How do you measure a year? Time? Worldly events? Personal growth? There are many things that you could measure the time of a year against. Here at Psychedelic Invest, we choose to measure the year in psychedelics!

The story of 2022 in psychedelics weaves through political offices, sterile research labs, colorful retreats, and more. It paints a picture of a future where all people have access to psychedelic treatments. 

This year has been a rollercoaster– to say the least. It has been a mix of ups, downs, and some extreme emotions. There has been fear, anger, excitement, and most importantly hope! Hope that millions of people will gain access to life-changing medicines.

Progress is never a straight shot. Progress hits hurdles, takes detours, and is forced to forge new paths. That is what psychedelics have been doing for the past few decades– clawing their way back into the mainstream. This year all that hard work has come to an apex. Though the psychedelic industry continues to face challenges, the momentum and excitement are too great to stop at this point. 

The economic downturn has posed a hurdle for companies, but that hasn’t hindered the psychedelic industry from making huge strides in 2022. Capital has been more difficult to come by, which has caused companies to cut excess spending, and some companies to shut their doors. The companies that have strategically positioned themselves will continue to forge forward. 

In 2022, more people have had access to psychedelic treatment than ever before. The end of the psychedelic PR crisis has prompted more people to seek out these medicines than ever before. Perceptions have shifted and are allowing for changes on all levels of society. This year has been one of major progress for the industry, despite some hurdles, and it gives hope for the future of the psychedelic industry.

This section of the report is not quite as starry-eyed and exciting as many of the others. This year can be largely summed up as a shift from a bull to a bear market. 2022 has been a reality check for many investors in the psychedelic field. The excitement of psychedelics becoming widely accessible drove excitement in 2020 and 2021. There is a lot to be excited about regarding the progress of the psychedelic industry, especially this year. There have been regulation changes and clinical trial results that insinuate a bright future for psychedelic medicine. However, stocks and capital has been on more of a downslope than the rest of the industry. 

It has not been a positive year for the stock market, especially the psychedelic index. Investors are reacting to the bear economy and impending recession by decreasing their willingness for risk. The economy is slowing the growth of new businesses in the psychedelic field because capital has been more difficult, but not impossible, to come by. 

The companies that have been smart with their cash reserves and utilized 2022 to prepare for a potential recession will continue to make exciting progress throughout 2023. Companies that have not been able to secure their position may struggle to make it through another year. Investors know this and are looking to companies that offer minimal risk and a high potential for reward, despite the bear market. 

The psychedelic industry has a unique pool of investors. Many people have invested in psychedelic companies because they are passionate about their benefits. For anyone who has found healing growth through psychedelic medicines, the belief that they have incredible potential is a given. Many investors jumped into psychedelics believing that returns would be a straight shot. However, this is a long game. Retail investors and venture capitalists have both been victims of this mentality. 

As the stock market began to decline and capital dried up, investors were struck with the reality of investing in psychedelics. Many of the public psychedelic companies are in biotechnology. The biotech field is a risky investment in itself. In combination with the uncertainty of psychedelic regulations, the ups and downs become amplified. Despite a difficult year, there is still potential for high rewards for those who are able and willing to wait out the storm. Gold comes with patience.

The psychedelic index hit its all-time high when it spiked in February of 2021. It then remained relatively stable until November. Since then, it has been on a steady decline. The index was up in August and September of 2022. It then plummeted to its lowest point since ever in December.

There was a handful of IPOs this year, though less than in 2021. After-market offerings were many as companies attempted to secure enough capital to make it through 2023 and beyond. The companies that are being considered the lowest risk are those with a cash runway that will keep them up and running until 2025. Those without that cash runway may not make it through the bear market. During the latter half of 2022, many companies looked to secure capital and minimize cash burn. Mergers, acquisitions, and thinning of programs have been commonplace in 2022. 

Atai, Compass, and MindMed have been popular among retail investors looking to mitigate risk. These three companies have a strong pipeline and enough cash to make it to 2025. Some investors, however, are unsure of MindMed because of its drama with Freeman Capital.

It would be remiss not to mention the issues going on within MindMed that have many investors worried about the future of the company. Although MindMed has a good cash runway and strong pipeline, questions raised about the handling of the company’s intellectual property and the ability of its management have increased volatility in MindMed’s stock. If you want to get the whole picture of what is happening with the company, Psychedelicinvest.com has been covering the story.

2020 and 2021 were exciting times for psychedelic companies going public. IPOs did incredibly well. 2021 was home to the first billion-dollar valuation of a psychedelic company. This year was quite a bit more bearish, but that is just part of the process of an emerging industry caught in a difficult economic climate. 

There are many factors influencing the psychedelic index. Of course, the state of the macroeconomy is going to play a big hand in where the index moves. It is also influenced by the shifting of social stigmas and government regulations– two things that have been moving in a positive direction this year. Major clinical trials such as Compass Pathways phase 2b results (released Dec. 2021) and MAPS phase 3 trials influence confidence in psychedelic stocks. All of this, and more, has affected the index this year. 

Reverse stock splits and dilutive financing from a handful of companies in the index have also had a negative influence on psychedelic stocks this year. All the companies maintain that it was the right decision for the long-term performance of the stock and investor returns. However, it has shaken investor confidence in the companies. Psychedelicinvest.com’s in-house retail investor, Adam Tubero, said that he is looking for companies to wait for their valuation to go up before diluting. He has more confidence in companies that secure non-dilutive financing while waiting for their share price to come up to a more accurate number before opting for dilutive financing– if at all. 

IPOs and Private Placement

There were a handful of companies that went public this year, though it wasn’t as big of a year for psychedelic IPOs as 2021 was. Compass Pathways was the first psychedelic company to reach a billion-dollar market cap after its IPO in 2020. Compass still has one of the highest market caps of all the companies included in the index despite being valued at less than half of what it was originally.

Psychedelic companies continue to enter the public market, though the number of IPOs is not as high as in 2021. Here are a few 

Reunion Neuroscience, the drug development division of Field Trip Health, listed on the Toronto Stock Exchange as its own public company.

Albert Labs begins trading on the Canadian Securities Exchange with private placement.

Psych Captial raises 810k (EU) with IPO on AQSE

Uplistings

Clearmind Medicine Announces Closing of US $7.5 Million Public Offering and Uplisting to the Nasdaq

Silo Pharma up lists to Nasdaq and raises $5 million in offering of common stock.

Private companies play an important role in the industry. This year has been a big year for the development of the infrastructure that is required to scale psychedelic treatment through an increasing number of private companies. Though capital is not as readily available as it was in 2020 and 2021, many psychedelic companies have been able to raise the money they need to set up shop and bring services to market. 

As it becomes more evident that psychedelic medicines will become legally available, companies are starting to build the infrastructure needed to scale psychedelic treatment. Clinics, media, education, investor resources, data, and technology are all necessary for the growth of the psychedelic industry. Psychedelics have unique needs that require tools designed specifically for this type of medicine. 

Private investors and venture capital firms continue to put money into the expanding range of psychedelic companies. One of the industry’s main venture capital firms, Iter investment, has put money into bioscience, education, and even a psilocybin retreat center this year. Investors remain confident in the long-term rewards of investing in the psychedelic industry. 

Private companies have had success this year with psychedelic services. Last month, Nucleus launched a marketing and client management software designed for psychedelic clinics and practitioners. Interest in the program has been significant since its launch. Nucleus also provides news and data for investors, practitioners, and entrepreneurs through psychedelicinvest.com and Neuly. 

This year, many of the new and emerging private companies have been working to provide support for the industry over the next five years. With MDMA and psilocybin therapy on the horizon, supporting resources for psychedelic treatment need to begin development now, and that is just what has been happening in 2022. 

There are also new psychedelic biotechnology companies seeking funding. 2022 is still so early in the development of psychedelic drugs that it is hard to say which companies will be the most successful. The most effective and popular psychedelic drugs, from the pharmaceutical side, are likely still in the development stage or have not been discovered yet. 

New biotechnology companies do have the potential to compete with the likes of Compass, Atai, and MindMed. It is difficult to say which compounds and analogs will be the most effective because research into psychedelics is still so new. What will not be successful is new biotech companies coming in and pushing drugs through the pipeline that are too similar to what companies that are already further along in the clinical trial process are pushing through. Emerging companies have to bring something new and creative to the table to gain the confidence of investors. 

