GAIA BioMedicine, Inc.

GAIA BioMedicine Inc. (headquarters: Fukuoka City, Japan; President and CEO: Kazuyuki Kuramori; hereinafter “GAIA”) is pleased to announce that a preclinical research article on an improved manufacturing method for our allogeneic NK-like cell product, GAIA-102 (rINN: fulamleucel), has been published online in the Journal for ImmunoTherapy of Cancer, a leading international academic journal in the field of cancer immunotherapy. This improved method was developed to enable large-scale mass production based on our existing manufacturing platform. The article reports the establishment of a cell product generated in a feeder-free culture system using peripheral blood mononuclear cells (PBMCs) from healthy donors, in which the addition of the CD137 agonist Urelumab and IL-21 at the initial stage of culture substantially improved manufacturing scalability while maintaining the characteristic phenotype and functional properties of GAIA-102. This achievement represents a further advancement of the manufacturing foundation that underpins the clinical value of GAIA-102, with future supply expansion in view. In addition, the study demonstrated in animal models that this cell product exhibits high tumor-infiltrating capacity and cytotoxic activity not only against hematologic malignancies but also in solid tumor models, and may also contribute to the establishment of long-term antitumor effects through the induction of tumor-specific CD8-positive T-cell responses mediated by host NK cell-derived IFN-γ. In essence, this study indicates that this cell product, based on GAIA-102, is capable of integrating two important therapeutic actions: immediate cytotoxic activity and sustained antitumor effects mediated through the induction of acquired immunity. We believe that these findings provide important support for the potential of a novel allogeneic cell therapy approach for solid tumors. GAIA has been advancing the research and development of allogeneic cell therapies based on the GAIA-102 platform. This publication scientifically demonstrates the potential for further development of its manufacturing methodology, while also deepening the understanding of the mechanism of action of GAIA-102. In light of these findings, GAIA will continue to advance the research, development, and clinical application of the GAIA-102 platform. Publication Information: Title: Novel NK cell-like phenotype expressing CCR5 and its ligands elicits tumor-specific acquired immunity to carcinomatous peritonitis via host NK-derived IFN-γ Authors: Situo Zheng1), Yui Harada2), Yosuke Morodomi1), Noriko Yasuda1), Kenta Ishimoto1), Yoshikazu Yonemitsu3) 1) Kyushu University 2) Kyushu University, R&D Laboratory for Innovative Biotherapeutics 3) Kyushu University, Graduate School of Pharmaceutical Sciences Journal: Journal for ImmunoTherapy of Cancer DOI: 10.1136/jitc-2025-014300 Journal Link

GAIA BioMedicine, Inc. (Headquarters: Fukuoka City, Japan; President and CEO: Kazuyuki Kuramori; hereinafter “GAIA”) is pleased to announce that its pipeline product, GAIA-102, has been included in the Recommended International Nonproprietary Name (rINN) list as “fulamleucel.” This was published by the World Health Organization in WHO Drug Information, Vol. 40, No. 1, 2026, Recommended INN: List 95. International Nonproprietary Names (INNs) are globally recognized nonproprietary names assigned to pharmaceutical substances and serve as a universal identifier used in research and development, academic publications, regulatory affairs, and international communications. Following this listing, GAIA will utilize “fulamleucel” for GAIA-102 in its global development and corporate communications. GAIA remains committed to advancing the research and development of cell therapies and to delivering new treatment options for patients worldwide through exploring the full potential of GAIA-102 (fulamleucel). WHO Recommended INN: List 95

GAIA BioMedicine Inc. (Headquarters: Fukuoka City, Fukuoka; President and CEO: Kazuyuki Kuramori; hereinafter “GAIA”) announced today that it has begun the development of its proprietary Cell Processing Center (CPC) within ” f-labs Kyushu University Hospital ” (hereinafter “f-labs”). f-labs is a rental wet lab and startup support facility for life science companies produced by Fukuoka Jisho Co., Ltd. (Headquarters: Fukuoka City, Fukuoka; President and Representative Director: Ichiro Enomoto; hereinafter “Fukuoka Jisho”) on the Kyushu University Hospital campus. This project is being undertaken in close collaboration with Fukuoka Jisho. Background and Objectives: GAIA received investment from Fukuoka Jisho in 2023, and the construction of this CPC marks the first concrete collaborative project between the two companies. With the establishment of this CPC, GAIA aims to solidify a robust supply system that extends beyond the manufacturing of investigational drugs to include future commercial production. Through this strong partnership, the companies are committed to accelerating the realization and widespread adoption of innovative cancer treatments. About the Opening Ceremony: The opening ceremony for f-labs was held on January 26, 2026. Yoshikazu Yonemitsu, M.D., Ph.D. (CSO/CMO; Professor, Graduate School of Pharmaceutical Sciences, Kyushu University), took the stage at the event. In his address, Prof. Yonemitsu discussed the prospects for future business expansion utilizing the new CPC and expressed his high expectations for the role of f-labs as a key hub for life sciences. https://prtimes.jp/main/html/rd/p/000000014.000022997.html https://fj-lifescience.jp/