Autolus Therapeutics (AUTL) TD Cowen 46th Annual Health Care Conference summary

Product launch and market performance

• Launched first product, obe-cel, a CD19 CAR-T therapy for relapsed/refractory adult acute leukemia, achieving $75 million in first-year revenue and rapid market leadership.

• Secured approvals in the U.K. and Europe, including a positive NICE review, enabling routine commissioning and broad market access.

• Expanded to 70 U.S. centers with plans to reach 80+ by year-end, targeting $120–$135 million in net revenue and positive gross margin in year two.

• Achieved over 90% manufacturing success rate, with robust, semi-automated processes and no capacity limitations.

• Ongoing optimization of manufacturing and supply chain to improve gross margins over the next 24–36 months.

Clinical data and real-world outcomes

• Real-world data from the ROCCA Consortium shows zero high-grade CRS, 3% high-grade ICANS, and over 90% response rate, outperforming competitors.

• FELIX study and commercial experience confirm strong safety and efficacy, supporting rapid adoption and market leadership.

• Pediatric pivotal study in phase II, showing high response rates and good safety profile, even in high-risk frontline patients.

• Ongoing pivotal studies in lupus nephritis and exploratory study in progressive MS, leveraging differentiated mechanism of action.

Expansion into new indications

• Targeting pediatric ALL, lupus nephritis, and progressive MS, with pivotal and exploratory studies underway.

• Early-stage collaboration on BCMA/CD19 CAR-T for light chain amyloidosis, with initial data expected by year-end.

• Lupus nephritis pivotal study (LUMINOUS) enrolling 30 patients for full approval, with plans for expanded indications.

• Progressive MS study (BOBCAT) enrolling patients with high unmet need; initial data expected end of this year or early next.