- Expanded clinical infrastructure to support a growing portfolio
of clinical trials of novel interventions and for drug discovery;
14 registered clinical trials in depression, led by Company CEO and
Chief Medical and Scientific Officer, completed or in process
- Excellent progress on only psilocybin trial in Canada actively recruiting study participants
to receive psilocybin-assisted therapy
- Clinical footprint in Canada
has administered ~4,900 ketamine treatments to date; focus on
expansion opportunities in the U.S. and Europe
TORONTO, Nov. 29, 2021 /CNW/ - Braxia Scientific Corp.
("Braxia Scientific", or the "Company"), (CSE: BRAX) (OTC: BRAXF)
(FWB: 496), a medical research company with clinics providing
innovative ketamine treatments for persons with depression and
related disorders, today announced the filing of its fiscal
second-quarter results for the three-month period ending
September 30, 2021. Complete
financial statements along with related management discussion and
analysis can be found in the System for Electronic Document
Analysis and Retrieval (SEDAR), the electronic filing system for
the disclosure documents of issuers across Canada, at www.SEDAR.com.
"We have made tremendous progress on our strategic priorities,
including increasing access to novel treatments for patients with
depression through our clinics. We have also established a clinical
research infrastructure required to execute on our growing pipeline
of registered clinical trials alongside third-party sponsors, with
14 trials registered to date in the area of depression, including
Canada's first and only psilocybin
trial actively recruiting study participants to receive
psilocybin-assisted therapy," said Dr. Roger McIntyre, CEO, Braxia Scientific.
"Looking ahead to our clinical research and
development, our psilocybin trial is underway with newly
trained therapists. These therapists have the required skills to
execute a successful psilocybin-assisted therapy trial while
ensuring patients receive treatments according to approved
protocols and best practices – critical milestones that will create
near-term value for Braxia Scientific in terms of patient access,
drug development and implementation. While our product development
pipeline is at an early stage, we have made progress in our goal to
develop new ketamine derivatives and delivery formats underpinned
by our large proprietary health database from administering
~4,900 ketamine treatments to date at our clinics."
"We continue to prioritize the expansion of our clinical
footprint in Canada. We remain
disciplined in our growth efforts and continue to actively assess a
strong pipeline of opportunities to scale access to ketamine
treatments for patients in North
America."
Recent Operational Highlights and Corporate Update
Established Clinical Infrastructure to Advance Research and
Drug Development and Provide Patient Access to Ketamine, Psilocybin
and other Potential Psychedelics in Future
Building on management's extensive clinical expertise, the
Company has expanded the necessary infrastructure to provide novel
interventions that include ketamine, psilocybin and other potential
future psychedelics that become available.
More specifically, the Company infrastructure has:
- Established access to a high-quality source of psilocybin that
meets all regulatory requirements for human use in clinical
research
- Received over 100 referrals for psilocybin-assisted therapy at
our clinic in the first six weeks of opening patient recruitment
approved protocols to collect treatment outcome data to allow for
further optimization of treatment protocols and development of best
practice guidelines
- Established well-trained medical and research staff to assess
patients for psilocybin suitability. This includes twenty (20)
therapists licensed to practice in Ontario with specialized training in
psilocybin-assisted therapy
- Built physical space to safely provide psilocybin treatment
with a comfortable living room-like environment with appropriate
medical and psychological monitoring and evidence-based
protocols
This infrastructure enables Braxia Scientific to provide
psilocybin-assisted therapy as part of the current clinical trial,
and importantly, if psilocybin is approved in the future, Braxia
Scientific is positioned to provide access to psilocybin-assisted
therapy treatment for eligible patients immediately.
Fourteen (14) Clinical Trials Including Landmark Multi-Dose
Psilocybin Study: Dr. Joshua
Rosenblat, Chief Medical and Scientific Officer for Braxia
Scientific, recently commenced a landmark clinical trial to conduct
Canada's first multiple-dose
controlled psilocybin study for treatment-resistant depression
(TRD). Through this trial, patients will be able to receive
immediate access to psilocybin and be monitored by therapists with
specialized training in psilocybin-assisted therapy. Whereas most
other TRD studies limit participation to patients that have not
found relief from a maximum of five other potential remedies, this
trial does not impose an upper limit, and allows for patients that
have endured dozens of unsuccessful medical treatments, including
with ketamine and electroconvulsive therapy.
