Precigen's Strong Second Quarter Signals Significant Growth, Validates AdenoVerse Platform; PRGN-2009 Advances in HPV-Driven Cancers

Biotech in the News: The Longview

The Company's New Drug, the First FDA-Approved Therapy for Recurrent Respiratory Papillomatosis (RRP), is Delivering Strong Commercial Traction While Highlighting the Broader Potential of Its Proprietary AdenoVerse Therapeutic Platform in HPV-Associated Cancers

GERMANTOWN, MD / ACCESS Newswire / August 25, 2026 / For Germantown, MD-based Precigen Inc. (NASDAQ:PGEN), the second quarter marked a commercial inflection. PAPZIMEOS (zopapogene imadenovec-drba) generated $53.1 million in net product revenue-more than double the prior quarter-and helped the company achieve quarterly profitability.

Validated Platform

President and CEO Helen Sabzevari, PhD, framed the quarter as platform validation. "PAPZIMEOS demonstrates the AdenoVerse platform's ability to target HPV-associated diseases. We are building on that validated capability by advancing PRGN-2009 in HPV-driven cancers," she said.

PRGN-2009: Same Platform, Oncogenic HPV Targets

PRGN-2009 uses the identical adenovirus backbone as PAPZIMEOS but is engineered to target high-risk oncogenic types HPV 16 and HPV 18.

AdenoVerse vectors offer practical advantages: very low seroprevalence in humans, large genetic payload capacity, and the ability to be administered repeatedly without generating neutralizing antibodies that blunt subsequent doses. It is administered as a simple subcutaneous injection-an off-the-shelf product rather than a patient-specific cell therapy.

HPV-related cancers account for roughly 5% of all cancers worldwide and approximately 690,000 new cases annually. They include cervical, oropharyngeal (head and neck), anal, penile, vaginal, and vulvar cancers. Many patients still progress after receiving current standards of care, and there is growing interest in neoadjuvant approaches that could reduce the need for radiation or intensive surgery.

Phase 1 Signal and Ongoing Phase 2 Program

In a first-in-human Phase 1 study conducted with the National Cancer Institute, PRGN-2009 was well tolerated as monotherapy and in combination with a checkpoint inhibitor. In the combination arm (mostly checkpoint-resistant patients), the objective response rate was 20% to 30% and median overall survival reached 24.6 months.

Precigen is now conducting multiple Phase 2 trials:

• The first trial in newly diagnosed HPV-positive oropharyngeal cancer evaluates PRGN-2009 in combination with pembrolizumab, a PD1 checkpoint inhibitor in a neoadjuvant setting.

• A second multicenter study is evaluating PRGN-2009 plus pembrolizumab in recurrent or metastatic cervical cancer.

The company is looking forward to providing a data update in the head and neck program in the Fourth Quarter of this year.

Commercial Foundation and Next Milestones

PAPZIMEOS' rapid uptake - driven by field engagement, a permanent J-code, broad payer coverage, and Precigen Hub patient-support services - has given the company both cash flow and proof that an AdenoVerse product can achieve commercial success. The FDA granted PAPZIMEOS seven-year market exclusivity through August 2032. A marketing authorization application is under review by the EMA, which has also granted orphan designation, and Precigen is pursuing a U.S. pediatric label expansion.

PRGN-2009 now carries the broader potential of the AdenoVerse platform into HPV-associated cancers. If Phase 2 data confirm the immune and clinical signals observed in Phase 1, the same platform that dramatically reduced surgeries in a rare HPV-driven disease could have significant potential across the much larger oncology market.

Contact:
Steven Harasym
investors@precigen.com

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SOURCE: Precigen, Inc.