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Advancing Cell Therapeutic Products for Clinical Use

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Advancing Cell Therapeutic Products for Clinical Use Advancing cell therapeutic products for clinical use 1 Proprietary data of Pluristem Therapeutics Inc. Forward Looking Statement 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 2 Proprietary data of Pluristem Therapeutics Inc. Corporate Overview • Cell therapy company (NasdaqCM: PSTI, TASE: PSTI) • Using off-the-shelf, placenta-derived cells to achieve both local and systemic therapeutic effects – no tissue matching needed • First-in-class 3D cell culturing technology allowing for efficient, controlled production of multiple cell products in commercial quantities – “the process is the product” • Active with regulators in the U.S., EU, S. Korea, Australia & Israel • Demonstrated safety and efficacy in 3 clinical studies (two Phase I and one Phase I/II study) 3 Proprietary data of Pluristem Therapeutics Inc. Financial Overview • Market Cap: ~ $200 million • Cash and marketable securities: $41 million (March, 2015) • No debt • Net burn: ~ $23 million • 165 employees (16 PhD, 4 MD) • IP Ownership: over 40 granted patents and ~150 pending applications 4 Proprietary data of Pluristem Therapeutics Inc. PLX Technology 5 Proprietary data of Pluristem Therapeutics Inc. Selected for EU Adaptive Pathways – potential for marketing approval in 2018 6 Proprietary data of Pluristem Therapeutics Inc. Collaborations Partner Indication Deal structure Pulmonary Arterial Hypertension Licensing - (upfront payment (PAH) of $7M, additional $48M in Worldwide license milestones, cells supply (cost +) and royalties in gross margin IC, CLI JV following marketing South Korea only authorization of the Korean authorities Acute Radiation Syndrome U.S. National Institutes of Health to Support Development of Pluristem's PLX-R18 Pluristem keeps IP and manufacturing rights in all collaborations 7 Proprietary data of Pluristem Therapeutics Inc. Clinical Programs 8 8 Proprietary data of Pluristem Therapeutics Inc. 8 PLX-PAD 9 Proprietary data of Pluristem Therapeutics Inc. Completed, Ongoing and Planned Studies with PLX-PAD in Peripheral Artery Disease • Two completed Phase I studies in critical limb ischemia – positive results for both the U.S. and German trials • One ongoing Phase II study in intermittent claudication (N=150) • Planned studies in CLI: o Phase II/III in Europe via Adaptive Pathways pilot project Pluristem selected to Adaptive Pathways pilot project o Phase I/II in Japan via Accelerated Pathway for Regenerative Medicine (application submitted; cell quality and production methods already recognized by PMDA) 10 Proprietary data of Pluristem Therapeutics Inc. Conditional Approval vs. Traditional Pathway to Market in EU Conditional Aprroval Conditional Collection of real-world Data from Full Phase II RCT MA* patients treated with PLX-PAD MA* Conservative Pathway Phase II RCT Two Phase III RCTs Full MA* 2016 2017 2018 2019 2020 2021 MA = marketing authorization 11 Proprietary data of Pluristem Therapeutics Inc. Summary Data from Both Phase I Studies, N=27 12 month - 85% Amputation-Free Survival (AFS) Event Rate USA data (AFS- 100%) Germany data (AFS- 73%) Average (85%) Published historical data 12 Proprietary data of Pluristem Therapeutics Inc. PLX-PAD CLI program status in Europe • 3-4 years earlier in a multi-billion market • Manufacturing facility approved and inspected by European Qualified Person for Phase III and marketing • Granted European patent for the use of PLX in ischemic disease • Increased probability of a large pharma deal • EMA new approach to expand the use of PLX-PAD to additional indications within PAD and other ischemic conditions 13 Proprietary data of Pluristem Therapeutics Inc. PLX PAD- Orthopedic Indication Phase II Completed 14 Proprietary data of Pluristem Therapeutics Inc. Strong Clinical Data Muscle Injury following Total Hip Replacement N=20 15 Proprietary data of Pluristem Therapeutics Inc. Strong Data on Efficacy in Muscle injury Following Total Hip Replacement Improvement of 500% P=0.0067 16 Proprietary data of Pluristem Therapeutics Inc. Correlation Between Improvement in the Muscle Force of Injured and Contralateral Leg Injured (operated) Contralateral (non–operated) Placebo Placebo 150M PLX-PAD 150M PLX-PAD 300M PLX-PAD 300M PLX-PAD 30 150M vs. Placebo 40 25 150M vs. Placebo : p=0.0114 35 p=0.0067 20 30 15 25 10 20 ofoperated leg 15 5 10 0 5 -5 strenght 0 Time -10 (Week -5 Time (Weeks) -15 change in strenghtof contralateral leg -10 change in -20 -15 6 12 