Navigating the Psychedelic Landscape: Q3 Psychedelic Industry Report

Q3 Review and Highlights

This past quarter has been, without a doubt, the busiest and most transformative three months of this year— perhaps even of the entire history of the psychedelic industry. 

Of all the major developments, the release of the MAPP2 phase III clinical trial results was the biggest. The founder and president of MAPS is like the father of the modern psychedelic industry. Most companies in this space have only been around for about 3-5 years. However, Rick Doblin started MAPS 38 years ago. 

The culture of passion for psychedelics fizzled out and dove underground once they were made illegal. But, Doblin never stopped fighting to bring these compounds back into the mainstream. In a recent interview, Numinus CEO Payton Nyquvest said: “We’re all here because of MAPS.” He is right— the entire legal psychedelic market is following a path that is currently being forged by Rick Doblin and the work he is doing through the non-profit which he gave life to. 

So much hangs on the ability of this one man to design the path forward. If successful, Doblin and his team will be the first ever to get a psychedelic drug FDA-approved, and they will pave the way for other companies to do the same. And, most importantly, It will pave the way for clinics to bring novel treatments to people in need.

While there is a significant amount of research, business dealings, and growth in the industry, ultimately, everyone is waiting to see if a psychedelic drug can make it all the way to FDA approval. There is a lot depending on this. Millions of dollars have already been invested into programs that follow this path that Doblin is still yet to complete. It is, however, reaching the end of the road. 

The industry continues to work tirelessly to build services and products that will support the medicalization of psychedelics. Biotech companies are pushing their own psychedelic drugs through the FDA process. Clinic and education companies are preparing to support the rollout of these therapies. Media companies are perpetuating a shift in public perception of these once ostracized compounds. Novel data and technology platforms are being developed to support the growth of the industry. And, investors are pumping money into all of these spaces to ensure that the psychedelic industry has the foundation that it needs to reach its full potential. We are excited to offer you a complete picture of the growth of all of these areas of the industry in our 3rd quarter report.

Regardless of the MAPS news, this was a huge quarter for the industry. Big Pharma company Otsuka acquired psychedelic biotech company Mindset Pharma. This was the biggest acquisition in the psychedelic industry to date. However, it was not the only one this quarter. There was a lot of M&A action this quarter. These business transactions start to offer a more focused picture of how the psychedelic industry is beginning to come together.

This was also a major time for psychedelic policy. There was a lot of news regarding new psychedelic legislation on both a state and federal level these past few months, and it has made one thing clear— psychedelics is a bipartisan issue. Several of the politicians pioneering these efforts to increase psychedelic access hail from the republican party. Rick Perry and Dan Crenshaw have been major proponents of increasing psychedelic access for Veterans struggling with PTSD.

This overview only touches the tip of the iceberg when it comes to the news and events of the psychedelic industry these past three months. Quite frankly, this quarter has been enough to make anyone’s head spin. Keeping up with the developments of this industry that is moving so quickly can be a challenge. That is why we have put together this report. Our report covers everything you need to know from Q3 to ensure a full understanding of the state of the industry. Whether you are an investor, therapist, politician, scientist, or any other position within the psychedelic space, this report is designed to give you a full understanding of this complex industry. 

Q3 Highlights

Psychedelic Science

There have been many developments in the field of psychedelic science this quarter. Private companies and institutional research centers continue to make key advances in the Western understanding of psychedelic compounds and how they affect individuals and society at large. 

The third quarter of 2023 brought with it more significant data than the first two quarters of the year combined. These studies, surveys, and reviews offer insights into how psychedelics affect the body and mind, what patients and health professionals think about psychedelics, and what the future of psychedelic treatment might look like. 

We’ve highlighted all of the significant studies, with detailed summaries of the most important ones. In this section of the report, you will also find information about clinical trials that have made progress this quarter, including ones that gained FDA approval to begin or had significant milestones announced. 

Surveys

Several significant surveys came out this quarter that provided us valuable insights into public perception of psychedelics. They give us a complete picture of how preconceptions of psychedelics are changing over time, how much of the US public actually supports psychedelics, who is using them, and in what capacity they support legal reform. 

First up is UC Berkeley’s Psychedelic Survey. The University’s Center for Psychedelic Science conducted a comprehensive survey representing US voters and their views of psychedelics. It offers some interesting insights not only into what percentage of voters support psychedelic reform, but how they view psychedelics in relation to themselves and society.

