2014 Biotech Showcase Presentation

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CEO Chris Calhoun presents at the Biotech Showcase on January 13, 2014

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2014 Biotech Showcase Presentation

  1. 1. Cytori Corporate Overview NASDAQ: CYTX January 13, 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. Overview Transformative technology platform –  Cell therapy regulated as a device –  Business model: single use consumables Clinical experience in thousands of patients Strong IP protection Near term value drivers –  U.S. government contract milestones (BARDA) –  Phase II U.S. cardiovascular trial data –  International approvals and revenue growth
  4. 4. Easily Accessible in Hospital & Clinic Proprietary Formulation of Cells •  Autologous (Patient’s own cells) •  Point-of-care availability (no offsite manufacturing) •  Patented Technology •  Virtually ‘off the shelf’ – ideal for physician workflow
  5. 5. Commercial Model & Economics Cell therapies offered via device & single-use consumable… allows for favorable pricing, reimbursement, and margins System: •  •  Low six figure ASP (current generation) Next-generation system: smaller, faster, cheaper & higher cell yields Per-procedure consumable: •  •  •  $8,000-$12,000 for vascular indications $2,000-$3,000 for soft tissue >80% GM
  6. 6. Broad & Deep Intellectual Property DEVICES CURRENT DEVICES NEXT GENERATION COSMETIC & RECONSTRUCTIVE SURGERY CARDIOVASCULAR THERAPIES PIPELINE THERAPIES US: (6) CELUTION DEVICE (‘484) CELUTION DEVICE PLUS ADDITIVES (‘420) STEMSOURCE DEVICE (‘115) CELUTION DEVICE PLUS SENSORS FOR CLINICALLY SAFE OUTPUT (‘670) BEDSIDE COMPREHENSIVE DEVICE (‘059) CELUTION DEVICE CD31 POSITIVE CELLS (‘276) US: (1) CELUTION & FUTURE GENERATIONS (‘075) US: (7) CELUTION FOR MIXING ADRCS PLUS FAT (‘488) CELUTION OR NEXT GEN DEVICES FOR SOFT TISSUE DEFECTS (‘684) ADRCS PLUS FAT PLUS ADDITIVES (‘795) ADRCS PLUS FAT (‘672) ADRCS PLUS FAT COMPOSITION (‘121) CURRENT CELUTION DEVICE PLUS FAT (‘947) ADRC’S PLUS FAT PLUS BUFFER (‘834) EUROPE: (2) ADRCS FOR CARDIAC (‘382) OPPOSED DEVICE FOR RESTORING BLOOD FLOW (‘575) US: (4) CELUTION FOR BONE (‘043) CELUTION OUTPUT PLUS JAPAN: (2) CELUTION DEVICE (‘952) CELUTION FOR CLINICALLY SAFE OUTPUT (‘556) KOREA: (3) CELUTION DEVICE (‘995) STEMSOURCE DEVICE (‘812) CELUTION DEVICE (‘139) CHINA: (1) CELUTION & FUTURE GENERATIONS (‘241) HONG KONG (1) CELUTION & FUTURE GENERATIONS (‘322) INDIA: (1) CELUTION WITH FILTER (‘529) CENTRIFUGE OR AUSTRALIA: (1) CELUTION WITH CENTRIFUGE OR FILTER (‘937) INDIA: (1) CELUTION DEVICE (‘706) SINGAPORE: (1) CELUTION & FUTURE GENERATIONS (‘683) AUSTRALIA: (2) CELUTION DEVICE (‘135) STEMSOURCE DEVICE (‘901) ISRAEL: (1) CELUTION WITH CENTRIFUGE OR FILTER (‘800) CHINA: (1) CELUTION DEVICE (‘689) MEXICO: (1) CELUTION & FUTURE GENERATIONS (‘348) OLYMPUS-CYTORI PATENTS NEXT GENERATION DEVICE - JAPAN KOREA: (1) CELUTION WITH CENTRIFUGE OR FILTER (‘305) CENTRIFUGAL CONTAINER (‘020) DIGESTIVE ENZYMES (‘861) JAPAN: (1) CELUTION BUSINESS METHOD JAPAN: (1) CELUTION AND NEXT GEN DEVICES FOR MIXING ADRCS PLUS FAT (‘041) KOREA: (3) ADRCS PLUS FAT (‘454) CELUTION OR NEXT GEN DEVICES FOR SOFT TISSUE DEFECTS (‘508) ADRCS PLUS FAT METHOD (‘666) OPPOSED AUSTRALIA: (1) ADRCS FOR CARDIAC (‘858) ADRCS FOR REMODELING (‘046) SINGAPORE: (1) ADRCS FOR RESTORING BLOOD FLOW(‘309) CHINA: (1) ADRCS FOR RESTORING BLOOD FLOW (‘104) HONG KONG: (1) ADRCS FOR RESTORING BLOOD FLOW (‘085) RUSSIA: (1) CELUTION FOR RESTORING BLOOD FLOW (‘924) SOUTH AFRICA: (1) ADRCS FOR CARDIAC (‘446) MEXICO: (1) CELUTION FOR RESTORING BLOOD FLOW (‘775) ISRAEL: (1) ADRCS FOR CARDIAC (‘354) CANADA: (1) ADRCS FOR RESTORING BLOOD FLOW(‘510) JAPAN: (2) RESTORING BLOOD FLOW(‘787) CELUTION FOR REMODELING (‘155) CELUTION FOR PROSTHETIC FOR BONE RELATED DISORDERS (‘716) CELUTION FOR TREATING WOUND HEALING (‘580) ADRC’S FOR RENAL (‘229) EUROPE: (2) CELUTION FOR ACUTE TUBULAR NECROSIS (‘834) ADRCS FOR WOUND HEALING (‘833) JAPAN: (3) ADRCS FOR WOUND HEALING (‘699) CELUTION OUTPUT PLUS PROSTHETIC FOR BONE RELATED DISORDERS (‘119) CELUTION FOR PERIPHERAL VASCULAR DISEASE (‘511) INDIA: (1) ADRCS FOR WOUND HEALING (‘580) KOREA: (1) ADRCS FOR WOUND HEALING (‘909) CARDIAC CONTINUED KOREA (1) ADRCS FOR VENTRICULAR DILATION (‘170)
  7. 7. Adipose Derived Regenerative Cells •  More than just “stem cells” –  Device output yields multiple cell types –  Benefit from multiple mechanisms-of-action Primary Mechanisms •  Improve blood flow •  Modulate inflammation •  Wound healing
  8. 8. Areas of Focus Cardiac •  Completed proof-of-concept trial •  Enrolling U.S. Phase II HF trial •  Data in 2014 Soft Tissue •  Up to $106 MM in development funding •  Commercial preparedness contract with U.S. Government •  PMA for burns Commercial Research Market •  Japan approval •  EU ‘Vascular’ approval •  Clinical experience in thousands of patients
  9. 9. Cardiac Cell Therapy Current therapy does not address damage to the heart
  10. 10. Cardiac Cell Therapy Damage leads to: reduced function left ventricular failure . . . Death
  11. 11. Ischemic Heart Disease: Market Size 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
  12. 12. US Regulatory Path for Heart Failure Development Pipeline Chronic Pilot Complete U.S. Phase II (ATHENA) Pivotal 2015 Pilot trial: •  Cells shown to be safe; no adverse effects on rhythm at 6 & 18 months •  Statistically significant stabilization in VO2Max vs placebo Phase II ATHENA trials: •  90 patients, multi-center, double blind, placebo-controlled •  Advance to pivotal in 2015
  13. 13. PRECISE Trial Showed Proof-of-Concept Objective Safety and feasibility of intramyocardial injection in patients not amenable to revascularization Design Double-blind, randomized, parallel group, placebo-controlled Size 27 patients (Spain, Netherlands, Denmark; 21 Treated, 6 Placebo) Procedure •  Electromechanical mapping (NOGASTAR®) •  ≤ 15 intramyocardial injections of cells (median dose = 42 x 106 per subject) or placebo (indistinguishable solution) in the area with inducible ischemia via MYOSTAR® Injection Catheter
  14. 14. PRECISE Trial: Data Summary Results •  No safety issues •  No adverse effects on rhythm at 6 and 18 months •  VO2Max: improvement (p<0.05 vs. placebo) –  Supported by NYHA improvement trend •  MRI: reduction in infarct size (p<0.05 vs. placebo) •  Mortality [36 months]: placebo 33% (2/6) , ADRC 14% (3/21)
  15. 15. PRECISE Trial: Exercise Tolerance Change  in  VO2Max  at   6  and  18  Months 20 VO2 Max 18 16 ADRCs 14 Placebo 12 Baseline 6  months 18  months
  16. 16. ATHENA Trials (USA) •  Heart failure due to ischemic heart disease •  Phase II trial design based on PRECISE •  Prospective, randomized, double-blind, placebocontrolled trials –  90 patients: 30 patients at low dose, 30 patients at high dose, 30 placebo control –  Up to 10 centers •  First data readout targeted for 2014 •  Potential for pivotal trial initiation in 2015
  17. 17. ATHENA Trial Safety •  Treatment emergent Serious Adverse Events (SAEs) •  Arrhythmia assessment via 24-hour Holter monitoring •  MACE defined as Cardiac Death or Hospitalization for Heart Failure Efficacy •  VO2 Max (treadmill) (6 mo) •  LVEF, LVESV/LVEDV assessed by Echo (6 mo) •  Perfusion defect by Rest/Pharmacologic Stress SPECT (6 mo) •  Heart failure symptoms, angina, and quality of life (3, 6, 12 mo): •  NYHA and CCS classifications •  Minnesota Living with Heart Failure Questionnaire (MLHFQ) •  SF-36 Health Survey
