26th Annual Roth Conference


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CFO Mark Saad presents at the 26th Annual Roth Conference on March 12, 2014

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26th Annual Roth Conference

  1. 1. Cytori Corporate Overview NASDAQ: CYTX 26th Annual Roth Conference March 12, 2014
  2. 2. Safe Harbor Statement This presentation contains certain ‘forward-looking statements’ about Cytori Therapeutics, Inc. All statements, other than statements of historical fact, that address activities, events or developments that we intend, expect, project, believe or anticipate will or may occur in the future are forward-looking statements. Such statements are based upon certain assumptions and assessments made by our management in light of their experience and their perception of historical trends, current conditions, expected future developments and other factors they believe to be appropriate. The forward-looking statements included in this presentation involve known and unknown risks that relate to Cytori’s future events or future financial performance and the actual results could differ materially from those discussed in this presentation. Risks and uncertainties that may cause Cytori's actual results to differ materially from those discussed in the presentation can be found in the "Risk Factors" section of Cytori’s Form 10-K, Forms 10-Q and other filings with the United States Securities and Exchange Commission. We would advise reading our most recent annual report on Form 10-K and quarterly report on Form 10-Q filed with the United States Securities and Exchange Commission for a more detailed description of these risks. The forward-looking statements contained in this presentation represent Cytori’s estimates and assumptions only as of the date of this presentation and Cytori undertakes no duty or obligation to update or revise publicly any forward-looking statements contained in this presentation as a result of new information, future events or changes in Cytori’s expectations.
  3. 3. Cytori Investment Summary Highlights • Phase II U.S. heart failure trial • U.S. government contract (BARDA) for thermal burns • Pipeline of therapeutic indications from independent studies Adipose-derived cell therapy with device model • Cardiovascular disease & soft tissue injury • Product & contract revenue partially offsets cash burn • Thousands of patients treated worldwide
  4. 4. Cytori Cell Therapy Mechanisms • Improve blood flow • Modulate inflammation • Wound healing • Autologous • Virtually ‘off the shelf’ • Multiple cell types = multiple mechanisms
  5. 5. System: • Low six figure ASP • Next-generation system COGS < $10,000 Per-procedure consumable: • $8,000-$12,000 for vascular indications • $2,000-$3,000 for soft tissue • >80% GM Cell therapies via proprietary device & single-use consumables = Favorable pricing and margin opportunity Cytori Cell Therapy: Commercial Model & Economics
  6. 6. Therapeutic Focus CARDIAC SOFT TISSUE COMMERCIAL RESEARCH MARKET • U.S. Phase II in CHF • Long term data from CHF and AMI trials in EU • Burns: U.S. gov’t contract worth up to $106 MM • Hamstring injury: U.S. trial • EU/Japan approvals • Research sales • 50+ studies completed, ongoing or planned
  7. 7. Cardiac Cell Therapy • Damage to the heart leads to reduced function, heart failure and death • Current therapy does not address damage to the heart muscle
  8. 8. PRECISE Pilot Showed Proof-of-Concept PRECISE TRIAL: • 27 patient double-blind, randomized, placebo controlled European trial • Intramyocardial injection using electromechanical mapping in area with inducible ischemia • 18 month data presented, publication in process DATA SUMMARY: Feasibility (Exercise Tolerance) • VO2Max (maximum oxygen consumption): improvement (p<0.05 vs. placebo) • METS (metabolic equivalent): improvement (p<0.05 vs. placebo) Safety • No safety issues • Mortality [36 mo]: placebo 33%, ADRCs 14%
  9. 9. 12 14 16 18 20 Baseline 6 months 18 months VO2Max Change in VO2Max at 6 and 18 Months ADRCs Placebo PRECISE Pilot Trial: Exercise Tolerance
  10. 10. ATHENA I & II: U.S. Ischemic Heart Failure Trials • Prospective, double-blind, placebo-controlled trials – ATHENA I: 45 patients, 2:1 randomization at lower dose – ATHENA II: 45 patients, 2:1 randomization at higher dose – Up to 10 centers Development Pipeline Ischemic Heart Failure Pilot Complete U.S. Phase II (ATHENA I & II) Pivotal 2015
  11. 11. SAFETY • Serious Adverse Events (SAEs) • Arrhythmia assessment • MACE (Cardiac Death or Hospitalization for Heart Failure) EFFICACY • VO2 Max (6 mo) • LVEF, LVESV/LVEDV (6 mo) • Perfusion defect (6 mo) • Heart failure symptoms, angina, and quality of life (3, 6, 12 mo) ATHENA I Endpoints
  12. 12. Ischemic Heart Disease: Market Dynamics Ischemic heart disease in the United States • Direct & indirect costs of heart failure estimated at $19.5B (2009) • $11.7B paid to Medicare beneficiaries (2006) • Medical costs of IHD expected to double 2013 to 2030 • Estimated incidence is 200,000 – 500,000 patients/year in the U.S. alone Ischemic heart disease in Europe • IHD expected to cost EU economies €60B/yr • Estimated that 34.4M and 12.1M disability adjusted life years are lost in Europe and the EU respectively each year due to IHD Few, if any, new pharmaceutical approaches for IHD
