HAIFA, Israel, July 8, 2021 – Pluristem Therapeutics Inc. (Nasdaq:PSTI) (TASE:PSTI) (the “Company”), a leading biotechnology company announced today that it is bringing its Acute Respiratory Distress Syndrome (ARDS) associated with COVID-19 Phase II studies to clinical readout. The Company’s COVID-19 program included over 100 patients across two Phase II studies in the U.S., Europe and Israel, and in compassionate use and expanded access programs in the U.S. and Israel. The analysis will be based on 89 patients enrolled in the previously announced two Phase II studies, which investigated the safety and efficacy of Pluristem’s PLX cells as a treatment for severe COVID-19 cases complicated by ARDS.
This decision comes in response to COVID-19’s evolution as a disease, as well as changes in the standard of care and a decline in the most severe cases. For the same reason, the Company will not pursue plans announced in December 2020 to expand Pluristem’s COVID-19 program to Mexico in collaboration with Innovare R&D. Pluristem expects to announce the topline results of the readout during the fourth quarter of 2021.
As part of the clinical readout, Pluristem will examine the safety and efficacy of PLX cells for treating ARDS, a condition associated with a number of illnesses in addition to COVID-19 including sepsis, smoke and toxic chemical inhalation, head and chest injuries, and pancreatitis. ARDS continues to pose a significant clinical challenge that affects over 200,000 Americans annually, roughly 10 percent of Intensive Care Unit patients and 23 percent of ventilated patients worldwide.
Pluristem continues to advance its product candidate pipeline – PLX-PAD and PLX-R18 – on a number of fronts. Pluristem’s PLX-PAD treatment exhibits the potential to stimulate tissue regeneration in response to muscle trauma and inflammation. PLX-PAD is currently in a Phase III multinational clinical trial testing the safety and efficacy of accelerating muscle regeneration following HIP fracture surgery.
Additionally, Pluristem recently reported positive Phase I topline results from its evaluation of PLX-R18 cells to address incomplete hematopoietic recovery following Hematopoietic Cell Transplantation (HCT).
The Company’s unique proprietary process and advanced development and manufacturing capabilities enable it to produce PLX cells at significant scale.
Pluristem is pushing the boundaries of science and engineering to reimagine pharmacological treatments and improve the standard of care.
The Company’s cell therapies advance the field of regenerative medicine, with potentially groundbreaking applications for treating damaged muscle, hematology deficiencies, and inflammation.
Pluristem sources its therapeutic cells from the placenta, an ethically accepted and potent source. Cells are easy to collect and do not require blood or tissue matching.
Cells from one placenta can treat 20,000 patients.
The Company’s manufacturing platform, the bioreactor, is a patented and validated state-of-the-art 3D cell expansion system, designed to mimic the human body.
Pluristem’s method is uniquely accurate, cost-effective, and consistent batch-to-batch.
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 expected timing of the Phase II study clinical readout, the expected examination of the clinical readout in relating to treating ARDS for illnesses and causes in addition to COVID-19, the potential of its product candidates and its pipeline.
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
Die erste Tranche der Finanzierung wird ausgeschüttet, da der Biotech- Innovator einen wichtigen Zwischenschritt in der zuvor angekündigten 50-Millionen-Euro-Vereinbarung erreicht
HAIFA, Israel, 26. Mai 2021 /PRNewswire/ — Pluristem Therapeutics Inc. (Nasdaq: PSTI) (TASE: PSTI) (das „Unternehmen”), ein führendes Biotechnologie- Unternehmen, gab heute den Erhalt eines „Auszahlungsangebots” in Höhe von 20 Millionen Euro (ca. 24 Millionen US-Dollar) von der Europäischen Investitionsbank (EIB) bekannt.
Mit dieser Auszahlung – der ersten von drei Finanzierungstranchen – hat Pluristem einen wichtigen Zwischenschritt in einer zuvor angekündigten, nicht verwässernden Finanzierungsvereinbarung über 50 Millionen Euro erreicht. Gemäß der EIB-Vereinbarung erwartet Pluristem, diese erste Tranche der Mittel im Juni 2021 zu erhalten.
