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

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

5. GOP Congressman Says Psychedelic Therapy With Ibogaine ‘Changed My Life’ As Lawmakers Push Military Research

A Republican congressman who is a military veteran says undergoing psychedelic-assisted treatment with ibogaine and 5-MeO-DMT “changed my life” and was “one of the greatest things that ever happened to me.”

At a press briefing outside of the U.S. Capitol on Wednesday, several GOP lawmakers and military veterans discussed a newly introduced bill to create a $75 million federal grant program to support research into the therapeutic potential of psychedelics for certain health conditions among active duty military service members.

4. Nearly 1 In 5 U.S. Adults Have Been Diagnosed With Depression

A new report published Thursday by the U.S. Centers for Disease Control and Prevention finds that in 2020, 18.4% of US adults reported having ever been diagnosed with depression in their lifetimes – but, state by state, that percentage of adults ranged from an estimated 12.7% in Hawaii to 27.5% in West Virginia.

The researchers analyzed data from the CDC’s Behavioral Risk Factor Surveillance System, taking a close look at how adults answered survey questions in 2020 about whether they have ever been told by a doctor, nurse, or other health professional that they had a depressive disorder. Nearly 400,000 adults in all 50 states and Washington, DC, responded to the depression question.

The survey data showed that the 10 states with the highest prevalence of adults saying they’ve been diagnosed with depression before were, in descending order: West Virginia, Kentucky, Tennessee, Arkansas, Vermont, Alabama, Louisiana, Washington, Missouri, and Montana. When the researchers analyzed the data by county, they found that the prevalence of depression ranged from 10.7% in Alaska’s Aleutians East Borough County to 31.9% in Logan County, West Virginia.

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Most Depressed U.S. States By Aggregate Prevalence, Behavioral Risk Factor Surveillance System, United States, 2020

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3. Psychedelic Stocks Finish Moderately Higher And Mostly Inline With Peer Indices

The psychedelic sector rose moderately this past week, as reflected by the Advisorshares Psychedelics ETF (PSIL) ↑2.47%. The performance was higher, but mainly inline with biopharma peers indices such as the Nasdaq Junior Biotechnology Index ↑0.32% and Nasdaq Biotechnology Ishares ETF↑1.90%. The NASDAQ 100 ↑5.11% and S&P 500 ↑3.58%were sharply higher as Fed Reserve near term rate hike expectations tumbled after lower-than-expected CPI data was released on Tuesday morning.

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

In the news…

Adult mice and psychedelics…

American Medical Association (AMA) adopted new policies on substance use during its annual meeting of the House of Delegates.

Australian psychiatrists prepare for magic mushrooms to be legal treatment.

Awakn Life Sciences announced the closing of the second tranche and upsizing of its previously announced non-brokered private placement financing.

Braxia Scientific reported treatment volumes across its clinics increased 26.2% to 3,516 from 2,785 treatments on a year-over-year basis in Fiscal 2023. The company continues to experience increased demand across all of it 5 clinics.

California Sen. Scott Wiener (D) said that while the reform legislation advanced through his chamber, “it’s not guaranteed to pass” in the Assembly.

Clearmind Medicine announced that as part of the Company’s ongoing collaboration with SciSparc Ltd., it has entered into a research agreement with the Hebrew University of Jerusalem, to evaluate Clearmind’s and SciSparc’s combination treatment for obesity and metabolic syndrome.

COMPASS Pathways will present at the Cantor Fitzgerald Brain Week virtual conference presentation on June 20 at 3:00pm ET and HC Wainwright 4th Annual Virtual Neuropsychiatry virtual conference presentation on demand available on June 26 at 7:00am ET.

Cybin Inc. announced that Doug Drysdale, Cybin’s Chief Executive Officer, will participate in a fireside chat at the H.C. Wainwright 4th Annual Neuropsychiatry Virtual Conference taking place on June 26, 2023.

DMT: New EEG study shows how the psychedelic affects the brain, particularly alpha, delta, theta waves, and general brain activity.

FCM MM Holdings, LLC condemns Mind Medicine Inc.’s announced apparent plan to manipulate its corporate machinery to follow through with its 2023 annual general meeting and election of directors without earning the substantive support of its shareholders.

Fort Collins, Texas researchers at the Wholeness Center are examining the potential therapeutic use of LSD and, in particular, how—and at what dosage—it may impact people with generalized anxiety disorder.

Gul Dolen research on psychedelics (social reward learning)…

Hallucinogen usage surged between 2018 and 2021 among adults younger than 30 years in the United States, new research shows.

International Journal of Mental Health and Addiction study explored changes in substance use patterns in Canadians after taking psychedelics. According to the study findings, the participants reported significant changes in their substance use habits. 

