Loving the light fantastic – psychedelics sector in review

The psychedelics space is one of the hottest investment trips in the public markets today. Embryonic, wide open to possibility and with mounting scientific evidence of psychedelics’ healing properties, that potential will only increase. Now is the time to get acquainted with the players and position yourself on the profitable side of history. Here is my growing compendium of psychedelic investment opportunities:

Mind Cure Health (MCUR.C) seeks to provide a holistic answer to psychedelic mental health therapies through a digital platform and a drug pipeline which includes the development of pharmaceutical quality synthetic ibogaine compounds and an MDMA treatment solution for the unmet need of female Hypoactive Sexual Desire Disorder (HSDD). This company differentiates itself from the run-of-the-mill psychedelic venture which promises huge returns based on vague business models hinged on the legalization of psychedelics. Mind Cure CEO, Kelsey Ramsden, is cut from a different cloth and since the inception of Mind Cure has fostered a focused no-nonsense vision with a clear pathway. Her unique approach went against the established grain with the development of technology before drugs, giving the company near-term potential of multiple revenue streams as well as cementing Mind Cure as a thought leader and clinical partner in the emerging world of psychedelic-based mental health therapies. This isn’t a bloated SPAC-powered unicorn with more promise than performance, Mind Cure currently trades at $0.31 per share for a market cap of $28.49 million CAD. With $18.3 million in the till, Mind Cure sports a rare cash per market valuation ratio for its sector. This is one to keep your eye on. I was so impressed, in fact, I will be publishing an in-depth piece on Mind Cure next week, highlighting the company, its inner-workings and blue-sky prospects. Remember your due diligence!

Filament Health (FH.NEO) sets itself apart with the development of a deep natural psychedelics IP portfolio for the extraction and purification of psychedelic compounds. The company, which possesses in-house GMP manufacturing capabilities, also holds a Health Canada dealer’s license for all natural psychedelics through its wholly owned subsidiary, Psilo Scientific. Management believes natural extraction will yield benefits such as entourage effects where unknown compounds within the plants may add to the therapeutic impact of the extracted material. Since the company began trading on Canada’s newest exchange, NEO, back in June, it obtained an industry-first approval for FDA clinical trials featuring a GMP-grade natural mushroom compound, in partnership with the Translational Psychedelic Research (TrPR) program at University of California, San Francisco. So far, Filament has completed three batches of proprietary mushroom extracts, including leading drug candidates PEX010, PEX020, and PEX030 for upcoming FDA trials. As of June 30, 2021, Filament had $7.8 million cash after closing on a $5.0 million private placement. Filament operates out of a 3,500 square foot lab located in Burnaby, British Columbia. For the six months leading up to June 31, 2021, the company reported a comprehensive loss of $6.5 million. Drug development is a costly pursuit and Filament will have to go back to the market to power its FDA trials and the marketing of successful drug candidates depends on the regulatory restrictions to the use of medicinal psychedelics as well as the cultural shift required to adopt them into mainstream use. That said, if Filament can have products at the ready and executes delivery upon medical legalization, it could take a slice of the growing therapeutic psychedelics market expected to reach $6.33 billion globally by 2026. Currently Filament trades at $0.28 per share on the NEO exchange for a market cap of $46.2 million.

Cybin (CYBN.NEO) is another Canadian-based psychedelics player. Headquartered out of Toronto, Ontario, the company operates on a three-pillar strategy: a novel drug discovery platform, proprietary drug delivery and an innovative treatment regimen. With multiple patent filings over a wide range of novel psychedelic compounds, including targeted structural modifications to improve pharmcokenetic characteristics and safety profiles without altering receptor binding, the company hopes to utilize its proprietary drug delivery platforms to deliver consistent dosages with faster onset of action and higher bio availability, offering more control and better patient outcomes. The company is currently amid Phase IIA and Phase IIB clinical trials with CYB001, a sublingual psilocybin meant for treating patients with major depressive disorder. Cybin has three other drug candidates CYB003, CYB004 and CYB005 which have finished up preclinical studies. CYB003 and CYB004 are deuterated tryptamine intended to treat Alcohol Use Disorder and Anxiety Disorders respectively. CYB005 is being prepped for use in psychiatry/neurology indications. Like Mind Cure, Cybin is developing machine-learning technology to gather and analyze research data from clinical treatment to optimize patient outcomes. The company announced on Tuesday that it had completed 74 pre-clinical psychedelic molecule studies to propel its proprietary compounds into Investigational New Drug (“IND”)-enabling studies. This milestone will support advancing CYB003 and CYB004 as well as other molecules towards human trials which are expected to commence in early 2022. Cybin announced it would go over details of these findings during a Research and Development event in Q4 2021 which will be open to the public, media, analysts, and shareholders. The company has raised $120 million to date with a management team that not only have successfully previously brought multiple drugs to market but have previously raised over $4.0 billion within the healthcare sector. Cybin reported a net loss of $32.22 million for the year ending March 31, 2021, but also recorded a cash balance of $64 million at the end of the period. This is the building stage for Cybin and money will flow out the door in support of its drug development until the company can complete clinical trials and registration for CYB001 which may not be until late 2022. However, if it can keep on track, raise the necessary cash, Cybin could solidify itself in the psychedelics market. Currently the company trades at $2.44 per share for a market cap of $391 million, not cheap, but not unicorn insane either. Do your due diligence!

