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The contract will provide an initial commitment of $19.6 million and up to $135.2 million over a six-year period, supporting drug manufacturing and phase 1 trials for the two programs GigaGen’s recombinant polyclonals are part of Grifols’ robust innovation strategy and commitment to delivering the next generation of antibody drugs for patients and healthcare professionals SAN CARLOS, Calif., Oct. 03, 2024 (GLOBE NEWSWIRE) -- GigaGen Inc., a biotechnology company advancing transformative antibody drugs for immunodeficiencies, infectious diseases and checkpoint-resistant cancers, and a subsidiary of Grifols, announced today that it has been awarded a contract by the Biomedical Advanced Research and Development Authority (BARDA), part of the Administration for Strategic Preparedness and Response (ASPR) within the U.S. Department of Health and Human Services (HHS). The award, valued at up to $135.2 million, is to develop a recombinant polyclonal antibody therapy for botulinum neurotoxins (BoNT) and a second biothreat of interest to the agency that will be determined at a later time. “We are thrilled to have been awarded this BARDA contract and are proud to continue our collaboration with the U.S. government to advance innovative therapies against naturally emerging and intentional biological threats,” said Carter Keller, senior vice president of Grifols and head of GigaGen. “GigaGen aims to change the way infectious diseases are treated with the world’s only recombinant polyclonal antibody therapeutic platform. Building on our successful collaboration with the Department of Defense (DOD), this project demonstrates the versatility of our recombinant polyclonal antibody platform, which is ideally suited for rapid responses to imminent biological threats.” The BARDA project builds upon GigaGen’s contract awarded by the U.S. DOD Joint Program Executive Office for Chemical, Biological, Radiological and Nuclear Defense (JPEO-CBRND) in 2022. The DOD project demonstrated the utility of GigaGen’s first-in-class recombinant human polyclonal antibody discovery platform against biological threats, focusing on two BoNT variants. Following success in this program that included in vivo neutralization of the two botulinum neurotoxins, the BARDA project will support the manufacturing and initial clinical development of a drug product that targets all seven BoNT variants. BoNT, one of the most toxic biological substances, is produced by the bacterium Clostridium botulinum and can cause progressive muscle paralysis from the head to the rest of the body, which can be fatal if left untreated. GigaGen recently received clearance from the U.S. Food and Drug Administration (FDA) for its Investigational New Drug (IND) application to initiate a Phase 1 clinical trial to evaluate the company’s first recombinant polyclonal antibody therapeutic for the treatment of hepatitis B virus (HBV) infection, GIGA-2339. The company anticipates initiating the trial in Q4 2024. This project has been funded in whole or in part with federal funds from the Department of Health and Human Services; Administration for Strategic Preparedness and Response; Biomedical Advanced Research and Development Authority, under contract number 75A50124C00049. About GigaGen’s platformGigaGen’s next-generation recombinant polyclonal platform offers a novel way to develop synthetic polyclonal antibody therapeutics in the laboratory, which are potentially more powerful than what a natural immune response can provide. Using high-throughput, single-cell genomic and protein engineering technology, GigaGen creates cell lines that express recombinant human antibodies against a diversity of infectious disease antigens. The polyclonal cell bank can then be used to continuously manufacture recombinant polyclonal products against the pathogen of interest at existing manufacturing facilities. GigaGen has demonstrated that its products are hundreds of times more potent than plasma-derived antibody therapies. They replicate and enhance the natural antibody diversity, encompassing thousands of antibodies. This offers a significant advantage over monoclonal antibody therapies, as they can address the vast diversity of circulating pathogen variants and help prevent immune escape upon pathogen mutation. About GrifolsGrifols is a global healthcare company founded in Barcelona in 1909 committed to improving the health and well-being of people around the world. A leader in essential plasma-derived medicines and transfusion medicine, the company develops, produces, and provides innovative healthcare services and solutions in more than 110 countries. Patient needs and Grifols’ ever-growing knowledge of many chronic, rare and prevalent conditions, at times life-threatening, drive the company’s innovation in both plasma and other biopharmaceuticals. The company is focused on treating conditions across a broad range of therapeutic areas: immunology, hepatology and intensive care, pulmonology, hematology, neurology, and infectious diseases. A pioneer in the plasma industry, Grifols continues to grow its network of donation centers, the world’s largest with over 390 across North America, Europe, Africa and the Middle East, and China. As a recognized leader in transfusion medicine, Grifols offers a comprehensive portfolio of solutions designed to enhance safety from donation to transfusion, in addition to clinical diagnostic technologies. It