Psychedelic Medicine Sector

[MomsSpaghetti]

Congressional Psychedelics Advancing Therapies (PATH) Caucus - Full PDF from Association for Prescription Psychedelics Inc.

https://www.psychedelicsrx.org/wp-content/uploads/2025/03/RESPONSE_APP_PATH-Caucus_RFI_FINAL.pdf

[MomsSpaghetti]

FDA Under Trump and the Future of Psychedelics
A turning point for mental health?

$MNMD, $ATAI, $CMPS

Posted December 4, 2024 | Reviewed by Monica Vilhauer Ph.D.

https://www.psychologytoday.com/us/blog/psychedelics-to-the-rescue/202412/fda-under-trump-and-the-future-of-psychedelics

[MomsSpaghetti]

Senate panel advances RFK Jr.'s nomination to be health secretary

Big for Psychedelic stocks

https://www.nbcnews.com/politics/congress/senate-panel-advances-rfk-jrs-nomination-health-secretary-rcna190438

[MomsSpaghetti]

Woman free of anxiety meds 1 year after Cleveland Clinic MindMed (MNMD) LSD trial success

https://www.cleveland.com/medical/2024/05/woman-free-of-anxiety-meds-1-year-after-cleveland-clinic-lsd-trial-success.html

Barnett expects LSD to be approved as a psychiatric treatment by 2027 -- with intensive training and logistics before the treatment can be rolled out."

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>>> Why Innovative Industrial Properties Stock Plunged Today


by Jeremy Bowman

Motley Fool

December 20, 2024


https://finance.yahoo.com/news/why-innovative-industrial-properties-stock-173514594.html


Shares of Innovative Industrial Properties (NYSE: IIPR), the country's leading cannabis real estate investment trust (REIT), were taking a dive today after it announced that PharmaCann, one of its biggest tenants, was defaulting on all 11 of its leases.

As of 11:09 a.m. ET, the stock was down 20% on the news.

Challenges continue in the cannabis industry

This morning, IIP said that PharmaCann, the nation's largest privately held and vertically integrated cannabis company, defaulted on its rent obligation in six of its 11 leases. Rent owed for those six properties, each in a different state, totaled $4.2 million for December.

PharmaCann did pay rent for its remaining five leases, which total $90,000 for December, but because of cross-default provisions in the leases, PharmaCann also defaulted on the leases whose rent it had paid.

The two companies are continuing to negotiate, though IIP expects to "enforce its rights under the leases aggressively," which could lead to eviction.

What it means for IIP

The default is significant for Innovative Industrial Properties as the PharmaCann properties represented 17% of the company's revenue in the third quarter and the first three quarters of 2024.

IIP has experienced defaults in the past, but this may be the biggest one on record. The cannabis sector has continued to struggle as progress at the federal level has been stymied, and a supply glut continues to weigh on prices.

As a REIT, IIP rises and falls with the broader industry, meaning it's likely to struggle until growers start delivering consistent and reliable growth.

With PharmaCann's default, the outlook for the sector and IIP only looks more uncertain.

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[MomsSpaghetti]

$MNMD Notes and Updates

They have a cash runway through completing their Phase 3 trials. For which they have two. I suggest everyone look at their latest Corporate Presentation - December 2024:

https://d1io3yog0oux5.cloudfront.net/_25951dd8646049733b7a9ba6d9a4c850/mindmed/db/2265/21500/pdf/MindMed+Investor+Presentation+December+2024+.pdf

Also, since they have received FDA Breakthrough Status they also interacted with the FDA. See Docket Number: FDA-2023-D-1987: Psychedelic Drugs: Considerations for Clinical Investigations; Draft Guidance for Industry; Availability

https://downloads.regulations.gov/FDA-2023-D-1987-0197/attachment_1.pdf

They have also added an Ex-FDA person to their already stellar staff. He recently gave a presentation that is notable:

Psychedelic Clinical Trials: Regulatory Consideration from the FDA - Javier Muniz, MD - https://www.nationalacademies.org/documents/embed/link/LF2255DA3DD1C41C0A42D3BEF0989ACAECE3053A6A9B/file/DC13F898D77B1738F10CD41B1FB160CB84D5802C8F6F?noSaveAs=1

The stars are aligning and MindMed has a very high chance of being bought out or better yet actually bringing their main drug candidates to market.

I know the hype is around mushrooms, but they will likely become a commodity like cannabis. The money will be in true pharmaceuticals that will be hard to reproduce at the street level. I am not against the naturalists. But MindMed has the lock on LSD and will hit the market first (After J&J)

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>>> J&J’s comeback kid Spravato heads for blockbuster status


Yahoo Finance

by Meagan Parrish

October 25, 2024


https://finance.yahoo.com/news/j-j-comeback-kid-spravato-074632633.html


This story was originally published on PharmaVoice. To receive daily news and insights, subscribe to our free daily PharmaVoice newsletter.

Johnson & Johnson’s esketamine nasal spray Spravato didn’t look like a sure-fire win after it hit the market in 2019. Despite blazing a new trail as the first psychedelic-based treatment to score an FDA nod, the depression medication got off to a sluggish start, and the company didn’t even report sales figures for the first few years. Times have changed.

J&J reported that Spravato reached worldwide sales of $780 million in the first nine months of 2024 — 62% higher than the same period the year before. The story was the same in 2023 when Spravato sales spiked 89% in the first three quarters compared to 2022.

What’s been driving that growth?

Following the initial launch, critics took aim at Spravato’s efficacy and pricing, and the treatment was ultimately rejected for coverage in the U.K.

And then pandemic-related challenges further stymied the launch by complicating arrangements for the drug’s necessary medical supervision. After in-person doctor visits were once again the norm, J&J began to market the drug more heavily and raise its profile.

“We always knew it would take time to see significant uptake — new models of care always do — but the overwhelming patient need continues to drive treatment center expansion,” Bill Martin, global neuroscience therapeutic area head at Johnson & Johnson Innovative Medicine, said in an email.

J&J’s neuroscience darling

$780 million

Global Spravato sales in the first three quarters of 2024.

$483 million

Global Spravato sales in the first three quarters of 2023.

2,800

Treatment centers currently administering Spravato, according to J&J.

Martin pointed to the accumulation of safety and efficacy data over time as another contributor to its gradual acceptance — five years of real-world data and a head-to-head study demonstrating superior efficacy gave physicians higher confidence in the treatment, he said.

Now J&J’s fastest growing drug, Spravato could become a blockbuster, according to both analysts and the company, with forecasts for $1 billion to $5 billion in peak sales.

Winning expanded indications could help Spravato surpass that threshold. Spravato is currently approved as an adjunctive therapy alongside oral medications in treatment resistant depression and major depressive disorder, and in July, J&J asked the FDA to also greenlight the drug to be prescribed on its own.

“The filing is based on phase 4 data which showed rapid improvement in depressive symptoms at around 24 hours and was sustained through the four weeks endpoint,” Martin said. “If approved, it will be the first monotherapy treatment option available for adults with TRD.”

While J&J currently has a lock on the current market for esketamine, emerging companies are targeting a similar approach but in much earlier stages. Mira Pharmaceuticals, for example, is in preclinical development with a ketamine-based treatment for neuropathic pain and depression and aims to start clinical trials early next year.

For J&J, keeping Spravato’s momentum will be crucial for its plans to become a neuroscience powerhouse.

“Spravato is the foundation for our growing neuroscience portfolio in [major depressive disorder] and a growth driver for J&J,” Martin said.

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>>> MindMed Announces First Patient Dosed in Phase 3 Voyage Study of MM120 in Generalized Anxiety Disorder (GAD)


- Voyage is the first-ever Phase 3 study of lysergide D-tartrate (LSD) with the primary endpoint measuring the change from baseline in the Hamilton Anxiety Rating Scale (HAM-A) score at week 12 for MM120 Orally Disintegrating Tablet (ODT) 100 µg vs placebo -

- Study builds on positive Phase 2b study results presented at the American Psychiatric Association’s Annual Meeting in May 2024 -

- Topline data from the 12-week double-blind period anticipated in the first half of 2026 -


December 16, 2024


https://www.businesswire.com/news/home/20241216046321/en/


NEW YORK--(BUSINESS WIRE)--Mind Medicine (MindMed) Inc. (NASDAQ: MNMD), (the "Company" or "MindMed"), a clinical-stage biopharmaceutical company developing novel product candidates to treat brain health disorders, today announced that the first patient has been dosed in its Phase 3 Voyage study of MM120 ODT, a pharmaceutically optimized form of lysergide D-tartrate (LSD) for the treatment of GAD. Voyage is the first of two Phase 3 studies in GAD evaluating the efficacy and safety of MM120 ODT versus placebo and is expected to enroll approximately 200 participants in the United States. The Panorama study, the second Phase 3 trial, will be conducted in the U.S. and Europe and is on track to initiate in the first half of 2025.

“Management's Discussion and Analysis of Financial Condition and Results of Operations”

“Today marks a pivotal moment in our journey towards advancing a novel treatment option for the 20 million people1 in the U.S. living with GAD. Building on our scientifically rigorous Phase 2b study, which demonstrated efficacy that far exceeds today’s standard of care and a favorable tolerability profile, our Phase 3 studies are designed to adhere to the highest clinical and ethical standards and are in alignment with guidance from the U.S. Food and Drug Administration,” said Daniel R. Karlin, M.D., M.A., Chief Medical Officer of MindMed.

The 52-week Voyage study will be conducted in two parts: Part A, a 12-week, randomized, double-blind, placebo-controlled, parallel group period; and Part B, a 40-week extension period during which participants will be eligible for open-label treatment with MM120 ODT based on symptom severity. The primary endpoint of Voyage will measure the change from baseline in HAM-A at Week 12, which is consistent with the durable clinical effect observed in the Phase 2b study.

“It is critical to continue to develop new and effective treatment options for patients with GAD, a debilitating condition where there is an urgent need for transformational innovation,” said David Feifel, M.D., Ph.D., Professor Emeritus of Psychiatry at the University of California, San Diego and Director of the Kadima Neuropsychiatry Institute in La Jolla, California and an investigator in the Voyage study. “The design of the MM120 ODT Phase 3 clinical program directly builds on the robust Phase 2b study results and incorporates best-in-class methodologies to mitigate the impact of functional unblinding, including the use of independent central raters blinded to both treatment assignment and visit number. The studies have also been designed to isolate the standalone drug effect of MM120 ODT from other psychotherapeutic intervention and follow industry best practices for safety monitoring.”

About Generalized Anxiety Disorder (GAD)

GAD is a common condition associated with significant impairment that adversely affects millions of people. GAD results in fear, continuing anxiety, and a constant feeling of being overwhelmed. It is characterized by excessive, persistent, and unrealistic worry about everyday things. Approximately 10% of U.S. adults, representing around 20 million people1, currently suffer from GAD. This underdiagnosed and underserved mental health disorder is associated with less accomplishment at work and reduced labor force participation. Despite the significant personal and societal burden of GAD, there has been little innovation in the treatment of GAD in the past several decades, with the last new drug approval occurring in 2007.

About MM120 Orally Disintegrating Tablet (ODT)

MM120 ODT (lysergide D-tartrate or LSD) is a synthetic ergotamine belonging to the group of classic, or serotonergic, psychedelics which acts as a partial agonist at human serotonin-2A (5-HT2A) receptors. MM120 ODT is MindMed’s proprietary and pharmaceutically optimized form of LSD. MM120 ODT is an advanced formulation incorporating Catalent’s Zydis® ODT fast-dissolve technology which has a unique clinical profile with more rapid absorption, improved bioavailability and reduced gastrointestinal side effects.

The MM120 ODT Phase 3 clinical development program includes the Voyage and Panaroma studies in generalized anxiety disorder (GAD) and the Emerge study in major depressive disorder (MDD). Additional clinical indications are under consideration. MindMed’s Phase 2b study, MMED008, met its primary and key secondary endpoints and demonstrated rapid, clinically meaningful, and statistically significant improvements on the Hamilton Anxiety Rating Scale (HAM-A) at Week 4 and Week 12, with a 65% clinical response rate and 48% clinical remission rate sustained to Week 12 in the MM120 100 µg cohort. MM120 was generally well-tolerated in this study, with most adverse events rated as mild to moderate, transient, and occurring on the dosing day and being consistent with the expected acute effects of the trial drug.

Based on the significant unmet medical need in the treatment of GAD along with the initial clinical data from the Phase 2b study and other research conducted by MindMed, the U.S. Food & Drug Administration (FDA) has granted Breakthrough Therapy Designation (BTD) for the MM120 program in GAD.

About MindMed

MindMed is a clinical-stage biopharmaceutical company developing novel product candidates to treat brain health disorders. Our mission is to be the global leader in the development and delivery of treatments that unlock new opportunities to improve patient outcomes. We are developing a pipeline of innovative product candidates, with and without acute perceptual effects, targeting neurotransmitter pathways that play key roles in brain health. MindMed trades on NASDAQ under the symbol MNMD.

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>>> MindMed to Be Added to the Nasdaq Biotechnology Index


Business Wire

December 19, 2024


https://finance.yahoo.com/news/mindmed-added-nasdaq-biotechnology-index-120000637.html


NEW YORK, December 19, 2024--(BUSINESS WIRE)--Mind Medicine (MindMed) Inc. (Nasdaq: MNMD), (the "Company" or "MindMed"), a clinical-stage biopharmaceutical company developing novel product candidates to treat brain health disorders, today announced that it will be added to the Nasdaq Biotechnology Index (NBI), effective at market open on Monday, December 23, 2024.

"2024 has been a transformational year for MindMed. We’ve successfully executed many important milestones, including raising approximately $250 million through two equity financings, obtaining a newly issued patent covering MM120 orally disintegrating tablet (ODT) and extending intellectual property protection through 2041, expanding our pipeline to include MM120 ODT for major depressive disorder, and most recently, launching Voyage, our Phase 3 study of MM120 ODT in generalized anxiety disorder," said Rob Barrow, Chief Executive Officer of MindMed. "We are in a pivotal phase in our growth and the addition to the NBI further validates our potential in delivering long-term value to shareholders as we progress our pipeline and aim to deliver transformational innovation for people living with brain health disorders."

The NBI is designed to track the performance of a set of securities listed on The Nasdaq Stock Market® (Nasdaq®) that are classified as either biotechnology or pharmaceutical according to the Industry Classification Benchmark (ICB). The NBI is calculated under a modified capitalization-weighted methodology. Companies in the NBI must meet eligibility requirements, including minimum market capitalization, average daily trading volume, and seasoning as a public company, among other criteria. Nasdaq selects constituents once annually in December.

For more information about the NBI, please visit https://indexes.nasdaqomx.com/Index/Overview/NBI.

About MindMed

MindMed is a clinical-stage biopharmaceutical company developing novel product candidates to treat brain health disorders. Our mission is to be the global leader in the development and delivery of treatments that unlock new opportunities to improve patient outcomes. We are developing a pipeline of innovative product candidates, with and without acute perceptual effects, targeting neurotransmitter pathways that play key roles in brain health. MindMed trades on Nasdaq under the symbol MNMD.

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>>> FDA rejects psychedelic MDMA as treatment for PTSD, calling for additional study


AP

by MATTHEW PERRONE

8-9-24


https://www.msn.com/en-us/health/other/fda-rejects-psychedelic-mdma-as-treatment-for-ptsd-calling-for-additional-study/ar-AA1oyd81?ocid=BingNewsSerp


WASHINGTON (AP) — Federal health regulators on Friday declined to approve the psychedelic drug MDMA as a therapy for PTSD, a major setback for groups seeking a breakthrough decision in favor of using mind-altering substances to treat serious mental health conditions.

Drugmaker Lykos Therapeutics said the FDA notified the company that its drug “could not be approved based on data submitted to date,” and requested an additional late-stage study. Such studies generally take several years and millions of dollars to conduct. The company said it plans to ask the agency to reconsider.

Lykos and other psychedelic companies had hoped that MDMA would be approved and pave the way for other hallucinogenic drugs to enter the medical mainstream. If the FDA had granted the request, MDMA, also known as ecstasy or molly, would have become the first illegal psychedelic to become a federally approved medicine.

The FDA’s decision was expected after a panel of government advisors voted overwhelmingly against the drug’s use for post-traumatic stress disorder in June. The negative vote came after an all-day meeting in which experts scrutinized Lykos’ study data, research methods and possible risks of the drug, including heart problems, injury and abuse.

FDA said Friday the MDMA application had “significant limitations” that “prevent the agency from concluding that the drug is safe and effective for the proposed indication.” The agency said it will continue encouraging “innovation for psychedelic treatments and other therapies to address these medical needs.”

Lykos said the issues FDA raised in what's called a complete response letter echoed the concerns during the June meeting.

“The FDA request for another study is deeply disappointing," Lykos CEO Amy Emerson said Friday in a statement. “Our heart breaks for the millions of military veterans, first responders, victims of sexual and domestic abuse and countless others suffering from PTSD who may now face more years without access to new treatment options.”

Lykos is essentially a corporate spinoff of the nation’s leading psychedelic advocacy group, the Multidisciplinary Association for Psychedelic Studies, or MAPS, which funded the initial studies of MDMA by raising millions of dollars from wealthy backers.

The group has been a pioneer in researching the medical use of psychedelics, which major pharmaceutical companies have been unwilling to fund. Two small studies submitted to the FDA suggested combining MDMA with talk therapy led to significant easing of PTSD symptoms.

Antidepressants are now the only FDA-approved drugs for PTSD, which is closely linked to depression, anxiety and suicidal thinking and is more prevalent among women and veterans.

In recent years, MDMA research has been widely publicized by combat veterans, who say the lack of treatments options for the condition has contributed to higher rates of suicide among military personnel. Last month, veterans supporting psychedelic therapy rallied on Capitol Hill in support of the drug. And more than 80 House and Senate lawmakers have signed letters to the FDA in recent weeks urging MDMA's approval.

But FDA’s review brought new scrutiny to the research. The vast majority of patients in Lykos' studies correctly guessed whether they had received MDMA or a dummy pill, making it “nearly impossible” to maintain the “blinding” which is considered essential for medical research, according to FDA internal staffers.

In recent months, separate allegations of misconduct have emerged, including that some researchers involved in the studies coached patients to suppress negative results or inflate positive ones.

Despite the setback, many experts say other psychedelics may fare better before the agency.

MDMA is the first in a series of psychedelics that are expected to be reviewed by the FDA in coming years as part of a resurgence of interesting into their therapeutic potential.

The idea of using psychedelics to enhance psychotherapy is not new. A handful of therapists in California used MDMA during the 1970s and 1980s — when it was still legal — to facilitate couples therapy sessions. MAPS was founded in 1986 to oppose a federal decision placing MDMA in the same ultra-restrictive drug category as heroin, LSD and other illegal psychedelics.

MAPS' studies of MDMA began more than a decade ago. Since then, dozens of small, startup drugmakers have entered the field, studying other substances like psilocybin and LSD for conditions including depression, addiction and anxiety. Those studies are generally larger and more rigorous than the MDMA studies submitted to the FDA.

Two drug developers, Compass Pathways and Usona Institute, are conducting late-stage studies of psilocybin — the active ingredient in magic mushrooms — for severe depression.

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>>> Psilocybin mushrooms most popular hallucinogen in United States


UPI

by Carole Tanzer Miller

HealthDay News

6-27-24


https://www.msn.com/en-us/health/other/psilocybin-mushrooms-most-popular-hallucinogen-in-united-states/ar-BB1p0bDQ?ocid=BingNewsSerp


As psilocybin mushrooms become the most popular psychedelic in the United States, some states have started to ease regulations on its recreational use.

Now, a new report warns that the federal government will have to decide whether to follow suit.

RAND, a nonprofit research group, stresses in the report that if efforts to expand the recreational supply of psychedelics don't go well, the fallout could put a damper on potential medical uses.

"Based on what happened with clinical research on psychedelics after the 1960s, this is not an idle concern," lead author Beau Kilmer, a senior policy researcher, said in a RAND news release.

Indigenous groups that consider psychedelics spiritual medicines could also be affected, study co-author Michelle Priest, an assistant policy researcher at RAND, warned.

The popularity of psychedelic mushrooms now far outpaces that of other mind-altering drugs such as ecstasy (MDMA), the new report reveals.

It includes results of a December 2023 survey of almost 3,800 U.S. adults who were asked about their use of various substances, including psychedelics.

Twelve percent said they had used psilocybin at some point, and 3.1% had done so in the past year. The report estimated that 8 million U.S. adults used psilocybin last year.

Still, use is typically infrequent, the survey found -- 0.9% of respondents said they had used psilocybin in the past month, compared to 20% who used cannabis.

Things to know about microdosing psychedelics

As recreational use has expanded, enthusiasm about using psychedelic substances to treat mental health conditions has also grown in the past decade, the researchers pointed out.

But attention to public policy changes hasn't kept pace, the report added. It said the choice facing federal regulators is whether or not psychedelics should follow cannabis' for-profit path.

"The current situation with psychedelics reminds me of where we were with cannabis policy 12 years ago," Kilmer said. "Now is the time for federal policymakers to decide if they want to shape these policy changes or stay on the sidelines."

The report noted that despite a federal ban on supply and possession outside approved research settings and some religious exemptions, some states and local governments are loosening their approaches to psychedelics.

