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Mindset Pharma: Pursuing breakthroughs in the psychedelics field with the help of “hard science”

Psychedelic drug researchers have moved mountains over the last 30 years, helping to show that these misunderstood substances have vast potential to benefit people, while being safe and non-addictive.

Today, psilocybin is in Phase 2b clinical trials, MDMA is in Phase 3, and the US Food & Drug Administration (FDA) has given both trials breakthrough therapy status. There is tremendous momentum behind getting psychedelic drugs approved against a backdrop of two frustrating trends in North America: the opioid crisis and the negative effect of COVID-19 on mental health.

Mindset Pharma (CSE:MSET) saw early on that there would be a wave of interest in using psychedelic drugs as medication, but that ultimately there would be even more interest in next-generation drugs delivering greater benefits as medication with full patent protection.

From the outset, the company’s goal was to apply drug design, behavioural pharmacology and medicinal chemistry, which are essentially the tools of modern pharmacy, to try to harness the power of psychedelic drugs. 

Chief Executive Officer James Lanthier joined Mindset in early 2020 and was sold not only on the calibre of the scientists involved, but the specific strategy the team had developed.

“We’re applying hard science to these substances to try to create the best possible medications for people – that’s it, full stop,” Lanthier explains. “There’s now tremendous evidence to suggest that psychedelics have a breakthrough role to play to treat psychiatric mood disorders, but in our view, the classic psychedelic drugs did have some shortcomings.”

Essentially, Mindset wants to create new drugs that deliver the same or superior benefit but will work more predictably for the widest possible patient set. The team selected a psilocybin-like compound known as MSP-1014 from its Family Number One of novel drugs. The group of compounds is structurally closer to psilocybin but has the potential to deliver a more pronounced psychedelic experience than psilocybin does at similar doses. Given its higher efficacy, the drug would boast an improved safety profile because, theoretically, a patient could take less of it in order to achieve the same effect.

When Mindset tested MSP-1014 in mice and compared it to psilocybin at a range of doses, the company found that psilocybin reduced body temperature by as much as nearly six degrees, which is hardly a nominal amount. MSP-1014, however, showed no effect on body temperature, an early indication of the compound’s safety profile.

Another interesting piece of data from the lab studies confirmed MSP-1014 was comparable to psilocybin after a drug discrimination assay. In the lab, rats were able to determine the distinction between MSP-1014 and saline, which gives even further credence to the drug’s efficacy. “When we take a drug into clinical trials, you want to have as much confidence as possible that the drug is going to be effective and safe,” Lanthier says. “It’s another strong data point that will help us move forward with more confidence.”

Psilocybin is showing promise in early trials, but its effects can last up to eight hours. Mindset is hoping to tackle that challenge with its Family Four group of DMT analogues, which could offer similar benefits in a therapeutic context but with a much shorter trip of between 15 to 30 minutes. Its lead candidate in that group is MSP-4018, which is being compared against a serotonin analogue known as 5-MEO-DMT found in plant species and toad venom.

Researchers think this could be useful for in-clinic psychedelic-assisted psychotherapy. Because 5-MEO-DMT results in a total duration of experience of between 10 minutes and two hours, it would mean less time to spend in a clinic and fewer resources needed to treat a patient. 

Mindset’s research uncovered meaningful safety improvements with MSP-4018. “We saw signs of serotonin syndrome at a whole range of doses with 5-MEO DMT, which is a really unpleasant basket of symptoms that can afflict people with high levels of serotonin in their bodies,” Lanthier says. “MSP-4018 showed no signs of serotonin syndrome, but we saw behaviour that suggested that it was just as psychedelic as 5-MEO DMT. It’s really encouraging because it looks like we’ve got a drug that is just as psychedelic but potentially quite a bit safer.”

All of this is a step toward proving the concept behind Mindset to make better drugs than the original psychedelic by applying science. The company is building its value on those tweaks and improvements.

“This is about creating new chemical designs that make changes to the structure of the original drug, and then testing them rigorously to see the effect of the changes,” Lanthier explains.

Essentially, Mindset is changing the underlying molecule, synthesizing the elements of the particular drug. It’s an important distinction from its peer group, as companies can patent protect this type of intellectual property to a much greater degree than a formulation of the original drug.

“If you’re not changing the active pharmaceutical ingredient, but just putting it in a different solution, the level of intellectual property rights is quite shallow,” Lanthier states. “Another group can come along with a slightly different formulation and compete against you.”

In Mindset’s case, they’re getting intellectual property rights on the composition of matter, which Lanthier calls the “gold standard.”

The group has also selected two indications for its lead therapy MSP-1014: treatment-resistant depression and end-of-life cancer anxiety. Both are tragic mood disorders with, sadly, large populations.

Nearly 30% of people who suffer from depression do not find relief from traditional antidepressants or therapy sessions. It’s a field where pharmaceutical companies haven’t brought many innovations in the past few decades, leaving it ripe for psychedelic drugs to fill the void. And potentially, very lucrative: by dollar value, antidepressants represent a $15 billion industry.

Now comes the hard part. Mindset is hoping to move out of the lab and into clinical trials in 2022, which does not come without risks. As all drug discovery companies know, success in the lab doesn’t always translate to success in clinical trials. It takes a while to do all the testing and work through regulatory requirements until the drug gets to a point where regulators are comfortable having them taken by humans. 

But psychedelic discovery is different than many other drug discovery efforts because there is so much data available on how existing psychedelics work.

“Based on all the data, we have a pretty high level of confidence that many of these drugs will have a role to play in treating neuropsychiatric and mood disorders,” Lanthier says. “We’re not reinventing the wheel – we’re simply trying to make changes to the chemical structures that will make them safer and more effective. So, it’s a bit different than a typical biotech venture that’s working on something that’s brand new.”

The goal for Mindset is to stick to what they’re good at: discovering and developing new psychedelic drugs. The firm is positioning itself to partner with other groups, be it pharmaceutical firms or psychedelic companies, that want to get into the space and have the expertise and infrastructure to run clinical trials. 

“We don’t think that we’re going to have to raise billions of dollars to become the next Pfizer and take these drugs through late-stage clinical trials,” Lanthier notes. “We think there will be lots of opportunities for Mindset because we were filing intellectual property early and developing data early.”

This story was featured in the Canadian Securities Exchange magazine.

Learn more about Mindset Pharma at https://www.mindsetpharma.com/

Wesana Health: Leveraging personal and professional experience to help patients achieve better mental health outcomes

Former Chicago Blackhawks enforcer Daniel Carcillo spent much of his NHL career getting inside the heads of opposing teams, making sure they knew that if they crossed a certain line, things could go sideways.

Today, Carcillo is an entrepreneur whose mission is, for all intents and purposes, the opposite of what he did on the ice. Instead of contributing to head injuries, he now seeks to heal them.

The transition from hard charging two-time Stanley Cup winner to source of hope for people with mental health challenges began in 2015 when a seventh diagnosed concussion forced Carcillo into early retirement. At age 30, he entered the most emotional and anguished time of his life.

Years of fierce competition, and having his body repeatedly slammed into the ice, the boards, and competing players, resulted in Carcillo suffering traumatic brain injury (TBI). The undercurrent of anxiety and depression during early retirement got so bad that Carcillo, a husband and father, contemplated suicide.

He spent five years trying different concussion treatments, spending hundreds of thousands of dollars in the process. But it was all for naught. Carcillo found he was no closer to improving his brain health and quality of life. He hit rock bottom.

Then in 2019, hallucinogenic mushrooms helped him begin to turn things around. The experience compelled him to start a new journey assisting others suffering TBI-related symptoms. Athletes, soldiers, domestic violence victims and people recovering from serious accidents are among the many types of patients in need.

