Precigen Inc (NASDAQ: PGEN) is a clinical-stage biopharmaceutical company that develops gene and cell therapy product candidates. The company received FDA marketing approval for Papzimeos and is in early-stage commercialization of that product as of the 10-K filed March 25, 2026. Revenue is expected to come from product sales of Papzimeos, though management disclosed going-concern conditions and stated that existing cash, investments, and anticipated Papzimeos revenue are projected to sustain operations for at least one year from the filing date. Precigen carries $100 million in long-term debt as of December 31, 2025, with cash interest obligations of approximately $40.2 million over the life of the debt. The company has an accumulated deficit and relies on capital markets, having completed public equity offerings and a Series A Preferred Stock conversion of $79 million in stated value into common stock on September 15, 2025. Pipeline programs include PRGN-3005 UltraCAR-T for ovarian cancer, which entered a Phase 1b dose expansion study before being paused following an August 2024 strategic prioritization.

Revenue model

Product sales from the commercialized therapy Papzimeos, with revenue contingent on third-party payor coverage and reimbursement from Medicare, Medicaid, managed care providers, and private insurers. No royalty, licensing, or partnership revenue streams are described in the excerpts.

Products and services

Papzimeos, an FDA-approved product as of the filing date. PRGN-3005 UltraCAR-T, a cell therapy candidate evaluated in Phase 1/1b trials for ovarian cancer, paused as of August 2024 strategic prioritization. A marketing authorization application (MAA) for zopapogene imadenovec-drba for recurrent respiratory papillomatosis (RRP) in adults was submitted in at least one foreign jurisdiction.

Customers and end markets

End markets are patients treated in oncology and rare disease indications. Payors include Medicare, Medicaid, managed care organizations, and private health insurers in the United States. International reimbursement approval is required before product sales can commence in foreign markets.

Value-chain role

Drug developer and early-stage commercial manufacturer. Precigen develops, manufactures, and seeks regulatory approval for gene and cell therapy products, then commercializes directly and seeks payor reimbursement coverage.

Geographic exposure

Primary market is the United States. The company has submitted at least one MAA in a foreign jurisdiction for zopapogene imadenovec-drba, indicating pursuit of international approvals, but no international commercial revenue is described in the excerpts.

Source: SEC 10-K, filed 2026-03-25

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