Posted on

Is 5-MeO-DMT an accompaniment to the treatment of substance use disorders?

5-MeO-DMT by Malin Uthaug

by  Dr. Malin Vedøy Uthaug

5-methoxy-N,N-dimethyltryptamine (5-MeO-DMT) is a psychedelic substance that can be found in plants (Pachter et al. 1959), the secretion of the Incilius Alvarius toad (Weil and Davis 1994), and made synthetically (Hoshino 1936). The substance is well-known for its short-acting properties (depending on the route of administration) with subjective effects summarized in the following soundbite: ‘we are all one.’ This “sense of oneness” is similar to the experiences of ego dissolution (Nour et al. 2016) and mystical experiences (MacLean et al. 2011) evoked by other psychedelics which has been correlated with betterment in mental health-related symptoms (Barsuglia et al. 2017; Griffiths et al. 2006; Uthaug et al. 2019; Uthaug et al. 2018).

Despite being an understudied substance, current research suggests that the use of 5-MeO-DMT can evoke similar (therapeutic) effects as that of longer-acting psychedelics like psilocybin (magic mushrooms) (Barsuglia et al. 2017). Its ability to evoke the aforementioned subjective effects paired with its short-acting properties makes 5-MeO-DMT an attractive substance for Psychedelic Assisted Psychotherapy (PAP) as it could bypass some of the logistical and financial hurdles that stand in the way of individuals getting treatment. This is why I decided to study 5-MeO-DMT’s effects and its implications for aiding in the treatment of various mental health-related disorders, including substance use disorder.

Photo by Külli Kittus on Unsplash

My name is Malin Vedøy Uthaug, and I am currently working as a Postdoctoral Researcher at the Centre for Psychedelic Research at Imperial College in London. I recently joined Entheon Biomedical as a scientific advisor to aid in their quest to develop a treatment for substance use disorder using 5-MeO-DMT. For the past three years, as part of my Ph.D. work at Maastricht University in The Netherlands, I have conducted several studies on both ayahuasca and 5-MeO-DMT to explore their respective effect on mental health. Ayahuasca is a ‘psychedelic tea,’ a plant concoction containing N,N-Dimethyltryptamine (DMT) and monoamine oxidase inhibitors, used historically in a shamanic ceremonial context in the Amazon (Riba et al. 2003). 5-MeO-DMT is a similar substance to DMT known for its fast-acting properties, evoking a psychedelic experience within seconds that can last for 15-40 minutes (depending on the route of administration) (Uthaug et al. 2020; Weil and Davis 1994). I decided to write my Ph.D. on these substances primarily because ayahuasca is used in a ceremonial context, which I believe the scientific and medical communities can learn much from and that it will help us inform the design of PAP moving forward. Secondly, 5-MeO-DMT is a rather understudied substance that appears to have a similar therapeutic potential to longer-acting psychedelics such as ayahuasca and psilocybin (magic mushrooms). The fact that 5-MeO-DMT was and still is an unexplored territory compared to other entices my inner adventuress and fuels my motivation to pursue a career in psychedelic research.

My doctoral dissertation’s main objective was to explore whether the ingestion of ayahuasca and 5-MeO-DMT in a naturalistic setting was related to improvement in mental health-related variables. Those variables could include depression, anxiety, stress, mindfulness, satisfaction with life, creativity, empathy), and whether such an improvement depends on the magnitude of the psychedelic experience (i.e., the experience of ego dissolution). The five original studies I carried out are summarized in my thesis titled; “The Exploration of Naturalistically Used Ayahuasca and 5-MeO-DMT; An assessment of their respective Sub-acute and Long-term effects on Mental Health Related Variables”.

The thesis consists of seven chapters where Chapter 1 assesses the need for a new treatment option or mood-related disorders such as depression, while Chapter 2-3 and Chapter 4-6, summarizes the studies on ayahuasca and 5-MeO-DMT, respectively. Finally, Chapter 7 discusses the key findings of the studies in a broader perspective, explains the implications of the findings, and provides recommendations as we move into PAP’s future.

For all of my studies, I made use of ‘naturalistic observational design.’ This design makes observations and assessments (i.e., questionnaires and computer tasks) in individuals who voluntarily consume psychedelics like ayahuasca and 5-MeO-DMT in a naturalistic setting. There are drawbacks of this design, such as the lack of control for possible influencing non-pharmacological variables (i.e., set and setting, group dynamics, expectation, suggestibility, the potential bias of both researcher and participant). Despite those drawbacks, the design allowed me to collect valuable information that could engender future research and prospective clinical trials.

In a nutshell, my dissertation work suggests that both ayahuasca and 5-MeO-DMT used in a naturalistic setting is associated with persisting betterment (up to 4 weeks) in mental health-related variables (Chapter 2-6) and that this is correlated with the experience of ego dissolution (Uthaug 2020). Furthermore, the research suggests that 5-MeO-DMT may have immunomodulatory potential through the downregulation of cytokine IL-6 (a biomarker for inflammation) (Chapter 5). This echoes the findings of previously reported anti-inflammatory actions of 5-MeO-DMT (Dakic et al. 2017; Szabo et al. 2014) but warrants further longitudinal assessments. Additionally, a retrospective survey-study on the effects of different administration routes of 5-MeO-DMT (Chapter 6) indicated that there was no significant difference in impact and experiences of 5-MeO-DMT when administered through vaporization or intramuscular injection (IM). However, the results revealed that IM evoked the phenomenon of reactivation (defined as flashbacks/re-experiencing [parts of] the experience) less frequently, induces a slower onset of acute effects and had a strong potential to bring about the release of physical tension (somatic release). The results add weight to the clinical considerations of 5-MeO-DMT through IM by Sherwood and colleagues (2019), who identified IM as the most favourable route of administration of 5-MeO-DMT for the following reasons; 1) it avoids the first-pass metabolism; 2) has high bioavailability; 3) it allows for precise control of dosage, and 4) evokes a gentle onset with a slightly longer duration of effects.

Although the current scientific information about 5-MeO-DMT points to a similar (therapeutic) potential as other psychedelics (i.e. psilocybin), the findings from Chapter 3 (manuscript under review) in my dissertation work suggest that non-pharmacological factors such as set and setting may be steering some of the improvement in mental health-related variables. The “naturalistic placebo-control” study on the effects of ayahuasca ingested in a neo-shamanic setting signifies that while improvement in empathy was attributed to ayahuasca’s pharmacological actions, reductions in effect (depression, anxiety and stress) were moderated by non-pharmacological factors such as expectation and learning. Although we did not conduct a similar study on 5-MeO-DMT, it may very well be the case that such non-pharmacological factors played a role in the improvement in mental health-related variables following 5-MeO-DMT use too. Such factors may also include social desirability bias (Grimm 2010) and spiritual bypassing (Fox et al. 2017).

The latter is defined as the tendency to use spiritual ideas and practices to sidestep or avoid facing unresolved emotional issues, psychological wounds, and unfinished developmental tasks. Based on my observations in the field, and by watching over a hundred sessions in the underground, it seems that spiritual bypassing is a common occurrence in the underground where 5-MeO-DMT is used. My reasoning behind that is due to knowledge of the rapid onset and offset of 5-MeO-DMTs effects (through vaporization), and high doses used, which might push an individual to dissociate psychologically. Psychological dissociation is defined in Ralph Metzner’s book as ‘unconsciousness of one’s own bodily postures and gestures, vocalisations and verbalizations, as well as more or less disconnect of total awareness of ones surroundings‘ (2013). If a person dissociates during their experience with 5-MeO-DMT, they will not be ‘online’ to (somewhat) consciously work through material that may be causing them distress. Thus, there will be no resolution of unprocessed, unconscious material, and therefore it is very likely that the same pain will return. As Carl Jung once stated: what you resist persists.

Photo by Phil Coffman on Unsplash

Additionally, from speaking with many participants and facilitators before and after sessions, I became aware of romanticized ideas and expectations that they held about 5-MeO-DMT. Many believed that medicine would somehow set them free from various mental health-related difficulties. In other words, the substance would do the healing work for them. The idea of a “quick fix” is not unusual in our society and is evident in other areas besides mental health. If I go on this vacation, I’ll be happier! If I get this job, I’ll be more satisfied.  However, these are nothing but fabricated subjective illusions. The only thing you need is to take full responsibility for yourself and so too for your healing. The solution isn’t externally, but internally. Psychedelics like 5-MeO-DMT may aid in that internal process, but it won’t do the work for you nor anyone else.

I believe it is about time that beliefs about a ‘quick fix’ are reconsidered, not only by participants and facilitators of such ceremonies but also by individuals on a societal level. The reason for this is because healing is hard. If it were easy, we wouldn’t have a worldwide mental health epidemic and an urgent need for a novel treatment option for mental health-related disorders like addiction.

Although more research is needed, there is scientific literature supporting 5-MeO-DMT as an adjunct in therapy for various mental disorders. The idea would be to use it as a catalyst for a therapeutic process (i.e., Psychedelic Assisted Psychotherapy). A person would be supported by a therapist to lean into painful and repressed thoughts. Ideally, the patient undergoes therapeutic sessions before and after to prepare for and integrate the therapy with 5-MeO-DMT. The latter is particularly important, for as the title of the book by Jack Kornfield reads; after the ecstasy, the laundry.