Healthy once again and with a new team to lead, Carcillo is Co-Founder and Chief Executive Officer of Wesana Health Holdings (CSE:WESA). His mission with Wesana is to revolutionize the way neurological health and performance is treated through personalized medicine and bringing the promise of psychedelic drug-assisted therapy to the masses using psilocybin to treat TBI and migraines. His company is also working with ketamine through their Wesana Clinics and is in partnership discussions with the Multidisciplinary Association for Psychedelic Studies (MAPS) to explore the use of MDMA to treat TBI.

“Two and a half years ago, when I was suicidal and in my darkest moments, I used psilocybin in a really responsible setting,” Carcillo explains. “I was able to experience just an amazing recovery. And since then, we have found ways to establish Wesana with an outstanding team. We have this innovation that we think will help millions of people.”

Research suggests that psilocybin can create new neurons and new neural pathways in the brain, stimulating concussion-affected areas and reversing destructive, habitual thought processes. In Carcillo’s case, he started a regimen that includes occasional large doses of the hallucinogen and regular non-hallucinogenic doses, which are helping to produce normal brain scans and bloodwork. 

“You can rewire the brain, break up destructive thought patterns and then create new, positive ones,” explains Carcillo.

But he is realistic about the challenges Wesana faces in a new, undefined and increasingly crowded industry that must engage in a long dance with US Food & Drug Administration (FDA) and Health Canada regulators to eventually bring life-saving products to market.

“As it stands right now, there’s no approved pharmaceutical for TBI-related symptoms. And the number one cause of death is suicide. I know it all too well,” says Carcillo.

“I also know how fragmented everything is in this space, from treatment to research. And there are so many gaps and what makes it hard on the patients is getting a diagnosis. And then number two is finding the treatments. We’re here to make as big an impact as we can to positively influence this process for survivors and make it easier on them and their families and caregivers to understand what’s going on and then get them healing.”

Operationally, Wesana heads into the latter half of 2021 with a $21 million runway and plenty of media attention, stemming partly from Carcillo’s fame and passionate advocacy for psychedelic drug-assisted therapy.

In the product development pipeline, the company is advancing its SANA 0013 through the preclinical stage studying psilocybin to treat TBI-related major depressive disorder. Wesana is making headway with the FDA, as it has scheduled a pre-Investigational New Drug (IND) meeting with regulators around year’s end, to be followed by the opening of the IND in the third quarter of 2022.

While psilocybin remains the company’s focus, it recently staked its claim in the markets for ketamine and MDMA, two drugs far ahead in the regulatory approval process. Carcillo readily acknowledges that bringing psilocybin-based therapies to market will take years, as the drug remains illegal in the US, as does MDMA. The FDA approved ketamine as an anesthetic for humans in 1970.

To further its expansion, Wesana acquired Psychedelitech (known as PsyTech) in September 2021, gaining a chain of mental health clinics that can administer ketamine therapies.

Wesana also picked up a software platform that helps clinicians track patient outcomes in real time and supports a community forum of over 8,000 professionals, many of them respected resources for psychedelic therapy protocols and clinical best practices.

For MDMA, also known as the popular recreational drug “ecstasy” or “molly,” the company has developed a partnership with MAPS, which is mulling an MDMA-assisted therapy program to treat TBI. Wesana has committed to provide an initial US$1.5 million to assess the program’s viability and might establish a joint venture with MAPS.

MAPS’ research has primarily focused on MDMA-assisted therapy for post-traumatic stress disorder (PTSD), an affliction common among soldiers that causes similar mental health symptoms and outcomes as TBI. MAPS says current FDA-approved Phase 3 trials have demonstrated an 88% reduction in PTSD symptoms among participants.

“Using this medicine, MDMA can help alleviate that emotional spike during conversations, so it’s easier to deal with trauma,” says Carcillo, who envisions teaming with MAPS to create a “gold standard” of clinics. “Think of it in the context of why it worked so well for PTSD. And so for TBI, that journey is no different.” 

Laying the groundwork for an even deeper understanding of TBI, Carcillo says Wesana has formed partnerships with the World Boxing Council (WBC) and the University of South Carolina as it seeks methods to prevent, or at least minimize, TBI-related damage during boxing matches and other athletic competitions. Wesana will also be using the RESOLV lab to phenotype the TBI patient population that will be participating in the Phase 2 and 3 clinical trials. 

“What can we be doing as far as exercises and supplementation to better protect the brain?” Carcillo asks. “For example, when a WBC fighter knows they’re training for a fight, what can we do to better protect them? What can we implement, as far as supplements, to be neuroprotective before the fight to lessen the damage, and then train for processing speed, hand-eye coordination, reaction time, and neck strength that minimize TBI damage on the front end?”

At the university, the company plans to spend $1.5 million to establish the BrainStorm Lab, which will serve as a hub for neurological and cognitive improvement research, with an eye on developing compounds to enhance neural performance and act as neuroprotectants of the brain. The lab will also work with the US military – which has a large presence in South Carolina – on pre-battle protection and acute post-injury scenarios.

Looking ahead, Carcillo says Wesana plans to rapidly expand the acquisition of clinics and develop more partnerships while pushing along its drug development programs. Plans also include publishing two major white papers on TBI with a group of leading scientists, neuroscientists and pathologists. 

Carcillo, in the meantime, continues working to maintain his mental health while remaining busy growing Wesana with Co-Founder Chad Bronstein. But there is more at stake for him on his new personal journey – he is inspiring others through advocacy, action and education.

“It’s definitely a young space, but an exciting space to really impact people, and treat their traumas rather than putting on band aids and trying to manage symptomatology,” Carcillo concludes. “You have to kind of pinch yourself some days. It’s the most exciting thing to be a part of, trying to positively impact that.”

This story was featured in the Canadian Securities Exchange magazine.

Learn more about Wesana Health at https://www.wesanahealth.com/

Bright Minds Biosciences: A vision for “next generation” psychedelic medicines to treat neurological conditions

With the COVID-19 pandemic upending life in every corner of the world and putting unwelcome pressure on people vulnerable to depression, suicide and addiction, there has never been a better time to consider new treatments for mental health challenges. One field gaining particularly rapid traction is psychedelics.

Of course, substances such as LSD and magic mushrooms have been around for years. They are known for their “mind-altering” qualities, both positive and negative, but in many ways the chemical properties of these compounds and their potential to benefit the brain are only just beginning to be understood.

Bright Minds Biosciences (CSE:DRUG) is a biotech company at the vanguard of this movement. Bright Minds is developing the “next generation” of non-addictive psychedelic medicines to treat depression and other neurological conditions and aims to offer an alternative to today’s standard treatments such as selective serotonin reuptake inhibitors (SSRIs), of which the widely known Prozac and Citalopram are but two examples.

“There haven’t really been any new ideas in the last 30 years or so,” says Bright Minds Chief Executive Officer Ian McDonald, who added that while revolutionary when they emerged in the 1990s, SSRIs have not always been best for patient outcomes, as side effects can include weight gain and sexual dysfunction.

SSRIs, he noted, might not work at all, or can even be problematic, for patients suffering from the most severe forms of depression, or people struggling with post-traumatic stress disorder (PTSD).

McDonald is convinced that psychedelics is the most promising field for making progress over the next 20 or 30 years in psychiatric medicine, and that related treatments will help the people most deeply affected by such disorders.

With this in mind, Bright Minds has a portfolio of three patented mechanisms based on serotonin (5-HT) receptors that are being assessed for indications ranging from depression to chronic pain. And with $30 million raised to date, the company is fully funded for Phase 1 trials for two of its drugs, which are due to begin next year.

