Welcome to TDRs review of the Top 5 Psychedelic developments for the week of January 17. Aside from presenting a synopsis of events, we provide market commentary to summarize the week that was for publicly-listed companies.
5. Numinus Announces Key Milestones in MAPS-Sponsored MDMA-Assisted Therapy for PTSD Clinical Trial
Numinus Wellness (TSE:NUMI)(OTCMKTS:NUMIF) has completed key steps to prepare to enroll participants at its clinics participating in A multi-site open-label extension study of MDMA-assisted psychotherapy for PTSD (MAPPUSX), sponsored by the Multidisciplinary Association for Psychedelic Studies (MAPS).
This is an exciting next step in the MAPPUSX study, happening at our clinics in bothBritish ColumbiaandQuebec, and we look forward to how this work supports expanded collaboration with MAPS in the future.
The Canadian study sites, which will continue to study the safety of MDMA-assisted therapy in treating severe PTSD, under the leadership of MAPS Public Benefit Corporation (MAPS PBC) as study sponsor, have recently received regulatory authorization from Health Canada, ethical approval from an Institutional Review Board (IRB) and a Section 56 exemption from the Controlled Drug and Substance Act, which will allow the use of MDMA throughout the duration of the clinical trial.
4. Awakn Life Sciences Signs Memorandum of Understanding with MAPS
Awakn Life Sciences (NEO: AWKN) (OTCMKTS:AWKNF) has signed a Memorandum of Understanding (MOU) with the Multidisciplinary Association for Psychedelic Studies (MAPS) to explore a partnership to utilize MDMA-assisted therapy to treat Alcohol Use Disorder (AUD) in Europe.
Under the terms of this MOU, Awakn will explore a data licensing agreement with MAPS to support Awakns Phase IIb and planned Phase III studies for MDMA-assisted therapy for AUD in Europe. Awakn and MAPS will also assess a partnership to secure marketing authorisation/regulatory approval for the ethical commercialization of MDMA-assisted therapy for the treatment of AUD in Europe.
AUD is a chronic disease affecting 40 million people in Europe and 390 million people globally. It is also a pervasive and persistent public health issue, with alcohol use being one of the top five causes of disease and disability in the majority of countries in Europe. And for each person suffering from AUD, there is a friend, a partner, or a family also deeply affected by it.
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Mental Health Crisis Among Working Class Driving Labor Shortages and Recruitment Difficulties for Employers
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3. Biopharma Stocks Hammered As Market Goes Risk-Off Across Multiple Asset Classes
The psychedelic sector plunged this past week, following broad weakness in almost everything listed on the exchanges. TheHorizon Psychedelic Stock Index ETF(PSYK) fell9.46%, minting its 8th weekly loss over the past 10. The decline in PSYK was inline with the biotechnology sector in general, with theNasdaq Junior Biotechnology Index(10.48%) andNasdaq Biotechnology Ishares ETF(7.39%) both falling hard on pervasive risk off sentiment.
Another dreadful week for psychedelic companies from a capital markets perspective. Unlike much of 2021, the latest weakness appears to be a byproduct of plunging broad markets in general, for which there is little cover. As always, early-stage speculative industries generally bare a disproportional brunt of decline in such environments, and this week was no exception. And its hardly limited to the juniors in the space.
For example, COMPASS Pathways continued its deep dive lower, falling another 11.89% on the week and right through its IPO final go-public price of $17/share, which offered just a brief period of support. With its $15.77 close, CMPS has fallen 63.37% since releasing generally positive Phase 2b endpoints for Treatment Resistant Depression along with assisted-therapy using proprietary psilocybin formulation, COMP360. When a sector leader falls this hard in the absence of bad news, hard times will befall the rest of its peer group.
ATAI Life Sciences is another curiosity to the downside. Despite US$430.3 million in cash and cash equivalents (as of September 30, 2021) and an investment in COMPASS Pathways worth approximately $120 million in current dollars, ATAIs undiluted market cap is only $843 million. Thus, the market is ascribing little value to the companys drug developing pipeline or assets. ATAI has lost 47.50% in value since December 15 after announcing a key shareholder post-IPO lockup that could extend up to two years. The selling has been that indiscriminate.
