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The Year In Review For Psychedelic Drug Stocks: 2020

Published at PsychedelicStockWatch.com.

By Jeff Nielson

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In 2020, the psychedelic drug industry burst onto the radar of investors. As psychedelic drug research exploded and new capital has flooded into this sector, a vibrant core of public companies has commenced trading.

Still other pubcos have either added a psychedelics component to their business model or simply rebranded the entire company. Psychedelic drugs became the most important story in life sciences in 2020.

As investors look ahead to 2021, Psychedelic Stock Watch is looking back. We have prepared a 2020 Report Card for the psychedelic drug industry, measuring its development in 5 key categories.

Here is the Psychedelic Stock Watch 2020 review.

Stock performance:  A

After a subdued summer for psychedelic stocks, the industry caught fire in September with the Compass Pathways IPO. A new NASDAQ listing and the nearly $150 million raised by Compass for its IPO financing provided an instant credibility boost for these new public companies.

See: Compass Pathways Files For NASDAQ Listing: Psychedelics Game-Changer

Several stocks went vertical. Investors who got in early had a number of multi-bagger opportunities.

The Compass IPO was the initial catalyst driving this rally. But fueling upward momentum was a rapid-fire series of new financings that injected ~$500 million into the sector – in just the last 3 ½ months of 2020.

Raising capital:  A+

Drug development is expensive. Taking a single drug through the clinical trials process can cost in excess of $100 million – and consume several years of time.

Even building and operating a network of psychedelics-assisted treatment clinics requires robust infusions of capital. As the psychedelic drug industry was getting off the ground, many investors were justifiably skeptical as to whether the industry could attract sufficient capital.

As we reach the end of 2020, those doubts have evaporated.

We’ve seen companies (public and private) close on several nine-figure financings.

We saw one company (MindMed) go to capital markets with new offerings three times in just the last quarter. Each financing was at a dramatically higher unit price (CAD$1.05 –> CAD$1.90 –> CAD$4.40) and each one was oversubscribed.

Indeed, virtually every new psychedelics private placement in the fourth quarter was oversubscribed, as institutions and high net-worth investors engaged in a feeding frenzy.

Psychedelic drug R&D:  A

Psychedelic Stock Watch is assigning the industry an “A” for its progress in psychedelic drug R&D in 2020. But many readers may see even that high grade as being too low.

As we end the year, one psychedelic drug clinical trial is moving into (final) Phase 3 testing. MAPS’ MDMA-assisted psychotherapy for the treatment of PTSD has commenced this stage of the clinical trials process – with early indications strongly pointing toward a successful result.

Based on earlier promising results (and an urgent need), the FDA has granted Breakthrough Therapy Designation to this research, further streamlining the clinical trial process.

Numerous other psychedelics-based clinical trials are at various stages of a Phase 2 trial.

Among the public companies beginning or engaged in Phase 2 clinical trials involving psychedelics are: Compass Pathways, MindMed Inc, Cybin Corp, and Mydecine Innovations Group. Indeed, MindMed itself has three drug R&D initiatives in or beginning Phase 2 trials.

Of equal importance are the clinical results emerging from these drug trials.

Compass Pathways’ Phase 2 clinical trial for treatment-resistant depression has also received Breakthrough Therapy Designation, due to the strong results from its own research.

We are currently in the midst of a Mental Health Crisis, with stress-related disorders like depression, addiction, anxiety and PTSD afflicting over 1 billion people globally. Much of the reason why this has become a crisis is the appalling standard of care for many of these conditions.

Addiction therapy is a revolving-door failure. Rehab, release, relapse, repeat.

Front-line drugs to treat depression (antidepressants) are dangerous and addictive. And their efficacy is little better than that of sugar pills. Roughly two-thirds of Americans exhibiting symptoms of depression don’t even seek treatment.

Meanwhile, clinical testing on psychedelics-based therapies is consistently yielding spectacular success rates for addiction, depression and PTSD.

MAPS’ MDMA-assisted psychotherapy for PTSD has been generating positive results for ~90% of patients being treated. Conversely, roughly two-thirds of U.S. veterans being treated for PTSD by the Department of Defense express dissatisfaction with the current standard of care.

The Department of Defense has become a major booster of psychedelic drug research – and has itself contributed $10s of millions for research funding.

Why no “A+” for psychedelic drug R&D in 2020?

One simple reason: no psychedelic drug completed the clinical trial process in 2020. But we could easily see this occur in 2021 – earning the sector an even higher letter-grade next year.

Media/public opinion: A+

Most psychedelic drugs are illegal, and have been strictly prohibited for ~50 years. Through nearly all of this time, the mainstream media has demonized any/all usage of these substances.

Why are we reminding readers of these facts?

Because if we look around today at public attitudes and what is being written in the media about these drugs, visitors from a distant planet would never guess that these drugs are still (mostly) illegal.

In the medical community, a Renaissance has taken place regarding psychedelics-based research. A long-and-growing list of physicians are banging the drum for the medicinal potential of these drugs – including many of the brightest minds in medicine.

See: The Psychedelics Revolution: It’s No Longer BAD To Feel GOOD

Among the general public, there are two parallel tracks of interest that are both seeing exponential increases in support:

  • Gaining access to psychedelic medicines to elevate the standard of care for many mental health disorders.
  • “Biohacking” with these substances (generally via microdosing) as a new health-and-wellness trend to significantly improve quality of life and/or career performance.

Despite 50 years of anti-psychedelics propaganda (by government and media) fears/phobias toward these drugs are rapidly dissipating.

Most surprising, however, has been the change in media attitudes and coverage of psychedelic drugs.

The anti-drug propaganda is gone. It has been replaced by in-depth, fact-based coverage of psychedelics and psychedelic drug R&D, with mainstream media coverage universally positive.

Psilocybin Sessions: Psychedelics could help people with addiction and anxiety (CBS News, August 2020)

We can no longer ignore the potential of psychedelic drugs to treat depression (The Guardian, June 2020)

Psychedelic Drugs Like LSD and Magic Mushrooms Linked to Transformative Experiences, Feeling Connected With Others (Newsweek, January 2020)

The mainstream media still regularly smears the (legal) cannabis industry with archaic propaganda that has been completely discredited. But these same large corporations have turned over the proverbial “new leaf” when it comes to how they cover psychedelic drugs.

In turn, the consistently positive optics being projected on psychedelics by the media can only have a beneficial effect on political and regulatory attitudes toward psychedelic drugs.

Regulatory thaw:  B

In 2020, the psychedelic drug industry has addressed – and essentially eliminated – investor doubts in several key areas. When it comes to stock performance, capital raising, drug R&D and public opinion, the psychedelic drug industry couldn’t look any stronger as 2020 comes to a close.

Yet one area of doubt remains: the decriminalization/legalization of these substances and subsequently creating a regulatory framework for these emerging drugs.

Considerable progress has been made this year.