Die Vereinbarung wurde von der kENUP Foundation initiiert, einer globalen Partnerschaft zur Förderung von Innovationen mit hohem öffentlichen und gesellschaftlichen Nutzen.
Der Erlös der ersten Tranche wird für Forschung und Entwicklung (F&E) in der Europäischen Union genutzt, um die proprietäre regenerative Zelltherapie-Plattform von Pluristem zum Erfolg führen soll.
Die erste Tranche in Höhe von 20 Millionen Euro ist nicht besichert und wird fünf Jahre nach der Auszahlung in einer einzigen Zahlung an die EIB fällig. Der Zinssatz beträgt 4 %. Nach Erhalt der Tranche von 20 Millionen Euro wird Pluristem über einen Kassenbestand von mehr als 90 Millionen US-Dollar verfügen.
Der CEO und Präsident von Pluristem, Yaky Yanay, sagte: „Die Finanzierung durch die EIB ermöglicht es Pluristem, unsere operativen, klinischen und F&E-Aktivitäten durchzuführen, um unsere Plattform für regenerative Medizin weiterzuentwickeln. Die europäische Bevölkerung altert schnell und es besteht unserer Meinung nach ein klarer Bedarf an neuartigen Behandlungen für eine Reihe von Krankheiten und Leiden, um ihre Lebensqualität zu verbessern. Wir wollen diesen Finanzierungsmechanismus nutzen, um unsere Produktkandidaten bis zur Reife zu entwickeln. Wir danken der EIB für ihre andauernde Unterstützung und ihr Vertrauen in unsere Technologie.”
„Zu den wichtigsten Stärken von Pluristem gehört eine hochmoderne, automatisierte Zellexpansionstechnologie, die auf 17 Jahren Zelltherapieforschung basiert. Darüber hinaus ermöglichen unsere hauseigenen Produktionskapazitäten die Herstellung von allogenen Zellproduktkandidaten in großen Mengen mit einer Konsistenz von Charge zu Charge.”
Chen Franco-Yehuda, der CFO von Pluristem, fügte hinzu: „Pluristem verfügt über einen starken Barmittelbestand, mit denen wir unsere F&E-Bemühungen beschleunigen können, so dass wir neue regenerative Medikamente für Bedürftige bereitstellen können. Die Finanzierungsvereinbarung mit der EIB stellt für uns eine kreative, nicht verwässernde Form der Finanzierung dar und wir glauben, dass sie uns für die Zukunft gut positioniert.”
Die Europäische Investitionsbank (EIB) ist die Institution der Europäischen Union für langfristige Finanzierungen.
Ihre Anteilseigner sind die Mitgliedstaaten.
Sie stellt langfristige Finanzierungen für solide Investitionen zur Verfügung und trägt damit zur Erreichung der politischen Ziele der EU bei.
Pluristem Therapeutics Inc. ist ein führender Hersteller im Bereich der regenerativen Medizin, der neuartige plazentabasierte Produktkandiaten 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 mit der firmeneigenen dreidimensionalen Expansionstechnologie gezüchtet und können Patienten „von der Stange” verabreicht werden, ohne dass ein Abgleich der Gewebemerkmale notwendig ist.
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.
Diese Mitteilung enthält zukunftsgerichtete Informationen im Sinne des U.S. Securities Act und der Safe Harbor-Bestimmungen des U.S. Private Securities Litigation Reform Act von 1995 und anderer US-amerikanischer Wertpapiergesetze.
Pluristem verwendet beispielsweise zukunftsgerichtete Aussagen, wenn es den erwarteten Zeitpunkt und die Verwendung der Erlöse aus der ersten Tranche der EIB-Mittel erörtert und davon ausgeht, dass die Finanzierung es dem Unternehmen ermöglichen wird, seine operativen, klinischen und F&E-Aktivitäten durchzuführen, um seine Plattform für regenerative Medizin weiterzuentwickeln, und dass die Mittel das Unternehmen gut für die Zukunft positionieren. Diese zukunftsgerichteten Aussagen basieren ausschließlich auf den aktuellen Erwartungen des Managements von Pluristem und unterliegen einer Reihe von Faktoren und Ungewissheiten, die dazu führen könnten, dass sich die tatsächlichen Ergebnisse erheblich von jenen unterscheiden, die in vorausblickenden Aussagen zum Ausdruck gebracht wurden.
