Release Date: February 27, 2025
For the complete transcript of the earnings call, please refer to the full earnings call transcript.
Q: Could you discuss the COVID booster neutralizing antibody data in the context of what would be expected from the approved mRNA vaccines on the XPB 1.5 variant? And did any of the participants enrolled in the study have prior COVID-19 infection? A: The neutralizing antibody response levels are comparable to mRNA vaccines. Most participants had prior infections or vaccinations, which is known to reduce immune responses. This makes it challenging to find naive subjects, but the levels observed are in line with expectations for this patient population. - Kristin Longobardi, Senior Vice President - Strategic Operations
Q: What is your updated strategy in terms of patient population for the phase 3 ovarian cancer study and any other details you can share about the trial design? A: The phase 3 trial design is similar to Ovation 2, targeting a similar patient population to ensure consistency in results. The study will involve 500 patients, focusing on overall survival in both homologous repair deficient and intent-to-treat populations. - Douglas Faller, Chief Medical Officer
Q: You mentioned the possibility for accelerated approval. Could you discuss what pathways would be available for that? A: The possibility for accelerated approval is based on emerging evidence, particularly in subgroups like those receiving PARP inhibitors. As data matures, there could be a natural point for discussion with the FDA. The phase 3 confirmatory trial being underway is a key criterion for accelerated approval. - Stacy Lindborg, Independent Director
Q: How does the partnership environment look currently, especially with the impending cash crunch? A: Despite a tough market, we have viable investors interested in leading or co-leading financing. The strength of our phase 2 data and FDA support for phase 3 are significant advantages in securing funding. - Stacy Lindborg, Independent Director
Q: What impressed you most about the phase 2 data that made you join Imunon? A: The phase 2 data showed a significant extension in patient survival, offering hope for a disease that hasn't seen frontline treatment advances in over 25 years. The data suggests a straightforward path to approval with no safety concerns from the FDA. - Douglas Faller, Chief Medical Officer
For the complete transcript of the earnings call, please refer to the full earnings call transcript.
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