Oregon, for instance, allows professionally supervised psilocybin use and a similar system is scheduled to go into effect in Colorado next year.

Priest said indigenous peoples who have longstanding traditions with psychedelics that they regard as spiritual medicines must also be heard from as policy decisions are made.

"Engaging respectfully with Indigenous community members who are authorized to speak on these topics can help craft policies that benefit from generations of wisdom while protecting Indigenous rights," she said.

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>>> Psilocybin outperforms other treatments in easing depression in study


UPI News

5-2-24

by Dennis Thompson

HealthDay News


https://www.msn.com/en-us/health/other/psilocybin-outperforms-other-treatments-in-easing-depression-in-study/ar-AA1o2ppJ?OCID=BingNewsSerp


The active chemical in magic mushrooms could prove to be a powerful antidepressant, a new review finds.

Psilocybin outperformed a variety of "control" treatments in easing symptoms of depression, researchers reported Wednesday in the BMJ.

Those control groups received either placebo medications, the dietary supplement niacin (vitamin B), or microdoses of psychedelics.

"This review's findings on psilocybin's efficacy in reducing symptoms of depression are encouraging for its use in clinical practice as a drug intervention for patients with primary or secondary depression, particularly when combined with psychological support and administered in a supervised clinical environment," concluded the research team led by Athina-Marina Metaxa, a master's student with the University of Oxford's Department of Medicine in the U.K.

Depression affects an estimated 300 million people worldwide, an increase of nearly 20% over the past decade, researchers said in background notes.

Psilocybin has shown promise in reducing depression symptoms after one or two doses, with few side effects and no apparent risk of addiction, researchers said.

To provide an overview of where research now stands, a U.K. team examined data from seven clinical trials involving 436 people with depression.

Psilocybin provided a significantly greater change in depression scores than any of the control treatments, results show.

The treatment effects of psilocybin were significantly more powerful among patients who had depression alongside another mental illness, and when participants had previously used psychedelics, researchers found.

"Interestingly, a clear pattern emerged for past use of psychedelics -- the higher the proportion of study participants who had used psychedelics in the past, the higher the post-psilocybin treatment effect observed," the team wrote.

However, more evidence is needed to support psilocybin as an antidepressant, researchers said.

"Real-world" data is also needed, to assess both potential effectiveness as well as potential costs, researchers added.

Trial patients typically receive psilocybin in a calm living room with soothing music, under the supervision of a psychotherapist -- a situation unlikely to occur in typical healthcare settings.

"The combination of these elements makes this a relatively complex and expensive intervention, which could make it challenging to gain approval from regulatory agencies and to gain reimbursement from insurance companies and others," the researchers wrote.

"The high cost associated with the intervention also increases the risk that unregulated clinics may attempt to cut costs by making alterations to the protocol and the therapeutic process, which could have detrimental effects for patients," they added.

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Mind Medicine Inc (MNMD) - >>> Single dose of LSD provides immediate and lasting relief from anxiety, study says


CNN

by Sandee LaMotte, CNN

March 7, 2024


https://www.yahoo.com/lifestyle/single-dose-lsd-provides-immediate-120037213.html


A clinical trial’s encouraging results won US Food and Drug Administration breakthrough therapy status for an LSD formulation to treat generalized anxiety disorder, Mind Medicine Inc. announced Thursday. The biopharmaceutical company is developing the drug.

“A breakthrough designation is a recognition that a drug has demonstrated evidence of clinical efficacy in meeting an unmet medical need with morbidity and mortality associated with it,” said Dr. Daniel Karlin, assistant professor of psychiatry at Tufts University School of Medicine in Boston and chief medical officer for MindMed.

MindMed’s MM120 will still go through the standard FDA approval process, including phase III trials.

The designation, however, “is an offer from the agency to engage more closely in drug development,” Karlin said. “It affects timelines of response and our ability to get more interactions with the agency so that we can be sure that we’re in lockstep agreement as we move forward.”

Two other companies have also received FDA breakthrough therapy status: psilocybin for treatment-resistant depression and to MDMA, (3,4-Methyl?enedioxy?methamphetamine) commonly known as ecstasy or molly, for post-traumatic stress disorder or PTSD.

New results on efficacy at 12 weeks

A single dose of MM120 (lysergide d-tartrate) led to a 48% rate of remission from generalized anxiety disorder at 12 weeks following the drug’s administration, according to MindMed.

The MM120 drug also significantly improved clinical signs of generalized anxiety disorder for 65% of patients within three months, according to results of the phase 2b trial designed to test dosage levels, the company said.

Anxiety is the most common mental disorder in the United States, affecting over 40 million people age 18 and older each year, according to the Anxiety and Depression Association of America. Generalized anxiety order is characterized by excessive, ongoing thoughts that are difficult to control and interfere with day-to-day activities.

“The clinical improvement for many patients was more than double what we see with today’s standard of care,” Karlin said. “This occurred at all levels of anxiety, from moderate all the way up to severe.”

Standard of care for generalized anxiety disorder is a combination of cognitive behavioral therapy and medications such as selective serotonin reuptake inhibitors, or SSRIs, and buspirone — both of which work on levels of serotonin in the brain — as well as sedatives called benzodiazepines.

All of these medications need time to work and may require experimentation with various doses, adding time and expense to a patient’s treatment, Karlin said.

Determining proper dosage

The multicenter, randomized, double-blinded trial tested doses of 25, 50, 100 and 200 micrograms compared with a placebo.

“We’re very confident based on the results that 100 micrograms is the right dose to bring into our phase three studies, as we didn’t see any more improvement with 200 micrograms but did see additional adverse effects,” Karlin said.

Professor David Nutt, director of the Neuropsychopharmacology Unit at Imperial College London’s division of brain sciences, who researches psychedelics, said in an email that the study results “are very exciting data in what can be a difficult to treat population (anxiety).”

“They expand the likely utility of psychedelic treatment beyond depression,” said Nutt, who was not involved in the research. “And again, as with the depression trials, a single dose produces enduring effects, probable due to its breaking down persistent negative thought processes.”

While it was not the study’s primary purpose, results did show that MM120 also improved signs of depression, Karlin said. “We saw rapid and robust improvement on depression symptoms in people — depression and anxiety have overlapping disease definitions.”

No use of psychotherapy

Most research with MDMA and psilocybin has relied on the use of trained therapists who meet and establish a rapport with participants before the drug is administered. Those therapists are then on hand during the “trip” to help each person assimilate the experience, thus helping assure the lasting impact of any psychological insights.

The MM120 study, however, was accomplished without the use of psychotherapy during the session. Instead, monitors sat in the room to assure safety, but spent their time “mostly reading books,” Karlin said.

“While prior research has documented the benefits of combining LSD with psychotherapy to alleviate anxiety associated with life-threatening conditions, this groundbreaking study is the first to show that a single dose of LSD … can effectively treat generalized anxiety without the adjunct of psychotherapy,” said psychiatrist Dr. Gabriella Gobbi, a professor and scientist at McGill University Health Centre in Montreal and Canada Research Chair in Therapeutics for Mental Health. She was not involved in the clinical trial.

Compared with experiences with forms of LSD purchased illegally on the street, the study’s grade of MM120 did not appear to induce “bad trips,” Karlin said.

“LSD is difficult to manufacture with high purity and tends to degrade quickly in the presence of light and water,” Karlin said. “We’re manufacturing it to pharmaceutical industry standards, a highly pure version that is also shelf stable. So that’s a critical difference.”

Most adverse effects in the study were rated as mild to moderate by participants, occurring mostly on the day of the study, Karlin said. Those included euphoric feelings, illusions and hallucinations, anxiety, abnormal thinking, headaches, dizziness, nausea, excessive sweating, vomiting, numbness or tingling of the skin, and pupil dilation.

A long history of LSD research

When the MM120 clinical trial began in August 2022, it marked the first time LSD had been studied in a medical setting in over 40 years, Karlin said.

During the 1940s and early 1950s, tens of thousands of patients took LSD and other psychotropics to study their effects on cancer anxiety, alcoholism, opioid use disorder, depression, and post-traumatic stress disorder or PTSD. Researchers began to see psychedelics as possible “new tools for shortening psychotherapy.”

But when Harvard University psychologists Timothy Leary and Richard Alpert were fired from the Harvard Psilocybin Project in 1963 after the university discovered they had been giving LSD to their students, the use of psychedelics for research began to lose its luster.

Leary began to speak out publicly, encouraging young people to take LSD recreationally. He quickly became the face of the drug counterculture movement with his signature message, “Turn on, tune in, drop out.”

No longer administered solely in the relative safety of a lab or psychiatrist’s office, LSD began to feature in horror stories of bad “acid” trips at colleges and concerts — headlines that appeared alongside images of anti-Vietnam protests and Woodstock attendees.

In 1968, the United States outlawed LSD and research projects were shut down or forced underground. Then came the 1970 Controlled Substances Act, signed by President Richard Nixon. It classified all hallucinogenics, including psilocybin, as Schedule I drugs — substances with “no currently accepted medical use” and a high probability of abuse.

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>>> California could legalize psychedelic therapy after rejecting 'magic mushroom' decriminalization


by TRÂN NGUY?N,

Associated Press

2-6-24


https://www.msn.com/en-us/news/us/california-could-legalize-psychedelic-therapy-after-rejecting-magic-mushroom-decriminalization/ar-BB1hQViD?OCID=ansmsnnews11


SACRAMENTO, Calif. (AP) — A pair of California lawmakers introduced a bipartisan bill on Tuesday to allow people 21 and older to consume psychedelic mushrooms under professional supervision as part of an agenda to tackle the state's mental health and substance use crises.

It comes after Democratic Gov. Gavin Newsom last year vetoed legislation that would have decriminalized the possession and personal use of several plant-based hallucinogens, including psychedelic mushrooms. It was the first time the proposal by Democratic Sen. Scott Wiener made it through the legislature after years of stalling. In his veto message, Newsom, who championed legalizing cannabis in 2016, asked lawmakers to work on therapeutic guidelines and regulations.

Now Wiener has teamed up with Republican Assembly member Marie Waldron on a proposal to allow participations to consume psilocybin — the hallucinogenic component in what’s known as psychedelic mushrooms — under the supervision of a licensed therapist. The bill also would include dimethyltryptamine (DMT), MDMA and mescaline.

Colorado and Oregon have already decriminalized psychedelic mushrooms and established regulated systems for therapeutic use of the substances. In California, San Francisco, Oakland and Santa Cruz have effectively decriminalized possession of psychedelic mushrooms, meaning a person cannot be arrested or prosecuted for possessing limited amounts of plant-based hallucinogens.

“We know that Californians are struggling with mental health and addiction challenges, and we know that psychedelics, particularly when combined with therapeutic support, can be a powerful tool to help people get their health back (lol),” Wiener said at a Monday news briefing. “We know that California veterans and first responders have particularly benefited from these substances, and we know that many more people can as well.”

Waldron, who introduced a different bill to study the use of psychedelic therapy, said the bipartisan bill aligns with Newsom’s vision by providing safeguards around psychedelic therapy. A person would have to go through a comprehensive screening to determine if they’re fit to consume hallucinogens for therapy and engage in follow-up assessments.

The bill also would shift the state’s response to mental health crisis away from criminalization and punishment, Waldron said.

California already has “a massive network” of underground therapists who provide psychedelic therapy, Wiener said. He added the bill would “bring them above ground” through a new state licensing board that regulates the services.

The legislation does not allow for personal possession and use. That means clients can't buy the substance to go. The drugs would still be illegal under federal law. Wiener said he doesn't want to wait on actions from the federal government and that state lawmakers could authorize such regulated psychedelic use, similar to previous efforts to legalize therapeutic use of cannabis to treat cancers or HIV. (lol)

Touted as a mind-bending drug in the 1960s, psychedelic mushrooms have been used in religious or spiritual practices in some cultures for centuries and possibly thousands of years. Some researchers believe psilocybin and other drugs show promise in treating depression, anxiety and post-traumatic stress disorder (lol). The Food and Drug Administration in 2018 designated psilocybin a “breakthrough therapy” and published draft guidance last year for researchers designing clinical trials for psychedelic drugs.

The bill is sponsored by Heroic Hearts Project, a nonprofit working with veterans to overcome trauma. Juliana Mercer, a Marine Corps veteran and a Heroic Hearts Project board member, said she's used psychedelics to manage her PTSD through programs outside of the U.S. Her organization recently sent a group of veterans to Oregon for regulated psilocybin use.

“Through education and through regulation, we'll be able to take people from doing this underground, where it may not be safe, into a place where they can do it safely,” Mercer said.

She added that will allow them to “access the healing that they deserve without fear of negative repercussions.”

The California Coalition for Psychedelic Safety and Education, which opposed the measure to decriminalize psychedelics last year, also joined to support the bipartisan bill this year. Susan Sagy, executive director of the group, called it an approach “that balances the potential benefits of therapeutic treatment with the potential risks to public health.”

Proponents of the bill anticipate it would take 18 to 24 months to implement the program if the bill becomes law. The bill would also create an education program focused on harm reduction and the potential adverse effects of psychedelics.

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>>> 11 Best Psychedelic Stocks to Buy in 2024


Insider Monkey

Sheryar Siddiq

December 29, 2023


https://finance.yahoo.com/news/11-best-psychedelic-stocks-buy-134746256.html


In this article, we discuss 11 of the best psychedelic stocks to buy in 2024. If you want to see more stocks in this selection, check out 5 Best Psychedelic Stocks to Buy.

Unlike substances like marijuana or cocaine, psychedelics are potent and serve as a form of gateway to an 'alternate reality' for those who use them. Psychedelics represent a category of hallucinogenic drugs capable of inducing non-ordinary states of consciousness. This class encompasses various chemical substances, including LSD and plant-derived compounds. Psychedelics have the potential to alter or intensify sensory perceptions, thought processes, and energy levels, often facilitating spiritual experiences. They are classified into two main groups: empathogens and dissociative drugs (e.g., PCP) and serotonergic substances (e.g., LSD). Beyond recreational use, these drugs are being explored for therapeutic purposes, showing promise in treating conditions such as major depressive disorders, treatment-resistant depression, panic disorder, post-traumatic stress disorder, and opiate addiction, among others.

Venture-capital investors have played a pivotal role in the resurgence of interest in psychedelics. In early 2020, startups in this field noticed a surge in investor appetite, marking the onset of a "psychedelic renaissance." Clara Burtenshaw, a partner at Neo Kuma Ventures, the largest venture capital fund in Europe focused on psychedelic investments, expressed her enthusiasm for psychedelic healthcare on February 16, 2023, stating:

“Psychedelic healthcare is a very exciting area because it’s really this apex of drugs, clinics, and experimental treatments.”

Numerous pharmaceutical companies specializing in psychedelics are pursuing regulatory pathways for the legal approval of their drugs. Hallucinogens, notably psilocybin, are demonstrating significant potential in addressing conditions like depression and schizophrenia. Some of these pharmaceutical firms are publicly listed, including the likes of Johnson & Johnson (NYSE:JNJ), Merck & Co., Inc. (NYSE:MRK), and AbbVie Inc. (NYSE:ABBV), which have garnered heightened interest from investors. This trend mirrors the trajectory observed with marijuana stocks in recent years, where cannabis, once on the periphery, has evolved into a substantial and expanding industry.

Our Methodology

We selected the following psychedelic stocks based on overall hedge fund sentiment toward each stock. We have assessed the hedge fund sentiment from Insider Monkey’s database of 910 elite hedge funds tracked as of the end of the third quarter of 2023. The list is arranged in ascending order of the number of hedge fund holders in each firm.

11. Cybin Inc. (NYSE:CYBN)
Number of Hedge Fund Holders: 1

Based in Toronto, Canada, Cybin Inc. (NYSE:CYBN) is a biopharmaceutical company with a primary focus on the development of therapeutic solutions using psychedelics. The company is engaged in the creation of medications for major depressive disorders, anxiety, and alcohol use disorders, along with addressing neuroinflammation. Additionally, Cybin Inc. (NYSE:CYBN) has introduced EMBARK, a program centered around psychedelic-assisted psychotherapy.

In late November, Cybin Inc. (NYSE:CYBN) disclosed encouraging results from the Phase 2 trial of CYB003, its exclusive deuterated psilocybin analog designed for treating major depressive disorder ("MDD"). The company reported that CYB003 met the primary efficacy endpoint, demonstrating swift and statistically significant enhancements in depression symptoms following a single dose. Additionally, a second dose conferred clear incremental benefits, leading to remission in 4 out of 5 patients from their depression within 6 weeks.

As of the end of Q3, Steve Cohen's Point72 Asset Management emerged as the primary and sole stakeholder, based on Insider Monkey's third-quarter database.

In addition to Johnson & Johnson (NYSE:JNJ), Merck & Co., Inc. (NYSE:MRK), and AbbVie Inc. (NYSE:ABBV), Cybin Inc. (NYSE:CYBN) ranks as one of the best psychedelic stocks to invest in.

10. Mind Medicine (MindMed) Inc. (NASDAQ:MNMD)
Number of Hedge Fund Holders: 3

Mind Medicine (MindMed) Inc. (NASDAQ:MNMD) is a biotechnology company based in New York that specializes in psychedelic medicine. The company is dedicated to the development of psychoplastogens and therapeutic solutions inspired by psychedelics to tackle mental illnesses and addiction.

Mind Medicine (MindMed) Inc. (NASDAQ:MNMD) recently reported that it is nearing the launch of its LSD-based treatment for anxiety patients. The company anticipates more phase two trial data by the fourth quarter of this year and proof-of-concept data by the end of Q1 next year. In its Q3 financial report released on Thursday, the psychedelic firm disclosed a net loss of $17.9 million for the period ending Sept. 30, up from the $16.5 million loss in the same quarter last year. However, MindMed also stated having $117.7 million in funds, expected to cover ongoing trials and research activities "into 2026, if certain milestones are achieved that unlock additional capital."

In 2023, Mind Medicine (MindMed) Inc. (NASDAQ:MNMD) also expended $43.8 million in operating expenses, including $6.4 million for MM-120 studies, their LSD version for treating generalized anxiety disorder. Results from a 198-patient study of MM-120 are anticipated before year-end, with "safety and efficacy results" expected in Q1 next year. The proof-of-concept study, involving 53 patients, is also projected to reveal results in Q1 2024.

Among the hedge funds being tracked by Insider Monkey, Israel Englander’s Citadel Investment Group is a leading shareholder in Mind Medicine (MindMed) Inc. (NASDAQ:MNMD) with 237,475 shares worth more than $743,297. Overall, 3 hedge funds reported holding stakes in Mind Medicine (MindMed) Inc. (NASDAQ:MNMD) as of the third quarter of 2023.

9. Atai Life Sciences N.V. (NASDAQ:ATAI)
Number of Hedge Fund Holders: 5

Founded in 2018 and headquartered in Berlin, Germany, Atai Life Sciences N.V. (NASDAQ:ATAI) is a clinical-stage biopharmaceutical company specializing in the development of treatments for mental health disorders. These include conditions such as treatment-resistant depression, schizophrenia, opioid use disorder, anxiety disorder, and mild traumatic brain injuries.

In its third quarter 2023 financial results, Atai Life Sciences (NASDAQ:ATAI) reported limited revenue as the company continues to develop its drug portfolio. The net income of $44.2 million was primarily attributed to a $69 million non-cash change in the fair value of other investments related to an accounting method change for its CCOMPASS Pathways plc (NASDAQ:CMPS) investment. Additionally, Atai Life Sciences (NASDAQ:ATAI) recorded an $8.3 million non-cash share-based compensation expense. Despite this, the company maintains a robust cash position of $209 million, anticipating that it, along with committed term loan funding, will be sufficient to sustain operations into the first half of 2026.

According to Insider Monkey’s third quarter database, 5 hedge funds were bullish on Atai Life Sciences N.V. (NASDAQ:ATAI), compared to 7 funds in the earlier quarter. John Overdeck And David Siegel’s Two Sigma Advisors is the largest stakeholder of the company, with 107,500 million shares worth $138,675.

8. Seelos Therapeutics, Inc. (NASDAQ:SEEL)
Number of Hedge Fund Holders: 5

Seelos Therapeutics, Inc. (NASDAQ:SEEL) is a clinical-stage biopharmaceutical company headquartered in New York. The company is dedicated to advancing the development and commercialization of therapeutics targeting central nervous system, respiratory, and other disorders.

Seelos Therapeutics, Inc. (NASDAQ:SEEL) has two programs currently undergoing clinical testing. In September 2023, the company disclosed outcomes from a phase 2 study evaluating the intranasal ketamine drug SLS-002 for the treatment of acute suicidal ideation and behavior in patients with major depressive disorder. Additionally, SLS-005 (intravenous trehalose, a sugar containing two glucose molecules) is in phase 2b/3 trials for addressing the neurological disease amyotrophic lateral sclerosis (ALS) and is in phase 2 testing for managing the neurodegenerative disorder spinocerebellar ataxia type 3.

According to Insider Monkey’s third quarter database, 5 hedge funds were bullish on Seelos Therapeutics, Inc. (NASDAQ:SEEL), compared to 3 funds in the earlier quarter.

7. GH Research PLC (NASDAQ:GHRS)
Number of Hedge Fund Holders: 10

GH Research PLC (NASDAQ:GHRS) is a clinical-stage biopharmaceutical company that was established in 2018 and is headquartered in Dublin, Ireland. The company is focused on the development of therapies for the treatment of psychiatric and neurological disorders.

