Avoplacel (Pluristem Therapeutics)

Strategic initiative to address Ukraine’s urgent need for radiation countermeasures Hemafund’s infrastructure ensures secure storage and rapid deployment of emergency treatments Collaboration may potentially generate over $100 million in value for both parties Haifa, Israel – March 5, 2025 – Pluri Inc. (Nasdaq: PLUR) (TASE: PLUR) (“Pluri” or the “Company”), a leading biotechnology company leveraging its proprietary platform for cell-based solutions to create a collaborative network of ventures, today announced that it has signed an exclusive collaboration agreement with Hemafund Ltd. (“Hemafund”), a Ukrainian umbilical cord blood bank with clinical and research laboratories and facilities specializing in cell preservation and cryostorage (the “Collaboration” or the “Collaboration Agreement”). This Collaboration aims to establish a strategic initiative for stockpiling, distribution, and potential clinical advancement of Pluri’s innovative PLX-R18 cell therapy (“PLX-R18”) as a countermeasure against Hematopoietic Acute Radiation Syndrome (“H-ARS”) in Ukraine. Subject to certain conditions, the Collaboration Agreement will be effective for an initial period of three years and can be extended by the parties for an additional period of three years. Pursuant to the Collaboration Agreement, Pluri will produce and supply PLX-R18 as a potential treatment for H-ARS following nuclear radiation exposure. Hemafund will leverage its infrastructure and expertise in biostorage, logistics, and regulatory processes to support local distribution and ensure compliance with Ukrainian and European biobank standards. The parties will seek funding to build the necessary capacity of PLX-R18 and expect to enter into a specific separate definitive agreement once such funding becomes available. This Collaboration comes in response to recent escalations, including a recent Russian drone strike on the Chernobyl nuclear power plant, which caused a fire in the containment shell. Although the blaze was extinguished without an increase in radiation levels, the incident underscores the critical need for effective and readily available radiation countermeasures in the region. As part of this Collaboration, Pluri and Hemafund will work toward securing external funding to build an initial capacity of 12,000 doses of PLX-R18, ensuring preparedness for radiation-related emergencies. The PLX-R18 doses will be stored and managed by Hemafund, leveraging its state-of-the-art biobank infrastructure and logistics network to enable rapid deployment in case of need. The Collaboration, if successful, could potentially generate over $100 million in value for both parties, based on the estimated cost per dose and the projected stockpile of 12,000 doses, which is expected to be sufficient to treat 6,000 individuals (as each patient is expected to require two doses). The calculation of 12,000 doses is based on the actual availability of countermeasures in the U.S. Strategic National Stockpile for the U.S. population. This approach aligns with established preparedness measures designed to ensure the availability of countermeasures against H-ARS in response to public health emergencies[1]. H-ARS is caused by exposure to life-threatening amounts of ionizing radiation, such as those which may occur during a radiological or nuclear accident, terrorist activities, and/or warfare. The condition is characterized by a dose-dependent bone marrow suppression, leading to severe neutropenia, thrombocytopenia, anemia, and a heightened risk of mortality. Strategic Goals of the Collaboration: Stockpiling and Distribution: Hemafund will establish secure storage and facilitate the logistics of PLX-R18 delivery to medical institutions across Ukraine. Regulatory and Compliance Support: The Collaboration will seek necessary approvals from Ukraine’s Ministry of Health and ensure adherence to regional regulations for PLX-R18 use. Clinical Advancement: Pluri and Hemafund will explore opportunities for clinical trials to register the PLX-R18 as a radiation countermeasure. Public and Private Funding: This Collaboration aims to attract government and private sector funding to support the development and accessibility of PLX-R18 in Ukraine and potentially other regions. “As a company committed to leveraging cell-based technology for humanity’s greatest challenges, we see this Collaboration as a proactive measure to ensure our PLX-R18 therapy is readily available where it is needed,” said Yaky Yanay, Chief Executive Officer and President of Pluri. “We believe that Hemafund’s deep-rooted expertise in Ukraine’s biotech landscape makes them an ideal partner to facilitate local accessibility, storage, and regulatory integration of our solution.” Yaroslav Issakov, Founder of Hemafund Ltd., added, “We are excited to combine our efforts with Pluri to address this urgent medical need together. We believe that our state-of-the-art cryostorage facilities and logistics network position us well to support the introduction of PLX-R18 as a potential vital tool for radiation emergency preparedness in Ukraine. While we hope such treatments remain precautionary, our goal is to stand ready to distribute this potential therapy in the event of an emergency.” About Hemafund Hemafund is a family cord blood bank, located in a biotechnological complex in Ukraine, and specializing in the preservation of umbilical cord blood, placenta, and umbilical cord tissues. The company also provides long-term cryostorage services for human cells and tissues, with a focus on stem cell preservation. Hemafund operates a comprehensive facility that includes facilities such as clinical diagnostic laboratories, processing laboratories, and cryostorage facilities, and is a member of the international Cord Blood Association, coordinating a nationwide program for the