Strong QUELIMMUNE Revenue Growth
QUELIMMUNE net revenue of $495,000 in Q1 2026 versus $293,000 in Q1 2025, an increase of ~69% (nearly 70%). Management reports continued order momentum into Q2 and an annual net revenue target of approximately $2.0M for 2026.
Customer Expansion and Commercial Traction
Added 7 new hospitals in Q1 2026; company cited 17 customers overall and is pursuing a goal of 15 new customers in 2026. Management reports repeat orders and growing clinical interest driven by education and user forums.
Pivotal Trial Enrollment Progress
NEUTRALIZE-AKI pivotal trial has enrolled 198 of 339 planned patients (~58% complete). Company expects to finish enrollment around year-end 2026 and potentially report topline results mid-2027.
SAVE Registry Milestone
Completed enrollment at 50 patients in the SAVE Registry. 28-day safety analyses are underway and the company plans to request the FDA change the registry from mandatory to voluntary, which could reduce adoption friction if approved.
High Gross Margin
Reported gross profit margin of over 90% in Q1 2026 (consistent with prior three quarters).
Improved Cash Position
Cash balance of $9.3M as of March 31, 2026, up from $5.2M a year earlier (increase of ~79%), providing a stronger liquidity base versus prior year.
Disciplined Operating Spend and Improved Loss Metrics
Operating expenses were flat YoY at approximately $4.1M in Q1 2026. Net loss improved to ~$3.5M ($0.90 per share) from ~$3.8M ($4.38 per share) in Q1 2025 (net loss improvement ~8%), reflecting expense discipline and a larger share base.
Regulatory Engagement and Potential Pathways
Active discussions with the FDA on a modular PMA submission and accelerated/rapid approval pathways (including Breakthrough Device designation), which, if successful, could speed adult AKI approval and commercialization.