Die folgenden Faktoren könnten unter anderem dazu führen, dass die tatsächlichen Ergebnisse wesentlich von denen abweichen, die in den zukunftsgerichteten Aussagen beschrieben sind: Änderungen der Technologie und der Marktanforderungen; Pluristem könnte auf Verzögerungen oder Hindernisse bei der Einleitung und/oder dem erfolgreichen Abschluss seiner klinischen Studien stoßen; die Produkte von Pluristem könnten von den Aufsichtsbehörden nicht genehmigt werden, die Technologie von Pluristem könnte im weiteren Verlauf nicht validiert werden und die Methoden von Pluristem könnten von der wissenschaftlichen Gemeinschaft nicht akzeptiert werden; Pluristem könnte nicht in der Lage sein, wichtige Mitarbeiter, deren Wissen für die Entwicklung seiner Produkte wesentlich ist, in Schlüsselpositionen zu halten oder zu gewinnen; es könnten unvorhergesehene wissenschaftliche Schwierigkeiten mit dem Verfahren von Pluristem auftreten; die Produkte von Pluristem könnten sich als teurer erweisen als erwartet; die Ergebnisse im Labor könnten nicht zu gleich guten Ergebnissen in realen klinischen Umgebungen führen; die Ergebnisse präklinischer Studien könnten nicht mit den Ergebnissen klinischer Studien am Menschen korrelieren; Pluristems Patente könnten nicht ausreichend sein; Pluristems Produkte könnten den Empfängern schaden; Änderungen in der Gesetzgebung könnten sich negativ auf Pluristem auswirken; die Unfähigkeit, rechtzeitig neue Technologien, Produkte und Anwendungen zu entwickeln und einzuführen; der Verlust von Marktanteilen und der Preisdruck, der sich aus dem Wettbewerb ergibt, könnten dazu führen, dass die tatsächlichen Ergebnisse oder Leistungen von Pluristem wesentlich von jenen abweichen, die in solchen zukunftsgerichteten Aussagen zum Ausdruck gebracht wurden. Sofern nicht anderweitig gesetzlich vorgeschrieben, ist Pluristem nicht verpflichtet, Revisionen dieser zukunftsgerichteten Aussagen zu veröffentlichen, um Ereignisse oder Umstände nach dem Datum dieses Dokuments oder das Eintreten unvorhergesehener Ereignisse zu berücksichtigen. Für eine detailliertere Beschreibung der Risiken und Ungewissheiten bezüglich Pluristem wird auf die Berichte von Pluristem verwiesen, die regelmäßig bei der Securities and Exchange Commission eingereicht werden.
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Dana Rubin
Director of Investor Relations
+972-74-7107194
SOURCE Pluristem Therapeutics Inc.
La première tranche de financement doit être distribuée puisque l’innovateur en biotechnologie a franchi une étape clé dans l’accord de €50 millions d’euros annoncé précédemment
HAIFA, Israël, 27 mai 2021 /PRNewswire/ — Pluristem Therapeutics Inc. (Nasdaq : PSTI) (TASE : PSTI) (la « Société »), une société importante de biotechnologie, a annoncé aujourd’hui la réception d’une « offre de décaissement » d’un montant de €20 millions d’euros (environ $24 millions de dollars) de la Banque européenne d’investissement (BEI). Ce décaissement – le premier de trois tranches de financement – montre que Pluristem a franchi une étape clé dans l’accord de financement non dilutif de €50 millions d’euros annoncé précédemment. Conformément à l’accord de la BEI, Pluristem prévoit de recevoir la première tranche de fonds en juin 2021.
Le produit de la première tranche servira à financer la recherche et le développement (R&D) dans l’Union européenne afin de faire progresser la plateforme de thérapie cellulaire régénérative exclusive de Pluristem.
La première tranche de €20 millions d’euros ne sera pas sécurisée et sera payable à la BEI en un seul versement cinq ans après le décaissement, avec un taux d’intérêt de 4 %. Après avoir reçu la tranche de €20 millions d’euros, Pluristem disposera d’un solde de trésorerie de plus de $90 millions de dollars.