Needs that companies are addressing:

Companies Being Funded:

Lusaris Therapeutics launches 60 million Series A financing round.

Healing Maps closes 1 million USD seed funding round.

Freedom Biosciences emerges from stealth with 10.5 million seed financing.

MycoMedia Life Sciences raises 60 million.

Nue Life Health announces $23 million financing round led by Obvious Ventures and Western Technology Investment.

Fluence raises 3 million to scale psychedelic therapy training.

Gilgamesh Pharmaceuticals raises $39 million in Series B.

The psychedelic investment space is made up of many different types of investors. There are about a dozen VC funds focused exclusively on mental health solutions and psychedelics. And this year, more traditional VCs have been dipping their toes into psychedelics.

Iter Investments and Palo Santo– two psychedelic VCs– both announced the closing of major funds this year. Palo Santo announced the closing of their $50 million fund in October. Palo Santo has invested in over 20 portfolio companies ranging from biotech to clinics and therapist education.

Iter also announced the closing of its first fund in July. Due to investor interest, Iter surpassed its $20 million target. The fund has invested in some of the same companies as Palo Santo, including Beckley Psytech and Fluence.

These funds are important because they understand the unique needs of psychedelic companies. There are so many moving parts within the psychedelic industry that not all investors fully understand. Psychedelic-focused VCs have been crucial in the building of the industry. However, they aren’t the only ones betting on psychedelics.

This year there has been an increase in investments from major VCs and investors that are gaining interest in psychedelics. In August, Australian billionaire Andrew Forrest began showing interest in psychedelics. The Forrest family’s private holding company, Tattarang, launched a $172 million fund focused solely on biotechnology. The fund– Tenmile– has already invested in a company developing MDMA analogs. 

Phyto Partners launched a new fund focused on neuro wellness and psychedelics. They partnered with Ambria Capital for the management of Phyto IV. The team is experienced in healthcare and technology markets, which feeds into the psychedelic industry well. Interest in psychedelics from institutional investors has grown this year. More big funds and investors are seeing the potential of psychedelics to be a massive industry. 

Many initial investors came over from the cannabis space because of the social crossover between marijuana and psychedelics. However, the needs and trajectory of the psychedelic industry are vastly different than that of cannabis. Bringing in investors who understand the biotechnology, pharmaceutical, and mental health treatment side of the business helps bridge the gap between recreational and medical viewpoints. 

Interest in psychedelics from VCs has continued to grow during 2022. Psychedelic-focused VCs have continued to bring in capital and invest. Many of these funds are very new– opening in 2020 or 2021, and are happy to see positive growth. Uncertainty is high in a bear market, so it is a very good sign to see these VCs continuing to do well, even though the economy is not doing as well as when the funds were started. 

Another good sign for the market– major VCs and investors are beginning to put money into psychedelics. Interest in the psychedelic industry from funds that are broadly focused on new healthcare solutions is a sign that psychedelics are being accepted as a viable mental health treatment, and not just by people who have been personally impacted by psychedelics. The increase in institutional interest in psychedelics this year is a good sign for the future of the market. 

Top Psychedelic VCs

There is no doubt that investors are being more cautious with their money in this bear economy. However, there is still a lot of confidence in the long-term trajectory of the psychedelic industry. Studies have shown enough positive results from psychedelic treatment that the belief that psychedelics will become an integral part of the mental healthcare system is holding steadfast. 

The main concern for investors with the impending recession is ensuring that the companies that they invest in will be able to weather the bear economy. There will likely be some psychedelic companies going out of business or forced to sell to a bigger company with a stronger cash position. Biotech is particularly risky because of how much capital it takes to bring a drug to market, so building confidence in a team’s ability to produce viable drug candidates, properly handle intellectual property, and market a drug is crucial.

This year, the anticipation of a recession has played a big role in actions within all industries, and perhaps even more so in the psychedelic industry because the risk is so high. Psychedelic biotech companies have been focusing on ensuring that they have enough cash runway to make it through 2023. The companies with the strongest position have enough cash on hand to make it to 2025. 

Non-biotech companies have slightly less pressure on them because many of them have sources of revenue already. Any company that can offer services within a year, or so, of inception is a much less risky investment. If these companies can prove future profitability, they are likely not to be too significantly influenced by the economy. 

Despite the fear of a further economic downturn, consumer spending has remained stable and unemployment rates have not spiked. These factors have little effect on biotech but do have the potential to affect clinics and brands selling products. There is no indication companies are struggling with decreased revenue. Many psychedelic companies showed a positive increase in revenue in their Q3 reports (compared to the previous year).  

Historically, recessions have increased rates of depression and suicide– an issue that the psychedelic industry is developing incredible tools to treat. However, because available psychedelic treatments are not covered by insurance, it is unlikely to affect those who seek out psychedelic treatment significantly. 

The state of the macroeconomy is certainly affecting the psychedelic industry, however, companies that have utilized 2022 to prepare for the further downturn are likely to weather the storm. The bear economy poses some struggles for the psychedelic industry and will help to shape it. There will be some companies that go under and several consolidations as a result of the economic space, but it does not pose a significant threat to the industry and its workers.

The psychedelic industry has seen positive growth in many areas during 2022. Companies are developing, services are expanding, and new research is being conducted. The following will take a look at the growth of various and how the industry is developing as a whole.

Mergers & Acquisitions

There were a few significant mergers and acquisitions within the psychedelic industry this year. Some companies acquired new assets to increase revenue and bolster the company as part of their plan to strengthen their position in the face of an economic downturn. Other companies sold off assets to trim down their cash burn.

Mydecine, a biotech company, sold off its technology platform, Mindleap, to Pangenomic health in a deal that was finalized on December 12. The deal was part of an attempt by Mydecine to refocus its resources on drug development. The company has been struggling financially this year and decided to slim its focus so that its pipeline is successful.

Other acquisitions include companies buying intellectual property to bolster their pipeline and the purchase of clinics to roll out ketamine treatment and increase revenue.

Mergers and acquisitions will likely increase in 2023 as some companies move to expand their programs and others struggle to secure the capital to keep their doors open.

This year, drug research and development have made huge strides. Hundreds of patents for novel psychedelic compounds have been filed over the past few years. Whether or not one of the drugs that were patented this year will be the one that changes the face of mental health treatment is yet to be seen. Over a dozen companies have been working hard to put out a high number of new compounds. 

Patents

Patents are playing a few different roles in the development of psychedelic drugs. Of course, biotech companies utilize patents to protect their investments in research and development. There are a handful of patents that are simply a synthetic version of a natural psychedelic, or a slight variation on compounds such as free base LSD. These patents protect the investment that these companies are making in clinical trials. 

Some companies are utilizing patents to protect novel administrations of existing drugs to increase effectiveness or decrease side effects. Other research teams are focused on developing versions of psychedelic compounds that aim to change an ‘undesirable effect.’

Patents have been a controversial topic this year– perhaps one of the most divisive topics in the psychedelic industry. Some people fear that the patents being placed on psychedelic compounds will create a monopoly on treatment and prevent people from being able to access affordable care. Non-Profit– Freedom to Operate– has been particularly vocal about their disapproval of some major patents, including Compass Pathway’s COMP360. 

Many believe that companies have no right to patent drugs and treatment techniques that have been utilized by people for hundreds of years. Their concerns are valid, however, putting psychedelic compounds (such as synthetic versions of psilocybin) through the FDA approval process is the quickest path to legal psychedelic therapy. This process requires a significant amount of capital, and without patents, companies have no way to protect their investment.

Patents are important in protecting intellectual property that companies have poured millions of dollars into. That is not innately an issue. However, concern has been raised that companies are patenting drugs and protocols that are not ‘new and non-obvious.’

Several patents have been challenged this year– the most notable is the Compass Pathway synthetic psilocybin drug (COMP360). Freedom to Operate, a non-profit committed to ‘Protecting Psychedelic Science & Medical Development for Public Benefit,’ filed a petition for a review of the patent back in 2021. This year, it was decided that the patent would stand. 

Another patent that drew some scrutiny this year is MindMed’s combination of LSD and MDMA. This combination of drugs has been popular in the underground psychedelic culture for decades, and some felt that the patent took credit for something that is already common practice. The patent in question is a combination of the two compounds into one drug and does not restrict the use of MDMA and LSD together.

