NKGen Biotech Inc Stock Price, News & Analysis

NKGen Biotech (OTC:NKGN) presented groundbreaking Phase 1 data for troculeucel, their innovative NK cell therapy for Alzheimer's disease, at AAIC 2025. The therapy demonstrated remarkable efficacy with 92% of patients (12 out of 13) showing stable or improved cognitive function after three months.

Key findings revealed that troculeucel can cross the blood-brain barrier and exhibits multiple mechanisms of action, including reduction of neuroinflammation and ability to degrade both amyloid and α-synuclein proteins. Notably, two out of three moderate AD patients receiving the highest dose improved to mild-stage AD, maintaining improvement through one year of treatment.

The treatment showed dose-dependent improvements in CSF biomarkers, with 100% of high-dose patients showing improvements in CSF α-synuclein levels after six months, while maintaining stable Aβ42/40 ratio and p-Tau 181 levels.

NKGen Biotech (OTC: NKGN) announced its upcoming presentation at the Alzheimer's Association International Conference (AAIC) 2025 in Toronto, Canada from July 27-31, 2025. The company will present a poster detailing the mechanism of action of troculeucel, their enhanced non-genetically modified NK cell therapy for Alzheimer's disease.

The presentation by Dr. Paul Y. Song will take place on Sunday, July 27, 2025, from 7:30 AM to 4:15 PM ET in the Exhibit Hall. The poster will include Phase I biomarker data and will be available on NKGen's website after the presentation.

NKGen Biotech (OTC: NKGN) has received FDA authorization for an Expanded Access Program (EAP) for troculeucel, its autologous enhanced natural killer cell therapy. The authorization allows treatment of up to 20 patients with various neurodegenerative diseases, expanding beyond their current Phase 2a Alzheimer's trial.

The EAP will include patients with early-stage Alzheimer's, Parkinson's, ALS, Multiple System Atrophy, Progressive Supranuclear Palsy, Frontotemporal Dementia, Corticobasal degeneration, Multiple Sclerosis, and Lewy Body Dementia. Troculeucel has shown preliminary clinical benefits without drug-related adverse events in two Phase I Alzheimer's trials, demonstrating ability to cross the blood-brain barrier and reduce neuroinflammatory markers.

NKGen Biotech (OTC: NKGN) has formed a strategic partnership with HekaBio to accelerate the development and commercialization of troculeucel, their autologous NK cell therapy, in Japan. The partnership follows HekaBio's recent equity investment in NKGen.

HekaBio will spearhead clinical trials and regulatory activities in Japan for troculeucel, targeting neurodegenerative diseases including Alzheimer's and Parkinson's. Under Japan's Regenerative Medicine guidelines, which offer expedited commercialization paths, HekaBio aims to begin patient dosing within 12 months.

The therapy shows potential for both treating intractable neurodegenerative diseases and supporting Japan's aging population in the longevity/wellness space.

NKGen Biotech (OTC: NKGN) has secured $2 million in funding from a Japanese strategic investor through a common equity PIPE with warrants priced at $0.25 per share. The funding aims to help the company regain compliance with reporting obligations and listing standards after facing challenges from its former parent company NKMax's bankruptcy in June 2024.

The company's stock will temporarily move to the OTC Expert Market, limiting trading accessibility, with plans to uplist to OTCQB once SEC filings are current. NKGen is developing troculeucel, an NK cell therapy for Alzheimer's and neurodegenerative diseases, and is currently ramping up its Phase 2 clinical trial. The company expects to acquire a majority stake in NKMax, consolidating key IP rights across Asia, and aims to eventually return to Nasdaq or NYSE American listing.

NKGen Biotech (OTC: NKGN) has administered the first dose of troculeucel, an expanded autologous NK cell therapy, to a mild-stage Alzheimer's patient under FDA compassionate use authorization. The patient had shown continued cognitive decline despite treatment with lecanemab, an amyloid-targeting therapy.

The treatment is being conducted in collaboration with Dr. Anita Fletcher at AdventHealth Neuroscience Institute. While NKGen's current Phase 2a trial focuses on moderate-stage Alzheimer's, this marks their first potential expansion into mild Alzheimer's treatment, particularly for patients not responding to first-line therapies.

Troculeucel has demonstrated promising characteristics, including the ability to cross the blood-brain barrier and improve levels of various proteins in cerebrospinal fluid while reducing neuroinflammation.

NKGen Biotech (OTC: NKGN) has expanded its Phase 1/2a clinical trial for troculeucel, a cryopreserved expanded autologous NK cell therapy for moderate Alzheimer's disease, by activating two new clinical sites. The expansion includes the Ottawa Memory Clinic in Canada, led by Dr. Richard Bergeron, and AdventHealth Orlando in Florida, USA, led by Dr. Anita Fletcher. Dr. Bergeron, a renowned neuroscientist who has overseen more than 60 clinical trials, brings significant expertise as Founder and CEO of both Ottawa and Montreal Memory Clinics. The expansion follows Health Canada's clearance of NKGen's Clinical Trial Application and aims to broaden patient access, enhance trial diversity, and accelerate recruitment for the study. The trial can be referenced on clinicaltrials.gov under NCT06189963.

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.