EGenesis

What EGenesis does

eGenesis is a clinical-stage biotechnology company developing human-compatible, genetically engineered porcine organs to address the global shortage of transplantable human organs. Founded in 2014 and headquartered in Cambridge, Massachusetts, the company's core technology is its proprietary EGEN™ Genome Engineering and Production Platform, which applies CRISPR/Cas9-based multiplex gene editing to produce Yucatan miniature pig donors carrying three classes of simultaneous edits: endogenous retroviral inactivation (PERV), triple glycan antigen knockout (GGTA1, CMAH, β4GalNT2) to prevent hyperacute rejection, and insertion of seven human transgenes modulating immune, inflammatory, coagulation, and complement pathways. The platform — incorporating somatic cell nuclear transfer cloning, high-biosecurity donor production, and routine release testing — yields the company's branded HuCo™ product family, which includes the kidney program EGEN-2784 (FDA IND-cleared September 2025 for a Phase 1/2/3 trial in end-stage kidney disease), the liver program EGEN-5784 (FDA IND-cleared April 2025 in combination with the OrganOx ELC system for acute-on-chronic liver failure), and the preclinical heart program EGEN-4467. The company also pursues islet cell xenotransplantation research collaborations with University of Miami and Duke University.

eGenesis is pre-revenue and is funded primarily by venture capital, with cumulative financing of approximately $456 million across Series B ($100M, 2019), Series C ($125M, 2021), and Series D ($191M, 2024, led by Lux Capital with participation from ARCH, Khosla, Farallon, Alta, Fresenius Medical Care Ventures, Leaps by Bayer, DaVita, Eisai Innovation, NATCO, and Parkwood). The company employs 101–250 staff and has begun laying commercialization foundations via a newly appointed CFO (Glenn Vraniak, June 2026) and Chief Commercial Officer (Jennifer Bergheiser). Current distribution is limited to clinical trial sites anchored by Massachusetts General Hospital, where the world's first three successful living-patient transplants of EGEN-2784 have been performed under FDA Expanded Access authorization (Rick Slayman in March 2024, Tim Andrews in January 2025, Bill Stewart in June 2025). Strategic alliances with OrganOx (exclusive liver co-development), PorMedTec (Japan donor production), Eledon Pharmaceuticals (tegoprubart immunosuppression regimen), and Karius (mcfDNA infectious disease diagnostics) create an integrated xenotransplantation ecosystem.

The business model targets a multi-billion-dollar addressable market across three therapeutic segments: kidney (more than 800,000 U.S. ESKD patients with only ~27,000 transplants performed in 2025), liver (~35,000 U.S. ACLF hospitalizations annually, plus a >300,000 acute liver failure expansion opportunity), and heart (over 6 million U.S. adults with heart failure). Pricing has not been publicly disclosed and will be shaped by the future xenotransplantation reimbursement landscape; ultimate end-users are patients rather than a small number of buyers. Pricing model is expected to follow a quote-based, procedure-attached structure similar to other transplant biologics once commercial launch occurs.

Name

EGenesis

Legal name

eGenesis, Inc.

Website

https://egenesisbio.com

Company type

Private

Founded year

2015

Operating status

Operating

Headcount range

101–250 employees

Short description

eGenesis is a clinical-stage biotechnology company developing human-compatible, genetically engineered porcine organs via its proprietary EGEN™ CRISPR-based multiplex genome engineering platform to address the global transplant organ shortage, with lead kidney (EGEN-2784) and liver (EGEN-5784) candidates in FDA-cleared clinical trials.

Ownership category

akta.pro rank

Product category

Xenotransplantation Therapeutics

NAICS

Biological Product (except Diagnostic) Manufacturing (325414)

SIC

Biological Products, (No Disgnostic Substances) (2836)

akta.pro primary industry

Recombinant Protein Therapeutics (enzymes, hormones, growth factors) (HLAAAAAB)

akta.pro secondary industries

Protein Engineering & Directed Evolution Platforms (enzyme/therapeutic protein optimization) (HLAAAIAC), In Vitro Model Systems & Organoid Platforms (iPSC/organoids, microphysiological systems) (HLAAAIAJ), Synthetic Biology & Genetic Circuit Design Platforms (pathway engineering, chassis development) (HLAAAIAD), Organoids & Organ-on-Chip (regenerative models) (HLAAAGAD)

