On March 25, 2026 Precigen, Inc. (Nasdaq: PGEN), a commercial-stage biopharmaceutical company specializing in the advancement of innovative precision medicines to improve the lives of patients, reported full year 2025 financial results and business updates.

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"With the FDA approval and launch of PAPZIMEOS, 2025 marked a transformational year for Precigen as we transitioned from a clinical-stage to a commercial-stage company and recognized our first commercial product revenues toward the end of the year," said Helen Sabzevari, PhD, President and CEO of Precigen. "We are seeing strong alignment within the physician community around PAPZIMEOS as the first-line standard of care for adults with RRP, supported by its profile as the only approved therapy for RRP, the compelling safety and efficacy data, and the encouraging durability of response observed to date. This is an exciting time for Precigen, and we look forward to sharing further updates during our call regarding the significant momentum we’re seeing in the first quarter."

"Commercialization of PAPZIMEOS continues to move rapidly, with growing physician adoption and patient uptake since approval in August. Since deploying our full field organization, we have engaged all target medical institutions and are seeing prescriptions and active treatment across the United States in both major medical centers and community practices. Patient hub enrollment has surpassed 300 patients, reflecting strong demand, while payer coverage now extends to approximately 215 million lives across private insurers, as well as Medicare and Medicaid. The recently published Recurrent Respiratory Papillomatosis Foundation-sponsored expert consensus paper recommending PAPZIMEOS as the first-line standard of care for adults with RRP further reinforces the momentum we are seeing as we continue to see expanded patient access." said Phil Tennant, Chief Commercial Officer of Precigen.

KEY PROGRAM HIGHLIGHTS

PAPZIMEOS: Establishing a New Standard of Care for the Treatment of Adults with RRP

· PAPZIMEOS full approval with broad label: In August 2025, the FDA granted full approval of PAPZIMEOS with a broad label for the treatment of adults with RRP.
· PAPZIMEOS prescribing, treatment, and distribution: Since full deployment of the PAPZIMEOS field team in September 2025, 100% of target medical institutions have been engaged. PAPZIMEOS is now being prescribed nationwide across both major medical centers and community practices, with patients spanning a range of disease severities actively receiving treatment.
· Strong patient and physician demand: To date, PAPZIMEOS patient hub enrollment has surpassed 300 registered patients, reflecting substantial patient and physician demand. In addition to these registered patients, a significant number of patients have been identified outside of the PAPZIMEOS hub through the Company’s field engagement efforts.
· Positive payer coverage: Patient access continues to expand, with private health plan coverage now estimated at approximately 215 million US lives, including the significant majority of leading insurers. PAPZIMEOS is also covered under Medicare and Medicaid. Collectively, coverage now extends to approximately 90% of insured lives in the US.
· J-code assigned: The Centers for Medicare and Medicaid Services has assigned a permanent J-code, J3404, to PAPZIMEOS, effective April 1, 2026. J-codes are standardized reimbursement codes that allow healthcare providers to bill government and commercial insurers for physician-administered therapies. Assignment of a permanent J-code streamlines claims processing and will likely facilitate broader patient access.

· PAPZIMEOS recommended as new standard of care first-line treatment: In January 2026, an expert consensus paper sponsored and published by the Recurrent Respiratory Papillomatosis Foundation and authored by 16 leading physicians in the field of RRP recommended PAPZIMEOS as the new standard of care first-line treatment for adults with RRP in the US.
· Compelling long-term clinical and real-world evidence published: At AAO-HNSF 2025, SITC (Free SITC Whitepaper) 2025, and EUROGIN 2026, the Company presented long-term durable complete responses with PAPZIMEOS, and at ISPOR Europe 2025, the Company published data demonstrating the substantial healthcare resource utilization and patient-reported quality-of-life burden of RRP, underscoring the disease’s significant clinical, economic, and human impact.
· Redosing study initiated: The Company initiated an open-label study to evaluate safety, vector shedding, and retreatment efficacy of zopapogene imadenovec in adults with RRP (clinical trial identifier: NCT06538480).
· MAA under review by the EMA: Following submission in November 2025, the Marketing Authorization Application for PAPZIMEOS for the treatment of adults with RRP was validated by the European Medicines Agency and is under review. PAPZIMEOS was granted orphan drug designation by the European Commission.

