Provides Business Update
TORONTO, May 14, 2020 /CNW/ - FSD Pharma
Inc. (Nasdaq: HUGE) (CSE: HUGE.CN) (FRA: 0K9A) ("FSD Pharma" or
the "Company") today reported that management's discussion and
analysis of financial condition and results of operations
("MD&A") for the three months ended March 31, 2020 have been filed and can be viewed
on the Company's SEDAR profile at www.sedar.com.
FSD also provided an update on its primary business efforts:
- The Phase 1 first-in-human safety and tolerability study with
ultra micro-palmitoylethanolamide ("FSD201") in Australia is progressing. To date, three
single ascending dose cohorts have been completed. FSD201 has been
well tolerated with no serious adverse events reported. The Company
anticipates that the clinical portion of the study will be
completed before the beginning of Q320.
- FV Pharma, a licensed producer under Canada's Cannabis Act and Regulations and a
wholly-owned subsidiary of the Company, continues to operate at a
scaled back level due to the COVID-19 pandemic. The facility's
medical cannabis license remains in good standing. It is fulfilling
weekly shipments to its existing customers and continues to
maintain its genetics library.
- In Q120 the Company initiated efforts to strengthen available
cash on hand. It realized more than C$7.7
million by liquidating its equity interest in Cannara
Biotech (CSE: LOVE). It has also listed its real estate asset in
Cobourg, Ontario for sale and has
filed for a mixed shelf registration for up to C$100 million.
About FSD Pharma
FSD Pharma Inc. (Nasdaq: HUGE; CSE: HUGE.CN; FRA: 0K9A) is a
publicly traded holding company, since May
2018.
FSD BioSciences Inc., a wholly-owned subsidiary, is a specialty
biotech pharmaceutical R&D company focused on developing over
time a robust pipeline of FDA-approved synthetic compounds
targeting the endocannabinoid system of the human body to treat
certain diseases of the central nervous system and autoimmune
disorders of the skin, GI tract, and the musculoskeletal
system.
Through its acquisition of Prismic Pharmaceuticals in 2Q19, FSD
BioSciences Inc. is also making an effort to help address the
opioid crisis by developing opioid-sparing prescription drugs
utilizing the ultra micronized formulations of PEA.
The Company has Phase 1 first-in-human safety and tolerability
trials for its lead candidate, FSD 201 micro-PEA, currently
underway in Australia by principal
researcher Jason Lickliter, MD,
Chief Medical Officer of Nucleus Network.
FSD's wholly-owned subsidiary, FV Pharma, is a licensed producer
under Canada's Cannabis Act and
Regulations, having received its cultivation license on
October 13, 2017, and its full Sale
for Medical Purposes license on June 21,
2019. The Company is licensed to cultivate cannabis in
approximately 25,000 square feet of its facility in Cobourg, Ontario.
Forward-Looking Statements
Neither the Canadian Securities Exchange nor its regulation
services provider accept responsibility for the adequacy or
accuracy of this 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 U.S. Food and Drug
Administration ("FDA") approvals, development of any FDA approved
synthetic compounds, the successful treatment of diseases by such
compounds, the ability to address the opioid crisis, the
development of opioid sparing prescription drugs utilizing the
ultra micronized formulations of PEA, the intention and timing of
the initiation of Phase 1 first-in-human safety and tolerability
trials for PP 101 micro-PEA, maintenance of FSD Pharma's Cannabis
Act License, the ability to cultivate and sell cannabis produced in
FSD Pharma's facility, the progress and funding of the CBD Research
Project, the ability and technical feasibility of algae being
utilized to produce pharmaceutical-grade cannabinoids and the
ultimate success of the CBD Research Project, the production of
prescription drugs that can treat diseases affecting the central
nervous system, and related royalty fees. 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.
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.
SOURCE FSD Pharma Inc.