What makes the effects of 5-MeO-DMT any different from the effects of other psychedelics? What does 5-MeO-DMT do that psilocybin or ayahuasca can’t? We do not know yet, but what we do know is this: Previous reports from participants who received ayahuasca-assisted therapy stated that it helped them release the pain or trauma that was being masked by their substance use (Argento et al. 2019). Ayahuasca, it has been suggested, exerts its anti-addictive effect through biochemical, physiological, psychological, and transcendent pathways (Liester and Prickett 2012). Firstly, ayahuasca targets several brain regions associated with addiction, and secondly, reduces dopamine levels in mesolimbic pathways related to the development and maintenance of chronic substance use.

Furthermore, it has shown to help resolve trauma, and finally, induces transcendent experiences pathways (Liester and Prickett 2012).

Additionally, the setting (ritualistic) in which ayahuasca is used and the sense of community it facilitates has also been suggested as an essential factor in addiction cessation (Talin and Sanabria 2017). The latter, a group setting, has shown to be particularly important in the treatment of addiction (Flores 2001). 5-MeO-DMT might hold a similar potential as ayahuasca for the treatment of substance use disorder for similar reasons. Despite not being used in a similar group setting, research has shown that 5-MeO-DMT target several brain areas associated with addiction (Barsuglia et al. 2018; Dakic et al. 2017), and elicit profound mystical experiences akin to that of high-dose psilocybin experiences (Barsuglia et al. 2017). Furthermore, previous research suggests that 5-MeO-DMT has low addiction potential and excellent safety profile (Davis et al. 2018), anti-inflammatory properties through the sigma-1 receptor (Szabo et al. 2014; Uthaug et al. 2019a), the therapeutic potential for various mental health disorders (Davis et al. 2018).

Photo by Aleksandr Ledogorov on Unsplash

This still doesn’t tap into what makes 5-MeO-DMT so different, but I hope that the following might explain why:

In my opinion, while being mindful of my own bias, it seems to me that 5-MeO-DMT has this unique ability to amplify a person’s interoception (sense of the internal state of the body) to a different, and yet to be understood extent which I think can have important implications for treatment of addiction as well as Post-traumatic Stress Disorder (PTSD). From my perspective, it seems that 5-MeO-DMT can pierce through the dissociative veil that is ‘protecting’ people with addiction or PTSD from unprocessed material like trauma and thus get them in contact with their body. Under the influence of 5-MeO-DMT, while in a supportive therapeutic context, a person could have a chance to get in touch with the reality of the autonomic nervous system and the dysregulation that may be in it. This provides an opportunity to work through material that has been repressed and caused “issues in the tissues” (trauma).

With regards to addiction and based on statements and writings by Dr. Gabor Maté, someone who is misusing a substance (or more) is doing so to dim away or run away from pain. In his view, the place to target in treatment is not the addiction but the illness that is causing it. According to Dr. Maté that pain needs to be felt through to go away for ‘addiction starts and ends with pain.’

Like Dr. Gabor Maté, I also believe that pain needs to be acknowledged and felt. If not, it will continue to return like ‘pop-up notifications’ on a smart-phone as a reminder that something needs attention. I also believe that 5-MeO-DMT may help individuals feel through these things if done in the right setting with proper support from a therapist. The therapeutic relationship is also a key component of treatment success.

That said, it is premature to make conclusions about the place for 5-MeO-DMT in mental health treatments at the current time. There are still many unanswered questions to address, which will require rigorous research designs, testing and analysis. To that end, I am delighted to have joined Entheon Biomedical as an advisor. As we continue to search for, investigate and find the answers to many of these lingering questions, with the ultimate aim of developing therapies that will support those recovering from substance use disorder.

 

References

Barsuglia J, Davis A, Palmer R (2017a) Characterization of mystical experiences occasioned by 5-MeO-DMT-containing toad bufotoxin and comparison with prior psilocybin studies. Psychedelic Sci 23

Barsuglia JP, Davis AK, Palmer R, Lancelotta R, Windham-Herman M, Peterson K, Polanco M, Grant R, griffiths R (2017b) Characterization of Mystical Experiences Occasioned by 5-MeO-DMT-Containing Toad Bufotoxin and Comparison with Prior Psilocybin Studies 3rd International Psychedelic Science Conference

Barsuglia JP, Polanco M, Palmer R, Malcolm BJ, Kelmendi B, Calvey T (2018) A case report SPECT study and theoretical rationale for the sequential administration of ibogaine and 5-MeO-DMT in the treatment of alcohol use disorder. Progress in brain research 242: 121-158

Dakic V, Nascimento JM, Sartore RC, de Moraes Maciel R, de Araujo DB, Ribeiro S, Martins-de-Souza D, Rehen SK (2017) Short term changes in the proteome of human cerebral organoids induced by 5-MeO-DMT. Scientific reports 7: 12863

Davis AK, Barsuglia JP, Lancelotta R, Grant RM, Renn E (2018) The epidemiology of 5-methoxy-N, N-dimethyltryptamine (5-MeO-DMT) use: benefits, consequences, patterns of use, subjective effects, and reasons for consumption. Journal of Psychopharmacology 32: 779-792

Flores PJ (2001) Addiction as an attachment disorder: Implications for group therapy. International Journal of Group Psychotherapy 51: 63-81

Fox J, Cashwell CS, Picciotto G (2017) The opiate of the masses: Measuring spiritual bypass and its relationship to spirituality, religion, mindfulness, psychological distress, and personality. Spirituality in Clinical Practice 4: 274

Griffiths RR, Richards WA, McCann U, Jesse R (2006) Psilocybin can occasion mystical-type experiences having substantial and sustained personal meaning and spiritual significance. Psychopharmacology 187: 268-283

Grimm P (2010) Social desirability bias. Wiley international encyclopedia of marketing

Hoshino TaS, K. (1936) Über die synthese des bufotenin-methyl-äthers (5-methoxy-n-dimethyl-tryptamin) und bufotenins (synthesen in der indol-gruppe. xv). Bull Chem Soc Jpn 11: 221-224

Liester MB, Prickett JI (2012) Hypotheses regarding the mechanisms of ayahuasca in the treatment of addictions. Journal of psychoactive drugs 44: 200-208

MacLean KA, Johnson MW, Griffiths RR (2011) Mystical experiences occasioned by the hallucinogen psilocybin lead to increases in the personality domain of openness. Journal of Psychopharmacology 25: 1453-1461

Metzner R (2013) The Toad and the Jaguar: a Field Report of Underground Research on a Visionary Medicine: Bufo alvarius and 5-Methoxy-dimethyltryptamine. Regent Press, Regent Press

Nour MM, Evans L, Nutt D, Carhart-Harris RL (2016) Ego-Dissolution and Psychedelics: Validation of the Ego-Dissolution Inventory (EDI). Frontiers in Human Neuroscience 10: 269

Pachter IJ, Zacharias DE, Ribeiro O (1959) Indole alkaloids of Acer saccharinum (the Silver Maple), Dictyoloma incanescens, Piptadenia colubrina, and Mimosa hostilis. The Journal of Organic Chemistry 24: 1285-1287

Sherwood A, Kaylo K, Kargbo R, Davis A, Lancelotta R, Uthaug M, Barrow B (2019) CLINICAL CONSIDERATION OF 5-MeO-DMT International Forum on Consciousness, Madison, Wisconsin

Szabo A, Kovacs A, Frecska E, Rajnavolgyi E (2014) Psychedelic N, N-dimethyltryptamine and 5-methoxy-N, N-dimethyltryptamine modulate innate and adaptive inflammatory responses through the sigma-1 receptor of human monocyte-derived dendritic cells. PloS one 9

Talin P, Sanabria E (2017) Ayahuasca’s entwined efficacy: An ethnographic study of ritual healing from ‘addiction’. International Journal of drug policy 44: 23-30

Uthaug M, Lancelotta R, Szabo A, Riba J, Ramaekers J (2019a) Prospective examination of synthetic 5-methoxy-N,N-dimethyltryptamine inhalation: effects on salivary IL-6, cortisol levels, affect, and non-judgement. Psychopharmacology: 1-13

Uthaug M, Lancelotta R, van Oorsouw K, Kuypers K, Mason N, Rak J, Šuláková A, Jurok R, Maryška M, Kuchař M (2019b) A single inhalation of vapor from dried toad secretion containing 5-methoxy-N, N-dimethyltryptamine (5-MeO-DMT) in a naturalistic setting is related to sustained enhancement of satisfaction with life, mindfulness-related capacities, and a decrement of psychopathological symptoms. Psychopharmacology: 1-14

Uthaug M, van Oorsouw K, Kuypers K, van Boxtel M, Broers N, Mason N, Toennes S, Riba J, Ramaekers J (2018) Sub-acute and long-term effects of ayahuasca on affect and cognitive thinking style and their association with ego dissolution. Psychopharmacology 235: 2979-2989

Uthaug MV (2020) The Exploration of Naturalistically used Ayahuasca and 5-MeO-DMT; An assessment of their respective Sub-acute and Long-Term effects on Mental Health Related Variables. Maastricht University

Weil AT, Davis W (1994) Bufo alvarius: a potent hallucinogen of animal origin. J Ethnopharmacol 41: 1-8

Posted on

NEONMIND READY TO LAUNCH FOUR MUSHROOM COFFEE BLENDS

August 20,  2020 – Vancouver, BC: Better Plant Sciences Inc. (CSE:PLNT) (OTCQB:BOSQF) (FE:YG3) (“Better Plant”) announces that subsidiary NeonMind Biosciences (“NeonMind”) has completed final product development for four unique Ayurveda-inspired and botanical-enhanced mushroom coffee blends which are now moving into the mixing stage with a co-packer.

The coffees are fair trade and organic, with Ayurvedic organic botanicals and organic mushroom extracts. Each is formulated with adaptogenic, immune-boosting medicinal mushrooms that are antioxidant and nutrient-rich. The formulas contain special blends of reishi, cordyceps, lion’s mane and turkey tail mushrooms, all of which are widely regarded for their health benefits.

