Bright Minds Biosciences Provides Scientific Update - Seite 2

Pipeline Update

• 5‐HT_2C Program for the Treatment of Dravet Syndrome and Selected Behavioral Disorders:
  • Selected BMB-101, a novel, well-characterized highly selective compound with high 5‐HT_2C agonist potency and receptor subtype selectivity versus 5‐HT_2A and 5‐HT_2B as lead 5‐HT_2C clinical pipeline drug candidate. BMB-101 is a New Chemical Entity (“NCE”) with exceptionally strong intellectual property protection, which we believe differentiates its overall competitive position. This compound and its analogues were first invented by Bright Minds’ Chief Scientific Officer, Dr. Alan Kozikowski and Dr. Jianjun Cheng at the University of Illinois in Chicago.

• Identified Dravet Syndrome as lead indication for BMB-101. The Company demonstrated compelling efficacy signals with BMB-101 in well-established zebrafish models, with lower seizure duration and frequency.
  
  
• Advanced Investigational New Drug (“IND”) enabling safety and toxicology studies, which bolster our confidence in commencing human trials in 1H 2022.
  
  
• Identified other indications for BMB-101, which include Opioid Use Disorder and Binge Eating Disorder:
  
  
  • Preclinical studies of BMB-101 established efficacy in validated rat models for the treatment of opioid use disorder. These studies were conducted in collaboration with expert research laboratory of Professor Kathy Cunningham at the University of Texas Medical Branch, Galveston.

• Additional animal models demonstrated a clear dose response, as well as a reduction in binge eating episodes in rats of 50%.
  

• The Company commenced the manufacture of high purity cGMP API, which will satisfy our requirements for our forthcoming clinical studies.
  
  
• Currently, the Phase I studies are slated to begin in 1H 2022; Phase IIa targeted for 2H 2022.
  

• 5‐HT_2A Program for Treatment of Depression and other Neuropsychiatric Disorders:
  
  
  • The Company’s 5HT_2A program is currently screening several potential drug candidates as improved next-generation psychedelics, with the goal of expanding therapeutic scope and market potential versus psilocybin and other first-generation psychedelic drugs in the treatment of depression and other mental health disorders.
  • The Company is conducting in vitro and in vivo assays in collaboration with the well-known academic laboratories of Professor John McCorvy of the Medical College of Wisconsin and Professor Adam Halberstadt of the University of California, San Diego.
  • Novel drug compound discovery and optimization efforts are under way. Structure activity relationships (“SAR”) and lead compounds identified, with drug discovery and optimization program accelerated with medicinal chemist expansion to 22 full-time equivalents. Clinical trials are targeted for 2H 2022.
• 5-HT_2A + 5-HT_2C Mixed Agonist Profile:
  • The Company’s novel 5-HT_2A + 5-HT_2C compound is in early preclinical development for several chronic pain disorders/neuropathic pain syndromes, including cluster headaches and chemotherapy-induced peripheral neuropathy.

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