(Image via Numinus Wellness Inc.)
The emerging legal marketplace for psychedelic drugs has been well documented on Stockhouse, but this space could see major growth following recent efforts by cities and states to decriminalize psychedelic drugs.
In California, Bill SB519 has already passed State Senate review, and is expected to pass next year – which would legalize psilocybin, magic mushrooms, MDMA (also known as Ecstasy), and several other hallucinogenic substances. A movement to decriminalize psychedelics is also underway in Michigan, with the introduction of a bill in September to decriminalize two popular psychedelic drugs in a bid to make them available for therapeutic use. Seattle has also become the latest city to decriminalize non-commercial activity around a wide range of psychedelic substances.
This is all exciting news for companies involved with innovative interventions, such as psychedelic-assisted therapy, to help stem the current surge in mental health and substance abuse disorders.
Enter:
Numinus Wellness Inc. (TSX-V: NUMI, OTC: LKYSF, Forum) a mental health care Company developing proprietary, psychedelic-centred, therapeutic products and services through its own laboratory and R&D process, that will be delivered through a network of physical locations, digital solutions and global partnerships. Numinus offers practitioners training, resources and facilities – and also partners with medical leaders across psychedelic and mental health programming, as they help patients achieve their wellness goals.
At the forefront of a transformation that is aimed at healing, rather than managing symptoms for depression, anxiety, trauma, pain and substance abuse, the Numinus model includes psychedelic production, research, and clinic care from its own facilities. While the Company is currently focused on patient treatments and trials using Ketamine, Psilocybin and MDMA, Numinus has the Health Canada licensing and research capabilities to work with a wide variety of psychedelic compounds for therapeutic purposes. The Company also has a long-standing partnership with the
Multidisciplinary Association for Psychedelic Studies (MAPS) – widely regarded as the world-leading research and advocacy organization in the space.
In the past year, there have been interesting advancements made in using synthetic drug methylenedioxymethamphetamine (MDMA) to treat post-traumatic stress disorder (PTSD), which affects millions globally. In fact, Canada showed the highest incidence of PTSD in a large-scale study of 24 countries that indicated one in 11 Canadians will suffer from PTSD in their lifetime.
As part of its US Food and Drug Administration (FDA) clinical trials, MAPS conducted a Phase 3 study earlier this year to assess the efficacy and safety of MDMA-assisted psychotherapy versus psychotherapy with placebo control in participants diagnosed with at least moderate PTSD. The study found that 67% of participants who received three MDMA-assisted therapy sessions no longer qualified for a PTSD diagnosis and 88% experienced a clinically meaningful reduction in symptoms.
Responding to this success, Numinus’ Chief Executive Officer, Payton Nyquvest has stated that these Phase 3 results
confirm the substantial efficacy and safety of MDMA-assisted therapy for PTSD under the MAPS protocol.
“We hope this evidence encourages health regulators to urgently consider policy changes that broaden safe and evidence-based access not only to MDMA but other psychedelic-assisted therapies for mental health care.”
Phase 3 is the final phase of research required by regulators, such as Health Canada and the FDA, before deciding whether to approve MDMA as a legal prescription treatment for PTSD.
Research regarding the use of psychedelics for therapeutic purposes continues to grow. The US’ oldest research university – Johns Hopkins University – has also launched a dedicated centre for psychedelic studies, the first of its kind in the country and perhaps the world’s largest. The BC Centre on Substance Use had also gone on record to say it was interested to examine the effectiveness of psychedelic drugs to help people battling addiction. Mainstream acceptance is growing as these medical bodies advance their work into studying the effectiveness of psychedelic drugs to treat mental health.
Operating a state-of-the-art research facility in British Columbia, Canada
, Numinus Bioscience, the Company’s research and laboratory division, holds a Controlled Drugs and Substances license issued by Health Canada to allow the possession, production, assembly, sale, export, and delivery for a wide variety of psychedelic compounds and natural source materials, including Psilocybe mushroom fruiting bodies and extracts, Psilocybin, Psilocin, Ketamine, LSD, MDMA and DMT. This licensing is among the most extensive in the industry, including internationally.
As new extraction techniques, delivery methods, and novel compounds are discovered through Numinus’ research activities, the company intends to apply for patents to protect its IP. One such patent application was already submitted in June, for a
proprietary rapid production process for Psilocybe and other psychoactive fungi species.
The Numinus team will also soon be launching clinical trials to support and expand the safe, accessible, and evidence-based use of other psychedelic-assisted psychotherapies – including, a Phase 1 clinical assessment of a natural Psilocybe extract derived from the before mentioned patent pending technology.
