Quarterly Activities and Cashflow Report

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Bionomics Limited (BNOX | BNO) Releases Quarterly Cashflow Report and Announces Key Clinical Trial Updates

ADELAIDE, Australia, and CAMBRIDGE, Mass., July 31, 2023 (GLOBE NEWSWIRE) -- Bionomics Limited (Nasdaq: BNOX | ASX: BNO), (Bionomics or the Company) 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, today released its Appendix 4C – Quarterly Cashflow Report. Highlights during the Quarter ended 30 June 2023 (Quarter) and up to the date of this announcement include:

• On 27 April 2023, Bionomics announced that the Company has completed target enrolment of approximately 200 participants in its randomized, double-blind, placebo-controlled, multi-center Phase 2b ATTUNE clinical trial evaluating BNC210 in Post-Traumatic Stress Disorder (PTSD). Topline results are expected in the third quarter of 2023.
• On 28 April 2023, Bionomics released its Appendix 4C – Quarterly Cashflow Report for the quarter ended 31 March 2023.
• On 8 May 2023, Bionomics announced the establishment of an “at-the-market” program (the ATM Program) with Cantor Fitzgerald & Co. (Cantor), who will act as sales agent. Under the ATM Program, the Company may offer and sell up to US$11.5 million of ordinary shares in the capital of the Company (Shares) in the form of American Depositary Shares (ADSs), with each ADS representing one hundred eighty (180) fully paid Shares, through Cantor. Sales of ADSs under the ATM Program may be made from time to time, with the timing and amount of any sales to be determined by Bionomics based on a variety of factors. Bionomics may determine to sell some, all, or none of the ADSs under the ATM Program and may terminate the ATM Program at its discretion. Bionomics, through Cantor, may sell ADSs by any lawful method deemed to be an “at-the-market offering” defined by Rule 415(a)(4) under the Securities Act of 1933, as amended. Sales made through the ATM Program may be made at market prices prevailing at the time of a sale or at prices related to prevailing market prices. As a result, actual sales prices may vary. To effectuate the establishment of the ATM Program, the Company has entered into a Sales Agreement with Cantor, acting as sales agent. Bionomics currently intends to use the net proceeds from the ATM, together with its existing cash and cash equivalents, to fund its pipeline development and to maintain working capital and for general corporate purposes. The Company has filed a shelf registration statement on Form F-3, including a base prospectus relating to a proposed offer by the Company of securities (being Shares and ADSs, various series of debt securities and warrants to purchase any such securities) and a sales agreement prospectus relating to the ATM Program, with the Securities Exchange Commission (SEC), but such shelf registration statement has not yet been declared effective by the SEC. The securities referred to in the shelf registration statement may not be sold, nor may offers to buy them be accepted, prior to the time the registration statement becomes effective by the SEC.
• On 31 May 2023, Bionomics CEO made a poster presentation at 2023 American Society of Clinical Psychopharmacology annual meeting at 11.15am (ET), in Miami Beach, Florida. The poster presentation included previously disclosed and new results of a comprehensive analysis of the data from the Phase 2 PREVAIL study of BNC210 in Social Anxiety Disorder (SAD). These results are expected to enable the late-stage development of BNC210 in SAD.
• On 15 June 2023, Bionomics filed a press release in the U.S. advising that the Company was presenting at:
  • the Maxim Group Healthcare Virtual Conference’s Panel discussion titled “Mental Health, More Critical Than Ever” via webcast on 20 June 2023 at 2:00pm ET, and
  • H.C. Wainwright’s 4^th Annual Neuropsychiatry Virtual Conference at 7:00am ET on 26 June 2023.
• On 3 July 2023, Bionomics announced key leadership updates to drive its ongoing transformation to a U.S.-focused company, streamline its allocation of capital, and support its next stage of strategic growth. Alan Fisher, previously a non-executive member of the Board since 1 September 2016 and Chair of the Audit & Risk Committee, has been appointed Non-Executive Chair of the Board, effective from 1 July 2023. Mr. Fisher succeeds Errol De Souza, Ph.D., who remains on the Board as a Non-Executive Director. Tim Cunningham of Danforth Associates has been appointed Chief Financial Officer effective 1 July 2023. The Company has also engaged Francisco Bejar as a strategic advisor to head the business development efforts in the U.S. and abroad, whilst Connor Bernstein, Vice President, Strategy and Development, stepped down from his role with effect from 30 June 2023. Adrian Hinton, who was Acting CFO for the last four years, will continue supporting the Company as a Financial Controller.
• On 25 July 2023, Bionomics announced that it had submitted a formal request to the ASX to be removed from the official list of the ASX (Delisting).
• On 28 July 2023, Bionomics received formal approval from the ASX for the Delisting and notified shareholders whose securities are held on the Company’s Australian principal share register that, from the time the Delisting takes effect which is scheduled for close of business on 28 August 2023, Bionomics Shares will no longer be quoted or traded on the ASX, and informed those shareholders that if they wish to sell their securities on ASX they will need to do so before that date and if they don’t they will only be able to sell their securities on-market on Nasdaq. The Company also informed those shareholders of the availability of an ADS Conversion Facility and a Voluntary Sale Facility, and generally what options are available in respect of their holdings, under the Delisting.
  