provides high quality biological supplies for life-science research, clinical trials, and for manufacturing pharmaceutical and diagnostic products. The company also supplies tools, information and services that enable hospitals, pharmacies and healthcare professionals to efficiently deliver expert medical care. Grifols, with more than 24,000 employees in more than 30 countries and regions, is committed to a sustainable business model that sets the standard for continuous innovation, quality, safety, and ethical leadership. The company’s class A shares are listed on the Spanish Stock Exchange, where they are part of the Ibex-35 (MCE:GRF). Grifols non-voting class B shares are listed on the Mercado Continuo (MCE:GRF.P) and on the U.S. NASDAQ through ADRs (NASDAQ:GRFS). GigaGen is advancing transformative antibody drugs for immunodeficiencies, infectious diseases and checkpoint resistant cancers by leveraging industry-leading, single-cell technologies. Its novel technology platforms uniquely capture and recreate complete immune repertoires as functional antibody libraries. This approach has enabled the creation of first-in-class recombinant polyclonal antibody therapies for the treatment of infectious diseases. In addition, GigaGen’s lead oncology asset, GIGA-564, is an anti-CTLA-4 monoclonal antibody that has demonstrated improved anti-tumor efficacy and reduced toxicities in preclinical models through a unique mechanism of action. For more information, please visit www.grifols.com or www.gigagen.com. Media Contacts:Michael RubensteinLifeSci Communicationsmrubenstein@lifescicomms.comTel: +1- 561-289-7981 Grifols Press Officemedia@grifols.comTel. +34 93 571 00 02 LEGAL DISCLAIMERThe facts and figures contained in this report that do not refer to historical data are “future projections and assumptions”. Words and expressions such as “believe”, “hope”, “anticipate”, “predict”, “expect”, “intend”, “should”, “will seek to achieve”, “it is estimated”, “future” and similar expressions, in so far as they relate to the Grifols group, are used to identify future projections and assumptions. These expressions reflect the assumptions, hypotheses, expectations and predictions of the management team at the time of writing this report, and these are subject to a number of factors that mean that the actual results may be materially different. The future results of the Grifols group could be affected by events relating to its own activities, such as a shortage of supplies of raw materials for the manufacture of its products, the appearance of competitor products on the market, or changes to the regulatory framework of the markets in which it operates, among others. At the date of compiling this report, the Grifols group has adopted the necessary measures to mitigate the potential impact of these events. Grifols, S.A. does not accept any obligation to publicly report, revise or update future projections or assumptions to adapt them to events or circumstances subsequent to the date of writing this report, except where expressly required by the applicable legislation. This document does not constitute an offer or invitation to buy or subscribe shares in accordance with the provisions of the following Spanish legislation: Royal Legislative Decree 4/2015, of 23 October, approving recast text of Securities Market Law; Royal Decree Law 5/2005, of 11 March and/or Royal Decree 1310/2005, of 4 November, and any regulations developing this legislation. In addition, this document does not constitute an offer of purchase, sale or exchange, or a request for an offer of purchase, sale or exchange of securities, or a request for any vote or approval in any other jurisdiction. The information included in this document has not been verified nor reviewed by the external auditors of the Grifols group.

SOUTH SAN FRANCISCO, Calif., Sept. 15, 2022 (GLOBE NEWSWIRE) -- GigaGen Inc., a biotechnology company advancing transformative antibody drugs for immune deficiencies, infectious diseases and checkpoint resistant cancers, and a subsidiary of Grifols, announced today it has entered into a contract with the United States Department of Defense’s (DOD) Joint Program Executive Office for Chemical, Biological, Radiological and Nuclear Defense (JPEO-CBRND) to demonstrate the utility of its first-in-class recombinant human polyclonal antibody discovery platform against biological threats of interest to the DOD. The JPEO-CBRND awarded GigaGen this Prototype Agreement under the SPARK program, an idea incubator that fuels innovation and problem solving by providing funding for potentially transformative projects. As part of this award, GigaGen will demonstrate its platform’s capabilities by producing recombinant human hyperimmune products that target DOD-priority pathogens, including a recombinant polyclonal antibody drug designed to neutralize botulinum neurotoxins A and B, with high potency and military utility. The agreement will also allow the JPEO-CBRND to evaluate GigaGen’s platform against additional biological threats, and support functional testing, manufacturing, and clinical evaluation of recombinant polyclonal drugs that meet specific performance objectives. “We are proud to be working closely with the DOD to develop new and improved medical countermeasures against naturally emerging and intentional biological threats,” said Carter Keller, a senior vice president at Grifols and head of GigaGen. “Our novel technology platforms