Armed Forces Radiobiology Research Institute

Presentation to update the advanced development of BIO 300, an orally available medical countermeasure for Warfighters, to prevent toxicities due to radiation exposure. MINNEAPOLIS--(BUSINESS WIRE)--Updates on the development of Humanetics Corporation’s (Humanetics) new drug candidate, BIO 300, were presented at the 2024 Military Health System Research Symposium (MHSRS), held August 26-29 th in Kissimmee, Florida. MHSRS is the foremost scientific meeting of the U.S. Department of Defense (DOD), focusing on the unique medical needs of warfighters. BIO 300 was originally developed as a radioprotectant by researchers at the Armed Forces Radiobiology Research Institute (AFRRI) in Bethesda, Maryland. It was exclusively licensed to Humanetics for advanced development and commercialization. Collaborative studies continue with DOD scientists to develop BIO 300 as an oral drug that warfighters can take to provide protection against the effects of radiation from a radiological or nuclear event. Key Highlights of the Presentation: Novel Formulation: An overview of the BIO 300, an orally available drug designed for ease of use and rapid administration in various military and commercial settings. Efficacy and Safety: Insights into the nonclinical studies demonstrating the compound’s ability to protect against Acute Radiation Syndrome (ARS) and its safety in animal models. Clinical Development Pathway: An outline of clinical data supporting BIO 300’s safety and efficacy, including the proposed plan for human dose conversion under the FDA animal rule. Ongoing Development Activities: A detailed overview of ongoing and future development activities to support planned regulatory submissions. This work highlighted on BIO 300 research has positioned it as one of the most advanced prophylactic medical countermeasures currently under development for ARS. Developing countermeasures that protect individuals, especially military personnel, against ARS is paramount, considering the current geopolitical environment fueling the real and increasing threat of nuclear or radiological events. “We are thrilled to share our progress on the advanced development of BIO 300,” said Michael Kaytor, Ph.D., Vice President of Research and Development at Humanetics. “This drug could transform our ability to protect the men and women who serve our country, and anyone who may be at risk of intentional or accidental radiation exposure.” In addition to its military applications, BIO 300 is being evaluated in phase 2 clinical trials to prevent normal tissue injury resulting from cancer radiotherapy and to reduce inflammatory lung damage (e.g., COVID-19, Idiopathic Pulmonary Fibrosis, acute respiratory distress syndrome). The research presented was supported in part by grants from the US Department of Defense’s Congressionally Directed Medical Research Program and an Other Transaction Authority agreement with the Joint Program Executive Office for Chemical, Biological, Radiological, and Nuclear Defense (JPEO-CBRND). The views expressed herein are those of Humanetics and may not reflect the official policy or position of the Department of Defense or the US Government. Reference herein to any specific commercial products, process, or service by trade name, trademark, manufacturer, or otherwise, does not constitute or imply its endorsement, recommendation, or favoring by the U.S. government and shall not be used for advertising or product endorsement purposes. About Humanetics Corporation Humanetics Corporation is a clinical-stage pharmaceutical company engaged in the accelerated discovery, development and commercialization of proprietary drugs in markets with urgent and unmet needs with a focus on radiation modulators for oncology and medical countermeasures. For more information, visit . Contacts Michael Kaytor VP – Research and Development mkaytor@humaneticscorp.com

As part of Pluri’s previously announced $4.2 million 3-year contract with the U.S. National Institute of Allergy and Infectious Diseases (NIAID), the option for the second year of thecontract has been exercised to fund manufacturing, in-vitro, and in-vivo studies of Pluri’s cell therapy PLX-R18 is designed to be a first in class, effective treatment for ionizing radiation injuries that could be anticipated in the wake of a large-scale nuclear incident Work during the contract period is expected to make further progress toward marketing approval for PLX-R18as a medical countermeasure for exposure to radiation and lead to PLX-R18 becomingeligible for procurement by the U.S. Strategic National Stockpile, following FDA approval HAIFA, Israel, June 06, 2024 (GLOBE NEWSWIRE) -- Pluri Inc. (Nasdaq:PLUR) (TASE:PLUR) ("Pluri" or "the Company), a leading biotechnology company that transforms cells into solutions, today announced the U.S. National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH), has exercised its option for year two of the three-year $4.2 million contract it entered into with Pluri in July 2023. During the 12 months from July 1, 2024 through June 30, 2025, the NIAID will provide $1.4 million for the Company to manufacture the PLX-R18 cell therapy and to conduct both in vitro and