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Update is provided in advance of the company’s recruitment of first patient for its phase II Covid-19 study

 

HAIFA, Israel, May 14, 2020 – Pluristem Therapeutics Inc. (Nasdaq:PSTI) (TASE:PSTI), a leading regenerative medicine company developing a platform of novel biological therapeutic products, today reported an update on the status of COVID-19 infected patients treated with PLX cells under a compassionate use program in Israel and the FDA Single Patient Expanded Access Program in the U.S. All treated patients were in Intensive Care Units (ICU), on invasive mechanical ventilation and suffered from Acute Respiratory Distress Syndrome (ARDS) at the time of treatment. As of today, a total of 18 patients were treated in Israel and in the U.S., of which 8 (1 in the U.S. and 7 in Israel) so far have completed a 28-day follow up period.

28–day follow up highlights for 8 patients treated with PLX cells:

 

Notwithstanding the Company’s prior intention not to provide further updates on the status of patients treated under compassionate use, the Company is now providing this update in response to a substantial increase in shareholder inquiries, following the FDA clearance of Phase II study

1 Richardson S et al. Presenting Characteristics, Comorbidities, and Outcomes Among 5700 Patients Hospitalized With COVID-19 in the New York City Area. JAMA 2020. doi:10.1001/jama.2020.6775

 

and prior to recruitment of the first patient. The Company intends to provide a final update regarding the compassionate use program in Israel and the FDA Single Patient Expanded Access Program in the U.S. once it has completed such programs and after it has completed its previously announced Phase II study with respect to the use of its PLX cells for the treatment of severe COVID-19 cases complicated by ARDS.

“We are highly encouraged by this data. The 28-day follow up time marker is important, as our Phase II study’s primary efficacy endpoint is the number of ventilator free days during the 28-day study period from day 1 though day 28,” stated Pluristem CEO and President, Yaky Yanay. “We are currently focused on initiating the Phase II clinical study in the U.S., where we expect to treat the first patient in the coming days. Simultaneously, we continue to help treat patients through our compassionate use and FDA Single Patient Expanded Access Programs in Israel and the U.S.”

PLX Cells for COVID-19

PLX cells are available off-the-shelf and once commercialized, can be manufactured in large scale quantities. Pluristem believes its PLX cells will offer a key advantage in addressing the COVID-19 global pandemic. PLX cells are allogeneic mesenchymal-like cells that have immunomodulatory properties that induce the immune system’s natural regulatory T cells and M2 macrophages, and thus may prevent or reverse the dangerous overactivation of the immune system. Accordingly, PLX cells may potentially reduce the incidence and/or severity of COVID-19 pneumonia and pneumonitis leading hopefully to a better prognosis for the patients. Previous pre-clinical findings of PLX cells revealed therapeutic benefit in animal studies of pulmonary hypertension, lung fibrosis, acute kidney injury and gastrointestinal injury, which are potential complications of the severe COVID-19 infection. Clinical data using PLX cells demonstrated the strong immunomodulatory potency of PLX cells in patients post major surgery. Taken together, PLX cells’ potential capabilities with the safety profile observed from clinical trials involving hundreds of patients worldwide potentially position them as a therapy for mitigating the tissue-damaging effects of COVID-19.

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 intention to provide updates on the remaining patients treated under the compassionate use program in Israel and an Expanded Access Program in the U.S. once such programs, and its Phase II study, conclude, its intention to continue to treat patients in its compassionate use and Expanded Access Programs, the timing of the enrollment of its first patient in its Phase II study in the U.S., the potential of PLX cells in preventing or reversing the dangerous overactivation of the immune system, that PLX cells may potentially reduce the fatal symptoms of COVID-19 induced pneumonia and pneumonitis, and PLX cells’ position as a therapy for mitigating the tissue-damaging effects of COVID-19.
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 patents may not be sufficient; Pluristem’s products may harm recipients; changes in legislation may adversely impact Pluristem; 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 the actual results or performance of Pluristem to differ materially from those contemplated in such forward-looking statements.
Except as otherwise required by law, Pluristem undertakes 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 Pluristem, reference is made to Pluristem’s reports filed from time to time with the Securities and Exchange Commission.

Contact:

Dana Rubin

Director of Investor Relations 972-74-7107194

danar@pluristem.com

·      140 patients with severe COVID-19 and ARDS to be treated

 

HAIFA, Israel, May 8, 2020 – Pluristem Therapeutics Inc. (Nasdaq:PSTI) (TASE:PSTI), a leading regenerative medicine company developing a platform of novel biological therapeutic products, announced today that the U.S. Food and Drug Administration (FDA) has cleared the Company’s Investigational New Drug (IND) application for a Phase II study of its PLX cells in the treatment of severe COVID-19 cases complicated by Acute Respiratory Distress Syndrome (ARDS). The study, titled “A Randomized, Double-Blind, Placebo-Controlled, Multicenter, Parallel-Group Phase II Study to Evaluate the Efficacy and Safety of Intramuscular Injections of PLX-PAD for the Treatment of severe COVID-19” will treat 140 adult patients that are intubated and mechanically ventilated and are suffering from respiratory failure and ARDS due to COVID-19. The primary efficacy endpoint of the study is the number of ventilator free days during the 28 days from day 1 through day 28 of the study.

The objective of the study is to evaluate the efficacy and safety of one or two intramuscular (IM) injections, in three different dosages, of PLX-PAD for the treatment of ARDS resulting from COVID-19.
The primary endpoint determination will be performed at the end of the 28 day main study period. Safety and survival follow-up will be conducted at week 8, 26 and 52. Pluristem has been treating patients suffering from severe complications caused by COVID-19, such as ARDS and inflammatory complications, in the U.S. and Israel through compassionate use programs.
Preliminary data from these compassionate use programs in Israel was reported on April 7, 2020. A Clinical Trial Authorization (CTA) has also been filed in Europe for a Phase II COVID-19 trial, with the first European clinical sites planned in Germany and Italy.

“We are very pleased to gain clearance to commence our Phase II COVID-19 study in the U.S. We are shifting gears now with a main focus on a rapid initiation of the clinical trial, leveraging our technological and logistical competitive advantages developed through our clinical trial experience in the U.S. and Europe.
We believe we can complete enrollment quickly and we expect to provide guidelines on the expected study duration a few weeks following the commencement of the study,” stated Pluristem CEO and President, Yaky Yanay. “In the last few weeks, we have received dozens of applications from physicians and families seeking to participate in the Expanded Access per patient program.
We look forward to working with hospitals and physicians on a larger scale to deliver our PLX cells, through an off-the-shelf, easy to use PLX cell product candidate, which may potentially accelerate recovery time from life threatening conditions, and to improve survival, in the most severe COVID-19 cases.”

 

PLX Cells for COVID-19

PLX cells are available off-the-shelf and once commercialized, can be manufactured in large scale quantities. Pluristem believes its PLX cells will offer a key advantage in addressing the COVID-19 global pandemic.
PLX cells are allogeneic mesenchymal-like cells that have immunomodulatory properties that induce the immune system’s natural regulatory T cells and M2 macrophages, and thus may prevent or reverse the dangerous overactivation of the immune system. Accordingly, PLX cells may potentially reduce the incidence and/or severity of COVID-19 pneumonia and pneumonitis leading hopefully to a better prognosis for the patients.
Previous pre-clinical findings of PLX cells revealed therapeutic benefit in animal studies of pulmonary hypertension, lung fibrosis, acute kidney injury and gastrointestinal injury, which are potential complications of the severe COVID-19 infection. Clinical data using PLX cells demonstrated the strong immunomodulatory potency of PLX cells in patients post major surgery.
Taken together, PLX cells’ potential capabilities with the safety profile observed from clinical trials involving hundreds of patients worldwide potentially position them as a therapy for mitigating the tissue-damaging effects of COVID-19.

