SeaStar Medical : Investor Presentation December

Investor

Presentation

Bringing organ-restoring solutions to critically ill patients

December 2024

www.SeaStarmedical.com

Nasdaq: ICU

SEASTAR

MEDICAL

Commercial-stage company with patented, clinically 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 standard of care, one patient at a time

4

Seasoned, dynamic leadership

ERIC SCHLORFF

DAVID GREEN

KEVIN CHUNG, MD

SAI IYER, PHD​

TOM MULLEN​

TIM VARACEK​

Chief Medical Officer

SVP, Medical Affairs

SVP, Manufacturing

SVP, Commercial

CEO + Board Member

Chief Financial Officer​

and Clinical

and Product

Business Operations

Development

Development

5

Investment highlights

BEST-IN-CLASS	MULTIBILLION-	COMMERCIALIZING	PIVOTAL TRIAL	EXPERIENCED
TECHNOLOGY	DOLLAR MARKET	FIRST INDICATION	PROGRESS	EXECUTIVE TEAM

• 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-lifestability at room temperature

• Platform technology potential application in multiple high-value acute and chronic indications
• Technology requires minimal, if any, modifications for new indications
• Same SCD, Same Mechanism of Action, with access to a multitude of indications

• 1st FDA approval for pediatric acute kidney injury with sepsis
• Product shipped in July 2024
• QUELIMMUNE (SCD- PED) commercial strategy to target leading children's hospitals
• Approval validates platform and derisks future FDA approvals

• Enrolling patients in pivotal adult trial,
  NEUTRALIZE-AKI
• Adult acute kidney injury population 50x larger than pediatric
• CMS coverage for a portion of trial costs

• Seasoned, dynamic leadership with over 150 years of industry experience* and clear focus on advancing strategy
• Wealth of executive, operational, financial, clinical and regulatory expertise

*Based on the 6 members of the leadership team

Diverse application in multiple blockbuster potential, inflammation-driven diseases where vascular access is in place

6

Chronic

Dialysis

Acute

Respiratory

Distress

Syndrome

Cardiorenal

Syndrome -

w/ no

LVAD**

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 Ventricular Assist Device

	SCD-ADULT requires minimal to no modification
	for new indications
Cardiorenal	Covered by 40 U.S. and foreign issued patents
Syndrome -	and 8 pending applications
w/ LVAD**

Pediatric	FDA Approved
Acute Kidney

Injury

HDE*

Adult	NEUTRALIZE-
AKI
Acute Kidney	Pivotal Trial
Injury
Hepatorenal
Syndrome	Awarded Breakthrough
	Device Designation

7

FDA-approved for pediatric acute kidney injury and pivotal adult acute kidney injury trial underway

QUELIMMUNE is approved under a Humanitarian Device Exemption for the treatment of children with sepsis or septic condition*

Indication​
Pediatric acute kidney injury	FDA approval February 2024 - Commercial launch July 2024
Adult acute kidney injury	Pivotal trial underway

Pediatric acute kidney injury approval sets a strong precedent

for approvals in additional indications

*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

8

Blockbuster potential in near-term indications for adults

					Annual	Study Size
Indication				Patient
			(patients)
					Population
Adult-AKI	1, 2				210,000	200
Cardiorenal Syndrome - w/ no LVAD		580,000	50
Adult Acute Respiratory Distress Syndrome	3	200,000	100
Adult Hepatorenal Syndrome	1, 4, 5		50,000	50	7
Cardiorenal Syndrome - w/ LVAD	1		60,000	25
Total
Notes

1. Breakthrough Device Designation awarded by FDA
2. Silver SA, Chertow, GM Nephron 2017; 137 (4) 297-301.
3. American College of Physicians, ACP Hospitalist, Coding information from July 2019.
4. Sepanlou, et al. Lancet Gastroenterology & Hepatology, 2020 Mar;5(3):245-266.
5. Orman, et al JAMA Netw Open. 2019 Oct 2;2(10):e1913673.

Total cost of	Estimated	Estimated	Estimated
Peak Sales	Patient	Estimated Range of Peak Sales
Study	PMA Date
Year	Share, %
$15,000,000	2026	2031	20.0%	$945,000,000	to	$1,260,000,000
5,000,000	2029	2034	5.0%	652,500,000		870,000,000
10,000,000	2029	2034	7.5%	337,500,000		450,000,000
4,000,000	2027	2033	15.0%	168,750,000		225,000,000
4,000,000	2027	2032	5.0%	67,500,000		90,000,000
$40,500,000				$2,196,250,000		$2,895,000,000

SCD TECHNOLOGY PLATFORM

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Hyperinflammatory response can lead to multi-organ damage and death

Infection /	Innate Immune	Dysregulated immune response	End-Organ
Injury	Response	(hyperinflammation)	Damage

Activated monocytes

	Cytokines	Other
Activated​	inflammatory
neutrophils		mediators

• Pulmonary infiltrates
• Lung injury
• Acute respiratory distress syndrome
• Cardiovascular shock
• Disseminated intravascular coagulant
• Acute kidney injury

Patient Outcome:

Permanent Organ Damage or Death