Release Date: April 10, 2025
For the complete transcript of the earnings call, please refer to the full earnings call transcript.
Q: The use of antigens outside of the exome in the squamous program is unique. What early signs should we look for in the first-in-human clinical readout to indicate these antigens are having a preferential effect? Also, when can we expect a data readout from the Phase 1 trial? A: Myriam Mendila, Chief Scientific Officer & Head R&D: We use an extensive set of validation assays to ensure selected antigens are expressed on tumors and not on healthy tissue. We remain optimistic about seeing strong immune responses to these novel antigens. As for the data readout, we want to be cautious. We need to see how recruitment goes in the first cohort before providing a timeline for data release.
Q: Can you provide more detail on the regulatory path for the CVGBM asset and any impact from recent FDA changes? A: Alexander Zehnder, CEO: So far, we haven't seen any negative impact from FDA changes on our programs. Myriam Mendila, Chief Scientific Officer & Head R&D: We haven't had discussions with regulatory authorities yet for CVGBM as we await more data from Phase 1. If the data shows meaningful clinical activity, we would consider a randomized Phase 2 with an appropriate comparator arm.
Q: What criteria will determine the go/no-go decision for the glioblastoma program after Part B data? A: Myriam Mendila, Chief Scientific Officer & Head R&D: We have set a high threshold for GBM. We expect to see a median overall survival of 50 months or longer and/or an overall response rate of about 20%. If these criteria are met, it would warrant investment into a Phase 2.
Q: Regarding your cash runway guidance into 2028, how much operation is included given your ongoing and new pipeline projects? A: Axel Sven Malkomes, CFO: The current core programs, including early clinical phases, are included in the cash runway. However, not all Phase 1 and Phase 2 trials are prior to the potential cash out. We continue to focus on cost efficiency and pipeline development.
Q: What is your latest strategy on collaboration across oncology and non-respiratory infectious disease programs? A: Alexander Zehnder, CEO: We focus on technology innovation, research, and early development. We have collaborations with GSK for respiratory infectious diseases and MD Anderson Cancer Center for cancer vaccines. For large programs like oncology, we aim to partner for late-stage development and commercialization.
For the complete transcript of the earnings call, please refer to the full earnings call transcript.
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