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TDR’s Top 5 Psychedelic Developments For The Week Of September 12

Welcome to TDR’s review of the Top 5 Psychedelic Developments for the week of September 12. Aside from presenting a synopsis of events, we provide market…

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Welcome to TDR’s review of the Top 5 Psychedelic Developments for the week of September 12. Aside from presenting a synopsis of events, we provide market commentary to summarize the week that was for publicly-listed companies.

5. Revive Therapeutics Provides Update On Psilocybin Clinical Study For Methamphetamine Use Disorder and Oral Psilocybin Thin Film Strip Program

Revive Therapeutics Ltd. (CNSX: RVV) (OTCMKTS: RVVTF) is currently evaluating the use of oral psilocybin as a potential treatment for methamphetamine use disorder with the University of Wisconsin-Madison. Under an investigator-initiated IND, the Phase I/II clinical study to evaluate the safety and feasibility of psilocybin in adults with methamphetamine use disorder received both FDA and Institutional Review Board approval. The study is being conducted at the University of Wisconsin-Madison, School of Medicine and Public Health and School of Pharmacy.

The clinical data that is generated from the study will provide proprietary and valuable information on the safety, efficacy and dosing of oral psilocybin to support future pivotal FDA clinical studies for the company’s proposed oral psilocybin thin film strip product. In addition, the company will have exclusive access to key intellectual property from this study to support development, regulatory and commercial initiatives.

4. Numinus Provides Update On Acquisition Integration And Announces New Client Financing Options

Numinus Wellness Inc. (TSE:NUMI) (OTCMKTS: NUMIF) U.S. clinics have continued to perform well during fiscal Q4 (the three months ended August 31, 2022), with strong client appointment growth in recent months.  During August, more than 6,200 client appointments were held across Canada and the US, representing 25% growth compared to July. In total, the Company’s eight US wellness clinics – six in Utah and two in Arizona – completed more than 4,900 client appointments in August, representing an increase of 22% from July.

We continue to be pleased with the performance of our recently acquired US clinics – and their continued success in building strong client relationships. Impressively, 15% of the client appointments held in August at our US clinics were from new clients.

Payton Nyquvest, Founder and CEO, Numinus

Numinus is currently focused on growing its Ketamine-assisted therapy (KAT) offering across Canada.  Ketamine Therapy sessions at Numinus’ US clinics (including KAT, Spravato and Ketamine medicine) grew 35% in August, compared to July, to 1,520 appointments. Demand for TMS services also continues to grow. During August, the Company completed 725 TMS appointments – a 23% increase relative to the prior month.

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Rising Tide Of Public Perception: The Number Of Psychedelic Publications Over Time

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3. Rough Week For Psychedelic Stocks As Sector ETF Losses Double Broad Index Losses

The psychedelic sector was decidedly soft this past week, with the Horizon Psychedelic Stock Index ETF (PSYK) falling ↓9.71% on lowish weekly volume. The ETF underperformed both the Nasdaq Junior Biotechnology Index (5.10%) and Nasdaq Biotechnology Ishares ETF (4.23%), which both fell inline with the broad indexes. Punctuated by a warning of slower economic growth by shipping bellweather FedEx Corp., the NASDAQ 100 5.02% and S&P 500 4.05% both ended Friday on a sour note.

Here’s how the Health Care (Biotechnology) sector performed:

Notable Gainers:

In the news…

Algernon Pharmaceuticals has received approval to conduct a Phase 1 clinical study of an intravenous formulation of AP-188 (N,N-dimethyl tryptamine or DMT) for the treatment of stroke in the Netherlands from the Stichting Beoordeling Ethiek Biomedisch Onderzoek, an independent Medical Research Ethics Committee.

ATMA Journey Centers has received approval from Health Canada to move forward with its N500 Phase II psilocybin clinical trial.

Awakn Life Sciences announced financial results and business highlights for the three months ended July 31, 2022. 

Awakn Life Sciences has signed a drug development agreement with Catalent, the global leader in enabling biopharma, cell, gene, and consumer health partners to optimize development, launch, and supply of better patient treatments across multiple modalities.

Blackhawk Growth Corp. announced that its wholly-owned subsidiary, MindBio Therapeutics, will be presenting its Phase 1 clinical trial data from its LSD (Lysergic Acid Diethylamide) Microdosing studies in Miami on November 4th 2022 at the Wonderland Convention, the world’s largest psychedelics event.

