Life Science News

COMP360 psilocybin therapy shows potential in open-label study in type II bipolar disorder presented at ACNP

12 out of 14 patients went into remission for three months following a single 25mg dose of COMP360 psilocybin therapy, in an independent investigator-initiated, exploratory open-label study of type II bipolar disorder

New data from COMPASS' phase 2b trial, also presented at ACNP, validate potential of COMP360 psilocybin therapy in treatment-resistant depression

COMPASS Pathways plc (Nasdaq: CMPS) ("COMPASS"), a mental health care company dedicated to accelerating patient access to evidence-based innovation in mental health, today announced that new positive data demonstrating the potential of COMP360 psilocybin therapy in depression have been presented at the Annual Meeting of the American College of Neuropsychopharmacology (ACNP). The results were presented from an investigator-initiated, exploratory open-label study of investigational COMP360 psilocybin therapy in type II bipolar disorder and a mechanistic analysis of the phase 2b trial of COMP360 psilocybin therapy in treatment-resistant depression (TRD).

Type II bipolar disorder
Positive early signals have been presented in a poster from an open-label pilot study, which investigated the safety and efficacy of a single 25mg dose of COMP360 psilocybin therapy in participants with type II bipolar disorder depression. 1 The study, run by Dr Scott Aaronson at Sheppard Pratt Baltimore, found that 86% (12 out of 14) of the participants met response and remission criteria for the Montgomery-Åsberg Depression Rating Scale (MADRS) at 12 weeks after COMP360 psilocybin therapy. There was no increase in the suicidality score based on the MADRS, no manic symptoms and no unexpected adverse events or difficulties with the dosing sessions reported throughout the study.

"Type II bipolar disorder can have a huge impact on people's lives, as well as their loved ones, and is extremely difficult to treat. It is really encouraging to have seen 12 of 14 participants go into remission lasting three months, following just a single dose of 25mg of COMP360 psilocybin therapy. These findings now need to be validated in larger studies," said Scott Aaronson, MD, Chief Science Officer, Institute for Advanced Diagnostics and Therapeutics, Sheppard Pratt.

Treatment-resistant depression (TRD)
New data from the recently published phase 2b trial of COMP360 psilocybin therapy, also presented at ACNP, further demonstrated its potential in treatment-resistant depression, and how it may work: 2,3

  • Mechanism of action validated: experiencing emotional breakthrough* and specific aspects of the subjective psychedelic experience** predicted reductions in depression severity three weeks after receiving COMP360 psilocybin therapy. The relationship between positive psychedelic experience and treatment response was seen for all three doses studied.
  • Effect of higher dose: whilst both the 10mg and 25mg dose of COMP360 psilocybin produced a subjective psychedelic experience, the 25mg dose was significantly better at reducing depressive symptoms compared to a 1mg dose, whereas the 10mg dose was not found to be significantly better than 1mg.
  • Psychological support: the therapeutic alliance between the participant and therapist did not predict improvement in symptoms of depression, suggesting that COMP360 psilocybin may provide greater therapeutic effect via its pharmacological action. This hypothesis will be tested further in COMPASS' phase 3 programme.

Dr David Feifel, Principal Investigator in the COMPASS phase 2b study at Kadima Neuropsychiatry Institute, La Jolla, California, said, "The positive results published in the New England Journal of Medicine showed the efficacy of COMP360 psilocybin in treatment-resistant depression, and now these new findings are providing insights on how that antidepressant effect may be produced. This new analysis suggests that positive psychedelic experiences facilitate emotional breakthrough which may change thought patterns in people with depression."

Dr Guy Goodwin, Chief Medical Officer, COMPASS Pathways, added, "These studies provide further evidence to support COMP360 psilocybin therapy's potential for difficult-to-treat depression. Psilocybin binds to serotonin receptors in the brain, and by allowing different brain regions to connect and communicate more easily than usual, it produces a profound psychedelic experience. This experience is driven by drug dose and correlates with the effect on depressive symptoms. Psychological support is focused on safety, which facilitates the psychedelic experience, but does not directly drive the effect on depression: it is not a psychotherapy."

COMPASS Pathways is running the world's first phase 3 programme of COMP360 psilocybin therapy in treatment-resistant depression – for more information please click here .

*Measured by the Emotional Breakthrough Inventory, a validated scale which assesses emotional experience.

