What Precigen does

Precigen is a commercial-stage biopharmaceutical company headquartered in Germantown, Maryland, that develops precision immunotherapies and gene therapies for rare diseases and oncology. Following FDA approval of PAPZIMEOS in August 2025, the company transitioned from clinical-stage to commercial-stage operations. PAPZIMEOS (zopapogene imadenovec-drba) is the first and only FDA-approved therapy for adults with recurrent respiratory papillomatosis (RRP), a rare chronic respiratory disease caused by HPV types 6 or 11 that affects approximately 27,000 adults in the US and over 170,000 worldwide. The pipeline extends the same platforms into oncology: PRGN-2009 for HPV-associated cancers (in combination with pembrolizumab), PRGN-3006 for acute myeloid leukemia and higher-risk myelodysplastic syndromes, PRGN-3005 for ovarian cancer, and PRGN-3007 for hematological and solid tumors.

The pipeline is built on two proprietary technology platforms. AdenoVerse is a library of gorilla adenovectors featuring up to 12 kb payload capacity, low seroprevalence enabling repeat administration, and scalable manufacturing. UltraCAR-T is a non-viral CAR-T platform using the Sleeping Beauty transposon system that enables overnight autologous manufacturing (versus weeks for conventional CAR-T), expresses multiple genes simultaneously (antigen-specific CAR, kill switch, and membrane-bound IL-15), and includes a proprietary kill switch for selective elimination of the cell therapy in vivo. Supporting technologies include UltraVector for computational DNA construction, the licensed Sleeping Beauty system, AttSite recombinases, and the UltraPorator high-throughput semi-closed electroporation system.

Precigen generates revenue from commercial sales of PAPZIMEOS, priced at approximately $460,000 per four-dose patient regimen. Q1 2026 net product revenue reached $21.6 million, up from $3.4 million in Q4 2025 (the first partial quarter of launch), and total Q1 2026 revenue of $23.25 million exceeded the $20.8 million forecast. Distribution runs through direct physician and hospital channels with field sales led by Chief Commercial Officer Phil Tennant, supported by an Eversana-partnered patient hub for enrollment. Payer coverage spans approximately 297 million US lives, and a permanent J-code (J3404) effective April 2026 streamlines Medicare and Medicaid reimbursement. Precigen is publicly listed on NASDAQ under ticker PGEN, has 101-250 employees, and is led by President and CEO Helen Sabzevari, PhD, with Randal J. Kirk as Executive Chairman. The company has raised $184 million across public and private rounds in 2023-2024, secured a $100 million non-dilutive credit facility from Pharmakon Advisors in September 2025, and projects cash flow break-even by the end of 2026.

Name

Precigen

Legal name

Precigen, Inc.

Website

https://precigen.com

Company type

Public

Founded year

2015

Operating status

Operating

Headcount range

101–250 employees

Short description

Precigen is a commercial-stage biopharmaceutical company developing precision immunotherapies on its proprietary AdenoVerse and UltraCAR-T platforms, primarily serving adults with recurrent respiratory papillomatosis via FDA-approved PAPZIMEOS and pursuing an oncology pipeline.

Ownership category

akta.pro rank

Product category

Biopharmaceuticals

NAICS

Biological Product (except Diagnostic) Manufacturing (325414), Research and Development in Biotechnology (except Nanobiotechnology) (541714), Pharmaceutical and Medicine Manufacturing (3254)

SIC

Biological Products, (No Disgnostic Substances) (2836), Pharmaceutical Preparations (2834)

akta.pro primary industry

Gene Therapy for Rare/Monogenic Diseases (HLAAACAE)

akta.pro secondary industries

Gene Therapy CMC/Process Development Platforms (capsid engineering, producer cell lines, plasmids, upstream/downstream) (HLAAACAN), Therapeutic Vaccines (e.g., Cancer/Chronic Infection) (HLAIAEAG), Rare Immunology, Autoimmune & Autoinflammatory Therapies (HLAIAIAE)

