Precigen (PGEN) investor relations material

Portfolio and Technology Advancements

• Focus on differentiated cell and gene therapy platforms, including a proprietary gorilla adenovirus vector with high payload capacity, repeat dosing, and full IP protection.

• Platform enables strong T cell immunity, minimal seropositivity, and supports multiple injections over years without loss of efficacy.

• In-house manufacturing enables rapid development and commercialization.

• Lead product (Pepcimeus/PAPZIMEOS) approved for recurrent respiratory papillomatosis (RRP), with additional candidates in phase II for HPV-related cancers.

• Ongoing platform expansion through PRGN-2009 in head and neck and cervical cancers.

Commercialization and Market Execution

• Pepcimeus/PAPZIMEOS received full FDA approval in August 2025 for all adult RRP patients, regardless of disease severity, shifting care from surgery to medical management.

• U.S. commercial launch executed rapidly, with over 96% of target centers covered and strong payer uptake (170 million lives covered, ~80% of market).

• Significant increase in brand awareness among physicians and patients within three months post-approval, with unaided awareness rising sharply in both academic and community settings.

• Patient support hub established, with over 200 patients registered and parallel uptake through centers of excellence and community practices.

• Broad FDA label allows use across all severities and stages of RRP, supporting early intervention and reducing irreversible damage.

Clinical Data and Patient Impact

• Pivotal trials showed a 51% complete response rate, with complete responders having zero surgeries after four injections over three months and durable responses beyond three years.

• Partial responders saw reduced surgery frequency; safety profile comparable to a flu shot.

• Addresses a large unmet need: 27,000 U.S. patients, 35,000+ in Europe/Japan, 85,000+ in China.

• Early and broad adoption driven by physician and patient demand to avoid surgical interventions and irreversible harm.

• Enables repeat administration and is designed to generate a targeted immune response against HPV 6/11.