Quarterly Activities and Cashflow Report

Rhea-AI Summary

Bionomics Limited (Nasdaq: BNOX) released its Appendix 4C – Quarterly Cashflow Report for the quarter ending December 31, 2022. Key highlights include the announcement of the PREVAIL study results for BNC210 in Social Anxiety Disorder, which did not meet its primary endpoint but showed favorable trends in secondary endpoints. The company reported a cash balance of $30.70 million at the end of the quarter, down from $31.43 million. Additionally, research and development expenses rose by 77.71% to $6.32 million. Bionomics appointed Spyridon Papapetropoulos as CEO, effective January 5, 2023, to lead the ongoing analysis of the PREVAIL data.

Positive

• Favorable trends in secondary endpoints from the PREVAIL study for BNC210.
• Appointed CEO with experience in CNS clinical development.
• Sufficient cash runway until at least mid-2024.

Negative

• Primary endpoint of the PREVAIL study not met.
• Increased research and development expenses to $6.32 million.

ADELAIDE, Australia, Jan. 30, 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 31 December 2022 (Quarter) and up to the date of this announcement include:

• 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 released its Australian 2022 Annual Report.
• On 6 October 2022, the Company released its 2022 Corporate Governance Statement and Appendix 4G.
• On 12 October 2022, Bionomics hosted a Key Opinion Leader (KOL) Webinar on BNC210 and Social Anxiety Disorder.
• On 14 October 2022, Bionomics released 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 that the Company had received $4.6 million Australian Government R&D tax incentive refund relating to the financial year ended 30 June 2022.
• On 25 October 2022, Bionomics released the Quarterly Activities Report for the quarter ending September 2022.
• On 10 November 2022, Bionomics presented at the Credit Suisse 31^st Annual Healthcare Conference in Rancho Palos Verdes, California.
• On 11 November 2022, Bionomics announced the filing of a F-1 Registration Statement for a Proposed Offering of American Depositary Shares (“ADS”) in the U.S.
• On 15 November 2022, Bionomics announced a Proposed Underwritten Offering of ADS in the U.S. and filed a Registration Statement amendment.
• On 16 November 2022, Bionomics announced the results of its Annual General Meeting.
• On 17 November 2022, Bionomics announced the pricing of its underwritten Follow-On Offering of 614,026 ADS in the U.S. at a price of US$7.80 per ADS.
  
  The offering price of US$7.80 per ADS ($0.0641 per ordinary share) represented a 1.63% discount to the volume weighted average price for the 15 days ending on 16 November 2022 on which trades of the Company’s shares were recorded on the ASX.
• On 22 November 2022, Bionomics announced the Closing of a US$5 million underwritten offering of ADS in the U.S.
• On 29 November 2022, Bionomics participated in a Fireside Chat at the Evercore ISI 5^th Annual HealthCONx Conference.
• On 5 & 6 December 2022, Bionomics had two Poster Presentations at the 61^st Annual Meeting of the American College of Neuropsychopharmacology Meeting in Phoenix, Arizona entitled “Development of an Improved Oral Tablet Formulation of BNC210, a Negative Allosteric Modulator of the Alpha 7 Nicotinic Acetylcholine Receptor, Suitable for Evaluation as an Acute Treatment for Social Anxiety Disorder” and “Pharmacometrics Analysis and Drug Reformulation of BNC210 to Optimize its Evaluation in a Phase 2 Trial in PTSD Patients”, respectively.
• On 16 December 2022, Bionomics announced that it had appointed Spyridon “Spyros” Papapetropoulos, M.D., as President and Chief Executive Officer (CEO), effective 5 January 2023.
  
