CytoSorbents Corporation · NASDAQ:CTSO
CytoSorbents — Investor Presentation (November 2010)
35 slides from CytoSorbents's investor presentation, November 2010
Slide 1: CytoSorbents Corporation: Working to Save Lives Through Blood Purification
CytoSorbents Corporation Working to Save Lives Through Blood Purification CytoSorbents Investor Presentation 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: CytoSorbents Overview
CytoSorbents Overview CytoSorbents 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
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 • “Purif
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 S
Slide 6: Management Team
Management Team • Phillip Chan, MD, PhD – Chief Executive Officer and President Board-certified internal 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 healthc
Slide 7: Medical Advisory Board
Medical Advisory Board John Kellum, MD Professor of Critical Care Medicine & Anesthesiology University of Pittsburgh Medical Center Chair of the Sepsis Advisory Board Emil Paganini, MD Former Section Head of Dialysis and Extracorporeal Therapy with the Cleveland Clinic Foundation Joseph Parrillo, MD
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 sign
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) • Burn and smoke inhalation injury • Trauma • Influenza • Consequences of cardiac surge
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 du
Slide 11: CytoSorbents is a Critical Care Pure Play
CytoSorbents is a Critical Care Pure Play The cornerstone of our strategy to “actively treat” critical care diseases is CytoSorb TM An efficient cytokine filter that can potentially reduce deadly inflammation caused by Cytokine Storm 11
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 Cytokines Intestinal Clotting Injury Immune Shock Paralysis Lung Injury Cell Death Inflammation, Organ Failure and Infection 13
Slide 14: Cytokine Storm in Action
Cytokine Storm in Action TeGenero Anti-CD28 monoclonal antibody Phase I Trial • Designed to stimulate the immune system to treat cancer • Phase I safety trial (2006) – 6 healthy adult males • 90 minutes: All had systemic inflammatory response Headache, nausea, muscle pain, diarrhea, hypotension • 12
Slide 15: Cytokine Storm Plays a Pivotal Role
Cytokine Storm Plays a Pivotal Role Severe Burns Sepsis Inhalation Biowarfare ARDS/ALI Influenza Cytokine Storm Inflammation Cardiac Trauma SIRS/Sepsis Surgery Poor clinical outcome, Organ failure, Death 15
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: Blood Flow
Simulated for illustrative purposes only Blood Flow 17
Slide 18: CytoSorb Active in Cytokine Sweet Spot
CytoSorb Active in Cytokine Sweet Spot TM IL-18 IL-1β HMGB1 TNF-α monomer TGF-β IFN-γ monomer IL-6 IL-1Ra TNF-α trimer sFas ligand MCP-1 IL-13 sTNFR IL-10 MCP-1 IL-8 glycosylated IL-4 MIP-1α G-CSF IFN-γ dimer Albumin kDa 0 10 20 30 40 50 60 70 Hemodialysis 18
Slide 19: CytoSorb is State of the Art Technology
CytoSorb 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
Slide 20: CytoSorbents Manufacturing Capabilities
CytoSorbents 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, rep
Slide 21: The Sepsis Crisis
The Sepsis Crisis 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 sin
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 Cytokine Storm Pro-Inflammatory Anti-inflammatory TOXIC IN SU Death LT Organ Failure Recovery Time (days to weeks)
Slide 23: CytoSorb has strong in vitro data on cytokine removal
CytoSorb has strong in vitro data on cytokine removal 22
Slide 24: CytoSorb IL-6 Removal from Whole Blood
CytoSorb IL-6 Removal from Whole Blood Control vs. Arterial vs. Venous 1800 1600 1400 1200 [IL-6] (pg/mL 1000 Control Arterial 800 Venous 600 400 200 0 0 50 100 150 200 250 Minutes In vitro circulation system scaled for human treatment 23
Slide 25: CytoSorb has successful proof-of-concept in man and animals
CytoSorb has successful proof-of-concept in man and animals 24
Slide 26: CytoSorb improves survival in animals
CytoSorb improves survival in animals Two Septic Rat Models Demonstrate Substantial Improvement in Survival… Endotoxin Challenge (LPS) Cecal Ligation Puncture (CLP) CytoSorb CytoSorb Sham Sham CytoSorb Survival = 7/20 vs 1/20 for sham CytoSorb Survival = 11/17 vs 2/16 for sham Kellum, JA, Song M, Ve
Slide 27: …with prevention of shock
…with prevention of shock Effects of hemoadsorption CytoSorb on mean arterial pressure (MAP) (Mean +/- SEM, mm 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 (p<0
Slide 28: …and reduction of cytokines
…and reduction of cytokines CLP Animal Model Cytokine Data (Note: Natural Log Scale) 20 hours after cecal ligation and puncture, rats were treated for 3 hours with either CytoSorb or sham. Then treatment was discontinued and cytokine values were taken 6 hours after the end of treatment. Peng, ZY, Ca
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 CytoSorb treatment in patients with severe sepsis and respiratory failure • All data from a single major academic site (6 treated, 6 control) demonstrated substantial improv
Slide 30: CytoSorb European Sepsis Trial
CytoSorb European Sepsis Trial TM • 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 C
Slide 31: CytoSorb – A Powerful New Approach
CytoSorb™ – A Powerful New Approach CytoSorb has the potential to help save lives by reducing the cytokine storm that leads to multi-organ failure from many causes Severe Influenza Sepsis Cardiac Biowarfare Surgery CytoSorb ™ Trauma Burns ARDS/ALI 31
Slide 32: CytoSorbents Seeks Strategic Alliances
CytoSorbents Seeks Strategic Alliances CytoSorbents seeks partners for its growth technology portfolio that is protected by 27 issued patents, 2 new patent allowances, and multiple applications pending CytoSorb™ has blockbuster potential as a cytokine filter • US and EU total addressable market for
Slide 33: CytoSorbents Pipeline
CytoSorbents Pipeline CytoSorbents has a robust, innovative pipeline with strong development capabilities NAME INDICATION DESCRIPTION STATUS CytoSorb™ Severe sepsis and septic shock Highly efficient cytokine filter that is Current European Sepsis ARDS/ acute lung injury designed to treat cytokine st
Slide 34: CytoSorbents Goals and Milestones 2010-12
CytoSorbents Goals and Milestones 2010-12 With success, CytoSorbents seeks to transition from a development stage to a commercialization stage company with revenue – a major inflection point for the company ¾ Successful trial completion ¾ CE Mark approval ¾ European distribution and sales ¾ Out-lice
Slide 35: CytoSorbents Corporation
CytoSorbents Corporation Working to Save Lives Through Blood Purification Phillip P. Chan, MD, PhD CEO and President 7 Deer Park Drive, Suite K Monmouth Junction, NJ 08852 (732) 329-8885 pchan@cytosorbents.com