Mr. Jared Stanley of DeFloria reports

DEFLORIA ANNOUNCES POSITIVE RESULTS FROM PHASE 1 TRIAL OF AJA001 BEING DEVELOPED FOR THE TREATMENT OF AUTISM SPECTRUM DISORDER (ASD)

DeFloria LLC, a joint venture between Ajna BioSciences and Charlotte's Web Holdings Inc., has released positive results from a phase 1 single ascending and multiple ascending dose trial of AJA001 in development for the treatment of symptoms of autism spectrum disorder (ASD) in a poster presentation at the 63rd Annual Meeting of the American College of Neuropsychopharmacology in Phoenix, Ariz. AJA001 is an orally delivered, multicannabinoid botanical drug product (BDP) designed to provide a broad therapeutic effect.

In a poster entitled, "A Single and Multiple Ascending Dose and Food Effect Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of AJA001, a Full-Spectrum Hemp-Derived Botanical Drug for Autism Spectrum Disorder," said Marcel O. Bonn-Miller, PhD, chief scientific officer at Charlotte's Web, and board member at DeFloria, presented the results from the recently completed phase 1 randomized, double-blind, placebo-controlled trial that evaluated the tolerability and pharmacokinetic (PK)/pharmacodynamic (PD) profile of several dose levels of AJA001 in 70 healthy volunteers ranging from 19 to 55 years.

Results demonstrated that AJA001 was well tolerated at doses up to 680 milligrams per day administered as a single dose and up to 660 mg per day administered twice a day. In both the single and multiple ascending dose portions of the trial, AJA001 displayed dose-proportional PK for CBD and THC that matched or exceeded the plasma concentrations of the comparable cannabinoid therapeutics dronabinol, nabiximols and Epidiolex. PK data following multiple dose administration of AJA001 showed minimal accumulation of CBD or THC after seven days.

AJA001's PD effects were shown to be dose dependent and correlated with peak plasma concentrations of THC and its active metabolite 11-OH-THC after administration of single doses. An analysis of participant responses on the Drug Effects Questionnaire (DEQ) demonstrated that the magnitude and time course of AJA001's subjective drug effects were moderate and transient in nature.

The safety, PK and PD findings support doses from 100 mg to 660 mg of AJA001 per day for phase 2 trials in children, adolescents and adults with ASD. This is equivalent to an upper limit of 395 mg CBD and 15 mg THC per day. The most common treatment emergent adverse events in the AJA001 treated groups were somnolence, anxiety, dizziness and headache. One serious adverse event was reported by a participant receiving 906.4 mg of AJA001 who reported anxiety that resolved by the next day with no sequalae.

A copy of the poster is available on the DeFloria website.

"We are extremely encouraged by these results from our phase 1 single and multiple ascending dose trial, which demonstrate that AJA001 is well tolerated across a range of doses and provides a favorable pharmacokinetic profile for both cannabidiol and tetrahydrocannabinol," said Dr. Bonn-Miller. "Importantly, the results from this trial inform the doses to be evaluated in upcoming phase 2 clinical trials of AJA001 in children, adolescents and adults with ASD."

"We are excited to present this important data and look forward to initiating two phase 2 trials of AJA001 in ASD in the second quarter of 2025," said Jared Stanley, chief executive officer of DeFloria. "Despite its prevalence, ASD remains a difficult condition to treat. Moreover, currently available treatments for ASD are not well tolerated, making patient compliance a challenge. DeFloria is committed to supporting the ASD community and developing AJA001 to treat the behavioural symptoms associated with ASD with a drug product that is designed to provide broad therapeutic efficacy."

About ASD

Approximately one in 36 children may have ASD (Maenner et. al 2023). ASD is characterized by core deficits in (1) social communication, (2) impaired reciprocal social interactions, and (3) restricted, repetitive and stereotyped patterns of behaviours or interests. Irritability, impulsivity and "temper tantrums" are common symptoms and contribute to high care-giver burden (Lecavalier et. al 2006).

About AJA-001

AJA001 oral solution is a botanical drug product (BDP) containing full spectrum hemp extract (FSHE) botanical drug substance (BDS) derived from cannabis sativa L proprietary CW1AS1 hemp cultivar. The primary cannabinoid is cannabidiol (CBD). As an innovative multicannabinoid formulation, it may provide broad therapeutic efficacy. Its full-spectrum composition has potential therapeutic applications across various medical conditions due to its varied mechanisms of action.

About DeFloria LLC

DeFloria, a collaboration between Charlotte's Web Inc., AJNA BioSciences PBC and British American Tobacco PLC (BAT), is on a mission to address crucial health care needs through groundbreaking innovations from multicompound drugs originating in nature. With a combined century of experience in regulatory, research and quality-controlled standardized manufacturing, DeFloria's ambitious endeavour aims to secure FDA (Food and Drug Administration) approval for a novel cutting-edge botanical drug developed from Charlotte's Web proprietary hemp genetics that targets a neurological condition identified by the DeFloria leadership and research teams.

We seek Safe Harbor.