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 - 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]

Core Insights - Autolus Therapeutics plc is participating in the Jefferies Global Healthcare Conference in London, with CEO Dr. Christian Itin scheduled to present on November 18, 2025 [1]. Company Overview - Autolus Therapeutics plc is an early commercial-stage biopharmaceutical company focused on developing, manufacturing, and delivering next-generation programmed T cell therapies for cancer and autoimmune diseases [3]. - The company utilizes proprietary and modular T cell programming technologies to create targeted and controlled T cell therapies aimed at effectively recognizing and eliminating target cells [3]. - Autolus has a marketed therapy named AUCATZYL and is developing a pipeline of product candidates for hematological malignancies, solid tumors, and autoimmune diseases [3]. Event Details - A webcast of the fireside chat will be available on the company's website, with a replay archived for 90 days post-presentation [2].

Financial Data and Key Metrics Changes - In Q3 2025, net product revenue was $21.1 million, slightly up from $20.9 million in Q2 2025 [29] - Deferred revenue at the end of Q3 was $7.6 million, compared to $2.1 million in Q2 2025, indicating a healthy backlog of products ready for infusion [29] - The net loss for Q3 2025 was $79.1 million, reduced from a loss of $82.1 million in Q3 2024 [31] Business Line Data and Key Metrics Changes - AUCATZYL achieved $21.1 million in net sales for Q3 2025, with total sales of $51 million for the first nine months of the year [8][29] - The manufacturing success rate exceeded 90%, and patient access was achieved for over 90% of U.S. covered lives [9] Market Data and Key Metrics Changes - The CAR-T market share for the treatment of relapsed refractory B-ALL was approximately 15% before AUCATZYL's commercialization, increasing to around 20% within the 60 treatment centers currently active [10] Company Strategy and Development Direction - The company aims to drive market share in adult ALL, improve margins, and expand beyond ALL into pediatric ALL and other indications [8][33] - The focus is on optimizing operations and leveraging investments in infrastructure to enhance efficiencies [7][17] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the ongoing commercial launch of AUCATZYL, highlighting positive feedback from physicians and the potential for growth in the CAR-T market [5][10] - The company is preparing for upcoming data presentations at ASH and expects to initiate pivotal studies in lupus nephritis and pediatric ALL [33] Other Important Information - The company has made key leadership changes to strengthen its operational capabilities, including the appointment of a new Chief Technology Officer and Chief Commercial Officer [12][13] Q&A Session Summary Question: Can you talk about the patient flow and anticipated patient flow going forward? - Management noted a good proportion of patients were not initially considered for CAR-T therapy, indicating an expansion of market penetration [35][37] Question: What is the competitive positioning for obe-cel in pediatric patients? - The focus is on high-risk pediatric patients who currently have limited options, with a strong safety and efficacy profile for obe-cel [39][41] Question: Can you provide insights on the Q3 performance and expectations for Q4? - Management indicated that Q3 performance was impacted by CMS reimbursement policy changes, but they expect a healthy amount of deferred revenue for Q4 [46][50] Question: What are the growth opportunities in the CAR-T market? - The majority of patients are not yet receiving CAR-T therapy, presenting significant growth opportunities within existing treatment centers [58][60] Question: What data is expected at ASH? - Key data points will include pediatric ALL study results and expanded data from the CARLYSLE study, focusing on safety and efficacy [68][70]

Financial Data and Key Metrics Changes - In Q3 2025, net product revenue was $21.1 million, slightly up from $20.9 million in Q2 2025, with deferred revenue increasing to $7.6 million from $2.1 million in Q2 2025 [28][29] - Cost of sales for Q3 2025 totaled $28.6 million, while research and development expenses decreased to $27.9 million from $40.3 million in the same period of 2024 [29][30] - Selling, general, and administrative expenses rose to $36.3 million from $27.3 million in Q3 2024, resulting in a loss from operations of $71.6 million compared to $67.9 million in Q3 2024 [30][31] - The net loss for Q3 2025 was $79.1 million, reduced from $82.1 million in Q3 2024 [31] Business Line Data and Key Metrics Changes - The launch of AUCATZYL in the U.S. achieved $21.1 million in net sales for Q3 2025, with total sales of $51 million for the first nine months of 2025 [8][28] - The manufacturing success rate exceeded 90%, and patient access was achieved for over 90% of U.S. covered lives [9][10] Market Data and Key Metrics Changes - The CAR-T market share for the treatment of relapsed refractory B-cell ALL was approximately 20% within the 60 treatment centers currently active, indicating substantial growth potential [10][56] - The company aims to expand its geographic footprint and minimize travel distances for patients to access therapy [9] Company Strategy and Development Direction - The company is focusing on driving market share in ALL, improving margins, and expanding beyond ALL into pediatric ALL, lupus nephritis, and progressive multiple sclerosis [8][19] - The management is optimizing operations and leveraging investments made in infrastructure to drive efficiencies [7][17] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the ongoing commercial launch of AUCATZYL, highlighting positive feedback from physicians and interest in investigator-sponsored trials [5][6] - The company anticipates significant growth opportunities in the CAR-T market and is preparing for upcoming data presentations at ASH [10][32] Other Important Information - The company has made key leadership changes to enhance its operational capabilities, including the appointment of a new Chief Technology Officer and Chief Commercial Officer [12][13] - The company is well-capitalized with $367.4 million in cash and marketable securities as of September 30, 2025, to support its commercialization efforts [31] Q&A Session Summary Question: Can you talk about the patient flow and anticipated patient flow going forward? - Management noted a good proportion of patients were not initially considered for CAR-T therapy, indicating an expansion of market penetration [34][35] Question: What is the competitive positioning for OB/Cell in pediatric patients? - The focus is on high-risk pediatric patients who are not eligible for CAR-T therapy, emphasizing the product's good safety and efficacy profile [37][38] Question: Can you provide insights on the Q3 performance and expected trends for Q4? - Management indicated that the Q3 performance was impacted by CMS reimbursement policy changes, but a healthy amount of deferred revenue suggests a positive outlook for Q4 [44][46] Question: What are the expected data presentations at ASH? - Key data points from the pediatric ALL study and the Carlyle study will be presented, focusing on safety, efficacy, and long-term outcomes [66][68]

