Pluristem étend la portée de son programme sur la COVID-19 à l’Europe et reçoit une autorisation du PEI pour commencer une étude de phase II en Allemagne
HAÏFA, Israël, 12 août 2020 /PRNewswire/ — Pluristem Therapeutics Inc. (Nasdaq: PSTI) (TASE: PSTI), une société de premier plan dans le domaine de la médecine régénérative développant une plateforme de produits thérapeutiques biologiques novateurs, a annoncé aujourd’hui que l’agence allemande de réglementation de la santé, le Paul Ehrlich Institute (PEI), a approuvé le protocole clinique de phase II de la société pour son étude intitulée « A Randomized, 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 » (Une étude de phase II randomisée, contrôlée, multicentrique, en groupes parallèles pour évaluer l’efficacité et l’innocuité d’injections intramusculaires de PLX PAD pour le traitement des cas graves de COVID-19). Quarante
(40) patients hospitalisés présentant une forme grave de la COVID-19 accompagné de complications du syndrome de détresse respiratoire aiguë (SDRA) seront recrutés dans l’étude.
Le critère principal qui permettra de mesurer l’efficacité de l’étude est le nombre de jours passés sans respirateur pendant la totalité des 28 jours de l’étude. Le suivi du taux de survie et du niveau d’innocuité sera effectué au 60 ème jour , ainsi qu’aux semaines 26 et 52.
« Nous sommes ravis d’étendre notre programme sur la COVID-19 à un territoire supplémentaire et nous sommes impatients de commencer l’essai clinique de nos cellules PLX pour le traitement des cas graves de COVID-19 et ayant développé des complications du SDRA en Europe. Sur la base de nos discussions avec le PEI, il s’agira d’une étude indépendante, où le groupe expérimental sera comparé au groupe dit de contrôle suivant les recommandations thérapeutiques standards.
Pluristem mène plusieurs programmes de développement clinique avancé en Europe qui sont soutenus par Horizon 2020 et, dès réception des fonds, par la Banque européenne d’investissement (BEI). Nous sommes reconnaissants de leur soutien important à notre plateforme thérapeutique. Pluristem est déterminée à utiliser ce qui, selon nous, constitue les principaux avantages concurrentiels de notre plateforme technologique et à apporter des médicaments régénératifs aux patients en Europe et dans le monde entier », a déclaré Yaky Yanay, CEO et President de Pluristem.
Outre cette étude en Allemagne, Pluristem mène actuellement un essai de phase II sur la COVID-19 aux États-Unis, qui recrutera 140 patients.
Les cellules PLX peuvent être administrées sans ordonnance et, une fois commercialisées, elles peuvent être fabriquées en grandes quantités. Pluristem estime que ses cellules PLX offriront un avantage clé dans la lutte contre la pandémie mondiale
de COVID-19. Les cellules PLX sont semblables aux cellules allogéniques mésenchymateuses; les propriétés immunomodulatrices de ces cellules provoquent les régulateurs naturels du système immunitaire – les macrophages M2 et les lymphocytes T, et peuvent ainsi prévenir ou inverser la suractivation dangereuse du système immunitaire. Par conséquent, les cellules PLX peuvent potentiellement réduire l’incidence et/ou la gravité de la pneumonie provoquée par la COVID-19, menant, nous l’espérons, à un meilleur pronostic pour les patients. Les résultats de précédent es études précliniques sur les cellules PLX ont révélé des bienfaits thérapeutiques dans des études sur les animaux concernant l’hypertension pulmonaire, la fibrose pulmonaire, les lésions rénales aiguës et les lésions gastro-intestinales, qui sont des complications potentielles des graves infections à la COVID-19. Les données cliniques sur l’utilisation de cellules PLX ont démontré la grande puissance immunomodulatrice de celles -ci chez des patients ayant subi une intervention chirurgicale majeure. Les données cliniques préliminaires, obtenues au terme d’un suivi de 28 jours chez les patients atteints de la COVID-19 en unité de soins intensifs et traités dans le cadre d’un programme d’usage compassionnel, ont été précédemment publiées. Les capacités potentielles des cellules PLX, combinées avec le profil d’innocuité observé lors d’essais cliniques impliquant des centaines de patients dans le monde entier, placent les cellules PLX comme traitement potentiel pour atténuer les effets néfastes de la COVID-19 sur les tissus.
