RegCell
RegCell is a preclinical-stage biotech developing epigenetically reprogrammed regulatory T cell (S/F-Epigen-Treg) therapies to restore antigen-specific immune tolerance in autoimmune disease patients, founded by 2025 Nobel laureate Dr. Shimon Sakaguchi and headquartered in Emeryville, California.
- Company typePrivate
- Founded2016
- HeadquartersEmeryville, United States
- Headcount1–10
- GTM typeB2B
- OfferingHardware or Manufacturing
What RegCell does
RegCell is a preclinical-stage biotechnology company developing regulatory T cell (Treg) therapies for autoimmune diseases and organ transplant rejection. The company was co-founded by Dr. Shimon Sakaguchi, the 2025 Nobel laureate credited with discovering Tregs in 1995, and operates a dual-base footprint with U.S. headquarters in Emeryville, California (established March 2025) and scientific operations in Osaka, Japan, anchored at Osaka University where Sakaguchi is a Distinguished Professor.
The company's core product is its Precision Epigenetic Reprogramming Platform, which converts conventional CD4+ T cells into stable, antigen-specific regulatory T cells (termed S/F-Epigen-Tregs) without requiring genetic modifications or viral DNA reagents. This is achieved by using small molecules to activate Foxp3 and re-establish Treg-specific epigenetic programs, generating cells that suppress only disease-driving immune responses rather than broadly suppressing immunity — the central limitation of current autoimmune therapies. The platform is covered by filed-pending patents on the S/F-Epigen-Treg manufacturing method and was validated in two November 2025 peer-reviewed publications in Science Translational Medicine showing efficacy in IBD, GVHD, and pemphigus vulgaris preclinical models. The lead indication is autoimmune hepatitis, with first-in-human trials targeted for 2025; additional addressable indications span rheumatoid arthritis, Type 1 diabetes, multiple sclerosis, lupus, Crohn's disease, and ulcerative colitis.
RegCell has no commercial revenue and is funded by an oversubscribed $8.5M seed round (co-led by UTEC and FTI in March 2025, with Celadon, Mitsubishi UFJ Capital, OUVC, and Kyoto i-Cap participating) plus up to $37.3M in non-dilutive AMED V-ECO grant funding. It manufactures through a February 2026 CDMO partnership with Kincell Bio and employs 1-10 people. Revenue is intended to be generated through future therapeutic product sales and licensing of Treg cell therapies once clinical-stage assets receive regulatory approval; pricing and go-to-market details are not publicly disclosed at this stage.
RegCell firmographics
Firmographics- Name
- RegCell
- Legal name
- RegCell, Inc.
- Website
- https://regcellbio.com
- Company type
- Private
- Founded year
- 2016
- Operating status
- Operating
- Headcount range
- 1–10 employees
- Short description
- RegCell is a preclinical-stage biotech developing epigenetically reprogrammed regulatory T cell (S/F-Epigen-Treg) therapies to restore antigen-specific immune tolerance in autoimmune disease patients, founded by 2025 Nobel laureate Dr. Shimon Sakaguchi and headquartered in Emeryville, California.
- Ownership category
- akta.pro rank
RegCell industry classification
Industry- Product category
- Cell Therapy / Treg Cell Therapy
- SIC
- Biological Products, (No Disgnostic Substances) (2836)
- akta.pro primary industry
- Cell Therapy Quality, Analytics & Release Testing (potency, sterility, comparability) (HLAAABAK)
Keywords
Where RegCell is headquartered
LocationHeadquarters
- HQ city
- Emeryville
- HQ country
- United States
- HQ region
- North America
Offices2 records
Markets served
RegCell business model
Business model- GTM type
- B2B
- Offering type
- Hardware or Manufacturing
- Cost components
- Personnel, Technology or R&D, Operations, Supply Chain, Marketing or Sales
Revenue model
- Therapeutic Product Sales: RegCell plans to generate revenue through the development and commercialization of Treg cell therapies for autoimmune diseases and transplantation. The company is building toward first-in-human clinical trials targeting autoimmune indications.
Go-to-market motion1 record
Distribution channels1 record
Marketing channels5 records
RegCell product offering
Product offeringCore offering
RegCell is a clinical-stage biotechnology company that develops Treg cell therapies using a proprietary epigenetic reprogramming platform. The platform converts patients' conventional CD4+ T cells into stable, antigen-specific regulatory T cells (S/F-Epigen-Tregs) without genetic modifications, targeting autoimmune diseases with autoimmune hepatitis as the lead clinical indication.
Product overview
RegCell offers a unified therapeutic platform centered on its Precision Epigenetic Reprogramming Platform, which generates S/F-Epigen-Tregs (Stable/Functional Epigenetically Reprogrammed Tregs). This technology converts a patient's own conventional T cells into antigen-specific regulatory T cells without requiring genetic modifications, simplifying manufacturing and enhancing safety. The company's lead Treg Cell Therapy targets autoimmune diseases, with its first clinical indication targeting autoimmune hepatitis. The platform addresses key limitations of current autoimmune treatments by providing disease-specific immune tolerance rather than broad immunosuppression.
Differentiator
Problem solved
Functional benefit
Products and services
- Treg Cell Therapy for Autoimmune Diseases A clinical-stage cell therapy that converts disease-causing T cells into protective regulatory T cells to treat autoimmune diseases by restoring immune tolerance rather than broadly suppressing the immune system. The lead indication is autoimmune hepatitis, with additional target indications including rheumatoid arthritis, Type 1 diabetes, multiple sclerosis, lupus, Crohn's disease, ulcerative colitis, and prevention of organ transplant rejection.