One of the major issues is that much of the scientific research and discoveries that would help determine whether a patent is novel is not in the databases that are used to determine novelty. Psychedelics have been illegal for such a long time that much of the original scientific research and the work done underground are not readily available. Some companies could use this loophole to their advantage and gain control of psychedelics.

This poses a major issue for patients because statistically there is a 70-80% increase in price when a drug is patented. The psychedelic industry is largely driven by individuals who are passionate about helping people who are suffering. Unfortunately, history has shown us that a few big pharmaceutical companies do have the power to create a monopoly on life-changing drugs and prevent low-income (even middle-class) patients from accessing them. 

Some patents that we have seen this year, on the other hand, have the potential to fix this problem. One example is Mydecine’s family of MDMA analogs with a shorter half-life. Psychedelic treatment often costs thousands of dollars because the time spent with a therapist is significant. By decreasing the half-life (duration) of psychedelic compounds, some companies aim to decrease the cost of treatment.

Patents serve an important purpose, but when the system is abused it poses a threat to the psychedelic movement. The capital and patent systems should be used to encourage new discoveries that propel healthcare forward. Unfortunately, because of the way the system is designed, companies are overutilizing patents to assure investors that the extensive capital being put into these programs will turn a profit. 

This is a complex problem that requires structural changes in the pharmaceutical industry– something that is not likely to happen by the time some of these questionable patents hit the market. Without careful consideration of how the psychedelic industry is moving forward with patents, these issues could pose some serious challenges and roadblocks in the next 5-10 years.

Notable Patents this year…

Media has held a very positive role in the industry this year. In the US, 86% of adults turn to digital media as a source of news. That is good news for psychedelics because digital media has painted a very positive picture for the industry. 

There has never been more information about psychedelics available to the public. Media platforms that are covering psychedelic news have seen a steep growth in readership during 2022. In September, Psychedelic Spotlight announced that they had reached 1 million views for four consecutive months– which means that more people than ever are searching for information on psychedelics. 

There are over a dozen media outlets dedicated to providing information on psychedelics. Media is a crucial element in the industry. It doesn’t matter what scientists and entrepreneurs accomplish if people don’t have access to the information coming out of the industry in a simple, digestible form. The excitement from the public has been driving changes in psychedelic stigmas, which is crucial for the growth of the industry.  

Media platforms focused exclusively on the psychedelic industry are not the only ones covering the industry. Major news sources such as The New York Times, New York Post, Forbes, and Yahoo Finance (to name just a few) have been covering the industry in a very positive light. 

Major media sources have the power to make or break psychedelics. It was life magazine that originally brought magic mushrooms to the attention of the west. Later, the same magazine, along with other major news sources, published articles warning people about the dangers of psychedelics. 

Reporting on the benefits of psychedelic medicines and the growth of the industry is crucial for its development. Headlines like “Could the Latest Science on Psychedelics Revolutionise the Way We Understand Our Minds?” and “Researchers Look To Psychedelics To Transform Mental Healthcare” are helping to reframe psychedelics in the view of society.

2022 is the year that the psychedelic PR crisis finally came to an end. Though there are still people who hold onto outdated beliefs that psychedelics are dangerous, the media is no longer propelling that belief forward.

Most Influential Non-Profits in 2022

Non-profit organizations have played a pivotal role in the development of psychedelic access. The heart of the psychedelic movement is driving people to start non-profits that support research, access to treatment, and regulatory changes. 

Organizations such as MAPS and B. More are working on drug development and clinical trials to increase the availability of psychedelic treatment. MAPS has been a crucial force within the movement, with its founder Rick Doblin pushing forward psychedelic reform with decades of hard work. B. More is a non-profit clinical-stage biopharmaceutical company that recently gained FDA approval to begin a phase 2b study to test the efficacy of psilocybin in treating Alcohol Use Disorder (AUD).

Non-profits play a crucial role in legal reform. Natural Medicine Colorado was the driving force behind the passing of Measure 122 (Natural Medicine Act). More non-profits have followed suit and are pushing for decriminalization in their states and cities. For example– Mr. Psychedelic Law is a legal non-profit working on creating a responsible, legal framework for psilocybin use in Florida.

Laws are not going to change without groups lobbying in support of psychedelics. However, the psychedelic companies with the means to lobby are not necessarily incentivized to. Some in the biotechnology space believe that broadspread legalization could hurt the industry. The companies that have been pouring money and time into obtaining patents and FDA approval may have a difficult time selling their drugs if the traditional compounds that they are based on become widely available. 

Companies that are focused on building clinic networks are much more supportive of decriminalization and legalization efforts. Many of them would benefit from legal psilocybin clinics– as is happening in Oregon in Colorado. However, non-profit organizations are the ones doing the heavy lifting. 

Veterans of War has been going above and beyond just advocating for legalization. The organization covers the cost of its comprehensive 6-month program that utilizes ayahuasca to help veterans recover from PTSD. The work that Veterans of War and other non-profits are doing to help bring psychedelic treatment to those who need it should not be overlooked.

The purpose that is driving this industry is the desire to help people who are suffering. Non-profits are playing an integral role in achieving that goal, and everyone should be grateful for the difficult, sometimes grueling, work that they do.

Collaborations between different companies and research institutions are an important part of the growth of the industry. It has proven challenging for psychedelic companies to operate in a vertical framework, so many are turning to collaborations to help fill the gaps in their strengths. 

In an interview with psychedelicinvest.com earlier this year, Mydecine CEO Josh Bartch said that the company is focusing on narrowing its focus and outsourcing some of what it had been doing to other companies that can focus on being successful in that area. In trying to narrow its focus, Mydecine sold its technology platform MindLeap to a company that has the resources to give it the attention that the service needs. Mydecine is not the only company doing this. 

Trying to do it all can prove to be costly and inefficient. So many companies are outsourcing services that are beyond the scope of their specialty. The healthcare industry requires so many specific specialties, and one company can’t excel at all of them. Companies are banding together to strengthen their position and ability to bring psychedelic treatment to market. 

Another important space of collaboration in the industry is between biotech companies and the research institutions running clinical trials. The collaboration between biotech and research institutions, such as Johns Hopkins and Imperial College London (two big collaborators with the psychedelic industry), helps provide the funding to move psychedelic research forward and improve mental health care.

Collaborations propelling the industry forward in 2022:

Novamentis to produce psilocybin capsules for phase 2a clinical trial at Toronto Institute of Pharmaceutical Technology

Filament Health grants Psyence the right to commercialize psilocybin drug for palliative care in licensing agreement.

Small Pharma to provide drug candidate SPL026 to University College London neuroplasticity study.

Mindset Pharma and PharmAla enter into an exclusive sales agreement giving PharmAla the exclusive reseller of Mindset’s psilocybin drug.

Clinics offering ketamine treatment for depression, PTSD, anxiety, and addiction have continued to pop up across the globe. As the body of research supporting the benefits of psychedelic-assisted therapy continues to grow, the demand for psychedelic treatment is increasing as well. 

Because all other psychedelic compounds are illegal in most places, other kinds of psychedelic treatment remain underground. But, ketamine is allowing companies to begin setting up the framework for psychedelic clinics. Ketamine clinics are also one of the few ways that companies can bring in revenue without setting up in one of the few countries that allow the use of other psychedelic compounds, such as Jamaica and Mexico. 

Ketamine is a schedule III drug (in the US) that is used as an anesthetic. Off-label prescription is legal in the US and many other countries. This allows doctors to legally prescribe it for depression and other mental health indications. However, insurance does often cover this type of treatment. Many people who could benefit from ketamine therapy are not able to access it because they cannot afford it.

Despite the high price tag of ketamine treatment, it has become increasingly popular, and companies have continued to bet on ketamine treatment by opening up or acquiring new clinics. Wake Clinic Network saw 300% growth (reported year-to-date in November) this year compared to 2021. The popularity of Ketamine clinics is growing, and some companies that are currently focused on ketamine intend to offer treatment with other psychedelic compounds once it becomes legal.

In 2023, psilocybin clinics will begin opening in Oregon and some companies are already planning to expand into that market. Field Trip Health has expressed its intent to open psilocybin clinics in Oregon.

The companies working on expanding their psychedelic clinic networks are crucial for the future of the psychedelic industry. When more psychedelic compounds become legal for treatment, there needs to be preexisting infrastructure for treatment centers so that patients can gain access. The more clinics and programs that are developed now, the quicker psychedelic treatment will be able to expand down the road. 

