The Billion Dollar Brain Reboot

Whether you’ve experienced it personally or witnessed its effects on someone you love, nearly every American is touched by depression.

Consider this…

According to the National Institute of Mental Health (NIMH), more than 17 million adults in the U.S, or about 7.1% of the U.S. population age 18 and older, suffer from a major depressive episode in a given year. [1]

And as scary as it is to know that more than 17 million adults are battling depression, did you know that an estimated 3.2 million kids aged 12 to 17 in the U.S., and 13.3% of the total U.S. population, also suffered at least one major depressive episode in 2017?

Suppose we break down the number of adolescents suffering from depression by gender. In that case, the NIMH tells us that 20% of females suffered at least one major depressive episode in 2017, compared to 6.8% of adolescent males. [2]

Equally concerning is the statistic from The Journal of the American Medical Association that both girls and boys who are depressed are significantly more likely than their non-depressed peers to use alcohol, drugs, smoke, or binge. [3]

A major depressive episode isn’t the same as feel down for a day or two.  

People that suffer from major depressive disorder, or clinical depression, battle through major depressive episodes. According to the National Center for Biotechnology Information (NCBI), major depressive episodes are highly recurrent, with 50% of those who recover from an initial episode having one or more episodes again in their lifetime.[4]

Here’s how the National Survey on Drug Use and Health (NSDUH) defines a major depressive episode:

“A period of at least two weeks when a person experienced a depressed mood or loss of interest or pleasure in daily activities and had a majority of specified symptoms, such as problems with sleep, eating, energy, concentration, or self-worth.”[5]

What may be most frightening is the length of depressive episodes isn’t typically measured in days or weeks, but rather in months — With the average duration estimated to be between six and eight months.

Think about that…

When someone suffers through a depressive episode, they likely feel some combination of the following:

• sad, hopeless, or helpless
• guilty or worthless
• anxious
• irritable or frustrated
• fatigued
• restless
• exhibiting a loss of interest in things they once enjoyed
• trouble concentrating
• changes in sleep patterns
• exhibiting a loss of interest in living[6]

Major depression is much more than a temporary funk or a bad day. The symptoms listed above can last for months or even years. Unfortunately, modern-day antidepressants are shockingly ineffective for a huge percentage of the depression-suffering population.

The Inadequacies of Antidepressants

Did you know more than 50% of people who take antidepressants for depression never experience relief?

According to research from the Northwestern University Feinberg School of Medicine, the reason so many people fail to benefit from antidepressants is because “depression has been oversimplified and drugs designed to treat it aim at the wrong target.” [7]

To understand why modern-day antidepressants fail to work for so many people, we need to turn back the clock to 2009, when Eva Redei, a long-time depression researcher, and the David Lawrence Stein Professor of Psychiatry at Northwestern’s Feinberg School, presented her ground-breaking findings at the Neuroscience Conference in Chicago.

For years, scientists and researchers believed stressful life events and imbalances in neurotransmitters in the brain were triggers for depressive symptoms. But according to Redei, this long-held belief is false.

Redei’s research found that there is nearly no overlap between stress-related genes and depression-related genes. She added this:

“This is a huge study and statistically powerful. This research opens up new routes to develop new antidepressants that may be more effective. There hasn’t been an antidepressant based on a novel concept in 20 years.”[8]

Redei asserted antidepressants treat stress and not depression. Moreover, “the medications have been focusing on the effect, not the cause. That’s why it takes so long for them to work and why they aren’t effective for so many people.”[9]

The bottom line is while some people find benefit from antidepressants, more than 50% of depression sufferers never get relief. And if Redei is correct about antidepressants aiming at the wrong target, there’s no question that an entirely new form of treatment is needed.

The Depressing Truth About Antidepressants

Despite Redei’s assertion that antidepressants aim at the wrong target, some people benefit from modern-day medications. Studies have shown that many of the most severely depressed patients have benefited from taking an antidepressant.

