Cytosorbents Corporation · NASDAQ:CTSO
Cytosorbents — Investor Presentation (June 2011)
36 slides from Cytosorbents's investor presentation, Jun 27, 2011
Slide 1: Working to Save Lives Through Blood Purification
Working to Save Lives Through Blood Purification CytoSorbents Investor Presentation June 2011 OTCBB: CTSO Cyto Sorbents Corporation
Slide 2: Safe Harbor Statement
2 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
Slide 3: Overview
3 Overview is a critical care-focused device company using blood purification to treat disease, with its first E.U. approved product, CytoSorb™ 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 t
Slide 4: Concept is Simple But Elegant
4 Obtain venous access with temporary dialysis catheter Pump blood through the cartridge with standard pumps The polymer beads remove toxic substances “Purified” blood is pumped back into the patient Can treat 20-30 total blood volumes per treatment Each treatment uses a new cartridge The polymer be
Slide 5: Recent Company Highlights
5 Completed our targeted 100 patient enrollment of our European Sepsis Trial comparing CytoSorb hemoperfusion with SOC vs SOC alone In an interim analysis, successfully achieved the primary endpoint of the trial, demonstrating an average 49.1% IL-6 removal compared to control (p=0.01) Currently ramp
Slide 6: Management Team
6 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
7 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 Thera
Slide 8: Critical Care Is a Lucrative Market
8 Critical Care Is a Lucrative Market Critical care is a lucrative market for cost-effective therapies Cost of treating US critical care patients was $82 billion in 2005 or 0.7% of the US GDP * In 2000, US hospitals lost $6 billion on Medicare patients who spent at least 1 day in the ICU vs $2 billi
Slide 9: Critical Care Lacks "Active" Therapies
9 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 surgery Severe acute pa
Slide 10: But Treatment Today is Mainly Supportive
10 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
Slide 11: CytoSorbents is a Critical Care Pure Play
11 is a Critical Care Pure Play The cornerstone of our strategy to “actively treat” critical care diseases is An efficient cytokine filter that can potentially reduce deadly inflammation caused by Cyto Sorbents Cyto Sorb TM Cytokine Storm
Slide 12: CytoSorb - Approved For Sale in the E.U.
Broad indication as an extracorporeal cytokine filter in situations where cytokines are elevated. The only product, to our knowledge, approved for this specific indication Cytokine storm plays a critical damaging role in many life-threatening illnesses commonly seen in the intensive care unit. CytoS
Slide 13: Cytokines: A Dual-Edged Sword
13 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”, cytokines
Slide 14: Cytokine Storm Leads to Organ Failure
14 Shock Clotting Cytokine Storm Leads to Organ Failure Cytokines Lung Injury Cell Death Intestinal Injury Immune Paralysis Inflammation, Organ Failure and Infection
Slide 15: Cytokine Storm in Action
15 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 12-16 hours: All became critically ill Cytokine storm persis
Slide 16: Treating Cytokine Storm – The Holy Grail
16 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
Blood Flow Simulated for illustrative purposes only 17
Slide 18: Active in Cytokine Sweet Spot
18 Active in Cytokine Sweet Spot Hemodialysis 0 kDa 10 20 30 40 50 60 70 Cyto Sorb TM IL-1 ß TNF-a monomer IFN- monomer IL-1Ra IL-10 TNF-a trimer IFN- dimer HMGB1 TGF-ß IL-6 sFas ligand MCP-1 IL-13 MCP-1 glycosylated Albumin IL-8 MIP-1a IL-18 sTNFR IL-4 G-CSF
Slide 19: IL-6 Removal from Whole Blood
IL-6 Removal from Whole Blood In vitro circulation system scaled for human treatment 19 Cyto Sorb
Slide 20: CytoSorb is State of the Art Technology
20 is State of the Art Technology CE Mark approved 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 e
Slide 21: Sepsis
The Sepsis Severe sepsis and septic shock are often the result of an Afflicts 18 million people worldwide every year and is growing 1 million in the U.S. and 1.5 million in Europe annually Severe sepsis kills 1 in every 3 despite the best medical treatment. Septic shock kills 1 in every 2 Kills more
Slide 22: Sepsis has two facets but only one is treated
Sepsis has two facets but only one is treated Pro-Inflammatory Anti-inflammatory Death The infectious insult can be treated with antibiotics/antivirals, but there are currently no therapies to treat cytokine storm 22 Time (days to weeks) Organ Failure Recovery TOXIC Cytokine Storm
