Initial data validates FluoGuide’s near-infrared fluorescence approach
Although there is a long way to go, and significant uncertainty remains around safety/tolerability, utility in fluorescence-guided surgery, and ability to reduce cancer recurrence, it is difficult to overstate the significance of obtaining human data. The fact that any fluorescence was detectable at all at this dose (and with only two of three patients fluorescing, it seems likely that the signal was weak) speaks to the high signal-to-background ratio, an important initial validation of FluoGuide’s near-infrared fluorescence approach. We also note that, importantly, the blood-brain barrier in these two patients was not an impediment to penetrating CNS tissue for FG001, although we caution that it is well established that disruption of the BBB can occur in glioblastoma. At this point, we may have to await the complete dataset from the dose-escalation phase of the trial to further de-risk the case.

Exceeding expectations, first-in-human data offer basis for de-risking
Based on these initial encouraging findings, we have de-risked the case by increasing the probability of approval from 2-5% to 2-6%, and, accordingly, take our risk-adjusted valuation range to DKK 59-79 per share

Research from 20201218

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