What Orca Bio does

Orca Bio is a late-stage clinical biotechnology company developing high-precision allogeneic T-cell immunotherapies for the treatment of hematologic malignancies, including acute myeloid leukemia (AML), acute lymphoblastic leukemia (ALL), myelodysplastic syndromes (MDS), and mixed-phenotype acute leukemia (MPAL), with ongoing exploration of autoimmune indications. The company's lead product, Orca-T, is a donor-derived cell therapy composed of precisely defined ratios of regulatory T-cells, hematopoietic stem cells, and conventional T-cells, manufactured through a proprietary single-cell precision platform that selects cell populations at single-cell resolution. The therapy is designed to balance immune reconstitution — reducing graft-versus-host disease (GvHD) while preserving the graft-versus-leukemia effect — and Phase 3 Precision-T data demonstrated statistically and clinically meaningful superiority over standard-of-care allogeneic transplant (78% one-year chronic GvHD-free survival vs. 38%; 94% overall survival vs. 83%; 3.4% non-relapse mortality vs. 13.2%).

Orca-T is currently under FDA Priority Review with a Biologics License Application (BLA) accepted in October 2025 and a PDUFA target action date of July 6, 2026. Manufacturing is centralized at a 100,000+ square-foot GMP facility in Sacramento, California, with a second East Coast GMP site in Princeton, New Jersey announced in June 2026, supported by a $100 million debt facility from Silicon Valley Bank. The platform has demonstrated a 100% on-time delivery rate within 70 hours across the Phase 3 program, an operational reliability benchmark that is material in the cell-therapy category.

The business model is currently pre-revenue and clinical-stage. Once approved, Orca Bio will generate revenue through one-time sales of allogeneic cell therapy products to hospital-based transplant centers, with cell therapies in this category historically priced in the high six figures per treatment. The company is actively building commercial infrastructure — appointing a Chief Commercial Officer (Mike Hirschmann, ex-Legend Biotech), a Chief Medical Officer, and a Chief Development Officer, and tripling the Sacramento workforce — and has retained BGR Government Affairs for policy and reimbursement advocacy ahead of launch. Cumulative equity raised exceeds $300 million, including a $192 million Series D in 2020 and a $250 million aggregate Series E/F round in late 2025/early 2026.

Name

Orca Bio

Legal name

Orca Biosystems Inc.

Website

https://orcabio.com

Company type

Private

Founded year

2016

Operating status

Operating

Headcount range

251–500 employees

Short description

Orca Bio is a late-stage clinical biotechnology company developing high-precision allogeneic T-cell immunotherapies for hematologic malignancies. Its lead product Orca-T, under FDA Priority Review with a July 2026 PDUFA date, uses single-cell precision to engineer defined cell compositions that reduce graft-versus-host disease.

Ownership category

akta.pro rank

Product category

Cell Therapy / Biologics

NAICS

Biological Product (except Diagnostic) Manufacturing (325414)

SIC

Biological Products, (No Disgnostic Substances) (2836)

akta.pro primary industry

Cell Therapy Developers (Allogeneic/Off-the-shelf) (HLAAABAB)

akta.pro secondary industries

CAR-T & TCR-T Therapies (HLAAABAC), Oncology & Hematology Pharmaceuticals (HLAIAAAC)

Keywords

• Allogeneic cell therapy
• T-cell immunotherapy
• Cell therapy manufacturing
• Biologics pipeline development
• Precision cell therapy

Headquarters

HQ city

Menlo Park

HQ country

United States

HQ region

North America

Offices3 records

Markets served

GTM type

B2B

Offering type

Hardware or Manufacturing

Cost components

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

Revenue model

1. Cell Therapy Product Sales: Once approved, Orca Bio will generate revenue through sale of its allogeneic T-cell immunotherapy products (Orca-T, Orca-Q) to transplant centers and hospitals treating patients with hematologic malignancies. The company is building commercial infrastructure including manufacturing capacity, distribution, and sales organization to support product commercialization.

Go-to-market motion1 record

Distribution channels1 record

Marketing channels5 records

Core offering

Orca Bio develops high-precision allogeneic T-cell immunotherapies for the treatment of hematologic malignancies (AML, ALL, MDS, MPAL) and autoimmune diseases. Its products are manufactured using a proprietary single-cell precision platform that creates defined compositions of regulatory T-cells, hematopoietic stem cells, and conventional T-cells. The lead candidate Orca-T is under FDA Priority Review with a PDUFA date of July 6, 2026.

Product overview

Orca Bio is a late-stage biotechnology company developing a portfolio of high-precision allogeneic T-cell immunotherapies for the treatment of blood cancers and autoimmune diseases. The company's product portfolio consists of three main investigational therapies: Orca-T (lead product candidate for AML, ALL, MDS, MPAL with FDA BLA under Priority Review), Orca-Q (second-generation therapy designed for broader donor compatibility including haploidentical donors), and OrCAR-T (combination of Orca-T with allogeneic CAR-T cells). All products are manufactured using the company's proprietary single-cell precision platform that enables precise compositions of regulatory T-cells, hematopoietic stem cells, and conventional T-cells to achieve balanced immune reconstitution while minimizing graft-versus-host disease.