Where the market goes next is anyones guess. However, when not even one industry bellweather is valued at a billion dollars (undiluted), despite rapidly advancing research and enough cash to fund full-cycle clinical trials, we may be getting overdone.
In the news
BetterLife Pharma has obtained positive results from an in vivo oral bioavailability and food-effect pharmacokinetic (PK) study on BETR-001 in beagle dogs. BETR-001 (2-bromo-LSD, formerly TD-0148A) is a non-hallucinogenic derivative of lysergic acid diethylamide (LSD).
Betterlife has also received a written response from the FDA to its pre-investigational new drug application for the treatment of MDD with BETR-001. BETR-001 is currently undergoing IND-enabling non-clinical studies and GMP manufacturing for clinical trials.
Bipartisan members of Congress sent a letter on Tuesday requesting that the Drug Enforcement Administration (DEA) allow terminally ill patients to use psilocybin as an investigational treatment without the fear of federal prosecution.
A new survey conducted by The Harris Poll on behalf of Delic Holdings reports that nearly 2/3 of Americans who suffer from anxiety/depression/PTSD (65%) believe that psychedelic medicine should be made available to patients with treatment-resistant anxiety, depression or PTSD.
Eleusis, a clinical-stage life science company that aims to unlock the therapeutic potential of psychedelics, and Silver Spike Acquisition Corp. II, a publicly traded special purpose acquisition company (SPAC) sponsored by an affiliate of Silver Spike Capital announced a definitive business combination agreement expected to make Eleusis a public company. The implied combined enterprise value is $446 million.
Jupiter Wellness announces that its merger partner, Next Frontier Pharmaceuticals, Inc., through its wholly owned subsidiary, Benuvia Manufacturing, Inc., has entered into the global psychedelic drug development and active pharmaceutical ingredient market.
Levitee Labs announced that it is proposing to complete a non-brokered private placement of up to 15,000,000 units at a price of $0.20 per Unit for aggregate gross proceeds of up to CAD$3,000,000. The Private Placement is subject to approval from the Canadian Securities Exchange.
Mind Medicine has enrolled the first subjects into its Session Monitoring System study evaluating the passive collection of sensory data during a consciousness-altering therapeutic session.
Mindset Pharma insiders are buying stock following itstransformative collaborationwithThe McQuade Center for Strategic Research and Development.
Mydecine Innovations Group has signed a Letter of Intent withThe Newly Institute Inc., a Calgary, Alberta based company opening private inter-disciplinary mental health clinics across Canada, to collaborate on expanding psychedelic-assisted psychotherapy to patients.
Novamind has closed its acquisition of Arizona-based Foundations for Change, Inc., a mental health practice specialized in ketamine-assisted psychotherapy.
Numinus Wellness announced its fiscal first quarter results for the three months endedNovember 30, 2021.
Red Light Holland announced a collaboration with Psychedelic Medicine Alliance Washington to promote a psilocybin legalization bill in Washington State.
Revitalist Lifestye And Wellness Ltd. recapped the milestones is has reached in calendar year 2021. The company has significantly scaled its operations during 2021, ending the year with seven clinics and providing approximately 5,000 patient treatments which represented a 128% increase year over year.
Virginia lawmakers,Del. Dawn Adams (D),andSen. Ghazala Hashmi (D)along withSen. Jennifer Boysko (D), introduced new bills to decriminalize the possession of psychedelics.
2. Kansas Lawmaker Files Bill To Legalize Psilocybin Possession And Cultivation
A Kansas lawmaker has filed a bill to legalize the low-level possession and cultivation of psilocybin mushrooms. Rep. Aaron Coleman (D), a 21-year-old legislator who has been embroiled in controversy over a series of encounters with law enforcement, is sponsoring the legislation. It would remove criminal penalties for possessing up to 50 grams of psilocybin or psilocyn or cultivating the psychedelic compounds.
Kansas Lawmaker Files Bill To Legalize Psilocybin Possession And Cultivation: The legislation would remove criminal penalties for possessing up to 50 grams of psilocybin or psilocyn. https://t.co/NbiVePGOhf
Under the proposal, possession of more than 50 grams but less than 100 grams would be a civil offense punishable by a maximum $250 fine. Possessing more than 100 grams of the psychedelic would be considered a Class C misdemeanor, carrying a fine of up to $500 and a one month in jail.
