Autolus Therapeutics — Third Quarter 2026 Earnings Summary

Financial Performance:

• Net product revenue for the three months ended September 30, 2026, was $41.2 million, a 95% increase year-over-year compared to $21.1 million in the same period in 2025.
• Total revenue for the nine months ended September 30, 2026, was $113.1 million, compared to $51.1 million in the same period in 2025.
• Cost of sales for the three months ended September 30, 2026, decreased to $17.9 million from $28.6 million in the same period in 2025.
• Gross margin for the third quarter of 2026 was 57%, an increase from 55% in the second quarter of 2026 and a negative gross margin in the same period in 2025.
• Research and development expenses for the three months ended September 30, 2026, increased to $30.9 million from $27.9 million in the same period in 2025.
• Selling, general, and administrative expenses for the three months ended September 30, 2026, decreased to $35.9 million from $36.3 million in the same period in 2025.
• Loss from operations for the three months ended September 30, 2026, was $43.5 million, compared to $71.6 million in the same period in 2025.
• Net loss for the three months ended September 30, 2026, was $55.1 million, compared to $79.1 million in the same period in 2025.
• Basic and diluted net loss per ordinary share for the three months ended September 30, 2026, was $(0.21), compared to $(0.30) in the same period in 2025.
• Cash, cash equivalents, and marketable securities totaled $248.4 million at September 30, 2026, compared to $201.6 million at June 30, 2026.
• Total current liabilities were $98.6 million at September 30, 2026, compared to $73.4 million at December 31, 2025.
• Total shareholders' equity was $27.4 million at September 30, 2026, compared to $178.1 million at December 31, 2025.

Guidance and Future Outlook:

• Full-year 2026 AUCATZYL net product revenue is now expected to be at or exceeding the upper end of the prior guidance of $150 million.
• Based on current operating plans and anticipated proceeds of $100 million from the combined first and second tranches of the Perceptive credit facility, the company expects cash, cash equivalents, and marketable securities to be sufficient to fund operations into Q2 2028.
• Initial clinical data from the ALARIC Phase 1 trial in light-chain amyloidosis is expected to be reported at ASH in December 2026.
• Initial clinical data from the BOBCAT Phase 1 trial in progressive multiple sclerosis is expected to be presented at the ECTRIMS Global meeting in October 2027.
• Phase 2 data from the CATULUS trial in pediatric r/r B-ALL is expected to be reported by year-end 2027.
• Phase 2 data from the LUMINA trial in lupus nephritis is expected to be reported in 2028.

Business Segments and Product Lines:

• AUCATZYL (obecabtagene autoleucel) net product revenue growth was driven by increasing demand within existing authorized treatment centers, expansion into new centers, and contributions from UK sales.
• The Phase 2 portion of the CATULUS trial for obe-cel in pediatric r/r B-ALL is on track, with data expected at the end of 2027.
• Updated data from the Phase 1 CARLYSLE trial in severe refractory systemic lupus erythematosus (srSLE) will be presented at the ACR Annual Meeting on November 10, 2026, including up to 25 months follow-up in adults and ≥3 months in adolescents.
• The pivotal Phase 2 LUMINA study for obe-cel in refractory lupus nephritis continues enrolling in five countries.
• The FDA granted Regenerative Medicine Advanced Therapy (RMAT) designation to obe-cel for the treatment of SLE and LN on September 9, 2026.
• For progressive multiple sclerosis, KOL feedback suggests initial clinical activity is encouraging but requires longer follow-up; the company plans to move the first data presentation to October 2027 to ensure 12 months or more follow-up for the initial 12 patients.
• Lymphodepletion with both FLu/Cy and bendamustine is being evaluated for the progressive MS program.
• The Phase 1 ALARIC trial evaluating AUTO8 in light-chain amyloidosis is ongoing.

Market and Competitive Landscape:

• Gross margin improvement was driven by growing volumes and manufacturing efficiency initiatives, specifically a reduction in manufacturing cost per batch.
• Real-world data reported through the ROCCA consortium supported the growth in AUCATZYL revenue.
• KOL feedback at the ACTRIMS/ECTRIMS meeting indicated that initial clinical activity and biomarker data across CAR T programs in progressive MS are encouraging.

Risks and Challenges:

• Forward-looking statements regarding future expectations, clinical trial results, regulatory approvals, and cash runway involve risks and uncertainties that could cause actual results to differ materially.
• Specific risks include the potential for actual results to differ from guidance on revenue, gross margin, and restructuring activities.
• Safety risks associated with AUCATZYL include Cytokine Release Syndrome (CRS), Neurologic Toxicities (ICANS), secondary malignancies, infections, and HLH/MAS.
• The company notes that T cell malignancies have occurred following treatment with BCMA- and CD19-directed genetically modified autologous T cell immunotherapies.

Management Commentary and Tone:

• Dr. Christian Itin, CEO, stated the company delivered another strong quarter of AUCATZYL revenue, primarily driven by growth within existing treatment centers and supported by real-world data.
• Management highlighted strong execution on manufacturing efficiency initiatives leading to improved gross margins.
• Dr. Itin identified AUCATZYL's performance in adult r/r B-ALL as a key near-term value driver.
• Management expressed belief that expanding obe-cel across all stages of ALL and into autoimmune indications offers meaningful opportunities for scalable growth.
• The tone emphasized confidence in leveraging favorable profiles and proven manufacturing and commercial capabilities.

Other Key Points:

• The company secured proceeds from the combined first and second tranches of a Perceptive credit facility totaling $100 million.
• AUCATZYL was approved by the FDA for adult patients with relapsed or refractory B-cell precursor ALL on November 8, 2024.
• AUCATZYL received conditional marketing authorization from the MHRA in the UK and EMA in the EU in 2025.
• A conference call and webcast were held on November 10, 2026, at 8:30 am EST.
• The FELIX study evaluated the safety of AUCATZYL in 100 patients with relapsed or refractory B-cell ALL.
• Nine patients (9%) in the FELIX study experienced fatal adverse reactions, primarily due to infections, ascites, pulmonary embolism, and HLH/MAS.