Autolus Reports $74.3M Revenue in First Commercial Year, Aims for Positive Margins by 2026
Autolus Therapeutics reported $74.3 million in 2025 revenue during its first commercial year, while facing a -265% gross margin. The company aims to achieve positive margins by 2026 through scaling production and expanding into autoimmune diseases with promising early lupus trial results. The broader CAR-T therapy market is projected to reach $9.85 billion in the US by 2033.
Autolus Therapeutics reported 2025 revenues totaling $74.3 million in its first full year of commercial operations, successfully launching treatment at 67 centers across the United States. The company is now targeting a strategic expansion into autoimmune disease markets, though it continues to face substantial financial losses with a gross profit margin of -265% over the past year.
In the fourth quarter of 2025, the cost of sales reached $25.3 million, surpassing product revenue and resulting in an operating loss of $72.5 million. This earnings miss led to a 6.2% drop in share price during premarket trading, and the stock has fallen 35% year-to-date. Autolus anticipates reaching positive gross margins in 2026, driven by higher treatment volumes and better utilization of its manufacturing facilities.
The company closed 2025 with $300.7 million in cash reserves, which management believes will support operations through late 2027. This forecast is based on an anticipated 2026 revenue range of $120 million to $135 million from its flagship CAR-T therapy AUCATZYL. The ability to reach positive gross margins in 2026—by scaling production and improving efficiency—is pivotal to the company's financial strategy.
Early Phase 1 results for obe-cel in severe lupus show promise: among nine participants, three achieved complete remission and five experienced significant, lasting responses. The treatment showed a favorable safety profile with no severe neurotoxicity, a critical advantage for CAR-T therapies outside oncology. Autolus has launched a pivotal Phase 2 trial in lupus nephritis, selecting a 50 million cell dose based on early results.
Enrollment is also underway for a pivotal Phase 2 study in pediatric acute lymphoblastic leukemia. Additionally, the Phase 1 BOBCAT trial is exploring obe-cel's potential in progressive multiple sclerosis, with initial results expected by the end of 2026. These clinical advances are designed to significantly broaden the company's reach beyond oncology.
The US CAR-T cell therapy market reached $3.42 billion in 2024 and is expected to reach $9.85 billion by 2033, growing at a CAGR of 12.7% during the forecast period 2025-2033. Autologous CAR-T therapies dominate the US market with approximately 85-90% share, as most approved CAR-T treatments are currently developed using a patient's own T cells. CD19-targeted CAR-T therapies lead the market with nearly 55-60% share, driven by their extensive use in treating B-cell malignancies.
The global autologous cell therapy market is expected to reach $6.7 billion in 2026 and expand to $15.4 billion by 2033, registering a robust CAGR of 12.6%. Autologous stem cell therapy dominates the market with a 51.3% share due to broad applications in oncology and regenerative medicine. North America leads with a 55.1% market share, supported by advanced healthcare infrastructure and strong regulatory frameworks.