Allogene Therapeutics(US:ALLO)2020-05-09 05:16Financial Data and Key Metrics Changes - As of March 31, 2020, the company reported cash, cash equivalents, and investments totaling $553 million [27] - Research and development expenses for Q1 2020 were $42 million, including $6.6 million of non-cash stock-based compensation [27] - General and administrative expenses were $15.6 million, which included $7.6 million of non-cash stock-based compensation [28] - The net loss for Q1 2020 was $54.5 million or $0.50 per share, including non-cash stock-based compensation expense of $14.2 million [28] - The company expects full-year 2020 net losses to be between $260 million and $280 million, including estimated non-cash stock-based compensation expense of $70 million to $75 million [29] Business Line Data and Key Metrics Changes - The ALLO-501 Phase 1 trial continues to enroll patients, with initial data expected to be shared at the ASCO meeting [19] - The ALLO-715 trial for relapsed/refractory multiple myeloma is ongoing, with initial data expected in Q4 2020 [24] - The company is also advancing its anti-CD70 program, ALLO-316, with an IND submission planned by year-end [26] Market Data and Key Metrics Changes - The company is navigating challenges posed by COVID-19, which has affected recruitment in some studies, but it remains committed to maintaining trial momentum [10][12] - The company has implemented remote monitoring and data entry to adapt to the pandemic's impact on clinical trials [13] Company Strategy and Development Direction - The company aims to achieve five key milestones in 2020, including reporting initial ALLO-501 Phase 1 clinical data and submitting the ALLO-316 IND by year-end [11] - The focus is on optimizing the lymphodepletion strategy and exploring the potential of TurboCAR technology for enhanced efficacy in CAR-T therapies [25] - The company is committed to advancing allogeneic cell therapy as a more convenient and reliable alternative to autologous CAR-T therapy [17] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the company's ability to navigate the challenges posed by COVID-19 while maintaining business momentum [10] - The management team emphasized the importance of scientific innovation and collaboration in addressing medical challenges during the pandemic [9] - Future clinical trials are expected to be minimally affected by COVID-19, with a focus on maintaining supply chain integrity [53] Other Important Information - The construction of the GMP cell manufacturing facility in Newark, California, was temporarily interrupted due to COVID-19 but has since resumed [28][29] - The company is exploring the potential of ALLO-647 as a standalone lymphodepletion agent in future studies [73] Q&A Session Summary Question: Can you discuss the ALLO-501 data expected at ASCO? - Management clarified that the data will include the first nine patients treated and additional patients from previously cleared dose levels [33][35] Question: What drove the backfilling of patients in lower doses? - Management explained that this is standard practice in Phase 1 studies to accommodate patient and site needs [40] Question: How will COVID-19 impact CAR T clinical development? - Management indicated that while external factors are being monitored, they are optimistic that planned studies will not be significantly affected [52] Question: Will there be variability in baseline levels of rituximab in ALPHA trial patients? - Management confirmed that they have successfully managed patient selection to minimize issues related to rituximab levels [65] Question: What is the strategy for ALLO-647 as a lymphodepletion agent? - Management expressed interest in exploring ALLO-647's potential as a standalone agent after ensuring adequate lymphodepletion [73]