“Four unique blends will be available: two instant mushroom coffee blends and two roasted coffee blends. Functional mushrooms are booming in popularity as a supplement to boost immunity and brain function,” said Penny White, CEO of Better Plant.

According to Data Bridge Market Research, the global medicinal mushroom market is expected to reach US$78.7 billion by 2025, from US$38.1 billion in 2017 growing at a CAGR of 9.5% during the forecast period of 2018 to 2025.

“We worked directly with Ayurveda botanical companies in India that are fair trade to source the highest quality ingredients,” said Bhavna Solecki, Director of Research and Product Development at Better Plant. “Fair trade is important to us because we want to support producers in developing countries and contribute to building sustainable communities.”

The coffees will contain Ayurvedic botanical ingredients such as holy basil, which naturally decreases anxiety; moringa, which acts as an antiviral and antidepressant; gotu kola, which reduces anxiety and stress while improving circulation, and amla; a potent fighter against bacteria and viruses.

All four blends have been sent to a third-party lab for nutritional facts testing as per Health Canada regulations for functional foods. This will test for things such as: moisture, nutrition labeling, fat and fat composition, protein, carbohydrate, cholesterol, sugar, dietary fiber, iron, calcium, sodium, potassium, ash content, and energy.

NeonMind has completed the box and packaging design for the coffees, and has sourced environmentally friendly packaging for the products. NeonMind has commenced development of a website with full e-commerce capabilities, which it intends to launch in tandem with its expected initial product launch in October 2020. The website will be powered by Shopify, which will allow for an optimized user experience across all devices and encourage sales conversions.

 

About Better Plant Sciences Inc.

Better Plant Sciences develops and acquires intellectual property and other assets related to plant-based products and therapeutics, and develops, manufactures, markets, sells and distributes plant-based products that improve lives. It has over 200 proprietary wellness formulas at various stages of commercialization, including over 20 products that are now for sale through  e-commerce or brick and mortar retail stores. It also has signed an agreement to buy JUSU bar and JUSU body products and business and expects to complete the acquisition this fall, adding active websites with over 200 products for sale, and another 100 formulas to its assets.  It has 14 patent applications to protect its formulas.  Its majority-owned subsidiary NeonMind Biosciences Inc. is engaged in research into developing a psilocybin (psychedelic mushroom) based product for weight loss and is developing a line of coffees infused with health optimizing medicinal mushrooms including reishi, cordyceps, lion’s mane and turkey tail mushrooms.

 

Investor Relations Contact:

Kevan Matheson, Investor Relations

invest@betterplantsciences.com 

1-833-515-2677

The Canadian Securities Exchange has not reviewed, approved or disapproved the contents of this news release.

 

Cautionary Statement Regarding Forward-Looking Statements

This press release includes forward-looking information and statements (collectively, “forward looking statements”) under applicable Canadian securities legislation.  Forward-looking statements are necessarily based upon a number of estimates, forecasts, beliefs and assumptions that, while considered reasonable, are subject to known and unknown risks, uncertainties, and other factors which may cause actual results and future events to differ materially from those expressed or implied by such forward-looking statements.  Such risks, uncertainties and factors include, but are not limited to: risks related to the development, testing, licensing, brand development, availability of packaging, intellectual property protection, reduced global commerce and reduced access to raw materials and other supplies due to the spread of the Coronavirus, the potential for not acquiring any rights as a result of the patent  application and any products making use of the intellectual property may be ineffective or the company may be unsuccessful in commercializing them; and other approvals will be required before commercial exploitation of the intellectual property can happen.  Demand for the company’s products, general business, economic, competitive, political and social uncertainties, delay or failure to receive board or regulatory approvals where applicable, and the state of the capital markets.  Better cautions readers not to place undue reliance on forward-looking statements provided by Better, as such forward-looking statements are not a guarantee of future results or performance and actual results may differ materially. The forward-looking statements contained in this press release are made as of the date of this press release, and Better expressly disclaims any obligation to update or alter statements containing any forward-looking information, or the factors or assumptions underlying them, whether as a result of new information, future events or otherwise, except as required by law.

Posted on

Revive Therapeutics to Expand Phase 3 Clinical Trial for Bucillamine in COVID-19 in Asia-Pacific and Canada

TORONTO, Aug. 19, 2020 – Revive Therapeutics Ltd. (“Revive” or the “Company”) (CSE: RVV, USA: RVVTF), a specialty life sciences company focused on the research and development of therapeutics for medical needs and rare disorders, is pleased to announce that following the U.S. Food & Drug Administration (“U.S. FDA”) approval to proceed with the Company’s Phase 3 clinical trial to evaluate the safety and efficacy of Bucillamine in patients with mild-moderate COVID-19, the Company is proceeding with plans to expand the Phase 3 clinical trials in Asia-Pacific Countries (“APAC”) and Canada.

“With the approval from the FDA to conduct the Phase 3 clinical trial in COVID-19 and our progress that we have made to date, we are now establishing plans to complement and support our initiatives in the U.S. to include clinical sites in APAC and Canada,” said Michael Frank, Revive’s Chief Executive Officer.

Revive expects to open the Phase 3 clinical trial for patient enrollment and dosing in September 2020.  Further to the Company signing a Memorandum of Understanding with Attwill Medical Solutions Sterilflow, LP (“AMS”) to establish AMS as a resource for clinical packaging and distribution for the Phase 3 clinical trial, the Company continues to finalize vendor agreements in project management, medical monitoring, and data management.  In addition, Revive and its clinical trial partners are evaluating potential clinical sites and clinical  investigators in the U.S., APAC and Canada to complement some of the sites previously mentioned in California, Florida, Arizona, and Texas.

About the Phase 3 Confirmatory Clinical Study

The Phase 3 confirmatory clinical study titled, “A Multi-Center, Randomized, Double-Blind, Placebo-Controlled Study of Bucillamine in Patients with Mild-Moderate COVID-19”, will enroll up to 1,000 patients that will be randomized 1:1:1 to receive Bucillamine 100 mg three times a day (“TID”), Bucillamine 200 mg TID or placebo TID for up to 14 days.  The primary objective is to compare frequency of hospitalization or death in patients with mild-moderate COVID-19 receiving Bucillamine therapy with those receiving placebo.  The primary endpoint is the proportion of patients meeting a composite endpoint of hospitalization or death from the time of first dose through Day 28 following randomization.  Efficacy will be assessed by comparison of clinical outcome (death or hospitalization), disease severity using the 8-category NIAID COVID ordinal scale, supplemental oxygen use, and progression of COVID‑19 between patients receiving standard-of-care plus Bucillamine (high dose and/or low dose) and patients receiving standard-of-care plus placebo.  Safety will be assessed by reported pre-treatment adverse events and treatment-emergent adverse events (including serious adverse events and adverse events of special interest), laboratory values (hematology and serum chemistry), vital signs (heart rate, respiratory rate, and temperature), and peripheral oxygen saturation.

An interim analysis will be performed by an Independent Data and Safety Monitoring Board (“DSMB”) after 210 patients have been treated and followed up for a total of 28 days after randomization.  The better performing Bucillamine dose at the interim analysis will be selected and patients will then be randomized 2:1 to the selected Bucillamine dose or placebo. Additional interim analyses will be performed after 400, 600, and 800 patients have reached this same post-treatment timepoint.  The independent DSMB will actively monitor interim data for the ongoing safety of patients and will recommend continuation, stopping or changes to the conduct of the study based on the interim analysis reports.

The Company is not making any express or implied claims that its product has the ability to eliminate or cure COVID-19 (SARS-2 Coronavirus) at this time.

Scientific Rationale of Bucillamine for COVID-19

Preclinical and clinical studies have demonstrated that reactive oxygen species contribute to the destruction and programmed cell death of pulmonary epithelial cells.1 N-acetyl-cysteine (NAC) has been shown to significantly attenuate clinical symptoms in respiratory viral infections in animals and humans, primarily via donation of thiols to increase antioxidant activity of cellular glutathione2,3,4,5. Bucillamine (N-(mercapto-2-methylpropionyl)-l-cysteine) has a well-known safety profile and is prescribed in the treatment of rheumatoid arthritis in Japan and South Korea for over 30 years. Bucillamine, a cysteine derivative with two thiol groups, has been shown to be 16 times more potent as a thiol donor in vivo than NAC 6. The drug is non-toxic with high cellular permeability. The basis of the clinical study will analyze if Bucillamine has the potential, via increasing glutathione activity and other anti-inflammatory activity, to lessen the destructive consequences of SARS-CoV2 infection in the lungs and attenuate the clinical course of COVID-19.

About Revive Therapeutics Ltd.

Revive is a life sciences company focused on the research and development of therapeutics for infectious diseases and rare disorders, and it is prioritizing drug development efforts to take advantage of several regulatory incentives awarded by the FDA such as Orphan Drug, Fast Track, Breakthrough Therapy and Rare Pediatric Disease designations. Currently, the Company is exploring the use of Bucillamine for the potential treatment of infectious diseases, with an initial focus on severe influenza and COVID-19. With its recent acquisition of Psilocin Pharma Corp., Revive is advancing the development of Psilocybin-based therapeutics in various diseases and disorders. Revive’s cannabinoid pharmaceutical portfolio focuses on rare inflammatory diseases and the company was granted FDA orphan drug status designation for the use of Cannabidiol (CBD) to treat autoimmune hepatitis (liver disease) and to treat ischemia and reperfusion injury from organ transplantation. For more information, visit www.ReviveThera.com.