Thelegislation, titled the Legalized Homegrown Psilocybin Mushroom Act of 2022, would amend state statute to make it so it shall not be a violation of state law to cultivate psilocyn or psilocybin.
1. Bill Could Open the Door to Legalize Medical-Use Psychedelics in Utah
Rep. Brammer, R-Pleasant Grove, has filedHouse Bill 167, which creates a task force to explore whether psychedelics ought to be considered as a viable treatment option for mental health, PTSD and other issues. The bill is already being backed by one of the groups that got medical cannabis legalized in Utah.
It doesnt legalize anything. It asks our Huntsman Mental Health Institute and other experts in the field to review the science thats out there, the research thats out there, and make any recommendations that they have if they feel psychedelics can be safely administered through a prescription basis and under what circumstances, he said.
See more here:
TDRs Top 5 Psychedelic Developments For The Week Of January 17 - The Dales Report
- Review: Tripping on Utopia Complicates the History of Psychedelics - AOL - March 16th, 2024 [March 16th, 2024]
- Psychedelics Are Going Mainstream. Investing in Them Hasn't. - The Wall Street Journal - January 7th, 2024 [January 7th, 2024]
- Another Study Shows African Psychedelic Plant Ibogaine Treats Traumatic Brain Injury in Vets With 'Dramatic' Results - Good News Network - January 7th, 2024 [January 7th, 2024]
- Massachusetts Lawmakers Will Be Forced To Consider Psychedelics Legalization Measure That Activists Petitioned ... - Marijuana Moment - January 5th, 2024 [January 5th, 2024]
- VA to begin researching psychedelics as treatment option for veterans - Government Executive - January 5th, 2024 [January 5th, 2024]
- VA Is Funding New Research On Psychedelics' Benefits For Veterans With PTSD And Depression - Marijuana Moment - January 5th, 2024 [January 5th, 2024]
- VA ramps up study of psychedelic to treat PTSD - The American Legion - January 5th, 2024 [January 5th, 2024]
- Scientists predict DMT trip from cardiac activity - Big Think - January 5th, 2024 [January 5th, 2024]
- If psychedelics heal, how do they do it? | Proceedings of the National Academy of Sciences - pnas.org - January 5th, 2024 [January 5th, 2024]
- Psychedelics for acquired brain injury: a review of molecular mechanisms and therapeutic potential | Molecular ... - Nature.com - January 5th, 2024 [January 5th, 2024]
- U.S. Rep. Correa supports using psychedelics to treat veterans with PTSD - New Santa Ana - January 5th, 2024 [January 5th, 2024]
- DEA Confirms That Psychedelic Mushroom Spores Are Federally Legal Prior To Germination - Marijuana Moment - January 5th, 2024 [January 5th, 2024]
- Psychedelics for Psych Conditions Made Their Mark in 2023 - Medpage Today - January 5th, 2024 [January 5th, 2024]
- 2023: A Good Trip Around the Sun for Psychedelics - The National Law Review - January 5th, 2024 [January 5th, 2024]
- Understanding the Role of the FDA in Advancing Psychedelic Therapy - Medriva - January 5th, 2024 [January 5th, 2024]
- MAPS PBC Closes $100m Series A, Rebrands to Lykos Therapeutics - Psychedelic Alpha - January 5th, 2024 [January 5th, 2024]
- Closing the innovation gap: Advancing psychedelic therapy and medicines in EU mental health care - Open Access Government - January 5th, 2024 [January 5th, 2024]
- The Austin Chronic: SXSW Is High on Psychedelics, as Cannabis Programming Wanes - Austin Chronicle - January 5th, 2024 [January 5th, 2024]
- This Forgotten Psychedelic Could Revolutionize Traumatic Brain Injury Treatment - Inverse - January 5th, 2024 [January 5th, 2024]
- A 'milestone' for psychedelics: Pentagon directed to study alternative treatments for veterans - Washington Times - January 5th, 2024 [January 5th, 2024]
- Psychedelic Drugs Are Rushing Towards Approval for Therapy. Here's What's Next - Singularity Hub - January 5th, 2024 [January 5th, 2024]
