-Announces
Filing of Year-End 2020 Results and Provides Corporate
Update
FSD Pharma Inc. (Nasdaq: HUGE) (CSE: HUGE) (“FSD Pharma” or the
“Company”) today announces that it has entered into a license
agreement (the “License Agreement”) with Innovet Italia S.R.L.
(“Innovet”), under which Innovet granted the Company a license to
use ultramicronized-palmitoylethanolamide (or ultramicronized PEA)
(“ultra-micro PEA”) to develop U.S. Food and Drug Administration
(“FDA”) approved veterinary drugs for the treatment of
gastro-intestinal diseases in Canine and Feline (Dogs and Cats). In
addition, the Company today announces the filing of its year-end
results and provides corporate updates.
“The licensing agreement with Innovet Italia S.R.I, to evaluate
the use of ultra- micro PEA as a veterinary anti-inflammatory
prescription drug, is an exciting opportunity for the company to
enter into a new and untapped market,” said Dr. Raza Bokhari,
Executive Chairman & CEO. “With a balance sheet that is
stronger today than it was when we began our journey nearly three
years ago, we are actively exploring other M&A and licensing
opportunities to expand our drug development pipeline.”
License Agreement
The License Agreement grants the Company an exclusive, worldwide
license (excluding Italy, and subject to a first refusal right
maintained by Innovet, any other country in Europe) to research,
manufacture and commercialize products using certain proprietary
formulations of ultra-micro PEA (the “Licensed Products”) to treat
gastro-intestinal diseases in canines and felines. The License
Agreement provides that the Company shall develop the Licensed
Products with a view to submitting an Investigational Animal Drug
Application with the FDA within thirty-six (36) months of the date
of the agreement and shall submit a New Animal Drug Application
within sixty (60) months of the effective date of the
agreement.
Under the terms of the License Agreement, the Company is
required to make payments to Innovet upon the achievement of
specified milestones. An initial non-refundable sum of US$500,000
is due and payable to Innovet on the effective date of the License
Agreement and a second non-refundable sum of US$250,000 will be due
and payable to Innovet on the first anniversary of the effective
date of the License Agreement. Within thirty business days of the
first notification of approval of a New Animal Drug Application by
the FDA of the first Licensed Product to receive such approval in
the United States, the Company is required to pay an additional
non-refundable sum of US$750,000 to Innovet.
The License Agreement also specifies certain royalty payments.
Pursuant to the License Agreement, the Company is required to pay
Innovet 14% of any one-off lump sum payments it receives as
consideration for granting a sub-license to a third-party with
respect to a Licensed Product. In addition, the Company is required
to pay 5% of net sales of the Licensed Products.
The above description of the License Agreement is qualified in
its entirety by reference to the full text of such agreement, a
copy of which will be available under the Company’s SEDAR and EDGAR
profiles.
Corporate Update
The Company's annual and special meeting of shareholders for
2021 ("2021 AGM") has been scheduled for May 14, 2021. April
15, 2021 has been fixed as the record date for voting at the 2021
AGM. The Company's management information circular and related
proxy materials will be delivered to shareholders and made
available under the Company's SEDAR profile on or before April 23,
2021. This 2021 AGM is being held in lieu of Annual meeting of the
Shareholders meeting announced earlier for June 29th 2021.
The Company also has recently retained Randell J Mack, a veteran
pharmaceutical executive as President of FSD BioSciences, Inc. Dr.
Edward Brennan, has been named the Chief Medical Officer.
Filing of Year-End Results
The Company also reported its audited financial results for the
fourth quarter and full year ended December 31, 2020. These filings
are available for review under the Company's SEDAR profile at
www.sedar.com.
About FSD Pharma
FSD Pharma Inc. (www.fsdpharma.com) is a publicly-traded holding
company.
FSD BioSciences, Inc., a wholly-owned subsidiary, is a specialty
biotech pharmaceutical R&D company focused on developing over
time multiple applications of its lead compound, ultra-micro PEA by
down-regulating the cytokines to effectuate an anti-inflammatory
response.