Keywords

• Xenotransplantation technology
• Genome engineering platform
• Gene-edited organs
• Porcine organ transplant
• Clinical-stage biotechnology

Headquarters

HQ city

Cambridge

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, Personnel, Operations, Infrastructure, Marketing or Sales, Supply Chain

Revenue model

1. Pre-revenue clinical-stage development: eGenesis is a clinical-stage biotechnology company that has not yet generated commercial product revenue. The company is currently funded primarily by venture capital (Series B $100M, Series C $125M, Series D $191M) and is advancing lead product candidate EGEN-2784 through a Phase 1/2/3 clinical trial under FDA IND clearance (cleared September 2025). Future revenue is expected to come from commercialization of human-compatible engineered organs (kidney lead, liver and heart in pipeline) once regulatory approval is secured. The company has hired a Chief Commercial Officer (June 2026) to begin laying commercialization foundation.

Pricing tiers

Go-to-market motion3 records

Distribution channels3 records

Marketing channels7 records

Core offering

eGenesis develops genetically engineered, human-compatible organs (kidney, liver, heart) derived from pigs using its proprietary EGEN multiplex CRISPR/Cas9 genome engineering platform. The platform applies three classes of edits — endogenous retroviral inactivation, triple glycan antigen knockout, and insertion of seven human transgenes — to porcine cells that are then cloned to produce donor animals raised in high-biosecurity facilities for transplantation into patients with organ failure.

Product overview

eGenesis offers a single unified product offering organized around its proprietary EGEN™ Genome Engineering and Production Platform — a multiplex CRISPR/Cas9-based platform that applies three classes of genetic edits (retroviral inactivation, triple glycan-antigen knockout, and seven human transgene insertions) to porcine cells, which are then cloned into donor animals raised in high-biosecurity facilities. Built on this core platform, the company's named product candidates include EGEN-2784 (lead genetically engineered porcine kidney, FDA IND-cleared Sept 2025), EGEN-5784 ELC (genetically engineered porcine liver used with the OrganOx ELC system, FDA IND-cleared April 2025), and EGEN-4467 (preclinical heart program). All are marketed under the HuCo™ human-compatible organs designation.

Differentiator

Problem solved

Functional benefit

Products and services

• EGEN-2784 (genetically engineered porcine kidney) Lead product candidate: a genetically engineered porcine-derived kidney carrying three classes of edits (knockout of three glycan antigens, insertion of seven human transgenes regulating immune/inflammation/coagulation/complement pathways, and inactivation of porcine endogenous retroviruses). FDA IND-cleared in September 2025 for a Phase 1/2/3 trial in ESKD patients age 50+ who are dialysis-dependent and on the kidney waitlist, with primary endpoint at 24 weeks post-transplant. Designed for transplantation into patients with end-stage kidney disease.
• EGEN-5784 ELC (genetically engineered porcine liver with OrganOx ELC system) Human-compatible, genetically engineered porcine liver used in combination with the OrganOx extracorporeal liver cross-circulation (ELC) system for extracorporeal perfusion support of patients with acute-on-chronic liver failure (ACLF) suffering from decompensated liver function in the ICU setting. Co-developed with OrganOx under an exclusive clinical co-development agreement signed November 2024.
• EGEN-4467 (heart program) Genetically engineered porcine heart in preclinical development as part of eGenesis' heart failure program, planned for future expanded access cardiac xenotransplantation in patients with end-stage heart failure.

Quantifiable outcome

• 271 days dialysis-independent survival with EGEN-2784 (world record, Tim Andrews)
• +4 more outcomes

Named customers4 records

Segments5 records

Ideal customer profiles3 records

Technology focussed Yes

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

Integration5 records

Feature6 records

Partnerships

13 partnerships are on record, tiered flagship, minor and core.

