Apr 21, 2021

MedicalGold's Exclusive Interview with Timothy Ko, CEO of Entheon Biomedical

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Entheon Biomedical (CSE:ENBI) is a biotechnology research and development company committed to developing and commercializing a portfolio of safe and effective N,N-dimethyltryptamine based psychedelic therapeutic products (“DMT Products“) for the purposes of treating addiction and substance use disorders. Subject to obtaining all requisite regulatory approvals and permits, Entheon intends to generate revenue through the sale of its DMT Products to physicians, clinics and licensed psychiatrists in the United States, certain countries in the European Union and throughout Canada.

On 4/19/21, MedicalGold staff conducted an interview with Timothy Ko, CEO of Entheon Biomedical. Transcript below.

MedicalGold:

It’s great to speak with you again Tim. It feels like the medical psychedelics space is really in its infancy, and a lot of people don't really understand it well. From my experience speaking with investors a lot of people are skeptical of psychedelics and they seem to think that psychedelics are for quacks or for hippies. There are always questions as to the safety and efficacy of psychedelics for medical treatments.

I’m interested in your thoughts as to how you view the sector and what are some ways that companies like Entheon can help to add more clarity as to what the opportunity is in this space?

Timothy Ko:

Absolutely. I think to that point of psychedelics being sort of quack medicine or reserved for that realm of people that's the poet, the philosopher, the hippie, I think more and more we're seeing that psychedelics aren't only a comparable source of efficacy, but are actually head and shoulders above some of the existing medical treatment paradigms that exist.

Just recently one of our advisors, Robin Carhart-Harris, published a study finding that psilocybin is equally, if not more effective in treating depression. As effective as escitalopram, but also has a whole host of other benefits that are associated with it. So, I think more and more we're seeing that the reality is that the proposed medical interventions that exist right now just simply aren't working.e

I think we understand that the mental health crisis hasn't been effectively mitigated by the solutions that exist right now and that psychedelics have the potential to drastically alter and improve how we treat mental illness.

With regard to cannabis, I think legalization movements and growing adoption was loosely based on a medical presumption, but then the recreational market happened, and I guess that is the key component to its growth lately.

The reality with psychedelics is they are largely being researched within a medical/psychiatric context as a means to treat specific mental and physical health indications where there is massive medical need. Whether it's depression, anxiety, addiction, or PTSD, current treatment options are massively ineffective, and I think psychedelics can prove to be a potential frontline defense to some of those conditions that aren't being sufficiently addressed by the present model of care.

MedicalGold:

For investors who are looking for a major event that will catalyze the entire psychedelics sector, what should we be looking for? In cannabis, we had the legalization in Canada in October 2017, which was obviously a huge catalyst, and the entire sector rose aggressively in the months leading up six months ahead of recreational legalization in Canada. Obviously we are still very early days in the psychedelics sector, but we are beginning to see some US states decriminalize psychedelics, and as you mentioned ketamine is being used in a clinical setting for addiction therapy. What bigger picture catalysts do you see coming up for the sector? And could we see a major investment validation by a multi-billion dollar company such as we saw in cannabis with Altria and Constellation Brands investing billions of dollars?

Timothy Ko:

It’s a pertinent question. I know we're always looking for the next catalyst that will further legitimize the psychedelic market. I think COMPASS Pathways advancing their psilocybin trials, that will certainly be a huge catalyst to look for, also MAPS approving getting their MDMA product approved, that's going to be a huge catalyst

These are just a couple of stories that are going to give huge validation toward the sector. It'll be the continuation of story that I think has been building for over a year now, that these drugs, that were once thought of as a means to drop out or avoid reality, or were thought of as quack medicine that actually results in more harm than good are actually the exact opposite and very well may be the solution to some of society's most challenging problems.

So yeah, it's not necessarily just the COMPASS Pathways and the MAPS trials progressing, I think we're already a bit into the evolution of that understanding. I think Janssen with their ketamine product which targets treatment-resistant depression is a pretty clear indicator that the  environment is rapidly changing, and that psychedelic medicine is going to be a regulated and medical style of therapy which will be subject to the same regulatory and legal hurdles as conventional pharmaceutical drugs.

Ketamine was once believed to be a party drug and with no real therapeutic benefit, and we've obviously seen a variant of ketamine make its way through full market authorization. This former party drug is now actually helping thousands of people with their depression symptoms in such a way that is better or comparably effective to traditional antidepressants.