application of cord blood in Ukraine. Learn more at https://international.hemafund.com/ About PLURI 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 regenerative medicine, foodtech and agtech fields. The Company also offers Contract Development and Manufacturing Organization services. Pluri establishes partnerships that are aimed to leverage the Company’s proprietary 3D cell-based technology across various industries that require effective, mass cell production. To learn more, visit us at www.pluri-biotech.com 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 of the Collaboration and each party’s obligation pursuant to the Collaboration Agreement, the potential for PLX-R18 to be used for the potential treatment of H-ARS, the potential doses required and potential revenue to be derived from the Collaboration, the potential for both parties to secure necessary funds to build the necessary capacity of PLX-R18 and the expectation of the parties to enter into a separate definitive agreement when such funds become available. 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. 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Media Contacts Investors: investor.relations@pluri-biotech.com Israel Media: Or Erez at Or.Erez@gitam.co.il U.S. Media: Jennifer Ringler at jringler@quantum-corp.com 1 HHS boosts stockpile of products to treat acute radiation syndrome | HHS.govBARDA Awards $37.6 million Contract to Sanofi to Supply Leukine® (sargramostim) for Potential Public Health Emergency | Business WireGoLocalProv | U.S. Shells Out $290M to Stockpile Radiation Sickness Pills — Made by Amgen OUR STORY OUR TECHNOLOGY OUR VERTICALS PARTNERS MEDIA & EVENTS INVESTORS & ESG OUR STORY OUR TECHNOLOGY OUR VERTICALS PARTNERS MEDIA & EVENTS INVESTORS & ESG Pluri Biotech Ltd., Matam Park Building 5, Haifa 3508409, Israel Israel +972-74-7108600 USA +1-347-9732098 info@pluri-biotech.com Terms of use Use of the Pluri Web Site General Pluri Biotech Ltd., on its behalf and on behalf of its related companies, including without limitations, its parent company, Pluri Inc. 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Privacy and Data Protection Policy and Notice Last updated on 13 January 2025 Pluri Biotech Ltd. and its affiliates and related companies (“Pluri”, “we”, “our” or the “Company”, and their cognates) respects the privacy of its research partners, academic affiliate representatives, investors, clinical studies participants, employees, vendors and sites and website visitors, and others of whom we collect information, and is committed to protecting the personal information you may share with us (these and any others with respect to whom we collect personal data, shall collectively be referred to as “you”, “user”, or “data subject”). Pluri develops platforms to manufacture cell-based products aimed at improving human well-being, increasing sustainability, and addressing significant global challenges (the “Services”). This policy and notice (the “Privacy Policy”) explains the types of information we may collect from you, that we may receive about you or that you may provide in the course of your interest or in our Services, transactions, conferences or when you use our platforms or services or visit our website. We are transparent about our practices regarding the information we collect, use, maintain and process and describe our practices in this policy and notice. Please read the following carefully to understand our practices regarding your personal data and how we will treat it. For the purposes of EU General Data Protection Regulation ( “GDPR”), the California Consumer Privacy Act of 2018, as amended by the California Privacy Rights Act of 2020 (“CCPA”) other US State privacy laws, and any other applicable data protection and privacy laws, Pluri is usually a data controller (or ‘owner’) in relation to the personal data collected and processed through our Services or provided to us by our research partners. Summary: we collect various categories of personal data in order to meet our contractual obligations, and also to meet various legitimate interests, such as service improvement, fraud prevention and marketing. We collect data about you in connection with your transactions with us, or in processing data for our research partners. We also collect data about our visitors and website visitors. One type of data collected is non-identifiable and anonymous information (“non-personal data”). We also collect several categories of personal data (“Personal Data”), as described below. Personal Data which is being gathered consists of any details which are personally identifiable and which are provided consciously and voluntarily by you, or by an organization you represent or are associated with or through your use of our website and registration to and use of our Services (as described below), by email, or other ways in which you communicate and interact with us. This generally includes your name (first and last), email address, phone number, postal address, position and organization name and other information you may choose to provide to Pluri directly and willingly through your use of our Services. Additionally, we may obtain data related to the geographic location of your laptop, mobile device or other digital device on which the Pluri website or platform are used. You do not have any legal obligation to provide any information to Pluri, however, we require certain information in order to perform contracts, or to provide any services. If you choose not to provide us with certain information, then we may not be able to provide you or your organization with some or all of the services. By contacting us or submitting requests for information or support via the website, email etc., Pluri will collect details, including also your name, phone number and personal or company email you provided, country, professional