in vivo studies to develop PLX-R18 as a potential novel treatment for hematopoietic complications of the acute radiation syndrome (H-ARS). H-ARS is caused by exposure to life-threatening amounts of ionizing radiation, such as that which may occur during a radiological or nuclear accident, terrorist activities, and/or warfare. The condition is characterized by dose-dependent bone marrow depression, leading to neutropenia, thrombocytopenia, and anemia, and possibly death. The U.S. Food and Drug Administration (FDA) previously approved an Investigational New Drug application for PLX-R18 for the treatment of H-ARS in the case of nuclear or radiological or incidents and granted it Orphan Drug Designation. Over the past year, Pluri has collaborated with the U.S. Department of Defense’s (DoD) Armed Forces Radiobiology Research Institute at the Uniformed Services University of Health Sciences in Bethesda, Maryland, resulting in significant advancements in the development of PLX-R18 as a potential treatment for H-ARS. “PLX-R18 is being developed as a next-generation countermeasure against the damage caused by ionizing radiation, aiming to treat single-agent neutropenia, thrombocytopenia, and anemia. We would like to thank NIAID for its trust and for choosing to exercise its second-year option, this action validates the potential of PLX-R18 to treat H-ARS,” said Yaky Yanay, Chief Executive Officer and President of Pluri. “We are pleased to continue working with the NIH and the DoD’s Armed Forces Radiobiology Research Institute, to advance this potential treatment for a truly devastating medical condition, especially in light of recent geopolitical events and the global threat of nuclear disasters.” PLX-R18 has been safely tested in both humans and animals. Prior studies funded by the NIH/NIAID and conducted in accordance with the FDA’s Animal Rule pathway demonstrated that PLX-R18 administered to animals after radiation exposure for H-ARS significantly increased survival rates from 29% in the control group to 97% in the treated group (p<0.001). Studies conducted by the DoD have shown that PLX- R18, administered as a prophylactic measure 24 hours before radiation exposure, and again 72 hours after exposure, resulted in a significant increase in survival rates, from 4% survival in the placebo group to 74% in the treated group (log-rank test p< 0.0001). In addition, the data show a significant increase in recovery of white blood cell (p = 0.0047), platelet (p = 0.0070), neutrophil (p = 0.0003) and lymphocyte (p = 0.0025) counts compared to administration of vehicle, and also demonstrate a favorable safety profile. PLX-R18 was tested in humans with incomplete hematopoietic recovery following hematopoietic cell transplantation and was well tolerated with a favorable safety profile. Patients treated with PLX-R18 showed an increase in all three blood cell types compared to the baseline with platelet (p<0.001), hemoglobin (p=0.02) and neutrophil (p=0.15) levels increasing as early as 1 month following PLX-R18 administration and enduring up to 12 months following treatment, while experiencing a significant reduction in mean number of transfused units from a monthly 5.09 to 0.55 for platelets (p=0.045) and 2.91 to 0 for red blood cells (p=0.0005) over 12 months of follow-up. About Pluri Inc. Pluri™ is pushing the boundaries of science and engineering to create cell-based products for commercial use and is pioneering a biotech revolution that promotes global well-being and sustainability. The Company’s technology platform, a patented and validated state-of-the-art 3D cell expansion system, advances novel cell-based solutions for a range of challenges— from medicine and climate change to food scarcity, animal cruelty and beyond. Pluri’s method is uniquely accurate, scalable, cost-effective and consistent from batch to batch. Pluri currently operates in the field of regenerative medicine, foodtech and agtech. The Company also offers Contract Development and Manufacturing Organization (CDMO) services. Pluri establishes partnerships that leverage the Company’s proprietary 3D cell-based technology across various industries that require effective, mass cell production. To learn more, visit us at or follow Pluri on LinkedIn and X (formerly known as Twitter). 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, Pluri is using forward-looking statements when it discusses the potential benefits to be derived from the use of PLX-R18; its collaborations with strategic partners; its regulatory strategy; and that work during the contract period is expected to make further progress toward marketing approval for PLX-R18 as a medical countermeasure for exposure to nuclear radiation and lead to PLX-R18 becoming eligible for purchase by the U.S. Strategic National Stockpile. These forward-looking statements and their implications are based on the current expectations of the management of Pluri 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 about Pluri: changes in technology and market requirements; Pluri may encounter delays or obstacles in launching and/or successfully completing its clinical trials, if necessary; its products may not be approved by regulatory agencies, its technology