SANTA ANA, Calif., Oct. 09, 2025 (GLOBE NEWSWIRE) -- NKGen Biotech, Inc. (OTC: NKGN) (“NKGen” or the “Company”), a clinical-stage biotechnology company focused on the development and commercialization of innovative autologous and allogeneic natural killer (“NK”) cell therapeutics, today issued the following statement in response to recent shareholder inquiries regarding its current trading status on the OTC Expert Market and the display of a $0.00 common stock, $0.0001 par value per share (the “Common Stock ...

Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-K x ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year ended: December 31, 2024 or o TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the Transition Period from to. Commission File Number 001-40427 NKGen Biotech, Inc. (Exact name of registrant as specified in its charter) Delaware 86-2191918 (State or other jurisdi ...

SANTA ANA, Calif., Oct. 06, 2025 (GLOBE NEWSWIRE) -- NKGen Biotech, Inc. (OTC: NKGN) (“NKGen” or the “Company”), a clinical-stage biotechnology company focused on the development and commercialization of innovative autologous and allogeneic natural killer (“NK”) cell therapeutics, today announced that Paul Y. Song, M.D., Chairman and Chief Executive Officer of NKGen, will present at the XXVII World Congress of Neurology (“WCN 2025”) taking place in Seoul, South Korea, October 12-15, 2025. WCN 2025 is a prem ...

SANTA ANA, Calif., Sept. 18, 2025 (GLOBE NEWSWIRE) -- NKGen Biotech, Inc. (OTC: NKGN) (“NKGen” or the “Company”), a clinical-stage biotechnology company focused on the development and commercialization of innovative autologous and allogeneic natural killer (“NK”) cell therapeutics, today announced that Paul Y. Song, M.D., Chairman and Chief Executive Officer of NKGen, will present at the 3rd China Great Bay Cell and Gene Therapy Forum, taking place in Guangzhou, China, September 25-26, 2025. Dr. Song will d ...

NKGen acquires controlling stake in NKMax, marking a pivotal moment in its transformation into a fully integrated, self-sustaining, cell therapy company with global manufacturing and IP control.Approximately $16.9 million paid to acquire 65% equity stake in recapitalized debt-free NKMax, with NKMax operations now expected to be funded through 2026.Funding provided by AlpineBrook Capital GP 1 Limited and NKGen CEO Dr. Paul Y. Song. SANTA ANA, Calif., Sept. 09, 2025 (GLOBE NEWSWIRE) -- NKGen Biotech, Inc. (OT ...

Core Viewpoint - NKGen Biotech's Troculeucel shows promise in treating Alzheimer's disease by enhancing neuroinflammation modulation and improving cognitive function in patients, as evidenced by clinical trial data presented at AAIC 2025 [1][9]. Company Overview - NKGen Biotech, Inc. is a clinical-stage biotechnology company focused on developing innovative autologous and allogeneic natural killer (NK) cell therapeutics [12]. - The company is headquartered in Santa Ana, California, and is advancing Troculeucel for neurodegenerative disorders and various cancers [13]. Product Details - Troculeucel is a first-in-kind, autologous, non-genetically modified NK cell product with over 90% activating receptor expression and significantly increased cytotoxicity [2]. - The product has shown the ability to internalize and degrade amyloid and α-synuclein aggregates in vitro, indicating its potential effectiveness in Alzheimer's disease [5]. Clinical Trial Findings - In Phase 1 studies, 92% of patients (12 out of 13) exhibited stable or improved Alzheimer's Disease Composite Score (ADCOMS) after three months of treatment [7][14]. - Notably, two patients with moderate Alzheimer's improved to mild-stage after receiving the highest dose of Troculeucel [7]. - Biomarker data indicated that 60%, 90%, and 70% of patients showed stabilization or improvement in CSF levels of Aβ42/40, p-Tau181, and α-synuclein, respectively, after three months [5]. Mechanism of Action - Troculeucel demonstrates high expression of receptors involved in modulating neuroinflammation, including 91.25% CXCR3 expression, which facilitates migration towards the CSF in Alzheimer's patients [3][10]. - The therapy selectively targets autoreactive T cells while sparing resting T cells, potentially reducing neuroinflammation [4][9]. Additional Observations - Six out of ten patients showed decreased levels of Glial Fibrillary Acid Protein (GFAP) after three months, indicating a reduction in neuroinflammation [6]. - The findings suggest that Troculeucel may have broader applications for other neurodegenerative diseases beyond Alzheimer's [9].

Core Insights - NKGen Biotech, Inc. is set to present its findings on the mechanism of action for troculeucel, a non-genetically modified NK cell therapy for Alzheimer's disease, at the Alzheimer's Association International Conference 2025 [1][2] - The presentation will include Phase I biomarker data that confirms the therapy's enhanced cytotoxicity in Alzheimer's patients [2][3] - Troculeucel is recognized as SNK01 by the World Health Organization, marking a significant milestone in its development for treating neurodegenerative disorders and various cancers [4] Company Overview - NKGen Biotech is a clinical-stage biotechnology company based in Santa Ana, California, focusing on innovative autologous and allogeneic NK cell therapeutics [5] - The company aims to commercialize its therapies, with troculeucel being a key candidate in its pipeline [4][5]

SANTA ANA, Calif., July 21, 2025 (GLOBE NEWSWIRE) -- NKGen Biotech, Inc. (OTC: NKGN) ("NKGen" or the "Company"), a clinical-stage biotechnology company focused on the development and commercialization of innovative autologous and allogeneic natural killer ("NK") cell therapeutics, today announced that the U.S. Food and Drug Administration (FDA) has granted Expanded Access Program (EAP) authorization for its IND for an open-label, non-randomized, multi-center intermediate size expanded access protocol for us ...

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. has successfully raised $2 million from a Japanese strategic investor to support the development of its NK cell therapy, troculeucel, and to regain compliance with financial reporting obligations [2][3][4] Funding and Financial Compliance - The new funding consists of common stock priced at $0.25 per share and warrants, aimed at addressing the company's reporting obligations and listing standards [3] - The company plans to temporarily move its share trading to the OTC Expert Market, with the potential to uplist to OTCQB once SEC filings are current, and aims to return to Nasdaq or NYSE American thereafter [4] Strategic Developments - The investment comes at a critical time following the bankruptcy of NKGen's former parent company, NKMax Co., Ltd., which had disrupted capital raising efforts [4] - The company has secured a majority stake in NKMax out of bankruptcy, which is expected to close soon, allowing consolidation of key intellectual property rights across Asia [4] Product Development - Troculeucel is being developed for neurodegenerative disorders and various cancers, with its International Nonproprietary Name (INN) approved by the WHO, marking a significant milestone for NKGen [6] Future Plans - The company is committed to regaining compliance with financial filings and aims to uplist to Nasdaq or NYSE American as soon as it meets the necessary requirements [4]