Numinus Wellness Inc. (TSXV:NUMI) (“Numinus” or the “Company”) has received Health Canada approval to amend the Company’s existing Licence under the Controlled Drug and Substances Act to allow Numinus researchers to conduct research to standardize the extraction of psilocybin from mushrooms. The amendment means Numinus is the first publicly traded company in Canada to be granted a licence by Health Canada to conduct research of this kind.
With this regulatory approval, Numinus is able to proceed with the production of naturally sourced, sustainable psilocybin for research purposes that will support the emerging field of psychedelic assisted therapy and research, at lower costs to currently produced synthetic psilocybin. The licence also allows Numinus to develop and licence its own exclusive IP for further product development in partnership with leading research organizations — something the research community has been seeking to secure. The work will be eligible for the Government of Canada’s Scientific Research and Experimental Development (SR&ED) tax incentive program and will lay a foundation for grant applications.
“We are proud to be at the forefront of a new therapeutic category by advancing evidence-based science focused on wellness and personal connection at its core,” says Numinus CEO Payton Nyquvest. “Numinus is the only publicly traded company in Canada approved to develop a consistent psilocybin extraction method from naturally-produced mushrooms at a time when alternative therapeutic methods are increasingly being investigated and demand from clinical research is growing.”
Working from the 7,000 square-foot Numinus Bioscience research facility and laboratory, senior research scientists Dr. Kristina Grotzinger and Dr. Bernd Keller will focus on developing a proprietary extraction method from mushrooms to allow for consistent dosing and application of naturally produced psilocybin. Once a proprietary method has been developed, the Company intends to explore supply agreements with leading research organizations to make use of the product in their clinical and therapeutic work.
Researchers at Johns Hopkins University, the Multidisciplinary Association for Psychedelic Substances (MAPS) and other leading researchers have published studies showing the benefits of psilocybin in treating Post-Traumatic Stress Disorder (PTSD) and other mental health issues. Further, the US Food and Drug Administration has granted breakthrough therapy status for psilocybin for the treatment of PTSD — illustrating the growing demand for therapeutic access to psilocybin.
“In most cases, the creation of synthetic compounds are less pure than those found in nature, which is the case with psilocybin,” says Dr. Grotzinger. “There is risk of contamination from solvents, gases and other chemicals, which makes them less safe to work with and requires added safety and processing expense. By working directly with the mushroom in its natural state, these risks are reduced, as is the cost to extract the psilocybin.” Grotzinger added that standardized plant or fungi extracts are accepted by European standards and are a common dosage form in Europe.
Numinus is a Vancouver-based health care company helping to support the universal desire to heal and be well. Through its wholly-owned subsidiary Salvation Botanicals, Numinus has a Health Canada cannabis testing licence that allows the Company to test and analyze cannabis products from licensed producers. In addition, it is a late-stage applicant to receive a Health Canada standard processing licence to produce cannabis products. Numinus, through the same subsidiary, also has a dealer’s licence which allows the Company to test, possess, buy and sell MDMA, psilocybin, psilocin, DMT and mescaline. The Health Canada license also allows import/export, testing and R&D of these substances. The expanded licence will allow Numinus to support the growing number of studies on the potential benefits of psychedelic therapies through research projects, product development, and the supply and distribution of these substances. Numinus Wellness is dedicated to therapies that enhance and supplement existing options for people wanting lasting physical, mental and emotional health — with psychedelic treatments at its core when approved for therapeutic and research use. Psychedelics will be part of this offering but will only be available for treatment once approved by regulators and governing bodies — a process Numinus is helping to support. For more information, visit www.numinus.ca.
Forward Looking Statements
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