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Horizons Psychedelic Stock Index ETF - >>> Horizons ETFs Launches World’s First-Ever Psychedelic ETF on NEO Exchange
Yahoo Finance
January 27, 2021
https://finance.yahoo.com/news/horizons-etfs-launches-world-first-152800195.html
With much excitement, NEO proudly welcomes Horizons ETFs Management (Canada) Inc. ("Horizons ETFs") back to the NEO Exchange, with the launch of the world’s first-ever psychedelics-focused exchange traded fund. The Horizons Psychedelic Stock Index ETF began trading today under the symbol NEO:PSYK.
This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20210127005651/en/
Horizons ETFs Management (Canada) Inc. ("Horizons") participates in a digital market open to celebrate their launch of the world’s first psychedelics-focused exchange traded fund. The fund began trading today under the symbol NEO:PSYK.
With a growing number of companies across North America focused on developing therapeutic solutions using psychedelics to treat mental illness, addiction, and other medical conditions, Horizons ETFs is paving the way for investors to access the industry like never before. The Horizons Psychedelic Stock Index ETF contains 17 Canadian and U.S. publicly-listed life sciences companies that have significant business activities in, or significant exposure to, the psychedelics industry - including two NEO-listed companies.
"At Horizons ETFs, we strive to be at the forefront of key global transformative investment themes. We believe the opportunities with psychedelics not only provide a compelling investment case, but also the potential to provide life-changing impacts for those suffering with mental illness," commented Steve Hawkins, President and CEO of Horizons ETFs. "We are happy to be partnering with the NEO Exchange on our launch of PSYK, the world’s first psychedelic stock ETF. NEO has already taken a leadership position in being the first senior exchange to list psychedelic-focused equities, so the NEO Exchange was a natural fit for Horizons ETFs and PSYK. PSYK will give investors diversified exposure to the leading public companies undertaking this important research and the development of treatments for the more than 700 million people globally that, according to the World Health Organization, suffer from some form of mental illness, addiction, or eating disorder."
The Horizons Psychedelic Stock Index ETF joins another Horizons ETF already listed on the NEO Exchange: the Horizons US Marijuana Index ETF (NEO:HMUS). Investors can trade shares of PSYK and HMUS through their usual investment channels, including discount brokerage platforms and full-service dealers. Click here for a complete view of all NEO-listed securities.
"The unprecedented interest in the Horizons Psychedelic Stock Index ETF – even prior to launch – is a testament to the growing acceptance, credibility, and progress that the psychedelics industry and companies within it have achieved over the past few years," commented Jos Schmitt, President and CEO of NEO. "With the listing of MindMed and Cybin on the NEO Exchange in 2020 – two major holdings in the PSYK fund - NEO prides itself on being an advocate and catalyst for the continued growth of the psychedelics space. We are thrilled to partner with the team of financial visionaries at Horizons ETFs as we work together, once again, on forming the future of investments."
NEO consistently represents roughly 20% of all volume traded in Canadian ETFs and close to 15% of all trading in Canadian-listed companies.
About NEO Exchange
NEO Exchange is a progressive stock exchange that brings together investors and capital raisers within a fair, efficient, and service-oriented environment. Fully operational since June 2015, NEO puts investors first and provides access to trading all Canadian-listed securities on a level playing field. The NEO Exchange lists senior companies and investment products seeking a stock exchange that enables investor trust, quality liquidity, and broad awareness including unfettered access to market data.
Connect with NEO: Website | Twitter | LinkedIn | Instagram
About Horizons ETFs Management (Canada) Inc.
Horizons ETFs Management (Canada) Inc. is an innovative financial services company and offers one of the largest suites of exchange traded funds in Canada. The Horizons ETFs product family includes a broadly diversified range of solutions for investors of all experience levels to meet their investment objectives in a variety of market conditions. Horizons ETFs has over $17 billion of assets under management and 94 ETFs listed on major Canadian stock exchanges. For further information about PSYK, please visit: www.HorizonsETFs.com/PSYK
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>>> The world's first psychedelic ETF debuts
Jan 27, 2021
Yahoo Finance
by Alexis Christoforous
https://finance.yahoo.com/news/the-first-psychedelic-etf-is-ready-to-launch-135909326.html
Psychedelics just went mainstream. The world’s first psychedelics ETF (exchange traded fund) will began trading Wednesday. Horizons Psychedelic Stock Index ETF will trade on the Canadian NEO exchange under the ticker PSYK.
It will offer investors exposure to a basket of 17 publicly traded companies focused on using psychedelics like LSD to treat mental health issues such as depression, anxiety, obsessive-compulsive disorder, PTSD, and even eating disorders.
Among the companies included in that ETF is the New York-based biotech firm MindMed (MMEDF), which is backed by Shark Tank investor Kevin O’Leary. MindMed has seen its stock soar 250% in the past three months. The stock currently trades on Canada’s NEO Exchange as well as the over-the-counter market in the U.S. and has applied for an uplisting on the Nasdaq.
“The space is moving very, very quickly,” MindMed co-founder and co-CEO JR Rahn told Yahoo Finance Live. “What we're seeing now is, I believe, a demand from both retail investors and institutional investors on how to best index this space and how to gain the most exposure to the most amount of clinical trials and technologies. So it was just a natural progression that somebody was going to set up an ETF.”
Other American and Canadian life sciences companies included in the ETF’s initial portfolio are Abbvie (ABBV), COMPASS Pathways (CMPS), Seelos Therapeutics (SEEL) and Nova Mentis Life Science(NOVA).
The ETF launch is just the latest catalyst for the psychedelics industry. On Election Day, a handful of states including Oregon and Washington, D.C., voted to legalize the use of MDMA (also known as ecstasy) and other psychedelic substances at licensed facilities for mental health purposes.
In 2019, Denver became the first U.S. city to decriminalize the use of psilocybin, the psychedelic substance in "magic mushrooms."
Rahn believes the industry has an advocate in President Joe Biden.
“I really think that he's going to make treating the opioid crisis, and also greater mental health that's going to ultimately come out of COVID-19 here, a high priority for his administration,” said Rahn.
Biden has vowed to build on the Obama administration’s Affordable Care Act by doubling down on efforts to enforce existing mental health parity laws and expand funding for mental health.
“[Biden’s] own family has suffered from mental health and addiction,” Rahn said. “On the campaign trail you saw former President Trump chastise [Biden] in debates over his son, who had a cocaine addiction.”
Rahn, who admits he’s also a recovering cocaine addict, said 40% of Americans are struggling with mental health amid COVID-19.
“I think Biden’s going to come out and support mental health in ways that no other president has ever done, and we hope to have a dialogue with the administration about that,” he said.
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>>> Mind Medicine (MindMed) Inc. (MMEDF), a psychedelic medicine biotech company, 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 company is headquartered in New York, New York. <<<
>>> PharmaTher Inc. (PHRRF), a wholly-owned subsidiary of Newscope Capital Corporation (CSE: PHRM) (OTCQB: PHRRF), is a specialty life sciences company focused on the research and development of psychedelic pharmaceuticals such as ketamine and psilocybin, for FDA approval to treat mental health, neurological and pain disorders. <<<
https://www.pharmather.com/
Transdermal delivery of psychedelic pharmaceuticals
Fabio Chianelli, Chairman and Chief Executive Officer
Mr. Chianelli has over 15 years of experience with specialty life sciences companies. He was the Founder and President of Revive Therapeutics Ltd. (CSE: RVV) between 2012 and 2019. From January 2000 to January 2012, Mr. Chianelli held senior roles in investor relations, business development, and marketing and sales with Generex Biotechnology Corporation. Mr. Chianelli received his Bachelor of Commerce from Ryerson University.
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Dr. Beverly J. Incledon – Director
Dr. Incledon is the Executive Vice President, Research & Development of Ironshore Pharmaceuticals & Development, Inc., a wholly owned subsidiary of Toronto-based Highland Therapeutics Inc. Dr. Incledon has over 20 years of pharmaceutical industry experience encompassing drug discovery, product development, pre-approval inspections, development quality, project management, method/technology transfer, process improvement, manufacturing troubleshooting, new development facility start-up, and research on novel drug delivery technology. Dr. Incledon was a Post-Doctoral Fellow at Cornell University and obtained his PhD degree in Biophysics and Bachelor of Science (Honors) in Applied Biochemistry with a Minor in Biomedical Technology from the University of Guelph.