• OrganOxflagshipStrategic or Co-development Partner · 12 November 2024Exclusive clinical co-development agreement signed November 12, 2024 to combine OrganOx's normothermic machine perfusion (metra® NMP) technology and extracorporeal liver cross-circulation (ELC) system with eGenesis' EGEN-5784 genetically engineered porcine liver. Together targeting ~35,000 U.S. patients hospitalized annually for acute or acute-on-chronic liver failure, with potential expansion to >300,000 additional acute liver failure patients. PERFUSE-2 study has completed four decedent perfusions to date. Joint IND cleared by FDA April 2025.
• Apellis PharmaceuticalsminorStrategic or Co-development Partner · 4 September 2024Critical industry partner cited alongside Eledon and Karius in supporting the MGH kidney transplant program; role in immunosuppression/complications management.
• PorMedTeccoreStrategic or Co-development Partner · 13 February 2024Co-development collaboration announced February 13, 2024 to produce genetically engineered porcine donors in Japan using eGenesis' genetically engineered cells and PorMedTec's somatic cell nuclear transfer (cloning) process. Initial focus on kidney transplant to address Japan's severe organ shortage (only 3% of waitlist candidates receive a transplant, 15-year median wait time). Cells provided by eGenesis carry the same three classes of edits as EGEN-2784.
• University of Pennsylvania Transplant InstitutecoreStrategic or Co-development Partner · 19 January 2024Collaborator on the PERFUSE-2 study (2024) evaluating extracorporeal perfusion of brain-dead research donors with eGenesis' genetically engineered porcine liver (EGEN-5784) connected to OrganOx ELC system. Abraham Shaked, M.D., Ph.D. of Penn is a key investigator.
• Gift of Life Donor ProgramminorOthers · 19 January 2024Organ procurement organization collaborating on PERFUSE-2 study for the first successful extracorporeal perfusion using EGEN-5784. Richard D. Hasz, Jr., MFS, CPTC, President and CEO, is the named spokesperson.
• KariuscoreTechnology or Integration · 11 April 2023Partnership announced April 11, 2023 to develop infectious disease diagnostics for xenotransplantation. Karius leverages its liquid biopsy platform (microbial cell-free DNA detection) to power surveillance and diagnosis of potential infection in both porcine organ donors and recipients pre- and post-transplant. Joint work scheduled for completion by early 2024. Karius' technology was used to detect porcine cytomegalovirus in the first 2022 xenotransplant patient.
• Eledon PharmaceuticalscoreStrategic or Co-development Partner · 9 January 2023Collaboration for use of tegoprubart (Eledon's investigational anti-CD40L monoclonal antibody) in preclinical xenotransplantation studies, extended into clinical use. Tegoprubart has been part of immunosuppression regimen for all eGenesis kidney transplants to date (Slayman, Andrews, Stewart). Eledon supporting global xenotransplant collaborations with both United Therapeutics and eGenesis. Phase 3 registrational study for kidney allotransplantation planned by end of 2026.
• University of MiamiminorStrategic or Co-development Partner · 9 March 2022Research collaboration announced March 9, 2022 to evaluate human-compatible islet cells in diabetes model — supports eGenesis' broader islet cell transplant program.
• Leading Academic Medical CenterminorStrategic or Co-development Partner · 1 April 2021Expanded research collaboration with a leading academic medical center announced April 1, 2021 (building on November 2020 announcement).
• Duke UniversityminorStrategic or Co-development Partner · 9 November 2020Collaboration announced November 9, 2020 to develop insulin-producing pancreas cell xenotransplants.
• Leading Academic Medical Center (unnamed — context: MGH expansion)coreStrategic or Co-development Partner · 5 November 2020Research collaboration announced November 5, 2020 with a leading academic medical center (linked to later MGH expansion) to evaluate human-compatible organs and cells.
• Massachusetts General Hospital (Mass General Brigham)flagshipImplementation/ SI/ Consulting Partner · 2 June 2020Founding clinical research collaboration partner since 2020. MGH surgical teams led by Dr. Tatsuo Kawai, Dr. Nahel Elias, and Dr. Leonardo Riella performed the world's first successful genetically engineered porcine kidney transplant into a living patient (March 2024), plus subsequent transplants to Tim Andrews (Jan 2025) and Bill Stewart (June 2025). Site of multi-patient FDA-authorized Expanded Access study and Phase 1/2/3 EGEN-2784 clinical trial. Eledon, Apellis, and Karius cited as additional critical industry partners on the program.
• Qihan BiotechcoreStrategic or Co-development Partner · 1 August 2018Global collaboration announced August 1, 2018 to address global shortage of organs with xenotransplantation — partnership for production of genetically engineered porcine donors in China.

