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Sep 30, 2024
Precigen Q3 2024 Earnings Report
Precigen's financial performance and business operations were updated for Q3 2024.
Key Takeaways
Precigen reported a net loss of $24.0 million, or $(0.09) per basic and diluted share, for the third quarter of 2024. The company is focused on advancing PRGN-2012 and preparing for its potential launch in 2025, while also exploring strategic partnerships.
Completed pre-BLA meeting with the FDA for PRGN-2012 in RRP with full alignment on content and path for fourth quarter 2024 rolling BLA submission.
Commercial and manufacturing readiness campaign underway for PRGN-2012 in anticipation of a potential 2025 launch.
Initiated confirmatory clinical trial for PRGN-2012 in RRP in accordance with FDA guidance.
Presented preclinical data at SITC 2024 for PRGN-3008, a next generation UltraCAR-T targeting CD19.
Precigen
Precigen
Forward Guidance
Precigen is focused on fiscal management and investing in activities necessary for the potential launch of PRGN-2012 and is making good progress on a number of potential financing options, including strategic partnerships and other transactions.
Positive Outlook
- Focusing team and allocating resources to advance PRGN-2012 as rapidly as possible.
- Finalized pre-BLA meetings and are aligned with the FDA on the content for all modules and plan for submission in the fourth quarter.
- Commercial and manufacturing readiness campaigns for PRGN-2012 are well underway to support a potential 2025 launch.
- Continue to demonstrate the many advantages of the UltraCAR-T platform over conventional CAR-Ts.
- Making good progress on a number of potential financing options, including strategic partnerships and other transactions.
Challenges Ahead
- SG&A expenses increased due to commercial readiness costs and severance costs.
- Research and development expenses decreased due to portfolio reprioritization.
- Other income (expense), net, decreased due to the reclassification of cumulative translation losses and a reduction in interest income.
- Total revenues decreased due to reductions in product and service revenues at Exemplar.
- Net loss was $24.0 million, or $(0.09) per basic and diluted share.