Here are a few of the key data points from the survey:

The results show that beliefs about psychedelics have changed drastically since President Reagan waged war against them. However, a large percentage of people who support regulated, therapeutic use are still wary about the effects that they could have on society. This suggests that the FDA route to increasing access to psychedelics will likely be more popular in much of the US— as opposed to the more lax regulatory structure that places like Oregon and Colorado have taken. You can check out a full analysis of the survey here.

Next up is a Survey done by another prominent institutional player in psychedelic science— Johns Hopkins. The survey looked at the effects of psilocybin on long-term mental health and overall well-being. They surveyed 2,833 people who took high doses of psilocybin. 

“Prospective longitudinal data collected before and after a planned psilocybin experience on average showed persisting reductions in anxiety, depression, and alcohol misuse, increased cognitive flexibility, emotion regulation, spiritual wellbeing, and extraversion, and reduced neuroticism and burnout after psilocybin use.” 

There were some limitations to the survey. For example, most participants were white males, limiting the data to only one segment of the population. Nevertheless, the data showed that consuming psilocybin has positive effects on a large majority of people and that results are long-lasting. 

Another survey suggests that psychedelics could be beneficial for chronic pain, in addition to overall wellness. Chronic pain reportedly affects 20% of the population, and psychedelics could be a new solution. CEO of Numninus, Payton Nyquevest, has been vocal about his own journey treating chronic pain with psychedelics. Additionally, psychedelic biotech company MindMed is also exploring LSD as a drug treatment for this issue. So, it is clear that a growing percentage of the population is using psychedelics, and that they have positive effects. However, are people talking to their doctors about it?

A Canadian survey showed that while an increasing number of people are taking psychedelics, many of them are not talking to their health professionals about it. Over 80% of those surveyed who had taken psychedelics had never spoken to their doctor about it.

One of the major goals of the industry right now, especially educational companies/ non-profits, is to promote harm reduction and integration practices. This is difficult to do when people aren’t even talking to their doctors about their use of psychedelics. However, it is also worth pointing out that a large percentage of therapists and doctors do not feel prepared to support their patients with these experiences.

Addressing this issue requires a two-pronged approach— educating healthcare professionals in psychedelic harm reduction and encouraging patients to seek support for their psychedelic experiences. That doesn’t necessarily mean heading to a clinic for a mushroom trip. The same survey found that only 4.4% of the 2300 survey participants were in the presence of a therapist during their trip. People are likely going to continue heading out into the woods with some friends to take mushrooms, but therapists and doctors should be available to help their patients mitigate risk and increase the benefits through proper preparation and integration. 

Research

There have been a handful of study results this quarter that have offered unique insights into the developing field of psychedelic science. These types of studies are often, but not always, done by non-profit and institutional research organizations because they will not necessarily lead to direct income in the future. Several of the studies highlighted below were done by the top research programs in the industry, including Usona Institute and Johns Hopkins. There are also a number of interesting studies that were done by major for-profit companies such as COMPASS Pathways. Here are the top studies this quarter.

Clinical Trials

Top Trial Results

There were a lot of clinical trial results this quarter that will have major implications for the long-term trajectory of the industry. Here is what you need to know about clinical trials this quarter.

MAPP2

This quarter’s biggest clinical trial news was, of course, the readout of the MAPP2 results. As we’ve already mentioned in the introduction and Q3 highlights, MAPS released the results of its second Phase 3 trial testing MDMA-assisted therapy for the treatment of PTSD. The results were similar to the first study. This means that MAPS can now submit a new drug application to the FDA, and is expecting approval in the first half of 2024.

The randomized, double-blind, placebo-controlled study gave 104 PTSD patients three doses of MDMA, over a three-month period. The treatment was accompanied by extensive preparation and integration therapy support. After completing the treatment program, 71.2% of participants no longer met the criteria for diagnosis of PTSD. That statistic alone is why so many people are confident that this drug will gain FDA approval.

A follow-up of MAPS’s first phase III trial also showed that results are sustained long-term, which would make this treatment the only of its kind available for treating PTSD. All signs point to an FDA approval sometime next year. 

This clinical trial got the most attention of any and all psychedelic research this quarter, but it certainly isn’t the only major study.

COMPASS Pathways

COMPASS Pathways offered the industry some interesting results from two of its clinical trials of its signature synthetic psilocybin drug— COMP360. The first one that we will cover has major implications for the future of medicalized psychedelic-assisted therapy. 

