Allogene Therapeutics(US:ALLO)2021-11-05 03:43Financial Data and Key Metrics Changes - The company ended Q3 2021 with $861.7 million in cash, cash equivalents, and investments [23] - Research and development expenses for Q3 2021 were $58.7 million, including $10.1 million of non-cash stock-based compensation [23] - General and administrative expenses were $19 million for Q3 2021, which included $10.8 million in non-cash stock-based compensation [23] - The net loss for Q3 2021 was $78.2 million or $0.57 per share, including non-cash stock-based compensation expense of $20.9 million [23] Business Line Data and Key Metrics Changes - The company has treated over 130 patients with lymphoma, multiple myeloma, and renal cell carcinoma across five Phase 1 studies [11] - In the ALPHA1 trial, over 60 lymphoma patients were treated, with updated data expected to be shared at the ASH conference in December [11] Market Data and Key Metrics Changes - The FDA placed a clinical hold on the AlloCAR-T clinical programs due to a chromosomal abnormality observed in one patient in the ALPHA2 trial [7][9] - The company is actively engaged with the FDA to resolve the clinical hold and has submitted end of Phase 1 materials in anticipation of a potential ALLO-501A pivotal Phase 2 trial [10][33] Company Strategy and Development Direction - The company remains committed to advancing its platform and data despite the clinical hold, focusing on multiple workstreams including preparation for the Phase 2 pivotal trial on ALLO-501A [7][10] - The company believes in the potential of its AlloCAR T products and aims to increase access to therapy while decreasing manufacturing time and cost [9][10] - The company is preparing for the advancement of the ALLO-501A program into a pivotal Phase 2 study, although certain workstreams are delayed due to the clinical hold [15][23] Management's Comments on Operating Environment and Future Outlook - Management expressed appreciation for the FDA's engagement and is optimistic about resolving the clinical hold in a timely manner [9][10] - The company is focused on generating information to understand and address the chromosomal abnormalities observed in patients [9] - Management emphasized the importance of the AlloCAR T product as a therapeutic option for patients who cannot wait for autologous CAR T cells [11] Other Important Information - The company expects full-year 2021 operational expenses to be between $300 million and $330 million, excluding any impact from development activities [23] - The company continues to support multiple research and operational initiatives despite the clinical hold [23] Q&A Session Summary Question: Can you provide more details on the ongoing discussions with the FDA regarding the clinical hold? - Management confirmed receipt of a clinical hold letter detailing FDA's concerns and data requirements, and they are actively engaged in discussions with the FDA [27][29] Question: What are the timelines for interactions with the FDA? - Management indicated that discussions with the FDA are collaborative and ongoing, with a focus on addressing the concerns raised [31] Question: What needs to be checked off to get the go-ahead for the Phase 2 study? - Management stated that discussions with the FDA regarding the end of Phase 1 materials have been productive, but specific details cannot be disclosed [35] Question: Will the upcoming ASH presentation include additional data on the multiple myeloma study? - Management confirmed that additional data will be shared at ASH, focusing on patients treated since the last cutoff [38] Question: What triggers the second dose in the consolidation dosing protocol? - Management clarified that patients must have stable disease or better to receive the second dose, along with ALLO-647 prior to the second dose [72]