Seastar Medical Holding Corporation · NASDAQ:ICU
Seastar Medical — LMF Acquisition Opportunities — SPAC Merger (May 2022)
38 slides from Seastar Medical's SPAC merger presentation, May 4, 2022
Slide 1: Investor Presentation SeaStar Medical, Inc. LMF Acquisition Opportunities, Inc.
Investor Presentation SeaStar Medical, Inc. LMF Acquisition Opportunities, Inc. 1 May 3, 2022
Slide 2: Important Disclosures
Important Disclosures SeaStar Medical 2 This investor presentation (the “presentation”) is for information proposes only to assist interested parties in making their own evaluation with respect to the business combination (the “Transaction”) between LMF Acquisition Opportunities, Inc. (“LMAO”) and S
Slide 3: Important Disclosures (cont.) Forward Looking Statements
Important Disclosures (cont.) SeaStar Medical 3 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 limit
Slide 4: Important Disclosures (cont.) Industry and Market Data
Important Disclosures (cont.) SeaStar Medical 4 Industry and Market Data In this presentation, we rely on and refer to information and statistics regarding market participants in the sectors in which SeaStar expects to compete and other industry data. We obtained this information and these statistic
Slide 5: Overview of LMF Acquisition Opportunities
Overview of LMF Acquisition Opportunities SeaStar Medical 5 Bruce M. Rodgers, Esq. Chairman & CEO, President LMF’s team has significant public company experience to support SeaStar Medical’s growth plans 7+ years of public company experience plus over 20 years serving as outside counsel to public co
Slide 6: Overview of SeaStar Medical
Overview of SeaStar Medical SeaStar Medical 6 Innovative Acute Kidney Injury (“AKI”) Treatment Near-Term Commercial Opportunity in Pediatric AKI upon Approval under HDE* SeaStar Medical is a medical technology company developing a platform therapy to address hyperinflammation, with lead programs in
Slide 7: Clinical Focus: Hyperinflammation as a Disease State
7 SeaStar Medical Various diseases and health issues can trigger hyperinflammation through the release of cytokines (Cytokine Storm) from immunological effector cells. The COVID-19 pandemic has highlighted the devastating significance of this disease state and the inter-relationship between organs s
Slide 8: The Disease State Provides a Logical Expansion into Acute and Chronic Diseases
8 SeaStar Medical Control fluid and electrolyte balance Ventilator, proning, oxygen, and fluids Frequent dialysis treatment per week Diuretics, ultrafiltration Acute Kidney Injury Chronic Dialysis Acute Resp. Distress Synd. Cardio Renal Syndrome A major Cytokine Storm can lead to long term-term morb
Slide 9: Market Opportunity: AKI in the Acute US Hospital Setting
1. US Gov't: Agency for Healthcare Research - HCUPnet, 2012-2016 data extrapolation (CAGR 7.8%): https://hcupnet.ahrq.gov/#setup 2. Extrapolated with annual patient growth of 8% 8.0% Growth 6.0M Aging demographics will contribute to growth *Based on historical growth rate SeaStar Medical AKI inciden
Slide 10: Gained Critical Insights About Patient Populations
SeaStar Medical Gained Critical Insights and Developed Valuable Predictions About these Patient Populations and How Each are Treated ACTIVITY DURING COVID-19 ADDITIONAL PATIENT MARKET POTENTIAL SeaStar Medical gained the insight into the patient populations AKI (Stage 3 RIFLE) ARDS ECMO 1. Medpar. 2
Slide 11: SeaStar Medical's Selective Cytopheretic Device Key Components
IMMUNOMODULATING THERAPY 11 SeaStar Medical SeaStar Medical’s Selective Cytopheretic Device (SCD) Consists of Three Key Components and Leverages Current Installed Base of CRRT Systems Easy for ICU staff to add the SCD Flow pattern Citrate lowers ionized calcium in circuit Filter + + = CRRT = Continu
Slide 12: SCD is Designed to Modulate Immunological Effector Cells
Absorbers SeaStar Medical’s SCD Pathogen SeaStar Medical Exthera Medical Cytosorbent 12 SeaStar Medical’s SCD is Designed to Modulate the Immunological Effector Cells that Produce the Cytokine Release Pathogen removal has promise if used early in disease progression to remove pathogen load. In contr
