Allogene Therapeutics(US:ALLO)2022-05-05 02:48Financial Data and Key Metrics Changes - The company ended Q1 2022 with $733 million in cash, cash equivalents, and investments [22] - Research and development expenses for Q1 2022 were $60.2 million, including $11.1 million of non-cash stock-based compensation [22] - General and administrative expenses were $19.9 million for Q1 2022, which included $11.2 million of non-cash stock-based compensation [22] - The net loss for Q1 2022 was $79.9 million or $0.56 per share, including non-cash stock-based compensation expense of $22.3 million [22] - Full year 2022 operating expenses are expected to be between $360 million and $390 million, including an estimated non-cash stock-based compensation expense of $90 million to $100 million [22] Business Line Data and Key Metrics Changes - The company has treated more patients with its AlloCAR T candidates than any other player in the field, indicating a strong operational capacity [8] - ALLO-501A is projected to initiate a pivotal trial mid-year 2022, with ongoing enrollment in its Phase 1 study [13] - ALLO-715 and ALLO-605 are actively enrolling patients in trials for relapsed refractory multiple myeloma [13] Market Data and Key Metrics Changes - The market for second-line large B cell lymphoma and relapsed refractory multiple myeloma is large, consisting of many thousands of potentially suitable patients [11] - Autologous therapies have not been able to keep up with demand, creating a significant opportunity for allogeneic CAR-T products [11] - The company projects it can manufacture approximately 20,000 patient doses annually at scale, significantly reducing the number of required manufacturing runs compared to autologous therapies [11] Company Strategy and Development Direction - The company aims to industrialize cell therapy to serve tens of thousands of patients in a commercial setting [9] - The strategic importance of the Cell Forge 1 manufacturing facility is emphasized, as it supports clinical and commercial manufacturing [12] - The company is focused on advancing its AlloCAR T products into solid tumors and progressing multiple clinical programs [8] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the company's financial strength to weather the current biotech market downturn [21] - The company is optimistic about the competitive positioning of its BCMA program and expects to have data to make decisions by year-end [32] - Management highlighted the importance of addressing logistical challenges and manufacturing costs in the autologous CAR-T therapy space [10] Other Important Information - The company has welcomed a new Chief People Officer to oversee human resources efforts as it scales its teams [13] - The company is preparing to launch the EXPAND trial to support registration of ALLO-647, which is designed to enhance the expansion and persistence of AlloCAR T cells [16] Q&A Session Summary Question: What does the company need to show in the pivotal ALLO-501A trial for approval? - Management believes the data generated thus far shows comparable durability and complete response rates to autologous products, aiming to establish an off-the-shelf therapy for all patients [25] Question: What are the steps to starting the pivotal Phase 2 DLBCL study? - The pivotal study for ALLO-501A is on schedule to start mid-2022, with ongoing completion of CMC activities [28] Question: How confident is the company about proceeding with the BCMA program by year-end? - Management is pleased with the pace of the BCMA program and expects to have sufficient data to make decisions by year-end [32] Question: Will the pivotal Phase 2 portion of Alpha 2 need to start enrolling before the EXPAND study? - The EXPAND study will start after the Alpha 2 study, as the latter is the registration trial for ALLO-501A [37] Question: How does the company view competition with autologous products? - The company is confident in its manufacturing capabilities, estimating it can produce 20,000 doses annually, which is significantly more efficient than autologous manufacturing [49]