Braxia Scientific has successfully launched KetaMD in Florida.  KetaMD onboarded new patients and completed initial ketamine treatments.

Delix Therapeutics, a neuroscience company developing novel disease-modifying therapeutics for psychiatric and neurological conditions, has been named to Nature Biotechnology‘s list of leading spinouts of 2021. 

Hazel Park city council, the third Michigan city to approve a psychedelics decriminalization bill, is now reaffirming that decision by declaring September ‘Entheogenic Plant and Fungi Awareness Month’ to raise awareness on these substances. 

HealingMaps announced the close of $1 million USD in seed round funding from eight investors. The round was led by Phyto Partners along with Ambria Capital. As part of the investment, Cody Shandraw, Managing Partner of Ambria Capital and Phyto Partners will take on the role as Board Chairman for HealingMaps.

Joe Rogan explains how psychedelics made him ‘much kinder’ after Mike Tyson shared his experience.

Microdose Psychedelic Insights announced its partnership with Journey Clinical to better equip medical professionals with knowledge and access to evidence-based psychedelic-assisted psychotherapies through TheScience of Psychedelics program.

Mind Cure Health announced its financial results for the three and twelve months ended May 31, 2022. 

Mindset Pharma has received Scientific Advice from the UK Medicines and Healthcare products Regulatory Agency on a range of points to finalize its Phase 1 first-in-human clinical trial plan evaluating its lead psychedelic drug candidate MSP-1014 for the treatment of Major Depressive Disorders.

Mydecine Innovations Group announced that, in connection with its previously announced Common Share Subscription Agreement with a third-party investor dated August 26, 2022, the company has filed a shelf prospectus supplement to the company’s Final Short Form Base Shelf Prospectus.

PharmaTher Holdings announced that its Phase 1/2 clinical study of ketamine in the treatment of levodopa-induced dyskinesia in Parkinson’s disease was presented as a late-breaking abstract presentation at the MDS International Congress of Parkinson’s Disease and Movement Disorders.

Revitalist Lifestyle & Wellness and Wake Network, Inc. will now be jointly offering ketamine infusions in the United States and psilocybin clinical retreats internationally with a special focus on Veteran’s ethical need for access, establishing the world’s first international center of excellence.

Revive Therapeutics was added to the CSE25 Index after market close on Friday. The index contains the securities of the 25 largest index companies by market capitalization, and over 52.75% of the total weight of the Composite Index.

 Revive Therapeutics took another step towards a resolution of its current Phase 3 clinical trial to evaluate the safety and efficacy of Bucillamine to treat COVID-19. The company announced that pursuant to its intention to pursue new primary symptoms endpoints, it has officially filed an amended protocol to the U.S. Food & Drug Administration.

Seelos Therapeutics announced the participation of Acadia Healthcare Company, Inc. in the registration directed Proof of Concept study of SLS-002 (intranasal racemic ketamine) for Acute Suicidal Ideation and Behavior in patients with Major Depressive Disorder.

Silo Pharma announced that it will effect a 1-for-50 reverse split of its common stock in preparation for the planned listing of the company’s securities on The Nasdaq Capital Market. The reverse stock split will become effective at the open of business on Thursday, September 15, 2022, and the company’s common stock will begin trading on the OTC Markets system on a split-adjusted basis under the temporary ticker symbol “SILOD”.

Virtual Reality: A paper published in the journal Scientific Reports demonstrates how virtual reality group experiences can produce responses similar to those triggered by psychoactive drugs, such as hallucinogenic mushrooms or LSD.

Wall Street Journal: Investors bet ketamine treatment will revolutionize mental-health care. WSJ visits one clinic, Nushama, to learn why some entrepreneurs are betting that demand for ketamine will continue to rise.

2. Psychedelic Mushrooms Take Center Stage At Atlanta Council Hearing

An Atlanta councilwoman has introduced a measure that would advise police to make it a low priority to prosecute folks in possession of psychedelic mushrooms, which are illegal under federal law. Many of the arguments heard Monday during a public safety hearing were in favor of psychedelic mushrooms and mimic some of the arguments used successfully to legalize medical marijuana in Georgia.

The folks in the room said they were part of a national movement to normalize the use of psychedelic mushrooms and other plants now illegal under federal law. One therapist, Jeff Glattstein, cited the work of researchers “showing so many benefits of these natural traditional medicines for the treatment of mental health conditions, like depression, anxiety, PTSD trauma, (and) addiction, which we know is an epidemic.”