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 the scope, endpoints, and enrollment of patients in the Phase II COVID-19 study, the rapid initiation of the study, its expectation that it will complete a quick enrollment of its study, that it will be able to provide guidelines on the expected study duration in the coming weeks, that its PLX cell product candidate may potentially accelerate recovery time from life threatening conditions and improve survival in the most severe COVID-19 cases, when it discusses the potential of PLX cells in preventing or reversing the dangerous overactivation of the immune system, that PLX cells may potentially reduce the fatal symptoms of COVID-19 induced pneumonia and pneumonitis, and PLX cells’ position as a therapy for mitigating the tissue-damaging effects of COVID-19.
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 patents may not be sufficient; Pluristem’s products may harm recipients; changes in legislation may adversely impact Pluristem; 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 the actual results or performance of Pluristem to differ materially from those contemplated in such forward-looking statements.
Except as otherwise required by law, Pluristem undertakes 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 Pluristem, reference is made to Pluristem’s reports filed from time to time with the Securities and Exchange Commission.

Contact:

Dana Rubin

Director of Investor Relations 972-74-7107194

danar@pluristem.com

HAIFA, Israel, May 5, 2020 – Pluristem Therapeutics Inc. (Nasdaq:PSTI) (TASE:PSTI), a leading regenerative medicine company developing a platform of novel biological therapeutic products, announced today that it has entered into definitive agreements with two institutional investors in connection with a registered direct offering, providing for the issuance of an aggregate of 1,587,302 shares of its common stock at a price of $9.45 per share.

The net proceeds from the offering are expected to be approximately $15,000,000. Pluristem intends to use the net proceeds from the offering for working capital, including funding towards its Phase II study of PLX cell therapy in the treatment of complications arising from COVID-19 and other clinical trial activities, investment in capital equipment and other general corporate purposes.

The offering is expected to close on or before May 7, 2020, subject to customary closing conditions.

 

The shares of common stock offered in the registered direct offering described above are being offered by Pluristem pursuant to its shelf registration statement on Form S-3 (File No. 333- 218916) previously filed and declared effective by the Securities and Exchange Commission (the “SEC”) on June 30, 2017. The offering may be made only by means of a prospectus supplement and accompanying prospectus. A final prospectus supplement and accompanying prospectus relating to the offering will be filed with the SEC and will be available on the SEC’s website.

 

This press release shall not constitute an offer to sell or a solicitation of an offer to buy these securities, nor shall there be any sale of these securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction.

 

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 the offering, the expected timing of the closing of the offering and planned use of the net proceeds from the offering.
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 and those discussed in the “Risk Factors” section in Pluristem’s most recently filed Annual Report on Form 10-K, as well as other risks detailed in Pluristem’s subsequent filings with the Securities and Exchange Commission, among others, could cause actual results to differ materially from those described in the forward-looking statements: market risks and uncertainties, the success of the offering, use of proceeds of the offering, and the satisfaction of all conditions to, and the timely closing of, the offering; which could cause the actual results or performance of the Company to differ materially from those contemplated in such forward-looking statements. There can be no assurance that the actual results or developments anticipated by Pluristem will be realized or, even if substantially realized, that they will have the expected consequences to, or effects on, Pluristem.
Except as otherwise required by law, Pluristem undertakes 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 Pluristem, reference is made to Pluristem’s reports filed from time to time with the Securities and Exchange Commission.

Contact:

Dana Rubin

Director of Investor Relations 972-74-7107194

danar@pluristem.com

 

Today, the European Investment Bank and the Israel Innovation Authority will sign a cooperation agreement to jointly pursue investment opportunities in the domain of bio-convergence in health. The intersection of biopharma, information technology and engineering is an important building block in supporting global public health goals. The agreement, initiated by kENUP Foundation, aims at deepening the links between Israel and the EU, fostering innovation in the region, closing investment gaps and jointly assuming global leadership in the area of bio-convergence. Ultimately, it is set to benefit Israeli and European citizens and corporations.

In the context of this Memorandum of Understanding, the EIB is supporting Pluristem through its German subsidiary Pluristem GmbH, with a venture debt loan of €50 million. Pluristem is a regenerative medicine company with a focus on novel biological products. The company uses cells derived from placenta for the development of product candidates for the treatment of severe medical conditions such as infections, inflammation, ischemia, muscle injury, haematological disorder or acute radiation syndrome. It has recently extended its activity in response to the coronavirus pandemic and treated several COVID-19 patients with acute respiratory failure under the “compassionate use” programme, a treatment option which allows the use of unauthorised medicine for severely ill patients.

 

The financing will support Pluristem’s research and development in the EU, notably its regenerative cell therapy platform. It will also allow the company to push its advanced clinical pipeline towards marketing. Pluristem will receive the financing in three tranches, subject to the achievement of pre-agreed clinical regulatory and scaling up milestones. The first tranche will consist of € 20 million. The company is the first Israeli-European business to benefit from a guarantee from the European Fund for Strategic Investments, the financial centre-piece of the Investment Plan for Europe, in which the EIB and the European Commission are working together to mobilise investment in the EU. Pluristem was previously funded by the Israel Innovation Authority.

 

“Today’s signatures show that we are successful when we stand together,” said Ambroise Fayolle, EIB Vice-President in charge of innovation. “Israel is home to a thriving scene of innovative startups, which dominate the high-tech industry. Pluristem is an excellent example of Israeli-European cooperation and EIB support for them is particularly timely, as it will allow the company to develop a treatment for the most vulnerable COVID-19 patients. Working together often saves time and resources – in this case it has the potential to save lives.”

 

Dr Ami Appelbaum, Chairman, Israel Innovation Authority and Chief Scientist at the Ministry of Economy and Industry, explained: “Israel views bio-convergence as its next economic growth engine.

This innovative approach serves as an engine to find efficient, diverse and ingenious approaches to health problem solving. It integrates biology with engineering, AI, physics, computation, nanotechnology and material science in order to address unmet needs in numerous industries, including health, agriculture, energy and defence. The collaboration between the European Investment Bank and the Israel Innovation Authority provides a unique opportunity to advance this area providing companies with various financing opportunities from early stage to growth. As the COVID-19 pandemic spreads globally, it is of vital importance to employ cutting edge technological innovation with global outreach to provide the much needed relief the world is looking for.”

European Commission Executive Vice-President Valdis Dombrovskis said: “The Investment Plan for Europe has a strong track record of supporting ground-breaking research and development in the health sector. Pluristem is carrying out highly innovative and crucial work in the fight against coronavirus, now boosted by financial backing from the EU.”

EU Ambassador to Israel Emanuele Giaufret said: “A coordinated global response is needed to fight COVID-19, and the EU is launching a worldwide pledging marathon precisely to ensure that the world works together to find safe, effective and affordable treatments, diagnostics and vaccines. Today’s important agreement with the EIB will help to develop promising treatment for coronavirus, and is yet another achievement of the EU and Israel, strengthening our cooperation in research and innovation. We thank Israeli researchers for their efforts, and look forward to continued joint work for the benefit of all.”

