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Awakn Life Sciences' Phase III Trial to Be Delivered in the UK National Health Service

Awakn Life Sciences' Phase III Trial to Be Delivered in the UK National Health Service

Phase III trial confirmed to cost CA$3.75 million, with a UK Government agency funding 66% of this cost

Awakn Life Sciences Corp. (NEO: AWKN) (OTCQB: AWKNF) (FSE: 954) ('Awakn'), a revenue-generating biotechnology company researching, developing, and commercializing therapeutics to treat addiction with a near-term focus on Alcohol Use Disorder (AUD), announces that its Phase III clinical trial exploring the use of ketamine-assisted therapy for the treatment of severe AUD will be delivered across seven NHS sites in the UK. The trial has also been approved for grant funding for 66% of the costs by the National Institute for Health and Care Research (NIHR), a UK government agency. It is currently forecast the trial will cost approximately CA$3.75 million in total, with Awakn funding approximately CA$1.25 million of that.

The University of Exeter (UoE) will conduct the trial, with Professor Celia Morgan, Professor of Psychopharmacology at UoE and Awakn's Head of Ketamine-Assisted Therapy leading it. 280 people will be recruited with severe AUD and participants will be randomly allocated into two groups. Half will be given ketamine in conjunction with the proprietary psychological therapy, developed for the Phase II trial. The other half will be given a very low dose of ketamine and a seven-session education package about the harmful effects of alcohol.

The Phase III which is intended to be a pivotal trial, follows on from the impressive results of the Phase II a/b trial announced in January 2022, which resulted in participants experiencing on average 86% abstinence at six-months post treatment, versus 2% pre-trial. The Phase III trial will focus on establishing further definitive evidence and move towards the novel treatment being licensed for this indication. Awakn, UoE and the NHS will be working with the UK Department of Health and Social Care and other key stakeholders throughout the trial to facilitate the uptake within the NHS post trial, should the results be positive. It is expected to be the largest ketamine-assisted therapy clinical trial to date and the only Phase III psychedelic clinical trial ever to receive government funding.

Professor Celia Morgan commented: "More than two million UK adults have serious alcohol problems, yet only one in five of those get treatment. Unfortunately, three out of four people who quit alcohol will be back drinking heavily after a year. Alcohol-related harm is estimated to cost the NHS around £3.5 billion each year, and wider UK society around £40 billion. Alcohol problems affect not only the individual but families, friends and communities, and related deaths have increased still further since the pandemic. We urgently need new treatments. If this trial definitively establishes that ketamine and therapy works, we hope we can begin to see it used in NHS settings."

Anthony Tennyson Awakn CEO added "For this phase III to have the support and funding from the NIHR and for it to be delivered in the NHS is a great endorsement of this treatment's potential and a sign of how badly a new more effective treatment is needed to help the millions of people suffering from Alcohol addiction in the UK. We are very proud to be part of this important piece of work. With two Awakn clinics already open in the UK and more in Europe we are already seeing the incredible benefits of this treatment for our clients on an off-label basis."

About Awakn Life Sciences Corp.

Awakn Life Sciences Corp. is a revenue-generating biotechnology company researching, developing, and commercializing therapeutics to treat substance and behavioral addictions. Awakn has a near-term focus on Alcohol Use Disorder (AUD), a condition affecting 285m people globally for which the current standard of care is inadequate. Our goal is to provide effective therapeutics to addiction sufferers in desperate need and our strategy is focused on commercializing our R&D pipeline across multiple channels.

www.AwaknLifeSciences.com | Twitter | LinkedIn | Facebook | www.AwaknClinics.com

Notice Regarding Forward-Looking Information

This news release contains certain forward-looking information and forward-looking statements, as defined in applicable securities laws (collectively referred to herein as "forward-looking statements"). Forward-looking statements reflect current expectations or beliefs regarding future events or the Company's future performance. All statements other than statements of historical fact are forward-looking statements. Often, but not always, forward-looking statements can be identified by the use of words such as "plans", "expects", "is expected", "budget", "scheduled", "estimates", "continues", "forecasts", "projects", "predicts", "intends", "anticipates", "targets" or "believes", or variations of, or the negatives of, such words and phrases or state that certain actions, events or results "may", "could", "would", "should", "might" or "will" be taken, occur or be achieved, including statements relating the business of the Company. All forward-looking statements, including those herein are qualified by this cautionary statement.

