SANTA ANA, Calif., Aug. 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 13 th Annual Immuno-Oncology Summit... Read More

Troculeucel, a cryopreserved autologous, non-genetically modified NK cell product, appears to cross the blood brain barrier (BBB) via CXCR3, to reduce neuroinflammation via a simple IV administration. Troculeucel was shown to internalize and digest amyloid and α-synuclein proteins in vitro and to improve CSF levels of amyloid, α-synuclein, and p-tau in Phase 1 patients in a largely dose-dependent manner. Troculeucel... Read More

SANTA ANA, Calif., July 22, 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 it will present on the mechanism of action for troculeucel, enhanced non-genetically modified NK cell therapy, in Alzheimer’s... Read More

Troculeucel, a cryopreserved, autologous enhanced natural killer cell therapy, has demonstrated preliminary clinical benefit without any drug-related adverse events in two Phase I clinical trials in Alzheimer’s Disease. Company receives expanded access protocol authorization from the U.S. Food and Drug Administration (FDA) for troculeucel granted to treat patients with known diagnoses of multiple neurodegenerative diseases.... Read More

In connection with HekaBio’s recently announced strategic investment in NKGen, the partnership will expedite the regulatory, manufacturing, and commercial development of NKGen’s autologous NK cell therapy, troculeucel, in Japan. Under Japan’s Regenerative Medicine guidelines, cell therapies enjoy a regulatory environment with multiple paths for expedited commercialization. Troculeucel is well positioned to be the... Read More

Funding in the amount of $2.0M from Japanese strategic investor, in the form of common equity PIPE with warrants. New funding provides for necessary resources to regain compliance with reporting obligations and listing standards. Share trading will move to the OTC Expert Market temporarily, with potential to uplist to OTCQB as soon as SEC filings are current, with plan to return to Nasdaq or to NYSE American. SANTA ANA,... Read More

SANTA ANA, Calif., July 10, 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 the administration of the first dose of troculeucel, an expanded autologous NK cell therapy, under a single compassionate use,... Read More

Trading commencing on the OTC Markets on March 5, 2025. Trading expected to continue under ticker symbol “NKGN” for common stock and “NKGNW” for warrants. NKGen Biotech, Inc. (“NKGen” or the “Company”) has regained compliance on its public reporting obligations with the filing of its most recent quarterly report on Form 10-Q on March 4, 2025; and intends to continue complying with all Securities and Exchange (“SEC”)... Read More

SANTA ANA, Calif., March 03, 2025 (GLOBE NEWSWIRE) -- NKGen Biotech, Inc. (Nasdaq: 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 the administration of troculeucel, an expanded autologous NK cell therapy, in a stroke patient under a single compassionate... Read More

SANTA ANA, Calif., Feb. 21, 2025 (GLOBE NEWSWIRE) - - NKGen Biotech, Inc. (Nasdaq: 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 the administration of troculeucel, an expanded autologous NK cell therapy, in an FTD patient under a single compassionate use,... Read More

SANTA ANA, Calif., Feb. 19, 2025 (GLOBE NEWSWIRE) -- NKGen Biotech, Inc. (Nasdaq: 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 Anita Fletcher, M.D. has been appointed as the National Principal Investigator (“PI”) for its Phase 2a clinical trial of... Read More

The results from Phase 1 of the Troculeucel Clinical Trial demonstrated stable/improved outcomes in 90% of subjects, with no drug-related adverse events following troculeucel therapy. Troculeucel therapy was well-tolerated and resulted in beneficial effects on protein aggregate levels and neuroinflammatory biomarkers in the cerebrospinal fluid, with decreases in pTau181 and GFAP appearing to be dose dependent. A larger trial... Read More

The Fast Track designation accelerates troculeucel’s path to U.S. FDA submission for the treatment of patients with moderate Alzheimer’s disease. NKGen will benefit from increased FDA interactions, enhanced visibility and potential eligibility for Accelerated Approval, Priority Review, and Rolling Review of the regulatory dossier, with a faster path to market for troculeucel. SANTA ANA, Calif., Feb. 12, 2025 (GLOBE NEWSWIRE)... Read More

Upon closing, the transaction would secure global IP rights for NKGen. NKGen and its partners can begin to commercialize troculeucel in Korea, Japan and other markets where natural-killer (“NK”) cell therapy is already legal. NKGen proposal included up to $18 million in committed funding. Closing expected in 1Q 2025. SANTA ANA, Calif., Dec. 02, 2024 (GLOBE NEWSWIRE) -- NKGen Biotech, Inc. (Nasdaq: NKGN) (“NKGen” or the... Read More