 

Pluristem CEO and President Yaky Yanay stated: “Pluristem would like to thank the EIB for its financial support and its commitment to finding an effective treatment for life-threatening medical conditions, among them complications associated with COVID-19. Our company’s mission of harnessing the power of regenerative medicine to improve the wellbeing of an aging population has become more urgent than ever, as we work tirelessly to develop a treatment for COVID-19 complications while advancing our portfolio of products in advanced stage trials to treat a number of indications that may positively impact on global healthcare systems. We are honoured to become the first Israeli-European company to benefit from a guarantee from the European Fund for Strategic Investments.”

 

The signature event will be live streamed at 10.00 am CET. Speakers are:

Ambroise Fayolle, Vice President, EIB

Emanuele Giaufret, Ambassador, EU Delegation to Israel

Amiram Applebaum, Chairman of the Israel Innovation Authority and Chief Scientist at the Ministry of Economy and Industry

Yaky Yany, CEO Pluristem

Zami Aberman, Executive Chairman, Pluristem

To watch please go to: https://signing-ceremony.eu.

 

Background information

The European Investment Bank is the long-term lending institution of the European Union owned by its Member States. It makes long-term finance available for sound investments in order to contribute towards EU policy goals. The EIB also supports investments outside the EU.

 

About the Israel Innovation Authority

The Israel Innovation Authority, responsible for the country’s innovation policy, is an independent and impartial public entity that operates for the benefit of the Israeli innovation ecosystem and Israeli economy as a whole.
Its role is to nurture and develop Israeli innovation resources, while creating and strengthening the infrastructure and framework needed to support the entire knowledge industry. The Israel Innovation Authority provides a variety of practical tools and funding platforms aimed at addressing the dynamic and changing needs of the local and international innovation ecosystems.

 

About the Investment Plan for Europe

The Investment Plan for Europe is one of the EU’s key actions to boost investment in Europe, thereby creating jobs and fostering growth. To this end, smarter use is made of new and existing financial resources.
The EIB Group is playing a vital role in this investment plan. With guarantees from the European Fund for Strategic Investments, the EIB and EIF are able to take on a higher share of project risk, encouraging private investors to participate in the projects. To date, the projects and agreements

 

approved under EFSI are expected to mobilise around €478 billion of investments and to benefit over 1 million small and medium-sized companies throughout the EU.

 

About Pluristem

Pluristem 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 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.

 

 

About the EIB-IIA MoU

The Memorandum of Understanding between the EIB and the Israel Innovation Authority recognises the shared commitment to deepening the links between Israel and the EU, to foster innovation in the region, to close investment gaps and to jointly assume global leadership in the area of bio-convergence. The Israel Innovation Authority is a reliable partner for the EIB in view of its broad technical and sector expertise and its well-established relationships with relevant industrial and public players. At the invitation of kENUP Foundation, the EIB and the Innovation Authority convened a series of meetings between October 2018 and January 2020 to discuss future common endeavours. In addition, the EIB has identified a number of innovative smaller companies supported by the Innovation Authority with investments in Israel and in Europe, which are promising counterparts for EIB equity-type operations.

 

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 that the proceeds from the EIB financing will help it advance the clinical development of its cell therapies and address a number of severe medical conditions, as well as support its research and development of its regenerative cell therapy platform in the EU, and allow it to push its advanced clinical pipeline towards marketing, that the cooperation agreement between the EIB and the Israel Innovation Authority is set to benefit Israeli and European citizens and corporations and that the agreement with the EIB will help to develop a promising treatment for coronavirus. While the EIB and Pluristem have executed the loan agreement, there is no guarantee that Pluristem will achieve the milestones necessary to receive any or all of the three tranches.
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 patents may not be sufficient; Pluristem’s products may harm recipients; changes in legislation may adversely impact Pluristem; 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 the actual results or performance of Pluristem to differ materially from those contemplated in such forward-looking statements.
Except as otherwise required by law, Pluristem undertakes 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 Pluristem, reference is made to Pluristem’s reports filed from time to time with the Securities and Exchange Commission.

Press contacts

EIB

Marie Antonie Kerwien

 

Communication

Email: a.kerwien@eib.org Tel: +352437982175

 

Israel Innovation Authority

Hagit Sela-Lidor

International Marketing & Communications Manager Email: Hagits@innovationisrael.org.il

Tel: +972-50-5362288

 

Pluristem

Dana Rubin

Director of Investor Relations Email: danar@pluristem.com Tel: +972-74-710-7194

 

Delegation of the European Union to the State of Israel

Sharon Offenberger

Press and Information Officer

Email : sharon.offenberger@eeas.europa.eu Tel: +972 3-6000911 / Mobile: +972 544-282213

 

European Commission

Siobhán MILLBRIGHT

Press officer for employment, social inclusion and investment Email : siobhan.millbright@ec.europa.eu

Tel : +32 295 73 61 / Mobile :+32 460 757361

·       Elaborating on agreement terms and tranches schedule

HAIFA, Israel, April 30, 2020 – Pluristem Therapeutics Inc. (Nasdaq:PSTI) (TASE:PSTI) (the “Company”), a leading regenerative medicine company developing a platform of novel biological therapeutic products, today provided a summary of an Investor & Analyst Call (the “Call”) conducted on April 30, 2020, in conjunction with the European Investment Bank (“EIB”) and kENUP Foundation. The purpose of the Call was to discuss the €50 million venture loan financing (the “Financing”) to Pluristem by the EIB and followed a signing ceremony of the Financing contract on Innovation Cell Therapies (EGFF) between the parties.

Speakers on the Call included Pluristem’s CEO and President, Yaky Yanay, and the Company’s, CFO, Chen Franco-Yehuda; the kENUP Foundation’s Chairman Holm Keller; and the EIB’s Investment Officer, Anna Stodolkiewicz. During the Call, the speakers presented details regarding the EIB’s Financing to Pluristem in support of the Company’s research and development in the European Union to further advance its regenerative cell therapy platform, and to assist in moving its pipeline to market, with a special focus on clinical development of PLX cells as a treatment for complications associated with COVID-19. The presentation was followed by a question and answer session with financial and industry analysts.

Pluristem CFO, Chen Franco-Yehuda, summarized the EIB’s Financing to Pluristem and provided an update on the Company’s financial highlights.

 

Pluristem CEO and President, Yaky Yanay, provided an update on the Company’s clinical programs. An Investigational New Drug (IND) application has been filed with the U.S. Food and Drug Administration (“FDA”) and a Clinical Trial Authorization (CTA) application has been submitted in Europe, starting with Germany and Italy. Pluristem intends to commence Phase II studies of PLX cell therapy in the treatment of complications arising from COVID-19 as soon as it receives clearance from regulators in the U.S. and Europe. Anticipating responses in the next few weeks, Pluristem aims to complete enrollment and treatment in few months, by utilizing its logistical and technological competitive advantages to support effective enrollment. In parallel, the Company will conduct an Expanded Access Program in U.S and Europe. The EIB Financing, once received, will allow the Company to expedite the process.