details and other information provided by you. Pluri may use this information to offer Pluri’s services and support. When participating in clinical research conducted by us or in collaboration with our research partners, we collect the necessary information, including health-related data. Summary: we collect Personal Data when you or your organization send it to us, or when a vendor, distributor or other research partner sends it to us so; we collect Personal Data through our website and Services, and through our interactions with you. We collect Personal Data required to provide Services when you register interest, or when you provide us such information by entering it manually or automatically, or through your use of our facilities, website and Services, in the course of preparing a contract, or otherwise in engaging with us. We also may collect Personal Data when you call us for support, in which case we collect the information you provide us. On our website, we collect technical and behavioral information such as the user’s Internet protocol (IP) address used to connect your device to the Internet, your uniform resource locators (URL), operating system, type of browser, browser plug-in types and versions, screen resolution, time zone setting, the user’s ‘clickstream’ on our website, the period of time the user visited the platform etc. We also We likewise may place cookies on your browsing devices (see ‘Cookies’ section below). Summary: we process Personal Data to meet our obligations, protect our rights, and manage our activities. We will use Personal Data to provide and improve our services to you or to our research partners and others and meet our contractual, ethical and legal obligations. All Personal Data will remain accurate complete and relevant for the stated purposes for which it was processed, including for example: Processing which is necessary for the performance of a contract to which you are a party or in order to take steps at your request prior to entering into a contract: Carrying out our obligations arising from any contracts entered into between you or your employer or organization and Pluri or Pluri’s research partners and/or any contracts entered into with Pluri and to provide you with the information, products, support and services that you request from Pluri and its research partners; Verifying and carrying out financial transactions in relation to payments you make in connection with the Services. Processing which is necessary for the purposes of the legitimate interests pursued by Pluri or by a third party of providing an efficient and wide-ranging service to research partners: Notifying you about changes to our service; Collecting data from various publicly available sources, including commercially licensed databases to develop and improve our Services; Contacting you to give you commercial and marketing information about events or promotions or additional services offered by Pluri which may be of interest to you, including in other locations; Soliciting feedback in connection with the services; Tracking use of Pluri services to enable us to optimize them. For security purposes and to identify and authenticate your access to the Services. Processing which is necessary for compliance with a legal obligation to which Pluri is subject: Compliance and audit purposes, such as meeting our reporting obligations in our various jurisdictions, anti-money laundering, and for crime prevention and prosecution in so far as it relates to our staff, research partners, facilities etc; If necessary, we will use Personal Data to enforce our terms, policies and legal agreements, to comply with court orders and warrants and assist law enforcement agencies as required by law, to collect debts, to prevent fraud, infringements, identity thefts and any other service misuse, and to take any action in any legal dispute and proceeding; We aggregate and de-identify Personal Data (i.e., use your data in a way which no longer allows to identify you) to analyze and improve our Services, and to conduct research, and for other similar purposes. We may share non-personal aggregated information with third parties, as described below. Summary: we share Personal Data with our service providers, research partners and academic institutions, group companies, and authorities where required. We transfer Personal Data to: Research partners, Academic institutions and Collaborators. We transfer or receive Personal Data from our various partners in order to facilitate joint research projects, enhance the quality and scope of our studies, and ensure the accuracy and reliability of our findings. This data exchange enables us to conduct collaborative research and development activities, fulfill contractual obligations with research partners and collaborators, comply with regulatory requirements applicable to clinical studies and research and advance scientific discoveries and innovations in line with our mission. Third Parties. We transfer Personal Data to third parties in a variety of circumstances. We endeavor to ensure that these third parties use your information only to the extent necessary to perform their functions, and to have a contract in place with them to govern their processing on our behalf. These third parties include business partners, suppliers, affiliates, agents and/or sub- contractors for the performance of any contract we enter into with you. They assist us in providing the services we offer, processing transactions, fulfilling requests for information, receiving and sending communications, analyzing data, providing IT and other support services or in other tasks, from time to time. These third parties also include analytics and search engine providers that assist us in the improvement and optimization of our platform, website, and our marketing. We periodically