According to Insider Monkey’s third quarter database, 10 hedge funds were long GH Research PLC (NASDAQ:GHRS), compared to 13 funds in the earlier quarter. Mark Lampert’s Biotechnology Value Fund / BVF Inc is the biggest position holder in the company, with 9.27 million shares worth approximately $93.2 million.

Much like Johnson & Johnson (NYSE:JNJ), Merck & Co., Inc. (NYSE:MRK), and AbbVie Inc. (NYSE:ABBV), GH Research PLC (NASDAQ:GHRS) is one of the best psychedelic stocks that investors should pay attention to.

6. Relmada Therapeutics, Inc. (NASDAQ:RLMD)
Number of Hedge Fund Holders: 13

Relmada Therapeutics, Inc. (NASDAQ:RLMD) is a biotechnology company based in Florida, specializing in the clinical-stage development of diverse products for the treatment of central nervous system diseases and other disorders. Analysts consider it one of the promising psychedelic stocks in the market.

In September of this year, Relmada Therapeutics, Inc. (NASDAQ:RLMD) announced encouraging safety and efficacy outcomes from the extended Phase III REL-1017-310 trial, which assessed REL-1017 in individuals diagnosed with major depressive disorder (MDD). Over the course of up to one year, patients receiving daily doses of REL-1017 demonstrated enduring enhancements in depressive symptoms and related functional challenges. The extended administration of REL-1017 exhibited favorable tolerability in patients, featuring low rates of adverse events and the absence of any newly identified safety concerns.

According to Insider Monkey’s third quarter database, 13 hedge funds were long Relmada Therapeutics, Inc. (NASDAQ:RLMD), compared to 11 funds in the prior quarter. David Kroin’s Deep Track Capital held the biggest position in the company.

5. COMPASS Pathways plc (NASDAQ:CMPS)
Number of Hedge Fund Holders: 21

COMPASS Pathways plc (NASDAQ:CMPS) is a mental healthcare company based in the United Kingdom. The company is actively engaged in the development of psilocybin therapy, progressing through late-stage clinical trials in both Europe and North America. The focus is on patients experiencing treatment-resistant depression (TRD). COMPASS Pathways plc (NASDAQ:CMPS) has formulated COMP360, a psilocybin formulation incorporating pharmaceutical-grade polymorphic crystalline psilocybin. A Phase IIb clinical trial for psilocybin therapy in TRD has been completed across 22 sites in Europe and North America, evaluating the safety and efficacy of COMP360 in three doses: 1mg, 10mg, and 25mg.

During 2023’s September quarter, 21 out of the 910 hedge funds profiled by Insider Monkey had held a stake in the company. COMPASS Pathways plc (NASDAQ:CMPS)’s biggest hedge fund investor is Catherine D. Wood’s ARK Investment Management due to its $18 million investment.

4. Intra-Cellular Therapies, Inc. (NASDAQ:ITCI)
Number of Hedge Fund Holders: 37

Intra-Cellular Therapies, Inc. (NASDAQ:ITCI) is a biopharmaceutical company specializing in the discovery, development, and commercialization of small molecule drugs targeting unmet medical needs, particularly in neuropsychiatric and neurological disorders. Caplyta, the sole approved drug in Intra-Cellular Therapies, Inc. (NASDAQ:ITCI)’s portfolio, received FDA approval in December 2019 for the treatment of schizophrenia in adults. Subsequently, in December 2021, it gained FDA approval for treating bipolar depression. Following these approvals, Caplyta’s sales have experienced substantial growth, and the company anticipates maintaining this positive momentum.

In the third quarter of 2023, Intra-Cellular Therapies, Inc. (NASDAQ:ITCI) reported a loss of $0.25 per share. The incurred loss was narrower than the $0.57 per share loss in the same quarter of the previous year, attributed to increased product sales. The total revenues, which include product sales and grant revenues, reached $126.2 million, marking a significant increase from $71.9 million in the corresponding period of the prior year.

By the end of this year’s third quarter, 37 out of the 910 hedge funds part of Insider Monkey’s research had invested in the company. Intra-Cellular Therapies, Inc. (NASDAQ:ITCI)’s biggest hedge fund investor is David Kroin’s Deep Track Capital through its $135 million stake.

3. AbbVie Inc. (NYSE:ABBV)
Number of Hedge Fund Holders: 73

AbbVie Inc. (NYSE:ABBV) operates as a specialized biopharmaceutical company dedicated to researching, developing, manufacturing, and distributing medications tailored for chronic and intricate illnesses. The company is renowned for its flagship drug, Humira, a crucial treatment for conditions like moderate-to-severe rheumatoid arthritis and Crohn’s disease. In May 2020, AbbVie Inc. (NYSE:ABBV) entered the psychedelic drugs market by acquiring a stake in Allergan PLC.

With an impressive 50-year streak of continuous dividend growth, the American pharmaceutical giant currently boasts a dividend yield of 4.48% as of December 13.

As of the close of the third quarter in 2023, Insider Monkey’s database, monitoring 910 hedge funds, indicated 73 holdings in AbbVie Inc. (NYSE:ABBV), marking a slight decrease from the 74 hedge funds in the previous quarter. The collective value of these holdings surpasses $3.27 billion.

2. Merck & Co., Inc. (NYSE:MRK)
Number of Hedge Fund Holders: 85

Merck & Co., Inc. (NYSE:MRK) is a distinguished American multinational pharmaceutical company with its headquarters in Rahway, New Jersey. Originally part of the Merck Group established in Germany in 1668, it retains the name of its former parent company. Operating as Merck Sharp & Dohme or MSD outside the United States and Canada, the company holds a prominent position in the pharmaceutical industry, specializing in the development of medicines, vaccines, biologic therapies, and animal health products.

Showcasing a consistent pattern of dividend growth for 11 consecutive years, the company currently provides a quarterly dividend of $0.77 per share, resulting in a dividend yield of 2.91% as of December 13.

Insider Monkey delved into the investment activities of 910 hedge funds in the third quarter of 2023, revealing that 85 had invested in Merck & Co., Inc. (NYSE:MRK), marking an increase from 78 in the previous quarter.

1. Johnson & Johnson (NYSE:JNJ)
Number of Hedge Fund Holders: 88

Established in 1886, Johnson & Johnson (NYSE:JNJ) is a prominent American multinational corporation known for its groundbreaking contributions to medical devices, pharmaceuticals, and consumer packaged goods. The company’s pharmaceutical division has consistently demonstrated impressive dividend growth for over 62 years. As of November 19, Johnson & Johnson (NYSE:JNJ) offers a quarterly dividend of $1.19 per share, reflecting a dividend yield of 3.18%.

On October 17, Johnson & Johnson (NYSE:JNJ) reported adjusted earnings and revenue that exceeded Wall Street expectations, prompting an upward revision of its full-year guidance. The robust sales performance in both pharmaceuticals and medical devices contributed to the positive results. The company posted a net income of $4.31 billion, equivalent to $1.69 per share, maintaining consistency with the previous year’s net income of $4.31 billion, or $1.62 per share, for the same period.

In the third quarter of 2023, the number of hedge funds tracked by Insider Monkey with holdings in Johnson & Johnson (NYSE:JNJ) decreased to 84, down from 88 in the previous quarter. The collective investments by these hedge funds surpass a total value of $4.15 billion. Bridgewater Associates, led by Ray Dalio, stands out as a prominent hedge fund investor in Johnson & Johnson (NYSE:JNJ) with a substantial stake valued at approximately $424.3 million.

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Robert Forte reveals the shocking truth about who was behind the psychedelic movement of the 1960s (and today), and why --- > the CIA, MK Ultra, etc, with the goal of screwing up and neutering the population. So a similar rationale to the British Empire's Opium Wars of the 1800s, which forced opium upon China and produced a docile population of opium addicts staring at their navels, a population easily dominated by the British -


(best info starts ~ 49:00 minutes)

More -

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>>> Mind Medicine (MindMed) Inc. (MNMD), a clinical stage biopharmaceutical company, develops novel products to treat brain health disorders. The company's lead product candidates include MM-120, which is in phase 2 for the treatment of generalized anxiety disorder and attention deficit hyperactivity disorder; and MM-402, a R-enantiomer of 3,4-methylenedioxymethamphetamine for the treatment of core symptoms of autism spectrum disorder. The company also develops MM-110, an a3ß4 nicotinic cholinergic receptor antagonist that has completed phase 1 for the treatment of opioid withdrawal. The company is headquartered in New York, New York.

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Re-post - >>> Magic Mushrooms. LSD. Ketamine. The Drugs That Power Silicon Valley.


Entrepreneurs including Elon Musk and Sergey Brin are part of a drug movement that proponents hope will expand minds, enhance lives and produce business breakthroughs


Wall Street Journal

By Kirsten Grind and Katherine Bindley

June 27, 2023


https://investorshub.advfn.com/boards/read_msg.aspx?message_id=172218446

https://www.wsj.com/articles/silicon-valley-microdosing-ketamine-lsd-magic-mushrooms-d381e214?mod=hp_lead_pos7


Elon Musk takes ketamine. Sergey Brin sometimes enjoys magic mushrooms. Executives at venture-capital firm Founders Fund, known for its investments in SpaceX and Facebook, have thrown parties that include psychedelics.

Routine drug use has moved from an after-hours activity squarely into corporate culture, leaving boards and business leaders to wrestle with their responsibilities for a workforce that frequently uses. At the vanguard are tech executives and employees who see psychedelics and similar substances, among them psilocybin, ketamine and LSD, as gateways to business breakthroughs.

https://www.wsj.com/articles/silicon-valley-microdosing-ketamine-lsd-magic-mushrooms-d381e214?mod=hp_lead_pos7

AI at it's lowest form.

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>>> FDA issues draft guidance for research into psychedelics


UPI News

June 23, 2023

by Patrick Hilsman


https://www.msn.com/en-us/health/medical/fda-issues-draft-guidance-for-research-into-psychedelics/ar-AA1cWXg4


June 23 (UPI) -- The Food and Drug Administration issued guidelines Friday for scientific research with psychedelics. Among the requirements, researchers will have to submit critical information on what substances are being used.

"Sponsors must provide chemistry, manufacturing and controls information to ensure proper identification, quality, purity and strength of the investigational drug substance and drug product," the FDA said.

The agency added: "The evidentiary standard for establishing effectiveness of psychedelic drugs is the same as for all other drugs."

The FDA is seeking comments from industry, investigators and the public by Aug. 23, after which the agency will begin work on a final version of the guidance.

The document describes primary considerations in the drug development process, which includes the manner in which trials are conducted, data collection, safety of the subjects and and new drug application requirements.

"For example,' the FDA noted. "psychedelic drugs may produce psychoactive effects such as mood and cognitive changes, as well as hallucinations.

"As a result, there is the potential for abuse of these drugs, which is a drug safety issue that requires careful consideration and putting sufficient safety measures in place for preventing misuse throughout clinical development.

The stimulus behind the guidelines was "growing interest in the therapeutic potential of psychedelic drugs in recent years," the FDA said in a statement.

"They are being evaluated for use in the potential treatment of conditions such as depression, post-traumatic stress disorder, substance use disorders and other conditions."

In its draft guidance, the agency said, "Because this is an emerging area of drug development, there is limited experience as to the configuration of programs that may support approval of a psychedelic drug,

"Designing clinical studies to evaluate the safety and effectiveness of those compounds presents a number of unique challenges."

The director of the FDA's Division of Psychiatry, Tiffany Farchione, said, "Psychedelic drugs show initial promise as potential treatments for mood, anxiety and substance use disorders.

"However, these are still investigational products. Sponsors evaluating the therapeutic potential of these drugs should consider their unique characteristics when designing clinical studies."

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>>> Aaron Rodgers talks about mental heath at a psychedelics conference


San Diego Union Tribune

by JESSE BEDAYN

6-21-23


https://www.msn.com/en-us/sports/nfl/aaron-rodgers-talks-about-mental-heath-at-a-psychedelics-conference/ar-AA1cPMMC


An eclectic crowd of thousands — podcasters, vendors, startups, seekers — swarmed a psychedelics conference in Denver this week to experience everything from a dimly lit hall packed with kaleidoscope art and a wide-ranging lineup of speakers from a former Republican governor to NFL star quarterback Aaron Rodgers.

The conference, put on by a psychedelic advocacy group, took place months after Colorado’s voters decided to join Oregon in decriminalizing psychedelic mushrooms. While it’s a sign of growing cultural acceptance for substances that proponents say may offer benefits for things like post-traumatic stress disorder and alcoholism, medical experts caution that more research is needed on the drugs’ efficacy and the extent of the risks of psychedelics, which can cause hallucinations.

Rodgers, who’ll soon debut with the New York Jets after years with the Green Bay Packers, spoke Wednesday night with podcaster Aubrey Marcus. Rodgers described taking ayahuasca with his teammates as “radically life-changing,” and claimed many other pro athletes have reached out to him.

“I found a deeper self love,” said Rodgers of his ayahuasca experience. “It unlocked that whole world of what I’m really here to do is to connect, to connect with those guys, and to make those bonds and to inspire people.”

The organization hosting the conference, the Multidisciplinary Association for Psychedelic Studies, is the largest U.S. advocacy group. It has strategized to reach the full political spectrum, said Nicolas Langlitz, a historian of science who’s researched the boom and bust of psychedelic movements.

“At the time when any topic gets politically polarized, ironically, these super-polarizing substances now get bipartisan support," Langlitz said. Still, he added, the conference is “purely designed to promote the hype."

“Any kind of overselling is not good for science because science should be accurate rather than pushing things," he said. “It’s a tradeoff. (The conference) generates interest, it generates ultimately more research, even though the research might be skewed toward positive results.”

Psychedelics are illegal at the federal level, though acceptance and interest in studying their potential benefits has grown. For example, some researchers believe psilocybin, the compound in psychedelic mushrooms, changes the way the brain organizes itself and can help users overcome things like depression and alcoholism.

The drugs themselves — and the interest in them — are not new. Mid-last century, Aldous Huxley, Timothy Leary and Ken Kesey helped spur the use of psychedelics during the counterculture movement, and optimism brimmed among some psychologists over the drugs’ potential.

But the Nixon administration criminalized psychedelics, pushing them underground.

“In both cases you have this upwelling of exuberance that may or may not be irrational,” said author Michael Pollan, who wrote a book on psychedelics and will be speaking at the conference. “But I think a big difference (now) is that the enthusiasm for the potential of psychedelics cuts across a much more representative slice of the population — it’s not about a counterculture."

Republican strongholds, including Utah and Missouri, have or are considering commissioning studies into the drugs, partly inspired by veterans’ stories. Former Texas Republican Gov. Rick Perry spoke Wednesday about helping get a bill passed in the Texas legislature in 2021 to fund a study of psilocybin for veterans, though he doesn't support recreational use. In Congress, similar veteran-focused proposals brought progressive Democratic Rep. Alexandria Ocasio-Cortez from New York and far-right Rep. Matt Gaetz from Florida into an unlikely alignment.

Public interest also appears to be growing. Just six years ago in Oakland, California, the Multidisciplinary Association for Psychedelic Studies held a conference with roughly 3,000 attendees and a smattering of lesser-known speakers and die-hard proponents.

This time, organizers estimate at least 10,000 attendees. Other famous speakers will include former NHL player Daniel Carcillo, who owns a company specializing in psychedelic therapies; Olympic silver-medal figure skater Sasha Cohen; rapper and actor Jaden Smith; comedians Reggie Watts and Eric Andre, top-10 podcaster Andrew Huberman; and Carl Hart, the chair of Columbia University's psychology department.

Recruiting that celebrity support for psychedelics is part of MAPS' public relations strategy, founder Rick Doblin said. When asked whether platforming a non-expert like Rodgers could mislead the public, Doblin demurred, adding it would be “dangerous” for anyone to claim that there are no risks to taking psychedelics.

Doblin said taking MDMA should happen “only under the direct supervision of a therapist, it's never a take-home medicine.” He also emphasized what many speakers echoed during the first day about psychedelics being paired with mental health professional: “The treatment is not the drug, it’s the therapy that the drug makes more effective."

That was a more tempered approach than his introductory speech, when, to an overflowing theater, Doblin espoused grandiose goals such as “net-zero” trauma by 2070 through the use of psychedelics.

The American Psychiatric Association has not endorsed the use of psychedelics in treatment, noting the Food and Drug Administration has yet to offer a final determination. The FDA did designate psilocybin as a “breakthrough therapy” in 2018, a label that’s designed to speed the development and review of drugs to treat a serious condition. MDMA, often called ecstasy, also has that designation for PTSD treatment.

Both Pollan and Langlitz believe further research is key — especially as the nation faces an unprecedented mental health crisis and people struggle to find adequate treatment. But, Langlitz said, it's important to let research shape the narrative.

“I would just try to keep my mind open to the possibility that in retrospect we will tell a very different story from the one that the protagonists of psychedelic therapies are currently predicting,” he said.

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$CYBN the R&D day event today promises to deliver critical updates on Cybin's research and development efforts, most notably the cutting-edge CYB003 clinical trials, which, if approved, would become the first FDA-approved psychedelic drug for treating major depressive disorder and unlock tremendous growth potential.

Watch here: https://ir.cybin.com/investors/events-and-presentations/events/event-details/2023/Cybin-Virtual-RD-Day-2023-Innovating-New-Treatment-Approaches-for-Mental-Healthcare-2023-nICt-kZDwl/default.aspx

DD: https://canaccordgenuity.bluematrix.com/sellside/EmailDocViewer?encrypt=3f15ecfa-d7c5-4404-9d1f-7fc780d657d8&mime=pdf&co=Canaccordgenuity&id

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>>> Weekly Roundup on the Cannabis Sector & Psychedelic Sector


Market Exclusive

January 23, 2023·


https://finance.yahoo.com/news/weekly-roundup-cannabis-sector-psychedelic-023348419.html


Key Takeaways; Cannabis Sector

22nd Century announced partnerships with Core-Mark and Eby-Brown, two of the largest U.S. convenience store distributors.

Scotts Miracle-Gro announced timing for Q1 financial results and conference call.

Tilray’s revenue declines as net losses increase; if cannabis sales continue to be slow, the company may switch to fruit and beer sales.

Key Takeaways; Psychedelic Sector

Cybin announced positive findings from sponsored Kernel Flow® feasibility study measuring the brain’s response to psychedelics.

Awakn’s Project Kestrel fueling the company’s growth.

Cannabis stocks have started 2023 very strongly with the cannabis stock index up 9.0% year to year, which is well ahead of the 3.5% increase in the S&P 500. This week’s news will be dominated by earnings reports as several industry titans from a range of sectors are expected to release their financial results.

Below is a review of the companies that dominated the news in the cannabis and psychedelic industries during the past week, along with a preview of the upcoming week.

Top Marijuana Companies for Week

#1: 22nd Century

The largest distributors of convenience stores in the United States, Core-Mark International and Eby-Brown Company, both signed new distribution agreements with 22nd Century Group, Inc. (NASDAQ: XXII), which is a leading biotechnology company that’s committed to improve health through reduced nicotine tobacco use and cutting-edge plant technologies in hemp/cannabis and hops.

As part of the new collaboration agreement, the store distributors will assist in nationwide distribution of VLN®. According to a press statement from 22nd Century Group, the company’s VLN® solutions are now available for purchase by qualified Core-Mark and Eby-Brown clients as a part of the state and regional rollout program of 22nd Century Group.

In addition, 22nd Century stated that they will participate in 11 regional trade fairs in 2023 that are sponsored by the distributors, giving the company the chance to meet thousands of Core-Mark and Eby-independent Brown’s retail and chain store operators.

John Miller, president of tobacco products for 22nd Century Group, commented on this significant development: “22nd Century’s new partnership agreements with two of the largest, most respected convenience store distributors in the United States make possible the launch of VLN® cigarettes in virtually every key U.S. market we are targeting in our state-by-state, region-by-region roll-out strategy.”

#2: ScottsMiracle-Gro

The Scotts Miracle-Gro Company (NYSE: SMG), the top marketer of branded consumer products for indoor and hydroponic growth as well as lawn and garden, stated that its first quarter financial results will be released on February 1, 2023, ahead of the opening of the U.S. stock market. The Company then announced that they would hold a conference call to go through those results at 9:00 a.m. ET.

The stock of Scotts Miracle-Gro has increased by almost 25% since the beginning of the year, making it one of the best performers in the cannabis industry this year. The stock experienced a significant rally on Friday, rising by more than 7%.

With Scotts Miracle-Gro now expected to report earnings for the first quarter of 2023 on February 1, 2023. Analysts are expecting the company to report earnings of $4.4 per share, up from $4.09 per share reported in the same quarter of 2020. The company has seen solid revenue growth over the last few quarters and is expected to continue this trend in the first quarter. Analysts are forecasting revenue to increase 8.7% year-over-year to $2.3 billion.

With the anticipated legalization of cannabis in several states and the expanding acceptance of medical marijuana, the company is expected to benefit from increased demand for outdoor and gardening products. This should help drive higher sales and earnings for the company in 2023.

