Ajna BioSciences is charting a bold course in the pharmaceutical industry by pushing full-spectrum botanical extracts through the FDA’s rigorous drug approval pathway.

With its lead candidate DeFloria now entering Phase 2 trials for autism spectrum disorder (ASD), the company is making the case that complex, natural compounds can meet pharmaceutical gold standards.

Discover Pharma had a long discussion with CEO Joel Stanley to discuss standardization, regulatory navigation, intellectual property strategy, and more.

Standardizing nature

“Our lead candidate, DeFloria, just received IND clearance to enter Phase 2 trials,” he explained. “That milestone meant proving we could produce a consistent, high-quality product, batch after batch.”

DeFloria is an oral cannabinoid formulation derived from the same genetics used in Charlotte’s Web, protected by a utility patent.

Ajna’s expertise spans 15+ years in breeding, seed supply, stabilized genetics, cultivation, harvesting, extraction, and manufacturing. “That whole process is covered by a method-of-use patent to reinforce CMC compliance,” Stanley added.

Their second candidate, AJA002, is a full-spectrum tryptamine formula from mushrooms. “Standardizing mushrooms starts with using the exact same genetics every time,” he said.

“Each mushroom has its own molecular fingerprint, so we tightly control cultivation. Mushrooms are actually easier than cannabis in some ways because we grow them indoors.”

Ajna employs rigorous extraction methods and high-end technology to ensure each product is standardized and characterized.

“This isn’t like supplement manufacturing. We identify and quantify all the molecules, both active and potentially toxic, to set precise specifications.”

Regulatory collaboration, not conflict

Despite being among the first to push full-spectrum botanicals through the FDA, Stanley said the regulatory journey has been smoother than expected. “I wouldn’t say we’ve encountered any major sticking points. Most FDA comments were expected and standard—around clinical trial design, for example.”

He praised the FDA’s Botanical Drug Guidance for its clarity, though admitted, “even high-level pharma veterans often don’t realize that this guidance exists.”

“It’s a challenging process, but it’s also a well-defined regulatory pathway,” the CEO said. “It’s not so much about friction points as it is about following a less familiar roadmap.”

DeFloria’s Phase 2 trials in autism

Ajna is now conducting two Phase 2 studies for DeFloria targeting ASD. One trial will be in the US with around 60 adolescents and adults. The other will be in Australia and enroll about 40 children and adolescents.

Both studies will evaluate safety, tolerability, and effectiveness over 12 weeks. Stanley said: “We’re looking at core ASD symptoms—irritability, social withdrawal, and stereotypic behaviors—as well as related symptoms and caregiver burden.”

Ajna is using the Aberrant Behavior Checklist (ABC), a validated scale used in trials for the only two FDA-approved ASD drugs. “The data from both studies will inform the design of our Phase 3 trials.”

Addressing skepticism in pharma

To critics who argue botanicals can’t match the consistency of synthetic drugs, Stanley points to regulatory success. “You don’t get FDA clearance for pediatric Phase 2 trials without meeting strict standards.”

He also cites growing acceptance of the ‘entourage effect’—the idea that cannabinoids and other plant molecules work better together. “When I first talked about this over 15 years ago, it was almost laughed at. Now it’s widely accepted,” he added.

Stanley believes that nature offers a level of molecular complexity that synthetic chemistry can’t match. “We evolved alongside these plant compounds. Nature is the original master of molecules.”

Patients, providers and plant-based trust

Many families already turn to unregulated supplements for autism support. “They’re self-medicating without provider oversight or insurance coverage,” Stanley said. “We want to change that by bringing these treatments through the FDA process.”

Physician trust hinges on evidence. “Once you complete FDA trials, physicians can rely on clinical data. That’s something current plant-based options like CBD or psilocybin largely lack.”

Stanley is optimistic that once natural drugs are backed by clinical data, both patients and doctors will embrace them. “If a natural drug is safer and effective, the medical community will lean into it. And patients will choose it too. We haven’t really had that choice in over a century.”

Scaling without sacrificing quality

Ajna’s manufacturing advantage stems in part from its Charlotte’s Web legacy. “We helped build that $50 million infrastructure from the ground up. It’s vertically integrated and follows some of the highest quality standards in the supplement space.”

That infrastructure gives DeFloria a head start. As for their mushroom-based AJA002 Stanley said: “Scaling mushrooms is actually relatively easy. They grow indoors under controlled conditions.”

But he knows future botanical drugs will vary. “Every plant, root or tree brings unique scale-up challenges. But we’re ready for that.”

Patenting the unpatentable? Think again

“I disagree that botanicals are hard to patent,” he said. “Our lead candidate is protected by a plant variety patent. I actually invented the genetics back at Charlotte’s Web, which earned the first-ever plant variety patent for cannabis.”

Ajna protects extraction methods with process patents and relies on the inherent complexity of botanicals as a competitive moat. “A single-molecule drug can be easily copied. But try replicating a many-molecule botanical drug to FDA standards? Nearly impossible.”

The company says that botanical IP protection offers longer commercial viability. Stanley added: “Our counsel believes generics are unlikely. There’s no cliff like with conventional drugs. If your drug works, people stick with it.”

Managing drug interactions

Though full-spectrum products contain dozens of active molecules, he insists their approach to safety is robust. “Drug interaction studies are a core part of any development program—ours included.”

Each molecule’s role is carefully assessed. “We identify every active and potentially toxic compound. We know what to monitor. It’s not just about avoiding side effects, but understanding therapeutic synergy.”

Looking ahead

With DeFloria in Phase 2 and AJA002 following closely, Stanley believes botanical medicine is on the cusp of legitimacy. “The tide is turning. We’re combining the best of nature with the rigor of pharma.”

For a sector long dismissed as fringe, Ajna’s success signals a shift. “We’re not just proving that full-spectrum botanicals can meet FDA standards. We’re proving that they can do it better.”