FWP 1 formfwp.htm CYTORI THERAPEUTICS FWP 5-11-2016

Cytori Therapeutics NASDAQ: CYTX Issuer Free Writing ProspectusFiled Pursuant to Rule 433Registration Statement No. 333-210628May 11, 2016Enhancing lives through novel cell therapies Corporate Update I May 2016

Forward Looking Statements and Disclaimers 33% 15% 11% 22% 19% OTHER USA EU JAPAN ASIA-PACIFIC 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 future events or our future financial performance and the actual results could differ materially from those discussed in this presentation. Some of those forward-looking statements include: our commercialized and pipeline products and technologies; the timing and conduct of our clinical trials, and the associated financial, clinical and regulatory burdens; other parties’ abilities to conduct clinical trials involving Cytori Cell Therapy; the various medical indications and markets that may be addressed by Cytori Cell Therapy; the potential effectiveness of Cytori Cell Therapy, including clinical outcomes; our regulatory, reimbursement and commercial strategies and pathways; potential costs and other adverse effects of diseases targeted for treatment by our products, including the celution system, and; anticipated future funding and contract revenues. Some risks and uncertainties related to such forward looking statements include risks and uncertainties regarding the funding, conduct and completion of our clinical trials and other parties’ clinical trials involving Cytori Cell therapy, uncertain clinical outcomes, regulatory uncertainties, unfavorable reimbursement outcomes, inability to access sufficient capital on acceptable terms (including inability to fund, or find third party sources to fund, our proposed clinical trials or continued development of our technologies), failure to maintain our substantially reduced cash burn; our partners’ failure to launch products in China and other markets where we currently forecast sales; our abilities to service, pay and/or refinance our corporate debt; availability of future government funding and changes in government procurement priorities; the U.S. federal government’s ability to reduce, modify or terminate the BARDA contract if it determines it is in its best interests to do so, potential performance issues with our products and technologies, and other risks and uncertainties described under the "Risk Factors" section in our Securities and Exchange Commission Filings on Form 10-K and Form 10-Q. These risks and uncertainties may cause our actual results to differ materially from those discussed in this presentation. We 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 our estimates and assumptions only as of the date of this presentation and we undertake 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 our expectations.DisclaimersCaution: Within the U.S., the Celution System is an investigational device limited by U.S. law to investigational use.Celase, Celution, Celution (with design), Cytori Therapeutics, and Cytori (with design) are registered trademarks of Cytori Therapeutics. Cytori Cell Therapy is a trademark of Cytori Therapeutics. All third party trademarks are the property of their respective owners. * *

Free Writing Prospectus Statement 33% 15% 11% 22% 19% OTHER USA EU JAPAN ASIA-PACIFIC This presentation highlights basic information about us and the offering. Being a summary document, this slide deck does not contain all the information that you should consider before investing.We have filed a registration statement (including a preliminary prospectus) with the SEC for the offering to which this presentation relates. The registration statement has not yet become effective. Before you invest, you should read the preliminary prospectus in the registration statement (including the risk factors described therein) and other documents, including the Company's Form 10-Ks and Form 10-Q, that we have filed with the SEC for more complete information about us and the offering. You may get these documents for free by visiting the “Search EDGAR” section on the SEC web site at http://www.sec.gov. The preliminary prospectus, dated May 11, 2016, is available on the SEC website. Alternatively, we or the dealer-manager for this offering, Maxim Group LLC will arrange to send you a preliminary prospectus if you contact Maxim Group LLC, Prospectus Department, 405 Lexington Ave., New York, NY, 10174; Telephone: (212)-895-3745; Email: syndicate@maximgrp.com. * *

Cytori Overview Cell therapy technology with viable commercial modelMultiple programs in phase IIILead Indication- Scleroderma therapy EU introduction 2016 via early access program, anticipated US phase III data in 2H 2017 with goal for FDA approval in 2018Product & contract revenue growth- increasingly off-setting burnCompleted substantial corporate repositioning * *

Enrolling2 Cytori Cell Therapy: Clinical Pipeline ECCI-50 Enrollment Complete ECCO-50 Preclinical3 DCCT-10 Enrolling ECCS-50 Enrolling1 ECCS-50 Pre-Clinical Phase I/II Phase III Market (Estimate) >$1B >$500M >$3B >$75M >$50M 1 Cytori-supported, Investigator-initiated trial2 Japan Govt Sponsorship3 Funded by BARDA (US Govt.) Scleroderma Associated Hand Dysfunction Knee Osteoarthritis Urinary Incontinence Cutaneous Radiation & Thermal Injury Therapeutic Agent * *

