What Sonoma Biotherapeutics does

Sonoma Biotherapeutics is a clinical-stage biotechnology company founded in 2019 and headquartered in South San Francisco (with a Seattle R&D center opened in March 2024) that develops engineered regulatory T cell (Treg) therapies for autoimmune and inflammatory diseases. Its core programs include SBT-77-7101, an autologous CAR-Treg cell therapy targeting citrullinated proteins (Cit-P) currently in Phase 1 for refractory rheumatoid arthritis (REGULATE-RA) and hidradenitis suppurativa (Regulate-HS), and SBT-11-5301, a Teff-modulating biologic that has completed a Phase 1 healthy volunteer study. The company also operates a 50/50 strategic collaboration with Regeneron covering Treg programs for inflammatory bowel disease, celiac disease, and other autoimmune indications, with Regeneron holding an option for global late-stage development and commercialization of partnered assets.

The company's underlying technology platform is built on Nobel Prize-winning research by co-founders including Fred Ramsdell (2025 Nobel Prize in Physiology or Medicine) and Alexander Rudensky (co-discoverer of FOXP3), and combines proprietary CAR-Treg construct design, chimeric cytokine receptors for IL-2 signaling in low-cytokine environments, a full autologous manufacturing process (leukapheresis, isolation, transduction, expansion, cryopreservation, QC, infusion), and transcriptional fingerprinting for product release. Lead assets are designed as one-time therapies that do not require lymphodepletion or chronic administration, differentiating them from conventional CAR-T approaches.

Sonoma is pre-revenue and currently monetizes only through collaboration milestones, having received $75 million upfront (including $30 million equity) from Regeneron in March 2023 and a $45 million milestone payment from Regeneron in September 2024. The go-to-market model upon approval would be traditional pharmaceutical commercialization via hospital/specialty channels, with Regeneron retaining commercialization rights for partnered programs. To date the company has raised approximately $340 million from a syndicate including Ally Bridge Group (Series B lead), Arch Venture Partners, GV, Casdin Capital, Fidelity, Frazier Healthcare Partners, and others, and is led by President and CEO Stephen Dilly (appointed November 2025) with founder Jeff Bluestone serving as advisor and board member.

Name

Sonoma Biotherapeutics

Legal name

Sonoma Biotherapeutics, Inc.

Website

https://sonomabio.com

Company type

Private

Founded year

2019

Operating status

Operating

Headcount range

101–250 employees

Short description

Sonoma Biotherapeutics is a clinical-stage biotech developing engineered regulatory T cell (Treg) therapies, including CAR-Treg SBT-77-7101 for rheumatoid arthritis and hidradenitis suppurativa, and partnered Treg programs with Regeneron for IBD and celiac disease.

Ownership category

akta.pro rank

Product category

Engineered Cell Therapy (Treg-based therapeutics)

NAICS

Biological Product (except Diagnostic) Manufacturing (325414)

SIC

Biological Products, (No Disgnostic Substances) (2836)

akta.pro primary industry

CAR-T & TCR-T Therapies (HLAAABAC)

akta.pro secondary industries

Cell Therapy Developers (Autologous) (HLAAABAA), Rare Immunology, Autoimmune & Autoinflammatory Therapies (HLAIAIAE)

Keywords

• Engineered Treg therapies
• CAR-Treg cell therapy
• Autoimmune disease therapeutics
• Regulatory T cell platform
• Inflammatory disease biologics

Headquarters

HQ city

South San Francisco

HQ country

United States

HQ region

North America

Offices2 records

Markets served

GTM type

B2B

Offering type

Hardware or Manufacturing

Cost components

Technology or R&D, Personnel, Operations, Marketing or Sales, Infrastructure

Revenue model

1. Pharmaceutical/ Biopharmaceutical Product Sales: Pre-revenue clinical stage company developing engineered Treg cell therapies. Future revenue expected from sales of approved cell therapy products following regulatory approval.

Go-to-market motion2 records

Distribution channels2 records

Marketing channels6 records

Core offering

Sonoma Biotherapeutics is a clinical-stage biotechnology company developing engineered regulatory T cell (Treg) therapies for autoimmune and inflammatory diseases. Its wholly-owned lead program SBT-77-7101 is an autologous CAR-Treg cell therapy targeting citrullinated proteins for rheumatoid arthritis and hidradenitis suppurativa, and SBT-11-5301 is a Teff-modulating biologic. A second portfolio of Treg programs in inflammatory bowel disease and celiac disease is co-developed with Regeneron.

Product overview

Sonoma Biotherapeutics is a clinical-stage biotechnology company developing engineered regulatory T cell (Treg) therapies for autoimmune and inflammatory diseases. The company operates with a platform-plus-products model, with its core proprietary programs including SBT-77-7101 (a CAR-Treg targeting citrullinated proteins for rheumatoid arthritis and hidradenitis suppurativa) and SBT-11-5301 (a Teff-modulating biologic). The company also advances partnered programs with Regeneron targeting inflammatory bowel diseases including celiac disease, ulcerative colitis, and Crohn's disease. The technology platform is built on Nobel-winning research in Treg biology by company founders.

