Cytosorbents Corporation · NASDAQ:CTSO
Cytosorbents — Investor Presentation (December 2010)
35 slides from Cytosorbents's investor presentation, Dec 1, 2010
Slide 1: CytoSorbents November 2010
Soe rking to Sz November 2010 OTCBB: CTSO
Slide 2: Safe Harbor Statement
Safe Harbor Statement Statements in this presentation regarding CytoSorbents Corporation and its operating subsidiary CytoSorbents, Inc that are not historical facts are forward-looking statements and are subject to risks and uncertainties that could cause actual future events or results to differ m
Slide 3: Overview
Overview 5 is a critical care-focused device company in clinical trials using blood purification to treat disease The heart of the technology is a biocompatible, highly porous, polymer bead that can remove a wide range of toxic substances such as drugs, cytokines, and toxins from blood and physiolog
Slide 4: Concept is Simple But Elegant
Concept is Simple But Elegant The polymer beads are packed into cartridges compatible with standard hemodialysis machines or blood pumps Obtain venous access with temporary dialysis catheter Pump blood through the cartridge with standard pumps The polymer beads remove toxic substances “Purified” blo
Slide 5: Recent Company Highlights
Recent Company Highlights * 90% complete with enrollment of a 100 patient European Sepsis Trial Working simultaneously on the CE Mark application process Positive clinical improvement in 6 CytoSorb™ treated vs 6 control human sepsis patients from a major academic site in a randomized, controlled Sep
Slide 6: Management Team
Management Team Phillip Chan, MD, PhD — Chief Executive Officer and President Board-certified intemal medicine physician. MD/PhD from Yale School of Medicine. Internal Medicine residency at the Beth Israel Deaconess Medical Center at Harvard. Former Partner at NJTC Venture Fund heading up healthcare
Slide 7: Medical Advisory Board
Medical Advisory Board John Kellum, MD Emil Paganini, MD Joseph Parrillo, MD Claudio Ronco, MD Thomas Stewart, MD Professor of Critical Care Medicine & Anesthesiology University of Pittsburgh Medical Center Chair of the Sepsis Advisory Board Former Section Head of Dialysis and Extracorporeal Therapy
Slide 8: Critical Care Is a Lucrative Market
Critical Care Is a Lucrative Market Even with healthcare reform, critical care will likely remain a lucrative market ripe for cost-effective therapies * Treatment of critical care patients is extremely costly and is a major pain point for hospitals “Need to have’ life-saving therapies command signif
Slide 9: Critical Care Lacks "Active" Therapies
Critical Care Lacks “Active” Therapies There are few “active” therapies available for serious diseases seen in the intensive care unit Severe sepsis and septic shock Acute respiratory distress syndrome (ARDS) Bur and smoke inhalation injury Trauma Influenza Consequences of cardiac surgery Severe acu
Slide 10: But Treatment Today is Mainly Supportive
But Treatment Today is Mainly Supportive Aside from antibiotics, current standard of care treatment is mainly supportive care that helps keep the patient alive, but does not necessarily hasten recovery or reverse the organ failure that can lead to death Patients have a very high risk of death due to
Slide 11: CytoSorb: A Critical Care Pure Play
Sorbents is a Critical Care Pure Play The cornerstone of our strategy to “actively treat” critical care diseases is Sorb" An efficient cytokine filter that can potentially reduce deadly inflammation caused by
Slide 12: Cytokines: A Dual-Edged Sword
Cytokines: A Dual-Edged Sword * Cytokines are small proteins that, in moderation, normally help stimulate and regulate the immune system. They are required for proper immune system function + However, in excess, cytokines can cause disease - But in vast excess, often called “cytokine storm’, cytokin
Slide 13: Cytokine Storm Leads to Organ Failure
Cytokine Storm Leads to Organ Failure ae = SS F Intestinal Clotting TY | | \~ Injury ———$ Immune cae Paralysis Lung Injury! Cell Death — inflammation, Organ Failure and Inf | + Se
Slide 14: Cytokine Storm in Action
Cytokine Storm in Action TeGenero Anti-CD28 monoclonal antibody Phase | Trial Designed to stimulate the immune system to treat cancer Phase | safety trial (2006) — 6 healthy adult males * 90 minutes: All had systemic inflammatory response Headache, nausea, muscle pain, diarrhea, hypotension * 12-16
Slide 15: Cytokine Storm Plays a Pivotal Role
Cytokine Storm Plays a Pivotal Role ‘Severe ) Burns \ ~~ Sepsis : aaa ‘ —— name ‘Biowarfare ARDS/ALI | j — i. y, _ Influenza Cytokine Storm Poor clinical outcome, Organ failure, Death [cytoSorvents J
Slide 16: Treating Cytokine Storm — The Holy Grail
Treating Cytokine Storm — The Holy Grail Reduction in Cytokine Storm has been the target of the industry for three decades * Unfortunately, most drugs and biologics can only reduce a single cytokine or inflammatory mediator + Too much redundancy in the immune system for this strategy to work A Broad
Slide 17: a ic aa) fe} & oO
a 5 ic aa) fe} & oO
Slide 18: CytoSorb Active in Cytokine Sweet Spot
