2014 ARM Regen Med Investor Day

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Cytori President Dr. Marc Hedrick presents at the Alliance for Regenerative Medicine's Regen Med Investor Day in New York

Cytori President Dr. Marc Hedrick presents at the Alliance for Regenerative Medicine's Regen Med Investor Day in New York

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  • 1. Cytori Corporate Overview NASDAQ: CYTX
  • 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. NASDAQ: CYTX
  • 3. Cytori Overview Upcoming Highlights • Phase II U.S. heart failure data • Expansion U.S. government contract (BARDA) • Pipeline expansion from independent studies Autologous cell therapy with device model • Cardiovascular disease & soft tissue disorders • Product & contract revenue partially offsets cash burn • Thousands of patients treated worldwide NASDAQ: CYTX
  • 4. Cytori Cell Therapy • Autologous, mixed cell population from adipose tissue • Cells processed in real time - virtually ‘off the shelf’ • Multiple cell types: ADRCs (adipose derived regenerative cells) • Mechanism predominately via paracrine action, increased blood flow and enhanced wound healing NASDAQ: CYTX
  • 5. System: • Low six figure ASP • Next-generation system COGS < $10,000 Per-procedure consumable: • $8,000-$12,000 for intra vascular indications • $2,000-$3,000 for soft tissue • >80% GM Cell therapy via proprietary device & single-use consumables = Favorable pricing and margin opportunity Cytori Cell Therapy: Commercial Model & Economics NASDAQ: CYTX
  • 6. Therapeutic Focus CARDIAC SOFT TISSUE COMMERCIAL RESEARCH SALES • U.S. Phase II in CHF • Long term data from CHF and AMI trials in EU • Burns & Radiation: U.S. gov’t contract • Sports Medicine • EU/Japan approvals • Research sales • 50+ studies completed, ongoing or planned NASDAQ: CYTX
  • 7. Cytori Cell Therapy- Cardiovascular • Damage to the heart leads to reduced function, heart failure and death • Current therapy does not address damage to the heart muscle NASDAQ: CYTX
  • 8. PRECISE- Pilot Trial 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% NASDAQ: CYTX
  • 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 NASDAQ: CYTX
  • 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 NASDAQ: CYTX
  • 11. ATHENA I Endpoints NASDAQ: CYTX 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)
  • 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 New pharmaceutical approaches for IHD limited NASDAQ: CYTX
  • 13. Soft Tissue Disorders • Thermal burns with concomitant radiation injury • Gateway to wound repair indication • Sports medicine NASDAQ: CYTX
  • 14. BARDA Contract Pre-Treatment 18 Mo. Post-Treatment U.S. Government contract to develop treatment for thermal burns concomitant with radiation injury • Definitive review contract options anticipated in 1H2014 • Contract option for additional development including clinical trial • Cytori maintains commercial rights, possibility of government procurement purchases NASDAQ: CYTX
  • 15. BARDA Development Pathway Discussions Begin 2010 Award Announcement Fall, 2012 3 Objectives Trigger Option 1 & 3 Q2, 2014 3 Proof-of-concept Objectives Ongoing Cell viability Animal model POC Next Gen device feasibility Up to $32.6 M Option 1 Up to $23.4M Option 3 Commercial Acquisition at BARDA’s Discretion Up to $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 NASDAQ: CYTX
  • 16. • Broad range of indications, including: • Ex: Chronic wound from external beam radiation 16 Wound Repair Investigator-led Research Promising data from multiple independent research studies - Cryptoglandular peri-anal fistula - Fistula post gastroenterological surgery - Diabetic foot ulcer - Scleroderma associated digital ulcers - 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
  • 17. 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, ultimately contribution margin • Expands pipeline R&D to identify potential indications for future development, 3rd party funding and partnering NASDAQ: CYTX
  • 18. 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 associated sclerodactyly • Musculotendinous injury • Parry Romberg syndrome • Others NASDAQ: CYTX
  • 19. 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 NASDAQ: CYTX
  • 20. 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) NASDAQ: CYTX
  • 21. 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 contract expansion – Expand orthopedics, sports COMMERCIAL RESEARCH SALES – Growth in product & contract sales in 2014 – Achieve product registration for the Celution® System in China NASDAQ: CYTX
  • 22. Cytori Overview Upcoming Highlights • Phase II U.S. heart failure data • Expansion U.S. government contract (BARDA) • Pipeline expansion from independent studies Adipose-derived cell therapy with device model • Cardiovascular disease & soft tissue disorders • Product & contract revenue partially offsets cash burn • Thousands of patients treated worldwide NASDAQ: CYTX
  • 23. Cytori Corporate Overview NASDAQ: CYTX Thank you! NASDAQ: CYTX