Hitachi Chemical Advanced Therapeutics Solutions and apceth Biopharma GmbH Enter into Strategic Clinical and Commercial Manufacturing Agreements with bluebird bio

ALLENDALE, NJ. and MUNICH, GERMANY.– May 11, 2020– –– Hitachi Chemical Advanced Therapeutics Solutions, LLC (HCATS) and apceth Biopharma GmbH (apceth), both subsidiaries of Hitachi Chemical Co., Ltd. (Hitachi Chemical) today announced that they have expanded their relationship with bluebird bio (NASDAQ: BLUE) with long-term development and manufacturing services agreements for clinical and commercial supply for multiple therapies, including: Late stage drug product manufacturing at facilities in both Germany (apceth) and the United States (HCATS) for bluebird bio’s LentiGlobin™ for the treatment of patients with sickle cell disease (SCD) and commercial drug product manufacturing of LentiGlobin™ for SCD in both the United States and Europe Expanded commercial drug product manufacturing capacity in Europe for ZYNTEGLO®▼ (autologous CD34+ cells encoding βA-T87Q-globin gene), a one-time gene therapy for patients 12 years and older with transfusion-dependent β-thalassemia (TDT) who do not have a β0/β0 genotype, for whom hematopoietic stem cell (HSC) transplantation is appropriate but a human leukocyte antigen (HLA)-matched related HSC donor is not available Expanded clinical and commercial manufacturing capacity for bluebird’s investigational Lenti-D for cerebral Adrenoleukodystrophy (CALD) in Europe These agreements are the latest in a long-standing partnership between bluebird bio and Hitachi Chemical. In 2011, HCATS, which represents the North America region of Hitachi Chemical’s global regenerative medicine business, and bluebird bio entered into their first clinical services agreement. A commercial drug product manufacturing service agreement was also established between bluebird bio and apceth (which represents the Europe region of Hitachi Chemical’s global regenerative medicine business) in 2016. In January 2020, apceth announced its readiness to begin commercial manufacturing of ZYNTEGLO®▼ with bluebird’s announcement of the launch in Germany. “With three products in our severe genetic disease franchise to potentially launch between now and 2022, securing long-term commercial drug product manufacturing capacity is critical to our ability to deliver for patients, ” said Nick Leschly, chief bluebird. “Our partnership with Hitachi Chemical is a significant example of our continued progress on this front and we believe Hitachi Chemical’s recent expansion will help support our growing commercial needs. We are pleased to benefit from their expertise as well as their footprint in both the US and Europe as we work to bring transformative therapies to patients in need.” “We are excited to partner with bluebird bio through our new U.S. facility, utilizing our state-of-the-art capabilities and systems for late-stage clinical testing and ultimately commercial production once all applicable regulatory approvals are granted,” said Robert Preti, Ph.D., Chief Strategy Officer, Hitachi Chemical Life Science Business Headquarters. “It is our honor to support bluebird bio in the manufacture of their potentially transformative gene therapies, to the benefit of patients in both the United States and Europe, as the foundation for our collaboration to address this devastating disease” “We are very happy to deepen our trustful and productive strategic partnership with bluebird bio,” commented Dr. Christine Guenther, Deputy General Manager of the Hitachi Chemical Regenerative Medicine Business Sector and CEO of apceth Biopharma GmbH. “The apceth team is proud to be part of bluebird bio’s most exciting pioneering work for the advancement of cell and gene therapies and to supply patients suffering from severe genetic illnesses with potentially life-changing treatments.”   ▼This medicinal product is subject to additional monitoring.   About Hitachi Chemical’s Regenerative Medicine Business Hitachi Chemical provides cell and gene therapy contract development and manufacturing organization (CDMO) services at current Good Manufacturing Practices (cGMP) standards, including clinical manufacturing, commercial manufacturing, and manufacturing development. The global footprint of the business is over 200,000 square feet and includes operations in North America (Allendale, New Jersey and Mountain View, California), Europe (Munich, Germany), and Japan (Yokohama). The business leverages two decades of experience exclusively focused on the cell therapy industry. For more information on North America services, please visit www.pctcelltherapy.com For more information on Europe services, please visit www.apceth.com For more information on Japan services, please visit www.hitachi-chem.co.jp/english/   For more information, contact: Hitachi Chemical Advanced Therapeutics Solutions Eric Powers Director, Marketing and Communications Eric.powers.nj@hitachi-chem.com   apceth Biopharma GmbH Almut Windhager Manager, Business Development and Communications a.windhager@apceth.com    

apceth starts commercial manufacturing of Zynteglo, bluebird bio’s gene therapy for transfusion-dependent β-thalassemia