Johns Hopkins Medicine say new study in mice shows that psychedelic drugs are linked by their common ability to reopen such critical periods, but differ in the length of time the critical period is open—from two days to four weeks with a single dose.

Journal of Psychopharmacology study indicates that certain antidepressants, specifically SSRIs and SNRIs, may weaken the acute subjective effects of psilocybin in some individuals.

Meme Of The Week

Mind Medicine announced that the company’s Annual General Meeting of Shareholders on June 15, 2023 was convened at 10:00 a.m. EST and adjourned, without any business being conducted, due to lack of the required quorum.

National Institute on Drug Abuse (NIDA) is calling for research into the impact of evolving laws around psychedelics in cities and states across the country, including the effects of allowing regulated access to substances like psilocybin.

Nevada’s Governor Joe Lombardo (R), green-lighted legislation creating a psychedelics study group toward planned and regulated therapeutic access one week after it received final approval from the Assembly after having first passed the Senate.

Nue Life Health raised another $1.9 million from existing investors as the ketamine-assisted therapy startup releases a new app.

Numinus Wellness announced the appointment of Nikhil Handa as Chief Financial Officer, effective June 15, 2023, following a thorough executive search. Current Chief Financial Officer, John Fong, will be stepping down immediately to focus on family health matters.

Optimi Health has been selected to manufacture and supply MDMA for a practitioner experiential clinical trial, sponsored by Numinus Wellness Inc. This clinical trial will provide practitioners training to provide MDMA-assisted therapy with the opportunity to participate in experiential training – through a training partnership between Numinus and the Multidisciplinary Association for Psychedelic Studies.

PharmAla Biotech Holdings announced the receipt of an export permit for the shipment of its allotment of GMP LaNeo MDMA to the University of Sydney. The shipment will mark the completion of the Company’s US$125,000 contract with the University of Sydney, which was previously announced on August 31, 2022.

PharmAla Biotech Holdings announced a non-brokered private placement of a minimum 3,333,333 units and a maximum 16,666,666 units of the company at a price of $0.30 per Unit for aggregate gross proceeds of a minimum of $1,000,000 and a maximum of $5,000,000.

PharmaTher Holdings provided a corporate update outlining the development and commercialization plans and upcoming milestones for its KETARX™ (racemic ketamine) products and PharmaPatch™ (microneedle patch) delivery system.

Psychedelics reopen the social reward learning critical period, according to study published in Nature.

Psychedelic Science 2023: Next week, thousands of advocates, academics, entrepreneurs—as well as a slew of celebrities and politicians—will descend on Denver for the conference. The weeklong Multidisciplinary Association for Psychedelic Studies (MAPS) event is likely to be one of the largest gatherings of sacred plant medicine to date.

Sacred Mushroom Spores highlights the latest research investigating psilocybin’s ability to rewire the brain and its potential use in healing treatment-resistant depression.

Silo Pharma announced a research and development partnership to create a ketamine implant for the treatment of fibromyalgia and chronic pain

TRIPP PsyAssist completes Phase 1 feasibility study, demonstrating promising results for virtual reality as a pre-treatment experience prior to ketamine dosing.

2. Rhode Island House Passes Bill To Legalize Psilocybin And Prepare For Regulated Therapeutic Access

Rhode Island is one step closer to decriminalizing so-called “magic mushrooms” statewide. The House approved legislation Monday that would allow Rhode Islanders to possess up to one ounce of psilocybin or grow magic mushrooms at home for personal use.

It would also, contingent on approval from the Food and Drug Administration (FDA), allow psilocybin to be used as a treatment for chronic mental health disorders.

The legislation would require the Rhode Island Department of Health to regulate the use of psilocybin as a treatment should it be approved by the FDA. The provisions of the bill would sunset on July 1, 2025, unless extended by the R.I. General Assembly. The bill now heads to the Senate for consideration, where Sen. Meghan Kallman has introduced similar legislation.

1. Numinus Announces Partnership with MAPS to Support Therapist Psychedelic Experiential Training

Numinus Wellness (TSX: NUMI) (OTCQX: NUMIF) announced a partnership with the Multidisciplinary Association for Psychedelic Studies (MAPS), to support psychedelic experiential opportunities for practitioners as part of a clinical study. If the Clinical Trial Application (CTA) submitted to Health Canada is approved, the MDMA-assisted therapy experiential opportunity would be available only through Numinus. 

The CTA has been submitted by Numinus through its wholly-owned subsidiary Numinus Wellness Research Inc. If approved by Health Canada, the clinical trial would enable practitioners interested in MDMA-assisted therapy the ability to experience and observe MDMA sessions to further their understanding of psychedelic-assisted therapy.

The Numinus-sponsored clinical trial would use clinical MDMA produced by Optimi, a Canadian-based drug manufacturer and formulator licensed by Health Canada to produce and supply psychedelic substances for clinical trials.