 

“By leveraging our logistical and technological competitive advantages, we believe we can rapidly and effectively enroll and treat COVID-19 patients in the U.S. and Europe.
We believe that the EIB’s Financing allows us to expedite this process and we are immensely grateful for their support.
While we plan to treat COVID-19 patients through a clinical trial framework, we plan to have parallel expanded access and compassionate use programs in the U.S., Europe, and Israel, through which we can continue to deliver our potentially life-saving PLX therapy to patients in need,” concluded Mr. Yanay.

Holm Keller, Chairman of kENUP Foundation commented regarding Pluristem’s activity, “Pluristem is an exceptionally innovative company advancing regenerative medicine solutions with cell manufacturing technologies that can truly make cell therapy available in mass quantities and efficiently.
It is for this reason that kENUP was compelled to bring Pluristem and the EIB together in partnership to accelerate the commercialization of regenerative medicine.”

Anna Stodolkiewicz, Investment Officer of the EIB said: “Through our financing, we aim to support Pluristem in addressing life threatening medical problems.
Be it COVID-19, critical limb ischemia or the recovery following hip fracture – all of them disproportionally affect an aging population.
We especially appreciate that Pluristem seeks to accelerate regenerative, non- invasive treatments that ease the burden on patients and Europe’s healthcare systems alike. In addition, Pluristem will create highly skilled jobs and economic opportunities in the EU.”

About the European Investment Bank

The European Investment Bank (EIB) is the long-term lending institution of the European Union, owned by its Member States.
It makes long-term finance available for sound investment in order to contribute towards EU policy goals.

Investment Plan for Europe

The Investment Plan for Europe (the Juncker Plan) is one of the EU’s key actions to boost investment in Europe, thereby creating jobs and fostering growth.
To this end, smarter use will be made of new and existing financial resources.
The EIB Group, consisting of the European Investment Bank and the European Investment Fund, is playing a vital role in this investment plan.
With guarantees from the European Fund for Strategic Investments (EFSI), the EIB and EIF are able to take on a higher share of project risk, encouraging private investors to participate in the projects.
In addition to EFSI, the new European Investment Advisory Hub (EIAH) helps public and private sector project promoters to structure investment projects more professionally. The projects and agreements approved under EFSI (European Fund for Strategic Investments) so far are expected to mobilise almost €466 billion of investments and will benefit over 1 million start- ups and SMEs (Small Medium Enterprises) in the 27 Member States.

 

About kENUP Foundation

kENUP is a global partnership in innovation, promoting research-based innovation for Europe with public and societal benefit. kENUP develops projects to pursue market-leading positions for European innovation businesses. In this capacity, kENUP is supporting the execution of the European Fund for Strategic Investments (EFSI, the so-called “Juncker Plan”), alongside its successor EFSI 2.0 and of the current InvestEU Fund. kENUP is a not-for-profit organization established as a foundation in the Republic of Malta by Public Deed on November 6, 2014. kENUP’s activities are published in the European Transparency Register.

 

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 discuss the intended use of proceeds of the Financing from the EIB to support its research and development in the EU to further advance its regenerative cell therapy product candidates, with a special focus on the treatment of complications associated with COVID-19, the belief that its financial resources are expected to fund its operations for the next three years, the creation of jobs and opportunities by Pluristem in the EU, the expected timing of interim data readouts, patient enrollments and the timing of public announcements of its clinical trials, and the timing of enrollment of certain studies, and the expected response from regulators, with respect to its IND application for the use of its PLX cells for the treatment of complications associated with COVID-19.
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 patents may not be sufficient; Pluristem products may harm recipients; changes in legislation; inability to timely develop and introduce new technologies, products and applications and; loss of market share and pressure on pricing resulting from competition, which could cause Pluristem’s actual results or performance to differ materially from those contemplated in such forward-looking statements.
Except as otherwise required by law, Pluristem undertakes 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 Pluristem, reference is made to Pluristem’s reports filed from time to time with the Securities and Exchange Commission.

 

Contact:

Dana Rubin

Director of Investor Relations 972-74-7107194

danar@pluristem.com

CONTACT US

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Terms of Use

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privacy policy

©2025 pluri™ inc

Terms of use

Use of the Pluri Web Site

General

Pluri Biotech Ltd., on its behalf and on behalf of its related companies, including without limitations, its parent company, Pluri Inc. (collectively: “Pluri”) maintains [https://www.pluri-biotech.com/] (this “Website”) for informational purposes in favor of the Internet community. Access to and use of information presented on this Website is subject to the following terms and conditions which may be revised at any time by Pluri and to the Privacy Notice located on this Website and incorporated hereto by reference.

The information contained in these pages is not intended to provide medical advice, recommendation or instruction on the appropriate use of Pluri’s technology, nor that Pluri technology is marketable nor fit for a particular purpose.  In addition, nothing herein shall be deemed as solicitation for purchasing any of Pluri’s securities.

Please read carefully the following terms and conditions. The use of this Website is governed by these terms and conditions and our Privacy Policy, By using and accessing this Website, you agree to be bound by these terms of use including any amendments that may be made by Pluri from time to time at its sole discretion. Pluri encourages the users of this Website to periodically review these terms of use for any changes or amendments.

Forward-Looking Statements; SEC / TASE Filings

Pluri Inc., is a public company, which securities are traded on the Tel Aviv Stock Exchange (TASE) and Nasdaq.  Statements on this Website regarding Pluri’s business which are not historical facts are “forward-looking statements” within the meaning of the “safe harbor” provisions of the Private Securities Litigation Reform Act of 1995 and federal securities laws, that involve risks and uncertainties. Forward-looking statements can be identified by, among other things, the use of forward-looking language, such as “anticipate”, “believe”, “could”, “estimate”, “expect”, “future”, “intend”, “plan”, “potential”, and may describe opinions about future events. These forward-looking statements are based on the current expectations of the management of Pluri 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 our clinical trials; 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 progress; our products may wind up being more expensive than we anticipate; results in the laboratory may not translate to equally good results in real surgical settings; 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 the actual results or performance of Pluri to differ materially from those contemplated in such forward-looking statements. For a more detailed description of the risks and uncertainties affecting Pluri, reference is made to Pluri’s reports filed from time to time with the Securities and Exchange Commission (“SEC”). Pluri disclaims any intention or obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise. No information or statement in this website is intended to solicit in any manner whatsoever any person to purchase or deal in any securities of Pluri. Pluri may provide links to its filings with the SEC for informational purposes only, and not for trading or investment purposes. Pluri does not guarantee the sequence, accuracy or completeness of any information or data displayed through these links. Pluri does not assume any duty of disclosure and expressly disclaims any duty to update information set forth in its filings with the SEC.  The stock price performance shown on stock quotes may be available on or through this Website is not necessarily indicative of future price performance. All content is for informational purposes only and no content is intended to be relied upon for trading or investment purposes. Nothing on this website constitutes an invitation or offer to invest or deal in the securities of Pluri. In particular, actual results and developments may be substantially and materially different from any opinion or forecast expressed on this website.

Links to Third Party Websites

The Website may provide links to World Wide Web sites or resources. Because Pluri has no control over such sites and resources, you acknowledge and agree that Pluri is not responsible for the availability of such external sites or resources, and does not endorse and is not responsible or liable for any information, advertising, products, or other materials on or available from such sites or resources. You further acknowledge and agree that Pluri shall not be responsible or liable, directly or indirectly, for any damage or loss caused or alleged to be caused by or in connection with use of or reliance on any such information, goods or services available on or through any such site or resource.

