Plus Therapeutics, Inc. · NASDAQ:PSTV
Plus Therapeutics — Cytori Therapeutics — Corporate Update (March 2015)
31 slides from Plus Therapeutics's corporate update, Mar 4, 2015
Slide 1: Cytori Therapeutics Corporate Update March 2015
Cytori TherapeuticsNASDAQ: CYTXCorporate UpdateMarch 2015 NASDAQ: CYTX Restoring Lives *
Slide 2: Forward Looking Statements
Forward Looking Statements 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 occu
Slide 3: Cytori Recent Headlines
Cytori Recent Headlines Substantial refocus of strategy and restructure of the business - May’14BARDA executes $12M plus $8.3M conditional option for thermal burn injury trial – Aug’14BARDA ups contract option to $14M to accelerate thermal burn injury program – Dec’14Positive resolution ATHENA trial
Slide 4: Cytori Corporate Overview
Cytori Corporate Overview NASDAQ: CYTX * Autologous cell therapeutics from adipose Regulated as PMA device BARDA, Japan MHLW funded clinical trialsSignificant new opportunities possible PHASE III /Pivotal trial for SclerodermaEst. market value > $1B PHASE IIB for knee osteoarthritisEst. Market value
Slide 5: Cytori Platform Technology
Cytori Platform Technology NASDAQ: CYTX ECCS-50OICH-D3 PROPRIETARY DRUGS & REAGENTS DEVICE AND CONSUMABLES SOFTWARE FDA regulates technology & therapeutics via PMA device path(see FDA RFD# 090013) * Automated Bedside Manufacturing System Autologous Adipose Tissue CELLS DCCT-10 Multiple Indication-Sp
Slide 6: Cytori Cell Therapy Pipeline
Phase II/III Initiate 2015 Initiate 2015 Cytori Cell Therapy™ Pipeline Urinary Incontinence ECCI-50 Japan Govt Sponsorship US Govt Sponsorship Knee Osteoarthritis Phase IIA/B ECCO-50 Enrollment in progress Cutaneous Thermal Injury Preclinical DCCT-10 Preclinical Planning NASDAQ: CYTX * Initiate 2015
Slide 7: Cytori Cell Therapy for Scleroderma Hand Dysfunction
Cytori Cell Therapy forScleroderma Hand Dysfunction NASDAQ: CYTX *
Slide 8: Scleroderma Opportunity Overview
Scleroderma Opportunity Overview Hand dysfunction in scleroderma primary cause of disabilityMore disabling than RA Phase I/II data consistent with disease modifying effectOrphan indication Fast tracked in US - 80 patient pivotal in 2015EU orphan designation - 40 patient pivotal in 2015US market oppo
Slide 9: Systemic Scleroderma of the Hand (SSc-H)
Systemic Scleroderma of the Hand (SSc-H) Systemic sclerosis (SSc) or sclerodermaRare Autoimmune conditionAffects women:men, 4:1Cutaneous and visceral fibrosis Obliteration of the lumen of small vessels >90% patients hand disabilitySSc-H manifestations principal source of functional impairment and re
Slide 10: Rare Disease Basis for Scleroderma & Therapeutic Analogue
Rare Disease Basis for Scleroderma (SSc-H) & Therapeutic Analogue SclerodermaDefinitionAn autoimmune disorder causing collagen overproduction leading to fibrosis and impaired vasculature. Most commonly effects the hands but often affects multiple organ systems. EpidemiologyPrevalence: 50 – 75,000 (2
Slide 11: Comparison of Scleroderma and RA Hand Disability
Comparison of Scleroderma and RA Hand Disability Metric Outcomes Source Work disability (WD) WD was observed in 56% of SSc patients vs. 35% of RA patients Ouimet 2007 Work disability (WD) “…the prevalence of work disability in SSc is substantially higher than other common rheumatic conditions.” Shar
Slide 12: Development of ECCS-50 for Scleroderma (SSc-H)
Development of ECCS-50 for Scleroderma (SSc-H) NASDAQ: CYTX Study Phase Approach Status Key Findings Ref Scl0101 Preclin. (human) Feasibility Complete Preparation of ADRCs from scleroderma patients is feasible§ 1 Scl0412 Preclin.(murine) Drug-induced cutaneous fibrosis Complete Reduced skin thicknes
Slide 13: E.U. SCLERADEC I Pilot Trial for Scleroderma
E.U. SCLERADEC I Pilot Trial for Scleroderma (SSc-H) Study DesignSingle center (Marseille, France), open-label trial of 12 patients (NCT01813279)Funded by Groupe Francophone de Recherche de la SclérodermiePopulationMen and women with diagnosis of limited or diffuse sclerodermaAge ≥ 18 yearsFunctiona
Slide 14: E.U. SCLERADEC I Pilot Trial Results
E.U. SCLERADEC I Pilot Trial Results for Scleroderma (SSc-H) ECCS-50 SafetyNo serious AEs during follow-upFour minor AEs reported by four patientsAll resolved spontaneously within 15dECCS-50 EfficacyHand FunctionAverage 57% improvement in Cochin Hand Function Score at 6 monthsImproved grip and pinch
Slide 15: SCLERADEC I Results: Ulcers and Microvasculature
NASDAQ: CYTX ECCS-50 Treatment led to a progressive decrease in the number of ulcers and average ulcer area mean ± std err …and significant normalization of microvasculature mean ± std err p<0.05 p<0.05 E.U. SCLERADEC I Pilot Trial Results for Scleroderma (SSc-H)- II Granel et al (2014); Ann Rheum D