For more information, please contact:

Michael Frank
Chief Executive Officer
Revive Therapeutics Ltd.
Tel: 1 888 901 0036
Email: mfrank@revivethera.com
Website: www.revivethera.com

Neither the Canadian Securities Exchange nor its Regulation Services Provider have reviewed or accept responsibility for the adequacy or accuracy of this release.

Cautionary Statement

This press release contains ‘forward-looking information’ within the meaning of applicable Canadian securities legislation. These statements relate to future events or future performance. The use of any of the words “could”, “intend”, “expect”, “believe”, “will”, “projected”, “estimated” and similar expressions and statements relating to matters that are not historical facts are intended to identify forward-looking information and are based on Revive’s current belief or assumptions as to the outcome and timing of such future events. Forward looking information in this press release includes information with respect to the Offering, including the intended use of proceeds. Forward-looking information is based on reasonable assumptions that have been made by Revive at the date of the information and is subject to known and unknown risks, uncertainties, and other factors that may cause actual results or events to differ materially from those anticipated in the forward-looking information. Given these risks, uncertainties and assumptions, you should not unduly rely on these forward-looking statements. The forward-looking information contained in this press release is made as of the date hereof, and Revive is not obligated to update or revise any forward-looking information, whether as a result of new information, future events or otherwise, except as required by applicable securities laws. The foregoing statements expressly qualify any forward-looking information contained herein. Reference is made to the risk factors disclosed under the heading “Risk Factors” in the Company’s annual MD&A for the fiscal year ended June 30, 2019, which has been filed on SEDAR and is available under the Company’s profile at www.sedar.com.

References

1. S Ye et al, Inhibition of Reactive Oxygen Species Production Ameliorates Inflammation Induced by Influenza A Viruses via Upregulation of SOCS1 and SOCS3., American Society for Microbiology. 2015 Mar;89(5):2672-2683).

2. L. Carati et al, Attenuation of influenza-like symptomatology and improvement of cell-mediated immunity with long-term N-acetylcysteine treatment., Eur Respir J. 1997 Jul;10(7):1535-41).

3. M Mata et al, N-acetyl-L-cysteine (NAC) inhibit mucin synthesis and pro-inflammatory mediators in alveolar type II epithelial cells infected with influenza virus A and B and with respiratory syncytial virus (RSV)., Biochem Pharmacol. 2011 Sep;82(5):548-55.

4. D Ungheri et al, Protective effect of n-acetylcysteine in a model of influenza infection in mice., Int J Immunopathol Pharmacol. 2000 Sep-Dec;13(3):123-128.

5. RH Zhang et al, N-acetyl-l-cystine (NAC) protects against H9N2 swine influenza virus-induced acute lung injury., Int Immunopharmacol. 2014 Sep;22(1):1-8).

6. LD Horwitz, Bucillamine: a potent thiol donor with multiple clinical applications, Cardiovasc Drug Rev. 2003 Summer;21(2):77-90).

Posted on

BETTER ENTERS AGREEMENT TO ACQUIRE JUSU PLANT-BASED ASSETS FOR $2.25 MILLION

August 18,  2020 – Vancouver, BC: Better Plant Sciences Inc. (CSE:PLNT) (OTCQB:BOSQF) (FE:YG3) (“Better”)

announces that it has entered into an agreement to acquire JUSU branded plant-based assets from JUSU Bar Inc., JUSU Life Inc. and JUSU Cbd Inc. The assets include all inventory, packaging, raw ingredients, and intellectual property related to 300 plant-based products for the home, body and baby, as well as the e-commerce sites where the products are sold, the customer lists and all intangible assets relating to the chain of juice bars operated in British Columbia and Alberta under the name JUSU.

The purchase price of CAD $2.25 million will be paid in units consisting of escrowed securities and warrants. 22,500,000 shares shall be issued to JUSU Group with a trading restriction of no more than 30,000 shares per day, with trading restrictions extending over a 2.5 year period.  22,500,000 warrants to buy shares at $0.11 each are issued with a four month hold. Better Plant Sciences will not take on any liabilities or obligations as part of the deal. The transaction is expected to take place in the fall, once all due diligence is complete and all necessary approvals are obtained.

JUSU is a western Canadian health, wellness and lifestyle brand. It is positioned as a full spectrum wellness brand for premium plant-based products.

The asset purchase includes 300 JUSU products including:

  • JUSU Life: (156 products) cleaning and germ-fighting products, essential oils and aromatherapy
  • JUSU Body: (80 products)  baby products, body lotions and washes, bug and tick spray, hair and face products, soaps, deodorants, shaving creams and sun care
  • JUSU Bar: (35 products) cold-pressed juices, nut milks, health shots, smoothies and smoothie bowls, cold-brew, plant-based coffees, wraps and chia cups
  • JUSU Cbd: (30 formulas) cold-pressed juices, elixirs, health shots, skin care, cosmetics, aromatherapy, supplements and pet care

“I created JUSU because I was not satisfied with the products that were available on the market. I wanted to be able to provide my family with natural products that are safe and effective. That mission was at the core of everything we developed,” says Bruce Mullen, JUSU Founder and CEO. “The Better Plant Sciences team is exactly the kind of partner that I have been looking for. Their team has the knowledge, drive, and experience to take what I have built with JUSU to the next level.”

A 2019 report by BIS Research highlighted that the plant-based food and beverage alternatives market is expected to reach $80.43 billion by 2024, with a CAGR of 13.82% from 2019 to 2024. Statista estimates that the skincare segment will increase by approximately $48 billion over that same period to $189 billion by 2025.

“JUSU is an excellent fit for the Better Plant Sciences portfolio of plant-based products that promote health, humanity and sustainability,” says Penny White, CEO of Better Plant Sciences Inc. “JUSUs diverse value chain incorporates e-commerce, wholesale and franchise paths to market, and with this we are excited to diversify the ways that we reach our customers.”

 

About JUSU Inc.

JUSU is a full spectrum wellness brand with a mission to enlighten consumers to the protective and effective properties of plant based products. Its group of companies is committed to making pure, organic, plant-based products for consumption, body and personal care. This includes brick-and-mortar juice bar franchise locations as well as an extensive direct-to-consumer product offering including skin care and body products, aromatherapy and home cleaning lines. JUSU is fully dedicated to offering consumers healthier alternatives to currently available chemical-based skin care, edible, and beverage products. All JUSU Group companies provide customers only the highest-quality all-natural products made from 100% natural, non-GMO ingredients and operate under the moto: Great products for great people.

 

About Better Plant Sciences Inc.

Better Plant Sciences develops and acquires intellectual property and other assets related to plant-based products and therapeutics, and develops, manufactures, markets, sells and distributes plant-based products that improve lives. It has over 200 proprietary wellness formulas at various stages of commercialization, including over 20 products that are now for sale through e-commerce or brick and mortar retail stores. It has 14 patent applications to protect its formulas. Its majority owned subsidiary NeonMind Biosciences Inc. is engaged in research into developing a psilocybin (psychedelic mushroom) based product for weight loss and is developing a line of coffees infused with health optimizing medicinal mushrooms including chaga, lionsmane and cordyceps.

 

Investor Relations Contact:

 

Kevan Matheson, Investor Relations

invest@betterplantsciences.com

1-833-514-2677

The Canadian Securities Exchange has not reviewed, approved or disapproved the contents of this news release.

 

Cautionary Statement Regarding Forward-Looking Statements

This press release includes forward-looking information and statements (collectively, “forward looking statements”) under applicable Canadian securities legislation.  Forward-looking statements are necessarily based upon a number of estimates, forecasts, beliefs and assumptions that, while considered reasonable, are subject to known and unknown risks, uncertainties, and other factors which may cause actual results and future events to differ materially from those expressed or implied by such forward-looking statements.  Such risks, uncertainties and factors include, but are not limited to: risks related to the development, testing, licensing, brand development, availability of packaging, intellectual property protection, reduced global commerce and reduced access to raw materials and other supplies due to the spread of the Coronavirus, the potential for not acquiring any rights as a result of the patent  application and any products making use of the intellectual property may be ineffective or the company may be unsuccessful in commercializing them; and other approvals will be required before commercial exploitation of the intellectual property can happen.  Demand for the company’s products, general business, economic, competitive, political and social uncertainties, delay or failure to receive board or regulatory approvals where applicable, and the state of the capital markets.  Better cautions readers not to place undue reliance on forward-looking statements provided by Better, as such forward-looking statements are not a guarantee of future results or performance and actual results may differ materially. The forward-looking statements contained in this press release are made as of the date of this press release, and Better expressly disclaims any obligation to update or alter statements containing any forward-looking information, or the factors or assumptions underlying them, whether as a result of new information, future events or otherwise, except as required by law.

Posted on

YIELD GROWTH ANNOUNCES NAME CHANGE AND PROVIDES CORPORATE UPDATE

August 13, 2020 – Vancouver, BC: The Yield Growth Corp. (CSE:BOSS) (OTCQB:BOSQF) (FE:YG3) (the “Company”) announces that it will be changing its corporate name to Better Plant Sciences Inc. to reflect its strategic focus on the fast-growing market for plant-based consumer products. The Company’s new stock symbol on the CSE will be “PLNT”, and the name change will be effective on Tuesday, August 18, 2020.