  Following the Delisting, Bionomics will remain an Australian incorporated company and will maintain its listing of ADSs on Nasdaq under the trading symbol ‘BNOX’. Trading of ADSs on the Nasdaq will continue, uninterrupted, during and after the Delisting.
  
  Further information regarding the Delisting, is available on the Company’s website at https://ir.bionomics.com.au/

Bionomics is currently preparing for a U.S. Food and Drug Administration (FDA) End of Phase 2 (EoPh2) meeting to discuss the registrational program for BNC210 in SAD. The meeting is planned for mid-September 2023. Start-up activities for a planned Phase 3 trial of BNC210 in SAD are underway. Contingent upon advice received by the FDA, the company is planning to initiate dosing in the Phase 3 study in SAD during the Quarter ending 31 March 2024.

Payments for research and development expenditure during the Quarter decreased to $2.56 million mainly relating to the PTSD and SAD clinical studies. This represents a decrease of 54.45% from the previous Quarter’s payments of $5.62 million.

The Company’s cash balance on 30 June 2023 was $18.25 million (31 March 2023: $22.45 million).

For the purpose of Listing Rule 4.7C.3, the President, CEO and Director, Spyros Papapetropoulos, was paid $139,000 during the quarter in accordance with the employment agreement, and the other Directors were paid fees of $82,000 during the quarter.

Activity Report
Consistent with prior guidance, Bionomics is pursuing start-up activities for a planned Phase 3 study of BNC210 in SAD and preparing for an End of Phase 2 Meeting with the FDA, which it expects will take place in September 2023 with receipt of formal written feedback in early 4^th Quarter 2023.

In addition, Bionomics continued over-seeing its recurring Independent Safety Review Committee meetings in the ongoing Phase 2b ATTUNE study of BNC210 in PTSD which completed enrollment and remains on track for topline data readout expected by the end of September 2023.

Upcoming Milestones / Activities

• Topline data from the Phase 2b ATTUNE study of BNC210 in PTSD expected by the end of September 2023.
• An FDA End of Phase 2 Meeting to discuss a registrational program for BNC210 in SAD during September 2023 with an announcement in early 4^th Quarter 2023.
• Targeting First Patient Dosed in a Phase 3 study of BNC210 in SAD during 1^st Quarter 2024.
  

A copy of the full release, including a copy of the ASX Appendix 4C Cashflow Report can be found on the Company's website.

FOR FURTHER INFORMATION PLEASE CONTACT:

General:
Ms. Suzanne Irwin
Company Secretary
CoSec@bionomics.com.au

About Bionomics Limited

Bionomics Limited (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. Bionomics’ pipeline also includes preclinical assets that target Kv3.1/3.2 and Nav1.7/1.8 ion channels being developed for CNS conditions of high unmet need. 
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

FAQ

What are the highlights of Bionomics' Quarterly Cashflow Report?

The report highlights the completion of target enrollment for a Phase 2b clinical trial, the establishment of an 'at-the-market' program, key leadership updates, and the company's delisting from the ASX.

What key activities is Bionomics currently pursuing?

Bionomics is preparing for an FDA End of Phase 2 Meeting, overseeing Independent Safety Review Committee meetings for a Phase 2b clinical trial, and targeting the first patient dosed in a Phase 3 study.

What are the upcoming milestones for Bionomics?

Topline data from the Phase 2b clinical trial is expected by the end of September 2023, along with an FDA End of Phase 2 Meeting in September 2023, and targeting the first patient dosed in a Phase 3 study during the 1st Quarter of 2024.

How can shareholders sell their securities after Bionomics' delisting from the ASX?

Shareholders can sell their securities on Nasdaq under the trading symbol 'BNOX', and the company has informed shareholders of the availability of an ADS Conversion Facility and a Voluntary Sale Facility.