AUTOLUS THERAPEUTICS PLC Stock Price, News & Analysis

Autolus Therapeutics (AUTL) has secured two milestone payments of $35 million each from Blackstone Life Sciences, totaling $70 million, due to positive interim results from the pivotal FELIX Phase 2 trial of their CAR T cell therapy, obecabtagene autoleucel (obe-cel). The first payment was received earlier than expected due to the trial meeting its primary endpoint. The second payment follows the successful demonstration of the manufacturing process for obe-cel. Autolus aims to submit a Biologics License Application to the FDA by the end of 2023.

Autolus Therapeutics plc (AUTL) announced positive interim results from its Phase 2 FELIX trial for obe-cel in relapsed/refractory adult Acute Lymphoblastic Leukemia (ALL). The study showed a promising Overall Remission Rate (ORR) of 70% among 50 evaluated patients. Safety data indicated low rates of serious adverse events, with 3% experiencing Grade 3 Cytokine Release Syndrome (CRS) and 8% experiencing Grade 3 Immune Effector Cell-Associated Neurotoxicity Syndrome (ICANS). Additionally, a $35 million milestone payment from Blackstone Life Sciences was triggered.

Autolus Therapeutics (Nasdaq: AUTL) announced the completion of the first clean room at its new commercial manufacturing facility named ‘The Nucleus’ in Stevenage, UK. This milestone is part of a broader £120 million redevelopment project aimed at creating a life sciences district, housing a cluster of cell and gene therapy companies. The facility is expected to enhance Autolus' capacity for next-generation T cell therapies. Collaboration among Autolus, Reef Group, and Merit facilitated timely project delivery despite challenges posed by the pandemic and supply chain issues.

Autolus Therapeutics (NASDAQ: AUTL) announced the online publication of three abstracts for the upcoming American Society of Hematology Annual Meeting in December 2022. These abstracts will highlight the clinical data of three therapies: obe-cel in B-ALL and B-NHL, AUTO1/22 in pediatric ALL, and AUTO4 in T-Cell Lymphoma. CEO Dr. Christian Itin emphasized obe-cel's promising safety and efficacy profile, showing potential in long-term remission for B-ALL patients. The presentations are set for December 11 and 12, providing updated data for clinical trials.

Autolus Therapeutics plc (Nasdaq: AUTL) announced its Q3 2022 operational and financial results, highlighting several strategic progress points. The pivotal FELIX Phase 2 trial for obe-cel in relapsed/refractory adult ALL is on track for a Q4 2022 update. The commercial manufacturing facility in the UK is scheduled for completion in Q4 2022. Financially, cash decreased to $163.1 million, while the net loss expanded to $42.8 million compared to $34.0 million in Q3 2021. The company expects future pipeline updates at the upcoming ASH Annual Meeting in December 2022.

Autolus Therapeutics (Nasdaq: AUTL) will announce its Q3 2022 financial results and operational highlights on November 3, 2022, prior to the U.S. market opening. Management will hold a conference call at 8:30 am ET to discuss these results and provide updates on the company’s business. Participants are encouraged to pre-register for access details. Autolus is focused on developing next-generation programmed T cell therapies for cancer treatment, utilizing proprietary technologies for targeting and eliminating cancer cells in hematological malignancies and solid tumors.

Autolus Therapeutics plc (Nasdaq: AUTL) announces that Moderna has exercised its option to license proprietary binders for an undisclosed immuno-oncology target. This exercise follows a previous agreement granting Moderna options on four targets. Autolus has received an option exercise fee and stands to gain from development and commercial milestone payments, as well as royalties on net sales of products derived from this collaboration. This partnership underscores Autolus' capabilities in innovative cell programming technologies aimed at treating cancer.

Autolus Therapeutics has entered a strategic agreement with Bristol Myers Squibb to incorporate its proprietary RQR8 safety switch into selected cell therapy programs targeting cancer treatments. This agreement includes an upfront payment, potential option exercise fees, development milestone payments, and royalties on net sales of products utilizing the RQR8 switch. The RQR8 technology enhances safety in cell therapies, allowing for controlled elimination of cells experiencing severe side effects. This partnership aims to improve patient outcomes and represents a significant advancement in the field of advanced cell therapies.

Scholar Rock has appointed Dr. Jay Backstrom as CEO-Elect, effective September 20, 2022. With over 30 years of biopharmaceutical leadership, he previously held roles at Acceleron and Celgene, contributing to drug development and approval processes. Nagesh Mahanthappa will serve as interim CEO during the transition until October 20, 2022. Dr. Backstrom aims to advance the company’s clinical programs targeting spinal muscular atrophy and oncology, emphasizing growth milestones and innovative therapy approaches.