Several U.S. cities have decriminalized psychedelic drugs. In the recent U.S. election, the state of Oregon not only broadly decriminalized psychedelic drugs, it has legalized psilocybin for medicinal use.

In Canada, progress began a little later but is moving even faster – much like we saw with cannabis legalization.

It started at the beginning of August, when Health Canada granted “medical exemptions” to allow medicinal psilocybin use for four terminally-ill patients.

Subsequently, Health Canada has expanded these medical exemptions for psilocybin use for patients. More importantly, it has granted several psychedelics therapists permission to personally use these substances to help refine treatment.

In the space of a few months, Health Canada has gone from being cautiously receptive toward the medicinal use of psilocybin to moving clearly and methodically to broaden medicinal usage in Canada.

One observer with a strong interest in these developments is Doug Drysdale, CEO of Cybin Corp. Cybin is one of the public companies that is well-advanced into formal clinical trials with its psilocybin-based R&D.

Drysdale estimates that psilocybin-based therapies will start to be approved (as they emerge from these clinical trials) in roughly a two-year time frame. And he sees psilocybin legalization (at least in Canada) as a real possibility over the same time-horizon.

While the psychedelic drug industry earns a solid “B” for regulatory progress in 2020, the sector is still at the beginning of a long road.

Better days ahead for psychedelic stocks

As good as 2020 was for the psychedelic drug industry, expectations for 2021 are even higher. The half-billion in fresh capital that was raised in roughly the last quarter of 2020 is sufficient to drive plenty of growth in this industry in the first half of 2021.

Major industry catalysts loom for early 2021.

More companies will be going public. New investment capital will continue to flood into the industry. Regulatory progress should accelerate. And several psychedelic drugs should get much closer to the drug approval finish line in 2021.

Also, two dimensions of the industry that were just starting to gain prominence in 2020 will be squarely in the spotlight for investors in 2021.

DISCLOSURE: The writer holds shares in MindMed Inc, Numinus Wellness, Cybin Corp and Mind Cure Health. Mind Cure Health is a client of Psychedelic Stock Watch.

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INN: Psychedelics Outlook 2021: How Far Can This Industry Go?

Click here to read the previous psychedelics outlook. 

With interest in psychedelics investing starting to gain steam, companies and experts continue to point to the long road ahead in 2021 and beyond for the market.

Investor patience and belief in the sector will be tested as companies continue the arduous task of proving the efficacy of psychedelic drugs. While money-making opportunities will appear, new drug development programs will still take significant time.

Following the most critical year for psychedelics investment, how will 2021 stack up in the grand scheme and what’s at stake for investors?

Here the Investing News Network (INN) offers investors a look at what’s to come for the new segment in 2021 directly from experts and those involved in this space.

Psychedelics outlook 2021: What should investors know before diving in?

New marketplaces can be challenging to jump into, and psychedelics is no different. So far executives and experts agree in recommending a long-term approach to investors.

“Drug development takes time and is capital intensive, so investors should focus on those companies that are sufficiently capitalized and have a team with a strong track record to bring these treatments to market,” Doug Drysdale, CEO of Cybin (NEO:CYBN), told INN.

Drysdale’s comment hints at the psychedelics industry’s biggest identifier, which is that it is most closely related to the often slow-paced life science sector. According to one executive, this means companies’ plans will require significant time to develop.

“In many regards, we, and many other companies in the space, are traditional biotech, pharmaceutical and drug discovery firms, advancing psychedelic molecules through the conventional and established scientific, regulatory and legal framework required to bring any drug to a mass market,” said Timothy Ko, CEO at Entheon Biomedical (CSE:ENBI).

While companies may still perform as they work through these long pipelines, many experts cautioned that investors will not see a new rush similar to the one seen previously in Canada’s cannabis arena.

“It is a drug discovery, mental health, biotech play — not recreational and not cannabis,” Bill O’Hara, managing partner at LACG Capital and former managing director of institutional equity sales with Haywood Securities, explained to INN.

Ko agreed with O’Hara, telling INN that he thinks one of the biggest misconceptions in the psychedelics industry is that it is similar to the cannabis space.

Kelsey Ramsden, president and CEO of Mind Cure Health (CSE:MCUR,OTCQB:MCURF), said investors should pay close attention to the revenue horizons for companies in the space, and should also look for strong management teams and unique strategies.

“I think this will help investors land safely with companies who will create realizable value,” she said.

Psychedelics outlook 2021: Could big acquisitions be on the way in 2021?

With increased investor attention and potential upcoming medical approvals quickly changing the realities of the psychedelics space, one question has started to gain steam in this market: How likely is it for a big-name pharmaceutical entity to eye an early entry?

“It’s sort of becoming impossible to ignore in terms of the scientific evidence that’s accruing … and the potential that these compounds have for treating mental health conditions,” Adele Byrne, senior analyst with drug research firm Prohibition Partners, told INN.

During an online forum in August, Kris Miks, partner at Norton Rose Fulbright Canada, went so far as to say that major entries will be born out of companies’ desire to not be left behind.

“I think there’s going to be more of an appetite and more of an interest from large pharma to get into the space early and see if they can get involved,” Miks said at the time.

While the industry awaits a potential entry, it is undeniable that the sector has already seen significant investment from large figures in the market at large. Players like Peter Thiel, Kevin O’Leary and Bruce Linton have all thrown their support behind the psychedelics opportunity.

“Psychedelics are finally having their day in the sun — not as recreational drugs but as medicines to address society’s problems with mental illness and addiction — and I’m one of the many Wall Street investors who are now backing them,” O’Leary wrote in an op-ed.

When it comes to predictions, Leonard Lerer, CEO and founder of Back of the Yards Algae Sciences, a sustainable biotechnology firm that has committed to the benefits of entheogens, said 2021 may bring big opportunities for mergers and acquisitions.

“In 2021, we will see the first serious moves by the biopharmaceutical giants in this space,” Lerer said.

Josh Bartch, CEO of Mydecine Innovations Group (CSE:MYCO), told INN he sees next year as an opportunity for knowledge about psychedelic substances to grow.

“We see 2021 as a year of progress and continued public acceptance. With numerous clinical and R&D initiatives happening globally, much-needed information and discoveries will be uncovered during the upcoming year,” Bartch said.

Psychedelics outlook 2021: Investor takeaway

The psychedelics investment market is on pace to keep expanding and commanding the attention of more investors in 2021. With this uptick in attention, the industry will have to continue delivering results and proof of its promise in treating various mental health conditions.

As with any new market, it’s important for investors to remember that these are still the early days, and with this particular space the key theme is how much time it will take to mature.

“We have only just begun, there are a lot of companies entering the space who will not be here a year from now — the beginning of a new segment is always like this,” Ramsden said.

Don’t forget to follow @INN_LifeScience for real-time updates!

Securities Disclosure: I, Bryan Mc Govern, hold no direct investment interest in any company mentioned in this article.

Editorial Disclosure: Cybin and Mind Cure Health are clients of the Investing News Network. This article is not paid-for content.

