NKGen Biotech, Inc. - Common Stock (NKGN)

SANTA ANA, Calif., March 04, 2025 (GLOBE NEWSWIRE) -- NKGen Biotech, Inc. (Nasdaq: NKGN), a clinical-stage biotechnology company focused on the development and commercialization of innovative autologous and allogeneic natural killer (“NK”) cell therapeutics, today announced that on March 3, 2025 it received notice that the Nasdaq Hearings Panel determined to delist the Company’s common stock from the Nasdaq Global Market after the close of trading on March 4, 2025, solely due to the Company’s continued failure to comply with Rule 5450(b)(2)(A) of Nasdaq’s Listing Requirements, related to the market value of its common stock. After delisting from Nasdaq, the Company expects that the common stock will be traded on a market operated by the OTC Markets Group, Inc. commencing on March 5, 2025. The Company intends to apply to trade on the OTCQX platform, the highest OTC tier, which requires ongoing compliance with SEC public reporting requirements. After initial trading on OTC Pink in a short transition period, NKGen’s common stock and warrants are expected to begin trading on the OTCQX platform under the same ticker symbols, “NKGN” for shares of common stock and “NKGNW” for warrants.

NKGen explores the use of troculeucel as a potential treatment option for post-stroke patients.

NKGen takes a meaningful step towards potential treatment for frontotemporal dementia (“FTD”) patients with limited treatment options.

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 troculeucel, expanded enhanced autologous NK cell therapy, for the treatment of moderate Alzheimer’s disease (NCT06189963). In addition to Dr. Fletcher’s appointment as National PI, NKGen is pleased to announce AdventHealth Research Institute, Neuroscience Research in Orlando will be the first clinical site on the East Coast with the intent of enrolling moderate stage Alzheimer’s Disease (AD) patients in the very near term.

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.

The Fast Track designation accelerates troculeucel’s path to U.S. FDA submission for the treatment of patients with moderate Alzheimer’s disease.

SANTA ANA, Calif., Dec. 02, 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 it has been selected as the preferred stalking horse bidder for NKMax Co., Ltd. (“NKMax”) in NKMax’s court-managed rehabilitation process in South Korea. NKMax filed for rehabilitation in South Korea, roughly similar to Chapter 11 in the US, on April 18, 2024, and currently holds an approximate 25% equity interest in NKGen. NKGen’s proposal included up to $18 million in committed funding from a third-party investor. As is typical in US bankruptcies, there will now be a public offering process, with NKGen having final right of first refusal on any other qualified offers, with the final decision and ultimate rehabilitation plan approved by NKMax’s creditors and the court expected in February 2025 and closing thereafter (the “Acquisition”). NKGen and its financing partners expect to hold a majority of the equity of NKMax at closing.

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 10-Q for the period ended September 30, 2024 (the “Form 10-Q”) with the Securities and Exchange Commission (the “SEC”) on or before November 19, 2024, the extended period provided for the filing under Rule 12b-25(b) of the Securities Exchange Act of 1934, as amended. The delay is in part due to the additional time required for valuation and review of various derivative securities as the Company has taken on more reporting responsibility internally. The Notice from Nasdaq has no immediate effect on the listing or trading of the Company’s common stock on the Nasdaq Global Market.

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.

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 16th World Stroke Congress (“WSC 2024”) to be held in Abu Dhabi, UAE from October 23–26, 2024. Although accepted as an oral presentation, NKGen has opted to showcase troculeucel results in poster format.

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 the follow-up Phase 1/2a study of troculeucel in subjects with Alzheimer’s disease, at the 17th Annual Clinical Trials on Alzheimer’s Disease Conference (“CTAD”) to be held in Madrid, Spain from October 29 – November 1, 2024.

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.

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 at the H.C. Wainwright 26th Annual Global Investment Conference, on September 9-11, 2024.

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 Form 10-Q for the period ended June 30, 2024 (the “Form 10-Q”) with the Securities and Exchange Commission (the “SEC”) on or before August 19, 2024, the extended period provided for the filing under Rule 12b-25(b) of the Securities Exchange Act of 1934, as amended. The delay is in part due to the recent change in the Company’s independent registered public accounting firm and its valuation firm. The Notice indicated that the Company has 60 calendar days, or until October 21, 2024, to submit a plan to regain compliance and that Nasdaq can grant an exception of up to 180 calendar days from the Form 10-Q due date, or until February 18, 2025, to regain compliance. The Notice from Nasdaq has no immediate effect on the listing or trading of the Company’s common stock on the Nasdaq Global Market.

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

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 disease during a poster presentation at the upcoming Alzheimer’s Association International Conference (“AAIC”) to be held in Philadelphia, PA at the Pennsylvania Convention Center and online from July 28 – August 1, 2024.

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 Committee and Nominating and Corporate Governance Committee, effective July 11, 2024.

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 process by Paul Y. Song, MD, Chairman and Chief Executive Officer of NKGen, entitled, “Protecting Patients by Removing Need for Lymphodepletion to Better Preserve Immune Function”. Dr. Song also provided an update on the Company’s initial Phase 1 results using SNK02 to treat patients with advanced refractory solid tumors.

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New York - Feb 7, 2024 - 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 the way for certain next generation NK Cell Therapy companies to recognized as a licensed management business.

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 the way for certain next generation NK Cell Therapy companies to recognized as a licensed management business.

December 30, 2023 - NKGen Biotech, Inc. (Nasdaq: NKGN) is making strides in Alzheimer's disease (AD) treatment with the dosing of the first patient in its Phase 1/2a trial for SNK01, an autologous natural killer (NK) cell therapy. The innovative product, designed for moderate AD, has demonstrated promising results in neuroinflammation and cognitive function during its Phase 1 safety trial.

SANTA ANA, Calif., Dec. 29, 2023 - (Plato / Amplifi via 500NewsWire) -- NKGen Biotech, Inc. (Nasdaq: NKGN) is making strides in Alzheimer's disease (AD) treatment with the dosing of the first patient in its Phase 1/2a trial for SNK01, an autologous natural killer (NK) cell therapy. The innovative product, designed for moderate AD, has demonstrated promising results in neuroinflammation and cognitive function during its Phase 1 safety trial.

SANTA ANA, Calif. - Oct 24, 2023 - Today, NKGen Biotech Inc. ( Nasdaq: NKGN ), a trailblazer in the field of autologous, allogeneic, and CAR-NK natural killer cell therapeutics, proudly announced the progression of its SNK01 program targeting Alzheimer’s Disease (AD), backed by the green light from the U.S. Food and Drug Administration (FDA) for its Investigational New Drug (IND) application. NKGen is gearing up to initiate its Phase 1/2a clinical trial by the close of 2023, focusing on patients with moderate Alzheimer’s Disease.

SANTA ANA, Calif., Oct. 24, 2023 (Plato / Amplifi) -- Today, NKGen Biotech Inc. (Nasdaq: NKGN), a trailblazer in the field of autologous, allogeneic, and CAR-NK natural killer cell therapeutics, proudly announced the progression of its SNK01 program targeting Alzheimer’s Disease (AD), backed by the green light from the U.S. Food and Drug Administration (FDA) for its Investigational New Drug (IND) application. NKGen is gearing up to initiate its Phase 1/2a clinical trial by the close of 2023, focusing on patients with moderate Alzheimer’s Disease.