Release Date: March 27, 2025
For the complete transcript of the earnings call, please refer to the full earnings call transcript.
Q: On the CN insight, do you anticipate building up a major sales force or will you look for partners to commercialize this? A: Marc Hedrick, President and CEO: We do not plan to build a major sales force. This is a niche opportunity, and we are starting with academic neuro-oncologists at major oncology centers. There are about 300 neuro-oncologists in the country, and our initial focus will be on this narrow group of thought leaders and major institutions. Over time, we may expand to the broader medical oncology market. Partnering in the US or outside is something we will consider in the future.
Q: The recurrent GBM trial is the most advanced. What must happen to meet the goal of data this year? A: Marc Hedrick, President and CEO: Although superficially GBM is in late-stage phase two, LM could get approved before. We've enrolled over 50 patients, completed phase one, and are over halfway through phase two. The key is adding new sites, and we now have five sites enrolling. We are focused on completing the enrollment of 11 more patients this year.
Q: Can you remind me of the powering assumptions behind the GBM trial? A: Marc Hedrick, President and CEO: The phase two trial's comparator is the standard of care. We've conducted real-world control arms, and patients treated with monotherapy live under 8 months. The trial is powered at 80% with a comparator of about 8 months median overall survival. The trial size is around 100 to 150 patients, and discussions with the FDA about using real-world control data could reduce the number of active patients needed.
Q: On the LM study, you proposed a dose expansion at the 44 milli dose. Is that an additional cohort to the phase one study or part of the phase two study? A: Marc Hedrick, President and CEO: Ideally, the FDA would sign off on a phase 2 trial focused on breast cancer, with 15 patients each for HER2 positive and negative at the 44 milli dose. The phase one dose is a basket trial including various cancer patients. The goal is to sort out patient segmentation by molecular subtype and align with the FDA on endpoints, potentially leading to a phase 2 or phase 23 pivotal design.
Q: Regarding the multi-dose study, would you wait for the first data to come out before initiating a phase two, or would you build that into a phase two? A: Marc Hedrick, President and CEO: We plan to move directly into a phase two or phase 1B. The multi-dose data will be important for performance data and trial design. The phase one data is promising, with long tail survival observed. We aim to pursue a single dose approval quickly, with dose optimization layered on as data becomes available.
For the complete transcript of the earnings call, please refer to the full earnings call transcript.
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