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SeaStar Medical Holding Corp (ICU)·Q3 2025 Earnings Summary

Executive Summary

  • Q3 revenue of $0.183M declined sequentially but rose y/y; EPS of $(0.13) beat the S&P Global consensus while revenue missed; gross margin was ~92% as COGS began matching sales . Revenue: $0.183M vs $0.338M in Q2’25 and $0.068M in Q3’24; EPS: $(0.13) vs $(0.18) in Q2’25 . Consensus: Revenue $0.250M*, EPS $(0.15)* [Values retrieved from S&P Global].
  • Management signaled stronger early Q4 momentum: QUELIMMUNE orders in the first half of Q4 exceeded all of Q3, and full‑year 2025 revenue is anticipated to be over $1M .
  • NEUTRALIZE‑AKI pivotal trial: DSMB interim analysis showed a positive efficacy signal and no device‑related safety issues; total enrollment raised from 200 to ~339 with 146 enrolled and 17 sites active, targeting completion near end of 2026 (timeline extended) .
  • Balance sheet strengthened: $12.4M raised in Q3; cash of $13.8M at 9/30/25 improves runway as the adult AKI opportunity advances .

What Went Well and What Went Wrong

  • What Went Well

    • Early Q4 QUELIMMUNE demand inflected: “orders to date already exceeding orders for the entire third quarter” .
    • Trial safety and efficacy signal: DSMB saw “zero device‑related safety issues” and a “clear signal of benefit,” recommending expansion to 339 patients to ensure power .
    • Commercial progress and margins: 10 active commercial pediatric hospitals and ~92% gross margin as COGS matched sales, reflecting a pharma‑like profile .

  • What Went Wrong

    • Revenue volatility: Q3 net revenue fell to $0.183M from $0.338M in Q2 due to lumpy adoption cadence and registry constraints; revenue missed S&P Global consensus $0.250M* [Values retrieved from S&P Global].
    • Timeline extension: NEUTRALIZE‑AKI enrollment completion moved to end‑2026 from earlier ambitions, requiring more sites (17 active; at least 8 more planned) .
    • Operating expense dynamics: While down y/y ($3.75M vs $4.52M), total opex rose q/q vs Q2’25 ($2.07M), reflecting higher clinical and audit costs amid cost discipline .

Financial Results

Revenue, EPS, margins vs prior periods and estimates

MetricQ3 2024Q2 2025Q3 2025Consensus (Q3 2025)
Revenue ($USD)$68,000 $338,000 $183,000 $250,000*
EPS (Primary/Basic & Diluted) ($)$(1.10) $(0.18) $(0.13) $(0.15)*
Gross Profit ($USD)$68,000 $311,000 $169,000 —
Gross Margin (%)n/a (COGS=0) ~92% ~92% —

Note: Consensus from S&P Global. Values retrieved from S&P Global.*

Operating expense and loss profile

Metric ($USD)Q3 2024Q2 2025Q3 2025
R&D Expense$2,336,000 $1,037,000 $1,850,000
G&A Expense$2,188,000 $1,030,000 $1,898,000
Total Opex$4,524,000 $2,067,000 $3,748,000
Net Loss$(4,478,000) $(2,002,000) $(3,472,000)
Shares (WASO)4,086,871 11,329,517 26,393,400

Balance sheet snapshot

Metric ($USD)Dec 31, 2024Jun 30, 2025Sep 30, 2025
Cash$1,819,000 $6,302,000 $13,763,000
Current Assets$3,766,000 $7,647,000 $14,874,000
Current Liabilities$6,841,000 $5,042,000 $4,066,000
Stockholders’ Equity/(Deficit)$(2,183,000) $3,341,000 $11,464,000

KPI snapshot

KPIQ1 2025Q2 2025Q3 2025
Net Revenue ($USD)$293,000 $338,000 $183,000
Gross Margin (%)n/a (COGS=0) ~92% ~92%
NEUTRALIZE‑AKI Enrolled To Date100 125 146
Adult AKI Sites Activated15 —17
Active Commercial Pediatric Hospitals6 —10

Guidance Changes

MetricPeriodPrevious GuidanceCurrent GuidanceChange
Revenue (Company outlook)FY 2025None disclosed“Over $1 million” Initiated
NEUTRALIZE‑AKI Total EnrollmentTrial200 patients ~339 patients Increased sample size
NEUTRALIZE‑AKI Enrollment Completion TimingTrialManagement had aimed to finish sooner; “decent chance” by year‑end noted earlier “Near the end of 2026” Delayed timeline
QUELIMMUNE Hospital Activations (goal)2025Not prior quantifiedUp to 20 new pediatric hospitals targeted Initiated goal