Conduct

Within the course of your use of the Website you will strictly adhere with the following policies, such that, you must not:

·         Scan or use this Website via operation of a computer program designed to gather information or perform operations imitating a human user (including, without limitation, Bots or Crawlers);

·         Manipulate the architecture of this Website, or otherwise gain access to any of its engines and/or databases to which we did not provide you with an expressly permitted access (including, without limitation, URL Hacking);

·         Carry out any action which may infringe the copyrights and/or any other proprietary information of ours or any other copyright holder;

·         Copy, transmit, decompile, modify, create derivative works, reproduce, disassemble, republish, scrape, and/or reverse engineer (including any extraction of the work process) any algorithm, code, syntax and/or any other content associated with this Website and/or any components thereof and/or act to collect, harvest and/or data mine any data associated with the Website and/or any of its users (whether by computer programs, identity theft, impersonation, or otherwise) and/or take any action which may be deemed as impersonating another person or entity, identity theft, etc.;

·         Carry out any action which may infringe any laws, regulations, orders or any guidelines of any governmental authority, is likely to offend or harm any other users of this Website and/or the general public;

·         Steal or attempt to steal private information from other users of this Website;

·         Email us content which is or could be considered libelous, defamatory, indecent, vulgar, obscene, pornographic, sexually explicit or suggestive, racially or ethically offensive, harmful, harassing, intimidating, threatening, discriminatory, or abusive;

·         Carry out any action that violates these Terms, Privacy Notice and/or any other guidelines or policies as prescribed herein and/or as otherwise published by us from time to time.

·         Assist, encourage or enable others to do any of the preceding prohibited activities.

Intellectual Property Rights

You acknowledge that Pluri owns all copyrights in the information, selection, coordination, arrangement and enhancement of this Website, which may contain information, software, photos, video, text, graphics, or other material posted or uploaded by Pluri (collectively, the “Pluri Content”), and that these rights are valid and protected in all forms, media and technologies existing now or here after developed. Pluri has the full rights and authorization to use this Website’s name and logo. You may not modify, publish, transmit, participate in the transfer or sell, create derivative works, or in any way exploit, any of the Pluri Content, in whole or in part. Modification of the Pluri Content or use of any Pluri Content on any other website, networked computer environment or elsewhere is strictly prohibited. The Pluri Content is subject to copyright protection. You may not copy the contents of this Website other than for non-commercial individual reference with all copyright or other proprietary notices retained, and thereafter the contents may not be recopied, reproduced or otherwise redistributed. You may not distribute, modify, repost, copy, publish license or use the contents of this website, including information, photos, video, text, graphics or other material posted or upload by Pluri for public or commercial purposes. Some of the tradenames or trademarks used in this Website are registered trademarks of Pluri and/or its affiliates. The use or misuse of any of these trademarks or unregistered trademarks or any other materials, except as permitted herein, is expressly prohibited and may result, inter alia, in violation of copyright laws and trademark laws.

Subject to any applicable terms and conditions set forth in our Privacy Notice, any communication or other material that you send to us through the Internet or post on the Website by electronic mail or otherwise, such as any questions, comments, suggestions or the like, is and will be deemed to be non-confidential and we shall have no obligation of any kind with respect to such information. Pluri shall be free to use any ideas, concepts, know-how or techniques contained in such communication for any purpose whatsoever, including but not limited to, developing, manufacturing and marketing products.

Disclaimers

THE INFORMATION AND/OR STATEMENTS PROVIDED ON THIS WEBSITE ARE PROVIDED ‘AS IS’ AND FOR NO COST AND YOU MAY USE IT AT YOUR SOLE RISK. PLURI EXPRESSLY DISCLAIMS ALL WARRANTIES OF ANY KIND, WHETHER EXPRESS OR IMPLIED, INCLUDING, BUT NOT LIMITED TO THE IMPLIED WARRANTIES OF MERCHANTABILITY, FITNESS FOR A PARTICULAR PURPOSE AND NON-INFRINGEMENT. WITHOUT LIMITATION, PLURI MAKES NO WARRANTY THAT THIS WEBSITE AND/OR THE INFORMATION PROVIDED THEREIN WILL MEET YOUR REQUIREMENTS, THAT IT WILL BE UNINTERRUPTED, TIMELY, SECURE, OR ERROR-FREE, THAT THE RESULTS OBTAINED FROM THE USE OF THIS WEBSITE WILL BE ACCURATE OR RELIABLE, OR THAT THE QUALITY OF ANY INFORMATION OR OTHER MATERIAL OBTAINED THROUGH THIS WEBSITE WILL MEET YOUR EXPECTATIONS. ANY MATERIAL DOWNLOADED OR OTHERWISE OBTAINED THROUGH THE USE OF THIS WEBSITE IS DONE AT YOUR SOLE RISK AND YOU WILL BE SOLELY RESPONSIBLE FOR ANY DAMAGE TO YOUR COMPUTER SYSTEM OR LOSS OF DATA THAT RESULTS FROM THE DOWNLOAD OF ANY SUCH MATERIAL.

Limitation of Liability

YOU EXPRESSLY UNDERSTAND AND AGREE THAT PLURI INCLUDING ITS OFFICERS, DIRECTORS, SHAREHOLDERS, EMPLOYEES, SUB-CONTRACTORS AND AGENTS SHALL NOT BE LIABLE FOR ANY DIRECT, INDIRECT, INCIDENTAL, SPECIAL, CONSEQUENTIAL OR EXEMPLARY DAMAGES, INCLUDING BUT NOT LIMITED TO, DAMAGES FOR LOSS OF PROFITS, GOODWILL, USE, DATA OR OTHER INTANGIBLE LOSSES (EVEN IF PLURI HAS BEEN ADVISED OF THE POSSIBILITY OF SUCH DAMAGES), RESULTING FROM THE USE OF OR THE INABILITY TO USE THIS WEBSITE AND/OR INFORMATION PROVIDED THEREIN. SOME JURISDICTIONS DO NOT ALLOW THE EXCLUSION OF CERTAIN WARRANTIES OR THE LIMITATION OR EXCLUSION OF LIABILITY FOR INCIDENTAL OR CONSEQUENTIAL DAMAGES. ACCORDINGLY, SOME OF THE ABOVE LIMITATIONS MAY NOT APPLY TO YOU.

WITHOUT DEROGATING FROM THE GENERAL NATURE OF THE FOREGOING, WE ASSUME NO LIABILITY FOR ANY DAMAGES CAUSED BY VIRUSES, WORMS AND/OR OTHER MALICIOUS SOFTWARE WHICH MAY INFECT THE USER’S MACHINE(S).

Indemnification

You agree to indemnify, defend and hold harmless Pluri, its officers, directors, shareholders, employees, sub-contractors, affiliates, agents and anyone acting on their behalf, at your own expense and immediately after receiving a written notice from Pluri, from and against any damages, loss, costs, expenses and payments, including reasonable attorney’s fees and legal expenses, resulting from any complaint, claim, or demand, arising from or related to your breach of these terms of use, or any other terms, rules or regulations applicable to this website, or your violation, or infringement of other persons rights.

Miscellaneous

Governing Law. These terms of use shall be governed in accordance with the laws of the State of Israel without giving effect to any conflicts of law principles. Any dispute in connection with these terms of use shall be submitted to the exclusive jurisdiction of the competent courts situated in Tel Aviv, Israel.

