Plus Therapeutics, Inc. · NASDAQ:PSTV
Plus Therapeutics — Cytori Therapeutics — IPO Roadshow (October 2017)
37 slides from Plus Therapeutics's IPO roadshow presentation, Oct 18, 2017
Slide 1: Cytori Therapeutics Investor Presentation
NASDAQ: CYTX October 2017 Cytori Therapeutics Investor Presentation Issuer Free Writing Prospectus Filed Pursuant to Rule 433 Registration Statement No. 333-219967 October 18, 2017
Slide 2: Forward-looking statements
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 st
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 re
Slide 4: Overview
Overview U.S.-Based Biotechnology Company (NASDAQ: CYTX) Financial Highlights $11.4M in product and contract revenue in FY16 $9M of cash and $14.2M of debt as of 6/30 Restructuring implemented on Sept 1st, operating burn expected to be reduced to ~$1M/month NASDAQ: CYTX Operations in San Diego, CA a
Slide 5: Cytori Leadership
Cytori Leadership NASDAQ: CYTX President & CEO - Marc H. Hedrick, MD, MBA UCLA, Stemsource , General, Vascular & Plastic Surgeon Chief Financial Officer - Tiago Girao, CPA Ernst & Young, KPMG, NuVasive GM Cell Therapy - John Harris, MBA Tyco electronics, Ballard Medical, Kimberly-Clark, Becton Dicki
Slide 6: Business Highlights
Nanomedicine™ Oncology Platform Liposomal Doxorubicin bioequivalent to Caelyx® Manufacturing ramp up in 2017 Plan to file EMA MA application in 2018 Habeo™ Cell Therapy for Scleroderma US STAR trial showed safety & efficacy trends in patients with diffuse scleroderma FDA meeting & JP trial planned $
Slide 7: Pipeline
Pipeline *Substantial third-party financial support or investigator initiated trial # BARDA funded program † Licensee funded program †† Regenerative Medicine Law NASDAQ: CYTX Therapeutic Market Indication Preclinical Phase 1 Phase 2 Phase 3 Status/Anticipated Milestone Habeo™ Scleroderma FDA meeting
Slide 8: Cytori Habeo Cell Therapy Scleroderma
Cytori Habeo™ Cell Therapy Scleroderma NASDAQ: CYTX
Slide 9: Cytori Cell Therapy Platform
Cytori Cell Therapy™ Platform STEP HARVEST Small Volume Liposuction (100-360 mL) PROCESS Celution® System Cell Processing & Dose Preparation DELIVER Cytori Cell Therapy™ Injection or Infusion TIME 30 Min 120 Min 5 – 30 Min Same Day Manufacture with Proprietary Consumables, Software, and Enzymes Adip
Slide 10: Lead Indication: Scleroderma
Lead Indication: Scleroderma Rare, Debilitating Autoimmune Condition Affecting Women at 4:11 Ratio Pathophysiology Scientific Rationale for Cytori Cell Therapy™ Preclinical and in vitro studies reported modulation of perivascular inflammation, improved endothelial function, and reduction of extracel
Slide 11: Addressable Population
Addressable Population NASDAQ: CYTX UN Population Division Cleveland Clinic, Orphanet, MHLW Scleroderma Foundation van den Hoogen (2013) Estimate based on primary market research Population 1 Scleroderma Prevalence 2 Scleroderma Types 3 ~ 40,0005 Scleroderma Patients Worldwide with Moderate-Severe H
Slide 12: Product Positioning
Product Positioning 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 line treat
Slide 13: Habeo Cell Therapy Treatment Approach
Habeo Cell Therapy™ Treatment Approach Ambulatory/Outpatient Procedure room Local or mild conscious sedation Single administration Habeo 0.5cc injection to each NVB 4m cells/digit NASDAQ: CYTX
Slide 14: U.S. STAR Clinical Trial Results Summary
U.S. STAR Clinical Trial Results Summary Single administration well-tolerated, strong safety profile and few serious AEs, most of which occurred within the placebo arm and not related to study procedures Primary endpoint did not achieve statistical significance for combined patient group at 24 and 4
Slide 15: Key Endpoints: All Subjects
Key Endpoints: All Subjects Clinically meaningful efficacy trends noted combined group at 24 & 48 weeks Statistically significant benefit in all key endpoints @ 12 weeks in combined group Large placebo effect in combined group NASDAQ: CYTX p=0.28 p=0.029 p=0.44 p=0.34 p=0.30 Placebo Habeo™ Data pres
Slide 16: Key Endpoints: Subjects with Diffuse Disease
Key Endpoints: Subjects with Diffuse Disease Placebo Habeo™ Data presented as mean ± sem Other than the 24 & 48 week time for CHFS, p values are not corrected for multiple comparisons NASDAQ: CYTX p=0.09 p=0.008 p=0.111 p=0.102 p=0.069 p=0.31 0.096 p=0.086 p=0.273 p=0.044 p=0.64 p=0.022 p=0.479 p=0.
