Pluri Inc. · NASDAQ:PLUR
Pluri — Pluristem Therapeutics — IPO Roadshow (October 2017)
43 slides from Pluri's IPO roadshow presentation, Oct 30, 2017
Slide 1: Company Presentation October 2017
COMPANY PRESENTATIONOctober 2017
Slide 2: Forward-looking statements
This presentation contains express or implied forward-looking statements within the Private Securities Litigation Reform Act of 1995 and other U.S. Federal securities laws. For example, we are using forward-looking statements when we discuss the expected timing of obtaining regulatory approval for o
Slide 3: Corporate Overview
Cell therapy company using off the shelf placenta-derived cell products Entering late-stage trials in 3 indicationsMultifactorial therapy releasing a range of therapeutic proteins in response to signals from patient's body First in class 3D cell culturing technology allowing for efficient, controlle
Slide 4: Financial Glance
FINANCIAL GLANCE * Pluristem Therapeutics Inc. NASDAQ: PSTITASE: PSTI Stock Price (As of 10/27/2017) $1.97 Market Capitalization ~$192 million Cash and Marketable Securities (As of 6/30/2017) $26.7 million Debt $0 Employees 180 Intellectual Property Ownership 115+ granted~100 pending
Slide 5: Pluristem in one slide
PLURISTEM in one slide Teor Angiogenesis. “P Angiopoietin? igiog hee Osteopontin) Immunomodulation SOF baler) Goris reduction of MIF inflammation Decorin Muscle t ren regeneration 4 Galectint long term regenerative Adaptive slow effect release secretion of administration cytokines Simple IM Allogeni
Slide 6: The PLX Platform Technology
The PLX Platform Technology *
Slide 7: Best In Class GMP Facility
Best In Class GMP Facility *
Slide 8: 3D Manufacturing, In-house Cell Production
3D Manufacturing, In-house Cell Production Potential capability to manufacture up to 150,000 doses annually *
Slide 9: Manufacturing CMC approved
Manufacturing CMC* approved by * * Chemistry, Manufacturing, and Controls
Slide 10: Placenta Derived Cells
* Placenta Derived Cells Ethically acceptedRich & DiverseHighly potentPro-angiogenicImmunoregulatory Young donors Unlimited source & Easy to collectOver 25,000 Doses of 300 million cells per placenta The Placenta Project was Launched by the US National Institutes of Health (NIH) to further explore t
Slide 11: From The Miracle of Birth to Therapeutics for All
From The Miracle of Birth to Therapeutics for All *
Slide 12: Company Pipeline
IndicationCritical Limb Ischemia (CLI)Intermittent Claudication (IC)Hip Fracture***Acute Radiation Syndrome (ARS) LocationU.S.Europe*Japan**U.S., EuropeS. Korea, IsraelU.S. EuropeU.S. Late-stage trials Company Pipeline Pre-Clinical Phase 2 Phase 1 Phase 3 ProductPLX-PADPLX-PADPLX-PADPLX-R18 Single p
Slide 13: A Change in Regulatory Environment
A CHANGE INREGULATORYENVIRONMENT * Regulatory Status CLI (PLX-PAD) Fast track approvalSingle pivotal study (n=246) Adaptive regulatory pathwaySingle pivotal study (n=246)Potential conditional approval on interim report (n=123) Accelerated regulatory pathwaySingle pivotal study (n=75) Hip fracture (P
Slide 14: Regulatory Status
Regulatory Status CLI (PLX-PAD) Fast track approvalSingle pivotal study (n=246) Adaptive regulatory pathwaySingle pivotal study (n=246)Potential conditional approval on interim report (n=123) Accelerated regulatory pathwaySingle pivotal study (n=75) Hip fracture (PLX-PAD) Pivotal study Subject to FD
Slide 15: PLX-PAD: Peripheral Arterial Diseases, Orthopedic Injuries
Reduces inflammationStimulates growth of collateral blood vesselsStimulates repair of damaged muscle PLX-PAD Peripheral Arterial DiseasesOrthopedic Injuries *
Slide 16: PLX-PAD Mechanism of Action
PLX-PAD Mechanism of Action *
Slide 17: Completed and Ongoing Clinical Studies with PLX-PAD