add and remove third party providers. At present services provided by third-party providers to whom we may transfer Personal Data include also the following: – Website and platform analytics, including Google Analytics; – Expression and language measurement services; – Document management and sharing services; – Ticketing and support; – On-site and cloud-based database services; – CRM software; – Data security, data backup, and data access control systems; – Project management systems; – Our lawyers, accountants, and other standard business software and partners. In addition, we will disclose your Personal Data to third parties if some or all of our companies or assets are acquired by a third party including by way of a merger, share acquisition, asset purchase or any similar transaction, in which case Personal Data will be one of the transferred assets. Likewise, we transfer Personal Data to third parties if we are under a duty to disclose or share your Personal Data in order to comply with any legal or audit or compliance obligation, in the course of any legal or regulatory proceeding or investigation, or in order to enforce or apply our terms and other agreements with you or with a third party; or to assert or protect the rights, property, or safety of Pluri, our research partners, or others. This includes exchanging information with other companies and organizations for the purposes of fraud protection and credit risk reduction and to prevent cybercrime. For purposes of the California Consumer Privacy Act as amended (“CCPA”) or other US privacy state laws, Pluri does not “sell” or “share” personal information, nor do we allow any personal information to be used by third parties for their own marketing. However, we use analytics tools and other technologies (as described above), which may be construed as a “sale” under privacy laws to which you may opt- out of. For avoidance of doubt, Pluri may transfer and disclose non-Personal Data to third parties at its own discretion. Summary: we store your Personal Data across multiple locations globally We store your Personal Data in databases owned or controlled by us, or processed by third parties on our behalf, by reputable cloud-service providers (see the following section regarding international transfers). Summary: we transfer Personal Data within and to the EEA, USA, Israel and elsewhere, with appropriate safeguards in place. Personal Data may be transferred to, and stored and processed at, a destination outside its origin. EU data may be transferred outside the European Economic Area (EEA). This includes transfer to Israel, a jurisdiction deemed adequate by the EU Commission, and to the USA, which may be deemed adequate under certain circumstances but not always. Where your Data is transferred outside of the EEA, we will take all steps reasonably necessary to ensure that your Data is subject to appropriate safeguards, including entering into contracts that require the recipients to adhere to data protection standards that are considered satisfactory under EU law and other applicable, and that it is treated securely and in accordance with this Privacy Policy. Transfers to Israel are made based on an adequacy ruling by the EU Commission. Transfers to the USA are made based either on an adequacy ruling to members of the data privacy framework, or based on the Standard Contractual Clauses published by the EU Commission. For more information about these safeguards, please contact us as set forth below. We may transfer your Personal Data outside of the EEA, in order to: – Store or backup the information; – Enable us to provide you with the services and products and fulfill our contract with you; – Fulfill any legal, audit, ethical or compliance obligations which require us to make that transfer; – Facilitate the operation of our group businesses, where it is in our legitimate interests and we have concluded these are not overridden by your rights; – Collaborate with our research partners across multiple jurisdictions. Summary: we retain Personal Data according to our data retention policy, as required to meet our obligations, protect our rights, and manage our business and activities. Pluri will retain Personal Data it processes only for as long as required in our view, to provide the Services and as necessary to comply with our legal and other obligations, to resolve disputes and to enforce agreements. We will also retain Personal Data to meet any audit, compliance and industry practices. Data that is no longer retained may be anonymized or deleted. Likewise, some metadata and statistical information concerning the use of our services are not subject to the deletion procedures in this policy and will be retained by Pluri. We will not be able to identify you from this data. Some data may also be retained on our third-party service providers’ servers until deleted in accordance with their privacy policy and their retention policy, and in our backups until overwritten. Summary: we retain Personal Data according to our data retention policy, as required to meet our obligations, protect our rights, and manage our business. Summary: with your consent, we place cookies on your device. You control our use of cookies through a cookie management tool on our website, or through your device and browser. Pluri uses cookies, pixel tags and other forms of identification and local storage (together referred to as “tags/files” hereunder) to distinguish you from other users of the website and of websites of our network. This helps us to provide you with a good user-experience when you browse the website and websites of our network and also allows us to improve our website and our services. In many cases, these tags/files lead to the use of your device’s processing or storage capabilities. Some of these tags/files are set by Pluri itself, others by third