company presentation – september 2016 · pivotal pre -marketing trials. company pipeline....
TRANSCRIPT
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Company Presentation – September 2016
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This presentation concerning Pluristem Therapeutics may include forward-looking statements whichrepresent Pluristem Therapeutics' expectations or beliefs regarding future events. I caution that suchstatements involve risks and uncertainties that may cause actual results to differ materially from those inthe forward-looking statements. Consequently, all such forward-looking statements are qualified by thecautionary language and risk factors set forth in Pluristem Therapeutics' periodic and other reports filedwith the SEC.
There can be no assurance that the actual results, events or developments referenced in such forward-looking statements will occur or be realized. Pluristem Therapeutics assumes no obligation to updatethese forward-looking statements to reflect actual results, changes in assumptions or changes in factorsaffecting such forward-looking statements.
www.pluristem.com
Forward looking Statement
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• Cell therapy (Bio-therapy) company using off-the-shelf, placental-expanded cells to achieve
local and systemic therapeutic effects
Pluristem corporate overview
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• Cell therapy company entering late-stage trials for 2 products in 3 indications
• No tissue matching or immunosuppression is required to administer our placenta-derivedcell products
• First in class 3D cell culturing technology allowing for efficient, controlled production ofdifferent cell products in commercial quantities.
Pluristem corporate overview
• Regulatory approval for clinical trials in US, EU, Japan, South Korea, Australia and Israel.
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• Public company, Traded in:
• Market Cap: ~ $140 million
• Cash and marketable securities: $33 million (June 30, 2016)
• No debt
• Net burn: ~ $22 million
• No significant royalty liability (other than Israeli government)
• 170 employees (18 PhD, 5 MD)
• IP Ownership: over 75 granted patents and ~135 pending applications
PSTI PSTI/ PLTR
Financial glance
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Indication
Critical Limb Ischemia (CLI)*
Femoral Neck Fracture**
Acute Radiation Syndrome (ARS)
Location
U.S.Europe
Japan
U.S./ Europe
U.S.
Pivotal pre-marketing trials
Company Pipeline
Pre-Clinical Phase 2Phase 1 Phase 3 MarketProduct
PLX-PAD
PLX- PAD
PLX- R18
Conditional Approval Pathway
* One Multinational trial- U.S- phase 3, Europe- via adaptive pathway allowing early marketing approval** Pending FDA/EMA approval
Pivotal study via FDA Animal Rule
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• 3-4 million people in major pharmaceutical markets*
suffer from CLI (2010)
• Estimated cost for treating CLI is $12 billion per year
• Obstruction of arteries in the leg
• High mortality
• High amputation rates
• Poor treatment options
CLI & Market size
Source: Lifecells LLC
* (U.S., Europe)
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Pivotal trial in Japan approved by the PMDA under an accelerated approval pathway
Status of CLI Pivotal Trials
Pivotal Phase III trial design approved by the FDA and planning to submit BLA following single positive pivotal study
Pivotal phase III trial accepted to the Adaptive Pathways project in Europe- only six programs approved worldwide!