Keywords

• Gene therapy platforms
• Cell therapy manufacturing
• Immunotherapy products
• Rare disease treatments
• Adenoviral vector technology

Headquarters

HQ city

Germantown

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, Marketing or Sales, Supply Chain, Infrastructure

Revenue model

1. PAPZIMEOS Product Sales: Revenue from commercial sales of PAPZIMEOS (zopapogene imadenovec-drba), FDA-approved immunotherapy for recurrent respiratory papillomatosis. Product launched August 2025 with Q4 2025 revenue of $3.4M and Q1 2026 revenue of $21.6M. Revenue trajectory showing strong acceleration with projected cash flow break-even by end of 2026.
2. Non-Dilutive Financing: $100 million credit facility from Pharmakon Advisors to support US commercialization of PAPZIMEOS and potential international expansion including pediatric and HPV-related indications.

Pricing tiers

Go-to-market motion1 record

Distribution channels3 records

Marketing channels4 records

Core offering

Precigen is a commercial-stage biopharmaceutical company that develops and sells precision gene and cell therapies, with its flagship approved product PAPZIMEOS (zopapogene imadenovec-drba) being the first and only FDA-approved immunotherapy for adults with recurrent respiratory papillomatosis (RRP). The company leverages two proprietary technology platforms—AdenoVerse (gorilla adenovectors) and UltraCAR-T (non-viral cell therapy)—to manufacture and commercialize therapeutics in immuno-oncology, autoimmune disorders, and infectious diseases, and is advancing a clinical pipeline including PRGN-2009 for HPV-associated cancers and UltraCAR-T candidates for AML, MDS, and ovarian cancer.

Product overview

Precigen is a commercial-stage biopharmaceutical company with an approved product (PAPZIMEOS) and multiple pipeline candidates built on two core technology platforms: AdenoVerse (adenoviral vectors for immunotherapy) and UltraCAR-T (cell therapy using non-viral gene delivery). PAPZIMEOS, approved in August 2025, is the first FDA-approved immunotherapy for adult RRP and is now commercially available. The pipeline includes PRGN-2009 for HPV-associated cancers, and three UltraCAR-T candidates (PRGN-3006 for AML/MDS, PRGN-3005 for ovarian cancer, and PRGN-3007 for hematological and solid tumors). Supporting technology platforms include UltraVector for DNA construction, the Sleeping Beauty non-viral delivery system, AttSite recombinases, and UltraPorator electroporation equipment.

Differentiator

Problem solved

Functional benefit

Brands

• PAPZIMEOS: PAPZIMEOS (zopapogene imadenovec-drba) is the company's FDA-approved immunotherapy for recurrent respiratory papillomatosis (RRP), the first and only approved treatment for adults with this rare disease.

Products and services

• PAPZIMEOS (zopapogene imadenovec-drba) FDA-approved subcutaneous immunotherapy treatment (5×10^11 PU/mL) for recurrent respiratory papillomatosis (RRP) in adults, the first and only approved therapy addressing the root cause of RRP, an HPV 6/11-associated rare disease affecting approximately 27,000 adults in the US. Priced at approximately $460,000 per patient for a four-dose treatment regimen.
• PRGN-2009 AdenoVerse platform-based investigational HPV immunotherapy in clinical development for HPV-associated cancers, currently being evaluated in combination with pembrolizumab in clinical trials.
• PRGN-3006 UltraCAR-T Investigational UltraCAR-T cell therapy for acute myeloid leukemia (AML) and higher-risk myelodysplastic syndromes (MDS), utilizing non-viral gene delivery with overnight manufacturing process.
• PRGN-3005 UltraCAR-T Investigational UltraCAR-T cell therapy for ovarian cancer utilizing non-viral multigenic delivery with rapid overnight manufacturing.
• PRGN-3007 UltraCAR-T Investigational UltraCAR-T cell therapy for hematological and solid tumors, incorporating intrinsic checkpoint inhibition for improved anti-tumor activity.

