Monthly Archives: July 2021

The anesthesia medication ketamine is showing increased promise as a treatment for people experiencing depression who haven't found relief with other prescription medications.

Though ketamine is known for its recreational use as a party drug, it can also be prescribed legally by doctors. In recent years, ketamine has become more accessible for those struggling with depression. In 2015, there were fewer than 60 ketamine clinics in the U.S. Three years later, there were more than 300, according to the journal of Psychiatry and Clinical Neurosciences.

Generic ketamine isn't specifically approved as a depression treatment, but U.S. doctors are often allowed to prescribe Food and Drug Administration-approved medicines "off-label" for another use.

A growing body of evidence has shown ketamine, which has been used since the 1970s in the field of anesthesia, can be successful in treating depression and suicidal behaviors. In fact, ketamine is part of a growing field of research into whether drugs that have traditionally been viewed as illegal psychedelics or party drugs could, in certain contexts, help people with depression, post-traumatic stress disorder and other behavioral health and psychiatric disorders.

In 2019, the FDA approved Spravato, a ketamine-related nasal spray drug, given in conjunction with antidepressants that has been shown to help people with treatment-resistant depression. But many clinics offer generic ketamine, often in the form of intravenous infusions.

Dr. Steven Mandel, founder and president of Ketamine Clinics Los Angeles, said because ketamine is already a low-cost generic drug, it's unlikely that a pharmaceutical company would pay for the process that would be needed to get the drug approved specifically as a depression treatment.

"For a medicine like ketamine that is already approved and available, adding a new indication for the treatment of depression would probably cost tens of millions -- if not hundreds of millions -- of dollars," Mandel said. "No one wants to spend that money."

A Ketamine IV is prepared at a clinic, March 13, 2019, in Palo Alto, Calif.

But ketamine's unique status can create problems for patients. Ketamine's use for depression is off-label and it is typically not covered by health insurances. Because of this, "there are some access issues," said Dr. Panagiota Korenis, a psychiatrist and associate professor at the Albert Einstein College of Medicine.

"It's often limited to a subset of the population that can pay out of pocket or be a part of a trial," she said.

There are also certain risks associated with ketamine.

"It is a drug that can be abused potentially," said Korenis, who noted that patients typically need to be treated in the clinic and typically cannot take multiple doses of the medication home with them.

Nevertheless, Korenis is hopeful that ketamine may prove itself as another powerful option for those with depression.

"Ketamine certainly is being shown to be a medication of interest and one that has potential for the future," said Korenis.

Experts debate whether ketamine is a psychedelic and able to produce similar altered states of consciousness as MDMA and psilocybin, which have shown healing properties in some studies.

But many clinics are opting to administer ketamine in a manner similar to psychedelics in clinical trials. Ketamine-assisted psychotherapy, or KAP, is a combination of ketamine and therapy that is similar to psychedelic-assisted therapy used in recent carefully controlled clinical trials.

For example, MDMA, also known as molly or ecstasy, is a psychedelic drug that is now being studied in controlled therapy settings as a possible treatment for PTSD. But no psychedelic treatments are FDA-approved, meaning doctors cannot administer them outside of a clinical trial. MDMA is illegal for recreational use in the U.S.

For those who are unable to get into a clinical trial of psychedelics like MDMA and psilocybin, KAP may be the closest legal equivalent.

"Ketamine works for depression and suicidality -- it works quickly, it's safe," said Mandel. "For the other medicines, we just don't know. They seem to have great early promise, but we do need a lot more data and a lot more time before we can fully embrace them."

Psychedelics like MDMA and psilocybin may require a couple of more years until they receive FDA approval, according to Rick Doblin, Executive Director of the Multidisciplinary Association for Psychedelic Studies. In the meantime, Mandel hopes more patients learn about ketamine as an option for depression.

"Ketamine should be available to anyone suffering from these afflictions," said Mandel.

Nicholas Nissen, M.D., is an author, host of the "Brain Health with Dr. Nissen" podcast and a contributor for the ABC News Medical Unit.

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Doctors treating depression see promise in ketamine, a cheap drug already approved for anesthesia - ABC News

In a little over one year, the psychedelics industry has experienced exponential growth.

With more than 40 public companies and 6 listed on the Nasdaq, investors looking to bet on the psychedelic renaissance have a host of alternatives from which to choose.