Atai Life Sciences (ATAI.Q) is a bio-pharmaceutical company based out of Germany that utilizes a platform to innovate and accelerate the development of more effective mental health treatments by pooling resources and best practices across its business entities. With funding, domain experience, platform technologies, entrepreneurial incentives, and shared services, Atai’s programs and a strategic investment in Compass Pathways include 11 drug candidates covering the psychedelic gambit which range from completion of preclinical trials to completion of phase 1 trials. Atai Impact initative is a three-prong approach which consists of education, access, and development of a sector ecosystem. The effort was funded with 1% of the company’s June 2021 IPO on the Nasdaq as well as founder contributions. Atai also launched a Volunteer Paid Time Off Policy equaling 1% of employee’s time and is working with the Equity for Impact Initiative to encourage employees and investors to donate a portion of their equity to charitable endeavours. This is heartening to hear in a world of heartless, money-grubbing SPACs, but only time will tell if its more than just lip service. Back in September, insiders picked up 896K in common stock options which can be exercised at $16.46 USD per until September 10, 2031. Considering that the stock was trading at $16.46 the time the options were dispersed, not a lot of risk for insiders and one might think, if one is paranoid, that company directors were lining their pockets. However, share price has dipped since and Atai needs to pick up at least another dollar per share in value before the options are in the money once more. Shares currently go for $15.17 per for a market cap of $2.31 billion.

Compass Pathways (CMPS.Q) operates out of the United Kingdom and is focused on developing psilocybin therapy through late-stage clinical trials in Europe and North America as a therapeutic solution for treatment-resistant depression. Compass is utilizing a multi-faceted approach through therapist training, clinical trials, drug discovery alliances as well as partnership and grants. The company’s COMP360 psilocybin therapy for treatment-resistant depression is nearing completion of its Phase IIB trials as part of its Investigational New Drug application. Back in August 2020, Compass established a Discovery Center under a sponsored research agreement with University of Sciences in Philadelphia for the development and optimization of compounds targeted at the 5-HT2A receptor. The agreement outlines joint ownership and exclusive licensing for all new compounds generated with the project. Compass announced on Tuesday that it had been granted a U.S. patent for crystalline psilocybin. This patent covers the company’s Form A hydrate psilocybin which is distinct from the anhydrate psilocybin that Compass already has eight patents for in the U.S., UK, Germany and Hong Kong. On Wednesday, the company announced results from an open-label study of psilocybin therapy for depression in cancer patients. According to the study, 50% of the subjects experienced remission in depression symptoms which was sustained for the eight-week follow-up period. The study broadened the scope of treatment beyond those patients with late-stage cancer and the COMP360 treatment was found to be generally well tolerated with no treatment-related serious adverse events. Even though the study wasn’t double blinded like the phase IIB clinical trial of COMP360 but provided positive signal for treatment in cancer patients. Compass’ shotgun approach is made possible by its market cap, hopefully it can control its progression to market without losing focus. Currently Compass trades at $35.31 per share with a market cap of $1.74 billion.

 

Numinus Wellness (NUMI.V) is a Vancouver-based psychedelics play which utilizes an integrated business model to add to psychedelic research while providing best-in-class therapeutic protocols across its clinics. The company provides ketamine-assisted psychotherapy for the treatment of depression while building protocols for the treatment of conditions such as anxiety, PTSD and Substance Use Disorders. Numinus practitioners include clinical counsellors and registered social workers who combine cultural and trauma sensitive therapies like Neurofeedback, Mindfullness-based, Somatic, Eye Movement Desensitization Reprocessing (EMDR), Acceptance and Commitment, Emotion-focused, Cognitive-Behavioral and Psychedelic. The company has partnered with Multidisciplinary Association for Psychedelic Studies (MAPS) for a single-arm, open-label, compassionate access trial for MDMA-assisted therapy for PTSD. Numinus has also partnered with Syreon Corporation to create a single-arm, open-label compassionate access trial of Psilocybin-Research Intervention with Motivational Enhancement (PRIME) for substance use disorders. The company announced at the beginning of the month that it expanded its psychedelics research facility with an additional lab and application for federal licensing. The new lab will be housed in an existing Numinus-leased building adjacent to the current lab. At the same time, the company’s research vertical and provider of contract services, Numinus Bioscience, submitted its application to Health Canada for a second Dealer’s license for an additional 7,500 square feet which would double Numinus’ research footprint. Completion of the facility is expected in Summer 2022. Payton Nyquvest, founder and CEO of Numinus is well-known business figure in the mental health care space. He brings more than 15 years of finance, investment and retail banking to his role and has raised more than $100 million for a variety of small cap companies. This a midrange-valued investment opportunity trading at $0.73 CAD per share for a market cap of $148.35 million. Do your due diligence!