Pluristem Therapeutics Inc. est une société de premier plan dans le domaine de la médecine régénérative qui développe des produits candidats novateurs de thérapie cellulaire à base de placenta. La société a rendu compte de solides données d’essais cliniques dans plusieurs indications pour ses produits candidats brevetés à cellules PLX et mène actuellement des essais cliniques en phase avancée dans plusieurs indications. On estime que les produits candidats à cellules PLX libèrent une variété de protéines thérapeutiques en réponse à l’inflammation, à l’ischémie, aux traumatismes musculaires, aux troubles hématologiques et aux dommages par radiations. Les cellules sont développées à l’aide de la technologie d’expansion tridimensionnelle exclusive de la société et peuvent être administrées aux patients sans requérir une compatibilité tissulaire. Pluristem possède une solide position en matière de propriété intellectuelle : une usine de fabrication et de recherche certifiée GMP détenue et exploitée par la société, des relations stratégiques avec de grandes institutions de recherche et une équipe de direction chevronnée.
Contact :
Dana Rubin
Director of Investor Relations
+972-74-7107194
Pluristem weitet COVID-19-Programm auf Europa aus und erhält PEI-Zulassung für Phase-II-Studie in Deutschland
HAIFA, Israel, 12. August 2020 /PRNewswire/ — Pluristem Therapeutics Inc. (Nasdaq: PSTI) (TASE: PSTI), ein führendes Unternehmen für regenerative Medizin, gab heute bekannt, dass die deutsche Gesundheitsaufsichtsbehörde, das Paul-Ehrlich-Institut (PEI), das klinische Protokoll der Phase II des Unternehmens für seine Studie mit dem Titel „Eine randomisierte, gesteuerte, multizentrische Phase-II-Studie mit Parallelgruppen zur Bewertung der Wirksamkeit und Sicherheit von intramuskulären Injektionen von PLX PAD zur Behandlung schwerer COVID-19-Erkrankungen” freigegeben hat. Vierzig (40) Patienten, die mit schweren Fällen von COVID-19 und einem akuten Lugenversagen (ARDS) im Krankenhaus liegen, werden in die Studie aufgenommen.
Der primäre Wirksamkeitsendpunkt der Studie ist die Anzahl der beatmungsfreien Tage während der 28 Tage vom ersten Tag bis zum 28. Tag der Studie. Nachkontrollen zur Sicherheit und Überlebensrate werden am 60. Tag, in der 26. Woche und in der
„Wir freuen uns, unser COVID-19-Programm auf ein zusätzliches geographisches Gebiet auszuweiten und in Europa mit einer klinischen Studie unserer PLX-Zellen zur Behandlung schwerer COVID-19-Fälle mit einer ARDS-Komplikation zu beginnen. Basierend auf unseren Gesprächen mit dem PEI wird dies eine eigenständige Studie sein, bei der die Therapie mit PLX-Zellen mit dem aktuellen Pflegestandard verglichen wird. Pluristem führt in Europa mehrere fortgeschrittene klinische Entwicklungsprogramme durch, die durch Horizont 2020 und nach Erhalt der entsprechenden Mittel von der Europäischen Investitionsbank (EIB) unterstützt werden. Wir sind für diese wichtige Unterstützung unserer therapeutischen Plattform dankbar. Pluristem setzt sich dafür ein, die unserer Meinung nach großen Wettbewerbsvorteile unserer technologischen Plattform zu nutzen und Patienten in Europa und auf der ganzen Welt regenerative Medizin anbieten zu können”, sagte Yaky Yanay, CEO und Präsident von Pluristem.
Zusätzlich zu dieser Studie in Deutschland führt Pluristem derzeit auch in den USA eine Phase-II-COVID-19-Studie durch, in die 140 Patienten aufgenommen werden.
