May 9 2018
Akili Interactive ("Akili" or "Company"), a leading prescription digital medicine company developing novel treatments for cognitive dysfunction, today announced that it has successfully closed a $55 million Series C financing led by Temasek. Other participating institutional and strategic investors included Baillie Gifford, Amgen Ventures, M Ventures (the CVC fund of Merck KGaA, Darmstadt, Germany), JAZZ Venture Partners, Canepa Advanced Healthcare Fund, and Brooklands Capital Strategies.
The financing follows the positive top-line results in December 2017 from Akili's multicenter, randomized, controlled pivotal study of AKL-T01, the Company's flagship investigational product designed to treat pediatric attention deficit/hyperactivity disorder (ADHD). Akili is planning to file AKL-T01 for clearance by the U.S. Food and Drug Administration (FDA) in the coming months, which would enable it to be prescribed by physicians as a stand-alone treatment for children and adolescents with ADHD. If approved, AKL-T01 would be the first prescription digital treatment for pediatric ADHD.
AKL-T01 is one of several product candidates across Akili's pipeline that employs the Company's patented technology platform. Proceeds from the financing will be used to advance Akili's pipeline of prescription digital treatment candidates, including AKL-T01, through key regulatory milestones and to prepare for commercial launch. The funds will also be used to advance product candidates in depression and multiple sclerosis (MS) to potential registration trials and to broaden the Company's product pipeline.
"We are fortunate to be supported by such experienced investors, who bring successful long-term track records in innovative technology, medical device and pharmaceutical investment," said Eddie Martucci, Ph.D., Akili's co-founder and CEO. "We are thrilled with the vote of confidence in the potential of our technology platform to redefine healthcare, and we're excited about the progress we continue to make towards turning that vision into a reality for patients."
In addition to filing lead product candidate AKL-T01 with FDA, Akili anticipates a number of significant clinical milestones this year across several products in development. Study results from a pilot randomized controlled trial (RCT) evaluating AKL-T02 in high-functioning children with autism spectrum disorders (ASD), are slated to be presented at the International Meeting for Autism Research (IMFAR) in May. The company also expects results this year from a Phase 2 study of AKL-T03 for the treatment of cognitive dysfunction in adults with depression, and a pilot RCT for the treatment of cognitive dysfunction in MS. In April 2018, Akili announced it had been granted patents in the United States and Japan, protecting the foundational mechanics of these products and the underlying product platform targeting frontal cognitive dysfunction.