Welcome to our dedicated page for NKGen Biotech news (Ticker: NKGN), a resource for investors and traders seeking the latest updates and insights on NKGen Biotech stock.
NKGen Biotech, Inc. (OTC: NKGN) is a clinical-stage biotechnology company headquartered in Santa Ana, California, focused on autologous and allogeneic natural killer (NK) cell therapeutics. The NKGN news feed highlights company announcements, scientific presentations, regulatory updates, and corporate developments that shape its NK cell therapy programs.
Readers can find detailed coverage of NKGen’s work on troculeucel, a patient-specific, ex vivo expanded autologous NK cell immunotherapeutic drug candidate and the International Nonproprietary Name (INN) for SNK01. News items include presentations on troculeucel’s mechanism of action and biomarker data in Alzheimer’s disease, as well as updates on its evaluation across multiple neurodegenerative diseases through clinical trials and an FDA Expanded Access Program authorization.
The news stream also features information on NKGen’s allogeneic NK cell therapy, SNK02, in solid tumors, including scientific and early clinical findings shared at immuno-oncology conferences. Corporate news covers NKGen’s acquisition of a majority equity stake in NKGen Biotech Korea Co., Ltd. (formerly NKMax Co., Ltd.), governance developments at NKGen Korea, and strategic partnerships such as its collaboration with HekaBio in Japan to advance troculeucel under Japan’s regenerative medicine framework.
In addition, NKGen issues updates on its trading status on the OTC Expert Market, clarifying quotation practices and reporting steps taken to address reporting obligations. Investors and observers can use the NKGN news page to follow how NKGen communicates progress in its NK cell therapy pipeline, regional collaborations, manufacturing and intellectual property consolidation, and interactions with regulators and capital providers.
NKGen Biotech (Nasdaq: NKGN) received a notice from Nasdaq on November 20, 2024, stating non-compliance with listing rules due to delayed filing of Q3 2024 Form 10-Q. The delay stems from additional time needed for internal derivative securities valuation. Nasdaq granted a temporary exception until January 7, 2025, pending the Seoul Bankruptcy Court's decision on NKMax's rehabilitation and NKGen's proposal to acquire majority interest. The company must submit an updated compliance plan following the court's decision. The notice doesn't immediately affect NKGN's Nasdaq Global Market listing, and the company aims to file the Form 10-Q promptly.
NKGen Biotech presented Phase 1/2a trial data for troculeucel in Alzheimer's Disease at the CTAD Conference. The Phase 1 trial showed that troculeucel reduces several biomarkers detectable up to 10 years before dementia symptoms. In the Phase 1/2a trial, using the highest dose of 6 billion cells, all three treated subjects showed stable or improved cognitive function, with two subjects improving from moderate to mild disease after three months. The treatment demonstrated strong safety with no adverse reactions. The Phase 1 pilot trial showed 90% of evaluable subjects experienced stable or improved cognitive function, with reductions in neuroinflammation biomarkers.
NKGen Biotech Inc. (Nasdaq: NKGN), a clinical-stage biotechnology company, has announced its upcoming presentation at the 16th World Stroke Congress (WSC 2024) in Abu Dhabi, UAE from October 23–26, 2024. The company will showcase results of troculeucel, their innovative natural killer cell therapeutic, in a poster format.
The e-poster, titled "Therapeutic potential of expanded SNK01 (activated autologous natural killer cells) post-stroke to reduce neuroinflammation, inflammation-mediated cell death, and damage," will be presented in two sessions:
- Free Communications 09: Health Services & Implementation of Stroke Care on October 25, 2024, 8:00 am – 9:30 am GST in Hall F
- Plenary 03: Plenary, Awards & Late Breaking on October 25, 2024, 10:00 am – 11:30 am GST in Hall A/Plenary
The poster will be available on NKGen's website after the presentation.
NKGen Biotech Inc. (Nasdaq: NKGN) announced upcoming poster presentations at the 17th Annual Clinical Trials on Alzheimer's Disease Conference (CTAD) in Madrid, Spain from October 29 – November 1, 2024. The presentations will cover:
1. A final report of a Phase 1 dose escalation study and a preliminary report of the Phase 1 cohort in the follow-up Phase 1/2a study of troculeucel in Alzheimer's disease subjects.
2. Further biomarker analysis and implications for use in prevention of Alzheimer's disease using non-genetically modified natural killer cells (SNK01) with enhanced activity.
The posters will be presented during Poster Session 1 on October 29-30, 2024. Full abstracts will be included in the special CTAD edition of the Journal of Prevention of Alzheimer's Disease (JPAD).