Munich, Germany, January 13, 2020 – apceth Biopharma GmbH, a subsidiary of Hitachi Chemical Co., Ltd. and a leading company for the manufacturing of cell and gene therapeutics, starts the commercial manufacturing of ZyntegloTM ▼, a product of bluebird bio, Inc. Today bluebird bio announced the market entry of its gene therapy Zynteglo in Germany, the first country globally where Zynteglo is commercially available. Zynteglo is conditionally approved in the EU1 as a gene therapy for patients 12 years and older with transfusion-dependent β-thalassemia (TDT) who do not have a β0/β0 genotype, for whom hematopoietic stem cell (HSC) transplantation is appropriate but a human leukocyte antigen (HLA)-matched related HSC donor is not available. “Manufacturing this life-changing therapy for TDT patients in Europe marks a milestone for our company and the global Regenerative Medicine Business Sector at Hitachi Chemical Co., Ltd.”, commented Dr Christine Guenther, CEO of apceth Biopharma GmbH. “I am very proud of the teams of apceth and bluebird bio working together to make this happen. Our trustful partnership and persistent efforts over many years have made this vision come true for the patients.” “We appreciate the team at apceth for all of their hard work and commitment to patients living with TDT,“ said Nick Leschly, chief bluebird. “This is a critical step along our journey as we advance our launch and access activities in Europe. We look forward to continuing our work with our partners, the TDT community and health systems to bring Zynteglo to patients.“ 1 https://www.ema.europa.eu/en/medicines/human/EPAR/zynteglo ▼This medicinal product is subject to additional monitoring. About apceth Biopharma GmbH apceth Biopharma, a subsidiary of Hitachi Chemical Co., Ltd., is a pioneering company in regenerative medicines and a leading and certified Contract Development and Manufacturing Organization for cell and gene therapeutics with a broad international customer base. apceth owns state-of-the-art manufacturing facilities with Grade B/A, C and D cleanrooms (ISO 5, ISO 7, ISO 8, BSL2) and is certified according to regulatory requirements for cell and gene therapies (Advanced Therapy Medicinal Products, ATMPs). The company has a comprehensive expertise in GMP manufacturing of autologous and allogeneic cell types that are either native or genetically modified. It has long-standing experience with various cell products, including mesenchymal stem cells (MSCs), hematopoietic stem cells (HSC), lymphocytes, monocytes, dendritic cells, cord blood derived stem cells, and has the potential to expand to CAR-T and induced pluripotent stem cell (iPSC) technologies. apceth has successfully obtained manufacturing licenses for multiple cell therapy products for clinical use as well as one commercial cell-based gene therapy. apceth’s CDMO team provides fully customized solutions in the development and production of every customer product and process. Located centrally in the heart of Europe, apceth can perform efficient and fast supply for patients all over the continent. For more information on apceth, please visit www.apceth.com About Hitachi Chemical Co., Ltd. Hitachi Chemical Co., Ltd. (TSE:4217), headquartered in Tokyo, Japan, delivers wide range of innovative products, such as electronic materials, automobile parts, energy storage devices and systems, in global markets. The company’s consolidated revenues for fiscal 2018 (ended March 31, 2019) totaled 681 billion yen (5.5 billion euros*). For more information on Hitachi Chemical, please visit the company’s website at www.hitachi-chem.co.jp/english/ *The conversion rate is 1 euro = 124 yen. About the Hitachi Chemical Regenerative Medicine Business Sector The Hitachi Chemical’s Regenerative Medicine Business Sector provides contract development and manufacturing organization (CDMO) services at current Good Manufacturing Practices (cGMP) standards, including clinical manufacturing, commercial manufacturing, and manufacturing development. The global footprint of the business is over 200,000 square feet and includes operations in North America (Allendale, New Jersey and Mountain View, California), Europe (Munich, Germany), and Japan (Yokohama). The business leverages two decades of experience exclusively focused on the cell therapy industry. For more information on North America services, please visit www.pctcelltherapy.com For more information on Europe services, please visit www.apceth.com For more information on Japan services, please visit www.hitachi-chem.co.jp/english/ Contact apceth Biopharma GmbH Dr Christine Guenther, CEO Max-Lebsche-Platz 30 81377 Munich Germany Phone: +49 (0)89 7009608 0 Email: contact@apceth.com Web: www.apceth.com Press release as pdf in English and German  

apceth will operate as the commercial manufacturer in Europe for Zynteglo, bluebird bio’s gene therapy for β-thalassemia