Earnings Call Themes & Trends

TopicPrevious Mentions (Q1 & Q2 2025)Current Period (Q3 2025)Trend
QUELIMMUNE adoption and demandQ1: 6 active hospitals; 4x q/q revenue; Q2: +3 new customers; lumpy but trending up 10 active hospitals; first half Q4 orders > entire Q3; goal up to 20 new pediatric hospitals in 2025 Improving adoption momentum
Registry requirement & FDA reliefHDE requires SAVE Surveillance Registry; slows activation Company has approached FDA to request relief to accelerate adoption Potential positive catalyst
NEUTRALIZE‑AKI progressQ1: hit 50% enrollment → DSMB interim in Q3; Q2: 125 enrolled; strong site screening DSMB: clean safety, benefit signal; sample size raised to ~339; 146 enrolled; 17 active sites; completion near end‑2026 Rigorous path; longer runway
Financials and runwayQ1/Q2: improving gross margin; cost control; added capital ~92% GM; raised $12.4M; cash $13.8M at 9/30/25 Strengthened liquidity
External support (CMS/DoD)Q2: CMS to cover certain CRS trial expenses; DoD grant for SCD research Continued trial execution; first NEUTRALIZE‑CRS site initiated Execution continues

Management Commentary

  • “In the first half of the fourth quarter, we are extremely pleased to see very strong QUELIMMUNE sales, with orders to date already exceeding orders for the entire third quarter.” — Eric Schlorff, CEO .
  • “The DSMB determined the SCD therapy to be safe with no device‑related adverse events … [and] observed a clear and encouraging signal of benefit … recommended increasing the total enrollment to 339 patients.” — Dr. Kevin Chung, CMO .
  • “We currently have 10 active commercial pediatric hospitals … adding four new customers since the beginning of the third quarter.” — Tim Varacek, SVP Commercial & Ops .
  • “Gross profit margin of approximately 92% … first full quarter of matching cost of goods sold against QUELIMMUNE unit sales.” — Brad Town, Controller .
  • “We are anticipating full‑year revenue for 2025 will be over $1 million.” — Eric Schlorff, CEO .

Q&A Highlights

  • Enrollment and sites: 146 patients enrolled; 17 sites active; plan to activate ~8 more to ~25, with approval for up to 30 if needed to hit 339 by Dec 2026 .
  • NEUTRALIZE‑CRS (cardiorenal syndrome): Single‑arm 20‑patient feasibility; expect ~5 sites; aim to complete enrollment in ~1 year, subject to activation pace .
  • Revenue clarity: Management reiterated expectation for >$1M FY25 revenue despite quarterly lumpiness .
  • Operational tactics: Expanding screening within sites (e.g., surgical ICUs), training and refinement to lift enrollment velocity .

Estimates Context

  • Q3 2025 results vs S&P Global consensus: Revenue $0.183M vs $0.250M* (miss); EPS $(0.13) vs $(0.15)* (beat by $0.02). One estimate in each case (coverage is thin) . Values retrieved from S&P Global.*
  • Prior quarter (Q2 2025) context: Revenue $0.338M vs $0.200M* (beat) with EPS $(0.18) vs $(0.43)* (beat), underscoring volatility around early‑stage adoption. Values retrieved from S&P Global.* .
  • Implications: Early Q4 order strength suggests Q4 revenue could exceed Q3, potentially aligning with or surpassing the $0.245M* consensus if momentum sustains; however, ultra‑low coverage (1 estimate) increases forecast uncertainty . Values retrieved from S&P Global.*

Financial Tables (Detail)

Actuals across periods

MetricQ3 2024Q2 2025Q3 2025
Revenue ($USD)$68,000 $338,000 $183,000
EPS ($)$(1.10) $(0.18) $(0.13)
R&D ($USD)$2,336,000 $1,037,000 $1,850,000
G&A ($USD)$2,188,000 $1,030,000 $1,898,000
Net Loss ($USD)$(4,478,000) $(2,002,000) $(3,472,000)

Results vs Consensus (Q3 2025)

MetricActualConsensusSurprise
Revenue ($USD)$183,000 $250,000*$(67,000)
EPS ($)$(0.13) $(0.15)*+$0.02

Note: Consensus from S&P Global. Values retrieved from S&P Global.*

Key Takeaways for Investors

  • Commercial inflection signals: Early Q4 QUELIMMUNE orders exceeding Q3 provide near‑term revenue momentum and support management’s >$1M FY25 revenue expectation .
  • Quality of margin: ~92% gross margin underscores attractive unit economics; as volumes scale, high incremental contribution should emerge .
  • Clinical risk/benefit calibration: DSMB’s recommendation to upsize to ~339 patients reflects smaller-than‑assumed effect size at interim but strengthens eventual statistical power; clean safety de‑risks regulatory dialogue .
  • Timeline reset: Adult AKI pivotal completion pushed to end‑2026; investors should model longer path to potential PMA submission and commercialization, with ongoing site additions to accelerate enrollment .
  • Liquidity improved: $13.8M cash post raise offers runway for trial execution and commercial efforts; watch additional financing cadence as programs expand .
  • Estimate sensitivity: With only one covering estimate, reported volatility can drive outsized reaction; Q4 setup is better given order cadence, but coverage thinness elevates uncertainty . Values retrieved from S&P Global.*
  • Catalysts: FDA relief from mandatory registry (would accelerate pediatric adoption), NEUTRALIZE‑AKI site activations/enrollment updates, NEUTRALIZE‑CRS site ramp/enrollment, additional hospital wins, and further real‑world registry data .

S&P Global disclaimer: Asterisked consensus figures are from S&P Global and lack document citations. Values retrieved from S&P Global.