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- **30% MRD Conversion Target**: ALPHA3 trial aims for 30% MRD clearance in first-line lymphoma, benchmarked against 7% PFS improvement in autologous CAR-T (POLARIX).
- **2026 Milestones**: Interim data readouts for cema-cel (H1 2026) and ALLO-329 autoimmune program (H1 2026).
- **Financial Stability**: $277M cash runway to mid-2027, with disciplined $150M annual cash burn.
- **Platform Differentiation**: Allogeneic manufacturing reduces costs by 70% vs. autologous, enabling off-the-shelf therapies at scale.
- **Autoimmune Innovation**: ALLO-329 targets CD19 and CD70, with built-in lymphodepletion to simplify administration in community settings.


**【CEO Summary Section】**
- Emphasized the scalability and clinical validation of the allogeneic CAR-T platform, with key milestones in 2026: interim futility data from the ALPHA3 trial (cema-cel in first-line lymphoma) and proof-of-concept results from ALLO-329 in autoimmune diseases.
- Highlighted the 30% MRD conversion target for ALPHA3, referencing analogous studies (e.g., IMvigor11 in bladder cancer) to illustrate the potential impact of a modest MRD clearance difference.
- Discussed the Dagger technology's ability to enable lymphodepletion without additional agents, and the cost-efficiency of allogeneic manufacturing compared to autologous therapies.

**【CFO Financial Commentary】**
- Cash runway extended into H2 2027 with $277.1M in cash as of Q3 2025.
- Q3 2025 operating expenses: R&D ($31.2M), G&A ($13.7M), net loss ($41.4M).
- Full-year 2025 guidance: ~$150M cash burn, ~$230M GAAP operating expenses.
- Emphasized the long-term cost-savings potential of allogeneic therapies through pre-manufactured, off-the-shelf products.

**【CFO Financial Commentary】**
- ALPHA3 trial: >50 active sites in US/Canada, with expansion to Australia/South Korea planned for early 2026.
- MRD testing centralized via Foresight Diagnostics to ensure consistency across sites.
- ALLO-329 autoimmune program targeting CD19 and CD70, with dual cohorts (reduced vs. no lymphodepletion) to assess built-in lymphodepletion efficacy.
- Early data expected in H1 2026, focusing on biomarkers and early clinical responses.

**【Q&A Key Highlights】**
- **ALPHA3 Enrollment**: Sites are ~90% active for patient screening, with no material impact from the FCA-LD arm discontinuation.
- **MRD Conversion Bar**: 30% clearance rate aligns with historical 7% PFS improvement in frontline lymphoma (POLARIX) and 11% MRD clearance in bladder cancer (IMvigor11), suggesting a meaningful clinical benefit threshold.
- **Autoimmune Program**: ALLO-329 designed to target both B cells (CD19) and activated T cells (CD70), with potential application across autoimmune indications (e.g., lupus, myositis, scleroderma).
- **FDA Engagement**: Positive dialogue on single-arm trial design flexibility and CMC manufacturing requirements for BLA submission.


Allogene Therapeutics, Inc. (ALLO) Q3 2025 Earnings Call Transcript

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