Pluristem Provides Update on COVID-19: Preparedness, Current Phase III Clinical Trials Status and Treatment Development Activity

Pluristem Provides Update on COVID-19:

Preparedness, Current Phase III Clinical Trials Status and Treatment Development Activity

March 26, 2020 - Pluristem Therapeutics Inc. (Nasdaq:PSTI) (TASE:PSTI),

a leading regenerative medicine company developing a platform of novel biological products, today issued an update to its shareholders

from its Chief Executive Officer and President, Yaky Yanay.

Dear Fellow Shareholders,

the novel coronavirus pandemic (COVID-19), today we wanted to provide an update on the impact of the coronavirus pandemic on our

business and on our ongoing Phase III clinical studies of PLX-PAD in the treatment of Critical Limb Ischemia (CLI), and muscle

regeneration following hip fracture, as well as update you on our actions to provide a PLX

cell product as a potential treatment for the respiratory and inflammatory complications associated with

In managing our ongoing global clinical trials,

as well as our daily operations at our headquarters in Israel, we are taking all necessary precautions for the safety and well-being

of patients, healthcare providers involved in our trials, and our employees.

its operational and manufacturing activities, subject to the directives of the Israeli Ministry of Health, with a dedicated team

on site. In addition, Pluristem is using remote work technologies that enable other activities to be conducted without the need

for a physical presence in our facilities. Today, and into the foreseeable future, we believe that we are well positioned to operate

through the COVID-19 pandemic. Our allogenic, off-the-shelf approach and our advanced manufacturing

capabilities enabled us to complete the manufacturing of the entire stock needed to complete all of our current clinical studies.

We currently hold supplies of PLX cells in inventory in Israel, and in secure storage facilities in Europe and the U.S.

With regard to our operational business, while

we are preparing for the potential ramp up in production to supply PLX-PAD cells for the potential treatment of COVID-19 complications,

we have rapidly implemented a significant cost reduction plan. Our goal is to make sure that we will be able to operate through

any unforeseen or foreseen scenario, and I am glad to say that the company's stakeholders, including employees and suppliers,

are fully cooperating with our request and have agreed to our significant cost reduction plan. Until we have better clarity on

the global impact of COVID-19, we have applied a cost saving plan relating to employee compensation which includes a 50% reduction

in compensation for C-level executives and our management team, and a gradual reduction of between 20% to 50% for all employees

according to managerial level, with non-management employees having the lowest reduction. I would like to say that the past few

days have shown me once again how committed the Pluristem team is to the success of our company. I feel proud and blessed to lead

such a talented and committed team and I would like to thank each and every one of them for their loyalty and dedication.

to enroll and treat patients in our two ongoing pivotal Phase III studies of our PLX-PAD product candidate for the treatment of

CLI and muscle regeneration following hip fracture, we do so within the new guidelines provided by the U.S. Food and Drug Administration's

(FDA), "FDA Guidance on Conduct of Clinical Trials of Medical Products during COVID-19 Pandemic",

issued on March 18, 2020, and the European Medicines Agency's (EMA) "Guidance on the Management of Clinical

Trials during the COVID-19 (Coronavirus) pandemic" issued on March 20, 2020. In Israel, our

clinical studies are subject to the directives of the Israeli Ministry of Health.

As of today, we have enrolled over 80%

of the patients in our pivotal Phase III CLI trial, and close to 60% in our Phase III study of muscle regeneration following hip

fracture. While we continue enrollment in both studies, from what we have seen in the last few weeks, we believe it is reasonable

to expect a certain slowdown in the enrollment rate, as it is our commitment and obligation to ensure the safety and health of

our patients and medical team.

We are currently evaluating the impact

of COVID-19 on the original timelines for our interim analysis and full study readouts and will continue to provide updates on

our progress in our future quarterly reports.

In the last few months, we have been

holding discussions with the FDA and EMA in order to confirm and agree on the changes in the parameters and final protocol design

of the interim analysis of the CLI clinical data, which may lead to conditional marketing approval in Europe. I expect to be able

to update you on those understandings in the coming weeks.