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Christian Scovenna – Director
Mr. Scovenna is a highly experienced C-Suite Executive with over 13 years of capital market experience working with both private and public microcap companies in Canada. He has held numerous directorships with publicly-traded resource, pharmaceutical and cannabis companies and has experience structuring deals and acquisitions and raising capital. In his previous engagement with Mojave Jane Brands Inc. (formerly, High Hampton Holdings Corp.) (CSE: JANE), he was instrumental in building the company as one of the original founders and was a key member of the management team as interim CEO and Senior VP Corporate Finance while also serving on the board as a director. Mr. Scovenna currently serves as Director for Revive Therapeutics (CSE: RVV.C), Pasofino Gold Limited (formerly Enforcer Gold Corp.) (TSXV: VEIN) and Tevano Payment Systems as VP Of Corporate Development.
Carlo Sansalone – Director
Mr. Sansalone is President at Sanscon Construction Ltd. He is on the Board of Directors at Revive Therapeutics Ltd. (CSE: RVV.C). Mr. Sansalone received his undergraduate degree from Ryerson University
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>>> Here's What Happens When You Mix Psychedelic Drugs With Psychotherapy
Psychedelics
Researchers are still trying to figure out what, precisely, happens in the human brain once a psychedelic drug's active ingredients kick in.
Investor's Business Daily
by BILL PETERS
09/11/2020
https://www.investors.com/news/psychedelic-drugs-move-into-psychotherapy-inside-look/
When patients undergoing ketamine-assisted psychotherapy get an injection of the drug into their arm, the effects take hold several minutes later. Patients undergoing that therapy — the only form of psychedelic-assisted psychotherapy available outside of drug trials — can lie down on a couch.
They can take off their shoes and listen to music as the drug blooms inside them. Depending on the place, patients or the therapist choose the playlist. Anything from classical to mellow, panoramic electronica to David Gilmour-era Pink Floyd. Heavy metal, and songs with lyrics, are discouraged.
The peak of the drug's effect can last for 20 to 30 minutes. During this time, the patient might have trouble talking. The therapist might encourage the patient to turn their focus inward. Patients might utter something during the peak — a loose end that might lead to a bigger conversation afterward.
A Unique Experience
"People can forget that they came into the office to get a shot," said Wesley Ryan, a ketamine psychotherapist in Los Angeles. "They can forget where they are. They can forget who they are, or that they were ever a person who ever existed."
As psychedelic drugs drift into the mainstream and draw more investors, some psychotherapists are using them in an effort to tackle some of the most intractable emotional disorders, which hit epidemic levels even before the coronavirus pandemic and economic collapse sent millions of Americans into a psychological abyss.
But researchers are still trying to figure out what, precisely, happens in the human brain once a psychedelic drug's active ingredients kick in. They're also trying to find the best ways to tease out the full effects of pairing psychotherapy with those medications, which more research shows can help untangle the mental knots that keep people from overcoming depression, anxiety, addiction and post-traumatic stress disorder (PTSD).
Setting The Vibe For Psychedelic Drugs
The process can begin at a place like the California Center for Psychedelic Therapy, a facility that offers ketamine-assisted psychotherapy. The facility is in a converted two-floor home in Los Angeles' Larchmont Village, a suburb-like neighborhood with neatly-cut trees, pastel storefronts and cloth umbrellas over outdoor restaurant seating on its main drag.
Picket fences hem in the facility's small front yard. During a visit in January, before the coronavirus pandemic closed off visits to interiors of all kinds, classical music played in a hardwood-floored waiting area with autumn-colored furniture. A sofa with orange throw pillows faced a fireplace. A rocking chair sat in the corner, a book about Carl Jung on a glass coffee table, white noise emitting from a device on the floor.
"We're not looking for a spa vibe," co-founder Brooke Balliett said. "We're very clear about about the services that we give. But we want people to feel comfortable."
Ketamine treatment rooms in the facility have audio speakers, sofas and eyeshades. Most have blood pressure cuffs. Bathrooms are near those rooms, so patients don't have to walk through the waiting area. An enclosed patio for patient recovery, with a fountain and lounge chairs, faces the backyard. The back yard is being converted into a garden that will also be dedicated to recovery.
A room devoted trials of the drug MDMA has a camera mounted to the wall, per FDA requirements. MDMA patients stay overnight, under the care of a night attendant, and can eat dinner and breakfast in a kitchen. The house also has a laundry area. The facility does a lot of it; every time a patient lies down on a couch, that couch gets new bedding.
Before You Start Psychedelic Therapy
Ketamine-assisted psychotherapy tends to begin with a psychiatric evaluation, said Ryan, who works out of an office in a white brick building in Los Angeles' high-rise-lined Marina del Rey neighborhood. A window overlooked a row of docked sailboats on the water.
That assessment helps determine if other treatments, like antidepressants, might be used first or with therapy, he said. It can also help identify conditions, like high blood pressure and bipolar disorder, that the patient and doctor might need to address beforehand. Therapists are likely to avoid treating patients with disorders like schizophrenia.
Following the screening, the therapist often holds a psychotherapy session to prepare them for the treatment and help them get the most out of it, he said. The individual treatment session itself can run for around 90 minutes, sometimes longer.
Diving Into An Emotional Journey
Patients that use ketamine in a therapeutic setting can find themselves drifting through a range of emotions. They might experience a connection with something bigger. They might feel voices rather than hear them, or find their consciousness veering into underwater, cavernous places.
One ketamine patient, a Los Angeles woman in her mid-thirties who asked not to be identified, said she'd struggled with depression growing up. She was close with her uncle, who had AIDS but tried to keep it from her. She doesn't blame him for that. But his death, while she was 14, came on abruptly for her.
Before graduating high school, a close friend's teenage brother committed suicide. In college, another suicide, of someone she wasn't as close with, hung over her, and made her feel strangely unsafe.
Dealing With Painful Emotions
She described herself as being drawn to sadness. Imagining someone's final moments of despair, before they ended their life, broke her heart, she said. After ketamine therapy, she was less exhausted. She found she didn't want to be alone as much. The medication put her in a more tranquil space. But returning to rote humanness at the end of the first three sessions was difficult.
"I remember it was really peaceful," she said of her first experience with ketamine psychotherapy. "And I was really disappointed to come back into my body. I remember crying a lot and feeling physical and emotional pain return."
Back To Reality ... And Paying The Bill
Negotiating that comedown, she said, became part of the therapy work. In the process, she developed more respect for herself as a child, and her ability to size up what was happening in that part of her life. She believed her childhood memories more.
"It gave me more empathy for myself, too," she said. "It was like being able to look at yourself from someone else's perspective. And I was sad. I was sad for myself."
When a therapist reinitiates contact with a patient depends on the patient's response. But those interactions can be delicate.
"We really try and honor that whatever is happening in the brain, whatever is happening psychologically, is the right thing that's supposed to happen," said Balliett, who co-founded the Los Angeles facility with Cole Marta.
A single session of ketamine-assisted psychotherapy can go for around $500, with more sessions packed into the first weeks of therapy and spread out after.
Since therapists technically administer the ketamine off-label — or for a use that regulators haven't approved — insurance won't cover the medicine itself. Patients can get a so-called 'superbill,' which details the billing codes for other aspects of treatment, to help with reimbursements for the therapy.
Psychedelic Drug Questions Remain
Researchers are still trying to figure out the "therapy" part of ketamine therapy, and whether a person is most welcoming to a conversation with a therapist hours or days after initially taking the psychedelic drug as well as a derivative called esketamine.
"We have very good evidence that ketamine and esketamine can generate an antidepressant response," said Gerard Sanacora, a Yale psychiatry professor and director of the university's depression research program. "Where we have much less data is how to augment that response with other forms of therapy."
He added: "There's some real question about when is the ideal time to pair the therapy with the drug treatment,"
Sanacora said ketamine-assisted psychotherapy grew out of a loose network of early adopters, who have yet to settle on consistent standards.
Spravato, Johnson & Johnson's (JNJ) esketamine therapy, has FDA guidelines in place to manage risks, he said. But there's no coordinated way to collect data on ketamine taken in other forms, he added. And the tab for high-quality FDA-level studies can run into the millions of dollars.
Other Benefits Of Psychedelic Drugs
Other research shows the possible benefits of psychedelic drugs, including ones not cleared for use in therapy. At Johns Hopkins, for instance, researchers studied the impact of psilocybin, the psychoactive compound in magic mushroom, on tobacco and nicotine addiction. They found 80% of participants were smoke-free six months after treatment. Success rates for other medications tended to stay below 35%, the university said.