**Aspects including oceanic boundlessness, visual restructuralisation, and auditory alterations – as measured by the Five-Dimensional Altered States of Consciousness questionnaire.


About treatment-resistant depression (TRD)

More than 320 million people globally suffer with major depressive disorder (MDD) 4 , the leading cause of disability worldwide and one of the fastest growing mental health illnesses 5 . About a third of these patients – 100 million people – aren't helped by existing therapies and suffer with treatment-resistant depression (TRD) 6 . As many as 30% of these attempt suicide at least once during their lifetime 7,8 . TRD carries two to three times the medical costs of a non-TRD MDD patient, and patients with TRD have a higher all-cause mortality compared with non-TRD MDD patients 9 . The TRD population is by definition more difficult to treat and more likely to relapse than patients with major depressive disorder. In 2018, COMPASS received FDA Breakthrough Therapy designation for its COMP360 psilocybin therapy for TRD.

About type II bipolar disorder

Bipolar disorders are a complex group of severe and chronic disorders affecting approximately 40 million people globally 10,11 . Bipolar I disorder (BP-I) and bipolar II disorder (BP-II) are some of the major forms of bipolar disorders 12. While both involve shifts in mood, energy, activity levels and concentration, they differ in the intensity of manic episodes and the prevalence of major depressive episodes 9 . Bipolar disorders are associated with high levels of functional impairment, morbidity, mortality, and an increased risk of suicide 13 . In fact, they have the highest rate of suicide of all psychiatric conditions which is about 30 times that of the general population 14 .

About COMP360 psilocybin therapy

COMP360 is our proprietary stabilised, high-purity polymorphic crystalline synthesised formulation of psilocybin. Psilocybin acts on serotonin 2a receptors in the brain. It's believed that acting on this receptor may make the brain work with greater flexibility, allowing regions to connect and communicate more easily. Connections underlying unhealthy brain states, such as TRD, may reconnect in a healthier way after the drug effects have worn off 15 .

About the COMP360 psilocybin therapy phase 2b study

This randomised, controlled, multicentre, double-blind phase 2b trial is the largest psilocybin therapy clinical trial ever conducted, with 233 patients from 10 countries in North America and Europe. 94% of the patients had no prior experience with psilocybin. The objective of the trial was to find the appropriate dose for a larger, pivotal phase 3 programme, which COMPASS expects to begin in 2022.

The trial assessed the safety and efficacy of COMP360 psilocybin therapy at three doses: 1mg, 10mg, 25mg. A total of 233 patients enrolled in the study and were randomised and blinded into three arms comprising 79 patients for each of the 25mg and 1mg doses, and 75 patients for the 10mg dose. Patients were followed up for 12 weeks. The trial used the Montgomery-Åsberg depression rating scale (MADRS), a widely used and accepted scale for assessing depression; assessments were made by an independent, blinded rater. The primary endpoint was the change in the MADRS total score from baseline to week 3.

COMP360 psilocybin was generally well-tolerated. On the day of COMP360 administration, headache, nausea, and dizziness were the most common adverse events where a dose-related increase in incidence was evident . Suicidal ideation and intentional self-injury were seen in all treatment groups (as is regularly observed in a TRD population). The majority of cases occurred more than a week after the COMP360 psilocybin session. There was no mean worsening of suicidal ideation scores on the MADRS scale in any treatment group. Suicidal behaviours were reported at least one month after COMP360 administration for three non-responders in the 25mg arm.

About COMPASS Pathways

COMPASS Pathways plc (Nasdaq: CMPS) is a mental health care company dedicated to accelerating patient access to evidence-based innovation in mental health. Our focus is on improving the lives of those who are suffering with mental health challenges and who are not helped by current treatments. We are pioneering the development of a new model of psilocybin therapy, in which our proprietary formulation of synthetic psilocybin, COMP360, is administered in conjunction with psychological support. COMP360 has been designated a Breakthrough Therapy by the US Food and Drug Administration (FDA) and has received Innovative Licensing and Access Pathway (ILAP) designation in the UK for treatment-resistant depression (TRD). We have completed a phase 2b clinical trial of psilocybin therapy for TRD, in 22 sites across Europe and North America and we are preparing to commence a phase 3 programme by the end of 2022. This was the largest randomised, controlled, double-blind psilocybin therapy clinical trial ever conducted, and our topline data showed a statistically significant (p www.compasspathways.com

