On November 13, 2025 Precigen, Inc. (Nasdaq: PGEN), a biopharmaceutical company specializing in the advancement of innovative precision medicines to improve the lives of patients, reported third quarter 2025 financial results and business updates.
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"FDA approval of PAPZIMEOS in August marked the beginning of a new era for adults living with RRP," said Helen Sabzevari, PhD, President and CEO of Precigen. "PAPZIMEOS is the first and only treatment for adults with RRP, with an excellent safety profile and unmatched efficacy based on the groundbreaking pivotal study that supported full FDA approval, granted ahead of the PDUFA action date. PAPZIMEOS is already available to prescribers, and demand from both physicians and patients has been exceptional. For the first time, adults with RRP have access to an emerging standard of care—the first therapy capable of breaking the relentless cycle of surgeries by targeting the root cause of the disease."
"We are very encouraged by the strong early interest in PAPZIMEOS and the rapid pace of activation since approval in August and the deployment of our sales force in September," said Phil Tennant, Chief Commercial Officer of Precigen. "Patient identification has been outstanding, with prescribers and institutions actively working to bring PAPZIMEOS to their patients. To date, over 100 patients have already been registered in the PAPZIMEOS Patient Hub. In addition, a significantly larger number of patients have been identified through institutional patient hubs as potential candidates for treatment with PAPZIMEOS. Our team has swiftly mobilized the market: engaging over 90% of target institutions, advancing payer and formulary access, and driving broad educational and promotional outreach. These efforts have laid a firm foundation for PAPZIMEOS as the new standard of care for adults with RRP."
"PAPZIMEOS represents a monumental shift in how we care for adults with RRP," said Dr. Simon R. Best, MD, Associate Professor of Otolaryngology-Head and Neck Surgery, Johns Hopkins University School of Medicine. "For the first time, we can offer adult patients a safe and effective treatment that addresses the underlying disease rather than repeatedly managing symptoms through endless surgeries. The durable patient outcomes from the pivotal trial are nothing short of remarkable, and it’s clear PAPZIMEOS is poised to become the new standard of care for this debilitating condition."
KEY PROGRAM AND COMPANY HIGHLIGHTS
PAPZIMEOSTM (zopapogene imadenovec-drba) AdenoVerse Immunotherapy for Adults with RRP
· PAPZIMEOS full approval: In August 2025, the US Food and Drug Administration (FDA) granted full approval of PAPZIMEOS with a broad label and no requirement for a confirmatory trial for the treatment of adults with recurrent respiratory papillomatosis (RRP). Approval was supported by the groundbreaking results from the Phase 1/2 pivotal study—the only study in RRP ever conducted with a prospectively defined statistical primary endpoint.
· PAPZIMEOS now available: Following FDA approval in August 2025, PAPZIMEOS is now commercially available and commercial product is shipping to prescribers in the US for the treatment of adults with RRP.
· Early adoption momentum: Rapid commercial launch execution underway with over 90% of target institutions engaged since full deployment of the sales team in September. To date, over 100 patients have been registered in the PAPZIMEOS Patient Hub.
· Positive payer coverage: Private health insurance coverage is progressing rapidly with more than 100 million lives covered to date; PAPZIMEOS is also now available through Medicare and Medicaid.
· Long-term durability data published: The Company announced long-term follow-up results highlighting ongoing durable complete responses after treatment with PAPZIMEOS at the American Academy of Otolaryngology–Head and Neck Surgery Foundation (AAO-HNSF) 2025 Annual Meeting and the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) annual meeting 2025. As of the September 19, 2025 data cutoff:
o 15 out of 18 complete responders (83%) demonstrated continued complete response without any additional treatment interventions with a median follow-up of 36 months (range 27 to 37). Median duration of complete response has yet to be reached.
o Reduction in surgeries compared to the year prior to treatment with PAPZIMEOS was observed in 86% of patients in Year 1, 91% in Year 2, and 95% in Year 3.
o No new safety events observed during long-term follow-up.