McDonald is a former investment banker who started getting interested in psychedelics in 2014. He read all he could on the subject and concluded that while the efficacy of such drugs was not in question, they lacked the characteristics needed for the medical establishment and Big Pharma to embrace them.

Bright Minds aims to refine what could be seen as “coarse” substances and repurpose them. To do so, McDonald has assembled a top-notch team of scientists and researchers with extensive backgrounds in pharma and drug development.

Bright Minds Co-Founder Dr. Gideon Shapiro, for example, has over 100 patents to his name and is a leading commercial scientist creating novel psychedelics. He served as head of the Alzheimer chemistry group at Sandoz, the company first responsible for discovering LSD and marketing psilocybin, while Bright Minds’ Chief Scientific Officer and organic chemist Dr. Alan Kozikowski is world-renowned for his work with psychoactive substances.

“We’re not trying to reinvent the wheel,” says McDonald. “We’re taking compounds that already work and making them better. We’re sanding down the rough edges and polishing them up. I’d say it’s a much less risky approach than a lot of other biotechs who are doing a completely novel mechanism and where there are questions on efficacy.”

It is also worth highlighting that Bright Minds already has “composition of matter” patents covering all of its new chemical entity (NCE) portfolio, giving it a full monopoly over its drugs for 20 years. This approach is more akin to Big Pharma companies, which patent the molecules they invent.

Older drugs such as LSD and MDMA cannot be patented, and some companies simply pursue weaker patent strategies, according to McDonald. For example, they attempt to patent a method of production or the source of a compound. But these can easily be worked around by skilled chemists and may only offer an exclusivity period for five years, after which they become so-called generic drugs.

A drug maker’s profitability is at stake here. McDonald points out that potential revenue for a patented drug for depression, for example, could be between US$10,000 and $30,000 per patient per year compared to around $400 per year for a generic drug.

Indeed, the global market potentially open to Bright Minds is enormous. Antidepressants alone are expected to be worth $16 billion a year by 2025. And McDonald says this figure was based on generic depression drugs. For a patented one, based on the number of patients multiplied by $20,000 a year, the figure reaches an eye-watering $600 billion.

People who do well taking SSRIs will likely stick with them, McDonald concedes, but for that third of the patient population who do not, there is a potential market for alternatives of $200 billion.

The Bright Minds portfolio is already garnering attention. The company is partnering with the US government’s National Institutes of Health to test its drugs for epilepsy and chronic pain, not least to offer an alternative to opioid drugs in the latter case. McDonald says early findings have been encouraging.

In August of this year, the company reported positive pre-clinical data for its BMB-101 candidate (invented by Dr. Kozikowski) in treating the rare form of childhood epilepsy called Dravet Syndrome. This non-psychedelic drug is also being indicated as an antipsychotic for Alzheimer’s and to treat addiction disorders.

BMB-101 will be heading into Phase 1 trials early in 2022, with two Phase 2 studies potentially following in the second half. The company also aims to run a Phase 2 trial for its psychedelic candidate (5-HT2A) for depression and PTSD in 2022, says McDonald.

“We are entering a very catalyst-rich period. We have a number of clinical trials in 2022 coming up within the next year,” he adds.

Bright Minds appears to be a front-runner in this exciting new medical space and McDonald has the resources and team to see his plan through.

“We are really the leaders in this next generation of psychedelics, looking a step further I think than the other companies, and we have the team to do it – they’ve done it before, and we’re all very excited to get these drugs in the clinic and closer to patients.”

This story was featured in the Canadian Securities Exchange magazine.

Learn more about Bright Minds Biosciences at https://brightmindsbio.com

Entheon Biomedical: Data and DMT among the keys to creating safe and effective treatments for patients battling addiction

Entheon Biomedical (CSE:ENBI) Chief Executive Officer Timothy Ko speaks passionately about his company and its objectives within the burgeoning psychedelics industry, not only because he heads one of the most dynamic teams in the space, but also because he credits psychedelics with saving his life.

Following a childhood of challenges that continued into his adult years, Ko ultimately found peace of mind after psychedelic intervention enabled him to look at life differently than he had been, repair important relationships and, as he puts it, “learn to love again.”

Ko’s experience defined what is now a life mission for him. This shined through in an eloquent and authoritative discussion with Canadian Securities Exchange Magazine in mid-September.

It would be difficult to come out of a conversation with Ko not believing that there is something to psychedelic treatments for those working to overcome mental illness. It’s no longer about masking or dulling symptoms, but rather probing the drivers of problematic behaviour and replacing closely held, harm-inducing beliefs with new, healthier ones.

The specifics are best conveyed in Ko’s own words.

Entheon is researching and developing products to help treat addiction. There are already products on the market that are used for this purpose. What are you trying to achieve with your treatments that existing alternatives do not?

I think before I answer that directly, we first have to look at the treatment landscape for addiction as it currently stands. When we assess treatment options available for various addictions – be it tobacco, alcohol, or things like opiates – we see a rather bleak landscape where many of the treatments, though widely available, are not particularly efficacious.

And looking at the population, it is estimated that, globally, over 2% of the population struggles with an alcohol or illicit drug addiction. In spite of the options currently available for addiction recovery we still see hundreds of thousands, if not millions, of people die every year as a result of tobacco, alcohol and opioid use disorder. The reality is that many people are rendered treatment-resistant over the course of multiple failed attempts to address their condition.

Entheon believes that we can provide better outcomes for people who have not been helped by previous types of treatment. In our estimation, the treatment-resistant form of addiction is more common than generally thought, and Entheon treatments are designed for people for whom other forms of treatment have failed.

Entheon focuses on a fast-acting hallucinogenic known widely as DMT. Does DMT have advantages over other psychedelics for addiction treatment?

It’s important to demystify what psychedelics do. A really important observation of ours with DMT is that there is a feature that is present in other psychedelic molecules called entropy. Psilocybin, LSD and DMT can induce a state of heightened entropy, or randomness.

That might sound like a bad thing, but when you look at people with pathological conditions, there is often a degree of tunnel vision. These pathologies make it such that a severely depressed person, or an addicted person, is unable to look outside their normal frame of reference. Their reactions to stimulus or experiences are pre-determined, so you have this immobile state where they cannot envision a life outside of the one they have already experienced.

What DMT and other psychedelics do is to promote a state of hyper-connectedness. They allow individuals undergoing psychedelic treatment to enter a highly neuroplastic state that enables them to have entirely new experiences. In combination with therapy, they are able to experience old traumas, belief systems and memories, and rather than go to their pre-defined pathological reaction set, they are able to have perceptions that reshape their experience in a more positive way.

Where DMT is different is that it is very well metabolized by the body, which means the experience is short. Psilocybin is a bit of an unwieldy type of molecule to work with, as it is very powerful and the length of engagement is six to eight hours or longer. That window of engagement is commercially difficult to manage. And because these are such powerful experiences and the individual is often dealing with inherently difficult subject matter, the risk of an overwhelming experience is amplified.

With DMT, we can still facilitate powerful transformational experiences, but you have the benefit of being able to limit them to 30, 60 or 90 minutes. If we need to, we can stop the experience altogether and that person can return to a functional baseline in 10 to 15 minutes. If a person is having a difficult time with psilocybin, however, they are on that rocket ship for as long as the rocket has fuel.

In a recent news release, you discussed treatment algorithms through the Entheon IQ program. What is a treatment algorithm exactly, and what work is required to make the technology widely available?

The way Entheon sees the industry evolving is that there is a broad array of psychiatric conditions, as well as a broad spectrum of individuals appropriate for psychedelic use.

Not everyone will respond the same to different drugs. Different phenotypes will respond differently to different therapies.

