U.S. National Institutes of Health to Fund $4.2 Million Contract to Advance Development of Pluri’s PLX-R18 in Conjunction with U.S. DoD as a Medical Countermeasure for Hematopoietic Acute Radiation Syndrome

• Pluri's cell therapy is designed to be the first in class, effective treatment for ionizing radiation poisoning in the event of a large-scale nuclear incident.
  
• The work specified by the contract is based on communications with the FDA and will enable Pluri to make significant progress toward marketing approval for PLX-R18.
• PLX-R18 is developed with the intention of being eligible for purchase by the U.S. Strategic National Stockpile as a medical countermeasure for exposure to nuclear radiation, following FDA approval.
  

HAIFA, Israel, July 11, 2023 (GLOBE NEWSWIRE) -- Pluri Inc. (Nasdaq: PLUR) (TASE: PLUR) (“Pluri” or the “Company”), a leading biotech company that transforms cells into solutions that promote wellbeing and sustainability, today announced that it has signed a three year $4.2M contract with the U.S. National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH). Pluri will collaborate with the U.S. Department of Defense’s Armed Forces Radiobiology Research Institute (AFRRI)/Uniformed Services University of Health Sciences (USUHS) in Maryland, USA to further advance the development of its PLX-R18 cell therapy as a potential novel treatment for Hematopoietic Acute Radiation Syndrome (H-ARS). H-ARS is a deadly disease that can result from nuclear disasters and radiation exposure.

Recent geo-political events have reinforced the need for the global community to better prepare for nuclear disasters, such as seeking new medical treatments that are more cost-efficient and scalable than current options that can be proactively administered in advance of a potential nuclear event. H-ARS, also known as radiation poisoning, is caused by exposure to life-threatening amounts of ionizing radiation, such as what may occur during nuclear/radiological accidents, terrorist activities and warfare. H-ARS is characterized by dose dependent bone marrow depression, leading to life-threatening neutropenia, thrombocytopenia and anemia, and possible death.

This contract supports Pluri’s goal to achieve marketing approval for PLX-R18 with the U.S. Food and Drug Administration (FDA), which could qualify the product to be purchased for the U.S. Strategic National Stockpile as a medical countermeasure for exposure to radiation. The FDA previously cleared an Investigational New Drug (IND) application for PLX-R18 for the treatment of ARS in the case of nuclear events and granted it Orphan Drug Designation.