Seastar Medical Holding Corporation · NASDAQ:ICU
Seastar Medical — Investor Presentation (January 2025)
31 slides from Seastar Medical's investor presentation, Jan 13, 2025
Slide 1: Investor Presentation
January 2025 www.SeaStarMedical.com Nasdaq: ICU Investor Presentation Bringing organ - restoring solutions to critically ill patients
Slide 2: Forward-looking statements
Forward - looking statements This presentation contains certain forward - looking statements within the meaning of the “safe harbor” provisions of the Private Securities Litigation Reform Act of 1955. These forward - looking statements include, without limitation, SeaStar Medical’s expectations wit
Slide 3: SeaStar Medical
SEASTAR MEDICAL Commercial - stage company with patented, c linically validated, organ - agnostic therapeutic device targeting life - threatening hyperinflammation The Selective Cytopheretic Device (SCD) extracorporeal platform stops the cytokine storm and safely restores organ function Changing the
Slide 4: Seasoned, dynamic leadership
Seasoned, d ynamic leadership ERIC SCHLORFF CEO + Board Member TOM MULLEN SVP, Manufacturing and Product Development SAI IYER, PHD SVP, Medical Affairs and Clinical Development DAVID GREEN Chief Financial Officer KEVIN CHUNG, MD Chief Medical Officer TIM VARACEK SVP, Commercial Busines
Slide 5: Investment highlights
Investment highlights • Patented, proprietary SCD platform addresses life - threatening unmet medical needs • Clinically proven to reduce mortality and decrease dialysis dependency in acute kidney injury • Potential to dramatically reduce economic burden of disease • P roven delivery system • Shelf
Slide 6: Diverse application in multiple inflammation-driven diseases
Diverse application in multiple blockbuster potential, inflammation - driven diseases where vascular access is in place 1. America Hospital Directory Database Export, January 2020. 2. Silver SA, Chertow , GM Nephron 2017; 137 (4) 297 - 301. 3. *HDE – Humanitarian Device Exemption 4. **LVAD – Left Ve
Slide 7: FDA-approved for pediatric AKI and pivotal adult trial underway
FDA - approved for pediatric acute k idney i njury and pivotal adult acute kidney injury trial underway Pediatric acute kidney injury approval sets a strong precedent for approvals in additional indications Indication Pediatric acute kidney injury Adult acute kidney injury Pivotal trial und
Slide 8: Blockbuster potential in near-term adult indications
Blockbuster potential in near - term adult indications 8 Clinical Trial Costs $ in millions Total Addressable U.S. Market $ in millions 2 Annual U.S. Patient Population 1 Clinical Indication 15 4 4,700 – 6,300 210,000 Adult Acute Kidney Injury (AKI) 3 5 13,100 - 17,400 580,000 Cardiorenal Syndrome w
Slide 9: SCD Technology Platform
SCD TECHNOLOGY PLATFORM
Slide 10: Hyperinflammatory response can lead to multi-organ damage and death
• Pulmonary infiltrates • Lung injury • Acute respiratory distress syndrome • Cardiovascular shock • Disseminated intravascular coagulant • Acute kidney injury End - Organ Damage Innate Immune Response Dysregulated immune response (hyperinflammation) H yperinflammatory response can lead to multi - o
Slide 11: Neutralization of activated effector cells helps restore homeostasis
Neutralization of activated effector cells helps restore homeostasis Cyt okine storm Insult or injury Immune response Increased cytokine production from effector cells and the recruitment of additional leukocytes SCD targets the SOURCE of cytokine production SCD targets upstream source of effector c
Slide 12: Mechanism of action of QUELimmune
Mechanism of action of QUELimmune • S electivity of Binding : Neutrophils (70 - 80%), Monocytes (15 - 25%), Lymphocytes (0 - 2%) • Most Activated Neutrophils (CD11b density) and Pro - Inflammatory Monocytes (CD14+) bind to the membranes due to low iCa environment • For Neutrophils : Low iCa environm
Slide 13: Pathway for SCD integration
Standard venous return line (renal therapy standard - of - care) Hemofilter Hemofilter to SCD line SCD Venous return line SCD to venous return line Pathway for SCD integration SCD conveniently connects with existing continuous kidney renal therapy that’s widely available in U.S. ICUs today Pathway
Slide 14: SCD Clinical Evidence
SCD. CLINICAL EVIDENCE |»
Slide 15: Pediatric patients with AKI are vulnerable to cytokine storms
Pediatric patients with acute kidney injury are vulnerable to cytokine storms D espite ICU’s standard care in managing electrolytes, fluids and toxins, the condition of pediatric patients with acute kidney injury often worsens due to untreated hyperinflammation 27% Overall incidence of acute kidney
Slide 16: QUELIMMUNE clinical data in pediatric AKI
