SeaStar Medical Holding Corporation Q2 FY2026 earnings call

• Commercial Progress for QUELIMMUNE

  • Added 7 new hospital customers for QUELIMMUNE in Q1 2026, reaching a total of 17 customers as of the end of the quarter, putting the company on track to hit its 2026 full-year goal of 15 new customers
  • Confirmed repeat orders from existing customers, with growing order volume as adoption increases
  • Completed 50-patient enrollment in the mandatory SAVE Registry tracking QUELIMMUNE safety in pediatric patients; 28-day safety analysis of final patients is complete, and top-line data will be submitted to the FDA shortly, followed by a request to transition the registry to voluntary status
  • Expanded educational outreach including a sponsored symposium at the AKI and CRRT meeting, monthly virtual clinical user calls with care teams, presentations at leading specialty conferences, and the formation of an advanced practice provider advisory board to drive institutional adoption
  • Received prominent mainstream industry recognition: the American Society of Nephrology's Kidney News published two articles highlighting SCD therapy as a leading frontier in active immune modulation for kidney care

• Clinical Pipeline Progress

  • The NEUTRALIZE-AKI pivotal trial for SCD therapy in adult AKI has enrolled 198 of the planned 339 total patients
  • Added new clinical trial sites (including UCLA) to accelerate enrollment, targeting completion of patient enrollment by the end of 2026
  • Working with the FDA to develop a modular PMA submission pathway for adult AKI that enables early review of non-trial components, to speed overall approval; contingent on positive trial results, the final submission will be processed under the existing Breakthrough Device designation for accelerated review
  • Engaged in parallel FDA discussions to secure a rapid approval pathway for SCD therapy in other unmet need hyperinflammation indications

• Financial Performance

  • Reported a gross profit margin over 90% for Q1 2026
  • Operating expenses remained flat at ~$4.1 million in Q1 2026, matching the year-ago quarter, reflecting ongoing cost discipline
  • Q1 2026 net loss was ~$3.5 million ($0.90 per share), compared to a $3.8 million net loss ($4.38 per share) in Q1 2025
  • Cash balance as of March 31, 2026 was $9.3 million, up from $5.2 million at March 31, 2025

SeaStar Medical has one commercial product segment: QUELIMMUNE for pediatric acute kidney injury (AKI). In Q1 2026, QUELIMMUNE generated net revenue of $495,000, representing a 69% increase from $293,000 in Q1 2025. The segment achieved a gross profit margin of over 90%, consistent with the prior three quarters. 100% of the company's Q1 2026 net revenue is attributable to the QUELIMMUNE segment. The company's pipeline product, SCD therapy for adult AKI and other hyperinflammation indications, has not yet generated commercial revenue.

• Full-year 2026 QUELIMMUNE net revenue guidance is maintained at approximately $2 million, with the company on track to hit this target after a strong Q1 performance
• Full-year 2026 new customer acquisition guidance for QUELIMMUNE is maintained at 15 new hospital customers, with 7 already added in Q1 putting the company on track to meet the goal
• Enrollment completion for the NEUTRALIZE-AKI pivotal trial is maintained at end of 2026, with top-line results targeted for mid-2027
• R&D expenses are expected to increase a modest 5% per quarter for the remainder of 2026 to support expanded NEUTRALIZE-AKI trial site activity and enrollment
• General and administrative expenses are expected to remain steady quarter-over-quarter for the remainder of 2026, maintaining cost discipline

• Forward-looking statements (including clinical trial timelines, regulatory approval outcomes, and revenue targets) are subject to inherent risks and uncertainties that could cause actual results to differ materially from expectations, as detailed in the company's SEC filings
• Final enrollment timelines for the NEUTRALIZE-AKI trial depend on patient recruitment at new sites, which cannot be guaranteed
• The FDA may not approve the request to transition the SAVE Registry from mandatory to voluntary status, which would leave administrative burdens in place that could slow QUELIMMUNE adoption
• Approval of the adult AKI PMA submission is contingent on positive efficacy and safety results from the NEUTRALIZE-AKI trial, which cannot be guaranteed
• QUELIMMUNE treats an ultra-rare pediatric indication, so patient volume and revenue are dependent on unpredictable patient presentation at adopting hospitals, which may lead to variability in quarterly results

Q: David Bautz (Zacks) asked if SeaStar is seeing repeat orders from existing pediatric QUELIMMUNE centers, and how quickly reorders occur after a hospital first adopts the product. / A: Tim Varacek confirmed that the company definitely sees repeat orders from the existing customer base. Reorder frequency is entirely driven by unpredictable patient presentation at hospitals; some centers wait long periods between appropriate patients, while others may have multiple patients back-to-back after their first use.

Q: Bautz asked when SAVE Registry data will likely influence pediatric AKI treatment guidelines and standard of care. / A: Kevin Chung noted that guideline updates take significant time and typically require broad adoption and multiple randomized controlled trials. QUELIMMUNE's SCD therapy is already mentioned in the published pediatric ADQI consensus document on AKI, and positive results from the NEUTRALIZE-AKI trial will likely accelerate its inclusion as a recommended therapy in future updates.

Q: Bautz asked how difficult it is for hospitals to integrate SCD therapy into existing ICU workflows, as ASN Kidney News noted integration is nontrivial. / A: Kevin Chung explained that integrating the SCD cartridge into existing continuous renal replacement therapy (CRRT) circuits only takes minutes for trained ICU or dialysis staff, and is as simple as clinically possible. 99% of U.S. ICUs already use the citrate anticoagulation required for SCD therapy, so no major new protocols are needed for implementation.

Q: Anthony Vendetti (Maxim) asked for additional color on ordering patterns, total treated patients, and average revenue per center. / A: Eric Schlorff confirmed that 50 patients have been enrolled in the SAVE Registry, giving a general sense of total treated patients to date. Tim Varacek added that many established customers have set par inventory levels based on their utilization, but since the business is still scaling, newer customers are still establishing utilization cadence. QUELIMMUNE treats an ultra-rare indication, so revenue per center is fully patient-dependent, and the company does not disclose average revenue per center at this stage.

Q: Vendetti asked what additional educational efforts SeaStar is using to accelerate adoption at new and existing centers. / A: Kevin Chung explained that the company leverages the tight-knit pediatric critical care/nephrology community through monthly public virtual user calls that review actual patient cases, which generates organic interest from non-adopting centers when they hear positive outcomes. Tim Varacek added that the company has also formed an on-the-ground advanced practice advisory board of frontline providers to drive institutional protocol setup and training, and hosts ongoing symposia and field support to spread awareness across shift teams at adopting sites.