Company Presentation - May 2016 Forward looking Statement This - - PowerPoint PPT Presentation

Company Presentation - May 2016

This presentation concerning Pluristem Therapeutics may include forward-looking statements which represent Pluristem Therapeutics' expectations or beliefs regarding future events. I caution that such statements involve risks and uncertainties that may cause actual results to differ materially from those in the forward-looking statements. Consequently, all such forward-looking statements are qualified by the cautionary language and risk factors set forth in Pluristem Therapeutics' periodic and other reports filed with 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 update these forward-looking statements to reflect actual results, changes in assumptions or changes in factors affecting such forward-looking statements. www.pluristem.com

Forward looking Statement

• Cell therapy (Biotechnology) company using off the shelf placental expanded cells to achieve

local and systemic therapeutic effect.

• First in class 3D cell culturing technology allowing for efficient, controlled production of

different cell products in commercial quantities.

• Entering 3 pivotal pre-marketing clinical trials.

Pluristem corporate overview

• Active with regulators in USA, EU, Japan, South Korea, Australia and Israel.

• Public company, Traded in:
• Market Cap: ~ $130 million
• Cash and marketable securities: $38 million (March 31, 2016)
• No debt
• Net burn: ~ $22 million
• No significant royalty liability (other than Israeli government)
• 165 employees (15 PhD, 5 MD)
• IP Ownership: over 60 granted patents and ~150 pending applications

PSTI PSTI/ PLTR

Financial glance

Partner Indication Deal structure

IC, CLI South Korea only

Joint Venture following marketing authorization by the South Korean authorities

Pluristem keeps IP and manufacturing rights in all collaborations

Government Partnership Indication Deal structure

Acute Radiation Syndrome

U.S. National Institutes of Health (NIH) to Support Development of PLX-R18

Acute Radiation Syndrome

Pluristem will contribute cells and scientific knowledge, FMU will conduct the studies and provide the required resources.

Collaborations

• 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 Project Launched by the US National Institutes of Health (NIH) to Further explore the role of the placenta in health and disease.

Placenta derived cells

The PLX technology

Culture conditions

PLX-R18

Hematological

PLX-PAD

Angiogenesis

Culture conditions

PLX-CNS

Neuronal

PLX-IMMUNE

Immunological

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

3D Manufacturing, in-house cell production

150,000 doses annually

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

 Broad platform with tailored products per indication

• PLX cells can be customized to secrete a specific cytokine secretion profile to

target different indications

• Real off the shelf product requiring no additional manipulation at bedside

 Unique Immunological Properties

• No HLA- matching required
• Low immunogenicity confirmed :
• PLX does not induce in vivo priming of Th1 responses
• Repeated IM injections of PLX cells from the same placenta does not induce

patients memory T-cells activation.  Distinctive MOA

• Products demonstrate both local and systemic efficacy via intramuscular injection

How is PLX different from the competition?

 Superior Manufacturing

• In-house manufacturing which guarantees batch to batch

consistency and high margins  Near Term Product Approval

• First product approval expected 2018 for CLI

How is PLX different from the competition?

Product 1: PLX-PAD

• Reduces inflammation
• Stimulates growth of collateral blood vessels
• Stimulates repair of damaged muscle

• 1.7 million people in the major pharmaceutical markets*

suffer from CLI (2010) & Expected to increase to 2 million in 2020

• Estimated cost for treating CLI in the U.S. is $10 billion

per year

• Obstruction of arteries in the leg
• High mortality
• High amputation rates
• Poor treatment options

* U.S., France, Germany, U.K., Italy, Spain and Japan

CLI & Market size

Source: Lifecells LLC

• Positive clinical data
• Manufacturing facility & production process approved by U.S., Europe and Japan
• Target regulatory pathways that allow for early entry into the market

 Selected for Europe’s Adaptive Pathways project  Cleared to begin clinical trial via Japan’s rapid regulatory pathway for regenerative medicine targeting conditional marketing authorization

Strategy to shorten time to CLI market

Two Phase I/II Critical Limb Ischemia (N=27)

Pre-Treatment 8 Weeks After Treatment

Clinical data support shorten time to CLI market

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

PLX-PAD – Strong clinical data

Muscle Injury following Total Hip Replacement (N=20)

Change in Volume from Day 0

PLX-PAD – Strong clinical data

Improvement of 300% P=0.004

Muscle Injury following Total Hip Replacement (N=20)

Injured (operated) Contralateral (non–operated)

PLX-PAD – Strong clinical data

Product 1: PLX-R18

• Stimulates regeneration of damaged bone marrow to produce

blood cells (white, red and platelets)

Collaboration for ARS with US Government

U.S. National Institutes of Health to Support Development of Pluristem's PLX-R18

Collaboration with Fukushima Medical University and Science Center to develop PLX-R18 cells for the treatment of other component of ARS ( GI, Lung and Skin), and for morbidities following radiotherapy in cancer patients

Initiate pivotal pre-marketing clinical trials:

• Critical Limb Ischemia (CLI)- Europe
• Critical Limb Ischemia (CLI)- Japan
• Acute Radiation Syndrome (ARS) – U.S. trial (via Animal Rule)
• Complete enrollment In Intermittent Claudication (IC) trial ongoing in U.S, Germany, Israel

and South Korea

• Initiate Phase 1 trial in incomplete engraftment of hematopoietic cell transplant – U.S. FDA

cleared IND

• Add clinical development program for orthopedic indication into Adaptive Pathways project

Company milestones 2016

Unmet Medical Need

• Critical Limb Ischemia – limited treatment options
• Muscle Injury – need to improve muscle function in the elderly
• Damaged or poorly functioning Bone Marrow – ARS, HCT
• Preeclampsia – no treatment exists, orphan drug status

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 Differentiation

• Off-the-shelf therapy, no tissue matching needed
• Positive data in 3 completed clinical trials
• Well-described mechanism of action
• Placenta-derived

Pluristem Differentiation

• Expect to initiate 3 pivotal trials in 2016
• Broad pipeline
• FDA and EU – approved manufacturing facility
• 3D cell product production technology
• Strong balance sheet & IP

Investment Highlights

Zami Aberman Chairman & CEO Efrat Livne-Hadass VP Human Resources Racheli Ofir, Ph.D. VP Research & Intellectual Property Sagi Moran VP Operations Erez Egozi VP Finance Karine Kleinhaus, M.D., MPH Divisional VP, North America Esther Lukasiewicz Hagai, M.D., Ph.D. VP Clinical & Medical Affairs Lior Raviv Director of Development Hillit Mannor Shachar, M.D., M.B.A. VP Business Development Yaky Yanay President & COO Orly Amiran VP Quality Assurance

Management team

Thank you!