Since inception, all of the Company’s consumer product activities have been in the development and commercialization of all-natural, plant-based formulas. This began with the 2017 acquisition of a large plant-based formula library that includes skin care, personal care products, therapeutic products, beverages, edibles, topical wellness products, cleaning products, and a hand sanitizer – all developed under the guidelines of traditional Ayurvedic principles. The Company has also launched cannabis products through its Wright & Well brand in Oregon and has been working to develop the Jack & Jane line of cannabis products for Canada as well as medicinal mushroom products via its subsidiary, NeonMind Biosciences Inc. Continuing this momentum, the Company is committed to expanding its plant-based product portfolio across existing and new product categories and will continue to commercialize its extensive plant-based library of products.

“Herbal formulations based on traditional systems like Ayurveda have seen rapid growth in the past few years. We are committed to using the highest-quality, natural, plant-based ingredients in all of our products,” said CEO Penny White. “The name Better Plant Sciences is highly aligned with our mission, and positions us to capitalize on the growth in consumer demand for plant-based alternatives across all categories. We want to make it easy for consumers to make better choices for their health by making better products and holding ourselves to the highest standard to be a better company.”

The Company has put significant resources into fostering the growth of its direct-to-consumer business to drive sales, including the recent transfer of its Urban Juve e-commerce site onto Shopify as well as ensuring that products are also available on Amazon.ca. Creating product listings for U.S.-based consumers on Amazon.com is the next step in the Company’s direct-to-consumer sales focus.

“We have made the decision to focus solely on driving sales within Canada and the U.S. for the foreseeable future, as the COVID-19 pandemic has made those distribution channels a more reliable option. COVID-19 has also changed the outlook for retail channels worldwide and our strategy reflects this,” added White.

The Company has also been highly focused on developing the scalability of its operations while ensuring they remain true to its natural wellness and sustainability values. The company has stability tested more than 50 product formulations to ensure a 2-year shelf life for its products using plant-based preservatives. Cost-effective and environmentally friendly packaging solutions have also been sourced by the company.

“We strive to ensure our corporate practices are good to our people, customers, shareholders, employees, and our planet. Plant-based products made with high-quality natural and sustainable components, formulated to help our customers achieve optimal wellness is a crucial aspect of our business,” said White. “For our shareholders, we have ensured that we remain dedicated to staying on top of emerging trends and societal changes in order to stay relevant and set up our products for success. For employees, we offer a flexible, creative workplace, enabling remote work options that enable a healthy work-life balance.”

The new name and new symbol are intended to capture everything the Company has been developing thus far and what it plans to achieve moving forward: to make plant-based products and support wellness for a better life.

 

About The Yield Growth Corp.

The Yield Growth Corp. (CSE: BOSS), (OTCQB: BOSQF)  is a phytoceutical and consumer packaged goods company that develops and acquires intellectual property and other assets related to plant-based products and therapeutics, and develops, manufactures, markets, sells and distributes plant-based products that improve lives. It has over 200 proprietary wellness formulas at various stages of commercialization, including over 20 products that are now for sale through  e-commerce or brick and mortar retail stores. It has 14 patent applications filed in what the Global Wellness Institute reports is a $4.2 trillion-dollar global wellness market.  Its majority owned subsidiary NeonMind Biosciences Inc. is launching a line of medicinal mushroom products and is developing intellectual property in the emerging area of psychedelic medicine.  The Yield Growth management team has deep experience with global brands including Johnson & Johnson, Procter & Gamble, Skechers and Aritzia.

 

Investor Relations Contacts:

Penny White, President & CEO

Kevan Matheson, Investor Relations

invest@yieldgrowth.com

1-833-514-BOSS   1-833-514-2677

1-833-515-BOSS   1-833-515-2677

The Canadian Securities Exchange has not reviewed, approved or disapproved the contents of this news release.

 

Cautionary Statement Regarding Forward-Looking Statements

This press release includes forward-looking information and statements (collectively, “forward looking statements”) under applicable Canadian securities legislation.  Forward-looking statements are necessarily based upon a number of estimates, forecasts, beliefs and assumptions that, while considered reasonable, are subject to known and unknown risks, uncertainties, and other factors which may cause actual results and future events to differ materially from those expressed or implied by such forward-looking statements.  Such risks, uncertainties and factors include, but are not limited to: risks related to the development, testing, licensing, brand development, availability of packaging, intellectual property protection, reduced global commerce and reduced access to raw materials and other supplies do to the spread of the Coronavirus, the potential for not acquiring any rights as a result of the patent  application and any products making use of the intellectual property may be ineffective or the company may be unsuccessful in commercializing them; and other approvals will be required before commercial exploitation of the intellectual property can happen.  Demand for the company’s products, general business, economic, competitive, political and social uncertainties, delay or failure to receive board or regulatory approvals where applicable, and the state of the capital markets.  Yield Growth cautions readers not to place undue reliance on forward-looking statements provided by Yield Growth, as such forward-looking statements are not a guarantee of future results or performance and actual results may differ materially. The forward-looking statements contained in this press release are made as of the date of this press release, and Yield Growth expressly disclaims any obligation to update or alter statements containing any forward-looking information, or the factors or assumptions underlying them, whether as a result of new information, future events or otherwise, except as required by law.

Posted on

Field Trip Psychedelics Inc. Expands Stateside With Psychedelic-Enhanced Psychotherapy Clinic in New York City

Field Trip continues to usher in a new generation of effective treatments for mental health challenges with the opening of the New York location

NEW YORK, Aug. 13, 2020 /PRNewswire/ — Field Trip Psychedelics Inc. (“Field Trip” or the “Company”), the company redefining mental health and well-being through its ground-breaking work in psychedelics and psychedelic-enhanced psychotherapy, today announced that it is expanding stateside with the opening of a first-of-its-kind clinic in New York City. The clinic, opening under the Company’s Field Trip Health brand, exists to help people heal and overcome depression as well as other tough-to-beat mental health challenges through evidence-based, medically supervised psychedelic therapies.

Field Trip Health takes a step-by-step, integrated approach to using ketamine-enhanced psychotherapy to bring people on a path to mental wellness and healing. Evidence has shown that ketamine, a dissociative psychedelic that is also legal in the United states, is safe when administered in medically-supervised doses. Ketamine often provides rapid relief from symptoms of depression and other mental health conditions, and can create a period of neural plasticity through which people, with supportive therapies, experience improved well-being and healthier, more optimistic and more meaningful outlooks on life. Patients undergoing this therapy often see results after a single session.

“There is no better place to make our entry into the US than New York City. Known for the ‘Empire State of Mind,’ we’re excited for people here to experience the ‘Field Trip State of Mind,’ one filled with hope, optimism and wonder,” said Ronan Levy, Field Trip’s Executive Chairman. “With our Toronto clinic, we have demonstrated first-hand the transformative healing potential of psychedelics for people struggling with their mental health. Our expansion into New York gives us a unique opportunity to further demonstrate the power of psychedelic therapies, and help people in New York on their own personalized journey to healing.”

With setting playing a crucial role in the therapeutic experience of psychedelic-enhanced psychotherapy, Field Trip Health clinics are thoughtfully designed to be calm and inviting. Patient treatment is administered in a comfortable, spa-like environment that promotes tranquility and aids in the overall healing process.

“Our New York clinic includes Zen-inspired elements such as ikebana arrangements that are incorporated throughout the space to help patients ground and center themselves,” said Matt Emmer, Field Trip’s Director of Operations and Business Development, who oversaw the design and build of the New York clinic. “We created an intentional space and experience that is designed to touch people and create a resonance that we believe will promote healing. The addition of greenery and other natural elements serve to connect patients to their natural surroundings, from a custom-designed moss wall in the entryway to nature-inspired murals in each of the treatment rooms.”

The clinic also incorporates a red ochre handprint wall concept that is designed for patients to set their intentions at the start of their treatment and for closure at completion. Patients are invited to dip a hand in red ochre at each milestone moment to commemorate their journey. The wall also serves to inspire future patients embarking on the same transformative experience.

The Field Trip treatment program is an active process that spans over a 3-4 week engagement period, but can be accommodated to each patient’s schedule. Each Ketamine and Psychotherapy Exploratory session is 2-3 hours in length. Sessions are designed to get patients comfortable with the effects of the medicine and the psychedelic experience as a whole. Throughout a patient’s journey, the individual effect of the medicine will evolve and patients will go to deeper places in their therapy as they continue through the program.

“It’s a great testament to the Field Trip Health team that, despite the pandemic, we were able to complete the construction of the clinic and open its doors without significant delay in our expansion plans,” added Hannan Fleiman, President of Field Trip Health. “It is our second location that we have opened this year following the opening in Toronto. Our third location in Los Angeles is slated to open later this month, and many more will be opening across the US in the months and years to come.”

The New York clinic is located at 137 E. 25th St., 11th Floor, New York, NY 10010 and patients can book a consultation by phone (1-833-222-0084), email (nyc@fieldtriphealth.com) or online at https://www.fieldtriphealth.com/getstarted?l=new-york.

About Field Trip Psychedelics Inc.

Field Trip is the world’s first mental wellness company at the forefront of the scientific re-emergence of psychedelics and psychedelic-enhanced therapies. With Field Trip Health centres opening across North America, and advanced research on plant-based psychedelics through Field Trip Discovery, we help people, from those in treatment to those seeking accelerated personal growth, with a simple, evidence-based way to heal and heighten engagement with the world.

Learn more at https://fieldtriphealth.com

SOURCE Field Trip Health

Posted on

NEONMIND SUBMITS APPLICATION FOR PSILOCYBIN RESEARCH TO HEALTH CANADA

August 6, 2020 – Vancouver, BC: The Yield Growth Corp. (CSE:BOSS) (OTCQB:BOSQF) (FE:YG3) majority owned subsidiary NeonMind Biosciences Inc. (“NeonMind”) announces submission of an application to Health Canada for an exemption to use a controlled substance for scientific purposes, pursuant to Section 56(1) of the Controlled Drugs and Substances Act, S.C. 1996, c. 19 (a “Section 56 Exemption”) for NeonMind’s planned preclinical trial using psilocybin.