Some of the top companies that are working to expand their clinic network are… 

Field Trip Health

The company has 12 clinic locations around the world. They recently launched a new 12-month ketamine program which includes wellness classes and other holistic healing modalities alongside the ketamine treatment. The program utilizes a monthly subscription model to make it more financially accessible. It is available in person or at home.

Field Trip Health is one of the biggest names in ketamine therapy. They offer in-person, self-guided, and hybrid programs so that patients can choose the option that best fits their needs and budget. Cost is a roadblock for many people who could benefit from ketamine therapy, and Field Trip Health has made an effort to increase access to its services by offering a variety of programs.

Awakn Life Sciences

The well-known biotech company announced on December 2, 2022, the opening of its third ketamine clinic in the UK. They will be utilizing the treatment protocol recently published in their phase II a/b trial. While some companies, especially with a biotechnology focus, have been moving away from a vertical framework, Awakn is continuing to put money into drug development, clinical research, and clinics. 

Not all ketamine therapy programs have treatment protocols that are backed by clinical trials, in fact, most do not. This gives their patients some security as to the quality of treatment that they will receive, and makes the company’s psychedelic clinics more scaleable than a program that does not have a concrete and proven design.

Numinus

Numinus is a mental health company focused on providing evidence-based holistic care. The company has five clinics in the US and Canada that utilize ketamine treatment and other holistic healing modalities to provide patients with well-rounded care. Numinus has a targeted focus on improving patients’ physical, emotional, mental, and spiritual suffering caused by their illnesses.

In addition to its brick-and-mortar treatment centers, the company has a hand in clinical trials for MDMA and psilocybin. They plan to expand their treatment options as these compounds become available. Numinus is investing in the development of psychedelic treatment with its clinical trials and psychedelic practitioner training program. The company’s work targets multiple needs in the developing practice of psychedelic therapy, which puts them in a unique position to influence and profit from the growing industry. 

Retreats are playing the role of a bridge between the traditional and the clinical. Psychedelic retreats never lost traction the way that clinical practices did in the 70s. Even after psychedelic compounds became illegal in most countries, people continued to travel to Central and South America to partake in psychedelic retreats and ceremonies. 

Now that the clinical side of psychedelics is coming back into the picture, it is integrating with traditional practices to enhance the experience and benefits of partaking in a psychedelic retreat. Many retreats still operate fully in shamanic traditions. However, over the last few years, modern retreat centers that utilize new tactics have been entering the space. 

Most retreats are in Central/ South America and Jamaica because of the legal status of psychedelics. The practitioners are not restricted by government agencies– which tend to lean away from traditional psychedelic practices. Retreat companies are not constricted by the clinical side of the psychedelic industry, so they offer a unique middle ground between traditional and modern practices. This provides patients with the most beneficial aspects of both sides.

It is difficult to gather data on this area of the industry because most retreats are not at all regulated. Many people who work within the “traditional” psychedelic retreat space are concerned that an increase in regulation will lay waste to indigenous practices, however, this is unlikely. The places where indigenous psychedelic retreats and ceremonies are held (Costa Rica, Mexico, Peru, etc.) will not likely see any changes that have a significant influence on their practices. 

There are hundreds of psychedelic retreats around the world. The following are some of the retreat companies that have been setting high standards for the quality of care and developing new, innovative treatment programs.

Wake Clinical Retreat

In addition to several Ketamine clinics in the US, Revitalist Wellness has a psilocybin retreat center in Jamaica. They utilize clinical data and resources, alongside traditional psychedelic ceremonies, to help people overcome anxiety, PTSD, addiction, traumatic brain injuries, and other indications.

The retreat center utilizes holistic healing modalities, such as meditation and yoga, in tandem with clinical technology to gather real-time data to maximize the experience and improve their methods. They utilize EGG brain scans, HexoSkin monitoring, and more to gather data from participants that can be utilized to improve the process. 

Beckley Retreats

Beckley is an interesting addition to the space of psychedelic retreats. The program stems from the Beckley Foundation, which also funds Beckley Psychtech– one of the premier research groups working with psychedelics. 

They hold psilocybin ceremonies in Jamaica with preparation and integration done virtually. Integration is an essential part of healing through psychedelics, and Beckley Retreats understands that. The program includes 4 weeks of preparation before the retreat and 6 weeks of integration– all done virtually. 

Another interesting aspect of this program is the ceremony design. It is led by two people. One is a qualified psychotherapist and the other is versed in traditional practices. The clinical design of psilocybin therapy has turned away from utilizing traditional ‘shamans.’ Beckley understands the value in both schools of thought and brings them together to provide people with the most beneficial experience possible. 

The retreat also utilizes other holistic healing modalities, such as meditation and clean eating, to help people get the most out of their experience. 

Beond Ibogaine

The retreat center based out of Mexico is committed to setting the standard for safe and effective ibogaine treatment for mental health issues. Ibogaine has no accepted medical use (legally), except in New Zealand. The powerful medicine is difficult to gain access to, and not all clinics are of a high standard. This is, unfortunately, a common issue with psychedelic retreats because they aren’t regulated. 

Beond is setting a standard for quality of care at psychedelic clinics, especially ibogaine. Ibogaine requires more medical staff than other psychedelics because of potential side effects if patients aren’t properly vetted and cared for. Retreat centers must take the proper steps to ensure patient safety. Ibogaine has incredible potential for treating opioid addiction, among other indications. Properly run clinics could address a major global issue, and Beond is leading the way toward better care. 

As the psychedelic industry continued to grow in 2022, so too did the number of jobs. As with any industry, the type of jobs available is vast– from scientists and therapists to social media creators, HR specialists, and beyond. 

The area with the most demand is therapy– followed by research and ketamine. Though there has been some job loss due to companies slimming down their cash burn, there is still high demand for workers in the psychedelic industry. Companies continue to expand and require the personnel to do so. 

As demand for psychedelic treatment increases, so too does the demand for therapists. There has been a significant shortage of therapists this year. Demand for mental health services has increased significantly since the start of the pandemic. As psychedelics grow in popularity, there will be a high demand for therapists that cannot yet be supplied. There is room for a significant number of therapists to enter the psychedelic space, but the needs of psychedelic treatment are different than traditional therapy, and the cost of education can be high. 

The majority of jobs available are remote. This is in line with the general workforce. Before the pandemic, only 17% of US workers were remote. That number has now grown to nearly 50% in 2022. The psychedelic industry is growing in line with this new trend. This trend allows those interested in working in the industry to access jobs from anywhere. 

The only jobs that are primarily on location are research and therapy, though therapy is becoming increasingly remote as well. Covid caused some changes in the US that allow doctors to prescribe scheduled drugs through telehealth communications. Ketamine therapy has taken advantage of this change, so therapists providing ketamine therapy can work remotely. Once MDMA and psilocybin become legal through FDA channels over the next couple of years, therapists will be required to administer them in person. This year, however, the first take-home psilocybin clinical trial took place. Remote therapy will be a large part of the psychedelic industry in the future.

The psychedelic industry is made up of people from all around the world. The biggest hubs are the US, Canada, and Europe. As psychedelic retreats in Jamaica, Costa Rica, Mexico, and South America become increasingly popular, more jobs working directly with patients are becoming available. 

Though some of the major biotech companies have slimmed down their personnel, there is still high demand for workers in the psychedelic industry. Some areas of the industry have been struggling to fill positions. This year, many businesses have had a hard time finding workers. There is a surplus of jobs that a decreasing number of people are willing to fill. Therapy is a field where it has been difficult to keep up with demand. The psychedelic industry has been struggling with labor shortages just as many other industries have. 

Media platforms are taking on the role of educator for the public, however, there is a huge demand for education resources for people working in the industry. Demand for therapists who have the skills and knowledge to facilitate psychedelic-assisted therapy is rising.

Several new therapist training programs have started this year. Some major companies, such as Numinus and Cybin have been creating programs to help ensure that when their products and services do hit the market, there are enough qualified psychedelic therapists to keep up with demand. These companies see these programs as a crucial investment into the future of the market. 

This year, Cybin announced the graduation of the first class to complete its facilitator training program “Embark.” The graduation came a year after the start of the program. The Embark model is currently being tested in clinical trials. The model is currently being used in two clinical trials, including the phase 1/2a trial of Cybin’s deuterated psilocybin analog. 