Financial Data and Key Metrics Changes - In Q3 2025, net product revenue was $21.1 million, slightly up from $20.9 million in Q2 2025. Deferred revenue increased to $7.6 million from $2.1 million in Q2 2025, indicating a healthy backlog of products ready for infusion [28][29]. - Cost of sales for Q3 2025 totaled $28.6 million, while research and development expenses decreased to $27.9 million from $40.3 million in Q3 2024. Selling, general, and administrative expenses rose to $36.3 million from $27.3 million in the same period [29][30]. - The net loss for Q3 2025 was $79.1 million, reduced from a loss of $82.1 million in Q3 2024. Cash, cash equivalents, and marketable securities totaled $367.4 million, down from $588 million at the end of December 2024 [31][32]. Business Line Data and Key Metrics Changes - The launch of AUCATZYL in the U.S. achieved $21.1 million in net sales for Q3 2025, with total sales of $51 million for the first nine months of the year. The company has established 60 treatment centers, achieving over 90% patient access for U.S. covered lives [6][7][28]. - The manufacturing success rate is above 90%, and the company is focusing on optimizing operations and driving efficiencies [5][7]. Market Data and Key Metrics Changes - The CAR-T market share for the treatment of relapsed refractory B-cell ALL is approximately 20% within the 60 treatment centers, indicating significant growth potential as the majority of patients are still not receiving CAR-T therapy [8][58]. - The company is expanding its pipeline with ongoing studies in pediatric ALL, lupus nephritis, and progressive multiple sclerosis, indicating a strategic focus on diversifying its product offerings [6][18]. Company Strategy and Development Direction - The company aims to drive market share in adult ALL, improve margins, and expand beyond ALL into other indications. There is a focus on building relationships with treatment centers to enhance product uptake [4][6][33]. - The management is optimistic about the growth potential in the CAR-T market and is leveraging data collected from the initial launch phase to optimize processes and drive efficiencies [5][8]. Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the ongoing commercial launch of AUCATZYL, highlighting positive feedback from physicians and the establishment of a reliable product delivery system [4][5]. - The company anticipates key data points from ongoing trials to be presented at the ASH conference, which could further validate its product offerings and market position [33][70]. Other Important Information - The company has made significant leadership changes, appointing new key members to enhance its operational capabilities and drive future growth [10][11]. - The management emphasized the importance of innovation in manufacturing and market access to serve a larger patient population [16]. Q&A Session Summary Question: Can you talk about the patient flow and anticipated patient flow going forward? - Management noted a good proportion of patients were not initially considered for CAR-T therapy, indicating an expansion of market penetration [35][36]. Question: How does the competitive positioning for Obe-cel in pediatric patients compare to adults? - The focus is on high-risk pediatric patients who are not eligible for CAR-T therapy, with a strong safety and efficacy profile expected to drive interest [39][40]. Question: What drove the flat performance in Q3 compared to Q2? - The flat performance was influenced by a CMS reimbursement policy change that affected patient enrollment, but deferred revenue indicates a healthy pipeline for Q4 [46][50]. Question: Can you provide insights on CAR-T share growth and the competitive landscape in autoimmune diseases? - The company sees significant growth potential in CAR-T therapy as many patients are still untreated, and it believes it is well-positioned in the competitive landscape of autoimmune diseases [57][63]. Question: What data is expected at the ASH conference? - The company will present data from the pediatric ALL study and the Carlyle study, focusing on safety, efficacy, and long-term outcomes [69][70].