  18. 18. BARDA Contract Contract objective: National preparedness contract worth up to $106 million in reimbursed development funding to create a treatment for thermal burns combined with radiation Clinical development: »  PMA-based pathway for traditional burns »  Development from preclinical to FDA approval fully funded »  Cytori’s first U.S. soft tissue indication Commercialization & Procurement »  Cytori maintains commercial rights for approved label »  Government can make direct purchases or facilitate orders from hospitals for preparedness purposes »  Procurement potential is above and beyond contract funding
  19. 19. BARDA Contract Discussions Begin 2010 Award 3 Proof-of-concept Objectives Announcement Ongoing Fall, 2012 Cell viability Pre-Award, White Papers, Proposal, Negotiation 3 Objectives Trigger Option 1 & 3 Q1, 2014 Option 1 Objective Triggers Option 2 Q4, 2015 $32.6 M Option 1 Animal model POC $45.5M Option 2 Next Gen device feasibility $4.7M Phase 1 Proof of Concept $23.4M Option 3 Commercial Acquisition at BARDA’s Discretion
  20. 20. Commercialization Emphasis: Researchers performing independently funded studies »  50+ studies worldwide completed, in process or planned using Celution® Rationale: New indications & approvals expand pipeline and opportunities I.  BARDA contract worth up to $106 MM (Sep. 2012) II.  Lorem Vascular: $24 MM equity, $500 MM milestones (Nov. 2013) III.  Japan DIET passes new Regenerative Medicine Law to Fast Track Technology Growth: International regulatory approvals and partnerships I.  Japan Class I clearance achieved II.  Europe: Vascular delivery & ischemic tissue muscle approvals III.  Asia Pacific: »  Australia & Singapore approvals
  21. 21. RECOVER Trial (US) Objec&ve   •  evaluate  the  safety  and  feasibility  of  ADRC  injected  into  tears  of  the   hamstring  muscle     Trial  Design:   •  Randomized,  double-­‐blind,  placebo-­‐controlled   •  Part  A:  10  paBent  open-­‐label,  safety,  feasibility  &  dose-­‐escalaBon     –  Low  Dose:  5  paBents,    High  Dose:  5  paBents   •  Part  B:  60  paBent,  double-­‐blind,  placebo-­‐controlled  safety,  feasibility  &   dosing  study     –  Low  Dose:  20  paBents,    High  Dose:  20  paBents,  Placebo:  20  paBents   •  Safety  &  funcBonal  end-­‐points   21
  22. 22. Lorem Vascular Partnership Celution® System Commercialization rights Territories: Australia, China, Hong Kong, Malaysia, & Singapore Indications: All indications w/initial focus on cardiac, diabetes and renal Agreement Terms Equity: Milestones: $24 million; 8 million shares at $3.00 per share Up to $500 million in commercial milestones Supply agreement: Cytori receives transfer margin on long-term agreement Partner Lorem Vascular: Distribution Plan: Newly formed company dedicated to Celution® products Combination of direct sales and distributors
  23. 23. Upcoming Milestones ATHENA –  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 BARDA –  Achieve proof-of-concept objectives –  Qualify for up to $56 MM in further development funding –  Define & Initiate US Burn Pilot Trial (IDE) COMMERCIAL –  Growth in product & contract revenues in 2014 –  Obtain product registration for the Celution® System in China RECOVER –  Initiate enrollment in US trial (Part A) for hamstring injury
  24. 24. Cytori Corporate Overview NASDAQ: CYTX Thank you!

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