NKGen Biotech
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.
- Company typePublic
- Founded2015
- HeadquartersSanta Ana, United States
- Headcount51–100
- GTM typeB2B
- OfferingHardware or Manufacturing
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.
NKGen Biotech firmographics
Firmographics- 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
NKGen Biotech industry classification
Industry- 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
Where NKGen Biotech is headquartered
LocationHeadquarters
- HQ city
- Santa Ana
- HQ country
- United States
- HQ region
- North America
Offices1 record
Markets served
NKGen Biotech business model
Business model- GTM type
- B2B
- Offering type
- Hardware or Manufacturing
- Cost components
- Technology or R&D
Revenue model
- 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
NKGen Biotech product offering
Product offeringCore 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
Companies that use NKGen Biotech
Customer profileSegments2 records
Ideal customer profiles3 records
NKGen Biotech technology and API
TechnologyTechnology focussed Yes
API detail
- Has API
- No
- API docs
- API detail
Core technology
AI maturity
App detail
Feature4 records
NKGen Biotech partnerships and signals
Strategic signalPartnerships
Six partnerships are on record, tiered core and minor.
- HekaBiocoreStrategic 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 FoundationminorCollaboration 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.
- AffimedminorClinical 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, GermanyminorClinical 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.
- PfizerminorClinical trial collaboration and supply agreement alongside Merck KGaA for SNK01 combination therapy development.
- NKGen Biotech Korea Co., Ltd.coreMajority-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
NKGen Biotech competitors and assessment
Company assessmentDirect 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
NKGen Biotech social profiles
Digital presenceNKGen Biotech financial estimates
Financial estimateRevenue estimate
Valuation estimate
NKGen Biotech leadership team
Management profileNumber of profiles
Profiles3 records
NKGen Biotech subsidiaries and ownership
Company hierarchySubsidiaries2 records
NKGen Biotech funding detail
Funding detailFunding overview
Funding rounds4 records
Investors2 records
Funding detail is available on the Subscription and Enterprise plan.Contact sales →
NKGen Biotech M&A and investment
M&A and investmentM&A1 record
Investments
M&A and investment is available on the Subscription and Enterprise plan.Contact sales →
Frequently asked questions about NKGen Biotech
What does NKGen Biotech do?
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.
Is NKGen Biotech a public or private company?
NKGen Biotech is a public company. It is classified as public.
When was NKGen Biotech founded?
NKGen Biotech was founded in 2015. It employs 51 to 100 people.
Where is NKGen Biotech based?
NKGen Biotech is headquartered in Santa Ana, United States, in the North America region.
How does NKGen Biotech make money?
One revenue line is on record: biopharmaceutical Development.
Who are NKGen Biotech's main competitors?
Direct peers on record are Nkarta, Inc., Fate Therapeutics, ImmunityBio and Cytovia Therapeutics. Emerging players are Shoreline Biosciences, Century Therapeutics and Caribou Biosciences. Broad incumbents are Iovance Biotherapeutics, Adaptimmune Therapeutics and Cellectis.
Does NKGen Biotech have an API?
No public API is recorded for NKGen Biotech.
What industry is NKGen Biotech in?
NKGen Biotech's product category is Cell Therapy Biopharmaceuticals. Its primary akta.pro industry code is HLAAABAD, NK Cell Therapies, with a secondary code of HLAAABAA, Cell Therapy Developers (Autologous). Its NAICS code is 541714 and its SIC code is 2836.