OXFORD, Ohio and COCONUT CREEK, Fla., March 2, 2022 /CNW/ - PsyBio Therapeutics Corp.
(TSXV: PSYB) (OTCQB: PSYBF) ("PsyBio" or the
"Company"), an integrated and intellectual property driven
biotechnology company developing novel, bespoke psychoactive
medicinal candidates targeting the potential treatment of mental
health challenges, neurological disorders and other human health
conditions, today announces that it has reported its audited
financial results for the year ended December 31, 2021.
Annual 2021 Financial Results
A copy of the audited condensed consolidated annual financial
statements prepared in accordance with International Financial
Reporting Standards and the corresponding management's discussion
and analysis for the year ended December 31,
2021, can be found under PsyBio's profile on SEDAR
at www.sedar.com.
"PsyBio is developing an advanced life science platform
technology in the emerging psychedelic research industry," stated
Evan Levine, Chief Executive
Officer. "Our filed intellectual property is based on producing and
scaling drug candidates using genetically modified organisms. The
PsyBio team collectively has experience managing thousands of
clinical trials and achieving hundreds of regulatory approvals
related to therapeutics, diagnostics and devices. PsyBio has filed
sixteen patent applications to date on its discovery
accomplishments and is looking forward to filing an Investigational
New Drug ("IND") application for its first biosynthetic
therapeutic candidate and launching clinical trials this year."
Fourth Quarter Development Milestones
- The Company sponsored sixteen collaborative research abstract
presentations at two scientific conferences. These abstracts cover
a wide variety of topics including: biosynthetic pathway and
transcriptional methodologic development; evaluation; screening and
optimization of systems and organisms; increasing bioproduction
yields of natural and non-natural products, as well as the
evaluation of impulsivity, motivational, psychiatric, and
psychoactive effects of PsyBio's portfolio of compounds.
- The Company successfully completed its first pre-IND meeting
with the United States Food and Drug Administration (the
"FDA"). The focus of this pre-IND meeting was to discuss
potential indications, manufacturing strategy, and obtain
regulatory guidance as PsyBio guides its technology forward towards
regulatory approval. The responses received from the FDA to these
initial set of questions were constructive, and no changes were
proposed with respect to PsyBio's approach. Based upon this initial
discussion, PsyBio intends to submit compound specific pre-IND
meeting requests to define manufacturing and clinical trial
parameters.
- The Company established new research and development
laboratories to facilitate portfolio development progress. The new
laboratory space at Miami University is
expected to provide a comprehensive, state-of-the-art research
environment in which PsyBio's ever-expanding portfolio of compounds
can be more readily and rapidly developed. This continued
collaboration with Miami University is
anticipated to expedite progress toward PsyBio filing an IND
application with the FDA.
About PsyBio Therapeutics Corp.
PsyBio Therapeutics is a fully integrated and intellectual
property driven biotechnology company developing novel psychoactive
medicinal candidates produced by genetically modified organisms
targeting the potential treatment of mental health challenges,
neurological disorders and other human health conditions. The team
has extensive experience in drug discovery based on synthetic
biology and metabolic engineering as well as clinical and
regulatory expertise progressing drugs through human studies and
regulatory protocols. Research and development is currently ongoing
for naturally occurring psychoactive tryptamines originally
discovered in different varieties of hallucinogenic mushrooms,
other tryptamines and phenethylamines and combinations thereof. The
Company utilizes a bio-medicinal chemistry approach to therapeutic
development, in which psychoactive compounds can be utilized as a
template upon which to develop precursors and analogs, both
naturally and non-naturally occurring, specifically because they
are already known to have an effect within the brain.
