Quarterly Activities Report for September 2022
2022年10月25日 - 7:00PM
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 IrwinCompany Secretary+61 8 8150
7400CoSec@bionomics.com.au |
Investor
Relations:Mr Connor BernsteinVice President, Strategy and
Corporate Development+1 (831)
246-3642cbernstein@bionomics.com.au |
About Bionomics LimitedBionomics 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
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