Quantifiable outcome

• 83% of complete responders (15/18) maintained ongoing complete responses for at least 36 months without additional treatment
• +5 more outcomes

Named customers1 record

Segments3 records

Ideal customer profiles2 records

Technology focussed Yes

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

Feature6 records

Partnerships

Three partnerships are on record, tiered core and minor.

• Recurrent Respiratory Papillomatosis Foundation (RRPF)coreStrategic or Co-development Partner · 11 June 2026Continued collaboration to recognize International RRP Awareness Day on June 11, 2026 (third annual). Partnership focuses on amplifying patient and community voices through online hub rrpawareness.org. Foundation sponsored expert consensus paper recommending PAPZIMEOS as new standard of care published in The Laryngoscope.
• EversanacoreGTM or Marketing Partner · 26 May 2026Partnership for commercialization support including patient hub services and market access. Company presented at Eversana-hosted Biotech Showcase event alongside J.P. Morgan Healthcare Conference.
• Abu Dhabi Stem Cells Center (ADSCC)minorStrategic or Co-development Partner · 26 October 2024Presented Phase I clinical data on investigational UltraCAR-T products at Second Bone Marrow Transplant and Cellular Therapy Congress sponsored by ADSCC in Abu Dhabi.

Scale indicators12 records

Recent moves6 records

Expansion highlights5 records

Direct peers

• Krystal Biotech: Commercial-stage gene therapy company with an approved product (VYJUVEK) for a rare disease (DEB), similar in scale and trajectory to Precigen. Closely comparable as a small-cap gene therapy for rare diseases with a single approved asset driving commercial revenue.
• Iovance Biotherapeutics: Commercial-stage cell therapy company with FDA-approved Amtagvi for melanoma and lifileucel pipeline, addressing solid tumors through autologous cell therapy. Comparable in stage, scale, and focus on cell-based immuno-oncology platforms.
• Atara Biotherapeutics: Allogeneic T-cell immunotherapy company developing cell therapies for cancers and viral diseases. Comparable in cell-therapy platform approach and indication overlap in HPV-associated disease.
• Adaptimmune Therapeutics: TCR-T cell therapy company focused on solid tumors, including HPV-associated cancers. Comparable cell-therapy platform overlap and oncology indication set.
• Allogene Therapeutics: Allogeneic CAR-T cell therapy developer using non-viral gene editing approaches. Comparable cell-therapy platform focus and pursuit of next-generation CAR-T manufacturing.
• bluebird bio: Gene therapy company focused on rare diseases with multiple approved products (Zynteglo, Skysona, Lyfgenia). Highly comparable as a small-cap gene therapy for rare diseases navigating commercial launch.
• Ultragenyx Pharmaceutical: Commercial-stage rare disease company developing biologics and gene therapies, including Crysvita and Dojolvi. Comparable rare disease therapeutic focus and small/mid-cap commercial stage.

Broad incumbents

• Sarepta Therapeutics: Established commercial-stage gene therapy leader in rare diseases (Elevidys for DMD, Exondys 51). Comparable gene therapy for rare diseases but at a much larger scale and broader pipeline.
• BioMarin Pharmaceutical: Established rare disease biotech with a portfolio of approved biologics and gene therapies (e.g., Roctavian for hemophilia A). Comparable rare-disease commercial focus but at significantly larger scale.

Emerging players

• CRISPR Therapeutics: Gene-editing therapy company with Casgevy approved for sickle cell disease. Comparable in gene-based therapy platforms for rare diseases and adjacent oncology applications.

Market position

Strengths5 records

Weaknesses5 records

Competitive moat4 records

Key risks7 records

Key highlights7 records

Customer concentration

• Xx.com/precigen
• YouTubeyoutube.com/channel/UCbd51C9ftUDEnSfbheMjF2Q
• LinkedInlinkedin.com/company/precigen

Compliance1 record

Revenue estimate

Valuation estimate

Number of profiles

Profiles17 records

Funding overview

Funding rounds14 records

Investors5 records

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

M&A8 records

Investments1 record

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

Frequently asked questions about Precigen