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FSD Pharma

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FSD Pharma Inc., based in Toronto, Canada, is a publicly traded, clinical stage biotechnology company developing therapies for neurodegenerative disease, inflammatory conditions, and neuropsychiatric diseases.

History

FSD Pharma was formed under the Ontario Business Corporations Act on November 1, 1998, and operated under the name Century Financial Capital Group Inc. through May 2018[1]. In May 2018, via a three-cornered amalgamation involving the acquisition of FV Pharma, a licensed producer under Canada's Cannabis Act and Regulations, the company underwent a name change to FSD Pharma, operating as a specialty biotech pharmaceutical Research & Development company.

On May 29, 2018, the Class B Shares of FSD Pharma commenced trading on the Canadian Securities Exchange under the trading symbol "HUGE".[2]

From May 2018 to March 2020, the primary focus of FSD Pharma's business was the cultivation, processing, and sale of medical cannabis through its wholly-owned FV Pharma unit. In July 2020, FSD Pharma forfeited all its Canadian cannabis licenses and suspended all activities of FV Pharma.[3]

In June 2019, FSD Pharma acquired U.S.-based specialty research & development company Prismic Pharmaceuticals Inc. for approximately US$17,500,000 (CAD$23,400,000) in stock, pursuant to which all global research, manufacturing, and commercialization rights, excluding Italy and Spain, to FSD-PEA (now called FSD201) through a license agreement between Prismic Pharmaceuticals and Italian company Epitech Group SRL were assigned to FSD Pharma.[4]

On January 9, 2020, the Class B Shares of FSD Pharma commenced trading on the NASDAQ Capital Market under the trading symbol "HUGE”. On January 22, 2020, FSD Pharma rang the NASDAQ opening bell.[5]

In September 2021, FSD Pharma acquired 100% of the issued and outstanding shares of Lucid Psycheceuticals Inc., a Canadian biotechnology company developing therapeutics for the treatment of neurodegenerative diseases, for approximately US$9,000,000 (CAD$11,300,000) in an all-stock transaction.[6]

In May 2022, FSD Pharma exited the medical cannabis business, selling its manufacturing facility, a 26.1-hectare parcel of land and 50,800-square-meter building in Cobourg, Ontario, Canada for gross proceeds of CAD$16,400,000.[7]

Subsidiaries

FSD Pharma has four subsidiaries: FSD BioSciences, Inc., Lucid Psycheceuticals, Prismic Pharmaceuticals, and FV Pharma. Prismic Pharmaceuticals and FV Pharma have no operations since the acquisition and sale of cannabis assets, respectively. Lucid Psycheceuticals is headquartered at 1 Adelaide Street East, Suite 801, Toronto, ON, Canada M5C 2V9.

Drug development

As of September 2022, FSD Pharma generates no revenue and does not have any drugs approved for commercialization by the U.S. Food and Drug Administration, Health Canada, or any other regulatory agency.

FSD BioSciences is developing FSD201 for inflammatory conditions. Lucid Psycheceuticals is developing Lucid-Psych and Lucid-MS. Lucid-Psych is a molecular compound identified for the potential treatment of mental health disorders, including Major Depressive Disorder.[8][9] Lucid-MS is a molecular compound identified for the potential treatment of neurodegenerative disorders. Lucid-MS was initially developed at Canada's University Health Network (UHN) with Lucid Psycheceuticals acquiring exclusive worldwide rights to the compound. Lucid Psycheceuticals was founded and is led by Lakshmi P. Kotra, BPharm (Hons), PhD, Senior Scientist at University Health Network[10]; Professor, University of Toronto[11]; and the 2021 winner of the Julia Levy Award[12]. The results of the pre-clinical research on Lucid-MS have been published in various peer-reviewed medical journals, including Journal of Medicinal Chemistry[13] and The Proceedings of the National Academy of Sciences (PNAS).[14]

COVID-19 trial (discontinued)

In September 2020, FSD Pharma's FSD BioSciences filed an Investigational New Drug application with the U.S. Food and Drug Administration to evaluate FSD201 in a Phase 2 clinical trial as a treatment for severe cases of COVID-19.[15] Subsequently, FSD Pharma retained Bloom Burton Securities to perform a viability & commercial viability review of FSD201 for COVID-19, for which Bloom Burton determined that the drug was unlikely to be commercially viable for the indication. In August 2021, FSD Pharma discontinued the Phase 2 trial, citing other competitive products successfully being advanced, amongst other reasons.[16]

References

  1. "Sedar". Sedar.com. Retrieved 2022-09-26.
  2. "2018-0527 – New Listing – FSD Pharma Inc. (HUGE) | CSE - Canadian Securities Exchange". www.thecse.com. Retrieved 2022-09-26.
  3. Wood, Sam. "FSD Pharma's medical marijuana dreams go up in smoke". www.inquirer.com. Retrieved 2022-09-26.
  4. "FSD Pharma closes US$17.5M deal to acquire Prismic Pharmaceuticals". www.spglobal.com. Retrieved 2022-09-26.
  5. "FSD Pharma Rings NASDAQ Opening Bell". Nasdaq.com.
  6. "University Health Network Lucid Psycheceuticals Acquired". University Health Network.
  7. "FSD Pharma sheds cannabis facility as company moves away from weed". thegrowthop.com. Retrieved 2022-09-26.
  8. Wilson, Josh. "Documentary 'After The Roar' Looks At Men's Mental Health Post Sports Retirement". Forbes. Retrieved 2022-10-03.
  9. James, Joe (2022-06-13). "Multiple Sclerosis to Depression, Innovative Biotech aims for Total Brain Health". International Business Times. Retrieved 2022-09-26.
  10. "University Health Network Dr. Lakshmi P Kotra". University Health Network.
  11. "Lakshmi Kotra, Professor". UofT LDFP. Retrieved 2022-09-26.
  12. "Julia Levy Award". www.soci.org. Retrieved 2022-09-26.
  13. Tejeda, Elizabeth J. Curiel; Bello, Angelica M.; Wasilewski, Ewa; Koebel, Adam; Dunn, Shannon; Kotra, Lakshmi P. (2017-11-09). "Noncovalent Protein Arginine Deiminase (PAD) Inhibitors Are Efficacious in Animal Models of Multiple Sclerosis". Journal of Medicinal Chemistry. 60 (21): 8876–8887. doi:10.1021/acs.jmedchem.7b01102. ISSN 0022-2623.
  14. Caprariello, Andrew V.; Rogers, James A.; Morgan, Megan L.; Hoghooghi, Vahid; Plemel, Jason R.; Koebel, Adam; Tsutsui, Shigeki; Dunn, Jeffrey F.; Kotra, Lakshmi P.; Ousman, Shalina S.; Wee Yong, V.; Stys, Peter K. (2018-05-22). "Biochemically altered myelin triggers autoimmune demyelination". Proceedings of the National Academy of Sciences. 115 (21): 5528–5533. doi:10.1073/pnas.1721115115. ISSN 0027-8424. PMC 6003499. PMID 29728463.
  15. outsourcing-pharma.com. "FSD Pharma announces Phase II trial for potential COVID-19 treatment". outsourcing-pharma.com. Retrieved 2022-09-26.
  16. Singh, Vandana. "See Why FSD Pharma Terminated COVID-19 Trial - FSD Pharma (NASDAQ:HUGE)". Benzinga. Retrieved 2022-09-26.

External links


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