Financial Performance - AUCATZYL achieved net product sales of $21.1 million in Q3 2025[10] - Total revenue for Q3 2025 was $21.194 million[55] - Revenue for the nine months ended September 30, 2025, reached $51.0 million[11] - The company reported a total comprehensive loss of $84.9 million in Q3 2025[55] - As of September 30, 2025, the company's cash position was $367.4 million[56] AUCATZYL Launch and Market Access - AUCATZYL has been launched in the US, with strong initial execution in relapsed/refractory B-ALL (r/r B-ALL)[7] - The company has established 60 authorized treatment centers[14] - AUCATZYL has achieved patient access for over 90% of U S covered lives, exceeding initial expectations[14] - CAR T market share in relapsed/refractory disease in 2024 is approximately 15%[15] Obe-cel Expansion and Pipeline - The company is exploring the potential of obe-cel in new indications beyond adult B-ALL, including pediatric ALL, lupus nephritis, and multiple sclerosis[7] - In a Phase 1 study of obe-cel in Systemic Lupus Erythematosus (SLE), 83.3% (5/6) of patients achieved DORIS (Definition of Remission in SLE)[40] - In the SLE study, 50% (3/6) of patients achieved CRR (complete renal response)[40]

Core Insights - Autolus Therapeutics plc reported operational and financial results for Q3 2025, highlighting progress in the launch of AUCATZYL and plans for future growth in various therapeutic areas [1][2][5] Financial Performance - The company achieved net product revenue of $21.1 million for Q3 2025, with a deferred revenue balance of $7.6 million as of September 30, 2025 [4][12] - Cost of sales for the quarter totaled $28.6 million, while research and development expenses decreased from $40.3 million to $27.9 million compared to the same period in 2024 [13][14] - Selling, general and administrative expenses increased from $27.3 million to $36.3 million, primarily due to higher employment-related costs [15] - The net loss for Q3 2025 was $79.1 million, a slight improvement from a net loss of $82.1 million in Q3 2024 [17] Product and Pipeline Updates - AUCATZYL is gaining traction in the market, with over 60 treatment centers activated in the U.S. and coverage for more than 90% of U.S. medical lives [5][6] - Data from the ROCCA Consortium will be presented at the ASH Annual Meeting, showcasing real-world outcomes for AUCATZYL in adult patients with relapsed/refractory acute lymphoblastic leukemia [5][6] - The company is advancing obe-cel into pivotal studies for pediatric ALL and severe lupus nephritis, with promising early data [4][9] Leadership and Operational Changes - Autolus has strengthened its leadership team to support the next phase of growth, appointing Cintia Piccina as U.S. Chief Commercial Officer and Miranda Neville as Chief Technical Officer [8][16] - The company aims to optimize business operations and enhance market growth through strategic planning and operational excellence [11][16] Future Outlook - Autolus is well-capitalized with cash and cash equivalents totaling $367.4 million as of September 30, 2025, to support the commercialization of obe-cel and ongoing clinical trials [18][19] - The company anticipates significant data presentations at upcoming conferences, including initial clinical data from the CATULUS trial and longer-term follow-up from the CARLYSLE trial [11][12]

Core Insights - Autolus Therapeutics plc is set to release its third quarter 2025 financial results and operational highlights on November 12, 2025, before the U.S. market opens [1] - A conference call and webcast will be held at 8:30am EST / 1:30pm GMT to discuss the financial results and provide a business update [2] - Autolus specializes in next-generation programmed T cell therapies for cancer and autoimmune diseases, utilizing proprietary T cell programming technologies [3] Company Overview - Autolus Therapeutics plc is an early commercial-stage biopharmaceutical company focused on developing, manufacturing, and delivering T cell therapies [3] - The company has a marketed therapy, AUCATZYL, and a pipeline targeting hematological malignancies, solid tumors, and autoimmune diseases [3] - The company aims to engineer T cell therapies that can better recognize and eliminate target cells by overcoming their defense mechanisms [3]

Group 1 - Autolus Therapeutics plc is an early commercial-stage biopharmaceutical company focused on developing next-generation programmed T cell therapies for cancer and autoimmune diseases [3] - The company will present updated findings from the CARLYSLE study at the American College of Rheumatology Convergence 2025, highlighting its ongoing research in severe refractory systemic lupus erythematosus (srSLE) [1][2] - The CARLYSLE study's preliminary results indicate a manageable safety profile for the CD19-targeting CAR T therapy, with no dose limiting toxicities, ICANS, or Grade ≥2 CRS observed [2] Group 2 - Autolus utilizes proprietary T cell programming technologies to create targeted therapies that can effectively recognize and eliminate target cells [3] - The company has a marketed therapy, AUCATZYL, and is developing a pipeline of candidates for hematological malignancies, solid tumors, and autoimmune diseases [3]