Autolus reports $75 million in 2025 AUCATZYL revenue, projects growth

Autolus Therapeutics plc (NASDAQ: AUTL) reported preliminary unaudited net product revenue of approximately $24 million for the fourth quarter of 2025 and approximately $75 million for the full year from sales of AUCATZYL, according to a company statement.

The biopharmaceutical company projects net product revenue for AUCATZYL of between $120 million to $135 million for 2026. AUCATZYL received FDA approval for treating adult patients with relapsed or refractory B-cell precursor acute lymphoblastic leukemia in November 2024.

The company said more than 60 centers in the US now offer the treatment. Autolus also obtained regulatory approvals in the UK and EU, with commercial launch in the UK beginning in December 2025 under routine commissioning.

Independent real-world data from the ROCCA consortium presented at the American Society of Hematology meeting confirmed clinical activity and safety profile consistent with prior clinical trial results, the company stated.

Autolus reported preliminary data from its CATULUS Phase 1 trial in pediatric patients showed an overall response rate of 95.5%. The company is advancing to the Phase 2 portion and expects full enrollment in the first half of 2027.

The CARLYSLE trial in patients with severe refractory systemic lupus erythematosus showed deep B-cell depletion in all patients. The company selected 50 million cells as the recommended Phase 2 dose and has begun enrolling in the LUMINA trial for lupus nephritis.

Autolus dosed the first patient in its BOBCAT trial for progressive multiple sclerosis in October 2025, with initial data expected at the end of 2026.

The company expects to shift from negative gross margin to positive gross margin in 2026 due to increased patient numbers improving manufacturing plant utilization. Based on current operating plans, Autolus expects its cash, cash equivalents and marketable securities will fund operations into Q4 2027.

You May Also Be Interested In

• Accelsius deploys liquid cooling system at EdgeConneX training center
• AIxC secures $33,000 robot rental order and expands sale to 23 units
• Intuit (INTU) PT Lowered to $370 at Freedom Broker