parties; some only last as long as your browser session, while others can stay active on your device for a longer period of time. These tags/files can fall into several categories: (i) those that are necessary for functionality or services that you request or for the transmission of communications (functionality tags/files); (ii) those that we use to carry out website performance and audience metrics (analytics tags/files) and (iii) the rest (tracking across a network of other websites, advertising, etc.) (other tags/files). Internet browsers allow you to change your cookie settings, for example to block certain kinds of cookies or files. You can therefore block cookies by activating the setting on your browser that allows you to refuse the setting of all or some cookies. However, if you use your browser settings to block all cookies, you may not be able to access all or parts of the website, due to the fact that some may be functionality cookies. For further information about deleting or blocking cookies, please visit: https://www.aboutcookies.org/how-to-delete-cookies/ Functionality and analytical tags/files do not require your consent. For other tags/files, however, we request your consent before placing them on your device. You can allow cookies in your browser settings and using our website cookie management too. To consult the list of cookies which we use on our website, please check your browser’s settings. Instructions: https://www.wikihow.com/View-Cookies Summary: we retain Personal Data according to our data retention policy, as required to meet our obligations, protect our rights, and manage our business. We take great care in implementing, enforcing and maintaining the security of the Personal Data we process. Pluri implements, enforces and maintains security measures, technologies and policies to prevent the unauthorized or accidental access to or destruction, loss, modification, use or disclosure of Personal Data. We likewise take steps to monitor compliance of such policies on an ongoing basis. Where we deem it necessary in light of the nature of the data in question and the risks to data subjects, we may encrypt data. Likewise, we take industry standard steps to ensure our website and services are safe. Note however, that no data security measures are perfect or impenetrable, and we cannot guarantee that unauthorized access, leaks, viruses and other data security breaches will never occur. Within Pluri, we endeavor to limit access to Personal Data to those of our personnel who: (i) require access in order for Pluri to fulfill its obligations, including also under its agreements, and as described in this Privacy Policy, and (ii) have been appropriately and periodically trained with respect to the requirements applicable to the processing, care and handling of the Personal Data, and (iii) are under confidentiality obligations as may be required under applicable law. Pluri shall act in accordance with its policies and with applicable law to promptly notify the relevant authorities and data subjects in the event that any Personal Data processed by Pluri is lost, stolen, or where there has been any unauthorized access to it, all in accordance with applicable law and on the instructions of qualified authority. Pluri shall promptly take reasonable remedial measures. Summary: depending on the law that applies to your Personal Data, you may have various data subject rights, such as rights to access, erase, and correct Personal Data, and information rights. We will respect any lawful request to exercise those rights. Data subjects with respect to whose data GDPR, CCPA or other data protection or privacy laws apply, have rights under GDPR and local laws, including, in different circumstances, rights to data portability, rights to access data, rectify data, object to processing, and erase data. It is clarified for the removal of doubt, that where Personal Data is provided by a research partner or academic institution being the data subject’s employer or data controller, such data subject rights will have to be effected through that research partner, the data subject’s employer or supplier. In addition, data subject rights cannot be exercised in a manner inconsistent with the rights of Pluri employees and staff, with Pluri proprietary rights, and third-party rights. As such, job references, reviews, internal notes and assessments, documents and notes including proprietary information or forms of intellectual property, cannot be accessed or erased or rectified by data subjects. In addition, these rights may not be exercisable where they relate to data that is not in a structured form, for example emails, or where other exemptions apply. If processing occurs based on consent, data subjects have a right to withdraw their consent. A data subject who wishes to modify, delete or retrieve their Personal Data, including from our database, or to opt-out from using data to train our models, may do so by contacting Pluri (dataprotection@pluri-biotech.com). Note that Pluri may have to undertake a process to identify a data subject exercising their rights. Pluri may keep details of such rights exercised for its own compliance and audit requirements. Please note that Personal Data may be either deleted or retained in an aggregated manner without being linked to any identifiers or Personal Data, depending on technical commercial capability. Such information may continue to be used by Pluri. Data subjects in the EU, and in other locations have the right to lodge a complaint, with a data protection supervisory authority in the place of their habitual residence. If the supervisory authority fails to deal with a complaint, you may have the right to an effective judicial remedy. Summary: depending on the law that applies to your Personal Data, you may have various data subject rights, such as rights