Cytori 3-Step Bedside Process TIME  30 Min  120 Min 5 - 30 Min PROCESS HARVESTSmall Volume Liposuction(100-360 mL) PROCESSCelution® SystemTissue Processing, Cell Isolation & Dose Preparation DELIVERCytori® Cell TherapyTM Delivery Bedside Manufactureproprietary consumables,software, and reagents Adipose Tissue Non-Viable Cellular Debris, Waste & Enzymes Adipose Derived Regenerative Cells(ADRCs) Hand Scleroderma Knee Osteoarthritis * * 1 2 3

Cytori Cell Therapy: Why Adipose? Cells sourced from autologous adipose tissueHeterogeneous and uncultured- ADRC potency advantageCell therapeutic manufactured in bedside GMP process Stem & Stromal Cells Leukocytes Tissue Macrophages Endothelial VascularSMCs Adipose-derived regenerative cells- Clinical grade, heterogeneous cell population highly-enriched for adipose-derived stem, stromal, vascular, and immunoregulatory cell types * * Metabolic reservoirHigh baselineangiogenic potentialImmune organStem cells & progenitors

Cytori Cell Therapy: Mechanism of Action Cytori Cell Therapy is being developed with the goal of beneficially modulating multiple key pathologic processes which are anticipated to reduce pain and disability and improve quality of life Promotes angiogenesisNormalization of vessel architectureImproved vasomotor function1-5 Reduces development of fibrosisRemodels existing fibrosis2,10,11 Modulates expression of pro- and anti-inflammatory factorsModulates the function of pro- and anti-inflammatory cells3, 6-9, 1. Foubert et al (2015); 2. Koh et al (2011); 3. Premaratne (2011); 4. Morris et al (2015); 5. Eguchi et al (2015); 6. Feng et al (2010); 7. Hao et al (2014); 8. Dong et al (2013); 9. Data on file (Cytori); 10. Serratrice et al (2014); 11. Data on file (Cytori) Inflammation Fibrosis/Wound Remodeling Angiogenesis/Vasculopathy * *

* * Lead Indication: Scleroderma

Scleroderma Pathophysiology Scleroderma or Systemic SclerosisRare autoimmune conditionAffects Women: Men, 4:1US Prevalence: 50,000 patients>90% of patients have hand disabilityFibrosis, pain, and edema result in diminished mobility and hand function even with standard medical careSevere vasomotor symptoms Cytori Cell TherapyPreclinical and in vitro studies report modulation of perivascular inflammation, improved endothelial function, and reduction of extracellular matrix (fibrosis) Images reproduced with permission of the nonprofit International Scleroderma Network at sclero.orgImage on left by D Niklas, https://commons.wikimedia.org/wiki/File:Raynaud-Syndrom.JPG used under CC licenseImage on right reproduced with permission of the nonprofit International Scleroderma Network at sclero.org Raynaud’s Phenomenon Ulceration and Edema * *

Scleroderma: Market Overview Current Standard of CareNo therapies approved for treatment of hand dysfunction in scleroderma patientsExisting 1st and 2nd line treatments for treatment of Raynaud’s Phenomenon or other aspects of scleroderma are often inadequate and/or poorly toleratedExisting 3rd line treatments are costly ($30-$100k) and often very poorly tolerated DiagnosisAverage age: 30’s-50’s 1st/2nd Line TherapiesInadequately effective and/or poorly tolerated in ~50% of patients1,2Calcium channel blockers (eg: nifedipine)PDE5 inhibitors (eg: sildenafil)Topical nitratesSide effects: headache, dizziness, flushing, tachycardia, and edema 3rd Line TherapiesExpensive, often poorly-tolerated;doses titrated to tolerance rather than to symptom reliefEndothelin-1 receptor antagonist (eg: Bosentan)Intravenous (IV) prostaglandin (PG) analog (eg: Iloprost)Pain due to severe ischemia may require the use of analgesicsImmunosuppressive agents (eg: methotrexate, cyclophosphamide, azathioprine, mycophenolate)Surgical sympathectomy 1. Thompson et al Arthritis Rheum. 2001;44(8):1841-72. Herrick (2008) BMJ Clin Evidence 09:1125 * *

