FSD Pharma Inc. is a specialty biotech pharmaceutical company focused on developing a pipeline of synthetic compounds targeting the endocannabinoid system (ECS) of the human body. The Company is seeking to bring to market commercial FDA approved cannabinoid-based and endocannabinoid system (ECS)-targeting pharmaceuticals to treat certain diseases of the central nervous system and other autoimmune diseases.
FSD recently acquired U.S.-based specialty research and development (R&D) pharma company, Prismic Pharmaceuticals. With the goal of developing non-addictive prescription drugs to treat pain and inflammation to address the opioid crisis, Prismic is developing an ultramicronized formulation of palmitolylethonalamide (PEA) or ultramicronized-PEA. PEA is a naturally occurring anti-inflammatory agent that is expected to be effective for many inflammatory ailments, including chronic pain, arthritis, and fibromyalgia, among others. Micronization of PEA improves its oral bioavailability, with this technique protected by patents until 2030.
On March 9, 2020, FSD announced that it had received approval from the Ethics Committee of the Alfred Hospital, part of the Alfred Health group of hospitals serving the state of Victoria in Australia, to initiate a Phase 1, randomized, double-blind, placebo-controlled study to evaluate the safety, tolerability, and pharmacokinetics of single and multiple ascending doses of ultramicronized-PEA in normal healthy volunteers.
Patient populations with chronic pain continue to grow though remain underserved, with current treatment costs approaching $650 billion per year (Source: American Physical Therapy Association).
The Company has a diversified business model, which helps lessen risk. FSD seeks to de-risk investment by securing therapeutic assets that target large markets with significant unmet need.
In addition to its Prismic acquisition, FSD has formed strategic alliances and collaborative agreements. These relationships are with Canntab Therapeutics Ltd., SciCann Therapeutics, Solarvest BioEnergy Inc., Huge Shops, and Aura Health Inc. FSD is also pursuing alternative production methods of cannabinoids through a collaborative effort with Solarvest.
FSD has begun medical sales under the Sales for Medical Purposes License as of August 2019, achieving approximately C$260,000 during the most recent quarter. The Company is now waiting for the additional amendments to be able to sell the dried flower as well as a license for the sale of oil-based products. This ties in with partner Canntab Therapeutics such that FSD can begin selling their sustained-release tablets being produced through their patent pending technology.
Drug development is led by industry veterans and backed by industry leaders. Edward Brennan, MD, FACS, President of BioSciences Subsidiary, has three decades of experience coming from Johnson & Johnson and Glaxo SmithKline, where he was successful in identifying and developing promising clinical candidates. Charles Pollack Jr., chairman of the Scientific Advisory Board, is an expert in synthetic cannabinoid research, having been the founder of The Lambert Center for the Study of Medicinal Cannabis and Hemp at Thomas Jefferson University, in Philadelphia.
Worldwide patents protected for ten more years. The Company’s intellectual property (IP) portfolio covers ultra-micronized composition-of-matter and use features U.S. patent expiration dates ranging from 2029 to 2034.
FSD is well positioned financially. As of December 31, 2019, FSD had C$7.9 million in cash.