What we are doing with Entheon IQ is taking a data-focused approach to look at what individual factors make different drugs and different treatment types appropriate for different individuals. We have acquired a company that has a genetic test that looks at a variety of mental health risk factors based on genetics, as well as a function of metabolic factors that dictate whether a person is more or less likely to have a strong or weak response to drugs. We believe genetics is a very strong component of ensuring that appropriate treatments are prescribed to the right people.

We are also on the verge of launching a study with a partner in Texas looking at different biomarkers associated with the ketamine experience, and we’re also looking at biomarkers associated with DMT.

Without generalizing too much, Entheon IQ and Entheon DNA are working to create biomarkers to help predict and direct appropriate treatments for individuals across a broad spectrum of psychedelic molecules and psychiatric disorders.

Talk to us about your business model. At what point does monetization become a reality, and how do you scale the business?

I think that’s a question that the entirety of the psychedelic drug industry is looking at. The reality is that, as promising as the research is, in the interest of patient safety these development processes are bound to regulatory processes of governing bodies where we seek to commercialize.

We will need to make it through various stages of clinical validation, then have conversations with regulators and ensure our research is done in such a way that the data is irrefutable and highly understandable to the authorities that ensure these products are safe and effective.

The development timeline as it pertains to this approval process is five to 10 years, and we believe that we can have a timeline on the lower end of that range.

But in an earlier time frame, we think the development of tools to service the ketamine space should commercialize sooner.

You have a strong and growing advisory board of accomplished professionals in the addiction treatment space. Tell us how you choose new members for your team.

Our advisory board is among the best in the industry. It is populated by some of the most prominent and well-researched members in the psychedelic research space.

The psychedelic industry is under the general umbrella of science, yet it is highly specialized and the pioneers are limited to a very core group. When we started Entheon, we wanted to make sure we worked with minds that understood the unique properties of psychedelics better than other scientists.

Unlike other medicines that work in respect to brain chemistry, psychedelics take into account poorly understood features of the human psyche that are only now beginning to be characterized. We really wanted to select advisors with the most comprehensive understanding of the features of psychedelic medicine.

Let’s close with a look at the industry in general. Do you come across misconceptions in the broader audience that you feel need to be cleared up?

The stigma associated with psychedelics often unfairly highlights radicalism or esoteric belief systems. There was a comprehensive anti-drug policy in the 1960s and 1970s that sought to vilify psychedelic drugs as potentially catastrophic to society and having no therapeutic value.

Rather than us having to dispel these myths, I think the research is truly bearing out a rebuttal to the notion that there is no therapeutic value to psychedelics. With each passing month, we see more research that shows huge transformational capacity to help people with end-of-life anxiety, nicotine addiction, as well as major depressive disorders.

We exist within a very interesting moment where on a purely scientific basis, not only are these substances not addictive, harmful or detrimental, but they may actually be the molecules with the therapeutic potential to disrupt a system that has seen very little innovation in the past few decades.

This story was featured in the Canadian Securities Exchange magazine.

Learn more about Entheon Biomedical at https://entheonbiomedical.com/

Revitalist Lifestyle and Wellness: On a mission to treat mental health and chronic pain on a global scale with integrated care

An estimated 265 million people worldwide suffer from depression, with the related cost to society – financial and otherwise – almost too great to comprehend. A Stifel GMP research report published in January 2021 indicates that psychedelic-assisted psychotherapy clinics have an addressable market opportunity in the US alone of US$10 billion to $11 billion.

Knoxville, Tennessee-based Revitalist Lifestyle and Wellness (CSE:CALM) operates five ketamine infusion clinics in the United States. The company is dedicated to empowering individuals to achieve improved quality of life through a combination of comprehensive care and future-focused treatments provided by medical professionals, mental health experts and chronic pain specialists.

In a recent interview with Canadian Securities Exchange Magazine, Revitalist Chief Executive Officer Kathryn Walker discussed the company’s growth plans and the advantages of its business model.

How does Revitalist distinguish itself from other publicly traded mental wellness companies? What makes your model better?

Revitalist is the first clinic model to effectively integrate medical and mental health providers working in a team manner with each client. It’s something the medical community has been wanting to do for 30 years, but no one’s really known how to do it. Therapists have started working in medical providers’ offices, but they still don’t work seamlessly on the topic at hand.

The opportunity that we have with psychedelic treatments is that medical providers are making sure the client is safe while the mental health providers are intervening actively during the session, focusing on unfolding the unhealthy conditioning the brain has acquired through many years of ineffective treatments and therapies. We are the first effective model that is being actively covered by insurance, allowing us to expand access to individuals across the country.

What specific roles do psychedelics play in the treatment methods?

At this time, Revitalist primarily provides ketamine infusions. With the psychedelic piece, we have therapists that are trained through the FDA MAPS program. We also have anesthesia providers that have administered every intravenous medication, making them experts in critical care medicine and giving our clients that extra layer of safety and care.

Our anesthesia providers are oftentimes referred to as “pharmacologic physiologists.” In a time where psychedelics are being actively formed in research labs, an excellent person to have on your team is a pharmacologic physiologist. As the pharmacology piece evolves with FDA approval of these exciting medications, the big pharmaceutical companies will want CRNAs (Certified Registered Nurse Anesthetists) as part of their team, and Revitalist will be able to meet that need.

The mental health system is only about 30% effective with its current treatment models. This includes many of the medications that are prescribed, including SSRIs, SNRIs, TCAs and MAOIs. Anesthesia is more than 99% accurate.

What would you say has been Revitalist’s most significant accomplishment thus far?

I think the most significant accomplishment we have right now is in the works, where we are bringing the inpatient experts to the outpatient world. The providers we have with our company are all top line. They know how the current system operates, and they are aware of what should be converted to this system, and what should not.

Revitalist is here to create an entire new model of healthcare that will bridge the old system of health to the new system of psychedelics.

In the hospital sector, when a patient comes to the hospital, we know we have a team on standby and we are going to work together to give that person the best care they deserve. As medicine and insurance companies have evolved, so has our inpatient healthcare system. Now is the time to recreate a healthier structure that is more cost effective in an outpatient environment.

I personally think the mental health and medical system is imploding. The system is off balance, and everyone in and around it can feel that imbalance. We keep seeing more of it every day. Revitalist and the providers who know that system are reshaping a new one, and we are so ready and excited to do so. We’re able to address this issue not only locally and nationally, but also globally as our medical licenses are able to cross lines in over 39 countries.

The healthcare sector needs to recognize that it is in a transition period. It’s like changing homes. They need to leave behind what isn’t necessary and only take what makes sense for the system going forward. Only providers that understand the “old” system and realize the positivity of the “new” will be able to lead the bridged transition. The providers at Revitalist will be that bridge.

What needs to be done to take Revitalist to the next level? Talk about your growth strategy.

We plan on opening 48 clinics in 2021 and 2022 with a goal of having 157 locations in 2025.

What sets us apart is a shared governance with our clinic model. Our recruitment is key, and it makes us stand alone in this space. We have our lead providers, we have corporate personnel that can also act as providers, and we have our own locum providers. This allows us to create and keep consistency amongst every facility we open.

We provide every clinic we open with access to our operations teams, human resources departments, training centres, and marketing team, allowing robust support to everyone involved with our company.  And that upholds a quality of care that is consistent across the board.

Continuity of care is something we want every person that goes into a Revitalist to know and understand. If you are in Maine or in California and you see a Revitalist, you will know what you can expect from us.

Are the clinics you’re acquiring already profitable? What are their sources of revenue?

