• Widespread adoption underway
  • Five-year data suggest lasting disease control and prolonged freedom from surgery
  • New competing product said to face substantial uncertainty

Biotech in the News: The Longview

GERMANTOWN, MD / ACCESS Newswire / November 10, 2026 / Precigen Inc. (Nasdaq:PGEN) reported sharply improved third-quarter results late last week, driven by continuing rapid uptake of its flagship therapy PAPZIMEOS®, as the company achieved positive cash flow a quarter ahead of schedule and posted its second consecutive profitable period.

The company’s third-quarter PAPZIMEOS net revenue of $72.9 million was up 37% sequentially, bringing cumulative product revenue since launch to approximately $151 million.

Net income for the period was $35.8 million, or $0.08 per diluted share. Cash, cash equivalents and investments stood at $51 million.

The results highlight the commercial success of PAPZIMEOS, the first FDA-approved therapy for adults with recurrent respiratory papillomatosis (RRP). This rare disease causes recurring airway tumors and has traditionally been managed with repeated surgeries to remove them.

PAPZIMEOS generated an unprecedented 51% complete response rate in its pivotal trial, defined as patients requiring no surgeries during the year following treatment. This data set a new benchmark for RRP therapies.

“We have established an exceptional position of strength, with commercial momentum and a proven strategy driving our next phase of growth,” said Chief Executive Officer Helen Sabzevari, PhD. We achieved positive cash flow ahead of guidance, and PAPZIMEOS’ adoption trajectory puts us well on our way to realizing its blockbuster potential,”

Commercial Momentum Accelerates

Well over 500 patients have begun PAPZIMEOS treatment since its August 2025 approval, with more than 300 patients completing therapy, according to the company.

Executives said adoption continues to broaden across both academic medical centers, infusion centers and community practices, supported by widespread payer coverage (currently more than 315 million US lives), a permanent J-code and favorable clinical data.

New data presented at the American Academy of Otolaryngology-Head and Neck Surgery Foundation annual meeting showed ongoing complete responses for up to five years after treatment, suggesting that PAPZIMEOS may provide sustained disease control.

Dr. Sabzevari noted that a second treatment for RRP was recently granted conditional approval by the FDA with a label that “underscores the high bar PAPZIMEOS has established for treating RRP.” The competitor’s conditional approval requires a confirmatory study to confirm clinical benefit and was approved using a surrogate endpoint of reduction in surgeries instead of the current standard of complete response.

In an investor call last week, Dr. Sabzevari said the introduction of a competing therapy had been anticipated in the company’s strategic planning, commercial modeling, and investment decisions.

“Our strategy”; she added, “was built not simply to be first, but to establish enduring leadership in RRP based on four pillars: (1) PAPZIMEOS’ efficacy, safety, durability and ease of administration; (2) its regulatory foundation; (3) its commercial infrastructure; and (4) our ability to execute.”

PAPZIMEOS is the only RRP product with durability data in its label. Beyond the label, PAPZIMEOS has shown ongoing durable complete responses up to five years.

PAPZIMEOS pivotal trial data demonstrated no treatment-related adverse events above Grade 2 and no dose limiting toxicities. And the favorable safety profile is further supported by a large and growing safety file of more than 500 real-world patients.

PAPZIMEOS is given by a simple subcutaneous injection, while the competing product requires a specialized companion device with outstanding FDA commitments

The competitor’s product is anticipated to arrive at least a year and a half behind Precigen’s with a conditional approval and accompanying requirement for a confirmatory trial to demonstrate clinical benefit, and an electroporation device that still has open FDA commitments. For these reasons, Dr. Sabzevari adds, “We are confident that PAPZIMEOS will remain the preferred treatment of choice and continued market leader.”

FDA Designation Adds Pipeline Value

Momentum abounds at Precigen.

This past September it received an FDA Platform Technology Designation for its AdenoVerse® technology platform.

The designation could shorten development timelines for future programs by allowing the company to leverage existing manufacturing and preclinical data across multiple product candidates.

Also, the approval of PAPZIMEOS, the first product built on the platform, creates a regulatory precedent for future programs.

Precigen used the identical AdenoVerse vector backbone in PAPZIMEOS to engineer PRGN-2009 which is currently in Phase 2 trials in cancers associated with HPV 16 and HPV 18.

One Phase 2 trial is testing PRGN-2009 in combination with pembrolizumab, a PD1 checkpoint inhibitor, in newly diagnosed HPV oropharyngeal (head and neck) cancer in a neoadjuvant setting.

Another, a multicenter study, is evaluating PRGN-2009 plus pembrolizumab in recurrent or metastatic cervical cancer.

A data update in the head and neck program is expected at a forthcoming R&D Day.

HPV-related cancers account for roughly 5% of all cancers worldwide and approximately 690,000 new cases annually. They include cervical, 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.

Focus On Expansion Opportunities

With PAPZIMEOS now established commercially, management is pursuing several additional near-term growth drivers, including:

  • A redosing study designed to evaluate transition of partial responders into complete responders.
  • Pediatric development efforts.
  • European expansion, where regulators are reviewing PAPZIMEOS’ marketing application.
  • Continuing development of PRGN-2009

PAPZIMEOS is doing what the company hoped for: Providing a major life-altering advance in the treatment of adult RRP, while transitioning the company into a profitable, high growth enterprise with the proven ability to produce important medical advances with an FDA-approved platform technology that holds the potential for additional game-changing products.

Contact:
Steven Harasym
investors@precigen.com

Click here for more information on Precigen

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SOURCE: Precigen, Inc.

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