Munich, Germany, June 4, 2019 – apceth Biopharma GmbH, a leading company for the manufacturing of cell and gene therapeutics, will operate as the commercial manufacturer in Europe for ZyntegloTM, a product of bluebird bio. Yesterday the European Commission (EC) has granted conditional marketing authorisation for ZyntegloTM, a gene therapy for patients 12 years and older with transfusion-dependent β-thalassemia (TDT) who do not have a β0/β0 genotype, for whom haematopoietic stem cell (HSC) transplantation is appropriate but a human leukocyte antigen (HLA)-matched related HSC donor is not available. “We are proud to be the commercial manufacturing partner of bluebird bio and to be part of bringing this life-changing therapy to TDT patients in Europe”, commented Dr Christine Guenther, CEO of apceth Biopharma. “Being one of the very few companies worldwide to manufacture a cell-based gene therapy for commercial use marks a milestone for our company.” “We are looking forward to continue supporting bluebird bio with its other programs”, announced Dr Guenther. apceth Biopharma is bluebird bio’s clinical and commercial manufacturing partner for Europe not only for ZyntegloTM, but also for bluebird bio’s product candidate Lenti-D for cerebral adrenoleukodystrophy. Following a successful long-term manufacturing relationship, apceth Biopharma and bluebird bio entered a commercial drug product manufacturing agreement in 2016.   About apceth Biopharma GmbH apceth Biopharma, a subsidiary of Hitachi Chemical Co., Ltd. is a pioneering company in regenerative medicines and a leading and certified Contract Development and Manufacturing Organization for cell and gene therapeutics with a broad international customer base. apceth owns state-of-the-art manufacturing facilities with Grade B/A, C and D cleanrooms (ISO 5, ISO 7, ISO 8, BSL2) and is certified according to regulatory requirements for cell and gene therapies (Advanced Therapy Medicinal Products, ATMPs). The company has a comprehensive expertise in GMP manufacturing of autologous and allogeneic cell types that are either native or genetically modified. It has long-standing experience with various cell products, including mesenchymal stem cells (MSCs), hematopoietic stem cells (HSC), lymphocytes, monocytes, dendritic cells, cord blood derived stem cells, and has the potential to expand to CAR-T and induced pluripotent stem cell (iPSC) technologies. apceth has successfully obtained manufacturing licenses for multiple cell therapy products for clinical as well as commercial use. apceth’s CDMO team provides fully customized solutions in the development and production of every customer product and process. Located centrally in the heart of Europe, apceth can perform efficient and fast supply for patients all over the continent. For more information on apceth, please visit www.apceth.com   About Hitachi Chemical Co., Ltd. Hitachi Chemical Co., Ltd. (TSE:4217), headquartered in Tokyo, Japan, delivers wide range of innovative products, such as electronic materials, automobile parts, energy storage devices and systems, in global markets. The company’s consolidated revenues for fiscal 2017 (ended March 31, 2018) totaled 669 billion yen (5.4 billion euros*). For more information on Hitachi Chemical, please visit the company’s website at http://www.hitachi-chem.co.jp/english/ *The conversion rate is 1 euro = 124 yen.   About the Hitachi Chemical Regenerative Medicine Business Sector The Hitachi Chemical’s Regenerative Medicine Business Sector provides contract development and manufacturing organization (CDMO) services at current Good Manufacturing Practices (cGMP) standards, including clinical manufacturing, commercial manufacturing, and manufacturing development. The global footprint of the business is over 180,000 square feet and includes operations in North America (Allendale, New Jersey and Mountain View, California), Europe (Munich, Germany), and Japan (Yokohama). The business leverages two decades of experience exclusively focused on the cell therapy industry.   Contact For more information on North America services, please visit www.pctcelltherapy.com. For more information on Europe services, please visit www.apceth.com. For more information on Japan services, please visit www.hitachi-chem.co.jp/english/   apceth Biopharma GmbH Dr Christine Guenther, CEO Max-Lebsche-Platz 30 81377 Munich Germany Phone: +49 (0)89 7009608 0 Email: contact@apceth.com Web: www.apceth.com Press release as pdf: English and German Link to the press release of bluebird bio