· Healthcare resource utilization data published: The Company announced new data at the International Society for Pharmacoeconomics and Outcomes Research (ISPOR) Europe 2025 showing that, above and beyond the impact of surgery, healthcare resource utilization is substantially higher in adults with RRP with significantly higher emergency and healthcare visits, opioid use, and mental health service needs, reflecting the substantial burden on the healthcare system.
· Quality of life data published: The Company announced new data at ISPOR Europe 2025 showing results from a survey of adult RRP patients highlighting the substantial impact of RRP on the patient journey and quality of life. RRP patients reported a substantial physical and mental health burden that impacts overall well-being, results in job losses and productivity declines, and lowers overall quality of life.
· Geographic expansion: The Company submitted a Marketing Authorization Application (MAA) for zopapogene imadenovec for the treatment of adults with RRP to the European Medicines Agency (EMA) in November 2025.
PRGN-2009 AdenoVerse Immunotherapy in HPV-associated Cancers
PRGN-2009 is an investigational off-the-shelf 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.
· The Phase 2 randomized, open-label study of PRGN-2009 in combination with pembrolizumab in patients with HPV-associated recurrent/metastatic cervical cancer is ongoing with two additional clinical sites active in addition to NCI.
FINANCIAL HIGHLIGHTS
· Cash, cash equivalents, and investments totaled $123.6 million as of September 30, 2025, which is expected to fund the Company’s operations to cash flow break-even.
· In September 2025, the Company entered into a credit facility that provides up to $125 million of non-dilutive financing and received the first tranche of $100 million.
"In the third quarter of 2025, we significantly increased investment in commercialization efforts to support the successful launch of PAPZIMEOS," said Harry Thomasian Jr., Chief Financial Officer of Precigen. "With the launch now underway, we are confident that we are well-equipped to maximize the impact of the historic PAPZIMEOS launch, drive ongoing commercialization of PAPZIMEOS, and support sustainable growth. Importantly, based upon our present forecast, we expect our current cash position to fund operations through cash flow break-even, representing a strong financial foundation as we continue to execute on our commercial and strategic objectives."
Third Quarter 2025 Financial Results Compared to Prior Year Period
Total revenues increased by $2.0 million compared to the three months ended September 30, 2024. This increase was primarily driven by the increase in collaboration and licensing revenue 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 increased by $1.0 million, or 9%, compared to the three months ended September 30, 2024. The increase was primarily driven by increased manufacturing expenses and lab supplies related to commercial manufacturing of PAPZIMEOS prior to its FDA approval, professional fees incurred in connection with regulatory filing procedures as well as employee-related costs. These increases were partially offset by the capitalization of inventory-related costs subsequent to the FDA’s approval of PAPZIMEOS.
Selling, General and Administrative (SG&A) expenses increased by $14.2 million, or 144%, compared to the three months ended September 30, 2024. This increase was primarily due to a $9.0 million increase in costs incurred related to PAPZIMEOS commercial readiness, including sales and marketing efforts as well as professional and consulting fees. Other employee-related costs increased approximately $4.0 million, and professional and legal fees increased by $1.0 million.
Total other expense, net, increased by $109.2 million compared to the three months ended September 30, 2024. This change was primarily due to a non-cash $111.5 million increase in the fair value of warrant liabilities related to the convertible preferred transaction from 2024.
The Company recorded a one-time $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 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 $325.3 million, or $(1.06) per basic and diluted share for the three months ended September 30, 2025, compared to a net loss of $24 million, or $(0.09) per basic and diluted share, for the three months ended September 30, 2024. The increase in net loss was significantly impacted by non-cash items including the increase in the fair value of the warrant liabilities and the deemed dividend on preferred shares (combined impact of $0.95 per share for the three months ended September 30, 2025).
(Press release, Precigen, NOV 13, 2025, View Source [SID1234659915])