The Company filed an IND with the FDA on August 28, 2020 and was
approved on September 25, 2020 to initiate a phase 2 clinical trial
for the use of FSD201 to treat COVID-19, the disease caused by the
SARS-CoV-2 virus. The trial is currently underway and is expected
to randomize 352 patients in a controlled, double-blind multicenter
study.
Severe COVID-19 is characterized by an over-exuberant
inflammatory response that may lead to a cytokine storm and
ultimately death. The Company is focused on developing ultra-micro
PEA for its anti-inflammatory properties to avoid the cytokine
storm associated with acute lung injury in hospitalized COVID-19
patients.
The Company is not making any express or implied claim that its
product has the ability to eliminate, cure or contain the COVID-19
(or SARS-2 Coronavirus) infection at this time.
About Innovet
Innovet Italia is an innovative animal health company, founded
in Italy in 1996. Its main goal is to bring scientific innovation
in niche fields of the veterinary market. The philosophy that
drives Innovet's development is to follow where nature leads,
studying and mimicking natural protective body responses rather
than "artificially" fighting the mechanisms of diseases. Based on
such a strategic idea, Innovet's research team discovered and
patented a family of bioactive lipid amides (i.e., aliamides, whose
parent compound is palmitoylethanolamide, PEA) able to naturally
restore the physiological balance of the hyper-reactive tissues.
PEA, its micronized and ultramicronized forms and various other
congeners, are the main components of Innovet's innovative
products. Innovet's commercial effort is mainly focused on the
small animal health field, in many market segments (i.e.
dermatology, orthopedics, oral health, uro-nephrology, behavior,
gastroenterology, ophthalmology and algology). For more
information: http://www.innovet.it
Forward-Looking Statements
Neither the Canadian Securities Exchange nor its regulation
services provider accept responsibility for the adequacy or
accuracy of this press release.
Certain statements contained in this press release constitute
“forward-looking information” and “forward-looking statements”
within the meaning of applicable Canadian and U.S. securities laws
(collectively, “Forward-Looking Information”). Forward-Looking
Information includes, but is not limited to, information with
respect to FSD Pharma’s strategy, plans or future financial or
operating performance, receipt of any FDA or other regulatory
approvals, the completion of any trials regarding the use of FSD201
to treat COVID-19 or to treat canine and feline gastro-intestinal
diseases, the safety of FSD201 or whether FSD201 may be effective
in treating COVID-19 or to treat canine and feline
gastro-intestinal diseases, the costs associated with such planned
trials and our belief that we have sufficient cash to complete any
clinical trials or studies with respect to the foregoing, our
ability to obtain required funding and the terms and timing
thereof. The use of words such as “budget”, “intend”, “anticipate”,
“believe”, “expect”, “plan”, “forecast”, “future”, “target”,
“project”, “capacity”, “could”, “should”, “focus”, “proposed”,
“scheduled”, “outlook”, “potential”, “estimate” and other similar
words, and similar expressions and statements relating to matters
that are not historical facts, or statements that certain events or
conditions “may” or “will” occur, are intended to identify
Forward-Looking Information and are based on FSD Pharma’s current
beliefs or assumptions as to the outcome and timing of such future
events. Such beliefs or assumptions necessarily involve known and
unknown risks and uncertainties that could cause actual results to
differ materially from those expressed or implied in such
Forward-Looking Information. Certain of these risks and
uncertainties are described in the Company’s continuous disclosure
filings available under the Company’s SEDAR profile at
www.sedar.com and under the Company’s EDGAR profile at www.sec.gov.
Forward-Looking Information is not a guarantee of performance. The
Forward-Looking Information contained in this press release is made
as of the date hereof, and FSD Pharma is not obligated to update or
revise any Forward- Looking Information, whether as a result of new
information, future events or otherwise, except as required by law.
Because of the risks, uncertainties and assumptions contained
herein, investors should not place undue reliance on Forward
Looking-Information. The foregoing statements expressly qualify any
Forward-Looking Information contained herein.
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version on businesswire.com: https://www.businesswire.com/news/home/20210316006138/en/
Donal Carroll, Chief Financial Officer, FSD Pharma Inc.
Dcarroll@fsdpharma.com
Investor Relations IR@fsdpharma.com
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