But again, for all but the most severely depressed patients, antidepressants have been found to be only slightly more effective than a placebo.

The most popular antidepressants are selective serotonin reuptake inhibitors (SSRIs) like Prozac, Zoloft, Paxil, Celexa, and Lexapro. According to Hopkins Medicine, the goal of these SSRIs is to “increase your brain’s level of neurotransmitter (a chemical that transfers messages from brain cell to brain cell) called serotonin. This neurotransmitter is associated with feeling happy and content.”[10]

Unfortunately, SSRIs also happen to be famous for triggering problems with sexual function, nausea, and increased anxiety during the early stages of treatment.

It typically takes between two and six weeks for any antidepressant to have an impact. That may be as frustrating as the side effects. And because depression sufferers often fail to respond to certain medications, it is not uncommon for patients to spend months finding the type of drugs (along with the proper dosing) that works for them.

The grim reality facing depression sufferers is that while there are a myriad of FDA-approved antidepressants to choose from, it’s impossible to say whether any particular medication will work, how long it will work for, what the ideal dosing is, and how terrible the side effects will be.

Simply put–The inadequacies of modern-day major depressive disorder therapies are why depression sufferers continue to suffer. And it’s why we are here today, in search of a new path forward to address the unmet needs of people suffering from major depressive disorder.

Disrupting Habits and a Brighter Future for Depression Sufferers

The medical community and pill-popping public often believe more pills, stronger dosing, or a creative combination of medications represents the key to solving every problem–But this is simply not the case.

The key to reversing the downward spiral in effective depression treatments isn’t bigger, better, and stronger pills.

The millions of American depression sufferers and the hundreds of millions of worldwide depression sufferers need a novel approach to understand the brain, what triggers depressive episodes, and how to effectively treat the root cause.

Just as Eva Redei told us more than a decade ago that long-held beliefs about what triggers depressive symptoms are false, David John Nutt, an English neuropsychopharmacologist and the Edmond J Safra chair in Neuropsychopharmacology at Imperial College London, has been sharing his knowledge of the brain and how various drugs affect it with anyone willing to listen.

You see, an increasing number of forward-thinking medical professional believe that psychedelics, and more specifically, psilocybin, may hold the secret to disrupting the long-held habits and triggers that send depression sufferers into the dark abyss.

Here’s what Professor David Nutt told Science Focus’ Jason Goodyer in mid-2020:

“It turns out they [psychedelic drugs] all work on a particular receptor in the brain called the serotonin 5HT2A receptor. The human brain is loaded with them, all in the parts of the brain where you do your thinking and your analysis of yourself. They tie together your consciousness with your other senses. They’re really in that circuit that kind of defines what you are as a human being. When you stimulate those receptors with psychedelics, you change the way the brain processes things.

The brain is an amazing organ; it’s the most efficient computer, 10 times more energy efficient than any computer we’ve yet invented. One of the reasons that the brain is so efficient is that it learns very quickly what to predict. Brains make inferences and we live through those inferences because it’s just so much more efficient.

If your brain had to update every, say, 15 milliseconds, everything that’s gone into it, that would consumer enormous amounts of energy. So, the brain basically looks for change. It sees what’s there and listens to what’s there, and then when things change, it takes notice. The rest of the time, it just says that things haven’t changed.

That process is what we call a small world; the brain becomes very efficient at doing what’s just enough to make sure you can find your way home and you can do your homework and you can turn on the TV. You can do all the things you need to, but you do them almost in a reflex way. The brain develops these sophisticated habits and psychedelics disrupt those.” [11] [emphasis my own]

Now, without getting too deep in the weeds, David is essentially saying that while the brain is wired to develop negative and self-destructive habits, psychedelics like psilocybin can disrupt those habits and, in a sense, rewire the brain.  