Another Johns Hopkins study looked at psilocybin use and mood. It found that a single time using psilocybin "led to positive changes in moods, attitudes, and behavior for 14 months (and possibly longer), with 64% indicating the experience increased well-being or life-satisfaction."
Some research on neurons in rodents, published in Cell Reports in 2018, found that some psychedelics encouraged neuron connectivity. The findings, the researchers said, "underscore the therapeutic potential of psychedelics."
The visual that sometimes comes up to show the effects of psychedelics is a pair of diagrams that each depict the nodes of a brain's neural network as multi-colored points on a circle.
One diagram shows the brain of someone not under the influence of psilocybin, with a few brightly-colored lines leaping across the white space of the circle to the other end to form connections. The one for a person on psilocybin shows something far more active, that more closely resembles a ball of rubber bands.
'Adjunct To Therapy'
But as research accumulates, more serious concerns have also emerged. A Quartz report from March noted that MDMA can heighten sexual arousal. And the article said that with its benefits came risk of sexual abuse. The Multidisciplinary Association for Psychedelic Studies nonprofit group last year said it cut ties with two therapists involved in an MDMA study after a patient accused one of them of sexual assault.
What one patient gets out of therapy also depends on their commitment afterward. The woman in Los Angeles talked about her commitment to therapy growing up. So did Sean Roth, 38, a tattoo and piercing artist in Los Angeles who is a patient of Ryan's.
His mother moved to the U.S. from Israel, Roth said. His father was a Vietnam vet. Their own challenges in coming or returning to the U.S., as he described, strengthened his own commitment to therapy. He uses ketamine therapy in conjunction with an outside therapist. Without that therapist, the ketamine treatment, he said, wouldn't be as profound.
"I don't think psychedelics are a panacea," he said. "And I don't like looking at them as a cure-all. I think they're an adjunct to therapy, and the work you have to do outside of those experiences."
Conflicting Therapies
Sometimes, one form of ego dissolution can chafe with another. Roth said that after he went on a Vipassana silent retreat — a form of meditation he found overwhelming — he had reservations about another form of therapy that might dramatically remap his consciousness. During his first session, after the ketamine injection kicked in, he laid down on the sofa in Ryan's office. But he resisted the effects.
During the second session, however, he took off. Roth was leaning into the earth from far above, crying, absorbing himself into its embrace. He felt support from his family, the way he did as a child. He wanted to protect his childhood self from the world's chaos.
"How can you not love this part of you?" he said.
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>>> How Psychedelic Drugs Found In Nature Can Become Private Property
Psychedelic drugs
Evidence indicates people have used mushrooms and ayahuasca, which appear in nature, for at least 1,000 years
Investor's Business Daily
by BILL PETERS
09/04/2020
https://www.investors.com/news/psychedelic-drugs-face-millennium-old-risk-profitability/
When psychedelic drugs developer Compass Pathways filed its IPO paperwork last Friday, the company warned of a risk that could sabotage hopes for profitability.
"We rely on patents and other intellectual property rights to protect our investigational COMP360 psilocybin therapy, the enforcement, defense and maintenance of which may be challenging and costly," the filing said. COMP360 is Compass' therapy for treatment-resistant depression that incorporates synthetic psilocybin, the hallucinogenic compound in magic mushrooms.
The trouble is the most commonly known psychedelic drugs — LSD, magic mushrooms, ecstasy, ayahuasca — aren't exactly new. The longer a drug is around and the more it settles into the realm of public knowledge, the more difficult it is to claim ownership via a patent.
Nobody owns those psychedelic drugs. To land patent protection and prevent copycatting, psychedelic drug developers will likely need to tweak the molecular makeup of existing drugs. Or, they'll need to find new modes of delivering the drug into the human body.
"The rule is if something already belongs to the public, you can't take it away from them," Gretchen Temeles, special counsel at the Philadelphia law firm Duane Morris, said in an interview.
But as Compass Pathways, MindMed and other psychedelic startups try to box out rivals in the fight for intellectual property, some nonprofit research groups are vowing to offer up their inventions for the common good, adding an extra layer of drama in an industry gradually drifting into Wall Street's orbit.
Milestone In Psychedelics
London-based Compass Pathways, which is backed by PayPal (PYPL) and Palantir co-founder Peter Thiel, became the first pure-play psychedelic drug company to file for a U.S. IPO, seeking a Nasdaq listing under the ticker CMPS.
Psychedelics still face a long road ahead to legalization, but regulatory resistance began eroding over the past few years. Medical giant Johnson & Johnson (JNJ) got FDA approval last year for a ketamine-derived nasal spray for treatment-resistant depression. The FDA has also fast-tracked therapy that uses MDMA, also known as ecstasy or Molly.
But Compass has also highlighted the threat from nonprofits like the Usona Institute, which does its own research on psychedelics. The IPO filing warned that nonprofits like Usona "may be willing to provide psilocybin-based products at cost or for free, undermining our potential market for COMP360." Usona didn't respond to a request for an interview.
A Millennium In The Public Domain
Evidence indicates people have used mushrooms and ayahuasca, which appear in nature, for at least 1,000 years. A chemist at German pharmaceutical giant Sandoz first synthesized LSD in the 1930s and created synthetic psilocybin in the 1950s.
But research on psychedelics, to a large degree, went dark after the U.S. government crackdown on drugs began in the 60s and 70s. As a result, Temeles said, there hasn't been as much literature produced on psychedelics as for legal drugs.
Since there's less available literature on Schedule 1 substances, the universe of material for a patent examiner to search when evaluating claims is smaller.
"Sometimes claims get granted without having been searched real thoroughly," she said. "And that means challengers look at them and think, 'Hm. That claim looks kind of weak. Let me see if I can challenge it.'
"We haven't seen much of that," she continued. "The industry is too new. It has happened in the cannabis industry and it is likely to happen in the psychedelics industry."
How To Patent Psychedelic Drugs
A new substance doesn't necessarily have to depart that much from an original to be considered new. Nexium and Prilosec, for instance, are separated by slight molecular adjustments. In the end, though, a drug has to qualify as something new in the eyes of a patent examiner.
But which parts of a chemical's makeover meet the bar for originality — and which are too easy, obvious, unearned or insubstantial — can be a matter of debate. Patent litigation can be costly. And without sufficient patent protection, competition is likelier to devolve into a scenario in which drug developers hawk largely indistinguishable products and chew through their budgets as they try to out-market one another.
It also risks making drug companies less attractive to investors. Investors will likely be looking for signs a company values its inventions and the profits that come from them.
Florian Brand, co-founder and CEO of ATAI Life Sciences, Compass' biggest investor, noted the importance of being able to re-ornament chemical compounds in a way that makes them new — and patentable.
"If you talk about the psychedelic compounds, the well known ones, like psilocybin and ibogaine, you certainly have to be a little bit more creative, once there's a lot of knowledge on these molecules, to establish an ability to block," he said.
He continued: "We are working with attorneys on this, across the platform, with all companies, to have a strong ability to block in place. It ranges from composition of matter, to use patents to process formulation and manufacturing patents."
Brand believes generic competition is 10-20 years away. Companies able to bring a legal treatment to market early, he argued, had more time to build name recognition.
Patenting Is Just One Step
If a company lands a patent for a new molecular composition for a drug — a so-called composition of matter patent — others have to obtain a license to use that compound. While original drugs might offer a thicker layer of patent protection, they also might require more ingenuity to make.
"You have to invent the molecule. So yes, that is the hardest," said Rick Doblin, founder of the nonprofit Multidisciplinary Association for Psychedelic Studies, when asked if the composition patents were the most difficult to obtain.
Temeles notes that new chemical compositions are only part of the process of bringing a drug to market. Some drugs might be easy to make in small portions in a lab. But synthesizing larger quantities, at a purity level that is safe for human consumption, can be difficult. The process of synthesizing can also leave behind materials that have harmful side effects.
Claims that protect a certain production method can help in making drug chemicals that are difficult to produce in larger quantities. Companies can patent the form a drug comes in as well.
Early Psychedelic Drugs Patent Dispute
The race to accumulate intellectual property comes after people who worked with Compass expressed worry that it was hurrying its efforts to research and commercialize psilocybin, Quartz reported in 2018. They said the company, which started as a nonprofit before morphing into a for-profit company, was putting patients at risk and muscling its way toward market dominance in a way that resembled those of bigger pharmaceutical companies.
Meanwhile, groups like MAPS and the Usona Institute, want to take a more egalitarian approach to their inventions.
"If we have patents or patents pending, we will license that intellectual property, for no more than reasonable and ordinary administrative costs, to anyone who will use it for the common good (lol) and in alignment with these principles," Usona says in a statement on "open science." That statement was signed by dozens of people, from Usona, MAPS and other researchers and advocates.
