Bright Minds Biosciences Inc. announced positive results of the qEEG (Quantitative Electroencephalogram) data in Cohort 4 of its first-in-human Phase 1 study of its lead compound, BMB-101. During the EEG recording, subjects were seated with a U.S. Food and Drug Administration (FDA)- approved 19 electro EEG headset provided by Zeto?? Inc. Channels were sampled at 250 or 500 Hz and referenced to A1/A2 channels (linked-ears reference) during recording.

The Phase 1 study was conducted in Adelaide, Australia, by CMAX Clinical Research, a clinical trial center specializing in a range of early-phase trials and first-in-human studies. About the Phase 1 Study Part 1 - Single Ascending Dose; 4 cohorts (6 drug and 2 placebo) - single dose (oral solution); reached the planned top dose of 180 mg/70 kg, which approached preclinical exposure limits; Well tolerated with predictable PK; Most common adverse event was oral paresthesias from liquid formulation; Part 2 - Food Effect; 12 subjects - crossover with and without breakfast, 120 mg/70kg; Effect of food on BMB-101 levels was relatively small, and therefore BMB-101 can be administered without the need for fasting; Part 3 - Multiple Ascending Dose: 4 cohorts (6 drug and2 placebo) - twice a day dosing for seven days after meals; reached a top dose of 150 mg/70 kg twice a day; Biomarkers for central target engagement: Prolactin release and qEEG Good Manufacturing Practices (GMP) production completed for BMB-101 drug substance and drug product. Results of clinical trials and animal studies indicate that 5-HT2C receptor agonists may have therapeutic potential in the treatment of addiction by decreasing the intake of opioids as well as impulsive behavior that can escalate compulsive drug use.

All statements in this new release, other than statements of historical facts, that address events or developments that the Company expects to occur, are forward-looking statements. Factors that could cause the actual results to difference materially from those in forward-looking statements include continued availability of capital and financing, results of Phase 2 clinical trials with respect to BMB-101 and other compounds that the Company may seek to test in the future, results of further development and development in the future.