Mr. Zeeshan Saeed reports

FSD PHARMA SIGNS THE AGREEMENT WITH INGENU CRO TO CONDUCT A CLINICAL STUDY TO ASSESS THE SAFETY AND PHARMACOKINETICS OF MULTIPLE ASCENDING DOSES OF LUCID-21-302 (LUCID-MS) IN HEALTHY ADULTS

FSD Pharma Inc., through its subsidiary, HUGE Biopharma Australia Pty. Ltd., entered into an agreement with iNGENu CRO Pty. Ltd. on March 26, 2024, to conduct a phase 1, randomized, double-blind, placebo-controlled, multiple ascending dose study to evaluate the safety and pharmacokinetics of Lucid-21-302 in healthy adult participants.

"We are very pleased to formalize this agreement and to collaborate with iNGENu to conduct this clinical study," said Zeeshan Saeed, Co-Chairman and CEO of FSD Pharma. "This clinical study builds on our prior Phase 1 study of Lucid-21-302 and represents an important next step in our mission to develop novel therapeutics for the treatment of MS."

Lucid-21-302 is a first-in-class, non-immunomodulatory, neuroprotective compound with a unique mechanism of action for the treatment of multiple sclerosis (MS). It is a patented New Chemical Entity that has shown in preclinical models to prevent demyelination, a known cause of MS and other neurogenerative diseases characterized by damage to the myelin sheath surrounding nerve fibers in the central nervous system. In a prior Phase 1 single ascending dose study, Lucid-21-302 was shown to be safe and well-tolerated in the dose range of 50-300 mg p.o. administered once to healthy adults, with no difference in pharmacokinetics between the fed and fasted states.

"Over the next several days and weeks, our R&D team will closely work with iNGENu to start this clinical study swiftly." added Dr. Andrzej Chruscinski, Vice-President, Scientific and Clinical Affairs at FSD Pharma. "We are very eager to complete this clinical trial as efficiently as possible, and are encouraged by the strong data from the prior Phase 1 single ascending dose study supporting the safety and tolerability of Lucid-21-302."

About FSD Pharma

FSD Pharma is a biopharmaceutical company dedicated to building a portfolio of innovative assets and biotech solutions for the treatment of challenging neurodegenerative and metabolic disorders and alcohol misuse disorders with drug candidates in different stages of development. Through its wholly-owned subsidiary, Lucid Psycheceuticals Inc. ("Lucid"), FSD is focused on the research and development of its lead compound, Lucid-MS (formerly Lucid-21-302) ("Lucid-MS"). Lucid-MS is a patented new chemical entity shown to prevent and reverse myelin degradation, the underlying mechanism of multiple sclerosis, in preclinical models. FSD Pharma has also licensed unbuzzd(TM), a proprietary formulation of natural ingredients, vitamins, and minerals to help with liver and brain function for the purposes of quickly relieving individuals from the effects of alcohol consumption for use in the consumer recreational sector, to Celly Nutrition Corp. ("Celly Nu") and is entitled to a royalty on the revenue generated by Celly Nu from sales of products created using the technology rights granted under the licensing agreement. FSD Pharma continues its R&D activities to develop novel formulations for alcohol misuse disorders and continues the development of such treatments for use in the healthcare sector. FSD maintains a portfolio of strategic investments through its wholly-owned subsidiary, FSD Strategic Investments Inc., which represent loans secured by residential or commercial property.

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