In January, after challenges to or rejections of prior applications, Compass said it received a U.S. patent for COMP360. Shortly after, the law firm Kohn & Associates disputed the patent.
Kohn & Associates has challenged some of Compass' other efforts to obtain patents, according to Lucid News. As that outlet reported in April, Carey Turnbull, a board member of Usona and the Heffter Research Institute, another nonprofit focused on psychedelics research, has helped fund the law firm's efforts. But a U.S. Patent and Trademark Office panel dismissed Kohn's challenge to Compass' U.S. patent in August.
Compass also has one patent in Germany and two in the U.K., according to its IPO filing. It has more than 20 applications pending.
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>>> Psychedelic Drugs Eye Long Trip To Legalization But This U.S. IPO Won't Wait
Psychedelic drugs have been recast as possible solutions to a range of emotional problems.
Investor's Business Daily
by BILL PETERS
08/28/2020
https://www.investors.com/news/psychedelics-drugs-eye-legalization-wary-pot-stocks-dive/
Years before Sean Roth underwent ketamine-assisted psychotherapy — an early hint of what a fully legal psychedelic-drug industry might look like — he'd gotten out of a relationship. As he went through more traditional therapy, he decided to go on a 10-day silent retreat. But the meditative process, known as Vipassana, pulled the lid off his past and left his ego bruised. His therapist, with whom he'd become close, died. So Roth took antidepressants. As a side effect, he began obsessing over things.
Then Roth, a 38-year-old owner of a tattoo and piercing studio in the Los Angeles area, early last year tried ketamine therapy, which combines psychotherapy — sofa and all — with the legal anesthetic also used as a party drug. In the days that followed, he lost unwanted weight. He went deeper emotionally with his new therapist. He ran two marathons. Roughly a year into the ketamine treatment, Roth was off traditional, prescription antidepressants.
"It's just being mindful that you're a person in this world," he said of the therapy's effects. "People care about you. They love you. And they need your love in return."
With similar testimonials emerging, psychedelic drugs have been recast as possible solutions to a range of emotional problems. Scientists are revisiting hallucinogens like mushrooms, LSD and others as possible therapeutics for depression, addiction, PTSD, obsessive-compulsive disorder and anxiety. And as the coronavirus pandemic fries away the population's mental health, the possibilities are attracting more money.
Now, psychedelic startups, backed by investors dangling money and stock listings, are jumping in. As they do, they're also bringing capitalism's competitive drive to substances rooted in cultures that often avoided it.
On Friday, London-based Compass Pathways, which is backed by PayPal (PYPL) and Palantir co-founder Peter Thiel, filed for a U.S. IPO to trade on the Nasdaq Global Market under the ticker CMPS. It plans to use proceeds to research a depression therapy that uses psilocybin, the psychoactive compound found in "magic mushrooms."
Hopes For Legalization
Those companies are betting on wider legalization and new research that suggests psychedelics can succeed where traditional medications have failed or, at best, merely narrowed the emotional sine wave. And like the cannabis industry, the hype around psychedelic drugs – and everything that comes with it – is building.
Regulators, too, are showing signs of openness. Johnson & Johnson (JNJ) thudded into the space with a ketamine-derived nasal spray after an FDA approval. The FDA has also fast-tracked some forms of therapy that use magic mushrooms and MDMA, also known as ecstasy or Molly.
But even in a fully legal world — not exactly on the horizon — the risks and rewards will be similar to any other legal drug. And questions remain about how big the psychedelics industry can actually get and how it can get there.
Psychedelic Drug Investors
Michael Auerbach, founder of Subversive Capital, which has invested in psychedelic drug companies, said they have the potential to develop multibillion-dollar drugs. But he's not expecting concrete financial results anytime soon.
"These are all pre-revenue, development pharmaceutical companies," he said. He added later: "In the pipeline of psychedelic drugs, we're pretty far out from having a number of approved psychedelic compounds for treatments and medications by the FDA."
Still, investors are starting to turn on the spigot. The nonprofits Multidisciplinary Association for Psychedelic Studies (MAPS) and the Psychedelic Science Funders Collaborative raised $30 million toward research into a PTSD treatment that mixes psychotherapy with a dose of MDMA.
Bob Parsons, the founder of GoDaddy, and his wife Renee pitched in $2 million. A foundation run by hedge fund billionaire Steve Cohen and his wife Alexandria donated $5 million.
"The normal sources of government are the National Institute of Mental Health (and the Department of Veterans Affairs). They were all closed to us," said Rick Doblin, MAPS's founder.
Other big investors have taken notice. Germany-based Atai Life Sciences, a psychedelics research-and-development outfit that backs other companies, is in turn backed by billionaire investor Thiel. Atai is the largest shareholder of Compass Pathways, which just filed for the U.S. IPO.
MindMed, which wants to develop hallucinogenic and non-hallucinogenic drugs, has the backing of "Shark Tank's" Kevin O'Leary and Bruce Linton, former CEO of Canadian cannabis giant Canopy Growth (CGC). However, MindMed loaned Linton $500,000 to buy part of his share in the company. Co-founder JR Rahn said the deal was structured that way to make the deal more attractive. Linton said he would have backed MindMed anyway.
First Psychedelic Drug Stocks Emerge
Some advisors have cautioned psychedelic drug companies against rushing to the public stock exchanges. In doing so, they hope psychedelics can avoid the landslide sell-off investors dealt the cannabis industry after executives overhyped its potential. Yet some have plowed ahead — often on the path carved by the pot industry.
MindMed in March debuted on the NEO Exchange, a small bourse in Canada. Toronto-based Field Trip Psychedelics, which has opened clinics in Toronto and New York, said in June that it was working out a deal to complete a reverse takeover that would put it on the Canadian Securities Exchange.
In conjunction, Field Trip plans a private placement to raise up to $14 million. Stifel Nicolaus Canada and Canaccord Genuity, a financial firm that served as a frequent dealmaker for the cannabis industry, led that fundraising round. In February, Field Trip raised $8.5 million.
A handful of other psychedelic drug stocks — Red Light Holland, Champignon Brands, Revive Therapeutics — have also appeared on the Canadian Securities Exchange.
Psychedelic Vs. Cannabis Markets
Many of the companies researching psychedelic drugs envision a tightly supervised industry. Regulators like the FDA and DEA both have to approve any research on psychedelic drugs in the U.S.
Businesses would focus on patient therapy and everything surrounding it — from preparing patients for what to expect from a mind-altering substance to other forms of support.
If the industry follows that mold, it could be narrower than the one for cannabis, which can be consumed daily without supervision after purchasing it from a dispensary. Some, however, argue that broader uses are still possible, given the potential to chip away at antidepressant use. MindMed, for instance, wants to develop psychedelic-based non-hallucinogenic drugs that could be picked up at a pharmacy.
The MDMA-therapy fundraising drive co-led by MAPS offers other hints of what a legal industry might look like.
With that money, MAPS is analyzing data from the first of two Phase 3 studies — later-stage trials on larger numbers of people — required by the FDA. MAPS will have to demonstrate it can develop a pure, stable medical-grade drug. The group also hopes to have 300 to 500 therapists trained once the medication can be prescribed.
That training would later have to expand to thousands of people. Doblin, during a conference to discuss the funding, said some therapists have expressed interest in being cross-trained across multiple psychedelic substances. MAPS is also exploring group therapy — an option that could lower the costs.
A small number of specialized pharmacies, Doblin said during an interview, would have a list of prescribers that have been through MAPS' training program. Only those people would be able to order the MDMA and have it shipped to their offices. Doblin said MAPS had an arrangement worked out to manufacture the MDMA, and put the drug into capsules, in England.
Inching Toward Legalization
The FDA last year approved Johnson & Johnson's nasal spray Spravato, which uses a derivative of ketamine, for treatment-resistant depression. The agency this summer approved Spravato for people who are actively suicidal.
The FDA in 2018 gave breakthrough status to the psilocybin therapy being developed by Compass Pathways. In 2017, it gave breakthrough therapy status to psychotherapy assisted by MDMA, the compound in ecstasy, for PTSD.
Magic mushrooms are still federally barred in the U.S. But Oregon in November will vote on a measure to legalize psilocybin therapy. Denver residents voted last year to decriminalize psilocybin mushrooms. The city council of Oakland, Calif., voted last year to decriminalize the substance as well.
