Plus Therapeutics, Inc. · NASDAQ:PSTV
Plus Therapeutics — Cytori Therapeutics — IPO Roadshow (June 2018)
38 slides from Plus Therapeutics's IPO roadshow presentation, Jun 12, 2018
Slide 1: Cytori Therapeutics Investor Presentation June 2018
Cytori Therapeutics Investor Presentation June 2018 NASDAQ:CYTX Issuer Free Writing Prospectus Filed pursuant to Rule 433 Registration Statement No. 333-224502 June 12, 2018
Slide 2: Forward-Looking Statements & Disclaimers
Forward-Looking Statements & Disclaimers 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 th
Slide 3: Free Writing Prospectus Statement
Free Writing Prospectus Statement This presentation highlights basic information about us and the offering. Being a summary document, this slide does not contain all the information that you should consider before investing. We have filed a registration statement (including a preliminary prospectus)
Slide 4: About Cytori
About Cytori Cytori Therapeutics, Inc. is a U.S. headquartered company with global operations. We are committed to providing meaningful and quality therapeutic options with broad utility that benefit patients and healthcare providers around the world. Whether it’s advancing our product and technolog
Slide 5: Cytori Nanomedicine & Cell Therapy Platforms
Cytori Nanomedicine & Cell Therapy Platforms Anticipate Phase III trial read out in urinary incontinence indication Double-digit consumable growth in lead market- Japan* BARDA contract with financial offsets Lead: ATI-0918 potential 1st EU generic of market leading oncology drug ATI-0918 potential p
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Slide 7: Oncology Pipeline
Oncology Pipeline Therapeutic Market Indication Preclinical Phase 1 Phase 2 Phase 3 Anticipated Milestone ATI-0918 Breast, Ovarian, MM, Kaposi’s Launch 2020 w/ partner ATI-0918 Ovarian, MM, Kaposi’s BE 2018, need partner ATI-0918 Breast, Ovarian, MM, Kaposi’s BE 2018, need partner ATI-1123 Small Cel
Slide 8: Nanomedicine Encapsulation Platform
Nanomedicine Encapsulation Platform Lead: ATI-0918, liposomal doxorubicin, generic formulation of market leader Doxil/Caelyx. Pipeline: ATI-1123, liposomal docetaxel- ready for Phase II, proprietary technology for lipophilic compounds. Cytori operates dedicated liposomal manufacturing plant in Texas
Slide 9: The Liposomal Doxorubicin Story
‘The Liposomal Doxorubicin Story’ Doxorubicin- highly effective chemotherapeutic Liposomal encapsulation substantially lowers cardiotoxity of doxorubicin Widely used & profitable oncology drug as a branded therapeutic Therapy for advanced breast & ovarian cancer, multiple myeloma & Kaposi’s sarcoma
Slide 10: Lead- ATI-0918 Liposomal Doxorubicin
Lead- ATI-0918 Liposomal Doxorubicin Liposomal formulation superior to Doxorubicin alone Generic formulation of market leader, Caelyx, Doxil Primary indications: advanced breast & ovarian cancer Primary target markets: Europe, China, MENA Challenging manufacturing process, global shortages Anthracyc
Slide 11: ATI-0918 Clinical Bioequivalence
ATI-0918 Clinical Bioequivalence
Slide 12: ATI-0918 Liposomal Doxorubicin market segments and competitors
ATI-0918 Liposomal Doxorubicin Pegylated Liposomal Doxorubicin Europe China US Estimated Market Segment Size $120-$160M $110-$130M $180-$220M Reference Listed Drug / Reference Standard Janssen Caelyx - Janssen Doxil / Sun Lipodox Marketing Authorization – Brand Janssen Caelyx Janssen Caelyx (withdra
Slide 13: ATI-0918 Liposomal Doxorubicin Milestones
ATI-0918 Liposomal Doxorubicin Milestone Target Completion Date EU Bioequivalence Trial Complete Registration Lots & Stability Testing H2 2018 Partnering 2018 EMA MAA Submission 1H 2019 EMA MAA Approval 1H 2020 EU Launch 1H 2020 2018 2019 2020 EU Facility Validation Fabricate Stability Lots Stabilit