In May 2020, NeonMind completed the design of its preclinical study focused on using psilocybin as a treatment for weight loss and food cravings (the “Study”). NeonMind has identified a laboratory (the “Lab”) at a Canadian university in which to conduct the Study and the Section 56 Exemption application was submitted on July 27, 2020  by the person at the Lab who is expected to be the lead investigator in the Study.

Obesity has been formally recognized by the World Health Organization (WHO) as a global epidemic, with at least 2.8 million people dying each year as a result of being overweight or obese. The WHO reported that in 2016, more than 1.9 billion adults, 18 years and older, were overweight.

“We expect to receive the exemption within several months. Researchers at the Lab have previously successfully obtained Section 56 Exemptions for research involving controlled substances,” said Penny White, CEO of NeonMind. “Obesity is an enormous problem in modern society, increasing incidence of disease and putting a significant strain on our healthcare systems. The treatment of obesity is shifting focus towards root causes of the problem. We are looking at the problem from a more holistic standpoint, and believe that psychedelics may have great potential to make a positive impact in this area.”

The Lab must first obtain a Section 56 Exemption before it can use psilocybin, a controlled substance, in the Study.

“I believe that we are reaching a tipping point when it comes to awareness about what psychedelics can offer. Therapsil has just announced that four terminal cancer patients have been approved by Health Canada to use psilocybin therapy in the treatment of their end-of-life distress,” added White. “These are the first known patients to be able to legally use psilocybin since the compound became illegal in Canada in 1974.”

Theraspil is a non-profit coalition that advocates for legal, compassionate access to psilocybin therapy for palliative Canadians. The Minister of Health, Patty Hajdu, granted the approval for 4 patients to use psilocybin therapy, marking the first publicly-known individuals to receive a legal exemption from the Canadian Drugs and Substances Act.

The goal of NeonMind’s Study is to use preclinical models to generate data to demonstrate that psilocybin can be used as an effective treatment for weight loss. NeonMind plans to use data from the Study to inform dosing strategies in a Phase 2 human clinical trial to demonstrate potential efficacy of psilocybin as a weight loss treatment.

The global projected market for weight loss and weight management according to marketsandmarkets is estimated at US$245 billion.

Section 56 grants the Minister of Health the discretionary power to provide an individual with an exemption to possess a specified quantity of the controlled substance and to administer the controlled substance to human subjects or animals for the purpose of research. Section 56 states:

“The Minister may, on any terms and conditions that the Minister considers necessary, exempt from the application of all or any of the provisions of this Act or the regulations any person or class of persons or any controlled substance or precursor or any class of either of them if, in the opinion of the Minister, the exemption is necessary for a medical or scientific purpose or is otherwise in the public interest.”

The details of the Section 56 Exemption process are as follows:

An application form for a Section 56 Exemption to use a controlled substance for scientific purposes must be completed, which includes a declaration signed and dated by the person who will be the principal investigator, and sent to the Office of Controlled Substances. According to Health Canada guidelines, exemptions are protocol, principal investigator, site and substance specific. Sufficient information must be supplied to Health Canada to support the use of a controlled substance in the project or protocol and to provide confirmation that the controlled substance will be stored in a secure manner. According to the Government of Canada website, the average processing time for a Section 56 Exemption (once all information required is provided) is 42 working days.  An applicant may be contacted for clarification of information submitted or if the application is incomplete. Exemptions are valid for one year from the issuance date, and applications for extensions may be made if required.

 

About NeonMind Biosciences Inc.

NeonMind aims to be a leader in the fast-growing functional and adaptogenic foods market, and is engaged in research and the development of therapeutic products and services using medicinal and psychedelic mushrooms.  NeonMind has filed U.S. provisional patent applications to protect treatments using psilocin and/or psilocybin and certain other psychedelic substances for weight loss in individuals by reducing food cravings, counteracting compulsive overeating, improving quality of diet, increasing metabolism, treating diabetes, regulating blood glucose and reducing susceptibility to cardiovascular disease, high blood pressure, diabetes mellitus and other illnesses associated with obesity.  Yield Growth owns approximately 68% of the issued and outstanding stock of NeonMind.

 

About The Yield Growth Corp.

The Yield Growth Corp. is a phytoceutical and consumer packaged goods company that develops and acquires intellectual property and other assets related to plant-based products and therapeutics, and develops, manufactures, markets, sells and distributes plant-based products that improve lives. It has over 200 proprietary wellness formulas at various stages of commercialization including over 20 products that are now for sale through  e-commerce or brick and mortar retail stores.  It has 14 patent applications filed in what the Global Wellness Institute reports is a $4.2 trillion-dollar global wellness market.  Its majority owned subsidiary NeonMind Biosciences Inc. is launching a line of medicinal mushroom products and is developing intellectual property in the emerging area of psychedelic medicine.  The Yield Growth management team has deep experience with global brands including Johnson & Johnson, Procter & Gamble, Skechers and Aritzia.

For more information about Yield Growth, visit www.yieldgrowth.com or follow @yieldgrowth on Instagram.

 

Investor Relations Contacts:

Penny White, President & CEO

Kevan Matheson, Investor Relations

invest@yieldgrowth.com

1-833-514-BOSS   1-833-514-2677

1-833-515-BOSS   1-833-515-2677

The Canadian Securities Exchange has not reviewed, approved or disapproved the contents of this news release.

 

Cautionary Statement Regarding Forward-Looking Statements

This press release includes forward-looking information and statements (collectively, “forward looking statements”) under applicable Canadian securities legislation.  Forward-looking statements are necessarily based upon a number of estimates, forecasts, beliefs and assumptions that, while considered reasonable, are subject to known and unknown risks, uncertainties, and other factors which may cause actual results and future events to differ materially from those expressed or implied by such forward-looking statements.  Such risks, uncertainties and factors include, but are not limited to: risks related to the development, testing, licensing, brand development, availability of packaging, intellectual property protection, reduced global commerce and reduced access to raw materials and other supplies do to the spread of the Coronavirus, the potential for not acquiring any rights as a result of the patent  application and any products making use of the intellectual property may be ineffective or the company may be unsuccessful in commercializing them; and other approvals will be required before commercial exploitation of the intellectual property can happen.  Demand for the company’s products, general business, economic, competitive, political and social uncertainties, delay or failure to receive board or regulatory approvals where applicable, and the state of the capital markets.  Yield Growth cautions readers not to place undue reliance on forward-looking statements provided by Yield Growth, as such forward-looking statements are not a guarantee of future results or performance and actual results may differ materially. The forward-looking statements contained in this press release are made as of the date of this press release, and Yield Growth expressly disclaims any obligation to update or alter statements containing any forward-looking information, or the factors or assumptions underlying them, whether as a result of new information, future events or otherwise, except as required by law.

Posted on

Revive Therapeutics Update Following U.S. FDA Approval of Phase 3 Clinical Trial for Bucillamine in COVID-19

TORONTO, Aug. 05, 2020 – Revive Therapeutics Ltd. (“Revive” or the “Company”) (CSE: RVV, USA: RVVTF), a specialty life sciences company focused on the research and development of therapeutics for medical needs and rare disorders, is pleased to announce that following the U.S. Food & Drug Administration (“U.S. FDA”) approval to proceed with the Company’s Phase 3 clinical trial to evaluate the safety and efficacy of Bucillamine in patients with mild-moderate COVID-19, the Company is finalizing agreements and aligning resources to initiate the Phase 3 clinical trial in September.

“With the FDA approval of the Phase 3 clinical study to evaluate Bucillamine in the treatment of patients with mild-moderate COVID-19, our team and partners are working diligently to align our resources and expertise that will fast-track the Phase 3 study,” said Michael Frank, Revive’s Chief Executive Officer.

Revive expects to engage up to 10 clinical trial sites in the U.S. and open the Phase 3 clinical trial for patient screening in Q3-2020.  The Company is finalizing vendor agreements in the project management, medical monitoring, data management and clinical packaging for the  trials.  In addition, Revive and its clinical trial partners will be evaluating potential U.S. clinical sites and clinical  investigators in major COVID-19 affected U.S. states, such as Florida, California, Arizona and Texas.

About the Phase 3 Confirmatory Clinical Study

The Phase 3 confirmatory clinical study titled, “A Multi-Center, Randomized, Double-Blind, Placebo-Controlled Study of Bucillamine in Patients with Mild-Moderate COVID-19”, will enroll up to 1,000 patients that will be randomized 1:1:1 to receive Bucillamine 100 mg three times a day (“TID”), Bucillamine 200 mg TID or placebo TID for up to 14 days.  The primary objective is to compare frequency of hospitalization or death in patients with mild-moderate COVID-19 receiving Bucillamine therapy with those receiving placebo.  The primary endpoint is the proportion of patients meeting a composite endpoint of hospitalization or death from the time of first dose through Day 28 following randomization.  Efficacy will be assessed by comparison of clinical outcome (death or hospitalization), disease severity using the 8-category NIAID COVID ordinal scale, supplemental oxygen use, and progression of COVID‑19 between patients receiving standard-of-care plus Bucillamine (high dose and/or low dose) and patients receiving standard-of-care plus placebo.  Safety will be assessed by reported pre-treatment adverse events and treatment-emergent adverse events (including serious adverse events and adverse events of special interest), laboratory values (hematology and serum chemistry), vital signs (heart rate, respiratory rate, and temperature), and peripheral oxygen saturation.