Scale indicators13 records

Recent moves6 records

Expansion highlights6 records

Direct peers

• United Therapeutics Corporation: United Therapeutics is the most direct competitor in xenotransplantation via its Revivicor subsidiary, pursuing gene-edited porcine organs for kidney and other indications. Both companies are developing human-compatible organs using CRISPR-based gene editing of pigs and competing for first FDA approval in the field.
• Revivicor: Revivicor (a wholly-owned United Therapeutics subsidiary) develops gene-edited pigs for xenotransplantation and regenerative medicine, and is the closest technical peer to eGenesis's EGEN™ platform. Both companies engineer porcine donors with multiple genetic modifications to address immune rejection and viral risk.

Emerging players

• Makana Therapeutics: Makana Therapeutics is an early-stage xenotransplantation company developing gene-edited pig organs for human transplant. It overlaps with eGenesis in target indication (kidney) and approach (multi-edit porcine donors) but is at earlier stage and smaller scale.
• Beam Therapeutics: Beam Therapeutics is a clinical-stage precision genetic medicine company using base editing, a next-generation CRISPR-adjacent modality. It is comparable as a gene-editing platform peer focused on single-nucleotide corrections rather than the large multiplex edits eGenesis performs in pigs.

Regional players

• Qihan Biotech: Qihan Biotech is eGenesis's own China-focused gene-editing collaboration partner (since 2018), developing xenotransplantation and human organoid technologies in Asia. Qihan operates in the same gene-edited pig donor space but primarily serves China rather than directly competing in U.S. and EU clinical markets.

Broad incumbents

• CRISPR Therapeutics: CRISPR Therapeutics is a clinical-stage gene editing company developing CRISPR/Cas9-based therapies, with a much broader therapeutic pipeline (sickle cell, beta-thalassemia, oncology, regenerative medicine). Comparable as a CRISPR platform peer, but focused on ex vivo cell therapies rather than solid-organ xenotransplantation.
• Editas Medicine: Editas Medicine is a clinical-stage gene editing company using CRISPR/Cas9 and CRISPR/Cas12a for in vivo and ex vivo therapies. It shares eGenesis's CRISPR platform foundations but targets a different therapeutic scope (ocular, oncology, hemoglobinopathies), making it a broader-incumbent gene editing peer rather than a direct xenotransplantation competitor.
• Intellia Therapeutics: Intellia Therapeutics is a clinical-stage gene editing company developing in vivo CRISPR/Cas9 therapies for genetic diseases, with a pipeline spanning transthyretin amyloidosis, hereditary angioedema, and hemophilia. Comparable as a platform-level CRISPR peer, though Intellia focuses on single-gene in vivo editing rather than multiplex organ engineering.
• Vertex Pharmaceuticals: Vertex Pharmaceuticals has expanded into regenerative medicine, including its VX-880 islet cell therapy for type 1 diabetes and a CRISPR-based ex vivo sickle cell therapy. It is comparable as a large-cap incumbent pursuing cell- and gene-based cures for organ failure conditions, though Vertex does not develop solid-organ xenografts.

Others

• OrganOx: OrganOx is eGenesis's exclusive co-development partner for the EGEN-5784 liver program, providing the metra normothermic machine perfusion and extracorporeal liver cross-circulation (ELC) systems. It is an enabling integration partner rather than a competitor, but operates in adjacent transplant-infrastructure technology.

Market position

Strengths5 records

Weaknesses5 records

Competitive moat6 records

Key risks7 records

Key highlights8 records

Customer concentration

• Xx.com/egenesisbio
• LinkedInlinkedin.com/company/egenesisbio
• Facebookfacebook.com/eGenesisBio

Compliance3 records

Revenue estimate

Valuation estimate

Number of profiles

Profiles7 records

Subsidiaries1 record

Funding overview

Funding rounds6 records

Investors33 records

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

M&A1 record

Investments

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

Frequently asked questions about EGenesis