We’re probably doing a 90-10 split – that is, we are building 90% of the clinics and then acquiring approximately 10%. The space is very fragmented when it comes to psychedelics, and with ketamine clinics a lot of them are part-time clinics that are not making revenue. These are clinics that others seem to be acquiring, but this is a decision we feel would not benefit our company or our investors. Our location specialists analyze data for facility placements to find the biggest bang for our buck. We place our clinics with strong university presence and veteran hospitals, allowing continuation of our base revenue lines.

What do your shareholders have to look forward to in the next 12 months?

We have so many strategic partnerships coming to fruition. One of the biggest services we offer that sets us apart from the others is the fact that we accept federal and commercial insurance. We are also positioned with Veterans Affairs (VA). We have contracts allowing veterans to be directly referred to us under the protocols specific to the individual VA locations.

I think we’ll see insurance companies learn to accept it more. And we do have our own internal insurance team of specialists which, again, sets us apart immensely. We will be able to provide access to this on a cost-saving basis. If you look at what we need to operate, it’s about 10% cost-wise as compared to our competitors. We have so many projects going on behind the scenes, it’s going to be exciting seeing it all unfold.

One of the many reasons we are cost effective is because of the prices we charge. Our average is $275 per infusion, and I know some of our competitors charge on average around $1,200. If you’re charging $1,200, that’s really going to limit a lot of individuals’ access to these services, especially when they’re not accepting insurance. Given that we can accept insurance and our cost is significantly lower, I think you’ll see the need for our services develop much more quickly. For our investors, we’re working on becoming the first comprehensive psychedelic centre in the world.

This story was featured in the Canadian Securities Exchange magazine.

Learn more about Revitalist Lifestyle and Wellness at https://revitalist.com/

Revive Therapeutics: Developing Novel Treatments for TBI, Addiction, and COVID-19

Revive Therapeutics (CSE:RVV) is in the spotlight these days for good reason, thanks to a portfolio of prized intellectual property in the psychedelics field, as well as a COVID-19 drug candidate.

In March of last year, Revive acquired Psilocin Pharma for its psilocybin-based IP and treatments. Psilocin founder Derrick Welsh now spearheads Revive’s psychedelics division.

Revive further boosted its pipeline through an exclusive license with the Puerto Rico Science, Technology and Research Trust to advance medicinal mushroom Ganoderma lucidum compounds to help cancer patients.

On the COVID-19 front, Revive is evaluating rheumatoid arthritis drug Bucillamine as a potential treatment for inflammation caused by COVID-19. 

We recently caught up with Revive Chief Executive Officer Michael Frank to talk about the company’s strategy for building a valuable drug pipeline and patent portfolio.

Revive is working on solutions for quite a varied range of patient needs. Why is the company’s work a compelling story for investors?

Revive has a strong platform in two areas targeting rare disorders and infectious diseases. The FDA has approved a Phase 3 trial for Bucillamine aimed at COVID-19, which is a tremendous milestone for us. We’ve also got a strong portfolio around psychedelics, and we are working with a lot of US universities, so we have two best-of-breed platforms. We’re developing novel psilocybin and cannabidiol therapeutics and have a patent portfolio covering methods and compositions of drugs. 

The Psilocin Pharma acquisition has galvanized Revive’s move into psychedelics. What psilocybin treatments are you moving down the clinical path?

We acquired Psilocin from its founder over a year ago. We took our delivery systems in cannabis and transcended them to psychedelics. Psilocin Pharma has IP covering methods of production of psilocybin formulations, and we want to take it down the clinical path by developing products around breath strips, lozenges, and sprays.

We’re working with US universities on preclinical/clinical studies that aim to channel psilocybin in various formulations and delivery methods to treat mental health, substance use disorders, methamphetamine addiction, and neurological disorders. We’re partnering with the University of Wisconsin to conduct a Phase 1/2 clinical study to evaluate psilocybin in adults with methamphetamine use disorder and traumatic brain injury (TBI)/stroke.

We’re also working with the University of Health Sciences Antigua on our tannin chitosan drug delivery technology to deliver psychedelics in an oral thin film patch in human clinical studies to support regulatory approvals globally. We’ve developed a hydrogel that’s going to be used for dosing patients in Antigua. Revive will be one of the companies to have a psilocybin product that’s going to be taken by patients – in the next four to five months – to treat mental health and substance use disorders.

The University of Wisconsin has done the early stages of our formulation work and now have to move it along the clinical path with partners like LTS. The university has done a lot of work on opioid addiction and other areas, but these are Phase 1/2 clinical trials aimed at methamphetamine addiction and TBI/stroke. Enrollment will continue throughout Q1 2022, and we will have access to IP from the two studies. There’s early data that shows psilocybin could be effective for dealing with addiction as a whole.

What is driving Revive to look at psilocybin as a solution to managing TBI and stroke? 

We have data from our initial trial at the University of Health Sciences National Health Research Institutes. In the mouse model study, we saw favourable results in one group of mice, and the study signalled the neuro-reparative effect of psilocybin. 

The mice were assigned to four groups, which included the control group and the mice with TBI who were given psilocybin. Cognitive function was examined by the Morris water maze test. It found psilocybin, given after injury, improved cognitive function in TBI mice.  

Since the mice with concussions, who had high-dose psilocybin, did really well, we’re using the data to push forward with brain injury studies and an FDA clinical study at the University of Wisconsin-Madison with patient enrollment. It’s early stage, but we’re working with incredible universities to build the science. This is important work because millions of children with hockey, football, and other sports concussions end up with brain fog and a multitude of other symptoms. 

How are your psilocybin oral thin film strip development and psilocybin biosynthesis programs progressing?

The programs are progressing nicely. Our work with LTS Lohmann on oral thin film formulation is a unique opportunity – they are a one-stop shop for us. They are going to take the product, put it through testing, and by the end of it, we’re going to have data to support our claim for a pre-Investigational New Drug (IND) and IND.  

With the North Carolina State University collaboration, Revive is developing a biosynthetic version of psilocybin based on a natural biosynthesis enzymatic platform. It’s been developed by Dr. Gavin Williams at NC State for producing psilocybin efficiently using an engineered enzymatic pathway in E. coli.

Turning E. coli bacteria into a microbial factory for producing chemotherapy drugs has been successful. Vitamins also use E. coli or a yeast model. We’re looking to produce artificial biosynthetic psilocybin using the same E. coli pathway, but it won’t be exactly the same. We’re waiting on the Drug Enforcement Administration to permit us to go to the next step. 

Psilocybin is expensive; there’s limited supply, so companies will need synthetic options. At the end of our synthesis process, we are hoping to be able to provide the active pharmaceutical ingredients (APIs) for our own products. We’ll have a powertrain that can not only supply our own API, but build a great synthesis platform that will lend itself to mental health and addiction.

Let’s conclude with your work regarding Bucillamine as a treatment for lung inflammation in patients with mild-to-moderate COVID-19.

Our double-blind, placebo-controlled Phase 3 clinical trial for Bucillamine for COVID-19 is based on 1,000 patients and up to 50 sites in the US. We are adding viral load testing to support work done by the University of California, San Francisco for a minimum of 300 patients in this 1,000 person study. 

Bucillamine has a well-known safety profile – it’s been prescribed for rheumatoid arthritis in Japan and South Korea for 30 years. We’ve also successfully finished a Phase 2a FDA clinical trial of Bucillamine for gout back in 2015.

In late summer 2020, when we applied for a Phase 2 trial for COVID-19, we were fast-tracked by the FDA and asked to prepare an IND for a Phase 3 confirmatory trial for COVID-19 because of our gout study and the history and safety of Bucillamine.

Learn more about Revive Therapeutics at https://revivethera.com/

4Front Ventures: A “House of Operators” focusing on the sweet spot in the cannabis value chain

There are many ways to achieve success in the cannabis industry, but the core of most business plans tends to reflect one of two extremes: complete vertical integration or a focus on just one field, be it cultivation, processing or retailing.

