Summary of Allogene Therapeutics Conference Call Company Overview - **Company**: Allogene Therapeutics (NasdaqGS:ALLO) - **Founded**: 2018 - **Focus**: Development of Allogene CAR-T therapies, particularly in hematologic malignancies and autoimmune diseases [2][3] Key Programs and Developments 1. Cema-cel (CD19-directed CAR-T) - **Indications**: Hodgkin's lymphoma and large B-cell lymphoma - **Clinical Setting**: Targeting MRD positive patients post R-CHOP treatment, aiming for frontline consolidation therapy [3][9] - **Study Design**: Randomized one-to-one trial comparing cema-cel treatment to observation, with an expected enrollment of approximately 220 patients [10] - **Market Opportunity**: Estimated market size for frontline consolidation therapy is around $5 billion in the US and Europe, compared to $2.5 billion-$3 billion for relapse refractory settings [12] 2. Allo329 (Dual CD19/CD70 CAR-T) - **Indications**: Autoimmune diseases - **Objective**: Reduce lymphodepletion while targeting both B-cells and T-cells [4][5] - **Current Status**: Enrolling patients in a dose escalation study, with initial data expected in the first half of 2026 [14] 3. Allo316 (Solid Tumor Program) - **Indications**: Renal cell cancer - **Response Rate**: Approximately 31% in heavily pre-treated patients, with durable responses observed beyond one year [15][16] - **Safety Profile**: Consistent with active CAR-T therapies, including lymphodepletion-related cytopenia and cytokine release syndrome [17] Clinical and Market Insights - **MRD Testing**: Utilized to identify high-risk patients for targeted therapy, with a projected 25%-30% improvement in MRD conversion seen as a significant breakthrough [21][22] - **Regulatory Engagement**: Event-free survival (EFS) is the primary endpoint for the AlphaTreE study, with MRD negativity used as a proxy for efficacy [29] Strategic Initiatives - **Community-Based Treatment**: Expanding access to CAR-T therapies in community cancer centers to capture more patients [11][20] - **Manufacturing Capacity**: Dedicated facility capable of producing up to 60,000 doses per year, with reduced cost of goods to biologic levels [6] Future Expectations - **Upcoming Data Releases**: Initial interim analysis for cema-cel and proof of concept data for autoimmune studies expected in the first half of 2026 [32] Conclusion Allogene Therapeutics is advancing its innovative CAR-T therapies with a focus on addressing unmet needs in hematologic malignancies and autoimmune diseases. The company is strategically positioning itself to capture significant market opportunities while enhancing patient access through community-based treatment initiatives.

Financial Data and Key Metrics Changes - As of September 30, 2025, the company reported $277.1 million in cash, cash equivalents, and investments, with a cash runway extending into the second half of 2027 [17] - R&D expenses for Q3 2025 were $31.2 million, including $2.8 million of non-cash stock-based compensation, while G&A expenses were $13.7 million, including $5.9 million in non-cash stock-based compensation [17] - The net loss for Q3 was $41.4 million, or $0.19 per share, with an expected cash burn of approximately $150 million for 2025 [17][18] Business Line Data and Key Metrics Changes - The AlphaTru trial of cema-cel has been streamlined into a two-arm randomized study, with over 50 active sites across the U.S. and Canada, and expansion into Australia and South Korea expected early next year [8][9] - The Dagger technology has shown durable responses in nearly one-third of patients with metastatic kidney cancer, highlighting its potential in solid tumors [11][12] Market Data and Key Metrics Changes - The company is preparing for pivotal interim data from cema-cel in the AlphaTru trial and proof of concept from Allo329 in autoimmune disease, both expected to shape the next era of cell therapy [6][7] Company Strategy and Development Direction - The company aims to democratize access to cell therapies through Allogene XL Technology, which is designed to reduce costs and expand access to transformative treatments [5][6] - The focus remains on building scalable, reproducible therapies ready for patients, with significant milestones expected in the first half of 2026 [66] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the strength of the AlphaTru program and its potential to advance lymphoma treatment, with a focus on delivering meaningful clinical outcomes [11][15] - The company is optimistic about the upcoming milestones and believes they will validate the Allogene XL platform, shaping the company's trajectory [66] Other Important Information - The company is not waiting for the future of cell therapy but is actively creating it with a focus on data and a platform built for lasting impact [6][15] - The operational and scientific progress is supported by disciplined capital management, ensuring long-term value for shareholders [17][18] Q&A Session Summary Question: Can you see any data beyond MRD conversion for the futility analysis? - Management plans to focus on MRD conversion and not on primary endpoints for efficacy during the futility analysis [20][21] Question: What percentage of active sites are now able to start actively enrolling patients? - Nearly all of the over 50 active sites are open to enrollment, with only the most recently activated sites having minor setup tasks remaining [25][26] Question: What is the expected size and breadth of the data set for Allo329 next year? - Initial communication will involve a handful of patients showing biomarker and early clinical responses [29][30] Question: How many patients have consented for MRD testing in AlphaTru? - The pace of consenting has held steady, and the MRD positive rate is consistent with initial assumptions [33][34] Question: How are you controlling for variability in the MRD assay across different sites? - The MRD test is centrally conducted by Foresight Diagnostics, ensuring consistency in test performance [62][63]