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FSD Pharma Inc. (symbol: HUGE) is a leading biopharmaceutical company headquartered in Toronto, Canada. Originally founded in 1998, FSD Pharma is committed to developing innovative treatments for complex neuropsychiatric, neurodegenerative, and inflammatory disorders. The company operates through two main segments: Biopharmaceutical and Strategic Investments.
FSD Pharma, through its subsidiary FV Pharma Inc., focuses on producing medical-grade cannabis in Canada. The company is heavily involved in the research and development of cannabinoid-based therapies targeting central nervous system disorders, autoimmune diseases affecting the skin, gastrointestinal tract, and musculoskeletal system, such as chronic pain.
The company's core development pipeline includes FSD201, an ultra-micronized formulation of PEA, designed to treat inflammatory diseases, along with Lucid-Psych for mental health disorders and Lucid-MS for neurodegenerative conditions. FSD Pharma has formed strategic alliances with companies like SciCann Therapeutics Inc., Canntab Therapeutics, and Solarvest BioEnergy Inc. to bolster its research capabilities and expand its product portfolio.
One of the company's notable breakthroughs is the development of unbuzzd™, a proprietary blend of vitamins, minerals, and botanical extracts that aids in alcohol metabolism and mental alertness. This formulation has been licensed to Celly Nutrition Corp., which is responsible for its market launch in the United States.
FSD Pharma has been actively engaging in clinical trials to validate the efficacy and safety of its products. Recently, the company announced a Phase 1 trial for Lucid-MS aimed at evaluating its potential to prevent and reverse myelin degradation in multiple sclerosis. Another significant milestone is the METAL-2 trial, conducted in collaboration with the Applied Science and Performance Institute (ASPI), which aims to test the safety and efficacy of unbuzzd™.
FSD Pharma is also making strides in strategic investments through its wholly-owned subsidiary, FSD Strategic Investments Inc., which involves loans secured by residential or commercial properties. This diversified approach ensures a steady stream of funding for its core research and development activities.
In terms of financial health, FSD Pharma maintains a robust portfolio and is well-positioned to capitalize on future growth opportunities. The company has demonstrated a consistent commitment to advancing science and improving patient outcomes through its innovative biopharmaceutical solutions.
FSD Pharma announced that it received approval from Australia's Human Research Ethics Committee (HREC) to commence a Phase 1 clinical trial for Lucid-21-302 (Lucid-MS). This trial will study the safety and pharmacokinetics of Lucid-21-302 in healthy adult participants using a randomized, double-blind, placebo-controlled, multiple ascending dose design. Lucid-21-302 is a neuroprotective compound aimed at treating multiple sclerosis (MS) by preventing demyelination. This approval marks a significant milestone in the drug's clinical development. Additionally, FSD Pharma issued 400,000 Class B shares at $0.30 each to settle $120,000 in debt.
FSD Pharma (NASDAQ:HUGE) announced an exclusive option agreement with the University of Southern California (USC) to evaluate a novel dietary supplement technology. Signed on June 11, 2024, the agreement grants FSD Pharma a 6-month term to assess the technology, with an option to extend for an additional 6 months or obtain an exclusive license. The technology aims to enhance ingredients in unbuzzd™, a blend designed to accelerate alcohol metabolism, improve recovery from alcohol consumption, and boost mental alertness. FSD Pharma plans to launch unbuzzd™ this summer through a partnership with Celly Nutrition, led by industry veterans from Celsius Holdings and The Coca-Cola Company.
FSD Pharma has received Institutional Review Board (IRB) approval for its METAL-2 trial in the USA to study the safety and efficacy of Unbuzzd(TM) in acute alcohol intoxication. This approval allows the company to begin recruiting participants and planning the clinical study. Dr. Andrzej Chruscinski, Vice-President of Clinical and Scientific Affairs, emphasized the significance of this milestone in advancing research on acute alcohol intoxication.
On May 29, 2024, FSD Pharma (NASDAQ:HUGE) announced that the United States District Court for the Eastern District of Pennsylvania confirmed the company's Petition to Confirm Arbitration Awards against Dr. Raza Bokhari, its former CEO. The awards, issued by a Canadian arbitrator in 2022, total over CAD $3 million plus interest. The court found no valid basis to deny enforcement under the New York Convention. This legal victory follows Bokhari's termination in July 2021 and his unsuccessful arbitration challenge.
FSD Pharma has submitted a clinical trial protocol for Unbuzzd™, aimed at studying its safety and efficacy in treating acute alcohol intoxication. The METAL-2 trial will be conducted with healthy volunteers in a crossover design. The protocol is awaiting approval from an institutional review board (IRB) in the USA. Recruitment for the trial will commence once approval is granted. Dr. Andrzej Chruscinski, Vice-President of Clinical and Scientific Affairs at FSD Pharma, expressed enthusiasm about reaching this milestone.
On May 24, 2024, FSD Pharma announced an investor relations services agreement with IR Agency, starting on May 22, 2024. The agreement aims to enhance communication with the financial community through creating company profiles, media distribution, and building a digital community. The service will last one month and cost C$335,699 (approximately US$245,000). The IR Agency, led by Rafael Pereira, is independent of FSD Pharma and holds no equity interest in the company's securities. The agency will work from May 28, 2024, to June 28, 2024, to help the company achieve its communication goals.
On May 16, 2024, FSD Pharma and Celly Nutrition announced new packaging and logo for their beverage product, unbuzzd™. The product, designed to aid in alcohol metabolism and promote alertness, will launch this summer. The new design, developed with Six+One, features a vibrant green and yellow color scheme and a playful logo to appeal to a broad demographic. The packaging will be available in various formats, emphasizing the product's scientific development and benefits. Unbuzzd™ aims to balance fun with responsibility, promoting safe and mindful consumption.
FSD Pharma, a biopharmaceutical company, has submitted a Phase-1 clinical trial application for Lucid-21-302 in Australia. Lucid-21-302 is a neuroprotective compound for the treatment of multiple sclerosis, showing promise in preclinical models. The company aims to advance Lucid-21-302 into a phase-2 clinical trial, with optimism about its potential as a treatment for MS.
FSD Pharma signed an agreement with Applied Science and Performance Institute (ASPI) to conduct a clinical trial in the United States to assess the safety and efficacy of unbuzzd(TM) in an induced state of alcohol intoxication. The trial will compare the effects of unbuzzd(TM) to a placebo in thirty healthy volunteers. FSD Pharma aims to establish itself as a leader in products targeting alcohol intoxication.
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