Several psychedelic stocks released tangible news updates this week regarding execution on their respective fundamental strategies. With a dismal September for the sector in the rear view, and October’s arrival already sending money flow back into equities, will psychedelic stock performance finally start reflecting the hype?
Cybin (NYSE: CYBN)
Cybin Obtains Exclusive License to a Novel Catalog of Psychedelic-Based Compounds: Cybin paid Mindset a one-time license fee of US $500,000 with additional milestones payable upon the successful completion of certain future milestones to acquire an extensive targeted class of tryptamine-based molecules. The Acquisition provides CYBN access to a catalog of molecules that complement Cybin’s current preclinical library, with both complementary chemistry and properties; expands CYBN’s discovery and development platform to provide an enduring runway and pipeline of future drug candidates while broadening the space where CYBN has protected access to patent-eligible molecules and formulations; and strengthens CYBN’s intellectual property reach and scope of protection in support of continued investment in psychedelic therapeutics for mental health conditions. CYBN stock is down about 49% year to date (YTD).
Numinus Wellness (OTC: NUMIF, TSE: NUMI)
Numinus Develops Mushroom Tea for Use in Psychedelic Research: Numinus Bioscience, developed a psilocybin-containing tea bag for use in clinical research and, if appropriate regulatory approvals are granted, eventual treatment of clients in psychedelic-assisted therapy. Research behind the tea bag involved the development of processes and procedures to deliver 25mg per dose and the use of Numinus’ validated strains of Psilocybe cubensis. Tea bags will be studied in a phase 1 trial of practitioners receiving experiential training for psilocybin-assisted therapy to be used in Numinus’ research, including trial partnerships at Cedar Clinical Research, Numinus’ clinical trial management division. The product has also been submitted to Health Canada to be included on the psilocybin supplier list for the federal Special Access Program, through which health care providers can apply to provide psilocybin-assisted therapy, among other psychedelic-assisted therapies, to patients with demonstrable need. NUMIF stock is down about 52% YTD.
MindMed (Nasdaq: MNMD, NEO: MMED)
MindMed Collaborators Initiate Phase 1 Comparative PK/PD Trial of R-, S- and Racemic MDMA: The Phase 1 trial is a randomized, placebo-controlled, double-blind, 5-period crossover study. The trial plans to enroll 24 healthy subjects, who will receive R-MDMA (125 and 250mg), S-MDMA (125mg), MDMA (125mg), and a placebo. Primary outcome measures for this trial will assess acute subjective effects using the Visual Analog Scales (VAS) and the 5 Dimensions of Altered States of Consciousness (5D-ASC). Secondary endpoints will assess autonomic effects (blood pressure, heart rate, body temperature), mood on the days following the administration, endocrine effects, plasma concentration, and additional subjective effects (VAS, AMRS, SCQ, PIQ). MNMD stock is down about 85% YTD.
ATAI Life Sciences (Nasdaq: ATAI)
atai Life Sciences Announces First Subject Dosed in Phase 1 Trial of Buccal and IV VLS-01, a Synthetic Form of DMT: The trial is a randomized, double-blind, placebo-controlled study designed to evaluate the relative bioavailability of buccal versus IV formulations, the safety, and tolerability of VLS-01 administered by both routes, as well as pharmacodynamics of DMT using qEEG and other measures. Buccal VLS-01 is formulated to provide a psychedelic experience lasting 30 to 45 minutes, thus potentially allowing for shorter clinic visits compared to many other psychedelic compounds that may require a patient to be monitored for four or more hours. Behavioral assessments, in conjunction with the pharmacokinetic and safety readouts, are expected to inform the design of and doses tested in future Phase 2 clinical trials of VLS-01. ATAI stock is down about 57% YTD.
