Slides
Page 1
January 2026 www.SeaStarMedical.com Nasdaq: ICU Investor Presentation Transforming treatments for critically ill patients facing organ failure and potential loss of life.
Page 2
2 Forward-looking statements This presentation contains certainforward-looking statementswithin the meaning of the “safe harbor” provisions of the Private Securities Litigation Reform Act of 1955. Theseforward-looking statementsinclude, without limitation, SeaStar Medical’s expectations with respect to the timing of regulatory approval process and timeline of its products, the expected timing on enrollment, generation of study results, submission of PMA and other milestones, the ability of SCD to treat patients with AKI, the potential benefits of SCD to treat other diseases, the total addressable market for SCD applications and our ability to gain market share and generate sales with respect to the total addressable market for SCD applications. Words such as “believe,” “project,” “expect,” “anticipate,” “estimate,” “intend,” “strategy,” “future,” “opportunity,” “plan,” “may,” “should,” “will,” “would,” “will be,” “will continue,” “will likely result,” and similar expressions are intended to identify suchforward-looking statements.Forward-looking statements are predictions, projections and other statements about future events that are based on current expectations and assumptions and, as a result, are subject to significant risks and uncertainties that could cause the actual results to differ materially from the expected results. Most of these factors are outside SeaStar Medical’s control and are difficult to predict. Factors that may cause actual future events to differ materially from the expected results include, but are not limited to: (i) the risk that SeaStar may not be able to obtain regulatory approval of its SCD product candidates; (ii) the risk that SeaStar may not be able to raise sufficient capital to fund its operations, including clinical trials; (iii) the risk that SeaStar Medical and its current and future collaborators are unable to successfully develop and commercialize its products or services, or experience significant delays in doing so, including failure to achieve approval of its products by applicable federal and state regulators, (iv) the risk that SeaStar Medical may never achieve or sustain profitability; (v) the risk that SeaStar Medical may not be able to secure additional capital on acceptable terms; (vi) the risk that third-parties suppliers and manufacturers are not able to fully and timely meet their obligations, (vii) the risk of product liability or regulatory lawsuits or proceedings relating to SeaStar Medical’s products and services, (xiii) the risk that SeaStar Medical is unable to secure or protect its intellectual property, and (xi) other risks and uncertainties indicated from time to time in SeaStar Medical’s Annual Report on Form 10-K, including those under the “Risk Factors” section therein and in SeaStar Medical’s other filings with the SEC. The foregoing list of factors is not exhaustive. Forward-looking statements speak only as of the date they are made. Readers are cautioned not to put undue reliance on forward-looking statements, and SeaStar Medical assume no obligation and do not intend to update or revise these forward-looking statements, whether as a result of new information, future events, or otherwise.
Page 3
3 3 Our Mission High gross profit margin and efficient commercialization strategy Drive stakeholder value Our SCD therapy has pharmaceutical margins and concentrated markets Destructive hyperinflammation leads to organ failure and loss of life Stop organ failure Save lives Our SCD therapy has demonstrated ability to preserve organ function and save lives FDA Breakthrough Device Designations awarded for both ICU and clinical settings Expand indications and areas of treatment Our SCD therapy is agnostic to disease state First and ONLY therapy to neutralize destructive hyperinflammation Maximize market penetration Our SCD therapy is protected by 34 U.S. and foreign patents
Page 4
4 First indications in pediatric and adult AKI provide significant market opportunity for our SCD therapy 4 Sources: 1. Uchino S, et al. JAMA 2005. 2. Mehta RL, et al Kidney Int 2004. 3. Modem V, et al. Crit Care Med 2013. 4. Goldstein SL, et al. Kidney Int 2005. 5. Coca SG, et al. Kidney Int 2012. 6. 2022 USRDS Annual Report; accessed 20Aug2023 Estimates of Annual U.S. Patient Population and Total Addressable U.S. Market were derived from Silver SA, Chertow, GM Nephron 2017; 137 (4) 297-301; American College of Physicians, ACP Hospitalist, Coding information from July 2019; Sepanlou, et al. Lancet Gastroenterology & Hepatology, 2020 Mar;5(3):245-266; Orman, et al JAMA Netw Open. 2019 Oct 2;2(10):e1913673. Market sizing in graphic are representative and not to scale. The adult AKI market is estimated to be 50 times the pediatric AKI market. Market opportunities reflect assumptions regarding cartridge pricing and number of cartridges used per patient. AKI = Acute Kidney Injury High unmet need in adult AKI Adult AKI total US annual market ~$4.5B • ~200K total patient market • Pivotal trial underway Pediatric AKI total US annual market is ~ $100M • ~4K total US patient market • Launched 3Q’24 Mortality rates for critically ill patients with AKI requiring Renal Replacement Therapy in ICU setting1-4 50%+ 8X More likely to develop end- stage renal disease following severe AKI episode5 $100K Cost of a single patient for one year of dialysis6
