Data show deep, durable responses in the 50 million cell dose level cohort; initial data suggest substantial early improvement in three patients dosed with 100 million cellsAll patients show deep B-cell depletion after infusion, suggesting an immune resetNine patients were evaluable for safety, no ICANS or high-grade CRS were observed LONDON and GAITHERSBURG, Md., Dec. 08, 2025 (GLOBE NEWSWIRE) -- Autolus Therapeutics plc (Nasdaq: AUTL), an early commercial-stage biopharmaceutical company developing, manufa ...

Core Insights - Autolus Therapeutics presented preliminary data from the CATULUS Phase 1 trial of obe-cel for pediatric patients with relapsed or refractory B-cell acute lymphoblastic leukemia (B-ALL) at the ASH Annual Meeting, highlighting high remission rates and a favorable safety profile [1][2][3] Group 1: Pediatric Trial Insights - The CATULUS trial showed an overall response rate (ORR) of 95.5% in pediatric patients, with 90.9% achieving complete response (CR) [3] - The safety profile of obe-cel in pediatric patients was consistent with adult data, showing low rates of high-grade cytokine release syndrome (CRS) and immune effector cell-associated neurotoxicity syndrome (ICANS), both at 8.7% [3][4] - Twenty patients remained in ongoing remission at the data cut-off with a median follow-up of 8.8 months, supporting further exploration of obe-cel in this population [3] Group 2: Adult Trial Insights - Insights from the FELIX pivotal trial indicated that the detection of obe-cel in the blood three months post-treatment may predict long-term outcomes in adult patients with r/r B-ALL [2][4] - The analysis of the FELIX study revealed that a higher percentage of central memory cells in the drug product was an independent predictor of positive clinical outcomes, including overall survival [7] Group 3: Real-World Data - Real-world data from the ROCCA consortium corroborated the safety profile of obe-cel, showing low rates of high-grade CRS and ICANS, consistent with clinical trial results [2][4] Group 4: Product Characteristics - The unique features of the CAR T product, including the CAT19 binder, were highlighted as important for tracking CAR T expansion and persistence, which are critical for predicting treatment outcomes [6][7] - The study emphasized the need for further investigations to understand the impact of tumor characteristics and product features on clinical outcomes [7]

LONDON and GAITHERSBURG, Md., Dec. 01, 2025 (GLOBE NEWSWIRE) -- Autolus Therapeutics plc (Nasdaq: AUTL), an early commercial stage biopharmaceutical company developing, manufacturing and delivering next-generation programmed T cell therapies, today announced the appointment of Ryan Richardson to the Company’s Board of Directors. Mr. Richardson brings more than 20 years of strategy and corporate development experience and in the healthcare and investment banking industries to Autolus’ Board. “Autolus has ent ...

Core Insights - The U.K.'s NICE has recommended Autolus Therapeutics' Aucatzyl for use in the NHS for adult patients with relapsed or refractory B-cell precursor acute lymphoblastic leukemia [1][2] - Aucatzyl will be available through routine commissioning by the NHS, with plans for launch in England and Wales [2] - The MHRA granted conditional marketing authorization for Aucatzyl based on the FELIX study results [3] Company Developments - Autolus Therapeutics is preparing to launch Aucatzyl imminently in England and Wales and is pursuing access through the Scottish Medical Consortium [2] - The stock price of Autolus Therapeutics was reported at $1.38, with a notable increase of 10.48% to $1.37 at the time of publication [5][7] Product Information - Aucatzyl (obecabtagene autoleucel) is an autologous CD19 CAR T cell therapy designed for treating specific types of leukemia [3] - The therapy targets adult patients (≥26 years) suffering from relapsed or refractory B-cell precursor acute lymphoblastic leukemia [1][3]

Core Insights - Autolus Therapeutics plc announces that AUCATZYL (obecabtagene autoleucel) has received draft guidance from NICE recommending its use in the NHS for adult patients with relapsed or refractory B-cell precursor acute lymphoblastic leukemia (r/r B-ALL) [1][2] - AUCATZYL will be available through routine commissioning by the NHS in England and Wales, with plans for imminent launch [1][2] - The therapy has received conditional marketing authorization from the UK Medicines and Healthcare products Regulatory Agency (MHRA) based on the results of the FELIX study [2][6] Company Overview - Autolus Therapeutics plc is an early commercial-stage biopharmaceutical company focused on developing next-generation T cell therapies for cancer and autoimmune diseases [4] - The company utilizes proprietary T cell programming technologies to create targeted and controlled T cell therapies [4] Product Information - AUCATZYL is a CD19 CAR T cell therapy designed to improve clinical activity and safety compared to existing therapies [5] - It features a fast target binding off-rate to minimize excessive activation of T cells [5] - The therapy was approved by the FDA in November 2024 and received conditional marketing authorization from both MHRA and EMA in 2025 [5][6] Industry Context - The announcement of AUCATZYL's availability is seen as a significant advancement in treatment options for patients with aggressive B-cell ALL, which has a poor prognosis [3] - Collaboration among organizations like Anthony Nolan, Leukaemia Care, and Leukaemia UK has been crucial in ensuring patient perspectives were included in the NICE evaluation process [3]

