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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.
On September 27, 2022, FSD Pharma (NASDAQ: HUGE) received a notification from Nasdaq regarding non-compliance with the minimum bid price rule of $1.00 per share, effective for 30 consecutive business days. The Company has until March 27, 2023, to meet this requirement. Despite this notification, trading of Class B Subordinate Voting Shares remains unaffected, and the operations of the Company continue without disruption. FSD Pharma operates in the biotechnology sector, focusing on drug candidates targeting inflammatory and mental health disorders.
FSD Pharma Inc. (NASDAQ: HUGE) announced its participation in the H.C. Wainwright 24th Annual Global Investment Conference from September 12-14, 2022. Dr. Lakshmi Kotra, CEO of Lucid Psycheceuticals, will share updates on three drug candidates, including Lucid-MS for multiple sclerosis and Lucid-Psych for mental health conditions, which are advancing in IND-enabling studies. The company also received regulatory approvals for its Phase 2 trial of FSD201. The presentation will be available for 90 days, demonstrating FSD Pharma’s commitment to developing innovative therapeutics.
FSD Pharma Inc. (NASDAQ: HUGE) has received authorization from the FDA and Health Canada to proceed with its Phase 2 clinical trial of FSD201, aimed at treating chronic widespread musculoskeletal nociplastic pain associated with idiopathic mast cell activation syndrome. This follows a successful Phase 1 trial confirming FSD201's safety. The company is actively exploring partnerships to further develop this drug candidate, which is crucial given the increasing prevalence of chronic inflammatory diseases globally.
FSD Pharma Inc. (NASDAQ: HUGE) announced that its subsidiary, Lucid Psycheceuticals Inc., filed a provisional patent application for novel formulations of palmitoylethanolamide (PEA). This application is based on completed preclinical toxicology studies and a Phase 1 clinical trial of FSD201, an ultramicronized PEA. The company is actively developing FSD201 for various inflammatory disorders and aims to strengthen its intellectual property portfolio. The patent application is a strategic step in the commercialization of their therapeutic assets, enhancing shareholder value.
FSD Pharma Inc. (NASDAQ: HUGE) held its annual general meeting on June 23, 2022, with 164 shareholders representing 36.21% of votes. Key results include the election of board members Anthony Durkacz, Zeeshan Saeed, Donal Carroll, Adnan Bashir, and others, with over 96% voting in favor. The AGM also re-appointed MNP LLP as the Company’s auditor. Furthermore, the Company continues an active share repurchase program, having bought back 1,762,100 shares. Insiders, including company executives, are purchasing additional shares, indicating confidence in FSD Pharma's future.
FSD Pharma Inc. (NASDAQ: HUGE) has submitted an Investigational New Drug (IND) application to the FDA and Health Canada for a Phase 2 clinical trial of FSD-PEA, aimed at treating an unspecified inflammatory disorder. The company has transitioned away from cannabis to focus on its biotech pipeline, having completed the sale of its Cobourg facility for CAD$16.4 million, increasing its cash on hand to approximately CAD$50 million. FSD-201 is part of a set of drug candidates under development, with positive Phase 1 results reported.
FSD Pharma Inc. announced its annual general meeting on June 23, 2022, and issued a management information circular available on SEDAR. The company has adopted an equity incentive plan on May 16, 2022, allowing it to grant shares and performance share units (PSUs) amounting to 10% of Class B shares. Notably, PSUs were granted to various executives, with Anthony Durkacz receiving 699,502 units. This follows the cancellation of all options held by directors and officers. FSD Pharma is focused on developing drug candidates through its subsidiaries.
FSD Pharma (NASDAQ: HUGE) announced the successful sale of its non-core cannabis processing facility in Cobourg, Ontario, generating gross proceeds of CAD $16,400,000 and netting CAD $15,480,780 in cash. This transaction enhances the company's cash position to approximately CAD $50 million, equating to CAD $1.30 per share. The funds will support planned clinical trials and operational needs through 2025 without requiring additional capital. FSD Pharma aims to enhance shareholder value through strategic moves, including a share repurchase plan that has reduced shares outstanding by 1.52 million this year.
FSD Pharma (NASDAQ: HUGE) announced the successful dismissal of a derivative lawsuit filed by shareholder Maheep Goyal on July 20, 2021, in Delaware. The court ruled on May 5, 2022, that Goyal lacked standing, validating the Company's stance on the frivolous nature of such lawsuits. This is the second successful dismissal of a claim against the Company, following a similar ruling on December 13, 2021. FSD Pharma focuses on developing drug candidates including FSD-PEA for pharmaceutical research and mental health therapies.
FSD Pharma Inc. (NASDAQ: HUGE) announced a 24-month agreement with Tekkfund Capital Corp (TCC) for business development services, which includes a monthly fee of C$12,500 and issuing 7,000 Class B subordinate voting shares to TCC. Additionally, the company issued 30,000 shares to Crystal Research Associates for a prior research report. FSD Pharma focuses on advancing its drug candidates, including Lucid-PSYCH aimed at mental health and ultra-micronized palmitoylethanolamine (FSD-PEA). These forward-looking initiatives may lead to significant developments, though they carry inherent risks and uncertainties.
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