Bionomics Limited - BNOEF STOCK NEWS

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) announced plans to initiate a Phase 2 clinical trial for its lead compound BNC210, targeting acute treatment of Social Anxiety Disorder (SAD). This phase follows promising results from a prior study in Generalised Anxiety Disorder. The new oral tablet formulation of BNC210 shows rapid absorption, with maximal blood concentration achieved within 45 to 105 minutes, positioning it as a potential fast-acting solution for SAD patients. The trial aims to commence by the end of 2021, with topline data expected by late 2022.

Bionomics Limited (BNOEF) has announced plans for an initial public offering of American Depositary Shares (ADSs) in the U.S. and a concurrent listing on Nasdaq. The exact number of ADSs and pricing remain undetermined, pending SEC review. No final decision has been made regarding the Nasdaq listing, but shares will continue to trade on ASX post-listing. Forward-looking statements indicate potential risks, including market conditions and business developments, which could affect the offering's timeline and success.

Bionomics Limited (ASX: BNO, OTCQB:BNOEF) has initiated the Phase 2b ATTUNE Study to assess the efficacy of its BNC210 tablet formulation in treating Post-Traumatic Stress Disorder (PTSD). The study will enroll around 200 patients across approximately 25 clinical sites in the U.S., with results expected by 1H 2023. BNC210, a first-in-class drug, has received Fast Track designation from the FDA due to the unmet need for PTSD treatments. The study aims to evaluate PTSD symptom severity improvements using a double-blind, placebo-controlled design.

Novamind Inc. has increased its investment in Bionomics Limited, purchasing 951,133 shares at AU$0.145 for a total of AU$137,914. This adds to their previous investment of AU$827,486, bringing the total to AU$965,400. With Bionomics shares closing at AU$0.20, Novamind's total investment shows a 38% unrealized return. The funds will support a Phase IIb clinical trial of BNC210, a treatment for PTSD. Novamind is also being evaluated as a clinical research site for this trial, expected to start mid-2021.

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.