Page 5
5 • 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) THE PROBLEM: Hyperinflammatory response can lead to multi-organ damage and death Infection / Injury Activated monocytes Activated neutrophils Other inflammatory mediators Cytokines Patient Outcome: Permanent Organ Damage or Death
Page 6
6 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 renal replacement therapy that is widely available in U.S. ICUs today Pathway for standard hemofilter Standard of Care Ca2+ replacement Regional citrate anticoagulation Ionized Ca2+ levels: <0.4 mmol/L Unique mechanism of action restores reparative physiology HOMEOSTASIS- RESTORING THERAPY LOWER ionized calcium in circuit with citrate Selectively TARGET highly activated neutrophils & monocytes DEACTIVATE through neutrophil apoptosis and monocyte shift to repair phenotype =
Page 7
7 Neutralization of activated effector cells helps restore homeostasis Cytokine 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 The SCD therapy targets upstream source of effector cells and neutralizes effector cells that release cytokines Other drugs and therapies that focus on individual downstream inflammatory targets such as IL -6, TNF-⍺ etc. fail to address the high redundancy in the immune system Neutrophil & Monocyte effector cells SCD-Adult QUELIMMUNE
Page 8
8 Launched first commercial product and executing on a robust pipeline *QUELIMMUNE is approved by the FDA as a Humanitarian Use Device (HUD) to treat pediatric patients with acute kidney injury and sepsis or septic condition weighing 10 kilograms and requiring kidney replacement therapy Approved under a Humanitarian Device Exemption.* Launched in July 2024 Q1’24 Awarded Breakthrough Device Designation by FDA to provide timely access to medical devices by speeding up development, assessment and review for FDA approval. AKI* – Now over 40% Enrolled Cardiorenal syndrome 8 * Newsweek article cites AKI as post-operative risk in cardiac surgeryClick here to read more * Newsweek article cites AKI as post- operative risk in cardiac surgery Click here to read more Indication Investigational Feasibility study Pivotal trial Approved QUELIMMUNE: Pediatric acute kidney injury Pipeline Indications: SCD-ADULT indications require minimal to no device modification for new indications End Stage Renal Disease (ESRD) Hepatorenal syndrome Systemic inflammatory response in cardiac surgery - Adults Systemic inflammatory response in cardiac surgery - Pediatric
Page 9
9 QUELIMMUNE addresses a high unmet need in pediatric AKI Despite advances in supportive treatments, pediatric patients with acute kidney injury often deteriorate due to untreated hyperinflammation 27% Overall incidence of acute kidney injury in the pediatric ICU setting1 2x Patients with acute kidney injury stay in the ICU twice as long - 8 days vs 4 days2 50% For children with acute kidney injury and multi-organ dysfunction requiring continuous kidney replacement therapy3-5 ≥30% Incidence of chronic kidney disease for pediatric patients with acute kidney injury6 ICU ADMISSIONS LONGER IN ICU MORTALITY CHRONIC DISEASE 1. Kaddourah A, et al. NEJM. 2017; 376:11-20. 2. De Zan F, et al. Blood Purif. 2020;49:1-7. 3. Symons JM, et. al. Clin J. Am Soc Nephrol 2007. 4. Modem V, et al. Crit Care Med 2013. 5.Goldstein, SL, et al. Kidney Int 2005; 67; 653-658. 6. Menon S, et. al Ped Nephr 2023 (38) Suppl 1:S41.
Page 10
10 77% Survival1 At Day 60 Dialysis dependency2 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. QUELIMMUNE clinical data supporting FDA approval in pediatric acute kidney injury * Pooled data from two clinical trials n=22 QUELIMMUNE* Standard of Care 50% Activated neutrophil 10% to 30%
Page 11
11 Additional data from the Save Surveillance Registry mirror high survival rates from clinical data Data are on track to support a 50% reduction in loss of life compared to historical data, as reported in Kidney Medicine. The SAVE Surveillance Registry is assessing the use of the QUELIMMUNE therapy in the treatment of critically ill pediatric patients with life - threatening Acute Kidney Injury (AKI) and sepsis or septic condition requiring Renal Replacement Therapy (RRT) Data collected from the first 21 pediatric patients in the SAVE Surveillance Registry show NO device related safety events with the QUELIMMUNE therapy. Survival at Day 60 Survival at Day 90 0% 10% 20% 30% 40% 50% 60% 70% 80% 90% 100% 76% 71% Survival Analysis of First 21 Patients
Page 12
12 Safety Profile of SCD therapy across 6 adult & pediatric AKI studies • No device-related infections, immunosuppression or SAEs across >150 patients • >50% of these patients were septic Study # (Descriptor) # SCD Treated Patients # SCD Used per Patient (mean) Total # SCD Used Total SCD Exposure Time (hours) # AEs # SAEs # Device-Related SAEs # Device-Related Infections O-USA Pilot Study 9 3.9 34 816 14 0 0 0 ARF-002 Pilot Study 35 4.3 150 3,508 199 28 0 0 SCD-003 69 5.2 359 8,611 354 80 0 0 SCD-PED-01 16 5 80 1,936 47 12 0 0 SCD-PED-02 6 4.6 28 660 29 6 0 0 SCD-0051 22 8.2 181 4,344 70 50 0 0 TOTALS 157 5.3 832 19,875 713 176 0 0 In SCD-005, all but 1 patient had AKI. 1. Humes HD, et al. Crit Care Explor. 2023 Oct 19;5(10):e0995. OUS = outside U.S.