The Investing News Network does not guarantee the accuracy or thoroughness of the information reported in the interviews it conducts. The opinions expressed in these interviews do not reflect the opinions of the Investing News Network and do not constitute investment advice. All readers are encouraged to perform their own due diligence.

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Mydecine Speaker Series: Psychedelic Solutions

Published at truffle.report.com.

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By TANYA IELYSEIEVA

Panellists at the Mydecine Speaker Series last week highlighted the present and future potential of psychedelic therapies in relation to the mental health crisis.

The panel was hosted virtually on December 15 by the Microdose Psychedelic Insights and was moderated by Business Insider journalist Yeji Lee.

Panellists included Ruth Lanius, Professor of Psychiatry and director of the PTSD research unit at the University of Western Ontario, Robin Carhart-Harris, head of Centre for Psychedelic Research, Imperial College London and Mydecine’s scientific advisory board member, Rakesh Jetly, OMM, CD, MD, FRCPC, and Mydecine’s Chief Medical Officer, Robert Roscow, Chief Scientific Officer and Co-Founder of Mydecine.

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Mental Illness and The Function of Psychedelics as Treatment

Lee began the panel by asking participants for their thoughts on how recent studies shed new light on both mental illness and the function of psychedelics as treatment, and what technologies and methods, in particular, have had an impact on the field.

Lanius spoke about how recent developments, both for psilocybin and MDMA, have shown some promising effects in treating PTSD and depression. Lanius, who has spent the last two decades researching what happens in the minds and bodies of traumatized individuals, added that from her personal experience, “some clients, who’ve tried a lot of therapeutic modalities, have found the psychedelic treatments most beneficial. That’s not for all, but that’s certainly for some.”

“We often see in psychiatric disorders that the brain gets locked in certain patterns, and I think that promotes the distress individuals feel. And there’s a hypothesis, of course, that the psychedelic treatments can push people out of these locked places in the brain and reset the brain,” Lanius said.

Jetly, who has been a psychiatrist with the Canadian Armed Forces for 20 years, stressed that medical workers, who start their careers, are committed to evidence-based treatments, including cognitive behavioural therapy. However, as they get older, doctors start noticing where the evidence-based treatments end, who it doesn’t help, and why it doesn’t work.

“If we’re lucky in PTSD’s conventional treatments, medication and psychotherapy, it helps 50-60 percent of people. It’s a huge number of dropouts, and it’s extremely difficult,” Jetly said.

“I’ve been searching for the last decade for what else we can offer people when the evidence-based treatment doesn’t work. That’s why, scouring, looking for the evidence and looking for compelling research, it’s hard to ignore the quality research that’s being done in this space, whether it’s psilocybin, whether it’s MDMA. I think, for me, that’s trying to find something else that we can offer people that can help them,” he continued.

Psychedelic Research is ‘Not Shady Stuff Around The Corner’

Responding to a question by Lee about why there’s been a halt on new developments around mental health medications and treatments, Jetly said it is important to demonstrate the safety and efficacy of these psychedelic substances and to convince the regulatory bodies that this is “not shady stuff around the corner and this is completely above board.”

Lanius, agreeing with the comment by Jetly, said, “It’s so important to do these studies in a very meticulous, a very scientific way, and to follow people as long as we can to see the long-term effects. We can examine the long-term effects. I think people will want to know that, tracking what happens neurobiologically but also on a bodily level. Because that trauma has a big effect on the inflammatory markers, I think people will be curious to see if we can change mind, brain and body with these treatments, how can we change them and how long does it last.”

Roscow added that the most interesting aspect of this research is that these psychedelic substances address multiple systems and are active not only in the nervous system but in the digestive system, immune system, as inflammation response, and it is “an open question in this area of research as to how that branches into other conditions or helps more nuanced ways addressing the primary conditions like PTSD and depression.”

Psychotherapy and Psychedelic Treatment

As the discussion moved forward, Lee asked panellists about the process of psychedelic-assisted psychotherapy.

“There are different phases of it. There’s the preparation phase that, in my opinion, needs to look as closely to the psychedelic as possible. Things are very predictable for the client when they have these hallucinatory experiences and enter this different world. They’ve been grounded in the first session, pre-psychedelic, and that gives them a foundation and a holding environment to have this experience. During the psychedelic experience, the therapist again provides a container holding environment and provides safety for the patient to be able to form new connections, to reflect, and to experience new things,” Lanius explained.

“There’s also a place to start thinking about the follow-up care and how we can approach the follow-up care now that the individual sense of self is shifted. They’ve experienced new things, new avenues have opened up for them. How do we continue to process that with an individual? To foster a new sense of being in this world, which I think is something we want to achieve through good treatment,” she continued.

Jelty agreed to Lapius’s point and stressed out that “you want to guide, but you don’t want to get in the way.”

Pivotal Mental State and a Path for Treatment

According to Carhart-Harris, who has been researching psychedelics for 15 years, a pivotal mental state is referring to a few key criteria.

“One is that these states are hyperplastic. So, within these states, there is an exceptional ability for the mind, the brain and behaviour to be changed in relation to the conditions that those systems are in during that period. Also, those changes can be particularly marked or dramatic,” Carhart-Harris explained.

“What I discovered, while researching around this, was that stress is a particularly reliable condition in which these pivotal mental states defined by hyper plasticity, sensitivity to context and an upregulation of the serotonin receptor system, stresses a reliable natural way of inducing these states. And that makes sense to me in terms of the phenomenology around transformative psychological experiences that are often preceded by crisis, intense stress and prolonged stress. For me, working these things out, it’s a hypothesis and it’s there to be tested, and help me understand why we might have this system in our brains and bodies that can be engaged in the particularly challenging conditions where a period of intense plasticity might help us. Because maybe our lives depend on our ability to be exceptionally adaptive because whatever strategies, cognitive, behavioural aren’t working, maybe our life is in danger in some way, and something needs to give, something needs to change. It’s sort of understanding outside of the context of psychedelics; what can happen in the brain, what changes, what processes can play out that induce something akin to a psychedelic like experience that seems to engage the same pharmacological and other neurobiological mechanisms that psychedelics kind of hack, or hijack,” he continued.

The Rise of Interest and its Impact on Modern Society

Answering the question about the current state of psychedelic interest, Lanius said people feel “really stuck” with the current treatments.

“We’ve got some great treatments. However, a lot of people don’t progress, and a lot of people drop out. I think people are feeling stuck, they are feeling frustrated, and I think they’re ready to explore something new,” Lanius said.

Roscow, agreeing with Lanius, said, “That couldn’t have necessarily happened without the increase in the quality of the data that’s been associated with it. There’s been strong hints and strong pieces of data out of a piecemeal of research over the last 50 years, and because the quality of the data is caught up with it, I think it’s becoming much harder to argue against and that aspect that balance is what I see a shift in.”

