CytoSorbents Corporation · NASDAQ:CTSO
CytoSorbents — Investor Presentation (September 2009)
27 slides from CytoSorbents's investor presentation, September 2009
Slide 1: CytoSorbents, Inc. - Working to Save Lives Through Blood Purification
CytoSorbents, Inc. Working to Save Lives Through Blood Purification Wholly-Owned Operating Subsidiary of MedaSorb Technologies Corporation OTCBB: MSBT Frankfurt: HQE September 2009 Confidential
Slide 2: Safe Harbor Statement
Safe Harbor Statement Statements in this presentation regarding CytoSorbents, Inc and its parent MedaSorb Technologies Corporation 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 materi
Slide 3: Company Overview
Company Overview Goal To treat severe sepsis due to infection (bacterial or viral) Product CytoSorb – highly porous resin cartridge that acts as TM a cytokine filter to reduce cytokine storm in severe sepsis Clinical Status Currently enrolling up to a 100 patient European trial to treat septic patie
Slide 4: The Sepsis Crisis
The Sepsis Crisis Severe sepsis is often called “Overwhelming Infection” • Afflicts 18 million people worldwide every year and growing • Kills 1 in every 3 despite the best treatment • Kills more people in the U.S. than heart attacks, strokes, or any single type of cancer • Treatment costs the U.S.
Slide 5: What causes Severe Sepsis?
What causes Severe Sepsis? Cytokine Storm Pro-Inflammatory Anti-inflammatory TOXIC IN SU Death LT Organ Failure Recovery Time (days to weeks)
Slide 6: Cytokine Storm fuels the sepsis cascade
Cytokine Storm fuels the sepsis cascade Cytokines Intestinal Clotting Injury Immune Shock Paralysis Lung Injury Cell Death Tissue Ischemia, Organ Damage, Infection Organ Failure 6 Confidential
Slide 7: Example of Pure Cytokine Storm
Example of Pure Cytokine Storm 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 from injection – All had systemic inflammatory response Headache, nausea, muscle pain, diar
Slide 8: Treating Cytokine Storm – The Holy Grail
Treating Cytokine Storm – The Holy Grail Reduction in Cytokine Storm has been the target of Drugs and Biologics 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
Slide 9: Introducing CytoSorb
Introducing CytoSorb TM CytoSorb is a highly porous polymer resin TM that broadly removes cytokines and toxins from blood Concept is very straightforward • Obtain venous access with temporary dialysis catheter • Pump blood through the CytoSorb cartridge • The CytoSorb resin removes cytokines/toxins
Slide 10: Blood Flow
Simulated for illustrative purposes only Blood Flow
Slide 11: 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 11 Confidential
Slide 12: CytoSorb is State of the Art Technology
CytoSorb is State of the Art Technology • Very efficient in removing cytokines • Compatible with blood • Massive capacity • Easy to use • Compatible with standard hospital dialysis equipment • Low cost • Long shelf life • Low manufacturing risk 12 Confidential
Slide 13: CytoSorb Expected to Limit Cytokine Storm
CytoSorb Expected to Limit Cytokine Storm TOXIC IN SU LT Organ Damage CytoSorb Recovery Time (days to weeks)
Slide 14: CytoSorb has been extensively tested
CytoSorb has been extensively tested • CytoSorb removes cytokines in vitro and in simulated whole blood circulation systems on the order of 80-95% • CytoSorb increases survival to 35-65% from 5% in sham treated animals in different rat sepsis models • CytoSorb helped stabilize a 71 year old man in s
Slide 15: 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 Survival = 7/20 vs 1/20 for sham CytoSorb Survival = 9/17 vs 1/16 for sham Kellum, JA, Song M, Venkataraman, R “Hemoadsorption
Slide 16: …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 17: …and reduction of cytokines
…and reduction of cytokines CLP Animal Model Cytokine Data 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, Carter, MJ, Kellum, JA “Effe
Slide 18: European Clinical Trial
European Clinical Trial Randomized, controlled, multi-center, open-label study in up to 100 patients with severe sepsis in the setting of respiratory failure • Primary endpoint: IL-6 reduction • Secondary and tertiary endpoints include • 28-day and 60-day mortality • Ventilator free days • Organ dam
Slide 19: Anticipate CE Mark Approval in 2010
Anticipate CE Mark Approval in 2010 • European Sepsis Trial has enrolled 31 patients to date • Acceleration of recruitment is expected with twelve sites • Treatment is well-tolerated • No serious device related adverse events in more than 460 treatments, with more than 100 in sepsis patients • With
Slide 20: What makes CytoSorb different?
What makes CytoSorb different? No product is approved to treat cytokine storm directly CytoSorb is the most logical way to treat cytokine storm In doing so, may positively impact many of the pathways that lead to death in sepsis and improve survival 20 Confidential
Slide 21: Limited Competition
Limited Competition Pharmaceuticals and Biologics • Historically unsuccessful • Xigris (Lilly) is the only approved drug by the FDA, but limited usage • Phase III TLR-4 inhibitors (Takeda and Eisai) • Others are Phase II or earlier Devices • Standard blood purification techniques ineffective or inef
Slide 22: CytoSorb has big market potential
CytoSorb has big market potential Assumptions • Gambro Adsorba hemoperfusion ~ $500/device • CytoSorb hemoperfusion ~ $500/device (base) • CytoSorbents treatment (7 days) 7 devices • Average patient treatment revenue $ 3,500 • Annual incidence of severe sepsis 3 in 1000 $3.5 Billion US Market (~1 mi
Slide 23: CytoSorb is a Potential Blockbuster
CytoSorb is a Potential Blockbuster • Multi-billion dollar market with limited competition • Differentiated, broadly patented “best of breed” approach • Highly profitable “razor/razorblade” model • Reimbursement in the US and Germany is covered under favorable DRG reimbursement • Commercialization i
Slide 24: CytoSorbents not just a “sepsis” company
CytoSorbents not just a “sepsis” company CytoSorbents is a therapeutic device company with a valuable patented polymer technology and a robust pipeline NAME INDICATION DESCRIPTION STATUS CytoSorb™ Severe sepsis Highly efficient cytokine filter that is Registration clinical designed to treat cytokine
Slide 25: Valuation Comparables
Valuation Comparables* 1) Renal Solutions - $190 M • Privately-held company with a resin technology that regenerated dialysate • $40M in private equity, $25M in debt financing • $1M in revenue (2007) • Acquired by Fresenius in November 2007 for $190M 2) NxStage Medical (Nasdaq: NXTM) - $ 300 M • Pub
Slide 26: CytoSorbents Investor Advantages
CytoSorbents Investor Advantages Strong overall return potential based on current near-term targeted milestones • Successful trial completion • CE Mark approval • Out-licensing the sepsis application to a strategic partner • Commercial sales anticipated in 2010 • Commencement of pivotal trial in the
Slide 27: CytoSorbents, Inc.
CytoSorbents, Inc. For more information: Please contact Phillip Chan, MD, PhD – CEO pchan@cytosorbents.com Wholly-Owned Operating Subsidiary of MedaSorb Technologies Corporation Confidential
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