Cautionary Note Regarding Forward-Looking Statements
This press release contains statements that constitute
"forward-looking information" ("forward-looking
information") within the meaning of applicable Canadian
securities legislation. All statements, other than statements of
historical fact, are forward-looking information and are based on
expectations, estimates and projections as at the date of this news
release. Any statement that discusses predictions, expectations,
beliefs, plans, projections, objectives, assumptions, future events
or performance (often but not always using phrases such as
"expects", or "does not expect", "is expected", "anticipates" or
"does not anticipate", "plans", "budget", "scheduled", "forecasts",
"estimates", "believes" or "intends" or variations of such words
and phrases or stating that certain actions, events or results
"may" or "could", "would", "might" or "will" be taken to occur or
be achieved) are not statements of historical fact and may be
forward-looking information. Forward looking-statements in this
press release include statements regarding: the anticipated
benefits of the laboratory space at Miami
University on PsyBio's research and development activities;
PsyBio's plans to submit compound specific pre-IND meeting requests
to the FDA to define manufacturing and clinical trial parameters;
PsyBio's plans and ability to file an IND application with the FDA
within expected timeframes, if at all; PsyBio's plans and ability
to launch clinical trials within expected timeframes, if at all;
the ability of PsyBio to develop novel psychoactive medicinal
candidates produced by genetically modified organisms targeting the
potential treatment of mental health challenges, neurological
disorders and other human health conditions; the ability of PsyBio
to build its intellectual property portfolio of novel drug
candidates; the ability to achieve cost competitive synthesis with
reduced environmental impact over current production methods; and
the ability of PsyBio to move target candidates into scaled
commercial manufacturing and regulatory application.
In disclosing the forward-looking information contained in this
press release, the Company has made certain assumptions, including
that: PsyBio will be successful in protecting its intellectual
property; PsyBio will be successful in discovering new valuable
target molecules; the laboratories at Miami University will benefit PsyBio's research and
development activities; the continued collaboration with Miami
University will expedite progress toward filing an IND
application with the FDA; PsyBio will submit compound specific
pre-IND meeting requests to the FDA; the FDA will grant such
pre-IND meetings and the outcome of such meetings will be
favourable; PsyBio will file one or more IND applications with the
FDA; PsyBio will be able to obtain all necessary approvals for
clinical trials; PsyBio will be successful in launching clinical
trials; the results of preclinical safety and efficacy testing will
be favorable; PsyBio's technology will be safe and effective; a
confirmed signal will be identified in PsyBio's selected
indications; and that drug development involves long lead times, is
very expensive and involves many variables of uncertainty. Although
the Company believes that the expectations reflected in such
forward-looking information are reasonable, it can give no
assurance that the expectations of any forward-looking information
will prove to be correct. Known and unknown risks, uncertainties,
and other factors which may cause the actual results and future
events to differ materially from those expressed or implied by such
forward-looking information. Such factors include, but are not
limited to: compliance with extensive government regulations;
domestic and foreign laws and regulations adversely affecting
PsyBio's business and results of operations; decreases in the
prevailing process for psilocybin and nutraceutical products in the
markets in which PsyBio operates; the impact of COVID-19; and
general business, economic, competitive, political and social
uncertainties. Accordingly, readers should not place undue reliance
on the forward-looking information contained in this press release.
Except as required by law, the Company disclaims any intention and
assumes no obligation to update or revise any forward-looking
information to reflect actual results, whether as a result of new
information, future events, changes in assumptions, changes in
factors affecting such forward-looking information or
otherwise.
PsyBio makes no medical, treatment or health benefit claims
about PsyBio's proposed products. The FDA or other similar
regulatory authorities have not evaluated claims regarding
psilocybin and other next generation psychoactive compounds. The
efficacy of such products has not been confirmed by FDA-approved
research. There is no assurance that the use of psilocybin and
other psychoactive compounds can diagnose, treat, cure, or prevent
any disease or condition. Vigorous scientific research and clinical
trials are needed. PsyBio has not conducted clinical trials for the
use of its intellectual property. Any references to quality,
consistency, efficacy and safety of potential products do not imply
that PsyBio verified such in clinical trials or that PsyBio will
complete such trials. If PsyBio cannot obtain the approvals or
research necessary to commercialize its business, it may have a
material adverse effect on the PsyBio's performance and
operations.
The TSX Venture Exchange (the "TSXV") has neither
approved nor disapproved the contents of this news release. Neither
the TSXV nor its Regulation Services Provider (as that term is
defined in the policies of the TSXV) accepts responsibility for the
adequacy or accuracy of this release.
SOURCE PsyBio Therapeutics Corp.