Allogene Therapeutics(ALLO) - 2023 Q1 - Earnings Call Transcript

Financial Data and Key Metrics Changes - The company ended Q1 2023 with $514 million in cash, cash equivalents, and investments, indicating a strong balance sheet [22] - The net loss for Q1 2023 was $98.7 million, or $0.68 per share, which includes $18.8 million in non-cash stock-based compensation [23] - The company expects a decrease in cash, cash equivalents, and investments of approximately $230 million in 2023, with full-year GAAP operating expenses projected to be around $340 million [23] Business Line Data and Key Metrics Changes - Research and development expenses for Q1 2023 were $80.2 million, including $9.2 million of non-cash stock-based compensation [23] - General and administrative expenses were $18.9 million for Q1 2023, which includes $9.6 million of non-cash stock-based compensation [23] Market Data and Key Metrics Changes - The company highlighted the growing demand for CAR T therapies, with an estimated 300,000 patients eligible for autologous CAR T therapy by 2030, yet only about 10% expected to receive treatment [8][9] - The company is focused on addressing the limitations of autologous therapies by providing a one-time infusion of AlloCAR T products, which can start treatment within days of enrollment [9][10] Company Strategy and Development Direction - The company aims to submit a Biologics License Application (BLA) for ALLO-501A upon completion of the ALPHA2 trial and is evaluating manufacturing processes for optimal clinical performance [10] - The addition of Tim Moore as Chief Technical Officer is expected to enhance the company's ability to deliver CAR T products at scale [11] - The company is exploring the potential of Dagger technology to prevent early rejection of AlloCAR T cells, which could lead to a next-generation allogeneic CAR T platform [21][55] Management's Comments on Operating Environment and Future Outlook - Management acknowledged the challenging market environment for biotech companies but emphasized that success will be driven by scientific innovation, experience, and financial stewardship [22] - The company remains confident in its clinical data and the impact of its products on patients, despite stock price fluctuations [7][8] Other Important Information - The company has initiated the Phase II EXPAND trial designed to support the licensure of ALLO-647 as a lymphodepleting agent for ALLO-501A in LBCL [16] - The company is focused on reviewing the manufacturing process for ALLO-715 and 605, with plans to potentially resume dosing in 2024 [35][59] Q&A Session Summary Question: Can you provide details on the ASCO update? - Management confirmed that they will present data at ASCO and aim to ensure that key opinion leaders and investigators have access to the data in a peer-reviewed format [26][28] Question: What is the progress of the pivotal ALPHA2 trial? - The study is open to enrollment and is progressing as expected, with completion of enrollment anticipated in the first half of next year [31][32] Question: How are patients being enrolled in the ALPHA2 and EXPAND trials? - Patients being enrolled are those eligible for original autologous CAR T studies, and the company is ensuring that the two studies do not compete for patient enrollment [34][38] Question: What is the expected timeline for data from the EXPAND trial? - Data from the EXPAND trial is expected to be available around the same time as the ALPHA2 trial results [76] Question: What are the plans for Dagger technology? - Dagger technology is being explored for use in both liquid and solid tumor indications, with ongoing development of next-generation constructs [47][55] Question: What is the company's approach to partnerships? - The company is open to partnerships to advance its allogeneic CAR T programs, particularly for BCMA and ALLO-316, to accelerate development [66][72]