SANTA ANA, Calif., Nov. 26, 2024 (GLOBE NEWSWIRE) -- NKGen Biotech, Inc. (Nasdaq: NKGN) (“NKGen” or the “Company”), today announced it received a notice (the “Notice”) on November 20, 2024 from the Listing Qualifications Department of The Nasdaq Stock Market (“Nasdaq”) stating that the Company is not in compliance with Nasdaq Listing Rule 5250(c)(1) (the “Rule”) because it had not timely filed its Quarterly Report on Form... Read More

Newly analyzed biomarker data from the initial dose-escalation Phase 1 AD trial found that troculeucel reduces GFAP, NfL, p-tau181, GDF-15, and LTBP2 levels, which are detectable up to 10 years before dementia symptoms appear according to recent reports. This suggests a potential role for the use of troculeucel in delaying or preventing dementia onset in asymptomatic individuals with detectable biomarkers. Preliminary... Read More

SANTA ANA, Calif., Oct. 15, 2024 (GLOBE NEWSWIRE) -- NKGen Biotech Inc. (Nasdaq: NKGN) (“NKGen” or the “Company”), a clinical-stage biotechnology company focused on the development and commercialization of innovative autologous and allogeneic natural killer cell therapeutics, today announced acceptance of an oral presentation on the potential of troculeucel in patients with neurodegenerative disease and stroke, at the 16 th... Read More

SANTA ANA, Calif., Oct. 08, 2024 (GLOBE NEWSWIRE) -- NKGen Biotech Inc. (Nasdaq: NKGN) (“NKGen” or the “Company”), a clinical-stage biotechnology company focused on the development and commercialization of innovative autologous and allogeneic natural killer cell therapeutics, today announced upcoming poster presentations on a final report of a Phase 1 dose escalation study and on a preliminary report of the Phase 1 cohort in... Read More

Two of the first three patients in the Phase 1 cohort of the Phase 1/2a clinical trial, treated at the highest dose of 6 billion cells per treatment, were found to have improved CDR-SB cognitive scores, resulting in a clinical upgrade from moderate AD to mild AD after only three months on therapy. First patient dosed in the Phase 2 cohort of the trial, continuing at the highest dose of 6 billion cells per treatment. With the... Read More

SANTA ANA, Calif., Sept. 03, 2024 (GLOBE NEWSWIRE) -- NKGen Biotech, Inc. (Nasdaq: NKGN) (“NKGen” or the “Company”), a clinical-stage biotechnology company focused on the development and commercialization of innovative autologous, allogeneic and CAR-NK natural killer (“NK”) cell therapeutics, today announced that Paul Y. Song, MD, Chairman and CEO of NKGen, will participate in a virtual presentation and one-on-one meetings... Read More

SANTA ANA, Calif., Aug. 22, 2024 (GLOBE NEWSWIRE) -- NKGen Biotech, Inc. (Nasdaq: NKGN) (“NKGen” or the “Company”), today announced it received a standard notice (the “Notice”) on August 20, 2024 from the Listing Qualifications Department of The Nasdaq Stock Market (“Nasdaq”) stating that the Company is not in compliance with Nasdaq Listing Rule 5250(c)(1) (the “Rule”) because it had not timely filed its Quarterly Report on... Read More

SNK01, a cryopreserved autologous non-genetically modified NK cell product, is able to effectively reduce α-synuclein (α-syn) protein levels in the cerebral spinal fluid (CSF) of Alzheimer’s patients; an important finding since increased α-syn has been correlated with worse cognitive performance and is not a target for any currently approved Alzheimer’s treatments SNK01 treatment appears to stabilize or improve cognitive... Read More

SANTA ANA, Calif., July 18, 2024 (GLOBE NEWSWIRE) -- NKGen Biotech, Inc. (Nasdaq: NKGN) (“NKGen” or the “Company”), a clinical-stage biotechnology company focused on the development and commercialization of innovative autologous, allogeneic and CAR-NK natural killer (“NK”) cell therapeutics, today announced that it will present new biomarker data on SNK01 (autologous non-genetically modified NK cell therapy) in Alzheimer’s... Read More

SANTA ANA, Calif., July 15, 2024 (GLOBE NEWSWIRE) -- NKGen Biotech, Inc. (Nasdaq: NKGN) (“NKGen” or the “Company”), a clinical-stage biotechnology company focused on the development and commercialization of innovative autologous, allogeneic and CAR-NK natural killer (“NK”) cell therapeutics, today announced the appointment of Dr. Marco Gottardis as a director and member of the Company’s Audit Committee, Compensation... Read More