In July, the company released results from a phase II trial testing COMP360 in tandem with antidepressants. There has always been speculation on whether psychedelic compounds are safe to consume while taking Selective Serotonin Reuptake Inhibitors. Until now, studies testing the efficacy of psychedelics have required patients to quit taking their SSRIs before treatment. However, there was no empirical data to confirm how they interact.

According to the results of this study, it is perfectly safe to undergo psilocybin treatment while taking SSRIs. In addition to that, the results suggest that it may even be more beneficial— compared to requiring that patients first stop taking their medication. The sample pool was limited, and more comprehensive studies are needed. However, this data is a step in the right direction to better understand the interaction between psychedelic compounds and SSRIs.

COMPASS also released results from an initial study testing the efficacy of COMP360 in treating anorexia nervosa. This addresses a major need. 9% of people in the US will suffer from an eating disorder in their lifetime, resulting in over 10 thousand deaths per year. There are currently no pharmaceutical treatment options for this disorder, giving Compass a massive market potential for this treatment. Like the SSRI study, this area of research requires more studies to confirm the efficacy of treating eating disorders with psychedelics, but the initial results are promising. 

Small Pharma

Small Pharma reported positive results from a Phase 2a study testing its DMT drug, SPL026, alongside SSRIs. This study offers similar results to the Compass Pathways’ study looking at the interaction between SSRIs and psilocybin. Using these drugs together appears to be perfectly safe. Initial results also suggest that it may be beneficial to use the two treatments simultaneously. However, results are preliminary, and more research is needed to assess the best treatment options for people struggling with Major Depressive Disorder. 

Here are some more clinical trial results that we saw this quarter from psychedelic biotech companies:

Significant Trial Milestones

While several clinical trials have released positive results this quarter, even more have reached significant milestones. The progress of these trials signifies strong potential for psychedelics in the global drug market. It also gives a clearer picture of which companies are likely to be the first to bring these drugs to market.

Awakn Life Sciences garnered attention recently for the progress they have made in clinical trials for its ketamine drug in the treatment of Alcohol Use Disorder. The company submitted an application for a phase III trial, making it part of a small group of companies that have been able to push a psychedelic drug that far in the clinical trial process. This drug has significant market potential treating an issue with major health implications that has few viable solutions. 

This is one of the top psychedelic clinical trials to keep an eye on. Though, there are a few others that reached significant milestones this quarter and offer an interesting addition to the psychedelic space. Here are the pipeline developments from the top Psychedelic companies this quarter:

Regulations and Politics

United States

There was a lot of progress in psychedelic regulation in the US this past quarter— at both a federal and state level. In Congress, Representatives Dan Crenshaw and Alexandria Ocasio-Cortez spent a good chunk of this year fighting for increased funding and access to psychedelics for Veterans, and they were ultimately successful. The approved defense budget for the upcoming fiscal year will include $15 million for psychedelic research, and veterans will be given priority for clinical trials that could help them deal with PTSD.

The Vision Act was also introduced in Congress recently, and it may provide some relief for psychedelic businesses operating within their state’s legal framework. This piece of legislation addresses an issue that is unique to psychedelics and cannabis. Both of these classes of drugs are federally illegal but have become legal in several states. Businesses are able to operate without fear of state prosecution, but federal intervention remains a threat. Additionally, companies working with federally illegal drugs have trouble accessing banking services. 

If passed, the Vision Act would prohibit federal funds from being used to prosecute psilocybin use in legal jurisdictions, such as Oregon and Colorado. This would be a major win for companies operating legally within their state, but still fearing the possibility of federal persecution.

States

While legislative changes for psychedelics move monumentally slow at a federal level, states are currently running with the torch. As you probably know, two US states have already decriminalized several psychedelic compounds and legalized the therapeutic use of psilocybin. 

Additional states, including California and Massachusetts, have made moves to follow in the footsteps of Oregon and Colorado. While some states are taking the decriminalization route, others are focused on increasing access to psychedelics through the medicalized route of FDA approval. No matter the pathway, there is no doubt that psychedelic regulation reform is sweeping the nation at unprecedented rates. Let’s take a look at the states that have made major moves to legalize psychedelics during these past three months. 

California

California had a lot going on this quarter in regard to psychedelic reform. There were two major initiatives underway working to provide psychedelic treatment to those struggling with mental health conditions— SB58 and TREAT California

SB58 spent the entire three months slowly making it through the California legislature process. The bill would have decriminalized several natural psychedelic compounds, including psilocybin, mescaline, and DMT. 

