- The study is expected to be conducted at
25-30 hospitals in North America -
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 Drug Application (IND) for the use of FSD201
(ultramicronized palmitoylethanolamide, or ultramicronized PEA) to
treat COVID-19, the disease caused by the SARS-CoV-2 virus (the
“FSD201 COVID-19 Trial”). Severe COVID-19 is characterized
by an over-exuberant inflammatory response that may lead to a
cytokine storm and ultimately death. As previously announced, FSD
Pharma 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.
COVID-19 Trial Design
The FSD201 COVID-19 Trial will be a randomized, controlled,
double-blind, multicenter study, conducted at 25-30 sites in North
America to assess the efficacy and safety of FSD201 dosed at 600mg
or 1200mg twice-daily, together with standard of care
("SOC") compared to SOC alone in hospitalized patients with
documented COVID-19 disease.
Issuance of Share-Based Compensation and Early Warning
Disclosure for Dr. Raza Bokhari, Executive Co-Chairman &
CEO
Further to our news release dated July 31, 2020, the Board of
Directors has authorized the issuance of an additional 369,255
class B subordinate voting shares ("Class B Shares") to
certain of the Company's directors, officers, employees and
consultants as share-based compensation.
As will be more particularly described in an early warning
report to be filed under the Company's SEDAR profile, on August
[26], 2020, Dr. Raza Bokhari acquired 805,802 Class B Shares in
lieu of cash compensation for his services as Chief Executive
Officer and Executive Co-Chairman of the Company. As a result, Dr.
Bokhari now beneficially owns, or has control or direction over, in
aggregate, approximately 8.5% of the issued and outstanding Class B
Shares (on a non-diluted basis). Dr. Bokhari also continues to hold
33.3% of the Company’s outstanding class A multiple voting shares
(together with the Class B Shares, the "FSD Shares"). In
aggregate, Dr. Bokhari controls approximately 23% of the voting
rights attached to the issued and outstanding FSD Shares.
Dr. Bokhari acquired the Class B Shares for investment purposes
and has no present intention to sell such securities. Dr. Bokhari
is currently prohibited from selling any securities because of
lock-up agreements entered into in connection with the recent
equity financings by the Company for C$10.125 million on June 9,
2020 and US$10.0 million on August 6, 2020. Depending on market
conditions, general economic and industry conditions, trading
prices of the Company's securities, the Company's business,
financial condition and prospects and/or other relevant factors,
Dr. Bokhari may develop such plans or intentions in the future and
may from time to time acquire or dispose of securities of the
Company.
About FSD Pharma
FSD Pharma Inc. is a publicly-traded holding company, since May
2018.
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.
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.
View source
version on businesswire.com: https://www.businesswire.com/news/home/20200830005006/en/
Sandy Huard, Head of Communications, FSD Pharma Inc.
sandy@fsdpharma.com (647) 864-7969
Zeeshan Saeed, President, FSD Pharma Inc.
zeeshan@fsdpharma.com
Investor Relations IR@fsdpharma.com
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