to access, erase, and correct Personal Data, and information rights. We will respect any lawful request to exercise those rights. Minors. We do not knowingly collect or solicit information or data from or about children under the age of 16 or knowingly allow children under the age of 16 to register for Pluri services. If you are under 16, do not register or attempt to register for any of the Pluri service or send any information about yourself to us. If we learn that we have collected or have been sent Personal Data from a child under the age of 16 unlawfully, we will delete that Personal Data as soon as reasonably practicable without any liability to Pluri. If you believe that we might have collected or been sent information from a minor under the age of 16, please contact us at: dataprotection@pluri-biotech.com, as soon as possible. Changes to this Privacy Policy. The terms of this Privacy Policy will govern the use of the Services, website, and any information collected in connection with them. Pluri may amend or update this Privacy Policy from time to time. The most current version of this Privacy Policy will be available at: www. pluri-biotech.com/privacy-policy. Changes to this Privacy Policy are effective as of the stated “Last Revised” date and your continued use of our services will constitute your active acceptance of the changes to and terms of the Privacy Policy. Pluri aims to process only adequate, accurate and relevant data limited to the needs and purposes for which it is gathered. Note that due to the nature of the Services we cannot guarantee the accuracy of the output of the Services. You may request correction or removal of your data by reaching out to us at: dataprotection@pluri-biotech.com. Pluri aims to store data for the time period necessary to fulfill the purpose for which the data is gathered. we only collect data in connection with a specific lawful purpose and only processes data in accordance with this Privacy Policy. Our policies and practices are constantly evolving and improving, and we invite any suggestions for improvements, questions, complaints or comments concerning this Privacy Policy, you are welcome to contact us (details below) and we will make an effort to reply within a reasonable time frame. Pluri’s data protection officer (DPO) may be contacted at: info@pluristem.com; dataprotection@pluristem.com Physical address: Pluristem Ltd. Attention: Legal Counsel and DPO Matam Park, Building 05 Haifa, 3508409, Israel * * * * * ©2023 Pluri™ Inc., its logo, brand, product, and process names appearing in this issue are the trademarks of Pluri™ Inc. or its affiliated companies. All other brand, product, and process names appearing are the trademarks of their respective holders. Reference to or use of a product, or process other than those of Pluri™ Inc. does not imply recommendation, approval, affiliation, or sponsorship of that product, or process by Pluri™ Inc. Nothing contained herein shall be construed as conferring by implication, estoppel, or otherwise any license or right under any patent, copyright, trademark, or other intellectual property right of Pluri™ Inc. or any third party, except as expressly granted herein. All information herein is for general information only and is subject for change without notice.

Nov. 25, 2024 -- Pluri Inc. (Nasdaq: PLUR) (TASE: PLUR) (“Pluri” or the “Company”), a biotechnology company leveraging its proprietary platform for cell-based solutions to create a collaborative network of ventures, today announced that it is assessing its readiness to initiate mass production of PLX-R18, a novel potential treatment for hematopoietic complications of the acute radiation syndrome (H-ARS) following exposure to nuclear radiation, in response to heightened global tensions and escalating nuclear threats, particularly in Ukraine. PLX-R18 has shown potential promise in significantly improving survival and accelerating recovery from H-ARS in preclinical animal and human studies, conducted with support from leading global health and U.S. defense agencies. PLX-R18 demonstrated the ability to stimulate blood cell regeneration and potentially mitigate the effects of radiation exposure. H-ARS is caused by exposure to life-threatening amounts of ionizing radiation, such as those which may occur during a radiological or nuclear accident, terrorist activities, and/or warfare. The condition is characterized by a dose-dependent bone marrow depression, leading to neutropenia, thrombocytopenia, 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. Beyond what is required for ongoing clinical studies, the Company is actively examining the steps required to ramp up production in the event of increased and urgent global demand. Pluri’s state-of-the-art manufacturing facility is designed to handle large-scale production of cellular therapies and could be mobilized to scale up to mass production, if necessary. “At Pluri, we stand ready to support communities in need by leveraging our expertise to respond to global emergencies,” said Yaky Yanay, Chief Executive Officer and President of Pluri. “That is why we are evaluating our readiness to scale production if global circumstances escalate and demand arises. We believe that our proactive approach will ensure global preparedness.” 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 regenerative medicine, foodtech and agtech fields. The Company also offers Contract Development and Manufacturing Organization services. Pluri establishes partnerships that are aimed to leverage the Company’s proprietary 3D cell-based technology across various industries that require effective, mass cell production. To learn more, visit us at www.pluri-biotech.com or follow Pluri on LinkedIn and X (formerly known as Twitter). The content above comes from the network. if any infringement, please contact us to modify.