Top-Line Revenue Growth
Total revenue for Q1 2026 was $25.0M vs $19.8M in Q1 2025, an increase of approximately 26.3% year-over-year. HEPZATO KIT revenue was $23.3M and CHEMOSAT revenue was $1.7M.
Volume Momentum and New Patient Starts
Company reported record new patient starts in Q1 and new patient starts per site tracked at ~0.7 new patients per site per month (at or slightly higher than Q1 2025). Management cited 36% year-over-year volume growth for the quarter (per press release) and mid-20% quarter-over-quarter volume growth vs Q4 2025.
Commercial Footprint Expansion
Nearly completed U.S. commercial expansion into 9 regions; expanded MSL team fully trained and deployed; 29 REMS-certified sites as of the call and active discussions with over 50 potential centers (38 of which have had team members participate in precepting).
CHOPIN Clinical Evidence Driving Adoption
CHOPIN results (published in Lancet Oncology) showed response rates improving from ~40% with HEPZATO alone to ~76% with HEPZATO plus immunotherapy, including some complete responses and survival separation at 1 and 2 years. Management reported anecdotal physician adoption and that CHOPIN is influencing treatment patterns at multiple centers.
Guidance and Profitability Outlook
Company reiterated guidance of at least $100M total revenue for 2026 (reflecting 20% growth in HEPZATO kit volume over 2025), maintained gross margin guidance of 85%–87%, and expects to report positive adjusted EBITDA for the remainder of the year.
Clinical Program Progress
Metastatic colorectal cancer program has 13 sites active for screening and is on track to activate nearly all targeted 26 trial sites by year-end 2026; metastatic breast cancer program has 4 sites ready to screen and is targeting 15 sites by late 2026. Interim CRC results anticipated in late 2027.
Cash Position and Balance Sheet
Ended Q1 with $89.3M in cash and investments and no debt; cash provided by operations was $0.9M in the quarter. Company also executed share repurchases (~300,000 shares for ~$3M in Q1; $9M repurchased to date under $25M program).
Operational Initiatives to Mitigate Seasonality
Management implemented incentives to train second treatment teams at centers to reduce seasonal capacity disruptions and is building referral networks and multi-source identification strategies to accelerate patient referrals.