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Bionomics Limited announced that the U.S. FDA granted Fast Track designation to its BNC210 program for treating Social Anxiety Disorder (SAD) and related conditions. This follows a similar designation for Post-Traumatic Stress Disorder (PTSD) in November 2019. The Fast Track designation allows for expedited drug development and review, including priority review and rolling NDA submissions. BNC210 is an oral treatment aiming to provide rapid relief for anxiety, with a Phase 2 clinical trial, PREVAIL Study, expected to start by late 2021, focusing on self-reported anxiety levels during anxiety-inducing tasks.
Bionomics Limited has filed a registration statement with the SEC for a proposed public offering of American Depositary Shares (ADSs) in the U.S. The company plans to list its ADSs on Nasdaq under the ticker 'BNOX'. The total number of ADSs and pricing details are currently undetermined. This offering, alongside the existing ordinary shares traded on ASX under 'BNO', is aimed at supporting Bionomics' operations and expansion efforts. The registration statement has been filed but is not yet effective, meaning securities cannot be sold until it is approved.
Bionomics has secured FDA clearance for the IND of BNC210, to be evaluated in a Phase 2 clinical trial titled the PREVAIL Study for treating Social Anxiety Disorder (SAD). The trial is set to commence by the end of 2021, aiming for topline data release by late 2022. BNC210, a selective negative allosteric modulator targeting the α7 nicotinic receptor, previously showed effectiveness in a Phase 2a study for Generalized Anxiety Disorder. The PREVAIL Study will recruit 150 participants across 15 U.S. sites, assessing anxiety levels during social interactions.
Bionomics Limited (ASX: BNO, OTCQB:BNOEF) has successfully completed a 1 for 6 pro rata non-renounceable entitlement offer and a concurrent placement, collectively raising approximately A$22.9 million. The entitlement offer raised around A$20.4 million from 140.9 million new shares, with a subscription rate of about 60.7%. Additionally, the concurrent placement raised A$2.5 million. Bionomics is progressing towards starting a Phase 2b trial for its lead drug candidate BNC210 targeting PTSD in mid-2021, demonstrating strong shareholder confidence.
Bionomics Limited announced positive results from a 7-day pharmacokinetic study of its novel oral tablet formulation, BNC210, designed for the treatment of PTSD. The study showed that a 900 mg dose given twice daily exceeded the predicted blood exposure needed for effectiveness in future trials. BNC210, which received FDA Fast Track designation in 2019, is set for a Phase 2b trial expected to start in mid-2021. The new tablet formulation simplifies administration and improves consistency compared to the previous liquid formulation. Funding from a recent $16 million private placement will support further development.
Bionomics Limited (BNOEF) has entered a Memorandum of Understanding with EmpathBio Inc. to explore a combination treatment for Post-Traumatic Stress Disorder (PTSD) using BNC210 and the MDMA derivative EMP-01. BNC210, Bionomics' lead candidate, has received Fast Track designation from the FDA and is set for a Phase 2 study in mid-2021. The collaboration aims to evaluate the potential of these drugs to enhance treatment efficacy while minimizing side effects. Both companies express optimism about advancing PTSD treatment options through this partnership.
Bionomics Limited has announced a capital placement of A$15,991,634 at A$0.145 per share, supported by North American and European investors. This funding enables the Company to advance its Phase 2b clinical trial for BNC210, targeting PTSD, scheduled for mid-2021. The share price reflects a 263% premium compared to its September 2020 capital raise. Following the placement, an Entitlement Offer will allow eligible shareholders to purchase shares at the same price. The initiative minimizes dilution for current shareholders, with significant backing from reputable life sciences funds.