Carhart-Harris said that he is “very much enjoying the present mainstreaming of things.”

“It’s affirming. I remember the days of speaking to people at conferences where they would scoff at the triviality of studying how psychedelic drugs work in the brain. It is great, and it translates into more resources to do research, to ask more questions, and indeed, build that critical mass of evidence,” Carhart-Harris said.

“There’s a lot of this to be processed, nuances in relationships and new ways of thinking about mental health itself, as well as interventions for mental health. I do believe it’s very healthy. Having done a trial where we’ve gone head-to-head with conventional treatment for depression, that’s helped contextualize for me quite how different psychedelic therapy is to standard antidepressant medication, for example,” he continued.

Jelty believes that psychedelic research gave a voice to the patients as well.

“We’ve increased awareness of mental illness; it’s come out of the shadows. So, guess what, at a point, it was no longer stigmatizing and even talked about it. But beyond talking about it, they’re now demanding, they, sort of saying, ‘what you are giving us is not good enough’,” Jelty said.

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Mydecine Innovations Group Engages ethica CRO as Contract Research Organization Partner for Phase 2A PTSD Clinical Trials

Published at globenewswire.com.

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DENVER, Dec. 21, 2020 (GLOBE NEWSWIRE) — Mydecine Innovations Group (CSE: MYCO) (OTC: MYCOF) (“Mydecine” or the “Company”), an emerging biopharma and life sciences company committed to the research, development, and acceptance of alternative nature-sourced medicine for mainstream use, announced that it has engaged ethica CRO (“ethica CRO”), a full-service Contract Research Organization (“CRO”) that conducts and manages ethical clinical research on drugs, biologics, medical devices and more, as the contract research organization (“CRO”) for its upcoming Phase 2A PTSD clinical trials.

ethica CRO is a full-service, global CRO that provides drug development services to biopharmaceutical companies in clinical trials. ethica CRO provides a complete range of clinical study management and biometrics services for clinical research phases I through IV. Since its inception in 2002, ethica CRO has dedicated its efforts to bring a new dimension to the clinical research industry, the ethical dimension, focused on integrating research participants as partners in research rather than simply subjects of research. ethica CRO was the first CRO in the world to be accredited for its human research protection program in 2006 and is the only CRO in the world to have achieved accreditation from three different accrediting bodies

“We are excited to bring on a high-caliber partner in ethica CRO, which has extensive expertise in managing clinical studies to the highest standards of ethical and clinical practice, as the CRO for Mydecine’s upcoming Phase 2A PTSD clinical trials,” commented Josh Bartch, CEO of Mydecine Innovations Group. “Engaging ethica CRO is one of the key pieces of our preparations as we explore how the brain responds to psychedelics and develop a better understanding of the biological underpinnings created by the psychedelic experience. We maintain that their insight and unparalleled experience in trials of this nature provide the best opportunity to further drive Mydecine’s clinical development. We believe that with ethica CRO’s deep clinical experience, and through our achievements in trial preparation, we are optimally positioned for our upcoming Phase 2A PTSD clinical trials in Veterans in Canada and the United States.”

ethica CRO’s dedication to research participant protection made it a partner of choice for the Canadian Department of National Defence. ethica CRO has participated in a series of clinical development programs with the Canadian DND and various NATO allies, most notably synthetic cannabinoids in the treatment of PTSD, injectable antidotes to chemical weapons, and skin decontamination kits for neutralizing chemical warfare agents.

“Psychedelics and psychedelic-assisted therapies are rapidly proving to be some of the most exciting developments in mental health treatment in decades,” said Murray Jensen, Managing Director of ethica CRO. “Mydecine’s ambitious approach to researching and tackling the mental health challenges facing veterans and other frontline workers aligns with our values and mission at ethica and we are excited to hit the ground running with the Mydecine team as they push forward in their pursuit to transform mental health.”

Mydecine’s international Phase 2A clinical trials will focus on psilocybin-assisted psychotherapy to treat chronic PTSD in veterans and EMS personnel. The research will take place at Leiden University Medical Centre in the Netherlands; the University of Western Ontario; and the University of Alberta, with other clinical sites on the horizon in the USA, Europe, and Australia. Through these trials, Mydecine hopes to establish the safety and efficacy of psychedelic administered psychotherapy in a safe and supervised setting, utilizing strict protocols approved by research ethics boards and build upon the body of work that has led to psilocybin-assisted psychotherapy to receive “breakthrough” status by the FDA.

About Mydecine Innovations Group
Mydecine Innovations Group™ is an emerging biopharma and life sciences company dedicated to developing and commercializing innovative solutions for treating mental health challenges and enhancing wellbeing. The company’s world-renowned medical and scientific advisory board is advancing a robust R&D pipeline of psychedelic derived therapeutics, novel compounds, therapies, and controlled drug delivery systems. Mydecine has exclusive access to a full cGMP certified pharmaceutical manufacturing facility with the ability to import/export, extract, and analyze natural and synthetic psychedelic compounds with full government approval through Health Canada. Mydecine’s portfolio companies Mydecine Health Sciences™, Mindleap Health™, and NeuroPharm™ position the company at the forefront of disruptive modern medicine.

Learn more at: https://www.mydecine.com/ and follow us on Facebook, Twitter, and Instagram.

About ethica CRO Inc.
Founded in 2002, ethica CRO is a full-service contract research organization (CRO) that conducts all clinical phases of ethical research for new and innovative treatments on behalf of the pharmaceutical, biotechnology, medical device and natural health product industries. ethica CRO was the first Contract Research Organization (CRO) in the world to be accredited for its human research protection program in 2006 and is the only CRO in the world to have achieved accreditation from three different accrediting bodies. Human research protection program (HRPP) accreditation by an independent, industry-recognized organization confirms that an organization’s processes ensure the respect and protection of research participants, and that its services meet or exceed industry standards.

Learn more at: www.ethicaCRO.com and follow us on Twitter and LinkedIn.

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Psychedelics Industry Gearing Up For an Even Bigger 2021

Published at prnewswire.com.

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NEW YORK, Dec. 21, 2020 /PRNewswire/ — Investments continued flowing into the psychedelic medicine sector this year and will likely continue in 2021 as mental illness cases rise across the globe. The World Health Organization (WHO) estimates that 700 million cases of mental and neurological disorders are reported annually, accounting for 13% of global disease burden. Of course, these are only reported cases, so the number is likely much higher and will likely rise further due to the ongoing health crisis. Luckily, growing awareness around mental illness has led to a slew of research and development for effective novel treatments to help combat the growing mental health crisis. Psychedelic medicine for mental illness is one area that has gained the spotlight after Johnson & Johnson’s (NYSE: JNJ) severe depression drug was handed approval. Now, a number of psychedelic-focused companies like Mydecine Innovations Group Inc. (CSE: MYCO) (MYCOF), COMPASS Pathways Plc (NASDAQ: CMPS), Tonix Pharmaceuticals (NASDAQ: TNXP), and Numinus Wellness Inc. (NEO: NUMI) (TSXV: NUMI) (OTCPK: LKYSF) are joining the fight against mental illness with a variety of promising, psychedelic-based treatments.