In this industry. If you miss a day, you miss a year, saidSa'ad Shah, co-founder and managing partner of Noetic, a venture capital firm thatinvests in emerging and early-stage psychedelic-based wellness and pharmaceutical companies.

A rapidly-growing sector can mean great news for investors, but it can also make it difficult tonavigate within the sector, as new companies and lines of business pop up like mushrooms after a summer rain.

For Matias Serebrinsky, partner at PsyMed Ventures, virtually every trend that moved the industry a year ago has intensified.More companies, more funding, established biotech and healthcare players [are] playing a bigger role in the space.

However, as an early-stage investor who also co-hosts the Business Trippodcast,

Serebrinsky saidtheres stilla lot of innovation in the space that has notnecessarily reached retail investors.

Recent developments in the psychedelics sector may lead some to believe that the market is reaching some kind of stability.

But experienced investors say todays public companies are just the tip of the iceberg.

I think that the best companies out there are still private, they're not public, saidShah, whoseVC fund raised over $120 million in the last year alone.

Steve Hawkins, president and CEO of Horizons ETFs and manager of the first psychedelics ETF, saidmore IPOs from larger, well-funded companies are on the horizon.

There are many reasons why companies in the psychedelics space will choose to delay their IPOs. Shah encourages companies in Noetic'sportfolio to remain in the private space for as long as they can afford to.

A large part of the decision to go public versus staying private is about access to capital, Shah explained. For companies that are stirring strong, positive results with a compelling value proposition, its easy to raise private capital, so its in their best interest to delay an IPO for a more opportune time, avoiding operational costs of going public and guarding the flexibility that remaining private offers.

Today there are well over 45 publicly traded entities between the Canadian and the U.S. exchanges, Shah pointed out. When it comes to private companies, there could be well over 400 or 450 private companies, maybe even more than that.

Jeff Siegel, a managing partner at the JLS Fund and co-founder of Green Chip Stocks, said most investors are still in the dark about just how profitable this industry is going to become.

Were talking about a potential disruption of the mental health market that hasnt been seen since the 1970s. Hundreds of billions of dollars are up for grabs, and if these psychedelic molecules prove to be successful, which I believe they will, this industry, and those who invested early, are going to make a lot of money, Siegel said.

As companies in the psychedelics space move up their clinical research pipelines, the most anticipated inflection point will come with the regulatory approval of psychedelics currently under research,Horizons Hawkins noted.

But while the industry waits for MDMA to become the first psychedelic to receive approval sometime in late 2022 or early 2023, could the slow pace of the drug development process usher in a loss of excitement for the sector?

Hawkins saidhe believes well see a number of milestones that will propel positive market trends. Headvises investors not to write-off opportunities because of a loss of novelty.

Whether in the form of more major IPOs, drug stage advancements and approvals, NYSE and Nasdaq cross-listings, positive earningsand increased investor interest, new events can lead to short-term lifts and long-term growth.

One thing to consider is that not all of these companies will have to make it through Phase III clinical trials to be successful,JLS Jeff Siegelsaid.

If the IP is strong and earlier trial data is promising, a company could easily be acquired for a very nice premium. It happens all the time in the biotech space, and really, this is how investors should look at the psychedelics space, anyway. More of a biotech play than anything else, he added.

As far asSiegel is concerned, the psychedelics space is still far frommarket stabilization.

For one, a number of the early, pre-IPO shareholders in this space are still in a lock-up period, so we dont yet know if theres going to be massive dumps of cheap shares when those lock-ups expire, or if those pre-IPO investors are going to stick it out over the long-term.

That uncertainty feeds into instability, which for Siegel means that in the foreseeable future we will likely see far more traders than long-term investors.

Shah agreed.At some point, we may see a shoe drop," saidNoetics Shah.We may see the market take a big correction. It may be led by one or two stocks in the industry that perhaps are not able to continue to really show efficacy or perhaps run into some issues.

However, Shah noted that such an event could benefit the market as it will separate the wheat from the chaff.

Companies with the strongest cash positions will be the ones best fit to endure a dry spell in the market. However, in Shahs view, the biggest thing that will allow companies to continue to raise capital in the private markets is the quality of the science being done and the consistency of the management team.

PsyMeds Serebrinsky encourages investors to go back to the basics.Is there strong data to back a companys claims? Is the founding team experienced and capable of taking these medicines through clinical trials? Do they have a realistic plan and the means to secure funds to make it happen?

JLS Siegel highlights good management, significant cash reserves and strong IP as the winning formula.

