Strong Top-Line Growth
First quarter revenue of $71 million, an approximately 45% year-over-year increase, driven by strong Amtagvi demand.
Amtagvi Commercial Momentum
Amtagvi revenue of $60 million in Q1, up ~38% year-over-year and the company's second-highest quarterly Amtagvi result; March was the largest month ever for reported Amtagvi revenue.
Tight Q2 and Full-Year Revenue Guidance
Q2 total revenue guidance of $86M–$88M with Amtagvi expected at $79M–$81M (an ~23% increase versus the company's prior highest quarterly revenue); full-year 2026 guidance of $350M–$370M for Amtagvi and Proleukin.
Improving Financial Discipline and Runway Extension
Research and development expense declined for the third consecutive quarter (down 18% versus the prior period and 12% versus the prior quarter); cash and equivalents of ~$319M as of March 31 with expectation to fund operations into 2028.
Manufacturing Control and Capacity Restoration
Completed maintenance upgrades at internal iCTC manufacturing facility; Amtagvi is now exclusively manufactured in-house with a modular facility designed to provide uninterrupted supply and support global scale.
Favorable Unit Economics Signals
Reported gross-to-net impact remains below 2%; Q1 gross margin from cost of sales ~41% despite one-time upgrade costs and management expects margins to trend higher for the remainder of 2026 excluding one-time items.
Clinical and Pipeline Advances
Announced compelling early Phase II data in metastatic serous endometrial cancer with a confirmed objective response rate (ORR) of 40% and 100% disease control rate in first five patients; pursuing FDA engagement for expedited approval.
Broad Registrational and Next-Generation Programs
Progress across registrational trials and next-gen candidates: TILVANCE-301 (frontline melanoma) ongoing; lifileucel Fast Track in previously treated non-squamous NSCLC targeting accelerated approval and potential H2 2027 launch; IOV-SAR-201 (soft tissue sarcoma) enrollment beginning Q3 2026; IOV-5001 IND submitted (Phase I/II expected H2 2026); IOV-3001 and IOV-4001 advancing.
Commercial Reach and Awareness Growth
ATC network expanding (targeting ~110 by year-end) and physician awareness increased from 50% to 70% over the prior six months; first ex-U.S. treatment center authorized in Canada with regulatory progress planned in Australia (H1) and Switzerland (next year).