may not be validated as it progresses further and its methods may not be accepted by the scientific community; it 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 its processes; its 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; its patents may not be sufficient; its products may harm recipients or consumers; changes in legislation with an adverse impact; 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 Pluri to differ materially from those contemplated in such forward-looking statements. Except as otherwise required by law, Pluri 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 Pluri reference is made to Pluri's reports filed from time to time with the Securities and Exchange Commission. Media Contacts Investors: investor.relations@pluri-biotech.com Israel Media: Shachar Yental at shacharye@gitam.co.il U.S. Media: Jessica Daitch at Jessica@quantum-corp.com / Madeline Weirman at Maddie@quantum-corp.com

NORFOLK, Va.--(BUSINESS WIRE)-- ReAlta Life Sciences, Inc. (“ReAlta” or the “Company”), a mid-stage clinical biotech company dedicated to saving lives by rebalancing the inflammatory response to address life-threatening diseases, today announces that the company will be utilizing the preclinical services program offered by the National Institute of Allergy and Infectious Diseases (NIAID) to evaluate RLS-0071 as a medical countermeasure for Acute Radiation Syndrome (ARS). Under a research collaboration, scientists at the Armed Forces Radiobiology Research Institute (AFRRI), working with support from the Radiation and Nuclear Countermeasures Program (RNCP) at NIAID, will evaluate the ability RLS-0071 to mitigate the gastrointestinal effects of ARS (GI-ARS) in a preclinical mouse model. “We are very pleased to partner with NIAID and AFRRI to evaluate ReAlta’s lead drug candidate, RLS-0071, as a radiation countermeasure for GI-ARS,” says Dr. Ulrich Thienel, Chief Executive Officer of ReAlta. “Our collaboration may provide a much-needed therapy for radiation-induced tissue damage that is associated with high mortality.” Dr. Neel Krishna, Chief Scientific Officer at ReAlta adds that, “the anti-inflammatory, dual mechanism-of-action of RLS-0071 enables the rapid inhibition of both complement activation and neutrophil effectors that are key initiators of deadly inflammation in ARS.” About the National Institutes of Health (NIH) As one of the 27 institutes and centers of the U.S. NIH, NIAID conducts and supports basic and applied research to better understand, treat, and ultimately prevent infectious, immunologic, and allergic diseases. For more than 60 years, NIAID research has led to new therapies, vaccines, diagnostic tests, and other technologies that have improved the health of millions of people in the U.S. and around the world. About AFRRI AFRRI was established in 1961 and operated by the U.S. Defense Atomic Support Agency and the Defense Nuclear Agency until 1993, when it was realigned with the Uniformed Services University of the Health Sciences (USUHS). AFRRI is unique and powerful radiobiological research institute, with six decades of active, robust, and outstanding support to the U.S. Department of Defense through research, reach-back, and education. It is the only U. S. Department of Defense medical R&D facility dedicated solely to nuclear and radiological defense. About Acute Radiation Syndrome ARS, also known as radiation sickness or radiation poisoning, is a collection of health effects that are caused by exposure to high amounts of ionizing radiation in a short period of time. Symptoms can start within minutes of exposure and can last for several months. Early symptoms are usually nausea and vomiting. In the following hours or weeks, initial symptoms may appear to improve, before the development of additional complications, after which either recovery or death follows. Exposure to radiation can occur accidentally or intentionally, and may involve nuclear power reactor accidents or attacks, certain devices used in cancer therapy, dirty bombs, or nuclear or radiological weapons. About ReAlta Life Sciences ReAlta Life Sciences, Inc. is a mid-stage clinical biotech company dedicated to saving lives by rebalancing the inflammatory response to address life threatening acute inflammatory and rare diseases. The Company’s EPICC peptides are based on research into the human astrovirus, HAstV-1, which causes a non-inflammatory, self-limiting gastroenteritis unique among viruses by inhibiting components of the innate immune system. ReAlta’s therapeutic peptides leverage these virus-derived mechanisms to rebalance complement and inflammatory processes in the body. The company’s pipeline is led by RLS-0071, which has received IND clearance by the U.S. Food and Drug Administration (FDA) for the treatment of acute exacerbations of chronic obstructive pulmonary disease and acute graft-versus-host disease, and IND clearance, Orphan Drug Designation, and Fast Track Designation by the FDA, and Orphan Drug Designation by the European Medicines Agency, for the treatment of hypoxic-ischemic encephalopathy (HIE). The company launched in 2018 and is located in Norfolk, Virginia and Aguadilla, Puerto Rico. For more information, please visit .