PRECIGEN, INC. Q4 FY2024 earnings call

• PRGN-2012: Submitted BLA, FDA accepted with priority review (PDUFA date August 27, 2025). Pivotal study met primary efficacy endpoint with 51% complete response rate, durable responses (median 24 months, Phase 1 complete responders surgery-free for 3 years), well-tolerated, simple subcutaneous administration. Confirmatory trial initiated and enrolling patients.
• PRGN-2009: Phase 2 advancing for cervical and head and neck cancers, showed favorable safety, tolerability, 30% objective responses, complete and partial responders with responses spanning close to 2 years, and enhanced T-cell responses with repeated dosing.
• UltraCAR-T platform: Autologous CAR-T with overnight manufacturing, biomarker discovery in AML, data in autoimmune settings, preparing for FDA meetings and pivotal Phase 2.
• Manufacturing: In-house GMP facility upgraded, CDMO for fill/finish, built GMP quality control capabilities for PRGN-2012.
• Commercialization: Built commercial leadership team, partnered with EVERSANA for US launch, market analysis indicates ~27,000 US patients with RRP.

Precigen does not provide detailed financial performance for traditional product segments in terms of absolute revenue and contribution %. The focus is on key programs: PRGN-2012 is a lead asset with pivotal clinical data showing 51% complete response rate in RRP, durable responses, and favorable safety; PRGN-2009 is in Phase 2 for cervical and head and neck cancers with objective responses and repeated dosing tolerance; UltraCAR-T platform has biomarker discovery in AML and data in autoimmune settings.

• Anticipate commercial revenues from PRGN-2012 in the second half of 2025.
• PRGN-2009 continues Phase 2 advancement.
• UltraCAR-T platform preparing for FDA meetings and planning for pivotal Phase 2.

• Regulatory risks related to FDA review, inspections, and approval process for PRGN-2012.
• Market adoption and payer access challenges for PRGN-2012.
• Dependence on successful FDA approval of PRGN-2012 for commercialization.

Q: Can you give an update on interactions with FDA regarding PRGN-2012 and commercial field force size?

A: Helen mentioned close interaction with FDA, Phil stated field force is expected to be 15-20 representatives targeting ~500 fellowship trained otolaryngologists.

Q: Any line of sight on timing of FDA meetings, inspections, labeling discussions?

A: Helen said no comment on inspections but in close alignment with FDA, looking forward to further communication near PDUFA date.

Q: If PRGN-2012 approved, anticipate bolus of patients and how to address?

A: Harry said pent-up demand, plan to deploy team and efforts accordingly.

Q: Status of confirmatory trial for PRGN-2012 and PRGN-3006 data publication?

A: Confirmatory trial initiated and enrolling, PRGN-3006 data publication not specified yet.

Q: FDA manufacturing facility inspection timing and payer access discussions?

A: Rutul said anticipate pre-approval inspection, Phil discussed payer access with value proposition and utilization management considerations.

Q: Update on sites preparing for PRGN-2012 administration and pricing/payer access?

A: Phil said sites well-equipped, pricing and payer access involve value-based considerations and discussions with payers.