Mindset Pharma (OTC: MSSTF, CNSX: MSET)
Mindset Pharma Selects Lead Clinical Candidates From “Family 2” of its Next Generation Psychedelic Drug Portfolio: MSP-2020 and MSP-2003 are both novel and patentable compounds. They are covered under Mindset’s United States Patent and Trademark Office (USPTO) patent number 17/387,864, titled “3-Pyrrolidine-Indole Derivatives as Serotonergic Psychedelic Agents for the Treatment of CNS Disorders.” Mindset received a notice of allowance from the USPTO for this application. In side-by-side comparisons to psilocybin and psilocin, the two drug candidates elicit in vitro and behavioral responses consistent with a stronger and shorter acting psychedelic effect than psilocybin and a significantly reduced half-life. These drug candidates are being developed as optimized next-generation psychedelic drug candidates for the treatment of mental health disorders. MSSTF stock is down about 45% YTD.
Braxia Scientific (OTC: BRAXF, CSE: BRAX)
KetaMD Expands Access to Breakthrough Ketamine Therapy in Florida to Battle the Growing Mental Health Crisis and Shortage of Mental Health Care Providers: KetaMD is a wholly owned subsidiary of BRAX providing access to at-home ketamine treatments for people suffering from depression and related mental health conditions through its virtual platform and mobile app, recently launched and made available to residents in Florida. KetaMD offers safe, affordable, accessible, and reliable mental health treatment options. The KetaMD team is also available to support those with depression and mental health challenges that have been impacted by Hurricane Ian. Ketamine is rapidly gaining awareness as a proven treatment for various mental health conditions such as treatment-resistant depression. KetaMD is committed to battling the growing mental health crisis and alleviating the growing shortage of mental health care providers in Florida and across America, both issues further exacerbated by the COVID-19 pandemic. BRAXF stock is down about 47% YTD.
TRYP Therapeutics (OTC: TRYPF, CSE: TRYP)
Tryp Therapeutics Announces Publication of International PCT Patent Application for the Intravenous Administration of Psilocin and Psilocybin: The patent application includes a unique and proprietary formulation and delivery system to enhance the positive effects of psilocybin and in particular psilocin, while markedly reducing the limitations of psilocybin dosed through other routes of administration, including oral, nasal and sublingual. Oral administration, while convenient, has several limitations and challenges that TRP-8803 can address. TRYPF stock is down about 52% YTD.
Irwin Naturals (OTC: IWINF, CNSX: IWIN)
Irwin Naturals Agrees to Add Idaho Clinic to Its National Chain of Psychedelic Mental-Health Clinics: IWIN acquired Ketamine Infusions of Idaho, which operates a clinic in Idaho Falls. The clinic will join Irwin Naturals Emergence, a fast-growing national chain of psychedelic mental-health clinics, which already has deals to add a total of 11 clinics across six different states. This clinic will be the chain’s first in Idaho. IWINF stock is down 43% YTD.
Revive Therapeutics (OTC: RVVTF, CNSX:RVV)
Revive Therapeutics Provides Update on Phase 3 Clinical Trial for Bucillamine in COVID-19: Bucillamine is an oral drug with anti-inflammatory and antiviral properties, in patients with mild to moderate COVID-19. RVVTF has been in communication with the FDA to submit a revised protocol with a new primary efficacy endpoint, specifically, assessing the difference in the proportion of participants with at least two clinical improvements in symptoms of COVID-19 at Day 14 compared with baseline between Bucillamine versus placebo. Should the FDA agree with the revised protocol, the Data Safety Monitoring Board (“DSMB”) will review the completed Post-Dose selection data of approximately 500 subjects in the context of the new primary endpoint. RVVTF is not making any express or implied claims that its product has the ability to eliminate or cure COVID-19 (SARS-2 Coronavirus) at this time. RVVTF stock is down 45% YTD.
Craig D. Schlesinger is the CFO of PSYC Corp & Spotlight Media and a market analyst with over twenty years experience predicting price movements and trend reversals in various sectors. Follow his #MathOverMyth technical analysis and him on Twitter: @PSYCCraig
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Craig holds no positions in ATAI, BRAX, CYBN, IWINF, MNMD, MSSTF, NUMI, RVVTF, TRYP
*For purposes of this article, all percentages are approximated and rounded to the nearest percentage point from market data provided by Google Finance near market open on October 6, 2022
