Inside a 13,500-square-foot warehouse in Littleton, Colorado, Joel Stanley, one of the seven Stanley brothers known for popularizing CBD with their groundbreaking company Charlotte’s Web a decade ago, walks through a series of five isolated cultivation rooms where thousands of psychedelic mushrooms are being grown. Giant fruiting bodies of the potent fungi, which contain the mind-bending compound of psilocybin and other tryptamines, stand tall at his newest venture, the drug development company Ajna BioSciences.

Down the hall, a chemist in a white lab coat pours mushroom extract into silver cylinders to turn the tryptamine-rich liquid into a fine, eggshell-colored powder. While these magic mushrooms are known to induce an intense psychedelic experience, Ajna, which was founded in April 2021, is not growing them to expand people’s consciousness, but to develop what Stanley hopes to become a new billion-dollar, U.S. Food and Drug Administration-approved medicine for depression.

“We’re taking a pharmaceutical approach to nature,” says Stanley, Ajna’s 45-year-old CEO and founder. “Our entire process is totally organic, which means we could produce the first USDA-certified organic pharmaceutical.”

In another room, a chemist sitting next to a high-resolution mass spectrometer is working on identifying every molecule in Ajna’s frontrunner drug, codenamed AJA001— a botanical tincture of CBD and THC extracted from a patented strain of Charlotte’s Web hemp plants.

“We are mapping out the chemical structure to see every atom—I’m digging into the weeds,” she says, oblivious to her pun.

Ajna has raised a total of $11 million, about $4.5 million from the Stanley family, $5.5 million from Joel and other executives at his company, and the rest from early Charlotte’s Web investors, to develop a suite of botanical drugs from hemp, marijuana and psilocybin mushrooms. But Charlotte’s Web, which owns the intellectual property for AJA001, has licensed it to Joel’s brother Jared’s new company, DeFloria, to help Ajna get through the FDA approval process by raising $15 million from British American Tobacco. (DeFloria is a joint venture between Ajna, Charlotte’s Web and BAT.)

AJA001 is targeting what is arguably the central condition of the Make America Healthy Again era—autism, which now affects one in every 31 children and one in 45 adults. Jared Stanley, the 38-year-old CEO of DeFloria, says the autism drug is following the FDA’s botanical drug pathway, meaning it is wholly derived from the plant and not a synthetic single molecule drug, like most pharmaceuticals on the market.

Botanical drugs can be more difficult than single molecule drugs due to the sheer number of active compounds in plants. AJA001, for instance, contains 6,000 compounds. Currently, there are only four FDA-approved botanical drugs, including sinecatechins, a topical cream for genital warts made from green tea leaves and marketed as Veregen.

AJA001, which successfully passed Phase I of FDA clinical trials last summer, has been proven safe to use. In February, it was cleared to enter Phase II to study the drug’s efficacy and side effects—this is typically the second most difficult phase where only 33% of drugs make it through. If AJA001 makes it to Phase III, the most challenging part of the process with a bigger patient population to monitor adverse........

© Forbes