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Precigen (PGEN) investor relations material
Precigen Q3 2025 earnings summary
Complete event summary combining all related documents: earnings call transcript, report, and slide presentation.Q3 2025 earnings summary13 Nov, 2025
Executive summary
Achieved full FDA approval and US commercial launch of PAPZIMEOS for adult recurrent respiratory papillomatosis (RRP) in August 2025, marking a transition to commercial stage and rapid adoption with over 100 patients registered.
PAPZIMEOS is the first and only approved therapy for adult RRP, with unmatched efficacy (51% complete response, 86% surgical burden reduction) and a strong safety profile; no confirmatory trial required.
Broad label approval allows use in all adult RRP patients, regardless of disease severity or prior surgeries, and Orphan Drug designation in the US and EU.
Strategic pipeline prioritization in 2024 led to shutdown of ActoBio subsidiary, workforce reduction, and realignment to a single operating segment focused on PAPZIMEOS commercialization.
Submitted Marketing Authorization Application to the EMA in November 2025, expanding geographic reach.
Financial highlights
Cash, cash equivalents, and investments totaled $123.6 million as of September 30, 2025, following a credit facility drawdown.
Total revenues for Q3 2025 were $2.9 million, up over 200% year-over-year, driven by $1.8 million in collaboration/licensing revenue from agreement termination.
Net loss attributable to common shareholders for Q3 2025 was $325.3 million ($1.06 per share), mainly due to non-cash items including a $179 million deemed dividend and $111.5 million warrant liability change.
SG&A expenses rose by $14.2 million (144%) year-over-year in Q3 2025, primarily from PAPZIMEOS commercial launch costs and share-based awards.
Inventory at quarter-end was approximately $3 million, reflecting post-approval manufacturing costs.
Outlook and guidance
Cash and projected PAPZIMEOS revenues are expected to fund operations to cash breakeven, with breakeven targeted by end of 2026.
Gross-to-net revenue adjustment is anticipated in the high teens to low 20%, consistent with industry peers.
Ongoing investments in infrastructure, including a new ERP system and commercialization expansion, position the company for growth.
Future capital needs will depend on commercial success of PAPZIMEOS, R&D progress, and potential strategic transactions.
Management expects collaboration revenue to remain minimal unless new agreements are executed.
2026 cash breakeven: patient uptake assumptions?
Bottlenecks converting hub patients to doses?
Redosing strategy for broader payer coverage?
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Q4 202519 Mar, 2026
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Frequently asked questions
Precigen Inc is an innovator in the discovery and development of next-generation gene and cell therapies, with a mission to enhance the lives of patients through transformational technologies. The company operates in two segments, Precigen, Inc. and Cell Therapy Systems (CTS). The Precigen, Inc. segment discovers and develops the next generation of gene and cellular therapies that address medical needs in cancer, infectious disease and immunological disorders.
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