Plus Therapeutics, Inc. · NASDAQ:PSTV
Plus Therapeutics — Cytori Therapeutics — Corporate Update (September 2016)
32 slides from Plus Therapeutics's corporate update, Sep 13, 2016
Slide 1: Cytori Therapeutics Corporate Update September 2016
Cytori Therapeutics Enhancing lives through novel cell therapies Corporate Update I September 2016 Exhibit 99.1
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: Cytori Overview
Cytori Overview Late stage cell therapy company, forecasted breakeven 2018 Three phase III trials complete or enrolling Fully enrolled US phase III scleroderma trial, data 2017 Recent US Phase II trial readout in knee osteoarthritis Up to $106m US government (BARDA) contract, anticipate clinical tri
Slide 4: Cytori Cell Therapy: Clinical Pipeline
Enrolling2 Cytori Cell Therapy: Clinical Pipeline ECCI-50 Top-line preliminary results ECCO-50 DCCT-10 ECCS-50 Enrolling1 ECCS-50 Pre-Clinical Phase I/II Phase III Market (Estimate) >$1B >$500M >$3B >$75M >$50M 1 Cytori-supported, Investigator-initiated trial 2 Japan Govt Sponsorship 3 Funded by BAR
Slide 5: Cytori Cell Therapy: Same Day Procedure
Cytori Cell Therapy: Same Day Procedure TIME £ 30 Min £ 120 Min 5 - 30 Min PROCESS HARVEST Small Volume Liposuction (100-360 mL) PROCESS Celution® System Tissue Processing, Cell Isolation & Dose Preparation DELIVER Cytori® Cell TherapyTM Delivery Bedside Manufacture proprietary consumables, software
Slide 6: Cytori Cell Therapy: Why Adipose?
Cytori Cell Therapy: Why Adipose? Cells sourced from autologous adipose tissue Heterogeneous and uncultured- ADRC potency advantage Cell therapeutic manufactured in bedside GMP process Stem & Stromal Cells Leukocytes Tissue Macrophages Endothelial Vascular SMCs Adipose-derived regenerative cells- Cl
Slide 7: 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 angiogenesis Normalization of vessel architecture Improv
Slide 8: Lead Indication: Scleroderma
Lead Indication: Scleroderma
Slide 9: Scleroderma Pathophysiology
Scleroderma Pathophysiology Scleroderma or Systemic Sclerosis Rare autoimmune condition Affects Women: Men, 4:1 US Prevalence: 50,000 patients >90% of patients have hand disability Fibrosis, pain, and edema result in diminished mobility and hand function even with standard medical care Severe vasomo
Slide 10: Scleroderma: Market Overview
Scleroderma: Market Overview Current Standard of Care No therapies approved for treatment of hand dysfunction in scleroderma patients Existing 1st and 2nd line treatments for treatment of Raynaud’s Phenomenon or other aspects of scleroderma are often inadequate and/or poorly tolerated Existing 3rd l
Slide 11: Scleroderma: Treatment Approach
Scleroderma: Treatment Approach Ambulatory Procedure room Local or mild conscious sedation Single administration ECCS-50 0.5cc injection to each side of each finger
Slide 12: 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 - Marseille, France Endpoints Cochin Hand Function Scale Raynaud’s Condition Score Scleroderma Health Assessment Questionnaire Pain Modified Ro
Slide 13: ECCS-50 Treatment led to improvement in hand function, Raynaud's phenomenon, 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 outcomes Efficacy sustained to two years following a single treatment p<0.001 p<0.001
Slide 14: 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 strength 20% 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 Rh
Slide 15: 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 16: Scleroderma: Ongoing Clinical Trials
Scleroderma: Ongoing Clinical Trials STAR (Phase III) SCLERADEC II (Phase III)* Study size 88 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 Han
Slide 17: Scleroderma - Projected Development Timeline
