ADELAIDE, Australia – Bionomics Limited (NASDAQ:BNOX), a biopharmaceutical company, has announced the start of patient screening for its Phase 3 AFFIRM-1 clinical trial, which will evaluate the safety and efficacy of BNC210, a drug candidate for the treatment of social anxiety disorder (SAD). The trial will involve 330 adult patients across various U.S. clinical sites.
The AFFIRM-1 trial is a significant step for Bionomics, following successful capital-raising efforts and the expertise of its clinical development team. The study is designed as a multi-center, double-blind, placebo-controlled trial, where participants will be randomized to receive either 225 mg BNC210 or a placebo before a public speaking task.
The primary measure for the trial's success will be the change in the Subjective Units of Distress Scale (SUDS) scores during the speech.
BNC210 is an α7 nicotinic receptor modulator that has been described as fast-acting, non-sedating, and non-addictive, with potential for both acute and chronic administration in neuropsychiatric disorders. The Phase 3 trial builds on the Phase 2 PREVAIL study findings and discussions with the U.S. Food and Drug Administration (FDA) that took place in Q3 2023.
The drug has previously shown promise in reducing panic symptoms, anxiety levels in general anxiety disorder, and symptom severity in post-traumatic stress disorder (PTSD). BNC210 has received FDA Fast Track designation for the acute treatment of SAD and PTSD.
SAD is a common mental disorder affecting millions of Americans, characterized by a persistent fear of social and performance-related situations. Bionomics aims to address the unmet medical needs of those with SAD through the development of BNC210.
The company's progress with BNC210 and its potential impact on the treatment of anxiety disorders will be closely monitored by the medical community and investors alike. Results from the AFFIRM-1 trial are expected in Q3 2025.
This announcement is based on a press release statement from Bionomics Limited.
In other recent news, Bionomics Limited has been grappling with a Nasdaq delisting notice due to non-compliance with the minimum bid price requirement. However, the company has also secured significant funding which is expected to sustain operations into the third quarter of 2025. This funding, in a milestone-based structure, could yield up to $70 million for the company.
The financing deal is aimed at advancing BNC-201, Bionomics' drug candidate for PTSD treatment. H.C. Wainwright has maintained its Buy rating for the company following this announcement. The company has also secured up to $70 million in a private placement agreement with an institutional investor, which is expected to advance Bionomics' clinical pipeline, including BNC210.
The company has reported positive results from its Phase 2b ATTUNE trial for the treatment of PTSD, demonstrating significant improvement in PTSD symptom severity.
These are among the recent developments for Bionomics, positioning the company for upcoming clinical data releases.
InvestingPro Insights
As Bionomics Limited (NASDAQ:BNOX) embarks on its Phase 3 AFFIRM-1 clinical trial for BNC210, the company's financials and market performance provide additional context for investors. According to InvestingPro data, Bionomics holds a market capitalization of $11.12 million USD, reflecting its size within the biopharmaceutical industry. The company's revenue for the last twelve months as of Q2 2024 stood at $0.45 million USD, which indicates a quarterly revenue growth of 9.32% in Q2 2024. This suggests a positive trajectory in the company's revenue stream, despite a significant drop in revenue growth of -89.0% over the last twelve months.
InvestingPro Tips highlight that Bionomics holds more cash than debt on its balance sheet, which can be a sign of financial stability and potential for future investments in its clinical programs. Moreover, analysts anticipate sales growth in the current year, which may be buoyed by the progress of the AFFIRM-1 trial and other developmental milestones.
However, it's important to note that Bionomics has been suffering from weak gross profit margins, with a gross profit margin of -2405.04% over the last twelve months as of Q2 2024. Additionally, the company has not been profitable over the last twelve months, and analysts do not anticipate it will be profitable this year.
For those interested in a deeper dive into Bionomics' performance and prospects, additional InvestingPro Tips are available at https://www.investing.com/pro/BNOX. There are currently 9 more tips listed on InvestingPro, providing a more comprehensive analysis. To access these insights, consider using the coupon code PRONEWS24 to get up to 10% off a yearly Pro and a yearly or biyearly Pro+ subscription. This offer could provide investors with valuable information as they monitor Bionomics' journey through the AFFIRM-1 trial and its potential impact on the treatment of anxiety disorders.
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