NKGen Biotech develops clinical-stage natural killer cell therapeutics, with news centered on troculeucel, its patient-specific, ex vivo expanded autologous NK cell immunotherapy candidate also known as SNK01. Company updates commonly address Alzheimer’s disease, frontotemporal dementia and cancer development, including conference presentations, clinical and biomarker analyses, mechanistic data and regulatory naming for the program.
Recurring disclosures also cover NKGen’s OTC quotation and trading status, capital-market communications, scientific advisory activity and its majority-owned Korean affiliate, NKGen Biotech Korea Co., Ltd., which develops NK cell therapies and commercializes bioreagents and immunodiagnostic technologies.
NKGen Biotech (OTC: NKGN) announced that Chairman & CEO Paul Y. Song, M.D. has made a personal investment of $2.65 million in the company through shares and warrants. The funding comes from proceeds of Dr. Song's recent sale of Fuse Biotherapeutics, which he co-founded. This investment supplements $3.0 million in funding advances from AlpineBrook Capital in 2025, beyond their previous $5.5 million proceeds and $4 million commitments in convertible notes.
The new capital will be used to accelerate NKGen's Phase 2 clinical trial for Alzheimer's Disease, reduce company payables, and cover working capital and compliance-related expenses. The AlpineBrook advances are secured by personal guarantees from Dr. Song and Interim CFO James Graf.
NKGen Biotech (OTC: NKGN) announced an upcoming presentation of Phase 1 clinical data for troculeucel, their cryopreserved expanded autologous NK cell therapy for moderate Alzheimer's disease (AD), at the American Society of Gene and Cell Therapy (ASGCT) 28th Annual Meeting. The presentation, titled "Use of Expanded Non-genetically Modified Natural Killer Cells (Troculeucel) with Enhanced Cytotoxicity in Patients with Alzheimer's Disease. Preliminary Clinical and Biomarker Results," will be delivered by Dr. Paul Y. Song on May 14, 2025, at 2:30 PM CT in New Orleans.
NKGen Biotech (OTC: NKGN) has announced that its Chairman and CEO, Dr. Paul Y. Song, will present at the 7th China International Biotechnology Conference & Exhibition (BIOTEC-CHINA 2025) in Beijing from April 16-18, 2025.
The presentation, scheduled for April 17, 2025, at 10:20 am CST, will focus on troculeucel, the company's NK cell therapeutic treatment for Alzheimer's and Parkinson's disease. Dr. Song will discuss promising results from Phase 1 clinical trials and compassionate use cases, along with updates on their ongoing Phase 1/2a clinical trial for moderate Alzheimer's disease.
BIOTEC-CHINA 2025 is expected to attract approximately 1,500 biotechnology and pharmaceutical professionals, offering networking opportunities and covering various life science topics including drug discovery, biomanufacturing, genomics, nanotechnology, and cell therapy.
NKGen Biotech (OTC: NKGN) presented updated Phase 1 clinical data for troculeucel, their NK cell therapy for moderate Alzheimer's disease (AD), at AD/PD™ 2025. The trial administered the highest dose of 6 billion cells every three weeks to three patients with moderate AD.
Key findings after 12 months: Two patients completed all 17 doses, showing improvement from moderate to mild AD within 3 months. One patient achieved a CDR-SB score of 4.5, near the mild cognitive impairment threshold. No drug-related adverse reactions were reported. All patients showed decreased GFAP levels in CSF and plasma at 6 months, while the two completing patients demonstrated improved Amyloid Beta 42/40 ratios at 12 months.
The company is now proceeding with the randomized, placebo-controlled Phase 2a portion of the study, expecting significant cognitive and biomarker differences between treatment and placebo groups within 6 months.
NKGen Biotech (OTC: NKGN) has announced its upcoming presentation at the International Conference on Alzheimer's and Parkinson's Diseases (AD/PD™ 2025), scheduled for April 1-5, 2025, in Vienna, Austria. The event will also be available online.
