FSD Pharma Inc. (Nasdaq: HUGE) (CSE: HUGE) (“FSD Pharma” or the
“Company”) today announces the following corporate updates.
Corporate Update
The Company continues to pursue its strategy of completing a
Phase 2 clinical trial for the use of its lead compound,
ultramicronized-palmitoylethanolamide (or ultramicronized PEA)
(“FSD201”), to treat hospitalized COVID-19 patients in a
double-blind study (the “Study”). The Company is expected to
randomize 352 patients with COVID-19 infection to complete the
trial. The Company believes FSD201 to be a safe drug with
anti-inflammatory properties which may have the potential to
address the over-exuberant inflammatory response characterized by
COVID-19 infection that may lead to a cytokine storm and ultimately
death. Due to various factors, primarily relating to challenges
with patient recruitment due to active COVID-19 pandemic-related
restrictions in hospitals, the Company may not be in a position to
complete the Study prior to the end of 2021. 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 Company currently has a cash
balance of approximately C$22 million; the Company expects to
require additional financing primarily to initiate another Phase 2
FDA approved study for its lead compound FSD 201 and to effectuate
other potential in-licensing and acquisition opportunities. In
addition, the Company is actively seeking appropriate potential
buyers and is hopeful to finalize the sale of its non-core real
estate asset in Cobourg, Ontario. The Company and its counterparty
agreed to terminate the previously announced conditional sales
contract for this real estate asset.
Termination of Company President For Cause:
The Company has terminated the President of the Company, Mr.
Zeeshan Saeed, for cause with immediate effect. As a result of his
termination, in accordance with the terms of his employment
agreement, Mr. Saeed is deemed to have resigned from all other
positions held with the Company and its subsidiaries, including
from the Company’s board of directors.
Contested Shareholders Meeting
As previously disclosed, the Company will hold its annual
meeting of shareholders (the “Meeting”) on June 29, 2021. The
Company has received a requisition for a special meeting submitted
to the Company by certain shareholders of the Company (the
“Requisitioning Shareholders”) claiming to hold in excess of 5.1%
of the Company’s class B subordinated voting shares (“Class B
Shares”), including Mr. Zeeshan Saeed, the former President of the
company and Mr. Anthony Durkacz, who is a Director of the Company.
In addition to the Class B Shares controlled by this group, Mr.
Saeed and Mr. Durkacz each hold 24 of the Company’s class A
multiple voting shares (“Class A Shares”), with each Class A Share
being entitled to 276,660 votes. Dr. Raza Bokhari, the Company’s
Executive Chairman and Chief Executive Officer, holds the remaining
24 Class A Shares. As of the date hereof, the Company has 72 Class
A Shares and approximately 19,161,602 Class B Shares issued and
outstanding. The Requisitioning Shareholders are seeking to reduce
the size of the Company’s board of directors to five, and to
replace six of the incumbent directors, including Dr. Raza Bokhari,
with three directors selected by such shareholders. Shareholders
are not required to take any action at this time in respect of the
Meeting. Shareholders will receive detailed information about the
matters presented at the Meeting in a management information
circular sometime in early June 2021.
Board of Directors Update
In addition to Mr. Zeeshan Saeed immediate departure from the
Board of Directors, the company also announces the departure of Mr.
Jim Datin, from the Board of Directors effective April 30th 2021.
Mr. Datin has advised the Chairman of the Board that he is stepping
down because of other obligations. We thank Jim Datin for his
significant leadership and services as a valuable board member and
we wish him much success in his present and future endeavors.
About FSD Pharma
FSD Pharma Inc. is a publicly-traded holding company.
FSD Pharma 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,
FSD201, 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.
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 FSD201 for
its anti-inflammatory properties to avoid the cytokine storm
associated with acute lung injury in hospitalized COVID-19
patients.
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 approvals, the completion
of any trials regarding the use of FSD201 to treat COVID-19, the
safety of FSD201 or whether FSD201 may be effective in treating
COVID-19, the costs associated with such planned trials and our
belief that we have sufficient cash to complete the Phase 2 study,
our ability to obtain required funding and the terms and timing
thereof, the ultimate development of any FDA approved synthetic
compounds, the expected insurance recovery related to the
settlement agreement, the completion of the settlement contemplated
in the settlement agreement and the timing and closing of the sale
of certain non-core real estate assets. 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/20210126006143/en/
Donal Carroll, Chief Financial Officer, FSD Pharma Inc.
Dcarroll@fsdpharma.com
Investor Relations IR@fsdpharma.com
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