Quarterly Activities and Cashflow Report
28 4월 2023 - 7:00PM
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 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.
Bionomics (NASDAQ:BNOX)
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Bionomics (NASDAQ:BNOX)
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