PLX-Zellen sind gebrauchsfertig erhältlich und können nach der Kommerzialisierung in großen Mengen hergestellt werden. Pluristem glaubt, dass PLX-Zellen einen wichtigen Vorteil bei der Bekämpfung der globalen COVID-19-Pandemie bieten werden. PLX-Zellen sind allogene mesenchymalartige Zellen, deren immunmodulatorische Eigenschaften die natürlichen regulativen T-Zellen des Immunsystems und M2-Makrophagen induzieren und
somit eine gefährliche Überaktivierung des Immunsystems verhindern oder umkehren können. Dementsprechend können PLX-Zellen die Inzidenz bzw. Schwere einer COVID- 19- Lungenentzündung potenziell reduzieren, was hoffentlich zu einer besseren Prognose für Patienten führen wird. Frühere präklinische Befunde von PLX-Zellen zeigten einen therapeutischen Nutzen in Tierstudien bei Lungenhypertonie, Lungenfibrose, akuter Nierenverletzung und Magen-Darm-Verletzungen, die potenzielle Komplikationen einer schweren COVID-19-Infektion darstellen. Klinische Daten von PLX-Zellen belegten die starke immunmodulatorische Potenz von PLX-Zellen bei Patienten nach einer größeren Operation. Erste klinische Daten zum Abschluss einer nach 28 Tagen durchgeführten Kontrolle von COVID-19-Patienten, die auf der Intensivstation mit einem Compassionate- Use-Programm behandelt wurden, sind bereits veröffentlicht worden. Auf Basis des Sicherheitsprofils, das in klinischen Studien mit Hunderten von Patienten auf der ganzen Welt beobachtet wurde, lässt sich erkennen, dass die potenziellen Fähigkeiten von PLX- Zellen als eine Therapie zur Linderung der gewebeschädigenden Auswirkungen von COVID-19 genutzt werden könnten.
Pluristem Therapeutics Inc. ist ein führendes Unternehmen für regenerative Medizin, das neuartige plazentabasierte Produktkandidaten für Zelltherapien entwickelt. Das Unternehmen konnte robuste klinische Studiendaten mit mehreren Indikationen für seine patentierten PLX-Zell-Produktkandidaten zeigen und führt zurzeit klinische Studien mit mehreren Indikationen im Spätstadium durch. Es wird angenommen, dass PLX- Zellproduktkandidaten eine Reihe therapeutischer Proteine als Reaktion auf Entzündungen, Ischämie, Muskeltrauma, hämatologische Störungen und Strahlenschäden freisetzen. Die Zellen werden mithilfe der proprietären dreidimensionalen Expansionstechnologie des Unternehmens kultiviert und können in ihrer handelsüblichen Form ohne Gewebeanpassung an Patienten verabreicht werden. Pluristem verfügt über eine starke IP-Position, eine unternehmenseigene und vom Unternehmen selbst betriebene GMP-zertifizierte Produktions- und Forschungseinrichtung, strategische Beziehungen zu großen Forschungsinstituten und ein erfahrenes Managementteam.
Kontakt:
Dana Rubin
Director of Investor Relations
+972-74-7107194
HAIFA, Israel, August 10, 2020 – Pluristem Therapeutics Inc. (Nasdaq:PSTI) (TASE:PSTI), a leading regenerative medicine company developing a platform of novel biological therapeutic products, announced today that Germany’s health regulatory agency, the Paul Ehrlich Institute (PEI), has cleared the Company’s Phase II clinical protocol for its study titled, “A Randomized, 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.” Forty (40) patients hospitalized with severe cases of COVID-19 complicated by Acute Respiratory Distress Syndrome (ARDS) will be enrolled in the study.
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. Safety and survival follow-up will be conducted at day 60, week 26 and week 52.
“We are pleased to expand our COVID-19 program to an additional territory and look forward to commencing a clinical trial of our PLX cells for the treatment of severe COVID-19 cases complicated by ARDS in Europe. Based on our discussions with the PEI, this will be a standalone study, with the active arm compared to the current standard of care. Pluristem is conducting several advanced clinical development programs in Europe which are supported by the Horizon 2020 and, upon receipt of funds, by the European Investment Bank (EIB). We are grateful for their important support of our therapeutic platform. Pluristem is committed to utilizing what we believe is the major competitive advantages of our technological platform and to bringing regenerative medicine to patients in Europe and around the world,” stated Pluristem CEO and President Yaky Yanay.
In addition to this study in Germany, Pluristem is currently conducting a Phase II COVID-19 trial in the U.S. which will enroll 140 patients.
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, 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.
Initial clinical data at the conclusion of a 28 day follow up from COVID-19 ICU patients that were treated under a Compassionate Use Program, were previously published.
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 proposed study in Europe, its belief that its study will be a standalone study, with the active arm compared to the current standard of care, the potential receipt of funds from the EIB, that it is committed to utilizing what it believes is the major competitive advantages of its technological platform and to bringing regenerative medicine to patients in Europe and around the world, 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 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, July 21, 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,
During this challenging period marked by the ongoing global COVID-19 pandemic, we are continuing to advance our regenerative medicine product candidates with the aim of improving the lives and health of people around the world. In addition to our clinical programs, we are also taking an active role in finding an effective treatment solution to COVID-19 complications. We hope and believe that PLX-PAD may play an instrumental role in overcoming the devastating impact of the coronavirus.