In Canada, the government will allow four people with incurable cancer to use psilocybin therapy, said TheraPsil, a nonprofit group supporting the patients, recently. The therapy will be used for "the treatment of their end-of-life distress."
But regulators haven't always coalesced with businesses. The SEC temporarily suspended over-the-counter trading for Roadman Investments Corp., which owns a company focused on researching cedar leaf oil and has a joint venture to open a psychedelic treatment center in California if psilocybin is ever legalized. The SEC cited statements the company made about "cedar leaf oil as a promising treatment for COVID-19." The company did not respond to a request for comment.
New Research May Expand Opportunities
Additional research could help make the case for more incremental legalization moves. Lesser-known psychedelics are also possibilities.
DemeRx is trialing an opioid addiction treatment based on ibogaine. Ibogaine is psychoactive substance found in the root of a plant in Africa believed to smother out addiction.
MindMed, in collaboration with researchers in Switzerland, acquired the rights to a trial looking at LSD's effects on anxiety. In the fourth quarter, it plans to start trials in Switzerland and the Netherlands to look at LSD microdosing and its impacts on ADHD in adults.
The company is also looking at a compound based on ibogaine called 18-MC that it says is non-hallucinogenic and could be sold in drugstores. MindMed hasn't yet begun trials of any drugs in the U.S., but has filed an investigational new drug application for 18-MC with the FDA. It also wants to eventually conduct trials of 18-MC and LSD in the U.S.
Meanwhile, Johns Hopkins University opened up a center for psychedelic research last year. Researchers there have published more than 60 peer-reviewed articles. The U.S. government cleared the university researching psychedelics in 2000.
Big Pharma Involvement Looms
Auerbach, of Subversive Capital, also said that the activists promoting the benefits of psychedelics over the decades aren't likely to gel easily with big pharma. But the psychedelics industry might end up depending on it to get bigger.
"We are ultimately going to have to partner with other pharmaceutical companies to not only fund these programs, but also, I think, one day, deploy them," Rahn said.
Whether big pharma will want to join forces is another matter. Developers can tweak the molecular makeup of existing drugs and turn them into new ones. But nobody owns substances like LSD, or psilocybin or MDMA.
"Big pharma can't patent these substances because they've been around for a long, long time," Alan Fournier, founder of Pennant Investors, an investor in MAPS' MDMA therapy trial, said during the conference to discuss the therapy. "And they don't have the monetary profit incentive to make this happen."
Amy Emerson, CEO of the MAPS Public Benefit Corp., said that Big Pharma might still eventually express interest in psychedelics. But the therapy side of the treatment adds complications the pharmaceutical industry might prefer to avoid. The development of a dedicated therapist training program would bring extra costs. Psychedelic therapy, she said, tends not to be a regimen that puts people on daily doses of medications for years.
"This timeline doesn't fit into the traditional machinations of pharma companies, which could mean that rather than advancing these treatments, they would get lost in the shuffle and/or potentially languish in the commercial process," she said via email.
Big pharma companies, she said, were good at developing drugs. But that was a lot different from psychedelic treatments that tend to work best with a therapist.
"They're about medicine," Doblin said. "They're not about psychotherapy."
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Compass Pathways (CMPS) - >>> The First Psychedelic Drug Stock Jumps In Debut After Upsized IPO
Investor's Business Daily
by BILL PETERS
09/18/2020
https://www.investors.com/news/compass-pathways-sees-544-million-valuation-first-psychedelic-drugs-ipo/?src=A00220&yptr=yahoo
Compass Pathways (CMPS) jumped in its first day of trading on Friday, making it the first psychedelic drug company to go public on a big U.S. exchange.
Shares surged 42% to 24.09 in the stock market today, giving the company a market cap of more than $800 million. The debut comes a day after the company announced an upsized pricing for its IPO.
The London-based company, which is researching a therapy using the main ingredient in hallucinogenic mushrooms, said in a release late Thursday that its IPO priced at $17 a share, up from initial expectations for $14-$16 announced earlier in the week.
Compass said it sold 7.5 million American Depositary Shares in the offering, for total proceeds of $127.5 million. That was also above the 6.7 million planned. Each of the 7.5 million American Depositary Shares represented 7.5 ordinary shares in the offering.
The company has also granted the underwriters of its IPO a 30-day option to buy an additional 1,125,000 American Depositary Shares, up from 1,005,000 initially.
Compass Pathways filed for the IPO late last month. Cowen, Evercore ISI and Berenberg were the joint book-running managers for the Compass Pathways IPO. Canaccord Genuity, already an active deal maker in the cannabis industry, is the lead manager.
The psychedelic drugs industry has been put into the spotlight over the past year, as more investors pour their money into startups promising treatments for a range of mental illnesses.
With that trend have come concerns about a repeat of the cannabis industry's boom and bust. Most existing drugs in the industry — like LSD, MDMA and psilocybin — aren't yet legal or patentable.
Compass Pathways' COMP360 Therapy
The company, in a filing on Monday, said would have around 34 million shares outstanding after the offering, or 35 million if the underwriters fully exercise the option. That could give the company a valuation of nearly $600 million.
Compass Pathways has developed a crystalline form of psilocybin, called COMP360, for which it has a U.S. patent. Psychedelic drug developers, if they want to be profitable, will likely have to develop novel drug compounds and drug-delivery methods, a path similar to the legal pharmaceutical industry.
The drug developer plans to use COMP360 in conjunction with therapy for treatment-resistant depression. If regulators approve, Compass plans to market it to clinics and health care providers in the U.S. and Europe.
The FDA in 2018 gave breakthrough status to COMP360. Last year, the agency also approved the Johnson & Johnson (JNJ) drug Spravato, which uses a derivative of ketamine, for treatment-resistant depression. This summer, the FDA approved Spravato for people who are actively suicidal.
Ketamine — perhaps best known as a party drug — is regularly used, legally, as an anesthetic. Therapists also use ketamine for psychedelic-assisted psychotherapy.
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$PSYC September Newsletter to Feature Exclusive Interview with Retired NHL Heavy Hitter, Riley Cote
LAS VEGAS, Sept. 10, 2020 (GLOBE NEWSWIRE) -- Global Trac Solutions, Inc. (OTCPink: PSYC) (“Global” “PSYC” or the “Company”) is pleased to announce that the September 15th edition of its Microdose Monthly newsletter will be highlighted by an exclusive interview with retired National Hockey League player and medicinal psychedelic advocate, Riley Cote.
In his four years with the Philadelphia Flyers, Cote developed a reputation throughout the NHL as one of the league’s most physically intimidating enforcers by racking up more than 50 on-ice fights and delivering countless bone chilling body checks to his opponents on a nightly basis. Off the ice, however, Cote found himself engaged in a fight with addiction and symptoms of PTSD that he was unable to gain an upper hand on and was steadily beginning to lose.
The Psychedelic Spotlight exclusive interview and article written by PSYC CEO, David Flores, dives attentively into Cote’s road to recovery post-retirement with the help of alternative medicines and therapeutic treatments, including microdosing psilocybin. The article also covers Cote’s current and ongoing venture with BodyChek Wellness which Cote has developed to help other individuals who are facing challenges similar to those he experienced overcome them and reclaim their health in the process.
Said Global Trac Solutions, Inc. CEO, David Flores: “I am incredibly grateful for this opportunity to share Riley’s story of how his mindful integration of psychedelics into his recovery process contributed to him overcoming his battle with addiction and symptoms of PTSD. In my opinion, sharing stories such as his are not only important in helping to lend credibility to the benefits of medicinal psychedelics, but also in the hope that his story may inspire others out there who may be struggling with some of the same conditions Riley was able to successfully overcome. Acknowledging that you are losing a battle with your mental health is most often the first, and most difficult, step towards recovery. And so if we in any way can help encourage or motivate individuals who may be out there struggling with their mental health to take the first step towards getting the help they need through the stories, education, and information we are providing, then we are, in my opinion, accomplishing something quite profound from a societal perspective .”
Last month, the Company announced that in response to its ability to effectively increase its production of original content focused on the emerging psychedelic industry, that it’s Microdose Monthly newsletter will be distributed to subscribers on a semi-monthly basis (15th and 25th of each month). The Company encourages those who have not done so already, to subscribe to Microdose Monthly by visiting www.psychedelicspotlight.com.
About Global Trac Solutions, Inc. (OTCPink: PSYC)
Global Trac Solutions is a diversified holding company dedicated to identifying new and emerging industries. By utilizing our years of business development expertise our diverse team of innovators continuously leverages our experience to effectively execute go-to-market strategies in order to position ourselves for rapid growth through the creation of an evolving business foundation to enhance profitability potential.