Sorh” Active in Cytokine Sweet Spot 1L-4p TNF-a monomer IFN-y monomer iRa ‘TNE-+g trimer MCP-4 8 kDa 0 10 KH Hemodialysis [cytoSorvents J
Slide 19: CytoSorb is State of the Art Technology
is State of the Art Technology Very efficient at removing cytokines from whole blood Biocompatible and hemocompatible — ISO 10993 Good safety track record — 160 canine, ~650 human treatments Massive capacity Easier to use than dialysis Compatible with standard hospital dialysis equipment Inherently
Slide 20: Manufacturing Capabilities
Manufacturing Capabilities* CytoSorbents manufactures its own polymer and devices with several thousand made to date Manufacturing is a Mature and Scalable Process + Polymer manufacturing facility in New Jersey is now ISO 13485 certified (key for CE Mark approval) Well-documented, reproducible produ
Slide 21: The Sepsis Problem
The Sepsis Severe sepsis and septic shock are often the result of an “overwhelming infection” Afflicts 18 million people worldwide every year and is growing Kills 1 in every 3 despite the best medical treatment Kills more people in the U.S. than either heart attacks, strokes, or any single type of c
Slide 22: Sepsis has two facets but only one is treated
Sepsis has two facets but only one is treated The infectious insult can be treated with antibiotics/antivirals, but there are currently no therapies to treat cytokine storm Pro-Inflammatory Anti-inflammatory a. Organ Failure Recovery ie (days to weeks)
Slide 23: CytoSorb has strong in vitro data
Sorll has strong in vitro data on cytokine removal
Slide 24: CytoSorb IL-6 Removal from Whole Blood
CytoSorb IL-6 Removal from Whole Blood Control vs. Arterial vs. Venous 1800 1600 400 Po & 2 1000 5 & = 600 400 In vitro circulation system scaled for human treatment
Slide 25: CytoSorb has successful proof-of-concept in man and animals
Sor has successful proof-of-concept in man and animals
Slide 26: CytoSorb improves survival in animals
CyloSorh improves survival in animals Two Septic Rat Models . ee 2° : fs 3 © n,- CytoSorb Survival = 11/17 vs 2/16 for sham Peng, ZY, Carter, MJ, Kellum, JA “Effects of hemoadsorption ‘on cytokine removal and short term survival in rats" and improves short te mxemia” (Cait Care Med (2008) 36(5): 157
Slide 27: ...with prevention of shock
...with prevention of shock Effects of hemoadsorption ‘on mean arterial pressure GytoSorb (MAP) (Mean #1. SEM, mim Hg) in the CLP rat sepsis model. Hemoadsorption is shown in the dashed line while sham results are shown in the solid line, MAP was significantly different over time and between groups
Slide 28: ...and reduction of cytokines
..and reduction of cytokines a ‘6! ter the: “end of treatment. Peng, ZY, Carter, MJ, Kellum, JA “Effects of hemoadsorption on cytokine Black bars = CytoSorb removal and short term survival in rats” Crit Care Med (2008) 36(5): 1573-7 White bars = Sham cytoSorbents.
Slide 29: Positive Human Proof-of-Concept
Positive Human Proof-of-Concept Conducted a human sepsis pilot comparing standard of care therapy versus standard of care plus treatment in patients with severe sepsis and respiratory failure + All data from a single major academic site (6 treated, 6 control) demonstrated substantial improvements in
Slide 30: European Sepsis Trial
European Sepsis Trial * Conducting a 100 patient randomized, controlled clinical trial to treat patients with severe sepsis in the setting of respiratory failure + Nearing completion with 90 patients enrolled * Comparing standard of care therapy alone with standard of care therapy plus treatment + T
Slide 31: CytoSorb — A Powerful New Approach
Sorh™ — A Powerful New Approach Sorh has the potential to help save lives by reducing the cytokine storm that leads to multi-organ failure from many causes Severe ay \ ( 2 ) | Influenza | - Sepsis , . Cardiac . Sor” Biowarfare \ Surgery / \. Trauma Burns — ARDS/ALI |
Slide 32: CytoSorbents Seeks Strategic Alliances
Seeks Strategic Alliances seeks partners for its growth technology portfolio that is protected by 27 issued patents, 2 new patent allowances, and multiple applications pending has blockbuster potential as a cytokine filter US and EU total addressable market for these apps is ~ $10-15 billion Limited
Slide 33: CytoSorbents Pipeline
CytoSorbents Pipeline ‘oSorhents has a rob ovative pip e ong developme apabilitie NAME INDICATION ‘DESCRIPTION STATUS CytoSorb™ | Severe sepsis and septic shock | Highly efficient cytokine fiter that is Current European Sepsis ARDS! acute lung injury designed to treat cytokine storm Trial intended f
Slide 34: Goals and Milestones 2010-12
Goals and Milestones 2010-12 With success, s ents seeks to transition from a development stage to a commercialization stage company with revenue — a major inflection point for the company Successful trial completion CE Mark approval (4 European distribution and sales Out-licensing of non-core applic
Slide 35: Phillip P. Chan, MD, PhD
Phillip P. Chan, MD, PhD CEO and President 7 Deer Park Drive, Suite K Monmouth Junction, NJ 08852 (732) 329-8885 pchan@cytosorbents.com