Another company that has made a name for itself this year in psychedelic education is Fluence. The portfolio company announced the closure of its $3 million seed round back in February. Several of the major psychedelic VCs put money into the company, including Iter Investments and Palo Santo. Fluence has over a dozen courses scheduled for 2023 covering psilocybin therapy, integration, and more.  

Services that support the therapists who provide psychedelic therapy are crucial to the development of the industry. Education resources are part of the infrastructure required to scale the psychedelic industry over the next 10 years. The fact that companies are already preparing for an increase in demand for psychedelic therapists is a good sign for investors. It is one thing for biotech companies to be pushing through psychedelic compounds, but companies opening to serve the various niches of the industry shows great confidence in the future of psychedelic treatment as a global market. 

This has been an enormous year for psychedelic research. A handful of companies are progressing their drugs through clinical trials, which is a significant step towards bringing psychedelic treatment to the masses. Although some states, such as Oregon and Colorado, are legalizing psychedelic treatment, most states will not follow suit for quite some time. Gaining government approval for psychedelic drugs through clinical trials is the only way for the broader public to gain access. 

Clinical trials are not the only important research that is taking place. Studies are being done by universities and research institutions on everything from the neural effects of psychedelics to their effect on political views.

All research is crucial for the development of the psychedelic industry and the improvement of mental health treatment. There have been significant advancements in the treatment of mental health and central nervous system disorders this year. 

The research done in 2022 has proven that all of the main psychedelic compounds are safe for human consumption and beneficial to treating mental health conditions. This has played a crucial role in changing the false narrative that has turned people against psychedelics for decades.

Psychedelic research has three goals– overcome social stigmas, change regulations, and improve scientific understanding of the human mind and consciousness. With these goals in mind, it is safe to say that researchers were successful in 2022.

Clinical trials are offering the quickest route for people all over the world to gain access to psychedelic treatment. While many people are aware of the safety and efficacy of psychedelic treatment, governments don’t change laws without putting drugs through the bureaucratic ringer– and that is just what is happening. 

2022 was a year of firsts for psychedelic research. Dozens of clinical trials tested the efficacy of psychedelic compounds. Psychedelics have never been researched in this capacity. These studies are laying the groundwork for the future of mental health treatment. 

Top Trials

MDMA, psilocybin, and ketamine have taken the lead as the first psychedelics that will become widely available. These specific compounds have had the most clinical trials and moved the furthest along in the process. While it doesn’t mean that these compounds are ultimately superior to the other psychedelic compounds being developed and researched, trials have shown that they are effective in treating multiple indications.

The following is a comprehensive overview of the significant clinical trials that made progress during 2022.

Ketamine

This particular drug is in a unique position because in many countries it is not as highly scheduled as the rest of the compounds discussed in this report. Ketamine is used as a general anesthetic to sedate and manage pain in patients. It is currently being used off-label to treat depression, addiction, and other mental health disorders. Off-label prescriptions are not covered by insurance, so treatment is costly. FDA approval of ketamine to treat depression and anxiety could help increase access.

Clinics around the world are already offering ketamine treatment for multiple indications. Many biotech companies are developing ketamine analogs with various delivery methods to determine the most effective treatment methods.

Project Kestrel: Ketamine-assisted therapy for the treatment of alcohol use disorder– Awakn Life Sciences

The results from phase II a/b were released in January. Phase 3 will commence in 2023. This is the largest clinical trial of Ketamine-assisted therapy to date and the first phase 3 psychedelic trial to receive government funding.

A Study of SLS-002 (Intranasal Racemic Ketamine) in Adults With Major Depressive Disorder at Imminent Risk of Suicide– Seelos Therapeutics Inc.

Phase 1/2 clinical Study of ketamine in the treatment of levodopa-induced dyskinesia in Parkinson’s disease.– Pharmather

MULTIDISCIPLINARY ASSOCIATION FOR PSYCHEDELIC STUDIES (MAPS)

MAPS has been a leader in psychedelics since the beginning, and this year is no exception. The non-profit’s clinical trials continued to make history in 2022, and will likely do so again next year with its MDMA treatment for PTSD getting close to FDA approval.

MDMA will be the first psychedelic treatment to gain FDA approval. MDMA-assisted therapy has gotten attention for its treatment of PTSD. Given the large number of veterans that return from war with psychological issues, governments have no choice but to acknowledge any treatment that offers significant improvement in PTSD. 

Over a dozen clinical trials are being funded and run by major companies and research institutions. MDMA-assisted therapy for the treatment of PTSD is furthest along. The compound is also progressing through clinical trials for addiction, eating disorders, and anxiety.

MAPS has a strong lead in MDMA clinical trials. On November 17, 2022, they announced to completion of their second phase 3 trial for the treatment of PTSD with MDMA-assisted therapy. This was the first study of an entheogenic compound to make it to phase three clinical trials. With the completion of the study, MAPS will move to gain FDA approval in 2023. 

The results from the first phase 3 trials, published in May of 2021, saw improvement in 88% of participants. That makes it significantly more effective than other available treatments for PTSD.

A Multi-Site Phase 3 Study of MDMA-Assisted Therapy for PTSD (MAPP2)– MAPS

A Placebo-Controlled, Randomized, Blinded, Dose Finding Phase 2 Pilot Safety Study of MDMA-Assisted Therapy for Social Anxiety in Autistic Adults (MAA-1)– MAPS

An Open-Label, Multi-Site Phase 2 Study of the Safety and Feasibility of MDMA-Assisted Therapy for Eating Disorders– MAPS

Compass Pathways Phase III

Compass Pathways made a name for itself with the completion of the largest psilocybin study to date, which finished at the end of 2021. They recently announced the pivotal program design for the phase III trial– the first phase III trial for psilocybin.

While the phase IIb results weren’t what some were hoping for, they did show improvement in the patient’s depressive symptoms. If the results from phase 3 are positive,  COMP360 (Compass’s formulation of psilocybin) may gain FDA approval sometime in 2024/2025.

COMP360 is likely to be the first psilocybin treatment to hit the market through the FDA channels. The results of these clinical trials will have major implications in all areas of the industry. They will give concrete data to lawmakers, influence the psychedelic stock index, and affect how other companies move forward with their drug development plans. 

PTSD

MDMA treatment for PTSD has been designated a breakthrough therapy by the FDA– making it a promising indication to go after. MDMA has certainly taken the lead in effective compounds to treat PTSD, but psilocybin and other compounds are also being researched for this indication. 

PTSD has helped psychedelics gain bipartisan support. In the US, in particular, conservatives have historically been strongly opposed to psychedelics. However, helping veterans has remained at the top of their agenda. Since many veterans struggle with PTSD– a mental health condition for which there are few viable treatment options – Republicans have recently started to support psychedelic reform. 

The first indication that psychedelics will gain FDA approval is PTSD– likely coming in the next two years. With the success of the MAPS trials, more companies will continue to research compounds and best practices in treating PTSD with psychedelic-assisted therapy. 

A Multi-Site Phase 3 Study of MDMA-Assisted Therapy for PTSD (MAPP2)– MAPS

Approval granted for the first North American take-home multi-dose psilocybin clinical trial evaluating the safety and efficacy of APEX-52 (psilocybin) in treating depression in Veterans with Post Traumatic Stress Disorder (“PTSD”).– Apex Labs

Depression

There was a big shake-up in depression treatment this year. It has long been believed that depression is caused by a chemical imbalance in the brain, however, a systematic review (published in July) brings into question the studies that support that claim. The data suggesting that depression is caused by a chemical imbalance is not as definitive as once thought. The review sent scientists back to the drawing board to discover what causes depression.

Between 2015 and 2018, the CDC reported that 13.2% of Americans had used anti-depressants, which may not be as effective as previously believed because they rely on chemical imbalance theory. There is evidence that anti-depressants have little benefit compared to a placebo. The pandemic caused a 21% increase in antidepressants, anxiety, and sleeping pills. New and improved treatments for depression are desperately needed.

Psilocybin treatment for depression will be next up to the plate– following MDMA for PTSD. It gained ‘breakthrough’ status from the FDA in 2021, and clinical trials for depression continue to move forward with positive results. 

