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Autolus Therapeutics (AUTL)

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Research analysts who have asked questions during Autolus Therapeutics earnings calls.

Recent press releases and 8-K filings for AUTL.

Autolus Therapeutics Secures Ten-Year Lentiviral Vector Supply Agreement
AUTL
New Projects/Investments
  • Autolus Therapeutics plc's subsidiary, Autolus Limited, entered into a ten-year Master Service Agreement with AGC Biologics S.p.A. on January 21, 2026, for the manufacture and supply of lentiviral vector, a critical raw material for CAR-T products.
  • This agreement includes a commitment to purchase a minimum of 14 batches of lentiviral vector during the first two calendar years and a minimum value of EUR 25 million of products and services over the subsequent five-year period.
  • AGC Biologics also received the first right to negotiate for new manufacturing activities related to Autolus's obecabtagene autoleucel (obe-cel) product.
Jan 26, 2026, 9:07 PM
Autolus Therapeutics Announces Preliminary Q4 and Full Year 2025 Revenue and 2026 Guidance
AUTL
Earnings
Guidance Update
Product Launch
  • Autolus Therapeutics announced preliminary unaudited net product revenue for AUCATZYL® of approximately $24 million for the fourth quarter of 2025 and approximately $75 million for the full year 2025.
  • The company provided full year 2026 net product revenue guidance for AUCATZYL® of $120 million to $135 million.
  • Autolus expects its current and projected cash, cash equivalents, and marketable securities to be sufficient to fund operations into the fourth quarter of 2027.
  • The company is progressing its CATULUS, LUMINA, and BOBCAT trials, with initial data from the BOBCAT and ALARIC trials expected by the end of 2026.
  • Autolus successfully launched AUCATZYL in the US with over 60 centers and initiated commercial launch in the UK in December 2025, with plans to expand its US commercial footprint to over 80 centers in 2026.
Jan 12, 2026, 1:36 PM
Autolus Therapeutics to Evaluate Automated Manufacturing Platform for AUCATZYL®
AUTL
New Projects/Investments
  • Autolus Therapeutics will evaluate Cellares' Cell Shuttle platform for the automated manufacturing of its approved CAR T cell therapy, AUCATZYL® (obe-cel).
  • This assessment is intended to prepare for expansion into new indications and to manage future demand that may surpass the manufacturing capacity of its Nucleus facility.
  • AUCATZYL® is currently approved in the United States, UK, and Europe for adult patients with relapsed or refractory B-cell precursor acute lymphoblastic leukemia.
Jan 6, 2026, 2:00 PM
Autolus Therapeutics Presents Positive Clinical Data for Obe-cel in Pediatric B-ALL
AUTL
Product Launch
  • Autolus Therapeutics plc presented initial clinical data from its CATULUS Phase 1 trial, demonstrating that obe-cel achieved a 95.5% overall response rate and 90.9% complete response in pediatric patients with relapsed/refractory B-cell acute lymphoblastic leukemia.
  • The safety profile of obe-cel was consistent with adult experience, showing low rates of high-grade cytokine release syndrome and immune effector cell-associated neurotoxicity syndrome (both 8.7%), with 20 of 21 responding patients remaining in ongoing remission at data cutoff.
  • Planning for the Phase 2 expansion of the CATULUS trial is underway to further explore obe-cel in this patient population.
Dec 19, 2025, 12:44 PM
Autolus Provides Update on Ocatzel Launch and Pipeline Expansion
AUTL
Product Launch
New Projects/Investments
Revenue Acceleration/Inflection
  • Autolus has successfully launched its lead CAR-T cell therapy, Ocatzel (OB-Cell), in the U.S. for adult acute leukemia, with approvals also in the U.K. and Europe, and has expanded to over 60 active centers.
  • The company reported $51 million in sales for Ocatzel for the first nine months and has achieved market leadership within CAR-T therapies for acute leukemia.
  • Ocatzel demonstrated a 77% overall remission rate and a median duration of response of 42 months in the Felix study, alongside a favorable safety profile with 2% high-grade cytokine release syndrome and 7% high-grade neurological adverse events.
  • Autolus is actively pursuing label expansion for Ocatzel into pediatric ALL (with RMAT designation and a planned registrational package) and is exploring its utility in autoimmune diseases, including lupus nephritis (Lumina study) and multiple sclerosis (Bobcat study).
  • The company maintains a strong cash balance sufficient to fund current studies, but future launch costs for new indications are not included and would depend on continued sales growth.
Nov 18, 2025, 12:30 PM
Autolus Therapeutics Reports Strong Aucatzyl Launch and Expansion Plans
AUTL
Product Launch
New Projects/Investments
Revenue Acceleration/Inflection
  • Autolus Therapeutics' lead asset, Aucatzyl (OBE-cel), has achieved $51 million in sales for the first nine months and market leadership in CAR-T therapies for acute leukemia, with the product now active in over 60 centers in the U.S., U.K., and Europe.