Today I would like to provide an update on the key clinical milestones and corporate developments for the year to come. We are heading towards a pivotal year with four clinical readouts, on multiple opportunities for success in advancing PLX product candidates towards registration with applicable regulatory agencies. The entire Pluristem team is dedicated to success, and I would like to make sure all of you are aware of important milestones ahead of us.
Over the last few months, we held discussions with the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) to reaffirm understandings related to the interim readout of our global pivotal Phase III study of PLX-PAD in CLI. We expect to announce top line interim data analysis results during the fourth quarter of calendar 2020.
An analysis of the interim data will have three possible outcomes: a) an earlier than planned end- of-study may be achieved if the top line interim data analysis achieves overwhelming efficacy (p
≤0.01), b) the study may be declared futile if there is no probability of successfully achieving the primary endpoint on the full data set after enrolling all patients, or c) the study is in line with the protocol assumptions and considered to be in a promising zone for success. If the third possible outcome results, Pluristem will continue to enroll patients, and will analyze the data again on the full data set.
Following the FDA’s and EMA’s advice and recommendations, the following are the main items implemented in the study design and the interim readout:
After a slowdown in enrollment due to COVID-19, we currently expect the pace of enrollment to accelerate and forecast to complete enrollment of the study population in the U.S., Europe and Israel by the fourth quarter of calendar 2020. This expectation takes into consideration the impact of COVID-19 on the access to treatment and follow up sites while maintaining the safety of the patients, as we continue to follow FDA and EMA guidelines for conducting clinical studies during COVID-19.
For our Phase III trial of PLX-PAD in muscle regeneration following hip fracture in the U.S., Europe and Israel, we have enrolled more than 60% of the 240 patients planned for the study and we expect to complete enrollment by the end of calendar 2020.
Top line results are expected in the third quarter of calendar 2021.
The Phase II U.S. study evaluating PLX-PAD in patients suffering from severe COVID-19 complicated by Acute Respiratory Distress Syndrome (ARDS) is planned to enroll 140 subjects.
We continue to open sites in accordance with the changing dynamics of the spread of COVID-19 in the U.S. In addition, we are finalizing our discussions with Germany’s health regulatory agency, the Paul Ehrlich Institute, in order to launch a study in Europe.
Our target is to complete enrollment and to provide top line 28-days follow-up data on our U.S. study during the fourth quarter of calendar 2020.
Our Phase I study of PLX-R18 in hematology, specifically for incomplete hematopoietic recovery following HCT, is enrolling patients in the U.S. and in Israel.
Following discussions with our advisory board, we intend to complete enrollment with 20 patients.
We expect to meet this milestone by the end of the third quarter of calendar 2020, and subsequently provide top line results in the first quarter of calendar 2021.
Pluristem had approximately $59 million in cash and cash equivalents as of June 30, 2020.
We expect that our current resources, together with the funds expected from the European Investment Bank (EIB), assuming all agreed milestones are achieved, will support our operations for over three years.
We believe this will enable us to complete the development of our current pipeline, with the goal to bring multiple product registrations both in the U.S. and Europe.
In these times of global challenges, we continue advancing our ongoing clinical trials, while keeping our commitment to the health and wellbeing of all of our stakeholders.
We wish all our shareholders, clinical and business partners, employees and patients good health and resilience at this time.
Sincerely, Yaky Yanay
Chief Executive Officer
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 hope and belief that PLX-PAD will play an instrumental role in overcoming the impact of the coronavirus, the expected timing of the completion of enrollment and release of top line readouts from its various clinical studies, the potential outcomes from the top line interim data analysis results relating to its Phase III CLI study, the belief that the changes in the primary endpoint for the interim analysis from the Phase III CLI study will enable its study to meet the required endpoints for both the FDA and EMA and to start discussions regarding filing of a BLA, that it expects to receive the funds from the EIB and, such funds together with its existing cash and equivalents, will fund and support its operations for over three years and will enable it to execute its goals.
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, June 11, 2020 – Pluristem Therapeutics Inc. (Nasdaq:PSTI) (TASE:PSTI), a leading regenerative medicine company developing a platform of novel biological therapeutic products, announced today the activation of clinical sites and initiation of enrollment in its Phase II U.S. Food and Drug Administration (FDA) study of PLX cells for the treatment of severe COVID-19 complicated by Acute Respiratory Distress Syndrome (ARDS). The Company is focused on expanding to clinical sites throughout the U.S. in accordance with the changing dynamic spread of the COVID-19 pandemic, using its advanced operational capabilities and cold chain agility. The trial is expected to include up to 25 sites.