#3: Tilray

Tilray Brands, Inc. (NASDAQ: TLRY) released financial results for the second fiscal quarter that concluded on November 30, 2022. Sales decreased 7% from $155 million in 2021 to $144 million in 2022. In addition, revenue decreased from the $153 million it was in the prior quarter. On the positive note, the company did manage to generate $25.4 million in free cash flow and $29.2 million in operating cash flow during the quarter.

Furthermore, according to Tilray CEO, Irwin Simon, if cannabis sales continue to decline, the company may increase its footprint in the alcoholic beverage market or start cultivating fruits and vegetables to make up for a shortfall in the cannabis sales.

Top Psychedelic Companies for Week

#1: Cybin

Biopharmaceutical company Cybin Inc. (NYSE: CYBN), which focuses on advancing psychedelics to therapeutics, released key findings from a feasibility study that was recently completed by its partner HI, LLC dba Kernel. The study examined Kernel’s Flow® wearable technology to assess the psychedelic effects of ketamine on cerebral cortex hemodynamics. According to the company, the findings of this company-sponsored study will help determine the program’s future pathway.

Cybin, a Canadian biotechnology company, has seen a return of 233.9% in January 2023, strongly outperforming the S&P and other major composite index. The company’s strong performance in January was driven by strong news flow related to its Phase 1 clinical trials of its lead drug candidate CYB003. The company announced positive results from the study, showing that the drug was well tolerated and had a positive effect on reducing symptoms of depression.

The results of the clinical trial have added to the excitement surrounding the company’s drug pipeline and have further solidified the company as one of the leaders in the psychedelic drug space. This positive sentiment has sent the stock soaring as investors have been piling into the stock in expectation of continued success from the company.

#2: Awakn

Awakn Life Sciences Corp. (NEO: AWKN) (OTC: AWKNF) is a Canadian biotechnology company focused on the development of psychedelic therapeutics, mainly focusing on Ketamine-Assisted Psychotherapy for Alcohol Use Disorder. Awakn experienced a successful year in 2022 thanks to substantial accomplishments in the psychedelic sector.

The company’s strong performance has been driven by Project Kestrel, which is the company’s lead clinical development program. Phase II a/b KARE clinical study of its lead drug candidate results showed that the drug was well tolerated and had a positive effect on the treatment of Alcohol Use Disorder.

Overall, Awakn has had a remarkable run and investors are optimistic about the company’s future prospects. With Phase II clinical trial in the bag, investors are now looking ahead to the Phase III study, which is funded by UK Government agencies. If the results from the Phase 3 trials are equally positive, then the stock could continue to rise.

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>>> Psychedelic "magic mushroom" drug may ease some depression


AP

by LINDSEY TANNER

November 2, 2022


https://www.yahoo.com/news/psychedelic-magic-mushroom-drug-may-210137044.html


The psychedelic chemical in “magic mushrooms” may ease depression in some hard-to-treat patients, a preliminary study found.

The effects were modest and waned over time but they occurred with a single experimental dose in people who previously had gotten little relief from standard antidepressants.

The study is part of a resurgence of research into potential medical uses of hallucinogenic drugs, and the results echo findings in smaller studies of the mushroom compound psilocybin. The researchers said larger and longer studies are needed to determine the effectiveness and safety of using psilocybin for depression. Their results were published Wednesday in the New England Journal of Medicine.

“The findings are both intriguing and sobering,’’ said Bertha Madras, a psychobiology professor and researcher at Harvard Medical School.

Commenting in a journal editorial, Madras said the study is the most rigorous study to date evaluating psilocybin for treating depression. She was not involved in the research.

Researchers tested the chemical in 233 adults in the U.S., Europe and Canada. Each swallowed capsules containing one of three doses of psilocybin during a 6-to 8-hour session. Two mental health specialists guided them through hallucinatory experiences.

Results for the highest and medium-strength doses were compared with those in the very low dose control group. There was no comparison with an inactive dummy drug or with conventional antidepressants, and there were other limitations.

Depression symptoms declined in all three groups, with the greatest initial improvement in the highest-dose group. At three weeks, 37% of high-dose recipients had substantially improved. But those effects weren’t as good as seen in studies of standard antidepressant drugs, and the results waned in the following weeks.

At three months, 20% in the high-dose group still saw substantial improvement.

Compass Pathways, a London-based firm developing psilocybin for commercial use, paid for and helped conduct the study. It recently announced it is launching a larger, more rigorous study.

Side effects, including headaches and nausea, were common in all three study groups. Serious side effects were uncommon but they included suicidal thoughts and self-injury — mostly in participants with a history of suicidal thoughts.

Dr. David Hellerstein, a co-author and Columbia University research psychiatrist, said those side effects are not surprising given the intensity of the psychedelic experience from the drug. But he said they underscore the importance of using psilocybin in a medical setting.

“This is not a home run, but it’s very encouraging,’’ Hellerstein said, noting that improvement was seen after just one dose.

However, he said it’s likely that additional doses would be needed to achieve long-lasting results. That could make use costly, given the need for several hours of medically supervised treatment.

More than 180 studies of psilocybin and other psychedelics for use in depression, PTSD and other mental conditions are listed on a National Library of Medicine website.

The U.S. government still classifies the chemical as a controlled substance, with no accepted medical use. Several cities have already decriminalized magic mushrooms and Oregon is the first state to approve medical use.

Philip Corlett, an associate psychiatry professor at Yale University, said many important challenges remain, including determining whether psilocybin has any real effect on reducing depression.

One theory is that it stimulates portions of the brain that control levels of the mood-influencing chemical serotonin. It also may reconnect brain circuits — but both theories remain to be proven.

“I think we should be taking our foot off the gas a little bit and figure out exactly how they (psychedelics) work in order to optimize it,’’ Corlett said. “They don’t work for everybody.’’

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[MomsSpaghetti]

New Patent: ($MNMD) USING GENO-
OR PHENOTYPING TO ADJUST LSD
DOSING

https://appft.uspto.gov/netacgi/nph-Parser?
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adv.htm|&r=1&f=G&1=50&d=PG01851=20220280
501&0S=20220280501&RS=20220280501

Patent Alert! A new U.S. patent application No.
20220280501 was published yesterday
containing broad claims regarding the use of
#genetic and #metabolic assessment to
determine #sd #dosing. Prior art can be found at
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>>> The secret to his success: Aaron Rodgers credits ayahuasca for his career rejuvenation


MSN

by Mark Schofield


https://www.msn.com/en-us/sports/nfl/the-secret-to-his-success-aaron-rodgers-credits-ayahuasca-for-his-career-rejuvenation/ar-AA10iE6t


Green Bay Packers quarterback Aaron Rodgers is coming off a pair of MVP seasons. After the team drafted Jordan Love in the first round of the 2020 NFL draft, Rodgers put together one of his best years as a pro, completing 70.7% of his passes for 4,299 yards and a career-high 48 touchdowns. Then this past season he completed another 68.9% of his throws for 4,115 yards and 37 touchdowns en route to his second-straight MVP.

And he knows exactly how it happened: Ayahuasca.

On a recent appearance of the Aubrey Marcus Podcast, the quarterback revealed that he consumed ayahuasca, a plant-based psychedelic, prior to the back-to-back MVP years while traveling in South America. He credits the experience with improved mental health, confidence and overall mindset.

I don’t think it’s a coincidence. There’s signs and synchronicities all around us at all times if we’re awake enough to see them and to take them in and to listen to our intuition when it’s speaking to us or pounding us in the head saying, ‘Hey dummy, this is what you’re supposed to be doing.’

Rodgers continued to say that following the trip and the experience, he knew that “I was never going to be the same.” He also outlined that while many people focus on the negative side effects of ayahuasca — such as nausea, vomiting, diarrhea, hallucinations, panic and fear — there are positives, such as “deep and meaningful and crazy mind-expanding possibilities and also deep self-love and healing that can happen on the other side.”

The quarterback credits ayahuasca with changing his view on himself, and in turn, impacting his relationship with his teammates:

To me, one of the core tenants of your mental health is that self-love. That’s what ayahuasca did for me, was help me see how to unconditionally love myself. It’s only in that unconditional self-love that I’m able to truly be able to unconditionally love others. And what better way to work on – this is my own belief – but what better way to work on my mental health than to have an experience like that.

The greatest gift I can give my teammates, in my opinion, is to be able to show up and to be someone who can model unconditional love to them. I mean, obviously it’s important I play well and show up and lead and all that stuff, but they won’t care about what you say until they know how much you care.

It is worth noting that ayahuasca contains Dimethyltryptamine, or DMT, which is a Schedule I controlled substance in the United States. As such, it is illegal to manufacture, buy, possess or distribute.

In recent years, some cities have moved to decriminalize psychedelics such as DMT. For example, the Oakland City Council passed a resolution stating that “no city funds or resources” are available to impose criminal penalties on the use and possession of “entheogenic plants by adults.” That includes ayahuasca. In October of 2021, Seattle decriminalized natural psychedelics, making the investigation, arrest and prosecution of related activities their “lowest enforcement priority.”

You can start your “Rodgers to Seattle” rumors…now.

In the meantime, the quarterback continues to appreciate how the experience gave him a deeper appreciation for what he has:

No, it gave me a deep and meaningful appreciation for life. My intention the first night going in was ‘I want to feel what pure love feels like.’ That was my intention. And I did. I really did. I had a magical experience with the sensation of feeling a hundred different hands on my body imparting a blessing of love and forgiveness for myself and gratitude for this life from what seemed to be my ancestors.

What he has, in our view, is a rocket right arm:

And perhaps a full explanation for this off-season tattoo:

https://www.instagram.com/p/CfrnlPHPUnF

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>>> Psychedelic Intelligence – The C.I.A. and the Counterculture (2014) <<< -

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>>> Vistagen tries not to get depressed despite bad omens
author

Evaluate Vantage

by Madeleine Armstrong

May 3, 2019


https://www.evaluate.com/vantage/articles/news/trial-results/vistagen-tries-not-get-depressed-despite-bad-omens


A flop in a small depression trial hits Vistagen Therapeutics, but the group insists that all is well ahead of its main event.
Silhoutte of man standing at the end of a wooden jetty in front of a lake

Vistagen yesterday tried to reassure investors that the failure of its ketamine-like antidepressant project AV-101 in an investigator-sponsored trial might not bode ill for a bigger mid-stage trial. But the group’s stock plunged 47% yesterday as backers got the jitters ahead of the Elevate study readout, expected in the third quarter.

There are some differences between the two studies, which Vistagen was keen to point out. The 19-patient NIMH-sponsored trial that failed yesterday was testing AV-101 as a monotherapy, while Elevate is evaluating the project on top of standard antidepressants.

This latter adjunctive use is the same one for which Johnson & Johnson’s ketamine-like drug Spravato was recently approved, albeit on flimsy evidence of efficacy (Esketamine floats past adcom vote, February 13, 2019).

Dimmer hopes

Vistagen will no doubt take heart from the two projects’ similar mechanisms of action. Both inhibit the NMDA receptor, though Spravato, which is given intranasally, is a complete channel blocker, while the oral AV-101 inhibits NMDA receptor function rather than blocking it.

Vistagen’s chief executive, Shawn Singh, has described AV-101 as more like a dimmer light switch versus Spravato’s cruder “on/off” button.

This could help AV-101 avoid the ketamine-like side effects that have been linked with Spravato, Vistagen hopes. However, the latest data raise fears that AV-101’s different mechanism could mean that it is less effective.

The recent failure of Allergan’s NMDA-modulating contender rapastinel will not have helped Vistagen’s cause, either – that was also supposed to be a safer alternative to Spravato (Rapastinel flop leaves Allergan in a hole, March 7, 2019).

Now Vistagen must await readout of Elevate. The phase II trial has enrolled 180 patients with an inadequate response to one to three FDA-approved oral antidepressants, whose current depressive episode has lasted two years or less.

The trial will compare AV-101 with placebo, both on top of an oral antidepressant; the primary endpoint is change in the 10-item Montgomery Åsberg Depression Rating Scale (MADRS-10) at two weeks.

Vistagen is also planning another trial, called Relay, evaluating whether AV-101 can prevent relapse in patients who have previously responded to intravenous ketamine or Spravato. However, this is not slated to start until next year, and might be a dead end if Elevate disappoints.

The company is heavily reliant on AV-101, which is also in phase I development for suicidal ideation and is set to go into phase II in neuropathic pain and levodopa-induced dyskinesia in Parkinson’s disease. Mr Singh previously told Vantage that the group also had high hopes for AV-101 as monotherapy in depression.

These aspirations have now been dashed by the NIMH trial failure. Vistagen's market cap now sits at just $23m, so investors clearly do not think much of AV-101's chances. If Elevate is also a flop, the company's future will look bleak.

Vistagen pipeline

Project Indication Description Status 2024e sales ($m)

PH94B Social anxiety disorder Neuroactive steroid nasal spray Phase III imminent -

AV-101 Major depressive disorder AMPA agonist and NMDA antagonist Phase II 68

PH10 Major depressive disorder Neuroactive steroid nasal spray Phase II -

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>>> Psilocybin Spurs Brain Activity in Patients With Depression, Small Study Shows

The chemical derived from psychedelic mushrooms helped alleviate symptoms of depression and generated detectable neural responses that lasted weeks.


The New York Times

By Andrew Jacobs

April 11, 2022


https://www.nytimes.com/2022/04/11/health/psilocybin-depression.html


Psychedelic compounds like LSD, Ecstasy and psilocybin mushrooms have shown significant promise in treating a range of mental health disorders, with participants in clinical studies often describing tremendous progress taming the demons of post-traumatic stress disorder, or finding unexpected calm and clarity as they face a terminal illness.

But exactly how psychedelics might therapeutically rewire the mind remains an enigma.

A group of neuroscientists in London thought advanced neuroimaging technology that peered deep into the brain might provide some answers. They included 43 people with severe depression in a study sponsored by Imperial College London, and gave them either psilocybin, the active ingredient in magic mushrooms, or a conventional antidepressant; the participants were not told which one they would receive. Functional magnetic resonance imaging, which captures metabolic function, took two snapshots of their brain activity — the day before receiving the first dose and then roughly three weeks after the final one.

What they found, according to a study published Monday in the journal Nature Medicine, was illuminating, both figuratively and literally. Over the course of three weeks, participants who had been given the antidepressant escitalopram (Lexapro) reported mild improvement in their symptoms, and the scans continued to suggest the stubborn, telltale signs of a mind hobbled by major depressive disorder. Neural activity was constrained within certain regions of the brain, a reflection of the rigid thought patterns that can trap those with depression in a negative feedback loop of pessimism and despair.

By contrast, the participants given psilocybin therapy reported a rapid and sustained improvement in their depression, and the scans showed flourishes of neural activity across large swaths of the brain that persisted for the three weeks. That heightened connectivity, they said, resembled the cognitive agility of a healthy brain that, for example, can toggle between a morning bout of melancholia, a stressful day at work and an evening of unencumbered revelry with friends.

Although the authors acknowledged the limitations of the study, including its small size and short time frame, they said psilocybin appeared to have a “liberating” effect on the brains of people with severe depression.

“Psilocybin, it would seem, allows you to see things in an entirely new light, particularly when you have a psychotherapist who can help guide you through that experience,” said Richard Daws, a cognitive neuroscientist and a lead author of the study. “You can unpack difficult experiences that might define how you see the world, which is interesting because that’s exactly what traditional cognitive behavioral therapy is trying to do.”

Experts not involved with the study said that the results were not entirely surprising but that they provided a possible biologic explanation for the anecdotal accounts about therapeutic breakthroughs with psychedelic medicine.

Patrick M. Fisher, a neuroscientist at the Neurobiology Research Unit in Copenhagen who studies psilocybin’s effects on the brain, said the findings could help explain why study subjects in psychedelic research often report long-term relief from psychological ailments. “One or two doses of psychedelic drugs seem to impart lasting clinical benefits and changes in personality and mood, and that’s an unusual characteristic of drugs,” he said. “Although these brain imaging data are important for resolving the brain mechanisms that support these lasting changes, this study leaves prominent questions unanswered.”

Other researchers agreed, saying the results highlighted the need for further study. Dr. Stephen Ross, associate director of the N.Y.U. Langone Center for Psychedelic Medicine, who has been studying the antidepressant effects of psilocybin on cancer patients, cautioned against drawing sweeping conclusions given the relatively brief monitoring period of participants’ brain activity. “It’s a little bit like looking out into the universe with a telescope and seeing interesting things and then starting to build theories based on that,” he said. “This is an important contribution though I’m more interested in what happens in three months or six months.”

A separate, smaller experiment that was included in the Nature Medicine paper appeared to support the notion that psilocybin therapy could provide enduring benefits. In that trial, 16 patients were recruited with the knowledge that they would receive psilocybin for their treatment-resistant depression. Brain scans taken a day after the final doses were administered showed similar results to the other study. And when the researchers followed up six months later, many participants reported that the improvements to their depression had not subsided.

“These results are very promising, but obviously no one should go out and try and procure psychedelics without speaking to a doctor or a therapist,” Dr. Daws said.

The field of psychedelic medicine is still in its infancy following a decades-long gap in research, a direct result of antidrug policies that prevented most scientists in the United States from investigating mind-altering compounds. But as the stigma has faded and research funding has begun to flow more freely, a growing number of scientists have begun exploring whether such drugs can help patients suffering from a wide range of mental health conditions, including anorexia, substance abuse and obsessive-compulsive disorder.

Along with psilocybin, MDMA, popularly known as Ecstasy, has been especially promising. A study last May in Nature Medicine found that the drug paired with talk therapy could significantly lessen or even eliminate symptoms of PTSD. Phase 3 clinical trials are now underway, and some experts believe the Food and Drug Administration could approve MDMA therapy for PTSD as soon as next year.

Depression remains one of most common and intractable mental health challenges in the United States, with an estimated 21 million adults reporting a major depressive episode in 2020, according to the National Institute of Mental Health. Although Prozac and other antidepressants known as S.S.R.I.s have been effective for many, they have significant side effects and the drugs do not work for everyone.

For that reason, the handful of small studies on psilocybin and depression have electrified mental health experts and patients.

Another author of the Nature Medicine article published on Monday, Robin Carhart-Harris, director of the Neuroscape Psychedelics Division at the University of California, San Francisco, said the functional magnetic resonance imaging scans offered intriguing clues about the way depression inhabits the brain. The resulting images, he suggested, might be best compared to an undulating pastoral landscape marked by hills and deep valleys. People with depression, he said, often get stuck in a valley. Although S.S.R.I.s can make them feel better, the drugs do not appear to change the overall landscape of their brain, as it were, suggesting that the drugs do little more than ease the symptoms of their depression.

But the psilocybin treatments, he said, seemed to provide a way out of those metaphorical valleys by inducing what scientists call global increases in brain network integration — essentially touching off activity across parts of the brain that were previously cut off from one another.

“Psilocybin therapy seems to flatten the landscape so you move out of the valley,” Dr. Carhart-Harris said. “It makes you freer to move on.”

Still, he acknowledged that the two trials raised a multitude of unanswered questions that he hoped researchers would explore. And he expressed caution against the headlong embrace of psychedelics without supervision, noting the acute vulnerability of patients experiencing a psychedelic journey.

“It might sound trite to say, but I think psilocybin therapy opens up the mind, and that’s its strength,” Dr. Carhart-Harris said. “But that’s also arguably where the risk comes in, which is why it needs to be managed and to happen alongside psychological support.”

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>>> Wesana Health Announces Inclusion in the AdvisorShares Psychedelics ETF


Wesana Health

October 1, 2021


https://finance.yahoo.com/news/wesana-health-announces-inclusion-advisorshares-113000896.html


CHICAGO and TORONTO, Oct. 01, 2021 (GLOBE NEWSWIRE) -- Wesana Health Holdings Inc. (“Wesana” or the “Company”) (CSE: WESA; OTCQB: WSNAF), an emerging data driven life sciences company focused on developing innovative approaches for better understanding, protecting and improving neurological health and performance, including through the advancement of psychedelic medicines, is pleased to announce its inclusion in the AdvisorShares Psychedelics ETF (the “Fund”), currently trading under the ticker symbol “PSIL” on the NYSE Arca exchange.

The recently launched Fund primarily focuses its strategy on investing in publicly traded companies in the life sciences, biotechnology and pharmaceuticals sectors that derive at least 50% of their net revenue or devote 50% of their assets to the advancement of psychedelic compounds. The Fund looks to highlight the leaders in the psychedelics sector as their core holdings.

Chad Bronstein, Executive Chairman of Wesana, commented: “We are incredibly pleased to have been selected as a core constituent in the new AdvisorShares Psychedelics ETF. Inclusion in this ETF is another validation in the evolution of Wesana as a publicly traded company and the impact Wesana’s core initiatives have had on the psychedelics sector. By strengthening our shareholder base and improving our visibility in the global investment community, we are excited for the next steps in bringing Wesana’s unique approach to neurological health and wellness to patients across the country.”

You can find additional information on the AdvisorShares Psychedelics ETF here.

About Wesana Health
Wesana Health is an emerging life sciences company championing the development of innovative approaches for better understanding, protecting and improving neurological health and performance. Through extensive clinical research and academic partnerships, Wesana Health is developing evidence-based formulations and protocols, including psilocybin-based therapies, that empower patients to overcome neurological, psychological and mental health ailments. Learn more at www.wesanahealth.com.