Slide 16: STAR Trial (US Pivotal) and Scleradec II (EU Confirmatory)
STAR Trial (US Pivotal) Scleradec II (EU Confirmatory) Study Design Randomized, double blind, 48 weeks Randomized, double-blind, 6 months (+6 months open label) Control Placebo, crossover 48 weeks* Placebo, crossover after 24 weeks (cryopreserved)* Sample size 80 (1:1 randomization) 40 (1:1 randomiz
Slide 17: Cytori Cell Therapy for Knee Osteoarthritis
Cytori Cell Therapy for Knee Osteoarthritis NASDAQ: CYTX *
Slide 18: Summary of Osteoarthritis Opportunity
Summary of Osteoarthritis Opportunity Knee osteoarthritis has high prevalence and market opportunity >$3BOpportunity for symptom or disease modification- bridge anti-inflammatory drugs and knee replacementSubstantial preclinical and proof of concept clinical dataUS phase IIb trial enrolling- data 20
Slide 19: ACT-OA (US Phase II)
ACT-OA (US Phase II) ACT-OA (US Phase II) Study Design Randomized, double blind, 48 weeks duration, dose escalation (low and high dose cell ECCO-50 therapy) Control Placebo, no crossover Sample size 90 (1:1:1 randomization) Sites Up to 15 in USA Key Inclusion OA of Knee, pain > 6 months, pain on wal
Slide 20: Knee Osteoarthritis
Knee Osteoarthritis NASDAQ: CYTX Osteoarthritis (OA) DefinitionDisease of the entire joint involving the cartilage, joint lining, ligaments, and underlying bone. The breakdown of tissues leads to pain and joint stiffness 2014E 2014E 2014E Treatment Modality # Patients / Treatments ASP Market Size Ce
Slide 21: Development of ECCO-50 for Knee Osteoarthritis
Development of ECCO-50 for Knee Osteoarthritis NASDAQ: CYTX Study Phase Approach Status Key Findings Ref OA0103 Preclinical(human) Demonstration of in vitro differentiation towards chondrocytes Complete Expression of multiple markers characteristic of chondrogenesis 1 OA0203 Preclinical(caprine) Inj
Slide 22: Development of Cytori Cell Therapy for Knee Osteoarthritis
Development of Cytori Cell Therapy for Knee Osteoarthritis NASDAQ: CYTX * Goat Injury ModelTreatment led to greater healing of cartilage 4 months after injury1 Jurgens et al 2013; BioResearch 2 (4) pp. 315-25Black et al 2007; Vet Ther. 8 (4) pp. 272-84Koh et al 2013; Knee Surg Sports Traumatol Arthr
Slide 23: Cytori Business Development Activity & Financials
Cytori Business Development Activity & Financials NASDAQ: CYTX *
Slide 24: Cytori-U.S. Government Collaboration for Thermal Burn Countermeasure
Cytori-U.S. Government Collaboration for Thermal Burn Countermeasure GoalDevelop a medical countermeasure for use following mass casualty attack involving thermal burn & radiation injuryContract value: up to $106mGoal - United States Government acquisition contract for Cytori Cell TherapyStatus$4.7m
Slide 25: Stress Urinary Incontinence
Source: Gotoh et al. Regenerative treatment of male stress urinary incontinence by periurethral injection of autologous adipose-derived regenerative cells: 1-year outcomes in 11 patients. Int J Urology 2013 * NASDAQ: CYTX Stress Urinary Incontinence Study objectivesEfficacy and safety of ADRCs for m
Slide 26: ATHENA Trial - Heart Failure
ATHENA TRIAL - Heart Failure * ATHENA Trials SummaryRandomized, DB, PC trial in US of OICH-D3 treatment in patients with chronic heart failure- primary endpoint VO2 max. ATHENA I 28 2:1 active:control lower dose ATHENA II 2:1 active:control higher dose 3 NASDAQ: CYTX Enrollment stopped after 31 pati
Slide 27: Cytori's Global Patent Estate
75 patents issued worldwide; 45 applications pending Cytori’s Global Patent Estate NASDAQ: CYTX 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, osteoarthritis, and several other p
Slide 28: Business Development & Revenue
Business Development & Revenue Direct sales- Japan & Europe Approach to Business Development & Revenue NASDAQ: CYTX * Revenue Drivers (*) Excludes share based compensation. Licensing partners US BARDA contract revenue Out licensing activity in non-core geographies and indicationsOver $100MM in non-d
Slide 29: Operating Expense Reductions & Capitalization
Operating Expense Reductions & Capitalization NASDAQ: CYTX * Capitalization Summary Expense Reductions & Focus: Operating Cash Burn Management FOCUS - 2015 expectation of >50% OPEX in R&D vs. 2014 (~40%)
Slide 30: Forthcoming 2015 Milestones
Forthcoming 2015 Milestones Chinese FDA Class-I clearance, Lorem Vascular POEMEA final opinion on orphan drug status for Cytori’s ECCS-50Initiate enrolment of scleroderma STAR trialPublish SCLERADEC-I 12 month data and initiate enrollment of EU SCLERADEC-II trialComplete enrollment of ACT-OA trial,
Slide 31: Thank you! Questions, please contact ir@cytori.com
Cytori Corporate OverviewNASDAQ: CYTXThank you! QUESTIONS, please contact ir@cytori.com NASDAQ: CYTX *