The need is clear, since the WHO says that mental health disorders are the leading cause of disability around the world and nearly a billion people have some kind of mental illness.
There are many psychedelic pharmaceutical companies developing drugs that follow the legal regulatory pathway to approval. Several of these drugmakers are publicly traded, and they're receiving increased attention from investors. We've seen a similar phenomenon with marijuana stocks over the past several years. Cannabis was once on the fringe but is now a significant and growing industry.
This article will discuss four psychedelic therapy stocks that could see significant price increases in 2023.
lobe sciences ltd. (OTC: LOBEF)(CNSX:LOBE) is a life sciences company focused on practical psychedelic medicines. Lobe Sciences works with industry leaders to do research and development on proprietary patent drugs psychedelic compounds, and ways to deliver drugs that will Its overall goal is to allow Family Physicians to treat patients without the induction of hallucinations improving mental health and wellness.
Lobe Sciences' main goal is to create new patient focused medicines, PTSD, to treat neurological disorders including Pediatric Orphan Indications. At the moment, the company has filed for a total of 16 provisional patents and on the precipice of initiating its first in man Phase 1 studies.
At the tail end of the previous year, the North American company provided an update on the most recent developments concerning its clinical trials. Psilocin is the source of the novel compound L-130, which is currently undergoing research and development for potential future use. According to the most recent report, we discovered that LOBE had successfully submitted the required documentation in order to import L-130.
Lobe Sciences stated in their plan that the first phase 1 clinical trials would make use of Clearway Global's network of contract research organizations, and that they would begin their first subject trial in the month of December 2022. This indicates that preliminary data will be accessible in the first quarter of 2023. Astute investors will be watching for LOBEF to announce the trial results.
CSO of Lobe Sciences Maghsoud Dariani remarked, "It is important to remember that in just 12 months, Lobe has transformed into a fully integrated virtual drug development company. We now have multiple New Chemical Entities' (NCE's) including L-130 that is entering human trials. L-131 is entering pre-clinical trials as we prepare a pediatric Orphan Drug Application with the potential of receiving a Priority Review Voucher for L-131. All of this positions Lobe Sciences among the leaders in the small group of companies who are in clinical development of psychedelic drugs."
LOBEF has the potential to make a splash this year given that the psychedelic therapy industry is positioned for significant expansion in 2023. Smart investors should put this stock on their watchlist because there is a good potential for significant updates throughout the year as the company continues to make progress with clinical trials.
Atai Life Sciences (NASDAQ: ATAI) is a clinical-stage biopharmaceutical company aiming to transform the treatment of mental health disorders.
In the first week of the new year, the stock plummeted when the failed results of ATAI's NYC-based subsidiary, Perception Neuroscience's Phase 2a study of proprietary R-ketamine PCN-101 on patients with treatment-resistant depression (TRD), were released.
The company said that the compound showed efficacy signals at all time points, but the trial did not meet its primary endpoint of a statistically significant change from baseline in participants' MADRS (Montgomery-Sberg Depression Rating Scale) scores at 24 hours when compared to a placebo. MADRS is a widely used clinician-rated measure of depressive severity.
In response to the results that were shared, ATAI said that it would continue to look at the study data and work with Perception to figure out what to do next, which could include "seeking strategic partnership options."
While the company's stock plunged on the news, down 30% to $1.86 per share, do not count ATAI out, as this study of R-ketamine PCN-101 is one of many ongoing trials the company is working on.
2023 could be a make or break year for the company.
Mind Medicine Inc. (NASDAQ: MNMD) is a biotech company that discovers, develops, and commercializes psychedelically inspired medicines and therapies to treat addiction and mental illness. The company is putting together a strong drug development pipeline based on psychedelic drugs like psilocybin, LSD, MDMA, DMT, and 18-MC, which is a derivative of Ibogaine.
Mind Medicine CEO Rob Barrow is looking forward to 2023 and the plans for the company. Recently, he commented, "Following a year of continued strong execution, our progress in 2022 has set the stage for a meaningful 2023, a year in which we plan to further elucidate the potential of our MM-120 product candidate in generalized Anxiety Disorder (GAD) and initiate the first clinical trial for our MM-402 program."
MM-402's preclinical results are expected in the first half of 2023, and the company plans to start the first clinical trial this year to assess tolerability, PK, and PD, as well as early efficacy on core ASD symptoms.
With a plan set in place for the new year, investors should look for big news coming from MNMD throughout 2023, making it a top runner in the psychedelic stock sector.
Cybin Inc. (AMEX: CYBN) is a biopharmaceutical company focused on developing safe and effective therapeutics for patients suffering from a variety of mental health issues. The company develops proprietary drug discovery platforms, drug delivery systems, formulation methods, and mental health disorder treatment regimens to advance psychedelics as therapeutics.
CYBN is working on developing a proprietary psilocybin analog known as CYB003. This potential treatment for Major Depressive Disorder is currently being assessed in a phase 1/2a study.
Another proprietary psychedelic that CYBN is working on in 2023 is CYB004. This is an intravenous (IV) DMT deuterate, designed for the treatment of anxiety disorders that is being tested in a Phase 1 trial for safety and dosing optimization.
Traditional DMT cannot be taken orally because it is metabolized. As preclinical results show, CYBN and CYB004 are working to improve oral and pulmonary bioavailability, onset with lower doses, inter-subject variability, and dose titration for fewer side effects than oral and IV DMT.
With multiple trials underway, this stock is another to keep an eye on as 2023 continues.
Conclusion
It is difficult to deny the striking similarities between the expansion of the medical cannabis market and that of the psychedelics market. Both were once thought to be only for drug addicts and dropouts, but new research has shown that each can treat conditions that traditional drugs can't reach.
The overall sentiment toward these medicines is changing, as they clearly have a place in the medical landscape. Investors hoping to get in and benefit should pay close attention to news and advances that these biotech companies make as their clinical research continues.
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Figure one: Individual patient (001-005) and pooled results highlighting improvements in fibromyalgia domains as presented by University of Michigan 9 August 2024 (adapted)
Figure two: Individual patient and pooled results as presented by University of Michigan 9 August 2024 (adapted)