U.S / Europe trial- N=250Japan trial- N=75
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Accepted to accelerated regulatory pathways by the European and Japanese
regulatory authorities, significantly shortening time to market
Targeting regulatory approval in both U.S. and Europe using data from a
single pivotal Phase III trial in 250 patients
Awarded $8 Million Grant from Europe’s Horizon 2020 Program
Program supported by the Israeli Chief Scientist
CLI Development Plan – Achievements
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• Primary endpoint is time to amputation or death
• Other methods of efficacy include: AFS, Quality of life, TcPO2, Pain Score
• Dosing regimen: two doses of 300 million cells, two months apart
• No HLA matching or immunosuppression required
Study Design for U.S. Pivotal Phase 3 Trial (N=250)
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• Amputation Free Survival at 6 months:
• US (total n=12) - 100%
• Germany (total n=15) - 93%
• Comparison to published data on no-option CLI:‒ TASC II: 20% death and 40% major amputations in 6m
‒ TAMARIS (n=259 control pts.): 76% AFS in 6m (196/259)
‒ Meta-analyses (Benoit 2011, Weems 2015): 67%-77% AFS at 6m
‒ The majority of events usually occur in the first 6m
Early Clinical Studies Support Design of Pivotal Phase 3 Trial
Pre-Treatment
8 Weeks After Treatment
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• Amputation Free Survival at 12 months:
• US (total n=12) - 100%
• Germany (total n=15) - 73%
• Comparison to published data on
no-option CLI:‒ TASC II - (all CLI): 45% AFS, 30% MA &
25% death at 1y‒ Reinecke 2015 - (all CLI): 68% AFS at 1y
R4+R5
Early Clinical Studies Support Design of Pivotal Phase 3 Trial
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Additional Supportive Data
Quality of life (VascuQoL) - GermanyQuality of life (VascuQoL) - USA
• Improvement of the quality of life within the first 3m• Higher improvement at 2m repeated dosing• Improvement in quality of life maintained for 12m
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Additional Supportive Data
Increase of mean TcPO2 - GermanyIncrease of mean TcPO2 - USA
• Improvement of TcPO2 - after 1 month• Earlier and higher improvement at 2m repeated dosing• Improvement in TcPO2 maintained for 24 months in German study
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Additional Supportive Data
Reduction of Pain Score (VAS) - GermanyReduction of Pain Score (VAS) - USA
• Overall pain decrease at month 3 • Most notable decrease with repeated dose
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Indication
Critical Limb Ischemia (CLI)
Femoral Neck Fracture**
Acute Radiation Syndrome (ARS)
Location
U.S.Europe*
Japan
U.S./ Europe
U.S.
Pivotal pre-marketing trials
Company Pipeline
Pre-Clinical Phase 2Phase 1 Phase 3 MarketProduct
PLX-PAD
PLX- PAD
PLX- R18
Conditional Approval Pathway
* One Multinational trial- U.S- phase 3, Europe- via adaptive pathway allowing early marketing approval** Pending FDA/EMA approval
Pivotal study via FDA Animal Rule
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Muscle Injury following Total Hip Replacement (N=20)
Improvement of 500%
P=0.0067
Change at week 26 in Mean (±SE) Gluteus Medius
MVIC from Day 0 (mITT)
MVIC = Maximum Voluntary Isometric Construction
Orthopedic – Strong clinical data
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Muscle Injury following Total Hip Replacement (N=20)
Change in Volume from Day 0
Orthopedic – Strong clinical data
Improvement of 300%
P=0.004
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Muscle Injury following Total Hip Replacement (N=20)
Injured (operated) Contralateral(non–operated)
Orthopedic – Strong clinical data
Improvement of 4000%
P=0.012
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Indication
Critical Limb Ischemia (CLI)
Femoral Neck Fracture**
Acute Radiation Syndrome (ARS)
Location
U.S.Europe*
Japan
U.S./ Europe
U.S.
Pivotal pre-marketing trials
Company Pipeline
Pre-Clinical Phase 2Phase 1 Phase 3 MarketProduct
PLX-PAD
PLX- PAD
PLX- R18
Conditional Approval Pathway
* One Multinational trial- U.S- phase 3, Europe- via adaptive pathway allowing early marketing approval** Pending FDA/EMA approval
Pivotal study via FDA Animal Rule
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Collaboration for ARS with U.S. Government U.S. National Institutes of Health to Support Development of Pluristem's PLX-R18
Collaboration with Fukushima Medical University and Science Center to developPLX-R18 cells for the treatment of other component of ARS (GI, Lung and Skin),
and for morbidities following radiotherapy in cancer patients
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Indication
Intermittent Claudication (IC)
Support for Hematopoietic Cell Transplantation
Hematopoietic Cell Transplantation failure
Pulmonary Arterial Hypertension (PAH)
Additional Clinical TrialsCompany Pipeline
Pre-Clinical Phase 2Phase 1 Phase 3 MarketProduct
PLX-PAD
PLX-R18
PLX- R18
PLX-PAD
Cleared for U.S. FDA phase 1 study
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• Rich & Diverse• Highly potent
• pro-angiogenic• immunoregulatory
• Young donors• Unlimited source• Easy to collect• Ethically accepted• Over 20,000 Doses of 300
million cells per placenta
The NIH Placenta ProjectLaunched by the U.S. NationalInstitutes of Health (NIH) toFurther explore the role of theplacenta in health and disease.