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>>> Mindset Pharma Announces Inclusion in NYSE Listed AdvisorShares Psychedelics Exchange Traded Fund (ETF)


Mindset Pharma Inc.

September 23, 2021


https://finance.yahoo.com/news/mindset-pharma-announces-inclusion-nyse-113000882.html


TORONTO, Sept. 23, 2021 (GLOBE NEWSWIRE) -- Mindset Pharma Inc. (CSE: MSET) (FSE: 9DF) (OTCQB: MSSTF) ("Mindset" or the "Company"), a drug discovery and development company focused on creating optimized and patentable next-generation psychedelic medicines to treat neurological and psychiatric disorders with unmet needs, today announced that it has been included in the AdvisorShares Psychedelics ETF traded on the NYSE Arca under the ticker symbol “PSIL.”

PSIL is an actively managed exchange-traded product that invests in the emerging psychedelic drugs sector. The PSIL offers exposure to biotechnology, pharmaceutical and life sciences companies deriving the majority of their net revenue or devoting the majority of their assets to psychedelic drugs, and only holds companies that they see as leading the way in this industry.

“Mindset’s inclusion in the actively-managed PSIL is another positive step in building awareness and education for the exciting developments at Mindset, as well as the psychedelics industry as a whole. We are thrilled to be considered a leader in the space and appreciate the support from the capital markets as we progress our differentiated pipeline of next generation psychedelic-inspired drug candidates towards the clinic,” said James Lanthier, Chief Executive Officer of Mindset.

For more information, please contact:

Investor Contact:
Allison Soss/Tim Regan
KCSA Strategic Communications
Email: [e-mail]
Phone: [phone]

Company Contact:
James Lanthier, CEO
Email: [e-mail]

Jason Atkinson, VP, Corporate Development
Email: [e-mail]
Phone: [phone]

About Mindset Pharma Inc.

Mindset Pharma Inc. is a drug discovery and development company focused on creating optimized and patentable next-generation psychedelic medicines to treat neurological and psychiatric disorders with unmet needs. Mindset was established in order to develop next generation pharmaceutical assets that leverage the breakthrough therapeutic potential of psychedelic drugs. Mindset is developing several novel families of next generation psychedelic compounds, as well as an innovative process to chemically synthesize psilocybin as well as its own proprietary compounds.

For further information on Mindset, please visit our website at www.mindsetpharma.com.

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>>> Revive Therapeutics Included in AdvisorShares® Newly Launched Psychedelics ETF


Revive Therapeutics Ltd.

September 21, 2021


https://finance.yahoo.com/news/revive-therapeutics-included-advisorshares-newly-134500064.html


TORONTO, Sept. 21, 2021 (GLOBE NEWSWIRE) -- Revive Therapeutics Ltd. (“Revive” or the “Company”) (OTCQB: RVVTF) (CSE: RVV) (FRANKFURT: 31R), a specialty life sciences company focused on the research and development of therapeutics for medical needs and rare disorders, announces today that AdvisorShares® Investments LLC (“AdvisorShares”), a leading sponsor of actively managed exchange-traded funds (ETFs) has included Revive Therapeutics in the inaugural launch of its AdvisorShares Psychedelics ETF (“PSIL”).

PSIL invests in the emerging psychedelic drugs sector, offering exposure to biotechnology, pharmaceutical, and life sciences companies leading the way in this nascent industry. The ETF at launch includes 16 publicly listed companies offering investors exposure to companies who are leading the way in the emerging psychedelics space.

“We are pleased to be included in the inaugural launch of the PSIL ETF as it provides further validation of our pharmaceutical psychedelics strategy in pursuing novel uses, formulations and delivery forms of psilocybin for the treatment of mental health and neurological conditions,” said Michael Frank, CEO of the Company.

PSIL commenced trading on September 16, 2021, debuting on the New York Stock Exchange under ticker symbol (NYSE: PSIL). The holdings of PSIL and its current portfolio weights are regularly updated and available at https://advisorshares.com/etfs/psil/.

About Revive Therapeutics Ltd.

Revive is a life sciences company focused on the research and development of therapeutics for infectious diseases and rare disorders, and it is prioritizing drug development efforts to take advantage of several regulatory incentives awarded by the FDA such as Orphan Drug, Fast Track, Breakthrough Therapy and Rare Pediatric Disease designations. Currently, the Company is exploring the use of Bucillamine for the potential treatment of infectious diseases, with an initial focus on severe influenza and COVID-19. With its acquisition of Psilocin Pharma Corp., Revive is advancing the development of Psilocybin-based therapeutics in various diseases and disorders. Revive’s cannabinoid pharmaceutical portfolio focuses on rare inflammatory diseases and the company was granted FDA orphan drug status designation for the use of Cannabidiol (CBD) to treat autoimmune hepatitis (liver disease) and to treat ischemia and reperfusion injury from organ transplantation. For more information, visit www.ReviveThera.com.

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>>> Psyched: First Active Psychedelics ETF Hits NYSE, Compass Dives Into Novel Molecules, Atai Subsidiary Launches Phase 2a Trial


Benzinga

Natan Ponieman

September 20, 2021


https://finance.yahoo.com/news/psyched-first-active-psychedelics-etf-165103534.html


AdvisorShares Launches First NYSE-listed Actively-managed Psychedelics ETF

On Thursday, AdvisorShares launched the country’s first actively managed ETF covering the psychedelics sector.

The AdvisorShares Psychedelics ETF (NYSE: PSIL), launched on the NYSE Arca market, providing exposure to biotechnology, pharmaceutical and life sciences companies that the firm deems are “leading the way in this nascent industry.”

So far, this is the third ETF covering the psychedelics sector in North America. The Horizons Psychedelic Stock Index ETF (NEO: PSYK) was first to launch in January of this year, followed by Defiance’s Next Gen Altered Experience ETF (NYSE: PSY), which broke ground as the first passive U.S.-listed ETF in the sector.

Dan Ahrens, CEO of AdvisorShares and portfolio manager of PSIL, said he believes that by investing in select companies in the psychedelics space, his firm can provide a compelling long-term investment opportunity. Still, the CEO said this is also an area of the marketplace in its early innings.

“We feel that our active-management and specialized approach can potentially help investors capture the early growth potential of psychedelics and its prominent promise on therapeutics and medical fields,” Ahrens added.

Compass Pathways Expands Portfolio Beyond Psilocybin Into Psychedelics 2.0

Compass Pathways (NASDAQ: CMPS) has purchased an intellectual property portfolio that includes patent applications for a variety of psychedelic and empathogenic substances.

This announcement marks an expanded strategy for the company, looking into other molecules beyond COMP360, its proprietary version of synthetic psilocybin, currently in phase 2 clinical trials.

The IP purchased was developed together with inventor Dr. Matthias Grill, founder and CEO of MiHKAL GmbH in Basel, Switzerland, who will be working with Compass on a research project to develop new product candidates.

The new substances include novel derivatives of known compounds, which attempt to increase confidence in therapeutic effects and safety profile while offering optimized characteristics.

“Chemistry still happens inside the flask and not on paper,” said Grill, who has synthesized psychedelic substances for a number of human research studies, including at the University of Basel and the National Institute of Mental Health in the Czech Republic.

Pasithea Therapeutics Goes Public On The Nasdaq With $24M IPO

Pasithea Therapeutics (NASDAQ: KTTA), a biotech focused on the research and discovery of new treatments in psychiatry, including ketamine therapy, launched a million IPO on the Nasdaq under the symbol “KTTA.”

“Our successful IPO is testament to our work as a biotech company paving the way for new solutions to address how we treat mental health disorders,” Dr. Tiago Reis Marques, CEO and director of Pasithea told Benzinga, adding that the company plans to develop novel central nervous system drugs to solve psychiatric and neurological disorders.

Pasithea is targeting treatment-resistant depression and PTSD using ketamine infusions. The research will be conducted under the leadership of Professor Lawrence Steinman, a renowned neurologist and immunologist based at Stanford University and Reis Marques, who also serves as psychiatrist and neuroscientist at Imperial College and King’s College London.

The IPO offered 4.8 million units (of one share and one share purchase warrant) at a price of $5 per unit.

Pasithea shares opened on Wednesday at $4, dropping to $3.15 by the end of Friday’s trading session.

Enveric Closes Acquisition Of MagicMed Industries In $23 Million Transaction

On Friday, Enveric Biosciences (NASDAQ: ENVB) confirmed that its previously announced acquisition of MagicMed Industries has gone through.

Enveric issued the shareholders of MagicMed approximately 9.5 million shares. Now, Enveric shareholders own approximately 68% of the combined company, while MagicMed shareholders own approximately 32%.

The new Enveric also received approximately CA$4 million ($3.1 million) in cash from the MagicMed treasury.

At a current stock price of $2.46 for Enveric shares, the transaction is valued at approximately $23 million.

As a result of the acquisition, Enveric will feature a new drug discovery and research arm with a strong focus on psychedelic drugs and cannabinoids.

Dr. Joseph Tucker, founder of MagicMed has become CEO of Enveric. David Johnson, Enveric's former CEO, is being appointed executive chairman of the company.

Currently, Enveric is pushing preclinical work on CBD for radiation dermatitis and glioblastoma and is also researching a compound in the treatment of chemotherapy-induced pain.

With the acquisition of MagicMed, development-focused Enveric will feature a new R&D side, which includes several ongoing research programs into psychedelic substances like psilocybin and DMT.

Wesana Health And MAPS Team Up To Study MDMA For Traumatic Brain Injury

Wesana Health (CSE: WESA) (OTCQB: WSNAF) and the Multidisciplinary Association for Psychedelic Studies (MAPS) are teaming up to analyze the effectiveness of MDMA-assisted therapy in the treatment of traumatic brain injury (TBI).

The TBI-oriented company announced Monday that it has committed an initial $1.5 million to assess the viability of MDMA for treating a subset of conditions resulting from TBI that currently lack a cure or successful treatment, including chronic traumatic encephalopathy.

With the funding, MAPS will create a team to “evaluate the scope of unmet need for traumatic brain injury treatment and help to define terms of a desired joint venture between MAPS and Wesana.”

The proceeds will be used for legal support in drafting and finalizing a partnership agreement, business development and executive staff costs as well as other research-related expenses.

“Wesana is a serious, thoughtful and ethical company engaged in the development of psychedelic-assisted therapy. What Daniel [Carcillo, Wesana CEO] and his team are doing is in line with MAPS’ ethics, mission, values and scientific rigor,” said MAPS executive director Rick Doblin, Ph.D.

Perception Launches Phase 2a Trial on Arketamine

Perception Neuroscience, an Atai Life Sciences (NASDAQ: ATAI) subsidiary, is starting a Phase 2a clinical trial on PCN-101, its lead drug candidate.

The study will evaluate the safety and efficacy of a proprietary formulation of arketamine that could have a similar therapeutic action to ketamine in the treatment of depression, with less dissociative effects.

The Phase 2a trial is a double-blind, placebo-controlled study in patients with treatment-resistant depression. Three parallel arms will enroll 31 patients at multiple locations. Patients will receive either a placebo, a 30 mg dose, or a 60 mg dose of arketamine intravenously.

“We believe PCN-101 holds promise in helping such treatment-resistant patients, as a potential rapidly-acting antidepressant which can be administered at home,” said Terence Kelly, CEO of Perception Neuroscience.

The company said that non-clinical depression model studies in rodents suggest that arketamine could have more durable and potent effects than esketamine and potentially a more favorable safety and tolerability profile.

Resurgent Launches Survey Into The Effects Of Psychedelics In Traditional Contexts

Resurgent Biosciences, a subsidiary of Goodness Growth Holdings, Inc. (CSE: GDNS) (OTCQX: GDNSF) is launching a survey study that will look into the varying effects of entheogen and psychedelic experiences for therapeutic, religious and spiritual purposes.

The goal of the company is to understand the naturalistic use of entheogens and other substances typically used for healing in specific cultural and spiritual contexts.

The study’s approach seeks to complement current research into psychedelics, which is often done with synthetic substances (like MDMA, LSD or isolated psilocybin), in a strictly clinical context.

The observational pilot survey, which will be done online with one hundred anonymous subjects, has received approval from an independent Institutional review board registered with the Office for Human Research Protections at the federal Department of Health and Human Services.

The survey will help inform Resurgent on future developments into psychedelic-based therapies by collecting anonymous data from adults who self-report having participated in entheogen therapy centers and retreats during the last five years.

The survey is currently open for participation via this link.

Detroit Will Vote To Decriminalize Psychedelics

Detroit could soon decriminalize the personal use and possession of naturally-occurring psychedelics via a ballot vote to be held in November.

A local ballot will allow Detroiters to adopt an amendment to the 2019 Detroit City Code that would “decriminalize to the fullest extent permitted under Michigan law the personal possession and therapeutic use of entheogenic plants by adults, and make the personal possession and therapeutic use of entheogenic plants by adults the city’s lowest law-enforcement priority.”

If voters approve it, Detroit would be added to the list of jurisdictions in Michigan to decriminalize the personal use of plant-derived psychedelics, which include Ann Arbor and Washtenaw County.

Awakn To Buy Ketamine Clinic in Norway

Awakn Life Sciences Corp. (NEO: AWKN) (OTCQB: AWKNF) has signed a binding agreement to acquire Axonklinikken AS, a ketamine-assisted psychotherapy clinic in Norway.

As part of the transaction Axon will be renamed as ‘Awakn Oslo AS’, and Axon’s majority shareholder Dr. Lowan Stewart will be appointed as regional director for the Nordic region and managing director of Awakn Oslo AS.

The acquisition comes as a first move into an ambitious expansion plan into Norway, Sweden, Denmark, Finland and Iceland, as well as the U.K. and Ireland.

“This acquisition will enable Awakn to accelerate the first element of our three-pronged revenue generation strategy: clinics in the UK and Europe, licensing partnership beyond the UK and Europe, and therapeutics commercialization,” said Anthony Tennyson, Awakn’s CEO.

As part of the acquisition, Awakn will issue 200,000 common shares of Awakn at a deemed price of $2.50 per share to the shareholders of Axon. Additional payments could come thereafter on the basis of specific milestones achieved by the Axon management, related to further expansion into the Nordic region.

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>>> Atai Life Sciences announces the launch of PsyProtix, to develop a precision psychiatry approach for Treatment-Resistant Depression (TRD)


Atai Life Sciences

Yahoo Finance

October 11, 2021


https://finance.yahoo.com/news/atai-life-sciences-announces-launch-120000713.html


NEW YORK, Oct. 11, 2021 (GLOBE NEWSWIRE) -- atai Life Sciences (Nasdaq: ATAI) (“atai”), a clinical-stage biopharmaceutical company aiming to transform the treatment of mental health disorders, announced the launch of PsyProtix, a new platform company formed with Chymia LLC, a Duke University biotechnology spinout. PsyProtix is a precision psychiatry company focused on developing therapeutics for treatment-resistant depression (TRD) and other mental health indications.

PsyProtix takes a precision psychiatry approach, an emerging field that aims to treat disorders by factoring each patient’s variability in genes, metabolism, environment, and lifestyle. Traditionally, psychiatric patients are diagnosed and treated based on guidelines and protocols designed for the majority, which can often lead to trial and error as physicians attempt to best meet each individual patient’s needs.

Precision psychiatry is designed to allow physicians to prescribe treatments specifically targeted to the individual, rather than relying on the trial and error approach and/or adding on treatments, such as antidepressants or antipsychotics, in the quest to achieve a therapeutic benefit.

Over 300 million people suffer with a major depressive disorder (MDD) worldwide, with a third of these patients diagnosed with TRD. Direct medical costs for TRD patients are estimated to be two to three times higher than non-TRD MDD patients. These statistics highlight the importance and potential of a mechanistically targeted therapeutic approach. PsyProtix will focus on metabolomic mechanisms underlying depression symptoms for certain patients with the goal of deriving more tailored treatments.

“Our view is that each patient is unique, meaning that any given patient will likely have specific individual needs,” said Srinivas Rao, Chief Scientific Officer and co-founder of atai Life Sciences. “This emerging technology adapts to the variability of conditions, such as depression, with the aim of allowing patients with psychiatric disorders to potentially be diagnosed and treated more accurately and efficiently according to their specific needs. It’s an honor to be collaborating with Professor Rima Kaddurah-Daouk and her team at Duke, given their great work in advancing the research of metabolomics and their study of neuropsychiatric disorders.”

Dr. Kaddurah-Daouk, is a Professor of Psychiatry and Behavioral Sciences in Duke’s School of Medicine. She leads large NIH funded consortia to implement a precision medicine approach for the study of neuropsychiatric diseases where the metabolome is used to capture net influences of diet exposome gut microbiome and genome on brain health and disease.

The work licensed by Duke to start PsyProtix captures efforts of a large number of scientists working collaboratively under the Mood Disorder Precision Medicine Consortium which is led by a Duke principal investigator (PI). Their approach has the promise to potentially optimize the selection of drugs most effective for each patient, easing the healing journey in important and impactful ways.

About atai Life Sciences

atai is a clinical-stage biopharmaceutical company aiming to transform the treatment of mental health disorders. atai was founded in 2018 as a response to the significant unmet need and lack of innovation in the mental health treatment landscape. atai is dedicated to acquiring, incubating and efficiently developing innovative therapeutics to treat depression, anxiety, addiction, and other mental health disorders. atai's business model combines funding, technology, scientific and regulatory expertise with a focus on psychedelic therapy and other drugs with differentiated safety profiles and therapeutic potential. By pooling resources and best practices, atai aims to responsibly accelerate the development of new medicines across its companies, seeking to effectively treat and ultimately heal mental health disorders. atai's mission is to bridge the gap between what the mental healthcare system currently provides and what patients need. atai has offices in New York, London, and Berlin. For more information, please visit www.atai.life.

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>>> AdvisorShares Launches Psychedelics ETF (Ticker: PSIL)


Yahoo Finance

September 16, 2021


https://finance.yahoo.com/news/advisorshares-launches-psychedelics-etf-ticker-122700695.html


AdvisorShares Psychedelics ETF delivers focused exposure to invest in a new medical frontier


BETHESDA, Md., Sept. 16, 2021 /PRNewswire/ -- AdvisorShares, a leading sponsor of actively managed exchange-traded funds (ETFs), today announced the launch of the AdvisorShares Psychedelics ETF (Ticker: PSIL). PSIL begins its trading as the first U.S.-listed actively managed ETF to deliver dedicated investment exposure to psychedelics and this emerging equity theme.

PSIL seeks long-term capital appreciation by investing in the fast-evolving psychedelics space, offering exposure to those biotechnology, pharmaceutical and life sciences companies which the portfolio manager views as leading the way in this nascent industry. Ongoing and growing research has shown various psychedelic substances offer promising medical and therapeutic potential for treating mental health issues and neurological disorders. PSIL concentrates its portfolio on companies which derive the majority of their net revenue or devote the majority of their assets to psychedelic drugs.

"We believe that by investing in select companies in the psychedelics space can provide a compelling long-term investment opportunity, however, this is also an area of the marketplace in its early innings," said Dan Ahrens, chief operating officer of AdvisorShares and portfolio manager of PSIL. "We feel that our active management and specialized approach can potentially help investors capture the early growth potential of psychedelics and its prominent promise on therapeutics and medical fields."

Ahrens has an established expertise and track record of actively managing complex areas of the equity markets including as the portfolio manager of AdvisorShares Pure US Cannabis ETF (Ticker: MSOS), AdvisorShares Pure Cannabis ETF (Ticker: YOLO) and the AdvisorShares Vice ETF (Ticker: VICE). He is also portfolio manager for the AdvisorShares Hotel ETF (Ticker: BEDZ) and AdvisorShares Restaurant ETF (Ticker: EATZ) which both launched in June 2021.

"We believe that delivering this strategy in an ETF structure with daily transparency, intraday liquidity and operational efficiency provides an ideal way for advisors and investors to access this burgeoning market," added Noah Hamman, chief executive officer of AdvisorShares. "As we continue to navigate highly specialized areas of the marketplace, we also remain steadfastly committed to providing ongoing investment education for our ETF shareholders, prospective investors and the investment community at large."

AdvisorShares regularly hosts live webinars featuring portfolio managers and leading industry experts. You may learn more and register at the AdvisorShares Event Center for upcoming events sessions on different investment strategies including on psychedelics and PSIL.

About AdvisorShares

AdvisorShares is a leading provider of actively managed ETFs. For financial professionals and investors requesting more information, call 1-877-843-3831 or visit www.advisorshares.com. Follow @AdvisorShares on Twitter and Facebook for more insights.

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>>> Revive Therapeutics Provides Update on Psychedelics Clinical Product Pipeline


Yahoo Finance

Revive Therapeutics Ltd.

August 10, 2021


https://finance.yahoo.com/news/revive-therapeutics-provides-psychedelics-clinical-114800107.html


Focusing on novel uses, production and delivery forms of psilocybin as a next generation solution for mental illness, substance abuse and neurological disorders

Advancing to FDA clinical studies for methamphetamine use disorder and stroke


TORONTO, Aug. 10, 2021 (GLOBE NEWSWIRE) -- Revive Therapeutics Ltd. (“Revive” or the “Company”) (OTCQB: RVVTF) (CSE: RVV) (FRANKFURT:31R), a specialty life sciences company focused on the research and development of therapeutics for medical needs and rare disorders, is pleased to provide an update on the Company’s psychedelics development and clinical programs with a focus on psilocybin.

