AWAKN earns their Nutt; ATAI adds Kratom; a Legal primer for psychedelic co's; Champignon Wounded

Jul 15, 2020

“AWAKN Life Sciences Inc. ("AWAKN") is pleased to announce the appointment of Professor David Nutt as Chairman of its newly formed Scientific Advisory Board (SAB).”

It is challenging to size up a new entrant to a new sector.

There are signals that day-traders look for, there are signals that cautiously optimistic activists and advocates look for, there are signals that patients, therapists, and clinicians look for, there are signals that long term investors look for. There are signals that obsessive, one-track-mind bloggers look for :)

A useful signal is a company's Scientific Advisory Board (SAB). A few weeks ago, I was curious about the role of the SAB and came across this document from MIT from 2004. It is a helpful primer on this aspect of Life Science companies and.

A cynical take on the SAB is that they are merely optics since such boards have no fiduciary obligation, decision-making power, or liability.

An optimistic take is that the SAB, when comprised of experts in the company's field, offers invaluable insight, advice, and guidance on strategy— in addition to the cachet of association with leaders of a field.

Another feature of evaluating a new entrant is the stated strategy.

Some entrants are tightly focused on one domain, i.e., manufacturing, drug discovery, drug development, therapist training, etc.

On the other hand, we have entrants who are diversifying through developing consumer products, cultivation, and pharmaceutical development. A strategy that tries to reap both Golden Goose pharmaceutical returns and a place at the table assuming its only a matter of time before the domino of cannabis legalization reaches psychedelics.

AWAKN is diversifying through a different set of integrated problems around the Last Mile Problem of psychedelic medicine:

Clinical Research
Clinic Infrastructure
Therapist Training.

The nature of psychedelics requires specialized handling of all three.

Study Design, including blinding and outcome measures, are challenging in psychiatry and mental health, to begin with, adding in the unique features of the psychedelic experience, adds even more complexity. If AWAKN's research division intends to operate as CRO (Contract Research Organization) servicing other psychedelic drug developers, the association with Ben Sessa and David Nutt will be incredibly useful.

AWAKN marked their arrival a few weeks ago with the acquisition of Dr. Sessa's clinic and his appointment as CMO. Having been involved with MAPS' MDMA trials gives Dr. Sessa a unique perspective into both the management of clinical trials as well as the future psychedelic clinic.

“ATAI Life Sciences AG, a global biotechnology company builder that envisions an end to mental illnesses, has acquired a majority stake in New York-based pharmaceutical company Kures, which targets the important intersection between pain and opioid use disorder.”

Endpoints News has a nice piece about the Kures' story and founder Andrew Kruegel, including the FDA's attempt to reschedule Kratom, which lead to the formation of the company.

“The DEA, though, saw the “opioid-like” properties and, citing an “imminent threat to public safety,” announced on August 30, 2016, that in a month, they would make it a Schedule 1 drug, the same classification as LSD, heroin and marijuana…The DEA reversed course in October, even as new FDA chief Scott Gottlieb took the mantle, repeatedly calling to regulate what he saw as a dangerous opioid with no proven benefit.
Before the controversy, Kruegel thought only a few internet enthusiasts knew about the drug; the outpouring from kratom users surprised him. It also gave him an idea: If the plant was helping so many patients with opioid abuse or pain, why not turn its main ingredient into a drug for a country desperate for alternatives to oxycontin and its opiate cousins?”

It is not clear if the DEA will revisit the possibility of scheduling Kratom as an illegal drug. This piece from U.S. Pharmacist gives a good overview of the situation.

However, this got me thinking about the opportunity for a natural experiment of sorts. Kratom offers a chance to observe both personal use and scientific study without the constraints of prohibition.

The prohibition against psychedelics and cannabis forced researchers to jump through bureaucratic hoops to conduct research, slowing the process and making it more expensive.

On the other side are individuals who, for various reasons, seek out the experiences and effects of psychedelics and other drugs are forced to go through illegal routes to obtain them, subjecting themselves to 1. uncertainty of the product and 2. possibility of legal repercussions.

Kratom offers an opportunity for both consumers to legally obtain the substance and scientists to conduct research without red tape, particularly around the following:

The 'BigPharma-skeptic' in me wonders if pharma lobbying groups will oppose rescheduling until it has been developed into a drug and then reverse course.
I assume that Kratom is regulated more like coffee than cannabis—what effects does this have on the market, quality of the product, price, access?
How would such regulation affect the investment into this market?
Are there lessons that we can take for Decriminalization and Legalization measures for psychedelics?

Furthermore, and a bit of a tangent, but while I am thinking about it—how does ATAI, MindMed, COMPASS, etc. react to measures like Oregon's IP-34? Will there by active opposition to such measures as they presumably pop up in other states and jurisdictions?

Legal and Regulatory Landscape for Psychedelics Companies Considering "Going Public" in Canada

A nice high-level overview of the regulatory and legal forces acting on the psychedelic sector, from the perspective of Canadian law.

Generally speaking, from our perspective, companies in the sector can be broadly divided as operating in one or a combination of four market segments, namely:
Pharmaceutical – the activities of these companies include research and development activities, clinical trials and other similar activities with both hallucinogenic and non-hallucinogenic compounds and their delivery systems;
Clinic or treatment centres – the activities of these companies include the treatment of various conditions, including mental illness and addiction, in a clinical, treatment centre or wellness centre setting;
Nutraceutical/wellness products – the activities of these companies include the development and formulation of various nutraceutical or wellness products using non-psychoactive substances; and
Medical tourism/recreational usage – the activities of these companies include medical tourism activities, such as microdosing psilocybin, and recreational usage, such as truffles, in jurisdictions where such activities are legal.

The legal and regulatory restrictions that many of the non-pharmaceutical companies are betting on being lifted or changed come from:

(i) a successful court challenge under Section 7 of the Charter of Rights and Freedoms, (ii) a broader exemption under Section 56 of the CDSA for medical or scientific purposes, (iii) an exemption otherwise being in the public interest or on human rights grounds, (iv) through approvals granted by Health Canada under existing regulatory processes, or (v) enactment of legislation.

Champignon Wounded

From a recent press release:

“The Company continues to work with the British Columbia Securities Commission (the “Commission”) to complete its continuous disclosure review…
The Company also clarifies that its previously announced intention to undertake a corporate rebranding, and to change its name did not result from any specific transaction undertaken by the Company. At this time, the board of directors has resolved not to proceed with the corporate rebranding and name change…
The Company announces that the term sheet entered into with the Wellness Clinic of Orange County Inc. has been terminated, and the Company will not be proceeding with the proposed transaction at this time…
A BAR in connection with the acquisition of AltMed would otherwise be due on July 13, 2020, based on the timeframe prescribed by National Instrument 51-102 (Continuous Disclosure Obligations), and is now expected to be filed no later than August 27, 2020.”