The randomized, double-blind, placebo-controlled, multicenter, parallel-group 140 patient study is evaluating the efficacy and safety of intramuscular (IM) injections of PLX-PAD for the treatment of severe COVID-19 cases complicated by ARDS. The primary endpoint is the number of ventilator free days during the main 28-day study period. Safety and survival follow-up will be conducted at week 8, 26 and 52. Secondary efficacy endpoints include all-cause mortality, duration of mechanical ventilation, ICU free-days, and hospitalization free-days.
“Pluristem is closely following the spread of the COVID-19 pandemic globally as well as the ‘hot spots’ in the U.S. We are targeting locations that show the highest rate of new cases and incorporating the ready-to-use advantages of our PLX-PAD product candidate. Pluristem’s confirmed operational and unique cold chain logistical capabilities enable us to treat patients within hours of notice. We also believe this will enable us to deliver COVID-19 treatments in a timely manner and in the right place, while assisting the healthcare systems in the fight against COVID-19, its complications, and its burden on the medical infrastructure.”
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 focus on expanding clinical sites throughout the U.S., the expected number of clinical sites it expects will be included in the trial, the belief that its confirmed operational and unique ‘cold chain’ logistical capabilities enable it to treat patients within hours of notice, its belief that it will be able to deliver potential COVID- 19 treatments in a timely manner, and in the right place, while assisting the healthcare systems in the fight against COVID-19, its complications, and its burden on the medical infrastructure and 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, June 3 , 2020 – Pluristem Therapeutics Inc. (Nasdaq:PSTI) (TASE:PSTI), a leading regenerative medicine company developing a platform of novel biological products, today announced that it was selected as a member of the CRISPR-IL consortium, a group funded by the Israeli Innovation Authority. CRISPR-IL brings together the leading experts in life science and computer science from academia, medicine, and industry, to develop artificial intelligence (AI) based end-to-end genome-editing solutions. These next-generation, multi-species genome editing products for human, plant, and animal DNA, have applications in the pharma, agriculture, and aquaculture industries. Pluristem’s Vice President Research & Intellectual Property, Racheli Ofir, will lead CRISPR-IL’s pharma working group.
CRISPR-IL is funded by the Israeli Innovation Authority with a total budget of NIS36 million, or approximately US$10 million, for a period of 18 months, with a potential for extension of an additional 18 months and additional budget from the Israeli Innovation Authority. CRISPR-IL participants include leading companies, and medical and academic institutions.
In addition to Pluristem, key participants from industry include BTG – Bio-technology General Israel, Colors Farm, Hazera Seeds, NRgene, Evogene, TargetGene Biotechnologies and Rahan Meristem Ltd.; medical institutions include Sheba Medical Center and Schneider Children’s Medical Center; and members from academia include Bar-Ilan University, Ben Gurion University of the Negev, Hebrew University of Jerusalem, the Weizmann Institute of Science, IDC Herzliya, and Tel-Aviv University.
CRISPR is a genome-editing technology for detecting and modifying DNA sequences. It is used as a tool to enable genetic changes.
The technology enables the development of unique bio-based products and novel therapeutics while reducing the time and cost of development.
Current CRISPR-based workflows target precise areas within the DNA; however, these workflows still face several challenges, which prevent more extensive use of this tool, including: (i) accidental off- target modification, (ii) inefficient modifications and (iii) inaccurate measuring tools to ascertain if the modification was effective as intended.
The CRISPR-IL consortium intends to develop an AI- based system to provide users improved genome-editing workflows.
The system aims to provide end-to-end solutions, from the user interface to an accurate measurement tool.
The system is expected to include the computational design of on-target DNA modification, with minimal accidental, off-target modifications, improve modification efficiency and provide an accurate measuring tool to ensure the desired modification was made.
“CRISPR gene editing technology creates new technological options in healthcare that are both personalized and regenerative. We see cell therapy and gene editing as highly synergistic methods to treat and cure diseases using advanced technologies. Pluristem is honored to bring its allogeneic cell therapy and manufacturing expertise to the CRISPR-IL consortium and to lead the development of next generation of allogeneic cell therapies for treating the diseases of today and the future,” stated Pluristem CEO and President, Yaky Yanay. “Our future product development strategy leverages our well established PLX platform to integrate CRISPR technology, opening new opportunities for Pluristem to provide an expanded pipeline of products.”
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 potential of CRISPR gene editing technology and its potential integration with Pluristem’s PLX platform leading to new opportunities and an expanded pipeline of products.
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
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
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
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