Mr. Zeeshan Saeed reports

FDA AND HEALTH CANADA CLEAR IND FOR FSD PHARMA TO PROCEED WITH PHASE 2 TRIAL OF FSD201 FOR NOCIPLASTIC PAIN ASSOCIATED WITH IDIOPATHIC MAST CELL ACTIVATION SYNDROME

FSD Pharma Inc. has received a study may proceed letter for the investigational new drug (IND) application from the U.S. Food and Drug Administration (FDA) and notice of authorization from Health Canada for its phase 2 clinical trial of FSD201. The corresponding study protocol is titled "A Randomized, Double-Blind Placebo Controlled Parallel Group Study of Safety and Efficacy of FSD201 in Patients with Chronic Widespread Musculoskeletal Nociplastic Pain Associated with Idiopathic Mast Cell Activation Syndrome (Disorder)."

"We are delighted to receive authorization to proceed with our planned efficacy clinical trial of FSD201 from both FDA and Health Canada. We are working with our clinical sites in the U.S. and Canada to initiate the study and intend to release more details on the study very soon," said Dr. Lakshmi Kotra, chief executive officer of FSD Pharma subsidiary Lucid Psycheceuticals. "Our regulatory and clinical teams led by Dr. Andrzej Chruscinski, vice-president for clinical and scientific affairs, worked tirelessly with our expert advisers developing the protocols, and we are looking forward to the next stage of clinical development of FSD201. We believe FSD201 is a compelling drug candidate, and we are actively exploring opportunities for development partners and other synergistic collaborations that will maximize shareholder returns."

FSD201 is a proprietary formulation of ultramicronized palmitoylethanolamide (PEA). FSD Pharma's successfully completed phase 1 clinical trial showed FSD201 to be safe and well tolerated. This is especially important as chronic inflammatory diseases are the leading cause of death globally and the World Health Organization ranks chronic disease as the greatest threat to human health. This immense problem has limited treatment options. This is why FSD Pharma continues to work relentlessly to bring a new and safe inflammatory treatment option to market.

About FSD Pharma Inc.

FSD Pharma is a biotechnology company with three drug candidates in different stages of development. FSD BioSciences Inc., a wholly owned subsidiary, is focused on pharmaceutical research and development of its lead compound, FSD201, an ultramicronized PEA (palmitoyl ethylamine), for the treatment of inflammatory diseases. Lucid Psycheceuticals, a wholly owned subsidiary, is focused on the research and development of its lead compounds, Lucid-Psych and Lucid-MS. Lucid-Psych is a molecular compound identified for the potential treatment of mental health disorders. Lucid-MS is a molecular compound identified for the potential treatment of neurodegenerative disorders.

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