A Message for Patients

For patients participating in our studies,

patient safety remains our top priority. We are working closely with the clinical trial sites and evaluating options and adjustments.

In the next few days, we expect the clinical trial sites will publish guidelines for continuing to conduct these studies during

this pandemic. I wish you all good health.

Treatment of Complications from COVID-19

Pluristem is fully committed to the global

drive towards developing and delivering healthcare products to potentially treat severe pneumonia resulting from COVID-19. Towards

this end, we are collaborating with the BIH Center for Regenerative Therapy (BCRT) and the Berlin Center for Advanced Therapies

(BeCAT) at Charit University of Medicine to evaluate the therapeutic effects of our PLX cell product candidates for the

treatment of the respiratory and inflammatory complications associated with COVID-19. We also received the Israeli Ministry of

Health's clearance to seek approvals to treat COVID-19 patients under a per-patient compassionate use framework in Israel.

Currently, our main effort is to initiate treatment of patients as soon as possible. We are now holding discussions with regulators

to define our clinical strategy for COVID-19, while we start with compassionate use programs in order to provide the product immediately

to patients. We are targeting a potential full development plan in the U.S., Europe and Israel with the goal of supporting global

healthcare systems' tremendous effort to fight off COVID-19 and bring life back to normal.

Pluristem is a strong company, and I believe

we are well prepared for the challenges and opportunities we face with the COVID-19 situation. Pluristem is committing and harnessing

all of its knowledge, experience and dedication to be part of the global solution for this pandemic. Our team is passionate about

improving the wellbeing of patients and we believe that our regenerative medicine product candidate is ideally suited to today's

healthcare challenges. I thank you all for your support and loyalty to Pluristem and I wish you and your families good health.

Chief Executive Officer and President

About Pluristem Therapeutics

Pluristem Therapeutics Inc. is a leading regenerative

medicine company developing novel placenta-based cell therapy product candidates. The Company has reported robust clinical trial

data in multiple indications for its patented PLX cell product candidates and is currently conducting late stage clinical trials

in several indications. PLX cell product candidates are believed to release a range of therapeutic proteins in response to inflammation,

ischemia, muscle trauma, hematological disorders and radiation damage. The cells are grown using the Company's proprietary three-dimensional

expansion technology and can be administered to patients off-the-shelf, without tissue matching. Pluristem has a strong intellectual

property position; a Company-owned and operated GMP-certified manufacturing and research facility; strategic relationships with

major research institutions; and a seasoned management team.

Safe Harbor Statement

This press release 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, Pluristem is using forward-looking statements when it discusses its belief that it is well positioned to operate

through the COVID-19 pandemic, with ample supplies of PLX cells in inventory in Israel, and in secure storage facilities in Europe

and the U.S., that it is preparing for the potential ramp up in production to supply PLX-PAD cells for the potential treatment

of COVID-19 complications, its belief that it is reasonable to expect a slowdown in the enrollment rate of its clinical studies,

its expectation to provide updates with respect to its original timelines for its interim analysis and full study readouts in its

future quarterly reports as well as its discussions with the FDA and EMA regarding changes in the parameters and final protocol

design of the interim analysis of the CLI clinical data which may lead to conditional marketing approval in Europe, that it is

targeting a potential full development plan in the U.S. and Europe with the goal of supporting global healthcare systems'

tremendous effort to fight off COVID-19 and its belief that its regenerative medicine product candidate is ideally suited to today's

healthcare challenges. . These forward-looking statements and their implications are based on the current expectations of the management

of Pluristem 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; Pluristem may

encounter delays or obstacles in launching and/or successfully completing its clinical trials; Pluristem's products may not

be approved by regulatory agencies, Pluristem's technology may not be validated as it progresses further and its methods

may not be accepted by the scientific community; Pluristem may be unable to retain or attract key employees whose knowledge is

essential to the development of its products; unforeseen scientific difficulties may develop with Pluristem's process; Pluristem's

products may wind up being more expensive than it anticipates; 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; Pluristem's