Differentiator

Problem solved

Functional benefit

Products and services

• SBT-77-7101 An autologous engineered CAR-Treg cell therapy that targets citrullinated proteins (Cit-P). It is being developed for moderate-to-severe rheumatoid arthritis and hidradenitis suppurativa and is designed to restore immune balance without target cell destruction, and without requiring lymphodepletion conditioning or chronic administration. Interim Phase 1 data in refractory RA showed favorable safety (no dose-limiting toxicities, no cytokine release syndrome, no ICANS), 67% of participants achieving ≥50% reduction in swollen and tender joint counts by Week 4, and 83% showing reductions in DAS28-CRP and CDAI disease activity scores.
• SBT-11-5301 An effector T cell (Teff)-modulating biologic designed to selectively eliminate highly activated effector T cells that drive autoimmune and inflammatory disease. It completed a Phase 1 healthy volunteer study and is intended for use in combination with Sonoma's Treg cell therapy programs.
• Regeneron-Partnered Treg Cell Therapy Programs Engineered regulatory T cell-based therapeutics developed in partnership with Regeneron Pharmaceuticals for inflammatory bowel diseases (ulcerative colitis and Crohn's disease) and celiac disease, using Regeneron's VelociSuite antibody and TCR discovery technologies combined with Sonoma's Treg cell platform. The programs are 50/50 partnered with Regeneron, which holds an option for global late-stage development and commercialization.

Quantifiable outcome

• 67% of participants (4/6) experienced ≥50% reduction in swollen and tender joint counts from baseline by Week 4
• +3 more outcomes

Named customers2 records

Segments3 records

Ideal customer profiles2 records

Technology focussed Yes

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

Feature5 records

Partnerships

Two partnerships are on record, tiered supporting and core.

• ScaleReady (Bio-Techne/Wilson Wolf Manufacturing)supportingTechnology or Integration · 3 November 2025Sonoma received $300,000 G-Rex Grant to facilitate transition to G-Rex manufacturing platform technology and explore process optimization and innovation strategies for gene-modified Treg cell therapy manufacturing.
• Regeneron PharmaceuticalscoreStrategic or Co-development Partner · 28 March 2023Collaboration to discover, develop, and commercialize regulatory T cell therapies for autoimmune diseases. Sonoma received $75 million upfront including $30 million equity investment, with potential milestone payments. Regeneron contributes VelociSuite technologies for antibody and TCR discovery. Regeneron has option for global late-stage development and commercialization.

Scale indicators6 records

Recent moves7 records

Expansion highlights6 records

Direct peers

• Kyverna Therapeutics: Closest direct competitor to Sonoma, also developing CAR-Treg cell therapies for autoimmune diseases including lupus nephritis and other B-cell-driven conditions. Both companies pioneered the autologous CAR-Treg approach and target overlapping autoimmune indications.
• Quell Therapeutics: UK-based Treg cell therapy company focused on autoimmune and inflammatory diseases, including liver transplant tolerance and inflammatory bowel disease. Uses engineered Treg approaches similar to Sonoma's CAR-Treg platform.
• Sangamo Therapeutics: Clinical-stage cell and gene therapy company with programs in autoimmune diseases using engineered Treg approaches. Shares Sonoma's modality of engineered cell therapy for immune system rebalancing in autoimmune indications.
• Fate Therapeutics: Develops iPSC-derived cell therapies including off-the-shelf NK and T-cell candidates for cancer and autoimmune diseases. Comparable as a cell therapy platform pursuing engineered immune cell approaches.
• Caribou Biosciences: Clinical-stage cell therapy company developing allogeneic CAR-T cell therapies for oncology and autoimmune diseases. Comparable cell therapy modality and target indication overlap.
• Allogene Therapeutics: Pioneer in allogeneic CAR-T cell therapies with a manufacturing platform for off-the-shelf engineered T cells. Comparable engineered cell therapy platform and clinical-stage biotech profile.

Emerging players

• Editas Medicine: Clinical-stage gene editing company developing CRISPR-based therapies, with overlap in autoimmune/inflammatory disease programs. Both target immune system modulation through advanced cell engineering technologies.
• CRISPR Therapeutics: Leading gene editing company with Casgevy approved for sickle cell disease and ongoing autoimmune programs. Comparable advanced therapy modality and clinical-stage biotech profile.
• Cellectis: Clinical-stage cell therapy company developing allogeneic CAR-T cells using gene editing platforms. Comparable cell therapy engineering expertise and target indication overlap in autoimmune and oncology.

Broad incumbents

• Vertex Pharmaceuticals: Major biotech pursuing cell therapy approaches (including acquisition of ViaCyte for type 1 diabetes) and established autoimmune/inflammation programs. Comparable commercial ambition and cell therapy pipeline development.

Market position

Strengths5 records

Weaknesses5 records

Competitive moat4 records

Key risks7 records

Key highlights7 records

Customer concentration

• Xx.com/sonomabio
• LinkedInlinkedin.com/company/sonoma-biotherapeutics

Revenue estimate

Valuation estimate

Number of profiles

Profiles16 records

Funding overview

Funding rounds5 records

Investors25 records

Funding detail is available on the Subscription and Enterprise plan.Contact sales →

M&A

Investments

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

Frequently asked questions about Sonoma Biotherapeutics