Placenta derived cells
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Culture conditions
PLX-R18Hematological
PLX-PADAngiogenesis
Culture conditions
PLX-CNSNeuronal
PLX-IMMUNEImmunological
Each PLX Product Secretes a Different Range of Proteins to Address Different Varieties of Indications
Culture conditions
Culture conditions
Human placenta- a platform for cell products
Stimulates regeneration of damaged bone marrow to produce blood cells (white, red and platelets)
Reduces inflammation Stimulates growth of collateral blood
vessels Stimulates repair of damaged muscle
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3D Manufacturing, in-house cell production150,000 doses annually
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CMC & Manufacturing Facility for PLX-PAD approved by FDA,
German, EU, South Korean, Japanese &
Israeli Regulatory Agencies for 3D
culturing for Phase II, III trials and marketing
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Late-stage bio-therapy company preparing for 3 pivotal trials
PLX cell products each target different indications with customized cytokine secretion profiles
Low immunogenicity confirmed and NO HLA-MATCHING required• PLX products do not induce in vivo priming of Th1 response • Repeated IM injections of PLX cells from the same placenta do not induce
activation of patients’ memory T-cells• Designed to be used “off-the-shelf” convenience in many medical settings
Key Differentiators
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In-house manufacturing with certified batch-to-batch consistency
Proprietary 3D cell production process
CMC & Manufacturing Facility for PLX-PAD approved by FDA and EU Regulators for 3D
culturing for Phase II, III clinical trials and marketing
Key Differentiators
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CollaborationsPartner Indication Deal structure
IC, CLISouth Korea only
Joint Venture following marketing authorization bythe South Korean authorities
Acute Radiation Syndrome
U.S. National Institutes of Health (NIH) to SupportDevelopment of PLX-R18
Acute Radiation Syndrome
Pluristem will contribute cells and scientificknowledge, FMU will conduct the studies andprovide the required resources.
Acute Radiation Syndrome
Conducting trials to test PLX-R18 cells in thetreatment of ARS and understanding of MOA
CLI, Immunology,Cardiovascular,
Orthopedic
Research to test the unique immunology of theplacenta and cells MOA
Pluristem keeps IP and manufacturing
rights in all collaborations
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Initiate pivotal pre-marketing clinical trials in:
• Critical Limb Ischemia (CLI)-
U.S and Europe- Phase 3 study (N=250)
Japan- pivotal trial (N=75) via Conditional Approval pathway for regenerative medicine
• Acute Radiation Syndrome (ARS) – Large animal study via FDA Animal Rule, funded by the NIH
• Hip Fracture Repair- Entering advanced clinical trials in U.S and Europe subject to regulatory approvals
Complete enrollment In Intermittent Claudication (IC) trial ongoing in U.S, Germany, Israel and South Korea
Patients recruitment for Phase 1 trial in incomplete engraftment of hematopoietic cell transplant cleared by the FDA
Company milestones- 12 months
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Unmet MedicalNeed
• Critical Limb Ischemia – limited treatment options• Muscle Injury – need to improve muscle function following
trauma• Damaged or poorly functioning Bone Marrow – ARS, HCT
Significant Market
Opportunity
• CLI – $12 billion global market• Orthopedic indications – broad markets• Hematologic indications – broad markets• Incidence of many indications increasing in aging populations
PLX cells Products
• Off-the-shelf therapy, no tissue matching or immunosuppression• Well-described mechanism of action• Placenta-derived • Convenient for use in most medical settings
Pluristem • Late-stage bio-therapy company preparing for 3 pivotal trials• Primary endpoint met in all completed clinical trials• FDA, EU and Japan – approved manufacturing facility• Highly efficient 3D cell production technology • Broad platform with tailored products• Strong balance sheet & IP
Investment Highlights
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Zami AbermanChairman & CEO
Efrat Livne-Hadass VP Human Resources
Racheli Ofir, Ph.D.VP Research & Intellectual Property
Sagi MoranVP Operations
Erez Egozi VP Finance
Karine Kleinhaus, M.D., MPHDivisional VP, North America
Esther Lukasiewicz Hagai, M.D., Ph.D. VP Clinical & Medical Affairs
Lior RavivDirector of Development
Hillit Mannor Shachar, M.D., M.B.A.VP Business Development
Yaky YanayPresident & COO
Orly AmiranVP Quality Assurance
Management team
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Thank you!