1. New Study Suggests Ketamine May Ease Severe Depression

The buzz around ketamine, a dissociative anesthetic drug, is booming. More and more research continues to suggest the drug has the potential to help people with severe mood disorders, including a new study that was just published in The Journal of Clinical Psychiatry.

For the study, researchers evaluated the drug’s effects in more than 400 people who received ketamine infusions in three unregulated private clinics in Virginia; people were paying for these treatments out of pocket and, on average, received six infusions over 21 days. During each visit, the participants filled out surveys about their physical and mental well-being.

The researchers found that 50% of people who were dealing with suicidal thoughts were in remission after six infusions, while 75% of them no longer experienced suicidal thoughts after 10 infusions. People also had a 30% reduction in anxiety symptoms within six weeks. 

The post TDR’s Top 5 Psychedelic Developments For The Week Of September 12 appeared first on The Dales Report.

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Biden’s Secret Promise To OPEC Backfires: Shellenberger

Biden’s Secret Promise To OPEC Backfires: Shellenberger

Submitted by Michael Shellenberger,

In early September, United States Secretary of…

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Biden's Secret Promise To OPEC Backfires: Shellenberger

Submitted by Michael Shellenberger,

In early September, United States Secretary of Energy, Jennifer Granholm, told Reuters that President Joe Biden was considering extending the release of oil from America’s emergency stockpiles, the Strategic Petroleum Reserve (SPR), through October, and thus beyond the date when the program had been set to end. But then, a few hours later, an official with the Department of Energy called Reuters and contradicted Granholm, saying that the White House was not, in fact, considering more SPR releases. Five days later, the White House said it was considering refilling the SPR, thereby proposing to do the exact opposite of what Granholm had proposed.

The hand of Russia's President Vladimir Putin (right) is now strengthened within the OPEC+ cartel controlled by Saudi Arabia's Crown Prince Mohammed bin Salman (left), which today decided to cut production by 2 million barrels.

The confusion around the Biden administration’s petroleum policy was cleared up yesterday after a senior official revealed that the White House had made a secret offer to buy up to 200 million barrels of OPEC+ oil to replenish the SPR in exchange for OPEC+ not cutting oil production. The official said the White House wanted to reassure OPEC+ that the US “won’t leave them hanging dry.” The fact that this offer was made through the White House, not the Department of Energy, may explain why a representative of the Department called Reuters to take back the remarks of Granholm, who has shown herself to be out-of-the-loop, and at a loss for words, relating to key administration decisions relating to oil and gas production.

The revelation poses political risks for Democrats who, in the spring of 2020, killed a proposal by President Donald Trump to replenish the SPR with oil from American producers, not OPEC+ ones, and at a price of $24 a barrel, not the $80 a barrel that the Biden White House promised to OPEC+. At the time, Trump was seeking to stabilize the American oil industry after the Covid-19 pandemic massively reduced oil demand. Trump and Congressional Republicans proposed spending $3 billion to fill the SPR. Senate Democratic Leader Chuck Schumer successfully defeated the proposal, and later bragged that his party had blocked a “bailout for big oil.”

Even normally strong boosters of the Biden White House viewed the Democrats’ opposition to refilling the SPR as a major blunder. “That decision,” noted Bloomberg, “effectively cost the US billions in potential profits and meant Biden had tens of millions of fewer barrels at his disposal with which to counter price surges.” Moreover, observed Bloomberg, it will take significantly more oil today to fill the SPR than it would have two years ago. In spring 2020, the SPR contained 634 million barrels out of a capacity of 727 million. Now, the reserve is below 442 million barrels, its lowest level in 38 years.

The decision looks even worse in light of the decision by OPEC+ today to cut production, which will increase oil prices. The Biden administration in recent days has been pulling out the stops trying to persuade Saudi Arabia and other OPEC+ members, a group that includes Russia, to maintain today’s levels of oil production. Last Friday, the Biden administration sought a 45-day delay in a civil court proceeding over whether Saudi Arabia’s Crown Prince Mohammed bin Salman should have sovereign immunity for the murder of Washington Post columnist Jamal Khashoggi, for which bin Salman has taken responsibility.

The behavior by the Biden White House displays a willingness to sacrifice America’s commitment to human rights for the president’s short-term political needs. Instead of pleading with OPEC+ to maintain or increase high levels of oil production, the Biden administration could have simply allowed for expanded domestic oil production. Instead, Biden has issued fewer leases for on-shore and off-shore oil production than any president since World War II. As such, the pleadings by Biden and administration officials have backfired. The perception of the U.S. in the minds of OPEC+ members has weakened while the influence of Russian President Vladimir Putin has strengthened.