It would be foolish to expect scientists to unravel the brain’s inner workings before pressing forward with research into the potential medical benefits of psilocybin. But a basic understanding of what may be misfiring in the brain would be hugely beneficial to researchers.

Here’s what David Nutt, David Erritzoe, and Robin Carhart-Harris wrote in their research paper, Psychedelic Psychiatry’s Brave New World:

“Arguably all of the conditions in which psychedelics have been shown to work share the common feature of being internalizing disorders. In depression, patients continually ruminate about their failings, reiterate thoughts of guilt, and engage in self-critical inner narratives. In addictions, the object of addiction takes on the role of negative thinking in depression, driving behavior that is specific, narrow, and rigid; addicts ruminate on relief afforded by the object, how to get it, how to pay for it, etc. The rational for using psychedelics in OCD and anorexia is consistent given that there is rumination on intrusive thoughts, e.g., about contamination or calorie mismanagement. Psychedelics likely work by dysregulating activity in systems and circuits that encode these habits of thought and behavior, allowi9ng them to recalibrate as the acute effects of the drugs subside.”[12]

There’s no question scientists and researchers have a long way to go before they claim to understand the brain and what triggers depressive episodes. However, the insights provided by Professor Nutt and his colleagues regarding the need to disrupt the brain’s sophisticated habits and the fact that psychedelics have shown promise when it comes to treating internalizing disorders offers mental health sufferers the first glimmer of hope they’ve had in years.

Better yet, Professor Nutt’s work is already influencing and encouraging companies to advance their own studies into psychedelics and how its effects can positively impact the lives of the millions of people worldwide suffering from depression and other neurological disorders. 

And in a few minutes, I’m going to introduce you to a small biotech company focused on developing novel therapeutics, delivery methods, and treatment regimens targeting the treatment of neurological disorders–All by progressing psychedelic therapeutics.

Advancing Psilocybin-Assisted Therapy

No one is naïve here.

We know it’s foolish to expect researchers, medical professionals, investors, and the non-investing public to abandon their long-held biases overnight.

• A high potential for abuse.
• No currently accepted medical use in treatment in the United   States.
• A lack of accepted safety for use under medical supervision.

The truth is, it’s unrealistic to expect everyone to hop on board the psychedelics train and embrace this form of therapy without an abundance of safety and clinical efficacy trial data.

So, with that in mind, let’s talk about the science supporting psilocybin-assisted therapy.

I want to tell you about a study published in the Journal of the American Medical Association (JAMA) Network on November 4, 2020.

The study’s objective was to investigate the effect of psilocybin therapy in patients with major depressive disorder (MDD). It was a randomized, waiting-list-controlled clinical trial conducted at the Center for Psychedelic and Consciousness Research at Johns Hopkins Bayview Medical Center in Baltimore, Maryland.

The study was open to adults aged 21 to 75 years with an MDD diagnosis but not currently using antidepressant medications and without a history of psychotic disorder, serious suicide attempts, or hospitalization. A total of 27 participants were randomized to an immediate treatment group and a delayed treatment group.

The inclusion of a delayed treatment control was to differentiate the psilocybin intervention from spontaneous symptom improvement.

Now, while the study wasn’t large, the results were incredible.

Before I get to what the researchers had to say about the study, you need to know that “71% of people who took psilocybin for MDD showed a greater than 50% reduction in symptoms after four weeks, and half of the participants entered remission!”[13]

Suffice it to say that with less than 50% of antidepressant users ever experience lasting relief, the idea that a psilocybin-assisted therapy trial resulted in 71% of patients experiencing a drastic reduction in symptoms after only four weeks is stunning. Almost unbelievable.

Oh, and as far as side effects are concerned, “there were no serious adverse events in this trial.”