Scleroderma: Treatment Approach AmbulatoryProcedure roomLocal or mild conscious sedationSingle administration ECCS-500.5cc injection to each side of each finger \ * *

Pilot/Phase I SCLERADEC I Trial SCLERADEC I Study size 12 Randomization Open label Administration Single administration (~4m cells/finger) Sites Single site (IIS) - Marseille, France Endpoints Cochin Hand Function ScaleRaynaud’s Condition ScoreScleroderma Health Assessment QuestionnairePain Modified Rodnan Skin ScoreCapillaroscopy Adverse eventsOther Follow-Up 24 months Status Complete Six and 12 month data published1,224 month data presented at Systemic Sclerosis World Congress in Lisbon, Portugal, February 19, 2016 1. Granel et al (2014); Ann Rheum Dis Aug 11: doi: 10.1136/annrheumdis-2014-2056812. Guillaume-Jugnot et al (2015) Rheumatol. 10.1093/rheumatology/kev323 * *

ECCS-50 Treatment led to improvement in hand function, Raynaud’s phenomenon, and pain SCLERADEC I Improvement Through 24 months Key Observation:Concordant reduction (~50% ) in four key symptomatic patient reported outcomesEfficacy sustained to two years following a single treatment p<0.001 p<0.001 p<0.001 p=0.052 p<0.002 * * Cochin Hand Function Score Raynaud’s Condition Score Pain Scleroderma Health Assessment Questionnaire p=0.01 1. 6-month data: Granel et al (2014); Ann Rheum Dis Aug 11: doi: 10.1136/annrheumdis-2014-2056812. 12-month data: Guillaume-Jugnot et al (2015) Rheumatol. 10.1093/rheumatology/kev323

Normal Range 15-39kg Normal Range 3.5-7.7kg SCLERADEC I- Other Endpoints Sustained improvement in hand strength & skin stiffness 330% improvement in pinch strength20% improvement in grip strength p=0.005 12% improvement in mRSS of the hand * * p=0.004 p=0.05 1. 6-month data: Granel et al (2014); Ann Rheum Dis Aug 11: doi: 10.1136/annrheumdis-2014-2056812. 12-month data: Guillaume-Jugnot et al (2015) Rheumatol. 10.1093/rheumatology/kev323

Reduction in digital ulcers, improved microvascular architecture Image at top reproduced with permission of the nonprofit International Scleroderma Network at sclero.org SCLERADEC I- Other Endpoints 30-35% improvement in vascular suppression score 40% improvement in number of ulcers Baseline 12 Months p<0.001 * * VSS data at 24 months not available 1. 6-month data: Granel et al (2014); Ann Rheum Dis Aug 11: doi: 10.1136/annrheumdis-2014-2056812. 12-month data: Guillaume-Jugnot et al (2015) Rheumatol. 10.1093/rheumatology/kev323

Scleroderma: Ongoing Clinical Trials STAR (Phase III) SCLERADEC II (Phase III) Study size 80 40 Randomization 1:1, active: placebo 1:1 (dose from Pilot, placebo) Crossover Placebo, crossover at 48 weeks Placebo, crossover at 24 weeks (cryo) Sites Up to 20 in USA 6 France Primary Endpoint Cochin Hand Function Score (CHFS) at 6 months Cochin Hand Function Score at 3 months Secondary Endpoints CHFS, Raynaud’s Condition Score, Scleroderma Health Assessment Questionnaire, Pain, Modified Rodnan Skin Score, Hand Mobility in Scleroderma Test, Adverse events CHFS, Raynaud’s Condition Score, Scleroderma Health Assessment Questionnaire, Pain, Modified Rodnan Skin Score, Capillaroscopy, Adverse events Follow-Up 48 weeks 24 weeks Status Enrolling Enrolling Clinical/Regulatory StrategyEU SCLERADEC I trial data used to support US FDA STAR trial approvalUS FDA STAR trial for US PMA approvalUS STAR trial ± SCLERADEC II to obtain EU Conditional Marketing Authorization/Normal Marketing Authorization * *