Core Insights - Autolus Therapeutics plc has received draft guidance from NICE recommending AUCATZYL (obecabtagene autoleucel) for use in the NHS in England and Wales for adult patients with relapsed or refractory B-cell precursor acute lymphoblastic leukemia (r/r B-ALL) [1][2] - AUCATZYL is expected to be launched imminently in England and Wales, with plans to pursue access through the Scottish Medical Consortium [1][2] - The therapy has received conditional marketing authorization from the UK MHRA based on the results of the FELIX study, which demonstrated its efficacy [2][4] Company Overview - Autolus Therapeutics plc is an early commercial-stage biopharmaceutical company focused on developing next-generation T cell therapies for cancer and autoimmune diseases [3] - The company utilizes proprietary T cell programming technologies to create targeted and controlled therapies [3] Product Details - AUCATZYL is a CD19 CAR T cell therapy designed to improve clinical activity and safety compared to existing therapies [4] - It was approved by the FDA in November 2024 and received conditional marketing authorization from the MHRA and EMA in 2025 [4]

Core Insights - Autolus Therapeutics plc is positioning itself as a leader in CAR-T therapies, with a focus on expanding its product line and market reach [1][2][4] Group 1: Financial Performance - The company generated $21.1 million in product revenue in Q3, primarily from its CAR-T therapy AUCATZYL [1] - Autolus reported $51 million in sales from its flagship product Ocatzel for adult acute lymphoblastic leukemia (ALL) in the first nine months of the year [2] Group 2: Product Development and Market Expansion - Plans are in place to explore the use of Ocatzel in Pediatric ALL and autoimmune diseases to broaden its market target [3] - The company aims to increase physician adoption and patient awareness to enhance market share over the next two years [3] - Autolus has established an end-to-end infrastructure to improve production and supply capabilities in the UK and the US [3]

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Summary of Autolus Therapeutics Conference Call Company Overview - **Company**: Autolus Therapeutics (NasdaqGS:AUTL) - **Industry**: Biotechnology, specifically focused on CAR-T cell therapies Key Points and Arguments 1. **Product Launch**: Autolus is focused on the launch of its lead asset, Ocatzel (OB-Cell), for treating adult patients with acute leukemia, having received approvals in the U.S., U.K., and Europe [doc id='3'][doc id='4'] 2. **Manufacturing and Logistics**: The manufacturing facility is located in Stevenage, U.K., with a robust logistics system that has proven effective during the pandemic, allowing for timely delivery of products from the U.S. to the U.K. and back [doc id='4'][doc id='5'] 3. **Clinical Data**: The Felix study, which included 127 patients, showed an overall remission rate of 77% with manageable safety profiles, including only 2% experiencing high-grade cytokine release syndrome [doc id='6'][doc id='7'] 4. **Market Performance**: In the first nine months, Autolus reported $51 million in sales, achieving market leadership in CAR-T therapies for acute leukemia [doc id='9'] 5. **Market Penetration**: The company has reached approximately 20% market penetration in active centers, with significant growth opportunities identified [doc id='10'][doc id='11'] 6. **Future Indications**: Plans to explore the use of Ocatzel in frontline settings for acute leukemia and expand into pediatric populations, with discussions ongoing with the FDA for a registrational package [doc id='12'][doc id='15'][doc id='16'] 7. **Autoimmune Disease Research**: Autolus is also investigating the use of Ocatzel in autoimmune diseases, with promising data indicating potential for significant patient benefit [doc id='17'][doc id='21'] 8. **Pipeline Expansion**: The company is focused on expanding its pipeline beyond acute leukemia, targeting advanced stages of autoimmune diseases and multiple sclerosis [doc id='18'][doc id='22'] 9. **Data Collection**: A consortium called the ROCA Consortium is tracking real-world data for patients receiving Ocatzel, with initial results expected to be presented at the ASH meeting [doc id='14'][doc id='22'] 10. **Financial Position**: Autolus is well-positioned financially to run current studies, although the costs associated with launching new indications are not included in the current cash position [doc id='25'][doc id='26'] Additional Important Information - **Safety Profile**: The safety profile of Ocatzel is favorable, with no high-grade adverse events reported in a small cohort of patients with autoimmune diseases [doc id='19'] - **Market Dynamics**: The company is observing a shift in physician behavior towards adopting Ocatzel as a new therapeutic option, which is expected to impact market share growth over the next two to three years [doc id='26'][doc id='27']

Core Viewpoint - The investment thesis for Autolus Therapeutics plc (AUTL) remains cautiously optimistic despite market and company-specific risks associated with launching another CD19 cell therapy [1] Company Analysis - Autolus Therapeutics is focused on developing CD19 cell therapies, which are part of a competitive market landscape [1] - The company has faced challenges typical of the biotech sector, particularly in clinical trials and regulatory approvals [1] Industry Context - The broader biotech industry is characterized by high risks and potential rewards, particularly in the area of cell therapies [1] - There is a growing interest in the science behind biotech investments, emphasizing the importance of due diligence for investors [1]