Allogene Therapeutics(ALLO) - 2021 Q2 - Earnings Call Transcript

Financial Data and Key Metrics Changes - In Q2 2021, Allogene Therapeutics reported a net loss of $70.9 million, or $0.53 per share, which included $21.1 million in non-cash stock-based compensation [27] - Research and development expenses were $52.3 million, including $10.5 million of non-cash stock-based compensation, while general and administrative expenses were $18.8 million, which included $10.6 million of non-cash stock-based compensation [27] - The company expects full-year 2021 operating expenses to be between $300 million and $330 million, indicating a significant ramp-up in expenses during the second half of the year [28] Business Line Data and Key Metrics Changes - The ALPHA trial demonstrated an overall response rate of 75% and a complete response (CR) rate of 50% in CAR-T naive patients with relapsed-refractory non-Hodgkin's lymphoma [9] - The six-month CR rate was reported at 36% in patients with large B-cell lymphoma histology [9] - ALLO-501A is on track to enter a pivotal phase 2 trial by the end of 2021, focusing on relapsed refractory non-Hodgkin's lymphoma [8][19] Market Data and Key Metrics Changes - The company is advancing its AlloCAR-T therapies in Greater China, Taiwan, South Korea, and Singapore through a joint venture with Overland Pharmaceuticals [26] - The ALLO-605 candidate received US FDA Fast Track designation for the treatment of patients with relapsed and refractory multiple myeloma [16] Company Strategy and Development Direction - Allogene aims to transition from a clinical-stage company to a commercial enterprise, focusing on product positioning and maximizing adoption [12] - The company is preparing for the industry's first allogeneic pivotal trial and has begun building its commercial team [12][14] - The Cell Forge 1 manufacturing facility is set to enhance the company's ability to deliver off-the-shelf CAR-T therapies faster and more reliably [14][15] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the safety and efficacy profile of ALLO-501A, highlighting its potential to provide timely treatment to patients [10][11] - The company is optimistic about the potential of its AlloCAR-T platform to address unmet medical needs in both liquid and solid tumors [16][24] - Management emphasized the importance of ongoing clinical trials and the generation of data to inform future strategies [17][19] Other Important Information - The company has five clinical trials underway, including two in the CD19 program and two targeting BCMA [15] - The ALLO-316 program is focused on clear cell renal cell carcinoma, with initial data expected next year [16][24] Q&A Session Summary Question: What type of data will be presented at year-end regarding consolidation? - Management indicated that they expect to present longer follow-up data on patients from ASCO, including more patients accrued in ALPHA and ALPHA2 trials [32] Question: Will the pivotal trial be a single dose or randomized for consolidation? - Management noted that the decision on trial design will depend on accumulating evidence and discussions with the FDA [36][38] Question: What are the expectations for infection rates with the consolidation regimen? - Management stated that the infection rates observed are similar to those in the autologous setting, and the split dosing may lead to lower rates [74][75] Question: What are the plans for ALLO-501A in follicular lymphoma? - Management confirmed that there are ongoing discussions about continuing development in follicular lymphoma alongside large B-cell lymphoma [60] Question: What is the rationale for targeting renal cell carcinoma with ALLO-316? - Management highlighted the attractiveness of CD70 as a target in both hematological and solid tumors, with renal cell carcinoma chosen as the first indication [64]