Availability of other information about COMPASS Pathways

Investors and others should note that we communicate with our investors and the public using our website (www.compasspathways.com), our investor relations website (ir.compasspathways.com), and on social media (LinkedIn), including but not limited to investor presentations and investor fact sheets, US Securities and Exchange Commission filings, press releases, public conference calls and webcasts. The information that we post on these channels and websites could be deemed to be material information. As a result, we encourage investors, the media, and others interested in us to review the information that is posted on these channels, including the investor relations website, on a regular basis. This list of channels may be updated from time to time on our investor relations website and may include additional social media channels. The contents of our website or these channels, or any other website that may be accessed from our website or these channels, shall not be deemed incorporated by reference in any filing under the Securities Act of 1933.

Forward-looking statements

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, as amended. In some cases, forward-looking statements can be identified by terminology such as "may", "might", "will", "could", "would", "should", "expect", "intend", "plan", "objective", "believe", "contemplate", "estimate", "potential", "continue" and "ongoing," or the negative of these terms or other comparable terminology, although not all forward-looking statements contain these words. Forward-looking statements include express or implied statements relating to, among other things, the safety or efficacy of COMP360 psilocybin therapy as a treatment for treatment-resistant depression or bipolar II depression, COMPASS's ability to secure regulatory approval for COMP360 psilocybin therapy, COMPASS's business strategy and goals, including its ability to launch and commercialise COMP360 psilocybin therapy, COMPASS's ability to continue to advance its research or develop plans to bring COMP360 psilocybin therapy to patients, including COMP360, and COMPASS's expectations regarding the benefits of its COMP360 psilocybin therapy. The forward-looking statements in this press release are neither promises nor guarantees, and you should not place undue reliance on these forward-looking statements because they involve known and unknown risks, uncertainties, and other factors, many of which are beyond COMPASS's control and which could cause actual results, levels of activity, performance or achievements to differ materially from those expressed or implied by these forward-looking statements.

These risks, uncertainties, and other factors include, among others: clinical development is lengthy and uncertain, and therefore our clinical trials may be delayed or terminated, or may never advance to a regulatory filing or support regulatory approval; and those risks and uncertainties described under the heading "Risk Factors" in COMPASS' most recent annual report on Form 10-K or quarterly report on Form 10-Q and in other reports we have filed with the U.S. Securities and Exchange Commission ("SEC"), which are available on the SEC's website at www.sec.gov. Except as required by law, COMPASS disclaims any intention or responsibility for updating or revising any forward-looking statements contained in this press release in the event of new information, future developments or otherwise. These forward-looking statements are based on COMPASS's current expectations and speak only as of the date hereof.

Enquiries

Media: Amy Lawrence, amy@compasspathways.com, +44 7813 777 919
Investors: Stephen Schultz, stephen.schultz@compasspathways.com, +1 401 290 7324

References:

[1] An Open Label Study of the Safety and Efficacy of COMP360 (COMPASS Pathways Proprietary Synthetic Psilocybin) in Participants with Type II Bipolar Disorder (BP-II) Depression.
[2] Dose-dependent acute subjective psychedelic effects following COMP360 psilocybin across three clinical studies and its relationship to therapeutic response [poster]. Presented at the Annual Meeting of the American College of Neuropsychopharmacology; December 4-7, 2022; Phoenix, Arizona. Available at: https://compasspathways.com/wp-content/uploads/2022/11/COMPASS_ACNP_DoseDependentEffects.pdf
[3] Predicting depression outcomes through the influence of therapeutic alliance and the psychedelic experience using path modeling in a phase IIb randomized controlled trial of COMP360 psilocybin therapy [poster]. Presented at the Annual Meeting of the American College of Neuropsychopharmacology; December 4-7, 2022; Phoenix, Arizona. Available at: https://compasspathways.com/wp-content/uploads/2022/11/COMPASS_ACNP_PathAnalysis.pdf
[4] WHO (2017). Depression and Other Common Mental Disorders Global Health Estimates [Online]. Available at: https://apps.who.int/iris/bitstream/handle/10665/254610/WHO-MSD-MER-2017.2-eng.pdf [Accessed November 2022]
[5] WHO (2012). Depression: A Global Crisis [Online]. Available at: https://www.wfmh.org/2012DOCS/WMHDay%202012%20SMALL%20FILE%20FINAL.pdf [Accessed November 2022]
[6] Al-harbi. (2012). Treatment-resistant depression: therapeutic trends, challenges, and future directions. Patient Preference and Adherence, 369. https://doi.org/10.2147/ppa.s29716
[7] Bergfeld, I. O., Mantione, M., Figee, M., Schuurman, P. R., Lok, A., & Denys, D. (2018). Treatment-resistant depression and suicidality. Journal of Affective Disorders, 235, 362–367. https://doi.org/10.1016/j.jad.2018.04.016
[8] Dong, M., Lu, L., Zhang, L., Zhang, Q., Ungvari, G. S., Ng, C. H., Yuan, Z., Xiang, Y., Wang, G., & Xiang, Y.-T. (2019). Prevalence of suicide attempts in bipolar disorder: a systematic review and meta-analysis of observational studies. Epidemiology and Psychiatric Sciences, 29. https://doi.org/10.1017/s2045796019000593
[9] Li, G., Fife, D., Wang, G., Sheehan, J. J., Bodén, R., Brandt, L., Brenner, P., Reutfors, J., & DiBernardo, A. (2019). All-cause mortality in patients with treatment-resistant depression: a cohort study in the US population. Annals of General Psychiatry, 18(1). https://doi.org/10.1186/s12991-019-0248-0
[10] McIntyre, R. S., Berk, M., Brietzke, E., Goldstein, B. I., López-Jaramillo, C., Kessing, L. V., Malhi, G. S., Nierenberg, A. A., Rosenblat, J. D., Majeed, A., Vieta, E., Vinberg, M., Young, A. H., & Mansur, R. B. (2020). Bipolar disorders. The Lancet, 396(10265), 1841–1856. https://doi.org/10.1016/s0140-6736(20)31544-0
[11] WHO (2022). Mental disorders [Online]. Available at: https://www.who.int/news-room/fact-sheets/detail/mental-disorders
[12] National Institute of Mental Health. (2020, Jan.). Bipolar Disorder. https://www.nimh.nih.gov/health/topics/bipolar-disorder/index.shtml [13] Munoli, R. N., Praharaj, S. K., & Sharma, P. S. V. N. (2014). Co-morbidity in Bipolar Disorder: A Retrospective Study. Indian Journal of Psychological Medicine, 36(3), 270–275. https://doi.org/10.4103/0253-7176.135377
[14] Miller, J. N., & Black, D. W. (2020). Bipolar Disorder and Suicide: a Review. Current Psychiatry Reports, 22(2). https://doi.org/10.1007/s11920-020-1130-0
[15] Carhart-Harris, R. L., & Friston, K. J. (2019). REBUS and the Anarchic Brain: Toward a Unified Model of the Brain Action of Psychedelics. Pharmacological Reviews, 71(3), 316–344. https://doi.org/10.1124/pr.118.017160


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FREE 2023 Psychedelics Investor Report

FREE 2023 Psychedelics Investor Report

Find out what is in store for psychedelics in 2023!

The Investing News Network (INN) spoke with analysts, market watchers and insiders about which trends will impact psychedelics in the year ahead.

✓ Trends        ✓ Forecasts       ✓ Top Stocks


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 Outlook 2022



A Sneak Peek At What The Insiders Are Saying

"I think right now and into the next year will be a great market for new (psychedelics) investors."
— Maria Velkova, Tabula Rasa Ventures

“We've now seen a real focus (among psychedelics companies) in prioritizing what is really going to create value."
— Payton Nyquvest, Numinus Wellness


Who We Are

The Investing News Network is a growing network of authoritative publications delivering independent,
unbiased news and education for investors. We deliver knowledgeable, carefully curated coverage of a variety
of markets including gold, cannabis, biotech and many others. This means you read nothing but the best from
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of research yourself.

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investment advisor: We choose our content based solely on its informational and educational value to you,
the investor.

So if you are looking for a way to diversify your portfolio amidst political and financial instability, this
is the place to start. Right now.

Psychedelics Outlook 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.

Anthony Tennyson


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

Keep reading...Show less
person using psychedelics treatment

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.

Keep reading...Show less

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