Michael Frank, CEO of the Company, commented, "We are advancing a robust psychedelics-based product pipeline that includes product development, preclinical and clinical studies that aim to unlock the potential therapeutic value of psilocybin in various uses, formulations and delivery methods to treat mental health, substance abuse and neurological disorders. Revive is embarking on the next stage of growth of its psychedelics strategy by focusing on building key partnerships with US academic institutions and other leading organizations, as well as developing intellectual property and entering into FDA clinical studies with psilocybin.”

Psilocybin in the Treatment of Methamphetamine Use Disorder

The Company is working with the Board of Regents of the University of Wisconsin System under a clinical trial agreement to conduct a Phase I/II clinical study to evaluate the safety and feasibility of psilocybin in adults with methamphetamine use disorder. Study start-up activities have taken place and enrollment activities are to continue throughout the remainder of the year. As a result of the study, clinical data will provide proprietary and valuable information on the safety, efficacy and dosing of psilocybin to support future pivotal FDA clinical studies in oral forms of delivery including oral thin film strips. The clinical study will be conducted at the University of Wisconsin-Madison, School of Medicine and Public Health and School of Pharmacy, which holds a Wisconsin special authorization and DEA license to perform clinical research with psilocybin. In addition, the Company will have exclusive access to key intellectual property from this study to support development, regulatory and commercial initiatives.

Psilocybin in the Treatment of Traumatic Brain Injury (TBI) and Stroke

The Company is advancing the research and intellectual property acquired from PharmaTher Holdings Ltd. (OTCQB: PHRRF) (CSE: PHRM) on psilocybin as a potential solution to managing TBI and stroke. Preclinical studies demonstrated that psilocybin, given after injury, improved cognitive function in TBI mice. The Company is proceeding to an FDA clinical study to be conducted at the University of Wisconsin-Madison, School of Medicine and Public Health and School of Pharmacy. Start-up activities have already begun and patient enrollment is expected to commence in Q4-2021.

Psilocybin Oral Thin Film Strip Development

The Company has initiated the product development program under a feasibility agreement with LTS Lohmann Therapie-Systeme AG, a leader in pharmaceutical oral thin films, to develop and manufacture a proprietary psilocybin oral thin film strip for mental illness, substance abuse and neurological disorders. Research grade prototypes will be available to evaluate dosing and delivery rates in various dosage forms with the expectation to conduct clinical studies in 2022.

Psilocybin Biosynthesis Program

Under its research collaboration with North Carolina State University (NC State), the Company is developing a novel biosynthetic version of psilocybin based on a natural biosynthesis enzymatic platform developed by Dr. Gavin Williams, Professor and Researcher at NC State. The biosynthetic platform developed by Dr. Gavin Williams provides a potentially simple and efficient method for rapidly producing natural products, such as psilocybin, using an engineered enzymatic pathway in E. coli. Certain technical milestones have been achieved to date, offering a clear path towards completing validation methods to demonstrate a novel yet simple production process of biosynthetic psilocybin that can be used at a critical scale for clinical and commercial use.

Psilocybin International Research and Commercialization

The Company recently entered into an agreement with the University of Health Sciences Antigua to utilize Revive’s novel psychedelic-assisted therapies including its tannin-chitosan delivery system and to pioneer the clinical research and development of psychedelics in Antigua and Barbuda. Clinical research will be conducted at the University in Q4-2021 with the aim for commercialization in 2022 in Antigua and Barbuda. Once approved for sale, the Company will seek commercial partnerships with specialty pharmaceutical companies in the Caribbean and Latin America.

About Revive Therapeutics Ltd.

Revive is a life sciences company focused on the research and development of therapeutics for infectious diseases and rare disorders, and it is prioritizing drug development efforts to take advantage of several regulatory incentives awarded by the FDA such as Orphan Drug, Fast Track, Breakthrough Therapy and Rare Pediatric Disease designations. Currently, the Company is exploring the use of Bucillamine for the potential treatment of infectious diseases, with an initial focus on severe influenza and COVID-19. Through its subsidiary Psilocin Pharma Corp., Revive is advancing the development of Psilocybin-based therapeutics in various diseases and disorders. Revive’s cannabinoid pharmaceutical portfolio focuses on rare inflammatory diseases and the company was granted FDA orphan drug status designation for the use of Cannabidiol (CBD) to treat autoimmune hepatitis (liver disease) and to treat ischemia and reperfusion injury from organ transplantation. For more information, visit www.ReviveThera.com.

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>>> 3 Disruptive Mental Health Stocks to Consider Buying Before They're Huge

They're the first pioneers in exciting new markets.


Motley Fool

Alex Carchidi

Aug 14, 2021


https://www.fool.com/investing/2021/08/14/3-disruptive-mental-health-stocks-to-consider-buyi/?source=eptyholnk0000202&utm_source=yahoo-host&utm_medium=feed&utm_campaign=article


Key Points

Mental health treatments could become an even larger market over the next decade.

Psychedelic medicines are at the bleeding edge of drug development for mental health disorders.

Combining telehealth with behavioral health may be especially lucrative.


In any sector with entrenched competitors, there's room for a disruptive upstart to come in and steal oodles of market share. Such innovative new entrants can often be great picks for your portfolio, as they have the benefit of doing things differently to address problems that have already proven to be profitable to solve. Of course, there's always a chance that a scrappy young business will fail to gain traction, but if it succeeds, it has a solid chance of going big.

Each of the three healthcare companies I'll analyze today is pioneering a unique business model to address the needs of patients with difficult-to-treat issues. If everything goes according to plan, they'll excel and become the very first juggernauts of their kind. And that could make the people who invest now significantly richer.


1. Compass Pathways

Compass Pathways (NASDAQ:CMPS) is developing psychedelic chemicals like psilocybin into therapies for difficult conditions including treatment-resistant depression. Aside from its drugs, Compass' lead depression program also includes elements of psychotherapy to help patients prepare for and adjust after their treatment with psilocybin. Working with chemicals formerly eschewed by the medical establishment is one thing that makes Compass a disruptor, but the idea of combining psychedelics with support from trained clinicians into a cohesive package is even more important.

The thing to appreciate about Compass' conception of psychedelic therapy is the numerous options it offers to add value for customers beyond what might be "normal" for a biotech company's product.

Before patients even get to the front door of the therapy clinic, they've interacted with the company's automated online prep platform, which helps them to get ready for their experience. And they've already had contact with the support staff that will be a part of their therapy. Once they're in the clinic for the duration of the eight-hour therapy experience, the company's carefully designed therapy rooms are packed with amenities to support their comfort and healing (padded walls).

All of the above gives Compass the ability to command a high price for its services while also providing the opportunity for customers to build positive feelings about its brand, thereby creating a competitive advantage and cementing market share. If it were only in the business of making psychedelic drugs, it would not be able to accomplish either of those things.

At the moment, Compass' lead program is in phase 2b of clinical trials, and it could report results by the end of the year. By the end of the decade, it could be operating therapy clinics everywhere if its brand of clinician-assisted psychedelic therapy is proven to be effective, and that's what makes it worth a purchase today.


2. Talkspace

Talkspace (NASDAQ:TALK) provides telehealth services for behavioral health, so its psychotherapists and psychiatrists can help patients who would otherwise be far beyond the geographical reach of robust local mental health systems. It sells subscriptions to businesses, insurers, and consumers, all of which pay monthly according to the services their patients use.

Right now, the company is leading other behavioral telehealth providers in brand awareness, though it isn't profitable. Growing its membership base and forming a core of loyal customers domestically are the challenges of the moment. In the future, it plans to expand its coverage outside the U.S. to all of the English-speaking world.

The key point of uncertainty is whether Talkspace will be able to outcompete the other behavioral telehealth companies once the market shakes out, including those that currently do mental healthcare only as an ancillary service. On the basis of its plans at the moment, it could report positive earnings before interest, taxes, depreciation, and amortization (EBITDA) as soon as 2022 while growing annual net revenue by as much as 64%. Aggressive investors may want to consider buying the stock sometime over the next few quarters, as proof of progress toward those estimates starts to trickle out.


3. Atai Life Sciences

Atai Life Sciences (NASDAQ:ATAI) is a biotech that aims to combine the innovative therapies of Compass Pathways with the behavioral telehealth of Talkspace, though its primary focus is on drug development for the time being.

Atai is collaborating with Compass Pathways on its psilocybin program for treatment-resistant depression. But it also has a few other development collaborations for projects addressing opioid use disorder, generalized anxiety disorder, and post-traumatic stress disorder (PTSD), to name a few. The majority of Atai's pipeline is in the early stages, which means that it could be years before it brings a drug to the market.

Atai's innovation is to make treatment with novel psychedelic drugs into something that's safe, effective, scalable, and accessible via telemedicine. To accomplish this, it's building a suite of telehealth tools for remote counseling of patients during their treatment with psychedelics. And it's also developing new drug discovery and delivery technologies so its therapies are more effective and more efficient than competitors'.

Its telehealth tools are what could enable Atai to scale its psychedelic therapies to address a huge swath of the market for novel behavioral health solutions. If the company's therapists can prescribe its medications for patients to take in the comfort of their homes with continuing support from afar, that would negate the need to operate costly clinics -- and keep the price of treatment much lower, too.

In sum, Atai is planning to make its psychedelic therapies scale better than any other company can manage, and that's why it's worth considering as an investment.

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>>> Seelos Therapeutics Announces Mid-Year 2021 Business and Clinical Update


Yahoo Finance

August 9, 2021


https://finance.yahoo.com/news/seelos-therapeutics-announces-mid-2021-120000687.html


NEW YORK, Aug. 9, 2021 /PRNewswire/ -- Seelos Therapeutics, Inc. (Nasdaq: SEEL), a clinical-stage biopharmaceutical company focused on the development of therapies for central nervous system disorders and rare diseases, today announced its mid-year 2021 business and clinical update.

"In the first half of 2021, the Seelos team continued to execute at a very high level. Part 1 of the SLS-002 study demonstrated rapid antidepressant and anti-suicidal effects with a well-tolerated safety profile. We have begun the placebo-controlled Part 2 of this registration directed study and plan to enroll in up to 30 sites," said Raj Mehra Ph.D., Chairman and CEO of Seelos. "The SLS-005 IV trehalose program's pivotal study in ALS, which was accepted into the HEALEY ALS Platform Trial at Harvard, plans to commence dosing patients in the third quarter as well. We have begun additional in vivo studies with our gene therapy program SLS-004 after demonstrating its capability of reducing alpha-synuclein expression targeting Parkinson's disease, and we continue to evaluate additional indications for both SLS-002 and SLS-005."

In the first half of 2021, Seelos achieved several major clinical and financial milestones and continued to make progress on its multiple clinical stage development programs.

Seelos Business Update

As of the end of Q2, Seelos had $87.2mm of cash. It currently has no outstanding debt.

In January, Seelos raised $33.5 million in net proceeds in an offering of common stock. The company raised an additional $65 million in net proceeds in another offering of common stock. Proceeds were used for the full repayment of Seelos' prior convertible promissory notes and the remainder is for general corporate purposes and to advance the development of its product candidates.

Also in January, Seelos was selected as one of 17 companies included in the world's first psychedelic Exchange Traded Fund (ETF), the Horizons Psychedelic Stock Index Fund, which trades on Canada's NEO exchange and, in June, Seelos was included in the Defiance Next Gen Altered Experience ETF, the first U.S. listed Exchange Traded Fund (ETF) focused on psychedelics, which began trading on May 28th.

In February, Seelos announced an amendment of its agreement with Vyera Pharmaceuticals AG for the development of SLS-002 (intranasal racemic ketamine) to repurchase in cash 9% of the royalties payable on any future net sales of SLS-002.

In April, Seelos announced a Strategic Device Partnership with AptarGroup, Inc. for the co-exclusive use and supply of Aptar Pharma's Bidose (BDS) Liquid System device for SLS-002 in the investigational development programs for the treatment of suicidality, depression, and Post-Traumatic Stress Disorder (PTSD) and under the terms of the agreement, Seelos has certain rights to add other undisclosed indications to the Strategic Device Partnership.

Seelos was added to the Russell 2000®, Russell 3000®, and Russell Microcap® Indexes at the end of June, as part of the 2021 Russell US Indexes Reconstitution.

Seelos Clinical Update

SLS-002 (intranasal racemic ketamine)

Data for Part 1, the open-label cohort, of the registration directed study for Acute Suicidal Ideation and Behavior in patients with Major Depressive Disorder demonstrated a significant treatment effect plus a well-tolerated safety profile.

In early July, dosing of Part 2, the double-blind, placebo-controlled cohort of the study commenced. A super-majority of the trial sites are in various stages of onboarding.

On June 15th, Seelos completed a Type C meeting with the FDA to discuss the regulatory pathway for the SLS-002 program.

SLS-005 (IV trehalose)

Seelos was issued a patent from the Australian Patent Office covering the parenteral administration of SLS-005 in multiple neurodegenerative indications.

A Notice of Allowance was received from the Japanese Patent Office covering the parenteral administration of SLS-005 in treating oculopharyngeal muscular dystrophy (OPMD).

SLS-005 received European Orphan Drug designation for ALS.

In the third quarter, Seelos is expected to commence dosing of a pivotal Phase IIb/III trial in amyotrophic lateral sclerosis (ALS) as part of the HEALEY ALS Platform Trial led by Harvard Medical School at Massachusetts General Hospital at several dozen trial sites across the U.S.

SLS-004 (Parkinson's disease gene therapy programs)

In vivo data was released in early July demonstrating down-regulation of SNCA mRNA and protein-expression from a study of SLS-004 in an in-vivo rodent model utilizing CRISPR-dCas9 gene therapy technology.

Additional studies have commenced to explore efficacy of SLS-004 in the induced Parkinsonism in an in vivo rodent model.

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>>> 10 Best Psychedelic Stocks to Buy Now


Insider Monkey

by Usman Kabir

July 14, 2021


https://finance.yahoo.com/news/10-best-psychedelic-stocks-buy-165743252.html


Psychedelic treatments for mental health disorders like depression, anxiety, and post-traumatic stress have revolutionized the industry in the past few years, helping the market for the novel therapies to grow from $2 billion in 2019, as per a report by Data Bridge Market Research, to almost $5 billion in 2020, according to a study by Research and Markets. The sector offers explosive growth potential, evidenced by the recent positive coverage of psychedelic stocks by investment research firms like Citi, Credit Suisse, Canaccord Genuity, and Cantor Fitzgerald.

Some of the companies already making a big splash in the as yet small sector include COMPASS Pathways plc (NASDAQ: CMPS), Atai Life Sciences N.V. (NASDAQ: ATAI), and Seelos Therapeutics, Inc. (NASDAQ: SEEL), among others. COMPASS Pathways plc (NASDAQ: CMPS) and Atai Life Sciences N.V. (NASDAQ: ATAI) recently debuted on the stock market, fetching billion dollar valuations, while Seelos Therapeutics, Inc. (NASDAQ: SEEL) has been soaring in trading the past few days on the back of positive results from a clinical study.

The success of these firms in the psychedelic market has attracted the attention of industry giants like Pfizer Inc. (NYSE: PFE), Eli Lilly and Company (NYSE: LLY), AbbVie Inc. (NYSE: ABBV), Bristol-Myers Squibb Company (NYSE: BMY), Abbott Laboratories (NYSE: ABT), and GlaxoSmithKline plc (NYSE: GSK). These biopharma companies market different kinds of drugs for mental health disorders and sense a business opportunity as novel treatments for depression and anxiety become more widely accepted in the United States.

Investments in psychedelic startups have also increased in the past few months, with investors flocking to early stage psychedelic firms that are working on innovative new technologies to help psychedelics become more mainstream. Research institutions, like the Center for Psychedelic and Consciousness Research at John Hopkins University in Baltimore, which has already published more than 50 research papers on the subject, have also contributed to the industry. However, despite these advances, psychedelics remain a niche market in the pharma sector.

Investors looking to invest in the industry should be wary of certain challenges that the psychedelic companies will have to negotiate before unleashing their true growth potential. These challenges include an uphill legal battle to get approval for use of psychedelic substances in new drugs, a capacity-building campaign in the wider public to debunk the myths and stigma surrounding the use of psychedelics, as well as financial hurdles that an industry still in its infancy might face as it struggles for wider recognition.

The psychedelic industry has the potential to disrupt the biopharma sector in the coming years much like the rise of fintech has transformed the finance world. The entire hedge fund industry is feeling the reverberations of the changing financial landscape. Its reputation has been tarnished in the last decade, during which its hedged returns couldn’t keep up with the unhedged returns of the market indices.

With this context in mind, here is our list of the 10 best psychedelic stocks to buy now. These were ranked keeping in mind basic business fundamentals, hedge fund sentiment, and analyst ratings for each.

Best Psychedelic Stocks to Buy Now

10. Small Pharma Inc. (OTC: DMTTF)

Small Pharma Inc. (OTC: DMTTF) is placed tenth on our list of 10 best psychedelic stocks to buy now. The company’s shares have returned 14% to investors over the past five days. The company is working on rapid-acting antidepressants. These are used to treat patients with mental health conditions such as depression. The firm has a market cap of over $100 million and a 279% return on equity. It is based in the United Kingdom.

On June 25, Small Pharma Inc. (OTC: DMTTF) announced that it would be participating in two upcoming conferences on psychedelics in order to present and share the progress it had made in the assisted therapy department for depression.

In February this year, Small Pharma Inc. (OTC: DMTTF) had announced that it was beginning a clinical program related to DMT-assisted therapy. According to details provided by the firm, the program included a Phase I and Phase 11a trial of a leading drug candidate.

Just like COMPASS Pathways plc (NASDAQ: CMPS), Atai Life Sciences N.V. (NASDAQ: ATAI), Seelos Therapeutics, Inc. (NASDAQ: SEEL), Pfizer Inc. (NYSE: PFE), Eli Lilly and Company (NYSE: LLY), AbbVie Inc. (NYSE: ABBV), Bristol-Myers Squibb Company (NYSE: BMY), Abbott Laboratories (NYSE: ABT), and GlaxoSmithKline plc (NYSE: GSK), Small Pharma Inc. (OTC: DMTTF) is a solid investment in the health sector.

9. Revive Therapeutics Ltd. (OTC: RVVTF)

Revive Therapeutics Ltd. (OTC: RVVTF) stock has returned 123% to investors over the past year. The firm operates as a life sciences company focusing on the development of drugs, like psychedelics, for treatment of rare disorders and infectious diseases. It is ranked ninth on our list of 10 best psychedelic stocks to buy now. The firm has a market cap of more than $135 million and a 52-week price high of $0.72 per share. It operates from Canada.

On June 25, Revive Therapeutics Ltd. (OTC: RVVTF) CEO Michael Frank announced that the company would begin trading on the OTCQB Market at the end of June, helping broaden the awareness and shareholder base in the United States.

Earlier that month, Revive Therapeutics Ltd. (OTC: RVVTF) had revealed an agreement with Supriya Lifescience in India for the manufacture, registration, and the marketing of a COVID-19-related drug named Bucillamine.

Revive Therapeutics Ltd. (OTC: RVVTF) is a top stock for the pharma industry, along with COMPASS Pathways plc (NASDAQ: CMPS), Atai Life Sciences N.V. (NASDAQ: ATAI), Seelos Therapeutics, Inc. (NASDAQ: SEEL), Pfizer Inc. (NYSE: PFE), Eli Lilly and Company (NYSE: LLY), AbbVie Inc. (NYSE: ABBV), Bristol-Myers Squibb Company (NYSE: BMY), Abbott Laboratories (NYSE: ABT), and GlaxoSmithKline plc (NYSE: GSK).

8. Numinus Wellness Inc. (OTC: LKYSF)

Numinus Wellness Inc. (OTC: LKYSF) is a company that works closely on the development and delivery of psychedelic-assisted psychotherapy. It is placed eighth on our list of 10 best psychedelic stocks to buy now. The company’s shares have returned 282% to investors over the past twelve months. The firm has a market capitalization of over $165 million and posted more than $675,000 in annual revenue last year.

On July 12, Numinus Wellness Inc. (OTC: LKYSF) announced that authorities in Canada had approved a single-arm, open-label safety and feasibility study evaluating assisted therapy for post-traumatic stress disorder. Payton Nyquvest, the CEO of the firm, shared the news.

Earlier that month, Numinus Wellness Inc. (OTC: LKYSF) had announced that it would be purchasing the Neurology Centre of Toronto for $500,000 in cash and shares. The company plans to transform the centre into a treatment centre focusing on psychedelics.

Investors who are interested in COMPASS Pathways plc (NASDAQ: CMPS), Atai Life Sciences N.V. (NASDAQ: ATAI), Seelos Therapeutics, Inc. (NASDAQ: SEEL), Pfizer Inc. (NYSE: PFE), Eli Lilly and Company (NYSE: LLY), AbbVie Inc. (NYSE: ABBV), Bristol-Myers Squibb Company (NYSE: BMY), Abbott Laboratories (NYSE: ABT), and GlaxoSmithKline plc (NYSE: GSK) should also check out Numinus Wellness Inc. (OTC: LKYSF).

