Bionomics Provides a Review of 2023 and of 2024 Plans - Seite 2

Social Anxiety Disorder

• BNC210 may become the first intermittent “as-needed” non-sedating, non-habit forming, cognitively non-impairing anxiolytic for the treatment of anxiety in patients with SAD.
• In March 2023, the Company completed, on time and within budget, the full data analysis of the Phase 2b PREVAIL study demonstrating that BNC210 reduced anxiety during a public speaking challenge and provided support for further evaluation in Phase 3 clinical trials.
• A successful EoP2 meeting with the FDA in September 2023 confirmed the Phase 3 enabling nature of the PREVAIL dataset and clarified the plans for the registrational program for BNC210 in SAD, including the number of trials, trial designs, endpoints, sample sizes, size of the safety database and nonclinical requirements for registration.
  

The results of the Phase 2b trials of BNC210 in SAD and PTSD, along with previous results observed in earlier trials in general anxiety disorder (GAD) and panic attacks, underscores BNC210’s potential in multiple, highly prevalent neuropsychiatric indications with significant market opportunity.

Positive Allosteric Modulators (PAMs) of the α7 Nicotinic Acetylcholine Receptor Program with Merck & Co., Inc.
The ongoing partnership with MSD* on α7 PAMs for the treatment of cognitive disorders such as Alzheimer's disease (AD) and cognitive impairment associated with schizophrenia (CIAS) has generated two clinical candidates that are currently in late Phase 1 clinical development after completing several Phase 1 safety, tolerability, pharmacokinetic and biomarkers studies. The partnership has a potential value of $500m in regulatory and clinical milestones with additional potential royalties from commercialization.

Key Corporate Highlights

• In support of the Company’s transformation into a commercial-stage company, expanded the U.S.-based team with new highly experienced management appointments, positioning it to become a leading company in neuropsychiatry.
• Voluntarily delisted from the Australian Stock Exchange in August 2023 and is currently solely listed on the NASDAQ Global Market.
• Further reduced cash burn through efficient capital allocation.
• Maintained its current institutional investors’ support while adding new institutional investors to its register.
• Sustained strong analyst coverage that highlights the Company's potential future value.
• The Company has no outstanding debt, convertible securities, or warrants.
• Continued strengthening BNC210 intellectual property portfolio in the U.S. and abroad.