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Precigen Posts Strong Q3: PAPZIMEOS Net Revenue Rose 37%; Positive Cash Flow Achieved Ahead of Schedule

PGEN
  • Precigen Inc. reported third-quarter net income of $35.8 million ($0.08 per diluted share) driven by $72.9 million in PAPZIMEOS revenue, a 37% sequential increase.
  • Cumulative PAPZIMEOS revenue since its August 2025 launch reached approximately $151 million with over 500 patients treated & more than 300 completing therapy.
  • The company achieved positive cash flow a quarter ahead of schedule, marking its second consecutive profitable period with $51 million in cash, equivalents, & investments.
  • PAPZIMEOS demonstrated a 51% complete response rate in pivotal trials, with new data showing sustained disease control & freedom from surgery for up to five years.
  • A new competitor received conditional FDA approval based on a surrogate endpoint, requiring a confirmatory study & utilizing a specialized device with outstanding FDA commitments.
  • Precigen's CEO stated the competitor's delayed entry & regulatory hurdles position PAPZIMEOS as the preferred treatment based on efficacy, safety, durability, & ease of administration.
  • PAPZIMEOS benefits from widespread payer coverage affecting over 315 million US lives, a permanent J-code, & a safety profile with no treatment-related adverse events above Grade 2.
  • The company received FDA Platform Technology Designation for its AdenoVerse technology in September, potentially shortening development timelines for future programs.
  • Pipeline candidate PRGN-2009 is in Phase 2 trials for HPV-related cancers, including a neoadjuvant study for head & neck cancer & a multicenter study for cervical cancer.
  • Near-term growth drivers include a redosing study for partial responders, pediatric development efforts, & European marketing application reviews.
Company
Precigen, Inc
Keywords
Biotechnology, Company Update