During the discussion part of the Jama study, the researchers stated that when comparing psilocybin to widely prescribed antidepressants:

“Given that psilocybin was associated with nonserious adverse effects that were frequently reported as mild-to-moderate headache and challenging emotions that were limited to the time of sessions, this intervention may be more acceptable to patients than widely prescribed antidepressant medications that confer substantially more problematic effects (suicidal ideation, decrease in sexual drive, and weight gain). The effectiveness of psilocybin therapy after a single or only a few administrations represent another substantial advantage over commonly used antidepressants that require daily administration.”[14][emphasis my own]

The study concludes with this succinct opening line:

“Results of this randomized clinical trial demonstrated the efficacy of psilocybin-assisted therapy in producing large, rapid, and sustained antidepressant effects among patients with MDD.”

Look, many of us grew up being told how terrible psychedelic drugs are for the body and mind. It doesn’t matter whether we blame that misguided view on the misinformation that flowed from those supporting the passing of the CSA in 1970 or one of a dozen other plausible reasons, the bottom line is the science debunks virtually all the misinformation we were spoon fed.

Based on the above JAMA study from Johns Hopkins and several others like it, scientific trials of psilocybin-assisted therapy demonstrate the tremendous potential to bring relief to the millions of adults suffering from major depressive disorder.

Capitalizing on the Billion Dollar Brain Reboot

By now, you understand the severity of major depressive disorder, and depression in general, is for this country.

Consider this statistic from the folks at Analysis Group:

“For every dollar spent treating depression, an additional $4.70 is spent on direct and indirect costs of related illnesses, and another $1.90 is spent on a combination of reduced workplace productivity and the economic costs associated with suicide directly linked to depression. ”[15]

The Analysis Group states that depression in America now costs society $210 billion per year.

While the effects of depression are torturous for both the people plagued with it and their families, the economic reality is psilocybin-assisted therapy amounts to a billion-dollar opportunity.

The billion-dollar brain reboot isn’t a winner take all situation.

Instead, the winners will be the early innovators.

I’m talking about the companies that create innovative drug delivery systems, successfully develop chemically synthesized and pharmaceutically acceptable forms of psilocybin or psilocin, and ones that can optimize the pharmacokinetic profiles of their synthetic molecules to provide better dose management and reduced side effects.

From an individual company standpoint, we want to stick with biotechnology companies with experienced management teams, backed by multi-million-dollar war chests, and that are already laying the groundwork for clinical trials.

I know this sounds like an impossible number of wants, but I’m thrilled to tell you that I’ve found one company that checks all these boxes.

Allow me to introduce you to Cybin (CLXPF), a company focused on progressing psychedelic therapeutics by developing proprietary drug discovery platforms, efficient drug delivery systems, and formulating approaches and treatment regimens to treat psychiatric disorders better.

The Right Team to Eradicate Mental Illness

Under the leadership of Chief Executive Officer Doug Drysdale, Cybin has raised nearly C$90 million over the past year, which places this company in an ideal position to progress its clinical trials and future business endeavors.

Now, you should know a few things about Doug…

While many small-cap biotech companies cannot attract top talent to their executive suite, Doug, who holds a bachelor’s degree in microbial and molecular biology from the University of East Anglia U.K, was recognized as Entrepreneur of the Year by Ernst and Young in 2012.

Doug joined Cybin, having chaired the board of directors of a Nasdaq-listed company, built and turned-around three pharmaceutical companies, completed 15 corporate acquisitions, and raised $4 billion of both public and private capital.

In his mission to eradicate mental illness, joining Doug’s team is an array of fantastic scientists: Alex Nivorozhkin, Ph.D. as Chief Scientific Officer, Michael Palfreyman, Ph.D. as Chief R&D Officer, Jukka Karjalainen, Ph.D. M.D. as Chief Medical Officer, Brett Greene as Chief Innovation Officer, and Alex Belser, Ph.D. as Chief Clinical Advisor.

Combined, this team has facilitated billions in pharmaceutical sales–including the successful launch of such widely used drugs as Allegra, Sabril, Anzemet, and Vaniqa.

