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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 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.
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.
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.
Dana Rubin
Director of Investor Relations 972-74-7107194
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.
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.
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.
Dana Rubin
Director of Investor Relations 972-74-7107194
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.
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.
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.
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.
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.
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.
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.
Marie Antonie Kerwien
Communication
Email: a.kerwien@eib.org Tel: +352437982175
Hagit Sela-Lidor
International Marketing & Communications Manager Email: Hagits@innovationisrael.org.il
Tel: +972-50-5362288
Dana Rubin
Director of Investor Relations Email: danar@pluristem.com Tel: +972-74-710-7194
Sharon Offenberger
Press and Information Officer
Email : sharon.offenberger@eeas.europa.eu Tel: +972 3-6000911 / Mobile: +972 544-282213
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
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.
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.
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.
Dana Rubin
Director of Investor Relations 972-74-7107194
EIB, kENUP Foundation and Pluristem Will Host Investor & Analyst Call
HAIFA, Israel, April 27, 2020 – Pluristem Therapeutics Inc. (Nasdaq:PSTI) (TASE:PSTI), a leading regenerative medicine company developing a platform of novel biological therapeutic products, cordially invites investors, the media, and the public to join a signing ceremony and analyst & investor call on Thursday, April 30, 2020.
Signing of a Memorandum of Understanding on Bio-Convergence in Health between the European Investment Bank and Israel Innovation Authority of the State of Israel
&
Signing of Finance Contract on Innovation Cell Therapies (EGFF) between the European Investment Bank and Pluristem.
Bio-Convergence Health is a collaboration between Israel and Europe to advance technological and investment alliances.
As previously announced, the European Investment Bank is providing a €50 million non-dilutive financing to Pluristem in support of the Company’s research and development in the EU to further advance its regenerative cell therapy platform, and to assist moving the products in its pipeline to market, with a special focus on clinical development of PLX cells as a treatment for complications associated with COVID-19.
The half-hour signing ceremony will be live streamed at: https://signing-ceremony.eu/
The European Investment Bank, kENUP Foundation and Pluristem will conduct a call to discuss the €50 million financing. Analysts are invited to ask questions during the Q&A session. The public is invited to listen to the call at: https://signing-ceremony.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.
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.
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 expectation to receive the financing from the EIB, the belief that the financing will support its research and development in the EU to further advance its regenerative cell therapy platform, to assist moving the products in its pipeline to market, with a special focus on clinical development of PLX cells as a treatment for 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’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.
Dana Rubin
Director of Investor Relations 972-74-7107194
EXPECTED ONLINE SIGNING CEREMONY ON APRIL 30, 2020
HAIFA, Israel, April 24, 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 European Investment Bank (“EIB”) has approved a €50 million non- dilutive financing for the Company (the “Approved Financing”). This Approved Financing, once received, will support Pluristem’s research and development in the EU to further advance its regenerative cell therapy platform, and to assist moving the products in its pipeline to market, with a special focus on clinical development of PLX cells as a treatment for complications associated with COVID-19. The Approved Financing will be deployed in three tranches, subject to the achievement of certain clinical, regulatory and scaling up milestones, with the first tranche consisting of €20 million. The expected signing date of the financing agreement relating to the Approved Financing is April 30, 2020.
Pluristem recently formed a wholly-owned subsidiary in Berlin, Germany, underscoring the Company’s commitment to having a physical presence in Europe to advance research and development, and to prepare for commercialization, for its product candidates.
The Approved Financing is backed by a guarantee from the European Fund for Strategic Investments (EFSI), the financial pillar of the Investment Plan for Europe, under which the EIB and the European Commission are working together as strategic partners to boost Europe’s economic competitiveness. The transaction has been initiated by kENUP Foundation, a global partnership in innovation, promoting research-based innovation for Europe with public and societal benefit.
The Approved Financing, once granted, will not be secured and will be payable to the EIB in a single payment following five years from the disbursement of the first and second tranches and in two annual payments starting on the fourth year from disbursement of the third tranche, with each tranche having an interest rate of between 3% to 4%. The Approved Financing will support up to 50% of Pluristem’s R&D project cost. In addition, the EIB would be entitled to receive royalties from future revenues for a period of seven years starting 2024, at a rate of 0.2% to 2.3%, pro-rated to the amounts that the Company received from the Approved Financing.
“We are extremely honored to have been selected by the EIB for this prestigious financing. We believe that this financing will allow us to significantly advance the clinical development of our lead product candidates, which if successful we expect will improve the quality of life for millions of patients around the world. Having established research partnerships with leading European institutions such as Charité University of Medicine Berlin, BIH Center for Regenerative Therapy (BCRT) and the Berlin Center for Advanced Therapies (BeCAT), as well as formed a subsidiary in Berlin, we understand the importance of having a physical presence in key markets,” stated Pluristem CEO and President, Yaky Yanay. “As we move forward into a multinational clinical trial for PLX cells to treat patients suffering from complications associated with COVID-19, we expect this EIB financing will accelerate our path to approval and to making a potentially effective COVID- 19 treatment available worldwide.”
