Lobe Sciences Provides Update For 2023 Milestones

Psychedelics Outlook 2023

Table of Contents

Psychedelics Market Update: H1 2022 in Review

Psychedelics Market 2022 Year-End Review

Psychedelics Market Forecast: 3 Top Trends That Will Affect Psychedelics in 2023

Psychedelics Market Update: H1 2022 in Review

Click here to read the latest psychedelics market update.

While the first half of 2022 didn't bring forth the clinical trial approvals investors are eager to see, psychedelics companies continue to move along as the market gears up for this milestone.

The industry's progress has been stunted, however, by the increasingly difficult market conditions caused by a global economic downturn that is affecting all industries.

Here the Investing News Network (INN) provides an update on the state of the psychedelics investment market at the halfway mark of the year with commentary from experts.

Psychedelics market update: 2022 prediction panning out

Coming into 2022, INN asked Andrew Charrette, director of regulatory affairs and psychedelic advisor with KGK Science, if change in the market would require a significant regulatory approval.

“It'll be difficult, and it's going to be difficult for even the best companies as they're still flying blind right now,” he said at the time. That projection has panned as 2022 has brought market difficulties across the board.

It's clear that the macroeconomic conditions affecting virtually every sector in the investment landscape are impacting the current financial reality for psychedelics stocks.

Jim Gilligan, chief scientific officer and interim CEO at Tryp Psychedelics (CSE:TRYP,OTCQB:TRYPF), said a variety of companies, including his own, have seen significant valuation declines “despite making advances,” explaining that these drops have been based on nothing coming out of company pipelines.

“There have been changes in market dynamics in biotech and psychedelics in particular that are sort of outside of our control,” Gilligan said. He was referring to the immense pressures created by the poor economic conditions at large, which are sending markets across the board into a decline.

Payton Nyquvest, founder and CEO of Numinus Wellness (TSX:NUMI,OTCQX:NUMIF), told INN he has seen several cycles of new capital coming into the market. Right now he is encouraged by what he described as a new level of knowledge. From his perspective as the founder of one of the first psychedelics firms to hit the public market, investors are more educated now than they were during the initial wave of hype.

That rush led to “not completely clear business plans,” which according to Nyquvest have fueled a consolidation trend in the space. “We've now seen a real focus in prioritizing what is really going to create value,” he said.

Psychedelics market update: Not all companies will be winners

Evan Levine, CEO of PsyBio Psychedelics (TSXV:PSYB,OTCQB:PSYBF), told INN he is worried about the value proposition of the entire psychedelics sector based on how little time companies have been around.

“A lot of these companies were formed just using the word 'psychedelic,' in my opinion,” Levine said.

Investors will have to be more cautious than ever before with the names they pick in psychedelics, according to the PsyBio executive. “Do I think our sector is a screaming buy? No, I don't,” he said. “I think that there's a few companies out there that have a real shot at succeeding within our industry.”

Levine agreed with Gilligan’s assessment that macroeconomics are having a significant impact on the progress and valuation of the psychedelics category.

“There's not a lot of value in a lot of the companies out there,” Levine said.

Psychedelics market update: 2022 studies show market progress

The psychedelics industry has grown thanks to the progress of clinical trials, which are adding to the medical promise of substances that were previously thought of as dangerous.

The development of these studies has become pivotal for the overall health of the market, with players on the sidelines looking forward to the first approval just as much as drug makers themselves.

Experts have previously told INN that the market is expected to see a slew of new studies launch this year. And when it comes to the studies everyone is watching in 2022, some have already brought promising data readouts.

Gilligan and Levine both told INN they are keeping a close eye on the progress of COMPASS Pathways' (NASDAQ:CMPS) primary study evaluating the company's lead psilocybin candidate.

In May, COMPASS shared an update on its Phase IIb study at the American Psychiatric Association's annual meeting, and said it plans to begin the critical third phase in H2 2022.

Psychedelics market update: Regulatory progress updates

Nyquvest told INN there’s never been more clarity when it comes to the psychedelics industry and regulators.

Aside from medical regulators who oversee the progress of clinical studies with substances like MDMA and psilocybin, there have been more changes for regulation at the policy maker level. The Numinus executive pointed to moves from the states of Oregon and Colorado, as well as new policies from Health Canada.

For his part, Gilligan told INN he is hoping for an efficiency upgrade over the application of rules by federal regulators in the US, the home of the most prominent psychedelics studies.

The Drug Enforcement Agency (DEA) and US Food and Drug Administration play key roles in the progress of psychedelic medicines, and with the recent explosion of companies launching studies, there’s been a need to adjust the previous understanding surrounding these substances.

“They're becoming more comfortable with the administration of psychedelics,” Gilligan said.

The executive said there are still frustrations with the licensing lag created by the DEA’s role when it comes to psychedelic studies. “Performing clinical studies that involve a multitude of states, you need to have a multitude of DEA approvals … and there's tremendous variability in state to state.”

The executive remains hopeful that thanks to the uptick in studies, the DEA is becoming more comfortable with the rules surrounding psychedelics.