Although the Company believes that the expectations expressed in such statements are based on reasonable assumptions, such statements are not guarantees of future performance and actual results or developments may differ materially from those in the statements. There are certain factors that could cause actual results to differ materially from those in the forward-looking information. These include, but are not limited to:COVID-19; fluctuations in general macroeconomic conditions; the business plans and strategies of the Company; the ability of the Company to comply with all applicable governmental regulations in a highly regulated business; the inherent risks in investing in target companies or projects which have limited or no operating history and are engaged in activities currently considered illegal in some jurisdictions; changes in laws; limited operating history; reliance on management; requirements for additional financing; competition; fluctuations in securities markets; inconsistent public opinion and perception regarding the medical-use of psychedelic drugs; expectations regarding the size of the addiction market; and regulatory or political change. Readers are cautioned that the foregoing list of factors is not exhaustive of the factors that may affect forward-looking statements. Accordingly, readers should not place undue reliance on forward-looking statements. The forward-looking statements in this news release speak only as of the date of this news release or as of the date or dates specified in such statements.

Investors are cautioned that any such statements are not guarantees of future performance and actual results or developments may differ materially from those projected in the forward-looking information. For more information on the Company, investors are encouraged to review the Company's public filings on SEDAR at www.sedar.com. The Company disclaims any intention or obligation to update or revise any forward- looking information, whether as a result of new information, future events or otherwise, other than as required by law.

This news release does not constitute an offer to sell, or a solicitation of an offer to buy, any securities in the United States. The Company's and Awakn's securities have not been and will not be registered under the United States Securities Act of 1933, as amended (the "U.S. Securities Act") or any state securities laws and may not be offered or sold within the United States or to U.S. Persons unless registered under the U.S. Securities Act and applicable state securities laws or an exemption from such registration is available.

Investor Enquiries:
Anthony Tennyson, CEO, Awakn Life Sciences
anthony.tennyson@awaknlifesciences.com

Media Enquiries:
Gordo Whittaker, CMO, Awakn Life Sciences
gordo@awaknlifesciences.com

To view the source version of this press release, please visit https://www.newsfilecorp.com/release/147820

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Awakn Life Sciences Announces Signing of Lease for Second Clinic in Norway

Awakn Life Sciences Announces Signing of Lease for Second Clinic in Norway

Trondheim in central Norway will be the location of Awakn's 4th clinic

Awakn Life Sciences Corp. (NEO: AWKN) (OTCQB: AWKNF) (FSE: 954) ('Awakn'), a revenue-generating biotechnology company researching, developing, and commercializing therapeutics to treat addiction with a near-term focus on Alcohol Use Disorder (AUD), announces today the signing of a 5-year lease to open Awakn Clinics Trondheim. The new clinic is part of the second stage of Awakn's Nordic expansion plans, following on from last week's announcement of a move to a larger premises for its Oslo clinic.

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Awakn Life Sciences Announces Location for Larger Oslo Clinic

Awakn Life Sciences Announces Location for Larger Oslo Clinic

Awakn's Nordic expansion begins with new Awakn Clinics Oslo

 Awakn Life Sciences Corp. (NEO: AWKN) (OTCQB: AWKNF) (FSE: 954) ('Awakn'), a revenue-generating biotechnology company researching, developing, and commercializing therapeutics to treat addiction with a near-term focus on Alcohol Use Disorder (AUD), announces today the signing of a 5-year lease to open a larger Awakn Clinics Oslo. The move to the new Oslo premises is the first stage of Awakn's Nordic expansion plans.

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Awakn Life Sciences Signs Its Third Licensing Partnership Agreement in North America, and First in New York

Awakn Life Sciences Signs Its Third Licensing Partnership Agreement in North America, and First in New York

Awakn will Partner with Nushama, One of New York's Leading Ketamine-assisted Therapy Centers

Awakn Life Sciences Corp. (NEO: AWKN) (OTCQB: AWKNF) (FSE: 954) ('Awakn'), a revenue-generating biotechnology company researching, developing, and commercializing therapeutics to treat addiction with a near-term focus on Alcohol Use Disorder (AUD), announces it has signed its third Licensing Partnership agreement in North America. The agreement is with Nushama a leading network of ketamine-assisted therapy centers that exist to humanize medicine, together they will bring Awakn's Ketamine-assisted therapy treatment for AUD to Nushama's clinic in New York City (NYC).