77% survival 1 At Day 60 dialysis dependency 2 At Day 60 (Post - ICU Discharge) device - related immunosuppression, serious adverse events or infections NO NO 1. Goldstein SL, et al. Kidney Medicine . 2024; 6(4);100792. 2. Goldstein SL, et al. Kidney Int Rep . 2020; 6(3):775 - 84. QUELIMMU
Slide 17: Adult AKI study outcomes consistent with pediatric studies
Adult acute kidney injury study outcomes consistent with pediatric studies Combined PED - 01 / PED - 02 (N=22) SCD - PED - 02 (10 - 20 kg) (N=6) SCD - PED - 01 (≥ 15kg) (N=16) Study / Parameter 17 (77%) 1 5 (83%) 12 (75%) Survival Day 60 0% 0% 0% Dialysis Dependence Day 60* 87.5% Normal Kidney Funct
Slide 18: Safety Profile of SCD Across Adult & Pediatric AKI Studies
Safety Profile of SCD Across 6 Adult & Pediatric AKI Studies >150 critically ill ICU patients with AKI >800 devices used & ~20,000 hours of exposure No device - related infections, immunosuppression or SAEs >50% of these patients were septic # Device - Related Infections # Device - Related SAEs # SA
Slide 19: Commercial & Regulatory Strategies: Pediatrics
COMMERCIAL & REGULATORY STRATEGIES PEDIATRICS
Slide 20: Commercial strategy targeting top 50 children's hospitals
Commercial strategy for pediatric acute kidney injury targeting top 50 leading children’s hospitals 1. https://www.childrenshospitals.org. 2. America Hospital Directory Database Export January 2020 3. https://www.beckershospitalreview.com/lists - and - statistics/30 - largest - childrens - hospitals
Slide 21: QUELIMMUNE provides value to a hospital's bottom line
QUELimmune provides value to a hospital’s bottom line Critically ill patients with characteristics similar to those in SCD studies - continuous kidney replacement therapy with sepsis, high use of mechanical ventilation and/or vasopressors : 1 • Mean total length of stay is >30 days • Mean total hosp
Slide 22: Clinical Study & Regulatory Strategies: Adult
CLINICAL STUDY & REGULATORY STRATEGIES ADULT
Slide 23: Adult AKI pivotal trial design
Adult acute kidney injury pivotal trial design • Adults aged 18 - 80 in ICU with acute kidney injury > stage 2 requiring CKRT (CKRT > 12 h < 48 h) • One additional life - threatening organ dysfunction • Commitment to maintain current level of care for > 96 h • C - reactive Protein > 3.5 mg/dL Patien
Slide 24: NEUTRALIZE-AKI pivotal trial gaining momentum
NEUTRALIZE - AKI pivotal trial gaining momentum • 74 of up to 200 subjects enrolled (37% to date) • 14 of up to 30 medical sites activated • Mix of academic, military and community hospitals • Interim data review of first 100 subjects at 90 - days post - treatment • Final analysis following last 90
Slide 25: Expanding Science & Future Indications
EXPANDING SCIENCE & FUTURE INDICATIONS
Slide 26: SCD platform approach to clinical development
SCD platform - Approach to clinical development: Scientifically Driven, Cost - Effective, Medical - Community Focused 26 Engage and Drive the Science SCD PLATFORM Presentations at scientific meetings Publish manuscripts Research grants (non - dilutive financing) University of Michigan research Scien
Slide 27: Strategy is to expand indications with platform technology
Strategy is to expand indications with platform technology Evaluate inflammation - based conditions or diseases driven by activated neutrophils / monocytes High Burden of disease and unmet medical need in an operable patient setting Clear commercial opportunity based on population size and or lack o
Slide 28: Capital structure
28 Capital structure As of January 8, 2025 Ticker Symbol Price Shares Outstanding* Market Capitalization Warrants Outstanding Weighted Average Exercise Price for Warrants Interest - bearing Debt ICU $2.00 5,977,246 $11,954,492 2,359,829 $92.88 Zero *at 12/31/2024
Slide 29: 2024 financial highlights
2024 financial highlights 29 $0 Substantial Asset Value • QUELIMMUNE FDA approved for pediatrics Q1 2024 • Adult pivotal clinical trial, 37% enrolled • Four FDA "Breakthrough Device Designations" awarded • Seven high - value indications available for the same device Commercial Activity • Successful
Slide 30: Catalysts to drive value creation
2024 2025 2026 QUELIMMUNE commercial product launch Breakthrough Device Designation for additional indications Initiate pivotal trial in cardiorenal syndrome QUELIMMUNE launch expansion 20 to 25 hospital systems $3.6 million NIH grant for severe cardiorenal syndrome Topline data severe cardiorenal s
Slide 31: Investment highlights
Investment highlights • Patented, proprietary SCD platform addresses life - threatening unmet medical needs • Clinically proven to reduce mortality and decrease dialysis dependency in acute kidney injury • Potential to dramatically reduce economic burden of disease • Proven delivery system • Shelf -
SeaStar Medical Holding — Investor Presentation (January 2025) on 6ix