Biopharma and life sciences company Mydecine Innovations Group is focused on developing and commercializing innovative solutions to treat mental health problems and enhance well being. Since the beginning of 2020, the company has hit several significant milestones to help progress its robust pipeline of psychedelic derived therapeutics, novel compounds, therapies, and controlled drug delivery systems.

Mydecine Innovations Edges Towards FDA Filing

Sentiments toward psychedelic-derived medicines have evolved significantly in the last couple of years, especially following the US Food and Drug Administration’s (FDA) approval of  Johnson & Johnson’s (NYSE:JNJ) Ketamine-like drug treatment for severe depression in March 2019. The FDA approved Spravato as a fast-acting treatment for patients with hard-to-treat depression and it became the first of several psychoactive substances moving through the US regulatory process. The administration has since granted Breakthrough Therapy Designation to two psychedelic treatments, paving the way for others to follow suit.

Mydecine Innovations Group just announced that it has partnered with ProPharma Group to proceed with the FDA filing and approval of its drug development platform and various stage clinical trials. ProPharma is the leading provider of regulatory and compliance services to the pharmaceutical, biotech, and medical device industries with “a strong track record of working with life sciences and biopharma companies to ensure full compliance with all FDA regulations, including all necessary steps for eventual global federal approvals.”

Earlier this month, Mydecine Innovations reached another exciting milestone by completing its first commercial harvest of 20 kilograms of psilocybin mushrooms at its research and cultivation facility in Jamaica. The company is now preparing to export the harvest to its Canadian cGMP Facility, which holds a Health Canada schedule 1 Dealer’s License, allowing for legal import.

Once Mydecine’s facility receives the psilocybin mushrooms, they will be extracted, refined, and turned into a cGMP product that can be used for controlled therapeutic purposes. The final product will be available for purchase by licensed institutions and companies conducting clinical research of these compounds to treat various health conditions like anxiety, addiction, depression, and PTSD. Portions of the harvest will also be kept for Mydecine’s proprietary genetic, pharmacology, and clinical research, including psilocybin-assisted psychotherapy to treat PTSD in veterans and frontline workers.

Another company looking to combat PTSD is Tonix Pharmaceuticals (NASDAQ:TNXP), although it isn’t using psychedelic compounds in its formulation like Mydecine. The company began studying TNX-601 (tianeptine oxalate) for the treatment of PTSD in September 2019. However, Tonix hit a speedbump in its Phase III RECOVERY study in February 2020 and decided to stop enrollment in the study following inadequate results. However, Tonix has since gone back to the drawing board and recently outlined a new statistical method to analyze future PTSD drug studies.

Growing Number of Psychedelic Companies Entering the Public Markets

The psychedelic drugs market is forecast to grow at a CAGR of 16.3% to reach $6.85 billion by 2027, fueled by the growing acceptance of psychedelic-derived meds to treat mental health coupled with the rising prevalence of mental disorders like depression and anxiety. Loosening legislation is also favoring the psychedelics market, leading to a growing number of psychedelic-focused pharma companies entering the public markets and bringing in investment dollars.

Integrated mental health company Numinus Wellness Inc. (NEO:NUMI) (TSXV:NUMI) (OTC:LKYSF) joined the TSX Venture Exchange in September 2020 after getting the green light from Health Canada to produce and extract psilocybin from mushrooms and closing an oversubscribed $4.6 million offering. In December, the company announced a $10 million bought deal offering, which was increased to $15 million two days later, and completed the first legal extraction of psilocybe mushrooms.

COMPASS Pathways Plc (NASDAQ:CMPS) also joined the public markets in September after closing an astounding $146.6 million initial public offering (IPO). The listing came nearly two years after the company was handed FDA Breakthrough Therapy designation for its psilocybin therapy for treatment-resistant depression. On November 12, Compass announced its Q3 results, highlighting the steady progress in its Phase IIb clinical trial of COMP360 psilocybin therapy for treatment-resistant depression and the opening of a new trial site in Berlin, Germany. The company also joined an international collaboration to accelerate drug discovery in mental health care.

Mydecine Innovations Group has also inked a partnership agreement this year with Applied Pharmaceutical Innovation to advance its research and development efforts for mental health care solutions. This partnership helps to put Mydecine ahead of the curve in this innovative market.

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2020: A Year In Review for the Psychedelic Renaissance

Published at Microdose.com.

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By Gaurav Dubey

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2020 has indeed brought forth unforeseen challenges into the world due to the global coronavirus pandemic. However, this year has also seen monumental victories for psychedelic medicine–a radical new hope for a brighter future. The current state of mental healthcare, which has been starkly exposed due to the pandemic, is seriously insufficient.There is a significant need for new and better mental health treatments now more than ever before.

Fortunately, between the groundbreaking clinical research into psychedelic medicine at leading universities and institutions and the incredible amount of capital flowing into the space, one thing is clear: psychedelics are making a massive comeback. Here are some of the major highlights and victories witnessed by the psychedelic renaissance in this otherwise challenging year.

psychedelic renaissance research development science
psychedelic renaissance research development science
psychedelic renaissance research development science

Groundbreaking Research Into Psychedelic Medicine Pushes Policy Reform Ahead

2020 Has Been A Really Big Year for Magic Mushrooms

Robust clinical research has been the backbone of the modern psychedelic renaissance, and 2020 certainly had its share of exciting developments here. Leading institutions such as Johns Hopkins, NYU and the Imperial College of London have conducted historic trials demonstrating the efficacy of drugs like psilocybin, the active ingredient in magic mushrooms, for end-of-life anxiety and severe treatment resistant depression.

Fascinating research by renowned scientists like Robin Carhart Harris utilizes fMRI technology to uncover the mysterious mechanisms in the brain that characterize the beneficial effects of psilocybin therapy. The below diagram by Carhart-Harris shows increased brain connectivity and communication while under the influence of magic mushrooms and has become a hallmark of psychedelic science in 2020.

this is your brain on mushrooms robin carhart harris psilocybin brain connectivity

Communication between brain networks in people given psilocybin (right) or a non-psychedelic compound (left).

The dynamic group at Mydecine, which includes Carhart-Harris and Dr. Rakesh Jetly, are also spearheading trials investigating psilocybin for PTSD in veterans. Their recent speaker series featured their all-star science team and explored many of these important topics.

Such trials have been so profound that earlier this year, Canada’s Health Minister Patty Hajdu, in response to Therapsil’s advocacy efforts, approved the first four Canadian’s for psilocybin assisted psychotherapy. This has since been expanded to include non-terminally ill Canadian patients–-a genuine testament of Hajdu’s dedication to progressive drug policy. Canada isn’t the only one embracing psychedelics, however.