Scleroderma - Projected Development Timeline 2015 2016 2017 2018 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 PMA Submission & Panel Approval EMA MAA Submission for Full Marketing Authorization (based on STAR) Approval Phase III Data Conditional Ap
Slide 18: European Managed Access Program
European Managed Access Program 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 o
Slide 19: Pipeline Indications
Pipeline Indications Knee Osteoarthritis Urinary Incontinence Radiation/Thermal Burn
Slide 20: Knee Osteoarthritis
Knee Osteoarthritis Osteoarthritis Progressive loss of joint function Imbalance between anabolic (cartilage-forming) and catabolic (cartilage-destroying) processes driven by synovial inflammation Distinct from RA Epidemiology OA is the most common form of arthritis 13.9% of adults >25 years 33.6% (1
Slide 21: 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 impact Combination of veterinary, preclinical, in vitro, and pilot clinical da
Slide 22: ACT-OA Trial
ACT-OA Trial 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, not powered Secondary Endpoints KOOS, pain/function questionnaires, disease activity pain meds, SF-36, MRI@ 48 weeks Follow-Up 48 w
Slide 23: ACT-OA Trial Preliminary Top-line Data, Patient Reported Outcomes
ACT-OA Trial Preliminary Top-line 48 Week Data, Patient Reported Outcomes Placebo Treated Reported Placebo Range KOOS Pain Subscore ACT-OA ‘Placebo’ Effect Pain on 50ft Walk VAS OA Damage OA Activity Reduction in Pain Rescue Meds (tabs/wk) ** * ** * *Internal top-line data analysis, final statistica
Slide 24: ACT-OA Trial Preliminary Top-line Data, MRI or MOAKS
ACT-OA Trial Preliminary Top-line 48 Week Data, MRI or MOAKS Placebo Treated % Subjects with Worsened Regions % Subjects with Cartilage Worsening in Central/Medial Regions % Subjects with Worsening of Osteophyte Size Placebo Treated Percentage of Regions Worsening From a Baseline of Zero Percentage
Slide 25: ACT-OA Trial 48 Week Preliminary Data
ACT-OA Trial 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, not powered Secondary Endpoints KOOS, pain/function questionnaires, disease activity pain meds, SF-36, MRI@ 48 weeks Follow-Up 48 w
Slide 26: Stress Urinary Incontinence Program
Stress Urinary Incontinence Program ‘ADRESU’ Trial Objectives Approved, reimbursed therapy for SUI in men following prostate intervention Unmet need for patients Support proof of concept in female incontinence Support Investigator initiated with Cytori support Substantial funding via Japanese Minist
Slide 27: Radiation/Thermal Burn Program
Radiation/Thermal Burn Program Objectives Development medical countermeasure for mass casualty event- thermal burn ± radiation exposure Proof of concept clinical data for use of Cytori Cell Therapy in wound healing Support Funded by contract of up to $106MM from Biomedical Advanced Research and Deve
Slide 28: Corporate Information
Corporate Information
Slide 29: Cytori Cell Therapy: Global Patent Estate
89 patents issued worldwide; over 76 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 6/30/16 Cash ~ $20.0MM Senior term loan ~ $17.7MM Common Shares outstanding ~ 20.5MM Outstanding options, RSAs and warrants ~ 4.4MM Fully diluted share count ~ 24.9MM Market capitalization ~ $42MM* * Based on share price of $2.05 at closing on September 2,
Slide 31: Update - Corporate Objectives & Milestones
Update- Corporate Objectives & Milestones 2016 Milestones 1st Half EU MAP program launch 24 WK ACT-OA interim data evaluation SCLERADEC-I two year follow-up data Full STAR phase III trial enrollment 2nd Half 48 WK ACT-OA data evaluation Japan & MAP progress reported FDA BARDA and Orphan approvals SC
Slide 32: Thank You
Thank You
Cytori Therapeutics — Corporate Update (September 2016) on 6ix