NKGen Biotech

What NKGen Biotech does

NKGen Biotech is a clinical-stage biotechnology company headquartered in Santa Ana, California, developing natural killer (NK) cell therapies for cancer and neurodegenerative diseases. Its lead product, troculeucel (formerly SNK01), is an autologous NK cell therapy with FDA Fast Track Designation in moderate Alzheimer's disease and ongoing clinical programs in oncology and neurodegeneration. The company is also advancing SNK02, an allogeneic, cryopreserved "off-the-shelf" NK cell therapy targeting solid tumors.

The company's core technology is its proprietary SNK platform, which enables large-scale NK cell expansion and cryopreservation suitable for both autologous and allogeneic product formats. In September 2025, NKGen acquired NKMax (now operating as NKGen Korea), consolidating manufacturing and platform IP under a single entity. The company holds multiple INDs, an FDA-authorized Expanded Access Program (July 2025), and partnerships with HekaBio (Japan distribution), Affimed, Merck KGaA, Pfizer, and the Parkinson's Foundation.

NKGen has no approved products and generates no commercial revenue. It is publicly traded, having moved from Nasdaq to the OTC Expert Market in March 2025 amid significant share price decline. The company is funded primarily through debt and small equity injections, with total debt of $38.19M against a market capitalization of $7.84M–$23.5M and shares trading in the $0.06–$0.18 range. With 51–100 employees, the company operates at clinical-stage scale with international manufacturing capability through NKGen Korea.

Name

NKGen Biotech

Legal name

NKGen Biotech, Inc.

Website

https://nkgenbiotech.com

Company type

Public

Founded year

2015

Headcount range

51–100 employees

Short description

NKGen Biotech is a clinical-stage biotechnology company developing autologous and allogeneic natural killer (NK) cell therapies, including lead candidate troculeucel, for patients with cancer and neurodegenerative diseases.

Ownership category

akta.pro rank

Product category

Cell Therapy Biopharmaceuticals

NAICS

Research and Development in Biotechnology (except Nanobiotechnology) (541714), Biological Product (except Diagnostic) Manufacturing (325414)

SIC

Biological Products, (No Disgnostic Substances) (2836), Pharmaceutical Preparations (2834)

akta.pro primary industry

NK Cell Therapies (HLAAABAD)

akta.pro secondary industries

Cell Therapy Developers (Autologous) (HLAAABAA), Cell Therapy Developers (Allogeneic/Off-the-shelf) (HLAAABAB), Cell Therapy Enabling Technologies (gene editing, cell engineering, delivery methods) (HLAAABAL)

Keywords

• NK cell therapy
• Cell immunotherapy
• Neurodegenerative therapeutics
• Oncology cell therapy
• Autologous cell therapy

Headquarters

HQ city

Santa Ana

HQ country

United States

HQ region

North America

Offices1 record

Markets served

GTM type

B2B

Offering type

Hardware or Manufacturing

Cost components

Technology or R&D

Revenue model

1. Biopharmaceutical Development: NKGen Biotech is a clinical-stage biotechnology company focused on developing and commercializing NK cell therapeutics. The company is pre-revenue with all products in clinical development stage. Revenue generation is contingent on successful clinical trials, regulatory approvals, and eventual commercialization of troculeucel or SNK02.

Go-to-market motion2 records

Distribution channels3 records

Marketing channels5 records

Core offering

NKGen Biotech develops natural killer (NK) cell therapy candidates built on its proprietary SNK platform. Its lead candidate Troculeucel (SNK01) is an autologous ex vivo expanded enhanced NK cell therapy targeting neurodegenerative disorders (Alzheimer's, Parkinson's, FTD, stroke) and refractory cancers, while SNK02 is an allogeneic NK cell therapy for solid tumors. The company operates an FDA-authorized Expanded Access Program and is advancing candidates through Phase 1/2a and Phase 2 clinical trials.

Product overview

NKGen Biotech is a clinical-stage biotechnology company developing a portfolio of NK (natural killer) cell therapies. The core platform is the proprietary SNK technology, which produces enhanced NK cells with increased activity through a specialized manufacturing and cryopreservation process. The main product candidates are Troculeucel (SNK01) - an autologous enhanced NK cell therapy for neurodegenerative diseases and cancer - and SNK02 - an allogeneic NK cell therapy for solid tumors. The company operates an FDA-authorized Expanded Access Program for troculeucel in certain neurodegenerative conditions.

Differentiator

Problem solved

Functional benefit

Products and services

• Troculeucel (SNK01) Novel cell-based, patient-specific, ex vivo expanded autologous enhanced NK cell immunotherapy drug candidate for the treatment of neurodegenerative disorders (Alzheimer's disease, Parkinson's disease, FTD, stroke) and a broad range of cancers. International Nonproprietary Name (INN) assigned by WHO.
• SNK02 Allogeneic NK cell therapy product candidate for the treatment of solid tumors. Non-genetically modified enhanced NK cells that can be administered without lymphodepletion.
• Troculeucel Expanded Access Program FDA-authorized intermediate-size Expanded Access Program providing access to troculeucel for up to 20 patients with serious or life-threatening neurodegenerative diseases who have exhausted other treatment options.