- The top 8 psychedelic books you need to read | GreenState - GreenState - January 5th, 2024 [January 5th, 2024]
- Lykos Therapeutics Secures $100M in Series A Funding, Rebrands from MAPS PBC - Green Market Report - January 5th, 2024 [January 5th, 2024]
- DEA Calls For Even More THC, Psilocybin And DMT To Be Produced For Research In 2024 - Marijuana Moment - January 5th, 2024 [January 5th, 2024]
- Here's What You Missed in Cannabis, Psychedelics This Week - TipRanks.com - TipRanks - January 5th, 2024 [January 5th, 2024]
- You're not tripping: State and local leaders give psychedelics another chance - Route Fifty - December 22nd, 2023 [December 22nd, 2023]
- Are Consciousness-Expanding Psychedelics Like Psilocybin More Effective Than Prozac, Zoloft, Xanax, and Other ... - Nautilus - December 22nd, 2023 [December 22nd, 2023]
- RFK, Ramaswamy And Williamson Push Psychedelics Reform On Presidential Campaign Trail - Marijuana Moment - December 22nd, 2023 [December 22nd, 2023]
- Peyote is the darling of the psychedelics renaissance. Indigenous users say it co-opts a sacred way of life - The Guardian US - December 22nd, 2023 [December 22nd, 2023]
- USask researchers explore untold history of psychedelics - News - University of Saskatchewan - USask News - December 22nd, 2023 [December 22nd, 2023]
- California Governor Says Psychedelics Have 'Profound' Healing Potential, But He's Undecided On Legalization Bill As ... - Marijuana Moment - September 25th, 2023 [September 25th, 2023]
- As psychedelic-assisted therapy grows, so does interest from a new group: chaplains - NPR - September 25th, 2023 [September 25th, 2023]
- This Maine City Moves Unanimously On Decriminalizing Psychedelics: Focus On Public Health - Benzinga - September 25th, 2023 [September 25th, 2023]
- Tech Leaders Are Finding Balance Through Microdosing Psychedelics - The Dales Report - September 25th, 2023 [September 25th, 2023]
- Chronic Pain Can Be Treated by Psychedelics, Survey Suggests - Psychedelic Spotlight - September 25th, 2023 [September 25th, 2023]
- Insights Into the First Psychedelic-Assisted Therapy Guidelines With ... - Psychedelic Spotlight - September 25th, 2023 [September 25th, 2023]
- Living with long-term cancer is depressing. Texas doctors say psychedelics could help - The Hill - July 19th, 2023 [July 19th, 2023]
- Couples Are Doing MDMA and Ketamine Therapy To Save Their Relationships - VICE - July 19th, 2023 [July 19th, 2023]
- The Way People Are Using Psychedelics Is Changing Amid Reform ... - Marijuana Moment - July 19th, 2023 [July 19th, 2023]
- [WATCH] Turn on, tune in, legalise: Could psychedelics be next in ... - MaltaToday - July 19th, 2023 [July 19th, 2023]
- Will Psychedelics Be Rescheduled After FDA Approval? - Harris Bricken - July 19th, 2023 [July 19th, 2023]
- The Psychedelic Preparedness Scale: A Tool to Optimize Trip ... - Filter - July 19th, 2023 [July 19th, 2023]
- How to Test Psychedelics for Adulterants with Testing Kits - Psychedelic Spotlight - July 19th, 2023 [July 19th, 2023]
- Cannabis Science Conference to debut in Providence, R.I., with ... - GlobeNewswire - July 19th, 2023 [July 19th, 2023]
- New Speaker Rivas weighs in on psychedelics, housing and health care worker minimum wage - Yahoo News - July 19th, 2023 [July 19th, 2023]
- TDR's Top 5 Psychedelic Developments For The Week Of July 10 - The Dales Report - July 19th, 2023 [July 19th, 2023]
- Psychedelic Treatment with Psilocybin Relieves Major Depression, Study ... - February 20th, 2023 [February 20th, 2023]
- Johns Hopkins Launches Center For Psychedelic Research - February 20th, 2023 [February 20th, 2023]
- Psilocybin Treatment for Major Depression Effective for Up to a Year ... - February 20th, 2023 [February 20th, 2023]
- Inside the Johns Hopkins Psilocybin Playlist - Hopkins Medicine - February 20th, 2023 [February 20th, 2023]