MedicalGold:

Yeah, I think that's a great point you make about ketamine, and that's actually becoming a sort of frontline treatment here in Florida where there are a lot of addiction recovery centers.

Timothy Ko:

Sure.

MedicalGold:

Okay, so let's talk about HaluGen. So, you guys put out some pretty important news on April 6th about this genetic test kit and platform. Can you tell us a little bit more about that test and what's the revenue opportunity there? I also read that you're planning to launch it in the US.

Timothy Ko:

Absolutely, yeah. HaluGen’s ”Psychedelics Genetic Test” is the first product of its kind and was launched in Canada on April 6, 2021.. So, just a bit about HaluGen. We acquired HaluGen early in 2021, so it's a wholly owned subsidiary of Entheon. HaluGen isn't just a test, it is also a platform, and for us the acquisiton and the products HaluGen is developing are a response to the evolving psychedelic therapy landscape.  The reality is that though DMT is this molecule of huge potential for treating not only addiction issues, but a variety of other mental health illnesses, we don't want to be exclusively revenue-dependent on something that is multiple years away. Not just from a revenue opportunity perspective, but I do think from a real sector need perspective, HaluGen is taking the steps that are needed to address what right now is a bit of an unmet need.

Psychedelics are a very powerful class of molecules and can provide profound effects and insights to those ingesting them. That being said, we also understand that different people have different physiological responses to various psychedelics. So, what HaluGen's test looks for is specific biomarkers that indicate likelihoods and risk factors for people who may have negative adverse reactions based on their genetic makeup, such as psychosis or schizophrenia which we know certain psychedelics can trigger. Also, looking for specific metabolic rates that are indicated by the presence of genetic biomarkers, to better determine how a given person’s system may breakdown a particular psychedelic compound, providing a better estimate of how intense a given dose of psychedelics will be and how long its effects will last.

We understand that certain people will metabolize classic psychedelics like psilocybin, LSD and DMT more strongly or weaker, and so that could result in a stronger or weaker response, it could ultimately result in a good or a bad trip. We also understand that certain people metabolize ketamine at different rates due to genetics, and so this test will give some indication of whether the person is more likely to have a strong, weak, good, or bad psychedelic or a ketamine experience.

So, what that signals is that we're not just focused exclusively on DMT, but rather on creating safety and diagnostic tools that are important for the near-term mass-adoption of psychedelic therapies and into the future as the psychedelic industry evolves. Ultimately, there is a whole class of people that are seeking psychedelic therapies in whatever form that takes, whether it's of their own volition or whether they're trying to determine whether they should take psilocybin or ketamine. We're trying to provide the industry a tool so that these individuals that are looking to take that very brave step of bettering themselves have the most-informed basis from which to make those decisions, one that considers for safety and for the highest potential for positive impact.

MedicalGold:

What is your bigger vision for Entheon and what are the value drivers that you see for shareholders going forward?

Timothy Ko:

From its origin Entheon has been committed to developing targeted and scientifically-validated solutions for addiction disorder, but our commitment to the addicted person's betterment extends beyond our in-development DMT product. We want to ensure that ultimately anyone who is taking the brave step of receiving psychiatric care and potentially psychedelic enhanced therapies, is doing so with full assuredness that their safety is top-priority. So, the larger vision for Entheon is the development of tools that are relevant to not only DMT therapy, but to additional segments of the psychedelic space as we begin to see more companies with different therapies, focused on different drugs and psychedelic molecules, coming to the market.

We would be not fulfilling our duty of care to psychedelic assisted therapy patients if we didn't create tools that would help to bolster their safety and make use of that opportune moment of willingness to change. And so some of the direction that we're going in is ensuring that we commit  time and effort to the development of a safety and diagnostic platform that really optimizes an individual’s drug treatment program, one that leverages genetics and neurophysiology in the development of a system of personalized medicine. This is of vital importance because people and patients that are entering the conversation of receiving therapy do so with a certain amount of urgency and desperate need to overcome something that is destroying their lives. We've seen personalized medicine evolve within the oncology cancer space, in part because there is a sense of urgency applied. We think there is also a sense of urgency involved for those who are desperate to overcome addiction disorder.

