PRECIGEN, INC. Q2 FY2024 earnings call

Key Programs and Highlights

• PRGN-2012: A gene therapy designed to elicit immune responses to HPV6 and HPV11. It received breakthrough and orphan drug designations. Phase 1 and 2 trials showed 51% of 35 patients achieving complete response (no surgery required for 12 months) and 86% reducing surgery frequency. On track to submit BLA by end of 2024. Confirmatory trial initiated with strong patient interest. Commercial scale manufacturing facility operational.
• Strategic Prioritization: Reduced workforce by over 20% to redirect resources to PRGN-2012. Paused some UltraCAR-T trials (PRGN-3005, PRGN-3007). Finished enrollment of PRGN-3006 (UltraCAR-T for AML) and continues CRADA partnership for PRGN-2009. Shut down ActoBio subsidiary.
• Commercialization: Phil Tennant joined as CCO to lead commercialization efforts for PRGN-2012, focusing on market access, distribution, and medical affairs integration.

There is no detailed financial breakdown by traditional product segments. The key focus is on the PRGN-2012 program, a gorilla adenovirus gene therapy for recurrent respiratory papillomatosis (RRP). However, no absolute revenue figures or segment contribution percentages are provided in a traditional sense.

Forward-Looking Statements

• Anticipate submitting BLA for PRGN-2012 by end of 2024.
• Confirmatory trial for PRGN-2012 already initiated with enrollment underway.
• Confident in commercial scale manufacturing facility to provide doses for US and ex-US launch.
• Preparing for potential commercialization of PRGN-2012 in 2025.

No detailed discussion of specific risks in the transcript. General risks related to regulatory approval timelines, clinical trial outcomes, and market acceptance could be implied but not explicitly detailed.

Q: What are the gating factors for commencing rolling BLA submission of PRGN-2012?

A: Focus on drug treatment, positioning for 2025 launch, with BLA on track for end of 2024.

Q: Will PRGN-2012 get an outcome meeting?

A: Cannot predict outcome meetings, but clinical data met endpoints, data spoke for itself at ASCO.

Q: Thoughts on PRGN-2012 attracting Phil Tennant?

A: Attracted by high unmet need in RRP, therapeutic impact potential. Priorities include right-sizing commercial footprint and medical affairs.

Q: UltraCAR-T programs update?

A: PRGN-3006 enrollment finished, preparing for phase 1b discussions with FDA; PRGN-3005/3007 trials paused, focusing on strategic partnerships.

Q: Additional data for PRGN-2012 before BLA?

A: Phase 1 and 2 data presented at ASCO, no further data needed before BLA submission.

Q: EU submission for PRGN-2012?

A: Engaged with EU authorities, excited about ex-US potential.

Q: Commercial team size for PRGN-2012?

A: Small but joined medical affairs approach, tens of sales team.

Q: Bar for confirmatory trial response and enrollment?

A: Bars similar to phase 1/2, confirmatory trial initiated, enrollment ongoing.

Q: Pace of confirmatory trial enrollment?

A: Similar to prior trials, high patient interest, confident in orderly enrollment.

Q: Global monetization strategy for PRGN-2012?

A: Global ambition, assessing XUS markets, considering vaccine program impacts.