Autolus Therapeutics (AUTL) Company Report

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

Transcript

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

Transcript

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

Transcript

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

Transcript

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

Presentation

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

Transcript

Autolus Therapeutics Reports Q3 2025 Financial Results and Business Updates

AUTL

Earnings

Management Change

Product Launch

Autolus Therapeutics reported Q3 2025 AUCATZYL net product revenue of $21.1 million and deferred revenue of $7.6 million as of September 30, 2025.
The company achieved 60 authorized treatment centers in the U.S. and secured patient access for over 90% of total U.S. medical lives.
For Q3 2025, the loss from operations was $71.6 million and the net loss was $79.1 million, resulting in a basic and diluted net loss per ordinary share of $(0.30).
The U.S. FDA granted Regenerative Medicine Advanced Therapy (RMAT) designation to obe-cel for pediatric r/r B-ALL in October 2025.
Autolus bolstered its leadership team with the appointment of Patrick McIlvenny as Principal Accounting Officer, Cintia Piccina as U.S. Chief Commercial Officer and Country General Manager, and Miranda Neville as Chief Technical Officer.

Nov 12, 2025, 1:13 PM

8-K

Earnings Transcripts

Quarterly earnings call transcripts for Autolus Therapeutics.

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