Why is that? Why did the Biden administration decide to spend so much political capital trying, and failing, to get Saudi Arabia and other OPEC+ members to expand production when it could have simply expanded oil production domestically? What, exactly, is going on?

President Joe Biden greets the Saudi Crown Prince on July 15, 2022.

Substack subscribers can click here to read more...

Tyler Durden Thu, 10/06/2022 - 22:20

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Government

What Really Divides America

What Really Divides America

Authored by Joel Kotkin via UnHerd.com,

The Midterms aren’t a battle between good and evil…

Reading the…

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What Really Divides America

Authored by Joel Kotkin via UnHerd.com,

The Midterms aren't a battle between good and evil...

Reading the mainstream media, one would be forgiven for believing that the upcoming midterms are part of a Manichaean struggle for the soul of democracy, pitting righteous progressives against the authoritarian “ultra-MAGA” hordes. The truth is nothing of the sort. Even today, the vast majority of Americans are moderate and pragmatic, with fewer than 20% combined for those identifying as either “very conservative” or “very liberal”. The apocalyptic ideological struggle envisioned by the country’s elites has little to do with how most Americans actually live and think. For most people, it is not ideology but the powerful forces of class, race, and geography that determine their political allegiances — and how they will vote come November.

Of course, it is the business of both party elites — and their media allies — to make the country seem more divided than it is. To avoid talking about the lousy economy, Democrats have sought to make the election about abortion and the alleged “threat to democracy” posed by “extremist” Republicans. But recent polls suggest that voters are still more concerned with economic issues than abortion. The warnings about extremism, meanwhile, are tough to take seriously, given that Democrats spent some $53 million to boost far-Right candidates in Republican primaries.

Republicans are contributing to the problem in their own way, too. Rather than offering any substantive governing vision of their own, they assume that voters will be repelled by unpopular progressive policies such as defunding the police, encouraging nearly unlimited illegal immigration, and promoting sexual and gender “fluidity” to schoolchildren. They ignore, of course, the fact that their own embrace of fundamentalist morality on abortion is also widely rejected by the populace. And even Right-leaning voters may doubt the sanity of some of the GOP’s eccentric candidates this November.

In short, both major parties stoke polarisation, the primary beneficiaries of which are those parties’ own political machines. But most Americans broadly want the same things: safety, economic security, a post-pandemic return to normalcy, and an end to dependence on China. Their divisions are based not so much on ideology but on the real circumstances of their everyday life.

The most critical, yet least appreciated, of these circumstances is class. America has long been celebrated as the “land of opportunity”, yet for working and middle-class people in particular, opportunity is increasingly to come by. With inflation elevated and a recession seemingly on the horizon, pocketbook issues are likely to become even more important in the coming months. According to a NBC News poll, for instance, nearly two-thirds of Americans say their pay check is falling behind the cost of living, and the Republicans hold a 19-point advantage over the Democrats on the economy.

A downturn could also benefit the Left eventually. As the American Prospect points out, proletarianised members of the middle class are increasingly shopping at the dollar stores that formerly served working and welfare populations. Labour, a critical component of the Democratic coalition, could be on the verge of a generational surge, with unionisation spreading to fast food retailers, Amazon warehouses, and Starbucks.

To take advantage of a resurgent labour movement, however, Democrats will have to move away from what Democratic strategist James Carville scathingly calls  “faculty lounge politics”: namely, their obsession with gender, race, and especially climate. For instance, by demanding “net zero” emissions on a tight deadline, without developing the natural gas and nuclear production needed to meet the country’s energy needs, progressives run the risk of inadvertently undermining the American economy. Ill-advised green policies will be particularly devastating for the once heavily Democratic workers involved in material production sectors like energy, agriculture, manufacturing, warehousing, and logistics.

To win in the coming election and beyond, Democrats need to focus instead on basic economic concerns such as higher wages, affordable housing, and improved education. They also need to address the roughly half of all small businesses reporting that inflation could force them into bankruptcy. Some progressives believe that climate change will doom the Republicans, but this is wishful thinking. According to Gallup, barely 3% of voters name environmental issues as their top concern.