PSYC has expressed its intent and commitment to positioning itself at the forefront of the psychedelic revolution and as a resource center for discovering and understanding the latest research and business opportunities surrounding psychedelic inspired medicines. In conjunction with the FDA’s more open-minded approach to psychedelic medicines, and as several major U.S. cities continue to approve the decriminalization of psilocybin, investors are speculating that the psychedelic boom could be bigger than that of cannabis. PSYC is your source for current investment related news specific to psychedelic medicines and cutting-edge research improving overall health, moving this sector into the mainstream.
We believe in a forward-thinking approach that embraces groundbreaking new technology and innovations and through the vision of business development we intend to continue to evolve into these unchartered territories as the industry leaders of the future. We truly are the right TRAC to follow.
Forward-Looking Statements Disclaimer:
This press release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. In some cases, you can identify forward-looking statements by the following words: "anticipate," "believe," "continue," "could," "estimate," "expect," "intend," "may," "ongoing," "plan," "potential," "predict," "project," "should," "will," "would," or the negative of these terms or other comparable terminology, although not all forward-looking statements contain these words. Forward-looking statements are not a guarantee of future performance or results and will not necessarily be accurate indications of the times at, or by, which such performance or results will be achieved. Forward-looking statements are based on information available at the time the statements are made and involve known and unknown risks, uncertainty and other factors that may cause our results, levels of activity, performance or achievements to be materially different from the information expressed or implied by the forward-looking statements in this press release. This press release should be considered in light of all filings of the Company that are disclosed on the OTC Markets.com website.
Disclaimer: Global Trac Solutions, Inc. does not in any way encourage or condone the use, purchase, sale or transfer of any illegal substances, nor do we encourage or condone partaking in any unlawful activities. We support a harm reduction approach for the purpose of education and promoting individual and public safety. If you are choosing to use psychedelic substances, please do so responsibly.
Corporate Contact:
Global Trac Solutions, Inc. (PSYC)
http://www.globaltracsolutions.com
(702) 239-1919
info@globaltracsolutions.com
OTCPINK: PSYC
$PSYC Establishes New Partnership with Industry Leader, Microdose Psychedelic Insights
LAS VEGAS, Aug. 18, 2020 (GLOBE NEWSWIRE) -- Global Trac Solutions, Inc. (OTCPink: PSYC) (“Global” “PSYC” or the “Company”) is pleased to announce that in an effort to accelerate the Company’s development of premium industry centric content for its Psychedelic Spotlight website (www.psychedelicspotlight.com) and Microdose Monthly newsletter, PSYC has established a content development partnership with Microdose Psychedelic Insights (“Microdose”) (www.microdose.buzz), the leader in psychedelic media and events based out of Toronto, Canada.
Through this partnership with Microdose, PSYC will have the distinct ability to work in a collaborative effort with Microdose’s talented and knowledgeable content development team to produce and present original, broad-minded content that offers a unique and in-touch perspective related to the emerging space of psychedelic medicine.
Said Global Trac Solutions, Inc. CEO David Flores: “We are delighted to have established this outstanding partnership with a firm like Microdose who have such a compelling and impressive finger on the pulse of the medicinal psychedelic industry. More importantly, I am thrilled to partner and work with a company where our passion, principles, and overall vision within this industry are so perfectly aligned and the opportunity it will present to unify each of these critical aspects in producing exceptional informational and educational-focused content that I hope will contribute to the advancement of psychedelic medicines as a recognized treatment. It is also our intent to leverage this terrific opportunity to more distinctly develop our identity and expand our reach within this quickly evolving sector.”
Said Patrick Moher, Microdose Partner: “We are pleased to be aligning the team at Psychedelic Spotlight, amplify our ability to produce high quality, evidence based, original psychedelic content. We believe that collaboration is critical to create a successful industry in the long term and are excited to see where this partnership takes us.”
In addition to this partnership, the Company has also demonstrated considerable focus in recent weeks towards expanding its pool of talented and experienced freelance writers within the field of medicinal psychedelics and with the intent of increasing its production and output of original content over the next several weeks and in the months ahead.
About Global Trac Solutions, Inc. (OTCPink: PSYC)
Global Trac Solutions is a diversified holding company dedicated to identifying new and emerging industries. By utilizing our years of business development expertise our diverse team of innovators continuously leverages our experience to effectively execute go-to-market strategies in order to position ourselves for rapid growth through the creation of an evolving business foundation to enhance profitability potential.
PSYC has expressed its intent and commitment to positioning itself at the forefront of the psychedelic revolution and as a resource center for discovering and understanding the latest research and business opportunities surrounding psychedelic inspired medicines. In conjunction with the FDA’s more open-minded approach to psychedelic medicines, and as several major U.S. cities continue to approve the decriminalization of psilocybin, investors are speculating that the psychedelic boom could be bigger than that of cannabis. PSYC is your source for current investment related news specific to psychedelic medicines and cutting-edge research improving overall health, moving this sector into the mainstream.
We believe in a forward-thinking approach that embraces groundbreaking new technology and innovations and through the vision of business development we intend to continue to evolve into these unchartered territories as the industry leaders of the future. We truly are the right TRAC to follow.
About Microdose Psychedelic Insights
Microdose Psychedelic Insights aims to unlock the potential of psychedelics through Industry events, market intelligence, original, evidence-based content, strategy and community. We enable and empower society at large to make better, more mindful decisions about psychedelics and its intersection with healthcare, medicine and personal growth. We work with the industry's most influential stakeholders, some of the world's best-known brands and an unrivalled network of scientists, researchers, analysts, innovators, investors and advisors.
Contact: info@microdose.buzz
Forward-Looking Statements Disclaimer:
This press release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. In some cases, you can identify forward-looking statements by the following words: "anticipate," "believe," "continue," "could," "estimate," "expect," "intend," "may," "ongoing," "plan," "potential," "predict," "project," "should," "will," "would," or the negative of these terms or other comparable terminology, although not all forward-looking statements contain these words. Forward-looking statements are not a guarantee of future performance or results and will not necessarily be accurate indications of the times at, or by, which such performance or results will be achieved. Forward-looking statements are based on information available at the time the statements are made and involve known and unknown risks, uncertainty and other factors that may cause our results, levels of activity, performance or achievements to be materially different from the information expressed or implied by the forward-looking statements in this press release. This press release should be considered in light of all filings of the Company that are disclosed on the OTC Markets.com website.
Disclaimer: Global Trac Solutions, Inc. does not in any way encourage or condone the use, purchase, sale or transfer of any illegal substances, nor do we encourage or condone partaking in any unlawful activities. We support a harm reduction approach for the purpose of education and promoting individual and public safety. If you are choosing to use psychedelic substances, please do so responsibly.
Corporate Contact:
Global Trac Solutions, Inc. (PSYC)
http://www.globaltracsolutions.com
(702) 239-1919
info@globaltracsolutions.com
Info site - Psycheledic Spotlight -
https://www.psychedelicspotlight.com/
$PSYC Positions Psychedelic Spotlight for Next Phase of Growth With Strategic Updates
LAS VEGAS, Aug. 11, 2020 (GLOBE NEWSWIRE) -- Global Trac Solutions, Inc. (OTCPink: PSYC) (“Global” “PSYC” or the “Company”) is pleased to announce that within the past several days it has begun to push critical updates to the Company’s Psychedelic Spotlight website (www.psychedelicspotlight.com) in an effort to more effectively align the site with the growth initiatives and strategies it has established, and infusing it with features intended to optimize potential revenue generation capabilities over the next several months.
The Company contends that some of the most significant updates to the site were made to its homepage where its objective was to provide a more intuitive layout designed to magnify news headlines within the emerging space of psychedelic medicine, along with its own original industry-based content, and encourage a more impactful user experience for its growing number of visitors. Additionally, considerable thought and effort was focused on placing the necessary building blocks in place with the intent of ensuring the site is adequately positioned to begin incorporating potential revenue-driven opportunities within the coming months.
Said Global Trac Solutions, Inc. CEO, David Flores: “I positively view our Psychedelic Spotlight website as a continuously evolving endeavor which is why I believe it is essential for us to ensure that we have a solid foundation for it in place that is capable of sustaining and maximizing the growth and expansion that I anticipate it experiencing over the next several months. With the constant eye that I have on revenue opportunities for the website such as the sale of advertisement space and other promotional marketing opportunities, I am truly encouraged with the direction we are now moving in with the site given these critical updates we have been able to incorporate in recent weeks. I believe these updates should also provide a fairly accurate glimpse into the identity we are focused on establishing for PSYC and the specific sector of this emerging industry that we are looking to carve out for ourselves as we move forward.”