Entire Agreement. These terms and conditions contain the entire agreement between the parties with respect to the subject matter hereof, and supersede all prior and contemporaneous representations, promises, agreements and understandings, whether oral or written, between the parties concerning the subject matter hereof.

Severability. If any provision of these terms of use shall be deemed to be invalid, void, illegal or for any reason unenforceable, that term or condition shall be deemed severable and shall not affect the validity and enforceability of the remaining terms set forth herein. Subject to any applicable law, all disputes between you and us shall only be resolved on an individual basis and you shall not have the right to bring any claim against us as a plaintiff or a member of a class, consolidated or representative actions (or any other legal proceedings conducted by a group or by representatives on behalf of others).

Assignment. You may not assign any rights and/or obligations you may have under these terms and conditions and/or Privacy Notice without our prior written consent. We may freely assign any of its rights and/or obligations herein, without limitations; provided that, your rights herein shall not be adversely affected.

Change of Control. It is clarified that in the event of a merger, change of control and/or any similar transaction involving Pluri, Pluri may transfer and export all information it may have gained through the course of the use of the Website, and your use of this Website constitutes as consent for the foregoing; provided however, that any such transfer shall be subject to applicable data privacy requirements and standards.

Amendment. Pluri reserves the right to amend or revise any of these terms of use. Any such change or amendment shall be updated on this Website.

The content, text, graphics, data, and services offered herein are provided solely to educate users of this Website on Pluri and the goods and/or services it may provide.  Nothing in said content should be considered, or used as a substitute for, medical advice, diagnosis or treatment.  Always seek the advice of your physician or other qualified health provider with any questions you may have regarding a medical condition.  Reliance on said content or any portion thereof, or other visitors to the web site, is solely at your own risk.

If you have cause to believe any content found on the Platform to be in violation of these terms and conditions and/or infringe any third party proprietary rights and/or applicable law, kindly notify us of such content via email to info@pluri-biotech.com,  stating the violating content and the nature of violation.

Physical address:  Matam Park, Building 05, Haifa, 3508409, Israel

Accessibility

Accessibility Statement

Pluri Biotech Ltd. is committed to making its electronic and information technologies accessible to individuals with disabilities by meeting or exceeding the requirements of the Web Content Accessibility Guidelines and we make every effort to ensure our communications – including this website – are accessible to people with special needs.

We have striven to make this website adhere to priority 1 and 2 guidelines of the W3 Web Content Accessibility Guidelines.

 

Navigation and navigation aids

  • The full site navigation is located on every page.
  • A link to the home page is available on each page.
  • Navigation menus are marked up as HTML lists and styled with CSS.
  • Some links have title attributes, which describe the link in greater detail. Most links are self-explanatory.
  • Links are written so as to make sense out of context.
  • Some links, mostly to downloadable files such as PDFs, open a new browser tab.

Help with finding content

Although we do our best to meet the requirements and guidelines, it is possible that some of the content is not yet fully accessible and compatible to people with special needs.

We continue to develop and improve our website as part of our general commitment to make every effort to ensure our communications are accessible to all.
If you require assistance or wish to report an issue related to the accessibility of any content on this website, please contact info@pluri-biotech.com. If applicable, please include the web address or URL and the specific problems you have encountered.

Privacy and Data Protection Policy and Notice

Last updated on 13 January 2025

Pluri Biotech Ltd. and its affiliates and related companies (“Pluri”, “we”, “our” or the “Company”, and their cognates) respects the privacy of its research partners, academic affiliate representatives, investors, clinical studies participants, employees, vendors and sites and website visitors, and others of whom we collect information, and is committed to protecting the personal information you may share with us (these and any others with respect to whom we collect personal data, shall collectively be referred to as “you”, “user”, or “data subject”).

Pluri develops platforms to manufacture cell-based products aimed at improving human well-being, increasing sustainability, and addressing significant global challenges (the “Services”). This policy and notice (the “Privacy Policy”) explains the types of information we may collect from you, that we may receive about you or that you may provide in the course of your interest or in our Services, transactions, conferences or when you use our platforms or services or visit our website. We are transparent about our practices regarding the information we collect, use, maintain and process and describe our practices in this policy and notice. Please read the following carefully to understand our practices regarding your personal data and how we will treat it.

For the purposes of EU General Data Protection Regulation ( “GDPR”), the California Consumer Privacy Act of 2018, as amended by the California Privacy Rights Act of 2020 (“CCPA”) other US State privacy laws, and any other applicable data protection and privacy laws, Pluri is usually a data controller (or ‘owner’) in relation to the personal data collected and processed through our Services or provided to us by our research partners.

 

  1. WHICH INFORMATION MAY WE COLLECT?

Summary: we collect various categories of personal data in order to meet our contractual obligations, and also to meet various legitimate interests, such as service improvement, fraud prevention and marketing.

We collect data about you in connection with your transactions with us, or in processing data for our research partners. We also collect data about our visitors and website visitors. One type of data collected is non-identifiable and anonymous information (“non-personal data”). We also collect several categories of personal data (“Personal Data”), as described below.

Personal Data which is being gathered consists of any details which are personally identifiable and which are provided consciously and voluntarily by you, or by an organization you represent or are associated with or through your use of our website and registration to and use of our Services (as described below), by email, or other ways in which you communicate and interact with us. This generally includes your name (first and last), email address, phone number, postal address, position and organization name and other information you may choose to provide to Pluri directly and willingly through your use of our Services. Additionally, we may obtain data related to the geographic location of your laptop, mobile device or other digital device on which the Pluri website or platform are used.

You do not have any legal obligation to provide any information to Pluri, however, we require certain information in order to perform contracts, or to provide any services. If you choose not to provide us with certain information, then we may not be able to provide you or your organization with some or all of the services.

By contacting us or submitting requests for information or support via the website, email etc., Pluri will collect details, including also your name, phone number and personal or company email you provided, country, professional details and other information provided by you. Pluri may use this information to offer Pluri’s services and support.

When participating in clinical research conducted by us or in collaboration with our research partners, we collect the necessary information, including health-related data.

 

  1. HOW DO WE COLLECT PERSONAL DATA OF YOURS ON PLURI FACILITIES AND SERVICES?

Summary: we collect Personal Data when you or your organization send it to us, or when a vendor, distributor or other research partner sends it to us so; we collect Personal Data through our website and Services, and through our interactions with you.

We collect Personal Data required to provide Services when you register interest, or when you provide us such information by entering it manually or automatically, or through your use of our facilities, website and Services, in the course of preparing a contract, or otherwise in engaging with us. We also may collect Personal Data when you call us for support, in which case we collect the information you provide us.

On our website, we collect technical and behavioral information such as the user’s Internet protocol (IP) address used to connect your device to the Internet, your uniform resource locators (URL), operating system, type of browser, browser plug-in types and versions, screen resolution, time zone setting, the user’s ‘clickstream’ on our website, the period of time the user visited the platform etc. We also We likewise may place cookies on your browsing devices (see ‘Cookies’ section below).

 

  1. WHAT ARE THE PURPOSES OF PERSONAL DATA WE COLLECT?

Summary: we process Personal Data to meet our obligations, protect our rights, and manage our activities.