Racial divides are also important — though not in the way that media hysterics about “white supremacy” would lead you to believe. Florida Governor Ron DeSantis’s decision to fly undocumented immigrants to Martha’s Vineyard was undoubtedly a political stunt, and one arguably in poor taste. But it succeeded in its main goal: highlighting the enormous divide between the border states affected by illegal immigration and the bastions of white progressivism who tend to favour it.

Under Biden, the Democrats have essentially embraced “open borders” — illegal crossings are at record levels, and few of the migrants who make it across the border are ever required to leave. This policy reflects a deep-seated belief among elite Democrats that a more diverse, less white population works to their political favour. Whether they are right to think so, however, is far from clear. Black people still overwhelmingly back the Democrats, but Asians (the fastest-growing minority) and Latinos (the largest) are more evenly divided, and have been drifting toward the Republicans in recent years.

Here, too, class is a key factor. Many middle and upper-class minorities are on board with the Democrats’ anti-racist agenda. But many working-class Hispanics and Asians have more basic concerns. After all,  notes former Democratic Strategist Ruy Teixiera, these are the people most affected by inflation, rising crime, poor schools, and threats to their livelihoods posed by draconian green policies.

Culture too plays a role. Immigrants, according to one recent survey, are twice as conservative in their social views than the general public and much more so than second generation populations of their own ethnicity. Like most Americans, they largely reject the identity politics central to the current Democratic belief system. Immigrants and other minorities also tend to be both more religious than whites; new sex education standards have provoked opposition from the Latino, Asian, African American and Muslim communities.

The final dividing line is geography, always a critical factor in American politics. For decades, the country seemed to become dominated by the great metropolitan areas of the coasts, with their tech and finance-led economies. But even before the pandemic, the coastal centres were losing their demographic and economic momentum and seeing their political influence fade. In 1960, for example, New York boasted more electoral votes than Texas and Florida combined. Today, both have more electoral votes than the Empire State. Last year, New York, California, and Illinois lost more people to outmigration than any other states. The greatest gains were in Florida, Texas, Arizona, and North Carolina. These states are high-growth, fertile, and lean toward the GOP.Likewise, regional trends suggest that elections will be decided in lower density areas; suburbs alone are  home to at least 40% of all House seats. Some of these voters may be refugees from blue areas who still favour the Democrats. But lower-density areas, which also tend to have the highest fertility rates, tend to be dominated by family concerns like inflation, public education and safety, issues that for now favour Republicans.

Put the battle between Good and Evil to one side. It is these three factors — class, race, geography — that will shape the outcome of the midterms, whatever the media says. The endless kabuki theatre pitting Trump and his minions against Democrats may delight and enrage America’s elites — but for the American people, it is still material concerns that matter.

Tyler Durden Thu, 10/06/2022 - 21:40

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International

Switzerland, Not USA, Is The ‘Most Innovative’ Country In The World

Switzerland, Not USA, Is The ‘Most Innovative’ Country In The World

The World Intellectual Property Organization (WIPO) has released its 2022…

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Switzerland, Not USA, Is The 'Most Innovative' Country In The World

The World Intellectual Property Organization (WIPO) has released its 2022 Global Innovation Index. It evaluated innovation levels across 132 economies focusing on a long list of criteria such as human capital, institutions, technology and creative output as well as market and business sophistication, among others.

The 2022 index has found that innovation is still blossoming in some sectors despite the global economic slowdown and coronavirus pandemic, especially in industries to do with public health and the environment.

As Statista's Katharina Buchholz reports, Switzerland topped the rankings with a score of 64.6 out of 100, the 12th time it has been named the world leader in innovation. The United States come second while the Sweden rounds off the top three.

You will find more infographics at Statista

One of the biggest winners of the ranking was South Korea, which climbed up from rank 10 in 2020 to rank 6 in 2022.

China is now the world's 11th most innovative nation, up from rank 14 in 2020 and 2019 and rank 17 in 2018.

China was also named the most innovative upper middle-income country ahead of Bulgaria (overall rank 35), while India (overall rank 40) came first for lower middle-income countries, followed by Vietnam (overall rank 48).

Notably, China is now on a par with the United States in terms of the number of top 100 Science & Technology clusters

Finally, WIPO notes that on the one hand, science and innovation investments continued to surge in 2021, performing strongly even at the height of a once in a century pandemic. On the other hand, even as the pandemic recedes, storm clouds remain overhead, with increasing supply-chain, energy, trade and geopolitical stresses.

Tyler Durden Thu, 10/06/2022 - 20:40

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