Hitachi Chemical Co. Ltd. Completes Acquisition of apceth Biopharma GmbH, Expanding Global Footprint of its Cell and Gene Therapy Contract Development and Manufacturing Services

Munich, April 4, 2019 – We are pleased to announce that Hitachi Chemical Co. Ltd. (Head Office: Chiyoda-ku, Tokyo; President and CEO: Hisashi Maruyama; hereinafter “Hitachi Chemical”) has completed its acquisition of apceth Biopharma GmbH (Head Office: Munich, Germany; CEO: Dr. Christine Guenther; hereinafter “apceth Biopharma”), a contract manufacturer of cell and gene therapy products, adding its capabilities to the Hitachi Chemical’s Regenerative Medicine Business Sector’s offerings. apceth Biopharma manufactures cell and gene therapy products for American and European clients through two manufacturing sites in Munich, Germany, both certified for GMP manufacture since 2010. These facilities are fully compliant with all current EU regulations (ATMP regulation (EC) No.1394/2007) and ICH guidelines. The company’s strength stems from its experience and comprehensive quality management systems allowing the manufacturing and development of a wide range of complex cell and gene therapy products, which will be integrated into the Hitachi Chemical Regenerative Medicine Business Sector. By combining apceth’s gene and cell therapy manufacturing expertise and facilities in Europe to Hitachi Chemical’s capabilities and facilities in North America and Japan, we will enhance our global footprint, while preserving what customers value most: high-quality GMP manufacturing from a trusted partner that is a pioneer in the industry. Existing clients of apceth Biopharma will enjoy continuity of service and executive leadership. In the near future, Hitachi Chemical’s Regenerative Medicine Business Sector aims to offer customers the possibility to manufacture their products throughout Europe, North America, and Japan. Our combined strength will make us a world leader in the field and will allow us to address all of our customers’ manufacturing and process development needs. Our global contract development and manufacturing services platform currently includes two U.S. facilities, in Allendale, NJ and Mountain View, CA, and a recently opened facility in Yokohama, Japan. Construction is underway for a third U.S. facility in Allendale, NJ that will provide manufacturing capability for products after the opening in April 2019. About apceth Biopharma GmbH apceth Biopharma, a subsidiary of Hitachi Chemical Co., Ltd. is a pioneering company in regenerative medicines and a leading and certified Contract Development and Manufacturing Organization for cell and gene therapeutics with a broad international customer base. apceth owns state-of-the-art manufacturing facilities with Grade B/A, C and D cleanrooms (ISO 5, ISO 7, ISO 8, BSL2) and is certified according to regulatory requirements for cell and gene therapies (Advanced Therapy Medicinal Products, ATMPs). The company has a comprehensive expertise in GMP manufacturing of autologous and allogeneic cell types that are either native or genetically modified. It has long-standing experience with various cell products, including mesenchymal stem cells (MSCs), hematopoietic stem cells (HSC), lymphocytes, monocytes, dendritic cells, cord blood derived stem cells, and has the potential to expand to CAR-T and induced pluripotent stem cell (iPSC) technologies. apceth has successfully obtained manufacturing licenses for multiple cell therapy products for clinical as well as commercial use. apceth’s CDMO team provides fully customized solutions in the development and production of every customer product and process. Located centrally in the heart of Europe, apceth can perform efficient and fast supply for patients all over the continent. For more information on apceth, please visit www.apceth.com About Hitachi Chemical Co., Ltd. Hitachi Chemical Co., Ltd. (TSE:4217), headquartered in Tokyo, Japan, delivers wide range of innovative products, such as electronic materials, automobile parts, energy storage devices and systems, in global markets. The company’s consolidated revenues for fiscal 2017 (ended March 31, 2018) totaled 669 billion yen (5.4 billion euros*). For more information on Hitachi Chemical, please visit the company’s website at http://www.hitachi-chem.co.jp/english/ *The conversion rate is 1 euro = 124 yen. About the Hitachi Chemical Regenerative Medicine Business Sector The Hitachi Chemical’s Regenerative Medicine Business Sector provides contract development and manufacturing organization (CDMO) services at current Good Manufacturing Practices (cGMP) standards, including clinical manufacturing, commercial manufacturing, and manufacturing development. The global footprint of the business is over 180,000 square feet and includes operations in North America (Allendale, New Jersey and Mountain View, California), Europe (Munich, Germany), and Japan (Yokohama). The business leverages two decades of experience exclusively focused on the cell therapy industry. Contact For more information on North America services, please visit www.pctcelltherapy.com. For more information on Europe services, please visit www.apceth.com. For more information on Japan services, please visit www.hitachi-chem.co.jp/english/ For more information on North America and Japan services, contact: Eric Powers Director, Marketing and Communications Hitachi Chemical Advanced Therapeutics Solutions, LLC epowers@pctcelltherapy.com Tel: +1 201 786 7941 For more information on Europe services, contact: Dr. Almut Windhager Manager Business Development and Communications apceth Biopharma GmbH a.windhager@apceth.com Tel: + 49 89 665472259