The state of Oregon recently made history by legalizing psilocybin assisted psychotherapy and decriminalizing small amounts of all drugs. This is a huge move by Oregon that sets a strong precedent for other states in the US who also wish to embrace and reintegrate psychedelics into society.

psychedelic renaissance research development science

MAPS Successful Trials Mean MDMA Assisted Psychotherapy is on the Horizon

The Multidisciplinary Association of Psychedelic Studies, also known as MAPS, have spearheaded trials investigating MDMA-assisted psychotherapy for PTSD with remarkable success. After raising $30 million in non-profit donations for these trials, they are now currently in phase 3 trials and have paired with the team at Numinus to help bring the treatment to market. Their partnership with Numinus aims to expand upon the phase 3 trials going on in the US by conducting trials in Canada if they gain approval. MDMA has now received “breakthrough therapy” status by the FDA, allowing its trials to be expedited. In a time where traditional mental health treatments are failing, this is hugely significant. As this important data continues to pour out of the world’s top research institutions, drug policy is expected to continue to align with science and data.

psychedelic renaissance research development science

Great Minds Connected Despite Lockdowns to Share Big Ideas

While the lockdown may have kept us indoors, that didn’t stop the psychedelic community from virtually connecting and sharing big ideas. In fact, Microdose, in conjunction with The Conscious Fund, hosted the world’s largest virtual psychedelic conference in April, shortly after lockdowns began. The Microdose team carried this momentum into future events, including their monthly Psychedelic Capital conference series and their insightful molecular masterclasses, such as The Ketamine Conference and The Mushroom Conference.

By convening the most influential voices in the field of psychedelic medicine, Microdose helps foster communication and creativity in this emerging space. Event sponsors included major players in the space, including MagicMed Industries, Psygen, The Wake Network and many more.

Despite global lockdowns preventing live conferences, the psychedelic community took the internet by storm to share ideas and spark important conversations. Indeed, the public is becoming increasingly interested in the promise of these powerful medicines. Additionally, investor interest is at an all time high, with major financings and deals in the sector.

psychedelic renaissance research development science

Psychedelics Are Winning Big With Major Players Drawing Serious Investment Interest

Money tends to follow efficacy in biotech and pharmaceutical investing, and psychedelics have certainly exhibited incredible efficacy. Indeed, 2020 has witnessed several companies IPO, crazy stock surges and some major financings. In fact, in just the last week, psychedelic company MindMed upsized to an $80 million bought deal, MagicMed Industries closed an upsized $8.1 million dollar deal, and Tryp Therapeutics has launched their IPO and are now trading on the Canadian Stock Exchange (CSE: TRYP).

Billionaire Peter Thiel-backed psychedelic pioneers, Compass Pathways (NASDAQ: CMPS), were the first psychedelic company to debut on the NASDAQ this year. They are certainly leaders in the space and have helped establish a powerful precedent for psychedelic medicine. Additionally, their immense commitment to research is a powerful indicator of their teams success.

All signs certainly point towards a bright and lucrative future for psychedelic medicine and the companies leading the charge.

psychedelic renaissance research development science

Celebrating and Thanking the Forerunners of Psychedelic Medicine

2020 has seen an enormous amount of headlines, clinical breakthroughs, and financial successes within the psychedelic medicine field. Likewise, this year has seen a dramatic increase in event attendees, investor capital, and general indicators of mainstream curiosity. That being said, we ought to enter the new year in gratitude for those who positioned us to have these conversations. Thank you to Imperial College London, John Hopkins, NYU, Drug Science, and all the other organizations who fought this decade-plus uphill battle for us. Thank you Matthew W. Johnson, Rolland R. Griffiths, David Mokler, Robin Carhart Harris, and all the researchers dedicating their lives to understanding the gnosis of these compounds. Let’s end this year and begin the new one with an emphasis on the working class, corporate social responsibility, and evidence-based exploration of psychoactive drugs.

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16 healthcare professionals granted access to psilocybin

Canadian Government Agency Removes Barrier for Psilocybin Therapy

Health Canada removed a barrier for psilocybin research by allowing 16 health-care professionals to legally possess and consume psilocybin-containing mushrooms in clinical settings, the same exemptions previously given to more than a dozen terminally-ill patients. TheraPsil, a Victoria non-profit that aims to treat mental health issues with psilocybin, celebrates these exemptions, as they could lead to important new medical applications in the mental health sector.

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INN: Psychedelic Trends 2020: The Heat is On

2020 marked the beginning of the psychedelics investment story as the capital markets fully embraced the alternative drug sector.

The idea of investing in a psychedelic drug company may have sounded unlikely before 2020.

But now investors are enjoying the dawn of a new alternative drug market that is trying to capitalize on the medical benefits of psychedelic substances.

In 2020, investors saw the arrival of a number of new public companies that are exploring various pathways in the psychedelics space, primarily operating under the promise of new medicine.

It’s no exaggeration to say that 2020 served as the launching pad for psychedelics in the eyes of the capital markets. And that included us, as here at the Investing News Network (INN) we launched our own psychedelics-focused vertical.

Read on to get a sense of the psychedelics trends that are setting the stage for this promising new industry, with commentary from insiders and experts.

Psychedelics trends 2020: Markets get their bets ready as listings erupt

As mentioned, this year catapulted a fresh stock universe into existence as a variety of new companies went public across different exchanges.

While it wasn’t the first of the year, the listing of Compass Pathways (NASDAQ:CMPS) was one of the biggest landmark events for the industry in 2020. The company was the first psychedelics operation to list directly on the NASDAQ, opening the door for others to follow.

“It’s shown to the world what insiders have known for a long time — that this vision of bringing psychedelic medicine to the world isn’t a pipe dream, it’s very real and it’s happening now,” Michael Hoyos, co-founding partner, Americas, with the Conscious Fund, previously told INN.

Fellow companies also celebrated Compass Pathways’ debut as the arrival of a new era.

“Compass’ successful IPO is further evidence that psychedelics are gaining traction as a viable solution for treating mental health and addiction,” JR Rahn, co-founder and co-CEO of Mind Medicine (MindMed) (NEO:MMED,OTCQB:MMEDF), said.

During an online talk in the leadup to the Compass Pathways listing, Bill Stern, managing partner at Venture Group Capital, said the listing looked set to “change the industry dramatically.”

Dugan Selkirk, media relations manager for Vancouver-based private firm Universal Ibogaine, was not elusive about the significance of the NASDAQ listing. “The top blew off with Compass Pathways’ mega IPO in the US markets, which has put the wind back into the sails of the industry, and we see this pattern continuing with momentum into 2021.”

Jos Schmitt, president and CEO of the NEO Exchange, told INN he believes investors have to get over any stigma surrounding these substances, because he believes the opportunity is too great to pass up.

Back in March, when MindMed went public, the NEO saw Canada’s first official listing of a company operating in the psychedelics space.

A fellow securities executive previously told INN he was unsure when he first heard about the psychedelics investment shot. “I will admit, I was a bit skeptical at first,” said Richard Carleton, CEO of the Canadian Securities Exchange (CSE).