- Research Story Tip: Psychedelic Drug Psilocybin Tamps Down Brains Ego ... - February 20th, 2023 [February 20th, 2023]
- Psychedelics: Risks, benefits, and more - Medical News Today - February 18th, 2023 [February 18th, 2023]
- Psychedelic Drug Effects, Side Effects & Dangers - January 25th, 2023 [January 25th, 2023]
- Psychedelics Decriminalization Project In Berkeley, Cal Includes ... - January 6th, 2023 [January 6th, 2023]
- Ancient mummified child was drugged with psychedelics before ritual ... - December 14th, 2022 [December 14th, 2022]
- The therapeutic potential of psychedelics - Science - December 14th, 2022 [December 14th, 2022]
- Changing Lives with Psychedelics: How Connecticut researchers are using magic mushrooms to help people overcome depression, OCD - WTNH.com - November 19th, 2022 [November 19th, 2022]
- Penis Envy Mushroom | Legal Psychedelics | Magic Mushroom - November 7th, 2022 [November 7th, 2022]
- Psychedelics. Discussing natural and synthetic friends. Science, News ... - November 5th, 2022 [November 5th, 2022]
- The Harms of Psychedelics Need to Be Put Into Context - WIRED - November 5th, 2022 [November 5th, 2022]
- Packers' Aaron Rodgers says psychedelics led to his back-to-back MVP ... - October 28th, 2022 [October 28th, 2022]
- With Promise of Legalization, Psychedelic Companies Joust Over Future Profits - The New York Times - October 25th, 2022 [October 25th, 2022]
- How do psychedelics work? This brain region may explain their effects - PBS - October 21st, 2022 [October 21st, 2022]
- Why is the American right suddenly so interested in psychedelic drugs? - The Guardian - October 19th, 2022 [October 19th, 2022]
- Can Psychedelics Cure? Science Is on the Verge of Finding Out - Newsweek - October 19th, 2022 [October 19th, 2022]
- Large national survey suggests that the use of psychedelics is not associated with lifetime cancer development - PsyPost - October 19th, 2022 [October 19th, 2022]
- This Pharma Company Just Scored Another Psychedelics Patent And Set Its Sights On 70 More - Small Pharma - Benzinga - October 19th, 2022 [October 19th, 2022]
- What Made the Mushrooms Magic: Psychedelic Study Explores the Odd Evolution of Mind-Altering Fungi - The Debrief - October 19th, 2022 [October 19th, 2022]
- Psychedelics And Wellness: The Healing Company Buys PepsiCo-Backed Superfoods Company - (HLCO) - Benzinga - October 19th, 2022 [October 19th, 2022]
- What's on the Colorado ballot? Housing, psychedelics, school meals, alcohol, taxes and more | FOX31 Denver - FOX 31 Denver - October 19th, 2022 [October 19th, 2022]
- DoseConnect to Sponsor the Tech Stage at Wonderland Miami by Microdose - Benzinga - October 19th, 2022 [October 19th, 2022]
- What Is Going on With Bright Minds (DRUG) Stock Today? - InvestorPlace - October 19th, 2022 [October 19th, 2022]
- Psychedelics May Ease Fear of Death and Dying - October 17th, 2022 [October 17th, 2022]
- TDR's Top 5 Psychedelic Developments For The Week Of October 10 - The Dales Report - October 17th, 2022 [October 17th, 2022]
- DEA Wants To Boost Production Of Cannabis & Psychedelics For Research In 2023 - Benzinga - October 17th, 2022 [October 17th, 2022]
- Talk set to explore psychedelics and mental health - Reading Today - October 17th, 2022 [October 17th, 2022]
- Silo Wellness Closes Acquisition of Dyscovry Science and Its Psilocybin Pharmaceutical Biosynthesis and Research Portfolio - Yahoo Finance - October 17th, 2022 [October 17th, 2022]
- How does psilocybin rewire the brain? - Open Access Government - October 17th, 2022 [October 17th, 2022]
- HYTN Awarded Controlled Drugs and Substances Dealers License Allowing for Production and Sale of Psilocybin - Yahoo Finance - October 17th, 2022 [October 17th, 2022]
- The Healing Company acquires leading superfoods business, Your Super, and lands $150M credit facility to expand community of brands - Yahoo Finance - October 17th, 2022 [October 17th, 2022]