PGEN News & Events

EPS was impacted by non-cash items including the increase in the fair value of the warrant liabilities and the deemed dividend on preferred shares, for a combined impact of 95c per share. Reports Q3 revenue $2.92M vs. $953K last year. Cash, cash equivalents, and investments totaled $123.6M as of September 30, 2025, expected to fund the company's operations to cash flow break-even. "FDA approval of PAPZIMEOS in August marked the beginning of a new era for adults living with RRP," said Helen Sabzevari, CEO. "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". "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. "To date, over 100 patients have already been registered in the PAPZIMEOS Patient Hub...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."

Precigen announced long-term follow-up data demonstrating durable responses to PAPZIMEOS for the treatment of adults with recurrent respiratory papillomatosis. These data were presented at the American Academy of Otolaryngology-Head and Neck Surgery Foundation 2025 Annual Meeting. PAPZIMEOS was granted full approval by the United States FDA in August 2025, becoming the first and only approved therapy for the treatment of adults with RRP. PAPZIMEOS approval was supported by results from the pivotal study, which successfully met its primary safety and pre-specified primary efficacy endpoints. PAPZIMEOS was well-tolerated with no dose-limiting toxicities and no treatment-related adverse events greater than Grade 2. 51% of study patients achieved complete response, requiring no surgeries in the 12-month period after treatment with PAPZIMEOS. Results from the pivotal clinical study of PAPZIMEOS were published in The Lancet Respiratory Medicine.