4Front Ventures (CSE:FFNT) is positioned firmly in the former camp and styles itself as a “House of  Operators.” The company operates in multiple states, cultivating and retailing mass-produced, low-cost, yet high-quality branded cannabis products.

4Front’s brand portfolio spans more than 21 names, including Marmas, Crystal Clear, Funky Monkey, Pebbles, and the Pure Ratios wellness collection. The brands feature prominently in third-party retail outlets as well as in 4Front’s own chain of Mission dispensaries in Illinois, Massachusetts and Michigan.

Additionally, the company plans to bring its brands to the world’s largest cannabis market later this year when it commences operations at what is expected to be one of the biggest manufacturing facilities in the United States, at 170,000 square feet in Commerce, California.

Public Entrepreneur sat down with 4Front Ventures Chief Investment Officer Andrew Thut recently to find out what makes the company tick.

The “House of Operators” concept sees your team operate multiple divisions across the cannabis value chain. Can you explain to us how this works?

At 4Front, we have licenses and operations in five states. Notably, our facilities in Washington state have a dominant position in that market – we have close to a 10% market share, and rank as the number two flower producer and number one edibles producer.

Our strategy is really quite straightforward. Longer term, you don’t want to be a cultivator, though it is necessary, particularly in these early stages of the market. We also don’t want to be a large retailer.

We think the value in the industry is going to be in manufacturing finished goods, meaning having branded products in the market that people really enjoy and that have dominant market share.

As a result, we’re replicating the low-cost finished goods production that we’ve fine-tuned in the Washington facilities, and we’re putting this into four other states: Massachusetts, Illinois, California and Michigan. We’re also hoping to get a license in New Jersey.

In a nutshell, if you can get a customer because of a great product at an excellent price, you tend to take outsized market share. And because we have low-cost production, we have the ability to offer customers great value and still make very good margins.

You are completing a new manufacturing facility in California and your production is increasing. Do you have plans to begin selling excess product into the wholesale market?

Absolutely. In California, we are ready to roll out what, to my knowledge, is the largest cannabis production facility in the world. It’s about 170,000 square feet and we’re going to make our entire product line of tinctures, edibles, gel caps, vape pens and infused pre-rolls there.

As mentioned, we have developed what we think is some of the industry’s lowest cost production in our Washington facilities. But because we’re going into California, which is the biggest cannabis market in the world, we’re able to invest a lot more on automation. We’re basically taking the low-cost methodologies developed in Washington and putting them on steroids for the California market.

This is really a large-scale consumer packaged goods facility, and we intend to have the capacity to do about half a billion dollars of revenue out of it. We plan to really attack the California market and put all of our products into it eventually, starting this summer.

Your retail model is customer-centric and highly scalable. How did you develop your model into what it is today?

We started officially in 2011 as a consultancy for the industry and developed one of the earliest training programs, not only for cultivation and production personnel but also for retail staff.

When we look at what differentiates us from a retail standpoint, it’s having a warm and welcoming environment for customers. We’re trying to normalize the cannabis experience but we’re also having really knowledgeable sales staff there.

And we also have what we think is a terrific breadth of product in the store, together with great availability of that product, meaning we’re not out of stock often because we are producing most of what we sell.

We also lead on price. In cannabis, you have what we call an 80/20 rule back from my finance days, where 80% of the product is consumed by 20% of the customers. And those customers that are big consumers of cannabis are very, very price sensitive, which means they’re looking for a quality product at a terrific price. That’s exactly what we are giving them.

4Front says it has some of the best minds in the industry, providing depth of knowledge and operational expertise. Are there other areas you could adapt this expertise to?

This is a very nascent industry and we think that we are in the second inning of what is roughly a $100 billion industry here in the US. 

We are so early that some of the big alcohol, tobacco and consumer packaged goods companies haven’t really been able to enter the space because they trade on US exchanges that will not allow them to enter a federally illegal business.

We have a lot of the boxes checked with the consumer products expertise that we bring, plus a finance team that has been in the game for over 20 years. So, we have the ability to navigate the capital markets and capitalize the projects that we need to fund.

All of this is in preparation for building out our beachhead well before some of the bigger brands come in. We feel that if we can prove that we have tried and true production methodologies that would be valuable to a larger player, with products and brands that would also be valuable and that have meaningful market share in the states in which we operate, then that would be attractive to other folks that come in.

We’re really focused on executing on that in a terrific industry where you’re learning new things every day, and we’re just plotting our own course as the industry unfolds. But it’s mostly about keeping your head down and making sure that you’re executing and creating products that customers love.

What can investors expect from 4Front in the medium term?

We have a great growth trajectory in front of us. We’re in five states currently and, hopefully, we’ll add New Jersey. We have a lot of confidence in our capabilities and our business. And when we go into a state where we can execute, and the numbers start to bear that out, we are seeing great revenue growth and profitability. When you’re taking market share, you want to take on more projects and have more assets that you can operate and sprinkle your know-how and pixie dust on.

4Front is very much in growth mode. We’ve been very clear to the market that we want to be bigger and have aspirations to be very solidly in that top 10. And we think that as this industry continues to unfold, we’re going to be part of that conversation.

I think investors should really figure out where they want to be in the value chain and look at who has executed.

We think the sweet spot is in consumer packaged goods, so that’s where we want to be. And we have a very clear runway to create a lot of value organically, just with the plan we have in front of us.

I would also say to stay tuned for a lot of M&A that’s going to come in the cannabis space in the coming year. People are looking to get bigger; people are looking to fill out geographies; they’re looking to fill out skill sets they don’t have. I think there is going to be a big wave of M&A in the industry over the next 12 to 18 months.

This story was featured in the Canadian Securities Exchange magazine.

Learn more about 4Front Ventures at https://4frontventures.com/

Red White & Bloom Brands: Strong brands and acquisitions underpin rapid growth strategy

Red White & Bloom Brands (CSE:RWB) is positioning itself to become one of the top three multi-state cannabis operators in the US legal cannabis and hemp sector.

On the cannabis front, Red White & Bloom is predominantly focusing investment on major markets, including Michigan, Illinois, Florida, California, Arizona and Massachusetts. For hemp-based CBD products, US and international markets both feature prominently. 

The company is also building on existing advantages through investments and pending acquisitions in Michigan and Massachusetts, plus a completed purchase in Illinois. It recently entered Florida and has been operating in California through its Platinum Vape brand for some time.

Public Entrepreneur sat down with Red White & Bloom Chief Executive Officer and Chairman Brad Rogers to find out more about his fast-growing company’s outlook and business plan.

Red White & Bloom has said its goals for the rest of 2021 are to build upon the Michigan footprint and focus on growing market share and expanding earnings. How will you achieve this? 

The plan is to grow the bottom line as vertically as we can, and obviously to cut costs where we need to. But what we’re also going to be doing is holding the price point with our brand strategy.

In Michigan, specifically, we have the biggest brand in the state, which is Platinum Vape. And we’re rolling out our High Times line there.

When you look at the potential of when commoditization happens – after October, November, December or so – what you’ll see will be prices coming down. But we’re holding our price because of our brand strategy and our distribution strategy, with respect to how we’re handling our product portfolio and product mixes into stores.

Beyond that, with operational efficiencies, as well as our best practices and buying power, we have a strategy to make sure that we’re well fortified when this stuff commoditizes, much like coffee. We’re going to be well positioned to be able to sustain pricing and increase margins as well. 

You are also looking for additional strategic relationships and to enter more US states with a “brands only” strategy that minimizes capital spending. How is this progressing?