Developing the Next Generation of Clinicians: The Braxia
Institute, the Company's training centre focused on advancing
psychiatric clinical practice and health services of ketamine and
psychedelic treatment therapy, is set to graduate the first cohort
of medical professionals from its psilocybin-assisted therapy
training program. This multidisciplinary group of 20 therapists
from diverse psychiatry and psychotherapy backgrounds experienced
and learned, through pre-readings, didactic teaching, peer
teaching, group discussion and simulations, which provided
important background on the use of psilocybin for treating
depression and practical considerations for providing
psilocybin-assisted psychotherapy. All the enrolled therapists are
also required to complete a practicum component, in which medical
professionals gain experience in administering psilocybin-assisted
therapy for participants with depression as part of an upcoming
Health Canada-approved clinical trial.
The Company anticipates that, subject to the regulatory approval
of psilocybin, therapists would also be trained to implement
psychedelics in clinical practice.
Growing Proprietary Ketamine Research Database: As the
Company continues to focus on developing novel ketamine
derivatives, Braxia Scientific's team of researchers also continue
to carry out multiple research trials adding to the Company's large
database of proprietary data critical to future drug development
efforts.
The Canadian Rapid Treatment Centre of Excellence (CRTCE), a
wholly owned Braxia subsidiary, has comprehensive health data from
administering approximately 4,900 ketamine treatments at CRTCE
clinics. Braxia Scientific's researchers have published 39
ketamine-related manuscripts in peer-reviewed biomedical
journals.i
During the quarter, the Company reported encouraging preliminary
findings of an important ketamine clinical study that suggest
ketamine may be as effective as a standalone antidepressant, versus
as an adjunctive therapy. The study, which was conducted at the
CRTCE, showed comparable clinical benefits (e.g., antidepressant
effects and reduction in suicidal thoughts) in a sample of 220
patients with treatment-resistant depression (TRD) who received
intravenous (IV) ketamine infusions as a monotherapy, as compared
with those receiving IV ketamine in addition to oral
antidepressants.
Following the study protocols, participants in the ketamine
monotherapy group achieved response and remission rates of 39.1%
and 17.4%, respectively. Meanwhile, those receiving ketamine
treatment adjunct to antidepressants, saw corresponding rates of
21.9% and 6.7%.
These initial findings support ketamine's effectiveness as a
rapid-acting antidepressant treatment approach as evidenced by its
ability to improve depression as a monotherapy, and the data is
particularly important, because it shows that the benefits of
ketamine may not be dependent on the co-prescription of other
medications.
Publishing timely studies: Braxia Scientific was pleased
to announce the publication of a new analysis led by the Company's
CEO, Dr. Roger McIntyre, in the
Journal of the Royal Society of Medicine. The study, which
showed a decrease in the Canadian suicide mortality rate during the
first year of the COVID-19 pandemic, was initiated to evaluate the
impact on national suicide rates in Canada of federal, public health and social
support programs that were put in place to mitigate the coinciding
abrupt changes to social and financial provisions. The findings
also underscore Braxia Scientific's core objective to develop
derivatives of ketamine and other psychedelics as additional
measures to further reduce suicidality.
Growing Canadian Patient Treatments: To accommodate
increasing demand for ketamine treatments, the Company expects to
commence expansion of its existing clinics in Toronto and Ottawa in the coming months, as well as ramp
up personnel at its existing clinics. Through its four
multidisciplinary, community-based Canadian clinics, the Company
continues to see increased patient referrals and treatments which
led to a year-over-year increase in revenue of nearly 55% in the
second quarter of fiscal 2022.
North American Clinic Expansion – Following the
publication by the American Journal of Psychiatry of the
international guidelines and best practices for clinicians on the
use of IV ketamine, which is based on research conducted by the
Company's research team, including CEO Dr. Roger McIntyre and
Chief Medical and Scientific Officer Dr. Joshua Rosenblat, at
CRTCE, the Company remains focused on expanding its clinical
footprint beyond Canada into the
U.S. and Europe. The Company
continues to be disciplined in deploying capital towards
acquisition initiatives.
Cultivating Name Recognition: Braxia Scientific was
featured in recent national and local news coverage, discussing
access and promoting the use of ketamine to treat brain-based
illnesses, bolstering the Company's brand awareness. Braxia
Scientific CEO Dr. Roger McIntyre
was featured on CTV's W5, Canada's most-watched current affairs and
documentary program. The episode, entitled "Psychedelic Healing,"
aired on October 23, 2021.
Braxia Scientific and the CRTCE were also highlighted in a
recent article by Toronto Life, a monthly magazine. In the
piece, Dr. McIntyre and Dr. Rosenblat discussed the benefits of
ketamine therapy to rapidly treat mental disorders like
treatment-resistant depression (TRD) and the access to the
treatments Braxia Scientific provides through its clinics.