Doug’s Scientific Leadership Team has also participated in hundreds of peer-reviewed publications on addiction and psychedelics, been involved with nearly 40 exits across the biotech sector and other related verticals as well as overseen more than 60 investigational new drug (IND) programs with the FDA.

The bottom line: Between Doug’s leadership and the scientific know-how of his team, these are the people with the necessary experience required to address the unmet medical needs of major depression disorder sufferers in this country.

A Small Company with Big Plans

To say Cybin has an ambitious set of goals would be an understatement. After all, here’s how the company describes its business in its Annual Information Form (AIF) filed with SEDAR:

“The company is a life sciences company focused on advancing pharmaceutical therapies, delivery mechanisms, novel compounds and protocols as potential therapies for various psychiatric and neurological conditions.”

In simpler terms, Cybin aims to develop the following:

• FDA-approved psychedelic-based therapies.
• A new way of delivering the psychedelic drug that enables rapid onset but allows doctors and therapists to control the intensity and duration of the drug’s effect.
• Optimized pharmacokinetic profiles, or how a drug interacts and moves within the body, of proprietary psychedelic molecules to provide ideal dose management and as few side effects as possible.

While I know it sounds like Cybin already has a huge job ahead of them with the creation and testing of a novel delivery system and proprietary molecules, check out this list of objectives the company laid out for investors in their AIF.

Over the next 12 months, Cybin expects to:

• Work with third parties to chemically synthesize psychedelic APIs for potential use in clinical trials. 

• Retain licensed pharmaceutical research companies to develop intellectual property of which the company will be the owner.

• Collect and analyze data from the Canadian microdose study conducted by the Canadian Centre for Psychedelic Science (pursuant to the CCPS Agreement, the company has seven months’ early access to the data from the Canadian microdose study, prior to publishing research and rights, to acquire any intellectual property given to the Canadian Centre for Psychedelic Science by the University of Toronto). 

• Commence clinical trials with the University of West Indies (UWI) regarding the safety and efficacy surrounding the delivery of psilocybin.

• Expand its intellectual property portfolio through internal development of novel psychedelic tryptamine and phenethylamine molecules and through acquisition strategies.  

• Commence an M&A strategy to acquire biotech and pharmaceutical technologies with a core focus on novel chemical compounds and psychedelic research.

• Commence an M&A strategy to acquire companies with a core focus on consumer mental wellness in North America.

• Launch a nutraceutical (non-psychedelic) product line currently anticipated to be labeled as Journey or such other labels as the company may determine (the “Product Line”) via an eCommerce platform to be potentially followed by wholesale and retail distribution.  

I think you’ll agree that Doug has laid out an incredibly ambitious set of goals for his partners at Cybin, and in just a couple of minutes, you’ll understand precisely why I believe they’ve got the financial firepower to meet, and exceed, their lofty objectives.

An Exploration of the Brain

Did you know there are tens of billions of neurons in the human brain?

It’s true.

According to the folks at BrainsFacts.Org, there are more than 85 billion neurons in the brain, and they’re ALL being used!

And there’s more.

The brain can malfunction in many ways, and these glitches can lead to disorders like depression that have an enormous social and economic impact. [16]

The reality is we know incredibly little about the brain.

According to neurobiologist Lu Chen, Ph.D., “we know about connections, but we don’t know how information is processed.”

And in Vivian Lam’s Scope blog post on Standford.edu, she writes this:

“Learning, for example, doesn’t just require good memory but also depends on speed, creativity, attention, focus, and, most importantly, flexibility. Understanding exactly how the neural pathways function could lead to improved treatments for depression, genetic disease, and many other conditions.”[17]

I know that’s a lot to digest, but you need to appreciate how complex an organ the brain is to understand the value of the deal that Cybin recently completed.

