Company Description
NKGen Biotech, Inc. (NKGN) is a clinical-stage biotechnology company focused on the research, development, and commercialization of autologous and allogeneic natural killer (NK) cell therapeutics. According to company disclosures, NKGen concentrates on NK cell–based approaches for neurodegenerative diseases and cancer, positioning itself within the biotechnology research and development segment of the professional, scientific, and technical services sector. The company is headquartered in Santa Ana, California, USA, and its common stock and warrants trade on the OTC Expert Market.
Business focus and therapeutic platform
NKGen describes itself as a company dedicated to developing NK cell therapeutics that are either autologous (patient-specific) or allogeneic. Its work centers on enhanced NK cells designed to act on disease pathways relevant to neurodegenerative disorders and solid tumors. The company highlights a lead autologous NK cell candidate, troculeucel, and an allogeneic NK cell program referred to as SNK02 in solid tumors. Across public communications, NKGen emphasizes the use of non-genetically modified, ex vivo expanded NK cells with enhanced cytotoxicity and specific receptor expression profiles.
Troculeucel (SNK01) and neurodegenerative disease programs
Troculeucel is described by NKGen as a novel, cell-based, patient-specific, ex vivo expanded autologous NK cell immunotherapeutic drug candidate. It is the International Nonproprietary Name (INN) assigned by the World Health Organization for SNK01. NKGen reports that troculeucel is being developed for the treatment of neurodegenerative disorders, including Alzheimer’s disease, and a broad range of cancers. Company materials state that troculeucel is a cryopreserved, autologous, non-genetically modified NK cell product with increased cytotoxicity and high expression of activating receptors.
NKGen has presented data and scientific rationale for troculeucel in Alzheimer’s disease at multiple scientific meetings, including the Alzheimer’s Association International Conference and the World Congress of Neurology. In these communications, the company describes troculeucel as an investigational therapy for moderate or advanced Alzheimer’s disease and other neurodegenerative conditions, and indicates that it is conducting clinical trials, including Phase 1 and Phase 2 studies, to evaluate biomarker changes and cognitive outcomes.
Allogeneic NK cell program (SNK02) in solid tumors
In addition to autologous therapies, NKGen reports development of an allogeneic enhanced NK cell therapy, identified as SNK02, for solid tumors. The company has described scientific and early clinical findings for SNK02, including evaluation of allogeneic NK cells in solid tumors without the need for lymphodepletion. NKGen has presented this work at an immuno-oncology summit, emphasizing the role of NK cells as primary effector cells in innate immune responses against cancer and the potential for allogeneic NK cell products in oncology.
Clinical-stage status and regulatory interactions
NKGen consistently characterizes itself as a clinical-stage biotechnology company. Public statements reference multiple clinical trials, including Phase 1 studies and a double-blind randomized Phase 2 trial in moderate-stage Alzheimer’s disease. The company has also announced that the U.S. Food and Drug Administration granted an Expanded Access Program authorization for an investigational new drug application (IND) to use troculeucel in an open-label, non-randomized, multi-center intermediate-size expanded access protocol for several neurodegenerative diseases. These include Alzheimer’s disease and other conditions such as Parkinson’s disease, amyotrophic lateral sclerosis, multiple system atrophy, progressive supranuclear palsy, frontotemporal dementia, corticobasal degeneration, multiple sclerosis, and Lewy body dementia.
Geographic footprint and partnerships
NKGen is headquartered in Santa Ana, California, and its activities extend internationally through subsidiaries and partnerships. The company is the majority owner of NKGen Biotech Korea Co., Ltd. ("NKGen Korea"), a clinical-stage biotechnology company based in Seoul, South Korea. NKGen Korea, formerly NKMax Co., Ltd., develops NK cell therapies and commercializes bioreagents and immunodiagnostic technologies. It operates a GMP-certified cell therapy manufacturing facility that supports domestic and international clinical trials and research programs. NKGen describes NKGen Korea as a majority-owned subsidiary.
NKGen has also announced a strategic partnership with HekaBio K.K., a Japan-based healthcare platform, to accelerate regulatory, manufacturing, and commercial development of troculeucel in Japan. Under this arrangement, HekaBio is expected to lead clinical trials in Japan and oversee regulatory activities with the Pharmaceuticals and Medical Devices Agency for pre-market approval of troculeucel in several neurodegenerative disease indications.
Acquisition of NKGen Biotech Korea Co., Ltd. (formerly NKMax Co., Ltd.)
NKGen has reported the completion of an acquisition of a majority equity stake in NKMax Co., Ltd., a Korean biotechnology company, out of bankruptcy. Following this transaction, the Korean entity was renamed NKGen Biotech Korea Co., Ltd. NKGen states that this acquisition grants it control over global manufacturing infrastructure, intellectual property, and exclusive commercialization rights associated with NK cell therapies. The company describes this step as a significant development in its evolution toward a more integrated cell therapy business with manufacturing and intellectual property assets aligned under its control.
Trading status and capital structure context
NKGen’s common stock and warrants are registered securities that trade on the OTC Expert Market under the symbols NKGN and NKGNW, respectively. The company has clarified that its common stock is tradable but that public quote dissemination is limited due to its status on the OTC Expert Market, which is a venue for securities of companies that are not current in their public disclosures. NKGen has stated that the display of a $0.00 price on certain financial websites reflects these quotation limitations rather than a change in the company’s underlying operations.
In a Form 8-K filing, NKGen reported entering into a secured promissory note with AlpineBrook Capital GP I Limited. The note documents certain cash advances primarily related to NKGen’s acquisition of a majority stake in NKGen Korea through the Korean bankruptcy process, along with an additional advance funded at execution. The filing describes interest terms, maturity, restrictive covenants, collateral arrangements, and a "most favored nation" provision related to future financings.
NKGen Korea board and governance developments
As the majority owner of NKGen Korea, NKGen has commented on changes to the NKGen Korea Board of Directors following a shareholder-approved name change from NKMax Co., Ltd. to NKGen Biotech Korea Co., Ltd. NKGen Korea announced the appointment of several new board members for defined terms. NKGen has stated that these appointments are intended to support NKGen Korea’s growth and development in the Asia-Pacific region as it emerges from rehabilitation and advances NK cell therapies.
Scientific communication and conference activity
NKGen frequently shares scientific and clinical data through presentations at international conferences and forums. These include events focused on neurology, neurodegenerative diseases, cell and gene therapy, and immuno-oncology. The company has highlighted mechanistic data, biomarker results, and early clinical outcomes for troculeucel in Alzheimer’s disease, as well as data for SNK02 in solid tumors. NKGen indicates that copies of presentations and posters, along with previously disclosed scientific data, are made available through its scientific publications resources.
Summary
Overall, NKGen Biotech, Inc. presents itself as a clinical-stage biotechnology company centered on NK cell–based therapies, with a lead autologous candidate, troculeucel, in neurodegenerative diseases and oncology, and an allogeneic NK program in solid tumors. Through majority ownership of NKGen Korea and collaborations such as its partnership with HekaBio in Japan, NKGen links its research, clinical programs, and manufacturing capabilities across multiple regions while maintaining its corporate headquarters in Santa Ana, California.