  • Aucatzyl demonstrates a strong clinical profile with a 77% overall remission rate and a median duration of response of 42 months in the FELIX study, alongside a manageable safety profile including 2% high-grade cytokine release syndrome and 7% high-grade neurological adverse events.
  • The company is pursuing significant expansion opportunities for Aucatzyl, including a registrational package for pediatric acute leukemia (with RMAT designation) and advancing into autoimmune diseases such as lupus nephritis (LUMINA study) and multiple sclerosis (BOBCAT study).
  • Autolus maintains a strong cash balance sufficient to fund ongoing studies and is focused on optimizing manufacturing efficiency to reduce costs per unit, while also driving market share growth in its current indication.
Nov 18, 2025, 12:30 PM
Autolus Therapeutics Reports Q3 2025 Financial Results and AUCATZYL Launch Progress
AUTL
Earnings
Product Launch
New Projects/Investments
  • Autolus Therapeutics reported $21.1 million in net product revenue for Q3 2025, contributing to $51 million in sales for the first nine months ended September 30, 2025, for its AUCATZYL product.
  • The company achieved market leadership for AUCATZYL in the U.S. for relapsed refractory B-ALL, authorizing 60 treatment centers and securing patient access for over 90% of U.S. covered lives.
  • The net loss for Q3 2025 was $79.1 million, with cash, cash equivalents, and marketable securities totaling $367.4 million as of September 30, 2025.
  • Autolus is expanding the development of obe-cel/AUCATZYL into new indications, including a potentially pivotal Phase II study in pediatric ALL, a Phase II study in lupus nephritis, and an exploratory Phase I study in progressive multiple sclerosis.
Nov 12, 2025, 1:30 PM
AUTL Reports Q3 2025 Financial Results and Provides Business Update
AUTL
Earnings
Product Launch
Management Change
  • AUTL reported Q3 2025 net sales of $21.1 million and a net loss of $79.1 million, with cash, cash equivalents, and marketable securities totaling $367.4 million as of September 30, 2025.
  • AUCATZYL achieved $21.1 million in net sales for Q3 2025 and $51 million for the first nine months ended September 30, 2025, with deferred revenue of $7.6 million at quarter-end. The company met its target of 60 authorized treatment centers and reported a manufacturing success rate well above 90%.
  • The company is expanding its pipeline for Obe-cel (AUCATZYL) with a potentially pivotal Phase 2 study in pediatric ALL, a pivotal study in lupus nephritis, and an exploratory Phase 1 study in progressive multiple sclerosis.
  • Leadership changes include the appointment of Miranda Neville as Chief Technology Officer, Cynthia Pugina as US Chief Commercial Officer and Country Manager, and Patrick Milveni as Chief Accounting Officer.
Nov 12, 2025, 1:30 PM
Autolus Reports Q3 2025 Financial Results and Operational Highlights
AUTL
Earnings
Product Launch
New Projects/Investments
  • Autolus reported AUCATZYL net product sales of $21.1 million for Q3 2025 and $51.0 million for the nine months ended September 30, 2025, supported by 60 authorized treatment centers and a manufacturing success rate exceeding 90%.
  • For Q3 2025, the company recorded total revenue, net, of $21,194 thousand, leading to a loss from operations of $(71,621) thousand and a total comprehensive loss of $(84,900) thousand.
  • Obe-cel showed promising Phase 1 data for Lupus Nephritis (SLE/LN), with 83.3% of patients achieving DORIS and 50% achieving CRR, and was well-tolerated with no DLTs, ICANS, or high-grade CRS. This data supports progression into a Phase 2 trial.
  • The company appointed Miranda Neville as Chief Technology Officer, Cintia Piccina as U.S. Chief Commercial Officer and Country GM, and Patrick Mcllvenny as SVP Finance & Chief Accounting Officer , and anticipates dosing the first patient in the Phase 2 LUMINA trial for lupus nephritis by year-end 2025.
Nov 12, 2025, 1:30 PM
Autolus Therapeutics Reports Q3 2025 Financial Results and AUCATZYL Launch Progress
AUTL
Earnings
Product Launch
Management Change
  • Autolus Therapeutics reported net product revenue of $21.1 million for the third quarter of 2025, with deferred revenue of $7.6 million at the end of Q3 2025. For the nine months ended September 30, 2025, net sales for AUCATZYL reached $51 million. The company's net loss for Q3 2025 was $79.1 million, and cash, cash equivalents, and marketable securities totaled $367.4 million as of September 30, 2025.
  • The commercial launch of AUCATZYL in the U.S. for relapsed refractory B-cell ALL has achieved market leadership, broad market access, and reliable product delivery, with 60 authorized centers and a manufacturing success rate well above 90%. Patient access has been attained for more than 90% of U.S. covered lives.
  • The company is expanding the opportunity for AUCATZYL (Obe-cel) by initiating a potentially pivotal phase two study in pediatric ALL, a pivotal study in lupus nephritis (Lumina), and an exploratory phase one study in progressive multiple sclerosis (Bobcat), with the first patient dosed in Bobcat in October.
  • Autolus Therapeutics announced several leadership team changes, including Miranda Neville as Chief Technology Officer, Cynthia Pugina as US Chief Commercial Officer and Country Manager, and Patrick Milveni as Chief Accounting Officer.
Nov 12, 2025, 1:30 PM