Slide 13: Robust Clinical Development Pipeline in Multiple Organs
SeaStar Medical 13 Pivotal Approved Indication Pediatric Acute Kidney Injury on CRRT Feasibility FDA HDE Adult Acute Kidney Injury on CRRT FDA PMA Cardiorenal Syndrome in Congestive Heart Failure (no LVAD) Cardiorenal Syndrome in Congestive Heart Failure (LVAD) Myocardial Stunning in End Stage Renal
Slide 14: Pediatric AKI is Accessed through Fewer Hospitals
Pediatric Acute Kidney Injury is Accessed through Fewer Hospitals SeaStar Medical 14 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
Slide 15: Pediatric Acute Kidney Injury Remains an Unmet Need
Pediatric Acute Kidney Injury (AKI) Remains an Unmet Need 1. Kaddourah A, et al. N Engl J Med. 2017;376:11-20. 2. De Zan F, Amigoni A, Pozzato R, Pettenazzo A, Murer L, Vidal E: Acute Kidney Injury in Critically Ill Children: A Retrospective Analysis of Risk Factors. Blood Purif 2020;49:1-7 s 3. Sym
Slide 16: Consistency of the SCD's Clinical Results is a Vital Value Proposition
16 Note: All subjects in these studies were patients with Acute Kidney Injury (AKI) *Case matched controls based on SOFA Scores and age **Treated per protocol (iCa in therapeutic range using citrate) ***Historical control based on published studies ARF: Acute Renal Failure Dialysis Dependency Mortal
Slide 17: Validation: SCD-005 COVID-19 Pilot Study
17 Primary End Points All-cause mortality at Day 60 Dialysis dependency at Day 60 Ventilation free survival at Day 28 Indications Acute Kidney Injury and/or Acute Respiratory Distress Syndrome Patient Pilot Trial 22 Sites 2 SCD-005 Current Pilot Studies Underway* Acute Kidney Injury Acute Respirator
Slide 18: Mortality of SCD-005 Treated Patients Significantly Lower Than Control
Mortality of SCD-005 Treated Patients was Significantly Lower Than Contemporaneous Control Population Standard of Care 60-day mortality of SCD-treated patients (ITT population and PP population) was lower than in the contemporaneous control group 18 ITT=intent to treat; PP=per protocol; SOC=standard
Slide 19: Clear Clinical Development Path Offers Multiple Catalysts
SeaStar Medical HDE: Humanitarian Device Exemption PMA: Pre Market Approval LOS: Length of ICU/Hospital Stay *Pending discussions and regulatory approval with FDA 19 Clear Clinical Development Path Offers Multiple Catalysts Over Next 24 Months Launch Pediatric AKI SCD in Q1 2023* and complete Adult
Slide 20: Key Relationships in Place to Execute on Business Strategy
Key Relationships in Place to Execute on Business Strategy SeaStar Medical 20 Supply Agreement Distribution Agreement Right of first refusal to distribute both pediatric and adult AKI products in United States Contract Research Organization in Place for SCD 006 US supply for pediatric and adult indi
Slide 21: Comprehensive Patent Estate for Modulating Inflammation
SeaStar Medical 21 U.S. Patent Portfolio 17 granted; 4 pending Of the granted patents, the last will expire in 2032* Ex-U.S. Patent Portfolio 20 granted; 16 pending Of the granted patents, the last will expire in 2032 *Once US Regulatory Approval is granted, company will apply to extend patent life
Slide 22: SeaStar Medical Management Team
SeaStar Medical Management Team SeaStar Medical 22 Over 30 years of accounting and finance experience in private and public companies WPP, Tiffany & Co, CDM Group University of Maryland Caryl Baron Controller Over 20 years of business leadership at both large and growing companies Dow Chemical, Dow
Slide 23: Board of Directors – SeaStar Medical Holding Corporation
Board of Directors – SeaStar Medical Holding Corporation SeaStar Medical 23
Slide 24: SeaStar Medical Corporate Highlights
SeaStar Medical Corporate Highlights 24 SeaStar Medical 1. See slides 9-10 for market data 2. Pediatric Acute Kidney Injury product expected to launch in early 2023 under HDE; Pivotal trial ready program in Adult Acute Kidney Injury, with projected interim and final data readouts in 2023/2024 (PMA)
Slide 25: Summary Transaction Overview