Hitachi Chemical Co. Ltd. to acquire apceth Biopharma GmbH

Munich, Germany, January 31, 2019. apceth Biopharma GmbH, a leading contract manufacturing organization in the field of cell and gene therapy, announces today that Hitachi Chemical Co., Ltd. will enter into an agreement to acquire all shares of apceth Biopharma GmbH. This acquisition is expected to close in April 2019. Founded 2007, apceth is a pioneer in cell and gene therapy and has developed into a leading European contract development and manufacturing organization (CDMO) for Advanced Therapy Medicinal Products (ATMPs). The company has state-of-the-art facilities located in Munich, Germany, which are fully compliant with all current EU ATMP regulations, BSL2 and ICH guidelines. With the acquisition of apceth, Hitachi Chemical will be expanding its business presence footprint in Europe―the world’s second-largest market for regenerative medicine after the United States. “We are very pleased to become part of Hitachi Chemical. Our combined strengths within Hitachi Chemical will allow us to manufacture complex cell and gene therapies for clients in North America, Asia, and Europe. This will allow our clients to supply patients around the world with highly needed innovative and high-quality cell and gene therapies”, said Christine Guenther, MD, CEO of apceth Biopharma. “apceth had been built by a great team and strong support of its shareholders into Europe’s leading independent cell therapy manufacturer. We are very proud that these joint efforts resulted in apceth Biopharma now being chosen as Hitachi Chemical’s hub for cell therapy in Europe,” commented Manfred Ruediger, PhD, Chairman of the Board of apceth. “We are proud having been able to accompany apceth on its successful journey from its foundation in 2007 until today. We are very pleased to have found an excellent partner for apceth’s future endeavors with Hitachi Chemical,” said Helmut Jeggle, Managing Director of Santo Holding (Deutschland) GmbH, majority shareholder of apceth. “The addition of apceth Biopharma to Hitachi Chemical will strengthen our presence in the second-largest cell and gene therapy market in the world, and enable us to offer a truly harmonized global operation, providing our customers with ready access to new markets and maximizing the value we bring to the industry,” said Robert A. Preti, PhD, CEO and President of Hitachi Chemical Advanced Therapeutics Solutions, LLC and General Manager of the Hitachi Chemical Regenerative Medicine Business Sector.   About Hitachi Chemical Hitachi Chemical Co., Ltd. (TSE:4217), is headquartered in Tokyo, Japan, delivers wide range of innovative products, such as electronic materials, automobile parts, energy storage devices and systems, in global markets. The company’s consolidated revenues for fiscal 2017 (ended March 31, 2018) totaled 669 billion yen (5.4 billion euros*). For more information on Hitachi Chemical, please visit the company’s website at http://www.hitachi-chem.co.jp/english/ *The conversion rate is 1 euro = 124 yen.   About apceth Biopharma GmbH apceth Biopharma is a pioneering company in regenerative medicines and a leading and certified Contract Development and Manufacturing Organization for cell and gene therapeutics with a broad international customer base. apceth owns state-of-the-art manufacturing facilities with Grade B/A, C and D cleanrooms (ISO 5, ISO 7, ISO 8, BSL2) and is certified according to regulatory requirements for cell and gene therapies (Advanced Therapy Medicinal Products, ATMPs). The company has a comprehensive expertise in GMP manufacturing of autologous and allogeneic cell types that are either native or genetically modified. It has long-standing experience with various cell products, including mesenchymal stem cells (MSCs), hematopoietic stem cells (HSC), lymphocytes, monocytes, dendritic cells, cord blood derived stem cells, and has the potential to expand to CAR-T and induced pluripotent stem cell (iPSC) technologies. apceth has successfully obtained manufacturing licenses for multiple cell therapy products for clinical as well as commercial use. apceth’s CDMO team provides fully customized solutions in the development and production of every customer product and process. Located centrally in the heart of Europe, apceth can perform efficient and fast supply for patients all over the continent.   Contact apceth Biopharma GmbH Dr Christine Guenther, CEO Max-Lebsche-Platz 30 81377 Munich Germany Phone: +49 (0)89 7009608 0 Email: contact@apceth.com www.apceth.com   Press release as pdf: German and English

