Biocentury Future Leaders of the Biotech Industry 2013


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CFO Mark Saad presents at Biocentury's Future Leaders in the Biotech Industryon Friday, April 5

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Biocentury Future Leaders of the Biotech Industry 2013

  1. 1. C Y TherapyIPersonalized Cell TOR BioCentury Future Leaders Conference April 5, 2013 NASDAQ: CYTX 1
  2. 2. Safe Harbor StatementThis presentation contains certain ‘forward-looking statements’ about Cytori Therapeutics, Inc. Allstatements, other than statements of historical fact, that address activities, events or developmentsthat 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 byour management in light of their experience and their perception of historical trends, currentconditions, expected future developments and other factors they believe to be appropriate.The forward-looking statements included in this presentation involve known and unknown risks thatrelate to Cytori’s future events or future financial performance and the actual results could differmaterially from those discussed in this presentation. Risks and uncertainties that may cause Cytorisactual results to differ materially from those discussed in the presentation can be found in the "RiskFactors" section of Cytori’s Form 10-K, Forms 10-Q and other filings with the United States Securitiesand Exchange Commission. We would advise reading our most recent annual report on Form 10-Kand quarterly report on Form 10-Q filed with the United States Securities and Exchange Commissionfor a more detailed description of these risks.The forward-looking statements contained in this presentation represent Cytori’s estimates andassumptions only as of the date of this presentation and Cytori undertakes no duty or obligation toupdate or revise publicly any forward-looking statements contained in this presentation as a result ofnew information, future events or changes in Cytori’s expectations. 2
  3. 3. Cytori Cell Therapy① Game changing technology platform② Arriving at points of leverage • US Cardiac Data • Barda Contract • International Revenues③ Expansive IP portfolio protects technology long-term 3
  4. 4. Cytori Cell TherapyProprietary formulation of a patient’s own adipose- derived stem and regenerative cells • Autologous • Virtual ‘off the shelf’ • Mixed population • Multiple mechanisms • Patented process 4
  5. 5. Cytori Cell Therapy: Multiple Cell Types Vascular Smooth 45 Muscle CellsEndothelial 9% Tissue cells 7% Macrophages 30 23% White Blood CD34+/CD31 15 - 37% Cells 22% 0 Total Nucleated Cells in Adipose Stem Cells 2%Heterogeneous Cell Therapy uniquely leverages multiple mechanisms 5
  6. 6. Cytori Cell Therapy: System + Single-Use Cartridge Processing System: Low six figure ASP Per-procedure consumable: $2,000-$12,000 Dependent on indications and formulation 60-80% Margin 6
  7. 7. Cytori Cell Therapy: Business Overview Cardiac • US heart failure trial BARDA Commercial • Up to $106 in development funding • Japan research market • US Government large end-customer • EU vascular approval • Cytori to sell into all other burn markets • EU tissue ischemia approvals • Cell & tissue banking
  8. 8. PRECISE Trial 20.0 19.0 P<0.05 P<0.02 18.0 VO2Max 17.2 17.1 ADRC’s 16.6 Increased 16.0 Mortality 15.5 Standard of Care 15.3 14.0 Transplant List Baseline 6 Mos 18 MosChange in Peak Oxygen Consumption (VO2Max) from Baseline to 6 & 18 months 8 N=27; 21 active, 6 control
  9. 9. PRECISE Trial: Max VO2 a Predictor of 1 Yr. SurvivalReflects the degree of impairment in:• Ventricular function (pumping capacity)• Vascular function (O2 delivery),• Skeletal muscle metabolic capacity (O2 utilization).Pts with Max VO2 ≤ 14 ml/kg/min hada 1 year survival rate of only 47%.Mancini et al, Circulation 1991Figure: Survival curves for all patients subdivided by Max VO2 & EF (p<0.05; VO2 ≤ 10 vs. > 14 ml/kg/min)
  10. 10. U.S. Refractory Heart Failure TrialStatus: All centers actively screening • Minneapolis Heart Institute (Timothy Henry MD) • Texas Heart Institute (Emerson Perin MD, PhD, James, Willerson, MD) • University of Florida (Carl Pepine MD) • University of South Florida (Leslie W. Miller MD) • Scripps Green Hospital (Richard Schatz MD) • Cardiology P.C. (Farrell Mendlesohn MD) On-track to complete mid-Summer 2013 6-month data first half 2014 Pivotal Trial Design • Detailed protocol and trial size to be determined by ATHENA outcomes • Likely endpoints to include a functional and composite clinical outcome 10
  11. 11. BARDA: Up to $106 MM for Thermal Burn Development U.S. Govt. contract: Thermal burns combined with radiation injury • National preparedness to counter radiological bomb • Funds complete development: preclinical to FDA submission • New soft tissue pipeline application in U.S. • Procurement potential above and beyond contract Options 1 & 2• $4.7 MM in funding • Up to $45 MM• Preclinical model • Pivotal trial • Up to $55 MM• Next-Gen Celution® • FDA submission • Development development including clinical• Up to 2 years • Govt. has Proof-of- procurement ability Option 3 Concept 11
  12. 12. BARDA: Supporting Desktop System Development Celution® System product and technological evolution 1. Cytori developed interim Celution 800 System (Cytori) 2. Olympus designed Celution One System (OC-JV) 3. Cytori designed Next Gen System (BARDA)1. 2. 3. Smaller. Faster. Cheaper. Higher Yields.
  13. 13. Translational Medicine: Near-Term Revenue DriverInvestigator-initiated trials resulting in:• Meaningful sales to offset burn Vascular CE Mark Radiation• Expansion of physician and injury hospital network• Strategic benefit of development Incontinence of new applications/pipeline Pivotal trials, grants (BARDA), partnerships, regulatory approvals, reimbursement
  14. 14. FinancialsCurrent Select DataPF cash & AR (YE 2012) $32 MMSenior Term Loan (GE) $22 MM maturing in 2015Shares outstanding 67 MMWarrants 10 MM @ $3.25 avg. exercise price2013 GuidanceRevenue $15 MM ($12 m product, $3 m contract)SG&A Flat for yearR&D Slight increase, more than offset by BARDA revenue
  15. 15. 2013 Milestones Present / Publish PRECISE long-term data (18 months) Complete patient enrollment in ATHENA by mid-summer 2013 Advance BARDA toward Phase II Achieve $15 million revenue target for 2013 (incl $2.5 - 3m Barda) Expand Celution approvals ( ie Canada, Australia)
  16. 16. Personalized CellQ&A Therapy