FluoGuide (FLOU) Investor Call summary

Safety and tolerability

• Dose escalation committee found FG001 safe and well tolerated across 27 patients; 25 had high-grade glioma and 2 had other brain cancers.

• All 27 patients had a satisfactory safety profile, including patients described as severely ill.

• Light was detected in 25 of 27 patients; increasing light intensity was generally observed at higher doses.

Efficacy findings

• Light was detected in all 3 patients in cohort 7 at 36 mg per patient, supporting evidence that tumors illuminate with FG001.

• Neurosurgeons perceived the tumor contrast as valuable; histology at the selected Phase I dose was expected in Q1 2022.

Clinical development plans

• Additional patients will help determine optimal pre-surgery administration timing; Phase II was planned to start in Q1 2022.

• Final Phase I/II results were expected in mid-2022; completing the trial is required before the pivotal Phase III trial for marketing authorization in aggressive brain cancer.

• FG001 development may expand to lung and breast cancer, described as each around 30 times more prevalent than brain cancer.