Le PDG et président de Pluristem, Yaky Yanay, a déclaré : « Le financement de la BEI permet à Pluristem de mener à bien ses activités opérationnelles, cliniques et de R&D pour faire progresser sa plateforme de médecine régénérative.
La population vieillissante de l’Europe connaît une croissance rapide et nous pensons qu’elle a un besoin évident de nouveaux traitements pour un certain nombre de maladies et d’affections afin d’améliorer la qualité de vie.
Nous sommes déterminés à tirer parti de ce mécanisme de financement pour renforcer le développement de nos produits candidats jusqu’à leur maturation. Nous sommes reconnaissants à la BEI pour son soutien continu et sa confiance en notre technologie.
« Les principaux avantages concurrentiels de Pluristem comprennent une technologie d’expansion cellulaire automatisée de pointe qui s’appuie sur 17 années de recherche en thérapie cellulaire. En outre, nos capacités de fabrication en interne permettent de fabriquer des produits candidats à base de cellules allogéniques à grande échelle e d’assurer la conformité des lots. »
Chen Franco-Yehuda, directeur financier de Pluristem, a ajouté : « Pluristem dispose d’un important solde de trésorerie pour accélérer nos actions en matières de R&D afin d’apporter de nouveaux médicaments régénérateurs à ceux qui en ont besoin.
Nous pensons que le contrat de financement de la BEI représente une forme de financement créative et non dilutive, et nous sommes convaincus qu’il nous place en bonne position pour l’avenir. »
La Banque européenne d’investissement (BEI) est l’institution de financement à long terme de l’Union européenne, détenue par ses États membres. Elle met à disposition des financements à long terme pour des investissements viables afin de contribuer à la réalisation des objectifs politiques de l’UE.
Pluristem Therapeutics Inc. est une des principales sociétés de médecine régénérative qui développe de nouveaux produits candidats de thérapie cellulaire à base de placenta.
La société a rapporté des données d’essais cliniques fiables dans différentes indications pour ses produits candidats brevetés à base de cellules PLX et mène actuellement des essais cliniques de stade avancé dans plusieurs indications.
Les produits candidats de la cellule PLX sont censés libérer de nombreuses protéines thérapeutiques en réponse à l’inflammation, aux traumatismes musculaires, aux troubles hématologiques et aux radiolésions.
Les cellules sont cultivées à l’aide de la technologie brevetée d’expansion tridimensionnelle de la société et peuvent être administrées aux patients sans qu’il n’y ait nécessairement de compatibilité tissulaire.
Pluristem est bien placée en matière de propriété intellectuelle, dispose d’une usine de fabrication et de recherche certifiée BPF détenue et exploitée par la société, de relations stratégiques avec d’importantes institutions de recherche et d’une équipe de direction chevronnée.
Déclaration d’exonération de responsabilité
Le présent communiqué de presse contient des déclarations prospectives, explicites ou implicites, au sens de la loi Private Securities Litigation Reform Act de 1995 et d’autres lois fédérales américaines sur les valeurs mobilières. Par exemple, Pluristem utilise des déclarations prospectives lorsqu’elle parle du calendrier et de l’utilisation prévus du produit de la première tranche de fonds versés par la BEI, de sa conviction que le financement lui permettra d’exécuter ses activités opérationnelles, cliniques et de R&D pour faire progresser sa plateforme de médecine régénérative et que les fonds la placent en bonne position pour l’avenir.
Ces déclarations prospectives et leurs implications sont fondées uniquement sur les attentes actuelles de la direction de Pluristem et sont soumises à un certain nombre de facteurs et d’incertitudes qui pourraient faire en sorte que les résultats réels diffèrent sensiblement de ceux décrits dans les déclarations prospectives.
