- The FDA has accepted the Investigational new Animal Drug
application for review
- The proposed trial is expected to be conducted at 5-10 sites
in USA and will enroll up to 200 dogs
- Shareholders URGED to Vote the BLUE proxy by 9:00 a.m. on
May 12, 2021
- Contact Gryphon Advisors Inc. for assistance at
1.833.292.5847 or by email at inquiries@gryphonadvisors.ca
FSD Pharma Inc. (Nasdaq: HUGE) (CSE: HUGE.CN) (“FSD
Pharma” or the “Company”) today announced that it has
submitted to the U.S. Food and Drug Administration (“FDA”)
an Investigational New Animal Drug Application (IND) for the use of
FSD201 (ultramicronized palmitoylethanolamide, or ultramicronized
PEA) to treat Gastrointestinal enteropathy in dogs. The application
has been accepted for review.
The proposed trial design is a randomized, double-blind,
placebo-controlled, crossover, trial comparing FSD201
(ultramicronized Palmitoylethanolamide (PEA)) dosed twice daily for
30 days to placebo for the treatment of canine inflammatory bowel
disease. The primary endpoint will be a validated diarrhea score,
evaluated by both treating veterinarian and dog owner. The trial
will be conducted at 5-10 sites in the USA, and will enroll up to
200 dogs.
Vote Only the BLUE Proxy FOR the
Management Director Nominees
FSD Pharma thanks shareholders for the strong support the
Company has received ahead of its upcoming Annual and Special
Meeting of Shareholders (the “Meeting”).
On May 5, FSD Pharma announced that Institutional Shareholder
Services Inc. (“ISS”), a leading independent international
corporate governance analysis and proxy advisory firm, had
recommended that shareholders vote FOR all Management Director
Nominees i and FOR the elimination of the dual-class share
structure (the "Dual-Class Sunset") at the Meeting.
FSD Pharma urges shareholders to go to FSD Pharma’s website
www.fsdfuture.com to cast their vote electronically and for
additional information on how the Company has the right strategy
and the right Management Director Nominees to build on its positive
momentum towards value creation for all shareholders. Shareholders
should contrast this plan with that of the Dissidents, whose
self-serving approach pulls the Company backwards, making promises
that are unlikely to materialize into real shareholder value
creation.
Shareholders are urged to vote immediately to ensure their
proxies are received by the proxy voting deadline – no later than
9:00 a.m. (Toronto time) on May 12, 2021. Shareholders with
questions or who require assistance voting their shares should
contact the Company's proxy solicitation agent, Gryphon Advisors
Inc. at 1.833.292.5847 toll-free in North America (1.416.902.5565
by collect call) or by email at inquiries@gryphonadvisors.ca.
Filing of Quarter-End Results
The Company also reported its reviewed financial results for the
first quarter ended March 31, 2021. 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, ultramicro 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.
Forward-Looking Statements
Neither the Canadian Securities Exchange nor its regulation
services provider accept responsibility for the adequacy or
accuracy of this release.
The Company's subject area experts continue to review the
scientific evidence/claims/research relevant to the application of
PEA and ultramicronized-PEA. The company is not making any express
or implied claims that its product has the ability to eliminate,
cure or contain the COVID-19 (or SARS-2 Coronavirus) at this
time.
The Phase 2 clinical trial program is subject to a favorable
toxicology study and successful completion of ongoing laboratory
studies, access to additional financing and review by the FDA of
our IND application. The duration and cost of clinical trials can
vary significantly depending on multiple factors, including the
enrollment rate of patients, country in which trials are conducted,
and specific trial protocols required. The process of developing
pharmaceutical products and receiving the necessary regulatory
approvals for commercialization typically takes several years.
Accordingly, no near-term revenues from product sales or services
are expected from our ultramicronized-PEA candidate(s). The
milestones described above represent customary inflection points
for financing by clinical-stage biotech companies. However, there
is no assurance that the Company will be able to achieve these
clinical milestones, nor, if successful in doing so, that the
Company will be able to access additional financing on terms or
timing acceptable to the Company.
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 approvals, including the
approval of our IND submission, the completion of any trials
regarding the use of FSD201 to treat COVID-19 or whether FSD201 may
be effective in treating COVID-19, the costs associated with such
planned trials, our ability to obtain required funding and the
terms and timing thereof and the ultimate development of any FDA
approved synthetic compounds. 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 on 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/20210510005281/en/
For further information:
Investors: Gryphon Advisors Inc. 1.833.292.5847 toll-free
in North America (1.416.902.5565 by collect call)
inquiries@gryphonadvisors.ca www.fsdfuture.com
Nathan Coyle, Interim Chief Financial Officer, FSD Pharma Inc.
ncoyle@fsdpharma.com
Media: Joel Shaffer Longview Communications and Public
Affairs jshaffer@longviewcomms.ca
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