The bill eventually made it to the California Assembly floor, where it passed in September. The State Senate then approved the bill a day later and it was sent to Governor Newsom’s desk, where it sat for nearly a month before it was vetoed. Less than a week before Newsom killed the bill, he signed a minor psychedelic bill that allows doctors to begin prescribing any Schedule 1 drug as soon as the federal government reschedules it. There is speculation that he was attempting to appease the large percentage of California voters who support the decriminalization of psychedelics without jeopardizing a potential presidential bid. 

When he vetoed the bill, he informed the state legislature that he would be open to a new version of the bill that established a medicalized framework for psychedelic use. So, it appears that medicalization is the route the Golden State will be taking to psychedelic access. This is a pathway to legalization that tends to be favored by more conservative states, such as Kentucky. Though it will provide access to psychedelics, it takes far longer than immediate decriminalization or legalization because it puts the drugs through the FDA approval process, which takes years to complete.  This is the route that TREAT California is targeting as well. 

TREAT California is a citizen-driven ballot initiative that would allocate $5 billion dollars to building out psychedelic infrastructure in California. It would help increase access to psychedelics by providing funding to private clinical trials pushing the drugs through the FDA approval process. This would not just provide novel treatments to Californians. By getting psychedelics FDA-approved, the drug would be available to anyone in the US through a medical provider. However, TREAT California takes things a bit further for California.

The initiative would use funds to set up an entire infrastructure for the psychedelic industry in California— including clinics, education, and equal access funds. Unlike SB58, this initiative will be put to voters to decide. Given the significant voter support for SB58, it will likely pass. Though its medical nature may have gotten it approved if it had landed on Newsom’s desk anyway. The initiative is currently in the process of gathering signatures to make it onto the 2024 ballot. Organizers need to collect 874,641 signatures by June 27, 2024. 

This quarter has been a rollercoaster for California, and the developments of the state’s psychedelic initiatives have been plastered across national headlines on a weekly basis. Given that California has generally led the fight for drug reform, it was assumed that things would be the same with psychedelics. That has yet to be the case, though that very well may change in 2024. For now, California psychedelic treatment remains illegal in the Golden State. 

Oregon

Oregon passed its psilocybin measure back in 2020, and the program officially went into play on the first of this year. It took about six months for businesses and therapists to become licensed and set up shop. So, it wasn’t until this quarter, that psilocybin centers officially started servicing patients. 

There is a significant shortage in psilocybin services, which was expected. Demand is high, but there is a small number of clinics and therapists that are able to provide psilocybin treatment legally. It is expensive and time-consuming for businesses to operate in this framework, which is why so few are doing it. There are currently thousands of people on the waiting lists for the few psilocybin service centers that do exist. Additionally, treatment comes at a high cost, making it difficult for people to access psilocybin therapy through legal channels.

Massachusetts

Massachusetts is currently looking at having a psychedelic decriminalization and legalization bill on the ballot in the November 2024 election. The New Approach Pac is pioneering this effort. This organization also put millions into the campaigns to decriminalize psychedelics in Colorado and Oregon. The initiative will decriminalize the possession and cultivation of several natural psychedelics. It would also create a service center program for psilocybin treatment. 

Michigan

Michigan already had several states where psychedelics are decriminalized, and now the state is looking to take it further. A Michigan lawmaker recently introduced a bill to legalize several psychedelic compounds state-wide, under the condition that use and possession does not include a monetary exchange. 

Kentucky

Kentucky has been the source of attention as its Opioid Abatement Committee discusses the possibility of allocating $40 million to developing Ibogaine as a medical drug treatment for opioid use disorder. The committee has held two hearings this quarter, where the members heard from doctors, scientists, and former opioid addicts who kicked their addiction and got their lives back with the help of this psychedelic drug. 

If the funding is approved, the state would work with a private company to push ibogaine through the FDA-approval process. Additionally, funding would be made available to help low-income communities access the treatment.

Canada

Canada has not had too much movement toward legalizing psychedelics this quarter, or this year for that matter. However, the illegal market is booming. Our sources in Canada told Psychedelic Invest that psychedelic dispensaries are continuing to pop up all across the country. Over here in the US, the media has made it seem like Canadian law enforcement has been taking a stance against these dispensaries, but that has not been the case. 

