Core Viewpoint - NKGen Biotech has formed a strategic partnership with HekaBio to accelerate the development of its autologous NK cell therapy, troculeucel, in Japan, targeting neurodegenerative diseases such as Alzheimer's and Parkinson's [1][2][3] Company Overview - NKGen Biotech is a clinical-stage biotechnology company focused on developing innovative autologous and allogeneic NK cell therapeutics, headquartered in Santa Ana, California [6] - HekaBio is a Japan-based healthcare platform that accelerates patient access to global medicines and MedTech, focusing on early-stage opportunities in CNS, oncology, and healthy longevity [8][9] Product Development - Troculeucel is an autologous, non-genetically modified cell therapy positioned to be a first-in-class treatment for several intractable neurodegenerative diseases [1][4] - The therapy is expected to be offered to patients in Japan on an accelerated path due to favorable regenerative medicine regulations, with first dosing aimed within the next 12 months [4][5] Regulatory and Clinical Strategy - HekaBio will lead all clinical trials in Japan and manage regulatory activities with the Pharmaceuticals and Medical Devices Agency for pre-market approval of troculeucel [3][4] - The partnership aims to leverage HekaBio's expertise to meet regulatory requirements and establish local manufacturing partnerships for effective commercialization [5]

Core Viewpoint - NKGen Biotech, Inc. is actively participating in the 7th China International Biotechnology Conference & Exhibition, showcasing its innovative NK cell therapeutics, particularly focusing on the treatment of neurodegenerative diseases like Alzheimer's and Parkinson's [1][2][3] Company Overview - NKGen is a clinical-stage biotechnology company based in Santa Ana, California, specializing in the development and commercialization of autologous and allogeneic natural killer (NK) cell therapeutics [6] - The company is developing a novel cell-based immunotherapeutic drug candidate named troculeucel, aimed at treating neurodegenerative disorders and various cancers [5] Conference Participation - Paul Y. Song, M.D., the CEO of NKGen, will present at BIOTEC-CHINA 2025, discussing the use of troculeucel for Alzheimer's and Parkinson's diseases [1][3] - The presentation will highlight promising results from Phase 1 clinical trials and ongoing Phase 1/2a trials for moderate Alzheimer's disease, with favorable clinical outcomes and biomarker data [3] Product Details - Troculeucel is recognized as the International Nonproprietary Name (INN) for SNK01, marking a significant milestone in NKGen's journey to market [5] - The therapy is designed to be patient-specific and is expanded ex vivo, indicating a tailored approach to immunotherapy [5]

Core Insights - NKGen Biotech, Inc. presented updated Phase 1 clinical data for troculeucel, a novel NK cell therapy for moderate Alzheimer's disease, at the AD/PD™ 2025 conference [3][4] - The highest dose of troculeucel administered was 6 billion cells per treatment, with significant cognitive improvements observed in two out of three patients after 12 months [1][4][5] - The company plans to evaluate troculeucel's safety and efficacy in a randomized, placebo-controlled Phase 2a trial [2][4] Group 1: Clinical Trial Results - In the Phase 1/2a trial, three patients received troculeucel intravenously every three weeks, with two patients completing 17 doses and one patient completing 10 doses [4] - After 12 months, two patients improved from moderate to mild Alzheimer's disease, with one patient achieving a CDR-SB score of 4.5 [1][4][5] - No drug-related adverse reactions were reported, and all patients showed stable or improved cognitive scores across various scales [4][5] Group 2: Biomarker Analysis - At 6 months, all patients exhibited decreased levels of Glial Fibrillary Acidic Protein (GFAP) in both CSF and plasma, correlating with cognitive improvements [4][5] - Improvements in the CSF and plasma Amyloid Beta (Aβ) 42/40 ratio were noted at 12 months, while p-Tau levels remained stable [4][5] Group 3: Company Overview - NKGen Biotech is focused on developing innovative autologous and allogeneic NK cell therapeutics for neurodegenerative disorders and cancers [6][7] - Troculeucel is the International Nonproprietary Name (INN) for SNK01, marking a significant step towards market introduction [6]