Les facteurs suivants, entre autres, pourraient faire en sorte que les résultats réels diffèrent sensiblement de ceux décrits dans les déclarations prospectives : des changements dans la technologie et les exigences du marché ; Pluristem pourrait rencontrer des retards ou des obstacles dans le lancement et/ou la réussite de ses essais cliniques ; les produits de Pluristem pourraient ne pas être approuvés par les organismes de réglementation, la technologie de Pluristem pourrait ne pas être validée au fur et à mesure de ses progrès et ses méthodes pourraient ne pas être acceptées par la communauté scientifique ; Pluristem pourrait ne pas être en mesure de retenir ou d’attirer des employés clés dont les connaissances sont essentielles au développement de ses produits ; des difficultés scientifiques imprévues pourraient se développer avec le processus de Pluristem ; les produits de Pluristem pourraient s’avérer plus coûteux que prévu ; les résultats obtenus en laboratoire peuvent ne pas se traduire par des résultats aussi bons dans des environnements cliniques réels ; les résultats des études précliniques peuvent ne pas être en corrélation avec les résultats des essais cliniques chez l’homme ; les brevets de Pluristem peuvent ne pas être suffisants ; les produits de Pluristem peuvent nuire aux receveurs ; des changements dans la législation peuvent avoir un impact négatif sur Pluristem ; l’incapacité de développer et d’introduire en temps opportun de nouvelles technologies, de nouveaux produits et de nouvelles applications ; la perte de parts de marché et la pression sur les prix résultant de la concurrence, ce qui pourrait faire en sorte que les résultats ou les performances réels de Pluristem diffèrent sensiblement de ceux envisagés dans ces déclarations prospectives.
Sauf si la loi l’exige, Pluristem ne s’engage pas à publier une révision de ces déclarations prospectives pour tenir compte d’événements ou de circonstances postérieurs à la date des présentes ou pour refléter la survenance d’événements imprévus. Pour une description plus détaillée des risques et incertitudes affectant Pluristem, il est fait référence aux rapports de Pluristem déposés ponctuellement auprès de la Securities and Exchange Commission.
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Contact :
Dana Rubin
Directrice des relations avec les investisseurs
+972-74-7107194
First tranche of funding is to be distributed as biotech innovator meets a key milestone in previously announced €50 million agreement
HAIFA, Israel, May 25, 2021 – Pluristem Therapeutics Inc. (Nasdaq:PSTI) (TASE:PSTI) (the “Company”), a leading biotechnology company, today announced the receipt of a “Disbursement Offer” in the amount of €20 million (approximately $24 million) from the European Investment Bank (EIB). This disbursement – the first of three tranches of funding – reflects that Pluristem has achieved a key milestone in a previously announced €50 million non-dilutive financing agreement. Pursuant to the EIB agreement, Pluristem expects to receive the first tranche of funds during June 2021.
The proceeds of the first tranche will support research and development (R&D) in the European Union to advance Pluristem’s proprietary regenerative cell therapy platform.
The first tranche of €20 million will not be secured and will be payable to the EIB in a single payment five years after the disbursement, with an interest rate of 4%. Following the receipt of the €20 million tranche, Pluristem will have a cash balance of more than $90 million.
Pluristem’s CEO and President, Yaky Yanay, said: “The EIB funding allows Pluristem to execute our operational, clinical and R&D activities to advance our regenerative medicine platform. Europe’s aging population is growing rapidly, and we believe has a clear need for novel treatments for a range of diseases and conditions to improve quality of life. We are committed to leveraging this funding mechanism to strengthen the development of our product candidates to maturation. We are grateful to the EIB for their ongoing support and confidence in our technology.
Pluristem’s key competitive advantages include a state-of-the-art, automated cell expansion technology that draws on 17 years of cell therapy research. Additionally, our in-house manufacturing capabilities enable the production of allogeneic cell product candidates on a mass-scale with batch-to-batch consistency.”
Chen Franco-Yehuda, Pluristem’s CFO, added, “Pluristem has a strong cash balance to accelerate our R&D efforts to bring new regenerative medicines to those in need.
We believe that the EIB financing agreement reflects a creative, non-dilutive form of financing and believe it positions us strongly for the future.”
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.
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, 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 expected timing and use of proceeds of the first tranche of funds from the EIB, the belief that the funding will allow it to execute it operational, clinical and R&D activities to advance its regenerative medicine platform and that the funds position it strongly for the future.
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
For a full recording of the webcast click here
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HAIFA, Israel, April 29, 2021 – Pluristem Therapeutics Inc. (Nasdaq:PSTI) (TASE: PSTI), a leading regenerative medicine company, today reported positive topline results in its first study to evaluate the safety and exploratory efficacy of PLX-R18 in humans.