Here’s how Cybin describes the Kernel Flow technology:

“Flow is a full-head coverage, time-domain functional near-infrared spectroscopy system designed to detect hemodynamic changes in the brain that pulses light through the skull and into the bloodstream in order to measure how much oxygen the blood is carrying at any given time. Flow measurements can be used as analogues of local neural activity during a psychedelic experience. Cybin expects the quantitative measurements enabled by Flow may improve the development delivery and scaling of its psychedelic therapeutics.” [18]

As complicated as that description sounds, you need to understand Cybin believes Kernel’s Flow will allow it to measure where psychedelics work in the brain in real-time. And that will further enable Cybin to more accurately designed their future therapeutics. 

Remember what Professor David Nutt told Science Focus’ Jason Goodyer in mid-2020–“The brain develops these sophisticated habits, and psychedelics disrupt those.”

Suppose the Kernel Flow allows Cybin to understand better how, when, and why psychedelics like psilocybin disrupt the brain’s habits. In that case, this will turn out to be a hugely valuable partnership for the company. 

Cybin Enters Clinical Trials

The title of the clinical trial is a Phase 2, randomized, parallel-group, bioequivalence study of psilocybin 1 mg, 3mg, 5mg, and 7 mg administered with oral film to 25 mg oral capsule followed by placebo-controlled safety and efficacy trial with selected dose in patients with major depressive disorder (MDD).

The Phase 2a study’s primary objective is to choose the bioequivalent dose of psilocybin administered with oral film to 25 mg oral capsule in subjects with MDD. Simultaneously, the Phase 2b study’s primary objective is to evaluate the clinical efficacy by Montgomery-Asberg Depression Rating Scale (MADRS) score change post-dosing with oral film psilocybin film in comparison to placebo film.

The secondary objective of both studies is to evaluate the safety and tolerability of psilocybin.

Cybin’s goal is to begin the study in 2021, and the company hopes this study will act as the precursor to a global drug commercialization strategy.

The company’s current plan is to conduct the trial through the University of West Indies, with the trial adhering to International Conference on Harmonization (ICH) and Good Clinical Practice (GCP) guidelines.

It’s worth noting that Cybin’s decision to abide by ICH-GCP guidelines is a huge deal since these guidelines were designed to provide a unified standard for the European Union (EU), Japan, and the United States to facilitate the mutual acceptance of clinical data by the regulatory authorities in these jurisdictions.

Simply put, following the ICH-GCP guidelines allows Cybin to use the data they collect as a bridging strategy to enter other jurisdictions.

A War Chest Like No Other

It’s common knowledge that biotech companies burn through mountains of cash.

Remember, these companies rarely generate any meaningful revenue for years. They’re solely focused on developing products and molecules and testing them for safety and efficacy through the various FDA Phase trials.

The unfortunate reality is that cash can be tough to come by when for small-cap biotech companies. And when it is available, the terms for securing that financing often make dealing with the mafia a more appealing proposition.

But Cybin has had a different experience, as investors have anxiously thrown millions of dollars at the company from day one!

On October 19, 2020, Cybin completed a private placement offering 60,000,000 shares at C$.75, grossing the company C$45 million. While the company had to pay the typical Agent’s cash fee and offer up Broker warrants for shares, this was incredibly favorable financing for the company.

Now, if the C$45 million raised by Cybin in mid-October 2020 were all the financing the company secured up till now, I’d argue the company has been very successful on the fund-raising front.

But that’s not all the money the company has raised.

On January 18, 2021, Cybin agreed with Canaccord Genuity to execute a “bought deal” for 8,900,00 units of the company at C$2.25 per unit for gross proceeds of C$20,025,000.

Now, here’s what you need to understand about this second round of financing.

Each unit sold by Cybin consists of one common share at C$2.25 and one-half of one common share warrant at C$3.25. And when these terms were struck, Cybin was trading at C$2.28 on Neo exchange in Canada–So, investors were receiving virtually no discount to the current trading price.

Look, the terms Cybin secured for this second significant fund-raise were incredibly favorable for the company–but they got even better!