Carleton changed his mind after seeing the research that has been conducted and meeting with companies directly to discuss the sector.

The CSE is now the capital markets home of nearly 30 listings related to the psychedelics industry.

Psychedelics trends 2020: Pandemic highlights need for mental health alternatives

Florian Brand, co-founder and CEO of privately held ATAI Life Sciences, told INN he came into 2020 expecting a natural progression of the interest in therapies using psychedelics. But instead the executive found a significant jump in attention, thanks in large part to the focus on mental health created by the effects of a global pandemic.

Brand said the uncertainty surrounding COVID-19 has “precipitated an increased focus on mental health and the failures of our current standards of care.”

Doug Drysdale, CEO of Cybin (NEO:CYBN), echoed Brand’s sentiment, saying he believes the pandemic accelerated the acceptance of using alternative methods to treat mental health issues.

“We are seeing a paradigm shift in the public view and complacency for the norm of Big Pharma traditional, (and) in many cases dangerous and non-effective, treatments,” Josh Bartch, CEO of Mydecine Innovations Group (CSE:MYCO), told INN.

Psychedelics trends 2020: Executives ask for patience in face of growing buzz

As the psychedelics industry first started to develop, it became clear that one of the most direct points of comparison would be with the cannabis industry.

“Had cannabis not come along, it probably would have been a longer road to be having some of these conversations,” Ronan Levy, co-founder and executive chairman of Field Trip Health (CSE:FTRP), previously told INN.

To a degree it’s understandable, as both are alternative drug markets exploring new uses in the face of strict regulations. But some members of the psychedelics industry have been quick to deter investors from believing psychedelics will see similar hype runs to those experienced in the cannabis industry.

This leaves the question of if investors should play the market or get ready for long-term bets only.

Payton Nyquvest, chairman and CEO of Numinus Wellness (TSXV:NUMI), previously told INN that anyone entering this space has to understand the long-term roadmap ahead. “There’s no quick pathway to be able to do this,” he said.

Brand said it’s the responsibility of psychedelics companies to fully research these compounds and learn their entire medical benefits, as well as the potential risks attached.

“Viewing psychedelics as a panacea is alluring, but in reality there’s risks we still need to quantify,” said Brand of ATAI Life Sciences. “It’s incumbent on us and others in the space to build out the data and support for safe and accessible treatment, and not let excitement get ahead of the hard work to build a sustainable, impactful industry.”

Drysdale told INN that in his view the most challenging aspect for the psychedelics market in 2020 was the pressure to gain credibility and attention due to the rush of companies going public.

“Psychedelics are leading with science, creating massive intellectual property (IP) opportunities, and both of these things rely on regulation holding the industry to standards and pace,” Kelsey Ramsden, president and CEO Mind Cure Health (CSE:MCUR,OTCQB:MCURF), told INN. “As a company who is in high-growth mode with fast-moving IP projects, being patient can be challenging.”

That sentiment of longevity for investments was echoed by Carleton, who said he sees the psychedelics market as a “pharma play.”

Hoyos told INN the industry needs to be careful to not repeat the mistakes made in the cannabis space, which led to a large part of the sector wanting to make a quick buck compared to growing steadily.

“For investing in the space, I think the full value will be realized in the longer term, but there will be opportunities for exit liquidity events a lot sooner,” Hoyos added.

Psychedelics trends 2020: Studies set path for changing perspectives

One of the biggest factors helping psychedelics is the launch and continuation of medical studies evaluating particular drug treatments based on psychedelics and boosting the legitimacy of the industry.

Timothy Ko, CEO at Entheon Biomedical (CSE:ENBI), told INN that 2020 will be remembered as a year in which the psychedelics industry established itself and came into the spotlight thanks to the work of those “who have historically utilized, researched and spoken for the value of psychedelic compounds.”

Investors will need to keep an eye on the development of several studies moving forward, as these will offer the most concrete answers on whose drugs are worth betting on. These studies, particularly those to obtain approval from the US Food and Drug Administration, are extremely lengthy and costly events for the companies in play.

“I think the challenge and gift of regulation resting in the balance of scientific proof is what will both make this a stable and rapidly growing investment sector,” Ramsden said.

Thanks to recognition from medical authorities, more investors are starting to look into what’s at stake with psychedelics.

Psychedelics trends 2020: Investor takeaway

The psychedelics industry found its groove in 2020 and discovered investors ready to listen and get involved. This growth in attention may be partially due to the effects of lockdowns and the uncertainty caused by COVID-19, but it is also backed by the medical research being conducted.

In 2020, investors discovered the enthusiasm for psychedelics goes well beyond college dorm rooms.

Don’t forget to follow us @INN_LifeScience for real-time news updates!

Securities Disclosure: I, Bryan Mc Govern, hold no direct investment interest in any company mentioned in this article.

Editorial Disclosure: Cybin, Mind Cure Health, Numinus Wellness and Universal Ibogaine are clients of the Investing News Network. This article is not paid-for content.

The Investing News Network does not guarantee the accuracy or thoroughness of the information reported in the interviews it conducts. The opinions expressed in these interviews do not reflect the opinions of the Investing News Network and do not constitute investment advice. All readers are encouraged to perform their own due diligence.

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Push for Alternative Therapies Prods Researchers Towards Psilocybin

‍FinancialBuzz.com News Commentary

NEW YORK, Dec. 15, 2020 /PRNewswire/ — The psychedelics market is currently navigating a similar legal situation to the one the cannabis market found itself in for many years. Psychedelics are not legal for recreational use in Canada or the United States, yet medical research on the efficiency of such products may help reduce some of the stigma around them. In fact, some major developments have already begun to change the landscape for the better in this market. For example, earlier in 2019, the state of Colorado became the first state to decriminalize Magic Mushrooms (mushrooms containing psilocybin), taking the substance on a similar path to legalization as that of cannabis. Then, in November 2019, the FDA awarded the second Breakthrough Therapy designation to non-profit Usona Institute, which is studying the effects of psilocybin as an anti-depressant. Currently, despite the obstacles imposed by the legal status for such products, the psychedelic drugs market is expected to expand with a CAGR of 16.3%, reaching USD 6,859.95 Million by 2027, according to Data Bridge Market Research. Mydecine Innovations Group Inc. (OTC: MYCOF) (CSE: MYCO), Havn Life Sciences Inc. (OTC: HAVLF), Revive Therapeutics Ltd. (OTC: RVVTF), Mind Medicine (MindMed) Inc. (OTC: MMEDF), Hollister Biosciences Inc. (OTC: HSTRF)

In recent years, there has been a significant flow of new information describing the effects of psychedelic compounds on the brain. For instance, Proceedings of the National Academy of Sciences published data that helped explain that, under the influence of psilocybin, one of such active compounds often found in various types of mushrooms, the brain creates a feedback loop of neuron activity and neurotransmitter release (the chemical messengers that neurons use to communicate). According to the study, this provides an understanding of why psilocybin is showing considerable promise as a therapeutic intervention for neuropsychiatric disorders including depression, anxiety, and addiction. “Using this model will be crucial for truly understanding how psilocybin can rebalance neuropsychiatric disorders such as treatment-resistant depression and addiction,” Morten Kringlebach, the study’s first author and a senior research fellow at the University of Oxford, explained according to Inverse.