The company’s Phase I, open-label, dose-escalation study is evaluating the safety and exploratory efficacy of intramuscular injections of PLX-R18 in subjects with incomplete hematopoietic recovery following Hematopoietic Cell Transplantation (HCT).
Pluristem CEO and President, Yaky Yanay, said, “The promising topline results demonstrate insight into how PLX cells may provide a more effective therapeutic benefit than current technologies.
We believe that PLX-R18 affects the regeneration activity of the hematopoietic cells. By supporting blood cell lineage’s recovery, this approach could be used to address a variety of hematological deficiencies.
We intend to push forward the clinical development of PLX-R18 with the goal of establishing it as the new standard of care in the field.”
Poor graft function is a life-threatening complication for patients undergoing HCT.
Current standard-of-care treatments do not develop satisfactory blood counts in some or all blood cell lineages.
Consequently, patients are vulnerable to bleeding and recurrent infections, and require repeated costly transfusions of blood products, which only provide a short-term effect.
Pluristem’s PLX-R18 aims to improve the standard of care by stimulating the regenerative potential of the bone marrow.
This potentially enhances the production of all three blood cell lineages, differentiating it from other products which target only one of the three blood cell lineages.
The study enrolled 21 patients in the U.S. and Israel, who were at least three months after the HCT procedure (median: 236 days), and had low blood counts in at least one blood cell lineage. They were assigned to one of three treatment arms: 1 million cells/kg, 2 million cells/kg or 4 million cells/kg. Each patient received two treatments of the assigned dose.
The results demonstrate that PLX-R18 has the potential to stimulate the implanted hematopoietic cells to realize their therapeutic potential and generate improved blood counts over the long term in all three blood cell lineages at once – a meaningful advantage over other existing and proposed treatments.
Available data1 at six-month follow-up demonstrates:
The study supports previous preclinical results, conducted via the U.S. Food and Drug Administration’s (FDA) Animal Rule in collaboration with the U.S. National Institutes of Health (NIH), in which PLX-R18 was found effective in treating bone marrow failure from Acute Radiation Syndrome (ARS).
PLX-R18 is the first product candidate manufactured using Pluristem’s proprietary serum-free media on its 3D bioreactor system.
The company will conduct an analyst and investor call on May 3, 2021, at 10am EDT, for registration: https://Veidan.activetrail.biz/pluristem
1 Data from the six-month follow-up is available for 14 of the 21 treated patients: one patient was terminated early, three patients missed the 6-month visit and three died prior to the 6-month visit (two fatal events in the 2 million cell dose, and one fatal event in the 4 million cell dose).
All fatal events in the study were considered unrelated to the study treatment.
Mortality rates were in line with publicly available information (references: Gao et al 2020, , Halahleh et al 2021, Tang et al 2018, Sun et al. 2015, Zhao et al 2019)
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, 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 that PLX cells may provide a more effective therapeutic benefit than current technologies, that PLX-R18 may potentially enhance the production of three blood cell lineages, the belief that PLX-R18 affects the regeneration activity of the hematopoietic cells and its intention to push forward with the clinical development of PLX-R18 with the goal of establishing it as the new standard of care in the field.
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, February 2, 2021, Pluristem Therapeutics Inc. (Nasdaq:PSTI) (TASE:PSTI), a leading regenerative medicine company developing a platform of novel biological therapeutic products (“Pluristem” or the “Company”), today announced it has entered into definitive agreements with institutional investors for the purchase and sale of 4,761,905 shares of its common stock at a purchase price of $6.30 per share in a registered direct offering, for gross proceeds of $30 million before deducting placement agent fees and expenses. The closing of the offering is expected to occur on or about February 4, 2021, subject to the satisfaction of customary closing conditions.
A.G.P./Alliance Global Partners is acting as sole placement agent for the offering.
This offering is being made pursuant to an effective shelf registration statement on Form S-3 (File No. 333-239890) previously filed with the U.S. Securities and Exchange Commission (the “SEC”), under the Securities Act of 1933, as amended.