On January 19, 2021, Cybin announced that it and the Underwriters agreed to increase the offering’s size due to insatiable demand. The deal terms for the stock price and warrant’s price stayed the same, but the company would now sell 13,340,000 units for aggregate gross proceeds of C$30,015,000. And once the over-allotment option was exercised, that aggregate sum rose to C$34,517,250.

Raising money is a part of life for public companies, especially for small-cap clinical-stage biotech companies. The fact that Cybin has been able to raise tens of millions of dollars at favorable terms, without any revenue, and in an industry that is still in its infancy speaks volumes about the confidence investors have in both the company’s CEO and its scientific leadership team.

Risks to the Story

There’s a lot to like about Cybin and the potential benefits of psilocybin-assisted therapy, but this isn’t a risk-free investment. As with any small biotech company, Cybin will face binary, financial, regulatory, and competitive risks in its quest to eradicate mental illness.

When it comes to preclinical and clinical data releases, the news is generally good or bad. And these binary events can prove incredibly volatile. A good set of phase II data can send a stock soaring to all-time highs, while poor results can trigger a decline of 50%, 70%, or even 90%.

Since Cybin is entering Phase 2a and Phase 2b clinical trials with its sublingual psilocybin film delivery system, you must understand the binary risks associated with this trial’s outcome. Again, positive data will probably send the stock significantly higher, while disappointing data will almost certainly trigger a decline in the company’s shares.

Another risk every small biotech company deals with relates to financing.

Suppose the economy dips and risk appetite withers or a company cannot access financing to fund its research and development and ongoing clinical trials. In that case, that company’s stock will almost certainly struggle to gain ground.

Thankfully, Cybin has accomplished what few other companies its size has–They’ve raised a war chest of capital to complete a massive amount of their R&D. Frankly, I don’t view Cybin’s financial risk as all that serious–At least not over the next 18 to 24 months.

The most apparent risk Cybin faces is from regulators.

With psilocybin classified as a Schedule I drug under the CSA, the company will need the FDA and DEA to play ball and reschedule it. While rescheduling sounds like a tall order, I believe it’s a realistic possibility, provided the clinical data warrants the move.

A final risk to investors should be aware of has to do with industry competition.

You’ve read the statistics on depression and how ineffective many of today’s medicines are at treating the disease. And you’ve also read how promising the data on psychedelics like psilocybin is. So, it will come as no surprise to know that other companies are competing with Cybin for your investment dollars.

What give’s Cybin an advantage is its management team and financial war chest.

When it comes to pushing through R&D and multiple clinical trials, leadership and financing are everything! And with Cybin’s team and tens of millions of dollars in their coffers, I believe the company is well on its way to delivering an efficacious delivery system and an optimized molecule that will provide better dose management and reduced side effects than any of its competitors.

The Billion Dollar Brain Reboot–Connecting the Dots

If you believe, as I do, that Professor David Nutt is correct when he says we need to stimulate the 5HT2A receptors with psychedelics to change the way the brain processes things, you’ll also agree that as a society, we need a way to reboot the brain.

And based on Professor Nutt’s idea that psychedelics can disrupt the sophisticated habits developed by the brain, and the fact that the study conducted at Johns Hopkins Bayview Medical Center reported that 71% of patients who took psilocybin for MDD had a clinically significant response to the intervention, the evidence clearly shows that psychedelic-assisted therapy is sufficiently promising that it needs to be studied further in a clinical setting.

Look, you know how horrible the potential side effects of antidepressants can be. From weight gain and loss of libido to erectile dysfunction and fatigue, the common side effects of antidepressants are downright depressing!

Here’s what Science reporter for Quartz, Olivia Goldhill, wrote this about Prozac, one of the best-known antidepressants ever to be approved by the FDA:

“Taking a drug to tweak the biological chemical imbalances in the brain makes intuitive sense. But depression isn’t caused by a chemical imbalance, we don’t know how Prozac works, and we don’t even know for sure if it’s an effective treatment for the majority of people with depression.” [19]

The reality is depression sufferers need a way out of their abyss. And that way out shouldn’t have to be more pills.