Scleroderma - Projected Development Timeline 2015 2015 2016 2016 2016 2016 2017 2017 2017 2017 2018 2018 2018 2018 2019 2019 2019 2019 3 4 1 2 3 4 1 2 3 4 1 2 3 4 1 2 3 4 STAR Enrollment, 12 Month Follow-Up & Data Analysis FDA Original PMA Submission & Panel Approval Scleradec II Enrollment,6 Month Follow-Up & Data Analysis EMA MAA Submission for Full Marketing Authorization(based on SCLERADEC I/II and STAR) Approval Phase III Data Conditional Approval Full Approval EMA Conditional MAA Submission for(based on SCLERADEC I/II) * Device (PMA) Drug (ATMP) * EU Phase III Data Actual timelines may materially differ from current projections based on a variety of factors, including patient enrollment, clinical results of the contemplated trials and other factors

Managed Access Program Objectives ❶ Provide ethical and compliant access to Cytori Cell TherapyTM, ECCS-50, for hand scleroderma patients prior to EMA marketing authorization ❷ Increase awareness of and facilitate a positive experience with Cytori Cell TherapyTM among healthcare providers in advance of commercial launch❸ Track and collect key program data and documentation providing valuable insight regarding the demand for and use of Cytori Cell TherapyTM ❹ Implement a chargeable program in EMEA countries where regulations allow❺ Launch the program in Q1 and begin treating patients in Y1 and close the program once reimbursement is attained in each EMEA country * *

Scleroderma Managed Access Program Timeline 2015 2015 2016 2016 2016 2016 2017 2017 2017 2017 2018 2018 2018 2018 2019 2019 2019 2019 2020 2020 2020 2020 2021 2021 2021 2021 3 4 1 2 3 4 1 2 3 4 1 2 3 4 1 2 3 4 1 2 3 4 1 2 3 4 SCLERADEC-II French Clinical Study EMA Conditional MAA Submission*(based on SCLERADEC-II) EMA Full MAA Submission (based on SCLERADEC-II and STAR) Conditional EMA Approval* 6 Month Data Full EMA Approval 12 Month Data STARU.S. Clinical Study 1st Patient Treated ProgramDesign & Set UpPricing Strategy Access & Billing in Most EMEA Countries Country Expansion Peak Adoption Access & Billing in CRO, CZE, GER, HUN, ITA, KSA, POL, RUS, SAU, TUR(based on Conditional EU Approval) Close Program Transition to Commercial Launch * * * Earlier receipt of Conditional Marketing Authorization is possible if the EMA is willing to approve on the basis of SCLERADEC I data in the knowledge that SCLERADEC II and STAR data will be provided shortly thereafter

* * Pipeline IndicationsKnee OsteoarthritisUrinary IncontinenceRadiation/Nuclear Burn

Knee Osteoarthritis OsteoarthritisProgressive loss of joint functionImbalance between anabolic (cartilage-forming) and catabolic (cartilage-destroying) processes driven by synovial inflammation EpidemiologyOA is the most common form of arthritis13.9% of adults >25 years33.6% (12.4 million) >65 yearsEstimated 26.9 million US adults (2005) Pathophysiology * *

Scientific Rationale: Cytori Cell Therapy in OA Pathophysiology of OA (persistent synovial inflammation leading to cartilage destruction) overlaps with other clinical indications in which Cytori Cell Therapy shown to have impactCombination of veterinary, preclinical, in vitro, and pilot clinical data indicate significant potential for symptomatic improvement and perhaps disease modification * * Opportunity: Biologic/Cell Therapy to better address gap between oral analgesics and surgical management

ACT-OA Trial & Top-line 24 Week Interim Analysis Phase II (ACT-OA) Study Size 94 enrolled Randomization 1:1:1 (low dose, high dose, placebo) Sites 12 US Primary Endpoint KOOS - pain on walking @ 12 weeks Secondary Endpoints KOOS, pain/function questionnaires, disease activitypain meds, SF-36, MRI@ 48 weeks Follow-Up 48 weeks Status Enrolled- 48 week data Q3/16 * * Patient allocation equalNo safety concernsPain on walking endpoint @12 weeks- not statistically significantConsistent 12, 24 week trends favoring cell therapy effectStrong placebo response ~50% in certain endpointsCell therapy benefit over and above placebo effect 24 Week Interim Data- Top-line Results From Partial Unblinding