DMT and 5-MeO-DMT have gained traction along with psilocybin and ketamine for the treatment of depression. The two main sub-categories of depression that clinical trials are focusing on is treatment-resistant depression (TRD) and major depressive disorder (MDD).

Phase I clinical study of BPL-003, a synthetic intranasal formulation of 5-Methoxy-N, N-Dimethyltryptamine (5-MeO-DMT)– Beckley Psytech

Phase II trial on BMND01 candidate, a novel liquid inhaled formulation of N, N-Dimethyltryptamine (“DMT”) for Treatment-Resistant Depression (“TRD”)– Biomind Labs

The largest trial was done with DMT. Testing the safety of a 10-minute trip.

Phase III Trial testing COMP360 for Treatment-Resistant Depression is to Commence at end of 2022.– Compass Pathways

Phase IIa clinical trial of an intravenous formulation of N, N-dimethyltryptamine candidate, SPL026, with psychotherapy for the treatment of Major Depressive Disorder.– Small Pharma

Phase 1/2a clinical trial of CYB003, a proprietary deuterated psilocybin analog that is being developed for the treatment of the major depressive disorder (“MDD”).– Cybin

Phase IIa trial of intrevaneous DMT for major depressive disorder completed. –Small Pharma

Anxiety

Anxiety is another indication that has gained traction as one that would benefit from psychedelic treatment. In 2020, 30.2 million Americans used benzodiazepines– a highly addictive anti-anxiety medication. One million of those were under the age of 17. 

This drug numbs emotion to help people feel better, but it doesn’t solve the root problem that is causing anxiety. This causes mental dependence along with high-physical dependence to the drug. 

Scientists are looking at psychedelic treatment as a solution that helps patients face and overcome the fear that is causing them anxiety. Ketamine is already being used in clinics to treat anxiety, and clinical trials testing other psychedelic compounds are underway. 

Psychedelics for the treatment of anxiety disorders will not make it to market until after drugs are available for PTSD, depression, and addiction because those clinical trials are further along. 

Studies are looking at psychedelic treatment for generalized anxiety disorder, as well as anxiety as a result of other indications such as a terminal illness, job trauma, and autism.

Phase II psilocybin clinical trial. This trial is aimed at studying the potential relief of COVID-19-associated mental health concerns in frontline healthcare providers– ATMA Journey Centers Inc.

Phase 2b dose-optimization trial of MM-120, a pharmaceutically optimized form of lysergic acid diethylamide (LSD), for the treatment of Generalized Anxiety Disorder (GAD).– MindMed

Addiction

Drug and alcohol treatment was a $42 billion industry in 2020, with projections to grow 20% by 2025. Unfortunately, the current addiction treatment systems available offer embarrassingly low success rates in helping people overcome addiction. 

Alcohol use disorder was one of the first indications to be rigorously studied when psychedelic research first began in the mid-20th century. Because of past research proving its efficacy and the strong market potential, addiction has been one of the most commonly studied indications for psychedelic treatment. 

There are studies testing all psychedelic compounds for the treatment of various addictions, including, but not limited to, alcohol use disorder, opioid dependence, smoking cessation, and cocaine addiction. 

Addiction has not been at the forefront of psychedelic clinical trials like depression and PTSD have been, perhaps because there is an incredible amount of money to be made from patients relapsing and returning to rehab centers repeatedly. Insurance companies and governments, on the other hand, would save millions if a new and more effective addiction treatment became available.

Over 20 million Americans are addicted to alcohol and/or other drugs. Only 1 in 10 will receive help, largely due to the cost of treatment. Psychedelic-assisted therapy costs less than a 30-day rehab program, making it much more accessible to the people who need it. 

Governments and insurance companies are incentivized to approve psychedelics for treatment because addiction costs billions of dollars every year due to medical issues and lost productivity. 

Here are some of the top addiction-focused clinical trials that happened this year. 

Phase I clinical study of BPL-003, a synthetic intranasal formulation of 5-Methoxy-N, N-Dimethyltryptamine (5-MeO-DMT)– Beckley Psytech

Phase 2 clinical trial investigating psilocybin for the treatment of alcohol use disorder (AUD).– Clairvoyant

Phase I/II clinical study (the “Study”) to evaluate the safety and feasibility of psilocybin in adults with methamphetamine.– Revive Therapeutics

treatment for cocaine addiction using MEAI, a novel psychedelic molecule of Clearmind Medicine Inc.–SciSpark Ltd.

Phase 2b smoking cessation clinical trial for MYCO-001 (psilocybin)– Mydecine & Johns Hopkins University

behavioral addiction study investigating ketamine as a treatment for Gambling Disorder.– Awakn Life Sciences

Phase II Ibogaine for Opioid dependence– Iceers

Other

Some companies are moving past the common indications, such as PTSD, depression, and addiction. This area of research is so new that scientists don’t know how far the utilization of psychedelic therapy will go. 

Studies, mostly in the preclinical and phase I stages, are being done to test the psychedelic treatment on behavioral disorders, eating disorders, autism, and more. These studies will begin turning up more definitive results late next year and into 2024.

Phase 1 DMT Human Dosing Study in Healthy Individuals For Stroke Regeneration– Algernon Pharmaceuticals

double-blind randomized controlled phase II clinical trial investigating the efficacy of COMP360 psilocybin in people with anorexia nervosa.– Compass Pathways

Phase II trial treating Binge Eating Disorder (“BED”) with psilocybin in conjunction with psychotherapy.– Tryp Therapeutics

A Double-Blind, Randomized, Placebo-Controlled Study to Investigate the Safety, Tolerability, and Pharmacokinetics of Single, Ascending, Subcutaneous Doses of FT-104 HCl In Healthy Volunteers.– Field Trip Health (shortened half-life psilocybin)

phase one clinical trial testing the physiological and psychological effects of orally administered psilocybin and psilocin, and sublingually administered psilocin in healthy adults.– Filament Health (first naturally derived psilocybin and first psilocin)

Biotech companies aren’t the only ones researching psychedelic compounds. There are dozens of research institutions studying the effects of psychedelics on a variety of indications, and also how these compounds generally affect the human brain and body. It should be noted that clinical trials do happen through research institutions such as universities and non-profits. However, the depth of research that they are able to do spans beyond that.

Some of the major researchers have been: Johns Hopkins University, Beckley Institute, and University Hospital Basel– to name a few. The research being done through these channels is a bit different because it is not confined to what will ultimately produce the most returns for investors. 

Some researchers focus more on what psychedelic experiences can tell us about the human mind. Others are looking at medicines such as ayahuasca– something that has a low potential for a clinical setting but may still have substantial benefits.

Clinical trials are limited by several factors. All for-profit companies are bound to investor returns. Even non-profits, such as MAPS, must consider which treatments will gain approval the quickest based on political and social factors. That can, unfortunately, cause promising compounds and treatments to be under-pursued. 

Research institutions are bridging this gap and progressing psychedelic science through studies that for-profit companies simply cannot do– especially given the current state of the economy and the huge amount of capital that these studies require. 

Clinical trials are meant to test the safety and efficacy of treatment for a specific indication. Research institutions perform a broader range of research to make new discoveries on all aspects of psychedelics, which expands overall knowledge about these mysterious compounds. There is still much that is unknown about the effects that they have on the human mind and body, and scientists all over the world are seeking answers. 

These studies support the biotech companies that are working to bring new drugs to market by advancing psychedelic sciences. The following is a small sample of the vast amount of research that has been done over the past year. The list aims to highlight the various areas of psychedelic medicine and psychology that are being studied.

Studies

Psilocybin Treatment for Major Depression is Effective for Up to a Year for Most Patients.– Johns Hopkins

Study on the potential therapeutic effects of psilocybin on autistic adults.– Kings College London & was funded by Compass Pathways

Observational study on the benefits of ayahuasca for individuals who have experienced trauma. –Unlimited Sciences

Changes in music-evoked emotion and ventral striatal functional connectivity after psilocybin therapy for depression–Imperial College London

Effect of lysergic acid diethylamide (LSD) on reinforcement learning in humans– University of Cambridge

Alexander Shulgin Research Institute

The Alexander Shulgin Research Institute was created to carry on the legacy of Alexander “Sasha” Shulgin– a chemist and pharmacologist who perhaps did more psychedelic research than anyone in history. For 50 years he synthesized psychoactive compounds and tested them on himself, his wife, and a small group of their friends. He is known as “the godfather of ecstasy” because he is credited with popularising MDMA.

