Regulatory Filings • Oct 29, 2017
Regulatory Filings
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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 our various patient trials and clinical data readout, proposed trials that may occur in the future, the timing and implementation of our collaborations with various partners and the execution of definitive agreements relating to such collaborations and the potential benefits and impact our products could have on improving patient health care. These forward-looking statements and their implications are based on the current expectations of our management only, and are subject to a number of factors and uncertainties that could cause actual results to differ materially from those described in the forward-looking statements. The following factors, among others, could cause actual results to differ materially from those described in the forward-looking statements: changes in technology and market requirements; we may encounter delays or obstacles in launching and/or successfully completing our clinical trials; our products may not be approved by regulatory agencies, our technology may not be validated as we progress further and our methods may not be accepted by the scientific community; we may be unable to retain or attract key employees whose knowledge is essential to the development of our products; unforeseen scientific difficulties may develop with our process; our products may wind up being more expensive than we anticipate; results in the laboratory may not translate to equally good results in real clinical settings; results of preclinical studies may not correlate with the results of human clinical trials; our patents may not be sufficient; our products may harm recipients; changes in legislation; inability to timely develop and introduce new technologies, products and applications; loss of market share and pressure on pricing resulting from competition, which could cause our actual results or performance to differ materially from those contemplated in such forward-looking statements. Except as otherwise required by law, we undertake no obligation to publicly release any revisions to these forward-looking statements to reflect events or circumstances after the date hereof or to reflect the occurrence of unanticipated events. For a more detailed description of the risks and uncertainties affecting us, reference is made to our reports filed from time to time with the Securities and Exchange Commission


| Pluristem Therapeutics Inc. |
NASDAQ: PSTI TASE: 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 |


5












* Chemistry, Manufacturing, and Controls

http://www.the-scientist.com/?articles.view/articleNo/43618/title/The-Prescient-Placenta/

Launched by the US National Institutes of Health (NIH) to further explore the role of the placenta in health and disease




* One Multinational trial- U.S- phase 3, Europe- via adaptive pathway potentially allowing early marketing approval
** Via PMDA's accelerated regulatory pathway for regenerative therapies
*** Pending FDA/EMA approval
12




| FDA | EMA | PMDA | ||||
|---|---|---|---|---|---|---|
| CLI (PLX-PAD) | • • |
Fast track approval Single pivotal study (n=246) |
• • • |
Adaptive regulatory pathway Single pivotal study (n=246) Potential conditional approval on interim report (n=123) |
• • |
Accelerated regulatory pathway Single pivotal study (n=75) |
| Hip fracture (PLX-PAD) |
• • |
Pivotal study Subject to FDA approval |
• • |
Adaptive regulatory pathway Single pivotal study |
||









Pre-Treatment

8 Weeks post treatment


* One Multinational trial- U.S- phase 3, Europe- via adaptive pathway potentially allowing early marketing approval
** Via PMDA's accelerated regulatory pathway for regenerative therapies
*** Pending FDA/EMA approval



*Source: Sage Group- (link, link, link)
**Source: European Society for Vascular Surgery (link)

\$8 million grant from the EU Horizon 2020 program to support Phase III trial





* One Multinational trial- U.S- phase 3, Europe- via adaptive pathway potentially allowing early marketing approval
** Via PMDA's accelerated regulatory pathway for regenerative therapies
*** Pending FDA/EMA approval
23

Improvement of 500% P=0.0067


Improvement of 4000% P=0.012














\$8.7 million grant from the EU Horizon 2020 program to support this Phase III trial
* Source: Simran Mundi, Bharadwaj Pindiprolu, Nicole Simunovic, Mohit Bhandari

Stimulates regeneration of damaged bone marrow to produce blood cells (white, red and platelets)




In Preparations for pivotal study

Following or in support of a transplant of hematopoietic stem cells (HCT) Ongoing Phase I study in U.S and Israel


Autoimmune diseases, Genetic disorders, Chemotherapy, Radiation therapy, Side effects from treatments Covered by patent




* One Multinational trial- U.S- phase 3, Europe- via adaptive pathway potentially allowing early marketing approval
** Via PMDA's accelerated regulatory pathway for regenerative therapies
*** Pending FDA/EMA approval
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 body
High doses of radiation can destroy the bone marrow's ability to produce white cells, red cells and platelets; without these cells patients are at high risk of death



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











| Partner | Indication | Deal structure | |
|---|---|---|---|
| Collaborations | IC, CLI South Korea only |
Joint Venture following marketing authorization by the South Korean authorities |
|
| Pluristem keeps IP and manufacturing rights in all collaborations |
Acute Radiation Syndrome |
U S National Institutes of Health (NIH) to examine the effectiveness of PLX - R18 as a treatment for ARS following 24 hoursfrom exposure |
|
| Acute Radiation Syndrome |
U S Department of Defense to examine the effectiveness of PLX - R18 prior to, and within the first 24 hours of exposure to radiation |
||
| Acute Radiation Syndrome |
Pluristem will contribute cells and scientific knowledge, FMU will conduct the studies and provide the required resources |
||
| Acute Radiation Syndrome |
Conducting trials to test PLX - R18 cells in the treatment of ARS and understanding of MOA |
||
| CLI, Immunology, Cardiovascular, Orthopedic |
Research to test the unique immunology of the placenta and cells MOA |
||
| 39 | Umbilical Cord Blood Transplantation |
Evaluating PLX - R18 as an Adjuvant Therapy to Umbilical Cord Blood Transplantation |






Zami Aberman Chairman & Co-CEO



Erez Egozi CFO

Sagi Moran VP Operations

Racheli Ofir, Ph.D. VP Research & Intellectual Property

Yaky Yanay President & Co-CEO

Esther Lukasiewicz Hagai, M.D., Ph.D. VP Clinical & Medical Affairs

Orly Amiran VP Quality Assurance

Lior Raviv VP Development

Karine Kleinhaus, M.D., MPH Divisional VP, North America


[email protected] Israel +972-74-710-8600

U.S.- +1-914-512-4109
www.Pluristem.com


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