Strategy Analysis: Numinus & Field Trip; Oregon's Measure 109 Faces Opposition; Mithoefers Join AWAKN SAB; MindMed to study Psilocybin

Numinus & Field Trip: A Tale of Two Strategies

Announcements from Numinus and Field Trip highlight two different approaches and two different challenges.

Field Trip Announces First Development Candidate:

“Field Trip Psychedelics Inc…successfully completed GLP (Good Laboratory Practices) synthesis of its first molecule in development, FT-104…

Preliminary assessment from in-vitro and in-vivo tests confirms the activity of FT-104 at the 5HT2A receptor, which is believed to be responsible for psychedelic experiences…

It was selected as Field Trip's first drug candidate because it meets the criteria established by the Company for its drug development strategy in terms of differentiation, availability of intellectual property protection, and suitability for the intended condition it is being developed to treat.”

Numinus Cultivates 7,000 Square Feet of Psilocybe Mushrooms:

“Numinus…has begun cultivating Psilocybe mushrooms, for the purpose of psilocybin production, at its 7000 square-foot Health Canada licensed facility…

Under its Health Canada license for the production and extraction of psilocybin from mushrooms, Numinus intends to cultivate and harvest the mushrooms for a variety of purposes including:

• development of standardized extraction methods

• exploration of product formulations of naturally occurring psilocybin

• development and evaluation of qualitative and quantitative mycochemicals standardized test methodologies

• exploration of the ability to investigate naturally occurring psilocybin’s efficacy as an alternative supply to synthetic psilocybin currently used in research

• ultimately, the delivery of safe, evidence-based psilocybin-assisted psychotherapy at clinics including its own…

Numinus’ vertically integrated ecosystem positions the Company to be a first-in-market, trusted leader in the delivery of psychedelic-assisted psychotherapies when regulated.” (emphasis added)

Choose your Gauntlet

Drug development is no walk in the park and neither is restructuring the legislative landscape.

Psychedelic pharmaceuticals present a compelling opportunity in the face of stagnant psychiatric pharmaceuticals: very promising early research, virtually non-existent toxicity, long history of human use, huge unmet need, and a media that will take care of the marketing.

Field Trip is embarking on a journey of second-generation psychedelic drug development in which a new molecule doesn’t come with a longstanding ‘data set’ of religious/therapeutic/recreational human use and previous research. This presumably increases the risk on the one hand but the potential for innovation and a more robust patent strategy on the other.

This aspect of the Field Trip strategy is essentially traditional drug development and has assembled a board and advisors with this strategy in mind. Members include Michael Ehlers formerly of Biogen, Helen Boudreau formerly of Novartis and Pfizer, and Dieter Weinand the past CEO of Bayer.

Numinus, on the other hand, is taking a different approach and preparing for, and assisting in the development of a regulatory landscape that allows for the federally sanctioned administration of psilocybin therapy.

Such a regulatory framework requires a ton of details to iron out including what are essentially Risk Evaluation and Mitigation Strategies—who can receive treatment? Who can administer treatment? In what context and setting? With what level of preparation, integration, and monitoring? With what oversight? With products from where? How were they sourced? Extracted… the list goes on.

Numinus intends to be the platform that enables and delivers federally regulated psychedelic therapies and the development of naturally sourced, pharmaceutical-grade psilocybin.

Michael Tan, Chief Operating Officer:

“We envision a day when the option of natural, plant-based psilocybin is available for use in therapies at Numinus Clinics and by others, and this is a tangible step towards that goal.”

Shots Fired: American Psychiatric Association Opposes Measure 109

Saul Levin, CEO, and president of the American Psychiatric Association (APA) wrote to the Oregon Secretary of State denouncing Measure 109:

“On behalf of the American Psychiatric Association, a national medical specialty society representing more than 38,800 psychiatric physicians, as well as their patients and families, we write with concern about Measure 109. If passed, Measure 109 would allow for the manufacturing, delivery, and administration of psilocybin for the treatment of mental health conditions…

As medical experts in psychiatric care, we are concerned about determining medical treatment by ballot initiative. Such treatment should be evidence-based and determined solely by professional standards of care. Science does not yet indicate that psilocybin is a safe medical treatment for mental health conditions…

Given our limited understanding of psilocybin’s effects on patients and how it may interact with other medications, it is dangerous to allow practitioners – especially those with no medical training – to dispense a controlled substance.”

Here we go…

Friday’s post will be a deep dive into this debate.

Mithoefers Join AWAKN's Scientific Board

“AWAKN Life Sciences Inc. is pleased to announce the appointment of Dr. Michael Mithoefer and Ann Mithoefer to its Scientific Advisory Board (SAB).”

AWAKN is the rare psychedelic company not developing treatments, novel IP or cultivating natural sources. Rather, they are preparing to train therapists, offer treatment, and serve as a clinical research site.

AWAKN is assembling the OGs of psychedelic research with David Nutt, Ben Sessa, and now Ann and Michael Mithoefer.

This announcement incited two thoughts:

• There are many third-party sites conducting Phase II and III trials for MAPS, Usona, and COMPASS. How many of these sites might be able to pivot into full-fledged psychedelic clinics in the AWAKN model of offering treatment and therapist training as well? I would think that the research component would be the hardest to implement and since these sites across Europe and North America have already been doing this, adding training and ketamine treatments would be a low barrier to entry, no?

• COMPASS highlights “Centers of Excellence” as a key component of their strategy. Will these centers be restricted to academic and university-affiliated institutions or could outfits like AWAKN, Numinus, Field Trip, and others qualify? Would they want to?

MindMed adds Psilocybin Project to Portfolio

“Mind Medicine has collaborated with the University Hospital Basel's Liechti Lab in a study to compare the altered states of consciousness induced by psilocybin, an active ingredient found in species of mushrooms and hallucinogenic drug, Lysergic acid diethylamide (LSD). The study is anticipated to conclude in Q2 2021.

As part of the agreement, MindMed will retain exclusive license to all IP and any patents related data or findings from the study.”

News, Events, and Resources

Psychedelic Medicine Association

“The Psychedelic Medicine Association is a society of physicians, therapists, and health care professionals looking to advance their education on the therapeutic uses of psychedelic medicines.”

Psychedelic Patent Tracker

Psilocybin Alpha and patent attorney Graham Pechenik collaborated to create a database for psychedelic patents:

“we’ve pulled together all of the psilocybin-related patents and published patent applications that were filed in the U.S. or that later may be filed in the U.S. and become a U.S. patent (as discussed in further detail here). These start with Albert Hoffmann’s Sandoz patents from 1958 and ‘59, and go up through the most recent applications to publish.

Neuly.com the Psychedelic Industry Database

“Transparent information for entrepreneurs, investors, researchers, scientists, educators, policy makers, and anyone interested in the psychedelic industry.”

Denver Mushroom Dealer Pleads Guilty in Federal Court

“A Denver mushroom dealer who got busted by the feds after describing his business in multiple news articles last year has pleaded guilty in federal court to selling psychedelic mushrooms.”

Thanks for reading, see you next time.

Zach