Plus Therapeutics, Inc. · NASDAQ:PSTV
Plus Therapeutics — Cytori Therapeutics — IPO Roadshow (May 2016)
32 slides from Plus Therapeutics's IPO roadshow presentation, May 12, 2016
Slide 1: Cytori Therapeutics Corporate Update May 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
Slide 2: Forward Looking Statements and Disclaimers
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 tha
Slide 3: Free Writing Prospectus Statement
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 reg
Slide 4: Cytori Overview
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- increasi
Slide 5: Cytori Cell Therapy: Clinical Pipeline
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 F
Slide 6: Cytori 3-Step Bedside Process
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 Ad
Slide 7: Cytori Cell Therapy: Why Adipose?
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- Clini
Slide 8: Cytori Cell Therapy: Mechanism of Action
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
Slide 9: Lead Indication: Scleroderma
* * Lead Indication: Scleroderma
Slide 10: Scleroderma Pathophysiology
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 sy
Slide 11: Scleroderma: Market Overview
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
Slide 12: Scleroderma: Treatment Approach
Scleroderma: Treatment Approach AmbulatoryProcedure roomLocal or mild conscious sedationSingle administration ECCS-500.5cc injection to each side of each finger \ * *
Slide 13: Pilot/Phase I SCLERADEC I Trial
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
Slide 14: ECCS-50 Treatment Improved Hand Function, Raynaud's, and Pain
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
Slide 15: SCLERADEC I - Other Endpoints
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
Slide 16: Reduction in Digital Ulcers, Improved Microvascular Architecture
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 Mont
Slide 17: Scleroderma: Ongoing Clinical Trials
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
Slide 18: Scleroderma - Projected Development Timeline
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
Slide 19: Managed Access Program Objectives
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
Slide 20: Scleroderma Managed Access Program Timeline
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 o
Slide 21: Pipeline Indications
* * Pipeline IndicationsKnee OsteoarthritisUrinary IncontinenceRadiation/Nuclear Burn
Slide 22: Knee Osteoarthritis
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 years
Slide 23: Scientific Rationale: Cytori Cell Therapy in OA
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 dat
Slide 24: ACT-OA Trial & Top-line 24 Week Interim Analysis
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@ 4
Slide 25: Osteoarthritis Development: Anticipated Next Steps
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
Slide 26: Stress Urinary Incontinence Program
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 suppor
Slide 27: Radiation/Nuclear Burn Program
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 Aut
Slide 28: Corporate Information
* * Corporate Information
Slide 29: Cytori Cell Therapy: Global Patent Estate
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 indicat
Slide 30: Capitalization Summary
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 & man
Slide 31: Anticipated Key Corporate Milestones
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 * 201
Slide 32: Thank You
Thank You