Dr. Paul Y. Song, Chairman and CEO of NKGen, will present updated data from their Phase 1/2a clinical trial of troculeucel NK cell therapy for moderate Alzheimer's disease. The presentation will cover three-month cognitive and biomarker results from the Phase 1 cohort, along with new six-month analysis data.
AD/PD™ 2025 is a leading international conference that gathered over 4,700 participants from 70+ countries and featured 2,250 abstracts in 2024. The conference serves as a platform for experts to share the latest developments in Alzheimer's and Parkinson's research, clinical trials, and treatments.
NKGen Biotech (OTC: NKGN) announced its participation in the 13th Annual Alzheimer's & Parkinson's Drug Development Summit in Boston from March 18-20, 2025. Chairman and CEO Paul Y. Song will present on troculeucel, the company's autologous, non-genetically modified NK cell therapy for neurodegenerative diseases.
The presentation will focus on troculeucel's mechanism and promising Phase 1 clinical trial results, which led to FDA Fast Track designation for moderate Alzheimer's Disease and a new Investigational New Drug designation for Parkinson's Disease. The company also plans to explore troculeucel's potential in Frontotemporal Dementia and post-stroke/traumatic brain injury treatment.
The Summit, featuring over 150 experts, is the only industry-focused event covering the complete drug development process from discovery to commercialization, highlighting advancements in neurodegenerative therapeutics, presymptomatic diagnosis, and new treatment modalities.
NKGen Biotech (NKGN) announced its delisting from Nasdaq Global Market effective March 4, 2025, due to non-compliance with market value requirements. The company will transition to OTC Markets starting March 5, 2025, trading under symbols 'NKGN' for common stock and 'NKGNW' for warrants.
The company has cancelled its previously planned 1-for-6 reverse stock split and intends to apply for the OTCQX platform, maintaining SEC reporting compliance. NKGen's Phase 2a Alzheimer's trial enrollment is expected to complete by Q2 end, with initial readout planned for late 2025.
Despite challenges related to their former parent company NKMAX's financial restructuring, NKGen highlighted progress in their Alzheimer's program, including FDA Fast Track designation, Phase 1 results publication, and presentations at major conferences in 2024. The company aims to eventually re-list on Nasdaq once meeting listing requirements.
NKGen Biotech (NKGN) has administered its first dose of troculeucel, an expanded autologous NK cell therapy, to a stroke patient under an FDA-cleared compassionate use program. The treatment, administered at George Washington University Medical Center, marks the company's initial exploration into stroke treatment applications.
The initiative, led in collaboration with Dr. Dimitri Sigounas and Dr. Amarendra K. Neppalli, aims to investigate troculeucel's potential in reducing chronic neuroinflammation in post-stroke patients. This is particularly significant as stroke remains the second leading cause of death and long-term disability, with 20% of survivors developing dementia.
The company's previous Alzheimer's trials demonstrated troculeucel's ability to cross the blood-brain barrier and reduce cerebrospinal fluid levels of brain injury markers GFAP and NfL. This compassionate use program represents a stepping stone toward a possible full IND application for stroke treatment.
NKGen Biotech (NKGN) has administered its first dose of troculeucel, an expanded autologous NK cell therapy, to a frontotemporal dementia (FTD) patient under FDA-cleared compassionate use program. The patient carries the C9orf72 gene mutation, representing one of the estimated 60,000 people living with FTD in the U.S.
This administration marks a significant step in exploring troculeucel's potential for treating neurodegenerative diseases, particularly in cases where existing therapies have proven ineffective. The company's previous experience with Alzheimer's and Parkinson's patients has shown that troculeucel can cross the blood brain barrier and improve various protein levels in CSF, including reducing neuroinflammation markers like GFAP.
The treatment will be conducted at the Sarcoma Oncology Center under Dr. Sant Chawla and Dr. Erlinda Gordon's guidance, with patient assessment by UCLA's Dr. Mario Mendez. This compassionate use program serves as an initial step towards a future full IND application.