7. Hollister Biosciences Inc. (OTC: HSTRF)

Hollister Biosciences Inc. (OTC: HSTRF) is ranked seventh on our list of 10 best psychedelic stocks to buy now. The stock has offered investors returns exceeding 78% over the course of the past twelve months. The firm primarily makes and sells cannabis products but also has interests in the psychedelic products business. It has a market cap of over $55 million and posted more than $30 million in revenue last year.

On June 1, Hollister Biosciences Inc. (OTC: HSTRF) posted earnings results for the first quarter of 2021, reporting a revenue of more than $23 million over the period, an increase of a whopping 2,331% compared to the revenue over the same period last year.

Last year, Hollister Biosciences Inc. (OTC: HSTRF) had entered the psychedelic industry with the purchase of AlphaMind Brands, a firm working on the development of psychedelic products. Carl Saling, the CEO of the firm, noted the fast growth in the psychedelic market at the time.

COMPASS Pathways plc (NASDAQ: CMPS), Atai Life Sciences N.V. (NASDAQ: ATAI), Seelos Therapeutics, Inc. (NASDAQ: SEEL), Pfizer Inc. (NYSE: PFE), Eli Lilly and Company (NYSE: LLY), AbbVie Inc. (NYSE: ABBV), Bristol-Myers Squibb Company (NYSE: BMY), Abbott Laboratories (NYSE: ABT), and GlaxoSmithKline plc (NYSE: GSK) are some of the best stock options in the health industry, alongside Hollister Biosciences Inc. (OTC: HSTRF).

6. Field Trip Health Ltd. (OTC: FTRPF)

Field Trip Health Ltd. (OTC: FTRPF) is a firm concentrating on the development and delivery of psychedelic therapies. It is placed sixth on our list of 10 best psychedelic stocks to buy now. The company’s shares have offered investors returns exceeding % over the course of the past year. It is based in Toronto and has a market capitalization of over $300 million. The firm posted more than $750,000 in annual revenue last year.

Last month, Field Trip Health Ltd. (OTC: FTRPF) had announced that it had applied for a listing on the NASDAQ stock market in the United States. The firm had clarified that there would be no change to the shares, warrants, or the share structure as a result of the application.

In early May, Field Trip Health Ltd. (OTC: FTRPF) President Hannan Fleiman, while opening a field center, had said that psychedelic therapies were poised to play an important role in the treatment of mental health disorders that had sprung up as a result of the COVID-19 pandemic.

While COMPASS Pathways plc (NASDAQ: CMPS), Atai Life Sciences N.V. (NASDAQ: ATAI), Seelos Therapeutics, Inc. (NASDAQ: SEEL), Pfizer Inc. (NYSE: PFE), Eli Lilly and Company (NYSE: LLY), AbbVie Inc. (NYSE: ABBV), Bristol-Myers Squibb Company (NYSE: BMY), Abbott Laboratories (NYSE: ABT), and GlaxoSmithKline plc (NYSE: GSK) dominate the conversations around novel therapies, Field Trip Health Ltd. (OTC: FTRPF) is making for itself in this regard as well.

5. Cybin Inc. (OTC: CLXPF)

Cybin Inc. (OTC: CLXPF) stock has returned more than 3,485% to investors in the past twelve months. The firm operates as a life sciences company concentrating on the development of psychedelic drugs. It is ranked fifth on our list of 10 best psychedelic stocks to buy now. Some of the leading drug candidates of the firm include CYB001 and CYB003. The former is a treatment for major depressive disorder while the latter aims to tackle alcohol use disorder.

In early July, Cybin Inc. (OTC: CLXPF) announced that it had entered into an agreement with TMS NeuroHealth Centers to establish Mental Health Centers of Excellence that would facilitate research and development of innovative psychedelic therapies.

In late March, Cybin Inc. (OTC: CLXPF) had revealed that it signed a , a US-based biopharma firm, for use of Zydis orally disintegrating tablet technology. The new tech would be used as a delivery mechanism for the CYB003 drug being developed by Cybin.


4. Mind Medicine (MindMed) Inc. (NASDAQ: MNMD)

Mind Medicine (MindMed) Inc. (NASDAQ: MNMD) is placed fourth on our list of 10 best psychedelic stocks to buy now. The company’s shares have returned 19% to investors over the past twelve months. The firm is a New York-based biopharma company working on psychedelic medicines. It has a market capitalization of over $1.2 billion. The short interest on the stock is 1.14% and the share price touched a 52-week high of $5.77 in May.

On July 8, Mind Medicine (MindMed) Inc. (NASDAQ: MNMD) announced that it had teamed up with Datavant, a health information technology company, to link clinical trial data to external data. The move is part of a plan to build broad and detailed datasets for further use.

In late June, Mind Medicine (MindMed) Inc. (NASDAQ: MNMD) was included in the FTSE Russell 3000 Index. The inclusion came just two months after the firm was listed on the NASDAQ exchange in the United States.

3. Seelos Therapeutics, Inc. (NASDAQ: SEEL)

Seelos Therapeutics, Inc. (NASDAQ: SEEL) stock has returned 146% to investors over the past year. The firm is a biotech company that focuses on the development of psychedelic drugs for the treatment of post-traumatic stress and some depressive disorders. It is ranked third on our list of 10 best psychedelic stocks to buy now. The company is based in New York. The stock has a short interest of 2.89%. The 52-week high for the stock is $6.6.

On July 7, Seelos Therapeutics, Inc. (NASDAQ: SEEL) posted encouraging results from a SLS-004 rodent study. Raj Mehra, the CEO of the firm, made the results public. The share price of the firm jumped more than 4% after the announcement.

At the end of the first quarter of 2021, 11 hedge funds in the database of Insider Monkey held stakes worth $47 million in Seelos Therapeutics, Inc. (NASDAQ: SEEL), up from 4 the preceding quarter worth $1.3 million.

2. Atai Life Sciences N.V. (NASDAQ: ATAI)

Atai Life Sciences N.V. (NASDAQ: ATAI) is a Germany-based biopharma company focusing on the development of psychedelic drugs. It is placed second on our list of 10 best psychedelic stocks to buy now. The company’s shares have offered investors returns exceeding 6.9% over the course of the past week. The company is backed by legendary investor Peter Thiel. It went public last month and was valued at $2.3 billion.

On July 13, Atai Life Sciences N.V. (NASDAQ: ATAI) stock was initiated at Buy or Overweight rating by prominent investment advisors like Citi, Credit Suisse, Canaccord Genuity, and Cantor Fitzgerald, among others.

At the end of the first quarter of 2021, 3 hedge funds in the database of Insider Monkey held stakes worth $782,000 in Atai Life Sciences N.V. (NASDAQ: ATAI), up from 1 in the previous quarter worth $118,000.

1. COMPASS Pathways plc (NASDAQ: CMPS)

COMPASS Pathways plc (NASDAQ: CMPS) is ranked first on our list of 10 best psychedelic stocks to buy now. The stock has offered investors returns exceeding 10% over the course of the past five days. The company operates as a mental health care firm focusing on psychedelics. It is based in the United Kingdom and has a market cap of close to $1.5 billion. The company was founded last year.

In quarterly earnings for the fourth quarter of 2020, posted in March this year, COMPASS Pathways plc (NASDAQ: CMPS) reported earnings per share of -$0.52, missing market estimates by $0.16. On July 13, Bitritto-Garg initiated the stock at a Buy rating.

Out of the hedge funds being tracked by Insider Monkey, New York-based investment firm Perceptive Advisors is a leading shareholder in COMPASS Pathways plc (NASDAQ: CMPS) with 797,404 shares worth more than $29 million.

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>>> Cybin Inc. Announces 2021 First Quarter Financial Results and Business Highlights


Yahoo Finance

August 13, 2021


https://finance.yahoo.com/news/cybin-inc-announces-2021-first-230000145.html


-- Boosts current cash position to C$82.5M to progress clinical pipeline and business initiatives --


TORONTO, August 13, 2021--(BUSINESS WIRE)--Cybin Inc. (NEO:CYBN) (NYSE AMERICAN:CYBN) ("Cybin" or the "Company"), a biotechnology company focused on progressing psychedelic therapeutics, announces the unaudited financial results for the three-month period ended June 30, 2021. A copy of the Company’s unaudited interim condensed consolidated financial statements prepared in accordance with International Financial Reporting Standards and the related management’s discussion and analysis for the three month period ended June 30, 2021, can be found under the Company’s profile on SEDAR at www.sedar.com and with the U.S. Securities and Exchange Commission on EDGAR at www.sec.gov.

Recent Business Highlights:

Became the first psychedelic company to list on the NYSE American LLC stock exchange on August 5, 2021 under the symbol "CYBN";

Raised over C$120M with the inclusion of the Company’s latest equity financing round in August 2021, which successfully raised over C$34M;

Announced achievement of certain milestones by Adelia Therapeutics Inc., a wholly-controlled subsidiary of Cybin, for Year 1 Q3 (i)-(iii), and Year 1 Q4 (i) and (iii), as contemplated by the terms of a contribution agreement dated December 4, 2020;

Initiated the next phase of the Company’s digital therapeutics platform which is expected to better enable the evaluation of patient outcomes through a highly secure, patient-centered data analytics platform for pre- and post-psychedelic treatments;

Commenced scale up of the Company’s European operations and research activities with various academic and clinical research organizations, including the transfer of its intellectual property assets to its recently formed wholly-owned Ireland subsidiary;

Expanded patent portfolio to 13 patent filings which cover, amongst other things, novel psychedelic compounds, integration of delivery platforms, methods of use in psychiatric indications, drug discovery pipeline of modified and novel ergolines, tryptamines and phenethylamines;

Entered into an exclusive research and development collaboration agreement with TMS NeuroHealth Centers Inc. (the "Collaboration Agreement"), a wholly-owned subsidiary of Greenbrook TMS Inc. (TSX:GTMS) (NASDAQ:GBNH) ("Greenbrook"). Greenbrook operates 129 outpatient mental health service centers in the United States. Under the Collaboration Agreement, Cybin and Greenbrook will work together to establish Mental Health Centers of Excellence for the purpose of facilitating research and development of innovative psychedelic compound-based therapeutics for patients suffering from depression.

Doug Drysdale, CEO of Cybin stated, "During the past several months, Cybin has garnered a great deal of attention as an emerging leader in the psychedelic therapeutics space. We believe the molecules we have under development may have the potential to transform the treatment landscape and fill current unmet treatment needs for various psychiatric and neurological conditions. We look forward to sharing updates as we advance our pre-clinical and clinical programs and continue the scientific exploration that we believe will ultimately provide safer and more effective treatments for those suffering with mental illness and addiction issues."

Q1 Financial Highlights

Cash and cash equivalents totaled C$55.1 million as of June 30, 2021; and

Net loss was C$14.7 million for the quarter ended June 30, 2021 of which non-cash expenses totaled C$5.6 million and cash-based operating expenses totaled C$9.1 million.

About Cybin

Cybin is a leading biotechnology company focused on researching and progressing psychedelic therapeutics by utilizing proprietary drug discovery platforms, innovative drug delivery systems, novel formulation approaches and potential treatment regimens for psychiatric disorders.

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>>> All-Inclusive Magic Mushroom Retreats Are the New Luxury ‘Trips’
Resorts are starting to wake up to the appeal of mind expansion.


Bloomberg

By Max Berlinger

August 19, 2021


https://www.bloomberg.com/news/articles/2021-08-19/all-inclusive-magic-mushroom-ayahuasca-retreats-are-new-luxury-trips


Alisa Bigham was looking for a new beginning. She’d recently left her marriage of 47 years and was trying to understand who she was outside of that union. “I kept having the thought, ‘You just need to go on a retreat and get away from everything,’” she says. “My intention was a reset of who I am, something that could bring me a big transformation.”

Bigham, 64, had read Michael Pollan’s book How to Change Your Mind, which chronicles the new research into psychedelics and their medicinal properties. She came away from it interested in exploring those possibilities for herself.

So she booked a retreat at Silo Wellness, which operates in Jamaica’s Montego Bay resort community. She was drawn to its nightly ceremonies, during which participants take psilocybin mushrooms and, led by local Rastafarians, embark on a series of transcendental journeys that might include visions and an altered emotional state.

These mushrooms can have a bitter, earthy taste, so honey was also provided for those who wanted a chaser. After the first trip, she felt profoundly, fundamentally changed. “Like I had found my superpower,” she says.

Bigham’s experience is becoming more and more common as a new breed of retreat is offering not only the lush surroundings, pleasant accommodations, and well-prepared food of high-end vacations but also the spiritual healing and metaphysical self-discovery of guided, plant-based psychedelic experiences. Colloquially they’re called trips, though most practitioners prefer the term “journey.”

At the all-inclusive Soltara Healing Center, set amid 22 acres near the Gulf of Nicoya in Costa Rica, stays run from $2,600 to $8,900, depending on the length and room style. The main event of the itinerary, which ranges from 5 to 12 nights, isn’t a boozy luau or snorkeling excursion but an ayahuasca ceremony led by native Shipibo healers.

In Vancouver, the Journeymen Collective focuses on imparting spiritual well-being into the corporate world. Their guided mushroom ceremonies—in which 2 to 5 grams of psychoactive fungi are blended with gourmet chocolate—are held at local lodgings and aimed at helping business leaders and executive teams align their companies with a greater purpose.

Gary Logan founded theJourneymen Collective in 2018 with his husband, Robert Grover, and says their goal is to make guests feel taken care of. “We want to cradle you, nurture you, and guide you through this process,” he says. “We want people to relax and rest into the medicine, not worry if there’s a tarantula on their face.”

Douglas Gordon, chief executive officer of Silo Wellness, says his retreat is in line with the changing notions of luxury. “Real luxury is being able to wear flip-flops to dinner,” he says. “It’s not necessarily black tie, you know? It’s about an authentic experience, like, ‘Do you want to go to that amazing jerk chicken place down the road?’ That’s the type of person we want to attract, someone who puts value into experiences.”

Psychedelics in the public sphere have undergone a profound shift in recent years, sometimes referred to as the shroom boom. In a short time the thinking has evolved from viewing them as recreational drugs to understanding the experiences as therapeutic, with an array of potential benefits.

The year before Pollan published his 2018 book—which covers research demonstrating that substances such as DMT (the active ingredient in ayahuasca), LSD, and psilocybin may ameliorate the effects of PTSD, depression, and addiction—writer Ayelet Waldman published A Really Good Day. She chronicled the deeply positive effects for her of “microdosing” (taking extremely small amounts of) LSD daily.

More recently, Netflix’s The Goop Lab followed employees at Gwyneth Paltrow’s lifestyle website as they flew to Jamaica and took part in a psychedelic healing session that included lots of laughing, crying, and writhing around on the floor. Podcaster Joe Rogan is also a vocal advocate of ayahuasca.

Already it appears there’s serious money to be made: According to Data Bridge Market Research, the psychedelic market is projected to reach $10.7 billion by 2027, up from $3.8 billion last year.

Travel entrepreneurs are looking on with interest. “The wellness industry continues to grow in size and importance in consumers’ lives post-pandemic,” says Joe McDonnell, head of insights at the trend forecasting company WGSN. “Staying healthy mentally and physically is a top priority.” A study published in November 2020 by Research and Markets valued the overall wellness tourism industry at $735.8 billion; by 2027, the agency projected it would be worth $1.2 trillion.

Soltara may lack the five-star indulgences of, say, Utah’s decadent Amangiri resort, but its rooms are comfortably spartan and airy, the meals thoughtfully prepared, and the pool azure blue. If these perks seem at odds with the spiritual quests at hand, there’s a reason. Melissa Stangl, a founding partner at Soltara and its chief operating officer, says that while working at a rustic retreat in a remote corner of the Peruvian jungle she noticed the clientele had a specific “adventure-seeking” demographic, aka backpackers.

The sanctuary’s remoteness, she realized, limited its client base. So when Soltara opened in June 2018, it chose the more established tourist infrastructure of Costa Rica with lodging that leans toward the elegant—an effort to appeal to a broader swath of potential customers.

“This work can be uncomfortable,” she says of the ayahuasca ceremonies. (It’s not uncommon for those who drink it to vomit, for example.) “Being able to provide a space that’s comfortable for the guests, where they don’t have to worry about the danger they may feel in a remote part of the jungle, is important. We’ve found that when they’re at ease, they are more able to open up into the medicine.”

At Silo, Gordon oversees a retreat where each session is individually tailored to the person or group attending. (They offer specific bookings geared toward women, fitness enthusiasts, and the LGBTQ community.) On average they cost $3,995 per person or $6,400 per couple and are hosted at local villas or other high-end accommodations.

By offering an elevated travel experience, he’s found that clients are able to more fully embrace the overwhelming, and by some accounts exhausting, aspects of the core experience: the guided mushroom journey. “We’re trying to achieve that balance that speaks to luxury,” he says, “the food, the environment, and the service.” Often, intentions are set during introductory rituals, and there are integration practices afterward to help process the experience and incorporate the insights into one’s everyday life.

Despite their growing prominence in the zeitgeist, psychedelics, it should be said, are still illegal in most parts of the world, limiting the market scale of this wellness niche. Currently, Jamaica and the Netherlands, where the British Psychedelic Society has been offering psilocybin-assisted retreats since 2016, are primary destinations because of their liberal laws around psychoactive substances.

Options are popping up in locations like Canada, Mexico, and even the U.S. The Sacred House of Eden organizes retreats from its headquarters in Denver—the first American city to decriminalize psilocybin mushrooms. “Experiences that adopt holistic approaches to healing—balancing psychedelic experiences with more traditional wellness experiences, like yoga therapy—are gaining popularity as people seek to rebalance after the stresses of two years of lockdown,” McDonnell says.

Bigham, who attended the Silo retreat, recalls sitting on pillows and blankets during her mushroom journeys—a total of three during her five-day women’s retreat hosted at the plush Half Moon resort—all while looking out over the ocean or gazing at the stars. Her days were filled with yoga classes or seminars on nutrition before the nightly trips from about 7 p.m. to 11 p.m. Meals were taken on a patio overlooking the sea. There was barely time to take a dip in the on-site pool.

She went in with a small but meaningful goal in mind. “I felt like I was so self-conscious that I couldn’t close my bedroom door and dance by myself,” Bigham explains. “I said, ‘I want to go to Jamaica, and I want to dance.’ And we went out to this Rastafarian village, and they were playing the drums, and I said, ‘Hey, ask them if they’ll teach us how to dance.’ And they taught us how to dance.”

When she returned home, friends and family noticed a marked shift. “My daughter said, ‘Mom, you’re different.’”

Mind Expansion, on Arrival

SILO WELLNESS

These five-day, four-night sessions in Jamaica include daily meditation, yoga, meal-planning workshops, and, in some cases, intense workout routines. That’s in addition to psilocybin-assisted ceremonies with local Rastafarians overlooking the Caribbean. Recent retreats have included stays at the Half Moon Villas in Montego Bay, which have private living and dining rooms, outdoor space, and pools on two miles of beach. From $3,995 per person

JOURNEYMEN COLLECTIVE

Gary Logan and Robert Grover run this series of guided psychedelic experiences, described as “not a vacation nor a retreat,” outside Vancouver. The mushrooms are a prelude to subsequent coaching sessions focused on harmony in relationships and prosperity in business. Potential guests must submit an application. The duration of the program—ranging from 10 weeks to 18 months—can be customized. From $30,000

SOLTARA HEALING CENTER

Located in a rainforest on cliffs overlooking Costa Rica’s Gulf of Nicoya, Soltara specializes in ayahuasca. Packages, ranging from 5 nights with 3 ceremonies to 12 nights with 7 ceremonies, include yoga, flower baths, and consultations with healers. Accommodations are elegant—some cabins have thatched roofs and beamed ceilings—and the basics are covered: AC, king beds, writing desks, and full laundry services. From $2,600 per person for five nights

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Forgot about PSY, just started trading.

https://schrts.co/CbfzRhYa

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>>> Seelos Therapeutics Announces its Inclusion in the First U.S. Listed Exchange Traded Fund (ETF) Focused on Psychedelics


Yahoo Finance

June 1, 2021


https://finance.yahoo.com/news/seelos-therapeutics-announces-inclusion-first-120000043.html


- ETF Trades on the New York Stock Exchange Under the Symbol PSY


NEW YORK, June 1, 2021 /PRNewswire/ -- Seelos Therapeutics, Inc. (Nasdaq: SEEL), a clinical-stage biopharmaceutical company focused on the development of therapies for central nervous system disorders and rare diseases, announced today that it has been included in the Defiance Next Gen Altered Experience ETF, the first U.S. listed Exchange Traded Fund (ETF) focused on psychedelics which began trading on Friday, May 28th on the New York Stock Exchange under the symbol PSY.

Seelos' inclusion is based on its lead program SLS-002 (intranasal racemic ketamine), which recently released positive top-line data from Part 1, the open-label cohort, of its potentially registrational Proof-of-Concept study for Acute Suicidal Ideation and Behavior (ASIB) in patients with Major Depressive Disorder (MDD).

The Defiance Next Gen Altered Experience ETF, managed by Defiance ETFs, LLC, is the first U.S. listed psychedelic ETF which seeks to track the BITA Medical Psychedelics, Cannabis, and Ketamine Index, a rules-based index that tracks the performance of companies, listed in North American Exchanges, that operate business models focused on the usage of Psychedelics, Medical Cannabis, and Ketamine for medicinal and health treatment purposes. Companies included in the ETF must have a minimum market capitalization of $75 million, and operate in the production of, distribution of, or services related to medical psychedelics, medical cannabis or ketamine and its derivatives.