An interim analysis will be performed by an Independent Data and Safety Monitoring Board (“DSMB”) after 210 patients have been treated and followed up for a total of 28 days after randomization.  The better performing Bucillamine dose at the interim analysis will be selected and patients will then be randomized 2:1 to the selected Bucillamine dose or placebo. Additional interim analyses will be performed after 400, 600, and 800 patients have reached this same post-treatment timepoint.  The independent DSMB will actively monitor interim data for the ongoing safety of patients and will recommend continuation, stopping or changes to the conduct of the study based on the interim analysis reports.

The Company is not making any express or implied claims that its product has the ability to eliminate or cure COVID-19 (SARS-2 Coronavirus) at this time.

Scientific Rationale of Bucillamine for COVID-19

Preclinical and clinical studies have demonstrated that reactive oxygen species contribute to the destruction and programmed cell death of pulmonary epithelial cells.1 N-acetyl-cysteine (NAC) has been shown to significantly attenuate clinical symptoms in respiratory viral infections in animals and humans, primarily via donation of thiols to increase antioxidant activity of cellular glutathione2,3,4,5. Bucillamine (N-(mercapto-2-methylpropionyl)-l-cysteine) has a well-known safety profile and is prescribed in the treatment of rheumatoid arthritis in Japan and South Korea for over 30 years. Bucillamine, a cysteine derivative with two thiol groups, has been shown to be 16 times more potent as a thiol donor in vivo than NAC 6. The drug is non-toxic with high cellular permeability. The basis of the clinical study will analyze if Bucillamine has the potential, via increasing glutathione activity and other anti-inflammatory activity, to lessen the destructive consequences of SARS-CoV2 infection in the lungs and attenuate the clinical course of COVID-19.

About Revive Therapeutics Ltd.

Revive is a life sciences company focused on the research and development of therapeutics for infectious diseases and rare disorders, and it is prioritizing drug development efforts to take advantage of several regulatory incentives awarded by the FDA such as Orphan Drug, Fast Track, Breakthrough Therapy and Rare Pediatric Disease designations. Currently, the Company is exploring the use of Bucillamine for the potential treatment of infectious diseases, with an initial focus on severe influenza and COVID-19. With its recent acquisition of Psilocin Pharma Corp., Revive is advancing the development of Psilocybin-based therapeutics in various diseases and disorders. Revive’s cannabinoid pharmaceutical portfolio focuses on rare inflammatory diseases and the Company was granted FDA orphan drug status designation for the use of Cannabidiol (CBD) to treat autoimmune hepatitis (liver disease) and to treat ischemia and reperfusion injury from organ transplantation.  For more information, visit www.ReviveThera.com.

For more information, please contact:

Michael Frank
Chief Executive Officer
Revive Therapeutics Ltd.
Tel: 1-888-901-0036
Email: mfrank@fbn.436.myftpupload.com
Website: www.revivethera.com

Neither the Canadian Securities Exchange nor its Regulation Services Provider have reviewed or accept responsibility for the adequacy or accuracy of this release

Cautionary Statement

This press release contains ‘forward-looking information’ within the meaning of applicable Canadian securities legislation. These statements relate to future events or future performance. The use of any of the words “could”, “intend”, “expect”, “believe”, “will”, “projected”, “estimated” and similar expressions and statements relating to matters that are not historical facts are intended to identify forward-looking information and are based on Revive’s current belief or assumptions as to the outcome and timing of such future events. Forward looking information in this press release includes information with respect to the Offering, including the intended use of proceeds. Forward-looking information is based on reasonable assumptions that have been made by Revive at the date of the information and is subject to known and unknown risks, uncertainties, and other factors that may cause actual results or events to differ materially from those anticipated in the forward-looking information. Given these risks, uncertainties and assumptions, you should not unduly rely on these forward-looking statements. The forward-looking information contained in this press release is made as of the date hereof, and Revive is not obligated to update or revise any forward-looking information, whether as a result of new information, future events or otherwise, except as required by applicable securities laws. The foregoing statements expressly qualify any forward-looking information contained herein. Reference is made to the risk factors disclosed under the heading “Risk Factors” in the Company’s annual MD&A for the fiscal year ended June 30, 2019, which has been filed on SEDAR and is available under the Company’s profile at www.sedar.com.

References

1. S Ye et al, Inhibition of Reactive Oxygen Species Production Ameliorates Inflammation Induced by Influenza A Viruses via Upregulation of SOCS1 and SOCS3., American Society for Microbiology. 2015 Mar;89(5):2672-2683).

2. L. Carati et al, Attenuation of influenza-like symptomatology and improvement of cell-mediated immunity with long-term N-acetylcysteine treatment., Eur Respir J. 1997 Jul;10(7):1535-41).

3. M Mata et al, N-acetyl-L-cysteine (NAC) inhibit mucin synthesis and pro-inflammatory mediators in alveolar type II epithelial cells infected with influenza virus A and B and with respiratory syncytial virus (RSV)., Biochem Pharmacol. 2011 Sep;82(5):548-55.

4. D Ungheri et al, Protective effect of n-acetylcysteine in a model of influenza infection in mice., Int J Immunopathol Pharmacol. 2000 Sep-Dec;13(3):123-128.

5. RH Zhang et al, N-acetyl-l-cystine (NAC) protects against H9N2 swine influenza virus-induced acute lung injury., Int Immunopharmacol. 2014 Sep;22(1):1-8).

6. LD Horwitz, Bucillamine: a potent thiol donor with multiple clinical applications, Cardiovasc Drug Rev. 2003 Summer;21(2):77-90).

Posted on

Revive Therapeutics Announces U.S. FDA Approval of Confirmatory Phase 3 Clinical Trial for Bucillamine in COVID-19

TORONTO, July 31, 2020 – Revive Therapeutics Ltd. (“Revive” or the “Company”) (CSE: RVV) (OTCQB: RVVTF), a specialty life sciences company focused on the research and development of therapeutics for medical needs and rare disorders, is pleased to announce that the U.S. Food & Drug Administration (“U.S. FDA”) has approved the Company to proceed with a randomized, double-blind, placebo-controlled confirmatory Phase 3 clinical trial protocol to evaluate the safety and efficacy of Bucillamine in patients with mild-moderate COVID-19.

“The FDA approval of the Phase 3 study to evaluate Bucillamine in the treatment of patients with mild-moderate COVID-19 is a tremendous milestone for Revive and I am very proud of the dedication of our team and partners to bring forward a potential new treatment option for patients with a confirmed diagnosis of COVID-19 globally,” said Michael Frank, Revive’s Chief Executive Officer. “We thank the FDA for recognizing the importance of this Phase 3 study and we are now focused on executing on our plans for initiating the clinical trial in an expeditious manner.”

About the Phase 3 Confirmatory Clinical Study

The Phase 3 confirmatory clinical study titled, “A Multi-Center, Randomized, Double-Blind, Placebo-Controlled Study of Bucillamine in Patients with Mild-Moderate COVID-19”, will enroll up to 1,000 patients that will be randomized 1:1:1 to receive Bucillamine 100 mg three times a day (“TID”), Bucillamine 200 mg TID or placebo TID for up to 14 days. The primary objective is to compare frequency of hospitalization or death in patients with mild-moderate COVID-19 receiving Bucillamine therapy with those receiving placebo. The primary endpoint is the proportion of patients meeting a composite endpoint of hospitalization or death from the time of first dose through Day 28 following randomization. Efficacy will be assessed by comparison of clinical outcome (death or hospitalization), disease severity using the 8-category NIAID COVID ordinal scale, supplemental oxygen use, and progression of COVID‑19 between patients receiving standard-of-care plus Bucillamine (high dose and/or low dose) and patients receiving standard-of-care plus placebo. Safety will be assessed by reported pre-treatment adverse events and treatment-emergent adverse events (including serious adverse events and adverse events of special interest), laboratory values (hematology and serum chemistry), vital signs (heart rate, respiratory rate, and temperature), and peripheral oxygen saturation.

An interim analysis will be performed by an Independent Data and Safety Monitoring Board (“DSMB”) after 210 patients have been treated and followed up for a total of 28 days after randomization. The better performing Bucillamine dose at the interim analysis will be selected and patients will then be randomized 2:1 to the selected Bucillamine dose or placebo. Additional interim analyses will be performed after 400, 600, and 800 patients have reached this same post-treatment timepoint. The independent DSMB will actively monitor interim data for the ongoing safety of patients and will recommend continuation, stopping or changes to the conduct of the study based on the interim analysis reports.

Scientific Rationale of Bucillamine for COVID-19

Preclinical and clinical studies have demonstrated that reactive oxygen species contribute to the destruction and programmed cell death of pulmonary epithelial cells.1 N-acetyl-cysteine (NAC) has been shown to significantly attenuate clinical symptoms in respiratory viral infections in animals and humans, primarily via donation of thiols to increase antioxidant activity of cellular glutathione2,3,4,5. Bucillamine (N-(mercapto-2-methylpropionyl)-l-cysteine) has a well-known safety profile and is prescribed in the treatment of rheumatoid arthritis in Japan and South Korea for over 30 years. Bucillamine, a cysteine derivative with two thiol groups, has been shown to be 16 times more potent as a thiol donor in vivo than NAC 6. The drug is non-toxic with high cellular permeability. The basis of the clinical study will analyze if Bucillamine has the potential, via increasing glutathione activity and other anti-inflammatory activity, to lessen the destructive consequences of SARS-CoV2 infection in the lungs and attenuate the clinical course of COVID-19.

The Company is not making any express or implied claims that its product has the ability to eliminate or cure COVID-19 (SARS-2 Coronavirus) at this time.