Two completed Phase I studies in Critical limb ischemia (CLI) in U.S.and Germany, N=27Good safety profileTrends of efficacy (pain reduction and increase in tissue perfusion)Ongoing multinational Phase II study in Intermittent claudication (IC) in U.S., Germany, South Korea and Israel, N=172 Enrollme
Slide 18: Completed and Ongoing Clinical Studies with PLX-PAD
Ongoing multinational Phase III study In Critical Limb Ischemia (CLI) in U.S., Europe, N=246 Fast track designation from FDAAdaptive regulatory pathway from EMASupport from EU Horizon 2020 programPlanned multinational Phase III study In Hip Fracture in U.S., Europe Adaptive regulatory pathway from E
Slide 19: Company Pipeline
IndicationCritical Limb Ischemia (CLI)Intermittent Claudication (IC)Hip Fracture***Acute Radiation Syndrome (ARS) LocationU.S.Europe*Japan**U.S., EuropeS. Korea, IsraelU.S. EuropeU.S. Late-stage trials Company Pipeline Pre-Clinical Phase 2 Phase 1 Phase 3 ProductPLX-PADPLX-PADPLX-PADPLX-R18 Single p
Slide 20: Peripheral Arterial Disease (PAD)
Peripheral Arterial Disease (PAD) *Source: Sage Group- (link, link, link)**Source: European Society for Vascular Surgery (link) * Build up of fatty substances in the wall of the artery
Slide 21: CLI Phase III Study - U.S./Europe (N=246)
Primary endpoint is time to event (amputation or death); other measures of efficacy include AFS, quality of life, TcPO2, and pain scoreDosing regimen: two doses of 300 million cells, two months apart (n=144), placebo (n=72)No HLA matching or immunosuppression requiredFollow-up of 12-36 months increa
Slide 22: Clinical Development of CLI in Japan
Clinical Development of CLI in Japan Accepted to the PMDA’s accelerated regulatory pathway for regenerative therapiesA single 75 patient study may lead to early conditional marketing approval and reimbursementBinding term sheet with Sosei CVC to establish joint venture for the clinical development a
Slide 23: Company Pipeline
IndicationCritical Limb Ischemia (CLI)Intermittent Claudication (IC)Hip Fracture***Acute Radiation Syndrome (ARS) LocationU.S.Europe*Japan**U.S., EuropeS. Korea, IsraelU.S. EuropeU.S. Late-stage trials Company Pipeline Pre-Clinical Phase 2 Phase 1 Phase 3 ProductPLX-PADPLX-PADPLX-PADPLX-R18 Single p
Slide 24: Muscle Regeneration - clinical data
Injured (operated) Contralateral(non–operated) Improvement of 4000%P=0.012 Improvement of 500%P=0.0067 * Muscle Regeneration- clinical data Muscle injury following total hip replacement (N=20)
Slide 25: Muscle Injury following Total Hip Replacement
Muscle Injury following Total Hip Replacement (N=20) Change in Volume from Day 0 Improvement of 300%P=0.004 * Muscle Regeneration- clinical data
Slide 26: Phase III Hip Fracture Study
Phase III Hip Fracture Study Femoral neck fracture is the most common form of hip fracture Annual treatment costs in the U.S. are estimated to be between $10 to $15 billion, and are expected to rise due to the aging population, with mortality rates of up to 36%*Positive feedback from FDA and EMA on
Slide 27: PLX-R18 Hematologic Indications
* Stimulates regeneration of damaged bone marrow to produce blood cells (white, red and platelets) Acute Radiation Syndrome (ARS)Hematologic Indications PLX-R18
Slide 28: PLX-R18 Mechanism of Action
PLX-R18 Mechanism of Action *
Slide 29: PLX-R18 Programs
Acute Radiation Syndrome (ARS)In Preparations for pivotal study * PLX-R18 Programs Bone Marrow FailureFollowing or in support of a transplant of hematopoietic stem cells (HCT)Ongoing Phase I study in U.S and Israel Hematological DisordersAutoimmune diseases, Genetic disorders, Chemotherapy, Radiatio
Slide 30: Company Pipeline
IndicationCritical Limb Ischemia (CLI)Intermittent Claudication (IC)Hip Fracture***Acute Radiation Syndrome (ARS) LocationU.S.Europe*Japan**U.S., EuropeS. Korea, IsraelU.S. EuropeU.S. Late-stage trials Company Pipeline Pre-Clinical Phase 2 Phase 1 Phase 3 ProductPLX-PADPLX-PADPLX-PADPLX-R18 Single p