Slide 14: ATI-1123 Liposomal Docetaxel
ATI-1123 Liposomal Docetaxel Protein stabilization overcomes liposomal instability with lipophilic compounds (USPTO #7179484) 14 preclinical studies indicate: ATI-1123 serum AUC 4-5x higher than Docetaxel alone Better tissue distribution and greater activity in key tumors Potentially greater efficac
Slide 15: ATI-1123 Phase I Clinical Trial Summary
ATI-1123 Liposomal Docetaxel ATI-1123 Phase I Clinical Trial Summary 29 patients, dosing range from 15-110mg/m2 ATI-1123 achieved 20% increase in MTD vs. standard docetaxel & demonstrated signs of efficacy with 1 partial responder 16/26 evaluable patients (62%) had stable disease, with toxicity prof
Slide 16: ATI-1123 Initial Target: Small Cell Lung Cancer
ATI-1123 Liposomal Docetaxel Initial Clinical Target- Small Cell Lung Cancer, Highly Aggressive Rare Disease Small Cell Lung Cancer (SCLC) 30,000 adults in the U.S. 15% of total lung cancer cases 93% of patients relapse/refractory to 1st line therapy 68% of relapse/refractory patients receive 2nd li
Slide 17: ATI-1123 Regulatory Strategy
ATI-1123 Liposomal Docetaxel Regulatory Strategy- SCLC initial indication Potential eligibility for orphan status and US FDA 505(b)(2) pathway SPA Clinical Development Plan- Open label, single dose study of ATI-1123 Dosage of 90 mg/m2 on an every 3 week schedule. In phase 1 trial, doses of 75 - 90 m
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Slide 19: Cytori Cell Therapy Same Day Manufacture
Cytori Cell Therapy Same Day Manufacture with Proprietary Consumables, Software, and Enzymes Adipose Tissue Non-Viable Cellular Debris, Waste & Enzymes Adipose Derived Regenerative Cells 1 2 3 IV Infusion Sub-Q or Tissue Injection
Slide 20: Cytori Cell Therapy
Cytori Cell Therapy Adipose-derived regenerative cells- Clinical grade, heterogeneous cell population highly-enriched for adipose-derived stem, stromal, vascular, and immunoregulatory cell types Endothelial Metabolic reservoir Tissue Stromal Cells High baseline Macrophages angiogenic potential Immun
Slide 21: Cytori Cell Therapy
Cytori Cell Therapy Cytori Cell Therapy is being developed with the goal of beneficially modulating multiple key pathol which are anticipated to reduce pain and disability and improve quality of life Fibrosis/Wound Remodeling + Promotes angiogenesis + Modulates expression of pro- . Reduces developme
Slide 22: Cell Therapy Pipeline
Cell Therapy Pipeline Therapeutic Market Indication Preclinical Phase 1 Phase 2 Phase 3 Status/Anticipated Milestone Habeo™ Scleroderma Phase III required in Diffuse subset Habeo™ Scleroderma/Cryopreserved * Data in 2H 2018 Habeo™ Scleroderma Planned, funds permitting ECCO-50 Knee Osteoarthritis Pla
Slide 23: Commercial Performance in Japan
Commercial Performance in Japan Japan Regenerative Medicine Law- early market access in 2015 Full medical device commercial team in Tokyo Leverage safety & efficacy data from US & EU clinical trials Targeting historically self pay or ‘lifestyle’ procedures Expanded device approval- applied for class
Slide 24: Commercial Performance Japan
Commercial Performance Japan Procedure Utilization & Consumable Sales Growth Steady growth in Installations and Procedures since 2015 Preservation of ASP Building foundation for launch in Stress Incontinence Installations Growth
Slide 25: Urinary Incontinence Opportunity
Urinary Incontinence Opportunity Stress urinary incontinence (SUI), the 2nd most common type of incontinence in elderly, is caused by a loss of strength in pelvic floor muscles and urinary sphincter following childbirth and prostate surgery Published clinical data (n=20 patients) in Japan indicates