Page 13
13 Focused commercial strategy to drive early adoption 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-in-the-united-states.html First product shipped in July 2024 Adoption by Top 10 U.S. Pediatric Children's Hospitals 220 U.S. Children’s Hospitals Treat ~4,000 pediatric AKI patients 50 hospitals treat 50% of AKI patients Key elements of our commercial strategy: • Focus on top academic sites first to create brand recognition and treatment experience • Target early adopters: ~20% of top 50 hospitals have prior experience with QUELIMMUNE • Decouple device use through Human Device Exemption and requirement for Patient Registry participation to enable critical care use when patient presents at the hospital • Deploy skilled nursing and other experts to sites to ensure smooth transition to adoption of QUELIMMUNE • Manage all aspects of the sales and distribution process to reduce middleman fees and ensure prompt delivery of product
Page 14
14 QUELIMMUNE provides value to a hospital’s bottom line
Page 15
15 Adult AKI study outcomes consistent with pediatric studies * Of survivors (Day 60 Post-ICU Discharge) 1. Goldstein SL, et al. Kidney Medicine. 2024; 6(4);100792 2. Tumlin JA, et al. Semin in Dialysis. 2013;26(5):616-23. 3. Tumlin JA, et al. PLoS ONE. 2015; 10(8):e0132482. **Treated per protocol (iCa in therapeutic range using citrate) 4. Uchino S, et al. JAMA. 2005. 5.Bagshaw SM, et al. Crit Care. 2005. 0% 10% 20% 30% 40% 50% 60% 70% 80% 90% % Survival Day 60 Pediatric AKI Adult AKI Adult Historical Control 50% 0% 10% 20% 30% 40% 50% 60% 70% 80% 90% % Dialysis Dependence Day 60 No Dialysis Dependence at Day 60 No Dialysis Dependence at Day 60 25% Pediatric AKI Adult AKI n=16 n=35n=6 n=22 n=19 n=16 n=35n=6 n=22 n=19 Adult Historical Control Survival at Day 60 Dialysis Dependence at Day 60
Page 16
16 Pivotal trial underway in adult AKI • Adults aged 18-80 in ICU with acute kidney injury > stage 2 requiring CRRT > 12 and < 48 hours • One additional life-threatening organ dysfunction • Commitment to maintain current level of care for > 96 hours • C-reactive Protein > 3.5 mg/dL Patient Population Assess the safety & efficacy of SCD in acute kidney injury patients requiring continuous renal replacement therapy (CRRT) Trial Objective CRRT Control SCD Therapy + CRRT Patients need to be on CRRT for ≥ and meet I/E criteria N = Up to 339 Primary Endpoint: Composite of all-cause mortality or dialysis dependency Randomized 1:1
Page 17
17 NEUTRALIZE-AKI pivotal trial gaining momentum • 150 of up to 339 subjects enrolled (>40% to date)* • 17 medical sites activated • Mix of academic, military, and community hospitals • CMS reimbursement for Medicare/Medicaid patients ⎻ Reduces trial costs, increases site activations, and accelerates enrollment • Final analysis following 90-day endpoint • Present results at scientific conferences • Publish results in peer-reviewed medical journal • Anticipate PMA filing in 2027 with modular filings in 2026 to potentially speed approval process University of Cincinnati Methodist Hospital Metropolitan University of Iowa Hospital Methodist Hospital Main *As reported on 12/3/25
Page 18
18 Third potential indication for patients with chronic systolic heart failure awaiting LVAD or heart transplant Assess the safety & efficacy of SCD patients withchronic systolic heart failure complicated by cardiorenal syndrome (CRS)who are not candidates for heart transplant or even LVAD (Left Ventricular Assist Device). Trial Objective Screening Enrollment n = 20 SCD treatment Up to 6 hours daily for 6 days Follow-up Study Goals • Demonstrate improvement in renal and cardiac function to enable LVAD implantation or heart transplant • Demonstrate the feasibility of intermittent therapy for use in outpatient settings – encompassing a broad range of chronic hyperinflammatory diseases • File for FDA Humanitarian Device Exemption approval, pending positive study outcome
Page 19