26 6 12 26 17 Proprietary data of Pluristem Therapeutics Inc. Ongoing Clinical Trials – PLX-PAD • Intermittent Claudication (IC): Phase II multinational, randomized, double blind, placebo controlled study. Primary End Point: Maximal Walking Distance (MWD) at 12 months compared to baseline, N=150 (as of December 31, 2014, 64 patients enrolled) • Pulmonary Arterial hypertension (PAH): - Phase I, open label, dose escalation study. Primary End Point: safety & efficacy at weeks 6 and 12, and at 12 months, N=9 (as of December 31, 2014, 3 patients enrolled) 18 Proprietary data of Pluristem Therapeutics Inc. PLX R18 Hematologic Indications 19 Proprietary data of Pluristem Therapeutics Inc. PLX -R18 Target Indications Bone marrow failure including: • Incomplete engraftment after bone marrow transplantation • Acute Radiation Syndrome (ARS) – supported by the U.S. National Institutes of Health (NIH) • Two significant animal trials announced o Animal Rule pathway • Aplastic Anemia (AA) – FDA Orphan Drug designation • Chemotherapy induced bone marrow failure - Pre-Clinical PoC • Bone Marrow Transplant failure (compassionate use – human data) Support for Hematopoietic cell Transplantation (HCT): • Umbilical cord blood transplantation – Pre-Clinical PoC • Bone Marrow Transplantation – Pre-Clinical PoC 20 Proprietary data of Pluristem Therapeutics Inc. US Government Collaboration for ARS U.S. National Institutes of Health to Support Development of Pluristem's PLX-R18 21 Proprietary data of Pluristem Therapeutics Inc. Planned Clinical Trials • “Exploratory” Phase I/II trial in hematological indication with PLX-R18 under new expedited approval pathway for regenerative therapy in Japan o Positive results potentially sufficient for limited marketing authorization • Phase I trial in hematological indication with PLX-R18 in U.S. • Later-phase animal trials by U.S. National Institutes of Health for Acute Radiation Syndrome via Animal Rule pathway o NO human efficacy trials needed for approval o If approved, government stockpiling for ARS to be integrated with storage for civilian use in other indications 22 Proprietary data of Pluristem Therapeutics Inc. The Process is the Product 23 Proprietary data of Pluristem Therapeutics Inc. Allogeneic MSC “the process is the product” Pro-angiogenicMonolayer Vs. Multilayer Undetermined • 3D Cell-Cell interaction Anti-angiogenic • PLX cells harvested following extracellular collagen-cells interaction • High yield Paracrine/endocrine effects leads to emphasis on the secretion profile Proprietary 3D platform to enable controlled 3D culturing to ensure “batch-to-batch” comparability and to modify the secretion profile as needed- PLX-PAD, PLX-R18 and others. 24 Proprietary data of Pluristem Therapeutics Inc. 3D manufacturing = 150,000 doses annually 25 Proprietary data of Pluristem Therapeutics Inc. PLX-PAD CMC Approved by 5 Regulatory Agencies FDA, PEI (Germany), EMA, South Korean & Israeli Regulatory Agencies: • Confirmed Batch-to-Batch Comparability, Using Multiple Donors • CMC Certification for 3D culturing for Phase II, III and Marketing 26 Proprietary data of Pluristem Therapeutics Inc. Company milestones H2- H1- H2- H1- H2- H1- H2- H1- H2- indication 20 20 20 20 20 20 20 20 20 14 15 15 16 16 17 17 18 18 IC End of Data Licensin enrollme Readout g deal Adaptiv nt e Study End of Data Initial CLI (Adaptive EU) Pathwa initiatio enrollmen Reado approva y n t ut l approva l Study CLI (Japan) End of Data Conditiona initiatio enrollmen Readou l approval n t t Orthopedic indication We will seek to include the indication under the Adaptive licensing pathway- based on discussion with EMA Adaptive Hematology End of Data IND Study or phase initiation enrollment Readout II/III Data ARS Pivotal BLA Reado study application ut PAH UT will pursue IND upon completion of the phase I Preeclampsia We will seek to include preeclampsia under the Adaptive licensing pathway- based on discussion with EMA 27 27 Proprietary data of Pluristem Therapeutics Inc. Management Team Zami Aberman Chairman & CEO Yaky Yanay President & COO Efrat Livne-Hadass VP Human Resources Hillit Mannor Shachar, M.D., M.B.A. VP Business Development Racheli Ofir, Ph.D. VP Research & Intellectual Property Ohad Karnieli, Ph.D., M.B.A. VP Technology & Manufacturing Sagi Moran VP Operations Esther Lukasiewicz Hagai, M.D., Ph.D. VP Clinical & Medical Affairs Erez Egozi VP Finance Orly Amiran VP Quality Assurance Karine Kleinhaus, M.D., MPH Divisional VP, North America 28 Proprietary data of Pluristem Therapeutics Inc. 29 Proprietary data of Pluristem Therapeutics Inc. .
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