From a corporate perspective, the potential rewards of developing a safer and more effective treatment are worth the risks–even if those risks involve binary outcomes, regulatory, financial, and increased competitive pressures.

According to the National Center for Biotechnology Information, “the global direct and indirect economic costs of mental disorders are estimated at $2.5 trillion.” [20]And that dollar figure is based on data from 2010.

When the World Economic Forum asked a select group of health economists to ballpark the costs of mental disorders by 2030, the group projected the costs to reach a mind-blowing $6 trillion! [21]

I understand it can feel sleazy and cold-hearted to place a dollar value on delivering relief to an enormous group of folks suffering from an unmet medical need. But you know as well as I do that developing drugs is hugely expensive.

So, whether we consider the World Economic Forum’s $6 trillion price tag for mental disorders by 2030 or that fact that the World Health Organization believes “one in four people will be affected by mental or neurological disorders at some point in their lives”[22], the unfortunate reality is depression, and neurological disorders are, conservatively, a multi-billion-dollar problem.

And while addressing unmet medical needs is rarely a winner-take-all outcome, we, as investors, want to align ourselves with the one company best positioned to bring relief to patients and deliver superior shareholder returns. And I believe that company is Cybin!

Please consult your financial advisor if you’re considering adding Cybin (CLXPF) to your portfolio.

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[1] https://www.nimh.nih.gov/health/statistics/major-depression.shtml

[2] https://www.nimh.nih.gov/health/statistics/major-depression.shtml

[3] https://jamanetwork.com/journals/jamapediatrics/fullarticle/203918#:~:text=Depressed%20adolescent%20girls%20were%20also,drugs%2C%20smoking%2C%20and%20bingeing.

[4] https://www.ncbi.nlm.nih.gov/pmc/articles/PMC2169519/

[5] https://www.nimh.nih.gov/health/statistics/major-depression.shtml

[6] https://www.medicalnewstoday.com/articles/322495#symptoms

[7] https://www.sciencedaily.com/releases/2009/10/091023163346.htm

[8] https://www.sciencedaily.com/releases/2009/10/091023163346.htm

[9] https://www.sciencedaily.com/releases/2009/10/091023163346.htm

[10] https://www.hopkinsmedicine.org/health/wellness-and-prevention/why-arent-my-antidepressants-working

[11] https://www.sciencefocus.com/the-human-body/magic-mushrooms-and-mental-health-could-psychedelic-drugs-treat-depression/

[12] https://www.cell.com/cell/fulltext/S0092-8674(20)30282-8

[13] https://jamanetwork.com/journals/jamapsychiatry/fullarticle/2772630

[14] https://jamanetwork.com/journals/jamapsychiatry/fullarticle/2772630

[15] https://www.analysisgroup.com/the-growing-economic-burden-of-depression-in-the-united-states/#:~:text=Depression%20in%20America%20now%20costs,is%20associated%20with%20depression%20itself.

[16] https://www.brainfacts.org/core-concepts/your-complex-brain

[17] https://scopeblog.stanford.edu/2016/11/08/challenges-in-neuroscience-in-the-21st-century/

[18] https://www.cybin.com/cybin-partners-with-kernel-to-use-its-breakthrough-neuroimaging-technology-for-psychedelic-pharmaceutical-therapies/

[19] https://qz.com/1162154/30-years-after-prozac-arrived-we-still-buy-the-lie-that-chemical-imbalances-cause-depression/

[20] https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5007565/

[21] https://www.nimh.nih.gov/about/directors/thomas-insel/blog/2015/mental-health-awareness-month-by-the-numbers.shtml

[22] https://www.who.int/news/item/28-09-2001-the-world-health-report-2001-mental-disorders-affect-one-in-four-people