SANTA ANA, Calif., June 12, 2024 (GLOBE NEWSWIRE) -- NKGen Biotech, Inc. (Nasdaq: NKGN) (“NKGen” or the “Company”), a clinical-stage biotechnology company focused on the development and commercialization of innovative autologous, allogeneic and CAR-NK natural killer (“NK”) cell therapeutics, today presented details on its novel allogeneic blood-derived NK cell therapy (“SNK02”) commercial manufacturing and cryopreservation... Read More

SANTA ANA, Calif., June 03, 2024 (GLOBE NEWSWIRE) -- NKGen Biotech, Inc. (Nasdaq: NKGN) (“NKGen” or the “Company”), a clinical-stage biotechnology company focused on the development and commercialization of innovative autologous, allogeneic and CAR-NK natural killer (“NK”) cell therapeutics, today announced that Paul Y. Song, MD, Chairman and Chief Executive Officer of NKGen Biotech, will present details on their... Read More

SNK02 has the potential to be a first-in-class cryopreserved allogeneic NK cell therapy for solid tumors that does not require lymphodepletion before administration, which may lead to better overall synergy in future combination regimens with immune checkpoint inhibitors. In this Phase 1 trial, the best objective response of stable disease was demonstrated in 100% of patients that completed 8 treatment cycles of SNK02. SNK02... Read More

SNK01, a cryopreserved, autologous enhanced natural killer cell therapy, delivered in highest dose to date, demonstrates preliminary clinical benefit without any drug-related adverse events. Company advances SNK01 into Phase 2 in moderate Alzheimer’s disease; first patient enrolled in Phase 2 expected in Q2 2024. SANTA ANA, Calif., May 20, 2024 (GLOBE NEWSWIRE) -- NKGen Biotech, Inc. (Nasdaq: NKGN) (“NKGen” or the... Read More

SANTA ANA, Calif., May 16, 2024 (GLOBE NEWSWIRE) -- NKGen Biotech, Inc. (Nasdaq: NKGN) (“NKGen” or the “Company”), a clinical-stage biotechnology company focused on the development and commercialization of innovative autologous, allogeneic and CAR-NK natural killer (“NK”) cell therapeutics, today announced that Paul Y. Song, MD, Chairman and Chief Executive Officer of NKGen, will present highlights of the Company’s... Read More

NKGen advances its neurodegenerative disease program with FDA IND clearance for its Phase 1/2a SNK01 Clinical Trial in patients with Parkinson’s disease. The Company expects to initiate a Phase 1 clinical trial in PD in 2H 2024. SANTA ANA, Calif., April 29, 2024 (GLOBE NEWSWIRE) -- NKGen Biotech, Inc. (Nasdaq: NKGN) (“NKGen” or the “Company”), a clinical-stage biotechnology company focused on the development and... Read More

In vitro studies with SNK01 have shown a direct ability to phagocytose and digest amyloid and alpha-synuclein proteins while also secreting immunoregulatory cytokines and identifying and eliminating autoreactive T cells that contribute to neuroinflammation. SNK01 autologous NK cell therapy demonstrated a positive effect on improving cerebral spinal fluid (“CSF”) and plasma levels of Tau, amyloid, and alpha-synuclein proteins... Read More

SANTA ANA, Calif., April 24, 2024 (GLOBE NEWSWIRE) -- NKGen Biotech, Inc. (Nasdaq: NKGN) (“NKGen” or the “Company”), a clinical-stage biotechnology company focused on the development and commercialization of innovative autologous, allogeneic and CAR-NK natural killer (“NK”) cell therapeutics, today announced an online publication at the upcoming 2024 American Society of Clinical Oncology (ASCO) Annual Meeting to be held... Read More

SANTA ANA, Calif., April 18, 2024 (GLOBE NEWSWIRE) -- NKGen Biotech, Inc. (Nasdaq: NKGN) (“NKGen” or the “Company”), a clinical-stage biotechnology company focused on the development and commercialization of innovative autologous, allogeneic and CAR-NK natural killer (“NK”) cell therapeutics, today announced that Paul Y. Song, MD, Chairman and Chief Executive Officer of NKGen Biotech, will present details around its NK cell... Read More

The Company’s neurodegenerative clinical program remains on track, with continued advancement of the Alzheimer’s Phase 2 trial and anticipation of Parkinson’s Phase 1/2a trial initiation. Additional financing also to support the Company’s oncology clinical program, with interim safety data readout in Q2 for its allogeneic product candidate. SANTA ANA, Calif., April 11, 2024 (GLOBE NEWSWIRE) -- NKGen Biotech, Inc. (Nasdaq:... Read More