enable first-in-class recombinant polyclonal antibody drugs that combine the speed and scale of recombinant antibody manufacturing with the effectiveness of broadly neutralizing polyclonal antibody therapies. We look forward to using our platform to demonstrate the rapid response to pathogenic toxins like botulinum neurotoxins A and B, as well as other high-priority pathogens.” About Grifols Grifols is a global healthcare company founded in Barcelona in 1909 committed to improving the health and well-being of people around the world. A leader in essential plasma-derived medicines and transfusion medicine, the company develops, produces and provides innovative healthcare services and solutions in more than 110 countries. Patient needs and our ever-growing knowledge of many chronic, rare and prevalent diseases, sometimes life-threatening, drive our innovation in plasma-based therapies and other biopharmaceuticals to enhance quality of life. Grifols is focused on treating conditions across a broad range of therapeutic areas: immunology, hepatology and intensive care, pulmonology, hematology, neurology and infectious diseases. A pioneer in the plasma industry, Grifols continues to grow its network of donation centers, the world’s largest with over 400 across North America, Europe, Africa and the Middle East and China. As a recognized leader in transfusion medicine, Grifols offers a comprehensive portfolio of solutions designed to enhance safety from donation to transfusion, in addition to clinical diagnostic technologies. We provide high-quality biological supplies for life-science research, clinical trials, and for manufacturing pharmaceutical and diagnostic products. In addition, the company supplies tools, information and services that enable hospitals, pharmacies and healthcare professionals to efficiently deliver expert medical care. Grifols, with more than 27,000 employees in more than 30 countries and regions, is committed to a sustainable business model that sets the standard for continuous innovation, quality, safety, and ethical leadership. In 2021, Grifols’ economic impact in its core countries of operation was EUR 7.7 billion. The company also generated 141,500 jobs, including indirect and induced. The company’s class A shares are listed on the Spanish Stock Exchange, where they are part of the Ibex-35 (MCE:GRF). Grifols non-voting class B shares are listed on the Mercado Continuo (MCE:GRF.P) and on the U.S. NASDAQ through ADRs (NASDAQ:GRFS). GigaGen is advancing transformative antibody drugs for immune deficiency, infectious diseases and checkpoint resistant cancers by leveraging industry-leading, single-cell technologies. Its novel technology platforms uniquely capture and recreate complete immune repertoires as functional antibody libraries. This approach has enabled the creation of first-in-class recombinant polyclonal antibody therapies for the treatment of infectious diseases. In addition, GigaGen’s lead oncology asset, GIGA-564, is an anti-CTLA-4 monoclonal antibody that has demonstrated improved anti-tumor efficacy in vivo through a unique mechanism of action. For more information, please visit or . Media Contacts: Monica Rouco Molina, Ph.D. LifeSci Communications mroucomolina@lifescicomms.com Tel: +1-929-469-3850 Grifols Press Office media@grifols.com Tel. +34 93 571 00 02 LEGAL DISCLAIMER The facts and figures contained in this report that do not refer to historical data are “future projections and assumptions”. Words and expressions such as “believe”, “hope”, “anticipate”, “predict”, “expect”, “intend”, “should”, “will seek to achieve”, “it is estimated”, “future” and similar expressions, in so far as they relate to the Grifols group, are used to identify future projections and assumptions. These expressions reflect the assumptions, hypotheses, expectations and predictions of the management team at the time of writing this report, and these are subject to a number of factors that mean that the actual results may be materially different. The future results of the Grifols group could be affected by events relating to its own activities, such as a shortage of supplies of raw materials for the manufacture of its products, the appearance of competitor products on the market, or changes to the regulatory framework of the markets in which it operates, among others. At the date of compiling this report, the Grifols group has adopted the necessary measures to mitigate the potential impact of these events. Grifols, S.A. does not accept any obligation to publicly report, revise or update future projections or assumptions to adapt them to events or circumstances subsequent to the date of writing this report, except where expressly required by the applicable legislation. This document does not constitute an offer or invitation to buy or subscribe shares in accordance with the provisions of the following Spanish legislation: Royal Legislative Decree 4/2015, of 23 October, approving recast text of Securities Market Law; Royal Decree Law 5/2005, of 11 March and/or Royal Decree 1310/2005, of 4 November, and any regulations developing this legislation. In addition, this document does not constitute an offer of purchase, sale or exchange, or a request for an offer of purchase, sale or exchange of securities, or a request for any vote or approval in any other jurisdiction. The information included in this document has not been verified nor reviewed by the external auditors of the Grifols group.