FSD Pharma Inc. (NASDAQ:HUGE) (CSE:HUGE) (FSE:0K9A), a life sciences holding company dedicated to building a portfolio of assets and biotech solutions, announced the submission of an Investigational New Drug or “IND” application with the U.S. Food and Drug Administration and Health Canada. The IND application details a planned phase 2 clinical trial of FSD-PEA for the treatment of a yet-to-be-disclosed inflammatory disorder.
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FSD Pharma Inc. (NASDAQ:HUGE) (CSE:HUGE) (FSE:0K9A), a life sciences holding company dedicated to building a portfolio of assets and biotech solutions, announced the submission of an Investigational New Drug or “IND” application with the U.S. Food and Drug Administration and Health Canada.
The IND application details a planned phase 2 clinical trial of FSD-PEA for the treatment of a yet-to-be-disclosed inflammatory disorder.
Zeeshan Saeed, Co-Founder and President, stated: “Our current submissions of applications to FDA and Health Canada for FSD-201 efficacy trials represent a significant milestone in our drug development efforts. With our elite team and solid cash position, we find ourselves in a strong position initiating the efficacy trials with FSD-201. Further details on the clinical trial will be released as soon as the applications complete their review processes, and the clinical trial commences.”
The company recently completed the sale of its former cannabis production facility in Cobourg, Ontario for $16.4 million, resulting in a nice profit, having acquired the property in November 2017 for $5.5 million, and in the process growing cash on hand to approximately $50.0 million, while completing its transition away from the cannabis industry.
Zeeshan Saeed further stated: “Over the last year, we have strategically exited the cannabis business, whilst making a generous profit on the sale of the Cobourg facility and in the process, providing sufficient capital for at least three years of operations and clinical trials. No treatment currently exists to target neurodegeneration, Major Depressive Disorder is an indication in desperate need for new therapeutic approaches, and, as aforementioned, there are no PEA-based drugs approved by the FDA either. That said, we have unique drug candidates that have the potential to revolutionize patient outcomes in each of these notoriously hard-to-treat diseases via innovative mechanisms of action.”
Since assuming control of the company last year, the founders along with the company’s leadership team, focused the company’s resources on building a globally recognized biotechnology firm.
Highlights include the acquisition of Lucid Psycheceuticals, a specialty pharmaceutical company focused on the development of therapies to treat critical neurodegenerative diseases, led by Dr. Lakshmi P. Kotra, B.Pharm.(Hons), Ph.D.
Its Lucid-MS Neuroprotective compound has shown, in pre-clinical models, to prevent and reverse Myelin degradation, which is a cause for Multiple Sclerosis as well as other Neuro-degenerative disorders.
The current treatment market is valued at US$23 billion globally.
The company has been assembling world-class development and advisory teams, including highly qualified scientists, regulatory and medical professionals with expertise spanning the entire drug development spectrum.
The company is focussed on advancing its three novel drug candidates targeting lucrative areas of unmet medical needs like Muscular Sclerosis, Depression Disorders, and Inflammatory Disorders.
FSD Pharma holds exclusive worldwide, excluding Italy and Spain, licensing rights to FSD-201 for all conditions in all regulatory categories.
Anthony Durkacz, Interim CEO and Co-Executive Chairman, added: “We are highly focused on creating shareholder value while mitigating risk, and all our efforts are concentrated on optimally structured trials that hit their primary endpoints, which we believe will have a cascade effect on potential partners, suitors, and a market valuation that is an accurate reflection of our company. We recognize that Wall Street has under-appreciated the biotech sector and that we are lumped into the mix; that we cannot control. What we can control is efficient execution of our model, assembling a team with a lengthy bio-tech track record of success to provide guidance, responsibly managing budgets. We’re checking all these boxes and will keep shareholders abreast of all pertinent developments as they happen.”
In addition to the sale of its non-core asset, the company continues to enhance shareholder value via a share repurchase plan, which to date in 2022 has reduced the outstanding share position by 1.52 million shares.
It is always important to see company insiders supporting their company and since the beginning of 2022 Zeeshan Saeed and Anthony Durkacz have bought 331,192 and 150,003 shares respectively, in the open market.
The shares are currently trading at $1.24 on the Canadian Securities Exchange.
For more information on the company’s drug candidates, please visit the company’s website, www.FSDpharma.com, or contact Zeeshan Saeed, President and Executive Co-Chairman, at 416-854-8884 or by email at zsaeed@FSDpharma.com.
For investor relations email IR@FSDPharma.com.