SNK01 autologous NK cell therapy demonstrated a positive effect on cerebral spinal fluid (“CSF”) and plasma Tau proteins in Alzheimer’s patients. The additional Phase 1 SNK01 trial data suggest clinical activity regarding cognitive function in patients with advanced Alzheimer’s disease in addition to previously disclosed positive effects on amyloid protein and neuroinflammation biomarkers. SANTA ANA, Calif., March 25, 2024... Read More

SANTA ANA, Calif., March 04, 2024 (GLOBE NEWSWIRE) -- NKGen Biotech, Inc. (Nasdaq: NKGN) (“NKGen” or the “Company”), a clinical-stage biotechnology company focused on the development and commercialization of innovative autologous, allogeneic and CAR-NK Natural Killer (NK) cell therapeutics, today announced the acceptance of an abstract for presentation on the effect of SNK01 NK cell therapy on CSF proteins, plasma proteins,... Read More

New York, Feb 7, 2024 - (Plato Data) - On Thursday February 2, 2024, the bio industry welcomed the parliament’s passage of a bill that adds regenerative medicine organizations to the list of those considered for human cell management business licenses. The National Assembly passed the “Amendment to the Act on Safety and Support for Advanced Regenerative Medicine and Advanced Biopharmaceuticals” in a plenary session paving... Read More

NKGen Biotech’s autologous clinical program product candidate, SNK01, demonstrated improvement in neuroinflammation and cognitive function in patients with Alzheimer’s Disease (“AD”) in its Phase 1 dose-escalation safety trial. SNK01 consists of a non-genetically modified NK cell product with enhanced cytotoxicity and activating receptor expression for the treatment of moderate AD. Initial patient in this Phase 1/2a trial... Read More

NKGen’s SNK01 program continues to show positive progress with the FDA IND clearance in October 2023, and now the CTA clearance by Health Canada for a phase 1/2a clinical trial in moderate Alzheimer’s Disease patients Based on data generated from its Phase I dose escalation safety trial, presented at the recent CTAD conference in October 2023, NKGen is optimistic that the Phase 1/2a clinical trial could demonstrate more... Read More

SNK01 Phase I autologous clinical program demonstrated improvement in neuroinflammation and cognitive function in patients with Alzheimer’s Disease, expect to initiate Phase I/IIa by year end SNK02 Phase I allogeneic clinical program continues to progress; anticipated preliminary solid tumor data readout and IND filing for Parkinson’s Disease in 1Q24 SANTA ANA, Calif., Nov. 14, 2023 (GLOBE NEWSWIRE) -- NKGen Biotech Inc.... Read More

90% of patients demonstrated improvement or maintained stable cognitive function as per Alzheimer's disease composite score (ADCOMS) following 11 weeks SNK01 given intravenously (IV) appears to cross the blood-brain barrier to reduce Cerebrospinal Fluid (CSF) Aβ42/40 and pTau181 levels and neuroinflammation, as measured by Glial Fibrillary Acidic Protein (GFAP) SANTA ANA, Calif., Oct. 26, 2023 (GLOBE NEWSWIRE) -- NKGen... Read More

NKGen’s neurodegenerative program continues to advance with dosing in the Phase 1/2a clinical trial anticipated to commence by year-end 2023 NKGen’s SNK01 program continues to show positive progress in Alzheimer’s Disease, as demonstrated by results reported in recent poster presentations in July and October 2023 at AAIC and WCN, respectively. SANTA ANA, Calif., Oct. 24, 2023 (GLOBE NEWSWIRE) -- NKGen Biotech Inc. (Nasdaq:... Read More

SANTA ANA, Calif., Oct. 19, 2023 (GLOBE NEWSWIRE) -- NKGen Biotech Inc. (Nasdaq: NKGN) (“NKGen” or the “Company”), a clinical-stage biotechnology company focused on the development and commercialization of innovative autologous, allogeneic and CAR-NK natural killer cell therapeutics, today announced an upcoming poster presentation on a final report of a Phase I dose escalation study of SNK01 in subjects with Alzheimer’s... Read More

SANTA ANA, Calif., Oct. 17, 2023 (GLOBE NEWSWIRE) -- NKGen Biotech Inc. (Nasdaq: NKGN) (“NKGen” or the “Company”), a clinical-stage biotechnology company focused on the development and commercialization of innovative autologous, allogeneic, and CAR-NK natural killer cell therapeutics, today presented a poster with interim Phase I trial data on the use of its investigational NK cell therapy, SNK01, to treat patients with... Read More