Quarterly Activities and Cashflow Report
July 31 2023 - 6:00AM
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 30 June 2023 (Quarter) and up to the date of this
announcement include:
- On 27 April 2023,
Bionomics announced that the Company has completed target enrolment
of approximately 200 participants in its randomized, double-blind,
placebo-controlled, multi-center Phase 2b ATTUNE clinical trial
evaluating BNC210 in Post-Traumatic Stress Disorder (PTSD). Topline
results are expected in the third quarter of 2023.
- On 28 April 2023,
Bionomics released its Appendix 4C – Quarterly Cashflow Report for
the quarter ended 31 March 2023.
- On 8 May 2023,
Bionomics announced the establishment of an “at-the-market” program
(the ATM Program) with Cantor Fitzgerald & Co. (Cantor), who
will act as sales agent. Under the ATM Program, the Company may
offer and sell up to US$11.5 million of ordinary shares in the
capital of the Company (Shares) in the form of American Depositary
Shares (ADSs), with each ADS representing one hundred eighty (180)
fully paid Shares, through Cantor. Sales of ADSs under the ATM
Program may be made from time to time, with the timing and amount
of any sales to be determined by Bionomics based on a variety of
factors. Bionomics may determine to sell some, all, or none of the
ADSs under the ATM Program and may terminate the ATM Program at its
discretion. Bionomics, through Cantor, may sell ADSs by any lawful
method deemed to be an “at-the-market offering” defined by Rule
415(a)(4) under the Securities Act of 1933, as amended. Sales made
through the ATM Program may be made at market prices prevailing at
the time of a sale or at prices related to prevailing market
prices. As a result, actual sales prices may vary. To effectuate
the establishment of the ATM Program, the Company has entered into
a Sales Agreement with Cantor, acting as sales agent. Bionomics
currently intends to use the net proceeds from the ATM, together
with its existing cash and cash equivalents, to fund its pipeline
development and to maintain working capital and for general
corporate purposes. The Company has filed a shelf registration
statement on Form F-3, including a base prospectus relating to a
proposed offer by the Company of securities (being Shares and ADSs,
various series of debt securities and warrants to purchase any such
securities) and a sales agreement prospectus relating to the ATM
Program, with the Securities Exchange Commission (SEC), but such
shelf registration statement has not yet been declared effective by
the SEC. The securities referred to in the shelf registration
statement may not be sold, nor may offers to buy them be accepted,
prior to the time the registration statement becomes effective by
the SEC.
- On 31 May 2023,
Bionomics CEO made a poster presentation at 2023 American Society
of Clinical Psychopharmacology annual meeting at 11.15am (ET), in
Miami Beach, Florida. The poster presentation included previously
disclosed and new results of a comprehensive analysis of the data
from the Phase 2 PREVAIL study of BNC210 in Social Anxiety Disorder
(SAD). These results are expected to enable the late-stage
development of BNC210 in SAD.
- On 15 June 2023,
Bionomics filed a press release in the U.S. advising that the
Company was presenting at:
- the Maxim Group
Healthcare Virtual Conference’s Panel discussion titled “Mental
Health, More Critical Than Ever” via webcast on 20 June 2023 at
2:00pm ET, and
- H.C. Wainwright’s
4th Annual Neuropsychiatry Virtual Conference at 7:00am ET on 26
June 2023.
- On 3 July 2023,
Bionomics announced key leadership updates to drive its ongoing
transformation to a U.S.-focused company, streamline its allocation
of capital, and support its next stage of strategic growth. Alan
Fisher, previously a non-executive member of the Board since 1
September 2016 and Chair of the Audit & Risk Committee, has
been appointed Non-Executive Chair of the Board, effective from 1
July 2023. Mr. Fisher succeeds Errol De Souza, Ph.D., who remains
on the Board as a Non-Executive Director. Tim Cunningham of
Danforth Associates has been appointed Chief Financial Officer
effective 1 July 2023. The Company has also engaged Francisco Bejar
as a strategic advisor to head the business development efforts in
the U.S. and abroad, whilst Connor Bernstein, Vice President,
Strategy and Development, stepped down from his role with effect
from 30 June 2023. Adrian Hinton, who was Acting CFO for the last
four years, will continue supporting the Company as a Financial
Controller.
- On 25 July 2023,
Bionomics announced that it had submitted a formal request to the
ASX to be removed from the official list of the ASX
(Delisting).
- On 28 July 2023,
Bionomics received formal approval from the ASX for the Delisting
and notified shareholders whose securities are held on the
Company’s Australian principal share register that, from the time
the Delisting takes effect which is scheduled for close of business
on 28 August 2023, Bionomics Shares will no longer be quoted or
traded on the ASX, and informed those shareholders that if they
wish to sell their securities on ASX they will need to do so before
that date and if they don’t they will only be able to sell their
securities on-market on Nasdaq. The Company also informed those
shareholders of the availability of an ADS Conversion Facility and
a Voluntary Sale Facility, and generally what options are available
in respect of their holdings, under the Delisting.Following the
Delisting, Bionomics will remain an Australian incorporated company
and will maintain its listing of ADSs on Nasdaq under the trading
symbol ‘BNOX’. Trading of ADSs on the Nasdaq will continue,
uninterrupted, during and after the Delisting.Further information
regarding the Delisting, is available on the Company’s website at
https://ir.bionomics.com.au/
Bionomics is currently preparing for a U.S. Food
and Drug Administration (FDA) End of Phase 2 (EoPh2) meeting to
discuss the registrational program for BNC210 in SAD. The meeting
is planned for mid-September 2023. Start-up activities for a
planned Phase 3 trial of BNC210 in SAD are underway. Contingent
upon advice received by the FDA, the company is planning to
initiate dosing in the Phase 3 study in SAD during the Quarter
ending 31 March 2024.
Payments for research and development
expenditure during the Quarter decreased to $2.56 million mainly
relating to the PTSD and SAD clinical studies. This represents a
decrease of 54.45% from the previous Quarter’s payments of $5.62
million.
The Company’s cash balance on 30 June 2023 was
$18.25 million (31 March 2023: $22.45 million).
For the purpose of Listing Rule 4.7C.3, the
President, CEO and Director, Spyros Papapetropoulos, was paid
$139,000 during the quarter in accordance with the employment
agreement, and the other Directors were paid fees of $82,000 during
the quarter.
Activity ReportConsistent with
prior guidance, 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
September 2023 with receipt of formal written feedback in early 4th
Quarter 2023.
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 topline data readout expected
by the end of September 2023.
Upcoming Milestones /
Activities
- Topline data from
the Phase 2b ATTUNE study of BNC210 in PTSD expected by the end of
September 2023.
- An FDA End of Phase 2 Meeting to
discuss a registrational program for BNC210 in SAD during September
2023 with an announcement in early 4th Quarter 2023.
- Targeting First
Patient Dosed in a Phase 3 study of BNC210 in SAD during 1st
Quarter 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
IrwinCompany SecretaryCoSec@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. Bionomics’ pipeline also includes preclinical
assets that target Kv3.1/3.2 and Nav1.7/1.8 ion channels being
developed for CNS conditions of high unmet
need. 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
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