Awakn Life Sciences Corp. announced that it has successfully completed an investigative study to establish the dissociative effect of a proprietary and patent pending S-ketamine formulation, administered sublingually via an oral thin film ("OTF"). news builds on Awakn's announcement on December 20, 2023 of a global licensing agreement with LTS Lohmann Therapie-Systeme AG ("LTS"), a leading pharmaceutical technology company.

The agreement was for a proprietary and patents pending S-ketamine OTF, with global exclusivity in the treatment of Addiction, Anxiety Disorders, and Eating Disorders. LTS has successfully completed a Phase 1 ("Ph1") clinical trial and filed patents in the US and key international markets of China, Europe, and Japan for the S-ketamine OTF. Under the terms of the license, Awakn has secured access to this Ph1 data and patents thereby ensuring strong intellectual property protection and potential to rapidly progress to late clinical stage trials.

The mechanistic study, comprising 28 people who were harmful drinkers, investigated the impact of a single dose of the S- ketamine OTF on diss association and alcohol cravings. The S-ketamine OTF was well-tolerated by all participants, with no reports of serious adverse effects. The S-ketamineOTF exhibited significantly greater dissociative effects than placebo, which were of a magnitude observed with doses of intravenous racemic ketamine given in clinical treatment.

the S-ketamine O TF also demonstrated a statistically significant reduction in alcohol cravings in participants compared to placebo. Following the successful completion of the investigative study and the signing of the license agreement with LTS, Awakn is pleased to designate this program AWKN-002, S-ketamine OTF plus manualized relapse prevention cognitive behavioural therapy ("CBT") for AUD. AWKN-002 is focusing on the US market, with Awakn planning a pre-IND meeting with the U.S. Food and Drug Administration ("FDA") during the first half of 2024.

AWKN-002 will be complimented by Awakn's existing AWKN-001 program, intravenous ("IV") racemic ketamine plus manualized relapse prevention CBT for Severe AUD, which will now focus on the UK market only.