Publication of a Scientific Paper Reporting Results from the Japanese Phase 3 Study of HGF (Hepatocyte Growth Factor) for Acute Spinal Cord Injury

Press release 28 July 2026 Publication of a Scientific Paper Reporting Results from the Japanese Phase 3 Study of HGF (Hepatocyte Growth Factor) for Acute Spinal Cord Injury Osaka, Japan – Kringle Pharma, Inc. (Tokyo Stock Exchange Growth: 4884, “KRINGLE”), a late -stage clinical biopharmaceutical company developing innovative therapies for rare and difficult-to-treat diseases, today announced that a scientific paper relating to its Phase 3 clinical study, “A Non-randomized, Multicenter, Confirmatory Study of Intrathecal Administration of KP-100IT in Subjects with Acute Spinal Cord Injury” (Protocol No.: KP-100-ND004; ClinicalTrials.gov Identifier: NCT04475224), has been published online in the international peer-reviewed journal Journal of Neurotrauma. [Publication Information] Title: Intrathecal Recombinant Human Hepatocyte Growth Factor for Acute Cervical Spinal Cord Injury with AIS Grade A at 72 h Post-Injury: Phase III Study of Safety and Efficacy Authors: Kazuya Kitamura, Narihito Nagoshi, Osahiko Tsuji, Satoshi Nori, Tsunehiko Konomi, Mihoko Matsuoka, Yuichi Koga, Daichika Hayata, Yurika Abe, Kota Suda, Yasuo Ito, Takeshi Maeda, Morio Matsumoto, Hideyuki Okano, Masaya Nakamura Journal: Journal of Neurotrauma DOI: 10.1177/08977151261467225 URL: https://journals.sagepub.com/doi/full/10.1177/08977151261467225 (Open access) This paper reports the results of a Phase 3 clinical trial evaluating the safety and efficacy of KP -100IT, a recombinant human HGF protein therapeutic, in patients with acute severe cervical spinal cord injury who were classified as AIS Grade A at 72 hours after injury. In the study, intrathecal administration of KP-100IT demonstrated safety and efficacy trends consistent with findings previously observed in non-clinical studies and a Japanese Phase 1/2 clinical study. Kiichi Adachi, President & CEO of KRINGLE commented: “KRINGLE has been engaged for many years in the research and development of HGF -based therapeutics with the goal of improving functional recovery and quality of life for patients with spinal cord injury. We believe that the publication of our Phase 3 clini cal trial results in the Journal of Neurotrauma , a highly respected international journal in the field of spinal cord injury research, represents an important milestone in the development of HGF. We will continue to advance our development programs diligently to bring a new treatment option to patients as soon as possible.” About Hepatocyte Growth Factor (HGF) HGF, initially identified as an endogenous mitogen for mature hepatocytes, has demonstrated a wide array of biological functions, including mitogenic, motogenic , anti -apoptotic, morphogenic, anti -fibrotic, and angiogenic activities. It is crucial for the regeneration and protection of various organs. Importantly, HGF has shown neurotrophic effects and has been validated in animal models for its therapeutic potential in spinal cord injuries, as demonstrated by research conducted by Professors Hideyuki Okano and Masaya Nakamura at Keio University School of Medicine. Enthusiasm for HGF as a groundbreaking therapeutic agent for spinal cord injury continues to grow. Meanwhile, a research team led by Professor Shigeru Hirano in the Department of Otolaryngology and Head and Neck Surgery at Kyoto Prefectural University of Medicine has investigated the anti -fibrotic effects of HGF and demonstrated its effectiveness in treating vocal cord scarring. HGF is also emerging as a promising therapeutic option for a range of fibrotic diseases. About Kringle Pharma, Inc. https://www.kringle-pharma.com/en/ Founded in December 2001, Kringle Pharma is a late-stage clinical biopharmaceutical company focused on developing innovative biologics based on HGF. Oremepermin alfa is currently in Phase 3 in Japan for the treatment of acute spinal cord injury and vocal cord scarring. Kringle’s mission is to improve societal and global healthcare by advancing the research, development, and commercialization of HGF -based therapies for patients with incurable diseases. To accelerate the international development of oremepermin alfa, Kringle Pharma USA, Inc. was established in November 2025 as a U.S. subsidiary. Business Development, Investor, and Media Contact： Matt Vogelhuber President, US Head of Operations Kringle Pharma USA, Inc. Kazuki Kaneshiro Director, Corporate Strategy Office Kringle Pharma, Inc. Phone: 770-570-0641 Email: [email protected] Phone: +81-6-7653-6728 Email: [email protected]

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