ALPHA3 Trial Update: Contradictions in Enrollment, Data Expectations, and Lymphodepletion Strategies

ALPHA3 Study Streamlining:
- Allogene Therapeutics streamlined the ALPHA3 study, now a 2-arm randomized trial comparing cema-cel with standard lymphodepletion to observation.
- This decision was driven by patient safety concerns and the need for scientific judgment and regulatory alignment.

Advancements in Solid Tumors with ALLO-316:
- Compelling Phase I data for ALLO-316 in renal cell carcinoma showed robust CAR T expansion and clinical responses.
- Allogene aligned with FDA on a pivotal trial strategy, indicating potential for partnership and growth in this area.

First CAR T Study in Autoimmune Disease:
- The RESOLUTION study, focusing on autoimmune diseases, has begun enrollment, marking a first for allogeneic CAR T trials in this space.
- This expansion explores new lymphodepletion strategies, challenging established paradigms and seeking to reshape treatment approaches.

Financial Stability and Operational Efficiency:
- Allogene has extended its cash runway into the second half of 2027, with a current cash balance of $302.6 million.
- Operational progress and disciplined financial stewardship have allowed the company to maintain its financial stability despite ongoing investments in clinical development.