This is going incredibly well. We’re getting a lot of interest for our brands across many states. Platinum Vape, for instance, is going into Oklahoma, and we’re also doing other brands there. High Times is now in demand too in other states, such as Nevada and the rest of California. It’s really expanding.

Red White & Bloom has closed a number of deals in a short period of time. What advantage do you have in deal-making over your competitors?

I think the real competitive advantage is the fact that this is not our first time. We’ve done this before. When you look at what I’ve done in the past, I’ve had two very successful exits on companies that I built. One of those was Mettrum, which was bought for half a billion. I took another fledgling company in the medical space in Canada from zero to about a billion and a half in market cap in about 12 months.

There’s strong belief in what we do and how we do it. What we’re also doing is fortifying our product strategy to bring in some of the players and get deals done. We make sure that they know that we know what we’re doing and that their products will have the best chance to be able to actually succeed in the market with the distribution channels we’re setting up across each state. 

And then, of course, what they get is the halo effect of all the other brands that we’re bringing in and the distribution channels that we already have. And they can build upon that as well. 

There is a lot of potential when bringing in new folks and getting new deals done that are aligned with Red White & Bloom’s strategy. 

What do you think you personally bring to the company as its CEO and chairman? 

Well, like I said, I’ve been through the wringer here before. I’ve seen the space grow from its infancy, all the way down to full commoditization in Canada, and how that affects the marketplace and the customers. And having seen this twice already, in building companies from that embryonic state to where they are now, it really gives us a good solid vision as to what’s happening. 

The Wayne Gretzky analogy I use is: “Go where the puck is going, not where the puck is.” That’s where we want to be. We want to be where the puck is going and build for that versus where the puck is right now. Because everyone’s there, everyone thinks that “If you build it, they will come,” but that’s not the case.

What’s happening is that this is going to be a commodity and your brand is going to be the only thing that you’re going to be relying on, so you need to have great product, great strategy and good distribution.

Another analogy is Starbucks. I don’t know who grows the beans, and I don’t care because it always tastes good. It’s never something you think about. Once you build a good brand, with quality, price and convenience attached to it, you’re going to be standing tall. 

And that’s what I bring to the table. I’m bringing vision and marketing and a lot of strategy with respect to where this market is going. I’ve been very successful twice at it and I think the US right now is a great place to use that experience. 

What should Red White & Bloom shareholders expect from the company for the rest of the current year and beyond? 

Well, we finally got past our pre-qualification in Michigan, which is a huge thing for our company. It means that we can actually now report revenues from Michigan on the assets that we’ve invested in. And that’s transformational for us in that our investors have not seen to date what those assets are doing because we couldn’t report them. 

Now we’re going to be able to report those earnings, as well as grow the Platinum Vape business we purchased a little while ago in San Diego. So you’ll see exponential growth in that company in Michigan and California. We’re also entering Arizona and we’ve got Florida coming as well. 

When you look at the assets in the new states that we have, and the revenue that is going to be starting in Arizona and in Florida, we’re going to be seeing some nice revenue streams, both from existing states and from new ones. We’re really excited about that. 

Overall, I think it’s about the strategy in terms of who we are, what we do, and how we do it. It all comes down to how you’re approaching the market and what you’re doing in that market. We can be asset light and brand rich, and that’s what we’re executing on right now. And it’s playing out well for us.

To create the winner that we’re going to be in the space, we’ve got some catching up to do. We’re about five years late to the market, but when you look at what we do and how we spend, we’re very judicious with our dollars and we’re making great strides with respect to how much ground we’ve covered in a very short period of time. We’re looking forward to catching up to the big boys and really being at that top echelon.

This story was featured in the Canadian Securities Exchange magazine.

Learn more about Red White & Bloom Brands at https://www.redwhitebloom.com/

Ayr Wellness: Success is the outcome when everyone buys into a great strategy

Jonathan Sandelman, Chief Executive Officer of Ayr Wellness (CSE:AYR.A), takes interviews in a decidedly different direction than most CEOs. Rather than highlighting his company’s assets and achievements, Sandelman prefers to talk about the thing that, in his mind, most determines commercial success: corporate culture.

Ayr has big goals, and with nearly US$1.5 billion in assets on its balance sheet is well on its way to achieving them. The company expands organically thanks to exceptional product quality, and also through acquisitions, which can be tricky at the best of times.

But at the end of the day, if everyone at Ayr embraces Sandelman’s philosophy, and everyone pulls in the same direction, that’s the edge needed to come out on top. It’s an old saying in the investment industry, where Sandelman rose to become President of Bank of America Securities, that if you can’t tell someone what your edge is in just a few seconds, you don’t have one. Sandelman knew what Ayr’s edge was the day he established the company.

We connected with Sandelman in early July to discuss Ayr’s growth to date and the foundations of his confidence about its future.

Ayr has a very clear vision of where it is going and how it intends to get there. Talk to us about Ayr’s mission as a company and the corporate culture you need to make it a reality.

Our goal and mission statement at Ayr is to be the largest scale producer of high-quality flower in the United States. We don’t mean to insinuate that there aren’t smaller, boutique growers that grow really high-quality flower. But in the large MSO arena, we think one of the things that differentiates our company is our cultivation of high-quality flower at large scale.

Now, why is that important? First of all, in business you need to do something that differentiates your brand. In business school, we were taught about the unique selling proposition – what differentiates your brand from all other brands?

When we think about the industry and when we listen to our competitors, they talk a lot about branding, being a CPG (consumer packaged goods) company, and they are very focused on their box. “How does my box look?”

At Ayr, we tell our teammates, those in the marketplace, and our investors that it’s not about the box, but what’s inside the box. We believe that any time you underestimate the consumer, who has choice, who has multiple alternatives to consider – and for sure this industry is going to get more competitive – when you underestimate the consumer, I don’t care what business you’re in, you’re making a mistake. Because they know.

When I started my career as an investor, I typically bought into companies I thought had the best product in that category.

A lot of people in business want to be like Nike and Apple. I don’t buy Nike because it’s in an orange box. I buy it because I’ve been a marathoner and what’s inside the box is what motivates me to buy their product. When I think about Apple, while I think they have beautiful white boxes, I buy it because it’s the best laptop or phone. If it was simply an orange box or white box without being the best product, I wouldn’t buy it.

In Pennsylvania, we had our first harvest, our first flower for wholesale and our store shelves. The market tried our product and it sold out in a week. The consumer knows. We aimed to produce the highest quality flower in a market lacking high-quality product and it sold out in a week.

And then we recently introduced our Seven Hills flower brand. Again, consumers recognized the quality of our product and it sold out in a week. That’s why our focus is on growing the best quality flower.

Acquisitions are an important part of Ayr’s growth strategy. How do you assess potential acquisitions, and how do you successfully integrate acquired businesses?

We identify early on which states we want to build our businesses in. Then we have our M&A and strategy teams go into those markets and try to find the best assets. I’ve said from day one that the way I want to build this business is to cluster and penetrate. I like contiguous states so that when the consumer travels into a nearby market, they may not know the brands, but then they see the Ayr brand and they know what that stands for. They are going to buy Ayr even when they have other choices.

Equally important, that seller, who will remain with the company in most cases, must believe in our ethos. They must believe in honesty, integrity and transparency, and have values consistent with ours.

With talent, you win. For me, the companies that have the best culture, the best vision and the best talent pool win. The perfect transaction is one where we get a great asset as well as more team members.

Ayr was incorporated in July 2017, yet you have hundreds of millions in revenue and some US$1.5 billion in assets. How did the company grow so quickly?

I’ve been an investor and an operator for more than 30 years, with a deep understanding of the capital markets. I told my investors that Ayr would be EBITDA positive and cash flow positive from day one. That’s the disciplined way to act.