We will use Personal Data to provide and improve our services to you or to our research partners and others and meet our contractual, ethical and legal obligations. All Personal Data will remain accurate complete and relevant for the stated purposes for which it was processed, including for example:

Processing which is necessary for the performance of a contract to which you are a party or in order to take steps at your request prior to entering into a contract:

  • Carrying out our obligations arising from any contracts entered into between you or your employer or organization and Pluri or Pluri’s research partners and/or any contracts entered into with Pluri and to provide you with the information, products, support and services that you request from Pluri and its research partners;
  • Verifying and carrying out financial transactions in relation to payments you make in connection with the Services.

Processing which is necessary for the purposes of the legitimate interests pursued by Pluri or by a third party of providing an efficient and wide-ranging service to research partners:

  • Notifying you about changes to our service;
  • Collecting data from various publicly available sources, including commercially licensed databases to develop and improve our Services;
  • Contacting you to give you commercial and marketing information about events or promotions or additional services offered by Pluri which may be of interest to you, including in other locations;
  • Soliciting feedback in connection with the services;
  • Tracking use of Pluri services to enable us to optimize them.
  • For security purposes and to identify and authenticate your access to the Services.

Processing which is necessary for compliance with a legal obligation to which Pluri is subject:

  • Compliance and audit purposes, such as meeting our reporting obligations in our various jurisdictions, anti-money laundering, and for crime prevention and prosecution in so far as it relates to our staff, research partners, facilities etc;
  • If necessary, we will use Personal Data to enforce our terms, policies and legal agreements, to comply with court orders and warrants and assist law enforcement agencies as required by law, to collect debts, to prevent fraud, infringements, identity thefts and any other service misuse, and to take any action in any legal dispute and proceeding;

We aggregate and de-identify Personal Data (i.e., use your data in a way which no longer allows to identify you) to analyze and improve our Services, and to conduct research, and for other similar purposes. We may share non-personal aggregated information with third parties, as described below.

 

  1. SHARING DATA WITH THIRD PARTIES

Summary: we share Personal Data with our service providers, research partners and academic institutions, group companies, and authorities where required.

We transfer Personal Data to:

 

Research partners, Academic institutions and Collaborators. We transfer or receive Personal Data from our various partners in order to facilitate joint research projects, enhance the quality and scope of our studies, and ensure the accuracy and reliability of our findings. This data exchange enables us to conduct collaborative research and development activities, fulfill contractual obligations with research partners and collaborators, comply with regulatory requirements applicable to clinical studies and research and advance scientific discoveries and innovations in line with our mission.  

Third Parties. We transfer Personal Data to third parties in a variety of circumstances. We endeavor to ensure that these third parties use your information only to the extent necessary to perform their functions, and to have a contract in place with them to govern their processing on our behalf. These third parties include business partners, suppliers, affiliates, agents and/or sub- contractors for the performance of any contract we enter into with you. They assist us in providing the services we offer, processing transactions, fulfilling requests for information, receiving and sending communications, analyzing data, providing IT and other support services or in other tasks, from time to time. These third parties also include analytics and search engine providers that assist us in the improvement and optimization of our platform, website, and our marketing.

We periodically add and remove third party providers. At present services provided by third-party providers to whom we may transfer Personal Data include also the following:

– Website and platform analytics, including Google Analytics;

– Expression and language measurement services;

– Document management and sharing services;

– Ticketing and support;

– On-site and cloud-based database services;

– CRM software;

– Data security, data backup, and data access control systems;

– Project management systems;

– Our lawyers, accountants, and other standard business software and partners.

In addition, we will disclose your Personal Data to third parties if some or all of our companies or assets are acquired by a third party including by way of a merger, share acquisition, asset purchase or any similar transaction, in which case Personal Data will be one of the transferred assets. Likewise, we transfer Personal Data to third parties if we are under a duty to disclose or share your Personal Data in order to comply with any legal or audit or compliance obligation, in the course of any legal or regulatory proceeding or investigation, or in order to enforce or apply our terms and other agreements with you or with a third party; or to assert or protect the rights, property, or safety of Pluri, our research partners, or others. This includes exchanging information with other companies and organizations for the purposes of fraud protection and credit risk reduction and to prevent cybercrime.

For purposes of the California Consumer Privacy Act as amended (“CCPA”) or other US privacy state laws, Pluri does not “sell” or “share” personal information, nor do we allow any personal information to be used by third parties for their own marketing. However, we use analytics tools and other technologies (as described above), which may be construed as a “sale” under privacy laws to which you may opt- out of. For avoidance of doubt, Pluri may transfer and disclose non-Personal Data to third parties at its own discretion.

 

  1. WHERE DO WE STORE YOUR DATA?

Summary: we store your Personal Data across multiple locations globally

We store your Personal Data in databases owned or controlled by us, or processed by third parties on our behalf, by reputable cloud-service providers (see the following section regarding international transfers).

 

  1. INTERNATIONAL DATA TRANSFERS

Summary: we transfer Personal Data within and to the EEA, USA, Israel and elsewhere, with appropriate safeguards in place.

Personal Data may be transferred to, and stored and processed at, a destination outside its origin. EU data may be transferred outside the European Economic Area (EEA). This includes transfer to Israel, a jurisdiction deemed adequate by the EU Commission, and to the USA, which may be deemed adequate under certain circumstances but not always. Where your Data is transferred outside of the EEA, we will take all steps reasonably necessary to ensure that your Data is subject to appropriate safeguards, including entering into contracts that require the recipients to adhere to data protection standards that are considered satisfactory under EU law and other applicable, and that it is treated securely and in accordance with this Privacy Policy. Transfers to Israel are made based on an adequacy ruling by the EU Commission. Transfers to the USA are made based either on an adequacy ruling to members of the data privacy framework, or based on the Standard Contractual Clauses published by the EU Commission. For more information about these safeguards, please contact us as set forth below.

We may transfer your Personal Data outside of the EEA, in order to:

– Store or backup the information;

– Enable us to provide you with the services and products and fulfill our contract with you;

– Fulfill any legal, audit, ethical or compliance obligations which require us to make that transfer;

– Facilitate the operation of our group businesses, where it is in our legitimate interests and we have concluded these are not overridden by your rights;

– Collaborate with our research partners across multiple jurisdictions.

 

  1. DATA RETENTION

Summary: we retain Personal Data according to our data retention policy, as required to meet our obligations, protect our rights, and manage our business and activities.

Pluri will retain Personal Data it processes only for as long as required in our view, to provide the Services and as necessary to comply with our legal and other obligations, to resolve disputes and to enforce agreements. We will also retain Personal Data to meet any audit, compliance and industry practices.

Data that is no longer retained may be anonymized or deleted. Likewise, some metadata and statistical information concerning the use of our services are not subject to the deletion procedures in this policy and will be retained by Pluri. We will not be able to identify you from this data. Some data may also be retained on our third-party service providers’ servers until deleted in accordance with their privacy policy and their retention policy, and in our backups until overwritten.

 

  1. SERVICES AND WEBSITE DATA COLLECTION AND COOKIES

Summary: we retain Personal Data according to our data retention policy, as required to meet our obligations, protect our rights, and manage our business.

Summary: with your consent, we place cookies on your device. You control our use of cookies through a cookie management tool on our website, or through your device and browser.

