Autolus(US:AUTL)2021-08-07 14:45Financial Data and Key Metrics Changes - Cash and cash equivalents at June 30, 2021, totaled $216.4 million, down from $239 million at the end of Q1 2021 [37] - Total net operating expenses for Q2 2021 were $37.7 million, compared to $39.5 million for the same period in 2020 [37][38] - Net loss attributable to ordinary shareholders was $33.2 million for Q2 2021, compared to a loss of $32.1 million for the same period last year [42] Business Line Data and Key Metrics Changes - Research and development expenses increased to $32.1 million in Q2 2021 from $31.3 million in Q2 2020 [38] - General and administrative expenses decreased to $7.2 million in Q2 2021 from $8.5 million in Q2 2020 [40] Market Data and Key Metrics Changes - The company received PRIME designation from the European Medicines Agency and ILAP designation from the UK Medicines and Healthcare Agency, enhancing regulatory engagement [15][16] Company Strategy and Development Direction - The company is focused on executing the pivotal FELIX study for adult patients with relapsed/refractory ALL, which is one of the few pivotal studies in this area [44] - The company plans to provide updates on various indications, including pediatric ALL and non-Hodgkin's lymphoma, by the end of the year [45] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the stability in clinical trial enrollment due to increased vaccination rates and recovery from COVID-19 [10][11] - The company reiterated guidance for pivotal data to be available in 2022, maintaining confidence in the timelines for key studies [17][52] Other Important Information - The company sold approximately 2 million ADSs under the Open Market Sales Agreement, netting $14.3 million in additional capital [18] - A new Chief Development Officer and Head of Clinical Development were appointed, indicating a strengthening of the management team [19] Q&A Session Summary Question: What pushed back AUTO4 and AUTO5 to the first half of next year? - Management indicated that the impact on centers due to COVID-19 has been resolved, and they expect to enroll at the predicted rate moving forward [50] Question: Can you narrow the guidance for the FELIX study? - Management confirmed that the guidance remains unchanged, with primary endpoint data expected in the middle of next year [52] Question: What are the economics of the Moderna collaboration? - The collaboration includes option exercise fees, development milestones, commercial milestones, and royalties, but specific amounts were not disclosed [58] Question: How does the company view the competitive positioning of AUTO3 or AUTO1 in DLBCL? - Management noted that moving CAR-T therapy to earlier lines of treatment shows attractive outcomes compared to stem cell transplants, which will inform their strategy [59] Question: What feedback has been received regarding the Tecartus regulatory decision? - Management highlighted that while Tecartus shows some progress, the safety profile of their product indicates a significant improvement for patients [66] Question: Will the fully closed manufacturing process impact efficacy and cost of goods sold? - Management stated that the majority of patients are now manufactured using the enclosed system, which is expected to enhance efficacy, though the causal relationship is still being evaluated [84]