We would be disciplined because we understood that the public markets are cyclical. We thought we could be more aggressive when a correction happened and assets got cheaper because we were EBITDA and cash flow positive.

That’s exactly what you saw us do. We bought our initial companies, we paused for 13 months, the correction happened, and then we got aggressive about certain companies. It’s my belief that this once-in-a-lifetime opportunity to buy assets at bargain prices will eventually go away. There will be some form of federal legalization, and then what I call the “wall of money” will come in. It will flood the market and these multiples we are buying at today will trade even higher.

We are still aggressive about buying because I don’t think this will last even another year or two. That is the thought process behind what the future will bring for Ayr.

Given your background in finance and understanding of the cannabis industry, what is your outlook for the next five years and how does that shape Ayr’s business strategy?

I expect federal legalization of this industry because it is irrational that it’s not already legal. When almost every state in the US has some type of cannabis program, does it really make sense not to be federally legal?

For those who are uncertain about cannabis, I would vote for the SAFE Banking Act because it puts controls around the industry and creates insight and transparency that doesn’t really exist on the federal level. If you bank this industry, you know all the cash flows, from where the money is coming and where the money is going.

If you think about where alcohol is trading in terms of multiples, there is a lot of upside in our industry’s multiples and in individual stock multiples.

Ayr news often highlights acquisitions or new retail locations. Talk about the team and the dedication it takes to operate successfully at the pace you set.

I’m a believer in a culture of excellence. I’ve always had this philosophy that talent is free. That whatever I pay, or our shareholders pay, the rewards they are able to produce are just spectacular. Even when we were just a two-state operator, we had some of the best EBITDA and cash flow in the industry.

I think about the vision, what talents are required, what are the job functions, and then I think about who that type of individual would be.

It’s culture. You can’t just be the smartest person in your lane, you also have to be an extremely respectful person. When we’re in a meeting and I’m pushing you, you always understand that I am not pushing you to herd you, but to get you to think at a pace, at a level that you haven’t been able to in the past.

When I hire people, I always tell them my goal is for them to say to me a year from now that they’ve become the best version of themselves. There is something about this culture and this team that inspires them to do their best work and be the best person they have ever been in business.

I think our culture is the secret asset on our balance sheet. If the 1,500th person has the same vision as the people at the top, and we have 1,500 pairs of oars all rowing in the same direction, toward the same vision, then we win.

You are talking to me for this interview, but I am getting too much credit. I am the one talking, but it’s because we have a great team. We have built the best operating system and tech stack so we integrate these companies seamlessly. The people are so talented, and the systems and controls are so good, that we make it look easy. But it’s not.

Ayr is its people, and its dedication to its teammates, to its community, to its shareholders. That’s the ethos of this company.

This story was featured in the Canadian Securities Exchange magazine.

Learn more about Ayr Wellness at http://www.ayrwellness.com

Gage Growth: The steady hand wins the race in this company’s playbook

When it comes to cannabis in the state of Michigan, Gage Growth (CSE:GAGE) is the name an increasing number of consumers are turning to. Still a young company, having been in operation for just over 18 months, Gage has nonetheless amassed one of the largest asset portfolios in the state. Experience at the leadership level is key to this success.

Gage’s Chief Executive Officer, Fabian Monaco, is a former lawyer and investment banker who was actively involved in the evolution of the cannabis industry. He was a key member of the team that transacted the first cannabis acquisition, Tweed (now known as Canopy Growth)’s purchase of Bedrocan, and also the first-ever cannabis IPO. Also on the team is cannabis impresario Bruce Linton, who serves as Chairman. Another big name is TerrAscend’s Executive Chairman Jason Wild, who has a large stake in the company.

What is it about Gage that attracts some of the most successful executives in the cannabis industry? For one, Gage is on track to be Michigan’s number one operator by the end of 2021, with 14 facilities either in operation or planned. Its first set of financial statements as a public company showed a big quarter-over-quarter jump in revenue, and a corresponding increase in its profit margin.

Clearly, the decision to start things off in Michigan was a good one.

“One of our founders is from Michigan and the other founder has a strong connection to Michigan through family,” says Monaco. “The biggest reason we chose the state, though, is that it had the second-largest medical cardholder system behind California for many years. Their caregiver program was introduced in 2008, and thanks to that, individuals have been going to dispensaries for over a decade.”

Monaco goes on to explain that close to 75% of the population in Michigan is of age to consume, and that after December 1, 2019, which was the first day of adult-use sales in the state, cannabis commerce skyrocketed. Michigan was outside the top 10 states by revenue at the time, but quickly vaulted to sixth, just behind Illinois. Today, it surpasses Illinois consistently and ranks third.

“It’s been playing out pretty much as we thought it would,” says Monaco.

In a market that size, there is bound to be healthy competition. But Gage has established some important points of differentiation and leverages them to the fullest.

“We really focus on every part of the value chain of the business, from seed to smoke,” says Monaco. “We’re constantly hunting, looking for new cultivars to bring to the table for patients and for consumers. A lot of producers out there – especially some of the publicly traded ones – don’t really grow a lot of varieties, and we pride ourselves on having 40, 50, sometimes even 60 different flavours within our retail locations for people to choose from.”

Monaco says that post-production processes are just as important, and that Gage hang-dries its product, trims it, and packages it. “We have this fun, bright, engaging packaging as well for our flower that people enjoy, and we manage most sales through our own retail channels.“

In addition to having identified a prime jurisdiction in which to operate, Gage also knows who it’s targeting to buy its products.

“In general, we’re going after the former medical user – a refined consumer, someone who has been consuming the product for many, many years,” Monaco explains. “We have a really wide variety of customers.”

The Gage business strategy calls for vertical integration and establishing operations strongly in a single state before taking its proven model and applying it in other states.

“We’re going to focus on one market for the better part of 2021, although we do anticipate doing something outside of Michigan near the end of the year,” Monaco says. “We’re trying to follow that Trulieve (Trulieve Cannabis; CSE:TRUL) model where you execute really well in one state and use that as a springboard to enter other states. Once we feel comfortable with where we’re at, especially as we approach the end of the year, you’ll see us branch out into other states.”

With expansion seemingly just around the corner, the question of where Gage will decide to go next is an obvious one. Monaco believes there is “phenomenal” opportunity throughout the United States and his team has already assessed several states this year. He says there is a lot to like. Plans call for focusing on some of the larger markets with Gage’s first few acquisitions. Massachusetts, Illinois, Ohio, Maryland, California and Pennsylvania are all in the running.

“You’ll probably see us make a move into one of the larger states pretty soon,” says Monaco.

Looking out over the next two or three years, Monaco says Gage is strongly positioned to take advantage of a wide range of opportunities that present themselves as the industry evolves.

“We have a solid cash balance to execute our plans in Michigan and didn’t really take on any harsh payment obligations, in terms of sale leasebacks or debt, over the past couple of years,” Monaco explains. “Now we have the opportunity to tap into some of the lower cost of capital opportunities that cannabis companies are seeing these days. Because our cultivation assets are unencumbered, and we own our retail locations, it really affords us the opportunity to go after some debt to fuel growth without having to dilute shareholders.”

From an earnings perspective, Monaco believes Gage can both increase revenue and expand margins rapidly, because Gage products so frequently sell out.

As for the higher goals, Gage is probably not all that far from achieving some of them already, though the walk before you run mindset remains firmly in place.

“Personally, I’d love to be number one in Michigan, our home base, and then a top player in two or three other states. I think it’s important to remain focused in Michigan before we branch out. We’ll look to be one of the top three in each respective state we go to within the next 24 to 36 months.”

This story was featured in the Canadian Securities Exchange magazine.

Learn more about Gage Growth at http://www.gageusa.com