- Precision Epigenetic Reprogramming Platform Proprietary platform that epigenetically reprograms conventional CD4+ T cells into stable, antigen-specific regulatory T cells (S/F-Epigen-Tregs) without requiring genetic modifications or viral DNA reagents. Generates S/F-Epigen-Tregs with strong Foxp3 expression and established Treg-specific epigenetic programs for targeted immunosuppression to treat autoimmune diseases and prevent organ transplant rejection.
Quantifiable outcome
- Stable Foxp3 expression and established Treg-specific epigenetic programs achieved in preclinical models
- +2 more outcomes
Companies that use RegCell
Customer profileSegments1 record
Ideal customer profiles1 record
RegCell technology and API
TechnologyTechnology focussed Yes
API detail
- Has API
- No
- API docs
- API detail
Core technology
AI maturity
App detail
Feature4 records
RegCell partnerships and signals
Strategic signalPartnerships
One partnership is on record.
- Kincell BiocoreKincell Bio, a U.S. cell therapy CDMO, partnered with RegCell to provide CMC development and GMP manufacturing support for RegCell's lead Treg program. The collaboration includes process transfer, scalable manufacturing development, and clinical material supply for IND-enabling activities to advance toward clinical trials.
Scale indicators3 records
Recent moves7 records
Expansion highlights5 records
RegCell competitors and assessment
Company assessmentDirect peers
- Sonoma Biotherapeutics: Clinical-stage Treg cell therapy company developing antigen-specific regulatory T cells for autoimmune and inflammatory diseases. Directly comparable to RegCell on modality (Treg therapy), indication focus (autoimmune), and epigenetic/gene-editing strategies.
- Quell Therapeutics: Cell therapy company developing engineered Treg therapies for autoimmune diseases and transplant rejection, with a lead program in liver transplant tolerance. Direct peer based on Treg modality, antigen-specific tolerance approach, and autoimmune/transplant indication overlap.
- Kyverna Therapeutics: Clinical-stage CAR-Treg company developing cell therapies for autoimmune diseases including lupus and inflammatory bowel disease. Direct peer on cell therapy for autoimmune, though using engineered CAR-Treg rather than epigenetic reprogramming.
- Cabaletta Bio: Clinical-stage cell therapy company developing CAR-Treg (restrained immune cells) therapies for autoimmune diseases. Direct peer based on cell therapy modality, autoimmune focus, and clinical-stage regulatory path.
- TeraImmune: Preclinical/early-clinical Treg cell therapy company developing antigen-specific regulatory T cells for autoimmune and inflammatory diseases. Direct peer on Treg modality and indication overlap, though slightly earlier in clinical translation.
Broad incumbents
- CRISPR Therapeutics: Clinical-stage gene-editing company with broader cell therapy pipeline. Comparable as a larger, better-capitalized incumbent pursuing cell-based treatments where RegCell's epigenetic approach is a differentiated alternative to CRISPR-based strategies.
- Editas Medicine: Clinical-stage gene editing and cell therapy company. Broader incumbent in cell and gene therapy space with significantly more capital and clinical maturity, making it a relevant comparator for modality risk and commercialization pathways.
- Sangamo Therapeutics: Clinical-stage genomic medicine company with cell therapy and in vivo genome editing programs, including autoimmune applications. Broader incumbent providing a benchmark for cell therapy clinical execution and regulatory strategy.
Emerging players
- Century Therapeutics: Clinical-stage company developing iPSC-derived allogeneic cell therapies for autoimmune and oncology indications. Emerging player with overlapping cell therapy modality but distinct manufacturing and allogeneic approach.
- Fate Therapeutics: Clinical-stage iPSC-derived cell therapy company with off-the-shelf NK and T-cell programs. Emerging player with partial overlap on cell therapy modality and cell engineering strategies relevant to RegCell's Treg manufacturing approach.
Market position
Strengths5 records
Weaknesses5 records
Competitive moat3 records
Key highlights7 records
Customer concentration
RegCell social profiles
Digital presenceRegCell financial estimates
Financial estimateRevenue estimate
Valuation estimate
RegCell leadership team
Management profileNumber of profiles
Profiles6 records
RegCell funding detail
Funding detailFunding overview
Funding rounds6 records
Investors21 records
Funding detail is available on the Subscription and Enterprise plan.Contact sales →
RegCell M&A and investment
M&A and investmentM&A
Investments
M&A and investment is available on the Subscription and Enterprise plan.Contact sales →
Frequently asked questions about RegCell
What does RegCell do?
RegCell is a clinical-stage biotechnology company that develops Treg cell therapies using a proprietary epigenetic reprogramming platform. The platform converts patients' conventional CD4+ T cells into stable, antigen-specific regulatory T cells (S/F-Epigen-Tregs) without genetic modifications, targeting autoimmune diseases with autoimmune hepatitis as the lead clinical indication.
Is RegCell a public or private company?
RegCell is a private company. It is classified as venture growth investor backed and is currently operating.
When was RegCell founded?
RegCell was founded in 2016. It employs 1 to 10 people.
Where is RegCell based?
RegCell is headquartered in Emeryville, United States, in the North America region.
How does RegCell make money?
One revenue line is on record: therapeutic Product Sales.
Who are RegCell's main competitors?
Direct peers on record are Sonoma Biotherapeutics, Quell Therapeutics, Kyverna Therapeutics, Cabaletta Bio and TeraImmune. Broad incumbents are CRISPR Therapeutics, Editas Medicine and Sangamo Therapeutics. Emerging players are Century Therapeutics and Fate Therapeutics.
Does RegCell have an API?
No public API is recorded for RegCell.
What industry is RegCell in?
RegCell's product category is Cell Therapy / Treg Cell Therapy. Its primary akta.pro industry code is HLAAABAK, Cell Therapy Quality, Analytics & Release Testing (potency, sterility, comparability). Its SIC code is 2836.