OXFORD, Ohio and COCONUT
CREEK, Fla., Nov. 30, 2021 /CNW/ -
PsyBio Therapeutics Corp. (TSXV: PSYB) (OTCQB: PSYBF)
("PsyBio" or the "Company"), an intellectual property
driven biotechnology company focusing on discovering and developing
new, bespoke, psycho-targeted therapeutics to potentially improve
mental and neurological health, today announced that it
has reported its unaudited financial results for the interim
period ended September 30, 2021 and provided shareholders
with a corporate update.
Third Quarter 2021 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 interim period ended September 30, 2021,
can be found under PsyBio's profile at www.sedar.com.
Intellectual Property and Clinical Development
Milestones
- The Company furthered its intellectual property portfolio by
filing six additional manufacturing patent applications with the
United States Patent and Trademark Office (the "USPTO") that
cover a broad range of approaches to PsyBio's biologic methodology
as it pertains to the current landscape of biotechnology.
- The Company successfully demonstrated the ability to
manufacture PsyBio-11040, one of its first promising therapeutic
candidates, at commercial scale.
- The Company submitted a pre-Investigational New Drug
("IND") Application request to the United States Food and
Drug Administration ("FDA") seeking guidance on data
necessary to warrant an IND submission.
- The Company filed a provisional patent application with the
USPTO entitled Psilocybin and Norbaeocystin Compositions and
Methods of Treatment, which contained 67 new inventive
claims.
- The Company filed a provisional patent application with the
USPTO entitled NMDA Receptor Antagonist-Containing Compositions
and Methods of Treatment and initiated a new program to study
N-methyl-D-aspartate ("NMDA") receptor antagonists and
associated analogs for potential activity against a variety of
human health conditions.
Corporate Finance Update
- The Company filed and obtained receipts for a final base shelf
prospectus dated October 28, 2021, which is expected to help
facilitate institutional investor access to the Company's
securities.
- The Company's subordinate voting shares were made eligible for
electronic clearing and settlement through the Depository Trust
Company ("DTC") in the United
States, which is anticipated to benefit investors with
increased liquidity and execution speed.
- The Company was included in AdvisorShares Psychedelics Exchange
Traded Fund, which is listed on the NYSE Arca under the ticker
symbol (NYSE: PSIL) and was formed to actively manage investments
in the emerging psychedelic drugs sector.
The Company's subordinate voting shares commenced trading on the
OTCQB Venture Market at market open on July
14, 2021 under the symbol "PSYBF".
- The Company purchased an aggregate of 397,500 subordinate
voting shares under its normal course issuer bid ("NCIB")
during the month of October 2021, at
an average price of $0.314 per share.
All shares purchased under the NCIB were cancelled.
About PsyBio Therapeutics Corp.
PsyBio is an intellectual property driven biotechnology company
focusing on discovering and developing new, bespoke,
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.
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 ability of PsyBio
to develop novel formulations to potentially treat neurologic and
psychologic conditions and other disorders; the ability of PsyBio
to launch clinical trials; the ability of PsyBio to build its
intellectual property portfolio of novel drug candidates; the
ability of PsyBio to move target candidates into scaled commercial
manufacturing and regulatory application; the ability to achieve
cost competitive synthesis with reduced environmental impact over
current production methods; the ability of PsyBio to move target
candidates into scaled commercial manufacturing and regulatory
application; the impact of DTC eligibility on existing and
prospective investors' ability to trade the Company's subordinate
voting shares; and the impact of DTC eligibility on the liquidity
of the Company's subordinate voting shares.
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; PsyBio will file its initial pre-IND Application
request and IND Application within anticipated timeframes; PsyBio
will be successful in obtaining IND Applications and 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 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; 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.