About Revive Therapeutics Ltd.

Revive is a life sciences company focused on the research and development of therapeutics for infectious diseases and rare disorders, and it is prioritizing drug development efforts to take advantage of several regulatory incentives awarded by the FDA such as Orphan Drug, Fast Track, Breakthrough Therapy and Rare Pediatric Disease designations. Currently, the Company is exploring the use of Bucillamine for the potential treatment of infectious diseases, with an initial focus on severe influenza and COVID-19. With its recent acquisition of Psilocin Pharma Corp., Revive is advancing the development of Psilocybin-based therapeutics in various diseases and disorders. Revive’s cannabinoid pharmaceutical portfolio focuses on rare inflammatory diseases and the company was granted FDA orphan drug status designation for the use of Cannabidiol (CBD) to treat autoimmune hepatitis (liver disease) and to treat ischemia and reperfusion injury from organ transplantation. For more information, visit www.ReviveThera.com.

For more information, please contact:
Michael Frank
Chief Executive Officer
Revive Therapeutics Ltd.
Tel: 1-888-901-0036
Email: mfrank@fbn.436.myftpupload.com
Website: www.revivethera.com

Neither the Canadian Securities Exchange nor its Regulation Services Provider have reviewed or accept responsibility for the adequacy or accuracy of this release.

Cautionary Statement

This press release contains ‘forward-looking information’ within the meaning of applicable Canadian securities legislation. These statements relate to future events or future performance. The use of any of the words “could”, “intend”, “expect”, “believe”, “will”, “projected”, “estimated” and similar expressions and statements relating to matters that are not historical facts are intended to identify forward-looking information and are based on Revive’s current belief or assumptions as to the outcome and timing of such future events. Forward looking information in this press release includes information with respect to the Offering, including the intended use of proceeds. Forward-looking information is based on reasonable assumptions that have been made by Revive at the date of the information and is subject to known and unknown risks, uncertainties, and other factors that may cause actual results or events to differ materially from those anticipated in the forward-looking information. Given these risks, uncertainties and assumptions, you should not unduly rely on these forward-looking statements. The forward-looking information contained in this press release is made as of the date hereof, and Revive is not obligated to update or revise any forward-looking information, whether as a result of new information, future events or otherwise, except as required by applicable securities laws. The foregoing statements expressly qualify any forward-looking information contained herein. Reference is made to the risk factors disclosed under the heading “Risk Factors” in the Company’s annual MD&A for the fiscal year ended June 30, 2019, which has been filed on SEDAR and is available under the Company’s profile at www.sedar.com.

References

1. S Ye et al, Inhibition of Reactive Oxygen Species Production Ameliorates Inflammation Induced by Influenza A Viruses via Upregulation of SOCS1 and SOCS3., American Society for Microbiology. 2015 Mar;89(5):2672-2683).

2. L. Carati et al, Attenuation of influenza-like symptomatology and improvement of cell-mediated immunity with long-term N-acetylcysteine treatment., Eur Respir J. 1997 Jul;10(7):1535-41).

3. M Mata et al, N-acetyl-L-cysteine (NAC) inhibit mucin synthesis and pro-inflammatory mediators in alveolar type II epithelial cells infected with influenza virus A and B and with respiratory syncytial virus (RSV)., Biochem Pharmacol. 2011 Sep;82(5):548-55.

4. D Ungheri et al, Protective effect of n-acetylcysteine in a model of influenza infection in mice., Int J Immunopathol Pharmacol. 2000 Sep-Dec;13(3):123-128.

5. RH Zhang et al, N-acetyl-l-cystine (NAC) protects against H9N2 swine influenza virus-induced acute lung injury., Int Immunopharmacol. 2014 Sep;22(1):1-8).

6. LD Horwitz, Bucillamine: a potent thiol donor with multiple clinical applications, Cardiovasc Drug Rev. 2003 Summer;21(2):77-90).

Posted on

Numinus and Together We Can Partner to Support Addiction Recovery and Mental Wellness

Numinus provides tailored treatments for clients of one of Canada’s largest addiction treatment organizations

VANCOUVER, BC, July 29, 2020 /CNW/ – Numinus Wellness Inc. (“Numinus” or the “Company“) (TSXV: NUMI), a company creating an ecosystem of health solutions centered around developing and supporting the safe, evidence-based, accessible use of psychedelic-assisted therapies, is pleased to announce its partnership with Together We Can Addiction Recovery and Education Society (TWC). TWC is one of Canada’s largest addiction treatment organizations, a registered charity, licensed healthcare provider, and an approved Canadian Federal Government service provider for the veterans’ community. The partnership has enabled TWC to enhance its mental health and addiction recovery support services with tailored mind/body wellness programs. Numinus’s associated wellness clinic is benefitting from the partnership with a dedicated stream of revenue, reinitiated since the clinic’s re-opening post-COVID earlier this month. The active service provider partnership is designed to ultimately support psychedelic-assisted therapies when authorized for use in Canada.

One in five Canadians suffer from addiction in any given year, and deaths from the current overdose crisis attributable to opioid and other addictions are growing. Numinus and TWC share the view that new solutions and integrative approaches are needed to enhance traditional recovery-based approaches to help people make transformative change, heal, and be well. The partnership currently extends the continuum of care provided to TWC clients with specialized mind/body programs which include modalities such as naturopathy, registered massage therapy, trauma and somatic therapies, and breathwork through Numinus’s associated wellness clinic in Vancouver. Individualized programs are continually being developed for TWC clients, including Canadian Forces members and veterans dealing with addiction, PTSD, anxiety, grief and loss, and other diagnoses.

Says Brett S., a TWC client who has already benefited from the partnership, “While I was in treatment at Together We Can for my drug addiction, I was given the opportunity to try out the services of the clinic. They not only supported me through recovery from my addictions but also helped me address my ADHD. I’m so grateful that Numinus’s services were part of my overall recovery.”

Longer term, the partnership also aims to provide TWC clients early-access to safe, evidence-based, regulated psychedelic-assisted therapies through Numinus’s implementation science partnerships and to provide Numinus with a key partner when it is able to provide these therapies in addition to its current services.

Although psychedelic-assisted therapies are not yet available outside of a research context, both parties are optimistic these therapies hold great promise as new treatment options for addiction and mental health care and that they will become increasingly accessible through regulatory approvals. A growing body of evidence suggests psychedelics, especially psilocybin, may dramatically improve outcomes from substance use disorders. While more research is required to fully define the outcomes and safety of the therapeutic use of psychedelic substances, the Canadian federal government is under increasing pressure to provide access to psilocybin-assisted therapy for various mental health and addiction conditions.

“The partnership with Numinus is so important for our clients. There is more demand than we can manage for our services, and our clients need the complementary programs Numinus provides,” says Stacy Wilson, TWC Executive Director. “We are excited to find a partner that is aligned with our mission and to work with a team that is driven by heartfelt passion. We both believe whole body/mind integrated support is critical to recovery, and we are optimistic that psychedelic-assisted therapies will also play a significant role in addressing addiction recovery when they are regulated.”

Adds Numinus Chief Medical Officer, Dr. Evan Wood, an internationally recognized clinician scientist and expert in addiction treatment, “The growing body of research into the role of psychedelic-assisted therapy in the treatment of substance use disorders is incredibly compelling. This partnership creates a wonderful opportunity to consolidate new strategies with an implementation science lens that can ultimately improve safe access to those seeking additional strategies for treatment and recovery.”

About Numinus
Numinus is a Vancouver-based health care company creating an ecosystem of health solutions centred around developing and supporting the safe, evidence-based, accessible use of psychedelic-assisted therapies. Numinus’s ecosystem units include Numinus Bioscience, Numinus R&D, and Numinus Health. Each unit is undertaking distinct, synergistic initiatives to hasten approved access to psychedelic-assisted therapy models in Canada and position Numinus as a trusted industry leader for the eventual regulated rollout of these therapies once available. Numinus Bioscience includes a 7,000 square foot research and testing laboratory as well as numerous Health Canada licenses (through its wholly-owned subsidiary Salvation Botanicals), including a cannabis testing license which provides established and growing revenue. It is also a late-stage application for cannabis processing. Additionally, the Company holds a dealer’s licence which allows it to import, export, possess, and test MDMA, psilocybin, psilocin, DMT, and mescaline, and it is the only publicly listed company in Canada to be issued a Health Canada license to produce and extract psilocybin from mushrooms for the purpose of developing proprietary extraction methods. These licences 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 R&D leverages established relationships to position the Company for partnerships to host studies, develop medical and therapeutic protocols, and influence regulatory approval. Numinus Health, with one clinic already prototyping systems for efficiency and profitability, is dedicated to delivering therapies that enhance and supplement existing options—centred around psychedelic-assisted therapies when and where regulated—for people wanting lasting physical, mental, and emotional health. For more information, visit www.numinus.ca.

About TWC
Founded in 1993 and located in both Metro Vancouver and Vancouver Island, Together We Can – Addiction Recovery & Education Society is one of Canada’s premier treatment centres for men battling alcohol and drug addiction. Its mission is to educate and support individuals and their families who desire a new life in recovery. It provides over 310 individuals with an immersive 60-90 day recovery-based primary addiction treatment experience, followed by transitional housing in a therapeutic residential environment. For more information, visit www.twcrecoverylife.org.

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.

SOURCE Numinus Wellness Inc.

For further information: Dana Harvey, VP Communications and Investor Relations, Numinus, dana@numinus.ca, 778-929-3262; Daniel Maceachern, Operations Manager, TWC, dmaceachern@twcrecoverylife.org, (604) 451-9854