Mynd Life Sciences (MYND.C) is a neuro-pharmaceutical drug development company based out of Vancouver, British Columbia. Founded in 2010 by Dr. Wilfred Jefferies and Dr. Lyle Oberg, Mynd’s mandate has been to improve mental health. Since that time, the company has been engaged in collaborative research with the world-renowned Michael Smith Laboratories at University of British Columbia to better understand the complex nature of the pathogenesis of selected neurological and psychiatric disorders and as a result, develop innovative technologies to assist clinical decisions. Their research has determined that a common denominator in the pathogenesis of several neurological and psychiatric disorders is the induction of neuroimflammation. Knowing this, the company holds 38 licenses to allow for research into 38 different analogues of psilocybin to determine which one is most effective in modulating the Human Mycogene and subsequent decrease in inflammatory and immune responses leading to a reduction in depressive symptoms. Wow, that was a mouthful, but I think you got the gist. For fear of paraphrasing too much, brain swelling and adverse immune response help cause some types of depression, so taking care of the swelling and immune response, you can deal with the depression. The company’s Human Mycogene Modulation program (HMM) is geared to treat neuropsychiatric disorders through the dosing of formulations of psilocybin. MYND has applied for a patent concerning their method of treatment depression. Back in the middle of October, the company announced it was going to participate in a Monash University (Australia) proposal for a $3.0 million clinical trial. The proposed project would include an adaptive dose finding single phase IIB clinical trial of the efficacy and safety of psilocybin-assisted therapy for patients with treatment-resistant depression. MYND’s diagnostics suite of proprietary biomarkers would be utilized to assess and then monitor blood indicators of trial subjects’ response, progress and any relapsing to the psilocybin administered during the trials. MYND is science from the word go and may have trouble communicating its story to the average investor due to esoteric lab speak, but I trust the science and look forward to the trial results. Currently the company trades at $0.90 per share with 45.93 million shares outstanding.

MindMed’s (MMED.NEO) Canadian headquarters are in Vancouver, BC, but the company operates internationally and trades on the Nasdaq, but since most readers viewing this piece are above the 49th parallel, I will stick to the NEO exchange for financial matters. MindMed is a psychedelic-inspired medicine opportunity with multiple generations of potential drug candidates derived from classic psychedelics. The company works with DMT, MDMA, psilocybin and LSD to optimize molecules and dosage forms and in later generations, create a structural analogue to the classic form. MindMed has filed 45-plus patent applications with that many molecules covered and 30-plus 3rd generation NCEs covered. They also have more than 10 patent applications covering LSD and three-plus patent applications covering 18-MC. Needless to say, this builds a strong IP value proposition as well as significantly moating the company’s position within the sector. There is a lot historical research backing the use of LSD in the treatment of anxiety, depression and alcohol use disorder that MindMed can build on to capitalized on the overlooked and undervalued psychedelic mental health solution. The company’s non-hallucinogenic, non-cardiotoxic congener of ibogaine, 18-MC, targets substance abuse disorders without the classical ibogaine “trip” as well as utilizing different mechanisms than existing therapies. MindMed’s pipeline is full to bursting with two candidates in pre-clinical stage, four candidates in phase 1 clinical studies, seven candidates in Phase IIA and one candidate in Phase IIB, treating indications such as substance use disorder, adult ADHD, chronic pain and major depressive disorder. With strong R&D collaborative agreements with the likes of MindShift Compounds, and nextage, MindMed is driving their pipelines into commercialization. MindMed’s value proposition also include a digital medicine component to provide early engagement & education, treatment session monitoring and longitudinal patient engagement. The digital platform will assess a wide range of data types including audio, text, behavioral, genomic, biological, mobile, smart watch, and partner integrations, creating an ecosystem that facilitates and optimizes the entire ecosystem. MindMed is quick to point out in its company literature that its digital platform pipeline mirrors its drug development segment so it will become an important value add to the company’s compound marketing. The company has a full basket and money, but it will require strong management to keep it on a steady course and ensure all its segments are in harmony and won’t pull the ship apart. Currently MindMed trades at $3.08 per share for a market cap of $1.4 billion.

Okay, that really was a trip, my fingers ache and my eyes are blurry, so I am going step away from the keyboard and call this one done. I am sure I have missed some companies on this inaugural run, so let me know who you think should be included in this weekly rundown and I will do my best to add them on the next segment. Do your due diligence, pick your winners, and heal the global mind. Good luck to all!

–Gaalen Engen

The post Loving the light fantastic – psychedelics sector in review appeared first on Equity.Guru.

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