Quantifiable outcome

• 100% of moderate AD patients showed stable or improved cognitive function across all MCID thresholds at 3-month assessment
• +4 more outcomes

Segments2 records

Ideal customer profiles3 records

Technology focussed Yes

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

Feature4 records

Partnerships

Six partnerships are on record, tiered core and minor.

• HekaBiocoreStrategic or Co-development Partner · 17 July 2025Strategic partnership to bring NK cell therapy to Japan. HekaBio serves as NKGen's strategic partner for expanding access to troculeucel in the Japanese market. This partnership supports NKGen's international expansion strategy for its neurodegenerative disease therapies.
• Parkinson's FoundationminorStrategic or Co-development Partner · 4 November 2022Collaboration to bring novel natural killer cell therapy to the clinic for advanced Parkinson's disease. Supports clinical development and patient access for Parkinson's program.
• AffimedminorStrategic or Co-development Partner · 20 October 2020Clinical collaboration to study AFM24 (EGFR-targeted innate cell engager) in combination with autologous NK cell product SNK01 in solid tumors. FDA cleared IND for first-in-human Phase 1/2a trial of AFM24 combination with SNK01.
• Merck KGaA, Darmstadt, GermanyminorStrategic or Co-development Partner · 8 September 2020Clinical trial collaboration and supply agreement for combination of SNK01 with ERBITUX (cetuximab) in metastatic NSCLC. Expanded from original collaboration to include Phase I/IIa trial investigating the combination therapy.
• PfizerminorStrategic or Co-development Partner · 8 September 2020Clinical trial collaboration and supply agreement alongside Merck KGaA for SNK01 combination therapy development.
• NKGen Biotech Korea Co., Ltd.coreStrategic or Co-development PartnerMajority-owned subsidiary (formerly NKMax Co., Ltd.), based in Seoul, South Korea. NKGen acquired majority stake through Korean bankruptcy process in 2025, gaining full control of global manufacturing and intellectual property assets. NKGen Korea operates GMP-certified cell therapy manufacturing facility and commercializes bioreagents and immunodiagnostic technologies. Founded in 2002.

Scale indicators8 records

Recent moves6 records

Expansion highlights6 records

Direct peers

• Nkarta, Inc. Clinical-stage biotech developing allogeneic and autologous NK cell therapies for cancer and autoimmune disease, with overlapping platform technology and similar target indications. Direct competitor in engineered NK cell therapy space.
• Fate Therapeutics: Clinical-stage biotech developing iPSC-derived NK cell and T-cell cancer immunotherapies. Closest direct competitor with broader pipeline but similar NK cell engineering focus and clinical-stage maturity.
• ImmunityBio: Commercial-stage biotech with approved NK cell-based therapy (Anktiva) for bladder cancer. Comparable in NK cell therapy approach with deeper clinical and commercial experience — a benchmark for NKGen's potential path to approval.
• Cytovia Therapeutics: Clinical-stage biotech developing NK cell therapies and NK-engaging therapeutics for solid tumors and hematologic malignancies. Comparable in targeting NK cells for oncology with similar platform focus.

Emerging players

• Shoreline Biosciences: Clinical-stage company developing iPSC-derived allogeneic NK cell therapies with a scalable manufacturing platform. Comparable in cell engineering approach though at earlier clinical maturity than NKGen's lead programs.
• Century Therapeutics: Clinical-stage biotech developing iPSC-derived allogeneic cell therapies including NK and T cells. Comparable platform technology though focused on hematologic malignancies and solid tumors rather than neurodegeneration.
• Caribou Biosciences: Clinical-stage biotech developing allogeneic CAR-NK and CAR-T cell therapies using CRISPR gene editing. Comparable in NK cell engineering focus though at earlier clinical stage and targeting oncology rather than neurodegeneration.

Broad incumbents

• Iovance Biotherapeutics: Commercial-stage cell therapy leader with approved TIL therapy (Amtagvi). While focused on TIL rather than NK cells, Iovance is a relevant incumbent benchmark for cell therapy manufacturing, regulatory pathway, and commercial launch dynamics.
• Adaptimmune Therapeutics: Clinical-to-commercial cell therapy company with approved engineered T-cell therapy (Tecelra). Broader incumbent in cell therapy with relevant experience in autologous cell therapy manufacturing and FDA approval pathway.
• Cellectis: Clinical-stage cell therapy company developing allogeneic CAR-T and gene-edited cell therapies. Comparable as a gene-editing and cell engineering platform, though focused on T cells rather than NK cells.

Market position

Strengths4 records

Weaknesses5 records

Competitive moat3 records

Key risks7 records

Key highlights7 records

Customer concentration

• Xx.com/nkgenbiotech
• Facebookfacebook.com/nkgenbiotech
• LinkedInlinkedin.com/company/nkgen-biotech-inc

Revenue estimate

Valuation estimate

Number of profiles

Profiles3 records

Subsidiaries2 records

Funding overview

Funding rounds4 records

Investors2 records

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M&A1 record

Investments

M&A and investment is available on the Subscription and Enterprise plan.Contact sales →

Frequently asked questions about NKGen Biotech