Shasha died in 2014, and his wife Anne passed earlier this year. Their contributions to the psychedelic movement were immeasurable, and the institute’s mission is to carry on the work that Sasha did during his life. He created hundreds of psychoactive drugs that the research institute plans to research further. 

The institute raised over 7 million dollars in 2021. In June, a collaboration with CaaMTech was announced to continue research on his catalog of novel compounds. 

It takes decades to develop and test new compounds. Many of the scientists working to bring new drugs to market have only begun their work with psychedelics over the past few years. Sasha Shulgin, however, had already spent decades creating novel compounds and testing them– albeit not in the manner that would get the stamp of approval from government agencies. Nevertheless, his catalog of novel compounds may have a diamond within it. The Alexander Shulgin Research Institute is carrying on Sasha’s legacy by continuing his research to look for viable candidates that could have medical and social benefits.

2022 has housed the most (positive) regulation and political changes in psychedelic history. Those changes have come in many forms. Some of the developments actively increase access to psychedelic treatment, while others set the stage for changes in the future. 

One of the most exciting developments in psychedelic regulation this year came in November’s election. Colorado citizens took to the polls and voted to pass Proposition 122– a measure decriminalizing psychedelic plant medicines and allowing for regulated psilocybin clinics. This is the second measure of its kind. The first was measure 109, which passed in Oregon two years prior. 

Oregon has spent the last two years developing the regulations for the state’s psilocybin access program, and the rules were recently finalized. People can start applying for licenses to open clinics in Oregon in January 2023. Next year will be the first time that people can legally access psychedelic treatment in 50 years. Now that Prop 122 has passed, Colorado lawmakers have until September 2024 to build their system for psilocybin therapy. These two programs will set the stage for other states to begin changing their laws, and it already has.

Colorado and Oregon have taken the lead in psychedelic reform, and others are following close behind. Just before 2022 comes to an end, California State Senator Scott Weiner reintroduced Bill 58, which would decriminalize several psychedelics state-wide. The bill was voted down earlier this year when the state senate decided it would best be revisited in a year or two once more research was available on psychedelic therapy. However, the bill is already back with a few changes. This time around, synthetic psychedelic compounds LSD and MDMA are excluded from the bill. At this time, it is unclear whether or not the bill will pass. 

Despite there being no major changes in federal regulations yet, there has been movement this year that indicates legalization may be on the horizon. In June, Senators Cory Booker (D) and Rand Paul (R) introduced a bipartisan act (The Right To Try Clarification Act) to help terminally ill patients gain access to psilocybin therapy. There was also talk from the executive branch about the legalization of MDMA for PTSD and psilocybin for depression in the next two years. 

The last piece of promising news coming out of US lawmakers came in November when it was announced that a Psychedelics Advancing Clinical Treatments (PACT) caucus has been assembled in Congress. The purpose of this group is to increase awareness about psychedelic research in Congress. It does not change anything. It is simply a bureaucratic tool to make it seem like things are moving along positively while ultimately change is slow and grueling. 

Moving up north to Canada, it has been an interesting year as well. There have been no significant changes to regulations, however, they are far less strict than in the US. Many major Canadian cities have psychedelic shops that sell magic mushrooms and other psychedelic plant medicines. These shops have had no trouble with the law, despite being illegal. 

For more positive news to round out 2022, Quebec (a Canadian province) announced in December that they would be publicly funding psilocybin therapy. This makes the province the first governing body worldwide to front the cost of psychedelic treatment. At this time, the treatment is only covered if it is approved by Health Canada, which is only given to terminally ill patients for the most part.

In other 2022 political news, Thailand announce that they would be conducting studies to test the efficacy of psilocybin treatment for depression. If the studies show positive results, magic mushrooms may become legal.

All in all, significant strides have been made in 2022 toward legalizing psychedelics. Surprisingly big strides. Though it’s easy to get frustrated by the slow pace of the wheels of government turning, it should be acknowledged that progress with psychedelic regulation has been moving quite fast over the past few years, and this year in particular. At this rate, people may be able to get access to federally legal psychedelic therapy before cannabis is legalized. That is quite incredible to think about. 

Psychedelics have such steam and promise of solutions to some really big problems that they are moving through the regulation process fairly quickly. The speed of progress is relative. It is easy to be frustrated that it is not moving faster, considering the benefits and safety of psychedelic medicines compared to other drugs on the market. However, relative to the turtle pace of progress in government, psychedelics are progressing rather quickly. The progress made in 2022 should make investors and psychedelic advocates of all kinds confident in the future of a legal psychedelic market.

This psychedelic renaissance is growing in tandem with the quickest technological advances in the history of mankind. New technologies can be leveraged to increase patient access and change the way that psychedelics are delivered to improve outcomes. To keep up with the changing landscape of medicine, the psychedelic industry will have to grow with technological advances, not against them.

Companies of all types are utilizing advanced technology to further their work. Drug research and development teams are utilizing artificial intelligence and machine learning (AI/ML) to make the scientific process more efficient. Biotech company –Mydecine– has partnered with the University of Alberta to accelerate its drug development timeline using AI/ML. This allows them to run potential novel compounds through a computer system that judges the potential of the drug– saving the time and money of doing this manually. 

Technologies such as the ones being leveraged by Mydecine are increasing the chances of a new, highly-effective drug being developed, and saving investors millions of dollars in the process. Efficiency is the name of the game in healthcare and pharmaceuticals. In the fast-paced society that we live in, people expect quick solutions to their problems. Psychedelic drug development is not a particularly quick process, so technology that helps fastrack it will help improve investor confidence and provide life-changing mental health treatments quicker than ever before.

Technology is also being utilized to increase access to treatment. Companies are developing software to increase the availability of psychedelic treatment and integration resources and drive down costs. Software platforms, such as Mindleap and Psychedelic Finder (launching soon), are important technologies being developed within the psychedelic space. We live in a technological world. Since the beginning of the Covid-19 pandemic, people have increasingly been seeking services through digital platforms. Developing these platforms for the specific needs of the psychedelic space is crucial for connecting people to the resources that are available to them.

Technologies such as Mindleap help people access psychedelic experts who are otherwise difficult to reach because plant medicine treatment is still largely an underground business. Psychedelic finder will also connect people to psychedelic services to help them heal with psychedelics and integrate their experience.

The psychedelic treatment model has unique needs that can’t be fully met by tools developed for traditional therapy. Applications like Mindleap and Psydelic Finder are being developed to connect people to psychedelic practitioners and integrations tools by centralizing information that is otherwise difficult to locate. In addition to tools connecting people to treatment, technology is being leveraged to improve the outcome of psychedelic experiences– virtual reality is one of those technologies.

In June, Enosis therapeutics partnered with the Swinburne University of Technology to do the first study on the utilization of VR in the psychedelic experience– the results were positive. Though many people have questioned whether or not VR would increase the probability of a “bad trip,” it appears that it may be a useful tool to provide psychedelic therapy. Enosis recently teamed up with Ovid clinic– a ketamine treatment center in Berlin– to start integrating VR into psychedelic therapy. 

VR could be utilized to play with the ‘set and setting.’ There are different schools of thought on what that ‘ideal’ set and setting for psychedelic treatment is, but everyone agrees that it plays an integral part in the healing process. Virtual reality could increase the ability of therapists to customize the environment for each patient’s needs. Some companies are betting on this idea, and have seen success this year.

Virtual reality is taking the common psychedelic experience that ‘reality is a simulation’ to a whole new level. A tech startup by the name of Tripp is creating calming virtual worlds that the company has coined the ‘mindful metaverse.’ The current products offered by trip are ‘psychedelic inspired,’ however, it focuses on non-psychedelic mindfulness practices to support mental health. In 2021, the company acquired Psyassist– another VR company focused on offering products to help therapists treat mental health issues. PsyAssist is committed to integrating its products into the future of psychedelic therapy to give patients support before, during, and after their experience. Tripp has made quite a name for itself as one of the top technology companies in the psychedelic industry.

VR technology could also be used to hold group psychedelic ceremonies while cutting costs by allowing people to participate from the comfort of their own homes. Virtual reality could open up the possibility for patients to gain access to psychedelic therapy from anywhere in the world. People could join a group psychedelic session without having to travel to a physical location– something that is going to be sparse for the next 5-10 years. This model, however, will only work once it is legal for at-home psychedelic therapy. Currently, that is available for ketamine treatment, but, will not be available for other psychedelic compounds for some time.