NKGen Biotech (Nasdaq: NKGN) has announced promising interim data from the Phase 1 cohort of its Phase 1/2a clinical trial for troculeucel, an autologous enhanced NK cell therapy for moderate Alzheimer's disease (AD). Two out of three patients treated with the highest dose (6 billion cells) showed improved CDR-SB cognitive scores, upgrading from moderate to mild AD after just three months.
The company has also dosed the first patient in the Phase 2 cohort, continuing with the 6 billion cell dose. The Phase 2 trial will evaluate troculeucel's efficacy in a randomized, double-blind, placebo-controlled study with 30 moderate AD patients. NKGen has activated four clinical sites across North America and expects to increase enrollment soon.
NKGen Biotech (Nasdaq: NKGN), a clinical-stage biotechnology company specializing in NK cell therapeutics, has announced its participation in the H.C. Wainwright 26th Annual Global Investment Conference from September 9-11, 2024. Paul Y. Song, MD, Chairman and CEO of NKGen, will deliver a virtual presentation and engage in one-on-one meetings with investors.
Key points:
- The virtual presentation will be available on-demand starting September 9, 2024, at 7:00 AM Eastern Time
- Registered participants can submit questions after the presentation
- A webcast of the pre-recorded presentation will be accessible on NKGen's website
- The webcast replay will be available for 90 days following the presentation
This event provides an opportunity for NKGen to showcase its innovative NK cell therapeutics and engage with potential investors.
NKGen Biotech (Nasdaq: NKGN) has received a standard notice from Nasdaq on August 20, 2024, stating that the company is not in compliance with Nasdaq Listing Rule 5250(c)(1). This is due to the delayed filing of its Quarterly Report on Form 10-Q for the period ended June 30, 2024. The delay is partly attributed to recent changes in the company's independent registered public accounting firm and valuation firm.
NKGen has been given 60 calendar days, until October 21, 2024, to submit a plan to regain compliance. Nasdaq can grant an exception of up to 180 calendar days, until February 18, 2025. The notice has no immediate effect on the listing or trading of NKGen's common stock on the Nasdaq Global Market. The company is actively working to file the Form 10-Q promptly and regain compliance within the given timeframe.
NKGen Biotech presented new positive data on its SNK01 therapy for Alzheimer's disease at the 2024 AAIC. The study showed that SNK01, a cryopreserved autologous non-genetically modified NK cell product, can effectively reduce α-synuclein (α-syn) protein levels in the cerebrospinal fluid of Alzheimer's patients. This is significant as increased α-syn correlates with worse cognitive performance and is not targeted by current treatments.
Key findings include:
- 60% of patients showed decreased CSF α-syn levels
- 90% of patients demonstrated stable or improved cognitive function
- SNK01 also improved amyloid, tau, and neuroinflammatory markers
- The therapy was well-tolerated with no treatment-related adverse events
NKGen plans to expand investigation in a larger Phase II trial with higher doses and longer treatment duration.
NKGen Biotech (Nasdaq: NKGN) will present new biomarker data on its SNK01 therapy for Alzheimer's disease at the 2024 Alzheimer's Association International Conference. The poster presentation will showcase SNK01's ability to reduce α-synuclein in Alzheimer's patients, which is significant as α-synuclein correlates with worse cognitive function. The presentation, titled 'Subjects treated with expanded non-genetically modified autologous Natural Killer cells (SNK01) show improved changes in CSF α-synuclein and in cognitive function,' will be held on July 30, 2024. This data adds to previously disclosed Phase 1 results showing SNK01's positive effects on amyloid, tau, and neuroinflammation biomarkers in Alzheimer's patients.
NKGen Biotech (Nasdaq: NKGN) has appointed Dr. Marco Gottardis to its Board of Directors, effective July 11, 2024. Dr. Gottardis will serve on the company's Audit, Compensation, and Nominating and Corporate Governance Committees. He brings extensive experience in biopharmaceuticals and oncology research, having held senior positions at Replay Bio Holdings and Janssen Pharmaceuticals. Dr. Gottardis has a PhD in Human Oncology and has led strategies for novel research platforms and prostate cancer R&D portfolios.
NKGen's CEO, Dr. Paul Y. Song, expressed enthusiasm about Dr. Gottardis joining the board, highlighting his expertise in cell therapy research and development. This appointment is expected to strengthen NKGen's capabilities as they advance their NK cell therapy clinical programs in neurodegenerative diseases and cancer.