Bionomics reports Full Year Financial Results
25 August 2022 - 8:00PM
Bionomics Limited (ASX:BNO, Nasdaq:BNOX), today announced its
financial results for the 12 months ended 30 June 2022.
Bionomics is a clinical stage biopharmaceutical company
developing novel, allosteric, ion channel modulators designed to
transform the lives of patients suffering from serious CNS
disorders with high unmet medical need. Bionomics is advancing its
lead product candidate, BNC210, an oral proprietary selective
Negative Allosteric Modulator of the 7 nicotinic acetylcholine
receptor (“7 receptor”) for the acute treatment of Social Anxiety
Disorder (“SAD”) and chronic treatment of Post-Traumatic Stress
Disorder (“PTSD”).
During the fiscal year ended 30 June 2022, Bionomics made
several advancements with the ongoing clinical development of
BNC210. After receiving US Food and Drug Administration (“FDA”)
clearance to proceed with evaluating BNC210 for the acute treatment
of SAD followed by the FDA’s granting of Fast Track designation,
the Company initiated its Phase 2 clinical trial (“the PREVAIL
study”) in January 2022 to evaluate BNC210 for the acute treatment
of SAD, with topline data expected by the end of 2022. 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.
Additionally, the Company advanced the development of BNC210 in
a chronic indication in PTSD with the start of its Phase 2b ATTUNE
study in July 2021. The ATTUNE study is a randomised,
placebo-controlled study to evaluate the effects of twice daily
dosing (900 mg) of the Company’s newly developed tablet formulation
of BNC210. The topline data from the BNC210 Phase 2b ATTUNE study
are expected in mid-2023.
The Company’s expertise and approach have been validated through
its strategic partnership with MSD (known as Merck in the United
States and Canada) for the Positive Allosteric Modulator program,
which targets the 7 receptor that has garnered significant
attention for treating cognitive deficits. The MSD collaboration
currently includes two candidates that are in early-stage Phase 1
safety and biomarker clinical trials for treating cognitive
impairment. The first compound has completed Phase 1 safety
clinical trials in healthy subjects and is undergoing biomarker
studies. In 2020, a second molecule that showed an improved potency
profile in preclinical animal models was advanced by Merck under
this collaboration into Phase 1 clinical trials.
During the year, the Company completed a US IPO and Nasdaq
listing raising net proceeds of $26,670,801. The Company is now
dual-listed on the Australian Securities Exchange ("ASX") and
Nasdaq where its American Depositary Shares ("ADSs") are listed at
a ratio of 180 ordinary shares to one ADS under the ticker symbol
“BNOX.”
Near-term Outlook Bionomics remains focused on
the development of its ongoing clinical programs in BNC210 and is
closely managing both of its ongoing PREVAIL and ATTUNE clinical
studies with upcoming topline data readouts around the end of 2022
and mid-2023, respectively. The Company is continuing to manage its
Chemistry Manufacturing and Controls (“CMC”) and toxicology
activities related to non-clinical development of BNC210 for
planned future studies. In the ongoing effort to develop a
commercial strategy, Bionomics contracted with Bluestar BioAdvisors
to gain further insights into the US market potential for BNC210 as
a treatment for PTSD and SAD, the results of which the Company
plans to share more details of in the coming quarters.
Released on authority of the Board.
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 (650)
524-5143cbernstein@bionomics.com.au |
About Bionomics LimitedBionomics (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.
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