Slide 31: Acute Radiation Syndrome (ARS)
* ARS occurs following acute exposure to very high levels of radiation, and involves severe, potentially lethal injury to the bone marrow as well as to other organs and systems within the bodyHigh doses of radiation can destroy the bone marrow’s ability to produce white cells, red cells and platelet
Slide 32: Collaboration on ARS with U.S. Government
Late Post Exposure Department of Defense (DOD)Warfighter and Immediate Response Department of Health and Human Services (DHHS)First Responders and Hospitals Armed Forces Radiobiology Research Institute NIAID/NIH Chronic Phase (Months-Years) Response Phase Exposure Timeline ResearchInstitutes & Agenc
Slide 33: Collaboration on ARS with U.S. Government
* Studies are conducted and funded by the National Institute of Allergy and Infectious Diseases (NIAID) at the National Institutes of Health (NIH) and U.S the department of defense Collaboration on ARS with U.S. Government
Slide 34: PLX-R18 Data - Phase I equivalent study
* PLX-R18 Data- Phase I equivalent study (FDA animal rule) Survival Weight
Slide 35: PLX-R18 survival data by group
Placebo - 50% 20M/Kg - 67% 4/10M/Kg - 83/86% Non irradiated and low radiation - 100% Group Females Males Females and Males Total 04+10 only NR-00 3/3 = 100% 3/3 = 100% 6/6 = 100% 6/6 = 100% NR-04 3/3 = 100% 3/3 = 100% 6/6 = 100% 18/18 = 100% NR-10 3/3 = 100% 3/3 = 100% 6/6 = 100% 18/18 = 100% NR-20
Slide 36: PLX-R18 - Treatment of ARS
Allogeneic, ready to use as an off the shelf productEasy IM administrationBeneficial when administered even 48 hrs. following exposure to radiationNo need for prescreening – no effect if injected to those who were not exposed to radiationSupports recovery of all three blood lineages (red and white c
Slide 37: PLX-R18 Hematological Program
PLX-R18 Hematological Program * Out-licensing commercialization deals with partnersDirect sales of indications with small patients population & high market priceDirect sales of our PLX-R18 product for Acute Radiation Syndrome (governments) Commercialization Strategy *
Slide 38: Commercialization Strategy
Out-licensing commercialization deals with partnersDirect sales of indications with small patients population & high market priceDirect sales of our PLX-R18 product for Acute Radiation Syndrome (governments) Commercialization Strategy 38
Slide 39: Partners and deal structures
Partner Indication Deal structure IC, CLISouth Korea only Joint Venture following marketing authorization by the South Korean authorities Acute Radiation Syndrome U.S. National Institutes of Health (NIH) to examine the effectiveness of PLX-R18 as a treatment for ARS following 24 hours from exposure
Slide 40: Investment Highlights
Investment Highlights Publicly traded on the Nasdaq and Tel Aviv Stock Exchange [PSTI] Late-stage pipeline with products advancing towards commercialization and 3rd parties fundingAdvanced regulatory pathways that could shorten time to commercialization Expected near-term data readouts“Off the shelf
Slide 41: Upcoming Milestones – 12 Months
Initiate pivotal trialsCritical limb ischemia (CLI) – U.S., Europe (Japan yet to start)Hip fracture – U.S., EuropeARSClinical data readout Phase II Intermittent Claudication (IC) Phase I incomplete engraftment of hematopoietic cell transplantation – open labelPivotal study in ARSBusiness development
Slide 42: Management team
Zami AbermanChairman & Co-CEO Efrat Livne-Hadass VP Human Resources Racheli Ofir, Ph.D.VP Research & Intellectual Property Sagi MoranVP Operations Erez Egozi CFO Karine Kleinhaus, M.D., MPHDivisional VP, North America Esther Lukasiewicz Hagai, M.D., Ph.D. VP Clinical & Medical Affairs Lior RavivVP D
Slide 43: Investor relations contact
Investor.relations@Pluristem.com Israel +972-74-710-8600U.S.- +1-914-512-4109 www.Pluristem.com *