“What we're hoping is that there'll be this realization that they really should not be scheduling (drawings), and that will facilitate and make it much easier to do your clinical research,” Gilligan said.

Psychedelics market update: Investor takeaway

The psychedelics investment proposition finds itself in a unique place right now as the market anticipates the eventual arrival of massive catalysts by way of drug approvals.

While investors wait, there has been a drag in valuations and stock prices that is also connected to current market pressures at a bigger level outside of just biotech and pharmaceuticals.

Investors are more educated than ever when it comes to psychedelics, and will have to use those skills regularly as they try to pick winners while watching out for companies that may be on the way out in 2022.

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

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

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

Additional information on investing in psychedelics stocks — FREE

Psychedelics Market 2022 Year-End Review

After a promising beginning, the psychedelics investment story may be facing fatigue until major catalysts hit the market.

The psychedelics sector continued to wait for its first major drug approval in 2022, while at the same time macroeconomic factors put pressure on investments in this up-and-coming drug development industry.

Here the Investing News Network (INN) offers investors a recap of the most significant psychedelics events of the year.

Investors switch to long-term mindset

The first publicly traded psychedelics company reached the capital markets in 2019, and shortly after that the industry saw a significant burst of new players declare their intentions to focus on the space.

These psychedelics stocks came onto the scene near the end of the "green rush," a period when cannabis companies saw significant valuation jumps. Although the two industries are vastly different in many ways, the success initially seen in cannabis created unrealistic expectations in the psychedelics investment community.

According to one expert, those expectations affected the early stages of the psychedelics market, but now there has been a real change of guard when it comes to knowledge of the space. “I've seen a shift, and I've seen the majority transition, yes,” Najla Guthrie, CEO of Wellbeing Digital Sciences (NEO:MEDI), told INN at this year's Wonderland conference.

Guthrie was referencing a change in psychedelics investors from people with an interest in day-to-day trading to more established market participants with their eyes on the long-term outlook for the industry.

One sign of this change was the publication of the first note on the space by Morgan Stanley (NYSE:MS). While the firm has not begun coverage on any companies, its broad sector observations point to a positive outlook on the industry.

“You're still going to have, you know, that fringe element that still thinks it's going to be … like cannabis, but I think those are the minority today,” Guthrie explained to INN.

The expert said she is encouraged by the data being produced by the top drug makers in the psychedelics space.

“I'm looking forward to seeing a lot of those come through the pipeline,” Guthrie said. “I'm very, very excited and encouraged about where we're headed, and how we're transitioning.”

Economic headwinds cause psychedelics stocks to drag

Despite a recognized shift in the psychedelics investor base, this year has been a real test for stakeholders.

As of November 30, the Horizons Psychedelic Stock Index ETF (NEO:PSYK), which includes some of the biggest psychedelics companies, along with pharmaceutical stocks connected to the industry, was down 56.54 percent.

Companies like ATAI Life Sciences (NASDAQ:ATAI), COMPASS Pathways (NASDAQ:CMPS) and Cybin (NYSEAMERICAN:CYBN), standard bearers for the market, have all seen share price declines of over 50 percent each.

Before allowing panic to settle in, one expert told INN that investors need to recognize how much broad world events have impacted most industries, especially emerging sectors.

“Macro forces are not only affecting psychedelics, but all kinds of early risky assets,” Maria Velkova, managing partner at Tabula Rasa Ventures, told INN during the Wonderland conference.

The financial expert said the previous hype cycle seen in psychedelics will play a role in determining what the downturn will amount to. “I think (the downturn is) fitting well with the natural progression of the hype downturn as well,” she said.

Clinical data affecting psychedelics investment story

This past year offered a substantial amount of new clinical data and progress for the biggest psychedelics studies.

As these studies become more prominent and regulators engage with more of them, an added level of comfort has been created surrounding psychedelic substances and potential drug products.

Velkova told INN that regulators are in charge as strict overseers of the data produced from these studies.

“The data is the data,” Velkova said. “This is why the (US Food and Drug Administration) was set up — to ensure that companies that are developing medicines are collecting the right data.”

Velkova spent a decade in the pharmaceutical industry before stepping into psychedelics.

When asked for a theme indicative of the capital market's progress in 2022, Guthrie said it’s been very difficult.

“It's been a painful transition for a lot of companies in the sector; (they) have lost a lot of their value,” the expert explained, adding that this is a symptom of where the capital markets are right now.

Guthrie told INN that a lot of the initial capital raised for the sector came with “unrealistic expectations” for the drug pipeline timeline. In addition, the market has taken a beating from the effects of inflation in the global economy, supply chain problems affected by lingering COVID-19 issues and the aggravated results of the war caused by Russia’s invasion of Ukraine.

Velkova also thinks companies listing at early stages will affect the current flow of psychedelics companies. The expert expressed reservations about early stage drug development companies going public, a trend seen in the psychedelics space.

“But you know, people have made decisions,” she said. “And now they're trying to kind of deal with the consequences of the market forces, which are outside of their hands.”

Velkova told INN she has seen a slowdown in investment momentum alongside a stabilization in valuations. “I do think that they were way out of proportion before; there's still a lot of unanswered questions, and a lot of uncertainty in the space,” she said.