Second Quarter Financial Summary
The Company's cash and cash equivalents as of September 30, 2021, was $9,614,977, compared with $10,257,750 at June 30,
2021.
The Company recorded revenue of $385,525 for the second quarter fiscal 2022,
ended September 30, 2021 compared
with revenue of $249,049 in the
second quarter ended September 30,
2020, reflecting 54.8% increase year-over-year. Second
quarter 2022 gross margin was $57,140, compared with $3,603 in the prior year period. Revenues
consisted primarily of sales from the administering of ketamine
infusion treatments at the CRTCE clinics in Ontario.
Net loss for the quarter decreased 16%, to $1,709,942 including a non-cash share-based
compensation expense of $821,748,
compared to a net loss of $2,052,580
in the second quarter of the prior year period.
Looking Ahead
"Braxia Scientific's value proposition rests in our superior
human capital, well established clinical infrastructure and large
proprietary health database," said Dr. McIntyre. "Our team includes
three researchers ranked among the world's top 25 in depression, as
well as mood disorders research. Having conducted or registered 14
clinical trials for depression, we believe Braxia Scientific has a
distinct competitive advantage among the leading groups
endeavouring to research and develop new psychedelic treatments.
With this expertise and data, we will work to enhance our
intellectual property, including and developing new chemical
entities, while providing patients with access to new pathways to
treat their mental health disorders."
About Braxia Scientific Corp.
Braxia Scientific is a medical research company with clinics
that provide innovative ketamine treatments for persons with
depression and related disorders. Through its medical solutions,
Braxia aims to reduce the illness burden of brain-based disorders,
such as major depressive disorder among others. Braxia is primarily
focused on (i) owning and operating multidisciplinary clinics,
providing treatment for mental health disorders, and (ii) research
activities related to discovering and commercializing novel drugs
and delivery methods. Braxia seeks to develop ketamine and
derivatives and other psychedelic products from its IP development
platform. Through its wholly owned subsidiary, the Canadian Rapid
Treatment Center of Excellence Inc., Braxia currently operates
multidisciplinary community-based clinics offering rapid-acting
treatments for depression located in Mississauga, Toronto, Ottawa, and Montreal.
ON BEHALF OF THE BOARD
"Dr. Roger S. McIntyre"
Dr. Roger S. McIntyre
Chairman & CEO
The CSE has not reviewed and does not accept responsibility for
the accuracy or adequacy of this release.
Forward-looking Information Cautionary Statement
This news release contains forward-looking statements within the
meaning of applicable securities laws. All statements that are not
historical facts, future estimates, plans, programs, forecasts,
projections, objectives, assumptions, expectations, or beliefs of
future performance are "forward-looking statements."
Forward-looking statements include statements about the intended
promise of ketamine-based treatments for depression and the
potential for ketamine to treat other emerging psychiatric
disorders, such as Bipolar Depression. Such forward- looking
statements involve known and unknown risks, uncertainties and other
factors that may cause actual results, events, or developments to
be materially different from any future results, events or
developments expressed or implied by such forward-looking
statements. Such risks and uncertainties include, among others, the
failure of ketamine, psilocybin and other psychedelics to provide
the expected health benefits and unanticipated side effects,
dependence on obtaining and maintaining regulatory approvals,
including acquiring and renewing federal, provincial, municipal,
local or other licenses and engaging in activities that could be
later determined to be illegal under domestic or international
laws. Ketamine and psilocybin are currently Schedule I and Schedule
III controlled substances, respectively, under the Controlled Drugs
and Substances Act, S.C. 1996, c. 19 (the "CDSA") and it is a
criminal offence to possess such substances under the CDSA without
a prescription or a legal exemption. Health Canada has not approved psilocybin as a drug
for any indication, however ketamine is a legally permissible
medication for the treatment of certain psychological conditions.
It is illegal to possess such substances in Canada without a prescription. These factors
should be considered carefully, and readers are cautioned not to
place undue reliance on such forward-looking statements.
Although the Company has attempted to identify important risk
factors that could cause actual actions, events or results to
differ materially from those described in forward-looking
statements, there may be other risk factors that cause actions,
events or results to differ from those anticipated, estimated or
intended. Additional information identifying risks and
uncertainties that could affect financial results is contained in
the Company's filings with Canadian securities regulators,
including the Amended and Restated Listing Statement dated
April 15, 2021, which are available
at www.sedar.com. There can be no assurance that
forward-looking statements will prove to be accurate, as actual
results and future events could differ materially from those
anticipated in forward-looking statements.
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SOURCE Braxia Scientific Corp.