25 SeaStar Medical Summary Transaction Overview The combined company will be known as SeaStar Medical Holding Corporation Will operate under the same management team as SeaStar Medical Anticipated closing in Q3 2022 Overview Ownership Financing Transaction Rationale Use of Proceeds The transaction c
Slide 26: Detailed Transaction Overview
26 SeaStar Medical Detailed Transaction Overview
Slide 27: Thank You
Thank You May 2022 SH SEASTAR MEDICAL
Slide 28: Supplemental Medical Information
Supplemental Medical Information SeaStar Medical 28
Slide 29: Uncontrolled Hyperinflammation is at the Center of Acute and Chronic Organ Injury
Hyper- inflammation Acute Kidney Injury Cardio Renal Syndrome Hepato Renal Syndrome Intradialytic Hypotension in Chronic HD Cardio-Pulmonary Bypass Surgery Acute Respiratory Distress Syndrome Extracorp. Membrane Oxygenation (ECMO) Sepsis Myocardial Stunning in Chronic HD Organ Transplant SeaStar Med
Slide 30: High Hospitalization & Mortality Rate Indicates an Underserved Market
SeaStar Medical 30 1. American Hospital Directory Database, accessed Jan 2020 on 7,018 hospitals, data on file for 2018 2. D. E. Fry, L. Pearlstein, R. L. Fulton and H. C. Polk, “Multi- ple System Organ Failure: The Role of Uncontrolled In- fection,” Archives of Surgery, Vol. 115, No. 2, 1980, pp. 1
Slide 31: How SeaStar Medical's SCD Mimics Nature
How SeaStar Medical’s SCD Mimics Nature 31 Source: Caster et al Re-Examining Neutrophil Participation in GN JASN August 2017 Vol 28 (8): 2275 - 2289 SeaStar Medical Neutrophils are captured, roll, stop and enter endothelial cells SCD Activated Neutrophil Neutrophil Activated Neutrophils release cyto
Slide 32: SCD is Designed to Address the Host Inflammatory Response
An example of when each technology would be used1,2 1. Placement of our competitors based on stage in time course where their products are currently used or on management’s assessment of where they would be used 2. Some of the competitors are clinical stage while others are approved/commercial. Sour
Slide 33: Neutrophil Biomarkers Suggest SCD Captures Highly Activated Neutrophils
Neutrophil Biomarkers Strongly Suggest that the SCD is Capturing the Most Highly Activated Neutrophils 33 High CD11b expressed in hyperinflammation High CD62L signals reparative High CD66b associated with severity of sepsis and COVID 19 SeaStar Medical Data from SeaStar Medical - SCD 005 NCT04395911
Slide 34: Monocyte Biomarkers Suggest SCD Captures Highly Activated Monocytes
High CD11b expressed in hyperinflammation High CD14 expressed in hyperinflammation Monocyte Biomarkers Strongly Suggest that the SCD is Capturing the Most Highly Activated Monocytes 34 SeaStar Medical Data from SeaStar Medical - SCD 005 NCT04395911
Slide 35: Adult ARF-003 Ad-hoc Trial Results
SeaStar Medical 35 *Tumlin et al. A Multi-Center, Randomized, Controlled, Pivotal Study to Assess the Safety and Efficacy of a Selective Cytopheretic Device in Patients with Acute Kidney Injury. PLOS One. 2015;10(8) Adult Pivotal trial will have ~4x more patients Adult ARF-003 Ad-hoc Trial Results
Slide 36: Reductions of Activated Neutrophils, Monocytes and Cytokines in SCD-005
Significant Reductions of Activated Neutrophils and Monocytes and Pro-inflammatory Cytokines Were Seen in SCD-005 Treated Patients Cytometric analysis of cell surface markers reflective of neutrophil activation (CD11b,CD10) and monocyte activation (CD11b,CD14) demonstrated that SCD sequestered the m
Slide 37: Market Opportunity: Chronic Non-Hospital Setting (ESRD)
End Stage Renal Disease (ESRD) is a costly chronic disease burden that reduces life span. A proven innovation would address the unmet need and allow access to a large market 37 Number of US In Center Hemodialysis ESRD patients per year Source: usrds.org Between 30 and 50 % of hemodialysis patients h
Slide 38: SCD May Also Have Impact in the Chronic Setting with ESRD
15 African American ESRD patients (8 males/7 females) with high CRP Protocol was standard 4-hour hemodialysis session with heparin followed by Single 4-hour HD Session with citrate + SCD Shift in immune system from pro-inflammatory to reparative …And durable response 38 SeaStar Medical SCD May Also
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