The Company contends that in addition to the visual and layout-related updates it has released for Psychedelic Spotlight, that it is also beginning to work closely with search engine optimization (SEO) and data analytic experts to continue to identify opportunities to enhance the user experience for the site as well as other related enhancements focused on increasing the site’s online presence within the expanding medicinal psychedelic community.
About Global Trac Solutions, Inc. (OTCPink: PSYC)
Global Trac Solutions is a diversified holding company dedicated to identifying new and emerging industries. By utilizing our years of business development expertise our diverse team of innovators continuously leverages our experience to effectively execute go-to-market strategies in order to position ourselves for rapid growth through the creation of an evolving business foundation to enhance profitability potential.
PSYC has expressed its intent and commitment to positioning itself at the forefront of the psychedelic revolution and as a resource center for discovering and understanding the latest research and business opportunities surrounding psychedelic inspired medicines. In conjunction with the FDA’s more open-minded approach to psychedelic medicines, and as several major U.S. cities continue to approve the decriminalization of psilocybin, investors are speculating that the psychedelic boom could be bigger than that of cannabis. PSYC is your source for current investment related news specific to psychedelic medicines and cutting-edge research improving overall health, moving this sector into the mainstream.
We believe in a forward-thinking approach that embraces groundbreaking new technology and innovations and through the vision of business development we intend to continue to evolve into these unchartered territories as the industry leaders of the future. We truly are the right TRAC to follow.
Forward-Looking Statements Disclaimer:
This press release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. In some cases, you can identify forward-looking statements by the following words: "anticipate," "believe," "continue," "could," "estimate," "expect," "intend," "may," "ongoing," "plan," "potential," "predict," "project," "should," "will," "would," or the negative of these terms or other comparable terminology, although not all forward-looking statements contain these words. Forward-looking statements are not a guarantee of future performance or results and will not necessarily be accurate indications of the times at, or by, which such performance or results will be achieved. Forward-looking statements are based on information available at the time the statements are made and involve known and unknown risks, uncertainty and other factors that may cause our results, levels of activity, performance or achievements to be materially different from the information expressed or implied by the forward-looking statements in this press release. This press release should be considered in light of all filings of the Company that are disclosed on the OTC Markets.com website.
Disclaimer: Global Trac Solutions, Inc. does not in any way encourage or condone the use, purchase, sale or transfer of any illegal substances, nor do we encourage or condone partaking in any unlawful activities. We support a harm reduction approach for the purpose of education and promoting individual and public safety. If you are choosing to use psychedelic substances, please do so responsibly.
Corporate Contact:
Global Trac Solutions, Inc. (PSYC)
www.globaltracsolutions.com
(702) 239-1919
info@globaltracsolutions.com
Source: Global Trac Solutions, Inc
Spravato / Esketamine - >>> J&J's ketamine-based drug drives sea change for new depression treatments
By Joe Williams
March 07, 2019
FOXBusiness
https://www.foxbusiness.com/healthcare/jj-depression-drug-approval-spurs-new-hope-for-the-field
Nasal spray developed by Johnson & Johnson may be the key to fighting treatment resistant depression
The Trump administration’s Opens a New Window. approval of Johnson & Johnson’s ketamine-based depression treatment Opens a New Window. comes as a slew of other drugmakers look to advance their own medications Opens a New Window. for the disease, driving renewed investor interest in a dormant therapeutic area, according to industry executives and experts.
But while Spravato, developed by J&J unit Janssen, is seen as a pivotal turning point in what has been a decades-long drought of new depression drugs, significant questions remains over how popular the treatment will be after the Food and Drug Administration imposed strict safety requirements for patients seeking the treatment.
The field also remains a difficult one to study and there are no assurances that any of the still experimental treatments will succeed. Botox-maker Allergan, for example, announced on Wednesday evening that its highly anticipated depression drug rapastinel failed in late-stage trials.
Still, advocates are bullish that new, safer treatments under development will soon reach patients.
“There is a lot of activity in this space, looking at drugs that work faster and work on different mechanisms completely than what has been studied before,” Sanjay Mathew, vice chair for research at Baylor College of Medicine and a member of the Anxiety and Depression Association of America, told Fox Business. “The key will be to develop equally as effective drugs without the liability.”
Of particular interest, according to VistaGen Therapeutics Inc. CEO Shawn Singh, is the data the agency used to approve Spravato. Johnson & Johnson relied on what is referred to in the industry as a randomized withdrawal study, or a trial format in which a patient first receives a drug for a specific period of time and then either stays on the existing regiment or is transferred to a placebo.
“It is definitely the case that we need more innovative clinical trial designs in order to manage down what’s often the case is a placebo effect in neuropsychiatry studies,” he said. “Not only [will] companies developing new medicines for depression and other mood related disorders benefit, but certainly patients will.”
Small biotech companies have emerged to fill the white space left by large pharmaceutical firms that largely abandoned research on new depression treatments. But with an immense market of individuals that suffer from the disease and the success of Spravato, the sector is getting renewed interest.
“You need game-changing options to really drive the business-side and Wall Street’s attention,” Singh said. “Before this approval signaling that new options are on the horizon, there really wasn’t much reason to pay attention to this space. But now there certainly is.”
VistaGen is developing its own treatment for depression that aims to address the safety concerns the FDA had in approving Spravato to allow for in-home use.
On top of the mandate that prospective users fail on at least two other medications first, the agency is requiring that patients receive the drug in a clinician’s office and are monitored for two hours after the nasal spray is administered.
As with any new treatment, the industry is also watching closely to see how much patients will ultimately pay for Spravato, which will set the bar for future drugs. While the dosage and frequency will vary by individual, most will need it twice a week for at least the first month, totaling as much as $6,785 per month for the initial phase. Depending on the response, some patients could reduce their schedule to weekly or biweekly, lowering the cost to as much as $2,540 a month.
It remains to be seen how much physicians will charge to administer the drug and monitor patients afterwards, as well as what sort of discounts will be negotiated between Johnson & Johnson and pharmacy benefit managers. In order to provide the treatment, doctors must be certified by the company and clinics must meet a strict set of guidelines.
Given the hurdles to receive the drug, the universe of depression sufferers are unlikely to take Spravato. Still, it remains the most exciting development in the field in decades.
Johnson & Johnson “is taking on these really important challenges that other people are not taking on,” said Tonix CEO Seth Lederman, which is developing a drug for post-traumatic stress disorder in military veterans. “Getting this important drug approved was not easy and not inexpensive, so I’m not sure how this will translate down into smaller psychiatry companies.”
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>>> Psychedelic Medicine Stocks Capture The Attention Of Investors
Mar. 6, 2020
Includes: ACB, AMRS, ARNA, EHVVF, OGI, RVVTF, TLRY, WUHN
Seeking Alpha
by David Kugelman
https://seekingalpha.com/article/4330293-psychedelic-medicine-stocks-capture-attention-of-investors
Psychedelic medicine involves the use of psychedelic substances such as psilocybin (the chemical in magic mushrooms), MDMA, LSD, and ketamine to treat patients with mental health issues.
The big difference between psychedelic medicine and cannabis is the way in which they're used in therapy.
Mind Medicine became the first psychedelics pharmaceutical firm to go public.and involves "Shark Tank" investor Mr. Wonderful Kevin O'Leary and Canopy Growth Corp. CEO Bruce Linton.
The Center for Psychedelic and Consciousness Research at Johns Hopkins Medicine is a $17 million research center devoted to studying psychedelic medicine.
Cities like Denver, Oakland, and Santa Cruz voted to decriminalize magic mushrooms.
If you think investors made big money from cannabis stocks, you had better be ready to start buying psychedelic medicine stocks! Psychedelic medicine involves the use of psychedelic substances such as psilocybin (the chemical in magic mushrooms), MDMA, LSD, and ketamine to treat people with depression, addiction, PTSD, ADHD, and the psychological challenges posed by terminal illnesses.
