Release Date: August 14, 2024
For the complete transcript of the earnings call, please refer to the full earnings call transcript.
Positive Points
- PRGN-2012 has shown promising results with 51% of patients achieving complete response and 86% reducing the number of surgeries.
- The FDA has granted PRGN-2012 breakthrough designation and orphan drug designation, expediting its approval process.
- Precigen Inc (PGEN, Financial) has initiated the confirmatory trial for PRGN-2012 and has already started enrollment.
- The company has a commercial facility operational and is preparing for a potential launch of PRGN-2012 in 2025.
- Precigen Inc (PGEN) successfully raised $31.4 million through an equity issuance, providing a financial runway into early 2025.
Negative Points
- Precigen Inc (PGEN) reported a significant net loss of $58.8 million for Q2 2024, compared to $20.3 million in Q2 2023.
- The company had to implement a reduction of over 20% of its workforce as part of strategic prioritization.
- Clinical trials for PRGN-3005 in ovarian cancer and PRGN-3007 ROR1 CAR have been paused to minimize spending.
- The company is shutting down its Belgium-based subsidiary, ActoBio, as part of cost-saving measures.
- Despite the promising data, there is still uncertainty regarding the FDA's final approval and potential outcome meetings.
Q & A Highlights
Q: Recently a close competitor has announced it has delayed its BLA filing. What are the gating factors for you to commence the rolling BLA submission of PRGN-2012? And this way ensure you keep a lead in RRP.
A: We are laser-focused on our submissions and anticipate submitting our BLA by the end of 2024. We are on track for that and excited about the differentiation of PRGN-2012, which is a subcutaneous injection with favorable safety and efficacy.
Q: Given that PRGN-2012 represents a novel therapeutic modality for RRP, do you think you will get an outcome meeting? And what can you do to prepare for it if there is one?
A: Outcome meetings are at the discretion of the FDA, typically when there are questions about data consistency. Our clinical data has shown consistent results across both Phase 1 and Phase 2 trials, meeting primary and secondary endpoints.
Q: What attracted Phil Tennant to the opportunity at Precigen, and what will be the priorities in the coming months as the BLA is submitted and reviewed by FDA?
A: Phil Tennant was attracted by the high unmet need in RRP and the potential significant impact on patients. Priorities include right-sizing the commercial opportunity, understanding the patient journey, and building a precise commercial and medical affairs team to support the launch.
Q: How should we think about the UltraCAR-T programs, specifically PRGN-3006? Will there be a clinical update this year?
A: We are excited about the UltraCAR-T platform and have completed Phase 1b enrollment for PRGN-3006. We plan to use the Fast Track designation to prepare for a Phase 1b meeting and discuss regulatory strategies for advancement.
Q: Would we see any additional data on PRGN-2012 until you start talking about the confirmatory study?
A: We have presented comprehensive data at ASCO, meeting all required endpoints. There will be no further data releases until the BLA submission, but we will continue to follow and report on the durability of response.
Q: Are you discussing a potential submission in Europe for PRGN-2012?
A: We have engaged with EU authorities and received orphan drug designation. We are preparing for global distribution and manufacturing to provide the drug both in the US and ex-US by 2025.
Q: What size of a commercial team do you need to set up for PRGN-2012?
A: Given that it is a rare disease, the commercial team will be small but precise, focusing on a joined-up approach with medical affairs to support patients and customers effectively.
Q: Could you remind us what the bar for response you have to see in your confirmatory trial is? Do you need to complete enrollment before receiving approval?
A: The confirmatory trial has the same design and endpoints as Phase 1 and Phase 2. It only needs to be initiated at the time of BLA submission, not completed, for approval. We have already started enrollment and are confident in timely completion.
Q: What would the pace of enrollment in the confirmatory trial look like compared to the prior trial?
A: Enrollment for Phase 1 and Phase 2 was completed rapidly, even during COVID. Given the strong interest from patients and investigators, we expect the confirmatory trial to enroll quickly.
Q: Is global development for PRGN-2012 being explored? What are the steps to understand requirements for ex-US markets?
A: We have global ambitions for PRGN-2012 and are assessing market opportunities and regulatory requirements in ex-US markets. Despite different vaccine programs, there remains a significant commercial opportunity globally.
For the complete transcript of the earnings call, please refer to the full earnings call transcript.
