OXFORD,
OH and DENVER, CO,
May 30,
2022 /CNW/ - PsyBio Therapeutics Corp. (TSXV: PSYB)
(OTCQB: PSYBF) ("PsyBio" or the "Company"), a fully
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
announced that it has reported its interim financial results
for the three month period ended March 31, 2022 and
provided shareholders with a corporate update.
First Quarter 2022 Financial
Results
A copy of the unaudited condensed consolidated interim financial
statements prepared in accordance with International Financial
Reporting Standards and the corresponding management's discussion
and analysis for the three months ended March 31, 2022, can be
found under PsyBio's profile on SEDAR at www.sedar.com.
Intellectual Property and Clinical
Development Milestones
- The Company recently announced that it achieved a commercially
scalable purification method for one of its second-generation
compounds. This purification process methodology is a necessary
component for the Chemistry, Manufacturing and Controls section
("CMC") for an Investigational New Drug ("IND")
application with the United States Food and Drug Administration
("FDA").
- The Company recently announced that it expanded its preclinical
pipeline activities by initiating blood-brain barrier permeability
testing. Favorable results from this type of testing are
anticipated to expediate compound selection and progress toward the
filing of an IND application with the FDA.
- The Company recently announced that that it submitted an
application to convert existing provisional patents to full
patents. This submission covers major markets including North
America, Europe, Asia-Pacific, and Africa as
well as other important countries. The continued collaboration
with Miami University is anticipated to expedite progress
toward the filing of an IND application with the FDA.
- The Company recently announced that it is initiating the
process of recruiting, evaluating, and selecting highly qualified
investigators for upcoming clinical trials.
- The Company recently announced that it is in the process of
drafting its second pre-IND application in anticipation of seeking
IND approval from the FDA for clinical trials.
About PsyBio Therapeutics
Corp.
PsyBio is an intellectual property driven biotechnology company
developing new, bespoke, fully approved, psycho-targeted
therapeutics to potentially improve mental and neurological health.
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: PsyBio's plans for
filing IND applications with the FDA; PsyBio's plans to submit a
second pre-IND application to the FDA; the impact of PsyBio's
recently announced purification process methodology achievement on
the CMC section of PsyBio's IND application with the FDA; PsyBio's
plans and ability to conduct successful blood-brain barrier
permeability testing; the impact of favorable results from
blood-brain barrier permeability testing on compound selection and
progress toward the filing of IND applications with the FDA; the
ability of PsyBio to convert existing provisional patents to full
patents; the impact of continued collaboration with
Miami University on progress toward the
filing of IND applications with the FDA; PsyBio's ability to
develop novel formulations to potentially treat neurologic and
psychologic conditions and other disorders; PsyBio's plans to move
towards clinical trials for psycho-targeted therapeutics intended
to potentially improve mental and neurological
health; PsyBio's ability to launch clinical trials; PsyBio's
plans and ability to recruit clinical investigators for upcoming
clinical trials; PsyBio's ability to build its intellectual
property portfolio of novel drug candidates; PsyBio's ability to
achieve cost competitive synthesis with reduced environmental
impact over current production methods; and PsyBio's ability 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's recently announced purification process methodology
will enable commercial scale purification of bioreactor produced
products; this purification process methodology will have a
positive impact on potential in
vitro and in vivo testing; this
purification process methodology will have a positive impact on
progress toward the filing of IND applications with the FDA;
blood-brain barrier permeability testing will yield favorable
results; favorable results from blood-brain barrier permeability
testing will have a positive impact on compound selection and
progress toward the filing of IND applications with the
FDA; PsyBio will be successful in recruiting highly qualified
investigators for clinical evaluations; PsyBio will submit a second
pre-IND application to the FDA; PsyBio will receive approval from
the FDA to launch clinical trials; PsyBio will be successful in
launching clinical trials; clinical investigators will be trained
to conduct clinical investigations; clinical investigations will
help facilitate rapid trial initiation and completion; PsyBio will
be successful in protecting its intellectual property; PsyBio will
be successful in discovering new valuable target molecules; PsyBio
will be successful in submitting IND applications and will be able
to obtain all necessary approvals for clinical trials; the results
of preclinical safety and efficacy testing will be favourable;
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; and 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.