Idiopathic mast cell activation syndrome

New Board Members Add Operational and Product Development Expertise as KeifeRx Advances Pipeline of Novel Kinase Inhibitors for Multiple Disease Indications WASHINGTON--(BUSINESS WIRE)-- KeifeRx, an emerging clinical-stage biopharmaceutical company specializing in the discovery and development of new treatment options for neurodegenerative and immune diseases, announces the appointments of Dan Feehan and Alison Finger to its Board of Directors. Mr. Feehan and Ms. Finger’s diverse expertise and experience enhance KeifeRx’s ability to develop its expanding pipeline of novel kinase inhibitors for the treatment of neurodegenerative, neuroinflammatory, and mast cell-associated diseases. KeifeRx is currently conducting optimizing and IND-enabling studies involving four separate formulations – KFRX03, KFRX04, KFRX05, and KFRX06 – with patent life through 2037. Early-stage clinical trials conducted at Georgetown University, along with compelling preclinical research conducted at the university led by KeifeRx’s co-founder, Charbel Moussa, MBBS, Ph.D., and colleagues, demonstrated the ability of kinase inhibitors to penetrate the brain, induce autophagy, and enable the bulk disposal of disease-causing toxic proteins to treat neurodegenerative diseases, as well as the ability to target mast cells and simultaneously modulate peripheral and central immunity, providing therapeutic potential for an array of immune diseases. “On behalf of KeifeRx, I welcome Dan and Alison to our board of directors and look forward to their contributions as we advance our pipeline of new chemical entity kinase inhibitors across a range of significantly unmet and underserved indications, including Alzheimer’s disease, Lewy Body Dementia, ALS, mast cell activation syndrome (MCAS), and urticaria,” said Chris Hoyt, Chief Executive Officer of KeifeRx. “With our recently expanded licensing agreement with Georgetown University, we are optimally positioned to advance a portfolio of high-value, patent-protected drug products targeting disease classes, including neurodegenerative and neuroinflammatory, where innovation is desperately needed, and market demand is robust.” Mr. Feehan, who is currently the Chief Operating Officer, Workforce Screening at Vault Health, served as Principal Deputy Assistant Secretary of Defense in charge of Readiness for the Department of Defense. As a Captain in the U.S. Army, he served two combat deployments to Operation Iraqi Freedom as an Engineer and a Scout/Sniper Platoon Leader. Feehan was also a candidate for the U.S. House of Representatives, worked as a middle school teacher through Teach for America, and was a White House Fellow under President Obama. Mr. Feehan earned his master’s in public policy from Harvard Kennedy School and his B.A. in Science of Foreign Policy from Georgetown University. Ms. Finger, the Principal at Auburn House Consulting, LLC, serves on the Board of ADMA Biologics, Inc. and is an Advisor at Quantile Health. She previously held Board positions at Decibel Therapeutics, Vascular Biogenics and served as Chief Commercial Officer at Bluebird Bio. Ms. Finger also spent over two decades at Bristol-Myers Squibb serving as Vice President of Global Commercialization for Virology, Hematology and the Alzheimer’s Disease and Neuroscience programs in addition to her role as Managing Director of Australia and New Zealand. Ms. Finger earned her MBA from Duke University’s Fuqua School of Business and a B.A. in English from St. Lawrence University. About KeifeRx KeifeRx is an emerging clinical-stage biopharmaceutical company developing a portfolio of novel and optimized, low-dose, orally-delivered kinase inhibitors for the treatment of multiple, high-need neurodegenerative and immune diseases, including Alzheimer’s disease, Parkinson’s disease, amyotrophic lateral sclerosis (ALS), and Lewy Body Dementia. KeifeRx’s diverse pipeline of early- and late-stage products leverages mechanisms of action inherent to kinase inhibitors which thus far have been underexplored. This includes the ability to penetrate the brain, induce autophagy, and enable the bulk disposal of disease-causing toxic proteins to treat neurodegenerative diseases. Georgetown University owns several issued patents and pending patent applications on the underlying technology related to the use of kinase inhibitors for the treatment of neurodegenerative diseases with KeifeRx co-founder Charbel Moussa, MBBS, Ph.D., named as one of three inventors. KeifeRx has an exclusive license to intellectual property from Georgetown University. For more information on KeifeRx, please visit . View source version on businesswire.com: Contacts Chris Hoyt, CEO c.hoyt@keiferx.com Source: KeifeRx View this news release online at:

