Akili reports Q3 revenue $702,000, consensus $22,000

“We are pleased with early results of our previously-announced strategic shift from a prescription to a non-prescription business model focused on EndeavorOTC. It’s clear that there is strong demand from individuals struggling with ADHD, and that they are actively seeking new treatment options. Our direct-to-consumer strategy removes accessibility barriers to this clinically-validated treatment,” said Matt Franklin, CEO of Akili. “We’ve submitted EndeavorOTC for FDA review and authorization as an over-the-counter medical product in the adult ADHD market, and anticipate that these business model changes combined with our new direct-to-consumer marketing efforts will accelerate the path to profitability.” With respect to Akili’s ongoing partnership with Shionogi, the Phase 3 study for pediatric ADHD in Japan, which includes both a randomized phase and a longer term follow-up phase, is expected to be complete by the end of the first quarter of 2024. Shionogi plans to submit the results of this trial for regulatory approval to Japan’s Pharmaceuticals and Medical Devices Agency in 2024.