Slide 26: Cell Therapy in Urinary Incontinence
Cell Therapy in Urinary Incontinence Phase Approach Status Key Findings Preclinical (human)1 Demonstration of in vitro differentiation towards smooth muscle Complete Expression of multiple markers consistent with smooth muscle Preclinical (porcine)2 Injection into the rhabdosphincter immediately fol
Slide 27: Initial Clinical Data in Urinary Incontinence
Initial Clinical Data in Urinary Incontinence Pilot Trial Single center, open label study Patients with mild-to-moderate urine leakage persisting more than 2 years after prostatectomy 11 subjects enrolled and followed-up for 12 months Results1 No serious adverse events reported 55% (6/11) of patient
Slide 28: Persistence of Effect in Urinary Incontinence
Persistence of Effect in Urinary Incontinence Maximum Urethral Closing Pressure 24-Hour Pad Weight Mean change at 12 months = 40.9% (p=0.01) Mean change at 12 months = 38.8% (p=0.02) Gotoh et al (2014) Int. J. Urol. 21, 294–300 Gotoh et al (2017) International Continence Society: Abst 489 Gotoh et a
Slide 29: Pivotal Trial Design
Pivotal Trial Design Indication Stress urinary incontinence following prostatectomy Study Design Multi-center, single arm, open label Primary Endpoint Percentage of subjects with >50% reduction in urinary leakage at 1 year Anticipated percentage with spontaneous improvement with standard care is 10%
Slide 30: Anticipated Urinary Incontinence Timeline
Anticipated Urinary Incontinence Timeline 2018 2019 2020 1st Half 2nd Half 1st Half 2nd Half 1st Half 2nd Half Base Scenario Complete Enrollment Class III device Approval Analyze Data/ File for MHLW Approval Japan Approval Japan Launch Expedited Scenario Complete Enrollment Class III device Approval
Slide 31: BARDA Contract
BARDA Contract Goal Medical countermeasure for use in thermal burn injury ± concomitant radiation exposure Government acquisition contract for use of the countermeasure in burn mass casualty event Research and Development Contract Contract value up to $106MM ~$34MM awarded to date ~$20MM for preclin
Slide 32: Scleroderma
Scleroderma Primary Endpoint Secondary Endpoint Secondary Endpoint (RCS) ‘at 24 and 48 weeks at 48 weeks ‘at 48 weeks “Thom tond ren See 3 eakn aueviment Coton: Oty Ines Treated: 32 Bi Placebo Placebo: n=19 IB Habeo™ Clinically jingful efficacy early and ined for ion a disability in the diffuse subg
Slide 33: Scleroderma
Scleroderma as . Placebo MCID for CHES (29) Placebo ® ADRCs ‘Treated 0.0163 % © Improvement in HAQ-DI at 48 weeks : as ad : °e ° ° a & ° Percent Responders at 48w (%) en! CHES p95) HAQ.D1(>0.125) HAQ-D1(90.25) CHES(@5) and HAQ-04 (0.125) © | improvement in CHES at 48 weeks Definition of Responder ly
Slide 34: Scleroderma
Scleroderma Market | Agency Product Designation | Orphan Designation Us. FDA CBER | Habeo™ Fresh: Device (Class III) No = FDA CBER | Habeo™ Cryopreserved: Drug Yes iT eo PMDA Celution® System : — Japan MHLW * Device = Class | Yes with application * Consumables = Class | > Class III BSI Celution® Sys
Slide 35: Intellectual Property
Intellectual Property 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
Slide 36: Capitalization
Capitalization Select Data – as of 3/31/18 Cash ~ $5.9MM Senior term loan ~ $13MM Common Shares outstanding ~ 6.2MM Options, Series B, RSAs and warrants ~ 2.6MM Fully diluted share count ~ 8.8MM
Slide 37: Anticipated Milestones
Anticipated Milestones SCLERADEC-II trial readout First enrolled partient for US RELIEF trial funded by BARDA Identify commercial partner for ATI-0918 ATI-0918- complete manufacturing validation and production of stability lots ATI-0918- file for EMA approval following 6 months stability ATI-1123 de
Slide 38: The End
The End Investor Presentation June 2018 NASDAQ:CYTX