Sept. 12, 2022 12:30 UTC TORONTO--(BUSINESS WIRE)-- FSD Pharma Inc. (NASDAQ: HUGE) (CSE: HUGE) (FRE: 0K9A) (“FSD Pharma” or the “Company”), a biopharmaceutical company dedicated to building a portfolio of innovative assets and biotech solutions to address ailments affecting millions worldwide, today announces that it is presenting and participating via the on-demand session at the H.C. Wainwright 24th Annual Global Investment Conference taking place September 12-14, 2022. FSD Pharma’s on-demand presentation can be accessed by clicking this link, beginning Monday, September 12, 2022 at 7:00 A.M. EDT where it will be hosted for 90 days. The presentation and supporting materials will also be available shortly thereafter on the FSD Pharma website within the “For Investors” section. In this presentation, Dr. Lakshmi Kotra, who serves as Chief Executive Officer of FSD Pharma’s wholly owned subsidiary Lucid Psycheceuticals, delivers updates to the investment community on the business and status of three drug candidates being advanced. FSD Pharma’s Lucid-MS, the Company’s lead compound for the potential treatment of multiple sclerosis, and Lucid-Psych, its lead compound for mental health conditions, are well underway undergoing IND-enabling studies. FSD Pharma recently announced that it received a “Study May Proceed” letter for the Investigational New Drug application from the U.S. Food and Drug Administration 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 extremely motivated to develop and commercialize FSD Pharma’s portfolio of novel therapeutics and working with high quality institutional investors is instrumental in meeting our goals,” said Dr. Kotra, who also provides development oversight for the complete FSD Pharma pipeline. “As one of the country’s premier annual conferences, we look forward to the H.C. Wainwright event to interact with the investment community and elucidate on the tremendous potential of our pipeline.” About FSD Pharma FSD Pharma Inc. 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 ultra-micronized PEA, for the treatment of inflammatory diseases. Lucid Psycheceuticals Inc., 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. Forward Looking Information Certain statements contained herein are “forward-looking statements.” Often, but not always, forward-looking statement can be identified by the use of words such as “plans,” “expects,” “expected,” “scheduled,” “estimates,” “intends,” “anticipates,” “hopes,” “planned” or “believes,” or variations of such words and phrases, or states that certain actions, events or results “may,” “could,” “would,” “might,” “potentially” or “will” be taken, occur or be achieved. Forward-looking statements contained in this press release include statements relating to the H.C. Wainwright 24th Annual Global Investment Conference. FSD cannot give any assurance that such forward-looking statements will prove to have been correct. The reader is cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date of this press release. Since forward-looking statements relate to future events and conditions, by their very nature they require making assumptions and involve inherent risks and uncertainties. The Company cautions that although it is believed that the assumptions are reasonable in the circumstances, these risks and uncertainties give rise to the possibility that actual results may differ materially from the expectations set out in the forward-looking statements. Factors that may cause such material differences include without limitation: the fact that the drug development efforts of both Lucid and FSD BioSciences are at a very early stage; the fact that preclinical drug development is uncertain, and the drug product candidates of Lucid and FSD BioSciences may never advance to clinical trials; the fact that results of preclinical studies and early-stage clinical trials may not be predictive of the results of later stage clinical trials; the uncertain outcome, cost, and timing of product development activities, preclinical studies and clinical trials of Lucid and FSD BioSciences; the uncertain clinical development process, including the risk that clinical trials may not have an effective design or generate positive results; the potential inability to obtain or maintain regulatory approval of the drug product candidates of Lucid and FSD BioSciences; the introduction of competing drugs that are safer, more effective or less expensive than, or otherwise superior to, the drug product candidates of Lucid and FSD BioSciences; the initiation, conduct, and completion of preclinical studies and clinical trials may be delayed, adversely affected, or impacted by COVID-19 related issues; the potential inability to obtain adequate financing; the potential inability to obtain or maintain intellectual property protection for the drug product candidates of Lucid and FSD BioSciences; and other risks. Further information regarding factors that may cause actual results to differ materially are included in the Company’s annual and other reports filed from time to time with the Canadian Securities Administrators on SEDAR ( ) and with the U.S. Securities and Exchange Commission on EDGAR ( ) under the heading “Risk Factors.” Any forward-looking statement contained in this release speaks only as of its date. The Company does not undertake to update any forward-looking statements, except to the extent required by applicable securities laws.