Core Viewpoint - NKGen Biotech, Inc. is advancing its innovative NK cell therapeutics, particularly focusing on the presentation of preliminary results for its troculeucel therapy in treating moderate Alzheimer's disease at the upcoming AD/PD™ 2025 conference [1][3]. Company Overview - NKGen Biotech is a clinical-stage biotechnology company based in Santa Ana, California, specializing in the development and commercialization of autologous and allogeneic NK cell therapeutics [6]. - The company is developing troculeucel, a novel patient-specific NK cell immunotherapeutic drug candidate, for neurodegenerative disorders and various cancers [5]. Conference Participation - Paul Y. Song, M.D., the CEO of NKGen, will present at the AD/PD™ 2025 conference, which is a significant event for discussing advancements in Alzheimer's and Parkinson's research [1][2]. - The conference is expected to attract over 4,700 participants from more than 70 countries, showcasing 2,250 abstracts in 2024 [2]. Presentation Details - The presentation titled "Preliminary Cognitive Improvement in Phase 1 Cohort of Moderate Alzheimer's Disease Subjects Treated with Autologous Natural Killer Cells (Troculeucel; SNK01)" will take place on April 5, 2025, focusing on three-month cognitive and biomarker results from the Phase 1 cohort of the clinical trial [3]. - New data from the six-month analysis of this cohort will also be discussed during the presentation [3]. Product Information - Troculeucel, also known as SNK01, has received the International Nonproprietary Name (INN) approval from the World Health Organization (WHO), marking a significant milestone for NKGen in bringing this therapy to market [5].

Core Insights - NKGen Biotech, Inc. is focused on developing innovative NK cell therapeutics, with a presentation at the upcoming Alzheimer's & Parkinson's Drug Development Summit highlighting their autologous NK cell therapy, troculeucel, for neurodegenerative diseases [1][2] Company Overview - NKGen Biotech is a clinical-stage biotechnology company headquartered in Santa Ana, California, specializing in autologous and allogeneic NK cell therapeutics [6] - Troculeucel, the company's novel cell-based immunotherapeutic drug candidate, is being developed for neurodegenerative disorders and various cancers, with its International Nonproprietary Name (INN) assigned as SNK01 by the WHO [5] Presentation Details - Dr. Paul Y. Song will present on March 20, 2025, at 12:00 PM ET, focusing on the potential of enhanced NK cell therapies for neurodegenerative diseases, specifically introducing troculeucel [3] - The presentation will include data from a Phase 1 clinical trial showing early signs of clinical benefit, leading to FDA Fast Track designation for moderate Alzheimer's Disease and a new Investigational New Drug application for Parkinson's Disease [3] Summit Information - The Alzheimer's & Parkinson's Drug Development Summit is the only industry-focused event covering the entire drug development process, featuring over 150 experts discussing advancements in neurodegenerative therapeutics [2]

Core Viewpoint - NKGen Biotech, Inc. has been notified of its delisting from the Nasdaq Global Market due to non-compliance with market value requirements, and will transition to trading on the OTC Markets starting March 5, 2025 [1][6] Company Developments - The company will not proceed with a previously announced 1-for-6 reverse stock split following the move away from Nasdaq [2] - NKGen has faced significant challenges related to the financial restructuring of its former parent company, NKMAX, Co. Ltd., but maintains confidence in its scientific approach to treating neurodegenerative diseases [3] - The company has received U.S. FDA Fast Track designation for its innovative NK cell therapies and has presented promising data at major Alzheimer's conferences [3] - NKGen aims to complete enrollment in its Phase 2a Alzheimer's clinical trial by the end of Q2 2025, with preliminary results expected later in the year [6] Trading Information - NKGen's common stock and warrants will trade on the OTCQX platform under the ticker symbols "NKGN" and "NKGNW" respectively [1][6] - The company has regained compliance with SEC public reporting obligations as of March 4, 2025, and intends to maintain these obligations during its transition [6]

Core Viewpoint - NKGen Biotech has initiated the administration of troculeucel, an autologous NK cell therapy, to a stroke patient under a compassionate use IND approved by the FDA, marking a significant step in exploring its therapeutic potential in post-stroke treatment [1][3]. Company Overview - NKGen Biotech is a clinical-stage biotechnology company focused on developing and commercializing innovative autologous and allogeneic NK cell therapeutics, headquartered in Santa Ana, California [7]. Product Development - Troculeucel is a novel, patient-specific, ex vivo expanded autologous NK cell immunotherapeutic drug candidate, being developed for neurodegenerative disorders and various cancers. The WHO has assigned the International Nonproprietary Name (INN) "troculeucel" for SNK01, which is a significant milestone for the company [6]. Clinical Collaboration - NKGen is collaborating with Dr. Dimitri Sigounas and Dr. Amarendra K. Neppalli from George Washington University Medical Center to explore the potential of troculeucel in reducing chronic neuroinflammation and damage in stroke patients [3][5]. Clinical Assessment - The stroke patient receiving troculeucel will undergo regular independent assessments by Dr. Sigounas at GWU Medical Center to evaluate the treatment's effectiveness [4]. Research Insights - Neurofilament light chain (NfL) and glial fibrillary acidic protein (GFAP) are identified as markers of brain injury, and previous trials have shown that troculeucel can cross the blood-brain barrier to reduce cerebrospinal fluid levels of these markers, indicating its potential to improve outcomes in stroke patients [5].