Slide 17: QOL Benefit Correlates with Hand Function Improvements
QOL Benefit Correlates with Hand Function Improvements in Diffuse Patients NASDAQ: CYTX Percentage of Patients Reporting Problems Affecting Quality of Life at 48 weeks Placebo Habeo™ Quality of Life data from EQ-5D assessment tool EQ-5D subscores unrelated to the hand (eg: Anxiety and Mobility) did
Slide 18: Other Exploratory Endpoints Also Improved in Diffuse Patients
Other Exploratory Endpoints Also Improved in Diffuse Patients at 48 wks NASDAQ: CYTX Corner Distance- Hand Mobility Hand Volume Chuck Pinch: Thumb against index & middle fingers Lateral Pinch: Thumb against side of index finger Pulp Pinch: Thumb against pulp of index finger Sum of the 2nd-5th Finger
Slide 19: Regulatory Status/Plan
Regulatory Status/Plan U.S.- FDA meeting to define pathway and next steps - late 2017/early 2018 Japan - submit protocol for single-approval trial as orphan device EU - decision based on outcome SD-II trial NASDAQ: CYTX Market Agency Product Designation Orphan Designation U.S. FDA CBER FDA CBER Habe
Slide 20: Anticipated Roadmap
Anticipated Roadmap NASDAQ: CYTX Market 2017 2018 2019 2020 2021 U.S. Japan Europe STAR Trial FDA STAR P3, likely in diffuse subset PMA Prep PMA Submission PMA Prep PMA Submission Outcome based on pre-submission meeting: (1) file for approval or (2) follow on trial STAR JP PMDA Priority Review & MHL
Slide 21: Cytori Japan
Cytori Japan Commercial Platform with Low Cost R&D Upside NASDAQ: CYTX
Slide 22: Long-Term Established Presence in Japan
Long-Term Established Presence in Japan Standalone Business Unit with Multi-Functional Team Local CEO and organizational structure Expertise in regulatory, distribution & sales Profitable revenue generating business Significant installed base of devices Growth over last 2 years and anticipate contin
Slide 23: Device Installation by Facility Type
Device Installation by Facility Type # National University Hospitals 12 Private Hospitals (Incl. Private University Hospitals) 18 Public Hospitals 1 Clinics 27 Animal Clinic 1 Non-Bank StemSource Installations 2 Bank Installations 4 Pending Installations2 8 SUI Clinical Trial3 4 Total (as of Jul 30,
Slide 24: Strategic Initiatives
3 Strategic Initiatives Vision Cytori Japan Initiative Empower current customers to maximize utilization, solve for doctor problem & patient problem through focused targeting. Aesthetic Excellence Capture significant near-term growth in the Self-pay Knee OA market through targeted marketing and clin
Slide 25: Overview and Timeline
Overview and Timeline SAHD Est Mkt Size (2017): - $351,314,286; diffuse 50% KOA Est Mkt Size (2017): $469,860,000 Breast Recon Mkt Size: $125,714,286 Based on Management’s estimate †† Regenerative Medicine Law Phase 3 RML†† OK Large Available Market In Japan For 4 Key Indications along with an appro
Slide 26: ADRESU Clinical Trial – Stress Urinary Incontinence
Opportunity First approved cell therapy in Japan for SUI Pilot Trial Results Increased maximum urethral closing pressure Reduced 24-hour pad weight Increased blood flow 2 publications 1,2 ADRESU Trial 45 patient multicenter pivotal trial; substantial institutional and governmental support for trial