TORONTO--(BUSINESS WIRE)-- FSD Pharma Inc. (NASDAQ: HUGE) (CSE: HUGE) (FRE: 0K9A) (“FSD Pharma” or the “Company”), a biopharmaceutical company dedicated to building a portfolio of innovative assets and biotech solutions to address ailments affecting millions worldwide, today announces that it received “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, CEO 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 advisors 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 ultra-micronized 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.1 This immense problem has limited treatment options.2 This is why FSD Pharma continues to work relentlessly to bring a new and safe inflammatory treatment option to market. 1 Chronic Inflammation - StatPearls - NCBI Bookshelf (nih.gov); 2 50 of 2021’s best-selling pharmaceuticals | Drug Discovery; (Look%20out%20for%20more%20insights,generated%20%2420.7%20billion%20in%20sales. About FSD Pharma FSD Pharma Inc. 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 ultra-micronized PEA, for the treatment of inflammatory diseases. Lucid Psycheceuticals Inc., 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. Forward Looking Information Certain statements contained herein are “forward-looking statements.” Often, but not always, forward-looking statement can be identified by the use of words such as “plans”, “expects”, “expected”, “scheduled”, “estimates”, “intends”, “anticipates”, “hopes”, “planned” or “believes”, or variations of such words and phrases, or states that certain actions, events or results “may”, “could”, “would”, “might”, “potentially” or “will” be taken, occur or be achieved. Forward-looking statements contained in this press release include statements relating to the FDA and Health Canada Approval of IND for FSD Pharma to Proceed with Phase 2 Trial of FSD201 for Nociplastic Pain Associated with Idiopathic Mast Cell Activation Syndrome. FSD cannot give any assurance that such forward-looking statements will prove to have been correct. The reader is cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date of this press release. Since forward-looking statements relate to future events and conditions, by their very nature they require making assumptions and involve inherent risks and uncertainties. The Company cautions that although it is believed that the assumptions are reasonable in the circumstances, these risks and uncertainties give rise to the possibility that actual results may differ materially from the expectations set out in the forward-looking statements. Factors that may cause such material differences include without limitation: the fact that the drug development efforts of both Lucid and FSD BioSciences are at a very early stage; the fact that preclinical drug development is uncertain, and the drug product candidates of Lucid and FSD BioSciences may never advance to clinical trials; the fact that results of preclinical studies and early-stage clinical trials may not be predictive of the results of later stage clinical trials; the uncertain outcome, cost, and timing of product development activities, preclinical studies and clinical trials of Lucid and FSD BioSciences; the uncertain clinical development process, including the risk that clinical trials may not have an effective design or generate positive results; the potential inability to obtain or maintain regulatory approval of the drug product candidates of Lucid and FSD BioSciences; the introduction of competing drugs that are safer, more effective or less expensive than, or otherwise superior to, the drug product candidates of Lucid and FSD BioSciences; the initiation, conduct, and completion of preclinical studies and clinical trials may be delayed, adversely affected, or impacted by COVID-19 related issues; the potential inability to obtain adequate financing; the potential inability to obtain or maintain intellectual property protection for the drug product candidates of Lucid and FSD BioSciences; and other risks. Further information regarding factors that may cause actual results to differ materially are included in the Company’s annual and other reports filed from time to time with the Canadian Securities Administrators on SEDAR ( ) and with the U.S. Securities and Exchange Commission on EDGAR ( ) under the heading “Risk Factors.” Any forward-looking statement contained in this release speaks only as of its date. The Company does not undertake to update any forward-looking statements, except to the extent required by applicable securities laws.