2015 2015 2016 2016 2016 2016 2017 2017 2017 2017 2018 2018 2018 2018 2019 2019 2019 2019 2020 2020 2020 2020 3 4 1 2 3 4 1 2 3 4 1 2 3 4 1 2 3 4 1 2 3 4 Osteoarthritis Development: Anticipated Next Steps *Pending 48 week data, phase 3 funding, and FDA approval * ACT-OA Follow-Up & Data Analysis ACT-OA II Enrollment, 12 Month Follow-Up& Data Analysis * FDA Original PMA Submission & Panel Approval Approval Phase II/III Data Interim Phase II Data 48 wk Phase II Data * Full un-blinding & complete analysis after 48 week data collected (~ Q3 2016)Evaluation of individual responder rates & patient subset analysesEvaluate continued symptomatic improvement vs. placebo48 week MRI assessment for effect on cartilage

Stress Urinary Incontinence Program ‘ADRESU’ Trial ObjectivesApproved, reimbursed therapy for SUI in men following radical prostatectomySignificant need for patients not responding to conservative methodsSupport proof of concept in female incontinence SupportInvestigator initiated with Cytori supportSubstantial funding via Japanese Ministry of Health, Labour and Welfare Progress/DataPilot clinical trial data published 1,2Increase maximum urethral closing pressureReduction 24-hour pad weightIncreased blood flowOngoing 45 pt. Multicenter Pivotal TrialEnrollment started Q3/20152 years to enroll Development PlanOngoing pivotal anticipated as approval/reimbursement trialAssuming positive data, seek approval and reimbursement based on 12 month assessmentSeeking commercial partnership with Japanese company 1. Gotoh et al. (2014) Int J Urology 21 (3) 294-3002. Yamamoto et al. (2012) Int J Urology 19 (7) 652-9 * *

Radiation/Nuclear Burn Program ObjectivesDevelopment medical countermeasure for mass casualty event- thermal burn ± radiation exposure Proof of concept clinical data for use of Cytori Cell Therapy in wound healing SupportFunded by $106MM contract from Biomedical Advanced Research and Development Authority (BARDA)$18.7MM of funding allocated through September 2016 Progress/ Preclinical DataImprovement in multiple tissue repair parameters following administration of Cytori Cell Therapy1,2Effective via multiple routes of administration1,2Efficacy sustained following substantial exposure to radiation dose3 Development PlanSubmit IDE application in 2016 for a proof-of-concept clinical trialAdditional $8.3 funding pending receipt of IDE approval for clinical trial 1. Foubert et al. (2015) Burns doi:10.1016/j.burns.2015.05.0042. Foubert et al. (2015) Adv Wound Care doi:10.1089/wound.2015.06723. Foubert et al (manuscript in preparation) * *

* * Corporate Information

85 patents issued worldwide; over 75 applications pending Cytori Cell Therapy: Global Patent Estate Goal: Protect Cytori’s proprietary methods and devices for manufacturing Cytori Cell Therapy, as well as methods of using Cytori Cell Therapy in the treatment of scleroderma, and several other indications, including osteoarthritis and SUI. 28% 15% 11% 25% 21% OTHER USA EU JAPAN ASIA-PACIFIC * *

Capitalization Summary Select Data – as of 3/31/16 Select Data – as of 3/31/16 Cash ~ $9.4MM Senior term loan ~ $17.7MM Common Shares outstanding ~ 13.3MM* Outstanding options, RSAs and warrants ~ 1.1MM* Fully diluted share count ~ 14.4MM* Market capitalization ~ $50MM** * * Q2 2014- Corporate & management restructuring Change focus, eliminated/lowered outstanding liabilities and recapitalization * After giving effect to a 1:15 reverse stock split ** As of May 9th, 2016, based on closing share price of $3.95*

Anticipated Key Corporate Milestones 2016 Milestones 2016 Milestones 1st Half EU MAP program launch24 WK ACT-OA interim data evaluation2 YR follow up EU scleroderma trialFull STAR phase III trial enrollment 2nd Half 48 WK ACT-OA data evaluationJapan & MAP progress reportedFull SD-II enrollment * 2017 Milestones 2017 Milestones 1 YR STAR Phase III dataSD-II data evaluationFile US FDA PMA approval sclerodermaFile full EMEA approval sclerodermaUS Phase I Burn enrollmentFull ADRESU enrollment

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