If you or a loved one are having thoughts of suicide, please seek immediate medical help, go to your nearest emergency room, or call the National Suicide Prevention Lifeline at 1-800-273-8255.

About Defiance ETFs

Founded in 2018, Defiance ETFs, LLC is a FinTech asset manager and an exchange-traded funds (ETFs) sponsor focused on the next generation of investors. The Psychedelic ETF ($PSY) joins Defiance's suite of first-mover disruptive ETFs, which includes Next Gen H2 ($HDRO), the first SPAC ETF ($SPAK), and the first 5G ETF ($FIVG).

About SLS-002

SLS-002 is intranasal racemic ketamine with investigational new drug applications for the treatment of ASIB in MDD or Post-Traumatic Stress Disorder (PTSD). SLS-002 was originally derived from a Javelin Pharmaceuticals, Inc./Hospira, Inc. program with 16 clinical studies involving approximately 500 subjects. SLS-002 is being developed to address an unmet need for a therapy to treat suicidality in the U.S. Traditionally, anti-depressants have been used in this setting, but many of the existing treatments are known to contribute to an increased risk of suicidal thoughts in some circumstances, and if they are effective, it often takes weeks for the full therapeutic effect to be manifested. Based on information gathered from the databases of the Agency for Healthcare Research and Quality, there were more than 1,000,000 visits to emergency rooms for suicide attempts in 2013 in the U.S. alone. Experimental studies suggest ketamine has the potential to be a rapid, effective treatment for depression and suicidality.

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>>> FDA to Consider Allowing Trials for Algernon’s Psychedelic DMT


BioSpace

Mar 17, 2021

By Mark Zipkin


https://www.biospace.com/article/fda-to-consider-allowing-trials-for-algernon-s-psychedelic-dmt/


Drug repurposing company Algernon Pharmaceuticals has requested a pre-Investigational New Drug (IND) meeting with regulators in the hopes of launching a clinical trial in stroke patients for n,n-dimethyltryptamine (DMT), a naturally derived psychedelic compound. If approved, the trial could be the first psychedelic tested by a company in patients recovering from stroke.

Canada-based Algernon announced its clinical program in January based in part on a preclinical study published last year in Experimental Neurology by researchers from Semmelweis University, which showed DMT can promote neurogenesis and neuroplasticity in a rat model of brain ischemia.

The company’s compound, AP-188, is an intravenously delivered microdose of DMT that will not produced hallucinogenic effects, and it will seek a Breakthrough Therapy designation from the U.S. Food and Drug Administration (FDA).

The DMT program fits with Algernon’s approach to repurposing existing compounds. Its lead asset is NP-120 (ifenprodil), a decades-old N-methyl-d-aspartate (NDMA) receptor glutamate receptor antagonist that has been approved in some markets outside the U.S. for circulatory disorders.

The company is planning to release topline results from a Phase IIb study in patients with COVID-19 by the end of this month. Algernon is also planning a Phase II trial for NP-120 in patients with idiopathic pulmonary fibrosis.

In recent years, the FDA has approved a marijuana-derived drug, Epidiolex (cannabidiol), for rare forms of epilepsy, and ketamine–a dissociative anesthetic often used as a party drug–for treatment-resistant depression.

Academics and nonprofits have launched dozens of trials in recent years for psychedelics like 3,4-methyl?enedioxy?methamphetamine (MDMA), psilocybin, and lysergic acid diethylamide (LSD), primarily in patients with psychiatric diseases including depression, post-traumatic stress disorder, eating disorders, or alcohol use disorder.

DMT, a serotonergic agonist derived from the Psychotria viridis plant and used to make a traditional psychedelic compound called Ayahuasca, is in the same tryptamine family as psilocybin, but has not received the same amount of attention. COMPASS Pathways received an FDA Breakthrough Therapy designation for psilocybin in 2018 for treatment resistant depression.

Still, interest is increasing: it has been tested in clinical trials by academics in patients with depression. The first company-backed Phase I DMT trial, by London-based Small Pharma Ltd., launched in January in patients with anxiety and depression. And earlier this week, psychedelic specialty companies PharmaDrug and MindSet Pharma announced progress on preclinical programs researching DMT. PharmaDrug is exploring DMT for ischemia reperfusion injury in patients undergoing kidney transplantation.

And in November, Dublin-based GH Research, announced its DMT had completed the Phase I safety trial in patients with treatment-resistant depression for a similar psychoactive compound, 5-Methoxy-N,N-Dimethyltryptamine (5-MeO-DMT), and was beginning a Phase II trial.

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>>> ATAI Life Sciences Aims For U.S. IPO


Seeking Alpha

May 10, 2021

Donovan Jones


https://seekingalpha.com/article/4427016-atai-life-science-aims-for-us-ipo


Summary

ATAI Life Sciences N.V. has filed to raise $100 million in an IPO, although the final figure may differ.

The firm is employing a subsidiary approach to developing various mental health treatments.

ATAI's approach has advantages and disadvantages, so the proposed IPO terms will be interesting to learn.

Quick Take

ATAI Life Sciences N.V. (ATAI) has filed to raise $100 million in an IPO of its common stock, according to an S-1 registration statement.

The firm is a clinical stage biopharma developing treatment candidates for mental health disorders.

ATAI is advancing programs through a subsidiary approach, which has advantages and disadvantages.

I’ll provide a final opinion when we learn more about the IPO from management.

Company & Technology

Berlin, Germany-based ATAI was founded to develop psychedelic compounds for various mental health conditions including depression, substance use disorder and anxiety.

Management is headed by co-founder and CEO Florian Brand, who was previously CEO of Perception Neuroscience.

Below is a brief overview video of ATAI via an interview with CEO Brand:

The firm's lead candidate, PCN-101, is being developed by a subsidiary for treatment resistant depression, or TRD.

The company has a decentralized approach to drug development, preferring to create subsidiaries with each pursuing its therapeutic program. I presume the advantage of this structure is to allow each group to obtain financing resources based on its own characteristics, rather than being lumped in together with dissimilar programs.

Below is the current status of the company’s drug development pipeline:

Investors in the firm have invested at least $362 million in equity investment and include Apeiron Investment Group, Galaxy Group Investments, Kendall Capital Markets and Peter Thiel.

Market & Competition

According to a 2021 market research report by imarc, the global market for depression drugs grew to an estimated $12.7 billion in total value in 2020 and is forecast to reach $15 billion by 2026.

This represents a forecast CAGR (Compound Annual Growth Rate) of approximately 3% from 2021 to 2026.

Key elements driving this expected growth are a growing prevalence of mental disorders, including depression and social anxiety.

Also, there has been a surge of mental disorder prevalence during the COVID-19 pandemic, as large numbers of individuals experience anxiety and fear due to the size and scope of the pandemic.

Major competitive vendors that provide or are developing related treatments include:

Sage Therapeutics

Axsome Therapeutics

CIAS

Boehringer Ingelheim

Pfizer

Roche

Biogen

Vanda

Cadent

Others for other programs


Financial Status

ATAI’s recent financial results are typical of a development stage biopharma in that it has earned no revenue but has significant R&D and G&A costs associated with its subsidiary programs.

Below are the company’s consolidated financial results for the past two years:

As of December 31, 2020, the company had $190 million in cash and $6.9 million in total liabilities.

IPO Details

ATAI intends to raise $100 million in gross proceeds from an IPO of its common stock, although the final figure may differ.

No existing shareholders have indicated an interest to purchase shares at the IPO price.

Management says it will use the net proceeds from the IPO as follows:

to fund the ongoing and planned Phase 1 and Phase 2 clinical trials of our most advanced drug development programs at Perception, Recognify, DemeRx IB, GABA, Neuronasal and Viridia;

to continue funding of our preclinical programs, discovery, manufacturing and supporting research and development;

to fund the development of our enabling technologies;

to fund the acquisition of and development activities related to new programs and enabling technologies; although we have no material agreements, commitments or understandings with respect to any in-license or acquisition, we have and plan to continue to evaluate such opportunities and engage in related discussions with other business entities from time to time; and

the remainder to fund working capital and for general corporate purposes. (Source)

Management’s presentation of the company roadshow is not available.

Listed bookrunners of the IPO are Credit Suisse, Citigroup, Cowen, Berenberg, Cantor, RBC Capital Markets and Canaccord Genuity.

Commentary

ATAI is seeking public investment to pursue its decentralized biopharma development model for a range of treatment candidates.

The firm’s lead candidate, PCN-101, is being developed by a subsidiary for treatment resistant depression, or TRD.

The market opportunity for depression drugs is large and expected to grow at a moderate rate of growth in the near term.

Management has disclosed no collaboration relationships with major pharma firms for its programs or subsidiaries.

The company’s investor syndicate includes noted investor Peter Thiel.

Credit Suisse is the lead left underwriter and IPOs led by the firm over the last 12-month period have generated an average return of 43.1% since their IPO. This is a mid-tier performance for all major underwriters during the period.

ATAI is pursuing a new but not commonly used structure of separating its programs into subsidiaries with varying degrees of ownership percentage.

Perhaps this model will produce better results for financing by separating out the programs, although it also has the effect of diluting the company’s ownership of its programs and potentially control as the firm has two subsidiaries featuring only minority investment status.

Another downside is that attempting to value the firm’s holdings will be much more complex for institutional investors, leading to a potentially lower valuation.

When we learn more about the IPO’s valuation and pricing assumptions, I’ll provide a final opinion.

Expected IPO Pricing Date: To be announced.

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>>> Psychedelic drugmaker MindMed stumbles in Nasdaq debut, CEO says 'still very early innings'


Yahoo Finance

Alexis Christoforous

April 28, 2021


https://finance.yahoo.com/news/psychedelic-drugmaker-mind-med-stumbles-in-nasdaq-debut-ceo-says-still-very-early-innings-104340252.html


MindMed’s (MNMD) Nasdaq debut Tuesday made it the second psychedelic drug developer to be listed on a major U.S. stock exchange. UK-based Compass Pathways (CMPS) went public on the Nasdaq in September, while last week Peter Thiel-backed ATAI Life Sciences filed for an IPO.

Just a year ago, New York-based MindMed was a penny stock on the over-the-counter market.

Shares fell 29% in their first day of trading on the Nasdaq, but that’s after they ran up 65% Friday and 33% Monday on the OTCQB market in anticipation of the up-listing. The stock continues to trade on Canada’s NEO Exchange (MMED) and in Germany (MMQ).

“These are still very early innings for us,” MindMed’s co-founder and CEO JR Rahn told Yahoo Finance Live. “We’re not going to be dictated by the day-to-day fluctuations or hour-by-hour fluctuations of our stock. We have 180,000 shareholders. A lot of them are very mission driven.”

Rahn said graduating to the Nasdaq is a major milestone not just for his company, but for the industry, signaling a rapid shift in investor interest for psychedelics to treat addiction and mental health disorders such as anxiety and depression.

“I think it’s a sign that the entire psychedelics industry is growing up,” he said. “We’re accessing a whole new fresh set of investors that hasn’t been able to access us before. I think that’s going to include sovereign wealth funds, pension funds and further retail investors.”

MindMed, whose high-profile investors include “Shark Tank’s” Kevin O’Leary and Bruce Linton, former CEO of cannabis company Canopy Growth (CGC), is focused on improving mental health with treatments that use ingredients including MDMA, LSD, and psilocybin, also known as “magic mushrooms.”

“Our objective over the next few years is to conduct clinical trials on psychedelic substances like LSD, MDMA and others, and ultimately bring those to market,” he said. “To do that, you have to do it through the FDA pathway.”

The industry made great strides in 2020 in removing barriers to legalization. In November, Oregon became the first state to legalize the medical use of psilocybin, and several cities have decriminalized its use including Denver, Ann Arbor, Mich., and Washington, D.C.

In February, MindMed bought the digital medicine and therapeutics startup HealthMode for $32.5 million in cash and stock. The company uses artificial intelligence technology to speed up drug development. It also tapped HealthMode’s founder and former Google AI guru Bradford Cross as its chief technology officer.

“MindMed is as much a technology company as we are a drug development company,” said Rahn. “Because ultimately, psychedelic-assisted therapy, which requires therapists to administer, is going to need technologies that can help find therapists and scale these solutions to mental health. So we’re going to be building that tech over the next couple of years.”

Day traders on the Reddit forum, WallStreetBets, have been talking up MindMed, saying the stock is going "to the moon." They said the same thing earlier this year about the "meme" stock Gamestop (GME), which shot up more than 2,000% in less than a month.

Rahn said he thinks it's "great" that the Reddit crowd is paying attention.

"This is just a natural outcry from normal people that want to see a change in mental health, and suddenly, they can identify with something," he said. "I love to have empowered and passionate shareholders. We're very, very receptive and supportive. And you know, I think there's been a lot of hype around WallStreetBets, and meme stocks, and all of these things. But at the end of the day, people make markets. And it's great to have the people behind us."

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>>> First Psychedelics-Focused ETF Launches


May 28, 2021

ETF.com

Heather Bell


https://www.etf.com/sections/daily-etf-watch/first-psychedelics-focused-etf-launches


Today, Defiance ETFs rolled out the first U.S.-listed ETF to focus on psychedelics. The Defiance Next Gen Altered Experience ETF (PSY) focuses on companies legally operating in the medical field with business activities around marijuana, psychedelics and ketamine.

PSY comes with an expense ratio of 0.75% and lists on the NYSE Arca.

Defiance CEO Paul Dellaquila notes that mental health issues in the United States, like depression, spiked dramatically during the pandemic. At the same time, he points out that over the last decade, large pharmaceutical companies have decreased the resources they devote to developing treatments by 70%.

A research paper published by Defiance asserts that 30% of depression patients do not respond to any approved treatments, even as the number of diagnosed cases continues to rise. It goes on to note that multiple studies have found benefits from using psychedelics, especially psilocybin, to alleviate depression and anxiety, including some that saw results that far exceeded those achieved by existing approved treatments.

“There’s a unique benefit to it, medically,” said Dellquila. “I think the investment case is strong too—even just from a human aspect, I think there’s a lot of potential here.”

Methodology

PSY tracks the BITA Medical Psychedelics, Cannabis, and Ketamine Index, a benchmark with 21 constituents listed in North America and selected for their exposure to the targeted business areas. Companies included in the index must generate at least half of their revenue from the production of, the distribution of and services related to medical psychedelics, medical cannabis or ketamine, according to the prospectus.

Psychedelics, which can include psilocybin, and ketamine, in particular, are being studied as potential treatments for a variety of mental health issues like depression, addiction, anxiety and post-traumatic stress disorder, the document says.

Dellaquila emphasizes that the fund is focused exclusively on legally operating companies with a medicinal focus on psychedelics, marijuana and ketamine rather than a recreational focus.

Eligible companies must meet size and liquidity requirements, with the index rebalanced and reconstituted twice a year. Within the index, securities weighted using a modified market capitalization approach that limits the individual weights of the holdings, the prospectus says.

The top holdings for the fund at launch include Charlottes Web, Aurora Cannabis and Corbus Pharmaceuticals, but the portfolio also includes names like Mind Medicine and Compass Pathways, which are both considered pioneers in the psychedelics space. PSY is focused on pure plays, but Dellaquila notes that some very large names also operate in the space, with both Johnson & Johnson and AbbVie having brought to market ketamine-based treatments in recent years.

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>>> ETFs Get Trippy in the Shroom Sector (Podcast)


Bloomberg

February 17, 2021


https://www.bloomberg.com/news/audio/2021-02-18/etfs-get-trippy-in-the-shroom-sector-podcast


Magic mushrooms, LSD and ketamine used to be associated with psychedelic trips and fun weekends. Now they’re increasingly viewed as serious medicine that can be used to treat ailments such as depression and PTSD. The small but fast-growing industry even has its first ETF — the Canadian-listed Horizons Psychedelic Stock ETF, or PSYK.

On this episode of Trillions, Eric and Joel speak with Steve Hawkins, the CEO of the firm behind the ETF, who was also behind the world’s first cannabis ETF. He talks the about sector outlook, underlying business fundamentals, the design of the ETF — and whether he plans to start micro-dosing LSD.

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>>> ‘Altered Experience’ Fund Brings Psychedelics to U.S. ETFs


Bloomberg

By Claire Ballentine

May 28, 2021


https://www.bloomberg.com/news/articles/2021-05-28/-altered-experience-fund-is-bringing-psychedelics-to-u-s-etfs


Defiance’s PSY tracks medical uses of legal psychedelics

Follows launch of a similar Canadian fund in January


Curious investors looking for new experiences in the $6.3 trillion U.S. exchange-traded fund market can now dabble in the world of psychedelic drugs.

The Defiance Next Gen Altered Experience ETF began trading Friday under the ticker PSY, offering exposure to firms involved in “the next generation of medicine, including psychedelics, cannabis and other psychedelic-derived treatments,” according to a statement.

Although a similar product launched in Canada in January, the Defiance fund will be a first for the exchange-traded fund industry in the U.S. This version will track the BITA Medical Psychedelics, Cannabis and Ketamine Index, which includes companies that conduct federally legal medical activities with psychedelics, cannabis and ketamine.

“The focus of this is the medical aspect around psychedelics and mental health -- we’re seeing a lot of breakthroughs,” Paul Dellaquila, president of Defiance ETFs, said in an interview. “You’re seeing some of the bigger companies get involved in this type of treatment. Johnson & Johnson has a treatment that is ketamine-based for depression.”

Its top positions are in Charlottes Web Holdings Inc. and Aurora Cannabis Inc. During its first day trading, the fund rose 4.1%.

Despite poor performance, the Canadian product -- Horizons Psychedelic ETF (PSYK) -- has attracted about $50 million since its January launch, even as it plunged almost 20% amid a broader selloff in speculative bets. Top holdings in the fund include Seelos Therapeutics Inc., Mind Medicine MindMed Inc. and Cybin Inc.

Learn more: Trillions Podcast: ETFs Get Trippy in the Shroom Sector

Horizons ETFs has filed for a sister psychedelics ETF for U.S. markets, also trading under the ticker PSYK, although it has not yet been approved by U.S. regulators.

The market for psychedelic drugs is worth only about $2.8 billion but is growing rapidly and expected to reach $7.6 billion by 2028, according to Data Bridge Market Research.

“With cannabis becoming more accepted across the U.S., we believe the door is opening wider for alternative drugs, especially as substitutes for opioids,” wrote Eric Balchunas, ETF analyst for Bloomberg Intelligence, in a note

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>>> Defiance Next Gen Altered Experience ETF (PSY) is an exchange traded fund launched by ETF Series Solutions. The fund is co-managed by Defiance ETFs, LLC and Penserra Capital Management, LLC. It invests in the public equity markets of the United States and Canada. The fund invests in the stocks of companies operating in the life sciences companies conducting federally legal medical activities in the psychedelics, medical cannabis, hemp, and cannabidiol industries. It invests in growth and value stocks of companies across diversified market capitalizations. The fund seeks to replicate the performance of BITA Medical Psychedelics, Cannabis, and Ketamine Index, by using full replication technique. ETF Series Solutions - Defiance Next Gen Altered Experience ETF is domiciled in the United States.

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>>> MindMed To Commence Trading on Nasdaq


April 23, 2021


https://finance.yahoo.com/news/mindmed-commence-trading-nasdaq-113000089.html


NEW YORK, April 23, 2021 /CNW/ -- MindMed (Nasdaq: MNMD) (NEO: MMED) (DE: MMQ), a leading psychedelic medicine biotech company, announced today that the Company's subordinate voting shares have been approved for listing on The Nasdaq Capital Market ("Nasdaq"). Trading is expected to begin on Tuesday, April 27, 2021, under the symbol "MNMD" on the Nasdaq. MindMed will retain its listing on the Neo Exchange Inc. under the symbol "MMED" and the Company's subordinate voting shares will continue to trade on the OTCQB under the symbol "MMEDF" until trading on the Nasdaq commences.

"The listing of our stock on the Nasdaq represents a significant milestone in our growth as a publicly-traded company," said J.R. Rahn, CEO and Co-Founder of MindMed. "We believe this listing will increase our visibility in the marketplace, improve liquidity, broaden and diversify our shareholder base, and ultimately enhance long-term shareholder value. I would like to thank our employees, management, directors and our many collaborators for their hard work in making MindMed a member of the Nasdaq exchange, an important step that will help facilitate our mission to discover, develop and deploy psychedelic inspired medicines and therapies to address addiction and mental illness."

About MindMed

MindMed is a clinical-stage psychedelic medicine biotech company that discovers, develops and deploys psychedelic inspired medicines and therapies to address addiction and mental illness. The company is assembling a compelling drug development pipeline of innovative treatments based on psychedelic substances including Psilocybin, LSD, MDMA, DMT and an Ibogaine derivative, 18-MC. The MindMed executive team brings extensive biopharmaceutical experience to MindMed's approach to developing the next generation of psychedelic-inspired medicines and therapies.

MindMed trades on the Canadian exchange NEO under the symbol MMED and in Germany under the symbol MMQ. MindMed will commence trading on the Nasdaq under the symbol MNMD effective April 27, 2021; until then the Company will continue to trade in the United States under the symbol MMEDF on the OTCQB.

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