ADELAIDE, Australia, April 28, 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 March 2023 (Quarter) and up to the date of this announcement include:
- On 1 January 2023, Errol B. De Souza, Ph.D., assumed the role of Non-Executive Chairman of the Board of Directors. Dr. De Souza had previously served as Bionomics' Executive Chairman from November 2018 through 31 December 2022.
- On 5 January 2023, Spyridon "Spyros" Papapetropoulos, M.D., assumed the role of President and Chief Executive Officer (CEO).
- On 18 January 2023, Bionomics filed the Notice of Extraordinary General Meeting and Proxy Form.
- On 30 January 2023, Bionomics released its Appendix 4C – Quarterly Cashflow Report for the quarter ended 31 December 2022.
- On 21 February 2023, Bionomics announced the results of the Extraordinary General Meeting in which all resolutions successfully passed.
- On 23 February 2023, Bionomics released its Half-Year Report for the half-year ended 31 December 2022.
- On 9 March 2023, Bionomics announced a comprehensive analysis of the data from its Phase 2 PREVAIL study of BNC210 in Social Anxiety Disorder (SAD), the results of which support the late-stage development of BNC210 in SAD.
The comprehensive analyses of PREVAIL's results were discussed by Dr. Papapetropoulos and Bionomics Vice President of Strategy and Corporate Development Connor Bernstein in a webcast and conference call on 9 March 2023. A replay of the event is available here.
Bionomics is currently preparing for a U.S. Food and Drug Administration (FDA) End of Phase 2 Meeting to discuss a registrational program for BNC210 in SAD. Start-up activities for a planned Phase 3 trial of BNC210 in SAD are underway.
- On 27 April 2023, Bionomics announced the completion of enrollment in ATTUNE, a Phase 2b double-blind, placebo-controlled, randomised study of BNC210 in patients with Post-Traumatic Stress Disorder (PTSD).
- Payments for research and development expenditure during the Quarter decreased to $5.62 million mainly relating to the Phase 2 ATTUNE PTSD and PREVAIL SAD Study expenditures. This represents a decrease of 11.08% from the previous Quarter's payments of $6.32 million.
- The Company's cash balance on 31 March 2023 was $22.45 million (31 December 2022: $30.70 million).
For the purpose of Listing Rule 4.7C.3, from 1 January 2023, Errol de Souza, former Executive Chairman, resumed the position of Non-Executive Chairman (following the appointment of the new CEO) and received a transitional payment of $503,000, on 5 January 2023, Spyros Papapetropoulos commenced employment as President, CEO and director, and was paid $266,000 during the quarter in accordance with the employment agreement, and the other Directors were paid fees of $101,000 during the quarter.
Activity Report
Consistent with prior guidance, Bionomics reported a comprehensive analysis of the data from its Phase 2 PREVAIL study of BNC210 in SAD in 1Q2023. 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 2H2023.
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 mid-year completion and topline data readout expected in Calendar Year (CY)3Q 2023.
Finally, the Company has sufficient cash runway to support its ongoing activities through its anticipated milestones and into at least mid-2024.
Upcoming Milestones / Activities
- Topline data from the Phase 2b ATTUNE study of BNC210 in PTSD expected in CY3Q 2023
- An FDA End of Phase 2 Meeting to discuss a registrational program for BNC210 in SAD is anticipated in 2H2023
- Targeting First Patient Dosed in a Phase 3 study of BNC210 in SAD in CY4Q 2023 / CY1Q 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 +61 8 8150 7400 [email protected] | Investor Relations: Mr Connor Bernstein Vice President, Strategy and Corporate Development +1 (650) 524-5143 [email protected] |
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.
