VANCOUVER, BC, June 11, 2020 /CNW/ – Numinus Wellness Inc. (TSX-V: NUMI) (“Numinus” or the “Company”) wishes to correct the original news release dated June 11, 2020 that contained the following errors:
- the Multidisciplinary Association for Psychedelic Studies (MAPS) conducts research using psychedelic substances in relation to mental health conditions, but is primarily focussed on MDMA for Post-Traumatic Stress Disorder rather than psilocybin
- the US Food and Drug Administration has granted breakthrough therapy status for psilocybin for the treatment of depression, not PTSD
Below is the corrected news release in its entirety with the updated information.
Numinus receives Health Canada licence amendment to produce and extract psilocybin from mushrooms
Numinus becomes first publicly traded company in Canada approved to conduct research of this kind under a Health Canada licence
VANCOUVER (June 11, 2020)—Numinus Wellness Inc. (TSX-V: 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 Studies (MAPS) and other leading researchers have published studies showing the benefits of psychedelic substances in treating a range of mental health issues. Further, the US Food and Drug Administration has granted breakthrough therapy status for psilocybin for the treatment of depression — 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
This news release contains forward-looking statements within the meaning of applicable securities laws. All statements that are not historical facts, including without limitation, statements regarding future estimates, plans, programs, forecasts, projections, objectives, assumptions, expectations or beliefs of future performance, are “forward-looking statements.” Forward-looking statements can be identified by the use of words such as “plans”, “expects” or “does not expect”, “is expected”, “estimates”, “intends”, “anticipates” or “does not anticipate”, or “believes”, or variations of such words and phrases or statements that certain actions, events or results “may”, “could”, “would”, “might” or “will” be taken, occur or be achieved. Such forward-looking statements involve known and unknown risks, uncertainties and other factors that may cause actual results, events or developments to be materially different from any future results, events or developments expressed or implied by such forward looking statements. Such risks and uncertainties include, among others, dependence on obtaining and maintaining regulatory approvals, including acquiring and renewing federal, provincial, municipal, local or other licenses and any inability to obtain all necessary governmental approvals licenses and permits to operate and expand the Company’s facilities; regulatory or political change such as changes in applicable laws and regulations, including federal and provincial legalization, due to inconsistent public opinion, perception of the medical-use and adult-use marijuana industry, bureaucratic delays or inefficiencies or any other reasons; any other factors or developments which may hinder market growth; the Company’s limited operating history and lack of historical profits; reliance on management; the Company’s requirements for additional financing, and the effect of capital market conditions and other factors on capital availability; competition, including from more established or better financed competitors; and the need to secure and maintain corporate alliances and partnerships, including with research and development institutions, customers and suppliers. These factors should be considered carefully, and readers are cautioned not to place undue reliance on such forward-looking statements. Although the Company has attempted to identify important risk factors that could cause actual actions, events or results to differ materially from those described in forward-looking statements, there may be other risk factors that cause actions, events or results to differ from those anticipated, estimated or intended. There can be no assurance that forward-looking statements will prove to be accurate, as actual results and future events could differ materially from those anticipated in forward-looking statements. The Company has no obligation to update any forward-looking statement, even if new information becomes available as a result of future events, new information or for any other reason except as required by law.
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