apceth Biopharma GmbH manufactures DCprime’s cell-based cancer vaccine for phase II clinical study

Munich, Germany, November 16, 2018. apceth Biopharma GmbH, an established contract manufacturing organization in the field of gene and cell therapy, has started supplying clinical batches of DCprime’s cell-based cancer vaccine DCP-001 to a phase II clinical study for the treatment of Acute Myeloid Leukemia (AML). AML is a haematological cancer characterized by high risk of relapse, even after initial response to chemotherapy. Cancer vaccination with dendritic cells could be a successful strategy to boost the patient’s immune system and result in lasting disease control. DCprime announced yesterday that the first patient has been treated with the product DCP-001 at the Amsterdam University Medical Center (UMC). “We are proud to be the manufacturing partner of DCprime for DCP-001, the first off-the shelf dendritic cell vaccine in a cancer indication with high unmet medical need”, explained Dr Christine Günther, CEO of apceth Biopharma. “Our long-term collaboration with DCprime has always been constructive and cooperative, from technology transfer to the large-scale manufacturing process.” Dr Erik Manting, CEO of DCprime, commented: “Based on the recently published encouraging results of the phase I trial with our lead product DCP-001, we aim to confirm these results in the phase II ADVANCE-II trial and we are happy with the enrollment of the first patient. We would like to thank the apceth Biopharma team for their important contribution to the manufacturing of our product.” About apceth Biopharma GmbH apceth Biopharma is a pioneering company in cell therapies and regenerative medicine with an innovative portfolio of drug candidates for the treatment of inflammation, autoimmunity and solid tumors. apceth is developing two proprietary next generation gene therapy products, which are based on the introduction of therapeutic transgenes into mesenchymal stem cells (MSCs). apceth-201 expresses the immunomodulatory protein alpha-1 antitrypsin for the treatment of graft-versus-host disease. The company’s second program, apceth-301, expresses a potent immunostimulatory “cocktail” of cytokines, which locally activates the immune system to eradicate tumor cells. apceth-301 is currently being developed for glioblastoma as well as for other solid tumors. apceth Biopharma is also a leading and certified Contract Development and Manufacturing Organization for cell and gene therapeutics with a broad international customer base. apceth owns state-of-the-art manufacturing facilities with Grade B/A, C and D cleanrooms (ISO 5, ISO 7, ISO 8, BSL2) and is certified according to regulatory requirements for cell and gene therapies (Advanced Therapy Medicinal Products, ATMPs). The company has a comprehensive expertise in GMP manufacturing of autologous and allogeneic cell types that are either native or genetically modified. It has long-standing experience with various cell products, including mesenchymal stem cells (MSCs), hematopoietic stem cells (HSC), lymphocytes, monocytes, dendritic cells, cord blood derived stem cells, and has the potential to expand to CAR-T and induced pluripotent stem cell (iPSC) technologies. apceth has successfully obtained manufacturing licenses for multiple cell therapy products for clinical as well as commercial use. apceth’s CDMO team provides fully customized solutions in the development and production of every customer product and process. Located centrally in the heart of Europe, apceth can perform efficient and fast supply for patients all over the continent. Press release as pdf (English) Press release as pdf (German) Contact apceth Biopharma GmbH Dr Christine Guenther, CEO Max-Lebsche-Platz 30 81377 Munich Germany Phone: +49 (0)89 7009608 0 Email: contact@apceth.com www.apceth.com Please note: today apceth Biopharma focuses solely on the CDMO business

apceth to manufacture first potential one-time gene therapy for transfusion dependent β-thalassemia