A prospectus supplement describing the terms of the proposed offering will be filed with the SEC and will be available on the SEC’s website located at http://www.sec.gov. Electronic copies of the prospectus supplement may be obtained, when available, from A.G.P./Alliance Global Partners, 590 Madison Avenue, 28th Floor, New York, NY 10022, or by telephone at (212) 624-2060, or by email at prospectus@allianceg.com.
Before investing in this offering, interested parties should read in their entirety the prospectus supplement and the accompanying prospectus and the other documents that the Company has filed with the SEC that are incorporated by reference in such prospectus supplement and the accompanying prospectus, which provide more information about the Company and such offering.
This press release shall not constitute an offer to sell or the solicitation of an offer to buy 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, 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 expected closing of 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, 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, January 27, 2021 – Pluristem Therapeutics Inc. (Nasdaq:PSTI) (TASE:PSTI), a leading regenerative medicine company developing a platform of novel biological therapeutic products, announced that effective as of market open on January 29, 2021, its common shares have been approved for listing to the Nasdaq Global Market® and will continue trading under the company’s current ticker symbol – PSTI.
A listing on the Nasdaq Global Market® is considered an indicator of status and success for companies that qualify for listing.
Listed companies must satisfy stringent financial, liquidity and corporate governance requirements, both initially and on an ongoing basis.
“We believe that this move is important for the growth of our Company.
The listing of our common shares on the Nasdaq Global Market® may help increase our visibility within the institutional marketplace and enhance our ability to broaden our shareholder base with the goal of driving long-term shareholder value,” said Pluristem CEO and President, Yaky Yanay.
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, 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 a listing on the Nasdaq Global Market® is important for its growth, that the listing may increase its visibility within the institutional marketplace and that such a listing may enhance its ability to broaden its shareholder base with the goal of driving long-term shareholder value. 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, January 6, 2021 – Pluristem Therapeutics Inc. (Nasdaq:PSTI) (TASE:PSTI), a leading regenerative medicine company developing a platform of novel biological therapeutic products, is pleased to announce the appointment of Ms. Maital Shemesh-Rasmussen, a global health-tech marketing strategist, and Mr. Rami Levi, a leader in global marketing and international governmental affairs, to its Board of Directors.
Ms. Maital Shemesh-Rasmussen brings over 20 years of diverse commercialization experience across various industries. Driving growth in the health-tech sector, she has specifically focused on personalized care and patient-centric, data-driven products and value-based approaches. From 2018 to 2020, she served as Global Head of Solution Marketing at Roche Diagnostics Information Solutions, where she defined Roche’s new health-tech strategy, bringing to market advanced digital solutions and commercial models that positioned Roche as a world leader in health technology.
Key positions previously held by Ms. Shemesh-Rasmussen include: Director of Strategic and Product Marketing at Oracle Healthcare and Precision Medicine (2013-2016), where she drove penetration of the informatics, analytics and precision medicine market; Vice President of Global Marketing at JPMorgan Chase Bank (2002-2007), where she led global marketing and technology innovation to generate multimillion-dollar growth; Founder & CEO of Rasmussen Communications marketing agency, where she shaped marketing strategies and messaging for financial, health and technology firms; a consultant for startups; and a Board Member/Marketing Chair of Healthcare Information and Management Systems Society Northern California. Her education includes a BA in Behavioral Sciences, Magna Cum Laude, from Ben-Gurion University of the Negev, studies for an MA in Political Science and Communication at Bar-Ilan University, and the Executive Education Program in Strategy, Finance and Computer Science at Columbia University, New York.
Mr. Rami Levi, Founder and President of Catalyst Group International, brings over 30 years of experience in managing successful international projects on five continents, partnering with world leaders, and connecting nations and industry on a global scale. His career, spanning both the public and private sectors, has included five diplomatic missions on behalf of the State of Israel, as well as the founding of several successful companies. A leading expert in international affairs, global market development, crisis management, strategic planning and government regulatory management, Mr. Levi has generated and managed major cross countries agreements over the years.
As Senior Deputy General & Head of Marketing Administration at Israel’s Ministry of Tourism, Mr. Levi led numerous international initiatives and global partnerships involving 42 governments and world-leading conglomerates. In the private sector, he founded Catalyst Group, working as a consultant for governments, global law firms, banks, television networks and multinational NGOs. Mr. Levi’s holds an MA with Honors in Political Science from The Hebrew University of Jerusalem.