She doesn't doubt the effectiveness of these substances as novel drugs, but when it comes to the investment storyline, the expert questions whether there have been complete answers about the commercial rollout of these potential drugs.

Investor takeaway

There are clear signs that the psychedelic drug market is on the way to potentially revolutionizing the entire medical industry. But until that day begins to materialize, there will still be down periods, with even the biggest companies seeing severe stock losses.

Experts in the space have said this waiting period can offer opportunities to investors, but patience will be needed before the industry takes off in a significant way.

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

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

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

Additional information on investing in psychedelics stocks — FREE

Psychedelics Market Forecast: 3 Top Trends That Will Affect Psychedelics in 2023

Pull quote was provided by Awakn Life Sciences. This article is not paid-for content.

Before the psychedelics industry can deliver on the promise of its potential, the sector will need to overcome challenges and achieve milestones, with drug approvals currently at the top of the list.

What does 2023 have in store for stakeholders in this up-and-coming drug industry?

Here the Investing News Network (INN) presents a look at what may be on the horizon for the psychedelics investment market, with expert opinions on trends and key catalysts to watch in the next year.

1. If a psychedelic drug is approved, what's next?

Clinical trials have a gigantic role to play in the progress of the psychedelics business. These trials are set to essentially make or break the industry's viability, and have the potential to generate huge momentum for publicly traded companies.

Right now, the industry is waiting for companies to receive their first approvals so that they can move past clinical trials and forward to the next stage of drug development: commercial availability.

Maria Velkova, managing partner at Tabula Rasa Ventures, told INN a lot of uncertainty is still present in the story for psychedelic medicines. The investment expert, who has a decade-long background in the pharmaceutical industry, said since so much attention is paid to drug development, commercial rollout can be cast aside despite being just as important.

“Most people in the space have never launched a drug before or haven't worked in Big Pharma,” Velkova said.

She expects the rollout of psychedelic drugs to be the biggest challenge yet for the industry.

When asked if difficulties caused by a lack of experience in drug rollout could be eased by acquisitions from pharmaceutical corporations, Velkova said the Big Pharma model has morphed into a commercial engine rather than a drug development model.

“I think Big Pharma is really waiting for us to build out the entire infrastructure, because this is a completely new infrastructure … there are so many aspects of the psychedelic-assisted therapy process that are not just a drug,” she told INN.

Broad questions about the psychedelic drug business model remain, according to the expert, such as how insurance payments will work. “We're literally building out novel ways of stakeholder alignment that haven't naturally been seen in the past,” she said.

2. Psychedelics legality making progress, but still murky

The psychedelics industry is also facing uncertainty when it comes to the legality of medicines.

Top regulators like the US Food and Administration (FDA) have drugs under examination, which may open the doors to limited access to these substances, but broader framework changes are in the works as well.

Both the US and Canada have seen recent political adjustments geared at getting a better understanding of the work being done within the psychedelics industry. As part of this year's US midterm elections, the state of Colorado voted to decriminalize the use of psychedelic mushrooms in drug centers for people 21 and older.

The policy will come into effect in 2024, and an advisory board may add more psychedelic drugs to the legal system in 2026.

Colorado will join Oregon to become the second state to allow the medical use of psychedelic substances.

One drug policy lawyer told INN that a grassroots state-by-state approach to psychedelics policy will be vital, but federal policy will also be needed at some point. “It is going to take change at the federal level, but I don't think we can get there … without this local grassroots movement,” Courtney Barnes, a partner and lawyer with Barnes Caplan, said.

The lawyer said there could be a domino effect as states approach legalization programs for psychedelic drugs, and this could lead up to federal change. “I'm very grateful that we have a state regulatory pathway available,” she told INN.

3. Expert wants psychedelics industry to band together

Najla Guthrie, CEO of Wellbeing Digital Sciences (NEO:MEDI), told INN she wants to see more advocacy within the psychedelics space. In Canada, she hopes to build a coalition to unify a variety of interested parties.

“We need the regulatory framework to happen responsibly,” Guthrie said. The expert hopes for this coalition to lobby the Canadian government for “evidence-based change” as the market continues to grow.

When asked how comfortable regulators and the Canadian government are with the use and administration of psychedelic substances, Guthrie explained that these authorities are looking forward to receiving official data; however, the groundwork is being laid right now when it comes to their future actions.

“I think the government is looking for some guidance on what makes the most sense,” the expert said.

That’s where she hopes her association can come in and represent the sector as a whole. “I think we as an industry need to do a better job of having one voice, or being on the same page and being aligned with what we want to see happen,” Guthrie said.

Investor takeaway

Psychedelics investors have been impacted by 2022's broad financial downturn, but there's light on the horizon in 2023.

“I think there are deals still being done, depending on the opportunities that are out there … (a) different type of investor is now at the table,” Guthrie said, referring to more established players with longer-term views.

For her part, Velkova told INN that due to the economic downturn, many companies are desperate for new capital to come into play. “I think right now and into the next year will be a great market for new investors to come.”

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

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

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

Additional information on investing in psychedelics stocks — FREE