Quarterly Activities Report for September 2022

ADELAIDE, Australia, Oct. 25, 2022 (GLOBE NEWSWIRE) -- Bionomics Limited (ASX: BNO, Nasdaq: BNOX), (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 September 2022 (Quarter) and up to the date of this announcement include:

• On 13 July 2022, Bionomics’ Executive Chairman, Dr. Errol De Souza, participated in William Blair’s Biotech Focus Conference 2022 including the “Unmet Needs and Novel Therapies in Neuropsychiatry” panel.
• On 20 July 2022, Bionomics announced the issue of 7.7 million unlisted options to employees under the Company’s Employee Equity Plan.
• On 29 July 2022, Bionomics released its Appendix 4C – Quarterly Cashflow Report for the quarter ended 30 June 2022.
• On 8 August 2022, Bionomics announced the Company had received a $2.1 million Australian Government’s Research and Development (R&D) tax incentive refund relating to the financial year ended 30 June 2021.
• On 25 August 2022, Bionomics released its Appendix 4E and Full Year Financial Statements for the year ended 30 June 2022.
• On 21 September 2022, Bionomics announced it would be hosting a Key Opinion Leader (“KOL”) webinar on BNC210, a proprietary, first-in-class oral therapeutic with potential to treat Social Anxiety Disorder (“SAD”) on Wednesday, 12 October 2022, 2:30 – 3:30 pm EDT.
  
  The webinar featured anxiety disorder KOLs Murray B Stein, MD, MPH, FRCPC, and Charles T Taylor, PhD, both from the University of California San Diego, who discussed the unmet medical need and current treatment landscape for SAD patients, as well as Bionomics’ ongoing clinical development and Phase 2 PREVAIL Study paradigm.

• On 4 October 2022, Bionomics announced that it would be attending the Cantor Neurology & Psychiatry Conference including Bionomics’ Executive Chairman, Dr. Errol De Souza’s participation in the “Emerging Broad Pipeline for Psychiatric Indications Does Not Weigh on Our Minds” panel.
• On 6 October 2022, the Company filed its 2022 Annual Report.
• On 6 October 2022, the Company filed its 2022 Corporate Governance Statement and Appendix 4G.
• On 14 October 2022, Bionomics filed the Notice of Annual General Meeting and Proxy Form.
• On 17 October 2022, Bionomics filed the U.S. Annual Report on Form 20-F with the U.S. Securities and Exchange Commission for the financial year ended 30 June 2022.
• On 18 October 2022, Bionomics announced the Company had received a $4.6 million Australian Government’s R&D tax incentive refund relating to the financial year ended 30 June 2022.
• The Company’s cash balance on 30 September 2022 was $31.43 million (30 June 2022: $33.56 million).
• Payments for research and development expenditure during the Quarter decreased to $3.50 million mainly relating to the ATTUNE and PREVAIL Study expenditures. This represents a decrease of 16.28% from the previous Quarter’s payments of $4.18 million. The ATTUNE Study is evaluating the oral tablet formulation of BNC210 compared to placebo in approximately 200 Post-Traumatic Stress Disorder (“PTSD”) patients in the U.S. The PREVAIL Study is evaluating two doses of the oral tablet formulation of BNC210 compared to placebo as an acute treatment for SAD in approximately 150 patients in the U.S.

For the purpose of Listing Rule 4.7C.3, the Executive Chairman was paid during the Quarter $200,000 for consulting fees, $8,000 for reimbursement of health benefit insurance and a $450,000 bonus relating to FY22, in accordance with the consulting agreement, and the other Directors were paid fees of $82,000 during the Quarter.

Activity Report

During the quarter, Bionomics continued to closely manage both of its ongoing ATTUNE and PREVAIL clinical studies including over-seeing the recurring Independent Safety Review Committee meetings for the ATTUNE Study and working with the Contract Research Organization (“CRO”) to maximize the ongoing study enrollments. Topline results for the PREVAIL Study are anticipated by year-end 2022, consistent with the Company’s prior guidance.

In anticipation of this, the Company continued to manage its Chemistry Manufacturing and Controls (“CMC”) and toxicology activities related to development of BNC210 for future planned studies.

The Company also remained focused on engaging in a variety of Investor Relations activities including the conferences and KOL webinar highlighted over the Quarter. Furthermore, Bionomics used its KOL webinar to communicate the findings from a U.S. Commercial Market Analysis conducted by Bluestar BioAdvisors for BNC210’s potential in SAD upon reaching commercialization.

Finally, while the Company has sufficient cash runway to complete the ATTUNE and PREVAIL Studies, the Company continues to monitor its expenditures while taking several measures to preserve its cash on hand given the current capital markets landscape.

Upcoming Activities

• 2022 Annual General Meeting on 16 November 2022
• Topline data for BNC210 PREVAIL study in SAD expected YE’22
• Topline data for BNC210 ATTUNE study in PTSD expected Mid’23
  

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 +61 8 8150 7400 CoSec@bionomics.com.au

Investor Relations: Mr Connor Bernstein Vice President, Strategy and Corporate Development +1 (831) 246-3642 cbernstein@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.

www.bionomics.com.au