  13. 13. Soft Tissue • Thermal burns due to radiation injury • Sports medicine (hamstring injury) • Wound repair applications
  14. 14. BARDA Contract Pre-Treatment 18 Mo. Post-Treatment Ex. Cytori Cell Therapy in a chronic thermal burn case study National preparedness grant worth up to $106 MM to develop treatment for thermal burns combined with radiation injury • In-Process Review anticipated in 1H2014 to determine if contract options are awarded • Contract options fully fund development from preclinical through FDA PMA trial • Cytori maintains commercial rights, possibility of government procurement purchases
  15. 15. BARDA Development Pathway Discussions Begin 2010 Award Announcement Fall, 2012 3 Objectives Trigger Option 1 & 3 Q1, 2014 3 Proof-of-concept Objectives Ongoing Cell viability Animal model POC Next Gen device feasibility $32.6 M Option 1 $23.4M Option 3 Commercial Acquisition at BARDA’s Discretion $45.5M Option 2 Option 1 Objective Triggers Option 2 Q4, 2015 Pre-Award, White Papers, Proposal, Negotiation $4.7M Phase 1 Proof of Concept
  16. 16. • Trial Design: – Part A: 10 patient open-label, safety, feasibility & dose-escalation – Part B: 60 patient, double-blind, placebo-controlled safety, feasibility & dosing study – Safety & functional end-points 16 U.S. RECOVER Trial: Hamstring Injury Randomized, double-blind, placebo-controlled trial to evaluate Cytori Cell Therapy for tears of the hamstring muscle • Hamstring injuries are a persistent problem among elite and amateur athletes given the high incidence and recurrence rates, as well as the lengthy recovery time
  17. 17. • Broad range of indications, including: • Ex: Chronic radiation wound case study in Japan 17 Wound Repair: Independent Research Promising data from multiple independent research studies - Cryptoglandular peri-anal fistula - Fistula post gastroenterological surgery - Diabetic foot ulcer - Scleroderma in the hand - Crohn’s fistula Exposed Sacrum 1 Year Post OpImmediate Pre Op Intra Op, Debrided 90% cells to circular area around sore 10% cells to sore itself Intra Op, Post-Cell Rx
  18. 18. Commercial Research Market: Overview • Targeted commercial sales ex-US to researchers performing independently funded studies • System and consumables sales generate commercial revenue and gross margin • Expands pipeline R&D to identify potential indications for future development and partnering opportunities
  19. 19. Revenue Upside: Research Sales • Targeted global commercial sales • Research customers under international regulatory approvals: • Japan Class I clearance • CE Mark vascular delivery (Intravase®) • New markets: Australia, Singapore Completed or ongoing studies Planned studies
  20. 20. Worldwide Investigator-Led Research 50+ studies worldwide completed, in process or planned • Publications of independent research using Cytori Cell Therapy • Broad range of study indications including: • Stress urinary incontinence • Scleroderma • Hamstring injury • ACL • Parry Romberg syndrome • Ischemic heart disease
  21. 21. Strategic Upside: Research Sales • Outsources R&D for future pipeline indications • Supports partnerships and other strategic collaborations • Ex: BARDA: U.S. government contract supported by Japanese research radiation injury data and UK burn data • Ex: Lorem Vascular: commercialization partnership based on combination of Cytori clinical data and independent research data
  22. 22. Commercial Partnership: Lorem Vascular Celution® System Commercialization Rights Agreement Terms • Newly formed company dedicated to Celution® products • Australia, China, Hong Kong, Malaysia, & Singapore • $24 million; 8 million shares at $3.00 per share • Up to $500 million in commercial milestones • Cytori receives transfer margin on long-term agreement
  23. 23. Global Intellectual Property • 65 patents issued worldwide; 85 applications pending • Cover current & future Celution® Systems, methods, use of adipose-derived regenerative cells for soft tissue, cardiac and pipeline indications 29% 15% 7% 33% 16% Geographic Distribution U.S. Japan Europe Asia-Pacific - Other Other 41% 23% 18% 18% Patent Type Devices - Current/Next-Gen Cardiovascular Reconstructive Surgery Pipeline Therapies
  24. 24. Financials Current Select Data Cash $24.5 MM (pro forma as of 12/31/13) Senior Term Loan $27 MM (Matures 2017) Shares Outstanding 75 MM Warrants Outstanding 8.6MM @$2.63 (7.6 MM expire by Sept 2014)
  25. 25. Upcoming Milestones CARDIOVASCULAR – Complete enrollment in the U.S. ATHENA trial – Report six-month outcomes from the U.S. ATHENA trial – Publish PRECISE chronic ischemic heart failure trial long-term data SOFT TISSUE – BARDA decision for potential contract expansion – Initiate enrollment in U.S. trial (Part A) for hamstring injury COMMERCIAL RESEARCH SALES – Growth in product & contract sales in 2014 – Achieve product registration for the Celution® System in China
  26. 26. Cytori Investment Summary Highlights • Phase II U.S. heart failure trial • U.S. government contract (BARDA) for thermal burns • Pipeline of therapeutic indications from independent studies Adipose-derived cell therapy with device model • Cardiovascular disease & soft tissue injury • Product & contract revenue partially offsets cash burn • Thousands of patients treated worldwide
  27. 27. Cytori Corporate Overview NASDAQ: CYTX Thank you!