Management is the most important. Were seeing a lot of people come into the space who dont know the first thing about psychedelics or what it takes to get any kind of medicine or treatment through FDA trials. Theyre good at raising money, but thats about it. And those are the companies that will make management a lot of money but offer no value to shareholders or the industry, Siegel said.

Different Ball Game From Cannabis

As opposed to cannabis, which is a retail play, psychedelics are a biotech play and a pharma play. It's about clinical trials and new chemical entities, explainedShah, who added thatinvestors need to be very, very careful, becausepsychedelics are a case of buyer beware.

This is an industry that requires domain expertise. And so you either get that advice from outside or you do your own homework and just make sure you understand the space really well. Its a knowledge-based industry, Shah concluded.

Benzinga Photo.

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Will Psychedelics Continue To Grow In 2021? Fund Managers Share Insights And Strategies As More Companies - Benzinga

Cybin Inc. (NEO: CYBN) (OTCQB:CLXPF), a biotech company in the psychedelics space, announced on Thursday a conditional approval to liston the New York Stock Exchange.

A tier 1 listing in the U.S. can open up avenues to new and potential institutional buying, increased retail buying, and help increase the overall visibility of the company, Cybin CEO Doug Drysdale told Benzinga.

The companys over-the-counter shares will uplist into the NYSE Americans Small Cap Equity Market. Cybin shares listed on Canadas NEO Exchange willremain listed there. The Company has reserved the ticker CYBN for the NYSE.

Drysdale said the company expects expanded access to investors to further fuel our mission to develop revolutionary psychedelic therapeutics for patients suffering from mental health conditions."

Approval remains conditional and is still subject to final NYSE approval and the satisfaction of regulatory requirements.

While several psychedelics companies have already listed their stock on the Nasdaq, Cybin will be the first in the sector on the NYSE.

With a market cap of $473 million, Cybin has positioned itself as one of the best-equipped players in the psychedelics space. The companys multiple programs include Phase IItrials for a sublingual formulation of psilocybin in the treatment of major depressive disorder. Psilocybin isthe active ingredient in so-called magic mushrooms.

The company is also carrying out preclinical work on three other novel psychedelic molecules, which could offer increased therapeutic potential for indications such as alcohol use disorder and anxiety.

In a recent report, Stifel gave Cybin a 12-month price target of $12,with a speculative buy rating.

Cybin Stock was $2.98 at the time of this writing.

Photo by Cara Willenbrock on Unsplash

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Cybin Lands Conditional Approval To Become The First Psychedelics Company on The NYSE - Markets Insider

Microdose Psychedelic Insights (Microdose) are set to host their virtual Pyschedelic Capital: July 2021 conference on July 29, 2021. The event is set to play host to a number of companies, drawn from across the psychedelics industry, including, but not limited to, the functional mushrooms and phytopharmaceutical sectors.

Microdose Psychedelic Insights, a cutting-edge media company focused around promoting content, financial analysis, and engaging events focused around the psychedelics industry, have gained renown for their&

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Additional information about the Psychedelic Capital: July 2021 conference, as well as details for registration, can be found on the Psychedelic Capital conference website at https://microdose.buzz/shop/events/psychedelic-capital/psychedelic-capital-jul-2021/

About Microdose Psychedelic Insights:

Microdose Psychedelic Insightsis your guide to the psychedelic medicine industry. With a vision to shift the worlds perception of psychedelic medicine, we distribute and create the most compelling content, financial analysis, engaging events, and groundbreaking education to drive the psychedelics industry to the forefront of modern medicine.

About Psychedelic Capital:

This online event programming is dedicated to providing investment grade information for the nascent psychedelic sector and presents a curated group of CEOs, financial experts, thought leaders and investment luminaries from around the globe. Presentations are 30 minutes in length, with 10 minutes always allocated to a one-on-one Q&A session with the audience. Psychedelic Capital features the top companies, latest IPOs, newest opportunities and deepest insights into the emerging psychedelic space.

Contact:Microdose Psychedelic Insightskristina@microdose.buzz

Media Contact:InvestorBrandNetwork (IBN)Los Angeles, Californiawww.InvestorBrandNetwork.com310.299.1717 OfficeEditor@InvestorBrandNetwork.com

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Microdose Psychedelic Insight's Psychedelic Capital: July 2021 conference to take place on July 29, 2021 - StreetInsider.com