Quarterly Activities and Cashflow Report
2023年1月31日 - 8:23AM
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
31st 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 5th Annual HealthCONx Conference.
- On 5 & 6 December 2022, Bionomics had two Poster
Presentations at the 61st 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
Bionomics (NASDAQ:BNOX)
過去 株価チャート
から 11 2024 まで 12 2024
Bionomics (NASDAQ:BNOX)
過去 株価チャート
から 12 2023 まで 12 2024