PRGN-2009 AdenoVerse Immunotherapy in HPV-associated cancers

PRGN-2009 is an investigational AdenoVerse immunotherapy designed to activate the immune system to recognize and target HPV-associated cancers.

· PRGN-2009 Phase 2 clinical trials under a cooperative research and development agreement (CRADA) with the National Cancer Institute (NCI) in newly diagnosed HPV-associated oropharyngeal cancer are ongoing.
· PRGN-2009 Phase 2 clinical trial in combination with pembrolizumab in recurrent/metastatic cervical cancer is ongoing.

FINANCIAL RESULTS

"2025 was a game-changing year for Precigen with the FDA approval of PAPZIMEOS. We began preparing for the commercial launch of PAPZIMEOS well before the FDA’s approval and significantly increased our investment in commercialization efforts as 2025 progressed to support the successful launch of PAPZIMEOS," said Harry Thomasian Jr., Chief Financial Officer of Precigen. "Our first sale of PAPZIMEOS was recorded in the fourth quarter of 2025 and we are encouraged by continued revenue momentum we’re seeing as we begin the new year. Based upon our present forecast, we expect our current cash position and anticipated cash to be received from PAPZIMEOS sales will fund operations through cash flow break-even by the end of 2026, representing a strong financial foundation as we continue to execute on our commercial and strategic objectives."

Full Year 2025 Financial Results Compared to Prior Year Period

Total revenues increased by $5.8 million compared to the year ended December 31, 2024. This increase was primarily driven by the commencement of PAPZIMEOS product revenue, which totaled $3.4 million in 2025, reflecting the first partial quarter of US commercial sales following the Company’s commercial launch, as well as higher collaboration and licensing revenue of $1.8 million as a result of the recognition of the remaining deferred revenue associated with the termination of an exclusive channel collaboration agreement.

Research and development expenses decreased by $11.7 million, or 22.1%, compared to the year ended December 31, 2024. The decrease was primarily driven by a $5.4 million reduction in costs associated with ActoBio after the Company closed its operations in 2024. External services also declined by approximately $4.0 million, due to reduced activity for contract research organizations as a result of the strategic prioritization of the Company’s pipeline announced in the third quarter of 2024. In addition, the Company, upon FDA approval of PAPZIMEOS, began classifying manufacturing-related costs to inventory, which ultimately will be recorded as cost of products and services when the related inventory is sold. Manufacturing costs related to PAPZIMEOS were recorded as research and development expenses prior to the FDA approval of PAPZIMEOS.

Selling, General and Administrative (SG&A) expenses increased by $28.8 million, or 69.8%, compared to the year ended December 31, 2024. This increase was primarily due to a $27.3 million increase in costs incurred related to PAPZIMEOS commercial readiness, including sales force expansion, marketing and advertising, as well as professional and other fees associated with the commercial launch of PAPZIMEOS.

In connection with the suspension of ActoBio’s operations in 2024, the Company recorded $34.5 million of impairment charges related to goodwill and long-lived assets in the second quarter of 2024. Additionally, in the second quarter of 2025, the Company recorded $3.9 million of impairment charges related to the Exemplar reporting unit, compared to $5.8 million of impairment charges related to the Exemplar reporting unit in the prior year period.

Total other income (expense), net, decreased from income, net of $7.0 million in 2024 to expense, net of $140.1 million in 2025. This decrease was primarily driven by a $139.5 million increase in the fair value of warrant liabilities prior to their reclassification into permanent equity in the third quarter of 2025. Substantially all of the increase in the fair value of warrant liabilities was as a result of an increase in the Company’s common stock price at the valuation date compared to December 31, 2024.

The Company recorded a $179.0 million non-cash deemed dividend on preferred stock in the third quarter of 2025 as a reduction to additional paid-in capital (and an increase in net loss attributable to common shareholders when computing net loss per share) in accordance with US Generally Accepted Accounting Principles (GAAP). On September 15, 2025, all of the outstanding Preferred Shares were converted into common shares.

Net loss attributable to common shareholders was $429.6 million, or $1.37 per basic and diluted share for the year ended December 31, 2025, compared to a net loss of $126.2 million, or $0.47 per basic and diluted share, for the year ended December 31, 2024. The inrease in net loss was primarily driven by non-cash items, including the increase in the fair value of the warrant liabilities and the deemed dividend on preferred shares noted above (combined impact of $318.5 million or $1.02 per share)

(Press release, Precigen, MAR 25, 2026, View Source [SID1234663907])