Joel Stanley Shares Vision Behind Ajna’s Full-Spectrum Natural Psilocybin

Joel Stanley is co-founder and CEO of Ajna Biosciences, a botanical drug development company focused on full-spectrum cannabinoid and natural psychedelic options for mental health and neurological disorders. He is also former CEO and Chairman of the Board at Charlotte’s Web, international producer of botanical CBD and other hemp-based products.

Ajna is currently pursuing FDA approval for two new botanical drugs: a full-spectrum cannabinoid formulation for autism spectrum disorder (in partnership with Charlotte’s Web), and a full-spectrum psilocybin formulation for generalized anxiety disorder. Stanley recently shared some of the vision behind these drugs, the advantages of full-spectrum botanicals, and his viewpoints on the rapidly expanding gray market for psilocybin.


How would you describe your psilocybin formulation? What is it? What’s in it?

One of the easiest ways is to explain what it’s not: First, it’s not synthesized, and it’s not a single molecule. Most of the drugs that go to the FDA, including psilocybin, are a synthetic single molecule. And often they are isolated from a botanical source. Morphine is a great example, it was isolated from poppies. Methadone, meanwhile, is a synthetic version of an opioid. So our formulation is neither one of those things. It is a botanical drug. In order to be a botanical drug, we can’t deviate far from nature. We can extract it, but the more you try to purify it and get rid of other botanical compounds besides psilocybin or tryptamines, the further it gets from being what the FDA calls a botanical drug.

So, our formulation is standardized, cultivated mushrooms that we’ve bred and is our genetic IP. It’s highly standardized in our cultivation process, and then from there it goes into its extraction process. What we end up with is an extract that many people would call an API (active pharmaceutical ingredient) in the conventional drug realm. But for our regulatory pathway, it’s called a BDS (botanical drug substance), which is the same thing as API, it’s just different regulatory pathways. Then from that BDS we have optionality. We can go into different delivery systems, sublingual, transdermal, topical, injectable, nasal, inhalable, all these different systems. Ours will go into an oral format, either a capsule or gelcap.

As far as the specific mushrooms you’re using, your IP, did you breed your variety specifically for microdosing?

Great question. So, if you’re familiar with the story of Charlotte’s Web — and the CBD genetics we developed to treat Charlotte Figi’s epilepsy — Charlotte’s Web is really the only botanical supplement standardized to this level. Our psilocybin microdose drug will follow that same path. Back then we bred cannabis genetics that were high in CBD. In this case we have chosen and bred a specific phenotypic variety of mushroom to have a well-rounded tryptamine profile. Just like in those days when there were like 30 people in the world who could pronounce cannabidiol, and no one knew what it was going to be good for outside of a few research papers, psilocybin mushrooms and its various tryptamines are going to exist in that same area for a while. So we went for a well-rounded tryptamine profile, not just high psilocybin, with the very simple knowledge that these mushrooms have proven to be therapeutic and efficacious for people for a very, very long time. We know this. So we’re going for this natural version that has tryptamines that we know cross the blood-brain barrier, that have some level of entourage effect. And yet none of this has been proven. Back in the day we were laughed at for using the term entourage effect, and many researchers would say, “Yeah, nothing there.” Now it’s commonly accepted that with cannabinoid medicines that the full-spectrum botanic has advantages and certainly operates very differently. So we started with the belief that psilocybin is going to have the same. And in the end, when this is FDA approved, we want people to have access to a true ancient botanical representation covered by insurance not just the synthetics and the single molecule.

The FDA-approval pathway you’re pursuing is a microdose formulation to treat generalized anxiety disorder. Do you believe the same drug could be used effectively at macrodose levels and for other indications?

Absolutely. We can add additional indications once it’s approved for one indication. These drugs are always on a Phase 4 clinical trial forever. Physicians may prescribe off-label for lots of other things that psilocybin is anecdotally shown to work for. Then we can use that data to go back for more Phase 3 clinical trials to add indications with the FDA. The diversity of these drugs is fantastic for us, just beautiful. Once we’ve made it through the hardest part — characterization, chemical formulation, proving it’s reproducible, that it’s pharmaceutical grade — why wouldn’t we look at higher-dose formulations to offer people the opportunity to have psychedelic-assisted therapy with a natural botanical version of the drug?

With psilocybin decriminalization expanding across the country, are you concerned about the quality of mushrooms and mushroom products that are hitting the gray market?

Yes and no. There’s two sides to this for me. I’ve aligned my heart and mind on this. I’m one of those people who risked everything to make medicine for people. I’ve been through some hardships because of that with cannabis. So I believe in the hearts of a lot of people doing clandestine stuff to make medicine for people, medicines that have been prohibited for so long. They have my heart. I just hope they’re using high levels of quality control.

But this sort of gets to why I started Ajna. Why am I doing this? Because I also started the world’s most-recognized and largest-market share CBD company, which was really Ground Zero for CBD. Yet, it doesn’t help a fraction of the people that it could help. Instead, the single-molecule CBD drug that came five years later — which I believe is inferior to the full-spectrum Charlotte’s Web in some ways — reaches thousands and thousands of people with treatable disease states, but it’s only one option. The years we spent on our formulation for Charlotte Figi taught us how to bring a full-spectrum botanical drug through the FDA. This opens the door for physician advocacy and insurance coverage for many. It’s the same with psilocybin. It’s a longer R&D process, it’s capital-intensive, it’s expensive. But at the end of the day, this is the way to reach more people, to improve access for our grandmothers and other folks who would never do this in a clandestine or nonmedical way.

As far as clandestine product makers, many are cultivating real mushrooms. But many are also using 4-AcO-DMT in edibles and marketing it as psilocybin. Do you see this as a problem that’s equivalent to single-molecule CBD being marketed as — or confused with — botanical CBD?

I am in favor of the passionate hobby mycologists that are providing for friends and neighbors, I’ve been one, but the uneducated and unscrupulous players stand to harm the movement.

It’s just like the people who since the beginning of cannabis legalization have gone for the maximum intoxicating dose of, first, THC and then Delta-8. It’s purely a money grab. It’s not about helping people. And these greed-driven gray market people give us all a black eye. It saddens me, but let’s face it: Dietary supplements have also had scandalous ingredients that weren’t identified in their product because they knew they weren’t going to get caught. People are going to do that with psychedelics, and it’s very unfortunate. Hopefully people don’t get hurt.

This problem seems likely to grow as more cities and states decriminalize. Do you feel it’s a race now to get a botanical drug like yours to market as soon as possible — before people do get hurt?

So that’s why I am a fan of the state-regulated markets coming online in Oregon and Colorado. Just like how cannabis now comes with pesticide, herbicide, microbiological residual solvent testing through the dispensaries, it’s a much safer thing now than the black market. The rules in Oregon and Colorado will help make it safer.

But at the same time, if gray market psychedelics do end up hurting more people and giving this industry more of a black eye, then that will hurt the nonmedical regulated markets much more than the medical markets. In fact, it would actually be an incentive for federal regulators to work with us to get something good for the people who need it, so that they’re not out there trying products that might hurt them. It’s not what we want, of course, but the spread of potentially dangerous products could help to make a stronger case to get psilocybin drugs through the FDA process.