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Awakn Life Sciences Secures Funding to Expand Nordic Commercial Operations

Awakn Life Sciences Secures Funding to Expand Nordic Commercial Operations

Awakn has raised approx. CAD$775K to grow its Nordic clinics business

Awakn Life Sciences Corp. (NEO: AWKN) (OTCQB: AWKNF) (FSE: 954) ("Awakn"), a revenue-generating biotechnology company researching, developing, and commercializing therapeutics to treat addiction with a near-term focus on Alcohol Use Disorder (AUD), today announces that its wholly-owned subsidiary Awakn Oslo AS ("Awakn Oslo") has entered into a debt financing agreement (the "Loan Agreement") with TD Veen AS (the "Lender"), a family-owned, Norwegian investment company and current shareholder of Awakn.

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Awakn Life Sciences Reports Strong Q2 2022 Results

Awakn Life Sciences Reports Strong Q2 2022 Results

Awakn delivered revenue growth of 34% in Q2

Awakn also announces closing of first tranche of private placement financing

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Lobe Sciences, Ltd. Enters Collaborative Clinical Research Agreement with Integrative Headache Medicine of New York to Study the Effects of L-130 in the Treatment of Chronic Cluster Headache

Lobe Sciences, Ltd. Enters Collaborative Clinical Research Agreement with Integrative Headache Medicine of New York to Study the Effects of L-130 in the Treatment of Chronic Cluster Headache

Dr. Lauren R. Natbony to be Principal Investigator

lobe sciences ltd. (CSE: LOBE) (OTCQB: LOBEF) ("Lobe" or the "Company"), a North American Biopharmaceutical company committed to discovering and developing patient-focused psychedelic-derived medicines for neurologic and brain disease, today announced that it has signed an Investigator Initiated Research Agreement with Lauren R. Natbony, MD, FAHS, Founder and Medical Director of Integrative Headache Medicine of New York, to study the tolerability and efficacy of our proprietary psilocin compound L-130, in patients suffering from Cluster Headaches ("CH").

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Lobe Sciences Board of Directors Elects to Receive Shares in Lieu of Cash for All Board Fees

Lobe Sciences Board of Directors Elects to Receive Shares in Lieu of Cash for All Board Fees

  • Endorsement underscores transition into a fully integrated biotechnology company

lobe sciences ltd. (CSE: LOBE) (OTCQB: LOBEF) ("Lobe" or the "Company"), a North American biopharmaceutical company committed to discovering and developing psychedelic derived medicines for neurologic and brain disease today announced its Board of Directors voted to receive shares in Lobe in lieu of the traditional cash renumeration.

Philip J. Young, Chairman and Chief Executive Officer of the Company stated, "This is a tremendous endorsement of our progress and industry leading clinical development plans for 2023 and beyond. Lobe Sciences is proud of our transition into a fully integrated Biotechnology company that has developed the end-to-end capabilities to discover and produce pharmaceutical products. We have the capabilities for cGMP manufacturing, product development combined with industry leading expertise in the regulatory and clinical development of our proprietary psilocin drugs, L-130 and L-131."

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Lobe Sciences Provides Update For 2023 Milestones

Lobe Sciences Provides Update For 2023 Milestones

lobe sciences ltd. (CSE: LOBE) (OTCQB: LOBEF) ("Lobe" or the "Company"), a North American Biopharmaceutical company committed to discovering and developing patient focused psychedelic derived medicines for neurologic and brain disease today announced an updated overview for 2023.

Mr. Philip Young, Chairman and Chief Executive Officer of the Company, stated, "2022 was a productive year for Lobe Sciences. We increased our intellectual property portfolio with several new chemical entities (NCEs) derived from well-known psychedelic compounds, adding two of these, L-130 and L-131, to our development program. We solidified relationships with outstanding research and development teams, who affirmed their support for Lobe by taking an equity stake in the Company. Research collaborations with contract research organizations (CRO) were penned and we began work on a human Phase I Safety and Pharmacokinetics program to ascertain the bioavailability and metabolism of L-130. This trial will be the first of three similar trials that will determine the highest concentration of this NCE without an hullucinagenic effect. International Regulatory filings were completed and accepted in 2022. We expect to begin enrollment in early 2023."

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Trippy Trading: Top Psychedelic Stocks For 2023

Trippy Trading: Top Psychedelic Stocks For 2023

(NewsDirect)

When psychedelics were first studied more than 50 years ago, researchers discovered that they were useful in assisting people in exploring a greater sense of self. After a half-century hiatus, scientists are once again investigating psychedelics and other mind-altering substances such as MDMA, psilocybin, and ketamine as treatments for depression, PTSD, anxiety, and other mental health conditions.

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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


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The Investing News Network is a growing network of authoritative publications delivering independent,
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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.

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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?

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