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Pharma & Biotech

Numinus Wellness receives license amendments to strengthen its ability to lead psychedelics research and support the global sector

The company's Bioscience unit 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 LSD

Numinus Wellness Inc (CVE: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 strengthens the company's ability to lead psychedelics research and support the global psychedelics sector.

The company said its Numinus Bioscience unit, which operates a state-of-the-art research lab in British Columbia, 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.

READ: Numinus Wellness making good progress in its compassionate access study of psilocybin-assisted motivational enhancement therapy

"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, in a statement.

"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 value-added services, the company said that 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.

Upping psilocin and psilocybin production amounts

In addition, the company said 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 also acknowledged that the company can continue to supply verified and validated psilocybe mushroom spores and tissue cultures that do not contain controlled substances to other licensed dealers and can be listed as a supplier. In the 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 Numinus Wellness CEO Payton Nyquvest.

"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."

Contact the author: patrick@proactiveinvestors.com

Follow him on Twitter @PatrickMGraham

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