Slide 27: Cytori U.S. BARDA Contract Thermal Burn / Radiation
Cytori U.S. BARDA Contract Thermal Burn / Radiation NASDAQ: CYTX
Slide 28: U.S. BARDA Contract and RELIEF Trial
NASDAQ: CYTX U.S. BARDA Contract and RELIEF Trial Contract Goal Develop a national countermeasure to thermal burn complicated by radiation exposure Contract Funding Valued up to $106M $35M allocated through H1 2017 $13.4M awarded in May 2017 for clinical trial execution RELIEF Pilot Clinical Trial A
Slide 29: Cytori Nanomedicine Oncology
Cytori Nanomedicine™ Oncology NASDAQ: CYTX
Slide 30: Cytori Nanomedicine Platform
Cytori Nanomedicine™ Platform Protein Stabilized, Pegylated Liposomal Nanoparticle Technology Sustained release Shield toxic drugs Deliver molecules and growth factors Reformulation Cell and tissue targeting Capabilities and Experience New GMP facility in San Antonio, Texas 10 year track record in R
Slide 31: ATI-0918: Lead Product
Generic nanoparticle, pegylated liposomal encapsulated form of chemotherapeutic, Doxorubicin Anthracycline topoisomerase II inhibitor Activity via DNA intercalation Bioequivalence trial completed versus JNJ Caelyx®, approved for breast cancer, ovarian cancer, multiple myeloma, and AIDS-related Kapos
Slide 32: ATI-0918: Addressable Market
NASDAQ: CYTX Global Market Potential Expected to Grow to $1.4B by 2024 Europe Reference Drug: Caelyx® Revenue in 2014: $280.1 mn Revenue in 2024: $459.3 mn CAGR: 5.7% Notable markets: UK, Germany North America Reference Drug: Doxil® Revenue in 2014: $399.4 mn Revenue in 2024: $665.2 mn CAGR: 5.9% No
Slide 33: ATI-0918: Development Plan
ATI-0918: Development Plan NASDAQ: CYTX Milestone Anticipated Completion Date EU Bioequivalence trial Complete Initiate stability testing 1H’18 Partnering 2017/2018 File for EMA Approval 2018 Launch 2019/2020 Q4 2017 Q1 2018 Q2 2018 Q3 2018 Q4 2018 Q1 2019 Q2 2019 Q3 2019 Q4 2019 EU ATI-0918 Facilit
Slide 34: ATI-1123 Protein Stabilized Liposomal Nanoparticle
*Mahalingam et al (2014) Cancer Chemother Pharmacol. 74(6):1241-50 New Chemical Entity Protein Stabilized Liposomal Nano Particle Technology Pegylated & Albumin stabilized Branded Docetaxel (TAXOTERE, Sanofi) Available in 90 countries, approved for 11 indications Peak sales of €2.1B in 2010; €222M i
Slide 35: ATI-1123: Next Steps
ATI-1123: Next Steps Completed clinical and commercial evaluation Q3 2017 Initial clinical target- 2nd line for Small Cell Lung Cancer (SCLC) 30,000 patients in the US 93% patients relapse/refractory to 1st line and only approved 2nd line drug is Topotecan 68% relapse/refractory patients receive 2nd
Slide 36: Trade Secrets and Know-how
Trade Secrets and Know-how Celase® proprietary enzyme blend supplied exclusively to Cytori by Roche Cytori cell processing systems embody tissue collection, processing, and handling parameters resulting from >15 years of experience optimizing tissue processing, cell extraction and delivery Brand rec
Slide 37: 2017 & 2018 Anticipated Milestones
2017 & 2018 Anticipated Milestones US FDA Meeting on Habeo PMA pathway & next steps Planned ‘first patient in’ for US RELIEF trial funded by USG Planned completion of enrollment in Japan ADRESU trial (or Q1 2018) Planned completion of enrollment in EU SCLERADEC- II trial Identify commercial partners