Clinical research here is focused on developing psychedelic-assisted therapeutic protocols that can be embedded in mainstream healthcare, led by medical leadership with global research and policy reform experience, including:
- Dr. Evan Wood, Chief Medical Officer. Dr. Wood has published more than 500 scientific articles and has led efforts to legalize adult-use cannabis, supervised injection at a standard care facility, along with clinical therapeutic guidelines for a range of substance use disorders.
- Dr. Devon Christie, Clinical Director. MAPS trained and very well versed in the psychedelic space, Dr. Christie is a clinical instructor with the UBC Department of Medicine, and a family physician with a focused practice in Multidisciplinary Pain Management. Dr. Christie is also a Registered Therapeutic Counsellor emphasizing Relational Somatic Therapy for trauma resolution and is trained to deliver both MDMA-assisted psychotherapy for PTSD (MAPS USA) and ketamine-assisted psychotherapy, in a research setting. She is a recognized speaker and expert on the potential for incorporating psychedelic assisted therapies in an improved health care model for the future.
Numinus clinical trials are often completed at the Company’s own custom-designed patient clinics, which have treatment rooms specifically tailored for psychedelic assisted psychotherapies. Through these clinics,
Numinus Health – the Company’s division focused on delivering patient services, the business also supports psychotherapy practitioners in delivering best-in-class treatments by offering centralized training programs and other operational resources for effective care delivery and healthcare impact.
As interest in psychedelic assisted psychotherapies grow, Numinus is ready at the forefront, having completed two clinic acquisitions so far in 2021 that have expanded the business across Canada. First, in February, they acquired Mindspace Psychology Services Inc. (doing business as Mindspace Wellbeing) – a leader and pioneer in psychedelic programming. The acquisition expanded Numinus’ presence into Quebec, with two established locations and extensive virtual services as well as insights garnered from a decade of successful clinic management.
Just a few weeks ago, the Company acquired the Neurology Centre of Toronto (NCT) – a recognized leader and innovator in the treatment of neurological diseases that affect the brain, spinal cord, nerves, and muscles. Dr. Evan Lewis, a neurologist and clinical neurophysiologist who founded NCT in 2017 oversees more than 1,500 annual patient visits for concussion, post-concussion syndrome and brain injury. Many of these patients also experience significant psychological distress.
Today, Numinus owns and operates four clinics across Canada, with plans to expand into the US. The Company expects to add another 8 to 10 clinics to their platform during 2022 – and is well funded to do so, with more than C$60 million of cash on their balance sheet.
(Image via Numinus Wellness Inc.)
At a time when data regarding psychedelics use for treating certain mental health conditions continues to be more and more impressive, we also find ourselves in a time when treating mental health is becoming even more important. As CEO Nyquvest pointed out in an interview with Stockhouse Editorial that, considering COVID-19’s impact on our lives, mental health has come under even greater pressure.
“Everybody has been focusing on COVID, and people aren’t really talking about the mental health side of what the pandemic has created. I think with Psilocybin and MDMA, we are shifting our thinking around how we treat mental health. Rather than simply treating patients with a traditional anti-depressant (SSRI) for the rest of their lives … Psychedelics have curative intent, and interventions that may cure a host of mental health issues and allow people to get back to living healthier fulfilled lives.”
The team is optimistic that Psilocybin trials will see positive results. They are also planning to continue research into psychedelics and their role in substance use disorder indications.
“Looking towards the future, the sector is really moving towards a real cure for a lot of the different mental health issues that society is struggling with now more than ever,” CEO Nyquvest added.
On the financial side, this looks like a stable play for health care-focused investors. The Company noted that it has a cash balance of more than $60 million in its Q3 2021 report. Numinus has raised significant funds and advanced its compassionate access trial portfolio, acquisition strategy and innovation agenda while creating a strong foundation for long-term, sustainable growth across all lines of business. Earlier this year, they closed a $40 million bought deal financing with Canaccord and Eight Capital in March 2021.
CEO Nyquvest said that the Company is well set up for the balance of the fiscal year with a strong treasury, a strategy for future M&A, leadership in lab licensing, world-class clinical trial partnerships and a uniquely integrated approach to psychedelic production, research, and clinic care.
“Our focus remains on investments in our growth initiatives, and we are confident that we will continue advancing our leadership position in the implementation of evidence-based, psychedelic-assisted therapy.”
(Numinus Wellness Inc. stock chart – April 2021 to Oct 2021. Click to enlarge.)
Numinus is leading the integration of psychedelic-assisted therapies into mainstream clinical practice and building the foundation for a healthier society. The Company says its mission is to empower people to heal and be well. Numinus has already achieved several important milestones since its public markets debut and is proving to be one to watch for investors who want to broaden their portfolio in the health care market with an opportunity that is on the verge of fully blossoming.
To find out more about this Company, visit
www.numinus.com and find investor specific information at
www.investors.numinus.com.
FULL DISCLOSURE: Numinus Wellness Inc. is a client of Stockhouse Publishing.