19 SCD pipeline - Approach to clinical development: Scientifically driven, cost-effective, medical-community focused SCD PLATFORM Presentations at scientific meetings Publish manuscripts Research grants (non - dilutive financing) University of Michigan research Scientific Advisory Board Case studies and compassionate use requests Chaired by David Humes, MD, SCD inventor, Professor, Division of Nephrology - University of Michigan 11 world-renowned leaders in pediatric and adult nephrology, critical care and translational science Engage and Drive the Science Publications and Presentations
Page 20
20 Seasoned, dynamic leadership 20 ERIC SCHLORFF CEO and Board Member TOM MULLEN SVP, Manufacturing and Product Development SAI IYER, PHD SVP, Medical Affairs and Clinical Development KEVIN CHUNG, MD Chief Medical Officer TIM VARACEK SVP, Commercial Business Operations MIKE MESSINGER Chief Financial Officer
Page 21
21 Strong financial position December 31, 2022 (In thousands) December 31, 2023 (In thousands) December 31, 2024 (In thousands) September 30, 2025 (unaudited, in thousands) ASSETS Cash $47 $176 $1,819 $13,763 LIABILITIES Accounts payable $1,927 $4,372 $3,046 $2,018 Stockholders’ equity (deficit) $(20,762) $(13,870) $(2,183) $11,464 • No long-term debt as of September 30, 2025
Page 22
22 Capital structure Ticker Symbol Market Capitalization * Shares Outstanding ** Warrants Outstanding*** Weighted Average Exercise Price for Warrants*** Long-term Debt ICU $9.3 million 3.8 million 2.7 million $84.02 Zero * At market close 1/7/26 ** Approximate shares outstanding: 1/7/26 and reflects a 10-for1 reverse stock split on 1/5/26 *** Approximate warrants outstanding: 1/7/26
Page 23
23 2024 2025 2026 QUELIMMUNE commercial product launch Breakthrough Device Designation for 2 new indications, for a total of 6 Initiated feasibility trial in cardiorenal syndrome QUELIMMUNE launch expansion: 10 hospitals ordering product $3.6 million NIH grant for severe cardiorenal syndrome Advance clinical development of SCD therapy in chronic heart failureExpanded clinical sites to 17 to maximize NEUTRALIZE-AKI pivotal trial enrollment Catalysts to drive value creation QUELIMMUNE FDA approval for pediatric acute kidney injury SCD-ADULT QUELIMMUNE CMS coverage for adult acute kidney injury trial costs Complete enrollment in the NEUTRALIZE-AKI pivotal trial Awarded FDA Breakthrough Designation for Chronic Dialysis Double the QUELIMMUNE customer base Apply for FDA approval pathways that enable more rapid paths to commercialization
Page 24
24 24 Our Mission High gross profit margin and efficient commercialization strategy Drive stakeholder value Our SCD therapy has pharmaceutical margins and concentrated markets Destructive hyperinflammation leads to organ failure and loss of life Stop organ failure Save lives Our SCD therapy has demonstrated ability to preserve organ function and save lives FDA Breakthrough Device Designations awarded for both ICU and clinical settings Expand indications and areas of treatment Our SCD therapy is agnostic to disease state First and ONLY therapy to neutralize destructive hyperinflammation Maximize market penetration Our SCD therapy is protected by 34 U.S. and foreign patents
Page 25
25 • Achieved 150* of 339 patients enrolled in the NEUTRALIZE-AKI pivotal trial • Reported Interim Analysis of first 100 patients: efficacy signal and trial continuation of up to 339 patients • CMS coverage for a portion of trial costs • Adult acute kidney injury (AKI) population 50x larger than pediatric NEUTRALIZE-AKI pivotal trial in progress • Potential application in multiple billion dollar acute and chronic indications • Patented SCD therapy with same Mechanism of Action for multiple indications Multibillion-dollar market • Clinically proven to reduce mortality • Health Care Economics establishes dramatic cost reductions versus standard of care • Patented, proprietary SCD platform (34 U.S. and foreign issued patents) Best-in-class technology • FDA approval for pediatric acute kidney injury with sepsis in 2024 • QUELIMMUNE (SCD- PED) being adopted by foremost children’s hospitals • Continuing launch expansion into top 50 pediatric hospitals • Derisks future FDA approvals Commercializing first indication 25 Investment Highlights * As reported on 12/3/25
Page 26
January 2026 www.SeaStarMedical.com Nasdaq: ICU Investor Presentation Investor Contact: IR@SEASTARMED.COM Transforming treatments for critically ill patients facing organ failure and potential loss of life.