Pluristem Therapeutics Executive Chairman of the Board, Zami Aberman, said: “We are very happy to have Ms. Shemesh-Rasmussen and Mr. Levi on our Board of Directors. Maital is an innovation-driven global Health-Tech marketing strategist and an inspiring thinker, who is passionate about advancing healthcare through technology. Rami is a most impressive strategist and market developer, with proven business acumen and extensive global connections. Together they bring immense knowledge, experience and networking potential across industries in the global marketplace. We feel certain that their joint capabilities will boost our strategic resources, business development and market penetration, contributing significantly to the success of Pluristem’s endeavors.”
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, 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 that its new directors will enhance the Board’s strategic capabilities in preparation for future growth and commercialization endeavors.
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, December 29, 2020 – Pluristem Therapeutics Inc. (Nasdaq:PSTI) (TASE:PSTI), a leading regenerative medicine company developing a platform of novel biological therapeutic products, announced today it has entered into a collaboration agreement with Mexican pharmaceutical company Innovare R&D to expand its ongoing clinical program of PLX cells in the treatment of Acute Respiratory Distress Syndrome (ARDS) associated with COVID-19 in Mexico.
The Phase II study in Mexico is subject to the approval of local authorities, with the goal of being conducted under the U.S. Food and Drug Administration (FDA) cleared protocol.
In accordance with the agreement, Innovare will open clinical sites and enroll patients for the proposed clinical study in Mexico.
Innovare will fund the study in Mexico and will purchase PLX cells for the study from Pluristem.
Subject to potential positive clinical study results and Mexican regulatory approval for commercialization, the agreement grants Innovare exclusive distribution rights in Mexico to supply PLX cells for treating severe COVID-19 cases complicated by ARDS. All intellectual property and manufacturing rights remain with Pluristem.
With 1,389,430 cases and 122,855 deaths as of December 29, 2020, Mexico’s COVID-19 infection and mortality rates have been increasing.
Mexico has the highest deaths proportionally to COVID- 19 cases or population in the world as of December 28, 2020, as reported by Johns Hopkins University of Medicine.
“We are pleased to join forces with Innovare, a leading innovative company aiming to be part of the solution for combating the COVID-19 pandemic in Mexico,” stated Pluristem CEO and President, Yaky Yanay. “Thanks to our key competitive advantage of having in-house manufacturing facility, advanced logistical capabilities, and a global reach, we are able to supply PLX cells to clinical centers around the world while extending our global support for COVID-19 into Latin America. By conducting the study in both the U.S. and Mexico, in parallel to the E.U. and Israel, we are continuing our focus on achieving clinical milestones and objectives, while bringing the potential treatment of PLX cells to those in need.”
Gerardo Cárdenas Vogel, CEO of Innovare R&D commented, “As a company that is seeking worldwide partners showing clinical promise for unmet medical needs, we are excited to collaborate with Pluristem.
We look forward to leveraging our clinical and commercial capabilities with Pluristem’s advanced cell therapy solution to help develop and potentially bring a much needed treatment for ARDS patients associated with COVID-19 to Mexico.”
Pluristem is currently conducting two Phase II studies in ARDS associated with COVID-19 in the U.S., Europe and Israel, an Expanded Access Program in the U.S. and a per patient compassionate use program in Israel.
Innovare R&D comprises a group of pharmaceutical companies that develop and commercialize drugs in the areas of hematology, immunology, infectious disease, central nervous system, and urology.
They established a unique partnering model to collaborate with biopharmaceutical companies in a strategy to proof the applicability of their platform in improving patient´s outcomes. Innovare R&D has regional (Mexico) coverage for commercializing products that have already been approved by the FDA/ European Medicines Agency (EMA)/ Health Canada/ Swissmedic/ TGA, while Innovare R&D is leading their own product developments with partners in the U.S. and Europe.
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 Phase II study in Mexico, subject to the approval of local authorities, that it continues to focus on achieving clinical milestones and objectives, while bringing the potential treatment of PLX cells to those in need and potentially bringing a much needed treatment for ARDS patients associated with COVID-19 to Mexico.
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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