Mydecine Innovations Group Inc. (OTC: MYCOF) (CSE: MYCO) announced last week, “that it has completed its first commercial harvest of 20 kilograms of psilocybin mushrooms at its research and cultivation facility in Jamaica. The Company is now preparing to export the harvest to its Canadian cGMP Facility which has a Health Canada schedule 1 Dealer’s License attached to it, allowing for legal import.

‘We are pleased to announce the completion of our first commercial harvest of natural psilocybin mushrooms,’ said Joshua Bartch, CEO and Chairman of Mydecine. ‘There is more research needed on these compounds in order to better understand the entourage effect experienced by patients which has shown dramatically effective results compared to single-molecule synthetic psilocybin in preliminary studies. As the industry grows, the need for naturally occurring psilocybin and access to large quantities of these molecules will be paramount and we are excited to be the first to advance this movement at scale.’

Once received by the Company’s facility in Canada, the psilocybin mushrooms will be extracted, purified, and turned into a cGMP final product for controlled therapeutic purposes. Mydecine’s final product be made available for purchase by other licensed institutions and companies conducting clinical research into the efficacy of these compounds to treat various health conditions including anxiety, addiction, depression and PTSD. Portions of the harvest will also be used for Mydecine’s proprietary genetic, pharmacology, and clinical research. The clinical use will be for the studies and developing protocols of psilocybin-assisted psychotherapy to treat PTSD in veterans and other frontline workers.”

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Mydecine Innovations Group Engages the ProPharma Group to Proceed with FDA Filings and Approval for Novel Research and Multiple Phase Clinical Trials

Published at YahooFinance.com

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DENVER, Dec. 15, 2020 (GLOBE NEWSWIRE) — Mydecine Innovations Group (CSE: MYCO) (OTC: MYCOF) (“Mydecine” or the “Company”), an emerging biopharma and life sciences company committed to the research, development, and acceptance of alternative nature-sourced therapeutic medicine for mainstream use, announced that it has partnered with ProPharma Group, the leading provider of regulatory and compliance services to the pharmaceutical, biotech, and medical device industries. As part of the agreement, ProPharma Group will provide regulatory advisement as the company seeks approval from the Food and Drug Administration (FDA) for its drug development platform as well as the Company’s various stage clinical trials.

“ProPharma Group is a globally recognized firm with a strong track record of working with life sciences and biopharma companies to ensure full compliance with all FDA regulations, including all necessary steps for eventual global federal approvals,” said Josh Bartch, CEO and Co-Founder of Mydecine. “Mydecine currently has a jam-packed clinical trial calendar with plans to expand it to include additional various phase trials throughout the globe. Additionally, Mydecine has built a strong IP position in the psychedelics space. As we build upon our drug development platform, ProPharma Group will be a key partner for us as we explore the most efficient regulatory pathway in our mission to bring innovative treatments to the forefront for people suffering from mental health issues like PTSD and addiction.”

For more than 35 years, ProPharma Group has played an instrumental role helping its clients advance viable and efficient drug development pathways and solutions utilizing its scientific and regulatory acumen as well as its expertise in FDA, regulatory, quality and compliance, and company-related matters. With decades of experience and a positive working relationship with the FDA, ProPharma Group will serve as a key partner as Mydecine moves its drug pipeline and clinical research trials forward in an effort to increase compatibility and safety of psychedelics for therapeutic use.

“ProPharma Group has long held the leading position in working with our clients to develop strategies and supply them with viable and efficient drug development pathways and compliance solutions,” said Matthew Weinberg, Global VP for Regulatory Affairs, ProPharma Group. “Mydecine has shown a solid execution track record and is well positioned to lead in the development of the international psychedelics industry as regulations evolve. We look forward to working with the Mydecine team as they seek FDA approval for their clinical trials and drug development pipeline.”

About Mydecine Innovations Group
Mydecine Innovations Group™ is a life sciences company dedicated to developing and commercializing innovative solutions for treating mental health problems and enhancing wellbeing. The company’s world-renowned medical and scientific advisory board is progressing a robust R&D pipeline of psychedelic derived therapeutics, novel compounds, therapies, and controlled drug delivery systems. Mydecine has exclusive access to a full cGMP certified pharmaceutical manufacturing facility with the ability to import/export, extract, and analyze natural and synthetic psychedelic compounds with full government approval through Health Canada.

Learn more at: https://www.mydecine.com/ and follow us on Facebook, Twitter, and Instagram.

About ProPharma Group
ProPharma Group is the only truly global, independent, single-source provider of regulatory, compliance, pharmacovigilance, and medical information services serving pharmaceutical, biotechnology, and medical device firms. Our team of experts brings a comprehensive portfolio of regulatory and compliance solutions to help solve complex challenges in a dynamic regulatory environment. With our mission to improve the health and safety of patients, we are focused on delivering the highest quality of services throughout the full product lifecycle.

Learn more at https://www.propharmagroup.com

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The Canadian Securities Exchange has neither approved nor disapproved the contents of this news release and accepts no responsibility for the adequacy or accuracy hereof. This news release contains forward-looking statements, which relate to future events or future performance and reflect management’s current expectations and assumptions. Such forward-looking statements reflect management’s current beliefs and are based on assumptions made by and information currently available to the Company. Readers are cautioned that these forward-looking statements are neither promises nor guarantees, and are subject to risks and uncertainties that may cause future results to differ materially from those expected including, without limitation, the availability and continuity of financing, the ability of the Company to adequately protect and enforce its intellectual property, the Company’s ability to bring its products to commercial production, continued growth of the global adaptive pathway medicine, natural health products and digital health industries, and the risks presented by the highly regulated and competitive market concerning the development, production, sale and use of the Company’s products. Although the Company has attempted to identify important factors that could cause actual results to differ materially from those contained in forward-looking information, there may be other factors that cause results not to be as anticipated, estimated or intended. There can be no assurance that such information will prove to be accurate, as actual results and future events could differ materially from those anticipated in such information. These forward-looking statements are made as of the date hereof and the Company does not assume any obligation to update or revise them to reflect new events or circumstances save as required under applicable securities legislation. This news release does not constitute an offer to sell securities and the Company is not soliciting an offer to buy securities in any jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of such jurisdiction. This news release does not constitute an offer of securities for sale in the United States. These securities have not and will not be registered under United States Securities Act of 1933, as amended, or any state securities laws and may not be offered or sold in the United States or to a U.S. Person unless so registered, or an exemption from registration is relied upon.