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.
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.
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.
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 expectation that it will execute a definitive agreement for the Approved Financing and the proposed terms of such Approved Financing, the belief that the Approved Financing will support its research and development in the EU to further advance its regenerative cell therapy platform, to assist moving the products in its pipeline to market, with a special focus on clinical development of PLX cells as a treatment for complications associated with COVID-19, that such Approved Financing will allow it to significantly advance its clinical development of its lead product candidates which it expects will improve the quality of life for millions of patients around the world and the expectation that the Approved Financing will accelerate its path to approval of its COVID-19 multinational clinical trial and to making a potentially effective COVID-19 treatment available worldwide.
While the EIB has announced the approval of the Approved Financing, there is no guarantee that the Company and the EIB will execute the definitive agreement on April 30, 2020, if at all, or that it 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.
Dana Rubin
Director of Investor Relations
+972-74-7107194
HAIFA, Israel, April 13, 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 treated its first patient suffering from COVID-19 complications in the United States under the U.S. Food and Drug Administration’s (FDA) Single Patient Expanded Access Program, also called a compassionate use program, which is part of the U.S. Coronavirus Treatment Acceleration Program (CTAP), an emergency program for possible therapies that uses every available method to move new treatments to patients as quickly as possible.
The patient was treated with PLX cell therapy at Holy Name Medical Center in New Jersey, an acute care facility that is currently an active site for Pluristem’s Phase III critical limb ischemia (CLI) study. Prior to treatment with PLX, the patient was critically ill with respiratory failure due to acute respiratory distress syndrome (ARDS) and was under mechanical ventilation in an intensive care unit (ICU) for three weeks.
“We are receiving many inquiries and requests for treatment from healthcare providers and families worldwide. In parallel with our planned clinical trial, we expect to continue treating patients under compassionate use through the appropriate regulatory clearances in the United States and Israel, as well as expanding treatment under compassionate use in other countries. Our main focus remains however, the initiation of a multinational clinical study,” stated Pluristem CEO and President Yaky Yanay.
Pluristem’s main target is to initiate a multinational clinical trial as soon as possible for PLX cells in the treatment of patients suffering from complications associated with COVID-19. As the Company focus is the initiation of such clinical trial, it does not intend to provide further updates on the status of patients treated under compassionate use. Pluristem will update on the status and progress of its planned COVID-19 clinical trial program.
PLX cells are available off-the-shelf and once commercialized, can be manufactured in large scale quantities, offering a key advantage in addressing a 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.
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.
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 expectation that it will continue treating patients under compassionate use through the appropriate regulatory clearances in the United States and Israel, that it expects to expand treatment under compassionate use in other countries, that Pluristem’s main target is to initiate a multinational clinical trial as soon as possible for PLX cells in the treatment of patients suffering from complications associated with COVID-19, its intention not to provide further updates on the status of COVID-19 patients treated under compassionate use, when it discusses updating on the status and progress of its contemplated clinical trial program, 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.
Dana Rubin
Director of Investor Relations 972-74-7107194
HAIFA, Israel, April 7, 2020 – Pluristem Therapeutics Inc. (Nasdaq:PSTI) (TASE:PSTI), a leading regenerative medicine company developing a platform of novel biological therapeutic products, announced today preliminary data from its compassionate use program, treating seven patients suffering from acute respiratory failure and inflammatory complications associated with COVID-19 with Pluristem’s PLX cells, in three medical centers in Israel.
All seven patients approved for treatment under compassionate use program with PLX cells exhibited, prior to treatment, respiratory failure due to ARDS, which is a major cause of mortality and required mechanical ventilation in an ICU. Four of the patients also demonstrated failure of other organ systems, including cardiovascular and kidney failure, indicating critical disease and poor prognosis.
Six of the seven patients have completed the seven day follow up period (“Group A”). The seventh patient has not yet completed seven day follow up.
As a next step, the Company plans to apply for initiation of a multinational regulated clinical trial program for the potential use of PLX cells in the treatment of patients suffering from complications associated with COVID-19. In this regard, while Pluristem expects to continue treating patients for complications associated with COVID-19 under the compassionate use program in Israel, Pluristem does not intend to provide further updates on the status of this program and rather update on the status and progress of its contemplated clinical trial program.