The big difference between psychedelic medicine and cannabis is the way in which they're used in therapy. Psilocybin is used to enhance therapy and is not necessarily the treatment while cannabis mostly treats symptoms. The U.S. Food and Drug Administration (FDA) authorized Breakthrough Therapy Designation to both Compass Pathways' and Usona Institute's psilocybin therapy for depression in 2018. Johnson & Johnson's (NYSE: JNJ) ketamine-derived medicine, Spravato, has been available for pain relief for years. In March 2019, the FDA approved Spravato for treatment-resistant depression. This was huge, since ketamine not only has hallucinogenic properties, but is well known as a party drug by its common street names K, Special K, Kit Kat, and Jet, as well as a few others. Last September a group of private donors ponied up $17 million to start the Center for Psychedelic and Consciousness Research at Johns Hopkins Medicine, making it what's believed to be the first such research center in the U.S. and the largest research center of its kind in the world. Just as we saw with cannabis, voters in cities like Denver, Oakland, and Santa Cruz voted to decriminalize magic mushrooms.
There are several private companies like ATAI Life Sciences and COMPASS Pathways making headway in the psychedelic medicine space. Investors are looking for ways to profit, so let's take a look at a few of the publicly traded psychedelic medicine companies.
First, and most obvious, is Mind Medicine (MindMed) Inc. (NEO:MMED) (OTC:MMEDF), which became the first psychedelics pharmaceutical firm to go public. MindMed involves "Shark Tank" investor Mr. Wonderful Kevin O'Leary and Canopy Growth Corp. (NYSE:CGC) CEO Bruce Linton, so that alone has investors excited. MindMed raised $24.2 million privately before it came public March 3, 2020 on the NEO Exchange. Investors are bidding the shares up, since Canopy Growth and GW Pharmaceuticals (NASDAQ: GWPH) both delivered 1,000% plus returns for investors that bought their IPOs.
MindMed came public via a reverse merger with Broadway Gold Mining Ltd. and has traded between C$0.24 and C$0.64 with a current market cap in excess of C$115 million. At present, MindMed is preparing 18-MC, its lead development drug development program, for a Phase 2 clinical trial, planned to begin in the fourth quarter. 18-MC is a non-hallucinogenic drug candidate, based on the psychedelic substance ibogaine, which in extensive preclinical research has shown promise for helping to curb addictions. MindMed is also preparing to conduct a Phase 2 LSD microdosing clinical trial for adult ADHD, expected to begin later this year.
Here are a few words of caution on MindMed. It is very difficult for U.S. investors to buy a stock on the Canadian Neo Exchange. Many U.S. investors in search of the next big thing are snapping up shares of MMEDF on the U. S. OTC Gray Market. According to OTC Markets, Grey Market, "OTC" or "Other OTC" is a security that is not currently traded on the OTCQX, OTCQB or Pink markets. Broker-dealers are not willing or able to publicly quote OTC securities because of a lack of investor interest, company information availability or regulatory compliance. Also, MindMed filings on SEDAR reference an email address at the domain savanthwp.com. This is worth looking into, since on closing the transaction, Savant Addiction Medicine, LLC, received Multiple Voting Shares for each share of MindMed PrivateCo that it held immediately prior to completion of the transaction. Savant Addiction Medicine, LLC is currently the only holder of Multiple Voting Shares. All other former MindMed private company shareholders received Subordinate Voting Shares.
Ehave, Inc. (OTCPK:EHVVF) just announced plans to enter the $88 billion mental health market with plans to acquire 100% of PsychedeliTech, a division of Israel based Israel Cannabis Limited ("iCAN"). Ehave management believes PsychedeliTech could be a leader in the commercialization of research into psychedelics for the treatment of anxiety, depression, and other mental illnesses. Ehave, Inc. and PsychedeliTech intend to create an ecosystem to nurture the development of therapies using psychedelics. The ecosystem includes clinical trials, biosynthesis of psychedelic compounds, E-commerce, CPG'S, supply, dosage, delivery, data, conferences and business intelligence.
PsychedeliTech is also involved in the inaugural PsyTech Summit, which will take place June 14th and 15th, 2020 at the Hilton Hotel, on the Mediterranean Sea in Tel Aviv, Israel. Rick Doblin, Ph.D., Founder and Executive Director of the Multidisciplinary Association for Psychedelic Studies (MAPS) will be the gathering's keynote speaker. The landmark event will bring together scientists, innovators, regulators, investors, and advocates from around the world to expand minds to the potential of psychedelic medicine. Ehave also plans to drive researchers to its Ehave Connect mental health informatics platform. According to the Company, Ehave's Dashboard allows clinicians to make objective, data-driven decisions while keeping patients informed and engaged throughout their mental healthcare journey. Ehave's recently expanded its partnership with BurstIQ to bring its dashboard compliant with both HIPAA and GDPR standards using BlockChain technology. BurstIQ remains the only blockchain platform to receive compliance certification under SOC 2 Type 2 audit requirements.
Revival Therapeutics (CSE:RVV) (OTCPK:RVVTF) recently announced the acquisition of Psilocin Pharma Corp., which has developed production solutions for the active compound Psilocybin. Psilocin Pharma Corp. has developed 6 formulations under the Hydroxy Line including capsules, sublingual spray, gel caps, effervesce tablets, and breath strips. According to the Company, the precisely dosed formulations work with both natural and synthetically derived Psilocybin which will be targeted for clinical research and subject to eventually FDA approval in the treatment of Depression, Anxiety, Bi-polar disorder, Bulimia and Anorexia Nervosa. Psilocin Pharma also has strong relationships with specific lab partners in certain areas like Brazil, where these formulations are legally approved and plan to sell products in these jurisdictions. Interesting to note, Psilocin Pharma Corp, a company that was created just 6 days before the LOI was announced.
In April, 2019 Wuhan General Group, Inc. (OTCPK:WUHN) announced that its subsidiary MJ MedTech, Inc. created a new division dedicated to exploring opportunities in the psychedelic medicine space. The new division, M2BIO would be headed up by Wuhan's CMO, Dr. Anna Morera Lorelta. The new division, M2BIO aims to develop new therapies that will help patients who suffer from mental illness and ease the burden on healthcare systems globally. This division will be exploring additional indications for psilocybin, with the goal of bringing new therapies to market. One month later Wuhan General Group announced it had acquired a 49% interest in Cape Town, South Africa based Biodelta Nutraceuticals. According to a press release issued in July 2019, Wuhan General Group and Biodelta Nutraceuticals completed the transaction.
Champignon Brands Inc. (CSE:SHRM) is focused on a mushroom-to-market strategy by offering a range of teas, that make use of functional mushrooms to offer entry-level exposure to the burgeoning boom in mushroom products. Champignon is committed to cultivating and distributing artisanal medical mushrooms and the CPGs derived from those mushrooms. Champignon Brands recently completed its initial public offering of more than 18 million common shares at a price of C$0.15 per share for total gross proceeds of more than $2.8 million. The company's common shares were listed on the Canadian Securities Exchange beginning February 27, 2020. After being halted pending completion of the IPO, the common shares resumed trading on the CSE on March 2, 2020, under the symbol SHRM. The company is also in the process of securing a listing in Germany as it seeks to establish an early presence in both North America and Europe. Roadman Investments Corp. (TSX-V:LITT) is a Canadian-listed venture capital firm that recently invested in Champignon Brands, a British Columbia-based craft mushroom distributor with plans to expand into psilocybin mushrooms.
Companies conducting research on psychedelic medications have caught the attention of cannabis investors, so Psychedelics could become the next big investing opportunity in 2020. There is not a lot of information out there on psychedelic stocks, but a few groups on Twitter seem to provide some insight. Here are just a few @MAPS, @PsyTechSummit, @PspacePship, @TheTripReport1, @InvestmentPsych, @ShroomStreet, and @PsychedelicSto7. The research into psychedelics has shown amazing promise. Unlike cannabis, it is legal for companies to do this kind of research in the United States. Other companies will definitely come into the fray, but these are just a few of the companies in the sector early. There is always the possibility larger cannabis companies like Arena Pharmaceuticals, Inc. (NASDAQ:ARNA), OrganiGram Holdings, Inc. (NASDAQ:OGI), Amyris Inc. (AMRS) , Tilray Inc. (NASDAQ:TLRY), and Aurora Cannabis (NYSE:ACB) could enter the market.
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Name | Symbol | % Assets |
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Cybin Inc Ordinary Shares | CYBN.NE | 9.69% |
Mind Medicine Inc Ordinary Shares | MMED.NE | 9.65% |
Seelos Therapeutics Inc | SEEL | 5.67% |
Relmada Therapeutics Inc | RLMD | 5.37% |
ATAI Life Sciences NV | ATAI | 4.98% |
Gh Rsrch | GHRS | 4.97% |
Alkermes PLC | ALKS | 4.78% |
Vistagen Therapeutics Inc | VTGN | 4.68% |
Bright Minds Biosciences Inc Ordinary Shares | DRUG.CN | 4.66% |
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