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Positive Developments in 2023:
Phase 2b Data for BNC210 in PTSD: Bionomics announced positive results from the Phase 2b ATTUNE trial in PTSD, showing a reduction in total symptom severity and improvements in multiple symptom clusters. A discussion with the FDA about these results is anticipated in Q2 2024.
End of Phase 2b Meeting for BNC210 in SAD: Following the Phase 2b PREVAIL study, Bionomics had a successful meeting with the FDA, setting the stage for a registrational study in Social Anxiety Disorder (SAD).
Strategic Partnerships: The company is engaged in discussions for potential strategic partnerships for multiple pipeline assets and is exploring options to advance clinical development plans for BNC210 in both PTSD and SAD.
Key Highlights and Milestones:
BNC210’s Role in CNS Disorders: BNC210, a first-in-class α7 nicotinic receptor modulator, showed promise in treating PTSD and SAD. It could become the first “as-needed” non-sedating, non-habit-forming anxiolytic for SAD.
Alzheimer’s and Cognitive Impairment: In partnership with MSD, Bionomics is developing α7 PAMs for cognitive disorders like Alzheimer’s disease, with two clinical candidates in late Phase 1 development.
Corporate Developments: Bionomics expanded its U.S.-based team, delisted from the Australian Stock Exchange, efficiently allocated capital, and continued strengthening its intellectual property portfolio.
Financial Position: The company has no outstanding debt, convertible securities, or warrants and maintains support from institutional investors.
2024 Outlook and Anticipated Milestones:
Potential Catalysts
Phase 3 Study in SAD: Bionomics plans to initiate the first Phase 3 study of BNC210 in patients with SAD.
Discussions with FDA on PTSD Study: The company anticipates discussing a late-stage study of BNC210 in PTSD with the FDA, with an update expected by the end of Q2 2024.
Breakthrough Therapy Designation: Bionomics is exploring a request for Breakthrough Therapy designation in PTSD in Q2 2024.
Strategic Partnerships: The company aims to establish strategic partnerships for BNC210.
Conclusions from this corporate update:
Bionomics achieved significant milestones in 2023, particularly with the positive results of BNC210 in PTSD and SAD. Looking ahead to 2024, the company is poised for further growth with strategic plans, including initiating Phase 3 studies, pursuing regulatory discussions, and exploring partnerships. Developing innovative treatments for CNS disorders with high unmet medical needs (Large Markets!)
Source article: Original and full company update
Bionomics (BNOX) Strategic partnership with Merck & Co, Inc
The partnership with Merck & Co. on α7 PAMs, with a potential value of $500 million in milestones plus royalties, exemplifies the high-stakes nature of CNS drug development and the significant revenue potential for successful therapies.
Share Statistics
Current Price a/o the close 01/24/2024: 0.99/Share
52-Week Performance:
52 Week High: $7.71
52 Week Low: $0.93
Moving Averages:
50-Day Moving Average: $1.41
200-Day Moving Average: $2.09
Trading Volume:
Average Volume (3 months): 230.33k shares
Average Volume (10 days): 288.59k shares
Share Statistics:
Shares Outstanding: 10.26 million
Float: 8.81 million shares
Percentage Held by Institutions: 32.25%
Sources: Yahoo finance and dilution tracker
Summary
Bionomics (NASDAQ: BNOX) – FDA Announcements and Additional Potential Catalysts with Timeframes
Background:
Bionomics Limited, a clinical-stage biotechnology company, has made significant progress with its lead asset BNC210, aimed at treating Social Anxiety Disorder (SAD). Following a successful End-of-Phase 2 (EoP2) meeting with the U.S. Food and Drug Administration (FDA) in September 2023, the company is poised to advance BNC210 into Phase 3 registrational studies.
Key FDA Meeting Outcomes:
Agreement on Phase 3 Clinical Program: Bionomics and the FDA have agreed on conducting two randomized, placebo-controlled studies with a single administration of BNC210 during a public speaking task.
Primary Efficacy Endpoint: The Subjective Units of Distress Scale (SUDS) measured during a public speaking challenge will be the primary efficacy endpoint.
Doses for Phase 3 Studies: Specific doses of BNC210 to be studied in Phase 3 have been agreed upon.
Sample Size and Design Elements: The company has aligned with the FDA on the sample size assumptions based on the PREVAIL findings and the design of the open-label safety study required for the New Drug Application (NDA).
Safety Database Size: An agreement on the size of the safety database to support the NDA has been reached.
Nonclinical Toxicology Studies: Requirements for nonclinical toxicology studies needed for the NDA have been established.
Anticipated Timeframes and Potential Catalysts
Initiation of Phase 3 Program: Bionomics plans to begin the Phase 3 program in Q1 2024. This marks a significant milestone and potential catalyst for the company as it moves closer to potential commercialization.
Progress of Phase 3 Studies: The commencement and progress of the Phase 3 studies throughout 2024 will be crucial for Bionomics. Positive interim results or updates could serve as catalysts for investor interest and stock movement.
Strategic Partnerships: Potential partnerships or collaborations related to BNC210, especially in the wake of positive Phase 2 results, could emerge as additional catalysts.
Regulatory Milestones: Any subsequent positive interactions or feedback from the FDA, including potential breakthrough therapy designations or priority reviews, would be significant for the company’s trajectory.
Expansion in Other Indications: Given BNC210’s potential in multiple anxiety disorders, developments in expanding its application to other related CNS disorders could provide further upside.
Conclusion
Bionomics is positioned for a pivotal year in 2024, with the advancement of BNC210 into Phase 3 studies for SAD being a key focus. The alignment with FDA on critical aspects of the Phase 3 program underscores the company’s commitment to addressing the unmet needs in the treatment of SAD. The initiation of these studies, along with potential regulatory and strategic milestones, are poised to serve as significant catalysts for Bionomics in the near future.
Daily Chart
Chart source: Finviz
Stay tuned throughout 2024 for future updates on BNOX.
Your friend,
Steve Macalbry
Senior Editor, BestGrowthStocks.Com
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