Munich, Germany, Oct 5th, 2018 – apceth Biopharma GmbH, a leading company for the development and manufacturing of cell and gene therapeutics, congratulates its partner bluebird bio on the acceptance and validation of its market authorization application (MAA) by the European Medicines Agency (EMA). bluebird bio has applied for market authorization of its investigational LentiGlobin™ gene therapy for the treatment of adolescents and adults with transfusion-dependent β-thalassemia (TDT) and a non-β0/β0 genotype. “We congratulate our partner bluebird bio on this recent success”, commented Dr Christine Guenther, CEO of apceth Biopharma. “These are exciting times also for apceth, as we are now in the position to become one of the very few companies worldwide to manufacture a cell-based gene therapy for commercial use.” apceth has supported and will continue to support bluebird bio for obtaining the market authorization for LentiGlobin™. Following a successful long-term manufacturing relationship, apceth Biopharma and bluebird bio entered a commercial drug product manufacturing agreement in 2016. apceth Biopharma is bluebird bio’s clinical and commercial manufacturing partner for Europe not only for LentiGlobin, but also for bluebird bio’s product candidate Lenti-D for cerebral adrenoleukodystrophy.   Press release as pdf (English)  or pdf (German) Press release from bluebird bio     About apceth Biopharma GmbH apceth Biopharma is a pioneering company in cell therapies and regenerative medicine with an innovative portfolio of drug candidates for the treatment of inflammation, autoimmunity and solid tumors. apceth is developing two proprietary next generation gene therapy products, which are based on the introduction of therapeutic transgenes into mesenchymal stem cells (MSCs). apceth-201 expresses the immunomodulatory protein alpha-1 antitrypsin for the treatment of graft-versus-host disease. The company’s second program, apceth-301, expresses a potent immunostimulatory “cocktail” of cytokines, which locally activates the immune system to eradicate tumor cells. apceth-301 is currently being developed for glioblastoma as well as for other solid tumors. apceth Biopharma is also a leading and certified Contract Development and Manufacturing Organization for cell and gene therapeutics with a broad international customer base. apceth owns state-of-the-art manufacturing facilities with Grade B/A, C and D cleanrooms (ISO 5, ISO 7, ISO 8, BSL2) and is certified according to regulatory requirements for cell and gene therapies (Advanced Therapy Medicinal Products, ATMPs). The company has a comprehensive expertise in GMP manufacturing of autologous and allogeneic cell types that are either native or genetically modified. It has long-standing experience with various cell products, including mesenchymal stem cells (MSC), hematopoietic stem cells (HSC), lymphocytes, monocytes, dendritic cells, cord blood derived stem cells, and has the potential to expand to CAR-T and induced pluripotent stem cell (iPSCs) technologies. apceth has successfully obtained manufacturing licenses for multiple cell therapy products for clinical as well as commercial use. apceth’s CDMO team provides fully customized solutions in the development and production of every customer product and process. Located centrally in the heart of Europe, apceth can perform efficient and fast supply for patients all over the continent.   Contact apceth Biopharma GmbH Dr Christine Guenther, CEO Max-Lebsche-Platz 30 81377 Munich Germany Phone: +49 (0)89 7009608 0 Email: contact@apceth.com www.apceth.com Please note: today apceth Biopharma focuses solely on the CDMO business

apceth Biopharma receives an extended general manufacturing authorization for cell and gene therapeutics

