News Release Detail

ADELAIDE, Australia, Feb. 23, 2022 (GLOBE NEWSWIRE) -- Bionomics Limited (ASX: BNO, Nasdaq: BNOX), today announced its half-year report for the half-year ended 31 December 2021. The half-year ending 31 December 2021 represented a transformational period for Bionomics in which the Company made great strides on multiple fronts including the areas of pipeline progress and advancements, capital raising and implementation of corporate strategic initiatives getting the Company back on a renewed value-driving trajectory to create long-term shareholder value.

In the area of internal pipeline progress and advancements, in July 2021 the Company announced that it had initiated a Phase 2b trial (the ATTUNE Study) to evaluate the tablet formulation of BNC210 in patients with Post-Traumatic Stress Disorder (PTSD) with topline results expected in CY1H 2023. The ATTUNE Study is a randomised, double-blind, placebo-controlled, multi-centre Phase 2b clinical trial with a 12-week treatment period conducted at around 25 clinical sites in the U.S., recruiting approximately 200 patients with PTSD.

In September 2021, the Company announced that, as part of its broader pipeline expansion strategy and based on anti-anxiety signals in Generalised Anxiety Disorder patients, it had started preparing for initiation of a study by year end to evaluate its lead clinical compound, BNC210, as an acute treatment for Social Anxiety Disorder (SAD). In November 2021, the Company received U.S. Food and Drug Administration (FDA) clearance to proceed with evaluating BNC210 for the acute treatment of SAD in a Phase 2 clinical trial (the PREVAIL Study) and in December 2021, the U.S. FDA granted Fast Track designation to the program for the acute treatment of SAD and other anxiety-related disorders.

In early January 2022, the Company announced that it had initiated its Phase 2 PREVAIL Study to evaluate BNC210 for the acute treatment of SAD, with topline results expected by the end of 2022. The PREVAIL Study is a randomised, double-blind, placebo-controlled, multi-centre Phase 2 clinical trial with a single dose treatment, conducted at around 15 to 20 clinical sites in the U.S. and recruiting approximately 150 patients with SAD.

Whilst the internal focus and current research and development spend is restricted to CNS programmes, Bionomics continues limited activities to maximise the value of its legacy oncology programs through divestment and/or out-licensing of both BNC101 and BNC105. Of the non-core legacy oncology assets, the exclusive license agreement of BNC101 to Carina Biotech continued to make advancements and is expected to move forward into clinical development in late 2022. The Memorandum of Understanding the Company entered into in February 2021 with EmpathBio for exploring a potential combination of BNC210 and EMP-01 (an MDMA derivative) for the treatment of PTSD continued to progress in animal feasibility studies.

Bionomics also continued to see progress in its continuing partnership with Merck & Co (known as MSD outside the United States and Canada) to develop α7 receptor positive allosteric modulators (PAMs) targeting cognitive impairment in Alzheimer’s disease with two compounds undergoing Phase 1 safety and biomarker clinical trials.

The Company has also achieved several important capital raising and corporate strategic initiative milestones over the six-month period.

In August 2021, the Company announced that it planned to conduct an initial public offering in the United States (the Offering) of American Depositary Shares (ADSs) and concurrent listing of ADSs on Nasdaq. In December 2021, the Company announced the pricing and close of its the Offering of 1,622,000 ADSs, each representing 180 ordinary shares of Bionomics, at an initial public offering price of US$12.35 per ADS.

The gross proceeds from the Offering were US$20 million, before deducting underwriting discounts and commissions, and other offering expenses payable by Bionomics. The amount raised after deducting underwriting discounts and commissions, and other offering expenses was A$22.2 million. The ADSs began trading on the Nasdaq Global Market on 16 December 2021 under the ticker symbol "BNOX”. The Company granted the underwriters a 30-day option to purchase up to an additional 243,300 ADSs at the public offering price per ADS, less underwriting discounts.

On 6 January 2022, the underwriters exercised in full the underwriters’ option to purchase additional ADSs and 243,300 ADSs were issued at US$12.35 per ADS raising gross proceeds of US$3.0 million. The net proceeds received were US$2.8 million after deducting underwriting discounts and commissions.

The total gross proceeds from the Offering were US$23.04 million, before deducting underwriting discounts and commissions, and other offering expenses payable by Bionomics.

Following the closing of the Offering, Bionomics participated virtually in the Nasdaq Stock Market Closing Bell virtual ceremony in celebration of its ADSs trading on the Nasdaq Global Market under the ticker symbol "BNOX”.

The Board of Directors underwent several changes over the half-year ended 31 December 2021. In July 2021, the Company announced the appointment of Mr Miles Davies as a Non-Executive Director to the Board of Bionomics Limited, replacing Dr. Srinivas Rao as the second Board nominee of Apeiron Investment Group Ltd (Apeiron) under the Subscription Agreement dated 1 June 2020 between the Company and Apeiron.

On 31 December 2021, the Company announced the resignation of Mr Mitchell Kaye as a Non-Executive Director of the Board of Bionomics Limited effective 31 December 2021. Mr Kaye resigned under the terms of the agreement through which he was appointed in November 2018, as nominee of BVF Partners LP under the Placement Agreement dated 9 November 2018.

The Company’s cash balance at 31 December 2021 was A$40.35 million (30 June 2021: A$28.50 million).

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About Bionomics Limited
Bionomics (ASX:BNO, NASDAQ:BNOX) is a clinical-stage biopharmaceutical company developing novel, allosteric ion channel modulators designed to transform the lives of patients suffering from serious central nervous system (CNS) disorders with high unmet medical need. Bionomics is advancing its lead drug candidate, BNC210, an oral, proprietary, selective negative allosteric modulator of the α7 nicotinic acetylcholine receptor, for the acute treatment of Social Anxiety Disorder (SAD) and chronic treatment of Post-Traumatic Stress Disorder (PTSD). Beyond BNC210, Bionomics has a strategic partnership with Merck & Co, Inc (known as MSD outside the United States and Canada) with two drugs in early-stage clinical trials for the treatment of cognitive deficits in Alzheimer’s disease and other central nervous system conditions.

www.bionomics.com.au

Factors Affecting Future Performance
This announcement contains “forward-looking” statements within the meaning of the U.S. federal securities laws. Any statements contained in this announcement that relate to prospective events or developments, including, without limitation, statements related to the Offering are deemed to be forward-looking statements. Words such as “believes,” “anticipates,” “plans,” “expects,” “projects,” “forecasts,” “will” and similar expressions are intended to identify forward-looking statements. There are a number of important factors that could cause actual results or events to differ materially from those indicated by these forward-looking statements. The Company undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events, or otherwise. Actual results could differ materially from those discussed in this ASX announcement.