Autolus Therapeutics reports Q3 EPS (26c), consensus (25c)

Reports Q3 revenue $406,000, consensus $450,000. “The coming months will be an exciting and instrumental time for Autolus as we plan for our first BLA submission for obe-cel with the US FDA by year end and we continue with our preparatory activities for a planned commercial launch in 2024, pending the necessary regulatory approvals,” said Dr. Christian Itin, Chief Executive Officer of Autolus. “The data we have observed to date in the FELIX study highlights the potential of obe-cel to deliver a high complete remission rate combined with low levels of immunotoxicity and excellent CAR T expansion and persistence in adult patients with relapsed/refractory ALL. We look forward to building on the positive data when we present longer term follow up and additional subgroup analysis data at ASH in December. Alongside this, our commercial manufacturing facility, The Nucleus, completed process performance qualification activities in Q4 to support the BLA submission, and we believe we are in a strong position operationally to deliver product and meet the global demand for adult ALL treatment. Obe-cel’s excellent risk/benefit profile combined with its ability to make deep cuts into the CD19+ cell compartment, as illustrated by MRD-negative complete remissions in adult and pediatric ALL patients, is a strong foundation for the development of obe-cel in autoimmune disease. The clinical profile together with our commercial product delivery base, attractive cost of goods, and commercial infrastructure should help to drive an accelerated and differentiated expansion of the obe-cel opportunity. We are excited at the growing body of evidence that CAR T can address a significant unmet need in autoimmune disease, and we look forward to starting a Phase I study of obe-cel in refractory systemic lupus erythematosus patients in early 2024.”