Munich, Germany, Aug 7, 2018 – apceth Biopharma GmbH, a leading company for the development and manufacturing of cell and gene therapeutics, announced today that it has received an extended general manufacturing authorization by the District Government of Upper Bavaria. This manufacturing authorization for cell and gene therapeutics is now regulated on an activity-related and no longer product-related basis. The previously obligatory inspection by the regulatory authority becomes optional. “We are very pleased with the trust and confidence shown by the regulatory authority”, commented Dr Christine Guenther, CEO of apceth Biopharma. “I am very proud of the entire apceth team, which has successfully completed every inspection by the District Government of Upper Bavaria and the Paul-Ehrlich-Institute since the foundation of the company. This kind of regulatory approval is rarely found for cell and gene therapeutics.” The extended general manufacturing authorization includes the clinical as well as commercial supply of cell products with different manufacturing techniques. It allows the production of cell therapeutics from various starting materials, for example bone marrow and umbilical cord blood, the production of native and genetically modified cells as well as the autologous or allogeneic administration. “This gives us more flexibility, streamlines the manufacturing approval process and shortens the timelines for our new customers”, explains Dr Andreas Schmiede, head of the Contract Development and Manufacturing department (CDMO). In 2018, apceth has also expanded its manufacturing capacities with two new class B clean rooms and is continuously strengthening its Manufacturing and Quality Control teams. “Due to the high demand for capacity for the CDMO business, we are significantly enhancing our capabilities to meet the growing need of our customers”.   About apceth Biopharma GmbH apceth Biopharma is a pioneering company in cell therapies and regenerative medicine with an innovative portfolio of drug candidates for the treatment of inflammation, autoimmunity and solid tumors. apceth is developing two proprietary next generation gene therapy products, which are based on the introduction of therapeutic transgenes into mesenchymal stem cells (MSCs). apceth-201 expresses the immunomodulatory protein alpha-1 antitrypsin for the treatment of graft-versus-host disease. The company’s second program, apceth-301, expresses a potent immunostimulatory “cocktail” of cytokines, which locally activates the immune system to eradicate tumor cells. apceth-301 is currently being developed for glioblastoma as well as for other solid tumors. apceth Biopharma is also a leading and certified Contract Development and Manufacturing Organization for cell and gene therapeutics with a broad international customer base. apceth owns state-of-the-art manufacturing facilities (ISO 5, ISO 7, ISO 8, BSL2 cleanrooms) and is certified according to regulatory requirements for cell and gene therapies (Advanced Therapy Medicinal Products, ATMPs). The company has a comprehensive expertise in GMP manufacturing of autologous and allogeneic cell types that are either native or genetically modified. It has long-standing experience with various cell products, including mesenchymal stem cells (MSC), hematopoietic stem cells (HSC), lymphocytes, monocytes, dendritic cells, cord blood derived stem cells, and has the potential to expand to CAR-T and induced pluripotent stem cell (iPSCs) technologies. apceth has successfully obtained manufacturing licenses for multiple cell therapy products for clinical as well as commercial use. apceth’s CDMO team provides fully customized solutions in the development and production of every customer product and process. Located centrally in the heart of Europe, apceth can perform efficient and fast supply for patients all over the continent.   Contact apceth Biopharma GmbH Dr Christine Guenther, CEO Max-Lebsche-Platz 30 81377 Munich Germany Phone: +49 (0)89 7009608 0 Email: contact@apceth.com www.apceth.com Download the  press release (pdf, English or German) Please note: today apceth Biopharma focuses solely on the CDMO business

apceth Biopharma to Present at EHA-SWG Scientific Meeting

apceth Biopharma is proud to announce that it will be presenting its latest results on apceth-201 in graft-vs-host-disease (GvHD) during the European Hematology Society (EHA)-SWG Scientific Meeting in Amsterdam on November 23-25, 2017. apceth’s presentation will take place on November 24, 2017 between 16:00 – 17:00. For more information, please consult the full press release. Download Press Release_EHA-SWG Meeting Please note: today apceth Biopharma focuses solely on the CDMO business

DCPrime and apceth Biopharma GmbH announce manufacturing partnership

apceth Biopharma is proud to announce a new manufacturing partnership with DCPrime. The collaboration involves clinical batch production and the development of a commercial scale manufacturing process of cancer vaccines based on DCPrime’s technology platform DCOne®. The companies also announce that apceth has recently successfully passed an inspection by the District Government of Upper Bavaria and the Paul-Ehrlich-Institute for the manufacturing license for production of DCP-001, DCPrime’s lead program. This will enable DCPrime to enter into a Phase II Proof of Concept study in Acute Myeloid Leukemia. For more information, please consult the full press release: Download Press Release_DCPrime and apceth Biopharma Please note: today apceth Biopharma focuses solely on the CDMO business