Plus Therapeutics, Inc. · NASDAQ:PSTV
Plus Therapeutics — Cytori Therapeutics — Investor Presentation (January 2015)
26 slides from Plus Therapeutics's investor presentation, Jan 12, 2015
Slide 1: Cytori Therapeutics Investor Update January 2015
Cytori Therapeutics NASDAQ: CYTX Investor Update January 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: Corporate Overview
Cytori Cell TherapyTM Differentiated, adipose-based therapeutics platform with extensive clinical experience Autologous therapeutic- uniquely regulated as FDA Class III device Primary disease targets: immuno/inflammatory and ischemic disease Strong global intellectual property position Lead Indicati
Slide 4: Cytori Cell Therapy Pipeline
Region Phase III Pivotal Phase I/II Pilot Pre-Clinical Status Scleroderma Assoc. Hand Dysfunction Initiate 2015 Phase III Therapeutic Agent ECCS-50 ECCS-50 Phase III Initiate 2015 Cytori Cell Therapy™ Pipeline Urinary Incontinence ECCI-50 Phase II/III Japan Govt Sponsorship US Govt Sponsorship Knee
Slide 5: Cytori's Autologous Cell Therapy Solution
Cytori’s Autologous Cell Therapy Solution NASDAQ: CYTX ECCS-50 OICH-D3 DCCT-10 Modulation of the innate immune system and inflammation through down-regulation of pro-inflammatory factors incl. IL-6 and CXCL-2 Therapeutic Agent Primary Mechanism Increased angiogenesis and arteriogenesis through up-re
Slide 6: Cytori Cell Therapy for Scleroderma Hand Dysfunction
Cytori Cell Therapy for Scleroderma Hand Dysfunction NASDAQ: CYTX *
Slide 7: Scleroderma Associated Hand Dysfunction (SAHD)
Scleroderma Associated Hand Dysfunction (SAHD) Systemic sclerosis (SSc) or scleroderma Rare Autoimmune condition Affects women:men, 4:1 Cutaneous and visceral fibrosis Obliteration of the lumen of small vessels >90% patients hand disability Hand manifestations principal source of functional impairme
Slide 8: Development of ECCS-50 for Scleroderma (SAHD)
Development of ECCS-50 for Scleroderma (SAHD) 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 9: E.U. SCLERADEC I Pilot Trial for Scleroderma (SAHD)
E.U. SCLERADEC I Pilot Trial for Scleroderma (SAHD) Study Design Single center (Marseille, France), open-label trial of 12 patients (NCT01813279) Funded by Groupe Francophone de Recherche de la Sclérodermie Population Men and women with diagnosis of limited or diffuse scleroderma Age ≥ 18 years Func
Slide 10: E.U. SCLERADEC I Pilot Trial Results for Scleroderma (SAHD)
E.U. SCLERADEC I Pilot Trial Results for Scleroderma (SAHD) ECCS-50 Safety No serious AEs during follow-up Four minor AEs reported by four patients All resolved spontaneously within 15d ECCS-50 Efficacy Hand Function Average 57% improvement in Cochin Hand Function Score at 6 months Improved grip and
Slide 11: E.U. SCLERADEC I Pilot Trial Results for Scleroderma (SAHD)- II
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 (SAHD)- II Granel et al (2014); Ann Rheum Di
Slide 12: Phase 3/Pivotal Trial Design for Scleroderma
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 13: Rare Disease Basis for Scleroderma (SAHD) & Therapeutic Analogue
Rare Disease Basis for Scleroderma (SAHD) & Therapeutic Analogue Scleroderma Definition An autoimmune disorder causing collagen overproduction leading to fibrosis and impaired vasculature. Most commonly effects the hands but often affects multiple organ systems. Epidemiology Prevalence: 50 – 75,000
Slide 14: 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 15: Cytori Cell Therapy for Knee Osteoarthritis
Cytori Cell Therapy for Knee Osteoarthritis NASDAQ: CYTX *
Slide 16: Knee Osteoarthritis
Knee Osteoarthritis NASDAQ: CYTX Osteoarthritis (OA) Definition Disease of the entire joint involving the cartilage, joint lining, ligaments, and underlying bone. The breakdown of tissues leads to pain and joint stiffness Epidemiology OA is the most common form of arthritis 13.9% of adults >25 years
Slide 17: 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) I
Slide 18: Development of ECCO-50 for Knee Osteoarthritis
Development of ECCO-50 for Knee Osteoarthritis NASDAQ: CYTX * Goat Injury Model Treatment led to greater healing of cartilage 4 months after injury1 Jurgens et al 2013; BioResearch 2 (4) pp. 315-25 Black et al 2008; Vet Ther. 8 (4) pp. 272-84 Koh et al 2013; Knee Surg Sports Traumatol Arthrosc Canin
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: Development of OICH-D3 for Heart Failure
Development of OICH-D3 for Heart Failure * ATHENA Trials Summary Randomized, 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 p=0.04 p=0.01 PRECI
Slide 21: Cytori-U.S. Government Collaboration for Thermal Burn Countermeasure
Cytori-U.S. Government Collaboration for Thermal Burn Countermeasure Goal Develop a medical countermeasure for use following mass casualty attack involving thermal burn & radiation injury Contract value: up to $106m Status $4.7m- proof-of-concept phase completed $14m- contract option 1 for additiona
Slide 22: 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 23: Commercial Opportunities and Revenue Outlook
Commercial Opportunities and Revenue Outlook Direct sales- Japan Nov 2014, Regenerative Medicine Law in effect Expand Cytori’s ability to sell product under Class I approval Cytori KK has operated in Japan for more than 10 years Licensing partners Lorem Vascular- in SE Asia, Australia and China (lau
Slide 24: Financials & Expenses
Financials & Expenses NASDAQ: CYTX Select Data – as of 9/30/14 Select Data – as of 9/30/14 Cash ~ $8M (~ $20M pro-forma) Senior Term Loan ~ $25M (Matures 2017) Spend focus and reductions 2014 reduction in FT headcount from peak of 119 to 77, severance impact mostly complete by YE 2014 Operating cash
Slide 25: Anticipated Milestones
Anticipated 12 Month Milestones Clinical Milestones Trial Enrollment Osteoarthritis: ACT-OA, data 2016 Scleroderma: STAR, data 2016 Scleroderma: E.U. SCERADEC-II, data 2016 Japan male urinary incontinence trial: timeline announced & begin enrollment Clinical Data Cardiac: ATHENA 6 and 12 month data
Slide 26: Thank you! Questions, please contact ir@cytori.com
Cytori Corporate Overview NASDAQ: CYTX Thank you! QUESTIONS, please contact ir@cytori.com NASDAQ: CYTX *
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