Pluri uses cookies, pixel tags and other forms of identification and local storage (together referred to as “tags/files” hereunder) to distinguish you from other users of the website and of websites of our network. This helps us to provide you with a good user-experience when you browse the website and websites of our network and also allows us to improve our website and our services.

In many cases, these tags/files lead to the use of your device’s processing or storage capabilities. Some of these tags/files are set by Pluri itself, others by third parties; some only last as long as your browser session, while others can stay active on your device for a longer period of time.

These tags/files can fall into several categories: (i) those that are necessary for functionality or services that you request or for the transmission of communications (functionality tags/files); (ii) those that we use to carry out website performance and audience metrics (analytics tags/files) and (iii) the rest (tracking across a network of other websites, advertising, etc.) (other tags/files).

Internet browsers allow you to change your cookie settings, for example to block certain kinds of cookies or files. You can therefore block cookies by activating the setting on your browser that allows you to refuse the setting of all or some cookies. However, if you use your browser settings to block all cookies, you may not be able to access all or parts of the website, due to the fact that some may be functionality cookies. For further information about deleting or blocking cookies, please visit: https://www.aboutcookies.org/how-to-delete-cookies/

Functionality and analytical tags/files do not require your consent. For other tags/files, however, we request your consent before placing them on your device. You can allow cookies in your browser settings and using our website cookie management too.

To consult the list of cookies which we use on our website, please check your browser’s settings. Instructions: https://www.wikihow.com/View-Cookies

 

  1. SECURITY AND STORAGE OF INFORMATION

Summary: we retain Personal Data according to our data retention policy, as required to meet our obligations, protect our rights, and manage our business.

We take great care in implementing, enforcing and maintaining the security of the Personal Data we process. Pluri implements, enforces and maintains security measures, technologies and policies to prevent the unauthorized or accidental access to or destruction, loss, modification, use or disclosure of Personal Data. We likewise take steps to monitor compliance of such policies on an ongoing basis. Where we deem it necessary in light of the nature of the data in question and the risks to data subjects, we may encrypt data. Likewise, we take industry standard steps to ensure our website and services are safe.

Note however, that no data security measures are perfect or impenetrable, and we cannot guarantee that unauthorized access, leaks, viruses and other data security breaches will never occur.

Within Pluri, we endeavor to limit access to Personal Data to those of our personnel who: (i) require access in order for Pluri to fulfill its obligations, including also under its agreements, and as described in this Privacy Policy, and (ii) have been appropriately and periodically trained with respect to the requirements applicable to the processing, care and handling of the Personal Data, and (iii) are under confidentiality obligations as may be required under applicable law.

Pluri shall act in accordance with its policies and with applicable law to promptly notify the relevant authorities and data subjects in the event that any Personal Data processed by Pluri is lost, stolen, or where there has been any unauthorized access to it, all in accordance with applicable law and on the instructions of qualified authority. Pluri shall promptly take reasonable remedial measures.

 

  1. DATA SUBJECT RIGHTS

Summary: depending on the law that applies to your Personal Data, you may have various data subject rights, such as rights to access, erase, and correct Personal Data, and information rights. We will respect any lawful request to exercise those rights.

Data subjects with respect to whose data GDPR, CCPA or other data protection or privacy laws apply, have rights under GDPR and local laws, including, in different circumstances, rights to data portability, rights to access data, rectify data, object to processing, and erase data. It is clarified for the removal of doubt, that where Personal Data is provided by a research partner or academic institution being the data subject’s employer or data controller, such data subject rights will have to be effected through that research partner, the data subject’s employer or supplier. In addition, data subject rights cannot be exercised in a manner inconsistent with the rights of Pluri employees and staff, with Pluri proprietary rights, and third-party rights. As such, job references, reviews, internal notes and assessments, documents and notes including proprietary information or forms of intellectual property, cannot be accessed or erased or rectified by data subjects. In addition, these rights may not be exercisable where they relate to data that is not in a structured form, for example emails, or where other exemptions apply. If processing occurs based on consent, data subjects have a right to withdraw their consent.

A data subject who wishes to modify, delete or retrieve their Personal Data, including from our database, or to opt-out from using data to train our models, may do so by contacting Pluri (dataprotection@pluri-biotech.com). Note that Pluri may have to undertake a process to identify a data subject exercising their rights. Pluri may keep details of such rights exercised for its own compliance and audit requirements. Please note that Personal Data may be either deleted or retained in an aggregated manner without being linked to any identifiers or Personal Data, depending on technical commercial capability. Such information may continue to be used by Pluri.

Data subjects in the EU, and in other locations have the right to lodge a complaint, with a data protection supervisory authority in the place of their habitual residence. If the supervisory authority fails to deal with a complaint, you may have the right to an effective judicial remedy.

 

  1. GENERAL

Summary: depending on the law that applies to your Personal Data, you may have various data subject rights, such as rights to access, erase, and correct Personal Data, and information rights. We will respect any lawful request to exercise those rights.

Minors. We do not knowingly collect or solicit information or data from or about children under the age of 16 or knowingly allow children under the age of 16 to register for Pluri services. If you are under 16, do not register or attempt to register for any of the Pluri service or send any information about yourself to us. If we learn that we have collected or have been sent Personal Data from a child under the age of 16 unlawfully, we will delete that Personal Data as soon as reasonably practicable without any liability to Pluri. If you believe that we might have collected or been sent information from a minor under the age of 16, please contact us at: dataprotection@pluri-biotech.com, as soon as possible.

Changes to this Privacy Policy. The terms of this Privacy Policy will govern the use of the Services, website, and any information collected in connection with them. Pluri may amend or update this Privacy Policy from time to time. The most current version of this Privacy Policy will be available at: www. pluri-biotech.com/privacy-policy. Changes to this Privacy Policy are effective as of the stated “Last Revised” date and your continued use of our services will constitute your active acceptance of the changes to and terms of the Privacy Policy.

Pluri aims to process only adequate, accurate and relevant data limited to the needs and purposes for which it is gathered. Note that due to the nature of the Services we cannot guarantee the accuracy of the output of the Services. You may request correction or removal of your data by reaching out to us at: dataprotection@pluri-biotech.com.

Pluri aims to store data for the time period necessary to fulfill the purpose for which the data is gathered. we only collect data in connection with a specific lawful purpose and only processes data in accordance with this Privacy Policy. Our policies and practices are constantly evolving and improving, and we invite any suggestions for improvements, questions, complaints or comments concerning this Privacy Policy, you are welcome to contact us (details below) and we will make an effort to reply within a reasonable time frame.

Pluri’s data protection officer (DPO) may be contacted at: info@pluristem.com; dataprotection@pluristem.com

Physical address: Pluristem Ltd. Attention: Legal Counsel and DPO

Matam Park, Building 05 Haifa, 3508409, Israel

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©2023 Pluri™ Inc.

©2023 Pluri™ Inc., its logo, brand, product, and process names appearing in this issue are the trademarks of Pluri™ Inc. or its affiliated companies. All other brand, product, and process names appearing are the trademarks of their respective holders. Reference to or use of a product, or process other than those of Pluri™ Inc. does not imply recommendation, approval, affiliation, or sponsorship of that product, or process by Pluri™ Inc. Nothing contained herein shall be construed as conferring by implication, estoppel, or otherwise any license or right under any patent, copyright, trademark, or other intellectual property right of Pluri™ Inc. or any third party, except as expressly granted herein.  All information herein is for general information only and is subject for change without notice.

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