Nearly every week this quarter, there has been news about psychedelic dispensaries being raided, with its workers often facing serious drug trafficking charges. However, these raids are only a small piece of the whole picture. While a number of these businesses have run into trouble, tons of them are still operating across the country, providing patrons with a wide range of psychedelic products. 

On the legal side of things, Apex Labs scored a big win with the Special Access Program. The company will be providing its psilocybin drug to a veteran with Health Canada approval. Historically, this route to psychedelic treatment has only been available to people with end-of-life conditions, such as terminal cancer. This is the first time that anyone has gained legal access to psilocybin for Treatment-Resistant Depression as a symptom of PTSD.

This approval leaves way for more indications to be approved through the program in the future. This is particularly significant given recent developments in the country’s MAID program. MAID stands for Medical Assistance in Dying. It was originally designed for people suffering from terminal conditions, similar to the Special Access Program for psilocybin access. Recently, the program has been expanded to include people with mental health conditions— making it easier to access medically assisted suicide than it is to access psychedelics to improve quality of life. 

Events & Media

After the Psychedelic Science Conference last quarter, all events seem minuscule in comparison. Though no events were quite as big, there continues to be a growing number of psychedelic events around the world. The annual Entheofest in Ann Arbor, Michigan, drew significant attention this quarter, and other events like it have been happening across the world.

As for media, things haven’t been quite as uneventful this quarter. Search traffic for psychedelic topics is down significantly. As outlined in our recent Q3 Psychedelic Search Trend and Traffic Analysis, traffic took a steep dive at the beginning of the quarter and has yet to make a comeback. 

Business

Capital

Despite less-than-optimal market conditions, companies in the psychedelic space have continued to secure capital through public offerings, private funding, and loans. Compass Pathways and MindMed have been particularly successful in raising capital this quarter. Compass announced two private placements this quarter— for a total of $335 Million. This money will get the company well on its way to the commercialization of its psilocybin drug for treatment-resistant depression. MindMed was able to secure $50 Million. Although significantly lower than Compass, this is a significant amount of capital compared to what most companies in the industry were able to obtain.

Companies Raising Capital

Stocks 

It hasn’t been a great year for psychedelic stocks, or the stock market in general. This quarter was no different. The Psychedelic Index saw some major fluctuations. The Index is down 10.25% year-to-date. In July, it jumped to its highest point all year but has since dropped significantly, nearly reaching the lowest point of the year. 

Historically, September is a low point for the stock market. So, it is not surprising that we saw such a drastic drop in the Index during the final month of the quarter, even with the MAPP2 readout. Several financial experts in the industry predicted that psychedelic stocks would take a turn for the better once MAPS released its long-awaited study results. Although the results were positive and media coverage of it was extensive, stocks did not rise. The index has continued to drop since this mid-September announcement. It is reasonable to assume that is due to the September slump. However, we’ll have to wait and see if things turn around in the last three months of the year. 

Despite difficult market conditions, this quarter has seen a high number of public offerings and uplistings of psychedelic companies. Check out some of the highlights:

M&A

This was a huge quarter for mergers and acquisitions. While some companies are struggling, those in a strong position are using the situation to bolster their position in the industry. Here are some of the companies making major moves.

Otsuka Pharmaceutical to Acquire Mindset Pharma

This is the first acquisition of a psychedelic company by big pharma. It is a major step in the widespread validation of psychedelic medicines. Otsuka has shown interest in the industry for a few years now. The company has invested money into both Mindset and Atai Life Sciences, but this is the biggest step they have taken to solidify their place in the psychedelic industry. 

Cybin

In perhaps the second biggest acquisition in the psychedelic industry’s history, Cybin is set to acquire Small Pharma. This acquisition gives Cybin one of the most promising and expansive IP portfolios in the industry. 

Lucy Scientific

Lucy Scientific has been busy with acquisitions this year. In the first month of Q3, the company closed its deal to acquire Wesana Health. Then, the company announced two more acquisitions in September. The first is of High Times intellectual property. High Times is an iconic cannabis brand with a wide reach. This acquisition offers Lucy Scientific significant revenue growth and access to marketing channels that can help its wellness brands grow exponentially. These marketing channels are particularly useful given the company’s other acquisition— BlueSky Wellness. Lucy Scientific Discovery is continuing to solidify its position at the top of the psychedelic industry with a complex and fascinating business model. 

Others