“We are pleased with this initial outcome of the compassionate use program, and committed to harnessing PLX cells for the benefit of patients and healthcare systems. In order to maximize PLX cells’ impact on patient recovery and to work towards making our treatment widely available, we plan to quickly move forward into a clinical development program. Pluristem is dedicated to using its competitive advantages in large-scale manufacturing to potentially deliver PLX cells to a large number of patients in significant need. We believe that research and governmental funding may be available to Pluristem to support the use of PLX cells for patients suffering from COVID- 19 and are targeting such funding,” stated Pluristem CEO and President, Yaky Yanay.
PLX Cells for COVID-19
PLX cells are available off-the-shelf and once commercialized, can be manufactured in large scale quantities, offering a key advantage in addressing a 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 interim results from the use of PLX cells on certain patients suffering from COVID-19, its expectation to continue treating patients for complications associated with for COVID-19 under the compassionate use program in Israel and its intention not to provide further updates on the status of this program and rather update on the status and progress of its contemplated clinical trial program, its plans to apply for initiation of a multinational clinical trial in order to maximize PLX cells’ impact on patient recovery and to work towards making its treatment widely available, its dedication to using its competitive advantages in large-scale manufacturing to potentially deliver PLX cells to a large number of patients in significant need, its belief that research and governmental funding may be available to it to support its PLX cells for COVID-19 patients and its intent to target such funding, 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
HAIFA, Israel, March 30, 2020 – Pluristem Therapeutics Inc. (Nasdaq:PSTI) (TASE:PSTI), a leading regenerative medicine company developing a platform of novel biological therapeutic products, announced today that since its last update on COVID-19, it has dosed three patients in two different hospitals in Israel under a compassionate use program for the treatment of COVID-19, as approved by the Israeli Ministry of Health. Pluristem expects to enroll additional patients in Israel in the coming days and anticipates providing updates on clinical outcomes once significant data has been gathered.
All three treated patients are in a high-risk group based on age and preexisting conditions, have been experiencing severe respiratory failure, and intubation with a ventilator. Pluristem is closely following the medical condition of these patients in conjunction with the hospitals’ medical professionals delivering the care.
Pluristem is prepared for immediate ramp-up of PLX cell production with consistent batch-to- batch cell production quality through its GMP certified manufacturing facilities in order to meet potential demand.
“In this time of emergency, we are honored to be taking part in the global effort to support patients and healthcare systems.
We watch with great admiration the endless efforts of the outstanding medical teams at the hospitals, and we would like to thank them for their collaboration and support.
It is our hope that our mutual desire to help patients will result in improved outcomes for those hard hit by the life threating complications of COVID-19,” stated Pluristem CEO and President, Yaky Yanay. “In addition to our current activity in Israel, we are in discussions with regulators in the U.S and Europe to define our clinical strategy for COVID-19. Pluristems’ advanced manufacturing capabilities enable us to serve potential need of treating large numbers of patients under compassionate use and clinical studies across numerous countries and hospitals in accordance with our expansion program and regulatory approvals.
We are facing a very different global condition right now, and the entire Pluristem team is committed to being an important part of the solution.”
PLX cells are available off-the-shelf and once commercialized, can be manufactured in large scale quantities, offering a key advantage in addressing a 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.
The potential therapeutic effects of PLX cells for the treatment of respiratory and inflammatory complications associated with the COVID-19 are currently being studied through a collaborative agreement between Pluristem and the BIH Center for Regenerative Therapy (BCRT) and the Berlin Center for Advanced Therapies (BeCAT) at Charite’ University of Medicine Berlin.
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.
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 expectation to enroll additional patients in Israel in the coming days and anticipation of providing updates on clinical outcomes once significant data has been gathered, or when it discusses preparation for immediate ramp-up of PLX cell production with consistent batch-to-batch cell production quality through its manufacturing facilities in order to meet potential demand, or when it discusses that its advanced manufacturing capabilities enable it to serve potential need of treating large numbers of patients under compassionate use and clinical studies across numerous countries and hospitals in accordance with its expansion program and regulatory approvals, when it discusses the benefits and potential therapeutic effects of PLX cells that they may prevent or reverse the dangerous overactivation of the immune system, that they may potentially reduce the incidence and\or severity of COVID-19 pneumonia and pneumonitis leading hopefully to a better prognosis for the patients or that PLX cells’ potential capabilities with the safety profile observed from clinical trials potentially position them 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.
Dana Rubin
Director of Investor Relations 972-74-7107194
HAIFA, Israel, 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,
In light of 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 COVID-19.
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.
Pluristem continues 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.
While we continue 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.
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.
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 Charité 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.
Sincerely, Yaky Yanay
Chief Executive Officer and President
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.
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 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.
Dana Rubin
Director of Investor Relations 972-74-7107194
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