Regulatory Approvals Place Numinus Lab at the Forefront of Global Psychedelics Research
March 4th, 2021
Numinus Wellness Inc. (“Numinus”) (TSXV: NUMI), a global leader in supporting and expanding the safe, accessible and evidence-based use of psychedelic-assisted psychotherapies (PAP), has received new amendments under Canada’s Controlled Drugs and Substances Act that enhance the Company’s ability to lead psychedelics research and support the global psychedelics sector.
Numinus Wellness Inc. (CNW Group/Numinus Wellness Inc.)
Numinus Bioscience, which operates a state-of-the-art research lab in British Columbia, Canada, recently received amendments to its federal licence to allow the possession, production, assembly, sale, export, and delivery for a wide variety of psychedelics including – for the first time – Ketamine and Lysergic acid diethylamide (LSD). The amendment also supports Numinus Bioscience’s role in these activities related to Mescaline, N,N-Dimethyltryptamine (DMT), N-Methyl-3,4, methylenedioxyamphetamine (MDMA), Psilocin and Psilocybin.
“These amendments are not just exciting for Numinus and our researchers, but also for our partners, clients and potentially academic collaborators in the psychedelics space,” said Sharan Sidhu, Science Officer and General Manager for Numinus Bioscience. “The amendments dramatically expand the work we can do with a far larger group of psychedelics, and open up market-leading and revenue-generating opportunities for Numinus in R&D, psychedelic formulations, research and analysis. Moreover, we can now develop and implement standardized psychedelics testing on top of our existing high throughput capabilities, and formulate and produce psychedelic compounds in finished packaged products for clinical trials, clinical use under exemption, and export.”
Among other valued-added services, the amendments enable Numinus Bioscience to pursue formulation and stability studies to assemble finished products for all approved psychedelics.
Previously, Numinus Bioscience conducted R&D and analytical testing on Psilocybe mushrooms. New amendments allow Numinus Bioscience to conduct all activities related to possession, production, sale, export, delivery and assembly for Psilocybe mushroom fruiting bodies, both whole ground and extracted, to stakeholders that possess a Section 56 exemption.
In addition, the new amendments allow Numinus Bioscience to increase the amount of Psilocin and Psilocybin produced at the lab from 505 grams to 1000 grams annually, consisting of 750 grams of Psilocybin and 250 grams of Psilocin. Health Canada has also acknowledged that the Company can continue to supply verified and validated Psilocybe mushroom spores and tissue culture that do not contain controlled substances to other licensed dealers and can be listed as a supplier. In coming quarters, Numinus Bioscience will prepare to offer the expanded suite of psychedelic products and services allowed by recent amendments.
“The approvals announced today mark a key milestone in advancing the integrated services model we are building to research and ultimately deliver quality therapies to people who may benefit, across the spectrum of mental health disorders,” said Payton Nyquvest, CEO, Numinus. “We know that currently available treatments for mental health disorders are often ineffective and can lead to major unwanted side effects. To date, clinical trials for professionally supervised psychedelic-assisted psychotherapies have shown safety and efficacy, with fewer and less severe side effects than conventional medicines.”
As the first public entity to legally cultivate and extract Psilocybe mushrooms under its dealers’ license, Numinus Bioscience is already a research leader in the psychedelics industry. The BC lab is licensed by Health Canada.
The safety and efficacy of psychedelic-assisted psychotherapy is currently under investigation. It has not yet been approved by Health Canada or the U.S. FDA, does not work for everyone, and carries risks even in therapeutic settings. These statements are no guarantee of future Health Canada or FDA approval or availability of psychedelic-assisted psychotherapy. These statements necessarily involve known and unknown risks and uncertainties, which may cause actual outcomes to differ materially from projections.
Numinus Wellness Inc. (TSXV:NUMI) is a health care and research company creating psychedelic-centred solutions to treat mental illness, substance abuse and trauma.
Numinus Health delivers treatments through clinics and virtual services, with clinics in Vancouver and Montreal.
Numinus R&D develops clinical and therapeutic protocols to use in treatments, in collaboration with research partners and regulators.
Numinus Bioscience develops formulations and methods for a safe supply, using Health Canada licences, scientific expertise and cutting-edge technology.
Learn more at numinus.ca, and follow us on Facebook, Twitter, and Instagram.
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 licences and any inability to obtain all necessary governmental approvals licences 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; the development and implementation of medical protocols and treatment standard operating procedures for the use of psychedelic therapies; the Company’s goals to develop and implement partnerships with research organizations and other key players in the integrative mental health industry; the Company’s ability to successfully withstand the economic impact of COVID-19; the medical benefits, safety, efficacy, dosing and social acceptance of psychedelics; the approval and/or success of compassionate access clinical trials; the cultivation and harvest of psilocybe mushrooms; and the availability of trained personnel and medical professionals. 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.
SOURCE Numinus Wellness Inc.
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