Slide 23: CytoSorb Has Strong Animal Data
Has Strong Animal Data animal models simulating sepsis from a ruptured appendix with no antibiotics and only a single 3-hour treatment … Increased survival to 65% (treated) from 12.5% (sham) Peng, ZY, Carter, MJ, Kellum, JA “Effects of hemoadsorption on cytokine removal and short term survival in ra
Slide 24: …with prevention of shock
…with prevention of shock Peng, ZY, Carter, MJ, Kellum, JA “Effects of hemoadsorptionon cytokine removal and short term survival in rats” Crit Care Med (2008) 36(5): 1573-7 24 Note the stabilizing effect on blood pressure persists 6 hours after the 3 hour CytoSorb treatment compared to the rapid dec
Slide 25: …and reduction of cytokines
…and reduction of cytokines 20 hours after cecal ligation and puncture, rats were treated for 3 hours with either CytoSorb or sham. Treatment was discontinued and cytokine values were taken again 6 hours after the end of treatment. Peng, ZY, Carter, MJ, Kellum, JA “Effects of hemoadsorption on cytok
Slide 26: Positive Human Proof-of-Concept
26 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 treated patients compared to c
Slide 27: European Sepsis Trial
27 European Sepsis Trial Completed a 100 patient randomized, controlled clinical trial to treat patients with severe sepsis or septic shock in the setting of acute respiratory distress syndrome/ALI Compared standard of care therapy alone with standard of care therapy plus treatment Data on secondary
Slide 28: Controlled Market Release in 2011
Controlled Market Release in 2011 Focus will initially be on Germany – the largest medical device market in the E.U. and the third largest in the world Will conduct a 3-6 month controlled market release of CytoSorb™ in select areas in Germany later in 2011, before a broader launch in Germany in 2012
Slide 29: Why Germany?
Why Germany? With a population of 82M, and € 250 Billion spent annually on healthcare, Germany is the largest medical device market in the E.U. We have experience in Germany, working with major thought leaders in sepsis research during our European Sepsis Trial, many of whom are part of the SepNet S
Slide 30: Future Commercialization Plans
Future Commercialization Plans CytoSorbents intends to expand its footprint in Europe and in other countries that accept CE Mark approval Currently working to establish relationships with independent distributors in other key countries Targeting strategic partnership or distributorships that could h
Slide 31: CytoSorbents Seeks Strategic Alliances
31 seeks partners for its growth technology portfolio protected by 29 issued patents 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 competition Differentiated, “best of breed” approach Hig
Slide 32: Robust, Innovative Pipeline
32 has a robust, innovative pipeline with strong development capabilities Pipeline Cyto Sorbents Cyto Sorbents Four human pilot studies completed Removal of mid-molecular weight toxins that are inefficiently removed by standard dialysis Improvement of hemodialysis in end-stage renal disease BetaSorb
Slide 33: Many Applications for Military Use
33 is uniquely designed to address the key reasons why our wounded warfighters die Many Applications for Military Use Severe sepsis and septic shock from complex, penetrating wound injuries Blast burn and smoke inhalation injuries from incendiary munitions, IED and projectile explosions, and gasolin
Slide 34: A Powerful New Approach
34 – A Powerful New Approach has the potential to help save lives by reducing the cytokine storm that leads to multi-organ failure and death from many causes Sepsis ARDS/ALI Burns Smoke Biowarfare Trauma Pancreatitis Influenza Cyto Sorb™ Cyto Sorb Cyto Sorb ™
Slide 35: Goals and Milestones 2011-12
35 European distribution and sales Out-licensing of technologies Commencement of a US trial Government and/or military funding Stock listing on a national exchange Goals and Milestones 2011-12 With success, seeks to transition from a development stage to a commercialization stage company with revenu
Slide 36: Working to Save Lives Through Blood Purification
Working to Save Lives Through Blood Purification OTCBB: CTSO Phillip P. Chan, MD, PhD CEO and President 7 Deer Park Drive, Suite K Monmouth Junction, NJ 08852 (732) 329-8885 pchan@cytosorbents.com Cyto Sorbents Corporation