The foundations for new technologies to be integrated into psychedelic therapy are being set by companies like Enosis and Tripp. While access to psychedelics may come slowly, technology is not going to stop growing exponentially. While companies continue to push for legalization and FDA approval of psychedelics, the industry must keep up with technological advancements that could help increase the benefits of treatment.

This has been a big year for psychedelic gatherings– and not of the Woodstock kind. Conferences and events around the world have been bringing together investors, scientists, practitioners, and artists working with psychedelics. 

Psychedelic scientists, practitioners, investors, and entrepreneurs participated in dozens of events and conferences worldwide. Some events focused solely on discussing psychedelics, the issues the industry faces, and the solutions to those problems. Other events that included psychedelic speakers were focused more broadly on biotech, investing, and innovation. The wealth of these events this year speaks to the momentum that psychedelic medicine is picking up in the mainstream.

Here are some of the events this year that helped propel the field of psychedelic medicine forward. 

Nucleus Psychedelic Series

Nucleus has been holding a monthly psychedelic series throughout 2022 at the Soho House in Miami, and other locations throughout the US and internationally. The panel, led by Dustin Robinson, has included scientists, investors, artists, and more. 

With an increasingly remote workforce, it is crucial to bring people together to discuss the pressing issues in the psychedelic industry and mental health treatment. Though there are many benefits to a remote workforce, it can often lack the creativity and problem-solving that comes out of in-person collaboration. With these events, Nucleus has been bringing people together to discuss important topics and build community.

A Psychedelic Wonderland

In November, the largest psychedelic business gathering in history took place in Miami. Over 500 people were in attendance from all areas of the industry. Some of the biggest leaders in the industry were there and spoke on one of the many panels– including Rick Doblin, Paul Stamets, and Dr. Robin Carhart-Harris. 

Psychedelic advocates from around the world gathered to network and learn more about the industry in which they work. Wonderland was a huge event that would not have been possible just a few years ago. Historically, an event like this would have been taboo. The fact that Microdose was able to pull off such a successful event speaks to the progress that the psychedelic community has made in the past few years. 

This amazing gathering was not without some controversy. Shortly before the event commenced, a ‘banned list’ was leaked to the public with names of psychedelic community members that were not allowed at the event. No one ever took responsibility for this list and the reasons these particular individuals were banned are still unknown. 

The idea of a banned list at a psychedelic gathering has an ironic ring to it. This brings to light the fact that even the psychedelic community– touted for being inclusive– must overcome bias and discrimination. The scientific community often blacklists (metaphorically or literally) those who disagree with the accepted-standards norms. The psychedelic sector is not immune to this bias. It is something that the industry must overcome if it hopes to create a more inclusive community and reach its greatest potential because widely accepted ideas are not always the right ones.

The boundaries of psychedelics are set by two things– regulations and the limits of the people who make up the industry. Studies have found that there is an increase in new discoveries when the top scientist in a field dies. Exploration of new ideas is limited by the minds of the people who make up the fabric of this industry. 

We have already gone into detail on some of the issues facing the psychedelic industry. But, to sum it up, the top issues are (in no particular order)…

What to Expect in 2023

2023 is going to be another rollercoaster… for the US, the World, and certainly the psychedelic industry. We are heading in for a bumpy and exciting ride, so buckle up. The new year is going to be full of new discoveries, increased access to psychedelics, novel challenges, and important decisions. 

There will be more phase 3 clinical trials of psychedelic drugs. The results of these trials will give a concrete timeline of when the first psychedelic drugs will hit the market. Right now, the best guess says around 2025, but there is little certainty until a psychedelic drug makes it through the FDA process for drug approval. There will be lots of new clinical trial data coming out of all the major biotech companies in the space. There will be a wealth of new studies commencing, along with trials moving through the later stages of the drug approval process. Some early-stage studies are testing the efficacy of psychedelics for indications never before looked at in this manner.

The Canadian government recently approved funding for a study titled: “A proof-of-concept randomized controlled trial to show that the antidepressant effects of psilocybin do not require psychedelic effects.” This is the first psychedelic study to be funded by the Canadian government, but that’s not the only significant thing about this study. 

The plans for this study included a blocker to prevent the psychedelic effects of psilocybin. There have been discussions among scientists about whether the benefits of psychedelic treatment can be reaped without the psychedelic effects. If this hypothesis is proven to be true, it could significantly reduce the costs of psychedelic treatment. The results of this study have the power to shift the long-term direction of the psychedelic industry. Though, many would argue that the psychedelic effects are an important part of the experience. 

Despite the lengthy process that companies must go through to get a new drug approved by the FDA, there is going to be a significant amount of growth in access to psychedelic treatment in 2023.

That brings us to Oregon. January 1, 2023, marks the end of the two years that the Oregon Health Authority (OHA) had to build the container that will hold legal access to psilocybin. The state voted to legalize access in 2020, and this coming year we will get to see the new law come to fruition. 

January marks the beginning of the application process for those planning to open treatment centers. These health centers will likely be open for service in the second half of the year. By the end of 2023, the first round of data and feedback on Oregon’s psilocybin program will tell us the benefits and shortcomings of this type of program. Colorado will also be underway designing its own regulations for legal psilocybin treatment, however, access won’t start until 2024. 

On a less positive note, predictions for the global economy in 2023 are not looking fantastic, and this will have an impact on the psychedelic industry. 

With many experts predicting a recession, we may see a thinning out of the market in a “survival of the fittest” fashion. This year, capital has become harder to come by compared to 2020 and 2021 when investors were pouring money into psychedelic companies. Many companies have been preparing for an economic downturn by securing enough cash runway to last them another few years. The companies that have secured their financial position will continue to thrive in 2023, with lots of new developments on the horizon. However, those that have not been securing capital and decreasing cash burn may find 2023 impossible to survive. 

Though unfortunate for workers, it is natural to see some companies fall out as the stronger ones secure their place at the top of the market. This coming year we will likely see a few companies close their doors, or be acquired by companies that are in a stronger position. 

Stocks will continue to fluctuate because of uncertainty in the macro economy and psychedelic industry. As the biotech companies (which is most, but not all, of the public psychedelic companies) continue to progress through clinical trials, there will likely be an increase in confidence about psychedelic stocks– companies may see their stocks rise as a result. However, significant and sustained increases in the psychedelic index will not be seen until companies can start pulling in considerable revenue.

Next year will be much like this year in the psychedelic industry– full of excitement, hope, and challenges. The source of excitement and hope remain largely the same because those sentiments live in the belief that psychedelic medicines will transform the healthcare industry and society at large. 2023 will be a year full of huge strides toward that goal. 2023 will also be a year full of challenges– some new and some old.  

Long Term Outcomes

What the psychedelic industry will look like in 10 years is somewhat of a mystery. The research done over the past few years tells us that there is significant potential for psychedelics in medicine and society as a whole– how exactly that will manifest can only be told with time.

Psychedelics will continue to intertwine with the fabric of contemporary society. 20 years from now, psychedelics will undoubtedly be a keystone of society. Over the years, there will be conflicts and resolutions that send the industry in new and exciting directions. 

The compounds that are used to treat mental illness and the science that backs it will develop and create a system that is impossible to fully predict at this point. The industry is still in its infancy stage, and what it will become is beyond our wildest imagination. 

This year the industry has had many milestones that psychedelic advocates have dreamed of for decades. This year has also brought with it new conflicts as psychedelic medicine is integrated into the standard medical and financial model. There is strife between indigenous practices and the medical establishment on how psychedelic medicines should be administered. 

During a technology and psychedelics panel at Wonderland Miami, two indigenous practitioners dismissed the clinical take on psychedelic treatment as fueled by greed, but the community model of medicine is simply not applicable to the social systems that many people around the world live in. 

The integration of these two schools of thought into one psychedelic model will continue to shape the industry into what it will be in the future. The future of psychedelic medicine is a world with more compassion and understanding. It is a world will new technologies that can only be imagined at this time. It is a world with life-changing solutions to so many of society’s problems.

Being passionate about what psychedelics could do for the world means asking challenging questions and not being afraid to admit that there is no easy answer. If you are reading this report, you are a part of shaping the future of psychedelic medicine, and you have the responsibility to make sure it is a bright future.