology Key Priorities and Portfolio - **2026 Significance**: First year with catalysts across the entire portfolio, particularly for two high-priority T cell engager programs: - **CLN-978**: CD19 x CD3 bispecific T cell engager for autoimmune diseases - **CLN-049**: FLT3 x CD3 T cell engager for acute myeloid leukemia (AML) [5][6] CLN-978 Program - **Potential**: Considered a best-in-class molecule for autoimmune diseases with a global development program targeting lupus, rheumatoid arthritis (RA), and Sjögren's disease [6] - **Differentiation**: High binding affinity for CD19, small molecular size for better tissue penetration, and subcutaneous administration convenience [6] - **Data Readouts**: Planned throughout 2026 for all three indications [6] - **Market Interest**: B cell depletion remains a hot area, with strategic acquisitions in the sector, indicating strong market interest [7] CLN-049 Program - **Potential**: First-in-class potential for a broad group of AML patients, with compelling monotherapy efficacy data presented at ASH [8] - **Regulatory Designation**: Received Fast Track designation from the FDA, facilitating a pivotal single-arm study for potential approval [8] - **Commercial Opportunity**: Aiming for significant commercial potential in the AML market, with plans for a combination study later in the year [8][34] Financial Position - **Cash Reserves**: Over $430 million reported at the end of 2025, providing a runway into 2029 to advance programs without immediate capital raising needs [9] Clinical Development Updates - **Enrollment Progress**: Completed first two dose cohorts for CLN-978 and currently accruing into the 30 microgram dose level for lupus and RA studies [11] - **Efficacy Expectations**: Anticipating a dose-response effect for B cell depletion in upcoming data releases [14][15] Competitive Landscape - **Market Position**: The company aims to be the first to present company-sponsored data for a CD19 T-cell engager, enhancing competitive positioning [19] - **Strategic Acquisitions**: Acquired a BCMA TCE to expand the reach in autoimmune diseases, allowing for a broader patient base [27][28] Future Plans - **Pivotal Studies**: Plans to initiate a phase 2 single-arm study for CLN-049 in 2027, targeting relapsed refractory AML patients [40] - **Combination Studies**: Intent to begin a phase 1b/2 combination study with AZA in previously untreated AML patients [37] Zipalertinib Program - **NDA Submission**: Completion of the relapsed study marks a significant milestone, with Taiho leading further development [41] - **Financial Impact**: Potential for $130 million in regulatory milestones and a 50/50 profit share in the U.S. [42] Conclusion - **Outlook for 2026**: A defining year for Cullinan Therapeutics with multiple catalysts and significant potential in both autoimmune diseases and oncology, supported by a strong financial position and strategic development plans [9][43]

Summary of Artiva Biotherapeutics Conference Call Company Overview - **Company**: Artiva Biotherapeutics - **Founded**: 2019 - **Focus**: NK cell therapies, specifically non-genetically modified NK cells combined with monoclonal antibodies for enhanced B cell killing [2][3] Core Points and Arguments NK Cell Therapy Advantages - **Non-Genetically Modified NK Cells**: Artiva's NK cells are sourced from umbilical cord units, allowing for the production of thousands of vials with a billion cryopreserved NK cells each, with a shelf life of 3-4 years [2] - **Safety Profile**: NK cells are reported to have a safer profile compared to T cell modalities, reducing the risk of cytokine release syndrome [3][10] - **Efficacy**: The combination of NK cells with monoclonal antibodies enhances the potency of B cell killing, which has been demonstrated in clinical trials [6][7] Current Trials and Indications - **Autoimmunity Trials**: Artiva is currently running trials in the autoimmunity space, exploring various indications [4] - **CYFLU Regimen**: The use of cyclophosphamide (CY) and fludarabine (FLU) is intended to enhance NK cell survival and reduce B cell burden, with low doses deemed safe [10][12][13] Competitive Landscape - **Efficacy vs. Safety**: Artiva aims to demonstrate that their allo-NK therapy can achieve high efficacy while maintaining a favorable safety profile, making it suitable for community administration [6][7][19] - **Comparison with Other Therapies**: The company acknowledges the need to show superiority over existing therapies, including rituximab and other B cell depleting modalities [37][38] Enrollment and Data Generation - **Enrollment Update**: Over a dozen patients have been enrolled across more than a dozen sites, with a focus on generating robust safety and efficacy data [26][30] - **Data Sharing Plans**: Artiva plans to share pooled data on B cell depletion and safety by year-end, with a focus on demonstrating the therapy's effectiveness compared to standard care [30][32] Future Directions - **Lead Indication Announcement**: The company intends to announce its lead indication by year-end, aiming to differentiate itself in the competitive landscape [31][32] - **Pivotal Trials**: Artiva is optimistic about moving towards pivotal trials based on the data generated from ongoing studies [46] Other Important Content - **Prophylactic Measures**: The use of prophylactic antibiotics, antivirals, and antifungals is discussed to mitigate infection risks associated with lymphodepletion [19][22] - **Community Setting Compatibility**: The therapy is designed to be manageable in a community setting, allowing for outpatient treatment and reducing the need for hospitalization [23][24] - **Immune Reset Concept**: The concept of immune reset is introduced, where deep B cell depletion leads to a more naive phenotype of reconstituted B cells, potentially reducing autoantibodies [34][35] This summary encapsulates the key points discussed during the conference call, highlighting Artiva Biotherapeutics' innovative approach to NK cell therapies and its strategic positioning within the competitive landscape of autoimmune treatments.