MedicalGold:

So you have the tests available on the HaluGen website, so I'm just interested how many people have ordered tests and what do you see the opportunity here to sell this test, to help people get a better handle on what their psychedelic experience might be and the safety of it?

Timothy Ko:

The test recently launched and so far we are seeing good traction, with sales increasing on a week to week basis. We're looking to really amplify the marketing and visibility around it. And it's really hard to put an exact revenue projection in terms of how many tests we'll sell. But I think we do understand that there is already quite a large market of people that are interested in psychedelic usage. We've seen a recent boom in sort of gray markets, psychedelic retreats, as well as micro dosing, and of course in the sort of legal and regulated ketamine market.

As the interest expands, as more and more people are not being adequately treated by traditional pharmaceuticals, like antidepressants, we'll likely continue seeing a sort of explosion in terms of the interest for psychedelic therapies, as gauged by different conversations, web searches and queries. So we're looking to expand the visibility of the “Psychedelics Genetic Test” and actually partner with some well-established platforms that are positioned within the psychedelic space that already have captive psychedelics audiences and are looking to expand their audience and provide different services. So yeah we don't think it's unreasonable that HaluGen, within the next 24 months, has the potential to sell hundreds and hundreds, if not thousands of orders on a monthly basis.

MedicalGold:

Awesome! How does HaluGen and the genetic biomarker test help you to build out your bigger platform? Are you able to collect data and integrate it into your AI and machine learning?

Timothy Ko:

Neuro-physiology and genetics play a very important role. And the way that I characterize that is that right now a lot of the assessments that are made with regard to mental health and psychedelics are based on subjective and qualitative measures, like personal surveys, as well as individually self-reported personal narratives. We seek to provide a more accurate picture of the individual so that therapies can be specifically designed to address their unique needs based on their unique physiology, brain chemistry and family backgrounds. We look at it like a nature versus nurture picture of what a person's data is. Genetics provide that basis of understanding as to who a person is from the perspective of nature.

But we're also looking at EEG (electroencephalogram) to help determine what their functional reality is. Genetics only tell one part of the story. It's a very important part that will dictate how a person metabolizes drugs, but the EEG and neurophysiology actually show what's going on in the present day in real time. And so HaluGen is certainly important in terms of providing that initial nature basis of understanding, but we're trying to make that more robust with an EEG based nurture perspective. So we get a very fulsome view of what a person's individual variants and nuances are so that we can come up with a personal medicine paradigm that really helps physicians and patients understand what the risks are, what a person's highest likelihood of benefit in terms of therapy and support will be. And, as well, as inform the individual treatment programs that go into the preparation, as well as, the psychiatric components that go into this whole personalized treatment paradigm.

MedicalGold:

So you also announced that you signed an agreement with an Israeli company to conduct a pre-clinical study. Do you have a more accurate timeline of when you think that study will launch?

Timothy Ko:

We are getting ahead of our meetings with the FDA, anticipating what will be asked of us. Pre-clinical in-vivo trials are anticipated to take place in Israel, at the CRO, Science in Action, in Q3 of 2021.

MedicalGold:

I really like your philosophy that it’s possible to make money and do good at the same time. You became involved in finding more effective therapies to treat addiction through a very personal experience with your brother. Please tell us more about your experience and your philosophy on doing good, while also being able to create value for shareholders by meeting unmet needs and helping people.

Timothy Ko:

I know firsthand the agony of watching someone you love not get better, despite wanting to. I witnessed my brother be improperly diagnosed and treated by one size fits all recovery models ultimately losing him to an overdose while he was in a government funded facility. Prior to that he had the services of dozens if not hundreds of people trying their best to treat him with the tools they had. Sadly, my brother’s story is lived out by millions of other sufferers and their families every day. We at Entheon have a duty of care to these people and want to ensure that we develop the tools and products that get to the most effective treatments quickly, so as not to waste any precious time on misdiagnosis, ineffective treatments, or poorly structured therapies. There is good business in providing much needed services, and in my eyes there is nothing more urgent or fulfilling than helping those who want to get better.

MedicalGold:

Thank you Timothy, I appreciate learning more about Entheon and the tremendous opportunity that exists to help people dealing with a wide variety of mental health ailments in a safe and effective manner.

Disclosure

Author owns Entheon Biomedical shares at the time of publishing and may choose to buy or sell at any time without notice. Author has been compensated for marketing services by Entheon Biomedical.

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