Pluristem Therapeutics

Pluri, Inc. is a clinical stage company, which engages in cell therapy development. It develops placenta-based cell therapy product candidates for the treatment of multiple ischemic, inflammatory and hematologic conditions. The firm focuses on the development, clinical trials and manufacturing of cell therapeutics and related technologies. Its products include Clinical Pipeline, PLX-Immune, PLX-PAD, and PLX-R18. The company was founded by Doron Shorrer on May 11, 2001 and is headquartered in Haifa, Israel.

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Pluri, Inc. is a clinical stage company, which engages in cell therapy development. It develops placenta-based cell therapy product candidates for the treatment of multiple ischemic, inflammatory, and hematologic conditions. The firm focuses on the research, development, and manufacturing of cell-based products and technologies. Its products include Clinical Pipeline, PLX-Immune, PLX-PAD, and PLX-R18. The company was founded by Doron Shorrer on May 11, 2001 and is headquartered in Haifa, Israel.

HAIFA, Israel, Feb. 02, 2021 (GLOBE NEWSWIRE) -- 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.

Pluristem Therapeutics Inc. Announces $30 Million Registered Direct Offering

HAIFA, Israel, Dec. 29, 2020 (GLOBE NEWSWIRE) -- 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 .

Pluristem Enters Collaboration With Pharmaceutical Company Innovare R&D to Expand Pluristem's ARDS Associated With COVID-19 Program to Mexico

HAIFA, Israel, Dec. 09, 2020 (GLOBE NEWSWIRE) -- Pluristem Therapeutics Inc. ( Nasdaq:PSTI ) (TASE:PSTI), a leading regenerative medicine company developing a platform of novel biological therapeutic products, today announced that the independent Data Monitoring Committee (DMC) of its global pivotal Phase III study for the treatment of critical limb ischemia (CLI) issued its recommendation letter following the interim analysis. The clinical dataset was reviewed by the independent DMC for safety and analysis of the primary endpoint of amputation-free survival, defined as time to occurrence of major amputation of the index leg or death.

Pluristem Announces DMC Recommendation Following Interim Analysis of its Phase III CLI Study

Pluristem's CLI Phase III trial interim results should be published soon. Results are critical and might define the fate of the company.

Pluristem - Moment Of Truth

HAIFA, Israel, Nov. 18, 2020 (GLOBE NEWSWIRE) -- Pluristem Therapeutics Inc. ( Nasdaq:PSTI ) (TASE:PSTI), a leading regenerative medicine company developing a platform of novel biological therapeutic products, today reported the first clinical results for PLX-R18 in humans from its Phase I study evaluating PLX-R18 as a treatment for incomplete hematopoietic recovery following hematopoietic cell transplantation (HCT). The initial results consisted of the analysis of the first 19 patients enrolled, and not all patients completed a one year follow up.

Pluristem to Present Initial Results from Its Phase I HCT Study with PLX-R18 Demonstrating Safety and Efficacy at the ASH Annual Meeting

HAIFA, Israel, Oct. 20, 2020 (GLOBE NEWSWIRE) -- Pluristem Therapeutics Inc. ( Nasdaq:PSTI ) (TASE:PSTI), a leading regenerative medicine company developing a platform of novel biological products, today named medical experts to form the Steering Committee for its clinical program relating to Acute Respiratory Distress Syndrome (ARDS) associated with COVID-19. Pluristem is currently conducting Phase II studies of its PLX-PAD cells to treat hospitalized patients suffering from severe COVID-19 complicated by ARDS in the U.S., Europe and Israel. The Company is also conducting an Expanded Access Program in the U.S. and a per-patient Compassionate Use Program in Israel.

World Experts in Infectious Diseases & Critical Care Form Pluristem's COVID-19 Steering Committee

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Reports internal efficacy and safety data from first cohort Reports internal efficacy and safety data from first cohort

Pluristem Announces Clearance to Move Forward with Enrollment for Cohort II in an Investigator-Led Phase I/II Chronic Graft vs Host Disease Study

HAIFA, Israel, Oct. 07, 2020 (GLOBE NEWSWIRE) -- 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 received approval from the Israeli Ministry of Health to commence patient enrollment in Israel for the Company’s COVID-19 Phase II clinical trial, under the protocol that was approved by the Paul Ehrlich Institute (PEI), Germany’s regulatory agency. A total of 40 patients hospitalized with severe COVID-19 complicated by Acute Respiratory Distress Syndrome (ARDS) will be enrolled at clinical sites in Israel and Germany.

Pluristem Expands its Phase II COVID-19 European Clinical Trial to Israel

HAIFA, Israel, Aug.  27, 2020  (GLOBE NEWSWIRE) --   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 Expanded Access Program (EAP) for the use of its PLX-PAD cells to treat Acute Respiratory Distress Syndrome (ARDS) caused by COVID-19 outside of the Company’s ongoing  Phase II COVID-19 study  in the U.S. The program provides a pathway for patients that are not eligible for inclusion in the Phase II clinical trial to be treated with PLX-PAD cells. The EAP will include up to 100 patients, with the resulting data collected and evaluated alongside Pluristem’s clinical trial.

Pluristem Launches FDA-Cleared COVID-19 Expanded Access Program, Enabling Patient Treatment Outside of Clinical Trial

Pluristem (PSTI) completes enrollment in the phase I study in patients with complete hematopoietic recovery following hematopoietic cell transplantation in the United States and Israel.

Pluristem Completes Enrollment in Phase I Hematology Study

Top line efficacy results expected Q1 2021 Top line efficacy results expected Q1 2021

Pluristem Announces End of Patient Enrollment in its Phase I Hematology Study

HAIFA, Israel, July  21, 2020  (GLOBE NEWSWIRE) --   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.

Pluristem CEO Issues Shareholder Update on Clinical Programs

HAIFA, Israel, June  11, 2020  (GLOBE NEWSWIRE) --   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.  

Pluristem Announces Activation of Clinical Sites and Commencement of Patient Enrollment in U.S. FDA Phase II COVID-19 ARDS Trial

HAIFA, Israel, June  03, 2020  (GLOBE NEWSWIRE) --   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.

Pluristem Joins Forces with CRISPR-IL National Consortium to Advance Development of Cutting-Edge Genome Editing Solutions for Life Science Products

Is  (PSTI) Outperforming Other Medical Stocks This Year?

Has Pluristem Therapeutics (PSTI) Outpaced Other Medical Stocks This Year?

Pluristem Therapeutics: The Search For An ARDS Treatment, And Whether Its Growth Will Continue

Is Pluristem Therapeutics (PSTI) Outperforming Other Medical Stocks This Year?

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

Pluristem Provides 28-Day Follow Up for Ventilator-Dependent COVID-19 Patients under Compassionate Use Program in Israel and U.S.

HAIFA, Israel, May  08, 2020  (GLOBE NEWSWIRE) --   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.

U.S. FDA Clears Pluristem’s IND Application for Phase II COVID-19 Study

HAIFA, Israel, May  05, 2020  (GLOBE NEWSWIRE) --   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.

Pluristem Announces Pricing of Its Registered Direct Offering for Aggregate Proceeds of $15 Million

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Pluristem Therapeutics Inc. (PSTI) Shares March Higher, Can It Continue?

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• Elaborating on agreement  terms  and tranches schedule  • Provides update on cash position and clinical program

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