  Errol B. De Souza, Ph.D., who had been serving as Bionomics’ Executive Chairman since November 2018, would continue in his role through 31 December 2022 to ensure a seamless transition and resumed the role of Non-Executive Chairman of the Board of Directors effective 1 January 2023.
• On 19 December 2022, Bionomics announced topline results from its Phase 2 randomised, double-blind, placebo-controlled, multi-centre, dose-ranging PREVAIL study to evaluate the safety, tolerability, and efficacy of BNC210 for the acute treatment of Social Anxiety Disorder (SAD).
  
  While the primary endpoint as measured by the change from baseline to the average of the Subjective Units of Distress Scale (SUDS) scores during a 5-minute Public Speaking Challenge was not met in the BNC210-treated patients when compared to placebo, the findings do indicate a consistent trend toward improvements across primary and secondary endpoints and a favourable safety and tolerability profile consistent with previously reported results.
  
  The Company is continuing analysis of the PREVAIL dataset and is assessing next steps for the development of BNC210 in SAD.
• Payments for research and development expenditure during the Quarter increased to $6.32 million mainly relating to the Phase 2 ATTUNE PTSD and PREVAIL SAD Study expenditures. This represents an increase of 77.71% from the previous Quarter’s payments of $3.50 million.
• The Company’s cash balance on 31 December 2022 was $30.70 million (30 September 2022: $31.43 million).

For the purpose of Listing Rule 4.7C.3, during the Quarter, the Executive Chairman was paid $207,000 for consulting fees and $8,000 for reimbursement of health benefit insurance, in accordance with the consulting agreement, and the other Directors were paid fees of $140,000.

Activity Report
Consistent with the Company’s prior guidance, topline results were announced in late 4Q’2022 from the Phase 2 randomised, double-blind, placebo-controlled, multi-centre, dose-ranging PREVAIL Study in SAD in which the primary endpoint was not statistically met. However, the findings do indicate consistent trends favouring BNC210 compared to placebo in primary and multiple secondary endpoints, warranting a further and robust analysis of the PREVAIL dataset in order to assess the future development of BNC210 in SAD. The Company’s recent appointment of a new President & CEO, Spyridon ‘Spyros’ Papapetropoulos, MD, Ph.D., was timely given his extensive experience in CNS clinical development, which will facilitate the Bionomics team’s ongoing analysis of the PREVAIL Study data. The Company remains focused on conducting the analysis, including consulting with key opinion leaders, advisors and regulators, and is eager to share its findings upon reaching a conclusion and determining its path forward.

The Company also continued to closely manage its ongoing Phase 2b ATTUNE Study in PTSD including over-seeing the recurring Independent Safety Review Committee meetings and working with the Contract Research Organisation (“CRO”) to maximize the ongoing study enrollment. As part of these efforts, the ATTUNE Study has been expanded to include seven sites in the United Kingdom and these sites have recently begun enrolling study participants.

Finally, with the additional financing activities during the quarter, the Company has sufficient cash runway to support its ongoing activities and upcoming milestones with runway to at least mid-2024.

Upcoming Milestones / Activities

• Release of broader dataset for BNC210 PREVAIL study in SAD expected 1H2023.
• General Meeting of shareholders to be held virtually via an online platform, at 8:30am, Tuesday, 21 February 2023 (ACDT).
• Topline data for BNC210 ATTUNE study in PTSD expected Mid-2023.

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 (650) 524-5143 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

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 were the results of the BNC210 PREVAIL study announced by BNOX?

The PREVAIL study did not meet its primary endpoint but showed favorable trends in secondary endpoints.

What is the cash balance of Bionomics Limited as of December 31, 2022?

Bionomics reported a cash balance of $30.70 million as of December 31, 2022.

Who was appointed as CEO of Bionomics Limited?

Spyridon Papapetropoulos was appointed as CEO, effective January 5, 2023.

How much did Bionomics spend on research and development in the last quarter?

Bionomics' research and development expenditure increased to $6.32 million for the quarter ending December 31, 2022.

What is the expected timeline for topline data from the ATTUNE study in PTSD by BNOX?

Topline data for the ATTUNE study in PTSD is expected in mid-2023.