Differentiator

Problem solved

Functional benefit

Brands

• Orca-T: Lead investigational allogeneic T-cell immunotherapy for treatment of hematologic malignancies including AML, ALL, and MDS.
• Orca-Q
• OrCAR-T (Orca-T/CAR-T Combination)

Products and services

• Orca-T Orca-T is Orca Bio's lead investigational allogeneic T-cell immunotherapy for the treatment of hematologic malignancies including acute myeloid leukemia (AML), acute lymphoblastic leukemia (ALL), myelodysplastic syndrome (MDS), and mixed-phenotype acute leukemia (MPAL). It is a precisely defined composition of regulatory T-cells, hematopoietic stem cells, and conventional T-cells derived from matched donor blood, designed to reduce graft-versus-host disease while preserving graft-versus-leukemia effect.
• Orca-Q Orca-Q is Orca Bio's second-generation investigational allogeneic T-cell immunotherapy being evaluated in multiple hematologic malignancies, including in patients with haploidentical and mismatched donors. It is a proprietary composition of stem cells combined with specific T-cell subsets derived from healthy donors, designed for broader donor compatibility than Orca-T.
• OrCAR-T (Orca-T/CAR-T Combination)

Quantifiable outcome

• Survival free from moderate-to-severe chronic GvHD at one year: 78% with Orca-T vs 38% with conventional transplant (HR 0.26, p<0.00001)
• +4 more outcomes

Named customers1 record

Segments2 records

Ideal customer profiles2 records

Technology focussed Yes

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

Feature3 records

Partnerships

One partnership is on record.

• BGR Government AffairsminorOthersOrca Bio registered as a new client with BGR Government Affairs in June 2026, engaging a three-person lobbying team (Remy Brim, John Stone, Brent Del Monte) for federal lobbying activity focused on medical research and clinical laboratory sectors.

Scale indicators5 records

Recent moves9 records

Expansion highlights7 records

Direct peers

• Adaptimmune Therapeutics: Develops engineered T-cell therapies (SPEAR T-cells) for hematologic and solid tumors. Comparable as a late-stage cell therapy company targeting blood cancers.
• Allogene Therapeutics: Clinical-stage developer of allogeneic CAR-T cell therapies for hematologic malignancies. Closest direct peer to Orca Bio as another allogeneic cell therapy company targeting blood cancers.
• Atara Biotherapeutics: Develops allogeneic T-cell and CAR-T immunotherapies for hematologic malignancies and solid tumors. Comparable as a fellow allogeneic T-cell therapy platform addressing transplant and oncology indications.
• Fate Therapeutics: iPSC-derived NK and T-cell therapy developer for cancer and autoimmune disease. Comparable as an off-the-shelf cell therapy company targeting hematologic malignancies with an iPSC-based platform.
• Precision BioSciences: Developer of allogeneic CAR-T cell therapies using ARCUS gene editing for hematologic malignancies. Comparable as a fellow allogeneic cell therapy company in hematology.
• Cellectis: Clinical-stage gene-edited allogeneic CAR-T developer (TALEN-based). Comparable as an allogeneic T-cell therapy company with a focus on hematologic malignancies.
• Legend Biotech: Commercial-stage developer of Carvykti, an autologous BCMA CAR-T for multiple myeloma. Comparable as a CAR-T competitor in hematologic malignancies and source of Orca Bio's former CCO.

Emerging players

• Caribou Biosciences: Developer of allogeneic CAR-T cell therapies using CRISPR gene editing for hematologic malignancies. Comparable as an emerging allogeneic cell therapy peer.
• CRISPR Therapeutics: Commercial-stage gene-editing company with Casgevy (exagamglogene autotemcel) approved for sickle cell disease and beta-thalassemia. Comparable in adjacent gene-edited cell therapy category with overlapping platform technologies.

Broad incumbents

• Gilead (Kite Pharma): Owns Yescarta and Tecartus, leading autologous CD19 CAR-T franchises in lymphoma and ALL. Broad incumbent competing head-to-head with Orca-T in overlapping hematologic malignancy indications.

Market position

Strengths1 record

Weaknesses5 records

Competitive moat5 records

Key risks6 records

Key highlights6 records

Customer concentration

• Xx.com/orcabio
• LinkedInlinkedin.com/company/orcabio
• Facebookfacebook.com/orcabiosystems

Compliance4 records

Revenue estimate

Valuation estimate

Number of profiles

Profiles10 records

Funding overview

Funding rounds6 records

Investors12 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 Orca Bio